JIUQUAN, China, Sept. 30, 2022 /PRNewswire/ -- Qilian International Holding Group Limited (NASDAQ:QLI) (the "Company"), a China-based pharmaceutical and chemical products manufacturer, today announced its unaudited financial results for the first six months of fiscal year 2022 ended March 31, 2022. Mr. Zhanchang Xin, Chairman and CEO of the Company, commented, "Under the impact of uncertain political climate and COVID-19 variants, the prices of agricultural and energy products have been increasing globally in 2022, which also led to reduced profitability of the manufacturing industry in general. Our half-year report in 2022 presents a revenue of approximately US$32.1 million, an increase of 7 % over our revenue during the same period of time in previous year. Our profit fell by 89% to US$249,681 due to increasing raw material prices, as compared to our profit during the same period of time in previous year."  "We expect to complete certain construction projects in 2023. Along with expected control of COVID-19 pandemic in China, we expect the company's new growth in 2023." Mr. Xin added. Financial Highlights for the Six Months Ended March 31, 2022 For the Six Months Ended March 31, ($'000, except per share data) 2022 2021 % Change Revenue $ 32,086,522 $ 29,939,173 7 % Gross profit $ 2,820,252 $ 4,090,663 -31 % Gross margin 8.8 % 13.7 % -5 % Income from operations $ 1,227,245 $ 2,271,941 -46 % Net income $ 249,681 $ 2,245,327 -89 % Net Income attributable to Qilian International Holding Group Limited ("Qilian International") $ 87,862 $ 2,350,584 -96 % Basic and diluted earnings per share $ 0.00 $ 0.07 -97 %   Revenue increased by 7% year-over-year to $32.1 ...Full story available on Benzinga.com.....»»

Walt Disney (NYSE:DIS) has outperformed the market over the past 15 years by 1.06% on an annualized basis producing an average annual return of 6.78%. Currently, Walt Disney has a market capitalization of $172.21 billion. Buying $100 In DIS: If ...Full story available on Benzinga.com.....»»

 NEW YORK, Sept. 30, 2022  /PRNewswire/ -- AllianceBernstein National Municipal Income Fund, Inc. (NYSE:AFB), a registered closed‑end investment company, today announced earnings for the Fund's third fiscal quarter ended July 31, 2022. Total net assets of the Fund* on July 31, 2022 were $377,335,035 as compared with $373,215,526 on April 30, 2022, and $451,756,769 on July 31, 2021. On July 31, 2022, the net asset value per share of common stock was $13.13 based on 28,744,936 shares of common stock outstanding. July 31, 2022 April 30, 2022 July 31, 2021 Total Net Assets.....»»

U.S. stocks traded lower toward the end of trading, with the Dow Jones dipping more than 300 points on Friday. The Dow traded down 1.23% to 28,865.85 while the NASDAQ fell 0.92% to 10,638.61. The S&P 500 also fell, dropping, 0.97% to 3,605.32. Also check this: Bitcoin, Ethereum Remain Stable; Here Are The Top Crypto Movers For Friday Leading and Lagging Sectors Real estate shares rose by 1.5% on Friday. In trading on Friday, utilities shares fell by 1.3%. Top Headline Personal income in the US climbed by 0.3% from a month ago in August, while personal spending rose 0.4%. The personal consumption expenditure price index rose 0.3% month-over-month in August following a 0.1% decline in July. Equities Trading UP   F45 Training Holdings Inc. (NYSE: FXLV) shares shot up 43% to $3.1250 after a 13D filing showed the company received a non-binding proposal offer by one or more funds for a value of $4 per share. Shares of SOBR Safe, Inc. (NASDAQ: SOBR) got a boost, shooting 38% to $2.6550 after the company announced it signed three reseller agreements with national distributors. Ainos, Inc. (NASDAQ: AIMD) shares were also up, gaining 36% to $1.8799 after the company reported results from the additional preclinical study of its ...Full story available on Benzinga.com.....»»

Highlights for the Fiscal Year Ended June 30, 2022 11.5% Revenue Increase YoY to $27.1 Million 73% Increase YoY in Sales of Intelligent Pet Products 100% Increase YoY in Income Per Basic and Diluted Share 241% Increase YoY in Balance of Cash and Short-Term Investments PLANO, Texas, Sept. 30, 2022 /PRNewswire/ -- Dogness (International) Corporation ("Dogness" or the "Company") (NASDAQ:DOGZ), a developer and manufacturer of a comprehensive line of Dogness-branded, OEM and private label pet products, today announced its audited financial results for the fiscal year ended June 30 2022. Silong Chen, Chairman and Chief Executive Officer of Dogness, commented, "We continue to benefit from our priority focus of resources on the production and promotion of sales of our higher margin intelligent pet products. With both our existing models and the newly launched models of our smart products, we delivered a 73% increase in sales of our intelligent pet products in the fiscal year ended June 30, 2022, compared to the year ago period. We also continue to upgrade our production lines for traditional pet products to improve the productivity and lower the production costs. This has allowed us to lower our average unit selling price for our traditional pet products, while still maintaining desirable profit margins. Our sales strategy for traditional pet products has helped us to successfully retain our customers and attract new customers, which we have leveraged to increase awareness for our intelligent pet products. To mitigate the impact caused by COVID-19, we expanded our sales channels to more proven online shopping platforms, such as Amazon, Chewy, JD, Tmall, Costco.com, QVC.com and the live streaming sales platforms hosted by influencers, as well as maintaining the existing online and instore channels. These ecommerce sales normally have higher profit margin than traditional sales channels." "With the continued strong demand and pet culture growth in China and worldwide, more and more young consumers have become pet owners. Dogness is well positioned to benefit from this growth, which is serving as a sales catalyst for our intelligent pet products, including App-controlled smart pet food feeders, pet water fountains, pet tracking devices and smart pet toys. In addition, our sales and distribution channel has been further diversified due to the rapid change of technology and lifestyle. Younger generations are more tech savvy and more willing to purchase products from popular online shopping sites, including Amazon, Chewy, JD, Tmall and Taobao, and from live streaming sales platforms hosted by influencers. As a result, we strategically increased our marketing activities and sales efforts in the domestic market, especially on those online shopping sites and channels." "As we look forward we are even more excited about our growth potential led by our continued development of innovative, differentiated pet products and services, which allow us to build strong relationships with our customers, build brand loyalty, enhance our market position, increase transaction size and further enhance operating margins. Taken together, we believe Dogness is on track to further improve our sales, profitability and return on investment for our stockholders in the near future." Financial Results for the Fiscal Year Ended June 30, 2022 Revenues increased by approximately $2.8 million, or 11.5%, to approximately $27.1 million for the year ended June 30, 2022, compared to $24.3 million in the year ended June 30, 2021. The increase in revenue was primarily attributable to the increased sales of the Company's intelligent pet products, which have much higher average selling price than our traditional pet products. Revenue from the Company's intelligent pet products increased by approximately $5.7 million or 73.0%, from approximately $7.8 million in fiscal 2021 to approximately $13.5 million in fiscal 2022, primarily reflecting a higher selling price and increased sales volume. Revenue from traditional pet products decreased by approximately $2.9 million or 20.2% from approximately $14.3 million in fiscal 2021 to approximately $11.4 million in fiscal 2022, primarily reflecting a decreased average selling price per unit. Total sales in international markets increased by approximately $3.9 million or 36.8% to $14.5 million in the year ended June 30, 2022 from approximately $10.6 million in the year ago period. Domestic sales decreased by approximately $1.1 million or 8.3% from approximately $13.7 million in the year ended June 30, 2021 to approximately $12.6 million in the year ended June 30, 2022. The Company has seen a sharp increase in consumer demand in the U.S., Australia, Japan and other Asian countries because of the stimulus plan and the strong recovery of the economy. Sales to the U.S. increased by approximately $2.0 million or 32.4% to approximately $8.0 million in the year ended June 30, 2022 from approximately $6.0 million for the year ended June 30, 2021. Sales to Japan and other Asian countries and regions market increased by approximately $1.7 million or 131.0% to approximately $3.0 million for the year ended June 30, 2022 from approximately $1.3 million for fiscal 2021. Cost of revenues increased by approximately $1.8 million, or 11.8%, from approximately $15.2 million in the year ended June 30, 2021 to approximately $17.0 million in the year ended June 30, 2022. Gross profit increased by approximately $1.0 million or 10.7%, to approximately $10.1 million in the year ended June 30, 2022 from approximately $9.2 million in the year ago period due to the continued upgrading of the Company's production lines for both traditional and intelligent pet products, which led to improved productivity and lower production costs. Overall gross profit margin was 37.4% for the year ended June 30, 2022, as compared to 37.6% for the year ended June 30, 2020. Net income attributable to Dogness increased to $3.2 million or $0.10 per basic and diluted share for the year ended June 30, 2022 , compared to $1.5 million or $0.05 per basic and diluted share for the year ended June 30, 2021. The Company recognized a $3.2 million foreign currency translation loss for the year ended June 30, 2022, compared to a gain of $4.9 million in the year ago period. The Company had a balance of cash and short-term investments of approximately $16.7 million as of June 30, 2022, compared to approximately $4.9 million as of June 30, 2021. About Dogness Dogness (International) Corporation was founded in 2003 from the belief that dogs and cats are important, well-loved family members. Through its smart products, hygiene products, health and wellness products, and leash products, Dogness' technology simplifies pet lifestyles and enhances the relationship between pets and pet caregivers. The Company ensures industry-leading quality through its fully integrated vertical supply chain and world-class research and development capabilities, which has resulted in over 200 patents and patents pending. Dogness products reach families worldwide through global chain stores and distributors. For more information, please visit: ir.dogness.com. Forward Looking Statements No statement made in this press release should be interpreted as an offer to purchase or sell any security. Such an offer can only be made in accordance with the Securities Act of 1933, as amended, and applicable state securities laws. Certain statements in this press release concerning our future growth prospects are forward-looking statements regarding our future business expectations intended to qualify for the "safe harbor" under the Private Securities Litigation Reform Act of 1995, which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding lingering effects of the Covid-19 pandemic on our customers' businesses and end purchasers' disposable income, our ability to raise capital on any particular terms, fulfillment of customer orders, fluctuations in earnings, fluctuations in foreign exchange rates, our ability to manage growth, our ability to realize revenue from expanded operation and acquired assets in China and the U.S., our ability to attract and retain highly skilled professionals, client concentration, industry segment concentration, reduced demand for technology in our key focus areas, our ability to successfully complete and integrate potential acquisitions, and unauthorized use of our intellectual property and general economic conditions affecting our industry. Additional risks that could affect our future operating results are more fully described in our United States Securities and Exchange Commission filings. These filings are available at www.sec.gov. Dogness may, from time to time, make additional written and oral forward-looking statements, including statements contained in the Company's filings with the Securities and Exchange Commission and our reports to shareholders. In addition, please note that any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of the date of this press release. The Company does not undertake to update any forward-looking statements that may be made from time to time by or on behalf of the Company unless it is required by law.   DOGNESS (INTERNATIONAL) CORPORATION CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) 2022 2021 2020 For the Years Ended June 30, 2022 2021 2020 Revenues- third party customers $ 24,882,618 $ 23,112,435 $ 18,261,707 Revenues – related parties 2,212,579 1,207,686 909,651 Total Revenues 27,095,197 24,320,121 19,171,358 Cost of revenues – third party customers (15,654,952) (14,501,166) (16,146,856) Cost of revenues – related parties (1,301,180) (663,742) (633,132) Total cost of revenues (16,956,132) (15,164,908) (16,779,988) Gross Profit 10,139,065 9,155,213 2,391,370 Operating expenses: Selling expenses 2,077,174 1,815,771 2,336,229 General and administrative expenses 6,742,687 4,941,036 5,746,812 Research and development expenses 917,227.....»»

HAMILTON, Bermuda, Sept. 30, 2022 (GLOBE NEWSWIRE) -- American Overseas Group Limited BSX: AORE.BH) (Pink Sheets: AOREF.PK) ("AOG" or the "Company") today reported consolidated net loss available to common shareholders of $0.3 million, or $6.28 per diluted share, for the three months ended June 30, 2022. This compares to consolidated net loss available to common shareholders of $3.0 million, or $63.75 per diluted share, for the three months ended June 30, 2021. Book value per weighted share at June 30, 2022 was $775.49, a decline from the book value per weighted share of $1,003.21 at June 30, 2021. For the three months ended June 30, 2022, the Company had an operating loss of $0.5 million, or $11.58 per diluted share, compared to operating loss of $2.4 million, or $51.26 per diluted share for the three months ended June 30, 2021. For the three months ended June 30, 2022, net earned property and casualty premiums decreased $0.4 million from $5.5 million a year ago to $5.1 million. Fee income remained constant at $2.7 million while gross written premiums increased $1.9 million, moving from $114.7 million to $116.6 million. Quarterly direct written premiums were positively impacted by rate increases in current business. Loss and loss adjustment expenses as a percentage of earned premium increased from 66.1% to 71.4% as loss costs continued to increase in 2022 due to both frequency and severity. For the three months ended June 30, 2022, operating expenses decreased $2.1 million from $4.9 million to $2.8 million due to a one-time recognition in the amount of $1.2 million in the second quarter of 2021 of items previously held as a receivable against a personal guarantee contract and $0.9 million expense in 2021 year taxes, licenses and fees associated with program business written in Louisiana that was related to business written in the prior year. As part of its ongoing capital management efforts, the Company will continue to redirect excess capital within the group to debt reduction unless other compelling opportunities present themselves. Forward-Looking Statements This release contains statements that may be considered "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, without limitation, the Company's expectations respecting the volatility of its insured portfolio, losses, loss reserves and loss development, the adequacy and availability of its liquidity and capital resources, its current run off strategy, its strategy for writing other reinsurance businesses and its expense reduction measures. These statements are based on current expectations and the current views of the economic and operating environment and are not guarantees of future performance. A number of risks and uncertainties, including economic competitive conditions, could cause actual results to differ materially from those projected in forward-looking statements. The Company's actual results could differ materially from those expressed or implied in the forward-looking statements. Explanation of Non-GAAP Financial Measures The Company believes that the following non-GAAP financial measure included in this press release serve to supplement GAAP information and is meaningful to investors. Operating income (loss): The Company believes operating income (loss) is a useful measure because it measures income from operations, unaffected by non-operating items such as realized investment gains or losses. Operating income (loss) is typically used by research analysts and rating agencies in their analysis of the Company. Information About the Company American Overseas Group Limited is an insurance holding company incorporated in Bermuda and a tax resident of the United Kingdom. Its operating subsidiaries provide specialty property/casualty insurance, reinsurance and insurance management services. More information can be found at www.aoreltd.com. American Overseas Group Limited info@aoreltd.com American Overseas Group Limited Consolidated Balance Sheets (unaudited) As at June 30, 2022 and December 31, 2021       (dollars in thousands)                                                                      June 30, 2022     December 31, 2021 Assets                                             Investments:                   Fixed-maturity securities held as available for sale, at fair value     $ 109,497       $ 102,678         Equity investments held as available for sale, at fair value       2,619         3,781       Cash and cash equivalents       25,146         31,908       Restricted cash       2,232         4,440       Accrued investment income       417         553       Premiums receivable       89,048         76,626       Deferred insurance premiums       124,521         108,904       Reinsurance balances receivable, net       228,444         223,982       Deferred policy acquisition costs       4,424         4,588       Intangible assets       4,800         4,800       Goodwill       33,050         33,050       Other assets       4,491         3,166         Total Assets     $ 628,690       $ 598,476                                                   Liabilities and Equity                                       Liabilities:                 Loss and loss expense reserve     $ 220,290       $ 215,642       Deferred commission income       3,037         3,210       Unearned premiums       129,428         113,423       Ceded premium payable       94,424         82,059       Payable to general agents       5,783         7,121       Funds withheld       107,708         104,257       Accounts payable and accrued liabilities       14,319         12,420       Notes payable       16,521         16,521       Non-owned interest in VIE       300         300       Interest payable       451         451         Total Liabilities       592,259         555,404                             Shareholders' Equity:                 Common shares       4,698         4,698       Additional paid-in capital       189,179         189,179       Accumulated other comprehensive (loss) income       (5,328 )       1,124       Retained deficit       (157,570 )       (157,982 )       Total Shareholders' Equity       30,979         37,019       Non-controlling interest of preferred shares of subsidiaries       5,453         6,053       Total Equity       36,431         43,072                                                         Total Liabilities and Equity     $ 628,690       $ 598,476                               See Notes to June 30, 2022 Consolidated Financial Statements available on American Overseas Group Ltd. Website at www.aoreltd.com                         American Overseas Group Limited   Consolidated Statements of Operations   (unaudited)   (dollars in thousands, except share and per share amounts)                                                                                   Three months ended June 30,   Six Months ended June 30,                     2022       2021.....»»

NVIDIA (NASDAQ:NVDA) has outperformed the market over the past 5 years by 14.94% on an annualized basis producing an average annual return of 22.33%. Currently, NVIDIA has a market capitalization of $305.95 billion. Buying $1000 In NVDA: If an ...Full story available on Benzinga.com.....»»

Microsoft (NASDAQ:MSFT) has outperformed the market over the past 20 years by 4.66% on an annualized basis producing an average annual return of 12.46%. Currently, Microsoft has a market capitalization of $1.76 trillion. Buying $1000 In MSFT: If an ...Full story available on Benzinga.com.....»»

Nike (NYSE:NKE) has outperformed the market over the past 10 years by 3.87% on an annualized basis producing an average annual return of 13.34%. Currently, Nike has a market capitalization of $131.51 billion. Buying $1000 In NKE: If an ...Full story available on Benzinga.com.....»»

Costco Wholesale (NASDAQ:COST) has outperformed the market over the past 5 years by 16.23% on an annualized basis producing an average annual return of 23.55%. Currently, Costco Wholesale has a market capitalization of $210.42 billion. Buying $1000 In COST: If ...Full story available on Benzinga.com.....»»

Netflix (NASDAQ:NFLX) has outperformed the market over the past 20 years by 29.79% on an annualized basis producing an average annual return of 37.56%. Currently, Netflix has a market capitalization of $105.95 billion. Buying $100 In NFLX: If an ...Full story available on Benzinga.com.....»»

Carnival (NYSE:CCL) reported its Q3 earnings results on Friday, September 30, 2022 at 09:15 AM. Here's what investors need to know about the announcement. Earnings Carnival missed estimated earnings by 346.15%, reporting an EPS ...Full story available on Benzinga.com.....»»

Micron Technology, Inc. (NASDAQ: MU) posted upbeat earnings for its fourth quarter, while sales missed estimates. The company also issued Q1 revenue guidance below estimates. Micron reported fourth-quarter revenue of $6.64 billion, which missed average analyst estimates of $6.68 billion. The company's top-line results were down from $8.64 billion year-over-year. Micron shares gained 0.5% to $50.26 on Friday. These analysts made changes to their price targets on ...Full story available on Benzinga.com.....»»

U.S. stocks traded mixed this morning, with the Dow Jones dropping more than 50 points on Friday. Following the market opening Friday, the Dow traded down 0.22% to 29,160.17 while the NASDAQ rose 0.13% to 10,751.20. The S&P 500 also rose, gaining, 0.01% to 3,640.75. Also check this: Bitcoin, Ethereum Remain Stable; Here Are The Top Crypto Movers For Friday Leading and Lagging Sectors Real estate shares rose by 0.6% on Friday. In trading on Friday, consumer discretionary shares fell by 0.6%. Top Headline Personal income in the US climbed by 0.3% from a month ago in August, while personal spending rose 0.4%. The personal consumption expenditure price index rose 0.3% month-over-month in August following a 0.1% decline in July. Equities Trading UP   F45 Training Holdings Inc. (NYSE: FXLV) shares shot up 51% to $3.3001 after a 13D filing showed the company received a non-binding proposal offer by one or more funds for a value of $4 per share. Shares of InMed Pharmaceuticals Inc. (NASDAQ: INM) got a boost, shooting 54% to $8.85. InMed recently reported a FY22 net loss of $33.17 per share. Avenue Therapeutics, Inc. (NASDAQ: ATXI) shares were also up, gaining 30% to $9.39. The stock has been volatile after the company last week announced a 1-for-15 reverse split and received meeting minutes from the FDA regarding a ...Full story available on Benzinga.com.....»»

Benzinga Pro data, Bed Bath & Beyond (NASDAQ:BBBY) reported Q2 sales of $1.44 billion. Earnings fell to a loss of $366.16 million, resulting in a 2.37% decrease from last quarter. Bed Bath & Beyond collected $1.46 billion in revenue during Q1, but reported earnings showed a $357.67 million loss. Why Is ROIC Significant? Earnings data without context is not clear and can difficult to base trading decisions on. Return on Invested Capital (ROIC) helps to filter signal from noise by measuring yearly pre-tax profit relative to invested capital by a business. Generally, a higher ROIC suggests successful growth of a company ...Full story available on Benzinga.com.....»»

Benzinga Pro data, Comtech Telecomms (NASDAQ:CMTL) reported Q4 sales of $126.98 million. Earnings fell to a loss of $5.17 million, resulting in a 20576.0% decrease from last quarter. Comtech Telecomms collected $122.12 million in revenue during Q3, but reported earnings showed a $25 thousand loss. Why Is ROCE Significant? Earnings data without context is not clear and can be difficult to base trading decisions on. Return on Capital Employed (ROCE) helps to filter signal from noise by measuring yearly pre-tax profit relative to capital employed by a business. Generally, a higher ROCE suggests successful growth of a ...Full story available on Benzinga.com.....»»

According to Benzinga Pro, during Q3, Bassett Furniture Indus (NASDAQ:BSET) earned $7.63 million, a 83.81% increase from the preceding quarter. Bassett Furniture Indus's sales decreased to $118.01 million, a 8.31% change since Q2. Bassett Furniture Indus earned $47.12 million, and sales totaled $128.71 million in Q2. Why Is ROCE Significant? Earnings data without context is not clear and can be difficult to base trading decisions on. Return on Capital Employed (ROCE) helps to filter signal from noise by measuring yearly pre-tax profit relative to capital employed by a business. Generally, a higher ROCE suggests successful growth ...Full story available on Benzinga.com.....»»

Carnival Corp (NYSE: CCL) reported third-quarter FY22 revenues of $4.30 billion, missing the consensus of $5.13 billion. Passenger Cruise Day (PCD) increased 55% Q/Q to 17.7 million. Available lower berth days (ALBD) for Q3 were 21 million, representing 92% of total fleet capacity. Selling and administrative expenses rose 47% to $625 million. The operating loss for the quarter narrowed to $(279) million from a loss of $(2.1) billion last year. The company held ...Full story available on Benzinga.com.....»»

U.S. stocks traded higher midway through trading, with the Dow Jones gaining more than 100 points on Friday. The Dow traded up 0.36% to 29,330.93 while the NASDAQ rose 1.27% to 10,874.03. The S&P 500 also rose, gaining, 0.75% to 3,667.94. Also check this: Bitcoin, Ethereum Remain Stable; Here Are The Top Crypto Movers For Friday Leading and Lagging Sectors Materials shares rose by 1.5% on Friday. In trading on Friday, utilities shares fell by 0.4%. Top Headline Personal income in the US climbed by 0.3% from a month ago in August, while personal spending rose 0.4%. The personal consumption expenditure price index rose 0.3% month-over-month in August following a 0.1% decline in July. Equities Trading UP   F45 Training Holdings Inc. (NYSE: FXLV) shares shot up 41% to $3.0910 after a 13D filing showed the company received a non-binding proposal offer by one or more funds for a value of $4 per share. Shares of SOBR Safe, Inc. (NASDAQ: SOBR) got a boost, shooting 40% to $2.6996 after the company announced it signed three reseller agreements with national distributors. Ainos, Inc. (NASDAQ: AIMD) shares were also up, gaining 53% to $2.1056 after the company reported results from the additional preclinical study of its low-dose oral interferon formulation against Omicron. ...Full story available on Benzinga.com.....»»

         PRESS RELEASE AB SCIENCE PRESENTS ITS FINANCIAL INFORMATION FOR THE FIRST HALF OF 2022 AND THE KEY EVENTS OF THE PERIOD Clinical development Authorization by Health Canada in February 2022 to file a New Drug Submission for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) under the Notice of Compliance with Conditions (NOC/c) policy and formal start of the review in May 2022. Health Canada has a target of 200 calendar days maximum to review the application Filing for conditional Marketing Authorization to the European Medicines Agency (EMA) for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) and formal start of the review in August 2022 Launch of a confirmatory Phase 3 study with masitinib in progressive forms of multiple sclerosis Positive recommendation of the Data and Safety Monitoring Board to continue both Phase 2 studies in Covid-19 Financial information and other corporate information Operating loss of €9.6 million as of 30 June 2022, an increase of 58% compared to the first half of 2021 Cash position of €7.6 million as of 30 June 2022, plus the €7.1 million of 2020 and 2021 research tax credit and a financing agreement with the European Investment Bank of which 12.0 million euros are available at that date Paris, September 30, 2022, 6.30pm CET AB Science SA (Euronext - FR0010557264 - AB) today reports its revenues for the first half of 2022 and provides an update on its activities. CLINICAL DEVELOPMENT KEY EVENTS FOR THE FIRST HALF OF 2022 AND SINCE JUNE 30, 2022 Authorization by Health Canada to file a New Drug Submission for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) under the Notice of Compliance with Conditions (NOC/c) policy AB Science announced that Health Canada has granted authorization to file a New Drug Submission for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) under the Notice of Compliance with Conditions (NOC/c) policy. If granted, an NOC/c is authorization to market a drug with conditions. Such conditions will be discussed with Health Canada during the procedure. An assessment named Advance Consideration, performed by a Health Canada Adjudicating Committee, is necessary before being granted authorization to file under NOC/c policy. This assessment was made based on a pre-submission package sent by AB Science including, efficacy data of study AB10015, long-term survival data (75 months average follow-up from diagnosis) of study AB10015, and safety data. An estimated 3,000 Canadians are currently living with ALS. Each year approximately 1,000 Canadians die from ALS. A similar number of Canadians are diagnosed with ALS each year. Under the NOC/c policy, Health Canada has a target of 200 calendar days maximum to review the application. Filing for conditional Marketing Authorization to the European Medicines Agency (EMA) for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) AB Science filed an application for conditional Marketing Authorization to the European Medicines Agency (EMA) for Alsitek (masitinib) in the treatment of amyotrophic lateral sclerosis (ALS). The application is based on results from the phase 2/3 AB10015 study and its long-term survival follow-up. Study AB10015 was a randomized, double-blind, placebo-controlled trial over a 48-week treatment period, conducted with 394 ALS patients and evaluating Alsitek in combination with riluzole versus riluzole alone. This decision to file followed a pre-submission meeting held with the Committee for Medicinal Products for Human Use (CHMP) Rapporteur during which new data generated with Alsitek in ALS were presented, in particular, a clinical benefit in terms of a 25-month increase in median overall survival for patients with moderate ALS, which is a cohort that closely resembles newly diagnosed patients. During the pre-submission meeting, AB Science also presented how issues listed in the previous CHMP assessment for Alsitek on ALS (EMA/406203/2018) were resolved, in particular: The mode of action of Alsitek in ALS, which has been well-demonstrated and published in peer-reviewed publications. A remonitoring of all efficacy and safety data and a complete reassessment of the Alsitek safety database. Additional analyses for the primary efficacy endpoint, imputing all missing data for early discontinuation, and a conservative analysis imputing missing data with a penalty for patients who discontinued Alsitek for lack of efficacy or toxicity. These analyses were positive, and all showed a treatment effect in favor of Alsitek and convergent with the primary analysis. Long-term follow-up survival data showing a significant benefit in favor of Alsitek in moderate ALS patients (between group difference in median OS of +25 months, hazard ratio 0.56 (95%CI [0.32;0.96])). This application has now been validated by EMA and review by the CHMP has begun. The CHMP has a target of 210 active evaluation days to review the application. Launch of a confirmatory Phase 3 study with masitinib in progressive forms of multiple sclerosis AB Science announced that it has been authorized by the French Medicine Agency, ANSM, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS). The study will enroll 800 patients from numerous study centers with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 and absence of T1 Gadolinium-enhancing brain lesions as measured by magnetic resonance imaging (MRI). The primary objective of the study will be to evaluate the effect of masitinib on time to confirmed disability progression, with progression defined as 1-point worsening when EDSS baseline score ≤5.5, or 0.5 if baseline score >5.5 from randomization to week 96. This confirmatory study follows successful completion of a first Phase 2B/3 study (AB07002) in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis. This study met its primary analysis endpoint, demonstrating a statistically significant reduction in cumulative change on EDSS with masitinib 4.5 mg/kg/day (p=0.0256). Positive recommendation of the Data and Safety Monitoring Board to continue both Phase 2 studies in Covid-19 AB Science announced the continuation of the Phase 2 study evaluating masitinib in combination with isoquercetin in COVID-19, following the recommendation of the Data and Safety Monitoring Board (DSMB). This randomized (1:1), open-label, phase 2 study (AB20001) is designed to evaluate the safety and efficacy of masitinib plus isoquercetin in hospitalised patients with moderate COVID-19 (WHO 7-point ordinal scale level 4) or severe COVID-19 (level 5). The study is planned to recruit 200 patients (over 18 years of age with no upper age limit). The primary objective is to improve the clinical status of patients after 15 days of treatment, as measured by the WHO 7-point ordinal scale. The interim analysis was conducted with one third of the patients evaluated, as planned. The purpose of the interim analysis was to assess the safety and efficacy of the treatment. The DSMB recommends continuing the study without restrictions in moderate patients (level 4, i.e. hospitalized patients with oxygen supply.....»»