Ipsen to acquire ImCheck Therapeutics, expanding its leadership in oncology, strengthening its pipeline




Ipsen to acquire ImCheck Therapeutics, expanding its leadership in oncology, strengthening its pipeline

• Acquisition focused on lead clinical-stage program ICT01 in acute myeloid leukemia, where data from the ongoing Phase I/II EVICTION trial showed high treatment response
• ICT01 has the potential to be a new standard of care in combination in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults
• Ipsen to acquire all issued and outstanding shares of ImCheck Therapeutics, for which ImCheck Therapeutics’ shareholders will be eligible to receive a closing purchase price of 350 million euros and downstream payments contingent upon achievement of regulatory and sales-based milestones

PARIS AND MARSEILLE, FRANCE, 22 October 2025 – Ipsen (Euronext: IPN; ADR: IPSEY) and ImCheck Therapeutics today announced they have entered into a definitive share purchase agreement in which Ipsen will acquire all issued and outstanding shares of ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The anticipated acquisition is focused on the lead Phase I/II program ICT01 in first line acute myeloid leukemia (AML)³ patients who are ineligible for intensive chemotherapy. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer, and received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.

Many AML patients are unable to tolerate intensive chemotherapy and must rely on lower-intensity options, which often deliver limited and short-lived benefit.² This high-risk, unfit population continues to face a significant unmet medical need, highlighting the urgency for new therapies that can improve survival and quality of life. 

“At completion, the acquisition of ImCheck Therapeutics presents an opportunity for us to expand our pipeline in oncology and reinforces our commitment to deliver transformative therapies to the people who need them most,” said David Loew, CEO, Ipsen. “We feel confident that with the ICT01 promising data combined with Ipsen’s global development and commercialization expertise, we are well positioned to start a Phase IIb/III trial in 2026.” 

Interim data (n=45) orally presented at the annual American Society of Clinical Oncology 2025¹ from the Phase I/II EVICTION trial showed treatment with ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. In this single-arm trial, treatment response nearly doubled relative to those seen in historical standard of care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard of care (Ven-Aza).² ICT01 in combination with Ven-Aza was also shown to be well tolerated, underscoring ICT01’s potential as a novel immunotherapy to improve outcomes for patients with AML. 

“We are thrilled to become part of Ipsen, a company whose ambition for transformative care matches our commitment to bringing innovative treatments to patients. This transaction recognizes groundbreaking science originating from French academia,” said Pierre d’Epenoux, CEO, ImCheck Therapeutics. “It also highlights the exceptional work the ImCheck team and our partners have achieved to advance the understanding of butyrophilns and gamma delta T cells. Joining Ipsen will help us accelerate ICT01 toward registrational studies and commercialization. I remain grateful to the patients and investors for their contributions to furthering ImCheck’s pioneering science.”

Transaction details
Under the terms of the agreement, through a wholly owned affiliate of Ipsen SAS, shareholders of ImCheck Therapeutics will receive a 350 million euros payment on a cash-free and debt-free basis at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones, for a total potential consideration up to 1 billion euros.

The transaction is expected to close by the end of Q1 2026, subject to fulfilment of customary closing conditions including the expiration or termination of any required regulatory and governmental approvals under French and U.S. regulations.

Advisors
Allen & Overy Shearman (Paris) is acting as legal counsel to Ipsen. Centerview Partners is acting as exclusive financial advisor to ImCheck Therapeutics with Goodwin (London) and Dentons (Paris) acting as legal counsel.

About the EVICTION trial
EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical trial of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options, as well as newly-diagnosed AML. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).

About ICT01
ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that promotes the recognition and elimination of tumor cells by γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and are also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). Binding to BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. By altering the conformation of BTN3A, ICT01 promotes this binding, thereby selectively activating circulating γ9δ2 T cells. This leads to migration of γ9δ2 T cells out of the circulation and into the tumor tissue, and triggers a downstream immunological cascade through secretion of pro-inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in patients across several cancer indications.

About Ipsen

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. 

Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries.

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

About ImCheck Therapeutics
ImCheck Therapeutics is developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel superfamily of immunomodulators. By unlocking the power of γ9δ2 T cells, ImCheck’s innovative approach has the potential to transform treatments across oncology, autoimmune, and infectious diseases. 

The lead clinical-stage program, ICT01, has been advancing to late-stage trials, demonstrating a unique mechanism of action that modulates both innate and adaptive immunity. These “first-in-class” activating antibodies may deliver superior clinical outcomes compared to first-generation immunotherapy approaches, in particular in rationale combinations with immune checkpoint inhibitors and immunomodulatory anti-cancer drugs. Additionally, ImCheck’s pipeline compounds are progressing toward clinical development for autoimmune and infectious diseases. 

The company benefits from the pioneering research of Prof. Daniel Olive (Institut Paoli Calmettes, INSERM, CNRS, Aix-Marseille University), a global leader in γ9δ2 T cells and butyrophilins, as well as the expertise of a seasoned management team and the commitment of leading French, European and U.S. investors including Kurma Partners, Eurazeo, Bpifrance through its Innobio 2 and Large Venture funds, Andera Partners, Pfizer Ventures, Gimv, EQT Life Sciences, Earlybird, Wellington Partners, Pureos Bioventures, Invus, Agent Capital, Boehringer Ingelheim Venture Fund, Alexandria Venture Investments, and Blood Cancer United (previously LLS)®.

For further information: https://www.imchecktherapeutics.com/     

Ipsen Contacts

Investors
Henry Wheeler         henry.wheeler@ipsen.com       +33 7766471149
Khalid Deojee          khalid.deojee@ipsen.com        +33 666019526

Media
Sally Bain                sally.bain@ipsen.com                 +1 8573200517
Anne Liontas            anne.liontas.ext@ipsen.com        +33 0767347296

ImCheck Contacts

Media
Gretchen Schweitzer (EU and US)        ImCheck@trophic.eu                  +49 1728618540
Céline Voisin (France)                        Imcheck@atcg-partners.com        +33 (0)6 62 12 53 39

References

1. Dumas et al. γ9δ2 T-cell activation with ICT01 combined with azacitidine-venetoclax for older/unfit adults with newly diagnosed AML: preliminary efficacy and dose selection in Phase 1/2 study EVICTION. ASCO 2025. Available here: https://www.ImChecktherapeutics.com/fileadmin/Posters_Prez/ASCO2025-ICT01-AzaVen.pdf
2. Kone AS, Ait Ssi S, Sahraoui S, Badou A. BTN3A: A Promising Immune Checkpoint for Cancer Prognosis and Treatment. Int J Mol Sci. 2022;23(21):13424. Published 2022 Nov 3. doi:10.3390/ijms232113424
3. Short NJ, Rytting ME, Cortes JE. Acute myeloid leukaemia. Lancet. 2018;392(10147):593-606. doi:10.1016/S0140-6736(18)31041-9

Disclaimers and/or forward-looking statements

The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com.

Attachment

• Ipsen PR_Ipsen to acquire ImCheck Therapeutics_22102025

Novartis announces expiration of Hart-Scott-Rodino waiting period of Tourmaline Bio tender offer




Novartis announces expiration of Hart-Scott-Rodino waiting period of Tourmaline Bio tender offer

Basel, October 22, 2025 – Novartis today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), in connection with Novartis’ previously announced tender offer to acquire all of the outstanding shares of common stock, par value $0.0001 per share (the “Shares”), of Tourmaline Bio, Inc., a Delaware corporation (“Tourmaline”), at a price of $48.00 per Share, in cash, without interest and subject to any applicable withholding. The expiration of the HSR Act waiting period occurred at 11:59 p.m., Eastern Time, on October 21, 2025.  
  
Expiration of the waiting period under the HSR Act satisfies one of the conditions necessary for the consummation of the transactions contemplated by the Agreement and Plan of Merger, dated as of September 8, 2025 (the “Merger Agreement”), among Novartis, Torino Merger Sub Inc., a Delaware corporation and an indirect wholly owned subsidiary of Novartis (“Purchaser”), and Tourmaline, including the tender offer and the subsequent merger, which remain subject to the condition that there be validly tendered and not validly withdrawn in accordance with the terms of the offer, immediately prior to the Expiration Date (as defined below) a number of Shares that, together with any Shares then owned by Novartis or any of its direct or indirect wholly owned subsidiaries, represents at least a majority of Shares outstanding at the time of expiration of the offer. The offer will expire at one minute following 11:59 p.m., Eastern Time, on October 27, 2025, unless the offer is otherwise extended (such date or subsequent date to which the expiration of the offer is extended in accordance with the terms of the Merger Agreement, the “Expiration Date”) or earlier terminated in accordance with the Merger Agreement. 

Additional information 
This press release is neither an offer to purchase nor a solicitation of an offer to sell any Shares or any other securities. The tender offer for the outstanding Shares described in this press release commenced upon the filing by Novartis and Purchaser of a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, with the SEC on September 29, 2025. Tourmaline also filed a solicitation/recommendation statement on Schedule 14D-9 with the SEC. 

INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ BOTH THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A LETTER OF TRANSMITTAL AND RELATED DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES. 

An offer to purchase the Shares is only being made pursuant to the offer to purchase, the letter of transmittal and related offer documents filed as part of the Schedule TO. Those materials and all other documents filed by, or caused to be filed by, Novartis, Purchaser and Tourmaline with the SEC are available at no charge on the SEC’s website at www.sec.gov/ or by directing such requests to the information agent for the offer, which is named in the tender offer statement. The offer to purchase and related materials also may be obtained for free under the “Investors – Financial Data” section of Novartis’s website at www.novartis.com/investors/financial-data/sec-filings. The solicitation/recommendation statement also may be obtained for free under the “Investors” section of Tourmaline’s website at ir.tourmalinebio.com. In addition, Tourmaline files annual, quarterly and current reports and other information, and Novartis files annual reports and other information with the SEC, which are also available to the public at no charge at www.sec.gov. 

Disclaimer 
This press release contains statements that are not statements of historical fact, or “forward-looking statements,” including with respect to Novartis’s proposed acquisition of Tourmaline. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Tourmaline’s product candidates, Tourmaline’s platform, the proposed acquisition of Tourmaline and the expected timetable for completing the proposed acquisition, the benefits sought to be achieved in the proposed acquisition, or potential future revenues from Tourmaline’s product candidates. You should not place undue reliance on these statements. Such forward-looking statements are based on Novartis’s current beliefs and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that clinical trials for any of Tourmaline’s product candidates will be successful, that Tourmaline’s approach to the discovery and development of product candidates based on its AOC™ platform will produce any products of commercial value, that any of Tourmaline’s product candidates will be submitted for marketing approval or approved for sale or, if approved, receive approval for any additional indications or labeling, in any market, or at any particular time, nor can there be any guarantee that, if approved, any of Tourmaline’s product candidates will be commercially successful in the future. Neither can there be any guarantee that the conditions to the closing of the proposed acquisition will be satisfied on the expected timetable or at all or that the expected benefits or synergies from this transaction will be achieved in the expected timeframe, or at all. In particular, expectations regarding Tourmaline or the transaction described in this press release could be affected by, among other things, the timing of the offer and the satisfaction of customary closing conditions, including the tender of a majority of the outstanding Shares and the receipt of regulatory approvals on acceptable terms or at all; the risk that competing offers or acquisition proposals will be made; the effects of disruption from the transactions contemplated by the Merger Agreement and the impact of the announcement and pendency of the transactions on Novartis and/or Tourmaline’s businesses, including their relationships with employees, business partners or governmental entities; the risk that the offer or the merger may be more expensive to complete than anticipated; the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability; a diversion of management’s attention from ongoing business operations and opportunities as a result of the offer, the merger or otherwise; general industry conditions and competition; general political, economic and business conditions, including interest rate and currency exchange rate fluctuations; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s and Tourmaline’s filings and reports with the SEC, including Novartis AG’s Annual Report on Form 20-F for the year ended December 31, 2024, Tourmaline’s Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, and any subsequent filings made by either party with the SEC, available on the SEC’s website at www.sec.gov. Novartis is providing the information in this press release as of this date, and Novartis does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise, except to the extent required by law. 

About Novartis  
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide. 

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. 

# # # 

Press Release: Sanofi’s efdoralprin alfa met all primary and key secondary endpoints in alpha-1 antitrypsin deficiency emphysema phase 2 study




Press Release: Sanofi’s efdoralprin alfa met all primary and key secondary endpoints in alpha-1 antitrypsin deficiency emphysema phase 2 study

Sanofi’s efdoralprin alfa met all primary and key secondary endpoints in alpha-1 antitrypsin deficiency emphysema phase 2 study

• Efdoralprin alfa demonstrated superiority in a head-to-head study versus a standard of care plasma-derived therapy
• Results reinforce the potential of efdoralprin alfa to be the first restorative recombinant therapy that normalizes and maintains functional AAT levels
• Phase 2 data support both three-week and four-week dosing regimens for efdoralprin alfa – a potentially significant improvement in convenience – compared to a plasma-derived therapy dosed weekly

Paris, October 22, 2025. Positive results from the global ElevAATe phase 2 study (clinical study identifier: NCT05856331) showed that efdoralprin alfa (SAR447537, formerly known as INBRX-101), met all primary and key secondary endpoints when dosed every three weeks (Q3W) or four weeks (Q4W) in adults with alpha-1 antitrypsin deficiency (AATD) emphysema, a rare disease. Efdoralprin alfa is an investigational recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein. It demonstrated a statistically significant greater mean increase in functional AAT levels within normal range as measured by trough concentrations at steady state compared to those receiving weekly plasma-derived augmentation therapy at week 32 [p<0.0001]. The study also met key secondary endpoints, demonstrating superior mean increase in fAAT average concentration as well as higher percentage of days above the lower limit of the normal range for both Q3W and Q4W dosing.

The recombinant efdoralprin alfa was well tolerated with a similar adverse event profile to plasma-derived therapy. Additional safety follow-up will be assessed in the ElevAATe OLE phase 2 study (clinical study identifier: NCT05897424).

“These data demonstrate that efdoralprin alfa achieved consistently higher normal functional AAT levels, with less frequent dosing, compared to a current standard of care,” said Christopher Corsico, Global Head of Development at Sanofi. “This is particularly meaningful as maintaining protective protein levels is the cornerstone of pulmonary management of AATD and currently available treatments require weekly therapeutic infusions. The ElevAATe results represent the potential for efdoralprin alfa to be a restorative recombinant therapeutic option for the AATD community, reinforcing our commitment to develop treatments for both rare and respiratory conditions with great unmet medical need.”

“AATD is a debilitating condition that can be challenging to treat,” said Igor Barjaktarevic, MD, PhD, Associate Professor, David Geffen School of Medicine at UCLA and primary investigator on the ElevAATe phase 2 study. “Achieving and maintaining normal AAT levels with less frequent dosing and with complete independence from blood donation programs would be a welcome change to the current treatment experience for people living with AATD. With the current standard of care, patients reach but do not maintain normal protein levels between the infusions, leaving a remaining unmet need. I’m encouraged by the ElevAATe trial results and what efdoralprin alfa could mean for the AATD community.”

Efdoralprin alfa was previously granted fast track and orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of AATD emphysema. Efdoralprin alfa is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. Sanofi plans to present the data at a forthcoming medical meeting and engage with global regulatory authorities on the appropriate next steps.

About AATD
AATD is a rare, inherited disorder characterized by low levels or absence of AAT, a protein produced by the liver that protects the lungs from inflammation and damage.^1,3 The disease causes progressive deterioration of the tissue of the lungs and liver.^1,4 Without adequate AAT levels, affected individuals often experience lung damage and develop COPD, including emphysema, and in severe forms of the disease, patients can sometimes require lung transplantation. Plasma-derived therapies were introduced in 1987 to treat the condition but since then, no new therapies have been introduced. About 235,000 people worldwide live with AATD, with nearly 100,000 people in the US, but about 90% of individuals with AATD are likely undiagnosed.

About efdoralprin alfa
Efdoralprin alfa (SAR447537, formerly known as INBRX-101) is a recombinant human AAT-Fc fusion protein being investigated as a restorative therapy in adults with AATD emphysema, with Q3W or Q4W dosing. The investigational treatment is being studied to restore functional AAT levels to the normal range and inhibit neutrophil elastase, an enzyme that can cause lung tissue damage in patients with AATD. Efdoralprin alfa was granted fast track designation and orphan drug designation by the FDA for the treatment of AATD emphysema.

About ElevAATe
The ElevAATe phase 2 study was a double-blind, randomized study evaluating efdoralprin alfa versus a standard of care plasma-derived augmentation therapy in patients with AATD emphysema. ​Ninety-seven patients were randomized 2:2:1 to receive efdoralprin alfa every three weeks or every four weeks, or plasma-derived augmentation therapy once weekly. The primary endpoint was the mean change in average fAAT concentrations as measured from baseline to average serum trough fAAT concentrations at steady state in patients treated with efdoralprin alfa Q3W or Q4W compared with weekly plasma-derived augmentation therapy, following a treatment period of up to 32 weeks. Key secondary endpoints included mean change in serum fAAT concentration from baseline to fAAT average concentrations at steady state and percentage of days that steady-state functional AAT levels were above the lower limit of the normal range.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com

Investor Relations
Thomas Kudsk Larsen | + 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group.

Attachment

• Press Release

Ipsen to acquire ImCheck Therapeutics, expanding its leadership in oncology, strengthening its pipeline




Ipsen to acquire ImCheck Therapeutics, expanding its leadership in oncology, strengthening its pipeline

• Acquisition focused on lead clinical-stage program ICT01 in acute myeloid leukemia, where data from the ongoing Phase I/II EVICTION trial showed high treatment response
• ICT01 has the potential to be a new standard of care in combination in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults
• Ipsen to acquire all issued and outstanding shares of ImCheck Therapeutics, for which ImCheck Therapeutics’ shareholders will be eligible to receive a closing purchase price of 350 million euros and downstream payments contingent upon achievement of regulatory and sales-based milestones

PARIS AND MARSEILLE, FRANCE, 22 October 2025 – Ipsen (Euronext: IPN; ADR: IPSEY) and ImCheck Therapeutics today announced they have entered into a definitive share purchase agreement in which Ipsen will acquire all issued and outstanding shares of ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The anticipated acquisition is focused on the lead Phase I/II program ICT01 in first line acute myeloid leukemia (AML)³ patients who are ineligible for intensive chemotherapy. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer, and received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.

Many AML patients are unable to tolerate intensive chemotherapy and must rely on lower-intensity options, which often deliver limited and short-lived benefit.² This high-risk, unfit population continues to face a significant unmet medical need, highlighting the urgency for new therapies that can improve survival and quality of life. 

“At completion, the acquisition of ImCheck Therapeutics presents an opportunity for us to expand our pipeline in oncology and reinforces our commitment to deliver transformative therapies to the people who need them most,” said David Loew, CEO, Ipsen. “We feel confident that with the ICT01 promising data combined with Ipsen’s global development and commercialization expertise, we are well positioned to start a Phase IIb/III trial in 2026.” 

Interim data (n=45) orally presented at the annual American Society of Clinical Oncology 2025¹ from the Phase I/II EVICTION trial showed treatment with ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. In this single-arm trial, treatment response nearly doubled relative to those seen in historical standard of care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard of care (Ven-Aza).² ICT01 in combination with Ven-Aza was also shown to be well tolerated, underscoring ICT01’s potential as a novel immunotherapy to improve outcomes for patients with AML. 

“We are thrilled to become part of Ipsen, a company whose ambition for transformative care matches our commitment to bringing innovative treatments to patients. This transaction recognizes groundbreaking science originating from French academia,” said Pierre d’Epenoux, CEO, ImCheck Therapeutics. “It also highlights the exceptional work the ImCheck team and our partners have achieved to advance the understanding of butyrophilns and gamma delta T cells. Joining Ipsen will help us accelerate ICT01 toward registrational studies and commercialization. I remain grateful to the patients and investors for their contributions to furthering ImCheck’s pioneering science.”

Transaction details
Under the terms of the agreement, through a wholly owned affiliate of Ipsen SAS, shareholders of ImCheck Therapeutics will receive a 350 million euros payment on a cash-free and debt-free basis at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones, for a total potential consideration up to 1 billion euros.

The transaction is expected to close by the end of Q1 2026, subject to fulfilment of customary closing conditions including the expiration or termination of any required regulatory and governmental approvals under French and U.S. regulations.

Advisors
Allen & Overy Shearman (Paris) is acting as legal counsel to Ipsen. Centerview Partners is acting as exclusive financial advisor to ImCheck Therapeutics with Goodwin (London) and Dentons (Paris) acting as legal counsel.

About the EVICTION trial
EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical trial of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options, as well as newly-diagnosed AML. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).

About ICT01
ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that promotes the recognition and elimination of tumor cells by γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and are also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). Binding to BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. By altering the conformation of BTN3A, ICT01 promotes this binding, thereby selectively activating circulating γ9δ2 T cells. This leads to migration of γ9δ2 T cells out of the circulation and into the tumor tissue, and triggers a downstream immunological cascade through secretion of pro-inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in patients across several cancer indications.

About Ipsen

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. 

Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries.

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

About ImCheck Therapeutics
ImCheck Therapeutics is developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel superfamily of immunomodulators. By unlocking the power of γ9δ2 T cells, ImCheck’s innovative approach has the potential to transform treatments across oncology, autoimmune, and infectious diseases. 

The lead clinical-stage program, ICT01, has been advancing to late-stage trials, demonstrating a unique mechanism of action that modulates both innate and adaptive immunity. These “first-in-class” activating antibodies may deliver superior clinical outcomes compared to first-generation immunotherapy approaches, in particular in rationale combinations with immune checkpoint inhibitors and immunomodulatory anti-cancer drugs. Additionally, ImCheck’s pipeline compounds are progressing toward clinical development for autoimmune and infectious diseases. 

The company benefits from the pioneering research of Prof. Daniel Olive (Institut Paoli Calmettes, INSERM, CNRS, Aix-Marseille University), a global leader in γ9δ2 T cells and butyrophilins, as well as the expertise of a seasoned management team and the commitment of leading French, European and U.S. investors including Kurma Partners, Eurazeo, Bpifrance through its Innobio 2 and Large Venture funds, Andera Partners, Pfizer Ventures, Gimv, EQT Life Sciences, Earlybird, Wellington Partners, Pureos Bioventures, Invus, Agent Capital, Boehringer Ingelheim Venture Fund, Alexandria Venture Investments, and Blood Cancer United (previously LLS)®.

For further information: https://www.imchecktherapeutics.com/     

Ipsen Contacts

Investors
Henry Wheeler         henry.wheeler@ipsen.com       +33 7766471149
Khalid Deojee          khalid.deojee@ipsen.com        +33 666019526

Media
Sally Bain                sally.bain@ipsen.com                 +1 8573200517
Anne Liontas            anne.liontas.ext@ipsen.com        +33 0767347296

ImCheck Contacts

Media
Gretchen Schweitzer (EU and US)        ImCheck@trophic.eu                  +49 1728618540
Céline Voisin (France)                        Imcheck@atcg-partners.com        +33 (0)6 62 12 53 39

References

1. Dumas et al. γ9δ2 T-cell activation with ICT01 combined with azacitidine-venetoclax for older/unfit adults with newly diagnosed AML: preliminary efficacy and dose selection in Phase 1/2 study EVICTION. ASCO 2025. Available here: https://www.ImChecktherapeutics.com/fileadmin/Posters_Prez/ASCO2025-ICT01-AzaVen.pdf
2. Kone AS, Ait Ssi S, Sahraoui S, Badou A. BTN3A: A Promising Immune Checkpoint for Cancer Prognosis and Treatment. Int J Mol Sci. 2022;23(21):13424. Published 2022 Nov 3. doi:10.3390/ijms232113424
3. Short NJ, Rytting ME, Cortes JE. Acute myeloid leukaemia. Lancet. 2018;392(10147):593-606. doi:10.1016/S0140-6736(18)31041-9

Disclaimers and/or forward-looking statements

The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com.

Attachment

• Ipsen PR_Ipsen to acquire ImCheck Therapeutics_22102025

Novartis announces expiration of Hart-Scott-Rodino waiting period of Tourmaline Bio tender offer




Novartis announces expiration of Hart-Scott-Rodino waiting period of Tourmaline Bio tender offer

Basel, October 22, 2025 – Novartis today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), in connection with Novartis’ previously announced tender offer to acquire all of the outstanding shares of common stock, par value $0.0001 per share (the “Shares”), of Tourmaline Bio, Inc., a Delaware corporation (“Tourmaline”), at a price of $48.00 per Share, in cash, without interest and subject to any applicable withholding. The expiration of the HSR Act waiting period occurred at 11:59 p.m., Eastern Time, on October 21, 2025.  
  
Expiration of the waiting period under the HSR Act satisfies one of the conditions necessary for the consummation of the transactions contemplated by the Agreement and Plan of Merger, dated as of September 8, 2025 (the “Merger Agreement”), among Novartis, Torino Merger Sub Inc., a Delaware corporation and an indirect wholly owned subsidiary of Novartis (“Purchaser”), and Tourmaline, including the tender offer and the subsequent merger, which remain subject to the condition that there be validly tendered and not validly withdrawn in accordance with the terms of the offer, immediately prior to the Expiration Date (as defined below) a number of Shares that, together with any Shares then owned by Novartis or any of its direct or indirect wholly owned subsidiaries, represents at least a majority of Shares outstanding at the time of expiration of the offer. The offer will expire at one minute following 11:59 p.m., Eastern Time, on October 27, 2025, unless the offer is otherwise extended (such date or subsequent date to which the expiration of the offer is extended in accordance with the terms of the Merger Agreement, the “Expiration Date”) or earlier terminated in accordance with the Merger Agreement. 

Additional information 
This press release is neither an offer to purchase nor a solicitation of an offer to sell any Shares or any other securities. The tender offer for the outstanding Shares described in this press release commenced upon the filing by Novartis and Purchaser of a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, with the SEC on September 29, 2025. Tourmaline also filed a solicitation/recommendation statement on Schedule 14D-9 with the SEC. 

INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ BOTH THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A LETTER OF TRANSMITTAL AND RELATED DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES. 

An offer to purchase the Shares is only being made pursuant to the offer to purchase, the letter of transmittal and related offer documents filed as part of the Schedule TO. Those materials and all other documents filed by, or caused to be filed by, Novartis, Purchaser and Tourmaline with the SEC are available at no charge on the SEC’s website at www.sec.gov/ or by directing such requests to the information agent for the offer, which is named in the tender offer statement. The offer to purchase and related materials also may be obtained for free under the “Investors – Financial Data” section of Novartis’s website at www.novartis.com/investors/financial-data/sec-filings. The solicitation/recommendation statement also may be obtained for free under the “Investors” section of Tourmaline’s website at ir.tourmalinebio.com. In addition, Tourmaline files annual, quarterly and current reports and other information, and Novartis files annual reports and other information with the SEC, which are also available to the public at no charge at www.sec.gov. 

Disclaimer 
This press release contains statements that are not statements of historical fact, or “forward-looking statements,” including with respect to Novartis’s proposed acquisition of Tourmaline. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Tourmaline’s product candidates, Tourmaline’s platform, the proposed acquisition of Tourmaline and the expected timetable for completing the proposed acquisition, the benefits sought to be achieved in the proposed acquisition, or potential future revenues from Tourmaline’s product candidates. You should not place undue reliance on these statements. Such forward-looking statements are based on Novartis’s current beliefs and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that clinical trials for any of Tourmaline’s product candidates will be successful, that Tourmaline’s approach to the discovery and development of product candidates based on its AOC™ platform will produce any products of commercial value, that any of Tourmaline’s product candidates will be submitted for marketing approval or approved for sale or, if approved, receive approval for any additional indications or labeling, in any market, or at any particular time, nor can there be any guarantee that, if approved, any of Tourmaline’s product candidates will be commercially successful in the future. Neither can there be any guarantee that the conditions to the closing of the proposed acquisition will be satisfied on the expected timetable or at all or that the expected benefits or synergies from this transaction will be achieved in the expected timeframe, or at all. In particular, expectations regarding Tourmaline or the transaction described in this press release could be affected by, among other things, the timing of the offer and the satisfaction of customary closing conditions, including the tender of a majority of the outstanding Shares and the receipt of regulatory approvals on acceptable terms or at all; the risk that competing offers or acquisition proposals will be made; the effects of disruption from the transactions contemplated by the Merger Agreement and the impact of the announcement and pendency of the transactions on Novartis and/or Tourmaline’s businesses, including their relationships with employees, business partners or governmental entities; the risk that the offer or the merger may be more expensive to complete than anticipated; the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability; a diversion of management’s attention from ongoing business operations and opportunities as a result of the offer, the merger or otherwise; general industry conditions and competition; general political, economic and business conditions, including interest rate and currency exchange rate fluctuations; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s and Tourmaline’s filings and reports with the SEC, including Novartis AG’s Annual Report on Form 20-F for the year ended December 31, 2024, Tourmaline’s Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, and any subsequent filings made by either party with the SEC, available on the SEC’s website at www.sec.gov. Novartis is providing the information in this press release as of this date, and Novartis does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise, except to the extent required by law. 

About Novartis  
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide. 

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. 

# # # 

ENA Respiratory Attracts US$22.4m (AU$34m) to Fund Phase II Development of INNA-051 Nasal Spray Designed to Protect Against Symptomatic Viral Respiratory Infections




ENA Respiratory Attracts US$22.4m (AU$34m) to Fund Phase II Development of INNA-051 Nasal Spray Designed to Protect Against Symptomatic Viral Respiratory Infections

MELBOURNE, Australia, Oct. 22, 2025 (GLOBE NEWSWIRE) — ENA Respiratory, a clinical-stage pharmaceutical company developing antiviral host defense enhancers to minimize the impact of symptomatic viral respiratory infections, announces today that it has raised US$22.4m (AUD$34m) in its Series B financing.

The Company welcomed new investment from the Gates Foundation and the previously announced contribution from Flu Lab. Existing investors, Brandon Capital, Uniseed and Stoic Venture Capital also participated in the round.

The new funding will support the Phase II clinical development of INNA-051, ENA’s virus-agnostic once-weekly dry powder nasal spray, which primes the natural antiviral host defences in the nose, where viruses like colds, flu, RSV and coronaviruses typically enter, enabling the body to respond more quickly when challenged. Preclinical and clinical studies conducted to date suggest that INNA-051 has the potential to shorten the duration of symptomatic infections, prevent progression to the lungs, and reduce complications.

The planned Phase II community study (‘POSITS’) will evaluate the safety, tolerability and efficacy of up to three months’ treatment with INNA-051 and assess its impact on the incidence, duration and severity of symptomatic infections caused by common respiratory viruses, including influenza, RSV, rhinovirus, and coronaviruses in young adult participants at risk of illness due to living or working in crowded environments.

The study, which is due to start shortly, will recruit up to 1,100 participants and be conducted during the 2025-2026 North American respiratory virus season. Justin Ortiz, MD, MS, Professor of Medicine at the University of Maryland’s renowned global health institution, CVDGH, and a global health physician scientist with expertise in respiratory virus protection and control, will lead as a Principal Investigator.

The INNA-051 therapy aims to reduce the incidence of complications in patients at higher risk of severe illness. Seasonal respiratory infections such as flu take a significant toll on health systems and the economy, driving costly hospitalisations and workplace absences. The impact is most significant for patients with underlying medical conditions like asthma, COPD, heart disease, kidney disease, diabetes, primary immunodeficiency and cancer, who face a much higher risk of complications, with over a million hospitalizations and up to 200,000 deaths in the U.S. in 2025 from respiratory-related viral infections.

ENA Respiratory’s CEO, Christophe Demaison, PhD said: “This funding marks a major milestone for ENA Respiratory as we advance INNA-051 into a community Phase II trial. With an international investor syndicate and ongoing support from our Australian investors, we are now in a strong position to evaluate the impact of our once-weekly powder nasal spray, which stimulates the body’s natural antiviral defences, in a community setting and moves us closer to bringing it to the patients who need it most. This is an exciting step forward in our mission to deliver a first-of-its-kind preventative option for safeguarding vulnerable populations and has the potential to ease the global burden of respiratory viruses.”

Research by the patient advocacy group Global Allergy & Airways Patient Platform, supported by ENA, found strong interest in a convenient preventative option like INNA-051 among more than 3,000 U.S. adult respondents with relevant comorbidities. A majority of those who identify themselves as high risk for hospitalisation or emergency visits due to viral respiratory infections indicated that they would use a product such as INNA-051 once a week during the winter months.

These findings highlight a clear unmet need and potential high uptake for convenient therapies that can reduce hospitalisations, keep people healthier and ease pressure on health services.

Chris Smith, PhD, Non-Executive Director, ENA Respiratory and Brandon Capital partner, said: “Brandon Capital has supported ENA Respiratory since its earliest days because we recognised the potential of INNA-051 to transform the prevention and management of respiratory infections. With this new round of funding and the upcoming Phase 2 trial in the United States, ENA Respiratory is well on its way to delivering a therapy that could protect millions of vulnerable people worldwide.”

About ENA Respiratory

ENA Respiratory is a clinical-stage pharmaceutical company tackling respiratory viral infections through the development of host defense enhancers which locally prime and boost the body’s natural first line of defense against invading pathogens. Being virus-agnostic, ENA’s approach offers a solution to protect against common and emerging respiratory viruses for which vaccines or direct-acting antivirals have limitations or do not exist.

The company’s lead product, INNA-051, is being developed as a convenient, once-a-week nasal dry powder product to reduce the impact of viral respiratory infections and prevent severe complications in at-risk populations, including the elderly, those with an underlying medical condition (including chronic lung conditions, diabetes, kidney disease, and cardiovascular disease) and individuals with occupational risk (e.g. first responders, military or essential services personnel).

INNA-051 is a potent agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognising pathogens and potentiating innate immune responses. With a safety profile supporting seasonal prophylaxis use, it has demonstrated accelerated virus clearance and stimulation of antiviral host defenses, including IFN Type I & III responses, in a Phase IIa proof-of-principle study using a human influenza-challenge model.

Headquartered in Melbourne, Australia, with operations in the USA, ENA’s Investors include Brandon Capital, Flu Lab, the Gates Foundation, the Minderoo Foundation, Stoic Venture Capital and Uniseed. The Company is partnered with the US COPD Foundation to support patient-focused clinical development of INNA-051 in COPD and has been awarded contracts from the U.S. Government. It is an alumni member of BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate novel potential solutions for future pandemics.

For more information, please visit https://enarespiratory.com

Follow us on LinkedIn: https://www.linkedin.com/company/enarespiratory-pty-ltd/

About investors

Brandon Capital – https://brandoncapital.vc/

The Gates Foundation – https://www.gatesfoundation.org/

Flu Lab – https://theflulab.org/

Uniseed – https://uniseed.com/

Stoic Venture Capital – https://stoicvc.com.au/

For further information, please contact:

Media – Australia

Kirrily Davis, E: kdavis@bcpvc.com M: +61 (0)401 220228

Media – International

Charles Consultants

Sue Charles, E: sue.charles@charles-consultants.com M: +44 (0)7968 726585

Chris Gardner, E: Chris@CGComms.onmicrosoft.com M: +44 (0)7956 031077

Adlai Nortye to Present Short Talk on AN4035 Preclinical Results at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics




Adlai Nortye to Present Short Talk on AN4035 Preclinical Results at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Oct. 22, 2025 (GLOBE NEWSWIRE) — Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that it will deliver an oral presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held from October 22-26, 2025, in Boston, MA.

Key highlights of the presentation include:

• AN4035 demonstrated strong intracellular payload retention, driving nanomolar to picomolar cytotoxicity in CEACAM5-positive/RAS-addicted cancer cell lines, along with a potent bystander-killing effect
• AN4035 induced deep regression in CEACAM5-positive/RAS-addicted CDX and PDX models, achieving a 73% objective response rate in a patient-derived xenograft trial (N=26)
• AN4035 exhibited a favorable preliminary toxicology profile in cynomolgus monkeys

Tricomplex pan-RAS(ON) inhibitors currently in clinical development have demonstrated encouraging efficacy; however, their therapeutic potential has been limited by presumably on-target, off-tumor toxicities, particularly in the skin and gastrointestinal tract. AN4035, Adlai Nortye’s novel CEACAM5-targeting antibody-drug conjugate (ADC), was specifically designed to address these limitations. By delivering a proprietary pan-RAS(ON) inhibitor payload directly to tumors, AN4035 aims to reduce systemic toxicities, widen the therapeutic window and enable rational combination therapies.

“We are delighted that AN4035, our first-in-class CEACAM5-targeting ADC armed with our proprietary pan-RAS(ON) inhibitor payload, has been selected for an oral presentation at this prestigious conference,” said Archie Tse, MD, PhD, Head of Research and Development at Adlai Nortye. “We hypothesized that an ADC approach could overcome some of the limitations of pan-RAS(ON) inhibitors by focusing their activity within tumors, thereby improving efficacy while minimizing on-target, off-tumor toxicities. The encouraging preclinical results we have seen to date support this hypothesis and reinforce our belief that AN4035 could represent the next generation of therapies against RAS-addicted tumors — either as stand-alone treatments or in rational combinations, especially for CEACAM5 overexpressing tumors such as colorectal cancer.”

This recognition underscores the strength of Adlai Nortye’s integrated ADC and small molecule discovery platforms and reflects the Company’s continued commitment to delivering transformative oncology therapies that expand the therapeutic window for patients with difficult-to-treat cancers.

Oral Presentation details:

Abstract title: Discovery of AN4035: A novel CEACAM5-targeting antibody drug conjugate (ADC) armed with a proprietary pan-RAS(ON) inhibitor payload, designed to broaden the therapeutic window (Abstract# LB-C001)

Date and Time: Saturday, October 25, 2025; 11:45 AM – 12:15 PM ET

Session Title: Spotlight on Proffered Papers 3: Novel Therapeutic Agents

Location: Level 3, Ballroom AB, Hynes Convention Center, Boston, MA

Poster Presentation details:

Poster Title: Discovery of AN4035: A novel CEACAM5-targeting antibody drug conjugate (ADC) armed with a proprietary pan-RAS(ON) inhibitor payload, designed to broaden the therapeutic window

Poster Session date and time: Saturday, October 25, 12:30 AM – 16:00 PM ET

Location: Poster Session C

Poster Number: LB-C001

For more information, please refer to the AACR website and conference app.

About AN4035

AN4035 is a proprietary CEACAM5-targeting antibody drug conjugate (ADC) designed to deliver potent anti-tumor activity with an improved therapeutic window. It is armed with Adlai Nortye’s first-in-class pan-RAS(ON) inhibitor payload, which effectively target a broad spectrum of CEACAM5-expressing, RAS-driven cancers.

About Adlai Nortye

Adlai Nortye (NASDAQ: ANL) is a global clinical-stage company focused on the development of innovative cancer therapies, with global R&D centers in the U.S. and China. We are advancing a portfolio of innovative drug candidates across two key therapeutic areas: next-generation PD-1/L1 modulation, including AN8025, a multifunctional fusion protein designed to modulate both T cells and antigen-presenting cells, and AN4005, a first-in-class oral small-molecule PD-L1 inhibitor; and RAS-targeted therapies, including AN9025, an oral pan-RAS(ON) inhibitor with potential to address multiple RAS-driven cancers, and AN4035, a novel CEACAM5-targeting antibody-drug conjugate armed with a potent pan-RAS(ON) inhibitor payload.

Forward-Looking Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets” and similar statements. Among other things, statements that are not historical facts, including statements about the Company’s beliefs and expectations, the business outlook and quotations from management in this announcement, as well as the Company’s strategic and operational plans, are or contain forward-looking statements.

The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. Factors that could cause the Company’s actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of the Company’s preclinical studies, clinical trials and other therapeutic candidate development efforts; the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results will be predictive of real-world results; the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of the Company’s therapeutic candidates; the Company’s ability to establish, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; the implementation of the Company’s business model and strategic plans for its business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the PRC and United States or elsewhere. Further information regarding these and other risks is included in the Company’s filings with the SEC. All information provided in this announcement and in the attachments is as of the date of this announcement, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Company contact:
Investor Relations
Email: ir@adlainortye.com

Biomea Fusion to Participate in Citi’s SMID Biotech C-Suite Fireside Chat Series




Biomea Fusion to Participate in Citi’s SMID Biotech C-Suite Fireside Chat Series

SAN CARLOS, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it will participate in Citi’s SMID Biotech C-Suite Fireside Chat Series on Thursday, October 23, 2025, at 8:00 a.m. Pacific Time / 11:00 a.m. Eastern Time.

A live audio webcast of the discussion will be available here or by visiting the Investors & Media section of Biomea’s website at https://investors.biomeafusion.com/news-events/events. A replay of the webcast will be available following the live event.

About Biomea Fusion
Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. We aim to cure.

Visit us at biomeafusion.com and follow us on LinkedIn, X and Facebook.

Contact:
Meichiel Jennifer Weiss
Sr. Director of Investor Relations and Corporate Development
ir@biomeafusion.com

Sotera Health Announces Third-Quarter 2025 Earnings Release Date




Sotera Health Announces Third-Quarter 2025 Earnings Release Date

CLEVELAND, Oct. 21, 2025 (GLOBE NEWSWIRE) — Sotera Health Company (Nasdaq: SHC), a leading global provider of mission-critical end-to-end sterilization solutions, lab testing and advisory services for the healthcare industry, today announced it will release its financial results for the third-quarter ended September 30, 2025 before the market opens on Tuesday, November 4, 2025. Following the release, management will host a conference call at 9:00 a.m. Eastern Daylight Time to discuss the Company’s financial results and operating highlights.

To participate in the live call, please dial 1-844-481-2916 (toll-free in the United States), or 1-412-317-0709 if dialing-in from other locations. A live webcast of the conference call will be accessible at this link or via the Investor Relations section of the Company’s website at Presentation & Events | Sotera Health, along with the accompanying materials. A replay of the webcast will be available on the Company’s website later in the day on November 4^th.

About Sotera Health
Sotera Health Company is a leading global provider of mission-critical end-to-end sterilization solutions, lab testing and advisory services for the healthcare industry. Sotera Health goes to market through three businesses – Sterigenics^®, Nordion^® and Nelson Labs^®. Sotera Health is committed to its mission, Safeguarding Global Health^®.

Updates can be found from time to time on recent developments in matters relevant to investors on the Investor Relations section of the Company’s website at Investor Relations | Sotera Health. For developments related to Ethylene Oxide, updates can be found at Ethylene Oxide | Sotera Health.

Source: Sotera Health Company

Contacts
Jason Peterson
Vice President, Investor Relations & Treasurer
IR@soterahealth.com 

Kristin Gibbs
Chief Marketing Officer, Sotera Health
kgibbs@soterahealth.com 

Supernus Pharmaceuticals to Announce Third Quarter 2025 Financial Results and Host Conference Call on November 4, 2025




Supernus Pharmaceuticals to Announce Third Quarter 2025 Financial Results and Host Conference Call on November 4, 2025

ROCKVILLE, Md., Oct. 21, 2025 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company expects to report third quarter 2025 financial and business results after the market closes on Tuesday, November 4, 2025.

Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will host a conference call to present the third quarter 2025 financial and business results on Tuesday, November 4, 2025, at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be accessible in the Events & Presentations section of the Company’s Investor Relations website at www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website at www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel product candidates for CNS disorders.

For more information, please visit www.supernus.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management’s current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products, the products of its subsidiaries, and products acquired through the acquisition of Sage; the Company’s ability to increase its net revenue from its products, the products of its subsidiaries, and products acquired through the acquisition of Sage; the Company’s ability to commercialize its products, the products of its subsidiaries, and products acquired through the acquisition of Sage; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; changes to laws and regulations applicable to our industry, the impact of macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

CONTACTS:

Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
(301) 838-2591

Or

INVESTOR CONTACT:

Peter Vozzo
ICR Healthcare
(443) 213-0505
peter.vozzo@icrhealthcare.com