α7 receptor

$121.1 Million In Cash and Cash Equivalents at December 31, 2023, With an Additional $21.8 Million Raised In 2024 From Exercise of Warrants.A Total of Over 555 Study Participants Have Completed Our Phase 3 Studies.Topline Data Readout for Our 52-Week Phase 3 Trial Expected Year-End 2024.Internal Investigation by Outside Counsel Has Found No Evidence to Substantiate Allegations of Research Misconduct by the Company. AUSTIN, Texas, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial and operating results for the full year ended December 31, 2023 and presented corporate updates. “I see Alzheimer’s disease as one of the last great frontiers in medicine,” said Remi Barbier, President & CEO. “It’s clear to me these patients need new and more simplified treatment options. In 2024 and beyond, we’ll continue to try to make a meaningful difference in the lives of people who suffer from Alzheimer’s disease. I believe our Phase 3 program of simufilam in Alzheimer’s will reach important milestones in 2024, particularly in patients with mild disease.” Simufilam is Cassava Sciences’ investigational drug candidate for the proposed treatment of Alzheimer's disease dementia. Net loss for full year 2023 was $97.2 million, or $2.32 per share, compared to a net loss of $76.2 million, or $1.90 per share, in 2022. Net cash used in operations full-year 2023 was $82.0 million, consistent with previous guidance. Cash use for operations for the first half of 2024 is expected to be $35 to $45 million, driven primarily by expenses for our clinical program in Alzheimer’s disease. In 2024, the Company raised gross proceeds of approximately $21.8 million from the exercise of common stock warrants though February 26, 2024. “We expect our research and development expenses to decrease modestly in 2024 as a result of decreased spending for our Phase 3 program, as patient screening and enrollment are now complete for the Phase 3 clinical studies,” said Eric Schoen, Chief Financial Officer. “We also expect the decrease in Phase 3 program costs to be partially offset by increased enrollment in the open-label study as well as higher expenses in other parts of our operations.” Financial Results for Full-year 2023 At December 31, 2023, cash and cash equivalents were $121.1 million, compared to $201 million at December 31, 2022, with no debt.In 2024 through February 26, 2024, we received gross proceeds of $21.8 million from the exercise of warrants, resulting in the issuance of 989,000 shares of common stock. (This amount is not included in the above cash and cash equivalents at December 31, 2023.)Net loss was $97.2 million, or $2.32 per share. This compares to a net loss of $76.2 million, or $1.90 per share, in 2022. Net loss increased due primarily to increases in patient enrollment and associated costs to conduct the Phase 3 clinical program, as well as other studies with simufilam.Net cash used in operations full-year 2023 was $82 million.Net cash use in operations for first half 2024 is expected to be $35 to $45 million, driven primarily by expenses for our program in Alzheimer’s disease.Research and development (R&D) expenses were $89.4 million. This compared to $68 million for 2022. R&D expenses increased due primarily to increasing patient enrollment and costs to conduct the Phase 3 clinical program, as well as other studies with simufilam.General and administrative (G&A) expenses were $16.5 million. This compared to $12.0 million for 2022. G&A expenses increased due to increases in stock-based compensation as well as activities and expenses related to legal services. Recent corporate highlights include the following: In January 2024, we completed a dividend distribution of common stock warrants to shareholders. The warrants allow the holder to purchase additional shares of our common stock. The warrants trade on Nasdaq (SAVAW), separate from our common stock (SAVA). Unless earlier redeemed, the warrants will expire and cease to be exercisable on November 15, 2024. The warrants are redeemable at our sole option at any time with a redemption date on or after April 15, 2024. Cassava Sciences will provide at least 20 calendar days’ notice by press release of the date selected, if any, for a redemption.In February 2024, we reported that patients with mild Alzheimer’s disease who received simufilam treatment continuously for two years (n=47) had no decline in ADAS-Cog scores (± 1.51 SE) as a group. Patients with mild Alzheimer’s who received simufilam treatment non-continuously for two years (n=40) declined 1 point on ADAS-Cog (± 1.65 SE) as a group. Continuous treatment consisted of one year on open-label drug, six months randomized to drug and six months back on open-label drug. Non-continuous treatment consisted of the same, except randomized to placebo in that six-month period.In December 2023, we reported the appointment of three new members to the Board of Directors. Clause Nicaise, MD, Pierre Gravier, MS and Robert Anderson, Jr. are all highly respected, astute leaders in their fields. Their collective expertise in drug development, M&A, cybersecurity and dealing with large, complex governmental agencies will add a balance of experience and perspectives to the Board.In October 2023, we reported a potentially significant safety finding based on interim magnetic resonance imaging (MRI) brain data from Alzheimer’s patients who are enrolled in our 76-week Phase 3 trial (REFOCUS-ALZ). These MRI data suggest simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities, or ARIA. ARIA is a medical term used to describe a spectrum of brain MRI imaging abnormalities, such as edema and brain bleeds, and is a known risk factor for patients taking monoclonal antibody infusion drugs directed against beta amyloid.In September 2023, we reported a positive interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer’s disease. A routine, scheduled meeting of a Data and Safety Monitoring Board (DSMB) recommended that both of Cassava Sciences’ Phase 3 studies of simufilam continue as planned, without modification.In September 2023, we also reported new research that confirms the biological activity of simufilam. Researchers at the Cochin Institute (Paris, France) used a highly precise cell-based assay to show that simufilam interrupts amyloid binding to the α7 nicotinic acetylcholine receptor (α7nAChR). Their data show that simufilam potently disrupts a known pathological action of amyloid β using a robust and highly sensitive assay based on a technique called TR-FRET. Four academic institutions have now generated data in support of the biological activity of simufilam.In June 2023, we reported new research that examined the effects of simufilam on the mechanistic Target of Rapamycin (mTOR). Scientific literature shows overactive mTOR plays a key role in aging, Alzheimer’s disease and other conditions. When functioning normally, mTOR monitors cellular needs and is activated by insulin. The new published research shows mTOR is overactive in lymphocytes isolated from blood collected from Alzheimer's patients versus healthy controls. After oral administration of simufilam 100 mg twice daily to Alzheimer's patients for 28 days, lymphocytes showed normalized mTOR activity and restored sensitivity to insulin. These data suggest a meaningful impact of simufilam on mTOR signaling. The suppression of overactive mTOR signaling and its improved responsiveness to insulin represents a mechanistic benefit of simufilam beyond the disruption of pathogenic signaling pathways of soluble amyloid. These improvements in mTOR signaling may also result from reversing an altered conformation of FLNA, allowing FLNA to dissociate from the insulin receptor when insulin binds and initiates signaling. Because mTOR contributes to age-related cellular changes, simufilam’s suppression of mTOR overactivation, concurrent with improved insulin sensitivity, may slow certain aging processes and attenuate this pathological feature of Alzheimer’s disease, potentially benefiting brain function and memory.In August 2021, certain individuals, later revealed to be short sellers of the Company’s securities, publicly alleged that we had engaged in research misconduct. Today we report that an internal investigation conducted by outside counsel engaged by our Board of Directors has found no evidence to substantiate allegations that the Company or its employees engaged in or were aware of research misconduct. Status of Phase 3 Clinical ProgramBackground - Our Phase 3 program consists of two global, double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. Phase 3 Trials – In Fall 2021, we announced the initiation of two pivotal Phase 3 studies of simufilam in Alzheimer’s disease. Our first Phase 3 study, called RETHINK-ALZ, is designed to evaluate the safety and efficacy of simufilam 100 mg tablets twice-daily versus matching placebo over 52 weeks (NCT04994483). Our second Phase 3 study, called REFOCUS-ALZ, is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg tablets twice-daily versus matching placebo over 76 weeks (NCT05026177). Clinical sites are in the United States, Canada, Puerto Rico, Australia, and South Korea. Premier Research International is the clinical research organization (CRO) supporting the conduct of our Phase 3 clinical program. Entry Criteria – Criteria that potential patients must meet to be included in a Phase 3 study include an MMSE score of 16 to 27; a Clinical Dementia Rating (CDR)-Global Scale score of 0.5, 1 or 2; elevated plasma p-tau181 or prior evidence of Alzheimer’s neuropathology by PET or cerebrospinal fluid; and other inclusion/exclusion eligibility criteria. Patient Enrollment – In November 2023, we announced the completion of patient enrollment in both Phase 3 studies. Approximately 1,900 patients are randomized in these studies, with approximately 800 patients randomized in the 52-week study (RETHINK-ALZ) and approximately 1,100 patients randomized in the 76-week study (REFOCUS-ALZ). Preliminary Baseline Characteristics (all numbers are approximate) – Mean patient age for both studies is 74. Seventy percent (70%) of patients entered the studies with mild Alzheimer’s disease (MMSE 20-27), with remaining patients entering the study with moderate disease (MMSE 16-19). Both studies have a mean MMSE score of 22. Both studies have a mean ADAS-Cog score of 25. Both studies have a mean ADCS-ADL score of 65. Patient Completion – Over 340 patients have completed the 52-week RETHINK-ALZ study. Over 215 patients have completed the 76-week REFOCUS-ALZ study, for a total of over 555 completers. Efficacy Outcomes – Efficacy endpoints are ADAS-Cog12, a cognitive scale, and ADCS-ADL, a functional scale and iADRS, which is a combination of scores from ADAS-Cog and ADCS-ADL. Because the distribution of study participants is numerically skewed towards mild patients, we expect to rely predominantly on mild patients to evaluate drug safety and efficacy. Phase 3 Efficacy Results – All efficacy data from our Phase 3 program remain blinded. No interim analyses on efficacy outcomes are planned. We anticipate top-line data readout for our 52-week study (RETHINK-ALZ) approximately year-end 2024. We anticipate top-line data readout for our 76-week study (REFOCUS-ALZ) approximately mid-year 2025. Statistical Analysis Plan – We have initiated a discussion with the U.S. Food and Drug Administration (FDA) to finalize a statistical analysis plan (SAP), which is a formal document defining the detailed analysis that our independent biostatisticians will undertake as to efficacy data collected in our Phase 3 trials. The SAP includes in-depth technical details and descriptions on the intended clinical trial analysis, the statistical methods and models that will be used, the population being analyzed, the data variables that will be analyzed, how missing data will be accounted for, descriptions of covariates to be included in the statistical model, and other statistical factors, all of which will be prospectively defined, documented and finalized prior to unblinding of any efficacy outcomes. Open-label Extension Study – In October 2022, we announced the initiation of an open-label extension study for our Phase 3 program. This study is designed to provide no-cost access to oral simufilam for up to one year to Alzheimer’s patients who have successfully completed a Phase 3 study of simufilam and who meet other entry criteria. Patient enrollment for this study began in November 2022. To date, over 500 patients entered the open-label extension study. Update on SavaDxSavaDx is an early-stage program focused on detecting the presence of Alzheimer’s disease from a small sample of blood. Development activity related to SavaDx accounts for less than 1% of our research budget. Working with third parties, we continue to evaluate the use of mass spectrometry to detect FLNA or other proteins of interest. The data and information generated from these evaluations continues to be under review for potential intellectual property rights. Findings of Internal InvestigationBeginning in August 2021, certain individuals, later revealed to be short sellers of the Company’s securities, publicly alleged that the Company and certain of its employees and third-party collaborators had engaged in research misconduct in connection with the development of simufilam. These allegations related in part to research that was conducted at the City University of New York (CUNY) pursuant to research contracts with the Company. The Company takes allegations of research misconduct seriously. Accordingly, the Company’s Board of Directors engaged the law firm Orrick Herrington & Sutcliffe LLP to investigate these allegations. The investigation had access to Company personnel, communications, documents, data, and information, and counsel was assisted by technical experts with relevant experience and knowledge. The investigation has found no evidence to substantiate allegations that the Company or its employees engaged in or were aware of research misconduct. About SimufilamSimufilam is Cassava Sciences’ proprietary oral drug candidate. This investigational drug binds to altered filamin A protein in the brain and restores its normal shape and function. By targeting altered filamin A, simufilam may help patients with Alzheimer’s achieve better health outcomes. Cassava Sciences owns exclusive, worldwide rights to its investigational product candidates and related technologies, without royalty obligations to any third party. About Cassava Sciences, Inc.Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Our novel science is based on stabilizing—but not removing—a critical protein in the brain. For more information, please visit: https://www.CassavaSciences.com For More Information Contact:Eric Schoen, Chief Financial Officer(512) 501-2450 or ESchoen@CassavaSciences.com Cautionary Note Regarding Forward-Looking Statements: This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that may include but are not limited to statements regarding: the design, scope, conduct, continuation, completion, intended purpose, or future results of our on-going Phase 3 program of simufilam in patients with Alzheimer's disease; the timing of anticipated milestones; the suitability of clinical data from our Phase 3 program to support the filing of an NDA; interim MRI safety data for the Phase 3 program, including ARIA; the finalization of our SAP; the treatment of people with Alzheimer’s disease dementia; the safety or efficacy of simufilam in people with Alzheimer’s disease dementia; expected cash use in future periods; comments made by our employees regarding simufilam, drug effect, and the treatment of Alzheimer’s disease; and potential benefits, if any, of our product candidates. These statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” and other words and terms of similar meaning. Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines, the ability to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, the apparent ability of simufilam to favor patients with mild Alzheimer’s disease; the apparent safety or tolerance of simufilam in our open-label clinical trials; our current expectations regarding timing of clinical data for our Phase 3 studies; any expected clinical results of Phase 3 studies; the treatment of people with Alzheimer’s disease dementia; the safety or efficacy of simufilam in people with Alzheimer’s disease dementia, comments made by our employees regarding simufilam, drug effect, and the treatment of Alzheimer’s disease; potential benefits, if any, of our product candidates and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov. All our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates are approved or available for sale anywhere in the world. Our clinical results from earlier-stage clinical trials may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish. We are in the business of new drug discovery, development and commercialization. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K in its entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery, development and commercialization, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested. – Financial Tables Follow – CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited, in thousands, except per share amounts) Three months ended December 31, Year Ended December 31, 2023 2022 2023 2022Operating expenses Research and development, net of grant reimbursement$18,731 $17,652 $89,423 $68,032 General and administrative 4,058 3,285 16,534 11,988 Total operating expenses 22,789 20,937 105,957 80,020 Operating loss (22,789) (20,937) (105,957) (80,020)Interest income 1,579 1,554 7,833 2,777 Other income, net 291 249 907 997 Net loss$(20,919) $(19,134) $(97,217) $(76,246) Net loss per share, basic and diluted$(0.50) $(0.47) $(2.32) $(1.90) Weighted-average shares used in computing net loss per share, basic and diluted 42,188 40,775 41,932 40,202 CONDENSED CONSOLIDATED BALANCE SHEETS(unaudited, in thousands) Year Ended December 31, 2023 2022Assets Current assets Cash and cash equivalents $121,136 $201,015 Prepaid expenses and other current assets 8,497 10,211 Total current assets 129,633 211,226 Property and equipment, net 21,854 22,864 Operating lease right-of-use assets — 122 Intangible assets, net 176 622 Total assets $151,663 $234,834 Liabilities and stockholders' equity Current liabilities Accounts payable and other accrued expenses $10,573 $4,017 Accrued development expense 3,037 2,280 Accrued compensation and benefits 200 170 Operating lease liabilities, current — 104 Other accrued liabilities 385 492 Total current liabilities 14,195 7,063 Operating lease liabilities, non-current — 35 Other non- current liabilities — 197 Total liabilities 14,195 7,295 Stockholders' equity Common Stock and additional paid-in-capital 518,237 511,091 Accumulated deficit (380,769) (283,552)Total stockholders' equity 137,468 227,539 Total liabilities and stockholders' equity $151,663 $234,834

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.

Positive Phase 2b data announced for BNC210 on reduction of total symptom severity and multiple symptom clusters in post-traumatic stress disorder (PTSD), with a discussion with the U.S. Food & Drug Administration (FDA) anticipated in Q2’24. Positive End of Phase 2b (EoP2) meeting with FDA announced for BNC210 in Social Anxiety Disorder (SAD) following the Phase 3-enabling PREVAIL Phase 2 trial data readout. The Company is actively engaged in strategic partnership discussions with interested parties for multiple pipeline assets and is evaluating options to proceed with clinical development plans for BNC210 in both PTSD and SAD. ADELAIDE, Australia and CAMBRIDGE, Mass., Jan. 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 provided a 2023 review and its outlook for 2024. “Bionomics continued its evolution into a U.S.-focused, late-stage clinical company last year. We finished 2023 with strong momentum from our positive readout in Phase 2b ATTUNE trial in PTSD and the successful EoP2 meeting with the FDA, paving the path to a registrational study in SAD. These two BNC210 programs generated significant interest from potential strategic partners, including the opportunity to co-develop and commercialize BNC210 in PTSD and SAD in the U.S. and abroad. We will explore such potential opportunities in parallel with other pathways that provide near and long-term value to the Company and its shareholders. Additionally, we’ve been receiving interest in our promising preclinical assets, KV3.1/3.2 channel activators and Pan Nav inhibitors, where we have identified lead candidates and continued our work on the 2nd generation α7 nicotinic receptor negative allosteric modulator (NAM) lead series,” commented Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. 2023 Highlights Key Clinical Highlights BNC210 in Social Anxiety Disorder and Post-Traumatic Stress Disorder A first and best-in-class α7 nicotinic, Phase 3-ready NAM of the α7 nicotinic receptor with a unique and differentiated psychoactive profile suitable for acute and chronic dosing in multiple CNS indications: Post-Traumatic Stress Disorder Positive topline results from the Phase 2b ATTUNE study were announced in September 2023, meeting the primary endpoint on reduction in total symptom severity and highlighting the potential of BNC210 to improve multiple PTSD symptom clusters with notable effects on thought intrusions, mood, trauma-related cognition, and sleep. The BNC210 program is the only non-psychedelic program with a novel mechanism of action to advance in late-stage development in recent years. Social Anxiety Disorder BNC210 may become the first intermittent “as-needed” non-sedating, non-habit forming, cognitively non-impairing anxiolytic for the treatment of anxiety in patients with SAD.In March 2023, the Company completed, on time and within budget, the full data analysis of the Phase 2b PREVAIL study demonstrating that BNC210 reduced anxiety during a public speaking challenge and provided support for further evaluation in Phase 3 clinical trials.A successful EoP2 meeting with the FDA in September 2023 confirmed the Phase 3 enabling nature of the PREVAIL dataset and clarified the plans for the registrational program for BNC210 in SAD, including the number of trials, trial designs, endpoints, sample sizes, size of the safety database and nonclinical requirements for registration. The results of the Phase 2b trials of BNC210 in SAD and PTSD, along with previous results observed in earlier trials in general anxiety disorder (GAD) and panic attacks, underscores BNC210’s potential in multiple, highly prevalent neuropsychiatric indications with significant market opportunity. Positive Allosteric Modulators (PAMs) of the α7 Nicotinic Acetylcholine Receptor Program with Merck & Co., Inc.The ongoing partnership with MSD* on α7 PAMs for the treatment of cognitive disorders such as Alzheimer's disease (AD) and cognitive impairment associated with schizophrenia (CIAS) has generated two clinical candidates that are currently in late Phase 1 clinical development after completing several Phase 1 safety, tolerability, pharmacokinetic and biomarkers studies. The partnership has a potential value of $500m in regulatory and clinical milestones with additional potential royalties from commercialization. Key Corporate Highlights In support of the Company’s transformation into a commercial-stage company, expanded the U.S.-based team with new highly experienced management appointments, positioning it to become a leading company in neuropsychiatry.Voluntarily delisted from the Australian Stock Exchange in August 2023 and is currently solely listed on the NASDAQ Global Market.Further reduced cash burn through efficient capital allocation.Maintained its current institutional investors’ support while adding new institutional investors to its register.Sustained strong analyst coverage that highlights the Company's potential future value.The Company has no outstanding debt, convertible securities, or warrants.Continued strengthening BNC210 intellectual property portfolio in the U.S. and abroad. Future Anticipated Milestones for BNC210 Clinical Program Bionomics continues to plan the initiation of its first Phase 3 study of BNC210 in patients with SAD.The Company plans to discuss a potential dose-ranging late-stage study of BNC210 in PTSD with the FDA; an update on the next steps is expected by the end of Q2'24.The Company is exploring the submission of a request for Breakthrough Therapy designation in PTSD in Q2’24.Leveraging the inbound demand, the Company is looking to secure a strategic partnership for BNC210. “We look forward to continuing to strongly execute, in a timely and fiscally efficient manner, and keep progressing our BNC210 programs in SAD and PTSD while also aiming to establish strategic partnerships in the coming months. Following a transformational 2023 where we delivered on all anticipated milestones, I am confident 2024 will be an exciting year for Bionomics as we keep making strides towards building shareholder value through the development of new treatment options for patients in two psychiatric disorders with significant unmet needs and market potential,” concluded Dr. Papapetropoulos. * Known as MSD outside the United States and Canada FOR FURTHER INFORMATION PLEASE CONTACT: GeneralRajeev Chandra Company SecretaryCoSec@bionomics.com.auInvestor RelationsKevin Gardnerkgardner@lifesciadvisors.comInvestor RelationsChris Calabreseccalabrese@lifesciadvisors.com About Bionomics LimitedBionomics (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. www.bionomics.com.au Forward-Looking StatementsBionomics 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 profile or 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 (www.sec.gov) and on Bionomics’ website (www.bionomics.com.au) 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.