Bellicum Pharmaceuticals, Inc.

BRISBANE, Calif., Jan. 17, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the appointments of Habib Dable and Dr. William Grossman to its Board of Directors. “We are excited to welcome Habib and Bill to our Board during this pivotal phase of our growth,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Their deep expertise and leadership in oncology will further strengthen our Board and will be a great asset as we prepare for the potential launch of our first new medicine.” Mr. Dable has nearly 30 years of experience in the healthcare industry and is currently a part-time Venture Partner at RA Capital Management, L.P. He also serves as an Independent Director at Blueprint Medicines, Aerovate Therapeutics and PepGen Inc. Most recently, Mr. Dable was President and Chief Executive Officer of Acceleron Pharma Inc., a biopharmaceutical company targeting leading-edge therapies for patients with serious and rare diseases, until its acquisition by Merck in 2021. Prior to joining Acceleron in 2016, Mr. Dable spent 22 years at Bayer AG where he served as President of U.S. Pharmaceuticals; Executive Vice President, Global Head Specialty Medicine; Vice President, Ophthalmology; Global Launch Team Head, EYLEA®; Global Head, Neurology and Ophthalmology; and Vice President, Regional Head, Hematology and Cardiology. “It’s a privilege to join the Board of Day One at such an important time,” said Habib Dable. “I look forward to partnering with the executive leadership team and the Board as we drive continued progress in the pipeline and prepare for commercial launch.” Dr. Grossman is Senior Vice President, Oncology Clinical Development & Therapeutic Area Head at Gilead Sciences. He currently sits on the Board of Directors for Pionyr Immunotherapeutics and Tizona Therapeutics, Inc., and the Oncology Advisory Board for Bryologyx. Dr. Grossman has extensive experience leading large successful global clinical organizations. Prior to joining Gilead in 2021, he held Chief Medical Officer roles at Arcus Biosciences and Bellicum Pharmaceuticals, Inc., as well as leadership roles at Merck, Baxter, Biothera, AbbVie and Genentech/Roche. He began his career as a practicing hematologist/oncologist and at the Medical College of Wisconsin, he was Founder and Medical Director of the Clinical Immunodiagnostic and Research Laboratory, Professor for Microbiology and Genetics, and Director of the Bone Marrow Transplant Division for the Immunodeficiency Transplant Program. “It has been an honor to dedicate my career to the global Oncology community and help to bring more life to people with cancer,” said William Grossman, M.D., Ph.D. “I share Day One’s bold mission to further transform the treatment landscape through novel targeted therapies for children and families impacted by cancer. I am grateful to join the Day One Board with my colleague Habib, and look forward to contributing to the evolution of the company.” About Day One Biopharmaceuticals Day One Biopharmaceuticals is a clinical-stage biopharmaceutical company that believes when it comes to pediatric cancer, we can do better. We put kids first and are developing targeted therapies that deliver to their needs. Day One was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. The Company’s name was inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan. Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One. Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important emerging cancer treatments. The Company’s lead product candidate, tovorafenib, is an investigational oral, brain-penetrant, highly selective type II RAF kinase inhibitor. The Company’s pipeline also includes pimasertib, an investigational, oral, highly selective small molecule inhibitor of mitogen‐activated protein kinases 1 and 2 (MEK-1/-2). Day One is based in Brisbane, California. For more information, please visit or find the Company on LinkedIn or X. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s plans to develop cancer therapies, expectations from current clinical trials, the execution of the Phase 2 and Phase 3 clinical trial for tovorafenib as designed, any expectations about safety, efficacy, timing and ability to complete clinical trials, release data results and to obtain regulatory approvals for tovorafenib and other candidates in development, and the ability of tovorafenib to treat pLGG or related indications. Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Day One’s ability to develop, obtain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, rising interest rates, instability in the global banking system, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law. DAY ONE MEDIA Laura Cooper, Head of Communications media@dayonebio.com DAY ONE INVESTORS LifeSci Advisors, PJ Kelleher pkelleher@lifesciadvisors.com

DURHAM, N.C., Jan. 08, 2024 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK; NHWK), an integrated contract development and manufacturing organization (CDMO), today announced that it is changing the name of the Company to Scorpius Holdings, Inc. (“Scorpius”) to better reflect the Company’s successful shift into a pure-play, large molecule biomanufacturing CDMO. The Company will continue to operate its CDMO within the Scorpius BioManufacturing subsidiary. In connection with the name change, the Company’s ticker will change to SCPX as well. The name and symbol changes will not affect the Company's share structure or the rights of the Company's shareholders, and no further action will be required by existing shareholders. In addition, the Company announced that it has bolstered its leadership team with the promotions of Brian O’Mara to VP of Process Sciences and Steve Lavezoli to VP of Commercial Operations, as well as the additions of Juan Lagos as Senior Director of Cell-Based Technologies and Ania Szymanska as Site Head of Quality. Jeff Wolf, CEO of Nighthawk, commented, “Our rebranding to Scorpius Holdings is a testament to our successful transition and the growth of our CDMO operations. The industry faces a critical shortage of clinical-scale biologic manufacturing capacity, driven by increasing demand for large molecule CDMO services. Our state-of-the-art facility in San Antonio, Texas ideally positions us to address this gap in CDMO manufacturing capacity and services. The response from major biotech companies and leading research institutions to our CDMO capabilities has been positive, as evidenced by the expansion of our sales pipeline." Mr. Wolf further noted, “To better service increasing demand for our specialized CDMO services, we have expanded our team with key hires to support our growing client base. Each of these team members brings extensive industry experience and will help ensure that we continue to provide our clients with exceptional service. Given the investments in both our facility and operations, we now have significant capacity to scale our operations, which we expect will generate high incremental margins and attractive returns for our shareholders in the years ahead." Senior Promotions and Appointments Brian O’Mara - VP of Process Sciences. Mr. O’Mara joined Scorpius in June 2022 as the Senior Director, Manufacturing Science & Technology. He has more than 20 years of industrial biotechnology experience in downstream process development of early- and late-stage protein therapeutics from mammalian and microbial expression systems. He also has extensive experience in the development and scale-up of protein conjugates, including antibody-drug conjugates (ADCs), bi-specifics, and PEGylated molecules, as well as experience in technology transfer, CDMO management, process characterization, preparation and oversight of PPQ campaigns, and associated CMC regulatory filings. Brian earned a BS in Biology from Binghamton University and an MS in Chemistry from Lehigh University. Steve Lavezoli - VP of Commercial Operations. Mr. Lavezoli joined Scorpius in December 2022 as the Regional VP of Business Development for the central region. He now oversees Scorpius’ business development, proposals, and marketing strategy. He brings extensive experience in various roles throughout business development and marketing. He spent 12 years in the industrial gasses industry with Linde Gas, as well as W.L. Gore in their Startup Biopharmaceutical division working on a Commercial Business/Market Development role for Bulk Drug Substance Single-Use items. He also spent 3 years with Catalent Biologics, focused on Drug Substance Business Development in the US for early-stage clinical programs with clients to bring life-changing therapies to the market. Steve holds a BS in Chemical Engineering from Pennsylvania State University and an MBA in Marketing from Robert Morris University. Juan Lagos - Senior Director of Cell-Based Technologies. Mr. Lagos brings more than 20 years of experience in cell culture and upstream process development from lab bench to cGMP manufacturing and leads Scorpius’ cell-based technologies team, which is responsible for analytical and cell therapy processes. Before joining Scorpius, he was the Associate Director MS&T / LVV Suspension Process Development at Rocket Pharmaceuticals. His industry experience includes director-level and senior engineering roles at Allakos and Bristol Myers Squibb, as well as experience at biopharma service providers like WuXi Apptec and Patheon. He holds a dual B.S. in Computer Science and Chemical Engineering from Rutgers University, where he continues to pursue a Ph.D. in Biochemical Engineering. Ania Szymanska - Site Head of Quality. Ms. Szymanska brings over 19 years of leadership and management experience in Quality Control, Quality Assurance, and Compliance at pharmaceutical and biotech companies. She joined Scorpius from Marker Therapeutics, Inc. where she was Vice President of Quality and built the Quality Management Systems. She played a critical role in the design, construction, and qualification of their state-of-the-art cell therapy GMP manufacturing facility and Quality Control laboratories. Prior to Marker, she served as Director of Quality Control for Bellicum Pharmaceuticals, Inc. where she developed its Quality Control department and was responsible for aseptic facility qualification. She also served as Quality Validation Specialists of Opexa Therapeutics, Inc. and in roles of increasing responsibility at Woodfield Pharmaceutical, LLC (formerly Pernix Manufacturing, LLC), most recently as Director of Microbiology. Ms. Szymanska earned an M.S. in Microbiology from the University of Warsaw. NightHawk Biosciences, Inc. NightHawk Biosciences, through its Scorpius BioManufacturing subsidiary, is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit: or , and also follow us on Twitter. Forward-Looking Statement This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as generating high incremental margins and attractive returns for our shareholders in the years ahead. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to generate, high incremental margins and attractive returns for our shareholders in the years ahead, the Company’s ability to continue to grow revenue, leverage fixed costs and achieve long-term profitability; the Company’s ability to create substantial shareholder value as a pure-play CDMO in an underserved marketplace; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to successfully operate as a CDMO the ability to obtain regulatory approval or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure-play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law. Media and Investor Relations Contact David Waldman +1 919 289 4017 investorrelations@nighthawkbio.com

Alan A. Musso appointed as CFO effective August 7, 2023 CAMBRIDGE, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced the appointment of Alan A. Musso as chief financial officer, effective August 7, 2023. A 30-year veteran in the life sciences industry, Mr. Musso has held numerous financial and operational leadership positions over the course of his career. “We are delighted to welcome Alan to our executive leadership team,” said Alex C. Sapir, president and chief executive officer at Fulcrum Therapeutics. “Alan’s wealth of industry experience and impressive track record will be invaluable as we move into our next phase of growth and continue to advance our mission of delivering transformative therapies. Having known and worked with Alan for many years, I am confident his insights, leadership, and passion to help patients will make him a great addition to our organization." Prior to joining Fulcrum, Alan served for several years as chief financial officer of ReViral, which was acquired by Pfizer in 2022. Previously, he was the chief financial officer and treasurer at Peloton Therapeutics Inc., where he secured a $150 million mezzanine financing and prepared the company for an IPO until the company was acquired by Merck & Co. Alan also served as CFO and treasurer of other biopharmaceutical companies, including Bellicum Pharmaceuticals, Targacept, and Duramed Pharmaceuticals. He spent the early part of his career as a senior internal auditor for Pfizer as well as a certified public accountant (CPA) for KPMG International. Alan received a B.S. in Accounting from Saint Mary’s College of California, and a master's degree from the Thunderbird School of Global Management. He currently serves on the board of directors of Lung Therapeutics, Inc., a private company. “I am thrilled to join Fulcrum at this exciting time in the company’s trajectory,” said Mr. Musso. “As the company builds on progress made in the rare neuromuscular and hematologic disease spaces, I look forward to leveraging my experience to help bring critical new medicines to patients.” About Fulcrum Therapeutics Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s two lead programs in clinical development are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy (FSHD), and FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease (SCD) and other hemoglobinopathies, which is currently under a full clinical hold issued by the U.S. Food and Drug Administration. The company’s proprietary product engine, FulcrumSeek™, identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression. For more information, visit and follow us on Twitter @FulcrumTx and LinkedIn. About FTX-6058 FTX-6058 is an investigational oral small-molecule inhibitor of Embryonic Ectoderm Development (EED) that was discovered using FulcrumSeek™, Fulcrum’s proprietary discovery engine. Inhibition of EED leads to potent downregulation of key fetal globin repressors, including BCL11A, thereby causing an increase in fetal hemoglobin (HbF). FTX-6058 is being developed for the treatment of sickle cell disease (SCD) and other hemoglobinopathies. Initial data in SCD demonstrated proof-of-concept and achieved absolute levels of HbF increases associated with potential overall patient benefit. Through the March 2023 data cutoff date, FTX-6058 has been generally well-tolerated in people with SCD with up to three months of exposure, with no serious treatment-emergent adverse events reported. FTX-6058 has been granted U.S. Food and Drug Administration (FDA) Fast Track designation and Orphan Drug Designation for the treatment of SCD. FTX-6058 is currently under a full clinical hold issued by the FDA. About Sickle Cell Disease Sickle cell disease (SCD) is a genetic disorder of the red blood cells caused by a mutation in the HBB gene. This gene encodes a protein that is a key component of hemoglobin, a protein complex whose function is to transport oxygen in the body. The result of the mutation is less efficient oxygen transport and the formation of red blood cells that have a sickle shape. These sickle shaped cells are much less flexible than healthy cells and can block blood vessels or rupture cells. People with SCD typically suffer from serious clinical consequences, which may include anemia, pain, infections, stroke, heart disease, pulmonary hypertension, kidney failure, liver disease, and reduced life expectancy. About Losmapimod Losmapimod is a selective p38α/β mitogen activated protein kinase (MAPK) inhibitor. Fulcrum exclusively in-licensed losmapimod from GSK following Fulcrum’s discovery of the role of p38α/β inhibitors in the reduction of DUX4 expression and an extensive review of known compounds. Results reported from the Phase 2b ReDUX4 trial demonstrated slowed disease progression and improved function, including positive impacts on upper extremity strength and functional measures supporting losmapimod’s potential to be a transformative therapy for the treatment of FSHD. Although losmapimod had never previously been explored in muscular dystrophies, it had been evaluated in more than 3,600 subjects in clinical trials across multiple other indications, with no safety signals attributed to losmapimod. Losmapimod has been granted U.S. Food and Drug Administration (FDA) Fast Track designation and Orphan Drug Designation for the treatment of FSHD. Losmapimod is currently being evaluated in a Phase 3 multi-center randomized, double-blind, placebo-controlled, 48-week parallel-group study in people with FSHD (NCT05397470). About FSHD FSHD is a serious, rare, progressive and debilitating disease for which there are no approved treatments. It is characterized by fat infiltration of skeletal muscle leading to muscular atrophy involving primarily the face, scapula and shoulders, upper arms, and abdomen. Impact on patients includes relentless and accumulating muscle and functional loss impacting their ability to perform activities of daily living, loss of upper limb function, loss of mobility and independence and chronic pain. FSHD is one of the most common forms of muscular dystrophy and has an estimated patient population of 16,000 to 38,000 in the United States alone. Contact: Investors: Chris Calabrese LifeSci Advisors, LLC ccalabrese@lifesciadvisors.com 917-680-5608 Media: Dee Smith Executive Director, Corporate Communications Fulcrum Therapeutics, Inc. dsmith@fulcrumtx.com 202-746-1324