Odonate, Inc.

Combination of Assertio’s Omni-Channel Digital Sales Capabilities and ROLVEDON In-Person Commercial Team to Enhance Market Access and Growth Across All Products Transaction Expected to be Significantly Accretive to Assertio in 2024 LAKE FOREST, Ill., July 31, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, today announced that it has closed the proposed acquisition of Spectrum Pharmaceuticals, Inc. (“Spectrum”) (Nasdaq: SPPI), a biopharmaceutical company focused on novel and targeted oncology. Assertio intends to provide updated guidance for the combined business as part of its second quarter results call on August 3. “We are pleased to close the acquisition of Spectrum and its ROLVEDON® (eflapegrastim-xnst) Injection asset, as well as bring onboard an incredible commercial team with proven successful results,” said Dan Peisert, President and Chief Executive Officer of Assertio. “We believe this combination will expand and diversify Assertio’s revenue base, complement our digital non-personal marketing capabilities and enhance our IP portfolio as we continue to scale our platform and its capabilities. We look forward to building on the successful early results in the ROLVEDON® (eflapegrastim-xnst) Injection launch for the remainder of 2023, driving the business toward our goal of accretive contribution to our Adjusted EPS and operating cash flow in 2024.” As part of the closing, Assertio also announced the appointment of Jeffrey Vacirca, MD, FACP, to its Board of Directors. Vacirca qualifies as an independent director under Nasdaq rules. Jeffrey Vacirca, MD, FACP, is a renowned cancer physician and visionary leader with extensive experience and commitment to community oncology. Dr. Vacirca assumed the role of CEO and Chairman of the Board of New York Cancer & Blood Specialists (NYCBS) in 2008. After two years, the practice emerged as a stronger unified group of physicians dedicated to reinventing themselves as the premier cancer care deliverers of New York. He has led NYCBS through an unparalleled period of transformation and incredible growth to become the leading oncology practice that now sees nearly a million patients a year throughout more than 30 oncology locations and 35 hospital affiliations. Dr. Vacirca takes action against key billings, including abuse of pharmacy benefit managers (PBMs) and sequester cuts. He formed the Conquering Cancer PAC, which advocates for cancer patients and strives to ensure access and availability for all patients no matter where they live. He also serves on the board of directors of Annexus Health, Spectrum Pharmaceuticals, OneOncology, and the American Red Cross of Greater New York. Most of his roles in these remarkable companies focus on legislative advocacy for the cost of cancer care and access. Dr. Vacirca is the immediate past president of the Community Oncology Alliance (COA) and continues to be a member of their executive committee. He serves on the board of Scientific Advisory for Caris Life Sciences, and is president and co-founder of the National Translational Research Group. He has also been part of early funding for remarkable companies, including Cedar, Thyme Care, and Sherpa Health. Dr. Vacirca co-founded Odonate Therapeutics in 2016. Dr. Vacirca is the founder and Chairman of the Board of Directors of the New York Cancer Foundation, which provides financial assistance to patients undergoing treatment for cancer. In addition, Dr. Vacirca is the Medical Director of Oncology Network Development at Mount Sinai Health Network and Lab Director for the Long Island Association for AIDS Care (LIAAC). Dr. Vacirca was honored as Humanitarian of the Year by the American Red Cross and received its Corporate Leadership Award on behalf of NYCBS. He was awarded the Red Door Award for Leadership and Cancer Advocacy by the Red Door Community and received the Founders Medalist by The Brooklyn Hospital. Dr. Vacirca also received the Theodore Roosevelt Award for outstanding dedication to patient care and was named Newsday's Top Doctor. He was also honored for his role in enabling the Long Island Association for AIDS Care staff to bring state-of-the-art HIV testing to New York. About Assertio Assertio is a specialty pharmaceutical company offering differentiated products to patients utilizing a non-personal promotional model. We have built and continue to build our commercial portfolio by identifying new opportunities within our existing products as well as acquisitions or licensing of additional approved products. To learn more about Assertio, visit www.assertiotx.com. Assertio Forward Looking Statements Statements in this communication that are not historical facts are forward-looking statements that reflect Assertio's current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, the preliminary, unaudited financial results included in this press release, future events or the future performance or operations of Assertio, including our ability to realize the benefits from our operating model, successfully acquire and integrate new assets and explore new business development initiatives. All statements other than historical facts may be forward-looking statements and can be identified by words such as "anticipate," "believe," "could," "design," "estimate," "expect," "forecast," "goal," "guidance," "imply," "intend," "may", "objective," "opportunity," "outlook," "plan," "position," "potential," "predict," "project," "prospective," "pursue," "seek," "should," "strategy," "target," "would," "will," "aim" or other similar expressions that convey the uncertainty of future events or outcomes and are used to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the control of Assertio, including the risks described in Assertio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the U.S. Securities and Exchange Commission ("SEC") and in other filings Assertio makes with the SEC from time to time. Investors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak only as of this date. While Assertio may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by applicable law. Assertio Investor Contact Matt KrepsDarrow AssociatesM: 214-597-8200mkreps@darrowir.com

Nov. 17, 2021 12:45 UTC NEW YORK--(BUSINESS WIRE)-- Odonate Therapeutics, Inc. (NASDAQ: ODT) today announced that it will commence a share repurchase plan for up to 20 million shares in order to return capital to stockholders. This action is in connection with the Company’s previously announced decision to discontinue the development of tesetaxel. Repurchases may be made from time to time at the Company’s discretion. The plan has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases. As of September 30, 2021, as reported in its recently filed Form 10-Q, the Company had total stockholders’ equity of $71.4 million, or $1.85 per share, based on 38.5 million shares outstanding.

MINNEAPOLIS, MN / ACCESSWIRE / June 9, 2021 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, today announced the addition of two new senior executives to its clinical drug development and operations team. Igor Gorbatchevsky, MD, joined Celcuity as VP of Clinical Development and Jill Krause joined as VP of Clinical Operations. "We are very excited to have Igor and Jill join Celcuity and lead our clinical development and clinical operations teams. Each has very relevant experience at both large pharmaceutical and small biopharma companies," said Celcuity's Chairman and Chief Executive Officer, Brian Sullivan. "Igor has over two decades of hands-on oncology drug development experience, including successful regulatory IND and NDA/BLA filings across several drug classes. Jill brings deep clinical operations expertise, including over nine years of experience managing and executing trials in breast cancer." Prior to joining Celcuity, Dr. Gorbatchevsky worked for MEI Pharma (MEI), an oncology focused biopharmaceutical company, where he was the VP of Clinical Development. MEI's pipeline included zandelisib, an oral PI3K-delta inhibitor. He had previously served as the VP of Clinical Science at Iovance Biotherapeutics, as a Global Clinical Leader at Bayer Pharmaceuticals, and as a Senior Medical Director at Daiichi-Sankyo a global pharmaceutical company. At Bayer, his responsibilities included leadership of the Global Clinical Development Team for ALIQOPA (copanlisib), a pan-PI3K inhibitor approved by the FDA for treatment of patients with follicular lymphoma. Dr. Gorbatchevsky commented, "Gedatolisib is well positioned to become a first-in-class PI3K/mTOR inhibitor. It uniquely combines low nanomolar potency against all Class I PI3K isoforms and mTOR with a compelling pharmacokinetic profile. The clinical safety data obtained so far suggests gedatolisib is much better tolerated compared to other targeted agents in this class. The opportunity to develop gedatolisib for patients with ER+/HER2-negative metastatic breast cancer and other tumor types is very exciting." Prior to joining Celcuity, Ms. Krause worked for Odonate Therapeutics, a developer of an oral chemotherapy to treat breast cancer, where she served as VP of Clinical Operations Quality as well as VP of Study Management and Medical Affairs. She also served in a variety of different clinical operations roles at Pfizer for over 10 years and led clinical operations teams at several clinical research organizations. Ms. Krause commented, "I am excited to join Celcuity and continue my work managing breast cancer clinical trials and supporting the clinical development of gedatolisib." About Gedatolisib Gedatolisib is a potent, reversible dual inhibitor that selectively targets PI3K and mTOR. Gedatolisib was originally developed by Wyeth and clinical development was continued by Pfizer after it acquired Wyeth. Celcuity licensed exclusive global rights to gedatolisib from Pfizer in April 2021. An on-going Phase 1b trial evaluating patients with ER+/HER2- metastatic breast cancer was initiated in 2016 and subsequently enrolled 138 patients. Patient enrollment for the four expansion arms of the trial is complete. Based on the favorable preliminary results reported to date from the Phase 1b trial, Celcuity intends to initiate, subject to feedback from the FDA, a Phase 3 clinical trial evaluating gedatolisib in combination with palbociclib and an endocrine therapy in patients with ER+/HER2- advanced or metastatic breast cancer in the first half of 2022. About Celcuity Celcuity is a clinical-stage biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated companion diagnostic and therapeutic strategy. Our CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from targeted therapies. This enables a CELsignia CDx to support advancement of new indications for already approved targeted therapies. Our therapeutic efforts are focused on in-licensing and developing molecularly targeted therapies that address the same cancer driver our companion diagnostics can identify. By pursuing an integrated companion diagnostic and therapeutic strategy, we believe we are uniquely positioned to achieve our goal of helping cancer patients receive the therapeutic best suited to treat their cancer driver. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at . Forward-Looking Statements This press release contains statements that constitute "forward-looking statements." In some cases, you can identify forward-looking statements by terminology such as "may," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends" or "continue," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward looking statements in this press release include, without limitation, expectations with respect the results from the B2151009 Phase 1b clinical trial, the timing of launching a Phase 2/3 clinical trial, the expected benefits of gedatolisib, the expected impact of the growth of Celcuity's management team, and other statements regarding the future of Celcuity's business and results of operations. . Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Celcuity, which include, but are not limited to, the unknown impact of the COVID-19 pandemic on Celcuity's business and those other risks set forth in the Risk Factors section in Celcuity's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on February 16, 2021 and in Exhibit 99.4 to Celcuity's Current Report on Form 8-K filed with the Securities and Exchange Commission on April 8, 2021. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law. Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com 763-392-0123 Westwicke ICR Robert Uhl, robert.uhl@westwicke.com (619) 228-5886 SOURCE: Celcuity Inc. View source version on accesswire.com: