Bayer Healthcare Co., Ltd.

WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer today announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will work with the FDA on a voluntary withdrawal of the Aliqopa® (copanlisib) U.S. New Drug Application for adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. Aliqopa® was granted accelerated approval by the FDA in September 2017 based on CHRONOS-1, an open-label, single-arm Phase II study. The FDA required clinical benefit to be confirmed through the CHRONOS-4 study. In the study, the addition of Aliqopa® to standard immunochemotherapy regimens did not meet the primary endpoint of progression-free survival benefit versus the standard immunochemotherapy control arm in patients with relapsed follicular lymphoma. Bayer intends to publish the results of CHRONOS-4 in a timely manner. Bayer is exploring access options for patients currently receiving Aliqopa® who have experienced a favorable response to treatment, whose treating physician supports continuing treatment with Aliqopa®, and for whom there may be no suitable alternative treatments available. Patients currently being treated with Aliqopa® should consult their healthcare provider. No new patients should be prescribed Aliqopa®. For questions related to ongoing access, please contact Bayer Medical Communications at 1-888-84-Bayer. About non-Hodgkin’s lymphoma Non-Hodgkin’s Lymphoma (NHL) comprises a highly heterogeneous group of chronic diseases with poor prognosis. NHL is the most common hematologic malignancy and the tenth most common cancer worldwide. About Copanlisib (Aliqopa®) Copanlisib is currently approved in the U.S., China and Taiwan as a monotherapy under the brand name Aliqopa® for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to . © 2023 Bayer BAYER, the Bayer Cross and Aliqopa are registered trademarks of Bayer. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

On-track to present additional data from Phase 2 APEX trial by the end of 2022 Initial data from Phase 2 SUMMIT trial & lead-in data from Phase 3 PEAK trial planned for 1H23 Ended 2Q 2022 with $325.6 million, including $172.6 million in gross proceeds from June 2022 public offering, sufficient to fund operations into 2025 CAMBRIDGE, Mass. and BOULDER, Colo., Aug. 09, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the second quarter ended June 30, 2022. “In the second quarter we achieved a number of important milestones as we continued to advance bezuclastinib and grow the research and development pipeline,” said Andrew Robbins, President and CEO of Cogent Biosciences. “Most notably, we reported positive initial clinical data from our APEX trial that strengthened our belief in bezuclastinib’s potential to provide meaningful clinical activity for systemic mastocytosis patients, without the tolerability challenges seen with other available treatment options. We remain on track to provide another clinical update from this trial by the end of 2022. We are equally excited about the opportunity with bezuclastinib in non-advanced systemic mastocytosis and gastrointestinal stromal tumor (GIST) patients and expect to provide clinical data updates on these programs during the first half of 2023. Based on the positive APEX data, we were able to secure additional financing at the end of the quarter, and we are confident this will support our go forward strategy into 2025.” Recent Business Highlights In June 2022, Cogent reported positive initial data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor, bezuclastinib, in patients with advanced systemic mastocytosis (AdvSM). As of the data cutoff date, May 24, 2022, all 11 patients treated were evaluated for signs of clinical activity. Bezuclastinib demonstrated rapid reductions in serum tryptase, with all patients achieving a ≥50% reduction (10/11 achieved within the first week of treatment) and 6/11 achieving serum tryptase <20ng/mL. All patients remained on treatment with treatment duration ranging from 0.5 - 4.8 months. Bezuclastinib was generally well-tolerated at all doses with no reported periorbital or peripheral edema, cognitive effects or intracranial bleeding events. In April 2022, the Company presented early data and outlined its strategy to create best-in-class small molecules from the company’s growing pipeline of novel, targeted therapy programs at the American Association of Cancer Research (AACR) annual meeting and company sponsored R&D investor event. Announced plans to advance a potent, selective FGFR2 inhibitor toward candidate selection with a product profile that includes best-in-class selectivity against all known FGFR2 primary driver and secondary resistance mutations.Announced development of an ErbB2 mutant selective inhibitor for patients with mutations that are not well addressed by therapies currently approved or in clinical development. Appointed Fang Fang, Ph.D., Vice President, Biometrics in Development Operations. Dr. Fang joins Cogent with over 20 years of industry experience and leadership in oncology biometrics and biostatistics. Prior to joining, she was Vice President, Biometrics at Kiniksa Pharmaceuticals. Earlier in her career, Dr. Fang held roles of increasing responsibility at Merrimack Pharmaceuticals, Bayer Healthcare, Eisai Medical Research and Astellas Pharma. Dr. Fang received her Ph.D. in Biostatistics from Rutgers University. Upcoming Milestones Present additional data from APEX, a global, multicenter Phase 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) by the end of 2022.Present initial data from SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial with bezuclastinib for nonadvanced systemic mastocytosis (NonAdvSM) in the first half of 2023.Present lead-in data from PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with gastrointestinal stromal tumors (GIST), in the first half of 2023.File first internally developed Investigational New Drug application (IND) from Cogent’s potent, selective FGFR2 inhibitor program in the second half of 2023. Second Quarter 2022 Financial Results Cash Position: As of June 30, 2022, cash and cash equivalents were $325.6 million, as compared to $191.0 million as of March 31, 2022. The company believes that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2025. R&D Expenses: Research and development expenses were $29.5 million for the second quarter of 2022 as compared to $12.4 million for the second quarter of 2021. The increase was primarily due to costs associated with the on-going APEX, SUMMIT and PEAK clinical trials and costs related to expanding the Cogent Research Team, which was formed in the second quarter of 2021. R&D expenses include non-cash stock compensation expense of $2.1 million for the second quarter of 2022 compared to $1.0 million for the second quarter of 2021. G&A Expenses: General and administrative expenses were $6.4 million for the second quarter of 2022 as compared to $4.9 million for the second quarter of 2021. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $2.4 million for the second quarter of 2021 compared to $1.6 million for the second quarter of 2021. Net Loss: Net loss was $34.9 million for the second quarter of 2022 as compared to a net loss of $16.5 million for the same period of 2021. About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting FGFR2 and ErbB2. Cogent Biosciences is based in Cambridge, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: Twitter and LinkedIn. Information that may be important to investors will be routinely posted on our website and Twitter. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding plans to present additional data from APEX by the end of 2022, plans to present initial data from SUMMIT and lead-in data from PEAK in the first half of 2023, the company’s anticipated cash runway, bezuclastinib’s potential to provide meaningful clinical activity for systemic mastocytosis patients without the tolerability challenges seen with other available treatment options, and plans to file an IND for a selective FGFR2 inhibitor in the second half of 2023. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Cogent’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof. COGENT BIOSCIENCES, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Operating expenses: Research and development 29,479 12,388 54,949 20,601 General and administrative 6,376 4,904 12,324 9,491 Total operating expenses 35,855 17,292 67,273 30,092 Loss from operations (35,855) (17,292) (67,273) (30,092) Other income: Interest income 272 120 379 245 Other income 656 623 1,333 1,227 Change in fair value of CVR liability — — — 343 Total other income 928 743 1,712 1,815 Net loss and comprehensive loss $(34,927) $(16,549) $(65,561) $(28,277) Net loss per share attributable to common stockholders, basic and diluted $(0.71) $(0.43) $(1.39) $(0.77) Weighted average common shares outstanding, basic and diluted 49,388,936 38,441,729 47,259,261 36,670,353 COGENT BIOSCIENCES, INC. SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA (in thousands) (unaudited) June 30, 2022 December 31, 2021 Cash and cash equivalents $325,562 $219,684 Working capital $303,017 $205,556 Total assets $366,052 $232,092 Total liabilities $46,667 $17,908 Total stockholders’ equity $319,385 $214,184 Contact: Christi WaarichSenior Director, Investor Relationschristi.waarich@cogentbio.com617-830-1653

Bayer announced Tuesday that The U.S. Food and Drug Administration accepted its supplemental New Drug Application (sNDA) for Nubeqa as a potential treatment for metastatic hormone-sensitive prostate cancer. The sNDA allows Bayer to make changes to its product, Nubeqa (darolutamide), which was approved in 2019 to treat non-metastatic castration-resistant prostate cancer. Nubeqa inhibits androgen binding, specifically OATP1B1 and OATP1B3 transporters, AR nuclear translocation and AR-mediated transcription. Bayer is jointly developing the drug with Finnish pharmaceutical firm Orion Corporation. The FDA approved Nubeqa in July 2019 based on positive results from its Phase III ARAMIS study involving 1,509 patients diagnosed with non-metastatic castration-resistant prostate cancer who also had a bilateral orchiectomy or were receiving a concomitant gonadotropin-releasing hormone analog. The primary endpoint to assess efficacy was metastasis-free survival. Prostate cancer is the second most commonly diagnosed cancer in men worldwide, with 1.4 million diagnosed in 2020 and around 375,000 die from the disease. Most patients already have localized prostate cancer at the time of diagnosis, which means it may be curable with radiotherapy or surgery. Upon relapse, the disease becomes hormone-sensitive, thus requiring ADT as the primary mode of treatment. For the sNDA to be accepted, the FDA looked at the results from the investigational Phase III ARASENS trial, which is published in The New England Journal of Medicine. Scientists evaluated Nubeqa plus androgen deprivation therapy and chemotherapy docetaxel in 1,306 male patients living with mHSPC and compared results with those who received just ADT plus docetaxel. The participants were given 600 mg of Nubeqa two times a day. "Today’s sNDA acceptance, confirmation of Priority Review and participation in Project Orbis, bring us closer to adding a new indication for NUBEQA in combination with docetaxel to benefit men with mHSPC," commented Christine Roth, head of the oncology SBU at Bayer and a member of the executive committee of the firm's pharmaceutical arm. The sNDA is being conducted under Project Orbis, the FDA Oncology Center of Excellence's initiative, which sets the guidelines for the review and concurrent submission of potential cancer therapies among global health authorities. Bayer also filed applications with the Ministry of Health, Labor and Welfare in Japan, the European Medicines Agency and the Center of Drug Evaluation in China. More submissions for Nubeqa's mHSPC indication will be rolled out in other countries over the next months. Aside from the mentioned indications, Bayer is exploring Nubeqa's efficacy and safety in different stages of prostate cancer. These include the ARANOTE Phase III study on Nubeqa plus ADT versus monotherapy ADT for mHSPC and the Phase III co-operative group DASL-HiCaP trial evaluating the drug as adjuvant treatment for localized prostate cancer with high recurrence risk. The latter study is being performed alongside the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Bayer is flexing its muscles in the oncology space and recently revamped its leadership roster, appointing experts from other major pharmas to join the firm. The company currently has six marketed products in its oncology arm and several other products in clinical development.