Stomatognathic System Abnormalities

By acquiring The Sleep Center of Nevada, Vivos expands its business model to make its OSA treatments available to thousands of patients in the greater Las Vegas metro area Acquisition expected to close later this quarter or in the third quarter LITTLETON, Colo., April 16, 2025 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company”) (NASDAQ: VVOS), a leader in proprietary, non-invasive treatments for obstructive sleep apnea (OSA), today announced a definitive agreement to acquire the operating assets of The Sleep Center of Nevada (“SCN”), the largest operator of medical sleep centers in Nevada. Significant Vivos investor New Seneca Partners, Inc., a leading North American private equity sponsor, assisted in sourcing, structuring and executing this transaction. The acquisition is expected to close in the later this quarter or in the third quarter, subject to financing, audit and other customary conditions. The proposed transaction does not require Vivos shareholder approval. Vivos’ acquisition of the profitable and high patient volume SCN accelerates Vivos’ new marketing and distribution model following its June 2024 strategic alliance with Colorado-based sleep center operator Rebis Health. Vivos’ new model is designed to introduce Vivos’ FDA-cleared oral appliance treatments for OSA more directly to the very large and growing population of patients who suffer from OSA. Many of these patients are looking for lasting solutions for their OSA but are typically forced to choose between unappealing treatment options such as continuous positive airway pressure (CPAP) or surgery or abandoning treatment altogether. The acquisition aligns with Vivos’ mission to make its clinically proven treatments accessible to the millions of individuals who suffer with OSA. By leveraging SCN’s infrastructure and patient base, Vivos expects to enhance case acceptance, diversify services, and strengthen its market position in a fast-growing region. Founded in 2008 by Dr. Prabhu Rachakonda, a board-certified physician in internal medicine, pulmonology, and sleep medicine, SCN is the top sleep center operator in Nevada, serving the sleep testing and treatment referral needs of OSA patients. SCN sees approximately 3,000 new patients per month for testing, consultation, and treatment of conditions like OSA, insomnia and restless leg syndrome and has generated annual net revenues in the high seven figure range in recent years. About 90% of SCN patients test positive for OSA and/or other sleep disorders and yet, 95% of those patients are typically referred out for CPAP, traditional oral devices or surgical options, highlighting a critical need for alternatives like Vivos’ oral appliances. Since 2019, SCN’s physicians and nurse practitioners have tested and treated over 200,000 patients, many of whom have either stopped using CPAP or are looking for OSA treatment alternatives. Under Dr. Rachakonda’s leadership, SCN has grown to seven locations with nearly 50 beds currently available for overnight polysomnogram (PSG) testing and consultation. Vivos has agreed to pay up to $9 million for the SCN operating assets, including $6 million in cash and $1.5 million in Vivos common stock at closing. An additional $1.5 million in Vivos common stock may be earned in the future if SCN achieves an agreed to financial milestone. Vivos intends to secure the funding for the upfront cash payment primarily with a senior debt facility and also potential equity financing. Kirk Huntsman, Chairman and CEO of Vivos stated, “We believe this transaction will be a game-changer for Vivos, with the prospect of meaningfully adding to our revenues in the coming months through SCN’s diagnostic and other services as well as adding thousands of patients as candidates for Vivos OSA treatment. SCN has a dominant market share for OSA detection and treatment in the fast-growing Las Vegas region. We anticipate SCN patients will prefer Vivos treatment options over a lifelong maintenance device such as CPAP. Through our existing strategic alliance with Rebis Health in Colorado, we are seeing two-thirds of OSA patients selecting Vivos treatment over CPAP or surgical options. We will be working closely with Dr. Rachakonda and his team to expand the range of diagnostic and therapeutic services to patients, which we expect will materially impact revenue and gross profits even further. This transaction represents a great example of our initiative to extend Vivos’ technology and treatment options to as many OSA patients as possible by creating strategic collaborations with, or outright acquisitions of, key players in the approximately 2,600 AASM-certified sleep clinics around the country. We look forward to closing this transaction as we also continue to explore further expansions of our marketing and sales model.” Michael Skaff, Managing Director of New Seneca Partners, stated “As an investor in and strategic advisor to Vivos, we are very excited about this transaction and its potential to materially expand and further validate the ongoing strategic shift in Vivos’ business model. Moreover, we believe SCN’s existing revenues will be meaningfully augmented in several important ways, such as the expansion of diagnostic and consultative services and the sale of Vivos OSA treatment to SCN patients, all of which we expect to significantly reduce Vivos’ cash burn and move Vivos towards cash flow positivity. The SCN transaction and similar potential future strategic transactions can provide Vivos with access to the significant potential patient volume which is critical to executing on the new business model. We look forward to continuing our full support of this transaction through the financing, closing and post-closing integration phases.” Dr. Rachakonda commented on what this transaction will mean for SCN’s patients, “Sleep medicine has been waiting for many years for an alternative treatment for OSA that works to resolve the condition over a relatively short treatment time with potentially lasting effects. After looking carefully into Vivos’ appliance treatments, I believe the vast majority of our patients will choose Vivos over CPAP or other alternatives that they struggle with. We look forward to closing this transaction as we are eager to bring Vivos’ effective portfolio of OSA treatments options to our community.” Dr. Tara Rachakonda, also a board certified sleep specialist at SCN and the daughter of Dr. Prabhu Rachakonda, said “As a sleep specialist and parent of a child with sleep apnea, I’m particularly excited to expand our pediatric services with Vivos’ FDA-cleared DNA appliance treatment for children ages 6 to 17. Simply put, this transaction opens significant new growth opportunities for our practice and better care options for our patients.” Additional details will be disclosed in a Current Report on Form 8-K to be filed with the U.S. Securities and Exchange Commission. About Vivos Therapeutics Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults. Vivos’ devices have been cleared by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with all severity levels of OSA and moderate-to-severe OSA in children ages 6 to 17. Vivos’ groundbreaking CARE devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate to severe OSA in children. Obstructive sleep apnea (OSA) affects over 1 billion people worldwide, yet 90% remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it’s closely linked to many serious chronic health conditions. While the medical community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood. As a result, solutions are often mechanistic and fail to address the root causes of OSA. Vivos Therapeutics, founded in 2016 and based in Littleton, CO, is changing this. Through innovative technology, education, and partnerships with dentists, functional medicine doctors, and sleep specialists, Vivos is empowering healthcare providers to more thoroughly address the complex needs of patients. The Vivos Method offers a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope to allow patients to Breathe New Life. For more information, visit www.vivos.com. Cautionary Note Regarding Forward-Looking Statements This press release, including statements of the Company’s management and other parties made herein, contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as “may”, “would”, “should”, “expects”, “projects,” “potential,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal”. “aim” and variations of such words and similar expressions are intended to identify forward-looking statements. In this press release, forward-looking statements include, without limitation, those relating to (i) the timing for closing of the SCN acquisition (which remains subject to key conditions such as financing), (ii) the actual future impact of the SCN acquisition on Vivos’ future revenues and results of operations and (ii) the anticipated benefits and potential expansion of Vivos’ marketing and distribution model as described herein. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Readers are cautioned that actual results may differ materially and adversely from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to finance the cash portion of the acquisition purchase price on favorable terms, if at all, or otherwise, (ii) the risk that Vivos may be unable to successfully integrate SCN’s business into its own or otherwise implement sales, marketing and other strategies that increase revenues, (iii) the risk that some patients may not achieve the desired results from using Vivos’ products, (iv) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea diagnosis and treatment sector; (v) the risk that Vivos may be unable to secure additional financing beyond that which is needed to acquire SCN on reasonable terms when needed, if at all, or maintain its Nasdaq listing, (vi) market and other conditions that could impact Vivos’ business or ability to obtain financing, and (vii) other risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based. Media Inquiries: Karla Jo Helms JOTO PR™ 727-777-4629 jotopr.com

TARRYTOWN, N.Y. and WASHINGTON, March 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Society for Science (the Society) announced that Matteo Paz,18, of Pasadena, CA, won the top award of $250,000 in the 2025 Regeneron Science Talent Search, the U.S.’s oldest and most prestigious science and math competition for high school seniors. Now in its 84th year, the competition celebrates and rewards young innovators who are applying their Science, Technology, Engineering and Math (STEM) talent and leadership skills to push the boundaries of discovery and address today’s pressing challenges. Forty finalists, including Matteo, were honored this evening during an award ceremony at the National Building Museum in Washington, D.C, where they were awarded more than $1.8 million in prizes for their groundbreaking research, exceptional problem-solving skills and potential to shape the future of STEM. Matteo Paz, 18, of Pasadena, CA, won first place and $250,000 for designing machine-learning algorithms to efficiently comb through 200 billion entries of raw NEOWISE infrared full-sky data. By analyzing tiny changes in infrared radiation, the AI sorted the objects into 10 classes. He found 1.5 million new potential objects. Second place and $175,000 went to Ava Grace Cummings, 18, of Smithfield, NC, for creating a fruit fly model of STAC3 disorder, or Native American myopathy (a rare genetic muscle disease). She found that the common nettle herb, alone or combined with the experimental drug Tirasemtiv, improved movement in both adult flies and larvae. Third place and $150,000 went to Owen Jianwen Zhang, 18, of Bellevue, WA, for solving a long-standing math problem about objects called 3-uniform hypergraphs. He proved a maximum value for how many 3-uniform hypergraphs can have similar structures but differing connections. Owen's results have applications in computer science. "Congratulations to the winners of this year's Regeneron Science Talent Search," said Maya Ajmera, President and CEO, Society for Science and Executive Publisher, Science News. "The remarkable creativity and dedication of these students bring renewed hope for our future. Driven by their ingenuity, these young scientists are developing groundbreaking solutions that have the potential to transform our world and propel society forward." The Regeneron Science Talent Search provides a national platform for high school seniors to showcase original, innovative STEM research that proposes novel solutions to real-world issues. Finalists are evaluated for their scientific rigor, originality, critical thinking, leadership potential and commitment to drive meaningful impact across crucial STEM fields. “The Science Talent Search changed my life. At my high school, STS winners were treated like star athletes, and I never imagined I would belong in such an amazing group of kids who were operating at a whole different level than I had ever seen,” said George D. Yancopoulos, co-Founder, Board co-Chair, President and Chief Scientific Officer of Regeneron and a 1976 Science Talent Search finalist and top winner. “The experience of competing in STS and being named a top winner gave me the confidence to devote my life to science. So, congratulations to this year’s finalists and winners, you are America’s best and brightest. I hope this moment inspires you to push boundaries, challenge assumptions and use your brilliance to change the world.” Other top honors from the competition include: Fourth Place: Logan Lee, 18, of Honolulu, HI received a $100,000 award for helping sterile male mosquitoes survive in the wild. These males are important in mosquito control. Logan improved their survival by giving them a transplant of wild mosquito bacteria. His transplant helped the sterile mosquitoes grow faster and survive better in the wild. Fifth Place: Rivka Lipkovitz, 18, of San Francisco, CA received a $90,000 award for using statistical modeling to study U.S. voter ID laws. She found that presidential election turnout dropped by 2.4% in states that passed strict laws after 2008. Turnout for midterm elections increased. Knowing how laws affect turnout can help shape future policies. Sixth Place: Melody Heeju Hong, 17, of Wantagh, NY received a $80,000 award for developing a powerful, flexible statistical model for mapping sites called trans-methylation quantitative trait loci (trans-mQTL) within the human genome. These sites are key to understanding the interplay between genes and environment in disease and aging. Seventh Place: Kevin Shen, 18, of Olympia, WA received a $70,000 award for building a custom flight computer to control a 3D-printed airplane with oblique wings. These aircraft can be more fuel-efficient but are hard to control. His oblique-wing aircraft and flight computer improved flight efficiency by 9.2%. Eighth Place: Minghao Zou, 18, of Santa Clara, CA received a $60,000 award for simulating protons to probe environments that produce subatomic particles called neutrinos. He created an algorithm mimicking extreme astrophysical conditions, such as electromagnetic and gravitational forces and interactions with nearby particles. He verified it using known cases of particle motion. Ninth Place: Thanush Patlolla, 17, of Cary, NC received a $50,000 award for approximating the density of electrons using a finite nuclear model. Using a mathematical strategy called a density function, he created a model to map electrons in a nuclear simulation. The map increased the accuracy of energy distribution predictions by 0.6%. Tenth Place: Ray Zhang, 17, of Chantilly, VA received a $40,000 award for studying how to better treat drug-resistant Fusarium fungal infections. Ray studied how the fungus builds sticky communities of cells that resist drug treatment. He also found that using a combination of drugs better controlled the fungus. Akilan Sankaran, 17, of Albuquerque, NM was named the Seaborg Award winner and selected to speak on behalf of the Regeneron Science Talent Search Class of 2025. The 40 finalists chose Akilan as the student who best exemplifies their class and the legacy of nuclear chemist Glenn T. Seaborg, who won the Nobel Prize for Chemistry in 1951 and served on the Society’s Board of Trustees for 30 years. All other finalists received $25,000. All 40 finalists join a distinguished group of Science Talent Search alumni, many of whom have gone on to achieve world-changing careers in STEM, with some earning esteemed honors, including the Nobel Prize, National Medal of Science, and MacArthur Fellowship. In total, Regeneron awarded $3.1 million in prizes, including $2,000 to each top scholar and their school. Learn more about Regeneron Science Talent Search at https://www.societyforscience.org/regeneron-sts/ and learn about all their research projects at our Virtual Public Showcase. For media resources, visit https://www.societyforscience.org/2025-regeneron-science-talent-search-media-kit About Society for Science Society for Science is a champion for science, dedicated to promoting the understanding and appreciation of science and the vital role it plays in human advancement. Established in 1921, Society for Science is best known for its award-winning journalism through Science News and Science News Explores, its world-class science research competitions for students, including the Regeneron Science Talent Search, the Regeneron International Science and Engineering Fair and the Thermo Fisher Scientific Junior Innovators Challenge, and its outreach and equity programming that seeks to ensure that all students have an opportunity to pursue a career in STEM. A 501(c)(3) membership organization, Society for Science is committed to inform, educate and inspire. Learn more at www.societyforscience.org and follow us on Facebook, Twitter, Instagram and Snapchat (Society4Science). About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases. Regeneron believes that operating as a good corporate citizen is crucial to delivering on our mission. We approach corporate responsibility with three goals in mind: to improve the lives of people with serious disease, to foster a culture of integrity and excellence and to build sustainable communities. Regeneron is proud to be included on the Dow Jones Sustainability World Index and the Civic 50 list of the most “community-minded” companies in the U.S. Throughout the year, Regeneron empowers and supports employees to give back through our volunteering, pro-bono and matching gift programs. Our most significant philanthropic commitments are in the area of science education, including the Regeneron Science Talent Search and the Regeneron International Science and Engineering Fair (ISEF). For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. Media Contacts Joseph Brown, Regeneron 386-283-1323, joseph.brown2@regeneron.com Gayle Kansagor, Society for Science 703-489-1131, gkansagor@societyforscience.org Source: Regeneron Pharmaceuticals, Inc.

NEW YORK--( BUSINESS WIRE )--OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today provided a corporate update to the marketplace to contextualize recent positive clinical data, corporate and financial developments. “January 2025 was the most significant month in the Company’s history,” said Paul Romness, MHP, Chairman & CEO of OS Therapies. “We started OS Therapies because someone very close to my family developed osteosarcoma and we realized that if first line therapy failed, the metastasis that could follow had very poor long-term prognosis. The data we generated in our Phase 2b trial with OST-HER2 provides the first glimmer of hope in over 40 years that a paradigm shift could radically change the course of this deadly disease. We intend to stay laser focused on our mission of bringing this therapy to market so that when the next family that gets the devastating news of an osteosarcoma diagnosis, they’ll know that treatment options might exist in the event that chemotherapy and resection/amputation fail to prevent metastasis, which is the case in approximately 50% of patients.” Cash position and burn rate On January 14, 2025, the Company disclosed that it completed a $7.1 million financing round (the “Preferred Round”) designed to fund the Company through a Biologics Licensing Authorization (BLA) decision from the US Food & Drug Administration (“FDA”) regarding the OST-HER2 program in the prevention of metastases in osteosarcoma. This was in addition to the $6 million initial public offering the Company completed in August 2024. Taken together, this $13.1 million that the Company raised over the last 6 months provides sufficient capital to fund: Final payments for the OST-HER2 osteosarcoma trial (inclusive of any expected non-clinical work required by FDA). Commercial manufacturing required for FDA approval and product launch. Strategic & operational costs related to FDA & EMEA correspondence, meetings, and regulatory submissions. Commercial launch preparations. Acquisition of the Listeria monocytogenes (“ Listeria ”) platform from Ayala. Corporate overhead. Under the terms of the Preferred Round, the Company is precluded from raising additional capital for 6 months, in addition to being precluded from selling shares under its Equity Line of Credit (“ELOC”) so long as the price of the common stock is below $12.00. Additionally, the warrants issued in connection with the Preferred Round have certain forced exercise provisions when the common stock trades above $12.00. An additional condition of the Preferred Round was the appointment of Mr. Karim Galzahr as a new member of the Company’s Board of Directors to help the Company navigate towards value creation for shareholders. The Preferred Round was funded over 90% by pre-IPO and IPO investors of the Company, including leading funders from the osteosarcoma community. As a result of the significant investment made to help advance OS Therapies’ mission, certain investors are now considered affiliates of the Company by virtue of owning at least 10% of the common shares. It is important to note that while this significant ownership entitles the investors to representation, it also binds them to certain SEC requirements as it relates to liquidity, thus providing a layer of protection for all shareholders. To read more about affiliate Trading Volume Formula please visit: https://www.sec.gov/about/reports-publications/investorpubsrule144 . We also acknowledge the Company’s shares have experienced significant volatility in recent months. We believe this in large part due to the expiration of the lockup of pre-IPO shares that occurred on the week of January 27, 2025. The vast majority of our pre-IPO shareholders invested in the Company to succeed in its mission of delivering a new treatment option for osteosarcoma patients. The Company expects to complete a number of key milestones towards FDA approval. We are engaging with new institutional and retail investors to expand our shareholder base. Approval of OST-HER2 for osteosarcoma on or before September 30, 2026 (the Company is targeting a late 2025 approval) would grandfather into the FDA’s sunsetting Priority Review Voucher (“PRV”) program by virtue of the Rare Pediatric Disease Designation (“RPDD”) the FDA granted to the Company in 2021. This would result in non-dilutive capital, expected in the $150 million range. Regulatory Path to Approval for OST-HER2 in Osteosarcoma On January 15, 2025, the Company announced that it achieved the primary endpoint with statistical significance in its Phase 2b clinical trial of OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma. In discussions prior to the initiation of the Phase 2b study, FDA recommended 12-month Event Free Survival as the primary endpoint for a successful objective treatment response (“Responders”). The data showed that in comparison with the best available historical control group from United States published literature (the “Published Control”): 33% of OST-HER2 patients were Responders vs. 20% in the Published Control. A greater proportion of OST-HER2 treated patients vs. the Published Control were alive at the post-Resection interim 12-month timepoint (91% vs. 80%) and 24-month timepoints (61% vs. 40%) than the Published Control, in the 3-year overall survival secondary endpoint. 100% of patients on OST-HER2 who were disease free at 12 months were alive at the 12-month, 18-month, 24-month and 30-month timepoints, as of each of their last dates of contact. OST-HER2 was well tolerated, with a strong safety profile that is sufficient to support regulatory approval. Additionally, in preparation for further regulatory discussions with FDA regarding submission of OST-HER2 for accelerated or full approval, the Company sourced the only available database of osteosarcoma patients treated with the standard of care in the US to establish a matched historical external control arm (the “Matched Control”). We did this after receiving feedback from FDA regarding a Breakthrough Therapy Designation (“BTD”) request that noted the clinical subpopulation we studied in the Phase 2b trial met the BTD criteria and that a matched historical external control would be required to determination clinical efficacy. The Matched Control will provide the clinical comparator required by FDA to support approval, based on advice from senior regulatory advisors with experience in getting pediatric orphan therapies approved. While there were insufficient numbers of data points available to finalize the submission package for FDA as of January 2025, the interim data collected on the Primary Endpoint showed: 33% of OST-HER2 treated patients were Responders vs. 11% in Matched Control In Non-Responders, the average time to recurrence was 5.9 months in OST-HER2 treated patients vs. 4.7 months in Matched Control. In further discussions with key members of our Regulatory and Scientific Advisory Board, subgroup analyses that focused on the response to therapy among patients at different stages of disease offered important insight into the potential importance of OST-HER2 for patients and clinicians in osteosarcoma. In the OST-HER2 treated group: Patients who had multiple Resections (2+) showed greater propensity (55%) for achieving 12-month EFS than patients who had previously had only one Resection (25%); Patients who previously had only one Resection (25%) still performed better than patients from the Published Control (20%) and the Matched Control (11%). The likelihood that patients who have had multiple lung metastasis resections were Responders at a 55% rate was important to clinicians because patients with 1 prior Resection will likely progress to having multiple resections, with near 100% certainty. This makes OST-HER2 a therapy likely appropriate for a large proportion of patients. Taken together, the Company believes the efficacy data Matched Control will ultimately support regulatory approval in the prevention of metastases in osteosarcoma, considering the lack of options available in the market, the poor survival outcomes for patients and the strong safety profile of OST-HER2. The Company is working with both domestic and European osteosarcoma research groups to gather additional non-concurrent control arm data for FDA review. The Company intends to request a meeting (either Type B or Type C) with FDA to review the data and discuss the path towards BLA once the additional Matched Control data is ready for submission, expected in the first quarter of 2025. The Company expects meeting with FDA early in the second quarter of 2025. Later in the second quarter we plan to file the BLA, provided positive feedback from FDA. Upon filing the BLA, the Company expects approval within 6 months. Additionally, the Company owns the rights to OST-HER2 in canines , with strong efficacy data previously published. While the Company has prioritized development of OST-HER2 for humans with osteosarcoma, it does intend to make progress in making the conditionally-approved treatment available where possible while it works to secure full regulatory approval so that it can be made broadly accessible. Additional information will be forthcoming on this effort in the months ahead. Acquisition of Clinical Assets and IP from Ayala On January 29, 2025, the Company announced that it entered into an agreement to acquire certain clinical and intellectual property assets from Ayala (the “Acquisition”). As a result of the Acquisition, the Company gained rights to two new Listeria -based clinical-stage immunotherapy candidates: ADXS-503 for lung cancer and ADXS-504 for prostate cancer. While the clinical data for these candidates is encouraging, the primary reason the Company moved forward with the Acquisition was to eliminate an expected near-term cash milestone of $3.5 million due upon the earlier of receiving FDA approval of OST-HER2 or initiating a pivotal trial for OST-HER2 in a clinical indication. Given the likelihood that the recently completed Phase 2b clinical trial of OST-HER2 would be considered pivotal by virtue of the expectation that FDA will allow the data gathered to become the primary efficacy data utilized for BLA submission, this agreement reduces our expected cash needs for 2025. Additionally, the Acquisition reduces the Company’s royalty rate from 10% to 1.5% of net sales and eliminates $16.5 million in milestones on the first $100 million in sales, dramatically improving the potential margin gained by the Company in the early years for OST-HER2 in osteosarcoma. The Company is now positioned as the clear market leader in Listeria -based immunotherapy, a long-promising class of cancer immunotherapy. We expect it to become an important treatment option in situations where no treatments exist, such as recurrent, metastatic osteosarcoma, as well as an adjunct to the standard of care where treatment fails or is insufficient. There was previously considerable enthusiasm around the use of Listeria as an immunotherapy platform in cancer, and we believed this enthusiasm will renew as OST-HER2 makes its way through the FDA approval process. Strategic options for our tunable Antibody & other Drug Conjugate platform With the solidification of OS Therapies as the market leader in Listeria-based immunotherapy, we expect that the development funding priorities post-approval of OST-HER2 in osteosarcoma will be to evaluate OST-HER2 in other HER2-related oncology areas, as well as identify paths forward for ADXS-503 (to be renamed OST-503) in lung cancer and ADXS-504 (to be renamed OST-504) in prostate cancer - two large therapeutic areas with significant unmet medical need. The Company will accelerate the development of our groundbreaking tunable drug conjugate platform based on pH-sensitive tunable linker technology, capable of linking multiple different therapeutic payload combinations with multiple different targeting antibodies - without using our existing cash resources for development. Given the continued market interest in combining therapeutic interventions, such as antibody and vascular targeted drugs to target specific cancer cells, we believe our tunable drug conjugate platform could play an outsized role in creating combination therapies that will improve outcomes while reducing side effects. We will announce strategic options in the near future. Conclusion Our journey as a newly public company resulted in significant clinical and business accomplishments, alongside known challenges for biotechnology companies with relatively small capitalizations. OS Therapies is different from others because the Company has completed its capital-intensive clinical development phase. We are fully funded through a potential PRV sale - a significant revenue generating milestone. These distinctions could separate OS Therapies from others in this challenging biotech funding environment as the market becomes aware of our positioning. We thank the patients, families, clinicians and investors who believe in the mission of the Company to improve outcomes for osteosarcoma, and other solid tumors. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received rare pediatric disease, fast-track and orphan drug designations from the US FDA. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, with positive results released in the first quarter of 2025. The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicon linker technology, enabling the delivery of multiple payloads per molecule. For more information, please visit www.ostherapies.com . Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s registration statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.