Histogenics Corp.

Four life sciences CEOs and veteran biotech investor to guide Pelthos to next stage of growth DURHAM, N.C.--(BUSINESS WIRE)-- Pelthos Therapeutics (Pelthos), a biopharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens, today announced it has appointed five seasoned industry professionals to serve on its Board of Directors. “These directors bring deep operational, clinical and commercialization experience to Pelthos as we approach an important inflection point,” said Scott Plesha, CEO of Pelthos. “I’m proud to serve alongside these four highly accomplished individuals who have decades of experience bringing new treatments to market. The Board is committed to supporting the team at Pelthos as it brings a novel medicine to the patients who need it.” Pelthos new Board of Directors include: Peter Greenleaf, an industry executive with nearly 30 years of experience leading successful life sciences companies. He is currently the president, CEO and member of the Board of Directors of Aurinia Pharmaceuticals, Inc., a fully integrated, publicly traded biopharmaceutical company advancing innovative treatments for autoimmune diseases. He previously served as the CEO of Cerecor Pharmaceuticals, Sucampo Pharmaceuticals, and Histogenics Corp., and as President at MedImmune LLC, the global biologics arm of AstraZeneca. Matt Pauls, who since 2020 has served as Chair of the Board of Directors and CEO of Savara, Inc., a publicly traded biopharmaceutical company focused on rare respiratory diseases. He is also a member of the Board of Directors at Soleno Therapeutics and Amplo Biotechnology. From 2014 to 2019, Mr. Pauls was President and CEO and a member of the Board of Directors of Strongbridge Biopharma plc., a rare-disease focused biopharmaceutical company that he took public via IPO on the NASDAQ. Prior to 2014, he served as Chief Commercial Officer of Insmed, Inc., where he led both the global Commercial and CMC/Technical Operations teams. In addition, Mr. Pauls previously served as Chair of the Board of Directors of Mast Therapeutics and was a member of the Board of Directors of Zyla Life Sciences. Todd Davis, CEO of Ligand Pharmaceuticals and a member of Ligand’s Board of Directors. He has more than 30 years of operational and investment experience and has been involved in more than $4 billion in healthcare financings. Prior to Ligand, Mr. Davis was a Founder and Managing Partner of HealthCare Royalty Partners, a global healthcare investment firm that grew from zero to approximately $4 billion in capital commitments during his tenure. He began his career in sales at Abbott Laboratories, where he held several sales and marketing positions of increasing responsibility. Subsequently, he led corporate development and held strategic planning and general management responsibilities at Elan Pharmaceuticals. Richard Baxter, Ligand’s Senior Vice President of Investment Operations and a member of Ligand’s Investment Committee. He has more than 30 years of operating and investment experience. Mr. Baxter was the co-founder of the healthcare group at Fortress Investment Group, which invested approximately $1 billion in control equity and minority equity investments, senior secured debt financings, royalty financings, public bank debt and bond transactions. He also served as co-head of the healthcare team at Hayfin Capital Management LLP, which deployed $1.4 billion in capital over four years. Prior to working as an investor, Mr. Baxter held senior commercial positions at PathoGenesis Corp., ViroPharma Inc., and SmithKline Beecham. Scott M. Plesha, currently serves as CEO of Pelthos. He has more than 30 years of experience in the pharmaceutical industry, including two decades building and leading specialty pharma commercial organizations. Prior to Pelthos, Mr. Plesha was President and Chief Commercial Officer at BioDelivery Sciences (BDSI) until it was acquired by Collegium Pharmaceutical in 2022. He previously served as Senior Vice President of Gastrointestinal Sales at Salix Pharmaceuticals where he led a nationwide salesforce that grew product sales to more than $1.5 billion annually. Pelthos is a wholly owned subsidiary of Ligand Pharmaceuticals. About ZELSUVMI™ (berdazimer) topical gel, 10.3% ZELSUVMI (berdazimer) topical gel, 10.3% is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum in adults and pediatric patients one year of age and older. Complete prescribing information is available at . About Pelthos Therapeutics Pelthos Therapeutics is a biopharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens. Our lead product ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum is now approved by the U.S. Food and Drug Administration. In addition to ZELSUVMI, Pelthos has a pipeline of potential product candidates that utilize our proprietary nitric oxide-based technology platform, NITRICIL™. More information is available at . Follow Pelthos on LinkedIn and X.

Timely additions to leadership team and board of directors align with company's initiation of first-in-human clinical studies of novel HYALEX® Cartilage Platform LEXINGTON, Mich., April 15, 2024 /PRNewswire/ -- Hyalex Orthopaedics, a privately held medical device company developing cartilage repair products based on the transformative HYALEX® materials platform, today announced the appointment of Thomas "Tad" Vail, M.D., as chief medical officer. Dr. Vail is internationally recognized as a specialist in total and partial joint replacement and surgical treatment of hip and knee conditions, having most recently served as the Michael and Antoinette Pappas endowed chair and James L. Young professor of orthopaedic surgery at the University of California, San Francisco (UCSF). Additionally, Hyalex announced the appointment of Adam Gridley, the chief executive officer of Allay Therapeutics, to the company's board of directors. These two appointments significantly augment the scientific and operational expertise of the Hyalex team at a time when the company is bringing its novel HYALEX Cartilage platform into first-in-human clinical trials. "Hyalex is entering an exciting and transformational period for the company, as we advance our novel HYALEX Cartilage platform into the clinic for the first time. By adding Tad's deep scientific and clinical expertise in the orthopaedics field, along with Adam's impressive operational and transactional track record in the biotech and medical device space, we are significantly elevating the company's leadership to best position Hyalex for success," said Carl Vause, Hyalex's president and chief executive officer. "We look forward to the important contributions that both Tad and Adam will make to the success of the company." Prior to stepping down in 2023, Dr. Vail had served as chair of orthopaedic surgery at UCSF since 2007, helping to establish the department as an international leader in patient care, research, education, and global health. His research focuses on performance and outcomes of surgical procedures and devices, delivery of care in adult reconstruction, and cartilage repair strategies. He has published several hundred scientific articles, abstracts, book chapters and educational materials on many facets of hip and knee surgery, surgical training and innovation, health economics, and patient care. He is the past president of the Knee Society, the American Association of Hip and Knee Surgeons, and the Eastern Orthopaedic Association, past vice president of the American Board of Orthopaedic Surgery, and currently sits on the board of trustees for the Journal of Bone and Joint Surgery. Additionally, Dr. Vail has multiple patents for orthopaedic devices and has served as an industry consultant, participated on multiple scientific advisory boards, and helped to start companies in the musculoskeletal device space. "During my more than 16 years leading the orthopaedics department at UCSF, I was fortunate to have a front row seat to many of the most promising innovations in joint reconstruction and cartilage repair. With my perspective on the evolution of the field, along with an understanding of the ongoing unmet needs of patients in this area, I believe that the technology being advanced by Hyalex has an opportunity to be a true game changer," said Dr. Vail. "This platform has the potential to offer patients a joint restoration treatment that mimics the properties of natural cartilage in distinction to traditional orthopaedic materials. HYALEX Cartilage is designed to accelerate recovery from cartilage injury and degeneration, either as an alternative to biologic therapy or in combination. The opportunity to play a role in such a potentially significant advance in patient care was too exciting for me to pass up." Mr. Gridley has over 25 years experience in the biotechnology, medical device and pharmaceutical industries leading venture capital-backed startups to fully integrated public commercial organizations. He is the CEO of Allay Therapeutics, a drug delivery biotechnology company, and previously was the CEO of Entera Bio, a biotechnology company specializing in the oral delivery of large molecules and biologics, as well as the CEO of Histogenics, a cell therapy and biologics company developing novel therapeutics for cartilage defects. At Histogenics, he led its IPO, multiple fundraisings and strategic transactions, and oversaw several successful clinical and manufacturing initiatives for the company's Phase 3 trial of NeoCart. Prior to Histogenics, Mr. Gridley held several corporate and operational executive roles at Merz Pharma and BioForm Medical (including the sale to Merz), where he played a key role in an IPO as well as acquisitions and product launches. Mr. Gridley has served on the board of directors of LifeSprout and the Alliance for Regenerative Medicine (ARM) and is on the board of advisors for Life Science Cares Bay Area. "Having worked in the life science sector for more than two decades, including holding senior positions within innovative biotechnology and medical device companies, it is clear to me that Hyalex is strongly positioned to make a significant impact on patient care with its synthetic cartilage platform," said Mr. Gridley. "Simple yet effective cartilage repair solutions are still one of the largest unmet needs in orthopaedics for a broad demographic of patients seeking rapid recuperation and pain relief. Given the potential for the company's technology platform, I'm excited to join the Hyalex board and talented team and share my experiences in the cartilage repair and fundraising space as they work diligently to deliver innovative new therapeutic options for patients who are suffering with damaged and diseased joints." About Hyalex Orthopaedics Hyalex is a privately held medical device company headquartered in Lexington, MA, developing transformational synthetic cartilage technology and implant systems for diseased and damaged joints. HYALEX Cartilage is protected by more than 17 patents and trademarks worldwide. The HYALEX Cartilage platform has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration for a clinical trial in the United States. Hyalex is initiating first-in-human clinical studies of HYALEX Cartilage for knee cartilage repair in both the U.S. and Europe. For more information: Contact Information: Tim Brons Vida Strategic Partners (media) 646-319-8981 [email protected] SOURCE Hyalex Orthopaedics

Conference Call and Webcast Today at 8:30 a.m. ET OCU400 demonstrated favorable safety and tolerability profile in retinitis pigmentosa (RP) and Leber congenial amaurosis (LCA) subjects Completed dosing of three LCA patients including a pediatric patient OCU400 Phase 1/2 study results suggest stabilization or improvement of Best-Corrected Visual Acuity (BCVA) or Multi-Luminance Mobility Testing (MLMT) or Low-Luminance Visual Acuity (LLVA) in treated eyes of 83% (10/12) subjectsStabilization or improvement in MLMT scores from baseline in 86% (6/7) of RHO subjects demonstrated gene-agnostic property of OCU400 modifier gene therapy and its potential benefits in broader RP and LCA subjectsOcugen’s inhaled mucosal vaccine candidate for COVID-19—OCU500—selected by National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases' (NIAID) Project NextGen for inclusion in clinical trials MALVERN, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today reported third quarter 2023 financial results along with a general business update. “Ocugen has made significant pipeline progress in the third quarter,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “In particular, based on the OCU400 data presented in September, I am as enthusiastic as ever regarding the potential for our modifier gene therapy approach to make an important difference in the lives of people living with blindness diseases. OCU400—our lead candidate—has the potential to address multiple genetic mutations with a single product compared to traditional gene therapies that target one gene at a time.” This clinical efficacy update provided in September 2023 included data for 12 subjects who have completed a minimum of 6 months follow up. 83%, 83%, and 75% of subjects demonstrated stabilization or improvements in OCU400 treated eyes on BCVA, LLVA, and MLMT scores, respectively from baseline. 86% of subjects with the RHO gene mutation experienced either stabilization or increase in MLMT scores from baseline, including a subset of 29% that demonstrated a three Lux luminance level improvement. Preservation of remaining vision, slowing disease progression, or improving the vision can significantly impact patients’ quality of life. “The improvements in BCVA, LLVA and MLMT in RHO patients—a disease affecting more than 10,000 people in the U.S. alone—supports the gene-agnostic mechanism of action for OCU400,” said Dr. Musunuri. In October 2023, OCU500, was selected by the NIAID Project NextGen for inclusion in clinical trials. OCU500 will be tested via two different mucosal routes, inhalation into the lungs and as a nasal spray. Currently used injected vaccines, including mRNA vaccines, are not effective in preventing infection and spread although effective against severe infection. Generating mucosal immunity in nasal and respiratory airways could help block the infection at its origin, thus limiting spread. “NIAID support for our mucosal vaccine platform is the result of many months of hard work and dedicated effort by our Ocugen team and is a first step in potentially expanding the platform to flu and other respiratory viral diseases and infections,” said Dr. Musunuri. “Additionally, this funding makes it possible to focus the majority of Ocugen’s R&D and clinical resources on our first-in-class gene and cell therapies.” As Ocugen prepares to start Phase 3 for OCU400, begin dosing patients for OCU410 and OCU410ST, and initiate the Phase 1 trial for OCU500 in collaboration with NIAID, the company is making meaningful progress toward its long-term strategy and delivering on each of its scientific platforms in the near-term. Ophthalmic Gene Therapies—First-in-class OCU400 – Completed dosing adult RP patients in the dose-escalation and dose-expansion portions of the trial; completed dosing three LCA patients including a pediatric patient. Phase 3 clinical trial for the treatment of RP to be initiated in early 2024 following FDA concurrence on study design. Subsequently, the Company is expecting to expand the OCU400 Phase 3 clinical trial for LCA patients in the second half of 2024 based on Phase 1/2 study results in LCA patients and alignment with the FDA.OCU410 and OCU410ST – IND applications to initiate Phase 1/2 trials for both OCU410 and OCU410ST were cleared by the FDA and the Company intends to dose patients in Phase 1/2 trials by the end of 2023. Ophthalmic Biologic Product OCU200 – Continuing to work on the Company’s response to the FDA regarding the IND application and expect to initiate the Phase 1 clinical trial in the first half of 2024, contingent on the lift of the FDA hold and adequate availability of funding. Regenerative Cell Therapies—First-in-class NeoCart® – Ocugen’s autologous regenerative cell therapy (using patients’ own cartilage cells) remains on track to begin its Phase 3 clinical trial in the second half of 2024. A cGMP facility for manufacturing NeoCart is expected to be completed at the end of 2023 and qualification is expected in the first half of 2024. Vaccines Portfolio—First-in-class Mucosal Vaccine Platform – The Company is collaborating with NIAID to initiate clinical trials of OCU500 in early 2024. Third Quarter 2023 Financial Results The Company’s cash, cash equivalents, and investments totaled $53.5 million as of September 30, 2023, compared to $90.9 million as of December 31, 2022. The Company had 256.5 million shares of common stock outstanding as of September 30, 2023.Total operating expenses for the three months ended September 30, 2023 were $15.4 million and included research and development expenses of $6.3 million and general and administrative expenses of $9.1 million. This compares to total operating expenses for the three months ended September 30, 2022 of $23.1 million that included research and development expenses of $15.6 million and general and administrative expenses of $7.5 million.Ocugen reported a $0.06 net loss per common share for the three months ended September 30, 2023 compared to a $0.10 net loss per common share for the three months ended September 30, 2022. Conference Call and Webcast Details Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks. Attendees are invited to participate on the call or webcast using the following details: Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callersConference ID: 1787631Webcast: Available on the events section of the Ocugen investor site A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site. About Ocugen, Inc.Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn. Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s clinical development activities and related anticipated timelines; strategy, business plans and objectives for its clinical stage programs; plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof; expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials; the ability to initiate new clinical programs; and Ocugen’s financial condition. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Ocugen’s subsequent filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release. Contact:Tiffany HamiltonHead of CommunicationsIR@ocugen.com OCUGEN, INC.CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited) September 30, 2023 December 31, 2022Assets Current assets Cash and cash equivalents$53,477 $77,563 Marketable securities — 13,371 Prepaid expenses and other current assets 3,081 7,558 Total current assets 56,558 98,492 Property and equipment, net 14,469 6,053 Other assets 3,660 4,087 Total assets$74,687 $108,632 Liabilities and stockholders' equity Current liabilities Accounts payable$2,921 $8,062 Accrued expenses and other current liabilities 6,399 9,900 Operating lease obligations 540 498 Current portion of long term debt 1,276 — Total current liabilities 11,136 18,460 Non-current liabilities Operating lease obligations, less current portion 3,164 3,587 Long term debt, net 1,495 2,289 Other non-current liabilities 497 244 Total liabilities 16,292 24,580 Stockholders' equity Convertible preferred stock 1 1 Common stock 2,566 2,217 Treasury stock (48) (48)Additional paid-in capital 322,452 294,874 Accumulated other comprehensive income 27 26 Accumulated deficit (266,603) (213,018)Total stockholders' equity 58,395 84,052 Total liabilities and stockholders' equity$74,687 $108,632 OCUGEN, INC.CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except share and per share amounts)(Unaudited) Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Operating expenses Research and development$6,342 $15,622 $30,069 $32,544 General and administrative 9,082 7,497 26,839 28,174 Total operating expenses 15,424 23,119 56,908 60,718 Loss from operations (15,424) (23,119) (56,908) (60,718)Other income (expense), net 1,262 1,197 3,323 1,306 Net loss$(14,162) $(21,922) $(53,585) $(59,412) Shares used in calculating net loss per common share — basic and diluted 256,492,558 216,591,011 240,222,667 212,755,746 Net loss per share of common stock — basic and diluted$(0.06) $(0.10) $(0.22) $(0.28)