Critical Therapeutics, Inc.

Lead bispecific antibody, HSB-3215 designed to target novel conformational epitopes on high value validated targets, HER2 and HER3 Focus on optimizing ADCs to generate a more potent Bystander Effect and proprietary novel bovine-derived biologic platform, PicoKnobTM, targeting undruggable epitopes on PD-1 and TROP2 Experienced biopharmaceutical executive joins as Chief Operating Officer to spearhead execution of ADC and biologic strategy BRIDGEWATER, N.J., July 10, 2023 (GLOBE NEWSWIRE) -- Hillstream BioPharma (Nasdaq: HILS) a biotechnology company developing innovative therapeutic candidates targeting drug resistant and devastating cancers that can make a difference in patients’ lives, today announced a strategic reprioritization of its pipeline and provided a corporate update. The strategic assessment took into account, the pipeline’s near-term value creation opportunity and other factors. Hillstream will focus its pipeline on advancing novel oncology assets with the greatest potential and strong competitive profiles to address unmet needs across multiple solid tumors, such as bispecific antibodies and ADCs targeting novel conformational epitopes on high value validated targets, HER2 and HER3, with a more potent Bystander Effect. Bispecific antibodies (BsAbs) refer to a diverse group of molecules that recognize distinct epitopes on two different antigens, such as HER2 and HER3. These validated targets have been extensively studied and belong to the ERBB receptor tyrosine kinase family and are exploited by cancer cells to promote tumorigenesis and metastasis. HER2, an extensively studied and validated target, has multiple approved therapeutics for solid tumors. Meanwhile, emerging evidence suggests that HER3 plays a central role through interacting with neighboring receptors. While HER3 has little to no tyrosine kinase activity on its own, its activation to promote tumors depends on heterodimerization or locking into place with HER2 and EGFR, which is believed to unlock its cancer-causing potential. Hillstream’s lead asset, HSB-3215 is designed as a bispecific humanized immunoglobulin containing two arms targeting the extracellular domains of HER2 and HER3. HSB-3215 binds to both overlapping and different epitopes on HER2 when compared to trastuzumab, the first approved antibody against HER2, while adhering to novel epitopes on HER3, thus creating novel conformational epitopes. The Company intends to develop this novel BsAb and IND application with the US FDA late next year. By exploiting the “Bystander Effect”, a key aspect of ADCs which has been recently highlighted by the improved clinical efficacy of Daiichi Sankyo/AstraZeneca’s ENHERTU® (trastuzumab deruxtecan), the Company plans to optimize its BsAb pipeline with BiSpecific ADCs, i.e. BiSpecific antibodies conjugated with novel toxin payloads which are optimized to generate a more powerful Bystander Effect. ADCs are comprised of a targeting antibody chemically conjugated via a proprietary linker to a powerful, cancer-killing compound/toxin (payload). With a BsAb backbone utilizing HSB-3215, the Company intends to develop novel ADCs, targeting HER2/HER3 and better direct a payload to cancer cells overexpressing these receptors, while healthy cells don’t take up the unwanted compound. Hillstream also intends to further enhance its previously announced collaborations with Applied Biomedical Science Institute (ABSI) and Minotaur to develop novel bovine-derived biologics in multiple formats against highly validated targets, including PD-1, HER2 and TROP-2, referred to as PicoKnobsTM. An update regarding these collaborations will be announced during an R&D Day in the third quarter. “Our recently announced collaborations with ABSI are transforming Hillstream into a focused and targeted cancer biologics company,” said Randy Milby, Chairman and CEO of Hillstream. “With the HER2 and HER3 platform, we are building a diverse foundation of targeted biologics which can be utilized for our current portfolio as well for future in-licensed assets. We are confident that our focused approach and experienced management team best positions us for success.” The Company also announced the appointment of Sireesh Appajosyula, Pharm.D.as as Chief Operating Officer (COO). Sireesh brings over 20 years of experience in creating and advising biotechnology companies such as 9 Meters Biopharma Inc. through targeted transactions thus creating a pipeline as well as accessing the public capital markets. He was responsible for corporate development including portfolio strategy, in-licensing transactions and alliances for 9 Meters’s core assets as well as monetization of non-core assets. Previously, he spent eight years at Salix Pharmaceuticals, Inc. in various roles including medical & clinical affairs, product commercialization and business development culminating in Salix’s acquisition for $16 billion by Bausch Health. Prior to Salix, Sireesh held increasing roles and responsibilities at Amgen, Chiesi (Critical Therapeutics) and Sanofi S.A. (Aventis). Sireesh holds a Doctor of Pharmacy degree from the Ernest Mario College of Pharmacy at Rutgers University in New Jersey. “I am thrilled to join Hillstream and look forward to working alongside the team as we further our development programs. I believe the Company’s precision oncology strategy with the current HER2/HER3 antibody programs and pipeline have the potential to bring much needed treatments to cancer patients,” said Dr. Appajosyula. About Hillstream BioPharma, Inc. Hillstream BioPharma, Inc. is a biotechnology company developing a focused portfolio of therapeutic candidates targeting drug resistant and devastating cancers. The Company’s emerging immuno-oncology pipeline is led by HSB-3215, a novel anti-HER2 monoclonal antibody targeting unique epitopes with a novel mechanism of action. The erbB/HER family of cell surface proteins include well-known and validated drug targets including HER2 and HER3 found in multiple solid tumors, including breast, lung, GYN, endocrinological and CNS. For more information, please visit: . Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Hillstream’s expectations, strategy, plans or intentions. These forward-looking statements are based on Hillstream’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain Food and Drug Administration (“FDA”) clearances or approvals and noncompliance with FDA regulations. Investors should read the risk factors set forth in our Form 10-K for the year ended December 31, 2022, and our periodic reports filed with the Securities and Exchange Commission. However, these risks are not exhaustive and new risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release. Forward-looking statements included herein are made as of the date hereof, and Hillstream does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances, except as may be required by law. Investor Relations Contact Email: investorrelations@hillstreambio.com

SOMERVILLE, Mass.--(BUSINESS WIRE)-- Cellarity, a life sciences company founded by Flagship Pioneering to transform the way medicines are discovered, announced today the appointments of John Leaman, M.D., M.B.A., as Chief Financial Officer (CFO), Cameron Trenor, M.D., as Vice President and Head of Translational Medicine, and Anjali Kumar, Ph.D., as Vice President, Head of Business Development. In addition, Parul Doshi, M.B.A., has been promoted to Chief Data Officer in recognition of her significant contribution to the development of Cellarity and her leadership in the implementation of an efficient and scalable data infrastructure to support Cellarity’s unique approach to drug creation. Cellarity is fundamentally redesigning the way drugs are created. By shifting focus from a single molecular target to the underlying cellular dysfunction, the company unravels the complexity of disease biology to create medicines that are out of reach of target-based drug discovery approaches. The Cellarity platform uncovers novel actionable biology and creates non-intuitive drug candidates to address a vast array of diseases, even those with either limited or unknown targets. These new leadership appointments will allow Cellarity to accelerate development of its platform and progress its pipeline programs towards the clinic. “John, Cameron, and Anjali have well recognized expertise in their respective areas and bring new important capabilities to Cellarity at a time when we are progressing towards our first drug candidates,” said Fabrice Chouraqui, Pharm.D., CEO of Cellarity and a CEO-Partner at Flagship Pioneering. “Their appointments are a great complement to the already well experienced senior leadership team which includes Parul Doshi, recently promoted to Chief Data Officer. I look forward to working with this expanded leadership team to significantly improve how the industry discovers drugs and creates medicines that matter for patients.” John Leaman, M.D., M.B.A., CFO Dr. Leaman has extensive financing, licensing, and merger and acquisition (M&A) experience. He has served as CFO & CBO for Impel Pharmaceuticals (NASDAQ: IMPL), CFO and Head of Corporate Development for Selecta Biosciences (NASDAQ: SELB), and CFO of Medgenics Inc. (NASDAQ: MDGN). As Head of Corporate Development at InfaCare Pharmaceutical Corp., Dr. Leaman guided the acquisition of the company by Mallinckrodt plc. Earlier in his career, he held senior roles at Shire Pharmaceuticals and Devon Park Bioventures. Dr. Leaman began his career serving a range of life science companies as an Associate Principal at McKinsey & Company. He holds a B.A. from the University of Oxford in the UK, an M.D. degree from the University of Pennsylvania, and an M.B.A. from The Wharton School. Cameron Trenor, M.D., Vice President and Head of Translational Medicine Dr. Trenor has 15 years of combined clinical and drug development experience, bringing deep expertise in hematology drug development and experience in due diligence and disease strategy. Prior to joining Cellarity, he was previously Executive Medical Director in Clinical Development at Forma Therapeutics (acquired by Novo Nordisk) where he led their flagship sickle cell disease program. Previously, Dr. Trenor worked at Novartis as the medical lead for their early phase hematology pipeline. Dr. Trenor is a board-certified pediatric hematologist/oncologist and maintains a weekly half-day clinic at the Boston Children’s Hospital. He holds an M.D. degree from the University of Tennessee and an MMSc from Harvard Medical School. Anjali Kumar, Ph.D., Head of Business Development Prior to Cellarity, Dr. Kumar led External Innovation Search & Evaluation in East North America for therapeutics and platform technologies at Johnson & Johnson Innovation. Through strategic sourcing and transactions, she developed an external early-stage innovation pipeline aligned with the strategies of Johnson & Johnson’s pharmaceutical businesses. Prior to this, she was Due Diligence Lead in Corporate Development at Shire Pharmaceuticals, where she led large cross-functional due diligence teams performing integrated assessments for incoming M&A and in-licensing opportunities. Previously, Dr. Kumar spent 20 years in R&D at large and small companies, including The Upjohn Company, Genetics Institute/Wyeth, Critical Therapeutics, Clinquest Inc., and Flexion Therapeutics, where she held roles with increasing responsibilities in drug discovery and development, advancing programs from early discovery to regulatory approval. Dr. Kumar holds a Ph.D. in bioengineering from Georgia Tech, Atlanta, GA, and a bachelor’s in chemical engineering from the Indian Institute of Technology, Roorkee, India. Parul Doshi, M.B.A., Chief Data Officer Since her appointment in December 2021 as Senior Vice President, Data and Software Engineering, Parul Doshi has significantly contributed to the development of Cellarity and led the implementation of an efficient and a scalable data infrastructure to support Cellarity’s unique approach to drug creation. The company is pleased to announce her promotion to Chief Data Officer where she will continue to use her expertise to build a proprietary, integrated data and software application that bridges research and data science, adding to our unique ability to generate novel insights for drug creation. About Cellarity Cellarity is fundamentally redesigning the way drugs are created. By shifting the focus from a single target to the underlying cellular dysfunction, the company unravels the complexity of disease biology to create medicines that are out of reach with the target-based drug discovery approach. Founded by Flagship Pioneering in 2017, Cellarity has developed a platform that utilizes proprietary AI models trained on over 500 billion genomics data points to uncover novel actionable biology and create non-intuitive drug candidates in a vast array of diseases. The company currently has programs ongoing in several disease areas including those in metabolic disease, hematology, and immuno-oncology. For more info, visit . About Flagship Pioneering Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $100 billion in aggregate value. To date, Flagship has deployed over $3.3 billion in capital toward the founding and growth of its pioneering companies alongside more than $20 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 43 transformative companies, including Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Foghorn Therapeutics (NASDAQ: FHTX), Indigo Agriculture, Moderna (NASDAQ: MRNA), Omega Therapeutics (NASDAQ: OMGA), Sana Biotechnology (NASDAQ: SANA), and Seres Therapeutics (NASDAQ: MCRB).

Craig Collard Appointed CEO Adam Morgan Named Chairman of the Board SAN DIEGO, April 3, 2023 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, today announced the appointment of Craig Collard as Chief Executive Officer (CEO), effective today. Mr. Collard succeeds Barry Quart, Pharm.D., who has stepped down as CEO and Chairman of the Board. In addition, as part of the leadership change, the Board elected Adam Morgan as Chairman. Mr. Collard brings more than three decades of experience leading innovative pharmaceutical companies through periods of strategic change to deliver growth and enhanced value for stockholders. Most recently, as CEO of Veloxis Pharmaceutics A/S before its acquisition by Asahi Kasei Corp. "I am excited to be leading the Heron team," said Craig Collard. "Heron has exciting franchises in acute care and supportive oncology care. I am confident that we can continue delivering value to our patients, customers, employees, and stockholders as we transition to a commercially focused entity. I look forward to working closely with the Board and the Heron team to optimize and advance the Company into its next phase of growth." Lead Independent Director Craig Johnson commented, "On behalf of the entire company, I want to thank Barry for his many years of dedicated service. Barry is a world-class drug developer and has brought us to this important inflection point in the company's lifecycle." Barry Quart commented, "I am incredibly proud of the Heron team; few small biotechnology companies have developed and commercialized four FDA-approved products. It is the right time to move on as the company focuses on commercialization activities. I look forward to working with Craig to ensure a seamless transition in leadership." As part of the board of directors' commitment to strong corporate governance, the roles of Chairman and CEO will now be separate. Also with today's announcement, the size of the board will be reduced to seven members. About Craig Collard Mr. Collard most recently served as the Chief Executive Officer of Veloxis Pharmaceutics A/S (now Veloxis Pharmaceuticals Inc., "Veloxis") before it was acquired by Asahi Kasei Corp, a transplant-focused pharmaceutical company with its principal office in Cary, North Carolina, from 2015 to December 2021, and remains on the Veloxis board of advisors. Prior to joining Veloxis, Mr. Collard served as the Chief Executive Officer and the Chairman of the Board of Directors of Cornerstone Therapeutics, Inc., a pharmaceutical company ("Cornerstone"), from 2011 until it was acquired by Chiesi Farmaceutici S.p.A. in 2014. Mr. Collard also served as Cornerstone's Interim Chief Financial Officer, from 2010 to 2011, and as its President, from 2008 to 2011. Mr. Collard served as the Founder, President and Chief Executive Officer of Cornerstone BioPharma Inc. (formerly Cornerstone BioPharma Holdings, Ltd.), a pharmaceutical company, and as a member of its board of directors, from 2004 to 2008. Prior to that, Mr. Collard served as President and Chief Executive Officer of Carolina Pharmaceuticals, Inc., a specialty pharmaceutical company that he founded in 2003. Mr. Collard currently serves on the board of directors of TerrAscend Corp., a North American cannabis operator based in Mississauga, Canada, since December 2018. Mr. Collard previously served as a member of the board of directors of Sierra Oncology, Inc., a San Mateo, California-based late-stage biopharmaceutical company acquired by GlaxoSmithKline plc, from May 2020 to July 2022. He also served as Chairman of Opiant Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapies to treat substance and use disorders and drug overdose since October 2018 until being acquired by Indivior on March 1, 2023. Mr. Collard holds a B.S. in Engineering from the Southern College of Technology (now Southern Polytechnic State University). About Adam Morgan Mr. Morgan currently serves as the Chief Investment Officer of Velan Capital Investment Management LP, a healthcare-dedicated investment firm based in Alpharetta, Georgia. Mr. Morgan also currently serves on the board of directors of Alimera Sciences, Inc., where he serves as a director and member of the company's Compensation Committee, and Health Outlook Corporation, a privately-held developer of predictive healthcare technology and service based in New York, New York, where he serves as a director and chair of the company's audit committee. Previously, Mr. Morgan served as Senior Analyst at Broadfin Capital, LLC, a healthcare dedicated investment firm based in New York, New York, where he covered the Biotech and Pharmaceutical sectors, from February 2018 to June 2020. Prior to that, Mr. Morgan served as Senior Analyst at Iguana Healthcare Partners LLC, a healthcare-dedicated investment firm based in New York, New York, where he covered Medical Devices and Specialty Pharmaceuticals, from 2015 to January 2018. Mr. Morgan also served as an Analyst at Pura Vida Investments, LLC, a healthcare-focused investment firm, where he covered global Medical Devices, from 2014 to 2015. Earlier in his career, Mr. Morgan served as a Research Associate at Cowen and Company (a subsidiary of Cowen Inc.), a financial services company, on the firm's Medical Supplies and Devices team, from January 2014 to June 2014. Mr. Morgan received his B.S. in Chemistry from the University of Minnesota and his MBA from the Carlson School of Management at the University of Minnesota. About Heron Therapeutics Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit . Forward-Looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron 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, and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law. Investor Relations and Media Contact: David Szekeres Executive Vice President, Chief Operating Officer Heron Therapeutics, Inc. [email protected] 858-251-4447 SOURCE Heron Therapeutics, Inc.