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Raleigh pharma raising $122M to prep for potential commercialization

A Raleigh company developing a COPD treatment is raising more than $100 million as it moves closer to seeking regulatory approval......»»

Category: topSource: bizjournalsAug 14th, 2022

Spero (SPRO) Skyrockets 168% on Licensing Deal With GSK

The exclusive licensing agreement with GSK will fund Spero's (SPRO) existing operations and extend its current cash runway beyond 2024. Shares of Spero Therapeutics SPRO surged 168% after it announced an exclusive license agreement with GSK GSK for its experimental antibiotic candidate, tebipenem HBr.Tebipenem HBr is being developed to treat complicated urinary tract infection (“cUTI”), including pyelonephritis, caused by specific microorganisms in adult patients with limited treatment options.Per the terms of the agreement, Spero will receive an upfront payment of $66 million from GSK to grant the latter exclusive development and commercialization rights to the medicine. GSK will have the right to market the drug in all territories except Japan and certain other Asian countries. While Spero will be responsible for the follow-up late-stage study evaluating tebipenem HBr, GSK will be responsible for additional clinical development on the candidate and bear the costs for regulatory submissions and commercialization activities. In addition, GSK will also invest $9 million in Spero’s common stock. However, GSK will not hold more than a 20% equity stake in SPRO.Spero does not have any marketed drugs in its portfolio. A partnership with a pharma giant like GSK, which has huge cash resources and industry expertise and a global commercial presence, will help SPRO fund its other pipeline candidates currently undergoing clinical development. Following the deal with GSK, Spero expects that its current cash runway will be sufficient to fund its operations beyond 2024.Spero will also be eligible to receive potential milestone payments from GSK. The company will also be eligible to receive tiered royalties on net product sales if the candidate is approved.In the year so far, shares of Spero Therapeutics have plunged 86.3% compared with the industry’s 26.8% fall.Image Source: Zacks Investment ResearchIn June, Spero received a complete response letter (CRL) from the FDA for an NDA seeking approval for tebipenem HBr to treat adult patients with certain bacterial microorganisms that cause cUTI, including pyelonephritis. In the CRL, the regulatory body concluded that the data from the phase III ADAPT-PO study was insufficient to support approval during the prior review cycle.This month, Spero announced that it achieved common ground with the FDA on the regulatory path forward for tebipenem HBr in cUTI. The regulatory body indicated that positive results from a single additional phase III study, supported by confirmatory nonclinical evidence of efficacy, could be sufficient to back the approval of tebipenem HBr for treating cUTI, including pyelonephritis for a limited use indication.SPRO also reached alignment with the FDA on key components of the proposed pivotal phase III study design. Management intends to start this study next year.The successful development of the candidate will be a significant boost for a clinical-stage biopharmaceutical company like SPRO. If approved, tebipenem HBr will be the first oral carbapenem antibiotic in the United States.The meeting was also conducted to discuss the steps required to resubmit the new drug application (NDA) for tebipenem HBr to treat cUTI, including pyelonephritis.While tebipenem HBr is Spero’s most advanced pipeline candidate, the company is also evaluating other pipeline candidates. SPRO is also developing SPR720 as a novel oral therapy product candidate for treating a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.The company has an IV-administered next-generation polymyxin product candidate, SPR206, in its pipeline being developed to treat multi-drug resistant Gram-negative infections in the hospital setting.The development of SPR206 is supported by funding from the National Institute of Allergy and Infectious Diseases. Spero also has a license agreement with Pfizer PFE for the same.Pfizer previously announced a $40-million equity investment in Spero. Per the terms, Pfizer has the right to develop, manufacture and commercialize SPR206 in ex-U.S. and ex-Asia territories. In lieu, Spero is eligible to receive up to $80 million in development and sales milestone payments and high single-digit to low double-digit royalties on net sales of SPR206 in these territories.In July, SPRO achieved a regulatory milestone under its license agreement with Pfizer, which will earn it a $5-million milestone payment expected in the third quarter of 2022.Spero Therapeutics, Inc. Price  Spero Therapeutics, Inc. price | Spero Therapeutics, Inc. Quote Zacks Rank & Stock to ConsiderSpero Therapeutics currently carries a Zacks Rank #2 (Buy).A better-ranked stock in the overall healthcare sector is Morphic MORF, which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.80. Loss estimates for 2023 have narrowed from $3.91 to $3.62 during the same period. Shares of Morphic have lost 43.3% in the year-to-date period.Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%. Zacks Names "Single Best Pick to Double" From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all. It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time. This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.Free: See Our Top Stock And 4 Runners UpWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Spero Therapeutics, Inc. (SPRO): Free Stock Analysis Report Morphic Holding, Inc. (MORF): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksSep 23rd, 2022

Transcript: Lynn Martin

   The transcript from this week’s, MiB: Lynn Martin, President of the NYSE, is below. You can stream and download our full conversation, including the podcast extras on iTunes, Spotify, Stitcher, Google, and Acast. All of our earlier podcasts on your favorite pod hosts can be found here. ~~~ BARRY RITHOLTZ, HOST, MASTERS IN… Read More The post Transcript: Lynn Martin appeared first on The Big Picture.    The transcript from this week’s, MiB: Lynn Martin, President of the NYSE, is below. You can stream and download our full conversation, including the podcast extras on iTunes, Spotify, Stitcher, Google, and Acast. All of our earlier podcasts on your favorite pod hosts can be found here. ~~~ BARRY RITHOLTZ, HOST, MASTERS IN BUSINESS: I’m Barry Ritholtz. You’re listening to Masters in Business on Bloomberg Radio. My extra special guest this week is Lynn Martin. She is the president of the New York Stock Exchange, the world’s largest, with over 2,400 listed companies for a combined market cap of about $36 trillion. She is also chair of the fixed income and data services at ICE, Intercontinental Exchange. She began her career at IBM in Global Services and came to them with a BS in Computer Science and a master’s degree in Stats from Columbia. Lynn Martin, welcome to Bloomberg. LYNN MARTIN, 68TH PRESIDENT OF NYSE GROUP: Thanks so much for having me. RITHOLTZ: Thanks so much for joining us. I have so many things to ask you about, but I have to start out with you were at IBM pretty much in its heyday. Tell us what that experience was like. MARTIN: It was great. I’m going to date myself a little bit. RITHOLTZ: Yeah. MARTIN: But I was there through the Y2K crisis — RITHOLTZ: Right. MARTIN: — when global services was relied upon by customers around the globe to get them through that crisis. RITHOLTZ: Or near crisis, or almost crisis. Was it a crisis? MARTIN: Almost crisis. It wasn’t. That’s fair. It wasn’t a crisis, and that I remember waking up on New Year’s Eve 1999, I’m going to work in a call center because that’s what you do in your 20s, working at IBM. And we were watching the Australia open, the clocks hitting in Australia and everything was fine. RITHOLTZ: Right. MARTIN: And we sort of knew that once Australia opened okay, we were going to be okay. RITHOLTZ: So was this like a near miss, or was this, hey, a lot was made about something that turned out to be less of a — MARTIN: I think the industry became very well prepared. I don’t know that it was a near miss, but I think we got ahead of a potential challenge. There was a technical challenge and that computers only understood years in two digits as opposed to four digits. So 2000 could have been 1900, and that could have caused challenges. I don’t know if those challenges would have been as extreme as was forecasted or not, but I’m really glad we didn’t find out. RITHOLTZ: Yeah. To say the very least. So IBM, I’m sort of jumping ahead in the story, you began your career in Computer Science is coding on a Commodore 64. Would you like to explain that for the youth who don’t know what a Commodore 64 is? MARTIN: So I remember when I came home from elementary school one day, and my dad who was an electrical engineer, he used to design fuel gauges on airplanes, came home with this huge box. And it was a Commodore 64. I said, “What’s that?” He said, “The first home computer.” And I said, “What’s that?” And I was a kid, I had no idea. And he also brought home a stack of floppy discs, which were quite large for the youth that don’t remember. RITHOLTZ: They were literally floppy. They’re not like — MARTIN: They were floppy. You could bend them, twist them, whatever the case may be. RITHOLTZ: Right. Though you shouldn’t. MARTIN: Though you shouldn’t because your program would not work if you did that. And I just became hooked on it. And as any good kid does, you become hooked on video games first. So that’s really what got me into the Commodore 64. RITHOLTZ: So is that what led to a focus on data service and computer science, the simple C64? MARTIN: Well, what really led me in the path of studying for my undergrad was my dad giving me really good advice, which was way ahead of its time in the early ‘90s when I was applying to college, where he suggested I not go into the traditional engineering discipline, but instead go into computer science mainly because not only was I good at math and good at sciences, but he said there were always be opportunities for women in computer science. RITHOLTZ: That’s interesting. MARTIN: And it’s something that was just way ahead of its time and it sounded good to a 17-year-old filling out a bunch of college essays at the kitchen table. So I ticked off computer science despite, you know, not having a tremendous amount of experience with a computer aside from playing with video games and fiddling around more as a hobby than anything. RITHOLTZ: And now, you oversee a system that is a combination of advanced data systems, lots of hardware and software plumbing. You have to keep 2,400 listed companies up and running, trading as much as a billion shares a day. MARTIN: Yeah. RITHOLTZ: How do you go from the Commodore 64 to that? MARTIN: Fortunately, technology has been significantly advanced. And I think that’s what’s contributing to the volumes of liquidity that you actually see in the markets, but also the amount of incoming order messages that we see every day. RITHOLTZ: So when you say technology, it’s the technology at the New York Stock Exchange, as well as the technology at all the companies that are trading? MARTIN: Absolutely. Absolutely. And just macro technology, I remember the first classes I took in my CompSci major, I learned assembly language. I was coding on a mainframe. I was moving from register 1 to register 2, and that’s like the most basic form. And now, mainframes have become really thin machines. They’ve really moved into thin servers. They have moved into storage capacity like the cloud. So the advancement of technology, since I finished my degree in the late ‘90s to where it is today has really exploded into something that allows for more performant, more real-time type of interactions. RITHOLTZ: There’s a quote of yours I really like which probably explains your career, which is, quote, “The amount of satisfaction I would get when I compiled the program and the program did exactly what I wanted it to was beyond anything I had experienced previously.” Explain that. MARTIN: Absolutely. So I tend to view computer coding not that dissimilar to communicating in a foreign language. A lot of times you’re learning your French, Spanish to communicate with someone in a different country. When you’re learning computer coding, you’re just learning how to communicate with a machine. And a lot of times when you’re communicating with that machine, you think you’re telling them something really good and something really positive, and what comes out is something really not positive. So very frequently, maybe because I wasn’t the best coder, I would, you know, come back with errors or stuff stuck in what is known as an infinite loop, where the machine just keeps going and going and going. So those — RITHOLTZ: Rinse, lather, repeat is a great example. MARTIN: Exactly. It kept doing that. So on the days when I would put, you know, encode and the machine would do exactly what I told it to, I was like, “Oh, wow, that’s great.” RITHOLTZ: So you used the metaphor of a foreign language — MARTIN: Yeah. RITHOLTZ: — verb tense, syntax, punctuation, all these things really matter when you’re coding. MARTIN: It sure does. Syntax absolutely matters, efficiency also absolutely matters. The way I think of efficiency around computer coding is not that different to communicating with a local in a foreign country. They’ve got their — you’ve got your typical language, you know, the stuff that you would learn in textbooks, but then you’ve got, you know, the more shorthand types of communication. I kind of view efficient computer coding in the same fashion. RITHOLTZ: Really quite interesting. Let’s talk a little bit about the IPO process, how does this work when a company decides they want to go public? MARTIN: So a company will decide they want to go public. Typically, they will interview the variety of exchanges. That could be domestic U.S. exchanges. It could be — if they’re a foreign company, they will look at their home markets as well. Ultimately, they have a certain objective in mind. Do they want to raise capital? Do they not want to raise capital? If they want to raise capital, what investor base are they really targeting? (COMMERCIAL BREAK) MARTIN: More often than not, a company will select the U.S. markets because we have the most diverse, deepest pools of liquidity, the biggest access to investors, the biggest opportunity for a company to gain a global following. So typically they will select a U.S. exchange. RITHOLTZ: So you guys obviously have to prep when a company comes to you and says, “Hey, we’re considering you and some of your competitors.” What is your process like to prepare for — I don’t know if we still use the phrase beauty contest, but that was the old investment banking phrase. How do you gear up to say here’s why you should list with the NYSE and not our competitor? MARTIN: So my philosophy is very focused on how can we be a good partner to our listed companies, and what is that listed company seeking to achieve. And it’s not just about IPO day. IPO day I kind of equate to a wedding day. You’re going to have a great day. But — RITHOLTZ: Hopefully. MARTIN: Hopefully. But what I tend to think about is what happens a month after you go public, what happens six months after you go public. And how could we be a good partner to that firm in their public company journey? RITHOLTZ: I love the visual of this as a wedding day. So now, I’m thinking you have mother of the bride, father of the bride. Who are you working more closely with? Is it the investment bank? Is it management of the company? Who shepherds this along? MARTIN: You’re working with both. RITHOLTZ: Everybody, the caterers, the flowers. MARTIN: Yeah, exactly. Exactly. RITHOLTZ: The whole thing. MARTIN: You’re working with the banks who are underwriting the deal, the mother and father of the bride. RITHOLTZ: Right. MARTIN: I got to use your analogy. You’re also working very closely with the company, because the company has a vision. The company has been successful, and that they’ve gotten to the point where they’re graduating to the public markets, which is something that should be celebrated. But the company also has a two-year, three-year, five-year strategy of what they are really seeking to achieve, not just raising capital to fund operations, or to fund research and development. They have — may have M&A targets. They may want to expand their business through leveraging a community that the listings market, particularly the NYSE brings to the table. They may have specific concerns about certain areas of the market. One topic that CEOs are very focused on at the moment is ESG, environmental, social and governance, and how they are bringing sustainable practices to the market. So they want to tell that story. So everyone has got a different objective. So we spend a lot of time with CEO, CFO, IRO, the whole team, CMO, chief marketing officer, because they’re the ones that are, you know, orchestrating the story a bit. RITHOLTZ: Right. So let’s talk about the story a little. I just finished watching Apple iTunes’ WeCrashed. And what was so interesting was as they’re marching towards an IPO, it has nothing to do with the exchange. It has nothing to do with raising capital. The narrative just seemed to have taken over from your perch. You must see these things go by all the time, maybe not so much this year, which is a lighter IPO year. But last year, 2020, how do you look at these breaking new stories and all the buzz and mania around an IPO for both good and bad? How does that affect your job? MARTIN: Our job is ultimately to ensure that when a company comes to the market, they get the best experience possible when that stock opens and when that stock closes first week, first day, whatever the case may be. And that they’re happy with the experience. Ultimately, if there is news around the company, it may influence their decision to go public at a certain time. Ultimately the, the company that you are referencing did decide to go public. It just was at a different time. RITHOLTZ: Right. A little later. MARTIN: Yeah. RITHOLTZ: And there have been stories where that doesn’t necessarily work out well, or a company like Facebook goes public. The initial rollout is a little dicey. They announce something about mobile and suddenly the stock takes off. So when you talk about the month or the year after the wedding, these stories really very much change. It’s not just about the IPO day, is it? MARTIN: It’s not just about the IPO day, but that’s about the CEO articulating their strategy and executing on that strategy. And that’s what’s going to give the CEO and the public company, the next group of investors. They’re going to get a group of investors on IPO day. They’re going to do their road show right before the IPOs. They’re going to garner the initial set of interest. And a lot of times, companies will start that process even in a soft manner, even before they’re on the road for the IPO. But post-IPO day, it’s about execution. And when they have really exciting news to share, the market tends to reward it. You know, more people come into the stock. RITHOLTZ: Let’s talk about some other ways some people take their companies public. We’ve watched SPAC, super popular last year. They all seem to have blown up and done fairly poorly this year. How does the NYSE look at a product like a SPAC as an alternative method for a private company going public? MARTIN: Ultimately, we think SPACs are still a viable form for companies to go public. What you saw was a flood of SPACs coming to the market at the same time. So that may have contributed to some of the challenges that have now happened, given the time horizon that is associated with SPACs. But ultimately we see it as a very viable form for companies to continue to come to market. SPACs had been around for probably 15 to 20 years and that’s what — RITHOLTZ: Yeah, since the early 2000, people forget that. MARTIN: Yeah. And that’s what most people forget is that this was a form that companies were using to go public way before the last two years. They just became much more popular in the last couple of years, which is why you saw the flood. RITHOLTZ: To say the very least. There’s been a little bit of agitation towards direct listings, where there seems to be a decent amount of controversy on both sides. How do you guys look at direct listings as opposed to the IPO process? Well, we pioneered the direct listing. We pioneered it, I believe, three or four years ago. And we are quite proud of that innovation. It’s just another innovation allowing for private companies, in this case that didn’t want to raise capital, that didn’t need to raise capital, to become public companies, to have that public currency, to be able to fund their operations and/or to do M&A, and/or all the other great things that come along with being a public company, including providing investors, the opportunity to participate in the upside associated with the company. RITHOLTZ: What about the circumstances where investors can participate in the upside, specifically a lot of these venture-backed companies have stayed private for much longer. They kept doing rounds and have grown to sizes that we previously would think of as, hey, they should have gone public years ago. How do you guys look at that? Is this something that you pay attention to? Where do you think this goes? MARTIN: Yeah. I mean, we believe in the power of public markets. We believe in the upside that comes along with being a public company. Transparency, good governance you get. You’re able to reward your employees. You’re able to reward shareholders, allow a diverse group of shareholders to participate in the upside. And based on the feedback that we hear from companies who are private, the public currency is still very strong. Despite the fact that there’s volatility in the market, there is still demand for companies to go public. They’re just trying to figure out what time makes sense for them. RITHOLTZ: Interesting. My extra special guests this week is Lynn Martin. She is the president of the world’s largest stock exchange, the NYSE. They host 2,400 listed companies, with a market cap somewhere in the neighborhood of $36 trillion, doing more than a billion shares on a good day. That sounds like a pretty complex situation just to begin with. What’s it like managing something with so many moving parts? MARTIN: There are a lot of moving parts. But because I’m a technologist, I feel really good about the service that we provide. You know, one of the first things when I hopped into this role in January, unsurprisingly that I focused on was system capacity, and thinking about, you know, what’s our average response times? What sort of capacity do we have in the system to handle peak days? I’m glad I did that because a couple weeks after that, we had tremendous volatility. The week of January 24th, 25th, around then, the volatility — RITHOLTZ: Which is pretty funny because the prior year was almost no volatility. It was the quietest year in a long time. MARTIN: We started to see it a bit in December. So we saw the signs in December that volatility was starting to creep into the market. But we hadn’t seen that to your point, you know, really since the pandemic. The way we look at capacity is incoming order messages. For those listening and coming order messages is buy is coming into the system, sell is coming into the system, trades happening in the system. And very quickly, we started to see days that were in excess of 20% above pandemic levels from a messaging standpoint, and it equated to half a trillion messages being processed by our systems every day. So — RITHOLTZ: Half a trillion? MARTIN: Yes. RITHOLTZ: And by messages, it’s buy, sell and — MARTIN: Buy, sell, trade. Buy, sell, trade, that is it, incoming order messages, which is tremendous. And the fact that we were processing those with average response times in the stocks of about 30 microseconds was — RITHOLTZ: Micro? MARTIN: Yes. Yeah, micro. RITHOLTZ: Not milli, micro. MARTIN: Micro. RITHOLTZ: That’s incredibly critical. MARTIN: Incredible. Yeah. And you know, that really has continued. It’s been something I’ve had my eye on throughout the year. But our technologists have done a great job. We’ve recently upgraded our systems to our next generation matching engine technology. And our systems have, touch wood, held up beautifully from a response time standpoint. RITHOLTZ: So when all these things go right, we never hear about it. MARTIN: Exactly. RITHOLTZ: But when there’s a little snafu, it’s front page of the Wall Street Journal. Let’s talk about some of those. Let’s talk about what took place on the flash crash back in 2010. Do we really know whatever happened to that, or did just — and I’m going to give you guys credit. These are all old data systems. MARTIN: Yeah. RITHOLTZ: Everything that existed then have more or less been replaced, upgraded. MARTIN: Well, I think in a situation like that, you have seen a market structure evolve too to the point where there have been systems safeguards from a market structure standpoint, put in place around volatility halts, for example. RITHOLTZ: Before you go there, let me just back up a little bit. MARTIN: Yeah. RITHOLTZ: So this used to be a fairly manual system — MARTIN: Absolutely. RITHOLTZ: — with individual specialists, human beings — MARTIN: Yeah. RITHOLTZ: — at different posts on the floor for each individual stock. I kind of forget — having grown up with that, I kind of forget a lot of people are wholly unfamiliar with that. And there was a transition process where a lot of the manual processes were replaced with electronics and automated computers. There’s still humans involved but much less than they once were. Was that part of the impact in the flash crash? And how has that transition happened? A lot of which took place long before you got there. MARTIN: Yeah. It wasn’t necessarily as a result of any one particular area, other than just an evolution of the market. What I like to say is the most technologically advanced companies employ humans, and employ human interaction. Humans are there to make sense of what’s going on in the market, apply human judgment, remove noise from the system. It goes back to what we were talking about very early on, during our conversation today, which is when you’re writing code, frequently, what’s going to come back is an error, because that is just the computer reacting automatically to something. If you don’t have the human who can go in and fix the error, you’re going to remain in an error state. So the human’s job is really to remove the noise from the system, is to remove the volatility from the system. It’s something that I employed in my previous role, where we value $2.8 million securities on the fixed income opaque side of the market, using a lot of great systems, a lot of great mathematical mouth, and also couple hundred humans. And the reason why we have the best data set out there is because I have those humans who are all former bond traders and former muni specialists who can make noise of what’s coming into the system. I think the floor model is the exact same thing during really volatile days. You saw the human element really come into play. We saw two times less volatility on NYSE issued stocks at the open, three times less volatility on NYSE issued stocks at the close. And that is a 100% because of the job of the floor. RITHOLTZ: Really interesting. So let’s talk about — so you have stocks that are listed, and some of this is NYSE and some of this is Intercontinental Exchange. MARTIN: Yeah. RITHOLTZ: So they do stocks. They do bonds. They do options. They do derivatives. What else — and I don’t know if I left anything out, futures. What else is traded at either NYSE or ICE’s family of exchanges? MARTIN: We also have six clearing houses globally that clear the bulk of the credit default swaps market. In addition — RITHOLTZ: Where are those six located? MARTIN: Around the globe. Around the globe. Our largest — RITHOLTZ: Like London, Hong Kong? MARTIN: Yeah. Our largest clearing house is based in Europe. It is U.K. FCA registered. We’ve got a clearing house based in the U.S. We have a clearing house based in Singapore, as well as one in EMEA, one in Canada. So we’ve got them sprinkled throughout the globe. RITHOLTZ: And some of this is regional and some of this is redundancy and backup. MARTIN: Absolutely. RITHOLTZ: It makes a whole lot of sense. So I’ve been talking — I keep talking about the NYSE like it’s just the exchange. Let’s talk about the NYSE Group. MARTIN: Yeah. RITHOLTZ: That’s four electronic exchanges; NYSE Arca, which is the leader in ETFs; NYSE American Exchange; Chicago Exchange, National Exchange, plus two options exchanges, the American Options and Arca Options, which I think one is in New York, one is in San Francisco. Is that right? MARTIN: The floor is in San Francisco for Arca. RITHOLTZ: So how do all — I just mentioned four electronic exchanges, two option exchanges. How do all of these integrate with the NYSE’s operation? MARTIN: So common technology is really what pulls all of the exchanges together. The different medallions are really there to try different market models, different matching algorithms on the options side of the business, different market models from the equity side of the business. It gives us more flexibility to have — to be responsive to our customers. RITHOLTZ: Quite fascinating. So I mentioned 2021 was sort of aberrational. MARTIN: Yeah. RITHOLTZ: At no point in the year was the market less than 5% from all-time highs, that led to very, very little volatility in the year. How does a lack of volatility affect your daily work, or really the right way to ask that is when volatility spikes like we saw this year, does that make your job harder? MARTIN: It makes your job different. It makes your job focused more — (COMMERCIAL BREAK) MARTIN: — on thinking about things like system capacity, response times, you know, looking at that super closely because you always want to have a very responsive matching engine. You spend a little bit less time, though, welcoming IPOs to the market because many companies are not going to want to go out in a very volatile environment. RITHOLTZ: So this raises an interesting question. What can you guys do to — I don’t know if you can end volatility, but what can you do to tame it or make it more manageable? Is there anything in your trading process that can facilitate taking some of the spikes and volatility out of the market? MARTIN: Well, that’s where — that’s where our market maker model really resonates. And it’s really resonating with those companies who still believe in the public market currency, which there’s many of them, when they’re thinking about coming to the market because you can’t predict volatility. RITHOLTZ: Right. MARTIN: No one can control volatility. No one can predict volatility. But we can do things because of our market model to help the companies that are listed on us, have a less volatile experience. So our market model requires a designated market maker whose job is to trade that stock from the floor and they — RITHOLTZ: Create an orderly market? MARTIN: Correct. Correct, correct. And they smooth out volatility, not just intraday, but also at the open and the close. The open and the close are incredibly important moments in time for a company, particularly if you think of a company having quarter-end, or they’re having the share repurchases, or whatever the case may be. So that’s actually meaningful dollars, even post an IPO, in a CFO’s mind, when they’re doing share buybacks, things of that nature. So that’s where our market model really resonates, particularly in times like this, when you see the volatility in the market, when you see the VIX over 20, but you know that companies still want to go out in the public market. RITHOLTZ: You know, I think the public is probably less aware of some of the institutional order flow, like buy on open or sell on close, which it doesn’t hurt to have a professional overseeing that process so it doesn’t get too out of hand. MARTIN: Yeah. And also smoothen any imbalances because you’re not necessarily going to have a balanced book at the end of the day. RITHOLTZ: Which means they’re literally taking positions — MARTIN: They are. RITHOLTZ: — long or short in order to satisfy those orders. MARTIN: Absolutely. RITHOLTZ: So let’s talk about some imbalances, and I’m thinking about the sort of meme stock mania that began in 2020, when everybody was stuck at home during the pandemic, and just exploded in 2021. It was really a very unexpectedly wild ride, especially the companies involved. What was that experience like for you watching this? You weren’t yet president of the NYSE in 2020 or 2021, but you were still there. Tell us what that experience was like. MARTIN: I mean, it was incredibly interesting to watch the new retail interest in certain stocks and why they had picked certain stocks. And I think it’s just still something that is fascinating intellectually more than anything. I can’t really comment on any of their decisions, but it’s been interesting to watch how social media has really emboldened a new class of trader. RITHOLTZ: My favorite moment of that was the young — pretty handsome young couple. And the way we subsidize our lifestyle is we buy stocks. We only buy the stocks that are going up. And when they go up, we sell them. And we just do that over and over again from home. And I’m like, oh, I had no idea it was that easy. You could get rich trading stocks. Why didn’t someone tell me that 30 years ago? MARTIN: I tend to take the view that having a very balanced portfolio and knowing what you invest in, and investing for the long term is probably 9 times out of 10 the — maybe 9.5 times out of 10, the right philosophy to have. RITHOLTZ: I think Warren Buffett wouldn’t find anything to disagree with that. And yet we see people piling to companies of questionable potential. My favorite example was — was it Hertz that was bankrupt and everybody decided to buy Hertz since then? So as you’re observing this, is part of your brain saying we have to do X and Y and Z to stop this, or is it, well, that’s going to be an interesting end when that all — when that train stops? MARTIN: So our job is to make sure the markets are open and are available to the most diverse set of investors. RITHOLTZ: No paternalism. You just — MARTIN: Exactly. RITHOLTZ: Here’s the platform and make sure it runs. MARTIN: Ultimately, if there is questionable behavior, we police that. Our reg group who is a separate group, polices that and works closely with the regulator. RITHOLTZ: So let’s talk a little bit about that. You see behavior that sometimes it’s just — that looks pretty stupid. And sometimes it’s like, hey, this is looking a little suspicious, something doesn’t smell right here. What happens when your systems start flashing little alerts? Hey, look at this stock, something seems to be unkosher here. MARTIN: So that would be the job of reg to look at various trademarks. RITHOLTZ: Internally, the NYSE regulations. MARTIN: Yeah. They are a separate organization from the business, but they are an internal organization. And then, you know, they would either take enforcement action if it was suspicious activity, not stupid, not stupid. It’s not our job again to take views on whether or not a stock is worth something. That’s for the market to decide. And then if appropriate, refer it to the regulators. RITHOLTZ: So I would assume the NYSE has a fairly close relationship with the SEC and there’s probably a lot of back and forth on a regular basis. Tell us a little bit about that. How does the — MARTIN: Well, they are a regulator. We’re an SRO. So we do have a very close working relationship with them. We are — RITHOLTZ: So you’re a self-regulating organization. MARTIN: Yeah. RITHOLTZ: But you also have a, a relationship with the government regulator. MARTIN: Absolutely. Absolutely. RITHOLTZ: And I would imagine that’s a fairly productive relationship. MARTIN: It is. It is. Obviously, we have a very strong rule book. Anytime we make a change from a market structure standpoint from an order type standpoint, that has to be fully approved by the Commission. So we spend a lot of time with the SEC going through various rule changes. We want to introduce a new order type. We want to introduce a new — a different fee. There’s a variety of reasons why we need to do for filings. RITHOLTZ: So let’s use an example. I’m always — again, now I’m going to show my age. The circuit breakers from the ‘80s and ‘90s were pretty modest and things really had to go off the rails before they kicked in. Circuit breakers have very much been brought up to speed both on the broad market and individual companies. Tell us about the circuit breaker, is that coming from the NYSE? Is that coming from the SEC? MARTIN: So that is something in the wake of the volatility that has occurred at various points, various instances of stress in the market, whatever the case may be. RITHOLTZ: I mean, this goes back to ‘87, right? MARTIN: Absolutely. Pandemic. The market has really — the positive of every time there has been a challenge, the market has developed system safeguards, for lack of a better description. So — and they apply to all of the exchanges. So volatility halts, for example, we have volatility halts for securities, individual securities. But then we also have system halts when the entirety of the market has a certain drop. For example, you saw the market wide circuit breakers kick in, I believe, four times during the pandemic, really during the height of the pandemic and that’s — RITHOLTZ: March 2020. Yeah. MARTIN: Yeah. And the way that works is if the S&P is trading 7% below its opening level, it will automatically halt. RITHOLTZ: Opening level or previous close, how do you categorize that? MARTIN: Previous close. Previous close. Yeah. RITHOLTZ: So we close at 3000 and we open 210 points below that, there’s a halt right there? MARTIN: Yes. Yeah. RITHOLTZ: Makes sense. And individual companies, what are those circuit breakers like? MARTIN: It’s, I believe, 5% up or down. It will be at 10 halt. RITHOLTZ: So that’s a 10. And the first halt is — MARTIN: And actually, to be fair, it depends on the liquidity in the stock. It could be 5%. It could be wider, depending on the overall liquidity in market cap of the stock. RITHOLTZ: But when we — when we see a liquid stock take a 5%, or an 8%, or a 10% haircut, they tend to keep trading. MARTIN: You’ll have a very short halt, and then it will — RITHOLTZ: Just to let the book sort of rejigger? MARTIN: Correct. RITHOLTZ: So the first halt is how many minutes? Five minutes? MARTIN: I think it’s 10. RITHOLTZ: 10 minutes? MARTIN: Yeah. RITHOLTZ: All right. And then the second halt is longer. MARTIN: Yeah. And then if this continues to be a mess, it’s halted for the day. So the first, second, third strike, they’re out. We haven’t seen that in quite a while. What happens the next day when we reopen? How is that priced? Is it just the messages and orders, or is there a specialist trying to facilitate that? MARTIN: There is a specialist. That’s where the open — that’s where our market model shines. You have the opening auction and the closing auction, which again performed that function I mentioned earlier of smoothing out any imbalances, whatever the case may be to make for a smoother open and/or a smoother close. And that’s why when I mentioned earlier that we’ve seen two times less volatility at the open and three times less volatility at the close this year, that’s what I’m talking about. It’s the opening and the closing auctions. RITHOLTZ: Because a person is essentially — MARTIN: Because a person is trying to make sense of what’s going on. RITHOLTZ: Right. Smoothing that out and making it a little more balanced than it might have been. MARTIN: Correct. RITHOLTZ: And that means they’re also going at risk and taking positions to facilitate that. MARTIN: That’s right. RITHOLTZ: So you mentioned a couple of things I didn’t get to, I want to follow up on. One is the dual listing. So when a company is listed here and overseas, or is that the only reason to be a dual listing? How often — what are the other reasons to be — besides geographic, to be dual listed? MARTIN: A lot of times, it’s geographic. Very infrequently, there are some securities that are dual listed on us and our closest competitor in the U.S., but that’s very infrequent. So it’s typically to get access to a different group of investors. A lot of times you’ll also see a primary listing and then something called an ADR being listed in the U.S. where we’ll do the primary. And that’s more foreign issuers that want to have their primary listing on the home market, but then tap the liquidity in the U.S. market. So they’ll issue an ADR. RITHOLTZ: And then what about additions and subtractions? I know we occasionally see companies that were once smaller companies listed at what used to be considered regional exchanges — MARTIN: Yeah. RITHOLTZ: — graduate to the NYSE. And then every now and then, somebody, you know, is past their sell/buy date and they get de-listed. Tell us a little bit about what that process is like. MARTIN: Yeah. I mean, the de-listing process, you know, there’s a lot of things that go into the de-listing decision. RITHOLTZ: But it’s pretty mathematical, right? MARTIN: Yeah, it is. It is. RITHOLTZ: You know, check these boxes or — MARTIN: We’ve got — the reg has a variety of requirements to maintain your listing. It could be certain financial wherewithal. It could be the amount of shareholders, individual shareholders that are participating in your stock. So there is a formula that gets followed. RITHOLTZ: And what about the opposite? What about somebody graduating, for lack of a better phrase, to the NYSE? MARTIN: Yeah. And we’ve seen actually quite a few companies graduate to the NYSE this year alone. We’ve actually seen quite a few companies transfer to the NYSE this year. I think we’ve had 14 so far to date — RITHOLTZ: That’s a lot. MARTIN: — which is our best year on record. But we’ve seen — we have a smaller listings venue called NYSE American, which is for the smaller cap companies. And you know, we’re really happy when we see them graduate to the big board, for lack of a better description, because it means they’re having success. They’re having a tremendous amount of success in the public markets. RITHOLTZ: All right. Let me throw you a little bit of a curve ball. I’m going to ask you a question you can’t possibly answer, but I feel compelled to ask it. MARTIN: Awesome. RITHOLTZ: So I remember getting a tour of the floor of the exchange a million years ago, and it was giant room after room, after room down on Wall Street and Broad, and literally where physical chairs were being traded, traded physically person to person. That has slowly been computerized. That’s slowly been morphed into the modern market structure. But I have very fond memories of that massive building that takes up like two city blocks. Is there always going to be a physical exchange? This is the question that I don’t know if anybody can answer. But is there always going to be a physical exchange on Wall Street? At what point does that just, you know, become a venue for aftermarket IPO parties and things like that? MARTIN: There is always going to be the New York Stock Exchange at the corner of Wall and Broad. We’ve been here for 230 years, counting us being here for the next 230 years. We have survived many war, pandemic, volatility, crisis — RITHOLTZ: Explosions. MARTIN: — all sorts of — all sorts of unfortunate events. So there will always be an exchange at the corner of Wall and Broad. RITHOLTZ: That’s really good to hear. I have very fond memories of that. And not too far from there, the tour of the Federal Reserve gold. MARTIN: Federal Reserve, the vaults. Yeah. RITHOLTZ: Right. So those were — I think — I’m trying to remember if that was a high school teacher or a college teacher. It was ways ago. All right. So I know I only have you for a few minutes more. Let me jump to all my favorite questions we ask all of our guests, starting with what did you do to keep yourself entertained during the pandemic? What were you watching or listening to? (COMMERCIAL BREAK) MARTIN: Well, during the pandemic, I had the unique privilege of homeschooling two children in addition to doing my day job, which was focused on keeping the fixed income markets moving forward. So that was — that was a challenge. But I have to say I look back on it with fond memories, not just because our fixed income business provided a lot of transparency in a really opaque market, but also I got to spend some time — a lot of time with my kids. RITHOLTZ: That sounds like fun. Let’s talk about your mentors who helped to shape your career. MARTIN: I would say that I’ve had the opportunity to have mentors that have been bosses all throughout my career. It really started with my first project executive who was helping guide me through IBM, who taught me a lot of really important lessons that I still stay true to, one of which is you can never overcommunicate. But throughout my career, I’ve been lucky, fortunate that my bosses have always given me stretch jobs, where they give me an opportunity to do a job that maybe I didn’t have the background for, or I didn’t think I had the background for, but they thought I was the right person for that job. RITHOLTZ: Sounds interesting. What are some of your favorite books? What are you reading right now? MARTIN: Books are a challenge mainly because I have a finite amount of time in my day. Right now, you know, continuing to read a couple of interesting business books like, you know, I always go back to the Michael Lewis books because they’re just a good read — RITHOLTZ: Can’t beat them. MARTIN: — on top of anything. They’re a unique mix of storytelling and business, so it kind of scratches both itches, for lack of a better description. RITHOLTZ: Sure. I just reread Liar’s Poker — MARTIN: Yeah. RITHOLTZ: — on its 30th anniversary. It holds up surprisingly well. MARTIN: Yeah. RITHOLTZ: And you could see the outlines of, oh, it’s not quite a full Michael Lewis book, but there are hints of the writer he’s about to become. MARTIN: Yeah. RITHOLTZ: Really quite interesting. MARTIN: I also like Moneyball. Moneyball is one of my favorites. I mean, like that’s — RITHOLTZ: Hard to beat. MARTIN: You’re in baseball season. I’m a baseball fan. So therefore I’m going to, you know, focus on. RITHOLTZ: We may see the Mets go pretty deep into the playoffs this year. MARTIN: That I’m not going to — I’m going to hold my breath. We’re entering September and you know what usually happens to our boys from flashing in September, right? RITHOLTZ: They seem to be a little different team this year under another market participant, Stevie Cohen. MARTIN: You got to believe, right? RITHOLTZ: Listen, I grew up with, you know, the Lenny Dykstra era of you’re on the line and it’s so easy to get to Shea Stadium. MARTIN: Absolutely. RITHOLTZ: We used to go to games all the time and frequently to be disappointed, but so far — MARTIN: Well, I remember my first games were ‘85 and ‘86. RITHOLTZ: Oh, well, ’86 is — MARTIN: So I mean — and that’s when I just fell in love with them. RITHOLTZ: Bucky Dent and the little dribbler through the legs. That was it. MARTIN: Exactly. Like Bill Buckner and his name will go down in infamy I assume in Boston. But, man, I felt good in New York, right? RITHOLTZ: Yeah. MARTIN: So — and watching that team was a lot of fun with Strawberry and — RITHOLTZ: That’s right. MARTIN: — Ron Darling, who I think is a great broadcaster. By the way, he’s turned into a great broadcaster. RITHOLTZ: You know, they were always an interesting team, even if they didn’t bring home as many championships as the Yankees did. MARTIN: They were. They were. They were. I remember going to the Subway Series between them and the Yankees in the World Series in 2000, I think that was. And — RITHOLTZ: Is that a playoff or — MARTIN: No. They were in the World Series together. RITHOLTZ: Really? 2000 is kind of a blur to me. MARTIN: There you go. RITHOLTZ: That was like ’08, ’09, that year was a little bit of a blur. Our last two questions, what sort of advice would you give to a recent college grad who was interested in a career involving data services, listed stocks, any sort of trading or exchange-based work? MARTIN: The advice that I would give is to, in some respects, expect the unexpected. And what I mean by that is your traditional degrees aren’t necessarily going to be what’s going to make you successful. So be intellectually curious about the things, not just involved in finance. Be intellectually curious about the technology under that underpins the systems. And clearly, never be afraid to speak up if you want an opportunity, or take on an additional project that may not be in your day to day, but maybe something that is just an area that interests you. RITHOLTZ: Interesting. And our final question, what do you know about the world of data services, exchanges, market trading and public companies today you wish you knew 20 or so years ago? MARTIN: That is a great question. RITHOLTZ: We save it for last for a reason. MARTIN: I guess I wish I knew how important — I wish I knew how important the role of the programmer was going to become in financial markets. I understood then that, effectively, fair value was determined by a variety of mathematical — a bunch of math, for lack of a better description. Those mathematical models became much more sophisticated over time. But I don’t know that I fully appreciated that the guy or girl who is writing the code was going to be the one that was interacting with the systems 20 something years ago, and the importance of efficient interaction. RITHOLTZ: Quite fascinating. We have been speaking with Lynn Martin. She is president of the New York Stock Exchange. Thank you, Lynn, for being so generous with your time. If you enjoy this conversation, be sure and check out all of our previous 400 or so podcasts we’ve done over the past eight years. You can find those at iTunes or Spotify, or wherever you get your favorite podcast from. We love your comments, feedback, and suggestions. Write to us at mibpodcast@bloomberg.net. Sign up for my daily reading list at ritholtz.com. Follow me on Twitter @ritholtz. I would be remiss if I did not thank the crack team who helps put these conversations together each week. Bob Bragg is my audio engineer. Paris Wald is my producer. Atika Valbrun is our project manager. Sean Russo is my head of Research. I’m Barry Ritholtz. You’ve been listening to Masters in Business on Bloomberg Radio. END   ~~~     The post Transcript: Lynn Martin appeared first on The Big Picture......»»

Category: blogSource: TheBigPictureSep 7th, 2022

Days After Approving Another $3BN For Ukraine War, US Says No More Money For Free COVID Tests

Days After Approving Another $3BN For Ukraine War, US Says No More Money For Free COVID Tests Authored by Julia Conley via Common Dreams, "Well this is quite exactly the wrong thing to do going into fall/winter," Dr. Taison Bell, an infectious disease physician at University of Virginia, tweeted as the White House announced on its test-ordering website that a lack of congressional funding has forced the government to end shipments of free tests for the time being. The federal portal notes that shipments "will be suspended on Friday, September 2 because Congress hasn't provided additional funding to replenish the nation's stockpile of tests." Via Reuters The White House earlier this year requested $22 billion in coronavirus funding, including $5 billion in global aid to help people across the Global South and prevent new variants from spreading, but Republicans and Democrats were only able to agree on a $10 billion deal excluding global spending. That bill has so far failed to pass. The government has sent out more than 600 million tests so far, allowing households to place up to three orders since the program began in January under pressure from public health advocates. The Department of Defense said in February that the federal government spent roughly $2 billion on the first shipments of tests. While Republicans have refused to fund continued Covid spending this year, lawmakers from both parties have agreed to prioritize military spending, including nearly $3 billion in long-term aid for Ukrainian forces that was approved last week, a $40 billion Ukraine package that passed in May, and $782 billion in U.S. military funding that was approved in March—days after the Covid relief was pulled from omnibus legislation. MSNBC journalist Ayman Mohyeldin on Sunday noted the contrast between the supposed "lack" of funding for relatively inexpensive Covid-19 tests and the availability of hundreds of billions of dollars in defense spending. According to CBS News, the Biden administration is holding back its stockpile of Covid-19 tests until later in the year to prepare for what a senior official called a potential "new rise in infections and more acute need." Experts say a winter surge in infections could result in a million hospitalizations and nearly 200,000 deaths in a worst-case scenario. Advancing Health Equity founder Dr. Uché Blackstock noted that through the fall, sites such as libraries and community health centers will still be distributing free Covid tests in some areas, but noted that "the convenience of ordering the tests online was invaluable." A funding lapse is also likely to happen with vaccines, Blackstock said. Though Republicans have obstructed the passage of continued Covid-19 relief including funding for the test program, the White House has also expressed some eagerness to end the federal government's oversight of the coronavirus pandemic. Earlier this month, White House Covid-19 Response Coordinator Dr. Ashish Jha said at a U.S. Chamber of Commerce Foundation event that the Biden administration hopes to get "out of that acute emergency phase where the U.S. government is buying the vaccines, buying the treatments, buying the diagnostic tests." Shot/chaser: The Biden administration is announcing it will suspend taking orders for free at-home COVID tests through its government website as of this Friday, due to a lack of funding from Congress. pic.twitter.com/BoM8h1hN1f — Ayman (@AymanM) August 29, 2022 "My hope is that in 2023, you're going to see the commercialization of almost all of these products," Jha said. "Some of that is actually going to begin this fall, in the days and weeks ahead. You're going to see commercialization of some of these things." The Centers for Disease Control and Prevention's Operation Expanded Testing program, which provides tests to schools, will end on December 31, and pharmaceutical company Eli Lilly has begun direct commercial sales of its monoclonal antibody treatment to hospitals and states. The CEOs of Moderna and Pfizer have alluded to raising the prices of their vaccines once they are being sold in a "private market situation" rather than to the federal government. Harvard Medical School professor Dr. Adam Gaffney wrote in The New Republic last week that the coming "commercialization" of Covid-19 treatments, tests, and vaccines will sharply reduce access, leading to increased risks for public health. "Some Medicaid patients could see co-pays for Covid vaccines once they are commercialized—or not have access to these vaccines at all, according to a report from the Brookings Institute," Gaffney wrote. "Provision of vaccines to the uninsured, who are at increased risk of Covid, will almost certainly deteriorate when neither administration nor the products themselves are publicly funded. And co-pays and deductibles for treatments like Paxlovid will presumably pop up for the privately insured." "The partial decommercialization of the financing of Covid care was a departure from business as usual for American healthcare," he added. "So it is unfortunate, if unsurprising, to watch Covid become yet another illness inadequately covered by a faulty and fragmented financing system." Tyler Durden Tue, 08/30/2022 - 17:25.....»»

Category: worldSource: nytAug 30th, 2022

Foghorn (FHTX) Phase I AML/MDS Study on Full Clinical Hold

Foghorn (FHTX) receives yet another setback as the phase I dose escalation study of FHD-286 in relapsed and/or refractory AML and MDS has been put on full clinical hold. Foghorn Therapeutics Inc. FHTX recently announced that the FDA has placed a full clinical hold on the phase I dose escalation study of pipeline candidate FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).Shares of this clinical-stage biotechnology company are down in response to the news.FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM.Earlier, in May, the regulatory body had placed the study on a partial clinical hold following the report of a death in a subject with potential differentiation syndrome.Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect that is believed to be on-target for the proposed mechanism of action for FHD-286.The FDA observed additional suspected cases of fatal differentiation syndrome believed to be associated with FHD-286 in the data submitted in response to the partial hold.Consequently, the FDA has placed a full clinical hold on the AML/MDS study.The regulatory body has additional questions and requires further analyses before the clinical hold may be lifted.The clinical hold is a setback for the company, and investors are clearly disappointed.Shares of Foghorn have plunged 52.8% in the year so far compared with the industry’s decrease of 21.5%. Image Source: Zacks Investment ResearchNevertheless, the dose escalation phase I study of FHD-286 in metastatic uveal melanoma (mUM) continues per protocol. The company plans to report data from the mUM study in the first half of 2023.The company is also developing FHD-609, a targeted protein degrader that is currently being evaluated in a phase I study in synovial sarcoma.In December 2021, FHTX entered into a collaboration agreement with pharma giant Eli Lilly LLY, for which it received an upfront payment of $300 million in January 2022.The collaboration with Eli Lilly is for the development of novel oncology drugs by applying Foghorn’s proprietary Gene Traffic Control platform. The collaboration includes a co-development and co-commercialization agreement for Foghorn’s selective BRM oncology target, consisting of two programs and one additional undisclosed oncology target. The partnership includes three additional discovery programs.Zacks Rank and Stocks to ConsiderFoghorn currently carries a Zacks Rank #3 (Hold).  A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals BOLT and Dynavax DVAX.  Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.  Zacks' Top Picks to Cash in on Electric Vehicles Big money has already been made in the Electric Vehicle (EV) industry. But, the EV revolution has not hit full throttle yet. There is a lot of money to be made as the next push for future technologies ramps up. Zacks’ Special Report reveals 5 picks investorsSee 5 EV Stocks With Extreme Upside Potential >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Dynavax Technologies Corporation (DVAX): Free Stock Analysis Report Eli Lilly and Company (LLY): Free Stock Analysis Report Foghorn Therapeutics Inc. (FHTX): Free Stock Analysis Report Bolt Biotherapeutics, Inc. (BOLT): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksAug 23rd, 2022

54gene’s CEO Abasi Ene-Obong Wants to Fix the Racial Imbalance in Health Data

54gene's CEO Abasi Ene-Obong is on a mission to right the sharp racial imbalance in global health data. Born and raised in the Nigerian port city of Calabar, Abasi Ene-Obong remembers the exact moment that changed his life’s direction. Sitting in an introductory genetics class at medical school, in 2003, he heard the professor say that African genetic samples comprised less than 3% of health data bases in the world, creating a stunning vacuum in its ability to detect diseases and develop effective treatments for hundreds of millions of people. Ene-Obong ditched his plan to become a doctor, and instead left for London, and later Los Angeles, to study genetics, finally earning a Master’s degree in business focusing on the bioscience industry, at the Keck Graduate School in California, and a Ph.D. in cancer biology at the University of London. [time-brightcove not-tgx=”true”] With that, he launched 54gene in 2019—named for the 54 countries in Africa—with the mission to right the sharp racial imbalance in global health data. Headquartered in Lagos, Nigeria, and Washington, D.C., the startup was on TIME’s 2019 list of best health innovations. Three years on, Ene-Obong, 37, says every part of the mission has proved hugely challenging, from raising venture-captial funds to explaining to Big Pharma companies what 54gene is trying to do. TIME met Ene-Obong in Paris in June to discuss how his company intends to grow its business, make money and the process of winning over investors—and the health problems at stake. This interview has been condensed and edited for clarity. (For coverage of the future of work, visit TIME.com/charter and sign up for the free Charter newsletter.) What is the major problem you are trying to solve? This is a problem that affects everyone across the world. We’re all faced with new diseases, and even current diseases, like cancers and cardiovascular diseases, and there’s a need to find cures, with advancements in bio-computing, and AI and genomics. Because of the maturity of various tech verticals, where most groups are beginning to look at genetics, that could mean better diagnostics, and safer and more effective drugs for diseases. In order for us to understand human biology, we can’t just look at one group of people and assume that group represents all people. Right now most of the genetic [data in] databases across the world is Caucasian. I see 54Gene’s website says only 3% of the world’s genetic databases come from African genes. Actually it’s less than 3%, That is something my company is trying to solve. Africans represent the most diverse population on Earth, and what that means from a genetic standpoint is that lots of what we call variants that we need to understand, what we’re looking for is just differences. We’re not only talking between Africa and Caucasian, but also between [for example] Nigerians and Cameroonians. Nigeria has more than 300 ethno-linguistic groups. I am mixed, Efik and Igbo, from Calabar, which was one of the biggest exporters of slaves. Is this vacuum the fault of Big Pharma? Or is it African countries and governments that have simply not collected genetic data? It’s everybody’s fault. It’s both the fault of governments not prioritizing this, in many cases, not even understanding the need for this. And it’s also the fault of Big Pharma. Big Pharma has been opportunistic. They’ve gone to where the data exists. It has not really been their job to produce the data. But because of their role in the ecosystem, they could be a voice to really advance this part of medicine. I would put quite a lot of the fault on the lack of research and development in Africa. I want to make sure we are being honest with ourselves. If we as Africans take the initiative and the leadership in this, then others will come to the table. There was a lot of talk during the pandemic about vaccine nationalism and about African governments being cut out of any fair distribution. Is this part of the same problem—that Western pharmaceutical companies are basically rapacious? I’m not an apologist for the West, but I think we need to take more ownership and more action. You don’t have to match the West and put $2 billion into COVID, but you can put a portion of your budget. What we’re seeing is that they [African governments] were not even putting in that. Most of health care in Africa has typically been funded by international donors. So African governments have not owned their own health care. They have lots of international donors who put in the money and dictate the agenda for how funds should be used. And so after decades and decades of that type of behavior, they have to unlearn, and practice healthcare in the way it should be practiced. Now we’re beginning to see that in certain governments. What’s 54gene’s business model? And how do you partner with Big Pharma and other entities? Our goal is not so much to create the data and have anybody buy it. That would not be responsible. We have to fix systemic issues, where people come in [to Africa] to pay for samples, take the samples to their countries, all outside Africa, do the research and development outside, make the drugs, and they never come back to Africa. Right now, it takes 10 to 20 years for a drug launched in the U.S., or France, to come to Africa. Our business model is one that I believe is more inclusive and sustainable, and has Africans in mind. Rather than building a data set and sending it out, we are doing the R&D work, sometimes in partnership with pharma companies, the goal being that we will develop drugs or our data will be used to improve diagnostics for Africans and non-Africans. How are your discussions going with big pharmaceutical companies? We do have works in progress with a few pharmaceutical companies, both U.S. and European. When you talk to CEOs, is the work you’re doing something they understand, or is it a jump for them? We have some that understand the need to do this type of work in Africa, such as doing the [genetic] sequencing on the continent, with which we’ve built a sequence in the lab so that we don’t have to send them abroad, or doing the clinical trials in Africa such that African patients can also get access to innovative drugs very early on. So we see that some of these companies get it. A majority of them do not get it, because the majority of them are still looking at old business models. They want access to biological samples, to do the research and make whatever decisions the boardroom decides. Do you see health crises, or disease, where the outcome would have been different if Africa had this kind of genetic data? With COVID-19, we know we should have very robust surveillance systems. But in order to do that, you need to have the technical capability and infrastructure. Africa lacks quite a lot of that. Again, that is one of the things we are solving. But you know, there are 54 countries and 1.4 billion people. We could do much, much better. And yes, it could help prevent some infectious diseases. But people are not yet calling out the rise in non-infectious diseases, and we are seeing that in hospitals: Rises in cancer cases and cardiovascular disease cases. Most public funders have prioritized infectious diseases like HIV, tuberculosis, malaria. That’s where all the money has gone to. That has led to a lack of development in this non-infectious disease care management. I don’t think this is really understood. Are you saying that basically, to treat diseases like cancer, heart disease and diabetes, Africans might require treatment specific to them? In a lot of cancers, with the mutational drivers, most of our understanding is based on studies done in purely Caucasian populations. There was a study a year ago at the University of Chicago where they looked at breast cancers amongst Yoruba women, which found there was a different gene mutation causing a number of cases. The women got more severe breast cancer in their 40s. The drugs we’ve been using to treat breast cancer, and the diagnosis, have not really looked for this mutation. How hard has it been for you to raise funds for 54gene? We raise funds mostly through venture capital funding, where we give some equity, for investments. As of last year, we had raised $45 million. We are attracting very good investors. I see the company becoming a major player in the health tech space, measured by impact, rather than the monetary value. The work we are doing is going to improve health outcomes in various countries in Africa, covering hundreds of millions of lives, potentially. Globally, it’s going to help inform how diseases are looked at, how new drugs are developed. What is the potential impact on Black Americans? The work is going to impact all people of African origin, whether they are in Africa, France, the U.K., or the U.S., Brazil, or the Caribbeans. Many of them came from West Africa. We know Nigeria contributed about 25% during the slave trade. And we still see more Nigerians leaving. As the world gets more diverse, this is only going to get even more important. And then, of course, Nigeria will soon have more people than the U.S. Yes. And Africa will soon have more people than Asia. Big Pharma is notoriously focused on its bottom line. What do you say when they ask, ‘what is in it for us?’ Quite a few things are in it for them. One is it’s going to improve the pipeline of new products, not just products sold in Africa, but also globally. We’re not saying that your entire focus should be Africa. We are saying you can include Africa in your focus, and it could also impact your bottom line significantly. I’ll give you an example. There is a drug used to treat bad cholesterol. A lot of the insight for the work came from Africans, because the drug targets a rare mutation, that is more common in African populations. The discovery came from African populations in the U.S., actually. At what moment did you suddenly think to yourself ‘this is what I should do?’ A lot of it was serendipity. I was studying medicine as an undergraduate in Nigeria. I saw how genetics held the possibility of finding cures for rare diseases like Huntington’s and sickle cell disease. I got very interested at that age in doing genetics. By the time I was doing my Ph.D., I realized that I wanted to be running a company that was global, but also provided a platform for Africans to contribute globally to research and healthcare. In 2013, I moved to LA. I worked in the U.S. as a management consultant for pharmaceutical and biotech companies. The first sets of data coming out showed how diverse African populations were, and the lack of that data. So I knew that with my educational background and my work experience, and being born in Nigeria, that I could solve some of this problem. And so I went back to start it. Why does 54gene have a Washington base? What’s the purpose of that? It’s a global company. There are a lot of people, Africans and non-Africans, who want to contribute to this mission because it affects all of us as human beings. Right now we have over 100 people in Nigeria, and nearly 30 in the U.S. We’re sitting here at VivaTech, a tech conference in Paris, and there’s been a lot of talk for a long time about the tech industry being overwhelmingly white. How has your experience been? People solve what they know. It is the same for investors: Investors invest in what they know, and what they connect to. When you don’t have a diverse group of people in key decision-making positions in the tech industry, you are not going to get them to invest in Black businesses, or businesses from diverse communities, because they want to put their money in what they understand. We need to have more diversity in the VC [venture capitalist] offices. Investments are emotional, you have to have an emotional connection. I’m assuming when you are dealing with VCs it is mostly white men, correct? Yes. I have reason to believe investment is emotional, from my own personal experience. It could mean I am connected to the problem, or connected to the person who is solving the problem. One way we solve that problem is having people who are of diverse ethnic groups and experiences. When I talk to U.S. or U.K. or European VCs about the market in Africa and how it’s growing, many of them have never been to Africa. Many of them still have the same pictures that you see on TV, of somebody begging, of donating to charity. One investor meeting I had, he started mentioning what he does for charities. As I started talking, he was interjecting all the time. Some of his colleagues were getting uncomfortable. At some point I said, I didn’t come here to be insulted. I would rather not take your money. He had to take a step back and his colleagues apologized. So, for an investor like that, there is no sense that maybe there could be a return on the investment? When he stopped talking and started listening, he ended up saying, ‘oh this is this is actually cool.’ But that was an experience I do not want to repeat......»»

Category: topSource: timeAug 8th, 2022

Glaukos (GKOS) Q2 Earnings Miss Estimates, Revenues Beat

Glaukos' (GKOS) Q2 revenues fall year over year but beat estimates. Lower revenues along with higher expenses hurt margins significantly. Glaukos Corporation GKOS reported an adjusted loss per share of 83 cents for the second quarter of 2022, wider than the adjusted loss of 22 cents reported in the year-ago quarter as well as the Zacks Consensus Estimate of a loss of 44 cents. The significant widening of loss was due to lower revenues as well as higher operating and non-operating expenses.GAAP earnings per share (“EPS”) for the quarter were 96 cents against a loss of 38 cents per share in the year-ago period.Revenues in DetailGlaukos registered revenues of $72.7 million in the second quarter, down 6.9% year over year on a reported basis. The figure, however, surpassed the Zacks Consensus Estimate by 7.5%.Quarter in DetailsIn the quarter under review, Glaukos recorded Glaucoma net sales of $56.1 million and Corneal Health net sales of $16.6 million.Glaukos Corporation Price, Consensus and EPS Surprise Glaukos Corporation price-consensus-eps-surprise-chart | Glaukos Corporation QuoteMargin TrendIn the quarter under review, Glaukos’ gross profit rose 16.9% to $73.5 million. Gross margin contracted approximately 200 basis points (bps) to 75%.Selling, general and administrative expenses rose 10% to $49.9 million. Research and development expenses went up 31% year over year to $31.7 million. Total operating expenses of $70.8 million increased 12.2% year over year.Operating loss in the reported quarter totaled $91.6 million compared with a total operating loss of $74.6 million in the year-ago quarter.Financial UpdateGlaukos exited second-quarter 2022 with cash and cash equivalents, and short-term investments of $391.2 million compared with $415.4 million at the end of the first quarter.2022 GuidanceGlaukos raised the upper range of its revenue outlook for the full year based on solid execution globally and better-than-expected revenues.For 2022, Glaukos now expects net sales between $270 million and $280 million, compared with the previous projection of net sales between $270 million and $275 million. The Zacks Consensus Estimate for the same stands at $273.37 million.Our TakeGlaukos exited the second quarter of 2022 with mixed results, wherein earnings missed estimates but revenues beat the same.It launched iPrime — a new disco elastic delivery device — in the latter part of the second quarter. In the latter part of the first quarter, the company had launched the iAccess device for go anatomy procedures. The addition of these new devices will provide unique solutions designed to grow and improve treatment options for surgeons, customers and patients. The company’s iAccess device has positive market feedback.In a separate press release, Glaukos announced that it received the FDA 510(K) clearance for iStent infinite — the first FDA-cleared micro-invasive implantable device used as a standalone treatment option for glaucoma patients to reduce elevated intraocular pressure. The potential launch of the product, expected later this year, will likely accelerate Glaucoma net sales growth going forward. The company is also developing several other treatment options in its pipeline. These developments raise our optimism about the stock.However, wider adjusted loss per share and lower overall revenues on a year-over-year basis are disappointing. Glaukos incurred an operating loss in the reported quarter, raising our apprehension. The company’s operation in a stiff competitive space is also worrying.Zacks Rank and Other Key PicksCurrently, Glaukos carries a Zacks Rank #2 (Buy).Some other top-ranked stocks from the pharma/biotech sector include Lantheus LNTH, ShockWave Medical SWAV and Alkermes ALKS. While Lantheus and ShockWave Medical sport a Zacks Rank #1 (Strong Buy), Alkermes carries a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank stocks here.Estimates for Lantheus have improved from earnings of $3.04 to $3.08 for 2022 and $3.33 to $3.62 for 2023 in the past 60 days. LNTH stock has surged 162.7% so far this year.Lantheus delivered an earnings surprise of 77.82%, on average, in the last four quarters.ShockWave Medical’s earnings per share estimates have improved from $1.84 to $2.02 for 2022 and from $2.82 to $2.95 for 2023 in the past 60 days. SWAV has gained 23.2% so far this year.ShockWave Medical delivered an earnings surprise of 189.99%, on average, in the last four quarters.Alkermes’ earnings per share estimates have improved from loss of 17 cents to earnings of 20 cents for 2022 and from 31 cents to 33 cents for 2023 in the past 60 days. ALKS has gained 8.9% so far this year.Alkermes delivered an earnings surprise of 350.48%, on average, in the last four quarters. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2021. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alkermes plc (ALKS): Free Stock Analysis Report Glaukos Corporation (GKOS): Free Stock Analysis Report Lantheus Holdings, Inc. (LNTH): Free Stock Analysis Report ShockWave Medical, Inc. (SWAV): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksAug 4th, 2022

Founder and CEO of biotech company Nuritas is keeping the company"s mission fixed on "learning the language of life" to bring molecular food science to new heights

Founder and CEO of biotech company Nuritas said, "Technology is everywhere, but its success and failure will depend on its full integration and capability to perform a helpful task." BI GraphicsNuritas Nora Khaldi is the founder and CEO of Nuritas, a biotech company using proprietary AI technology to discover and develop plant-based bioactive peptides. Khaldi explained that Nuritas' approach to innovation is its focus on "learning the language of life." This article is part of Innovation Leaders, a series examining how business leaders view their role in driving tech innovation. Nuritas is a biotech company using proprietary AI technology to discover and develop plant-based bioactive peptides. Nuritas has amassed the world's largest peptide library with more than 5.2 million discovered and works with companies including Nestle, Mars, Sumitomo Corporation, Metagenics, Pharmavite, and more. Founder and CEO Nora Khaldi was named Woman of the Decade by the Women Economic Forum and inducted into World Economic Forum's Young Global Leaders and sits on the European Institute of Innovation and Technology (EIT) Governing Board. In a recent interview with Insider, Khaldi explained how she approaches innovative thinking to drive the company beyond expectations and meet new challenges: What is the biggest business challenge you're facing at the moment and how are you tackling it?We just announced that we are expanding to the US and building our new headquarters in Connecticut, near Yale University. Nuritas was founded in Ireland, so not only are we breaking new ground in a new country, we are coordinating a transatlantic move. I will also be relocating to oversee the expansion.  Nuritas is the innovation partner for many US companies with a mission to help them develop greener and safer products that bring natural efficacy to a new level, and we partner with leading food and pharma companies including Nestle, Mars, Sumitomo Corporation, Pharmavite, and Zero Day Nutrition. These and many more of our existing operational partners are located in the US, which factored into our decision to locate there. This further expansion will only help us in our collaborations while also allowing us to tap into the kind of talent we need to continue our growth, commercialization, and expansion.What products do you have in the pipeline?We've developed a sustainable, plant-based solution that can maintain muscle function for longer. It not only adds to the building blocks of muscle, but it can also repair the muscle—something the current, animal-based standard of care cannot do as well. Our plant-based solution is more efficacious, helping to make muscles younger and healthier. This is important across all aspects of life - from faster recovery after exercise for athletes, to maintaining lean muscle and strength during menopause.We are also working to bring a peptide we've discovered to market which can improve glucose metabolism and reduce signs of pre-diabetes. This is critically important, as diabetes is one of  the biggest epidemics in the world, with more than 420 million patients globally.What tech systems are you prioritizing in your budget plans?Our primary technology platform is the Nπϕ™ (Nuritas Peptide Finder). By leveraging AI, it can identify and develop new bioactive compounds within months rather than years, expediting the discovery process and surpassing traditional methods while significantly reducing costs.Our technology unlocks the language of nature, rapidly and efficiently targeting, predicting and revealing bioactive ingredients hidden within plants and natural food sources. These discoveries provide our partners with groundbreaking opportunities to treat and prevent existing and emerging diseases and meet the challenges of a changing world. We've been developing and refining this proprietary technology platform since 2014, discovering nearly 5.2m peptides, participating in 12 human trials and 15 scientific publications, collaborating with some of the largest global food and science companies and creating and launching three proprietary ingredients.Our state-of-the-art lab testing facility pioneered the Peptidomic Method Development, and we now offer the largest natural library of peptides in the world. With 50,000 peptides tested every week, Nuritas delivers 63% biological accuracy, 80% bioavailability accuracy, and 92% cell penetration accuracy, solving for many of the previously perceived problems associated with peptide use. As we continue our expansion, we continue to prioritize further optimization and development of Nπϕ. We anticipate that our new headquarters will also continue our tradition of pioneering new technologies and methods for peptide discovery.Who do you partner with internally and externally to drive business and tech decisions?Internally, we've built a team of 50+ innovators with 860 years of cumulative research experience between them. Together, we decide which of our massive library of peptides is worth developing further and commercialising, as well as where to direct our resources and research.Externally, we've been working with Yale Ventures and AdvanceCT as we build our US headquarters. They are helping us choose the final location for our new headquarters, and will also help us recruit the best talent across medicine, science, and engineering. They are both connected in the innovation and entrepreneurship ecosystem in Connecticut and have a pulse on all things in that space.How excited are you about the technology of the future and what it means for your business and your sector?Technology is everywhere, but its success and failure will depend on its full integration and capability to perform a helpful task. When it comes to nutrition and food, very little integration has been achieved to date. Today's technologies — and the developments in AI and ML –  can help us see nature differently and bring molecular food science to new heights. The products AI is helping us create have so many potential applications, and that is what makes what we do so exciting and inspiring. We have learned how to speak the language of life, finding unique peptides that are hidden and embedded within proteins and helping the human body to use them more efficiently.Read the original article on Business Insider.....»»

Category: topSource: businessinsiderJul 26th, 2022

Pharma Stock Roundup: MRK Buys Cancer Drug Rights, SNY Dupixent Kids Study Succeeds

Merck (MRK) buys co-development rights to prostate cancer candidate. FDA grants full approval to Pfizer's (PFE) COVID-19 vaccine for adolescents. This week, Merck MRK in-licensed co-development rights to Orion Corporation’s prostate cancer candidate. The FDA granted full approval toPfizer’s PFE COVID-19 vaccine for adolescents aged 12-15 years. Sanofi SNY and partner Regeneron’s REGN Dupixent showed the potential to improve signs of eosinophilic esophagitis (EoE) in a phase III pivotal study in children 1 to 11 years of age.Recap of the Week’s Most Important StoriesFDA’s Full Approval to Pfizer’s Comirnaty for Adolescents: The FDA approved Pfizer/BioNTech’s supplemental biologics license application, which sought full approval for Comirnaty in adolescents aged between 12 years and 15 years. The FDA had previously granted emergency use authorization to the Pfizer/BioNTech vaccine for use in this age group.Comirnaty currently enjoys full approval for use in individuals aged 16 years and above, granted by the FDA last August. Following this label expansion, Comirnaty is the first and currently the only COVID-19 vaccine to have received full approval for use in individuals aged 12 years and older.Pfizer/BioNTech submitted a variation to the European Medicines Agency requesting the agency to update the Conditional Marketing Authorization in the European Union for Comirnaty (3-µg dose) to allow its use in children 6 months to less than 5 years of age.Merck Buys Rights to Co-Develop Orion Corporation’s Prostate Cancer Candidate:  Merck signed a licensing deal with Finnish pharmaceutical company, Orion Corporation, for ODM-208, the latter’s investigational steroid synthesis inhibitor in a phase II study for the treatment of metastatic castration-resistant prostate cancer. Merck will make an upfront payment of $290 million to Orion for co-development and co-commercialization rights to ODM-208.The deal also includes an option for Merck to acquire a global exclusive license to ODM-208 compared to the present co-development and co-commercialization agreement.Sanofi’s Dupixent Meets Goal in Eosinophilic Esophagitis Kids Study: Sanofi and partner Regeneron’s Dupixent showed potential to improve signs of eosinophilic esophagitis in a phase III pivotal study in children 1 to 11 years of age. The study met its primary endpoint of histological disease remission at 16 weeks. In the study, 68% of children given the higher dose of Dupixent and 58% of those on the lower dose achieved the primary endpoint compared to 3% of children on placebo.Dupixent was approved to treat adults and children aged 12 and older with EoE, a chronic, progressive inflammatory disease, in May. Dupixent is the first and only medicine indicated for eosinophilic esophagitis in the United States. The medicine is however not yet approved to treat EoE in children under 12 years of age.The NYSE ARCA Pharmaceutical Index declined 2.0% in the last five trading sessions.Large Cap Pharmaceuticals Industry 5YR % Return Large Cap Pharmaceuticals Industry 5YR % ReturnHere’s how the eight major stocks performed in the last five trading sessions.Image Source: Zacks Investment ResearchIn the last five trading sessions, Merck rose the most (0.9%) while Pfizer declined the most (3.8%).In the past six months, Lilly rose the most (33.9%) while Roche declined the most (17.6%).(See the last pharma stock roundup here: AZN’s Small Cancer Firm Buyout, FDA Updates for PFE, RHHBY)What's Next in the Pharma World?Keep a tab on J&J’s Q2 earnings and regular pipeline and regulatory updates next week. Zacks Names "Single Best Pick to Double" From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all. It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time. This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.Free: See Our Top Stock and 4 Runners Up >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report Sanofi (SNY): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksJul 15th, 2022

Ionis (IONS), AstraZeneca"s Amyloidosis Drug Meets Study Goals

Ionis (IONS), along with partner AstraZeneca, reports positive data from a phase III study, which is evaluating eplontersen in hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). Ionis Pharmaceuticals IONS announced positive top-line data from the phase III NEURO-TTRansform study on its investigational anti-sense drug eplontersen in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). The candidate is being developed in partnership with AstraZeneca AZN.Data from the 35-week interim analysis of the NEURO-TTRansform study showed that eplontersen had a positive impact on disease progression in study participants who were treated with it. A large number of study participants treated with the drug also showed improvements in neuropathy impairment and quality of life.The study met its co-primary and secondary endpoints.It achieved its first co-primary endpoint of eplontersen achieving a statistically significant and clinically meaningful improvement in percent change in serum transthyretin (“TTR”) concentration.The study met another co-primary endpoint of change in the modified Neuropathy Impairment Score +7 (mNIS+7) with statistical significance in participants who were administered the drug compared to those who received placebo. The mNIS+7 is a measure of neuropathic disease progression.The study also achieved its secondary endpoint by demonstrating that eplontersen led to a statistically significant and clinically meaningful improvement inchange from the baseline in the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QoL-DN). Attaining this endpoint shows that the treatment with the drug improved patient-reported quality of life,as compared to the patients who were treated in the placebo group.Based on these results, Ionis and AstraZeneca plan to file a new drug application, seeking marketing approval for eplontersen in ATTRv-PN.In the year so far, shares of Ionis have risen 15.9% against the industry’s 27.1% decline.Image Source: Zacks Investment ResearchThe final primary endpoint analysis of the NEURO-TTRansform study will be completed at week 66. Ionis and AstraZeneca are also developing eplontersen as a potential treatment for amyloid transthyretin cardiomyopathy (ATTR-CM) in the phase III CARDIO-TTRansform study.AstraZeneca and Ionis entered into a strategic collaboration last December to develop and commercialise eplontersen for the treatment of transthyretin amyloidosis. AstraZeneca and Ionis are jointly responsible for developing and marketing the drug in the United States. However, AstraZeneca will have exclusive global rights to develop and commercialize the drug outside the country (excluding Latin America).Other than AstraZeneca, Ionis has partnerships with many pharma giants like Biogen BIIB and Novartis NVS. These partnerships enable IONS to enjoy diverse revenue streams, which include commercial products and royalties as well as numerous sources of collaborative and R&D revenues.Biogen and Ionis are collaborating on developing advanced treatments for neurological disorders. Ionis has licensed Spinraza to Biogen, which is approved for treating spinal muscular atrophy in pediatric and adult patients. While BIIB is responsible for commercializing Spinraza worldwide, Ionis receives royalties from Biogen on Spinraza’s sales.The company is developing another pipeline candidate, pelacarsen, in collaboration with Novartis. Ionis and Novartis are evaluating pelacarsen in the ongoing phase III cardiovascular outcome study, HORIZON, in patients with established cardiovascular disease and elevated lipoprotein(a), or Lp(a). Novartis is responsible for leading the global development and commercialization activities for the candidate.Ionis Pharmaceuticals, Inc. Price Ionis Pharmaceuticals, Inc. price | Ionis Pharmaceuticals, Inc. QuoteZacks RankIonis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Zacks Names "Single Best Pick to Double" From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all. It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time. This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.Free: See Our Top Stock and 4 Runners Up >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN): Free Stock Analysis Report Novartis AG (NVS): Free Stock Analysis Report Biogen Inc. (BIIB): Free Stock Analysis Report Ionis Pharmaceuticals, Inc. (IONS): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksJun 21st, 2022

PepGen Reports First Quarter 2022 Financial Results and Recent Corporate Developments

BOSTON, June 16, 2022 (GLOBE NEWSWIRE) -- PepGen Inc. ("PepGen"), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the first quarter ended March 31, 2022. "This has been a year of tremendous growth for PepGen, culminating in our recent transition to a clinical stage company and execution of a successful initial public offering," stated James McArthur, Ph.D., President and CEO of PepGen. "We are continuing to drive our programs forward, and in April of this year we entered the clinic with PGN-EDO51, our lead program for the treatment of individuals with Duchenne muscular dystrophy (DMD) who are amenable to an exon 51 skipping approach. We look forward to reporting safety, pharmacokinetic and exon skipping data from our Phase 1 healthy normal volunteer study of PGN-EDO51 by the end of 2022 – this will be an important milestone in our efforts to advance this therapy for patients in desperate need of more effective treatment options." Recent Corporate Highlights In May, PepGen completed an initial public offering, raising $122.9 million in gross proceeds before deducting underwriting discounts and offering expenses. In April, PepGen dosed the first healthy normal volunteer (HNV) adult male in a Phase 1 clinical trial of PGN-EDO51 for the treatment of individuals with Duchenne muscular dystrophy (DMD) who are amenable to an exon 51 skipping approach. In March, PepGen received clearance from Health Canada of its Clinical Trial Application to initiate the Company's first-in-human trial of PGN-EDO51. PepGen has made several key appointments during recent months, including Laurie Keating as Chair of the Board of Directors; Michelle Mellion, M.D., as Senior Vice President, Head of Clinical Development; Jennifer Cormier as Senior Vice President, Clinical Operations; and Jeffrey Foy, Ph.D. as Vice President, Toxicology. Anticipated Upcoming Milestones PGN-EDO51: PepGen anticipates presenting safety and tolerability, pharmacokinetic and exon 51 skipping data from a Phase 1 HNV trial of PGN-EDO51 for the treatment of DMD by the end of 2022. PGN-EDODM1: PepGen anticipates submitting an IND application for PGN-EDODM1 to the U.S. Food and Drug Administration (FDA) in the first half of 2023 to initiate a Phase 1/2 clinical trial in myotonic dystrophy type 1 (DM1) patients. Additional Pipeline Assets: PepGen expects to report non-human primate (NHP) exon skipping data for PGN-EDO53, the company's second DMD program for the treatment of exon 53 skipping amenable patients, in the second half of 2022. Additionally, the Company plans to nominate candidates for PGN-EDO45 and PGN-EDO44, which target the exon 45 and exon 44 DMD patient populations respectively, in the second half of 2022. Financial Results for the Three Months Ended March 31, 2022 Cash and cash equivalents were $118.9 million as of March 31, 2022, which excludes the proceeds from our IPO in May 2022. The Company expects that current cash and cash equivalents, including net proceeds from the initial public offering, to be sufficient to fund currently planned operating expenses into the first half of 2025. Research and Development expenses were $10.7 million for the three months ended March 31, 2022, compared to $5.5 million for the same period in 2021. The increase in research and development expenses was primarily due to preclinical and manufacturing costs in the lead-up to the Company's initiation of its Phase 1 HNV trial of EDO51, and preclinical activities for the Company's earlier-stage assets. General and Administrative expenses were $3.2 million for the three months ended March 31, 2022, compared to $1.1 million for the same period in 2021. The increase in general and administrative expenses was primarily due to personnel, legal, and finance-related costs to support public company operations. Net loss was $18.2 million, or $18.94 per share, for the three months ended March 31, 2022. About PepGen PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen's Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of the presentation of data from the ongoing Phase 1 study of PGN-EDO51, the filing of an IND application for PGN-EDODM1, the reporting of non-human primate data for PGN-EDO53 and the nomination of development candidates; and statements about our clinical and pre-clinical programs, product candidates, expected cash runway, achievement of milestones, and corporate and clinical/pre-clinical strategies. Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may fail to successfully complete our Phase 1 trial for EDO51 and pre-clinical studies of other product candidates and obtain required approval before commercialization; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning PepGen's programs and operations are described in its registration statement on Form S-1, which is on file with the SEC, and in its most recent quarterly report on Form 10-Q to be filed with the SEC. PepGen explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Investor ContactLaurence Watts Gilmartin GroupLaurence@gilmartinir.com  Media ContactGwendolyn SchankerLifeSci Communications(269) 921-3607gschanker@lifescicomms.com Condensed Consolidated Statements of Operations(unaudited)     Three Months EndedMarch 31,    2022     2021  Operating expenses:       Research and development $ 10,707     $ 5,530   General and administrative   3,186       1,098   Total operating expenses $ 13,893     $ 6,628   Operating loss.....»»

Category: earningsSource: benzingaJun 16th, 2022

4 Biotech Stocks With Bright Prospects to Buy Amid Recovery

New drug approvals and development of treatments for COVID-19 should maintain momentum for the Zacks Biomedical and Genetics industry. A strong portfolio and pipeline progress position ALKS, GERN, IMCR and BLU well amid the volatility. New drug approvals, acquisitions and other pipeline developments are back in the spotlight in the biotech industry, following the focus on the development of vaccines and antibody treatments for COVID-19 in the last two years. While the emergence of new variants of COVID-19 will ensure that companies focus on innovative treatments, most companies in the sector are looking to bolster their product portfolio through collaborations and acquisitions and pipeline development.Some biotech companies like Alkermes ALKS, Geron GERN, Immunocore IMCR and BELLUS Health Inc. BLU are well poised on a solid portfolio and pipeline progress.   Industry DescriptionThe Zacks Biomedical and Genetics industry includes biopharmaceutical and biotechnology companies that develop high-profile drugs using path-breaking technology. These biologically processed drugs, which address virology, neuroscience, metabolism and rare diseases, are manufactured using live organisms. The main goal of biotech companies is to use innovative technology to create breakthrough treatments. Quite a few companies in this space work on vaccines as well. Given the dynamic and evolving nature of technology, the sector is perceived to be riskier than the more stable large-cap pharma or drug industry.4 Trends Shaping the Future of Biotech IndustryInnovation, Execution Hold the Key: As only a few companies in this industry have approved drugs in their portfolio, the focus is primarily on the performance of these high-profile drugs and pipeline development. Most companies spend millions and billions to create a drug with path-breaking technology, which leads to significant research & development expenditure. Hence, it takes several years before a biotech company turns profitable. Additionally, successful commercialization is key to higher drug uptake as smaller biotechs generally lack the funds and expertise to execute the same. This, in turn, prompts collaboration deals with either pharma or biotech bigwigs, wherein sales are shared or royalties are received. Moreover, it might take quite a few years for any newly-approved drug to contribute significantly to its company’s top line.Consolidation to Fight Slowdown: Consolidation has always taken center stage in the biotech industry. This has been an important trend as leading pharma/biotech companies look to diversify their revenue base in the face of dwindling sales of high-profile drugs.  While the scale and pace of M&A activity slowed down last year due to the pandemic, the pace has picked up of late as biotech bigwigs like Gilead, Bristol Myers, among others, are evidently on the lookout to bolster their portfolios. While oncology and immuno-oncology are the key focus areas, treatments for rare diseases and gene-editing companies also promise potential, making them lucrative investment areas. Moreover, companies investing in mRNA technology are gaining a lot of attention, given the success of the technology in the development of COVID-19 vaccines.  An attractive pipeline candidate is a key lure for these companies, and cost synergies in research and development are an added benefit as quite a few smaller biotech companies are using innovative technologies to develop drugs and treatments.Opportunities Created by the Pandemic:  Though the onset of the COVID-19 pandemic impacted demand for drugs, it has turned out to be a growth opportunity for the companies in the biotech sector to develop innovative treatments for COVID-19. The successful development of treatments in such a short period has resulted in massive incremental revenues for these companies, which have developed vaccines, antibody treatments and antivirals for this disease. The emergence of new variants of the virus should keep the momentum going.Pipeline Setbacks & Competition: Pipeline setbacks are a key deterrent for biotech companies, given the exorbitant cost of developing drugs using expensive technology. Most drugs/therapies take years to gain a regulatory nod. An unfavorable outcome from a crucial trial on a promising candidate is a huge setback. The leading biotechs also face other headwinds like a decline in the sales of high-profile drugs due to intensifying competition. Zacks Industry Rank Indicates Encouraging ProspectsThe group’s Zacks Industry Rank is basically the average of the Zacks Rank of all the member stocks.The Zacks Biomedical and Genetics industry currently carries a Zacks Industry Rank #105, which places it among the top 42% of more than 252 Zacks industries, mirroring a bright outlook for the space, probably due to the economic recovery. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.Before we present a few biotech stocks that are well-positioned to beat the industry based on a strong portfolio/pipeline, let’s take a look at the industry’s stock market performance and current valuation. Industry Versus S&P 500 & SectorThe Zacks Biomedical and Genetics industry is a 710-stock group within the broader Zacks Medical sector. It has underperformed the S&P 500 Index and the Zacks Medical sector in the year so far.While the stocks in this industry have declined 25.4%, the Zacks Medical sector has lost 15.2%. The S&P 500 composite has lost 19.1% during this time frame.                                  Year-To-Date Performance Industry's Current ValuationSince most companies in the biotech sector do not have approved drugs, valuing these companies becomes a complex process. On the basis of the trailing 12-month price-to-sales ratio (P/S TTM), which is commonly used for valuing biotech companies with approved portfolios of drugs, the industry is currently trading at 2 compared with the S&P 500’s 3.88 and the Zacks Medical sector's 2.23.Over the last five years, the industry has traded as high as 3.86X, as low as 1.90X and at a median of 3.06X, as the chart below shows.                                                  Price/Sales TTM 4 Biotech Stocks Worth to Keep an Eye on Alkermes holds a diversified product portfolio and a promising pipeline of candidates targeting major central nervous system (CNS) disorders, including schizophrenia, depression, addiction and multiple sclerosis. Proprietary products, Vivitrol and Aristada, some partnered products – Vumerity, Risperdal Consta, Invega Sustenna/Xeplion, and Invega Trinza/Trevicta, continue to do well.   The FDA approval of Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia and adults who have bipolar I disorder has further broadened Alkermes’ portfolio. The consensus loss estimates for 2022 have narrowed to 3 cents from 14 cents over the past 60 days. Alkermes currently carries a Zacks Rank #2 (Buy).  The company's shares have gained 20.9% in the year so far.You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.                      Price and Consensus: ALKSGeron is developing imetelstat, a novel, first-in-class telomerase inhibitor, in hematologic malignancies. Data from phase II studies provide evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. The candidate has been granted Fast Track designation by the FDA for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. The successful development of the candidate will be a significant boost for Geron.Geron’s consensus loss estimates for 2022 have narrowed to 37 cents from 44 cents over the past 60 days. The company currently has a Zacks Rank #2. Its shares have gained 20.9% in the year so far.                          Price and Consensus: GERNImmunocore Holdings plc is a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases. The company’s most advanced oncology TCR therapeutic, Kimmtrak (tebentafusp-tebn), has been approved by the FDA for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). The drug has been recently approved by the European Commission. The company has entered into a collaboration and supply agreement with French pharma giant, Sanofi. Strategic collaborations like these will boost pipeline progress.IMCR’s consensus loss estimates for 2022 have narrowed to $2.78 from $4.22 over the past 60 days. The company currently has a Zacks Rank #2.                      Price and Consensus: IMCRBELLUS Health Inc. is a clinical-stage biopharmaceutical company developing BLU-5937, its highly selective, second-generation P2X3 antagonist product candidate for the treatment of refractory chronic cough (RCC). The company intends to have an end-of-phase II meeting with the FDA later in the month. During this meeting, BELLUS Health intends to discuss its planned phase III program, which it expects to initiate in the second half of 2022.  The company expects to initiate a phase I trial investigating a once-daily, extended-release formulation of BLU-5937 in the second half of the year.BLU’s consensus loss estimates for 2022 have narrowed to 76 cents from 87 cents over the past 60 days. The company currently has a Zacks Rank #2. Its shares have gained 1.9% in the year so far.                    Price and Consensus: BLU  Just Released: Zacks Top 10 Stocks for 2022 In addition to the investment ideas discussed above, would you like to know about our 10 top picks for the entirety of 2022? From inception in 2012 through 2021, the Zacks Top 10 Stocks portfolios gained an impressive +1,001.2% versus the S&P 500’s +348.7%. Now our Director of Research has combed through 4,000 companies covered by the Zacks Rank and has handpicked the best 10 tickers to buy and hold. Don’t miss your chance to get in…because the sooner you do, the more upside you stand to grab.See Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Geron Corporation (GERN): Free Stock Analysis Report Alkermes plc (ALKS): Free Stock Analysis Report Bellus Health Inc. (BLU): Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksJun 10th, 2022

Sanofi (SNY) Gets Breakthrough Therapy Tag for Hemophilia A Drug

The FDA bestows a Breakthrough Therapy designation to Sanofi's (SNY) efanesoctocog alfa for the treatment of people with hemophilia A. Sanofi SNY announced that the FDA has granted Breakthrough Therapy designation to its novel recombinant factor VIII therapy, efanesoctocog alfa (BIVV001), for the treatment of people with hemophilia A.A Breakthrough Therapy status is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.The Breakthrough Therapy tag was granted based on data from the phase III XTEND-1 study that evaluated efanesoctocog alfa for the treatment of hemophilia A, a rare and fatal bleeding disorder.Sanofi is collaborating with Swedish Orphan Biovitrum (Sobi) for the development and commercialization of efanesoctocog alfa.In March 2022, Sanofi and Sobi announced that the phase III study, XTEND-1, investigating efanesoctocog alfa for treating hemophilia A, met its primary as well as secondary endpoints.Data from the XTEND-1 study will support regulatory application submissions across the globe, including the FDA, in mid-2022. A European regulatory application will be filed in 2023 following the availability of data from an ongoing pediatric study — XTEND-Kids.Sanofi’s shares have gained 6.2% so far this year compared with the industry’s increase of 5.3%.Image Source: Zacks Investment ResearchSeveral approved replacement therapies for hemophilia A are available in the market, including Roche’s RHHBY Hemlibra.RHHBY has seen strong uptake for Hemlibra since its launch.Roche is developing a factor VIII gene transfer treatment for hemophilia A in a phase I/II study. Roche added the investigation of the hemophilia gene therapy with the acquisition of Spark Therapeutics in 2019.Several pharma/biotech companies like Roche, BioMarin and Pfizer are also developing novel gene therapies targeting the inherited disorder.Zacks Rank & Stocks to ConsiderSanofi currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Leap Therapeutics, Inc. LPTX and Aeglea BioTherapeutics, Inc. AGLE, both carrying Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.AegleaBio Therapeutics’ loss per share estimates narrowed 19.4% for 2022 and 30.2% for 2023 in the past 60 days.Earnings of AegleaBio Therapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AGLE delivered an earnings surprise of 9.47%, on average. Zacks Names "Single Best Pick to Double" From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all. It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time. This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.Free: See Our Top Stock and 4 Runners Up >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report Roche Holding AG (RHHBY): Free Stock Analysis Report Aeglea BioTherapeutics, Inc. (AGLE): Free Stock Analysis Report Leap Therapeutics, Inc. (LPTX): Free Stock Analysis Report To read this article on Zacks.com click here......»»

Category: topSource: zacksJun 2nd, 2022

Alpha Tau Medical Announces First Quarter 2022 Financial Results and Provides Corporate Update

-Debuted as publicly-traded oncology company in March 2022 under symbol DRTS while raising approximately $104 million in gross proceeds- -Targeted start of U.S. multi-center pivotal trial in skin cancers in the middle of 2022- JERUSALEM, May 26, 2022 /PRNewswire/ -- Alpha Tau Medical Ltd. (NASDAQ:DRTS) (NASDAQ: DRTSW), ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, reported first quarter 2022 financial results and provided a corporate update. "2022 is an important year for the Company, as we look to initiate a number of important clinical trials across large global markets, including our first U.S. pivotal trial as well as trials in internal organs such as the prostate," commented Alpha Tau CEO Uzi Sofer. "The first quarter of 2022 already saw us reach a number of meaningful milestones, including our first U.S. data read out and our debut as a public company traded on NASDAQ under symbol "DRTS." We are also working in parallel to expand our manufacturing capabilities and to strengthen our supply chain in the U.S., Israel, and Asia, as part of the expansion of our clinical trial activities and future commercialization." First quarter 2022 Corporate Highlights: Reported results in January 2022 from the first pilot multi-center study of Alpha DaRT in the United States, led by Memorial Sloan Kettering Cancer Center. In this trial of malignant skin and soft tissue cancer patients, a complete response, as measured by RECIST criteria, was observed in all ten out of ten tumors treated (100%), with no product-related serious adverse events reported. Alongside these data, a 98% overall response rate was observed in a pooled analysis of superficial tumors treated that reached their efficacy endpoint measurement by quarter end, across the Company's various trials. Completed patient recruitment in the Company's Japanese pivotal trial in head and neck cancer, with data submission targeted for the second half of 2022. Entered into a sponsored research agreement with investigators at The University of Texas MD Anderson Cancer Center in January 2022 to evaluate the combination of Alpha DaRT with DNA-repair inhibitors and immune checkpoint inhibitors for the treatment of breast tumors. Completed its business combination in March 2022 with Healthcare Capital Corp., a special purpose acquisition company, together with a concurrent Private Investment in Public Equity (PIPE) financing, raising a total of approximately $104 million in gross proceeds, and commenced trading of its shares and warrants on the Nasdaq Capital Market under the symbols "DRTS" and "DRTSW", respectively. Appointed Ruth (Ruti) Alon to its Board of Directors in March 2022. Ms. Alon brings a wealth of healthcare experience and serves on the boards of multiple private and public companies in the sector. Upcoming 2022 Milestone Targets Include: First Israeli patient in the prostate cancer feasibility trial in the second quarter of 2022. Initiation of multi-center pivotal U.S. trial in skin cancers in the middle of 2022. Recruitment in the Canadian feasibility trial in pancreatic tumors to begin in the second half of 2022. Submission of Alpha DaRT pivotal trial in head and neck cancer to Japan's PMDA in the second half of 2022 for marketing authorization. Financial results for the first quarter ended March 31, 2022 R&D expenses for the quarter ended March 31, 2022 were $5.2 million, compared to $2.2 million for the same period in 2021, primarily due to increased R&D activity and increased share-based compensation costs. Marketing expenses for the quarter ended March 31, 2022 were $0.2 million, compared to $0.2 million for the same period in 2021. G&A expenses for the quarter ended March 31, 2022 were $3.3 million, compared to $0.4 million for the same period in 2021, primarily due to costs associated with the merger with Healthcare Capital Corp., increased professional fees and share-based compensation. Financial expenses, net, for the quarter ended March 31, 2022 were $17.0 million, compared to $9.0 million for the same period in 2021, primarily due to an increase in the revaluation of warrants. For the quarter ended March 31, 2022, the Company had a net loss of $25.7 million, or ($0.54) per share, compared to a loss of $11.7 million, or ($0.29) per share, in the same period in 2021. Balance Sheet Highlights As of March 31, 2022, the Company had cash and cash equivalents, restricted cash and short term deposits in the amount of $107.0 million, compared to $31.9 million on December 31, 2021. In addition, incremental proceeds of approximately $13 million from the original PIPE were received after March 31, 2022. The Company expects that this cash balance will be sufficient to fund operations for at least two years. In addition, the Company's Board of Directors approved a program for the buyback of the Company's publicly traded warrants in an amount of up to $3 million. Repurchases may be started or suspended at any time without prior notice, depending on market conditions and other factors. About Alpha DaRT™ Alpha DaRT™ (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral insertion of radium-224 impregnated seeds. When the radium decays, its short-lived daughters are released from the seed, and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.  About Alpha Tau Medical, Ltd. Founded in 2016, Alpha Tau is an Israeli medical device company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; (xix) impacts from the COVID-19 pandemic; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's Annual Report on Form 20-F filed with the SEC on March 28, 2022, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release. Investor Relations Contact:IR@alphatau.com   CONSOLIDATED BALANCE SHEETS  U.S. dollars in thousands March 31, 2022 December 31, 2021 Unaudited Audited ASSETS CURRENT ASSETS: Cash and cash equivalents $      98,071 $     23,236 Restricted cash 837 618 Short-term deposits 8,092.....»»

Category: earningsSource: benzingaMay 26th, 2022

Moderna (MRNA) Beats on Q1 Earnings, to Start Two Late Studies

Moderna's (MRNA) Spikevax sales beat expectations. The company plans to start late-stage studies for Omicron-containing bivalent booster and seasonal flu vaccines later this year. Stock gains in pre-market. Moderna Inc. MRNA reported earnings of $8.58 per share for the first quarter of 2022, comfortably beating the Zacks Consensus Estimate of $5.18. The company had reported earnings of $2.84 per share in the year-ago quarter. The significant improvement in the bottom line was driven by strong year-over-year growth in revenues.Revenues in the quarter were $6.1 billion, significantly beating the Zacks Consensus Estimate of $4.50 billion. In the year-ago quarter, revenues were $1.93 billion. The significant increase in revenues was driven by the strong sales of its COVID-19 vaccine, Spikevax, and its booster doses.Moderna’s shares were up 4% in pre-market trading on May 4, following strong quarterly results. Shares of the company have declined 42.3% so far this year compared with the industry’s 21.4% decrease.Image Source: Zacks Investment ResearchQuarter in DetailsProduct sales, entirely from the COVID-19 vaccine, were $5.93 billion during the quarter. In the fourth quarter of 2021, product sales were $6.94 billion. The company had recorded product sales of $1.73 billion in the year-ago period.Grant revenues were $126 million compared with $194 million in the year-ago quarter. Collaboration revenues were $15 million compared with $10 million in the year-ago quarter. The company earns collaboration revenues from agreements with several big pharma/biotech companies, including AstraZeneca AZN, Merck MRK and Vertex Pharmaceuticals VRTX.Selling, general and administrative expenses were $268 million, compared with $77 million in the year-ago quarter. The significant increase was primarily due to an endowment to the Moderna Charitable Foundation along with an increase in certain commercialization costs.Research & development expenses were $554 million, up 38.2% from the year-ago period. The significant increase was primarily attributable to higher clinical costs, personnel-related cost, technology and facility-related costs, and a few others.The company ended the quarter with $19.3 billion in cash and cash equivalents, compared with $17.6 billion as of Dec 31, 2021.2022 GuidanceModerna stated that it has advance purchase agreements with different countries for Spikevax and its booster doses worth approximately $21 billion. The company believes that sales will be slightly higher in the second half of 2022 compared to the first half.The company expects R&D and SG&A expenses to be approximately $4 billion in 2022. It expects capital expenditure to be in the range of $600 million to $800 million.In February 2022, Moderna authorized a share repurchase program of $3 billion. It completed its previous share repurchase program, initiated during the third quarter of 2021, of $1 billion in January.Coronavirus Vaccine UpdateIn January, the FDA approved Moderna’s biologics license application for its COVID-19 vaccine, mRNA-1273. The company also received emergency use authorization (EUA) from the FDA for the use of its second booster dose in adults aged 50 years or older as well as in all adults with certain kinds of immunocompromise in March.The Committee for Medicinal Products for Human Use (CHMP) recommended the conditional marketing authorization for the use of Spikevax in children aged 6 to 11 years in February. In March, Canada’s government authorized the use of Spikevax in similar individuals.In April, Moderna submitted regulatory applications in the United States and Europe, seeking emergency/conditional authorization for the use of Spikevax in children aged six months to six years. The company had previously initiated filing an EUA with the FDA for the use of Spikevax in children aged 6 to 11 years.However, the authorization of mRNA-1273 for use in adolescents is pending in the United States. The authorization for the younger population is likely to happen after potential approval to the EUA request for adolescents.A phase II/III study is evaluating Moderna’s bivalent booster candidate targeting Omicron and the original COVID-19 strain. The company expects initial data from the study in June and plans to start the phase III portion later in 2022. A phase II study evaluating the Omicron-specific booster candidate is ongoing.Other Key Pipeline UpdatesModerna has several other mRNA-based pipeline candidates targeting different indications in its pipeline. The leading candidates among them are mRNA-1345 and mRNA-1647, evaluated in pivotal studies as a respiratory syncytial virus (RSV) vaccine and a cytomegalovirus (CMV) vaccine, respectively.During the first quarter, Moderna initiated a phase III study to evaluate its CMV vaccine candidate. An ongoing pivotal phase III study is evaluating the RSV vaccine candidate.The company has reported promising initial data from a phase II study evaluating its seasonal flu vaccine candidate, mRNA-1010. The company plans to start a phase III study in the Southern Hemisphere during the second quarter to evaluate the safety and immunogenicity of mRNA-1010. It may also start a late-stage study to evaluate the candidate’s efficacy during Fall 2022, if needed.The FDA has approved its investigational new drug application for its Nipah-virus vaccine candidate, mRNA-1215. A clinical study may begin soon.Menawhile, we note that Moderna has regained all rights to its mutant KRAS vaccine, mRNA-5671, from its partner, Merck. Moderna is evaluating the next steps for the program. Currently, Merck is conducting a phase I study on mRNA-5671 as monotherapy or in combination with its anti-PD 1 drug, Keytruda. Please note that Moderna continues to develop a personalized cancer vaccine candidate in collaboration with Merck.Moderna is also developing different candidates in collaboration with AstraZeneca. The candidate under the collaboration with AstraZeneca is in early- to mid-stage studies targeting oncology and cardiovascular indications. The leading candidate being developed in partnership with AstraZeneca is AZD8601 as a treatment for ischemic heart disease in a phase II study.Moderna is developing an mRNA therapeutic in collaboration with Vertex. Moderna and Vertex are developing the candidate to treat the underlying cause of cystic fibrosis. Vertex is planning to file an investigational new drug application to support the initiation of an early-stage clinical study in 2022.Moderna, Inc. Price, Consensus and EPS Surprise Moderna, Inc. price-consensus-eps-surprise-chart | Moderna, Inc. QuoteZacks RankCurrently, Moderna carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2021. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Vertex Pharmaceuticals Incorporated (VRTX): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksMay 4th, 2022

BeiGene (BGNE) Brukinsa Superior to Imbruvica in Leukemia Study

BeiGene (BGNE) is comparing Brukinsa to AbbVie's Imbruvica as a treatment for R/R CLL or SLL. Brukinsa achieves superior ORR versus Imbruvica in a phase III study. BeiGene, Ltd. BGNE announced that the phase III study — ALPINE — evaluating its BTK inhibitor drug, Brukinsa (zanubrutinib), for treating relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), met its primary endpoint of superiority compared to AbbVie’s ABBV popular cancer drug, Imbruvica (ibrutinib).Per the final response data from the ALPINE study, as assessed by an Independent Review Committee (IRC), Brukinsa demonstrated superiority over AbbVie’s Imbruvica in treating R/R CLL or SLL patients, measured by objective response rate (“ORR”). Data from the study, as determined by the IRC, showed that Brukinsa achieved an ORR of 80.4% versus 72.9% for AbbVie’s Imbruvica. The response data were based on patients in the study who were followed for a median of 24.2 months.Data from a previously completed interim analysis of the ALPINE data had demonstrated that Brukinsa was superior to AbbVie’s Imbruvica as measured by the investigator-assessed overall response rate.BeiGene also stated that the safety profile of Brukinsa was consistent with previous studies. The safety profile of Brukinsa seemed to be better than AbbVie’s Imbruvica. In a pre-specified safety analysis following a follow-up of a median of 24.2 months, the rate of atrial fibrillation or flutter was 4.6% for Brukinsa compared to 12% for AbbVie’s Imbruvica. Moreover, 13% of patients in the Brukinsa arm discontinued treatment due to adverse events compared to 17.6% for patients receiving Imbruvica. However, the occurrence of most commonly reported grade 3 or higher adverse events was lower for Brukinsa for pneumonia compared to Imbruvica. In contrast, neutropenia, hypertension, decreased neutrophil count and COVID-19 pneumonia were higher in the Brukinsa arm.The ALPINE study will continue to follow up patients for measuring progression-free survival (“PFS”) as the final analysis of the study. The potential superiority of Brukinsa over Imbruvica in PFS, coupled with the ORR superiority, will boost the prospect of the drug to receive an FDA approval for treating R/R CLL or SLL.Shares of BeiGene have declined 31.9% so far this year compared with the industry’s decrease of 12%.Image Source: Zacks Investment ResearchBeiGene’s Brukinsa was first approved in 2019 for treating mantle cell lymphoma (“MCL”) followed by label expansion to include Waldenström’s macroglobulinemia (“WM”) and marginal zone lymphoma (“MZL”) in 2021.We note that AbbVie’s Imbruvica is an FDA-approved therapy for treating R/R CLL or SLL. The drug is also approved for treating WM and MZL. BeiGene’s Brukinsa is likely to provide good competition to AbbVie’s Imbruvica going forward as both drugs target similar indications.Apart from Brukinsa, BeiGene has an anti-PD-1 antibody drug in its portfolio, tislelizumab, which is currently approved in China only. Tislelizumab is available in China for treating advanced squamous non-small cell lung cancer, classical Hodgkin’s lymphoma and locally advanced or metastatic urothelial carcinoma with PD-L1 high expression. BeiGene is seeking approval for the drug as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma in the United States. A decision from the FDA is expected on Jul 12, 2022.BeiGene’s promising oncology candidates and drugs and its presence in a growing market like China have attracted big pharma companies including Amgen AMGN and Novartis NVS for partnerships.In 2021, Novartis signed two agreements to gain rights to BeiGene’s pipeline candidates. Novartis signed a strategic collaboration agreement for in-licensing BeiGene’s tislelizumab in major markets outside of China. Novartis inked an option, collaboration and license agreement with BeiGene to obtain the development and commercialization rights to TIGIT inhibitor, ociperlimab, in the United States, Europe and a few other countries.Amgen and BeiGene had signed an oncology collaboration agreement in 2019. Amgen also made an investment of approximately $421 million in BeiGene in 2020. The company believes that the oncology collaboration is likely to generate enough potential for the company in China.BeiGene, Ltd. Price BeiGene, Ltd. price | BeiGene, Ltd. QuoteZacks RankBeiGene currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. 7 Best Stocks for the Next 30 Days Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops." Since 1988, the full list has beaten the market more than 2X over with an average gain of +25.4% per year. So be sure to give these hand-picked 7 your immediate attention. See them now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novartis AG (NVS): Free Stock Analysis Report Amgen Inc. (AMGN): Free Stock Analysis Report AbbVie Inc. (ABBV): Free Stock Analysis Report BeiGene, Ltd. (BGNE): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksApr 12th, 2022

Johnson & Johnson CEO On The Company’s Transformation

Following is the unofficial transcript of a CNBC interview with Johnson & Johnson (NYSE:JNJ) CEO Joaquin Duato and CNBC’s Senior Health & Science Reporter Meg Tirrell live during CNBC’s “Healthy Returns Summit: Reality, Recovery and Opportunity” today, Wednesday, March 30th. CNBC’s Interview With Johnson & Johnson CEO Joaquin Duato MEG TIRRELL: I want to bring […] Following is the unofficial transcript of a CNBC interview with Johnson & Johnson (NYSE:JNJ) CEO Joaquin Duato and CNBC’s Senior Health & Science Reporter Meg Tirrell live during CNBC’s “Healthy Returns Summit: Reality, Recovery and Opportunity” today, Wednesday, March 30th. CNBC’s Interview With Johnson & Johnson CEO Joaquin Duato MEG TIRRELL: I want to bring in now our first guest Joaquin Duato, the CEO of Johnson & Johnson. J&J of course was instrumental in the vaccine race for COVID-19. We’re going to talk about that but Joaquin first I just want to welcome you. You know first time we’ve gotten to chat since you’ve taken the CEO role in January. Thanks so much for being part of “Healthy Returns.” if (typeof jQuery == 'undefined') { document.write(''); } .first{clear:both;margin-left:0}.one-third{width:31.034482758621%;float:left;margin-left:3.448275862069%}.two-thirds{width:65.51724137931%;float:left}form.ebook-styles .af-element input{border:0;border-radius:0;padding:8px}form.ebook-styles .af-element{width:220px;float:left}form.ebook-styles .af-element.buttonContainer{width:115px;float:left;margin-left: 6px;}form.ebook-styles .af-element.buttonContainer input.submit{width:115px;padding:10px 6px 8px;text-transform:uppercase;border-radius:0;border:0;font-size:15px}form.ebook-styles .af-body.af-standards input.submit{width:115px}form.ebook-styles .af-element.privacyPolicy{width:100%;font-size:12px;margin:10px auto 0}form.ebook-styles .af-element.privacyPolicy p{font-size:11px;margin-bottom:0}form.ebook-styles .af-body input.text{height:40px;padding:2px 10px !important} form.ebook-styles .error, form.ebook-styles #error { color:#d00; } form.ebook-styles .formfields h1, form.ebook-styles .formfields #mg-logo, form.ebook-styles .formfields #mg-footer { display: none; } form.ebook-styles .formfields { font-size: 12px; } form.ebook-styles .formfields p { margin: 4px 0; } Get The Full Henry Singleton Series in PDF Get the entire 4-part series on Henry Singleton in PDF. Save it to your desktop, read it on your tablet, or email to your colleagues (function($) {window.fnames = new Array(); window.ftypes = new Array();fnames[0]='EMAIL';ftypes[0]='email';}(jQuery));var $mcj = jQuery.noConflict(true); Q4 2021 hedge fund letters, conferences and more JOAQUIN DUATO: Thank you Meg. So happy to be with you here today in this my first interview, and so proud to be the 8th CEO of Johnson & Johnson in its 135 years of history, and also the first one who is not US born for a company with such a rich global history, a legacy. TIRRELL: Well, absolutely. So, having taken the role in January, but of course, you've been with Johnson & Johnson for 33 years, I believe, what's priority number one in the top job? DUATO: Priority number one Meg is to be able to step up to the moment that we have in front of us in healthcare. I think we are in a moment of opportunity, where the combination that we are having of society recognizing the value of health, and science and technology bringing new therapies, it's gonna create more progress in health in this decade that we have seen in the last 100 years. So I'm very optimistic about the future and how Johnson & Johnson is going to step up to the moment. Now I also understand that we live in, in a difficult situation in volatile conditions. My heart goes to everybody affected by the war in Ukraine and at the same time, as you guys were discussing earlier, COVID-19 is still moving in certain regions of the world and we are monitoring the situation but overall, in taking the job, I’m convinced and filled of hope of the potential of science and technology to continue to deliver progress and how Johnson & Johnson is going to step up to the moment. TIRRELL: And you're also coming into the role at a time when J&J is embarking on a big transformation. You announced last November the plans to separate out your consumer healthcare business into its own publicly traded company. Those are of course the iconic brands that a lot of folks know J&J for, your Tylenol, Band-Aids, Listerine, things like that. So as you prepare to do that, what is the new J&J going to look like without those iconic brands? DUATO: Thank you and as you refer, that's what we do at Johnson & Johnson. We need to be able to evolve to meet the demands of our customers and patients around the globe. And we believe strongly in the rationale of creating two companies. One, our global consumer health company, which is going to be scaled to compete globally with the iconic brands that you described, like Tylenol, Aveeno, Neutrogena, Listerine, and then a new Johnson & Johnson around medtech and pharmaceuticals that is going to be focused in the patient and by combining medicines and surgical techniques is going to be at the forefront of the transformation in healthcare. So, we are very optimistic about what we are doing there. For the consumer health company, it's going to be an opportunity to deepen the relationships with consumers, to attract new investors, to inspire employees, and to be able to have a fit for purpose model, their own capital location priorities to thrive, and then for the new Johnson & Johnson is going to be an opportunity to be more focused, more competitive and to deliver increased growth. TIRRELL: Well, let's talk about some of those business units. You know, one area of focus for investors but also for other people in the healthcare world just trying to get a sense of what's happening with the pandemic. People have been looking at your medical devices business. You're always the first in the space to report earnings every quarter. And so folks look to J&J is kind of this bellwether for the health of folks going to the hospital and having surgeries and procedures. How predictable do you see that business being in the recovery of that business as we move through the pandemic and people are getting these kinds of procedures done again? DUATO: Thank you. So, we have seen a good performance, a strong performance of our medical device business in 2021, with close to 16% growth, so good performance there. Certainly, our medtech business is been affected by COVID and the reduction in elective procedures that COVID has brought. Now as we continue to move out of the pandemic and we are optimistic as you mentioned before that it will become a manageable condition as we continue to move out of the pandemic, what we see is that our medtech business is in a stronger competitive position. We have now we are now gaining share in all our priority platforms and we are poised to deliver also a good 2022 as the year continues to evolve. So, we are optimistic about the future of our medtech business. We think that the fundamentals of medtech are always there, that medtech is crucial to continue to deliver innovation for patients, improve surgical outcomes and our medtech is going to become increasing increasingly more digital, increasingly more connected, increasingly more smarter, and that's going to help surgeons to be able to deliver better surgical outcomes so very bullish about the future overall of our medtech business and our ability to become more competitive as we come out of this pandemic. TIRRELL: Well, let's talk also about your pharma business and where growth is coming from there. You know, what are the areas that you see the most exciting technologies in either inside the company or outside the company and how do you look at external opportunities like M&A, especially at a time when there's so much technology being developed? There's also so many biotech companies, it's really hard to keep track of all of these we hear from a lot of people in this space. How does J&J stay on top of all of that and how do you sort of plan for growth? DUATO: Absolutely. For us, innovation is the lifeblood of our business in everywhere in medtech, in consumer health, and in pharmaceuticals, and we invest in innovation. We increase our investment in innovation in 2021 by 23%, more than 2 billion in the middle of the pandemic. That's a sign of how much we believe in the opportunity that I was describing before of combined science and technology to deliver improvements in patient care. Focusing on our pharmaceutical business, what we have seen is a step change in our R&D productivity. In November, we had an R&D day in which we presented a lineup, a pipeline of 14 new medicines to be filed before 2025. All of them providing significant improvements in the standard of care and at the same time, all of them with more than a billion-dollar potential. What type of things are we seeing there that makes us hopeful about the future different treatment modalities make. For example, we just had the approval of CARVYKTI, which is our first cell therapy for the treatment of a type of cancer called multiple myeloma. CARVYKTI utilizes our immune system to attack the cancer cells and in the clinical trials, we were treating patients that had already had multiple lines of therapy and they were on their way to hospice and we have seen 98% responses there. So, we are very optimistic about the treatment modalities that we are bringing like cell therapy that are going to enable us, have an aspiration to be able to cure some diseases that were thought to be incurable. TIRRELL: Well, that's a great goal to have. And then just to follow up, how much are you looking externally for innovation to potentially partner or to acquire and how is the environment for acquisitions in the biotech space right now? DUATO: Thank you. External innovation has always been very important for Johnson & Johnson. Our company, as broad and as ambitious as we are, needs to look not only inside, but also outside. The best science is not always going to be inside of Johnson & Johnson and historically, our growth has come at least half, 50%, of that from external innovation. So every time we see cutting edge innovation out there, or even programs out there that may be better than our programs, we jump into action. We have a very sophisticated ecosystem to be able to identify and onboard external innovation. It can take different shapes, it can be, be partnerships, it can be, be collaborations, it can be via sometimes acquisitions. We also have, have created over time a network of incubators in which we have had more than 700 companies. We do hundreds of deals every year so external innovation is very important for Johnson & Johnson overall. Now, for the most part, our deals are things that are emerging technologies, areas in which we can create more value by utilizing our scale in discovery, in development, in manufacturing, in commercialization and many of them have translated into significant innovations. For example, we have done that with one of our largest medicines DARZALEX in multiple myeloma. Sometimes we also look at bigger M&A. We did it five years ago when we acquired Actelion. When we look at bigger acquisitions, it's more complex, and obviously, they always have to clear a higher financial barrier and more steep financial metrics. Overall, external innovation will remain a core focus for Johnson & Johnson and the important thing is to have the capability to understand where the pack is going, to understand where science is going, to be the first ones in onboarding new technologies like like cell therapy, gene therapy, that are going to transform the future of medicine and as I said before, Johnson & Johnson is going to be ready to step up to the moment. TIRRELL: Well, we're getting some great viewer questions, one of which dovetails with what the next thing I was going to ask you about, we know that you served as the Interim Chief Information Officer for J&J in 2019 and so you've got to focus on data science. Eric asks, “How are you starting to use artificial intelligence in your medtech devices and also pharmaceutical business” and I’d expand that, are artificial intelligence, data science in general, tell us about J&J’s strategy here. DUATO: Thank you. So, I had the pleasure to be the Interim CIO of Johnson & Johnson for almost a year so that gave me a great appreciation of how the combination of our increased insights into human genetics combined with artificial intelligence and machine learning can accelerate discovery and development of new medicines and I will give you some examples in a moment. But importantly, also how automation, optical recognition, machine learning, artificial intelligence can make surgeries smarter, and can help us through robotics. So, I believe that technology is going to be foundational in being able to deliver these new therapies that I was talking to you before. Let me give you some examples for, in understanding the origins of the disease. Now we can we can do genomic sequencing, and at the same time with large data sets, utilize AI and machine learning to create patterns in which we can correlate diseases with genomic profiling to identify where are going to be the underpinnings of diseases that are going to be the triggers. the targets that we are going to be able to utilize in our discovery. In our discovery now for example, we are using also machine learning and data science and optical recognition to transform we, the way we analyze new medicine. So now we use a cell, a single cell and we drop that test compound and through imaging, we can identify much faster than before what is going to be the pharmacological activity of this profile, what is going to be the expected toxicities and that accelerates the development on discovery of new medicines. Going into development, we can plan much better our clinical trials, we are able to create synthetic control groups instead of having placebo groups and we are also able to stratify and identify patients that are difficult to find in rare diseases utilizing algorithms that enable us to identify them. So, I'm very bullish about the potential of technology in accelerating discovery and developing new medicines but at the same time, I’m equally bullish about the potential of technology, medtech in improving surgical outcomes. I see a future in which all medical devices would be smarter connected to the cloud, being able to provide data to the surgeons for them to be able to in real time improve surgical outcomes and you are seeing that already, through the digitalization of medtech and through robotics, so very bullish on the potential of technology to accelerate progress in human health. TIRRELL: Well, this is fascinating. I could ask you about a half an hour's worth more of questions. We can do a whole conference just on this topic. But I will move on, you know, curious also, how is J&J adjusting to what you're seeing in terms of inflationary pressures? Are you passing those along to consumers at all? What can we expect from J&J there? DUATO: Thank you. As I said before, this is a volatile situation and we're seeing headwinds in different areas, for example, in inflation, in supply chain, in availability of important raw materials and components. We continue to be vigilant in monitoring all those things. And we believe that we are able to manage these things better than, better than most. Our scale, our size enable us to be able to navigate these circumstances better better than most. And most of it is already included in the guidance that we provided earlier in the year which which conveys a healthy growth rate, both in revenues and in EPS. We are optimistic about the future. Some of these trends are going to be mitigated as the year goes by. Some of them as inflation may take longer. But overall, we are very optimistic about the fundamentals of healthcare and the ability that we are going to have to continue to deliver new therapies, new medical devices that step up to the moment and create progress in addressing diseases in completely different ways. TIRRELL: And in the consumer business specifically because that's the one that most directly you're selling right to consumers, will they be feeling that that bite of inflation at all will Band-Aids cost more, you know, will Neutrogena, Aveeno products cost more? DUATO: The consumer business, as you mentioned, is one that obviously is more affected by the inflationary pressures. Overall, we've seen volatility in the consumer demand, but we continue to see a very solid consumer business coming through and we continue to try to deliver what is best for consumers and we continue to try to mitigate our cost increases by improving our own efficiency and in some cases also having price increases but overall, we are bullish about the potential of our consumer health business, and about our ability to navigate the inflationary pressures in a way that is optimal for consumers. TIRRELL: We're just about out of time, but I can't let you go without asking you about your COVID-19 vaccine and the efforts that you've put in there. What do you see is the future for J&J’s COVID vaccine, where you have the CDC having made a preferential recommendation for the mRNA vaccines over J&J’s vaccine? What role will it play going forward, both in the US and around the world? DUATO: Thank you. That's a great question and let me start by saying that we are so proud of Johnson & Johnson being able to develop a COVID-19 vaccine. Back in 2020, our scientists, our researchers, and thousands of people around the company jump in and develop a COVID-19 vaccine that was, that showed easy to distribute, a low-cost platform that is having a significant impact in addressing the pandemic there where it's most needed in places where have low resources, in places where they are still going through the first vaccination. And we are very proud about the role that our vaccine is playing and will continue to play in addressing the pandemic. For example, now in Africa, we just signed an agreement with a South African company in order to be able to manufacture and distribute our vaccine in Africa. So overall, we feel very proud about the role that our vaccine is playing, and we continue to see that important role in addressing the pandemic there where it's most needed. TIRRELL: All right, and I think we're just about out of time, but we did get one more audience question we want to put to you and then I want to bring in Tyler who I think has a question for you. But Mark from the audience asked, “What's the limiting factor for innovation right now? Is it money, talent, regulation, something else? All of the above.” What is it? DUATO: There's, there's, I said before, rather than the limitations, I prefer to focus on the opportunity. As I said, I believe strongly that we can make more progress in this decade than we made in the last 100 years. And there's a combination of factors which are fostering that. One is, on one hand, society has understood the value of having strong healthcare ecosystem. I think that what we have seen with the vaccines and the progress on how vaccines have supported others in the pandemic has reconfirmed society's belief on the importance of healthcare. On the other hand, we're seeing a great explosion on better understanding of the underpinnings of the disease, the genetic basis of the disease that helps us identify in the right targets to affect combined with new treatment modalities and the use of technology in surgery, which is going to improve outcome. So I want to look at the opportunities, opportunities to be able to address suffering globally, to address diseases that remain incurable and that's what I think you're going to see in this decade. Great progress in human health. TIRRELL: Tyler? TYLER MATHISEN: It's great to see you again. And I want to ask a question that that bears on some things that have happened at the company in the past years. You know, Johnson & Johnson, it’s no surprise perennially one of the most respected admired corporations in the country in your DNA I think every every employee lives by a pledge I can't remember exactly the the term that you use to to describe it. And yet in recent years, and there's no company that's probably done more to help more people live better than than your own, but in recent years, there have either been judgments or settlements or payments in at least three areas. One is talc, the other is hip replacement under the pinnacle subsidiary and the third is opioids that have amounted to in some cases, billions of dollars paid out and in others, hundreds of millions and some others that are still under litigation. The company has not under those terms they've not admitted any responsibility. I wonder whether those payments are material to the company's performance financially and have they been material to the company's otherwise sterling reputation? Could you talk me through that just a little bit in light of what's been going on? DUATO: So Tyler, what the plates do refer, it's what we call our credo, which is a statement of principles that dates backs already 75 years that puts the patients and consumer first, then our employees, then the communities and then if we do a good job for all these three stakeholders, then shareholders are going to have their return. So that's what we call our credo which is the DNA of Johnson & Johnson, what guides our decisions and the connective tissue that makes our organization a cohesive group and we understand that we have a reputation. We understand that we have a high bar and a high expectation from society overall and we are ready to step up to the moment as we have done during our more than 135 years of history. Yes, we have some challenges and when you refer to the litigation, we are always trying to have the same principle. We always try to do what is fair and equitable in finding a resolution that is good for all stakeholders. That has been our position in every situation regarding with the litigation. Ultimately, we want to always reach a fair and equitable resolution in order to be able to focus on what we do best and what we do best is to continue to develop medicines, medical devices, consumer products that improve consumer lives, and also are able to address patient's needs in multiple ways to alleviate suffering and to, as I said before, to get diseases that are incurable curable. So that's our mission. Our mission is to continue to affect the trajectory of health for humanity and that's where the 135 employees of Johnson & Johnson are focused every single day. MATHISEN: Forgive me for not remembering the word credo because it was, it was such a, in our last conversation, it was such a central part of it. I appreciate your reminding me. I appreciate your taking my question and the answer, and we're very, congratulations by the way, on your appointment as CEO. DUATO: Thank you. MATHISEN: It's wonderful to see you again Joaquin and Meg thank you so much for your participation as well. Very grateful to both of you and we appreciate it. Thanks, guys. DUATO: Thank you. TIRRELL: Thanks Tyler. Updated on Mar 30, 2022, 2:07 pm (function() { var sc = document.createElement("script"); sc.type = "text/javascript"; sc.async = true;sc.src = "//mixi.media/data/js/95481.js"; sc.charset = "utf-8";var s = document.getElementsByTagName("script")[0]; s.parentNode.insertBefore(sc, s); }()); window._F20 = window._F20 || []; _F20.push({container: 'F20WidgetContainer', placement: '', count: 3}); _F20.push({finish: true});.....»»

Category: blogSource: valuewalkMar 30th, 2022

Seagen (SGEN) Inks ADC Deal With Sanofi for Cancer Targets

Seagen (SGEN) inks a collaboration agreement with Sanofi to develop and commercialize antibody-drug conjugates for three cancer targets. Seagen Inc. SGEN announced that it has entered into an exclusive collaboration agreement with French pharma giant Sanofi SNY to design, develop and commercialize novel antibody-drug conjugates (“ADC”) for up to three cancer targets.The partnership is looking to combine Seagen’s proprietary ADC technology with Sanofi’s proprietary monoclonal antibody (mAb) technology to introduce promising anti-cancer drugs.Per the agreement, both Seagen and Sanofi will co-fund global development activities for the above-mentioned program. The companies will equally share all future profits.Seagen will be eligible to receive an undisclosed amount in payment from Sanofi for each of the three targets as they are selected. The first target under the latest collaboration has already been selected.The above collaboration complements Seagen’s portfolio of marketed drugs.Seagen’s portfolio of marketed drugs — Adcetris, Padcev, Tukysa and the newly approved Tivdak — target different types of cancer indications. Out of these, Adcetris, Padcev and Tivdak are based on the company’s ADC technology.Adcetris is approved for treating Hodgkin lymphoma, certain T-cell lymphomas, as well as some other cancers in the United States, Europe and several countries. Adcetris is approved by the FDA for six indications. The drug generated sales worth $705.6 million in 2021.Seagen has an agreement with Japan’s Takeda Pharmaceutical Company TAK for further development and commercialization of Adcetris.Seagen records royalty revenues on the sales of Adcetris from Takeda in ex-U.S. markets.Seagen’s second drug, Padcev, is approved for the treatment of patients with advanced/metastatic urothelial cancer who have been previously treated with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy. The drug generated sales worth $339.9 million in 2021.In July 2021, the FDA approved two supplemental biologics license applications that sought a label expansion for Padcev.In September 2021, the FDA granted accelerated approval to Tivdak (tisotumabvedotin-tftv) for the treatment of recurrent/metastatic cervical cancer in adult patients whose disease progressed on or after chemotherapy. The drug has been developed in collaboration with Denmark’s Genmab A/S GMAB.Tivdak generated sales worth $6.1 million in the first full quarter since its approval in September 2021. Seagen and Genmab equally share all costs and profits for Tivdak in the United States.Seagen and Genmab continue to evaluate Tivdak as a potential treatment for cervical cancer and other solid tumors in different clinical studies. Just Released: Zacks Top 10 Stocks for 2022 In addition to the investment ideas discussed above, would you like to know about our 10 top picks for the entirety of 2022? From inception in 2012 through 2021, the Zacks Top 10 Stocks portfolios gained an impressive +1,001.2% versus the S&P 500’s +348.7%. Now our Director of Research has combed through 4,000 companies covered by the Zacks Rank and has handpicked the best 10 tickers to buy and hold. Don’t miss your chance to get in…because the sooner you do, the more upside you stand to grab.See Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report Seagen Inc. (SGEN): Free Stock Analysis Report Takeda Pharmaceutical Co. (TAK): Free Stock Analysis Report Genmab AS Sponsored ADR (GMAB): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksMar 18th, 2022

Molecular Partners Reports Corporate Highlights From Q4 2021 and Key Financials for Full Year 2021

Research & Development Highlights: In January of 2022, announced positive topline results from Phase 2 EMPATHY clinical trial of ensovibep for the treatment of non-hospitalized COVID-19 patients, resulting in the option exercise of the program by Novartis triggering the receipt of CHF 150 million in January 2022 Continued to confirm ensovibep's pan-variant activity in in vitro studies demonstrating maintained high potency against all known SARS-CoV-2 variants of concern, including Omicron, Delta and Lambda Received FDA Fast Track designation for ensovibep for the treatment of COVID-19 Dosed more than 560 patients across clinical studies for ensovibep Announced collaboration with Novartis to develop DARPin-conjugated radioligand therapies for oncology Initiated enrollment in Phase 1 study of MP0317 targeting FAP and CD40 Nominated MP0533 for development for acute myeloid leukemia (AML), targeting CD3, CD33, CD70 and CD123 Presented data supporting oncology portfolio programs at AACR, ESMO Immuno-Oncology, ASH and Company's Virtual Oncology Day Leadership & Governance: Elected Agnete Fredriksen and Dominik Höchli to the Board of Directors at the Annual General Meeting of April 21, 2021 Promoted Alexander Zürcher to Chief Operating Officer, and Renate Gloggner to EVP People and Community. Both will be appointed to the Management Board effective July 1, 2022 Financial: Successfully completed initial public offering of American Depositary Shares ("ADSs") on the Nasdaq Global Select Market, raising $63.8 million (CHF 58.8 million) in gross proceeds in June 2021. Following positive topline data from the Phase 2 EMPATHY clinical trial, in January 2022 Novartis exercised its option to in-license global rights to ensovibep, which triggered a CHF 150 million payment to the Company. Under the license agreement, Molecular Partners is entitled to receive 22% royalties on sales of ensovibep in relevant territories while Novartis leads further development and commercialization. Additional collaboration with Novartis in the field of radioligand therapies (RLTs), resulting in an upfront payment of $20.0 million received in January 2022. Net cash outflow from operating activities of CHF 91.0 million in 2021. Ongoing strong financial position with CHF 291.3 in cash and short-term deposits as of February 28, 2022 (year-end 2021:CHF 132.8 million ), with the Company's cash runway expected to extend into 2025. Full year 2022 expense guidance of CHF 75-85 million, reflecting ambition to further broaden the pipeline both in oncology as well as in virology. ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., March 15, 2022 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR:Molecular Partners AG ((SIX: MOLN, NASDAQ:MOLN), a clinical-stage biotech company developing a new class of custom-built proteins known as DARPin therapeutics, today announced its corporate highlights and audited financial results for 2021."Ensovibep is our first antiviral DARPin, set to face one of the greatest medical challenges of our time, the COVID pandemic," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Our strong clinical data represent not only a clinical win against the virus, but also constitute a major milestone for DARPins as a new class of protein drugs. Along with the development of ensovibep, we were able to continue advancing our oncology DARPin programs and initiate additional virology programs, underlining the versatile potential of our platform. As we enter 2022, we have never been better positioned to deliver on the promise of DARPins to help patients around the world living with serious diseases." Antiviral program In early January, Molecular Partners and Novartis announced positive topline data from the randomized, double-blind, placebo-controlled EMPATHY Part A study of ensovibep for acute COVID-19 ambulatory patients. Results from the study showed that the primary endpoint was met with a statistically significant reduction in viral load over eight days, compared to placebo. The secondary endpoint of ER visits, hospitalization or death related to COVID-19 showed an overall 78% reduction in risk of events across ensovibep arms compared to placebo. Ensovibep also demonstrated a clinically meaningful time to sustained recovery benefit over placebo. No deaths occurred in any of the patients treated with ensovibep. All three dosing arms met the primary endpoint of viral load reduction over time, were well-tolerated with no unexpected safety issues, allowing for selection of the lowest dose of 75mg for future development. Following these results, Novartis exercised its option to in-license the global rights to ensovibep, triggering a milestone payment of CHF 150 million to Molecular Partners. These data are part of a submission to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA), which was announced in February 2022. Novartis has also indicated its intentions to submit ensovibep for review in the E.U. and additional relevant territories.If approved or authorized, ensovibep would be the first multi-specific antiviral candidate approved for the treatment of COVID-19 and Molecular Partners' first DARPin therapy approved by a regulatory agency.Ensovibep has continued to show retained potency against all variants of concern throughout the pandemic in in vitro studies. In December of 2021, preclinical studies confirmed that ensovibep maintains full neutralization of Omicron pseudoviruses that contain the identical mutations of the viral variant. In a panel of biologic drugs tested against the original (wild type) and Omicron variants of SARS-CoV-2, ensovibep maintained a uniformly high neutralizing potency across variants, while substantial reduction in potency was observed for numerous antibody drugs, both approved and investigational. The study design and results are published in BioRxiv, and have been submitted for peer-review publication. As a DARPin candidate, ensovibep is uniquely designed to retain pan-variant activity across all variants of COVID-19, including most recently the Omicron BA.2 variant, by engaging three domains of the SARS-CoV-2 virus simultaneously to inhibit viral entry into cells. This allows for a potentially broader efficacy and reduces the likelihood for the development of viral drug resistance. In addition, DARPin candidates are produced through rapid, high-yield microbial fermentation for potential speed and logistical advantages over mammalian cell production employed for antibodies.In November of 2021, Molecular Partners also announced that a planned futility analysis of ensovibep in the NIH-sponsored ACTIV-3 clinical study did not meet the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting. Oncology programs: New programs launched in AML and radioligand therapies MP0533 nominated as AML candidate Molecular Partners nominated MP0533 in 2021 as a new candidate for development for the treatment of acute myeloid leukemia (AML). MP0533 is a multi-specific DARPin T-cell engager candidate designed to deliver a highly potent and specific anti-tumor response to AML cells, with a reduced effect on healthy normal cells, and with the potential to counteract target escape mechanisms expected due to tumor heterogeneity. MP0533 is designed to engage CD3 on T cells and target AML cells via the tumor associated antigens CD33, CD123 and CD70. At the 63rd American Society of Hematology (ASH) Annual Meeting, Molecular Partners presented preclinical data from MP0533 demonstrating a significant decrease cytokine release syndrome (CRS) when compared to other mono-targeting T-cell engager therapies, confirming MP0533's potential for an improved safety profile compared to other approaches. In an ex vivo assay using fresh blood from healthy donors, the candidate induced significantly lower inflammatory cytokine production and reduction in platelet counts than T-cell engager candidates in development by other parties.The Company announced a research collaboration with the University of Bern in December 2021 to advance the development of MP053 into clinical studies, leveraging the Bern group's expertise in leukemic stem cells, a hard-to-target cancer progenitor cell population relevant to AML. The Company plans to initiate a Phase 1 clinical study of MP0533 in 2022. MP0317 study initiation In November 2021, Molecular Partners announced the first patient had been dosed in its Phase 1 clinical trial evaluating the safety and tolerability of MP0317, which targets both the fibroblast activation protein (FAP) and the immunostimulatory protein CD40 to enable tumor-localized immune activation. MP0317 is the second DARPin therapeutic candidate in the company's immuno-oncology pipeline to enter clinical trials. Through this mechanism of action, MP0317 is designed to activate immune cells specifically within the tumor microenvironment, potentially delivering greater efficacy with fewer side effects compared to other CD40-targeting agents.The open-label dose escalation study is designed to assess the safety and tolerability as well as pharmacokinetics and pharmacodynamics of MP0317 as a monotherapy in patients with solid tumors known to express fibroblast activation protein (FAP). Enrollment is taking place in the Netherlands and France. A total of up to 30 patients are expected to be enrolled across six dosing cohorts and up to 15 patients will be enrolled in a dose expansion cohort. In addition to evaluating monotherapy dynamics, the study will gather a wide variety of biomarker data to support the establishment of combination therapies with MP0317 in specific indications.In December 2021, Molecular Partners presented data on MP0317 and the Phase 1 clinical trial design at the ESMO Immuno-Oncology Congress. Initial data from this clinical study is expected in the second half of 2022. MP0310 clinical progress The ongoing Phase 1 clinical trial of MP0310 progressed in 2021, evaluating the optimal dosing regimen of MP0310. MP0310 is the second DARPin therapeutic candidate in the company's immuno-oncology pipeline to enter clinical trials targeting FAP and 4-1BB. It is designed to activate immune cells specifically in the tumor expressing these targets and not in the rest of the body, potentially delivering greater efficacy with less toxicity. Molecular Partners expects to share initial clinical data from the Phase 1 trial with Amgen in the first half of 2022. In April of 2021, Molecular Partners presented four posters highlighting research across its immuno-oncology programs at the American Association for Cancer Research (AACR) virtual Annual Meeting. New radioligand collaboration In December 2021, Molecular Partners announced a collaboration with Novartis in the form of a license agreement to develop, manufacture and commercialize DARPin-conjugated radioligand therapies (DARPin-RLTs). The collaboration combines DARPins' unique properties, including small size (under 20kDa) and very high affinities (low picomolar), with the RLT ...Full story available on Benzinga.com.....»»

Category: earningsSource: benzingaMar 15th, 2022

AbbVie (ABBV) Inks Deal for Neuropsychiatric Conditions

AbbVie (ABBV) forges an alliance with Gedeon Richter to develop novel treatments for neuropsychiatric diseases. Both collaborated in the past too on the blockbuster schizophrenia drug Vraylar. AbbVie, Inc. ABBV announced that it has entered into a new collaboration agreement with Hungary-based Gedeon Richter to research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric indications.Both companies will jointly finance pre-clinical and clinical R&D activities as part of this collaboration. Richter will receive an undisclosed upfront payment from AbbVie for the collaboration. Richter is eligible to receive potential developmental and commercial milestone payments. It is also eligible to receive royalties upon successful commercialization of the treatments for the given indication.  Per the terms of the deal, AbbVie will receive worldwide commercial rights to any drug developed under the collaboration, except for regions like Europe, Russia, other CIS countries and Vietnam where the drug will be marketed by Richter.The deal expected to be completed in second-quarter 2022 is subject to customary closing conditions and clearance from regulatory authorities.Shares of AbbVie have gained 10.1% so far this year against the industry’s 3.1% decline.Image Source: Zacks Investment ResearchThis collaboration between ABBV and Richter is based on data from the preclinical studies conducted by Richter. The deal includes several novel compounds which are selected for further development.We remind investors that AbbVie already has an existing relationship with Gedeon Richter. Both companies had previously collaborated on developing medications targeting the central nervous system (CNS) and jointly marketed Vraylar, an FDA-approved drug for schizophrenia and bipolar I disorder. Vraylar is one of the many blockbuster drugs of AbbVie. AbbVie recorded $1.7 billion from Vraylar’s U.S. sales in 2021. The drug is marketed by Richter outside the United States under the brand name Reaglia.Like Vraylar, AbbVie has deals with many large-cap pharma companies like J&J JNJ for Imbruvica and Roche RHHBY for Venclexta/Venclyxto.Both AbbVie and J&J jointly market Imbruvica in the United States. Imbruvica is approved for blood cancers, such as chronic lymphocytic leukemia (CLL) and certain forms of non-Hodgkin lymphoma. Both ABBV and JNJ share pre-tax profits and losses from U.S. sales, equally. Outside the United States, J&J has exclusive commercial rights for the drug.AbbVie’s haemotology drug Venclexta is jointly marketed with Genentech, a member of the Roche Group. Like Imbruvica, both ABBV and the Roche subsidiary share pre-tax profits and losses from the U.S. sales, equally. While Venclexta is marketed outside the United States solely by AbbVie, RHHBY’s Genentech receives royalties from the ex-U.S. sales of the drug.AbbVie Inc. Price AbbVie Inc. price | AbbVie Inc. QuoteZacks Rank & Stock to ConsiderAbbVie currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Vertex Pharmaceuticals VRTX, which carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 7.7% year to date.Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%. Just Released: Zacks Top 10 Stocks for 2022 In addition to the investment ideas discussed above, would you like to know about our 10 top buy-and-hold tickers for the entirety of 2022? Last year's 2021 Zacks Top 10 Stocks portfolio returned gains as high as +147.7%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buysAccess Zacks Top 10 Stocks for 2022 today >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY): Free Stock Analysis Report Johnson & Johnson (JNJ): Free Stock Analysis Report Vertex Pharmaceuticals Incorporated (VRTX): Free Stock Analysis Report AbbVie Inc. (ABBV): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksMar 14th, 2022

VerifyMe Reports Continued Revenue Growth for the Fourth Quarter 2021

Quarterly revenue of $255 Thousand, an increase of 240% compared to Q4 2020 Revenue of $867 Thousand for the year ended December 31, 2021, an increase of 153% compared to December 31, 2020 Diluted earnings per share of $0.49 for the year ended December 31, 2021, compared to a loss per share of $1.48 for December 31, 2020 Cash of $9.4 Million and Equity Investment of $11.0 Million as of December 31, 2021 Repurchased 79,593 shares at an average price of $3.28 per share in the fourth quarter of 2021 ROCHESTER, N.Y., March 14, 2022 /PRNewswire/ -- VerifyMe, Inc. (NASDAQ:VRME) ("VerifyMe," "we," "our," or the "Company"), providing brand owners with authentication, supply chain monitoring and data rich consumer engagement features using unique smartphone readable codes on their products, announced today the Company's financial results for the fourth quarter ended December 31, 2021 ("Q4 2021"). Key Financial Highlights for Q4 2021: Revenues of $255 thousand for the three months ended December 31, 2021, increased by 240% compared to $75 thousand for the three months ended December 31, 2020 Net loss of $1.0 million or ($0.13) fully diluted loss per share for the three months ended December 31, 2021, compared to a loss of $1.2 million or ($0.29) fully diluted loss per share for the three months ended December 31, 2020 Adjusted EBITDA, a non-GAAP financial measure, loss of $792 thousand for the three months ended December 31, 2021, compared to an adjusted EBITDA loss of $802 thousand for the three months ended December 31, 20201 ·Share repurchase of 79,593 at an average price of $3.28 per share and 216,945 at an average price of $3.34 per share in the fourth quarter of 2021 and year ended 2021, respectively and approximately $775 thousand remaining under the share repurchase plan as of December 31, 2021 Cash balance of $9.4 million on December 31, 2021 1 See "Use of Non-GAAP Information" below for information about this non-GAAP measure. A reconciliation to the most directly comparable GAAP measure, net income (loss), is included as a schedule to this release. Patrick White, VerifyMe's CEO stated, "For the year, VerifyMe achieved a record level of revenue which we expect to continue to grow during 2022. Until we reach a much larger base of recurring revenue, we can expect quarterly revenue to be volatile based on timing and the size of various projects.  We continue to see growth in quality prospect inquiries and projects, including in the apparel, pharma and food and beverage industries.  We are also continuing to pursue synergistic acquisition opportunities." Recent Business Highlights We are preparing to launch a new Non-Fungible Token ("NFT") linking product called VerifyNFTTM.   This technology will use VerifyMe patented dual-code technology to verify both physical products and their associated NFT certificates of ownership.  This dual-code technology will prevent the creation of counterfeit physical products linked to NFTs, a growing challenge for many NFT providers. VerifyNFTTM will integrate with the major blockchains, including Ethereum, Cardano, Solana, Polka Dot, Avalanche etc. To increase our global presence, we have recently signed two new agreements to promote, market, adapt and sell our products.  These consultants are well established in their respective countries and have been granted a non-exclusive license to sell VerifyMe's products and solutions. On December 5, 2021, we signed a reseller agreement with Kimoha Entrepreneurs in the United Arab Emirates.  Kimoha provides premium and specialty labelling and packaging solutions, for market segments like Cosmetics, Perfume, Lubricants, Food and Beverages, Pharmaceuticals, Aviation, Retail and Logistics, Garments, etc., in the Middle East and is a long-standing HP Indigo Partner.  On December 21, 2021, we signed a Sales Consultant agreement with The AAB in South Africa. The AAB is a virtual back office that specializes in financial management and supply chain risk management. They are focused on counterfeit and product diversion and are promoting both our overt and covert security printing solutions in major growth industries. Financial Results for the Three Months Ended December 31, 2021: Revenue for the three months ended December 31, 2021, was $255 thousand, a 240% increase as compared to $75 thousand for the three months ended December 31, 2020. The increase in revenue is primarily related to increased use of our security printing and authentication serialization technology with new cannabis companies using our unique smart phone readable codes which allow them to connect directly with their customer base. Gross profit for the three months ended December 31, 2021, was $170 thousand, compared to $62 thousand for the three months ended December 31, 2020. The resulting gross margin was 67% for the three months ended December 31, 2021, compared to 83% for the three months ended December 31, 2020. The decrease in our gross profit margin relates to a shift in product mix, with an increase in the use of our secure track and trace serialization technology and customer engagement products. We believe our high gross profit margins demonstrate our business model's ability to generate profitable growth. Operating loss for the three months ended December 31, 2021, was $1,163 thousand, a decrease of $11 thousand compared to $1,174 thousand for the three months ended December 31, 2020. The decrease is primarily related to the increase in gross profit of $108 thousand, and a decrease in legal expenses; partially offset by the increase of $200 thousand in salaries and number of employees. Our net loss for the three months ended December 31, 2021, decreased by $170 thousand to $1,004 thousand compared to a net loss of $1,174 thousand for the three months ended December 31, 2020. The decrease was primarily due to the fair value gain on our equity investment in the SPAC -G3 VRM Acquisition Corp contributing a fair value gain of $157 thousand.  The resulting loss per share for the three months ended December 31, 2021, was ($0.13) per diluted share, compared to a loss per share of ($0.29) per diluted share for the three months ended December 31, 2020. Adjusted EBITDA loss for the three months ended December 31, 2021, was $792 thousand, a decrease of $10 thousand, compared to a loss of $802 thousand for the three months ended December 31, 2020. Adjusted EBITDA is a non-GAAP financial measure. Please see "Use of Non-GAAP Financial Measures" for a discussion of this non-GAAP measure. A reconciliation to the most directly comparable GAAP measure, net income (loss), is included as a schedule to this release. At December 31, 2021, VerifyMe has a strong balance sheet with $9.4 million cash balance, $11.0 million equity investment and no debt. As of December 31, 2021, VerifyMe had 7,420,633 shares issued and 7,196,677 shares outstanding. About VerifyMe, Inc.VerifyMe, Inc. (NASDAQ: VRME), is a technology solutions provider specializing in products to connect brands with consumers. VerifyMe technologies give brand owners the ability to gather business intelligence while engaging directly with their consumers. VerifyMe technologies also provide brand protection and supply chain functions such as counterfeit prevention, authentication, serialization, and track and trace features for labels, packaging and products. To learn more, visit www.verifyme.com. Cautionary Note Regarding Forward-Looking Statements This release contains forward-looking statements regarding revenue opportunities, recurring revenue, commercialization efforts, our sales pipeline and opportunities, and co-sponsorship of G3 VRM Acquisition Corp. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Important factors that could cause actual results to differ from those in the forward-looking statements include the impact of the COVID-19 pandemic, intellectual property litigation, the successful development of our sales and marketing capabilities, our ability to retain key management personnel, our ability to work with partners in selling our technologies to businesses, production difficulties, our inability to enter into contracts and arrangements with future partners, issues which may affect the reluctance of large companies to change their purchasing of products, acceptance of our technologies and the efficiency of our authenticators in the field. These risk factors and uncertainties include those more fully described in VerifyMe's Annual Report and Quarterly Reports filed with the Securities and Exchange Commission, including under the heading entitled "Risk Factors." Should one or more of these risks or uncertainties materialize, or should any of our underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Use of Non-GAAP Financial MeasuresThis press release includes both financial measures in accordance with U.S. generally accepted accounting principles ("GAAP"), as well as non-GAAP financial measures. Generally, a non-GAAP financial measure is a numerical measure of a company's performance, financial position or cash flows that either excludes or includes amounts that are not normally included or excluded in the most directly comparable measure calculated and presented in accordance with GAAP. Non-GAAP financial measures should be viewed as supplemental to and should not be considered as alternatives to any other GAAP financial measures. They may not be indicative of the historical operating results of VerifyMe nor are they intended to be predictive of potential future results. Investors should not consider non-GAAP financial measures in isolation or as substitutes for performance measures calculated in accordance with GAAP. VerifyMe's management uses and relies on EBITDA and Adjusted EBITDA, which are non-GAAP financial measures. The Company believes that both management and shareholders benefit from referring to EBITDA and Adjusted EBITDA in planning, forecasting and analyzing future periods. The Company's management uses these non-GAAP financial measures in evaluating its financial and operational decision making and as a means to evaluate period-to-period comparison. The Company's management recognizes that EBITDA and Adjusted EBITDA, as non-GAAP financial measures, have inherent limitations because of the described excluded items. The Company defines EBITDA as net income before income tax expense (benefit), interest expense, depreciation and amortization. Adjusted EBITDA represents EBITDA plus stock-based compensation and the fair value of options, restricted stock awards, restricted stock units, and warrants issued in exchange for services, and fair value gain on equity investment. VerifyMe believes EBITDA and Adjusted EBITDA are important measures of VerifyMe's operating performance because they allow management, investors and analysts to evaluate and assess VerifyMe's core operating results from period-to-period after removing the impact of items of a non-operational nature that affect comparability. A reconciliation of EBITDA and Adjusted EBITDA to the most comparable financial measure, net income (loss), calculated in accordance with GAAP is included in this press release. The Company believes that providing the non-GAAP financial measures, together with the reconciliation to GAAP, helps investors make comparisons between VerifyMe and other companies. In making any comparisons to other companies, investors need to be aware that companies use different non-GAAP measures to evaluate their financial performance. Investors should pay close attention to the specific definition being used and to the reconciliation between such measure and the corresponding GAAP measure provided by each company under applicable SEC rules.   VerifyMe, Inc.Balance Sheets(In thousands, except share data) As of December 31, 2021 December 31, 2020 ASSETS CURRENT ASSETS Cash and cash equivalents $ 9,422 $ 7,939 Accounts Receivable 297 31 Prepaid expenses and other current assets 240 177 Inventory 52 54 TOTAL CURRENT ASSETS 10,011 8,201 INVESTMENTS Equity Investment 10,964 - PROPERTY AND EQUIPMENT Equipment for lease, net of accumulated amortization of $102 and $50 as of December 31, 2021 and December 31, 2020, respectively 193 200 Office Equipment, net of accumulated amortization of $1 and $0 as of December 31, 2021 and December 31, 2020, respectively 11 - INTANGIBLE ASSETS Patents and Trademarks, net of accumulated amortization of $354 and $320 as of December 31, 2021 and December 31, 2020, respectively 353 293 Capitalized Software Costs, net ofaccumulated amortization of $50 and $20 as of December 31, 2021 and December 31, 2020, respectively 156 80 TOTAL ASSETS $ 21,688 $ 8,774 LIABILITIES AND STOCKHOLDERS' EQUITY.....»»

Category: earningsSource: benzingaMar 14th, 2022