St. Joseph's University

Senior financial executive Ramzi Benamar joins leadership team as Chief Financial Officer Experienced board member, Chief Financial Officer and strategic consultant Gary Sender joins board of directors to Chair the Finance Committee Both appointments precede multiple value-creating catalysts, including Phase 3 results for AD109 as a first potential oral treatment for obstructive sleep apnea (OSA) CAMBRIDGE, Mass., Oct. 23, 2024 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company focused on discovery, development, and commercialization of first-in-class oral therapies that address the neuromuscular dysfunction of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced the appointments of Ramzi Benamar as Chief Financial Officer and Gary Sender to the Board of Directors and as Chair of the Finance committee. The strengthening of both the leadership team and Board of Directors brings decades of combined experience in critical functions, such as financial management, strategic planning, company capitalization, investor relations and corporate mergers and acquisitions. "We are pleased to welcome both Ramzi and Gary to Apnimed, as they bring proven leadership experience in leading-edge, science-driven companies, across a broad range of critical finance and strategic functions. I am confident their additions will help to continue to drive forward our financial strategy, deliver on key operational priorities, and build long-term shareholder value," said Larry Miller, MD, Chief Executive Officer of Apnimed. "These appointments come at a critical time, as we look forward to next year's Phase 3 clinical trial results for AD109 and preparation for its potential commercial launch as a once-nightly oral therapy for OSA." Mr. Benamar commented, "I am incredibly excited to join the Apnimed team during this transformational time for the company. With its ongoing, late-stage clinical development program for AD109 in OSA, a value generating joint-venture with Shionogi and a strong existing investor base, Apnimed is well-positioned to serve the needs of all stakeholders, and I look forward to contributing to the achievement of its next phase of growth." "Apnimed is in an excellent position to accelerate into the next stage of corporate development," noted Mr. Sender. "I am eager to contribute to the financial and strategic initiatives of the company and am confident in the organization's continued clinical and future commercial successes." About Ramzi Benamar, Chief Financial Officer Ramzi Benamar has over 25 years of experience in the biotech and pharma industry, where he has an extensive track record of supporting the development and commercialization of novel pharmaceutical products and serving in executive financial leadership roles in both public and private companies. Ramzi has led several rounds of financing as a CFO amounting to about $600M. He served as the CFO of BELLUS Health, where he contributed to the growth of the company toward its acquisition by GSK. Ramzi was also the CFO at DBV Technologies and Elucida, and Vice President and Head of Financial Planning and Analysis for Spark Therapeutics until its acquisition by Roche Holdings. Earlier in his career, Ramzi held numerous positions of increasing responsibilities in finance, strategy, and operations at various pharma companies including Shire, Johnson & Johnson, and Merck. He holds a bachelor's and master's degree in business administration from Temple University, and a master's degree from the University of the Sciences in Philadelphia (Saint Joseph's University). About Gary Sender, Independent Director and Chair of Finance Committee Gary Sender has extensive financial leadership experience across the biopharmaceutical industry, including serving on the board of directors of several public and private biotechnology companies. Mr. Sender joined the Board of Directors of both Schrödinger, Inc., and Harmony Biosciences when they were both private companies and currently Chairs both respective Audit Committees and the Schrödinger Compensation Committee. He currently Chairs the Audit Committee and serves on the Compensation Committee of iBio. Mr. Sender also joined the Board of Directors of Gennao Bio (Private) in September of 2021 and currently Chairs both the Audit and Compensation committees. In March 2021, Mr. Sender retired as the Chief Financial Officer of Nabriva plc. Prior to Nabriva, he was the Chief Financial Officer of Synergy Pharmaceuticals. Previously, Mr. Sender was the Senior Vice President of Finance for Shire plc, supporting its global commercial businesses and all functions of its specialty pharmaceuticals business. Prior to joining Shire, he was the Chief Financial Officer of Tengion, Inc. Earlier in his career, Mr. Sender held several increasingly senior finance-related roles, including a 15-year career at Merck & Co., Inc., most recently serving as Vice President and Controller for Merck's U.S. pharmaceuticals business. Mr. Sender earned his bachelor's degree in finance and management information systems from Boston University. He received his master's degree in industrial administration (MBA) with a concentration in Finance from Carnegie-Mellon University. About AD109 AD109 could be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the underlying neuromuscular cause of upper airway collapse in people with obstructive sleep apnea. It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective noradrenaline reuptake inhibitor (NRI). Their combined pharmacological synergy targets the root neuromuscular cause of OSA. AD109 is a once-nightly oral pill that is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep. In a disease characterized by complex and invasive treatment options, AD109 may be a simple solution to help improve oxygenation and health wellbeing for people living with OSA. About Obstructive Sleep Apnea Obstructive sleep apnea is a serious chronic sleep-related breathing disease where the upper airway repeatedly collapses during sleep, causing intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. The impact of OSA spans age, sex, and body type—there is no single face of the disease. Every night, greater than 54 million people in the U.S. and 1 billion people worldwide with OSA stop breathing, exposing them to serious, long-term health risks. An individual with OSA can experience hundreds of sleep apnea events in a single night. Each sleep apnea event reduces blood oxygen levels and deprives cells of the energy they need to perform vital functions. Ultimately, failure to effectively treat OSA increases the risk of long-term health consequences and quality of life impacts, including daytime fatigue, impaired judgement, premature death, and severe and potentially life-threatening health complications, such as high blood pressure, cardiovascular disease, and type 2 diabetes. Yet, even after being diagnosed, the majority of people with OSA either refuse, abandon, or underutilize treatment. In addition, no currently available treatments address the underlying neuromuscular dysfunction present in all OSA cases. About Apnimed Apnimed is a pharmaceutical company dedicated to breathing new life into the sleep-related breathing disease treatment landscape. The company envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and elevate the health and expectations of everyone in the sleep-related breathing disease community. Based in Cambridge, Mass., Apnimed is advancing a focused pipeline of oral pharmaceutical product candidates designed to help improve oxygenation for people living with obstructive sleep apnea and beyond, to other sleep-related breathing diseases, including several that are part of our joint venture with Shionogi & Co., Ltd, Shionogi Apnimed Sleep Science (SASS). Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Brian Ritchie [email protected] SOURCE Apnimed, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

-- VAX-31 Adult Phase 1/2 Study Topline Safety, Tolerability and Immunogenicity Data Expected in September 2024 -- -- Following VAX-31 Adult Phase 1/2 Study Results, Vaxcyte to Advance VAX-24 or VAX-31 to Adult Phase 3 Program -- -- VAX-24 Infant Phase 2 Study Topline Data from Primary Immunization Series Expected by End of First Quarter of 2025, Followed by Topline Data from Booster Dose by End of 2025 -- -- $1.9 Billion in Cash, Cash Equivalents and Investments as of June 30, 2024 -- SAN CARLOS, Calif., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the second quarter ended June 30, 2024, and provided a business update. “We continue to make significant strides toward building the potentially best-in-class pneumococcal conjugate vaccine (PCV) franchise and expect to announce the VAX-31 adult Phase 1/2 study topline safety, tolerability and immunogenicity data in September,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “Our clinical program assessing VAX-31, the broadest-spectrum PCV in the clinic today, will provide significant insights into the full potential of this vaccine candidate across the adult population. Following the VAX-31 adult data readout, we plan to advance either VAX-24 or VAX-31 into Phase 3 clinical development in adults.” Mr. Pickering continued, “Additionally, we look forward to delivering the topline data from the primary immunization series of the VAX-24 infant Phase 2 study by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025. We believe VAX-24 has a potential best-in-class profile for this vital population and is designed to cover more serotypes than any infant pneumococcal vaccine on-market today.” Key Second Quarter and Recent Highlights VAX-24 Phase 2 Data in Adults Aged 65 and Older Published in Vaccine: In July 2024, the results from the VAX-24 Phase 2 study in adults aged 65 and older were published in the journal Vaccine. The study evaluated the safety, tolerability and immunogenicity of Vaxcyte’s investigational 24-valent, carrier-sparing PCV compared to Prevnar 20® (PCV20), for the prevention of invasive pneumococcal disease (IPD) in healthy adults. The results showed VAX-24 demonstrated a safety and tolerability profile comparable to PCV20 across all ages and doses studied. The VAX-24 2.2mcg dose showed an overall improvement in immune responses compared to PCV20 relative to the results from the prior Phase 2 study in adults aged 50-64.National Institute of Allergy and Infectious Diseases (NIAID) Grant Awarded for Preclinical Chlamydia Vaccine Development Program: In July 2024, the NIAID awarded a five-year, $9.5 million grant to the University of North Carolina at Chapel Hill, Vaxcyte and the University of Chicago to develop a vaccine candidate for the prevention of Chlamydia. There is a significant need for a vaccine to protect against Chlamydia. It is the most common bacterial sexually transmitted infection worldwide, with nearly 130 million new cases per year. While it is treatable when detected early, it can cause permanent damage to the female reproductive system, potentially leading to complications such as infertility and ectopic pregnancy.Appointed Seasoned Industry Expert to its Board of Directors: In July 2024, Vaxcyte appointed John Furey to its Board of Directors. Mr. Furey is a seasoned biopharmaceutical executive with over 30 years of experience developing and implementing operational strategies and leading commercial and technical teams, including senior leadership roles in the U.S., Europe and Asia. He has extensive vaccine experience from his time at Baxter and Pfizer, including having served as the General Manager of Pfizer’s vaccine business unit in China and a leadership role overseeing Pfizer Vaccines’ global pricing and reimbursement. Earlier in his career, Mr. Furey held both commercial and operations positions at Wyeth Pharmaceuticals (prior to Pfizer’s acquisition of Wyeth), including serving as Project Director of the Grange Castle Biopharmaceutical Campus where Prevnar is manufactured. He currently serves as Chief Executive Officer of Imvax, a clinical-stage biotechnology company developing novel immunotherapies for cancer. Mr. Furey earned an executive Master of Business Administration from Saint Joseph’s University, a Bachelor of Science degree from Trinity College, Dublin, and a Diploma in Environmental Health from the Technological University, Dublin. Mr. Furey also serves on the Board of Directors of Adaptimmune and Sensorion. Anticipated Key MilestonesVaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones: PCV Franchise Adult Indication: Announce topline safety, tolerability and immunogenicity data from VAX-31 adult Phase 1/2 study in September 2024.Following VAX-31 data, advance either VAX-24 or VAX-31 to an adult Phase 3 program. If VAX-24: Following the initiation of Phase 3 pivotal, non-inferiority study in adults aged 50 and older, announce topline safety, tolerability and immunogenicity data in the second half of 2025.Initiate balance of expected Phase 3 studies in 2025 and 2026. If VAX-31: Initiate full complement of expected Phase 3 studies in 2025 and 2026. PCV Franchise Infant Indication: VAX-24: Announce topline safety, tolerability and immunogenicity data from VAX-24 infant Phase 2 study primary three-dose immunization series by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025. Second Quarter 2024 Financial Results Cash Position: Cash, cash equivalents and investments were $1,851.9 million as of June 30, 2024, compared to $1,242.9 million as of December 31, 2023. Research & Development (R&D) Expenses: R&D expenses were $131.5 million for the three months ended June 30, 2024 as compared to $72.7 million for the same period in 2023. The increase was due primarily to higher manufacturing expenses related to the Company’s PCV programs, including for potential future commercial launch and Phase 3 clinical trials; expenses related to the ongoing VAX-31 adult and VAX-24 infant clinical studies; and an increase in personnel expenses related to the growth in the number of R&D employees. General & Administrative (G&A) Expenses: G&A expenses were $21.5 million for the three months ended June 30, 2024, as compared to $14.5 million for the same period in 2023. The increase was due primarily to higher personnel expenses related to the growth in the number of G&A employees. Net Loss: For the three months ended June 30, 2024, net loss was $128.7 million, compared to $68.3 million for the same period in 2023.Commercial Manufacturing Suite: In the second quarter of 2024, Vaxcyte incurred an additional $38.2 million in capital and facility buildout expenditures related to the ongoing construction of the dedicated manufacturing suite at Lonza intended to support the potential global commercialization of the Company’s PCV programs. As of June 30, 2024, Vaxcyte had incurred $140.0 million in total capital and facility buildout expenditures that were reflected on the Company’s balance sheet as of that date. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a Phase 3-ready 24-valent, broad-spectrum, carrier-sparing PCV being developed for the prevention of IPD. VAX-31, the Company’s next-generation 31-valent PCV, is the broadest-spectrum PCV candidate in the clinic today. Both VAX-24 and VAX-31 are designed to improve upon the standard-of-care PCVs for both children and adults by covering the serotypes that are responsible for a significant portion of IPD in circulation and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice. Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of VAX-24 and VAX-31, including breadth of coverage, the ability to deliver the potentially best-in-class PCV franchise and improvement upon the standard-of-care; the process and timing of anticipated future development of Vaxcyte’s vaccine candidates; the timing and availability of data for the VAX-24 infant Phase 2 study and VAX-31 adult Phase 1/2 study; the advancement of either VAX-24 or VAX-31 into a Phase 3 adult clinical program, and the timing of such studies and their data readouts; the demand for Vaxcyte’s vaccine candidates; Vaxcyte’s ability to establish global commercial manufacturing capacity for its PCV candidates; Vaxcyte’s plans to utilize Lonza infrastructure to support the potential global commercialization of Vaxcyte’s PCV programs; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on August 6, 2024 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date. Contacts:Jennifer Zibuda, Senior Director, Investor RelationsVaxcyte, Inc.860-729-8902investors@vaxcyte.com Janet Graesser, Senior Vice President, Corporate Communications and Investor Relations Vaxcyte, Inc.917-685-8799media@vaxcyte.com Vaxcyte, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Operating expenses: Research and development (1) $131,507 $72,691 $226,094 $130,771 General and administrative (1) 21,474 14,456 41,359 27,567 Total operating expenses 152,981 87,147 267,453 158,338 Loss from operations (152,981) (87,147) (267,453) (158,338) Other income, net: Interest income 23,813 16,451 45,479 26,844 Grant income 394 2,464 520 3,119 Realized gains on marketable securities 27 - 49 - Foreign currency transaction losses 44 (107) (2,318) (426) Total other income, net 24,278 18,808 43,730 29,537 Net loss $(128,703) $(68,339) $(223,723) $(128,801) Net loss per share, basic and diluted $(1.10) $(0.70) $(1.95) $(1.40) Weighted-average shares outstanding, basic and diluted 117,256,561 98,057,870 114,473,758 92,165,076 (1) Amounts include stock-based compensation expense as follows: Research and development $10,855 $5,911 $19,673 $10,438 General and administrative 10,703 6,633 19,514 11,754 Total stock-based compensation expense $21,558 $12,544 $39,187 $22,192 Vaxcyte, Inc. Summary Consolidated Balance Sheet Data (in thousands) June 30, December 31, 2024 2023 Cash, cash equivalents and investments $1,851,940 $1,242,902 Total assets 2,087,267 1,407,917 Total stockholders' equity 1,986,132 1,240,468

Study sheds light on a medical accessibility issue, the need for alternative or modified concussion assessment norms and the need for baseline testing PHILADELPHIA, March 28, 2024 /PRNewswire/ -- Schools and colleges across the country rely on Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) evaluations to assess and manage student-athlete concussions on the sidelines. However, this FDA-cleared tool is not recommended for student-athletes with neurodevelopmental disorders, who often score significantly lower than neurotypical individuals. New research published Feb. 13 in the Archives of Clinical Neuropsychology demonstrates the need for alternative or modified concussion assessment norms and the need for baseline testing for autistic athletes. "Given the findings of the current study and other recent studies, there is a clear need for ImPACT normative reference data specifically for student-athletes with autism spectrum disorder (ASD)," says Philip Schatz, PhD, principal investigator and professor of psychology at Saint Joseph's University. "The [neuropsychology] field needs to expand assessment and interpretation practices and procedures for people with ASD and related developmental conditions." Individuals with attention deficit hyperactivity disorder (ADHD), learning disorder (LD) and ASD are not included in normative reference data. This means when autistic athletes are assessed for a concussion, their data is compared to age- and gender-similar neurotypical individuals. Therefore, the utility and accuracy of widely used test measures like the ImPACT test decreases. Within the United States, the prevalence of ASD has increased over the past 20 years, from 1-in-150 children in 2000 to 1-in-36 children in 2020. Nearly 91% of adolescents with ASD reported liking sports and exercise, meaning the potential for concussive injuries in this population is high. Furthermore, previous research at Saint Joseph's University has shown that exercise can be helpful in treatment for ASD. "This is a medical accessibility issue," says Joseph McCleery, PhD, assistant professor of psychology and executive director of academic programs in the Kinney Center for Autism Education and Support and co-author on the study. "We need to make medicine more neurodivergence friendly. Research like this is an important first step toward fixing the problem." The research team points to the study as a critical first step in creating normative reference values for young athletes with ASD, and looks forward to continuing their research as part of a larger conversation of neuroinclusive care. "Athletes' developmental diagnosis was self-reported in this study," says Schatz. "Moving forward, we will need a more objective way of measuring this factor. We also will need to evaluate the utility of various concussion assessment measures. I look forward to the future, as it is important everyone receives effective concussion management, including people who are on the autism spectrum." SOURCE Saint Joseph's University