Ipsen SA

Second licensed program created with Marengo's proprietary STAR precision T cell activation platform advances to IND-enabling phase CAMBRIDGE, Mass., March 3, 2025 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy in oncology and autoimmune diseases, today announced that Ipsen (Euronext: IPN; ADR: IPSEY) has nominated a second drug candidate (DC) under its multi-year strategic oncology collaboration with Marengo. This nomination marks the successful advancement of the second STAR bispecific T cell activator program included in the partnership between Ipsen and Marengo since it began in August 2022. The first DC nomination under the collaboration was announced in April 2024. "This second DC nomination is a testament to our strong collaboration with Ipsen and once again underscores the dedication and ingenuity of Marengo's research team in advancing innovative immunotherapy candidates to clinical trials," said Andrew Bayliffe Ph.D., Chief Scientific Officer of Marengo. "Our novel, first in class TCRVβ-targeted dual T cell agonists drive the revitalization of anti-tumor T cell responses in immunotherapy refractory tumor models, and we look forward to working with Ipsen as we translate this potential into people living with cancer." Under the terms of the agreement, Marengo will receive a milestone payment for this pre-defined pre-clinical milestone. Per the agreement, Marengo has led research and preclinical development efforts in partnership with Ipsen. Ipsen will assume responsibilities for IND filing, regulatory submissions, clinical development and commercialization. About Marengo Therapeutics Marengo Therapeutics, Inc, a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and autoimmune diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, Marengo's three proprietary platforms, Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (Tri-STAR) and T cell Depletor (M-STAR), leverage our unique ability to selectively target the right T cell in the right patient to create a world in which everyone's immune system can defeat cancer and autoimmune diseases. To learn more, visit marengotx.com. About the STAR™ Platform Marengo's STAR™ Platform is a multi-specific antibody-fusion platform derived from Marengo's proprietary library of antibodies targeting germline-encoded variable Vβ regions of the TCR fused to different T cell co-stimulatory moieties. Combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule, promotes a distinct mechanism of action that promotes durable anti-tumor Vβ T cell responses. Marengo Contacts: Media Peg Rusconi I [email protected] Investors Svetlana Makhni | [email protected] SOURCE Marengo Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Topline pivotal data expected in 2025 for both TKI pre-treated ROS1-positive and TKI pre-treated ALK-positive NSCLC populations First NDA submission planned for mid-year 2025 towards potential first approval in 2026 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population Development strategies in place for TKI-naïve populations, including planned initiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC in first half of 2025 Implemented global Expanded Access Programs for zidesamtinib and neladalkib, in line with goal of prioritizing patient access CAMBRIDGE, Mass., Feb. 27, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline and business progress, reiterated key anticipated milestones, and reported fourth quarter and full year 2024 financial results. "The efficient execution by the Nuvalent team to date reflects a shared sense of urgency driven by patient need for additional treatment options – a need that we believe has been clearly demonstrated by the robust enrollment momentum in our ARROS-1 and ALKOVE-1 trials," said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. "We believe we are on track to report pivotal data for TKI pre-treated patients from both trials this year and to submit our first NDA by mid-year 2025." Ms. Noci continued, "In parallel to advancing initial registration paths for zidesamtinib and neladalkib for TKI pre-treated patients, we continue to work with regulators towards our goal of bringing new therapies to all patients with ROS1-positive or ALK-positive NSCLC. Development programs for TKI-naïve patients are underway for both our ROS1 and ALK programs. To ensure patient access to these therapies, we are also pleased to announce the recent launch of global Expanded Access Programs for patients who are eligible and have no other treatment options outside of a clinical trial." "As we transition towards becoming a fully integrated commercial-stage biopharmaceutical company, we reiterate our commitment to meeting the medical needs of patients by advancing our programs as quickly as possible," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "This is an important time for Nuvalent and with a steady cadence of anticipated milestones across our pipeline this year, a strong balance sheet and a dedicated and proven team at the helm, we believe we are well-positioned to deliver on our near-, mid- and long-term goals." Recent Pipeline Progress and Anticipated Milestones ROS1 Program Nuvalent has implemented a global Expanded Access Program (EAP) for zidesamtinib for eligible patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously received at least one prior ROS1 tyrosine kinase inhibitor (TKI) and lack satisfactory therapeutic alternatives and are unable to access zidesamtinib through a clinical trial. As of December 31, 2024, a total of 430 patients had been enrolled in the Phase 1 and Phase 2 portions of the ongoing ARROS-1 Phase 1/2 trial of zidesamtinib for patients with advanced ROS1-positive NSCLC and other solid tumors, which is designed with registrational intent for TKI pre-treated and TKI-naïve patients with advanced ROS1-positive NSCLC. The company expects to report pivotal data for TKI pre-treated patients with advanced ROS1-positive NSCLC in the first half of 2025 in support of an anticipated New Drug Application (NDA) submission by mid-year 2025, with an initial target indication of TKI pre-treated patients with advanced ROS1-positive NSCLC. The company plans to continue engagement with the U.S. Food and Drug Administration (FDA) on accelerated opportunities towards a potential line-agnostic indication supported by the ongoing TKI-naïve cohort in the Phase 2 portion of the ARROS-1 trial. ALK Program Nuvalent has implemented a global EAP for neladalkib for eligible patients with locally advanced or metastatic ALK-positive NSCLC who have previously received lorlatinib or a second-generation ALK TKI and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial. As of December 31, 2024, a total of 596 patients had been enrolled in the Phase 1 and Phase 2 portions of the ongoing ALKOVE-1 Phase 1/2 trial of neladalkib for patients with advanced ALK-positive NSCLC and other solid tumors, which is designed with registrational intent for TKI pre-treated patients. The company expects to report pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC by year-end 2025. Nuvalent plans to initiate the ALKAZAR Phase 3 trial, its front-line development strategy for the company's ALK program, in the first half of 2025. The Phase 3 ALKAZAR trial will be a global, randomized, controlled trial designed to evaluate neladalkib versus the current standard of care for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients will be randomized 1:1 to receive neladalkib monotherapy or ALECENSA® (alectinib) monotherapy, reflecting input from collaborating physician-scientists and alignment with the FDA. HER2 Program Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330's pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2025. Business Updates Appointed Grant Bogle to Board of Directors: As previously announced, Nuvalent appointed Grant Bogle to its board of directors in December 2024. Mr. Bogle brings nearly four decades of proven leadership in building and growing biotechnology companies to the Nuvalent board. Throughout his career, he has served in senior leadership roles at several specialty pharmaceutical and biotechnology companies and worked alongside oncologists as part of the leadership of U.S. Oncology, the largest network of community oncology practices in the United States. He has a proven track record of success in the field of oncology and has guided numerous products from early-stage development to commercialization. Most recently, Mr. Bogle was the Chief Executive Officer at Epizyme, Inc., and oversaw the 2022 acquisition of the company by Ipsen. Prior to that, Mr. Bogle was Senior Vice President and Chief Commercial Officer of TESARO, which was acquired by GlaxoSmithKline in 2018. Earlier, he served as Senior Vice President of Pharmaceutical and Biotech Solutions at McKesson Specialty Health (formerly U.S. Oncology). Fourth Quarter and Full Year 2024 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $1.1 billion as of December 31, 2024. Nuvalent continues to believe that its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028. R&D Expenses: Research and development (R&D) expenses were $69.4 million for the fourth quarter of 2024 and $217.8 million for the year ended December 31, 2024. G&A Expenses: General and administrative (G&A) expenses were $16.9 million for the fourth quarter of 2024 and $62.6 million for the year ended December 31, 2024. Net Loss: Net loss was $74.8 million for the fourth quarter of 2024 and $260.8 million for the year ended December 31, 2024. About Nuvalent Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; Nuvalent's estimated cash runway; the expected timing of data announcements, clinical trial initiations, FDA submissions and potential product approval; the clinical development programs for zidesamtinib, neladalkib and NVL-330; the timing of the ALKAZAR trial; the potential clinical effects of Nuvalent's product development candidates; the design and enrollment of Nuvalent's clinical trials, including for ARROS-1 and ALKOVE-1 their intended pivotal registration-directed design; the potential of Nuvalent's pipeline programs, including zidesamtinib, neladalkib and NVL-330; the implications of data readouts and presentations; timing and content of potential discussions with FDA regarding potential accelerated approval pathways; Nuvalent's potential buildout of a commercial infrastructure; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: risks that Nuvalent may not fully enroll its clinical trials or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies and clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our zidesamtinib or neladalkib product candidates; risks that Nuvalent may not achieve the goals and milestones set forth in its OnTarget 2026 operating plan; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations, including the ARROS-1, ALKOVE-1, ALKAZAR and HEROEX-1 trials; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Nuvalent's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements. SOURCE Nuvalent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

bluebird stockholders to receive $3.00 per share in cash and a contingent value right of $6.84 per share in cash payable upon achievement of a net sales milestone, contingent upon offer conditions bluebird’s Board of Directors determined this transaction is in the best interest of stockholders following a comprehensive review of strategic alternatives Carlyle and SK Capital, in collaboration with a team of highly experienced biotech executives led by David Meek, to support bluebird’s growth SOMERVILLE, MA, USA I February 21, 2025 I bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird”) today announced that it has entered into a definitive agreement to be acquired by funds managed by global investment firms Carlyle (NASDAQ: CG) and SK Capital Partners, LP (“SK Capital”) in collaboration with a team of highly experienced biotech executives. David Meek, former CEO of Mirati Therapeutics and Ipsen, is expected to become CEO of bluebird upon closing. Carlyle and SK Capital will provide bluebird primary capital to scale bluebird’s commercial delivery of gene therapies for patients with sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. Under the terms of the agreement, bluebird stockholders will receive $3.00 per share in cash and a contingent value right per share, entitling the holder to a payment of $6.84 in cash per contingent value right if bluebird’s current product portfolio achieves $600 million in net sales in any trailing 12-month period prior to or ending on December 31, 2027, for a potential total value of up to $9.84 per share in cash, subject to the tender of a majority of the outstanding shares of bluebird, receipt of applicable regulatory approvals, and other customary closing conditions. bluebird’s Board of Directors (the “bluebird Board”) unanimously approved the agreement and recommends that stockholders tender their shares. Following a comprehensive review of bluebird’s strategic alternatives, including meeting with more than 70 potential investors and partners over a period of five months, and a third and final denial by the Federal Drug Administration of bluebird’s appeal for a priority review voucher, the bluebird Board determined that, absent a significant infusion of capital, bluebird is at risk of defaulting on its loan covenants. The bluebird Board has decided that this transaction is the only viable solution to generate value for stockholders. Additional details on the process will be available in bluebird’s Solicitation/Recommendation Statement on Schedule 14D-9, which will be filed with the U.S. Securities and Exchange Commission (“SEC”). “For more than a decade, bluebird has been at the forefront of gene therapy, delivering groundbreaking treatments to patients facing life-threatening genetic diseases,” said Andrew Obenshain, current CEO of bluebird. “However, as our financial challenges mounted, it became clear that securing the right strategic partner was critical to maximizing value for our stockholders and ensuring the long-term future of our therapies. After an extensive review process, this acquisition represents the best path forward – maximizing value for stockholders and bringing significant capital, commercial expertise, and a commitment to provide more patients the opportunity to benefit from potentially transformative gene therapies.” David Meek commented, “bluebird is built on an extraordinary legacy of scientific breakthroughs, and we are committed to unlocking its full potential for patients. With the backing of Carlyle and SK Capital, we will bring the capital and commercial capabilities needed to accelerate and expand patient access to bluebird’s life-changing gene therapies.” “Carlyle’s healthcare and Abingworth teams have significant experience investing in biopharma and are excited about what lies ahead for bluebird. We look forward to working with David and SK Capital to drive bluebird’s future growth and mission of delivering its therapies to improve patient outcomes,” said Joe Bress, Carlyle Partner and Global Co-Head of Healthcare. Bali Muralidhar, Partner and Chief Investment Officer & COO of Abingworth, Carlyle’s life sciences investment franchise, added, “Over the past decade, we have tracked and been impressed by bluebird’s success in researching and developing breakthrough gene therapies for large, unmet medical needs. Joining forces with Carlyle enables us to collaborate in supporting companies like bluebird in commercializing their innovations for patients.” Aaron Davenport, Managing Director at SK Capital, commented, “SK Capital has deep experience in the life sciences sector. We have long admired bluebird’s scientific leadership, dedicated focus on severe genetic diseases, and track record of successful product development and launch. We are excited to partner with David and Carlyle to invest in and accelerate the delivery of bluebird’s pioneering gene therapies to needing patients.” Transaction Details Under the terms of the agreement, bluebird stockholders will receive $3.00 per share in cash and a contingent value right per share, entitling the holder to a payment of $6.84 in cash per contingent value right if bluebird’s current product portfolio achieves $600 million in net sales in any trailing 12-month period prior to or ending on December 31, 2027. The transaction is expected to close in the first half of 2025, subject to the tender of a majority of the outstanding shares of bluebird, receipt of applicable regulatory approvals, and other customary closing conditions. bluebird has also entered into amendments to its loan agreement with Hercules Capital, Inc. to facilitate adequate liquidity to position it to maintain operations through the closing. Upon completion of the transaction, bluebird will become a privately held company, and shares of bluebird common stock will no longer be listed on any public market. Leerink Partners is acting as bluebird’s financial advisor, and Latham & Watkins LLP is serving as legal counsel to bluebird. Bourne Partners is acting as financial advisor to Carlyle and SK Capital, and Wachtell, Lipton, Rosen & Katz, Kirkland & Ellis LLP, and Orrick, Herrington & Sutcliffe are serving as legal advisors to Carlyle and SK Capital. About bluebird bio, Inc. Founded in 2010, bluebird has been setting the standard for gene therapy for more than a decade—first as a scientific pioneer and now as a commercial leader. bluebird has an unrivaled track record in bringing the promise of gene therapy out of clinical studies and into the real-world setting, having secured FDA approvals for three therapies in under two years. Today, we are proving and scaling the commercial model for gene therapy and delivering innovative solutions for access to patients, providers, and payers. With a dedicated focus on severe genetic diseases, bluebird has the largest and deepest ex-vivo gene therapy data set in the field, with industry-leading programs for sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward. bluebird continues to forge new paths as a standalone commercial gene therapy company, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds. About Carlyle Carlyle (NASDAQ: CG) is a global investment firm with deep industry expertise that deploys private capital across its business and conducts its operations through three business segments: Global Private Equity, Global Credit and Global Investment Solutions. With $441 billion of assets under management as of December 31, 2024, Carlyle’s purpose is to invest wisely and create value on behalf of its investors, portfolio companies and the communities in which we live and invest. Carlyle employs more than 2,300 people in 29 offices across four continents. Further information is available at www.carlyle.com . Follow Carlyle on X @OneCarlyle and LinkedIn at The Carlyle Group. About SK Capital SK Capital is a transformational private investment firm with a disciplined focus on the life sciences, specialty materials, and ingredients sectors. The firm seeks to build resilient, sustainable, and growing businesses that create substantial long-term value. SK Capital aims to utilize its industry, operating, and investment experience to identify opportunities to transform businesses into higher performing organizations with improved strategic positioning, growth, and profitability, as well as lower operating risk. SK Capital’s portfolio of businesses generates revenues of approximately $12 billion annually, employs more than 25,000 people globally, and operates more than 200 plants in over 30 countries. The firm currently has approximately $9 billion in assets under management. For more information, please visit www.skcapitalpartners.com . Additional Information and Where to Find It The tender offer in connection with the transaction described above has not yet commenced. This communication is not an offer to buy nor a solicitation of an offer to sell any securities of bluebird. The solicitation and the offer to buy shares of bluebird’s common stock will only be made pursuant to a Tender Offer Statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials, that Beacon Parent Holdings, L.P. (“Parent”) and Beacon Merger Sub, Inc. (“Merger Sub”) intend to file with the SEC. In addition, bluebird will file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Once filed, investors will be able to obtain a free copy of these materials and other documents filed by Parent, Merger Sub and bluebird with the SEC at the website maintained by the SEC at www.sec.gov . Investors may also obtain, at no charge, any such documents filed with or furnished to the SEC by (i) bluebird under the “Investors & Media” section of bluebird’s website at www.bluebirdbio.com or (ii) by Parent and Merger Sub by calling Innisfree M&A Incorporated, the information agent for the Offer, toll-free at (877) 825-8793 for stockholders or by calling collect at (212) 750-5833 for banks or brokers. SOURCE: bluebird bio