Seasonal Affective Disorder

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.

LONDON--( BUSINESS WIRE )--While Blue Monday traditionally signifies a peak in winter blues and shines a light on Seasonal Affective Disorder (SAD), the current global landscape is far more complex. The prolonged exposure to crises, economic uncertainties and climate anxieties are creating a sustained strain on individuals. Concerns regarding crisis fatigue and burnout among the global workforce are also prompting organisations to re-evaluate their mental health support strategies and to prioritise proactive mental health support for employees. The International SOS Risk Outlook 2024 data identifies burnout, the cost-of-living crisis and mental health concerns as the top risks to organisational wellbeing this year. Mental health emerges as a critical concern, as the pressures of burnout and financial difficulty can manifest in emotional and psychological distress. The survey data also underlines a growing understanding of the direct link between employee wellbeing and organisational success. With 82% acknowledging the vital role of health and wellness policies in recruitment and retention and 77% see safeguarding employee wellbeing as a board-level priority 1 . The World Health Organization also highlights that globally, an estimated 12 billion working days are lost every year to depression and anxiety at a cost of US$ 1 trillion per year in lost productivity. 2 Burnout rates among the global workforce have nearly doubled in just two years, soaring from 11-18% to 20-40%, with many reporting burnout levels as high as 50%. 1 This staggering data aligns with a recent McKinsey Health Institute study, revealing that 22% of employees across 30 countries are experiencing burnout symptoms at work. 3 Despite a significant rise in global burnout rates, the perceived risk its impact will have in 2024 varies across regions. Globally, 80% of surveyed global senior risk professionals identifies employee burnout as the top threat to their organisation and workforce 1 . Notably, this concern is most pronounced across the Middle East (93%), Oceania (88%), Africa (84%) and Americas (84%), which are exceeding the global average. 1 Dr Rodrigo Rodriguez-Fernandez, Global Health Advisor at International SOS said “The post-holiday return to work is known for its challenges and for many employees, this period can be a tipping point for exhaustion, chronic stress and burnout. Some may still be facing the lingering effects of the festive season, navigating financial pressures from rising bills after the holiday celebration. Heightened geopolitical uncertainties and ongoing global crises are also amplifying employee anxieties and creating a complex landscape for businesses navigating workforce wellbeing and productivity. “Employee demands for strengthened mental health and wellbeing support within the workplace had been steadily increasing even before the recent succession of crises. This pre-existing trend has now acquired greater urgency amidst employee experiences of burnout and crisis fatigue. Blue Monday offers a timely opportunity for organisations to assess and strengthen workplace mental health initiatives. When employees feel supported and empowered to take care of their mental health, they are likely to be more engaged, focused and able to excel in their roles. Organisations that recognise this and prioritise on cultivating psychosocially safe work environments – from providing stress management workshops to flexible work arrangements, are not just doing the right thing, they are also making a strategic investment in their workforce's potential.” International SOS urges organisations to take action and implement proactive strategies to prevent burnout and combat crisis fatigue in the workplace: Create an emotionally open culture and encourage open communication: provide a safe space for employees to talk about their mental health and wellbeing. Encourage them to speak up if they are feeling overwhelmed or struggling. Provide flexibility and promote work-life balance: support flexible working arrangements that help employees to balance their work and personal lives. Promote regular breaks and empower employees to prioritise their wellbeing. Invest in emotional wellbeing: provide access to mindfulness sessions, and stress management training. Partner with certified mental health professionals to offer confidential counselling and support services. Offer employee assistance programmes (EAPs) : consider providing support such as financial counselling services or benefits consultations to address anxieties surrounding economic uncertainties. Equip managers with mental health first-aid training: upskill managers to identify signs of distress and offer initial support to employees who may be struggling. Notes to Editor About the International SOS Group of Companies The International SOS Group of Companies is in the business of saving lives, protecting your global workforce from health and security threats. Wherever you are, we deliver customised health, security risk management and wellbeing solutions to fuel your growth and productivity. In the event of extreme weather, an epidemic or a security incident, we provide an immediate response providing peace of mind. Our innovative technology and medical and security expertise focus on prevention, offering real-time, actionable insights and on-the-ground quality delivery. We help protect your people, your organisation’s reputation, as well as support your compliance reporting needs. By partnering with us, organisations can fulfil their Duty of Care responsibilities, while empowering business resilience, continuity, and sustainability. Founded in 1985, the International SOS Group, headquartered in London & Singapore, is trusted by 9,500 organisations, including the majority of the Fortune Global 500 as well as mid-size enterprises, governments, educational institutions, and NGOs. 13,000 multi-cultural security, medical, logistics and digital experts stand by you to provide support & assistance from over 1,000 locations in 90 countries, 24/7, 365 days. To protect your workforce, we are at your fingertips: www.internationalsos.com 1. International SOS | Risk Outlook 2024 Report 2. World Health Organization | Mental Health at Work 3. McKinsey Health Institute | Reframing employee health: Moving beyond burnout to holistic health

Get the latest healthcare and health tech news from the J.P. Morgan Healthcare Conference in San Francisco. It's officially a new year for the healthcare industry, as biopharma executives, investors, reporters and others make the annual trek to the Westin St. Francis in San Francisco for the J.P. Morgan Healthcare Conference. We have you covered with the biggest headlines from Wednesday here, as well as across the site. And to keep up with the Fierce Biotech team, click here, or for updates from Fierce Pharma, click here. Follow the Fierce team's coverage of the 2024 J.P. Morgan Healthcare Conference here.  UPDATED Wednesday, Jan 10 at 7:13 p.m. Alignment Healthcare talks star ratings Alignment Healthcare CEO John Kao took time during his presentation to show off the company's recent star ratings successes. He said that 90% of members in North Carolina and Nevada are in 4.5 star plans, and Alignment is one of two public companies in California with four star plans going into next year. Only 56% of people enrolled in Medicare Advantage will be in four star or higher plans by 2025. Recent changes to the star ratings program by CMS seem to not be negatively affecting the insurtech like other payers. Earlier this month, Elevance Health filed a lawsuit over the changes, picking out implementation of the Tukey outlier deletion method as one of its top complaints. Elevance is expecting a $500 million hit to its bonus payments. Kao alluded to these star ratings criticisms in his remarks with little sympathy. "This was not a surprise," he said. "Some people didn't take Tukey seriously. We did. CMS gave everybody ample warning for it. We like it, what they're doing with stars, because it's normalizing the playing field." - Noah Tong UPDATED: Wednesday, Jan. 10 at 5:30 p.m. Headspace unveils all-in-one mental health service Digital mental health company Headspace rolled out an all-in-one mental health offering and expanded its employee assistance (EAP) replacement solution. The integrated app is accessible to more than 200,000 people within enterprise partnerships that include some of the biggest companies in the country and select health plan and navigation partners.  Headspace's mindfulness and meditation content will be accessible in the same app as its clinical care services such as coaching, therapy and psychiatry and its EAP replacement experience which includes therapy sessions, critical incident support, work-life services, global services and management service.  For Headspace's employer clients, their workforce will now have a single destination for end-to-end mental health support, including evidence-based mental health and mindfulness content, 1:1 mental health coaching, therapy and psychiatry, as well as work-life services. Headspace has also begun to roll out this offering to select health plan and navigation partners, including Accolade, Quantum Health and Virgin Pulse. Over the coming quarters, this comprehensive system of mental healthcare will be made available to Headspace consumer members as well, the company said Wednesday. Headspace, which merged with Ginger in a $3 billion deal in the fall of 2021, offers meditation and mindfulness services along with on-demand coaching, therapy and psychiatry services. The company now works with more than 4,000 employers across 200 countries and also works with an ecosystem of health plans and partners. A year ago, Headspace rolled out a new, unified product experience that brings together meditation and mindfulness services with Ginger's on-demand coaching, therapy and psychiatry services. That also included an expanded EAP (employee assistance program) offering. Headspace EAP is now available globally. EAP members can utilize the newly launched Headspace Hub to view available services and identify the support they need. Members can request an in-person provider, get support in finding local work-life services or help finding care for children ages six and older, according to the company. “Mental healthcare is long overdue for a solution that makes end-to-end, lifelong support a reality for all,” said Russell Glass, CEO of Headspace. “Our new, fully integrated app experience allows us to deliver on this promise for employers and employees, creating a singular destination for evidence-based mental health and mindfulness content, mental health coaching, therapy, psychiatry and work-life services – all seamlessly accessible through one app.” - Heather Landi UPDATED: Wednesday, Jan. 10 at 3:03 p.m. Oscar Health CEO sees ACA as 'here to stay' Amid speculation that the Republicans could once again move to kill the Affordable Care Act (ACA) if given the opportunity, Oscar Health CEO Mark Bertolini believes repealing the legislation will be extremely difficult to pull off. As member enrollment increases, its inevitability is more likely and the program is getting close to being "too big to kill," he said. Today, Centers for Medicare & Medicaid Services (CMS) announced that more than 20 million members are enrolled in the ACA. In October, Oscar Health said that it would be expanding into 165 new counties on ACA exchanges in 2024. "When you hear that the state of Texas is considering building their own health care exchange, that's a sign that the Republican resistance around that's going to go away," he said.  When asked how the outcome of the 2024 presidential election may affect policy, Bertolini predicts it will be a mess "as long as it's a divided government." - Noah Tong UPDATED: Wednesday, Jan. 10 at 1 p.m. GoodRx offers preliminary look at its 2023 finances Prescription discount company GoodRx said Wednesday that it expects to bring in between $749 million and $751 million in revenue for 2023, according to early data released ahead of its session at the J.P. Morgan Healthcare Conference. For the fourth quarter, the company projects between $195 million and $197 million, in revenue. It also said that it believes full year earnings before interest, taxes, depreciation and amortization (EBITDA) margins will be in the upper range of its guidance, thanks in part to the increased revenue. GoodRx's Interim CEO Scott Wagner said during the conference session that there were several key elements behind the improved performance. For one, the comapny saw higher volume, driven by a rise in seasonal illness requiring prescriptions. He said there was also higher volume as a result of its direct contracting program with certain retailers. He acknowledged that a rocky financial outlook is likely what brought him to the CEO role in April 2023, but said the company has worked hard to grow from that. "The things that we're working on reinforce the value proposition," Wagner said. — Paige Minemyer