Hereditary Leiomyomatosis and Renal Cell Cancer

-- Industry veteran brings more than 30 years of operational experience, in large pharma and emerging stage biotech, private and public companies, with extensive commercial experience and an established track record of financing in the capital markets -- Lerodalcibep, a novel, next generation PCSK9 inhibitor and the Company’s lead program, is expected to complete Phase 3 in 4Q’23; BLA and MAA filings planned in 1H’24 CINCINNATI--(BUSINESS WIRE)-- LIB Therapeutics Inc. (LIB), a late-stage biopharmaceutical company developing subcutaneous and oral PCSK9 inhibitor therapies for patients at very high and high-risk of cardiovascular disease (CVD), today announced that the Board of Directors has appointed David Cory as Chief Executive Officer and a member of the Board of Directors, effective immediately. Evan Stein, MD, PhD, who has served as the CEO since co-founding LIB in 2015, will continue in a full-time operational role as Chief Operating Officer and Chief Scientific Officer. Mr. Cory brings more than 30 years of leadership and operational experience in public and private, large pharma and emerging stage biotechnology companies, with an extensive commercial background spanning launches of global blockbuster products and targeted therapeutics for rare diseases, an established track record in the capital markets with over $1B+ raised and multiple companies which have successfully resulted in acquisition. “We are pleased to welcome David as our new CEO and Board member,” said August Troendle, MD, LIB co-founder and Chairman of the LIB Board. “David’s track record and credibility in transforming private late-stage biopharma into public commercial companies makes him the ideal candidate for LIB and our late-stage lerodalcibep program.” “With development of lerodalcibep close to completion and BLA submission planned for Q1 next year, David’s well-proven operating and commercial experience, combined with his drive and enthusiasm, is optimally suited to lead the company as it transitions to commercialization of lerodalcibep in the U.S, Europe, and rest of world,” said Evan Stein, MD, PhD, LIB co-founder and Board member. David Cory said, "Lerodalcibep has a compelling clinical pro differentiates itself in a growing PCSK9 inhibitor market which will approach $3 billion in 2023 and on target to reach or exceed $5 billion in 2025 when we anticipate approval and launch. I look forward to working with the LIB Board and the LIB operating team to make this exciting new therapy available for patients and healthcare providers in the future.” About David Cory Mr. Cory co-founded and most recently was President, CEO, and Director of Eiger BioPharmaceuticals, a commercial-stage company focused on the development of innovative therapies for serious, orphan diseases, and was responsible for negotiating multiple technology and product licenses, taking the company public, and obtaining the company’s first FDA and EMA product approvals. Previously, Mr. Cory was President and Chief Operating Officer of Prestwick Pharmaceuticals, an orphan CNS specialty pharmaceutical company, which was acquired by Biovail. Earlier, Mr. Cory was a co-founder of CoTherix, an orphan pulmonary arterial hypertension company, which was acquired by Actelion. Mr. Cory began his biotech career with the founding team at InterMune where he was Senior Vice President of Sales and Marketing. InterMune was acquired by Roche for $8 billion. Mr. Cory spent over a decade in large pharma in positions of increasing responsibility at Glaxo Smith Kline and The Upjohn Company. Mr. Cory earned a BS in Pharmacy from the University of Cincinnati, College of Pharmacy, was board certified in Pharmacy in the state of Ohio and holds an MBA from the University of Maryland. About Lerodalcibep Lerodalcibep is a next-generation, PCSK9 inhibitor in development to potentially overcome the limitations of current low-density lipoprotein (LDL-C), or ‘bad’ cholesterol, lowering treatments and reach new national and international guidelines to treat and prevent cardiovascular disease (CVD). The convenient, small injection volume, monthly dosing and long ambient stability combined with excellent and sustained LDL-C efficacy, lerodalcibep, if approved, will increase the treatment options for patients, including the 30 million with more severe inherited high-cholesterol, called familial hypercholesterolemia (FH). LIB Therapeutics expects to submit a biologics license application (BLA) with FDA in Q1 2024 and marketing authorization application (MAA) with EMA in Q2 2024. About Phase 3 LIBerate Program LIBerate is a large, comprehensive global Phase 3 program composed of 5 key studies with lerodalcibep in over 2,500 patients in patients with cardiovascular (CVD), very high and high-risk for CVD, heterozygous familial hypercholesterolemia (He-FH) and homozygous FH (Ho-FH). The Phase 3 studies LIBerate-HoFH (LIB-003-003, n=65) and LIBerate-HeFH (LIB-003-004, n=479) have completed and met their primary endpoints. The final two Phase 3 pivotal trials, LIBerate-CVD (LIB-003-005, n=923) and LIBerate-HR (LIB-003-006, n=923), added to maximally tolerated oral lipid-lowering therapies to assess LDL-lowering in CVD, very high and high-risk for CVD patients are anticipated to complete in early November. About LIB Therapeutics Inc. LIB Therapeutics is a privately held, late-stage biopharmaceutical company dedicated to bringing novel, safe and convenient subcutaneous and oral PCSK9 inhibitors to the millions of patients with cardiovascular disease, and the 30 million with familial hypercholesterolemia (FH), who require additional large reductions in low density lipoprotein-cholesterol (LDL-C) despite maximally tolerated statins and other lipid lowering agents. For more information, please visit: .

SAN DIEGO, Feb. 01, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that it has granted an inducement award to one new employee, Jennifer Neumann, who joined Oncternal as Director, Clinical Data Management. The award was made on February 1, 2023 under Oncternal’s 2021 Employment Inducement Incentive Award Plan, which provides for the granting of equity awards to new employees of Oncternal as an inducement to join the Company. The award consists of an option to purchase 33,300 shares of Oncternal common stock. The option has a 10-year term and an exercise price equal to the closing price of Oncternal’s common stock on the date of grant. The option vests over a four-year period, with 25% of the shares subject to the option vesting on the first anniversary of the employee’s start date, and the rest vesting in equal monthly installments over three years thereafter. The award was approved by Oncternal’s compensation committee, comprised entirely of independent directors, as required by Nasdaq Rule 5635(c)(4), and was granted as an inducement material to the employee entering into employment with Oncternal in accordance with Nasdaq Rule 5635(c)(4). About Oncternal Therapeutics Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer. The lead clinical program is zilovertamab, an investigational monoclonal antibody designed to inhibit the function of Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1). ZILO-301, a global Phase 3 Study to evaluate zilovertamab in combination with ibrutinib for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) has been initiated (NCT05431179). Zilovertamab continues to be evaluated in an ongoing Phase 1/2 study in combination with ibrutinib for the treatment of patients with MCL and chronic lymphocytic leukemia (CLL), and this trial was recently amended to include patients with marginal zone lymphoma (MZL) (NCT03088878). Zilovertamab is also being evaluated in two investigator-initiated studies, including a Phase 2 clinical trial of zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL, and in a Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). Oncternal is also moving into the clinic with ONCT-808, an autologous chimeric antigen receptor T (CAR T) cell therapy that targets ROR1, with an active U.S. IND as of the end of September 2022 for the treatment of patients with relapsed or refractory aggressive B cell lymphoma, including patients who have failed previous CD19 CAR T treatment. The preclinical pipeline also includes ONCT-534, a dual-action androgen receptor inhibitor (DAARI) that is undergoing final IND-enabling studies, as a potential treatment for castration resistant prostate cancer, including those with unmet medical need due to resistance to approved, standard of care androgen receptor inhibitors. More information is available at https://oncternal.com/. Contact Information: InvestorsRichard VincentChief Financial Officer858-434-1113rvincent@oncternal.com MediaCorey Davis, Ph.D.LifeSci Advisors212-915-2577cdavis@lifesciadvisors.com

LOUISVILLE, Ky.--(BUSINESS WIRE)-- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected by Eli Lilly to be a specialty pharmacy partner for JAYPIRCA™ (pirtobrutinib), which is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor (BTKi). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. “Onco360 is excited to announce our partnership with Eli Lilly and become a specialty pharmacy provider for JAYPIRCA patients,” said Benito Fernandez, Chief Commercial Officer, Onco360. “We are committed to supporting the highly specialized needs of patients battling relapsed/refractory mantle cell lymphoma which has failed prior lines of systemic therapy across the United States.” According to the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program, it is estimated that 80,470 new cases of Non-Hodgkin Lymphoma (NHL) will be diagnosed in 2022 in the United States with a corresponding 20,250 deaths in 2022.1 According to the National Comprehensive Cancer Network (NCCN) Guidelines for the Treatment of B-Cell Lymphomas, 3-5% of annual new NHL diagnoses are mantle cell lymphoma (MCL) cases. MCL is thought to possess the unfavorable characteristics of both indolent and aggressive NHL subtypes owing to the incurability of disease with conventional chemotherapy and a typically more aggressive disease course compared to indolent lymphomas. The five-year overall survival (OS) for MCL ranges from 50-70% dependent upon stage of disease.2 JAYPIRCA, a non-covalent BTKi, is commercialized by Eli Lilly. The FDA approval of JAYPIRCA is based on results Phase I/II BRUIN trial (NCT03740529), which was an open-label, single-arm study that, in part, evaluated the efficacy/safety of JAYPIRCA in 120 patients with relapsed/refractory MCL who were previously treated with BTKi therapy. JAYPIRCA administration resulted in a 50% overall response rate (ORR) in the aforementioned patient population. The most common adverse reactions (> 15%) in patients with MCL are fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising.3 About Onco360 Oncology Pharmacy: Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com. References: 1) Non-Hodgkin Lymphoma — Cancer Stat Facts accessed 1/30/23 2) b-cell.pdf (nccn.org) accessed 1/30/23 3) Mantle Cell Lympoma (MCL) Treatment | Jaypirca™ (pirtobrutinib)