Phobia, Social

First Cannabidiol treatment study of its kind to be approved by the FDA BURLINGTON, ON, March 11, 2024 /PRNewswire/ - EmpowerPharm Inc. is delighted to announce that the final participant has completed their treatment in the Phase II clinical trial assessing the efficacy of pharmaceutical-grade Cannabidiol (CBD) for Social Anxiety Disorder. The anticipated release of the top-line results are due next month in April. The trial, sponsored by EmpowerPharm, was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of CBD in individuals with Social Anxiety Disorder. It is the first study of its kind to be approved by the FDA. This pivotal Phase II study involved the enrollment of 239 patients from 19 clinical centers across the United States. The research team at EmpowerPharm has developed a novel, patented drug delivery platform using a Self-Nanoemulsifying Drug Delivery System (SNEDDS), which ensures superior bioavailability, consistent potency, extended shelf-life, and stability. This platform has potential applications for enhancing legacy drug molecules. "Coincidentally, the first product developed using the SNEDDS technology is a prescription cannabidiol (CBD) pill, which is poised to become the first pharmaceutical-grade prescription drug of its kind approved for the treatment of anxiety," said Chairman and Co-CEO, Aubrey Dan. "Over the last two decades, there has been a notable lack of innovation in the development of new medications for anxiety. There's an urgent demand for novel drugs that can offer effective relief without the adverse side effects and addictive potential of current prescriptions." After the report of Phase II Clinical Trials is complete and submitted in April, EmpowerPharm will move into Phase III clinical trials which will precede the FDA approvals process, marking anticipated availability to patients by 2028. "Our vision was to develop top-quality prescription pharmaceuticals to meet unmet needs. With over 15 million adults suffering from Social Anxiety Disorder in the United States, our mission is unequivocally clear," said Peter Billiaert, President and Co-CEO. EmpowerPharm is seeking strategeic partners to launch this breakthrough innovation. The market for Social Anxiety Disorder treatments was valued at $11.8 billion in 2022 and is expected to grow to $16 billion by 2030. EmpowerPharm anticipates that the introduction of the world's first CBD-based prescription drug could result in annual sales between $160 million and $320 million USD. This innovation not only has the potential to disrupt the market for Social Anxiety Disorder, but also holds promise for other patient populations. Its impact on conditions such as depression and sleep quality could open up additional market opportunities exceeding $8 billion. EmpowerPharm Inc. is led by Chairman and Co-CEO, Aubrey Dan, a seasoned pharmaceutical executive at Novopharm Limited with more than 20-years of industry experience, and EmpowerPharm President and co-CEO, Peter Billiaert. Billiaert is a veteran in the pharmaceutical industry with more than 40-years experience in R&D program management at Novopharm Limited and Teva Pharmaceuticals. SOURCE EmpowerPharm Inc.

ADELAIDE, Australia and CAMBRIDGE, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced that it will be presenting at the 2024 BIO CEO & Investor Conference taking place February 26-27, 2024 in New York, NY. Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics will be providing an update on the Company’s leading asset, BNC210, a Phase 3 ready, first- and best-in-class α7 nicotinic receptor negative allosteric modulator in development for the treatment of social anxiety disorder and post-traumatic stress disorder. Presentation information Day and date: Tuesday, February 27, 2024 Time: 10:15 AM EST Location: New York Marriott Marquis – Plymouth Room For those interested in meeting Bionomics’ management during the conference, please request a meeting through the conference portal or contact the Company’s Investor Relations. FOR FURTHER INFORMATION PLEASE CONTACT: General Rajeev Chandra Company Secretary CoSec@bionomics.com.au Investor Relations Kevin Gardner kgardner@lifesciadvisors.com Investor Relations Chris Calabrese ccalabrese@lifesciadvisors.com About Bionomics Limited Bionomics (NASDAQ:BNOX) is a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (“CNS”) disorders with high unmet medical need. Bionomics is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute treatment of Social Anxiety Disorder (SAD) and chronic treatment of Post-Traumatic Stress Disorder (PTSD). Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Bionomics’ pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for CNS conditions of high unmet need. Forward-Looking Statements Bionomics cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company’s plans to advance the development of its product candidates, the timing of achieving any development or regulatory milestones, and the comparability and potential of such product candidates, including to achieve any benefit or pro any product approval or be effective. The inclusion of forward-looking statements should not be regarded as a representation by Bionomics that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, the Company’s Annual Report on Form 20-F filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Bionomics undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included in Bionomics’ filings with the SEC which are available from the SEC’s website ( ) and on Bionomics’ website ( ) under the heading “Investor Center.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Fasedienol PALISADE Phase 3 program for the acute treatment of social anxiety disorder remains on track PALISADE-3 trial initiation anticipated in 1H 2024; PALISADE-4 trial initiation anticipated in 2H 2024 SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver first-in-class therapies for psychiatric and neurological disorders, today reported financial results for its fiscal year 2024 third quarter ended December 31, 2023 and provided a corporate update. "Momentum from clinical and corporate milestones achieved through the end of last quarter have significantly advanced our efforts to develop and commercialize fasedienol as a potential first-in-class acute treatment for adults with social anxiety disorder. Building on the positive results of our PALISADE-2 Phase 3 trial in SAD, we remain on track to initiate our PALISADE-3 Phase 3 trial in SAD during the first half of this year," said Shawn Singh, Chief Executive Officer of Vistagen. "In parallel, we continue to make significant progress toward Phase 2B development of two additional clinical-stage neuroscience assets in our pipeline, itruvone for major depressive disorder and hormone-free PH80 for women's health indications, including vasomotor symptoms (hot flashes) due to menopause." Fasedienol Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD) To complement Vistagen’s successful PALISADE-2 Phase 3 trial of fasedienol for the acute treatment of SAD, the Company’s PALISADE-3 trial, anticipated to initiate during the first half of 2024, as well as its PALISADE-4 trial, which is anticipated to be initiated in the second half of 2024, will be U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms in adult patients with SAD, after administration of a single dose of fasedienol during a public speaking challenge in a clinical setting, as measured using the patient-reported Subjective Units of Distress Scale (SUDS) as the primary efficacy endpoint. Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol U.S. New Drug Application (NDA) submission for the acute treatment of anxiety in adults with SAD. Itruvone Nasal Spray for Major Depressive Disorder (MDD) Leveraging a successful exploratory Phase 2A trial of itruvone for the treatment of MDD, preparations and planning are underway for Phase 2B development. PH80 Nasal Spray for Vasomotor Symptoms (Hot Flashes) due to Menopause and other Women’s Health Indications Expanding upon successful exploratory Phase 2A trials of PH80 in two women’s health indications, preparations and planning are underway for U.S. IND-enabling nonclinical studies to facilitate U.S. Phase 2B development of hormone-free PH80 for the treatment of vasomotor symptoms (hot flashes) due to menopause and, potentially, premenstrual dysphoric disorder (PMDD). Fiscal Year 2024 Third Quarter Financial Results Research and development (R&D) expense: R&D expense was $4.5 million and $6.9 million for the three months ended December 31, 2023 and 2022, respectively. The decrease in R&D expense was primarily due to a decrease in clinical and development expenses related to the timing of expenses incurred for the Company’s Phase 3 trials of fasedienol in SAD. General and administrative (G&A) expense: G&A expense was $3.8 million and $3.1 million for the three months ended December 31, 2023 and 2022, respectively. The increase was primarily due to increases in compensation and related expenses. Net loss: Net loss was $6.3 million and $9.8 million for the three months ended December 31, 2023, and 2022, respectively. Cash position: At December 31, 2023, the Company had cash and cash equivalents of approximately $126.6 million. As of February 12, 2024, the Company had 27,029,731 shares of common stock issued and 3,577,240 pre-funded warrants outstanding. Conference Call: Vistagen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to provide a corporate update. U.S. Dial-in (Toll-Free): 1-877-407-9716 International Dial-in Number (Toll): 1-201-493-6779 Conference ID: 13743176 Webcast: A live audio conference call webcast will also be available via the above link. Participants should access this webcast site 10 minutes before the start of the call. In addition, a telephone playback of the call will be available after approximately 8:00 p.m. Eastern Time on Tuesday, February 13, 2024. To listen to the replay, call toll-free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay access ID number: 13743176. About Vistagen Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver first-in-class therapies for psychiatric and neurological disorders. Five of Vistagen’s six clinical-stage product candidates belong to a new class of drugs known as pherines, which have the potential to rapidly deliver meaningful efficacy with a differentiated safety profile. Pherines are investigational neuroactive nasal sprays with innovative proposed mechanisms of action that activate chemosensory neurons in the nasal passages to impact fundamental neural circuits in the brain without the need for systemic absorption or binding to receptors in the brain. Vistagen’s sixth clinical-stage product candidate, AV-101, is an investigational oral drug candidate with the potential to inhibit, but not block, NMDA receptor activity. Vistagen is passionate about transforming what is possible in the treatment of anxiety, depression, and other neuroscience disorders. Connect at . Forward-looking Statements This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization and actual results or developments may differ materially from those projected or implied in these forward-looking statements. Among other things, there can be no guarantee that any of the Company’s drug candidates will successfully complete ongoing or, if initiated, future clinical trials, receive regulatory approval or be commercially successful, or that the Company will be able to successfully replicate the result of past studies of its product candidates, including fasedienol, itruvone, PH80 or its other drug candidates. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to the Company’s submission of an U.S. NDA to the FDA for any product candidate, including fasedienol; the ability of any clinical trial information submitted by the Company to the FDA to support an U.S. NDA; other risks and uncertainties related to delays in launching, conducting and/or completing ongoing and planned clinical trials, including PALISADE-3 and PALISADE-4 or additional Phase 2 clinical trials of itruvone or PH80; the scope and enforceability of the Company’s patents, including patents related to the Company’s pherine drug candidates and AV-101; fluctuating costs of materials and other resources and services required to conduct the Company’s ongoing and/or planned clinical and non-clinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of the Company’s product candidates. These risks are more fully discussed in the section entitled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2023, and in the Company’s Quarterly Report on Form 10-Q for the period ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). The Company’s SEC filings are available on the SEC’s website at . You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If the Company does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements. VISTAGEN THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS December 31, March 31, 2023 2023 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 126,559,200 $ 16,637,600 Prepaid expenses and other current assets 1,480,300 802,700 Deferred contract acquisition costs - current portion 74,500 67,100 Total current assets 128,114,000 17,507,400 Property and equipment, net 445,100 507,300 Right-of-use asset - operating lease 1,933,600 2,260,300 Deferred offering costs 325,700 495,700 Deferred contract acquisition costs - non-current portion 148,700 217,600 Security deposits 100,900 100,900 Total assets $ 131,068,000 $ 21,089,200 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 1,737,000 $ 2,473,100 Accrued expenses 129,300 787,400 Note payable - 105,300 Deferred revenue - current portion 1,762,800 714,300 Operating lease obligation - current portion 533,500 485,600 Financing lease obligation - current portion 1,900 1,700 Total current liabilities 4,164,500 4,567,400 Deferred revenue - non-current portion 1,899,400 2,314,600 Operating lease obligation - non-current portion 1,713,300 2,119,800 Financing lease obligation - non-current portion 6,000 7,400 Total liabilities 7,783,200 9,009,200 Commitments and contingencies (Note 10) Stockholders’ equity: Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2023 and March 31, 2023; no shares outstanding at December 31, 2023 and March 31, 2023 - - Common stock, $0.001 par value; 325,000,000 shares authorized at December 31, 2023 and March 31, 2023; 27,029,731 and 7,315,583 shares issued at December 31, 2023 and March 31, 2023, respectively 27,000 7,300 Additional paid-in capital 473,918,200 342,892,500 Treasury stock, at cost, 4,522 shares of common stock held at December 31, 2023 and March 31, 2023 (3,968,100 ) (3,968,100 ) Accumulated deficit (346,692,300 ) (326,851,700 ) Total stockholders’ equity 123,284,800 12,080,000 Total liabilities and stockholders’ equity $ 131,068,000 $ 21,089,200 VISTAGEN THERAPEUTICS CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (Unaudited) Three Months Ended Nine Months Ended December 31, December 31, 2023 2022 2023 2022 Revenues: Sublicense and other revenue $ 411,400 $ 179,600 $ 866,700 $ (402,900 ) Total revenues 411,400 179,600 866,700 (402,900 ) Operating expenses: Research and development 4,537,600 6,854,000 12,585,400 35,039,800 General and administrative 3,757,800 3,092,100 9,943,300 11,586,200 Total operating expenses 8,295,400 9,946,100 22,528,700 46,626,000 Loss from operations (7,884,000 ) (9,766,500 ) (21,662,000 ) (47,028,900 ) Other income, net: Interest income, net 1,534,200 5,300 1,823,900 13,700 Loss before income taxes (6,349,800 ) (9,761,200 ) (19,838,100 ) (47,015,200 ) Income taxes - - (2,500 ) (5,500 ) Net loss and comprehensive loss $ (6,349,800 ) $ (9,761,200 ) $ (19,840,600 ) $ (47,020,700 ) Basic and diluted net loss per common share $ (0.22 ) $ (1.42 ) $ (1.27 ) $ (6.82 ) Weighted average common shares outstanding, basic and diluted 29,388,085 6,894,603 15,632,451 6,891,641