Constellation Pharmaceuticals, Inc.

Dr. Scott Braunstein, Chairman and CEO of Marinus Pharma and Operating Partner of Aisling Capital; and Dr. Vincent Miller, global expert in cancer, and clinical trial design and interpretation join ahead of One Biosciences’ pending initiation of drug development activities.PARIS, March 27, 2024 (GLOBE NEWSWIRE) -- One Biosciences, a Home Biosciences biotech company, leveraging the power of single-cell analysis and A.I. to identify a new generation of precision medicine targets and develop new treatments, today announced the appointments of Dr. Scott Braunstein, and Dr. Vincent Miller, to its Board of Directors. David Schilansky, co-founder and CEO of Home Biosciences and Chairman of One Biosciences, commented "It is a rare instance when a biotech company can anchor its board this quickly — in particular, with members of this caliber which speaks volumes of One Biosciences’ efforts to attract the very best talent in order to advance its mission. Scott and Vince join at a crucial time, as One Biosciences prepares to enter the drug development phase.” Hedi Ben Brahim, CEO of One Biosciences, added "One Biosciences is advancing its pipeline across multiple ongoing projects in oncology and rare diseases. Our proprietary discovery engine has identified its first promising targets, and we are preparing to start drug development activities in 2025. Bolstering our Board with such seasoned leaders will be a key factor to success.” Dr. Scott Braunstein brings over 30 years of knowledge and experience gained in the biotechnology, pharmaceutical, and biotech portfolio management industries. Since 2015, Dr. Braunstein has served as an Operating Partner of Aisling Capital. He is also CEO of Marinus Pharmaceuticals since 2019 and Chairman of the Board since November 2022. Previously, he was Chief Operating Officer and Chief Strategy Officer at Pacira Pharmaceuticals. Before Pacira, Dr. Braunstein served as a healthcare portfolio manager at Everpoint Asset Management and spent 13 years with J.P. Morgan Asset Management where he was a healthcare analyst and managing director in the U.S. Equity team, and a portfolio manager of the JP Morgan Global Healthcare Fund. Dr. Braunstein is currently on the board at Trevena and Caribou Biosciences. He previously served on the boards of Constellation Pharmaceuticals (acquired by MorphoSys in July 2021), Ziopharm Oncology, Esperion Therapeutics, and Protara Therapeutics. Dr. Braunstein began his career as a practicing physician at the Summit Medical Group and as an Assistant Clinical Professor at Albert Einstein College of Medicine and Columbia University Medical Center. He earned his medical degree from the Albert Einstein College of Medicine and his B.S. from Cornell University. Dr. Vincent Miller is considered a world-expert in lung cancer and clinical trial design and interpretation. His role in collaborative research was critical to identifying certain EGFR mutations as the molecular basis of sensitivity and resistance to first-generation EGFR TKIs. Among his many accolades, Dr. Miller received the American Cancer Society Clinical Oncology Career Development Award. Dr. Miller has previously served as Physician-in-Chief, EQRx. and prior to that he served as Chief Medical Officer at Foundation Medicine. Before joining Foundation Medicine, Dr. Miller dedicated over 20 years to cancer patient care and research at Memorial Sloan Kettering Cancer Center. He has also served as Chief Medical Resident at Thomas Jefferson University Hospital where he completed his residency and fellowship at Memorial Sloan Kettering Cancer Center. Dr. Miller received his B.A. from the University of Pennsylvania and M.D. from New Jersey Medical School. About One Biosciences One Biosciences leverages the power of single-cell analysis and AI to unlock a new wave of targets and precision medicines for a broad range of difficult-to-treat conditions. One Biosciences is an integrated discovery engine combining a multi-disciplinary team with in-house computational capabilities. One Biosciences is backed by Institut Curie and Home Biosciences. For more information, visit: www.onebiosciences.fr US press for One Biosciences McCargo Mission-Aligned CommunicationsJanine McCargojanine@mmac.me

Novartis is building up its pipeline of cancer therapies with the acquisition of MorphoSys, a company whose lead drug is on track for an FDA submission for the treatment of myelofibrosis. But the €2.7 billion deal could raise scrutiny from antitrust regulators because Novartis already has a stake in another drug commercialized in this blood cancer. After the markets closed on Monday, Novartis announced it is acquiring MorphoSys for €68 per share. While that price is a modest premium to the company’s closing stock price Monday in Germany, shares had risen sharply due to speculation about an acquisition. In addition to regulatory approvals, the acquisition needs the acceptance of at least 65% of MorphoSys’s outstanding shares. The companies expect to close the deal in the first half of this year. The key piece of the acquisition agreement is MorphoSys drug candidate pelabresib. Myelofibrosis, a cancer affecting the bone marrow’s ability to normally produce red blood cells, has several approved treatments from a class of drugs that block cancer-driving JAK proteins. Pelabresib stands apart from these JAK inhibitors as a small molecule designed to inhibit bromodomain and extra-terminal domain (BET) proteins, which can help cancers grow. In Phase 3 results presented in December during the annual meeting of the American Society of Hematology, the MorphoSys drug, in combination with approved Incyte JAK inhibitor Jakafi, met its main goal of reducing spleen volume compared to treatment with Jakafi alone. But on a key secondary goal assessing symptom resolution, the pelabresib and Jakafi arm showed only a numerical improvement compared to Jakafi alone. Still, MorphoSys pointed to its drug’s ability to improve on the four hallmarks of myelofibrosis: enlarged spleen, anemia, bone marrow fibrosis, and disease-associated symptoms. The company said it intended to file for U.S. and European regulatory review of the drug. Novartis reiterated that plan, saying filings are planned for the second half of this year. In a note sent to investors Tuesday, Leerink Partners analyst Andrew Berens wrote that the deal could spark rigorous regulatory scrutiny in the U.S. and Europe. Novartis holds outside-of-the-U.S. rights to Incyte’s Jakafi (Jakavi in the rest of the world). Pelabresib’s therapeutic overlap with Jakavi outside of the U.S. could raise concerns with the European Commission, Berens said. Also, since Novartis receives royalties from Incyte’s U.S. sales of Jakafi, U.S. antitrust regulators might weigh in on the deal. Berens noted that a similar issue arose in Pfizer’s $43 billion Seagen acquisition. To close that acquisition, Pfizer had to divest royalties for bladder cancer drug Bavencio to avoid overlap with Seagen’s Padcev, which is approved in the same indication. Besides the royalties owed to Novartis from Incyte’s U.S. sales of Jakafi, Berens said the Federal Trade Commission could have concerns that Novartis’s interests in the drug outside of the U.S. could affect pelabresib R&D in myelofibrosis. Those interests could impede development of pelabresib, or pela, in myelofibrosis as part of combination with other JAK inhibitors, such as Swedish Orphan Biovitrum’s Vonjo and GSK’s Ojjaara. “This could be perceived as giving Jakafi an unfair competitive advantage,” Berens said. “However, despite these concerns, we think that the companies may be able to find remedies that may include divestiture of the U.S. Jakafi royalty stream by Novartis, as well as developing pela in conjunction with other JAK agents.” The other MorphoSys drug on the way to Novartis is tulminetostat, which is in Phase 1/2 testing for advanced solid tumors or lymphomas. This small molecule blocks two proteins, EZH2 and EZH1. Both tulminetostat and pelabresib came from MorphoSys’s $1.7 billion acquisition of Constellation Pharmaceuticals in 2021. That deal marked a strategy shift for MorphoSys, which for much of its history was a developer of antibody drugs, many of which were out-licensed to partners. MorphoSys’s new path as a small molecule cancer drug developer hasn’t been entirely smooth. In 2022, MorphoSys cut the drug discovery work that came with the Constellation deal. Nearly a year ago, MorphoSys stopped all of its preclinical research to focus on its two clinical-stage cancer drug candidates. Meanwhile, MorphoSys on Monday struck a separate deal to sell to Incyte its remaining rights to tafasitamab, an antibody drug for diffuse large B-cell lymphoma that’s marketed in the U.S. under the name Monjuvi (Minjuvi in the rest of the world). Under a prior agreement, the two companies collaborated on the clinical development and commercialization of the drug in the U.S. while Incyte had rights to the drug outside of the U.S. Under the new agrement, Incyte paid $25 million for the drug’s U.S. rights and will no longer owe milestone payments or royalties. MorphoSys will no longer continue to share in the drug’s profits. This agreement is effective immediately.

Tafasitamab sold to Incyte Novartis to launch a voluntary public takeover offer for all MorphoSys shares at a price of € 68.00 per share in cash Shareholders benefit from attractive premium of 94 percent to the one-month volume weighted average price before January 25, 2024 Novartis provides ample resources to maximize and accelerate pelabresib's potential on a global scale MorphoSys' Management Board and Supervisory Board unanimously support both agreements MorphoSys to host conference call and webcast on Tuesday, February 6, 2024 at 02:00 pm CET (01:00 pm GMT; 08:00 am EST) PLANEGG and MUNICH, GERMANY / ACCESSWIRE / February 5, 2024 / MorphoSys AG (FSE:MOR)(NASDAQ:MOR) today announced the company entered into a Business Combination Agreement with Novartis data42 AG and Novartis AG (hereinafter collectively referred to as "Novartis") based on Novartis' intention to submit a voluntary public takeover offer for all outstanding MorphoSys no-par value bearer shares at an offer price of € 68.00 per share in cash. As part of the Business Combination Agreement with Novartis, Novartis seeks to obtain exclusive, worldwide rights to develop and commercialize pelabresib, an investigational BET inhibitor, and tulmimetostat, an investigational next-generation dual inhibitor of EZH2 and EZH1, across all indications. Separately, MorphoSys entered into a Purchase Agreement to sell and transfer all rights worldwide related to tafasitamab to Incyte Corporation ("Incyte"). Currently, MorphoSys partners with Incyte on the development and commercialization of tafasitamab. MorphoSys' Management Board and Supervisory Board unanimously approved both agreements. "Novartis shares our steadfast commitment to develop and deliver transformative medicines that address the dire needs of cancer patients. Pelabresib - the investigational therapy at the forefront of our promising oncology pipeline - has the potential to shift the treatment paradigm in myelofibrosis and further expand into other indications. Novartis will provide ample resources currently unavailable to MorphoSys as a standalone biotech company to help accelerate the development opportunities and maximize the commercialization potential of pelabresib at a greater speed and scale," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are also pleased that Incyte will assume full responsibility of tafasitamab. Given the proposed acquisition by Novartis and our long-standing partnership with Incyte, we know Incyte is best positioned to drive tafasitamab's future growth opportunities forward successfully and more efficiently on its own at this time. We believe these agreements are in the best interest of MorphoSys, our shareholders and cancer patients." Benefits of Novartis' Public Takeover Offer Provides Attractive, Immediate and Certain Cash Value to MorphoSys' Shareholders: The offer provides MorphoSys' shareholders with an opportunity to realize significant value upfront and with certainty. Novartis intends to offer MorphoSys' shareholders € 68.00 per share in cash, for a total equity value of € 2.7 billion. The offer price corresponds to a premium of 94% and 142% on the volume-weighted average price during the last month and three months, as of the unaffected January 25, 2024 close, respectively - the day before first rumors on a potential takeover surfaced. It also represents a premium of 89% to the unaffected January 25, 2024 closing share price. Maximizes Potential of Pelabresib: In the Phase 3 MANIFEST-2 study, all disease hallmarks of myelofibrosis were improved with the pelabresib and ruxolitinib combination versus placebo plus ruxolitinib, which is the standard of care in this disease. These findings point to pelabresib and ruxolitinib as a potential paradigm-shifting first-line myelofibrosis treatment. Beyond myelofibrosis, early data suggest pelabresib's clinical benefit in additional indications, representing new opportunities with this investigational therapy. Novartis has the necessary financial resources, additional scientific expertise and global footprint to maximize the full scope of pelabresib's potential, helping ensure patients worldwide could benefit. Creates New Opportunities for MorphoSys' Colleagues: The agreement between Novartis and MorphoSys includes employee commitments. Novartis acknowledges that MorphoSys' dedicated workforce is the foundation of the company's current and future success. Subject to a careful review of the offer document, MorphoSys' Management Board and Supervisory Board intend to recommend to shareholders the acceptance of the offer proposed by Novartis in their joint reasoned statement. Details of Novartis' Public Takeover Offer The offer will contain customary closing conditions, in particular a minimum acceptance threshold of 65% of MorphoSys' share capital and regulatory clearances. The closing is currently expected to take place in the first half of 2024. MorphoSys and Novartis agreed to take MorphoSys private promptly after the public takeover offer has been settled. The offer document of the takeover offer will be published by Novartis at a later date in accordance with the provisions of the German Securities Acquisition and Takeover Act, after the German Federal Financial Supervisory Authority ("BaFin") has approved the publication. Promptly after the offer document is published, MorphoSys' Management Board and Supervisory Board will issue a joint reasoned statement in accordance with sec. 27 of the German Securities Acquisition and Takeover Act. In accordance with U.S. securities laws, Novartis data42 AG and Novartis AG will offer document and a Tender Offer Statement on Schedule TO and MorphoSys will Solicitation/Recommendation Statement on Schedule 14D-9 with the U.S. Securities and Exchange Commission (the "SEC"). The offer document (once available) and other information relating to the public takeover offer will be made public by Novartis, following approval by BaFin, on this website: . The Tender Offer Statement on Schedule TO and the Solicitation/Recommendation Statement on Schedule 14D-9 will be made available for free on the SEC's website at and under the "SEC Filings" section of MorphoSys' website at . Details of the Sale of Tafasitamab to Incyte Under the terms of MorphoSys' Purchase Agreement with Incyte, Incyte will obtain exclusive rights worldwide, assume full responsibility and cover all costs going foward for the development and commercialization of tafasitamab for a purchase price of US$ 25 million. MorphoSys and Incyte have been collaborating on tafasitamab since 2020. Prior to this agreement, tafasitamab was co-marketed in the U.S. by MorphoSys and Incyte as Monjuvi® (tafasitamab-cxix) and outside the U.S. by Incyte as Minjuvi®. Investor and Analyst Call Details MorphoSys will host an investor and analyst call on February 6, 2024 at 02:00 pm CET (01:00 pm GMT; 08:00 am EST). Participants for the call may pre-register and will receive dedicated dial-in details to easily and quickly access the call: The live webcast (audio and presentation) can be directly accessed via Centerview Partners is acting as lead financial advisor and Skadden, Arps, Slate, Meagher & Flom as legal advisor to MorphoSys. About MorphoSys At MorphoSys, we are driven by our mission: More life for people with cancer. As a global commercial-stage biopharmaceutical company, we develop and deliver innovative medicines, aspiring to redefine how cancer is treated. MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts. To learn more, visit us at and follow us on Twitter at X and LinkedIn. About Pelabresib Pelabresib (CPI-0610) is an investigational selective small molecule designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been approved by any regulatory authorities. The development of pelabresib was funded in part by The Leukemia and Lymphoma Society®. About MANIFEST-2 MANIFEST-2 (NCT04603495) is a global, double-blind, Phase 3 clinical trial that randomized 430 JAK inhibitor-naïve adult patients with myelofibrosis 1:1 to receive pelabresib in combination with ruxolitinib or placebo plus ruxolitinib. The primary endpoint of the study is a 35% or greater reduction in spleen volume (SVR35) from baseline at 24 weeks. The key secondary endpoints of the study are the absolute change in total symptom score (TSS) from baseline at 24 weeks and the proportion of patients achieving a 50% or greater improvement in total symptom score (TSS50) from baseline at 24 weeks. TSS is measured using the myelofibrosis self-assessment form (MFSAF) v4.0, which asks patients to report the severity of seven common symptoms, rating each of them on a scale from 0 (absent) to 10 (worst imaginable). The new key secondary endpoint, absolute change in TSS, was added to directly measure change in the average TSS from baseline to week 24 of treatment and is listed as the first key secondary endpoint in the MANIFEST-2 hierarchical testing scheme. The decision to update the MANIFEST-2 clinical trial protocol was made following a Type C meeting with the U.S. Food and Drug Administration (FDA) in September 2023. The final clinical protocol amendment is subject to approvals by health authorities outside of the U.S. Additional secondary endpoints include progression-free survival, overall survival, duration of the splenic and total symptom score response, hemoglobin response rate and improvement in bone marrow fibrosis, among others. Constellation Pharmaceuticals, Inc., a MorphoSys company, is the MANIFEST-2 trial sponsor. About Tafasitamab Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Please see the U.S. full Prescribing Information for Monjuvi for important safety information. In Europe, Minjuvi® (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Its safety and efficacy for these investigational uses have not been established in pivotal trials. Monjuvi® and Minjuvi® are registered trademarks of Incyte. Tafasitamab is marketed under the brand name Monjuvi® in the U.S., and Minjuvi® in Europe and Canada. XmAb® is a registered trademark of Xencor, Inc. Additional Information and Where to Find it The takeover offer described in this communication (the "Takeover Offer") has not yet commenced. This communication is neither an offer to purchase nor a solicitation of an offer to sell shares of MorphoSys AG (the "Company"). The final terms and further provisions regarding the Takeover Offer will be in the offer document once the publication of the offer document by Novartis data42 AG (the "Bidder") has been approved by the German Federal Financial Supervisory Authority (the "BaFin"), after which the offer document will be filed with the U.S. Securities and Exchange Commission (the "SEC"). A solicitation and an offer to buy shares of the Company will be made only pursuant the offer document. In connection with the Takeover Offer, the Bidder and Novartis AG will Tender Offer Statement on Schedule TO with the SEC (together with the offer document, an Offer to Purchase including the means to tender and other related documents, the "Takeover Offer Documents"), the Company's management board and supervisory board will issue a joint reasoned statement in accordance with sec. 27 of the German Securities Acquisition and Takeover Act and the Company will Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC (together with the joint reasoned statement, the "Recommendation Statements"). THE COMPANY'S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TAKEOVER OFFER DOCUMENTS AND THE RECOMMENDATION STATEMENTS BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TAKEOVER OFFER. The Takeover Offer Documents and the Recommendation Statements will be distributed to all stockholders of the Company in accordance with German and U.S. securities laws. The Tender Offer Statement on Schedule TO and the Solicitation/Recommendation Statement on Schedule 14D-9 will be made available for free at the SEC's website at . Additional copies may be obtained for free by contacting the Bidder or the Company. Free copies of these materials and certain other offering documents will be made available on the Company's website in English at morphosys.com/en/investors/Novartis-TakeoverOffer and in German at morphosys.com/de/investoren/Novartis-TakeoverOffer, by mail to MorphoSys AG, Semmelweisstrasse 7, 82152 Planegg, Germany or by phone at +49 89 8992 7179. In addition to the Offer to Purchase, including the means to tender and certain other Takeover Offer Documents, as well as the Solicitation/Recommendation Statement, the Company files other information with the SEC. The Company's filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at and are also available free of charge under the "SEC Filings" section of the Company's website at . In order to reconcile certain areas where German law and U.S. law conflict, Novartis AG and the Bidder expect to request no-action and exemptive relief from the SEC to conduct the Takeover Offer in the manner described in the offer document. Acceptance of the Takeover Offer by stockholders residing outside Germany and the United States of America may be subject to further legal requirements. With respect to the acceptance of the Takeover Offer outside Germany and the United States, no responsibility is assumed for the compliance with such legal requirements applicable in the respective jurisdiction. Forward Looking Statements This communication contains certain forward-looking statements concerning the Company, the Bidder and the Takeover Offer that involve substantial risks and uncertainties. Forward-looking statements include any statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "goal," "may," "might," "plan," "predict," "project," "seek," "target," "potential," "will," "would," "could," "should," "continue" and similar expressions. In this communication, the Company's forward-looking statements include statements about the parties' ability to satisfy the conditions to the consummation of the Takeover Offer; statements about the expected timetable for the consummation of the Takeover Offer; the Company's plans, objectives, expectations and intentions; and the financial condition, results of operations and business of the Company and Novartis AG. The forward-looking statements contained in this communication represent the judgment of the Company as of the date of this communication and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of the Company, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if the Company's results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Those risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include, among other things: uncertainties as to the timing of the Takeover Offer; uncertainties as to how many of the Company's stockholders will tender their stock in the Takeover Offer; the possibility that competing offers will be made; the possibility that various conditions for the Takeover Offer may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the Takeover Offer; the effects of the Takeover Offer on relationships with employees, other business partners or governmental entities; that the Bidder and Novartis AG may not realize the potential benefits of the Takeover Offer; transaction costs associated with the Takeover Offer; that the Company's expectations may be incorrect; the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements; the Company's reliance on collaborations with third parties; estimating the commercial potential of the Company's development programs; and other risks indicated in the risk factors included in the Company's filings with the SEC, including the Company's Annual Report on Form 20-F, as well as the Solicitation/Recommendation Statement on Schedule 14D-9 to be filed by the Company and the Tender Offer Statement on Schedule TO and related Takeover Offer Documents to be filed by the Bidder and Novartis AG. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this communication. The Company and the Bidder expressly disclaim any obligation to update any such forward-looking statements in this communication to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation. For more information, please contact: Media Contacts: Thomas Biegi Senior Vice President, Corporate Affairs Tel: +49 (0)151 / 74612318 thomas.biegi@morphosys.com Investor Contact: Dr. Julia Neugebauer Vice President, Global Head of Investor Relations Tel: +49 (0)89 / 899 27 179 julia.neugebauer@morphosys.com Eamonn Nolan Director, Corporate Communications & Investor Relations Tel: +1 617-548-9271 eamonn.nolan@morphosys.com SOURCE: MorphoSys AG View the original press release on accesswire.com