Advertisements


Two New Studies On Classical Psychedelics: Grading Ketamine"s Components, Tuning Down Psilocybin Dosing

Awakn’s First Study On Novel S-Ketamine Formulation To Assess Dissociative Effect read more.....»»

Category: blogSource: benzingaJan 24th, 2023

Field Trip Health Ltd. Reports Second Fiscal Quarter 2022 Financial Results and Provides Business Update

Announced plans to advance FT-104, its novel psychedelic compound, to clinic for Treatment-Resistant Depression and Postpartum Depression as the lead indications. Initiated a new pipeline research program focused on discovering novel psychedelics with a reduced cardiovascular risk profile compared to classic psychedelics (the "FT-200 Group") and filed a provisional patent in connection to the composition of matter for the first molecule identified in the FT-200 Group. Continued to invest in best-in-class clinical infrastructure, with nine clinics currently in operation and nine locations under construction or about to commence construction. Commenced trading on the NASDAQ Global Select Market ("NASDAQ") under the ticker symbol "FTRP". As at September 30, 2021, Field Trip had approximately $88 million in unrestricted cash and cash equivalents and short-term investments. Commenced a strategic review of the current corporate structure to assess options to maximize the value of the drug development and therapy delivery business units. TORONTO, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Field Trip Health Ltd. (TSX:FTRP, FTRP.WT, NASDAQ:FTRP) ("Field Trip"), a leader in the development and delivery of psychedelic therapies, reported its second fiscal quarter 2022 results for the three months ended September 30, 2021 and provided a business update. All results are reported under International Financial Reporting Standards ("IFRS") and in Canadian dollars, unless otherwise specified. Key Highlights and Recent Developments During the quarter, Field Trip progressed its strategy of building a leading psychedelic therapy company (Field Trip Health) and continued to invest in its drug development pipeline and program expansion (Field Trip Discovery). Field Trip Discovery FT-104 During the quarter, it was announced that the lead indications for FT-104, Field Trip's lead novel psychedelic compound in development (patent pending), will be Treatment Resistant Depression and Postpartum Depression. FT-104 is a novel, synthetic 5HT2A receptor agonist compound. It is currently advancing through preclinical studies with the in vivo portion completed, and final results from safety pharmacology and GLP toxicology are expected in calendar Q4 2021. To date, GLP toxicology, cardiovascular, pulmonary, and neurological safety pharmacology studies, as well as genotoxicity potential, all continue to be encouraging. In addition, final manufacturing of clinical trial material is scheduled for production to enable FT-104 to move into Phase 1 clinical trials in the first half of calendar 2022. The Company has experienced, and may continue to experience, delays in initiating Phase 1 clinical trials due to the ongoing COVID pandemic and delays at its contract manufacturing organization. FT-200 Group: Introducing Field Trip's Second Novel Psychedelic Program The Company also announced the discovery of a novel molecule that, based on in vivo assay details, has the structure of classical psychedelics and has demonstrated improved selectivity for the target serotonin 2A receptor (5HT2A) relative to FT-104 and psilocybin versus off target serotonin, 5HT1A, 5HT2B and 5HT2C receptors. This is meaningful because off-target 5HT2B activity has been associated with increased risk of cardiovascular toxicity. Based on this discovery, the Company is expanding the scope of its development pipeline to focus on a new group of molecules termed the FT-200 Group, (which includes the molecule mentioned above), that have the structure of classical psychedelics, with similar potency at the 5HT2A receptor as FT-104 and psilocybin, but with reduced or the absence of activity at the off-target 5HT2B receptor. The aim of the work is that by reducing or eliminating 5HT2B activity it may allow molecules like those in the FT-200 Group to be administered more frequently, such as more chronic or chronic intermittent administration or ‘microdosing' strategies. "The first molecule identified in the FT-200 Group demonstrates significant promise to maintain 5HT2A activity while reducing off-target serotonin receptor activity. We are continuing to conduct preclinical work on this molecule and will explore structural analogs within the FT-200 Group to better refine and optimize this new family of substances, understand their properties better and work towards identifying a lead candidate", said Joseph del Moral, Field Trip's Co-founder and CEO. On October 29, 2021 the Company filed a provisional patent application in the United States to protect the composition, as well as potential formulations and uses of the first molecule in the FT-200 group. Field Trip Health Centres Leveraging the growing awareness of Field Trip's psychedelic-assisted therapy clinics, Field Trip announced on August 31, 2021 the launch of the KAP Co-operative Program ("KAP Co-op"), a program that enables eligible independent psychedelic therapists to provide ketamine-assisted psychotherapy (and, in the future, other legal, psychedelic-assisted therapies) at its Field Trip Health Centres. Field Trip also announced the launch of training programs designed to provide interested psychotherapists or other qualified mental health professionals and clinicians with access to best-in-class training on KAP. The Company continues to invest in its clinics and during the quarter, entered into lease agreements for locations in Dallas, TX, Miami, FL and Scottsdale, AZ. Subsequent to the quarter end, the Company announced the opening of the Seattle, WA clinic, its sixth in the United States and ninth overall, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC. Hannan Fleiman, Field Trip's Co-Founder and President, said, "We continue to see strong growth in our clinic business and our team is proud of the outcomes we are helping our patients achieve. We have continued to make significant investments in building out the leading platform for the delivery of psychedelic therapies and to position our clinics to be at the absolute forefront of our industry in establishing the critical infrastructure for the current and emerging psychedelic therapies with 9 clinics now in operation and 9 locations under construction or about to commence construction. Importantly, the clinics enable Field Trip to capture significant amounts of patient data on clinical outcomes which we expect to help inform future clinical development and treatment strategies." From a brand perspective, Field Trip continues to be a globally recognized company in the industry. During the quarter, the Company was featured in many top-tier print and broadcast media outlets, including Forbes, Vox Media, Insider, People and others, generating nearly 2 billion total potential media impressions. Field Trip's brand presence and reach continues to generate strong website traffic and patient interest in the KAP treatments offered by the Company. NASDAQ Listing On July 29, 2021, Field Trip's Common Shares commenced trading on the NASDAQ Global Select Market ("NASDAQ") under the ticker symbol "FTRP", providing the Company with greater access to capital. The Common Shares continue to trade in Canada on the TSX under its current symbol FTRP. Concurrent with the NASDAQ listing, Field Trip's Common Shares ceased to be quoted on the OTCQX. The Company previously completed the process to ensure its shares are eligible for electronic clearing and settlement through the Depository Trust Company (DTC). In addition, Ronan Levy and Ellen Lubman joined the Compensation Committee and Mujeeb Jafferi and Dr. Ryan Yermus resigned as directors of the Company. Mr. Jafferi and Dr. Yermus continue to serve as Field Trip's Chief Operating Officer and Chief Clinical Officer, respectively. Mr. del Moral, continued, "The milestone of listing on NASDAQ during the quarter was testament to the rapid progress we have made and increased our visibility in the marketplace, improving trading liquidity and ultimately enhancing long term shareholder value as we further strengthen our leadership position in the psychedelic medicine industry." Strategic Review of Corporate Structure The Company has commenced a strategic review designed to ensure that each operating unit is best positioned, optimally resourced, and focused to provide maximum long-term value to all stakeholders. Mr. Joseph del Moral, said, "With the FT-104 nearing the clinic, the expansion of discovery efforts around our FT-200 Group, and the growing number of opportunities for Field Trip Health Centers we believe it is the correct time to review all strategic options to ensure we continue to maximize the growth potential and value of each business unit." The Company has engaged Bloom Burton Securities Inc. as its financial advisor in connection with the strategic review. Financial Highlights For the second fiscal quarter ended September 30, 2021, the Company earned patient services revenues of $907,816 from its Toronto, New York, Santa Monica, Chicago, Atlanta, Houston and Amsterdam clinics, an increase of $813,284 or 860% over the comparative quarter ended September 30, 2020 of $94,532 and an increase of $40,416 or 5% over the prior fiscal first quarter. The Amsterdam clinic began generating revenues in September 2021. Second fiscal quarter 2021 patient services revenues were generated from only two clinics, Toronto and New York. The modest quarter over quarter revenue increase was in part due to the COVID-19 Delta variant and seasonality associated with the slower summer months. Revenues in the first part of the third quarter indicate a clear upward trend as a result of recent process optimizations to accelerate patient on-boarding and increase clinic capacity. Net loss for the second fiscal quarter of $13,019,280 was primarily due to total operating costs of $15,638,596, of which $2,055,890 was related to non-cash share-based compensation and $848,712 was related to non-cash depreciation and amortization. This was partially offset by a foreign exchange gain of $1,856,088. This compares with a net loss of $3,932,444 in the second fiscal quarter of 2021. The increase from the prior year primarily reflects the Company's focus on growing the business and continued investment in its drug development pipeline and best-in-class clinic infrastructure. As the Company continues to scale, it is optimizing and streamlining the development of its psychedelic-assisted therapies. Total operating costs in the second fiscal quarter were $15,638,596 and were comprised of the following: general and administration expenses of $8,917,717, research and development expenses of $2,102,787, patient services expenses of $1,917,451, sales and marketing expenses of $1,315,434, depreciation and amortization of $848,712 and occupancy costs of $536,495. This compares with total operating costs of $3,810,177 in the second fiscal quarter of 2021. The difference in general and administrative expenses in the second fiscal quarter also included $596,055 in non-recurring expenses primarily related to the NASDAQ uplisting, $1,330,847 in recurring public company costs as well as non-cash share-based payments of $1,380,398. Balance Sheet As of September 30, 2021 Field Trip had unrestricted cash and cash equivalents, funds held in trust and short-term investments of $87,526,034. Selected Consolidated Financial Information The following table sets forth selected financial information derived from the Company's unaudited condensed interim financial statements for the three months and six months ended September 30, 2021 prepared in accordance with IAS 34 in a manner consistent with the Company's annual audited financial statements. The following information should be read in conjunction with the financial statements and management's discussion and analysis, which are available on the Company's website at www.fieldtriphealth.com and under the Company's SEDAR profile at www.sedar.com. FIELD TRIP HEALTH LTD STATEMENTS OF LOSS AND COMPREHENSIVE LOSS   3 months ended   3 months ended   6 months ended   6 months ended     September 30,2021   September 30,2020   September 30,2021   September 30,2020    .....»»

Category: earningsSource: benzingaNov 15th, 2021

Numinus Wellness Inc. Reports Q1 2023 Results

Q1 2023 revenues grew 618% year-over-year to $5.7 million Q1 2023 gross margin grew to 41.9% from 31.5% in prior quarter Gross profit of $2.4 million, an increase of $1.1 million from prior quarter Ended quarter with cash position of $26.4 million All financial results are reported in Canadian dollars unless otherwise stated. VANCOUVER, BC, Jan. 16, 2023 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX:NUMI) (OTCQX:NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its financial results for the three months ended November 30, 2022 ("Q1 2023").  "During the first quarter of fiscal 2023, we successfully implemented several initiatives to increase access to psychedelic and ketamine-assisted therapy. We believe expanded access will not only serve to elevate Numinus' leadership position within the psychedelic industry, but strongly supports the overall advancement of psychedelic medicine for the treatment of mental health. With our strengthened network of 12 wellness clinics and research operations firmly in place following our acquisition of Novamind, we leveraged our robust integrated mental health infrastructure to enhance our service offerings, driving a strong start to 2023," said Payton Nyquvest, Founder and CEO. "During the quarter, we developed a whole mushroom psylocibin-containing tea bag, EnfiniTea, which has demonstrated a more consistent dosing and longer shelf stability than other natural psilocybin-mushroom products. Our new clinical trial application for experiential psilocybin-assisted therapy training research will use our EnfiniTea for trial dosing, making this one of the first clinical trials globally to be conducted with whole Psilocybe mushrooms to assess their safety. This will also be one of the first training programs with the option to participate in an experiential trial for practitioners looking to expand their psychedelic-assisted therapy education. In addition, we launched Ketamine-assisted Therapy (KAT) at our Toronto location, introduced a wider assortment of ketamine-assisted therapy options at our Montreal clinics and launched KAT for Chronic and Serious Illness at our Utah clinics. Research continues to support the efficacy of these therapies and we are committed to continuously enhancing our service offerings to make psychedelics available to those in need." Commenting on the quarter's performance, Mr. Nyquvest continued: "We continued to focus on driving margin expansion during Q1 2023, through ongoing cost containment initiatives and a focus on reaching a growing number of clients. Overall, client appointments grew 13.7%, G&A expenses declined 8.5%, and gross profit increased 80% from last quarter to $2.4 million in the first quarter – representing a 41.9% gross margin.  We are proud of the growth and margin improvements we're seeing across our organization, and will continue to identify ways to reach profitability as soon as possible."  First Quarter Financial Highlights Revenues grew 618% year-over-year to $5.7 million in Q1 2023. Sequentially, revenues grew 35.7% from the prior quarter. Gross margin grew to 41.9% during Q1 2023 compared to 6.5% in Q1 2022. The improvement in gross margin is due mostly to the completion of the Novamind acquisition between periods and the offering of higher-margin services. Sequentially, gross margin grew 1,040 basis points from 31.5% in Q4 2022. Gross profit was $2.4 million in Q1 2023, a significant increase compared to gross profit of $50,965 in Q1 2022, and an 80% increase compared to $1.3 million in the prior quarter. G&A expenses declined 8.6% from the prior quarter as a result of ongoing cost containment initiatives. Cash balance of $26.4 million as of November 30, 2022. Operational Highlights During and Subsequent to Q1 2023 Numinus Wellness Clinic Network Q1 2023 revenue of $5.0 million, a 35.3% sequential increase from $3.7 million in Q4 2022, and a 669.5% increase compared to $647,915 million during the same period last year. The increase in clinic network revenues is primarily due to acquisitions completed during the past year, growth in client appointments and the expansion of clinic services. During Q1 2023, Numinus completed more than 19,774 client appointments – including one-on-one and group therapy sessions, neurology-related appointments, paid group programs, Ketamine-assisted psychotherapy (KAT), Transcranial Magnetic Stimulation (TMS) and Ketamine/Spravato medicine appointments, representing a 13.7% increase in clinic appointments compared to more than 17,000 appointments in Q4 2022. 9.7% of appointments during Q1 2023 were made by new clients. 3.7% of appointments during Q1 2023 were KAT or Ketamine/Spravato medicine related. 1,863 TMS appointments were made during Q1 2023. At the end of Q1 2023, Numinus had 138 practitioners providing client treatments through its wellness clinics and virtual services, a 13.1% increase from the beginning of the quarter. On September 13, 2022, Numinus launched a new financing option for clinic patients in Canada. This new payment option will increase the accessibility ...Full story available on Benzinga.com.....»»

Category: earningsSource: benzingaJan 16th, 2023

Numinus Wellness Inc. Reports Q1 2023 Results

Q1 2023 revenues grew 618% year-over-year to $5.7 million Q1 2023 gross margin grew to 41.9% from 31.5% in prior quarter Gross profit of $2.4 million, an increase of $1.1 million from prior quarter Ended quarter with cash position of $26.4 million All financial results are reported in Canadian dollars unless otherwise stated. VANCOUVER, BC, Jan. 16, 2023 /CNW/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX:NUMI) (OTCQX:NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its financial results for the three months ended November 30, 2022 ("Q1 2023").  "During the first quarter of fiscal 2023, we successfully implemented several initiatives to increase access to psychedelic and ketamine-assisted therapy. We believe expanded access will not only serve to elevate Numinus' leadership position within the psychedelic industry, but strongly supports the overall advancement of psychedelic medicine for the treatment of mental health. With our strengthened network of 12 wellness clinics and research operations firmly in place following our acquisition of Novamind, we leveraged our robust integrated mental health infrastructure to enhance our service offerings, driving a strong start to 2023," said Payton Nyquvest, Founder and CEO. "During the quarter, we developed a whole mushroom psylocibin-containing tea bag, EnfiniTea, which has demonstrated a more consistent dosing and longer shelf stability than other natural psilocybin-mushroom products. Our new clinical trial application for experiential psilocybin-assisted therapy training research will use our EnfiniTea for trial dosing, making this one of the first clinical trials globally to be conducted with whole Psilocybe mushrooms to assess their safety. This will also be one of the first training programs with the option to participate in an experiential trial for practitioners looking to expand their psychedelic-assisted therapy education. In addition, we launched Ketamine-assisted Therapy (KAT) at our Toronto location, introduced a wider assortment of ketamine-assisted therapy options at our Montreal clinics and launched KAT for Chronic and Serious Illness at our Utah clinics. Research continues to support the efficacy of these therapies and we are committed to continuously enhancing our service offerings to make psychedelics available to those in need." Commenting on the quarter's performance, Mr. Nyquvest continued: "We continued to focus on driving margin expansion during Q1 2023, through ongoing cost containment initiatives and a focus on reaching a growing number of clients. Overall, client appointments grew 13.7%, G&A expenses declined 8.5%, and gross profit increased 80% from last quarter to $2.4 million in the first quarter – representing a 41.9% gross margin.  We are proud of the growth and margin improvements we're seeing across our organization, and will continue to identify ways to reach profitability as soon as possible."  First Quarter Financial Highlights Revenues grew 618% year-over-year to $5.7 million in Q1 2023. Sequentially, revenues grew 35.7% from the prior quarter. Gross margin grew to 41.9% during Q1 2023 compared to 6.5% in Q1 2022. The improvement in gross margin is due mostly to the completion of the Novamind acquisition between periods and the offering of higher-margin services. Sequentially, gross margin grew 1,040 basis points from 31.5% in Q4 2022. Gross profit was $2.4 million in Q1 2023, a significant increase compared to gross profit of $50,965 in Q1 2022, and an 80% increase compared to $1.3 million in the prior quarter. G&A expenses declined 8.6% from the prior quarter as a result of ongoing cost containment initiatives. Cash balance of $26.4 million as of November 30, 2022. Operational Highlights During and Subsequent to Q1 2023 Numinus Wellness Clinic Network Q1 2023 revenue of $5.0 million, a 35.3% sequential increase from $3.7 million in Q4 2022, and a 669.5% increase compared to $647,915 million during the same period last year. The increase in clinic network revenues is primarily due to acquisitions completed during the past year, growth in client appointments and the expansion of clinic services. During Q1 2023, Numinus completed more than 19,774 client appointments – including one-on-one and group therapy sessions, neurology-related appointments, paid group programs, Ketamine-assisted psychotherapy (KAT), Transcranial Magnetic Stimulation (TMS) and Ketamine/Spravato medicine appointments, representing a 13.7% increase in clinic appointments compared to more than 17,000 appointments in Q4 2022. 9.7% of appointments during Q1 2023 were made by new clients. 3.7% of appointments during Q1 2023 were KAT or Ketamine/Spravato medicine related. 1,863 TMS appointments were made during Q1 2023. At the end of Q1 2023, Numinus had 138 practitioners providing client treatments through its wellness clinics and virtual services, a 13.1% increase from the beginning of the quarter. On September 13, 2022, Numinus launched a new financing option for clinic patients in Canada. This new payment option will increase the accessibility of its traditional therapy and Ketamine-assisted therapy ...Full story available on Benzinga.com.....»»

Category: earningsSource: benzingaJan 16th, 2023

California Lawmaker Introduces Bill To Legalize Magic Mushrooms, Other Psychedelics

California Lawmaker Introduces Bill To Legalize Magic Mushrooms, Other Psychedelics Authored by Jamie Joseph via The Epoch Times, A Democratic lawmaker in California introduced a bill Dec. 19 to decriminalize the personal use of plant-based psychedelic drugs—such as magic mushrooms, mescaline, and psilocybin—outside of school grounds for people 21 and up. “Criminalizing drug use and possession accomplish absolutely nothing other than to fill up our prisons with people who are addicted,” said Sen. Scott Wiener (D-San Francisco) outside of the state Capitol Dec. 19. “We need to treat drug use as a health issue instead of a criminal one.” Wiener, the author of Senate Bill (SB) 58, said that psychedelics—a type of hallucinogenic drug—“have huge promise” when it comes to helping those suffering from mental health issues such as opioid addiction, depression, anxiety, and PTSD. Sen. Scott Wiener speaks in front of the California State Senate on Aug. 31, 2022. (Screenshot via California State Senate) SB 58 will also allow the cultivation, transfer, or transportation of fungi or other plant-based materials that can serve as ingredients for these drugs, according to its text. The bill may be heard on or after Jan. 16, 2023. These drugs affect how people see, hear, taste, smell, or feel, and can radically affect the user’s mood and thought, sometimes resulting in psychosis, according to existing academic studies. One veteran, Michael Young, said at the press conference he came home to the United States with severe PTSD after 10 years of counter-terrorism missions in Afghanistan and Pakistan. “Psychedelics help heal the unseen scars from my years of service in the war on terror,” he said. “This sacred medicine showed me how to put myself back together again.” According to the National Institute on Drug Abuse, hallucinogens “can cause users to see images, hear sounds, and feel sensations that seem real but do not exist.” The effects of ingesting psychedelics generally begin within 20 to 90 minutes and can last up to 12 hours in some cases or as short as 15 minutes in others, according to the institute. Magic Mushrooms sit in a fridge in London, England, on July 18, 2005. (Daniel Berehulak/Getty Images) SB 58 is a comparably moderate version of a previous bill Wiener proposed but failed to pass in 2021, which would have legalized not only plant-based but synthetic psychedelics, such as MDMAs, LSD, and ketamine. Although it is rare for someone to die from an LSD overdose, “severe injury and death has occurred as an indirect result of using LSD, in that accidents, self-mutilation, and suicide have occurred … when people are largely unaware of what they are doing,” according to the American Addiction Centers. The Heroic Hearts Project—a co-sponsor of SB 519 of 2021 and psychedelic advocacy group for veterans struggling with PTSD—said “psychedelic treatment options provided these veterans with a level of relief and healing that many had come to believe was no longer possible.” Several law enforcement groups opposed the 2021 bill, including the California College and University Police Chiefs Association, California District Attorneys Association, California Narcotic Officers’ Association, California Police Chiefs Association, California State Sheriffs’ Association, California Statewide Law Enforcement Association, and Peace Officers’ Research Association of California, among other organizations. The Peace Officers’ Research Association of California “believes many of the penalties related to controlled substances work as a deterrent or a reason for individuals to get the treatment they need to turn their lives around,” according to a statement of opposition submitted to the state Assembly Health Committee in July 2021. “Furthermore, [the association] believes this bill will cause an increase in the selling and personal use of drugs, which will lead to greater crime and arrests in our communities,” the statement read. Under the CURES Act, signed into law in 2016 to expand medical innovations, many hallucinogenic substances—including LSD, DMT, mescaline, and psilocybin—are classified as Schedule 1 substances, meaning they pose a high risk of abuse and are not accepted for medical use. In September, the San Francisco Board of Supervisors unanimously passed a motion calling for law enforcement to deprioritize investigations and arrests of adults found in possession of psychedelics. This was a month after an Oakland church using magic mushrooms as its form of communion was raided by police. Tyler Durden Thu, 12/29/2022 - 19:40.....»»

Category: personnelSource: nytDec 29th, 2022

What to know about the booming psychedelics industry, where companies are racing to turn magic mushrooms and MDMA into approved medicines

Startups focused on turning psychedelic compounds into approved medicines have raised hundreds of millions of dollars. Psilocybin mushrooms on a mossy logjackfoto/iStock/Getty Images Plus A year ago, nonprofits and scrappy startups made up the psychedelics space.  Now, companies are raising millions from investors and going public on major exchanges. Here's what you need to know about the booming psychedelics industry. See more stories on Insider's business page. The psychedelics space is booming.Over the few years, startups focused on turning psychedelic compounds into approved medicines have raised hundreds of millions of dollars from private investors and dozens have gone public.Research on compounds like psilocybin, the active compound found in magic mushrooms, and MDMA is resurfacing after years of neglect amid the war on drugs.As companies get closer to receiving approval from the Food and Drug Administration to bring their psychedelic treatments to patients, they've also been planning out their patent strategies to carve out their share of the market.Here's a look at the booming psychedelics industry:Psilocybin mushroomsAnitram/ShutterstockVCs have deployed millions into psychedelics startups — here's what they say will happen nextVenture-capital investors have been at the center of the psychedelics boom. In early 2020, startups in the space said they were beginning to see signs that investor appetite was growing.Then, we saw a flurry of activity, which one industry exec called a "psychedelic renaissance."Soon, VC firms focused on psychedelics companies specifically began to emerge. Insider's list of the top 11 venture-capital investors in the space collectively deployed $139.8 million into startups in just a few short years. They also gave us their predictions for the coming months. Some told us that biotech giants were looking to get into the space, while others predicted a boom in tech companies and clinics that would lay the groundwork for when medications come to market. We can also expect to see new compounds and a slew of startup failures, they said.The top 3 VC firms told Insider about the green and red flags they see among startups in the space. Read more:Meet the top 11 VCs who've bet the most cash on turning MDMA and magic mushrooms into medical treatmentsTop VCs in psychedelics say Big Pharma is knocking at the door — and it could fuel a wave of dealsTop VCs predict new compounds and impending failures will shape the future of the psychedelics industry3 top VCs who've sunk the most cash into psychedelics say they prioritize data, deep expertise, and a clear market strategy when placing their betsMainstream  startup accelerators are also eyeing the spaceWoven Science and Founders Factory are teaming up to create an accelerator program for psychedelics startups. From left: Sahil Sachdev, head of venture design at Founders Factory; Nick von Christierson, CEO & Co-Founder at Woven Science; Shona Chalmers, venture design lead at Founders Factory; Damian Routley, chief commercial officer at Founders FactoryWoven Science & Founders FactoryIn a signal that the psychedelics space is becoming increasingly mainstream, startup accelerators known for investing in tech, retail, and healthcare are jumping into funding companies in the industry.Famed startups accelerator Y Combinator is dabbling in psychedelics: over the past few years, the organization has accepted at least four startups into its program. Insider spoke to three of the startups to ask them about their experiences and the advice they would give to other founders looking to be accepted.Founders Factory, an accelerator that's worked with companies like L'Oréal, Johnson & Johnson, and Marks & Spencer, is an example of another mainstream player that's eyeing the $100 billion industry. The organization is partnering with psychedelics company Woven Science to to support a handful of early-stage startups focused on psychedelics-based mental-health treatments.Read more:The famed startup accelerator Y Combinator is wading into the $100 billion psychedelics industry. Here's how 3 psychedelics firms got into the program.A startup accelerator that's worked with J&J and L'Oréal is getting into psychedelics as the industry goes mainstreamCEOs set the tone for the burgeoning spaceATAI Life Sciences CEO Florian Brand.ATAI Life SciencesA slew of companies have entered the psychedelics industry, but a few stand out as frontrunners.In February 2020, Atai CEO Florian Brand said that he was turning to pharma and biotech investors as the company looked to further grow. At the time, Atai was a private company that made headlines for winning over backers like Mike Novogratz and Peter Thiel.In March of this year, the company raised a record $157 million, pushing psychedelics further into the mainstream.Meanwhile, change has been bubbling on the state and local levels. In November, Oregon legalized psilocybin for therapeutic purposes — but that doesn't mean you'll see the giants rush in.The biggest companies in the space told Insider they were focused on seeking approval for their experimental substances from the Food and Drug Administration. Atai founder Christian Angermayer said recently that while he personally supports decriminalization, he thinks legalizing psychedelics could create a backlash for the industry.Compass Pathways CEO George Goldsmith told Insider soon after the company's IPO last fall that he expects treatments to come on the market by 2025. Atai's Brand said there are challenges to address between now and when treatments become widely available, such as scalability and reimbursement.Read more:The CEO of a $1.2 billion psychedelics company told us he expects psilocybin-based treatments by 2025 and predicts a 'Cambrian explosion' of innovation in the industryThe founder of the biggest psychedelics company says legalizing magic mushrooms risks creating a backlash that could undermine the industryThe CEO of the biggest psychedelics company lays out the 3 challenges he has to address before treatments hit the marketStartups are raising big sums for drug development and clinicsThe first page of Compass Pathway's 2019 pitch deck.Compass PathwaysDrug development takes a lot of capital, and startups are focused on getting the funding they need.Insider got ahold of three pitch decks that companies used to raise tens of millions of dollars. Beckley Psytech raised $18.6 million in December to develop a slew of new treatments focused on rare diseases and mental health.Compass Pathways raised $80 million from investors like Founders Fund in 2019, fueling its rise to the top.Meanwhile, startups focused on clinics, where psychedelic treatments are expected to be administered, are raising capital too. Novamind raised $7.8 million with this pitch deck.Psilocybin found in magic mushrooms is a type of psychedelicAlexander Volkov/Getty ImagesAnother way to get access to capital is to go public, and there are now dozens of psychedelics companies in the US and Canada.We broke down the 7 companies with the biggest market caps and laid out their business models, drug pipelines, and timeline to get treatments to market. Read more:What to know about the major public psychedelics companies, including a guide to their business models and when they expect to sell medicationsSee the pitch deck a psychedelics startup just used to raise $18.6 million to develop new treatments derived from the Sonoran Desert toadSee the 20-slide pitch deck a psychedelics startup used to raise funds to build out a network of ketamine clinicsSee the pitch deck that Compass Pathways used to raise $80 million and fuel its rise into one of the world's biggest psychedelics companiesThe top startups are racing forwardA look at a legal psychedelic retreat hosted by The Synthesis InstituteThe Synthesis InstitutePrivate startups are still a core part of the space.Earlier this year, we published a list of the psychedelics startups that raised the most cash in 2020. The 14 names on that list raised over $222 million.We recently asked the biggest investors in the space to name two top startups in the industry — one they had invested in and one in which they hadn't — and came back with 15 names.Read more:Meet the top 14 psychedelics startups raising the most cash to develop new ways of treating depression, addiction, and moreVCs name the top 15 startups in the psychedelics industryAs drug discovery and development heats up, companies are using patents to raise money and protect market sharePsychedelics companies are using patents to raise funds and protect future market shares.Marianne Ayala/InsiderPsychedelics treatments based on psilocybin and MDMA are inching closer to FDA approval.In November, Compass Pathways, one of the few psychedelics companies in mid-stage trials of its psychedelic treatment, released data around its phase IIb trials for its a synthetic version psilocybin, the psychoactive component found in magic mushrooms, to treat treatment-resistant depression, or depression that doesn't get better with at least two other treatments.Compass is also in the midst of a brewing debate over the role that patents should play in the world of psychedelics, which has traditionally been a field defined by open science and natural compounds. Critics say the psychedelics giant is attempting to dominate the industry with its overreaching patent strategy, while Compass says it is only using patents to protect new inventions.But virtually every company developing psychedelics as FDA-approved treatments is employing a patent strategy to protect its market share and raise money from investors. Patent lawyers told Insider that a slew of patent disclosures could determine the winners and losers of the space.  Read more:Experts share how a brewing fight could shape the future of the $100 billion psychedelics industryCompass Pathways released its latest study on a psychedelic to treat depression. A top Wall Street analyst says the results are 'very encouraging.'The future of the psychedelics industry hinges on patents. Whoever wins could make billions.Academics, lawyers, and analysts are wading into the burgeoning spaceDMT research at Imperial College LondonThomas Angus, Imperial College LondonMeanwhile, it's not just investors and companies that are building out the foundation for what could become a $100 billion market.Academics have continued to publish promising studies on the benefits of psychedelic compounds. Wealthy philanthropists are responsible for the rush of funding entering academia as prestigious universities set up psychedelic research centers. One scientist told us that as psychedelic research has emerged from the fringes, donors have begun to catch the "psychedelic bug.""What psychedelics seems to do is, when it grabs you, you really seem to get it," he said.Lawyers and analysts are also wading into the space. As a slew of companies began to go public, analysts at investment banks began to cover the industry. Lawyers originally focused on cannabis clients also took the plunge.Read more:A Canadian investment bank that capitalized on the cannabis rush is now looking toward a new market. Meet the first analyst covering the burgeoning psychedelics industry.Cannabis lawyers are wading into the psychedelics industry as companies push forward with mega-deals and medical trials to win a slice of the $100 billion marketWealthy donors are fueling a psychedelics renaissance as universities vie for funding to study 'magic mushrooms' and MDMAA landmark study shows the main compound in magic mushrooms could rival a leading depression drug This article was first published on Aug 3, 2021 and was updated on Jan 14, 2022. Read the original article on Business Insider.....»»

Category: personnelSource: nytJan 14th, 2022

Numinus Wellness Inc. Reports Q4 and Year End 2021 Results

Ended the year with strong cash position of $59.2 million Revenues grew 81% year-over-year to $0.5 million for Q4 2021 Revenues grew 72% year-over-year to $1.5 million for FY 2021 Gross profit of $31,818 for Q4 2021 Completed the acquisition of the Neurology Centre of Toronto in September 2021 Two clinical trials about to launch: Phase 1 study for proprietary psilocybe extract and Phase 3 open label extension study partnership with MAPS for MDMA for PTSD Recently received conditional approval to graduate to the TSX (from the TSX Venture) All financial results are reported in Canadian dollars unless otherwise stated. VANCOUVER, BC, Dec. 9, 2021 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV:NUMI) (OTCQX:NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal fourth quarter and full year results for the periods ended August 31, 2021. "During the fourth quarter we were focused on building the team, infrastructure, technologies and protocols that will allow us to scale our business over the next several years," said Payton Nyquvest, Founder and CEO. "We welcomed several new key executives, began our laboratory expansion, and filed a patent for a proprietary rapid production process for psilocybe." Mr. Nyquvest continued: "Since the quarter ended, we have started to see the benefits of these transformative initiatives, with the expansion of our Ketamine-Assisted Psychotherapy offering, the acquisition of the Neurology Centre of Toronto, the finalization of our Phase 1 clinical trial protocols for our proprietary psilocybe extract, a partnership with MAPS to conduct the Phase 3 extension study of MDMA for PTSD, and the development of new proprietary toxicity and potency testing tools for psilocybin." Fourth Quarter Financial Highlights: Cash balance of $59.2 million as of August 31, 2021 Revenues grew 81.1% year-over-year to $0.5 million in Q4 2021, due primarily to the acquisition of Mindspace. Gross profit of $31,818 in Q4 2021, compared to gross loss of $158,222 in Q4 2020 Loss was $7.8 million for Q4 2021, which included a $1.6 million non-cash goodwill impairment charge related to the acquisition of Mindspace1. __________ 1 The impairment is primarily related to the exclusion of future revenues derived from psychedelic-assisted psychotherapies as these services are currently unregulated. As a result of IFRS standards, the Company must recognize there is uncertainty of realization of such revenues, and the impact on expected revenue growth and profitability to related services, relative to management's forecasts. Fiscal 2021 Financial Highlights: Revenues grew 71.8 % year-over-year to $1.5 million in fiscal 2021, due primarily to the acquisition of Mindspace. Gross loss of $81,538, compared to gross profit of $88,047 in fiscal 2020 Loss was $18.8 million for fiscal 2021, which included a $1.6 million non-cash goodwill impairment charge related to the acquisition of Mindspace¹, compared to a loss of $9.6 million in fiscal 2020. Operational Highlights During and Subsequent to Fourth Quarter 2021: Numinus Bioscience – Research and Laboratory Q4 2021 revenue of $90,593, a decrease of 66.7% from Q4 2020. This is primarily due to the Company ceasing cannabis related activities during the year to dedicate resources towards advancing psychedelic-centered service offerings – including psychedelic analytical testing and contract laboratory services, to align with the Company's strategy and overall objectives. In June 2021, the Company filed a provisional patent application with the United States Patent and Trademark Office for a proprietary rapid production process for psilocybe and other psychoactive fungi species. This process dramatically increases the production of therapeutics for use in psychedelic-assisted psychotherapy and leads to standardized psychedelic extracts that are reproducible, scalable, cost-effective and commercially viable. In July 2021, Numinus received Health Canada approval for the MAPS-sponsored, single-arm, open-label safety and feasibility study evaluating MDMA-assisted therapy for PTSD. During the quarter, Numinus began the 7,500 ft. expansion of its psychedelics research facility, including the building of an additional laboratory. An application for federal licensing for the additional lab was submitted in September 2021. The new space (adjacent to Numinus' existing laboratory) will be dedicated to the following services: Bioanalytical testing, Bioassay and in-vitro studies, Research & development and formulation studies for several psychedelic compounds, including ketamine and ...Full story available on Benzinga.com.....»»

Category: earningsSource: benzingaDec 9th, 2021

Numinus Wellness Inc. Reports Q4 and Year End 2021 Results

Ended the year with strong cash position of $59.2 million Revenues grew 81% year-over-year to $0.5 million for Q4 2021 Revenues grew 72% year-over-year to $1.5 million for FY 2021 Gross profit of $31,818 for Q4 2021 Completed the acquisition of the Neurology Centre of Toronto in September 2021 Two clinical trials about to launch: Phase 1 study for proprietary psilocybe extract and Phase 3 open label extension study partnership with MAPS for MDMA for PTSD Recently received conditional approval to graduate to the TSX (from the TSX Venture) All financial results are reported in Canadian dollars unless otherwise stated. VANCOUVER, BC, Dec. 9, 2021 /CNW/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV:NUMI) (OTCQX:NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal fourth quarter and full year results for the periods ended August 31, 2021. "During the fourth quarter we were focused on building the team, infrastructure, technologies and protocols that will allow us to scale our business over the next several years," said Payton Nyquvest, Founder and CEO. "We welcomed several new key executives, began our laboratory expansion, and filed a patent for a proprietary rapid production process for psilocybe." Mr. Nyquvest continued: "Since the quarter ended, we have started to see the benefits of these transformative initiatives, with the expansion of our Ketamine-Assisted Psychotherapy offering, the acquisition of the Neurology Centre of Toronto, the finalization of our Phase 1 clinical trial protocols for our proprietary psilocybe extract, a partnership with MAPS to conduct the Phase 3 extension study of MDMA for PTSD, and the development of new proprietary toxicity and potency testing tools for psilocybin." Fourth Quarter Financial Highlights: Cash balance of $59.2 million as of August 31, 2021 Revenues grew 81.1% year-over-year to $0.5 million in Q4 2021, due primarily to the acquisition of Mindspace. Gross profit of $31,818 in Q4 2021, compared to gross loss of $158,222 in Q4 2020 Loss was $7.8 million for Q4 2021, which included a $1.6 million non-cash goodwill impairment charge related to the acquisition of Mindspace1. __________ 1 The impairment is primarily related to the exclusion of future revenues derived from psychedelic-assisted psychotherapies as these services are currently unregulated. As a result of IFRS standards, the Company must recognize there is uncertainty of realization of such revenues, and the impact on expected revenue growth and profitability to related services, relative to management's forecasts. Fiscal 2021 Financial Highlights: Revenues grew 71.8 % year-over-year to $1.5 million in fiscal 2021, due primarily to the acquisition of Mindspace. Gross loss of $81,538, compared to gross profit of $88,047 in fiscal 2020 Loss was $18.8 million for fiscal 2021, which included a $1.6 million non-cash goodwill impairment charge related to the acquisition of Mindspace¹, compared to a loss of $9.6 million in fiscal 2020. Operational Highlights During and Subsequent to Fourth Quarter 2021: Numinus Bioscience – Research and Laboratory Q4 2021 revenue of $90,593, a decrease of 66.7% from Q4 2020. This is primarily due to the Company ceasing cannabis related activities during the year to dedicate resources towards advancing psychedelic-centered service offerings – including psychedelic analytical testing and contract laboratory services, to align with the Company's strategy and overall objectives. In June 2021, the Company filed a provisional patent application with the United States Patent and Trademark Office for a proprietary rapid production process for psilocybe and other psychoactive fungi species. This process dramatically increases the production of therapeutics for use in psychedelic-assisted psychotherapy and leads to standardized psychedelic extracts that are reproducible, scalable, cost-effective and commercially viable. In July 2021, Numinus received Health Canada approval for the MAPS-sponsored, single-arm, open-label safety and feasibility study evaluating MDMA-assisted therapy for PTSD. During the quarter, Numinus began the 7,500 ft. expansion of its psychedelics research facility, including the building of an additional laboratory. An application for federal licensing for the additional lab was submitted in September 2021. The new space (adjacent to Numinus' existing laboratory) will be dedicated to the following services: Bioanalytical testing, Bioassay and in-vitro studies, Research & development and formulation studies for several psychedelic compounds, including ketamine and LSD, and, Small batch manufacturing......»»

Category: earningsSource: benzingaDec 9th, 2021

Quebec Approves Magic Mushrooms Under Public Health Coverage

Quebec Approves Magic Mushrooms Under Public Health Coverage Quebec, Canada last week approved the used of psilocybin - the primary psychoactive in "magic mushrooms," as a valid therapy under the state's medical system. Advocates hope the move will set a precedent for other Canadian provinces to take similar action, Forbes reports. "This decision is a huge step forward for the use of psilocybin-assisted psychotherapy as a legitimate medical treatment," wrote TheraPsil, a nonprofit group that advocates for the advancement of psilocybin therapies, in a Dec. 15 statement. "It not only provides greater access to this potentially life-changing treatment for patients in Quebec, but it also sets a precedent for other provinces to follow suit." Clinical research and other studies into psychedelics such as psilocybin have shown that the drugs have potential therapeutic benefits, particularly for serious mental health conditions such as depression, addiction and anxiety. Research published in the peer-reviewed journal JAMA Psychiatry in 2020 found that psilocybin-assisted psychotherapy was an effective and quick-acting treatment for a group of 24 participants with major depressive disorder. A separate study published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer. -Forbes As we noted in April, psychedelic mushrooms are becoming increasingly popular in the US as a possible treatment for psychiatric disorders, with their main active ingredient, psilocybin, moving from the fringes of medicine, to become increasingly mainstream. It appears that Canada, however, is actually making moves to bring the benefits to actual patients. And while the benefits of psilocybin have been evident for some time, access to the compound - and related therapy, has been extremely limited in Canada. In some cases, terminally ill patients suffering from palliative depression have been made to wait more than a year for a response from Health Canada - the national health regulator - to gain permission to use magic mushrooms legally. What's more, even when patients obtained a legal exemption to use the drug, healthcare practitioners were unable to bill for it due to a lack of codes to properly process charges. That all changed after two doctors, Dr. Houman Farzin and Dr. Jean-François Stephan, successfully billed Quebec after treating a patient with psilocybin which was legally allowed by Health Canada. After the treatment, Dr. Stephan compiled evidence and submitted a letter, cosigned by 15 colleagues, outlining the medical safety and efficacy of psilocybin. He argued that both doctors participating in the treatment should be covered, noting that existing codes would not allow two doctors to bill for the same patient at the same time. He also explained that scientific evidence demonstrates that patients who have legal access to psilocybin-assisted psychotherapy have a medical indication. -Forbes "I think it’s amazing news that patients have covered access to such an important treatment option and it’s an encouraging sign for psychedelic medicine. Quebec has chosen to align with the science in regards to psychedelic medicine and recognize it as a medically indicated service in specific circumstances. They didn’t delay this unnecessarily," said Dr. Stephan, who partnered with the governing body for general practitioners in Quebec, the Fédération des médecins omnipraticiens du Québec (FMOQ), which negotiated with the government to amend the codes. "It’s encouraging to see them recognize the evidence available, and make the necessary adjustments to support the financial aspects of treatment so that it’s not an obstacle for patient access. I’m pleased this happened in Quebec, and I hope other provinces follow in their footsteps."   Tyler Durden Mon, 12/19/2022 - 17:20.....»»

Category: personnelSource: nytDec 19th, 2022

A Y Combinator-backed startup just raised $39 million to develop new psychedelic treatments for depression

Gilgamesh Pharmaceuticals is working to develop psychedelics that work faster and may be free of hallucinogenic effects. Jonathan Sporn is the founder and CEO of Gilgamesh Pharmaceuticals.Gilgamesh Pharmaceuticals Gilgamesh Pharmaceuticals wants to develop the next generation of psychedelic medicines. The company is creating psychedelic drugs that work faster and may not have hallucinogenic effects. The company just raised $39 million from investors and plans to start clinical trials next year. Gilgamesh Pharmaceuticals is trying to develop a new type of psychedelic medicine — one that has all the mental health benefits of psychedelic treatment, but without the drawbacks. The Y Combinator alumnus is developing new treatments that work similarly to psychedelics like psilocybin, the psychoactive compound found in magic mushrooms, or DMT, the hallucinogen found naturally in many animals and plants, but that have been engineered to work faster, last shorter periods of time, or lack hallucinogenic effects all together. Gilgamesh announced on Thursday that it had raised a $39 million round led by Prime Movers Lab. The company said it plans to start clinical trials for two different treatments in early 2023 with the funding raised. "A lot of people still recognize that these particular drug targets that are amenable to rapid acting therapeutic effects are going to be the future, even though it may take a bit of time," Jonathan Sporn, Gilgamesh's cofounder and CEO, told Insider.Sporn said that Gilgamesh was borne out of the idea that while psychedelic molecules hold a lot of potential for treating mental illnesses, companies developing molecules that have already been existence for a long time would struggle to be successful in the long run because the treatments can be time-consuming to take for patients. Additionally, the medicines themselves are similar to what a lot of other companies are working on.The Gilgamesh Pharmaceuticals teamGilgamesh PharmaceuticalsSo as the psychedelics industry has developed over the past few years, companies like Gilgamesh have pivoted their focus to developing completely new drugs.These new drugs are easier to patent compared to well-known psychedelic compounds, which have been used and studied for a long time. Patents are essential for biotech companies like Gilgamesh to make money if their drugs are approved.But what Gilgamesh is also doing differently than other psychedelics companies like Compass Pathways and organizations like MAPS is creating drugs that work faster and have less hallucinogenic effects.Many psychedelics drugs in development today take hours to administer and have strong hallucinogenic effects, which makes treatment times lengthy and expensive; new drugs that lack those characteristics could be easier for practitioners to administer and for patients to access. "What we wanted to do was to look at these molecules, the scaffolds, the targets, and then develop novel molecules that had better therapeutic profiles than these first generation compounds," he said.Next year, Gilgamesh will start two early stage trials with a handful of patients— both of which will look at depression. One of the treatments in development is called GM-1020 and is similar to ketamine, a dissociative anesthetic with hallucinogenic effects that has shown promise in treating depression. Sporn told Insider that the company is developing the drug as a pill that can work quickly in patients and can hopefully be taken at home because it will lack the hallucinogenic effects of standard ketamine treatments.Another drug being tested, GM-2505, is a compound similar to DMT that is currently being developed as an IV infusion. GM-2505 will have psychedelic effects, though they're expected to last just an hour. By comparison, some other psychedelic drugs in development — like psilocybin and MDMA — have hallucinatory effects that are expected to last up to 8 hours in the clinic. Sporn told Insider that while the company's initial tests are focused on depression, they're also exploring whether these drugs could help treat other illnesses, like bipolar disorder, substance abuse disorders, anxiety, and OCD. "We think that those kinds of treatments where there's a very large unmet need will be particularly interesting," he said.Read the original article on Business Insider.....»»

Category: worldSource: nytDec 15th, 2022

Evelo Biosciences Reports Third Quarter 2022 Financial Results and Business Highlights

- Multiple Phase 2 readouts for EDP1815 in atopic dermatitis expected in 2023; data from first three cohorts expected in early 1Q 2023 and fourth cohort in 2Q 2023 - - Phase 2 data for first extracellular vesicle product candidate EDP2939 in psoriasis anticipated in 2H 2023 – - Continuing to advance regulatory discussions for registration trials for EDP1815 in psoriasis - CAMBRIDGE, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis, SINTAX, today announced its third quarter 2022 financial results and business highlights. "We are on-track to deliver on three Phase 2 clinical milestones throughout 2023: first, early in the first quarter of 2023, data from the first three cohorts in the Phase 2 trial of EDP1815 in atopic dermatitis; second, in the second quarter of 2023, data from the fourth cohort - the faster release capsule – in the Phase 2 trial of EDP1815 in atopic dermatitis; and third, in the second half of 2023, data from patients in the Phase 2 trial of EDP2939, our first extracellular vesicle (EV) product candidate, in psoriasis" said Simba Gill, Ph.D., Chief Executive Officer of Evelo. Dr. Gill continued, "We are pleased that the European Medicines Agency (EMA) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), through their respective scientific advice processes, acknowledged the appropriateness of our proposed registration clinical trial design for EDP1815 in psoriasis, including the primary and secondary endpoints. We have also received initial written feedback from the United States Food and Drug Administration (FDA) on the same topics and have requested a meeting to discuss our registration trial plans. We have the technical and manufacturing operations in place that we believe will allow for registration trials and commercial launch." Third Quarter 2022 Highlights and Upcoming Key Milestones EDP1815 in Atopic Dermatitis: On-Track for Phase 2 Data Read-outs in Early 1Q 2023 (cohorts 1-3) and 2Q 2023 (cohort 4) Recruitment for the first three cohorts in the Phase 2 trial of EDP1815 in atopic dermatitis is complete. Cohorts 1 - 3 are currently testing different concentrations, as well as twice daily administration versus once daily administration of the original capsule that had been used in previous clinical trials with EDP1815. Data are expected early in the first quarter of 2023. Recruitment for the fourth cohort is ahead of schedule, with data expected in the second quarter of 2023. The fourth cohort is testing a faster release capsule, which targets the upper part of the small intestine more effectively and has demonstrated greater efficacy than the original capsule in pre-clinical trials. EDP2939 in Psoriasis: Dosing Expected in 1Q 2023; Phase 2 Data Anticipated in 2H 2023 In November 2022, the Company received a request from the MHRA for additional information with respect to the Clinical Trial Application (CTA) submission for the EDP2939 Phase 1/2 trial. The Company is currently in the process of providing written responses to the MHRA questions, and anticipates dosing healthy volunteers in Part A of the trial in the first quarter of 2023, with Part B (the Phase 2 trial) to follow. Phase 2 data in the cohort of patients with psoriasis are still expected in the second half of 2023. EDP1815 in Psoriasis: Regulatory Feedback on Proposed Registration Trials The Company has completed scientific advice meetings and received feedback from the EMA and MHRA on the proposed registration trial design of EDP1815 in psoriasis, including the primary and secondary endpoints. Both agencies provided supportive feedback regarding critical components of the chemistry, manufacturing and control (CMC) for the proposed registration trials. Initial written feedback was received from the FDA. A meeting with the FDA has been requested to discuss the Company's registration trial plan. Recent Presentations In September 2022, Evelo presented a poster at the 2022 European Academy of Dermatology and Venereology (EADV) Congress. The poster included biomarker data demonstrating the broad anti-inflammatory effects of EDP1815 in a Phase 2 clinical trial in psoriasis. Treatment with EDP1815 led to a statistically significant reduction in the release of cytokines IL-6, IL-8, and TNF in stimulated blood cells compared to placebo. In addition, RNAseq analysis of skin biopsies taken from active lesions in a subset of patients who had achieved at least a 50% improvement in their Psoriasis Area and Severity Index (PASI) score (PASI-50) from baseline at week 16 showed reductions in disease relevant cytokines IL-23, IL-12b, and IL-17. This provides evidence of a systemic anti-inflammatory effect in addition to the tissue response. In September 2022, Evelo gave two presentations at the 5-Continent-Congress (5CC). The first presentation discussed the use of extracellular vesicles for the treatment of inflammatory diseases, and the second presentation discussed the treatment of psoriasis via the small intestine. In October 2022, Evelo presented two posters at the 2022 Fall Clinical Dermatology Conference. The posters described the significant unmet medical need identified by dermatologists and primary care physicians in the U.S. for new treatment options for patients with mild and moderate psoriasis and atopic dermatitis. Third Quarter 2022 Financial Results (Unaudited) Cash Position: As of September 30, 2022, cash and cash equivalents were $69.1 million, as compared to cash and cash equivalents of $68.4 million as of December 31, 2021. Research and Development Expenses: R&D expenses were $21.9 million for the three months ended September 30, 2022, compared to $22.6 million for the three months ended September 30, 2021. General and Administrative Expenses: G&A expenses were $7.1 million for the three months ended September 30, 2022, compared to $10.1 million for the three months ended September 30, 2021. Net Loss: Net loss was $30.6 million for the three months ended September 30, 2022, compared to $33.7 million for the three months ended September 30, 2021.About Evelo Biosciences Evelo Biosciences is a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis, SINTAX, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. The Company's product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles (EVs). Evelo's vision is to create therapies that are effective, safe, well-tolerated, and affordable to improve the lives of the billions of people living with inflammatory diseases. Evelo initially is developing EDP1815 in psoriasis and atopic dermatitis and EDP2939 in psoriasis. If shown to be effective in inflammatory disease mediated by the Th1, Th2 or Th17 inflammatory pathways, these same investigational medicines could be effective in additional inflammatory diseases, such as psoriatic and other forms of arthritis, asthma, allergy, and inflammatory bowel disease. For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn. Forward Looking StatementsThis press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements concerning the development of EDP1815 and EDP2939, the promise and potential impact of our product candidates, the timing of and plans for clinical trials, the timing and results of clinical trial readouts and the timing and nature of feedback from regulatory agencies. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding; our ability to meet our debt obligations (including restrictive covenants) or refinance our debt on acceptable terms, if at all; our limited operating history; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the likelihood of regulatory filings and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our reliance on third parties and collaborators to expand our microbial library, conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; our lack of experience in manufacturing, selling, marketing, and distributing our product candidates; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; our management and principal stockholders have the ability to control or significantly influence our business; costs and resources of operating as a public company; unfavorable or no analyst research or reports; the fact that we are subject to certain restrictive covenants under the terms of our loan and security agreements; and securities class action litigation against us. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the period ended September 30, 2022, and our other reports filed with the United States Securities and Exchange Commission, 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 we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Contacts Investors:Kendra Sweeney, 239-877-7474ksweeney@evelobio.com Media:Jessica Cotrone, 978-760-5622jcotrone@evelobio.com Evelo Biosciences, Inc.Condensed Consolidated Statements of Operations(In thousands, except share and per share data)(Unaudited)       Three Months Ended September 30,   Nine Months Ended September 30,       2022       2021       2022       2021   Operating expenses:                 Research and development   $ 21,928     $ 22,599     $ 62,470     $ 64,762   General and administrative     7,126       10,111       24,909       23,075   Total operating expenses     29,054       32,710.....»»

Category: earningsSource: benzingaNov 14th, 2022

Mydecine Reports Financial Results for the Third Quarter of Fiscal Year 2022

DENVER, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC:MYCOF) (FSE: 0NFA) ("Mydecine" or the "Company"), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today reported company highlights and financial results for the nine months ended September 30, 2022. Company Highlights In 2022, Mydecine continued to define its focus and clinical trial execution strategy. The Company reached several milestones with the goal to become an efficiently operated biotechnology company. Of significant note, Mydecine announced several advancements in drug development including first and second-generation drug candidates. The Company has identified and pursued the indications that management believes will be most promising from the view of treating global populations in need. The Company has matured significantly in every aspect of its operations, focus, efficiencies, corporate governance and execution in the pursuit of being a world class, purpose driven, drug development platform that is focused, credible and qualified to successfully accomplish its goals and bring significant value to its loyal shareholders. During the September 2022 reporting period, the Company signed a Letter of Intent to sell its digital technology subsidiary, Mindleap Health Inc. The Company would receive $4,000,000 CAD for its shares of Mindleap and would receive a further $100,000 for post-closing consulting services. Management decided to reduce the scope of daily operation within the Mindleap Health subsidiary. Software development activities were paused and the Company released Mindleap's consultants. The platform remained, and remains, available to subscribers and continued to generate operating revenues and expenses through September 30, 2022. During the three months ended June 30, 2022 management decided to cease the research of functional mushrooms that was being conducted in their facility located in Denver, CO. During the quarter, the employees at this facility were released or transferred to other functions of the Company. Management began preparations to liquidate the laboratory equipment and furniture in this location and, subsequently, negotiated an amendment that changed the termination date of the lease. During 2020 and the nine-months ended September 30, 2021, the Company controlled a variety of hemp-derived cannabis assets that cultivated, designed, manufactured, and distributed products. As well, up to September 30, 2021, the Company had a portfolio that included a rental property and land assets. These business assets were spun out into a separate corporate entity as of October 1, 2021, therefore are not represented in the company's year-to-date 2022 operating results. On September 16, 2022, the Company completed a private placement and issued 1,754,386 common shares for gross proceeds of $1,000,000. On August 16, 2022, the Company completed a private placement and issued 326,666 common shares for gross proceeds of $245,000. On July 19th, 2022 Mydecine announced it has successfully synthesized multiple short-acting MDMA analogs. This family of analogs have been specifically designed by experts at Mydecine to have a shorter half life than traditional MDMA. The Company has named this family of novel molecules MYCO-006 and have applied for patent coverage with the World Intellectual Property Organization. On May 27, 2022 the Company completed an overnight offering and issued 2,447,130 common shares for gross proceeds of $2,814,200. The Company paid broker fees of $186,043. On May 2, 2022, the Company, in connection with its previously announced Common Share Subscription Agreement (the "Subscription Agreement") with a third-party investor (the "Investor") dated March 18, 2022 and the subsequent filing of a second shelf prospectus supplement (the "Prospectus Supplement") in connection therewith on April 27, 2022, the Company has closed the second issuance (the "Offering") under the Subscription Agreement. The Offering resulted in the issuance of 1,254,396 common shares in the capital of the Company ("Shares") at a price of $1.35 per Share for aggregate gross proceeds of $1,693,434.60. The distribution of the Shares is qualified by the Prospectus Supplement. On April 13, 2022, the Company completed a reverse stock-split, thereby consolidating all of the Company's issued and outstanding common shares ("Common Shares") on the basis of one (1) post-consolidation Common Share for every fifty (50) pre-consolidation Common Shares. As a result of elimination of partial shares, the share count was adjusted by 13 shares. On February 16th, 2022 Mydecine announced the inclusion of a novel molecule with potentially heart-safe microdose enabling properties in their family of psilocin analogs. The Company has named this group of patent pending molecules MYCO-005. Ongoing Operations The Company's main focus is novel drug development. The Company's primary target indication at this time is Smoking Cessation. During the next 12 months, the Company intends to advance these projects on the following fronts: Using advanced artificial intelligence and machine learning to design and screen drugs of interest. Commence animal studies and subsequent human trials. Work closely with internationally recognized firms to conduct the clinical trials. Continue to develop molecule families MYCO-004, MYCO-005 and MYCO-006. Explore new strategic partnerships to leverage the company's ongoing efforts. The Company is currently conducting its psilocybin research in Canada at the University of Alberta. The Company also has a number of planned research and clinical trial sites internationally including Johns Hopkins University School of Medicine, Leiden University Medical Center, Macquarie University, The Imperial College of London, and several other prominent Universities throughout the United States and elsewhere. The Company's expectation on receiving regulatory approval to develop and market psychedelic medicine including but not limited to psilocybin and derivatives of psilocybin. The Company has been in communication with several clinical research organizations (CRO) on a global level that were chosen for their experience with similar compounds and the geographic support for psychedelic research. The location for the Phase I trial of a psilocybin analog will be chosen late 2022 with plans to dose the first patient in the Q2. Efforts towards MYCO-001, were pivoted towards MYCO-004, a psilocybin analog. Shortly after a positive pre-IND meeting with the FDA regarding MYCO-001, psilocybin prodrug development reached a point where a lead candidate could be chosen. The investigational psilocybin drug product received FDA approval NIDA grant funded trial at Johns Hopkins University (JHU) on smoking-cessation by Matt Johnson & Al Garcia-Romeu. The Company is donating the drug product for the NIDA trial and plans to have the MYCO-004 Phase II trial at JHU in lieu of the originally planned MYCO-001 trial, as part of the 5-year research collaboration agreement. Additionally, the company is planning to supply MYCO-001 drug substance for multiple studies in the European Union in 2023. The Company's expectations with respect to future performance, results and terms of strategic initiatives, strategic agreements and supply agreements. The Company has continued building the patent portfolio based on improving natural psychedelics so they may better fit into the current medical care system. The novel compound development pipeline increased production in Q3 (September) and looks to finish 2022 ahead of schedule. Multiple provisional & PCT applications and realized the publication of Novel Psilocin Analog Compositions And Methods of Synthesizing The Same. The Company is preparing for licensing relationships after another patent publication, Novel Functional Fungal Compound Formulations And Their Therapeutic Methods Of Use, became available. The Company plans to develop the technology further with a manufacturing partner and will be able to pursue licensing relationships with food, drink, and skincare brands by Q2 of 2023. Financial Results for the Nine Months Ended September, 2022 Net Loss: The net loss attributable to common stockholders was $11.47 million, from operations, or a basic and diluted loss per share of ($1.57). For the same period in 2021, loss from operations was $18.02 million, or a basic and diluted loss per share attributable to common stockholders of ($3.94) and which included a loss of $279,623 from discontinued operations. Cash Position: The Company had $88,933 in cash and cash equivalents as of September 30, 2022. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS - UNAUDITED.     For the three-months ended, For the nine-months ended,   Note September 30, 2022$   September 30, 2021 $   September 30, 2022 $   September 30, 2021$               Expenses           Finance cost 8,9 224,207   22,995   683,870   146,692   Corporate development   -   341,924   141,452   2,639,633   Depreciation 7,10 25,763   47,572   120,336   126,767   Consulting fees   904,273   1,396,635   3,032,041   3,195,631   Director and management fees 14 119,008   454,215   349,864   1,286,723   Foreign exchange loss (gain)   200,046   (65,862 ) 174,270   253,199   Insurance   617,232   171,704   1,166,106   324,927   Office and miscellaneous   5,783   420,759   246,328.....»»

Category: earningsSource: benzingaNov 14th, 2022

Elon Musk reportedly goes on "exploratory journeys" and likes to show friends a chart of the benefits of MDMA and mushrooms over alcohol

In the past, Elon Musk has expressed support for psychedelics, especially when it comes to treating PTSD and depression. Elon Musk next to picture of woman with psychoactive drug pills on her tongue having psychedelic trip with hallucinations - stock photoGetty Elon Musk likes to discuss the benefits of MDMA and mushrooms with friends, The New York Times reported. One friend said the billionaire had been on "mild exploratory journeys." Musk has discussed the benefits of psychedelics in the past. Elon Musk is no stranger to psychedelic drugs and often likes to discuss the benefits of the substances, according to a recent report from The New York Times.The billionaire likes to share a chart that shows MDMA and psychedelic mushrooms are healthier than alcohol use, one person who Musk shared the chart with on vacation told the publication.The Times spoke with over 40 people who have spent time with the richest man in the world over the past decade and a half, many under conditions of anonymity due to concerns of repercussions, as well as non-disclosure agreements that they were required to sign at the parties Musk attended.For the past 20 years, Musk has attended nearly every Burning Man festival — often accompanied by his younger brother, Kimbal Musk, the Times reported."I have been with him on mild exploratory journeys," David Marglin, a Bay Area lawyer who met Mr. Musk at Burning Man and has been his friend for 20 years, told The Times. "And he appreciates the value of those journeys. Nothing out of control or wild, but it's all night, and there's dancing and revelry."Neither Marglin nor Musk responded to Insider's requests to get in touch for comment ahead of publication.In the past, the Tesla CEO has expressed support for psychedelics. Earlier this year, he tweeted in a response to a thread on the issue from billionaire investor Marc Andreessen."I've talked to many more people who were helped by psychedelics & ketamine than SSRIs & amphetamines," Musk wrote on Twitter.More recently, the billionaire said in an interview with Full Send Podcast that he thinks psychedelics can be "pretty helpful" for PTSD and depression. Musk also noted he and the "whole of SpaceX" had been subjected to random drug tests for a year after he appeared on a podcast with Joe Rogan in which he smoked weed.What the science says Alcohol reduces production of serotonin and dopamine, mood-boosting chemicals in the brain. It has been linked to a higher risk for depression. Alcohol use is also linked to a number of health disorders and chronic conditions. Researchers have not compared health benefits from alcohol and psychedelic mushrooms head-to-head. And researchers are still studying whether psilocybin, the psychoactive ingredient in magic mushrooms, improves anxiety and depression.However, one small, 12-week trial, published last month, found psilocybin reduced the number of days heavy drinkers drank alcohol compared to those who took a placebo. As for MDMA, clinical trial results show promise for treating patients with post-traumatic stress disorder when taken under the supervision of a therapist. Again, researchers have not studied MDMA and alcohol head-to-head.Musk is far from the only tech CEO whose expressed interest in psychedelics. Apple founder Steve Jobs previously touted the practice of microdosing on psychedelic drugs, such as LSD or psilocybin mushrooms in order to promote creativity.Read the original article on Business Insider.....»»

Category: topSource: businessinsiderOct 11th, 2022

Psychedelics Companies Are Teaming Up To Offer Access Veterans

Two psychedelics companies have announced they’ll be collaborating to offer ketamine infusions in the US and psilocybin clinical retreats internationally with a special focus on  access needs for veterans.  read more.....»»

Category: blogSource: benzingaSep 14th, 2022

Numinus Wellness Inc. Reports Q3 2022 Results

Revenues grew 32% year-over-year to $0.74 million for the quarter Clinic network revenues grew 59.5% from the same quarter last year and 7.5% compared to prior quarter Achieved 24.4% gross margin and $180,845 gross profit of during Q3 2022 Ended quarter with strong cash position of $41.8 million Completed acquisition of Novamind, positioning Numinus as a leading, integrated mental healthcare company providing psychedelic-assisted therapies All financial results are reported in Canadian dollars unless otherwise stated. VANCOUVER, BC, July 14, 2022 /PRNewswire/ -  Numinus Wellness Inc. ("Numinus" or the "Company") (TSX:NUMI) (OTCQX:NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal quarter results for the three and nine months ended May 31, 2022 ("Q3 2022").  Q3 2022 results do not reflect contributions from the acquisition of Novamind, which completed subsequent to quarter end, on June 10, 2022.  "Our fiscal third quarter was highlighted by the announcement of our acquisition of Novamind, and the activities leading up to the completion of that strategic transaction on June 10, 2022. Now, with 13 wellness clinics across North America, four clinical research sites and a dedicated psychedelics research facility, Numinus is firmly positioned as a leading mental health care company providing psychedelic-assisted therapies. We're very pleased with how our operations are integrating and with the collaborative efforts we are already seeing across our new expanded team," said Payton Nyquvest, Founder and CEO. "We look forward to sharing our combined performance with you when we announce our fiscal fourth quarter results – which will be the first quarter demonstrating the power of our larger, cross-border platform." "Today, including the contributions of Novamind, Numinus is one of the highest revenue-producing mental health care companies providing psychedelic and ketamine-assisted therapies, with more than $12 million of combined proforma annual revenues (based on trailing four quarters). We continue to be excited about the momentum building across our business and our outlook ahead. With significantly strengthened revenue streams, a growing number of client services, and positive regulatory reforms underway, our focus is squarely on reaching profitability as quickly as possible. Our strategy to accelerate Numinus' path to profitability also includes expanding higher-margin services, increasing business development activities, and proactively managing our operating costs. Our goal is to achieve operational profitability within two years and corporate positive cashflow within three years," concluded Mr. Nyquvest. Third Quarter Financial Highlights Revenues grew 31.8% year-over-year to $741,064 million in Q3 2022, due primarily to the acquisitions of Mindspace and the Neurology Centre of Toronto. Sequentially, revenues declined by 5.7% from the prior quarter, due entirely to shifting strategic priorities at Numinus Bioscience – where analytical testing services for third-party corporate clients has ceased due to changing sector dynamics. The elimination of this revenue stream was partially offset by 7.5% revenue growth achieved through Numinus' clinic network operations. Gross margin grew to 24.4% during Q3 2022, compared to -2.8% in Q3 2021. The improvement in gross margin is due mostly to the completion of acquisitions between periods, and the offering of higher-margin services. Gross profit of $180,845 in Q3 2022, a significant improvement compared to the gross loss of $15,497 in Q3 2021. Loss was $7.0 million for Q3 2022, compared to a loss of $4.8 million in Q3 2021, due in part to corporate development and legal expenses related to the acquisition of Novamind Inc. Cash balance of $41.8 million as of May 31, 2022. First Nine Months Financial Highlights Revenues during the first nine months of fiscal 2022 grew 126.5% year-over-year to $2.3 million due primarily to the continued post-acquisition growth of Mindspace and the acquisition of NCT. Gross margin during the first nine months of 2022 was 19.9%, compared to -11.1% in the same period last year. Gross profit during the first nine months of 2022 was $460,569, a significant improvement compared to the gross loss of $113,356 in the same period of 2021. Loss was $20.2 million for the first nine months of 2022, compared to a loss of $11.0 million in the first nine months of 2021. Operational Highlights During and Subsequent to Q3 2022As a reminder, operational performance for the third quarter and first nine months of fiscal 2022 does not include contributions from the acquisition of Novamind, which completed subsequent to quarter-end, on June 10, 2022. Numinus Wellness Clinic Network Q3 2022 revenue of $731,064, a 7.5% sequential increase from Q2 2022, and a 59.5% increase compared to $458,316 during the same period last year. During Q3 2022, clients received a total of 5,634 appointments through Numinus clinics (including one-on-one and group therapy sessions, neurology-related appointments, paid group programs and Ketamine-assisted psychotherapy), representing a 5.9% increase in clinic appointments compared to Q2 2022. As of May 31, 2022, Numinus had five wellness clinics and two clinical research sites. As of July 14, 2022, following the acquisition of Novamind, Numinus has 13 wellness clinics offering services to clients (one in Vancouver, one in Toronto, three in Montreal, eight in Utah and two in Arizona). In addition, the Company has four dedicated research clinics where psychedelic studies are being conducted (two in Salt Lake City, one in Vancouver and one in Montreal). Following a review of its growth initiatives and opportunities, Numinus has decided to cancel its previously announced second wellness clinic location in Vancouver, Canada. The acquisition of ...Full story available on Benzinga.com.....»»

Category: earningsSource: benzingaJul 14th, 2022

Numinus Wellness Inc. Reports Q3 2022 Results

Revenues grew 32% year-over-year to $0.74 million for the quarter Clinic network revenues grew 59.5% from the same quarter last year and 7.5% compared to prior quarter Achieved 24.4% gross margin and $180,845 gross profit of during Q3 2022 Ended quarter with strong cash position of $41.8 million Completed acquisition of Novamind, positioning Numinus as a leading, integrated mental healthcare company providing psychedelic-assisted therapies All financial results are reported in Canadian dollars unless otherwise stated. VANCOUVER, BC, July 14, 2022 /CNW/ -  Numinus Wellness Inc. ("Numinus" or the "Company") (TSX:NUMI) (OTCQX:NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal quarter results for the three and nine months ended May 31, 2022 ("Q3 2022").  Q3 2022 results do not reflect contributions from the acquisition of Novamind, which completed subsequent to quarter end, on June 10, 2022.  "Our fiscal third quarter was highlighted by the announcement of our acquisition of Novamind, and the activities leading up to the completion of that strategic transaction on June 10, 2022. Now, with 13 wellness clinics across North America, four clinical research sites and a dedicated psychedelics research facility, Numinus is firmly positioned as a leading mental health care company providing psychedelic-assisted therapies. We're very pleased with how our operations are integrating and with the collaborative efforts we are already seeing across our new expanded team," said Payton Nyquvest, Founder and CEO. "We look forward to sharing our combined performance with you when we announce our fiscal fourth quarter results – which will be the first quarter demonstrating the power of our larger, cross-border platform." "Today, including the contributions of Novamind, Numinus is one of the highest revenue-producing mental health care companies providing psychedelic and ketamine-assisted therapies, with more than $12 million of combined proforma annual revenues (based on trailing four quarters). We continue to be excited about the momentum building across our business and our outlook ahead. With significantly strengthened revenue streams, a growing number of client services, and positive regulatory reforms underway, our focus is squarely on reaching profitability as quickly as possible. Our strategy to accelerate Numinus' path to profitability also includes expanding higher-margin services, increasing business development activities, and proactively managing our operating costs. Our goal is to achieve operational profitability within two years and corporate positive cashflow within three years," concluded Mr. Nyquvest. Third Quarter Financial Highlights Revenues grew 31.8% year-over-year to $741,064 million in Q3 2022, due primarily to the acquisitions of Mindspace and the Neurology Centre of Toronto. Sequentially, revenues declined by 5.7% from the prior quarter, due entirely to shifting strategic priorities at Numinus Bioscience – where analytical testing services for third-party corporate clients has ceased due to changing sector dynamics. The elimination of this revenue stream was partially offset by 7.5% revenue growth achieved through Numinus' clinic network operations. Gross margin grew to 24.4% during Q3 2022, compared to -2.8% in Q3 2021. The improvement in gross margin is due mostly to the completion of acquisitions between periods, and the offering of higher-margin services. Gross profit of $180,845 in Q3 2022, a significant improvement compared to the gross loss of $15,497 in Q3 2021. Loss was $7.0 million for Q3 2022, compared to a loss of $4.8 million in Q3 2021, due in part to corporate development and legal expenses related to the acquisition of Novamind Inc. Cash balance of $41.8 million as of May 31, 2022. First Nine Months Financial Highlights Revenues during the first nine months of fiscal 2022 grew 126.5% year-over-year to $2.3 million due primarily to the continued post-acquisition growth of Mindspace and the acquisition of NCT. Gross margin during the first nine months of 2022 was 19.9%, compared to -11.1% in the same period last year. Gross profit during the first nine months of 2022 was $460,569, a significant improvement compared to the gross loss of $113,356 in the same period of 2021. Loss was $20.2 million for the first nine months of 2022, compared to a loss of $11.0 million in the first nine months of 2021. Operational Highlights During and Subsequent to Q3 2022As a reminder, operational performance for the third quarter and first nine months of fiscal 2022 does not include contributions from the acquisition of Novamind, which completed subsequent to quarter-end, on June 10, 2022. Numinus Wellness Clinic Network Q3 2022 revenue of $731,064, a 7.5% sequential increase from Q2 2022, and a 59.5% increase compared to $458,316 during the same period last year. During Q3 2022, clients received a total of 5,634 appointments through Numinus clinics (including one-on-one and group therapy sessions, neurology-related appointments, paid group programs and Ketamine-assisted psychotherapy), representing a 5.9% increase in clinic appointments compared to Q2 2022. As of May 31, 2022, Numinus had five wellness clinics and two clinical research sites. As of July 14, 2022, following the acquisition of Novamind, Numinus has 13 wellness clinics offering services to clients (one in Vancouver, one in Toronto, three in Montreal, eight in Utah and two in Arizona). In addition, the Company has four dedicated research clinics where psychedelic studies are being conducted (two in Salt Lake City, one in Vancouver and one in Montreal). Following a review of its growth initiatives and opportunities, Numinus has decided to cancel its previously announced second wellness clinic location in Vancouver, Canada. The acquisition of Novamind has provided additional growth opportunities that ...Full story available on Benzinga.com.....»»

Category: earningsSource: benzingaJul 14th, 2022

Field Trip Shares Fiscal Q4 And Full Year 2022 Results & Update On Court-Approved Corporate Reorganization

Psychedelic therapies developer and provider Field Trip Health Ltd. (TSX: FTRP) (NASDAQ: FTRP) reported fiscal fourth quarter and full year 2022 results for the period ended March 31, 2022 and completed a strategic review resulting in the intention to separate the Field Trip Discovery and Field Trip Health divisions into two independent public companies. The company’s Discovery division leads the development of next-gen psychedelic molecules and conducts research on plant-based psychedelics, and the Health division runs centers for psychedelic therapies across North America and Europe. During the fiscal fourth quarter, Field Trip continued advancing on its drug discovery work focused on the R&A of its first drug candidate, FT-104, as well as other molecules such as the FT-200 series. Specifically, FT-104 is based on classical serotonin 2A psychedelics, like psilocybin, reported to successfully help a variety of mood disorders including depression, anxiety and substance abuse.  While FT-104 is a proprietary clinical-stage prodrug designed to produce a short duration experience, FT-200 constitutes a family of molecules with potentially reduced cardiovascular risk profiles. On the other hand, the Field Trip Health clinics ...Full story available on Benzinga.com.....»»

Category: earningsSource: benzingaJun 30th, 2022

PharmaTher Reports Financial Results for the Third Quarter of Fiscal 2022 and Provides Recent Business Highlights and Update

Nearly $12 million in cash and investment Fully funded for the Company's development programs, including ketamine injection and infusion product, ketamine microneedle patch and ketamine wearable pump device for mental health, neurological, and pain disorders Seeking FDA approval for KETARX™ (ketamine injection and infusion product) for anesthesia and procedural sedation TORONTO, April 25, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB:PHRRF) (CSE:PHRM), a leader in specialty ketamine pharmaceuticals, today reported financial results for its third quarter ended February 28, 2022, and provided recent business highlights and update. All amounts are stated in Canadian dollars unless otherwise indicated.  "We have made great progress with our product and clinical development programs for ketamine as a novel treatment use for near-rare and rare disorders, while also creating unique product profiles including injectables/infusions, microneedle patch and a proposed wearable pump device where each will provide a unique solution to treat various mental health, neurological and pain disorders in hospitals, clinics and homes," said Fabio Chianelli, Chief Executive Officer of PharmaTher. "We are focused on becoming a leader in advancing ketamine to treat unmet medical needs, and we are funded to complete our development programs for clinical studies and our expected submission for FDA approval of our ketamine injectable and infusion product for anesthesia and procedural sedation by the end of 2022." Third-Quarter Financial Highlights Cash and cash equivalents totaled $10,165,170 and Investment totaled $1,666,667 for a total of $11,831,837 as at February 28, 2022; and Accounts payable and accrued liabilities totaled $140,947 as at February 28, 2022. Recent Business Highlights Entered into a research collaboration agreement with Revive Therapeutics Ltd. (CSE:RVV) (OTCQB:RVVTF) for the development of a psilocybin microneedle patch; Granted U.S. Patent No. 11,213,495 and Japanese Patent No. 6967532 for the combination formulation of FDA-approved ketamine and betaine anhydrous ("KETABET™"), which has shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly; Completed its first research study evaluating its proprietary microneedle patch for delivering lysergic acid diethylamide ("LSD") and psilocybin; Entered into a process development agreement with LTS LOHMANN Therapie-Systeme AG for the clinical trial scale-up of PharmaTher's proprietary ketamine microneedle patch product; The U.S. Food and Drug Administration ("FDA") accepted an investigator-initiated investigational new drug application to proceed with a ...Full story available on Benzinga.com.....»»

Category: earningsSource: benzingaApr 25th, 2022

More Studies Highlight Medical Benefits Of "Magic Mushrooms" Active Ingredient

More Studies Highlight Medical Benefits Of 'Magic Mushrooms' Active Ingredient As we have reported numerous times in the past, psychedelic mushrooms are becoming increasingly popular in the US as a possible treatment for psychiatric disorders, with their main active ingredient, psilocybin, moving from the fringes of medicine, to become increasingly mainstream. Roland Griffiths, a professor who studies the neuropsychopharmacology of consciousness at Johns Hopkins University School of Medicine, received approval in 2000 to carry out the first experiments on psilocybin since the 1960s. He found in a survey of early study participants that more than half regarded it as one of the most meaningful experiences of their life. “The mystical experience itself does seem to be really important for therapeutic effects, but we published survey data to suggest it’s not actually the mystical experience itself, but the personal insights you can encounter or gain during that mystical experience that actually lead to therapeutic change,” Barrett said. “The idea here is that mystical experience can create the opportunity for personal insights." Since then, for example, studies in recent years have shown promise in using psilocybin-assisted therapy to treat psychiatric disorders like depression. Some have been used to identify their usefulness in smoking cessation (alongside talk therapy). They have also shown some usefulness in alleviating anxiety in people with terminal cancer. But the big question for researchers now is: how can they show conclusively that hallucinating leads to alleviating symptoms in people suffering depression or other chronic ailments. Frederick Barrett, Associate Professor of Psychiatry and Behavioral Sciences at the Johns Hopkins School of Medicine, explained how depression works and how mushrooms help to disrupt these pathways. "One common feature of depression is something you can think of as cognitive or psychological inflexibility,” Barrett said. "You get stuck in a rut of rumination. You get stuck in negative self-attribution, negative self-thoughts, and this is a kind of characteristic of depression that helps people develop and maintain their depression," he said. "It all boils down to a reduced capacity to think creatively or to think openly, and to think differently about yourself and your condition, situation and behavior. If it can increase our cognitive flexibility, if it can increase our neural flexibility, we think that essentially it gives people back the capacity to think broadly about how they fit into the world and reassess or reappraise things that might happen to them.”  A separate paper published just last week in Nature Medicine by researchers from the University of California, San Francisco and Imperial College London echoed similar findings, although Barrett notes there are several caveats associated with the study’s findings. “What we’re seeing in these data after psychedelics is that there’s an increase in the connectivity between systems, such that they are becoming less segregated from each other,” Robin Carhart-Harris, former head of the Imperial Center for Psychedelic Research who is now based at the University of California, San Francisco, told Changing America.  Meanwhile, Oregon became the first state to effectively legalize shrooms back in 2020. With more psychologists and psychiatrists suspecting that mushrooms do have a medical benefit, consumers should expect to see more cities/states legalize the drug for medical and/or recreational use. Tyler Durden Thu, 04/21/2022 - 23:20.....»»

Category: blogSource: zerohedgeApr 21st, 2022

3 Psychedelic Stocks to Play the Shroom Boom

Psychedelic substances are often grouped together with cannabis, but there are some important distinctions. ATAI, CMPS and FTRP are some of the best stocks in the space. Using psychedelic substances is nothing new. In fact, psychedelics have their roots in ancient culture where the super or ‘magical’ mushrooms from which they are derived were worshipped. In the 1950s and ‘60s, there were a number of people experimenting with them for recreational purposes, and for treating alcoholism and other conditions, mainly in informal situations.And although the more formal trials were many (more than 40,000 people took part in them), they weren’t of the same standard that the FDA approval process currently requires. Additionally, their association with the counterculture led to their condemnation and stigmatization. By 1968, LSD was banned in all states and with the passing of the Controlled Substances Act in 1970, there was also pressure on psilocybin, the safest psychedelic so far, because of limited accepted evidence of its efficacy and its potential for abuse. This meant that institutional funding for research wasn’t available and it was left to individual donors to take it forward.In 2004, the University of California (UCLA) started clinical trials of psilocybin on advanced-stage cancer patients with pain, anxiety and depression. In 2006, Johns Hopkins University, which has been researching psilocybin since the 1970s, issued a publication that led to the establishment of a separate research unit for the purpose. In 2020, the university established the Center for Psychedelic & Consciousness Research that has published over 27,000 articles on psychedelic drugs, including a thousand on psilocybin, the most-researched psychedelic substance.Pharma companies also tasted some success around then. In 2018-2019, two companies, Johnson & Johnson (JNJ) and Compass Pathways (CMPS), got FDA approval for their therapeutics for treatment-resistant depression. JNJ’s Spravato was a ketamine analog while Compass’s was a psilocybin treatment. The interest in alternatives has increased over the past decade as existing lines of research aren’t yielding the desired results. In fact, 30% of depression patients don’t respond to currently available treatments. Companies have dramatically reduced their research budgets in these areas. So most of the nearly 550 grants received for psilocybin research have been for its efficacy in treating mood and anxiety disorders such as cancer-related psychiatric distress.But the current level of excitement is partly related to the recent funding that Johns Hopkins has received from the National Institute of Health’s (NIH) National Institute on Drug Abuse to research its ability to get long-time smokers off the habit.Johns Hopkins did a clinical study on psilocybin back in 2014 and found remarkable success. The drug was given in 2 to 3 sessions, the first being on the date the subject quit smoking; the second was two weeks after that and the optional third one was after eight weeks. Before administering, the patient was put on a couch with dark glasses and music playing; and was given some idea about the experience. They returned each week for the next 10 weeks to have their breath and urine tested and again after six months and then 12 months. It turned out that after six months, 12 out of the 15 smokers had abstained from cigarettes for at least a week. Moreover, 67% had abstained up to 12 months while 60% had not smoked for at least 16 months. Since it was a small group, further testing was deemed necessary.With the NIH now providing $4 million, Johns Hopkins will lead a multisite study in collaboration with the University of Alabama and New York University to explore potential impacts of psilocybin on tobacco addiction.  So what exactly is a psychedelic? It is a class of hallucinogenic drugs that trigger different states of consciousness by binding to serotonin receptors, which modulate brain circuits involved in sensory perception and cognition. The most common psychedelics in use are mescaline, LSD, psilocybin and DMT.Investing in the PhenomenonPsychedelics are often compared with cannabis since both are used widely for recreational purposes. And since marijuana has generated big gains, there’s a similar expectation of psychedelics as well. However, marijuana is a much more mature market. It’s already legal in many states and some of the companies are also profitable.  On the other hand, psychedelics are still illegal in most places across the world, and certainly in the U.S. And despite all the research, actual products from companies could take a while to come to market, if at all they do.    3 Players Worth ConsideringIt’s possible to spread your risk in psychedelics by going for an ETF. And there are currently a couple available.One is the Defiance Next Gen Altered Experience ETF PSY, which made its debut in May 2021. The first US-listed psychedelic ETF, PSY tracks a market-cap-weighted index of North American companies focused on psychedelics, medical cannabis and ketamine for medicinal and health treatment purposes. The Defiance Next Gen Altered Experience ETF is focused on securities with at least 50% of their revenues coming from legal activities and is reconstituted and rebalanced semi-annually every March and September. It has an expense ratio of 0.75% and does not pay a dividend.The second is a psychedelics pureplay called AdvisorShares Psychedelics ETF: PSIL. PSIL is an actively managed ETF that seeks long-term capital appreciation by investing at least 80% of its net assets in securities of companies that derive at least 50% of their net revenue from or devote 50% of their assets to psychedelic drugs and derivatives that have economic characteristics similar to such securities. It has an expense ratio of 0.68% and does not pay a dividend.Or, you could place your bets on what are, at the moment, the most attractive psychedelic stocks-ATAI Life Sciences N.V. ATAIATAI Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders with previously overlooked or underused therapies, including psychedelic substances and digital therapies. It is headquartered in Berlin, Germany.ATAI has engaged in a number of acquisitions and invested in several variable interest entities (VIEs), in which it is the primary beneficiary. Its acquisitions include PsyProtix, Psyber, InnarisBio and Neuronasal.While the 21 cent loss that ATAI reported in the last quarter was better than the estimated 28 cent loss, the estimated loss for 2021 and 2022 have not improved materially in the last 90 days. The 2021 estimated loss is currently 86 cents, down from a loss of $1.05 estimated 90 days ago. For 2022, the estimated loss has gone from $1.15 to $1.11.COMPASS Pathways plc CMPSCOMPASS Pathways plc is primarily involved in researching and developing psilocybin therapy for end-of-life anxiety and the manufacture of psilocybin for research. Given the significant gap in treatment for mental illnesses, it is particularly focused on the development of psilocybin therapy for treatment resistant depression (TRD). It started clinical trials for the purpose in 2017. However, later stage clinical trials are still some way off, only after which will it be able to apply for regulatory approval, to be followed by commercialization and sales. COMPASS Pathways operates principally in New York, USA and is headquartered in London, UK.In the September quarter, COMPASS Pathways did better than expected, with its 38-cent loss coming in much stronger than the estimated 50 cents. The expected loss per share for 2021 is down from $1.87 to $1.72 in the last 90 days while the loss for 2022 is down from $2.29 to $2.24.Field Trip Health FTRPFounded in 2008, Field Trip Health Ltd. is involved in the development and delivery of psychedelic therapies in North America. The company operates Field Trip Centres that provide these therapies. In addition, it also offers Field Trip Digital apps. In the Field Trip Discovery division, the company investigates is developing next generation of psychedelic molecules Field Trip Health Ltd. is based in Toronto, Canada.In the September quarter, Field Trip’s results were slightly short of estimates. The estimated losses for 2022 (ending March) and 2023 are also edging up. For 2022, they’ve gone from 66 cents to 70 cents and for 2023 they’re up from 76 cents to 79 cents.ConclusionThe NIH funding ushers in a new era of legitimacy for psychedelics and to that extent this may be a good time to commit some of your money. But given that research is still ongoing, mainly at universities, that big pharma is yet to make big commitments and that legalization will of course take its own sweet time, it’s going to be a long wait.3-Month Price PerformanceImage Source: Zacks Investment Research 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 November, the Zacks Top 10 Stocks gained an impressive +962.5% versus the S&P 500’s +329.4%. Now our Director of Research is combing through 4,000 companies covered by the Zacks Rank to handpick the best 10 tickers to buy and hold. Don’t miss your chance to get in on these stocks when they’re released on January 3.Be First to New Top 10 Stocks >>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 atai Life Sciences N.V. (ATAI): Free Stock Analysis Report COMPASS Pathways PLC Sponsored ADR (CMPS): Free Stock Analysis Report Defiance Next Gen Altered Experience ETF (PSY): ETF Research Reports Field Trip Health Ltd. (FTRP): Free Stock Analysis Report AdvisorShares Psychedelics ETF (PSIL): ETF Research Reports To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksDec 23rd, 2021

Braxia Scientific Reports Second Quarter 2022 Financial Results and Provides Corporate Update

Expanded clinical infrastructure to support a growing portfolio of clinical trials of novel interventions and for drug discovery; 14 registered clinical trials in depression, led by Company CEO and Chief Medical and Scientific Officer, completed or in process Excellent progress on only psilocybin trial in Canada actively recruiting study participants to receive psilocybin-assisted therapy Clinical footprint in Canada has administered ~4,900 ketamine treatments to date; focus on expansion opportunities in the U.S. and Europe TORONTO, Nov. 29, 2021 /PRNewswire/ - Braxia Scientific Corp. ("Braxia Scientific", or the "Company"), (CSE:BRAX) (OTC:BRAXF) (FWB: 496), a medical research company with clinics providing innovative ketamine treatments for persons with depression and related disorders, today announced the filing of its fiscal second-quarter results for the three-month period ending September 30, 2021. Complete financial statements along with related management discussion and analysis can be found in the System for Electronic Document Analysis and Retrieval (SEDAR), the electronic filing system for the disclosure documents of issuers across Canada, at www.SEDAR.com. "We have made tremendous progress on our strategic priorities, including increasing access to novel treatments for patients with depression through our clinics. We have also established a clinical research infrastructure required to execute on our growing pipeline of registered clinical trials alongside third-party sponsors, with 14 trials registered to date in the area of depression, including Canada's first and only psilocybin trial actively recruiting study participants to receive psilocybin-assisted therapy," said Dr. Roger McIntyre, CEO, Braxia Scientific. "Looking ahead to our clinical research and development, our psilocybin trial is underway with newly trained therapists. These therapists have the required skills to execute a successful psilocybin-assisted therapy trial while ensuring patients receive treatments according to approved protocols and best practices – critical milestones that will create near-term value for Braxia Scientific in terms of patient access, drug development and implementation. While our product development pipeline is at an early stage, we have made progress in our goal to develop new ketamine derivatives and delivery formats underpinned by our large proprietary health database from administering ~4,900 ketamine treatments to date at our clinics." "We continue to prioritize the expansion of our clinical footprint in Canada. We remain disciplined in our growth efforts and continue to actively assess a strong pipeline of opportunities to scale access to ketamine treatments for patients in North America." Recent Operational Highlights and Corporate Update Established Clinical Infrastructure to Advance Research and Drug Development and Provide Patient Access to Ketamine, Psilocybin and other Potential Psychedelics in Future Building on management's extensive clinical expertise, the Company has expanded the necessary infrastructure to provide novel interventions that include ketamine, psilocybin and other potential future psychedelics that become available. More specifically, the Company infrastructure has: Established access to a high-quality source of psilocybin that meets all regulatory requirements for human use in clinical research Received over 100 referrals for psilocybin-assisted therapy at our clinic in the first six weeks of opening patient recruitment approved protocols to collect treatment outcome data to allow for further optimization of treatment protocols and development of best practice guidelines Established well-trained medical and research staff to assess patients for psilocybin suitability. This includes twenty (20) therapists licensed to practice in Ontario with specialized training in psilocybin-assisted therapy Built physical space to safely provide psilocybin treatment with a comfortable living room-like environment with appropriate medical and psychological monitoring and evidence-based protocols This infrastructure enables Braxia Scientific to provide psilocybin-assisted therapy as part of the current clinical trial, and importantly, if psilocybin is approved in the future, Braxia Scientific is positioned to ...Full story available on Benzinga.com.....»»

Category: earningsSource: benzingaNov 29th, 2021