Merck Data to be Presented at ASH 2025 Annual Meeting Showcase Continued Advancements in Hematology Pipeline and Novel Therapeutic Approaches

Merck Data to be Presented at ASH 2025 Annual Meeting Showcase Continued Advancements in Hematology Pipeline and Novel Therapeutic Approaches




Merck Data to be Presented at ASH 2025 Annual Meeting Showcase Continued Advancements in Hematology Pipeline and Novel Therapeutic Approaches

First presentation for MK-1045, a novel CD19xCD3 T-cell engager in patients with certain types of leukemia and lymphoma, and for bomedemstat, an LSD1 inhibitor, in patients with polycythemia vera

New data demonstrate continued progress with nemtabrutinib, an investigational non-covalent BTK inhibitor

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new data across multiple hematologic malignancies will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla. from Dec. 6-9. The data shared at the meeting will highlight the company’s ongoing commitment to advancing clinical research in hematology across Merck’s expanding and diverse pipeline of investigational candidates, with more than 20 abstracts being presented.


“The data we’re sharing at ASH 2025 reflect the continued growth and evolution of our promising hematology pipeline,” said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. “We continue to build on our leadership in oncology by advancing a diverse portfolio of investigational candidates and exploring novel modalities with the goal of improving outcomes and helping to address significant unmet needs for patients with hematologic neoplasms and malignancies.”

Data presentations will feature Merck’s pipeline candidates, including: MK-1045, an investigational CD19xCD3 T-cell engager; bomedemstat (MK-3543), an investigational, orally available lysine-specific demethylase 1 (LSD1) inhibitor; and nemtabrutinib (MK-1026), an investigational, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. Additionally, Merck will present new and updated results highlighting zilovertamab vedotin (MK-2140), an investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1).

Key data from Merck’s pipeline to be presented at the ASH 2025 Annual Meeting and Exposition:

– First presentation by Merck of updated results from the dose escalation and expansion portion of a Phase 1b/2 study assessing the efficacy and safety of MK-1045 in adults with relapsed or refractory B-cell acute lymphoblastic leukemia (Abstract #647)

– First-time results from the Phase 2 Shorespan-004 study evaluating bomedemstat for patients with polycythemia vera (PV) resistant or intolerant to cytoreductive therapy (Abstract #83)

– Initial results from an exploratory analysis of the BELLWAVE-003 study of acquired resistance and prognostic mutations in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated with nemtabrutinib (Abstract #797)

Details on abstracts listed above and additional key abstracts for Merck:

Acute lymphoblastic leukemia

Updated results from the Phase 1b/2 study of MK-1045, a novel CD19xCD3 T-cell engager, in adult participants with relapsed or refractory B-cell acute lymphoblastic leukemia. Y. Wang.

Abstract #647, Oral session, Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation

Polycythemia vera

Efficacy and safety of the LSD1 inhibitor bomedemstat in participants with polycythemia vera (PV) resistant or intolerant to cytoreductive therapy: the Phase 2 Shorespan-004 study. L. Rein.

Abstract #83, Oral session, Myeloproliferative Syndromes: Clinical and Epidemiological

Essential thrombocythemia

 

Shorespan-017: Phase 3 extension study for safety of bomedemstat in participants with essential thrombocythemia who received bomedemstat from a prior clinical study. M. Marchetti.

Abstract #2033, Poster session, Myeloproliferative Syndromes: Clinical and Epidemiological

Chronic lymphocytic & small lymphocytic lymphoma

Genomic assessment of acquired mutations in participants with CLL/SLL treated with nemtabrutinib in the Phase 2 BELLWAVE-003 study. T. Kipps.

Abstract #797, Oral session, Chronic Lymphocytic Leukemia: Clinical and Epidemiological

Nemtabrutinib plus venetoclax in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: results from the dose escalation and confirmation segment of the Phase 3 BELLWAVE-010 study. P. Ghia.

Abstract #2119, Poster session, Chronic Lymphocytic Leukemia: Clinical and Epidemiological

Marginal zone lymphoma

Phase 2 BELLWAVE-003 Cohort F: Updated clinical outcomes of nemtabrutinib in participants with relapsed or refractory marginal zone lymphoma. M. Ozcan.

Abstract #1801, Poster session, Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological

Follicular lymphoma

 

Nemtabrutinib in participants with relapsed or refractory follicular lymphoma: updated efficacy and safety from Cohort G of the Phase 2 BELLWAVE-003 study. W. Jurczak.

Abstract #3570, Poster session, Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological

Phase 1 study of MK-1045, a novel CD19xCD3 T-cell engager, in participants with relapsed or refractory follicular lymphoma. Y. Song.

Abstract #5372, Poster session, Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological

Diffuse large B-cell lymphoma

Phase 2/3 trial of zilovertamab vedotin plus standard of care in relapsed/ refractory diffuse large B-cell lymphoma: updated analysis of waveLINE-003. P. Armand.

Abstract #3745, Poster session, Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies

Phase 2 trial of zilovertamab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone plus rituximab in diffuse large B-cell lymphoma: updated analysis of waveLINE-007. M. Ladetto.

Abstract #5516, Poster session, Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies

Phase 1 study of MK-1045, a novel CD19xCD3 T-cell engager, in participants with relapsed or refractory diffuse large B-cell lymphoma. Y. Song.

Abstract #3740, Poster session, Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies

About Merck in hematology

Merck is committed to advancing innovation and care for people with hematologic neoplasms and malignancies. Building on its leadership in oncology, the company has a broad clinical development program that evaluates novel mechanisms of action to address longstanding unmet needs for patients with hematologic neoplasms and malignancies. Among Merck’s research efforts are studies evaluating multiple investigational medicines as monotherapy or in combination with other therapies across a range of hematologic neoplasms and malignancies.

About MK-1045

MK-1045 (previously CN201) is a novel, investigational CD19xCD3 T-cell engager, designed to redirect T-cells to specifically deplete malignant or pathogenic B cells. It is currently being evaluated in a Phase 1 trial for the treatment of patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NCT06189391) and in a Phase 1b/2 trial for patients with relapsed or refractory B-cell acute lymphocytic leukemia (ALL) (NCT05579132).

About bomedemstat (MK-3543)

Bomedemstat (MK-3543) is an investigational, orally available small molecule that inhibits lysine-specific demethylase 1 (LSD1), an enzyme that is potentially important for regulating the rapid reproduction of blood stem cells and the maturation of blood cells in the bone marrow. Bomedemstat is being studied across myeloproliferative neoplasms, including essential thrombocythemia, myelofibrosis and polycythemia vera. Two Phase 3 trials are ongoing: Shorespan-006 (NCT06079879), an open-label study comparing bomedemstat to best available therapy in patients with essential thrombocythemia who have an inadequate response to or are intolerant of hydroxyurea, and Shorespan-007 (NCT06456346), a double-blind study evaluating bomedemstat versus hydroxyurea in patients with essential thrombocythemia who have not previously received cytoreductive therapy.

About nemtabrutinib (MK-1026)

Nemtabrutinib is an investigational oral, reversible, non-covalent BTK inhibitor that suppresses oncogenic B-cell receptor signaling with activity against wild-type BTK and BTK pathway mutants. Nemtabrutinib aims to address a common mechanism of resistance with currently available covalent, BTK inhibitors by binding in an alternative way to the BTK protein. Merck is advancing research with nemtabrutinib across B-cell malignancies through its BELLWAVE clinical program. Two Phase 3 trials are ongoing: BELLWAVE-008 (NCT05624554), comparing nemtabrutinib to chemoimmunotherapy in previously untreated CLL/SLL without TP53 aberrations, and BELLWAVE-011 (NCT06136559), evaluating nemtabrutinib versus investigator’s choice of BTK inhibitors (ibrutinib or acalabrutinib) in previously untreated CLL/SLL.

About zilovertamab vedotin (MK-2140)

Zilovertamab vedotin is an investigational ADC that targets ROR1. ROR1 is a transmembrane protein that is overexpressed in multiple hematologic malignancies. Merck is committed to research with zilovertamab vedotin across B-cell malignancies and has established a robust program of clinical trials under the name waveLINE. The waveLINE program includes a Phase 3 study in patients with relapsed/refractory DLBCL (waveLINE-003, NCT05139017), a Phase 3 study in patients with previously untreated DLBCL (waveLINE-010, NCT06717347), a Phase 2 study in patients with select B-cell lymphomas (waveLINE-006, NCT05458297), a Phase 2 study in patients with germinal center B-cell-like DLBCL (waveLINE-011, NCT06890884) and a Phase 2 study in patients with previously untreated DLBCL (waveLINE-007, NCT05406401).

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they 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.

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 health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’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 the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

julie.cunningham@merck.com

Sofia DiMartino Bu

(857) 274-4296

sofia.dimartino@merck.com

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

peter.dannenbaum@merck.com

Steven Graziano

(732) 594-1583

steven.graziano@merck.com

BioCorteX Announces Strategic Partnership with CD Biopharma of China

BioCorteX Announces Strategic Partnership with CD Biopharma of China




BioCorteX Announces Strategic Partnership with CD Biopharma of China

UK company’s high tech expertise allows for accelerated development of anti-cancer drugs aimed at solid tumors

BioCorteX Carbon Mirror platform increases the likelihood of trial success

LONDON–(BUSINESS WIRE)–BioCorteX, the UK-based pioneering tech bio company, said Wednesday that it had entered into a strategic collaboration with Chinese biotech company CD Biopharma to accelerate the development of next-generation precision immunotherapy-based drugs that fight solid tumors such as lung and breast cancer.


“We are thrilled to be working with CD Biopharma on breaking new ground in treating cancer,” said Nik Sharma, Co-Founder and CEO of BioCorteX. “Our technology offers CD Biopharma and others a capability no other company can: Our Carbon MirrorTM technology allows us to test drugs in silico and chart the optimal route to success across tumour type, regions, geographies, and communities of people.

“We are truly excited at the real innovation occurring within the Chinese biotech space. Our platform helps de-risk assets that can fail when trialled in different geographies. There is only one shot at a real-world trial, and we believe that Carbon Mirror can help companies with exciting early clinical data looking to out or in-license to different geographies.”

“We have the ability to test candidates like those on CD Biopharma’s Bispecific Fusion Protein platform, including its leading clinical candidate, CD-001, and then help the company increase the probability of success of CD-001 across geographies,” Sharma said. “That knowledge de-risks development, unlocking value.”

CD Biopharma, founded in 2021, has rapidly emerged as an innovative force in precision immunotherapy, developing breakthrough treatments through its proprietary Bispecific Fusion Protein platform. The company’s unique approach targets specific cells to precisely tune immune responses, offering new therapeutic strategies across oncology, viral infections, and autoimmune diseases.

“This alliance with BioCorteX represents a significant milestone in our mission to revolutionize immunotherapy,” said Dr. Alan Xu, CEO of CD Biopharma. “Their expertise in in silico drug development, combined with our cutting-edge precision immunotherapy platform, creates a powerful synergy that will accelerate our path to bringing life-changing treatments to patients worldwide.”

CD Biopharma’s lead program, CD-001, has achieved significant regulatory milestones, with Investigational New Drug (IND) approvals from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) for advanced solid tumor indications. The First-in-Human (FIH) solid tumor trial is currently underway.

About CD Biopharma

CD Biopharma is a clinical-stage biotechnology company founded in 2021, dedicated to developing next-generation immunotherapies through precision immune system calibration. Based in Suzhou, China, the company’s proprietary platform includes breakthrough Bispecific Fusion Protein (BsFP) technology and unique cell modification approaches (IME Cell) that enable precise targeting of immune responses. CD Biopharma’s research covers oncology, viral infections, and autoimmune diseases, with its lead program CD-001 approaching clinical trials.

About BioCorteX

BioCorteX is a Draper—Sofinnova backed tech bio with ambitions of transitioning the mainstream pharmaceutical industry to a new era where in silico drug development unlocks more effective therapeutics. While immune-oncology is the beachhead, BioCorteX will eventually tackle several therapeutic areas to dramatically improve the 4% success rate and reduce the $ 244 billion spent each year across drug development.

We are characterised by a highly differentiated technology and scientific approach. We understand that creating novel technology is valuable but will only take you so far. It is the combination of our innovative technology with a ‘unified biology’ scientific approach that makes BioCorteX unique.

We focus on ADC & bispecifics that are moving regions, i.e. China, to Global. Our validated key product, Carbon Mirror™, uses the ‘right-first-time’ approach from aerospace to increase clinical success across drug development by uncovering drug-bacteria interactions. Carbon mirror is a foundational emulator that determines (in)compatibility across drug development.

Contacts

Media Contacts

Morgan Borer

Blair Reputation Management

+44 7444 869082

Mark Herr

Mark Herr Communications

203-517-8957

POXEL SA: Update on the Proposed Recovery Plan and Organisation of a Webinar

POXEL SA: Update on the Proposed Recovery Plan and Organisation of a Webinar




POXEL SA: Update on the Proposed Recovery Plan and Organisation of a Webinar

  • Poxel’s recovery plan has been finalised:

    • Main objectives:

      • accelerating commercial development and partnership-seeking activities for Imeglimine outside Japan, PXL 770 and PXL 065,
      • significantly reducing the Company’s costs, and
      • clearing the Company’s liabilities.
    • It was developed with the support of its long-standing financial partner IPF.
    • IPF and IRIS have committed to providing the Company with new financing of up to €11.25 million (including amounts drawn during the observation period) to turn it around.
    • The draft plan remains subject to the decision of the Commercial Court (Tribunal des activités économiques) of Lyon.
  • As a reminder, shareholders will meet at the annual general meeting on 11 December 2025 to approve, in particular:

    • Poxel’s 2024 annual and consolidated financial statements,
    • the listing of Poxel shares on Euronext Growth, and
    • the delegations relating to capital transactions aimed at carrying out:

      • a capital increase with preferential subscription rights, open to all shareholders,
      • a capital increase reserved for IPF, and
      • enable the new IRIS financing.
  • The implementation of these various financing and capital transactions is an essential condition of the recovery plan to maintain Poxel’s business and avoid judicial liquidation.
  • Organisation of a webinar open to all shareholders to present the draft recovery plan and future development prospects, to be held on next 26 November.

LYON, France–(BUSINESS WIRE)–Regulatory News:


POXEL SA (Euronext: POXEL – FR0012432516), a clinical-stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic diseases (the “Company“), provides an update on its proposed recovery plan and announces the organisation of a webinar.

Nicolas Trouche, Chief Executive Officer of Poxel, said: “The new management team has been working hard since August to bring the company out of receivership and avoid liquidation. Costs are now under control. The business development function has been significantly strengthened thanks to the contribution of Yves Decadt and the support of a committed board of directors with extensive experience in biotech. The draft recovery plan that we have developed with our partners ensures sustainable financing for the Company and a restructuring of its financial structure, while allowing its shareholders to fully benefit from its implementation.”

Update on the receivership proceedings and the draft recovery plan

Key aspects of the recovery plan

Poxel’s draft recovery plan has been finalised. As a reminder, Poxel has a new management team and a board of directors with experience in biotech, whose role is to implement the draft recovery plan. This includes a business development expert who has conducted a strategic review of Poxel’s portfolio to help develop this draft plan, whose priorities in terms of commercial development are as follows:

  • Establish new partnerships to commercialise Imeglimine in Asia, with priority given to China and countries that do not require new clinical studies;
  • Promote PXL770 in ADPKD; and
  • Leverage PXL065 in HCM.

Poxel’s new management team is fully committed to implementing this draft recovery plan and seeking partnerships to monetise Poxel’s assets in order to recreate value for the Company’s shareholders.

The proposed recovery plan is based on a structure that has been repositioned to focus on the core of its business, and the new management team has been working since August to streamline the cost structure in order to preserve cash flow and refocus spending on business development needs, in particular through:

  • An adjustment of the workforce and the possibility of using outsourced resources, according to the Company’s needs and when needed, capable of focusing on selected objectives in an efficient and cost-effective manner;
  • A significant reduction in administrative and audit costs, in particular through the transfer of the listing to Euronext Growth (subject to approval by the general meeting), which will reduce regulatory expenses; and
  • The outsourcing of central functions in order to reduce fixed costs on a long-term basis.

The Company’s proposed recovery plan is based on the settlement of liabilities as follows:

  • The Orbimed and IPF debts secured by trusts will be settled in accordance with their contractual terms. However, with a view to accelerating the Company’s debt reduction, as part of the financial delegations submitted to the general meeting for approval and the implementation of capital increases, part of the IPF debt will be converted into shares;
  • IRIS, which is also contributing to the financing effort, will have its financing settled in accordance with its contractual stipulations through the exercise of share subscription warrants (BSA) (subject to approval by the general meeting) in set off with some of its receivables; and
  • The other creditors will be repaid according to a schedule currently under discussion.

Update on financing and the planned schedule for strengthening the financial structure

IPF and IRIS, Poxel’s long-standing creditors, have committed to providing new financing over five years, subject to certain conditions, to meet Poxel’s financing needs, thereby demonstrating their confidence in the Company’s ability to recover and in its development prospects, as follows:

  • IPF has already made available up to €2.5 million for the receivership and has committed to providing additional financing bringing its total contribution to €6.25 million, in addition to the €11 million still owed to it to date; and
  • IRIS has committed to an equity line programme, limited to €1 million per year over five years, in order to limit the dilutive impact.

No other external player has yet come forward to finance Poxel’s recovery.

The new IRIS and IPF financing should cover Poxel’s financing needs until the Company generates positive cash flow.

Links between the new financing and the proposed recovery plan

As a reminder, the implementation of the financing and the recovery plan will require prior approval by:

  • the Commercial Court of Lyon (Tribunal des activités économiques), and
  • the general meeting of shareholders on 11 December 2025 to vote on the financial delegations to the Board of Directors, enabling in particular1 :

    1. the completion of a capital increase with preferential subscription rights for shareholders, open to Poxel shareholders and guaranteed by IPF provided that the threshold of 29.9% of the Company’s share capital is not exceeded as a result of the share capital increase (through offsetting of receivables held by IPF under the bond issue), offering shareholders the opportunity to subscribe at a very attractive discount;
    2. the completion of a capital increase through the offsetting of receivables (held by IPF in respect of the bond loan) reserved for IPF Partners, enabling Poxel’s debt to be significantly reduced, subject to certain conditions, it being noted that the number of shares to be issued as part of this capital increase will be determined by the Board of Directors so that IPF holds, approximately 29.9% of the Company’s share capital after completion of the two transactions;
    3. the issue of share warrants to shareholders on the one hand, and as part of the financing granted by IRIS on the other (thereby enabling the implementation of the IRIS Financing described below); and
    4. the listing of Poxel shares on Euronext Growth.

To date, subject to the approval of the resolutions and market conditions at the time of launch, it is envisaged that the capital increase with preferential subscription rights for shareholders will be carried out at a discount of between 30% and 50% to the current share price, and that the capital increase reserved for IPF, if implemented, will be carried out at a premium of between 5% and 10% compared to the price of the capital increase with preferential subscription rights. This confirms Poxel’s desire to involve its long-standing shareholders in strengthening its financial structure on very attractive terms.

Furthermore, in this context, Poxel, IPF Partners and IRIS have signed a term sheet setting out the terms and conditions for the provision of IRIS financing (the “IRIS Financing“) subject to the conditions mentioned above.

Main terms of the new IPF bond financing

The new bond financing made available to the Company by IPF is made possible by a contractual adjustment to Tranche D (the “PDR Tranche D“) of the existing IPF bond loan, for a total principal amount equivalent to that of Tranche D (i.e., €6.25 million), less the amount made available to the Company under the Tranche D financing made available during the observation period (the “PO Tranche D“).

This adjustment to Tranche D provides for the modification of the following provisions:

  • Capitalised interest rate for PDR Tranche D: 35%;
  • Commitment fee applicable to PDR Tranche D: 10%;
  • Exit fee of 13.7% applicable to PDR Tranche D and PO Tranche D: calculated on the basis of the total amount of bonds issued;
  • Allocation rate for Japanese royalties for all tranches of the IPF bond issue: 90%;
  • Availability: in addition to the conditions already set out in the Tranche D documentation, issues under PDR Tranche D will be conditional upon the achievement of Imeglimine sales targets;
  • Early repayment: 50% of the proceeds from any licensing transaction relating to the assets transferred to the 2024 Residual Intellectual Property Trust will be allocated, if IPF so requests, to the repayment of IPF’s receivables, up to an overall ceiling of €20 million.
  • Availability period: PDR Tranche D will be available until the fifth anniversary of the plan’s adoption. The Company will be able to request this financing whenever its net available cash is less than €500,000.
  • Security: PDR Tranche D is secured by trusts guaranteeing the IPF bond loan and granting the benefit of the post-money privilege provided for in Article L. 626-10 of the French Commercial Code (applicable by reference to Article L. 631-19); and

It is expected that the financing documentation relating to Tranche D and, where applicable, other financing documents relating to the IPF bond or the trusts, will be amended to reflect the above and to provide a contractual framework for the provision of PDR Tranche D.

The implementation of the new IPF bond financing has no dilutive impact on shareholders.

Main terms of the IRIS bond financing

The IRIS financing would take the form of a free allocation of 40 million share warrants entitling the holder to 40 million ordinary shares of Poxel, and IRIS would subscribe, at its sole discretion, to these ordinary shares of the Company in one or more tranches by exercising a sufficient number of warrants to provide the Company with an amount of at least €250,000 per quarter over five years, but only at the Company’s request (it being specified that the subscription price of the shares would be equal to 92% of the volume-weighted average value of the trading day immediately preceding IRIS’s sending of an exercise request) (the “IRIS Warrants“). Any amount of the exercise price exceeding this quarterly cash amount would be paid by offsetting it against the amounts then owed by the Company to IRIS (including its current bond debt). The warrants would be exercisable for a period of five years following their issue, which should take place as soon as the capital increases have been completed.

This financing benefits from the privilege provided for in Article L. 626-10 of the French Commercial Code (applicable by reference to Article L. 631-19).

For illustrative purposes only, based on the closing price of the Company’s shares on 21 November 20252, the number of shares that would be issued if all IRIS warrants were exercised would correspond to approximately 6% of the Company’s share capital per year on average over the term of the IRIS financing (based on the share capital after completion of the contemplated share capital increases).

Issue of Share Subscription Warrants to Shareholders

As part of the strengthening of Poxel’s financial structure and the desire to involve long-standing shareholders in the potential long-term gains expected from the recovery, without putting money in today, it is planned to allocate share subscription warrants (BSAs) to all shareholders, up to 10% of the post-capital increase share capital (transaction subject to approval by the general meeting) (the “Shareholder BSAs“).

These warrants will have the following characteristics:

  • They will be free of charge.
  • They will have a term of 10 years, and
  • They will have an exercise price set by the Board of Directors according to market conditions.

The implementation of these various financing and capital transactions are essential conditions of the recovery plan to accelerate Poxel’s business with new experienced governance and a healthier cost structure, thereby avoiding judicial liquidation.

Dilution

The implementation of the above transactions, which are expected to be carried out during the first half of 2026, could result in significant dilution for existing shareholders, particularly those who decide not to exercise their preferential subscription rights in connection with the capital increase with preferential subscription rights.

The dilution percentages below are provided for illustrative purposes only, based on the following assumptions:

  • Theoretical subscription price for the capital increase with preferential subscription rights corresponding to the closing price of Poxel shares on 21 November 20253, less a discount that could range from 30% to 50%, i.e. a theoretical subscription price of between 0.1150 euros and 0.1610 euros per share; and
  • Theoretical subscription price for the reserved capital increase corresponding to the theoretical subscription price for the capital increase with maintenance of the aforementioned pre-emptive subscription rights, increased by a premium of between 5% and 10%, i.e. a theoretical subscription price of between 0.1208 euros and 0.1771 euros per share.

The dilution percentages are presented based on the theoretical level of participation of existing shareholders in the capital increase with preferential subscription rights, it being recalled that this level of participation affects the number of shares issued as part of the capital increase reserved for IPF, which should enable IPF to hold, after completion of the capital increases, 29.9% of the share capital. No new shares would therefore be issued as part of the capital increase reserved for IPF if no existing shareholder participates in the capital increase with preferential subscription rights (leading IPF to subscribe to the capital increase with preferential subscription rights under its guarantee commitment to hold up to 29.9% of the Company’s share capital after the capital increase with preferential subscription rights ).

Subscription to the entire capital increase with preferential subscription rights by existing shareholders

The table below shows, for information purposes, the impact of the issue of new shares resulting from the capital increases, taking into account the participation of a shareholder holding 1% of the Company’s share capital prior to these issues (calculations based on the number of shares comprising the Company’s share capital as at 31 October 2025) according to their participation in the capital increases, in the event that the entire capital increase with preferential subscription rights is subscribed by existing shareholders.

 

Exercise of all its preferential subscription rights by the shareholder in respect of the capital increase with preferential subscription rights

Without exercise of its preferential subscription rights by the shareholder in respect of the capital increase with preferential subscription rights

Before completion of the transactions

1.000%

1.000%

– After the issue of approximately 26,828,778 new shares as part of the capital increase with preferential subscription rights at a theoretical subscription price of 0.1150 euros (lower end of the indicative range)

1.000%

0.6667%

 

– After the issue of approximately 26.828.778 new shares as part of the capital increase with preferential subscription rights at a theoretical subscription price of 0.1610 euros (upper end of the indicative range)

1.000%

0.6667%

– After the issue of approximately 34,477,719 new shares as part of the capital increase reserved for IPF at a theoretical subscription price of 0.1208 euros (lower end of the indicative range)

0.7001%

0.4667%

 

– After the issue of approximately 34,477,719 new shares as part of the capital increase reserved for IPF at a theoretical subscription price of 0.1771 euros (upper end of the indicative range)

0.7001%

0.4667%

Subscription to 50% of the capital increase with existing shareholders retaining their pre-emptive subscription rights

The table below shows, for information purposes, the impact of the issue of new shares resulting from the capital increases, taking into account the participation of a shareholder holding 1% of the Company’s share capital prior to these issues (calculations based on the number of shares comprising the Company’s share capital as at 31 October 2025) according to their participation in the capital increases, in the event that half of the capital increase with preferential subscription rights is subscribed by existing shareholders.

 

Exercise of all its preferential subscription rights by the shareholder in respect of the capital increase with preferential subscription rights

Without exercise of its preferential subscription rights by the shareholder in respect of the capital increase with preferential subscription rights

Before completion of the transactions

1.000%

1.000%

– After the issue of approximately 26,828,778 new shares as part of the capital increase with preferential subscription rights at a theoretical subscription price of 0.1150 euros (lower end of the indicative range)

1.000%

0.6667%

 

– After the issue of approximately 26.828.778 new shares as part of the capital increase with preferential subscription rights at a theoretical subscription price of 0.1610 euros (upper end of the indicative range)

1.000%

0.6667%

– After the issue of approximately 15,317,044 new shares as part of the capital increase reserved for IPF at a theoretical subscription price of 0.1208 euros (lower end of the indicative range)

0.8401%

0.5601%

 

– After the issue of approximately 15,317,044 new shares as part of the capital increase reserved for IPF at a theoretical subscription price of 0.1771 euros (upper end of the indicative range)

0.8401%

0.5601%

No subscription to the capital increase with existing shareholders retaining their pre-emptive subscription rights

The table below shows, for information purposes, the impact of the issue of new shares resulting from the capital increases, taking into account the participation of a shareholder holding 1% of the Company’s share capital prior to these issues (calculations based on the number of shares comprising the Company’s share capital as at 31 October 2025) according to their participation in the capital increases, in the event that the capital increase with preferential subscription rights is not subscribed by any existing shareholder.

 

Without exercise of its preferential subscription rights by the shareholder in respect of the capital increase with preferential subscription rights

Before completion of the transactions

1.000%

– After the issue of approximately 22,985,147 new shares as part of the capital increase with maintenance of pre-emptive subscription rights at a theoretical subscription price of 0.1150 euros (lower end of the indicative range)

0.7001%

 

– After the issue of approximately 22,985,147 new shares as part of the capital increase with preferential subscription rights at a theoretical subscription price of 0.1610 euros (upper end of the indicative range)

0.7001%

The Company will hold a webinar open to all shareholders to present the draft recovery plan on 26 November: https://app.livestorm.co/p/43c96e92-66d9-44da-93c1-6b73eaef7fe8

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, and Tokyo, Japan.

For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release concerning future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, but are not limited to, any statements preceded, followed or including words such as “objective,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “may have,” “likely,” “should,” “could” and other words and terms of similar meaning, or the negative form of these words and terms. Forward-looking statements are subject to inherent risks and uncertainties beyond the company’s control that could cause the company’s actual results or performance to differ materially from the results or performance expected, expressed or implied in such forward-looking statements. Actual events or results may differ from those described in this document due to a number of risks or uncertainties described in the Company’s 2024 Universal Registration Document available on the Company’s website and on the website of the AMF (https://www.amf-france.org/fr). The Company does not endorse or accept responsibility for the content of external hyperlinks mentioned in this press release.

This press release is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to purchase securities in any jurisdiction.

 

1 The proposed transactions involving Poxel’s share capital were announced in a press release dated 5 November 2025

2 That is 0.23 euro, to which an 8% discount would be applied to calculate the exercise price of the IRIS warrants (i.e., 0.2116 euro per share).

3 That is 0.23 euro.

 

Contacts

Investor Relations / Media

NewCap

Aurélie Manavarere, Théo Martin / Arthur Rouillé

investors@poxelpharma.com
+33 1 44 71 94 94

Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention

Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention




Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention

Not intended for UK Media

  • OCEANIC-STROKE demonstrates superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy
  • OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor
  • Bayer will globally engage with health authorities in preparation for the submission of marketing authorization applications and looks forward to presenting the results at an upcoming scientific congress

BERLIN–(BUSINESS WIRE)–Bayer today announced positive topline results from the global Phase III study OCEANIC-STROKE, with its investigational, once daily, oral FXIa inhibitor asundexian. The study met its primary efficacy and safety endpoints. Asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk ischemic attack. There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in combination with antiplatelet therapy. Detailed results of OCEANIC-STROKE will be presented at an upcoming scientific congress.

Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke.1,2 Despite available secondary stroke prevention options, the risk of secondary stroke remains high. One in five stroke survivors will have another stroke within five years.3 Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke.2,4,5

“As clinicians, we see every day how devastating a recurrent stroke can be for patients and their families2,” said Mike Sharma, MD, principal investigator of the Population Health Research Institute (PHRI) OCEANIC-STROKE study, Senior Scientist at PHRI (a joint institute of McMaster University and Hamilton Health Sciences), Director of the Stroke Program at Hamilton Health Sciences, and Michael G. DeGroote Chair in Stroke Prevention at McMaster University. “Even with currently available therapies, the risk of another stroke remains high, and each recurrence can have profound consequences. The topline results from OCEANIC-STROKE indicate that asundexian may become a new treatment option to reduce this risk – representing a potential major step forward in secondary stroke prevention.”

“We are excited by these positive topline findings which highlight the potential of Factor XIa inhibition as a new way to help protect patients from a recurrent stroke,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “This marks an important milestone in Bayer’s longstanding commitment to advancing innovation in thrombosis prevention. We extend our sincere gratitude to the investigators, patients, and colleagues whose dedication made this milestone possible.”

Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication.

About OCEANIC-STROKE

The OCEANIC-STROKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that has enrolled over 12,300 patients. The main study results will be presented at an upcoming scientific congress.

About FXIa inhibitors and Asundexian

Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage. Asundexian, a direct inhibitor of FXIa, is theorized to reduce thrombus formation that can lead to vessel stenosis or blockage, without a significant increase in major bleeding. Asundexian is currently being evaluated as a potential treatment option in thrombosis prevention. Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication.

About Bayer’s Commitment in Cardiovascular Diseases

Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. We have set a clear focus on developing innovative therapies to treat cardiovascular diseases (e.g., stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases. Our strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals

aj (2025-0215)

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

  1. Feigin VL, et al. World Stroke Organization (WSO): global stroke fact sheet 2022. International Journal of Stroke. 2022 Jan;17(1):18-29.
  2. Feigin VL, et al. Pragmatic Solutions to Reduce Global Burden of Stroke. Lancet Neurol. 2023;22:1160–1206.
  3. Kolmos M, et al. Recurrent ischemic stroke–a systematic review and meta-analysis. Journal of Stroke and Cerebrovascular Diseases. 2021 Aug 1;30(8):105935.
  4. Rochmah TN, et al. Economic burden of stroke disease: a systematic review. International journal of environmental research and public health. 2021 Jul 15;18(14):7552.
  5. Skajaa N, et al. Risks of stroke recurrence and mortality after first and recurrent strokes in Denmark: a nationwide registry study. Neurology. 2022 Jan 25;98(4):e329-42.

Contacts

Contact for media inquiries:
Anne Jorgal, phone +49 30 2215-41592
Email: anne.jorgal@bayer.com

Contact for U.S. inquiries:
Elaine Colón, phone +1 732-236-1587
Email: elaine.colon@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Owkin Unveils Europe’s First Pan-European Agentic Infrastructure for Biology at the Franco-German Digital Sovereignty Summit

Owkin Unveils Europe’s First Pan-European Agentic Infrastructure for Biology at the Franco-German Digital Sovereignty Summit




Owkin Unveils Europe’s First Pan-European Agentic Infrastructure for Biology at the Franco-German Digital Sovereignty Summit

BERLIN–(BUSINESS WIRE)–At today’s Franco-German Summit on Digital Sovereignty in Berlin, Owkin, together with leading academic partners Gustave Roussy (France) and Charité Comprehensive Cancer Center (Germany), announced a landmark initiative to build the first pan-European agentic infrastructure to make biological data AI-ready, as a key step towards biological super intelligence.




The project aims to develop and deploy modern AI methods to support biological research and drug development. An initial focus will be on supporting the harmonization and structuring of biomedical data across Europe to enhance scientific collaboration. It will combine agentic AI systems and cutting-edge biomedical data structuring, to power a new reasoning model capable of automating and augmenting every stage of biological research and drug development.

The development of specific AI methods and analytical procedures will be dynamic and will depend on the quality of available data as well as current advances in AI research. The partners are currently working on defining the technical and legal framework to meet the highest standards in data protection and data security.

The initiative underscores the partners’ commitment to strengthening the European research landscape through innovative approaches while consistently considering data protection requirements.

Positioned as a flagship pilot for European digital sovereignty in health, the initiative aims to deliver open, reusable, and immediately impactful outputs for researchers, clinicians, and innovators across the EU. It seeks to demonstrate that Europe can lead globally in the emerging field of AI-native biology, a domain where the race is still open, even as large US players dominate the field of general-purpose LLMs.

“Europe can be number one in biological AI. While the race for general-purpose LLMs has largely been won by American companies, the field of biology-native reasoning systems remains wide open, and it plays directly to Europe’s strengths: its healthcare systems, its academic excellence, and its unmatched biomedical data,” said Thomas Clozel, MD, Co-Founder and CEO of Owkin.

“This initiative demonstrates how Europe can turn its scientific excellence into tangible advances for patients. By combining data across borders with next-generation AI, we can accelerate the translation of discoveries into clinical impact, responsibly and securely,” said Fabrice André, MD, PhD, Director of Research, Gustave Roussy

“True digital sovereignty in health depends on trust. This initiative sets new standards for data governance and collaboration, ensuring that innovation happens within European institutions, under European values, for the benefit of European patients,” said Ulrich Keilholz, MD, Senior Professor, Charité Comprehensive Cancer Center

By aligning major research institutions, next-generation AI capabilities, and a shared vision for sovereignty, this project paves the way toward biological artificial superintelligence, a strategic domain with the potential to transform healthcare, accelerate discoveries, and ensure that Europe remains in control of the technologies shaping its future.

About Owkin:

Owkin is an AI company on a mission to solve the complexity of biology. It is building the first Biology Super Intelligence (BASI) by combining powerful biological large language models, multimodal patient data, and agentic software. At the heart of this system is Owkin K, an AI copilot and its new LLM finetuned on biology called Owkin Zero, used by researchers, clinicians, and drug developers to better understand biology, validate scientific hypotheses, and deliver better diagnostics and therapies faster.

About Gustave Roussy:

Ranked first in France, first in Europe and sixth in the world, Gustave Roussy is a centre of global expertise entirely dedicated to patients living with cancer. The Institute is a founding pillar of the Paris Saclay Cancer Cluster. Source of therapeutic innovations and diagnostic breakthroughs, the Institute welcomes more than 50,000 patients each year, including 3,500 children and adolescents, and develops an integrated approach combining research, care and teaching. An expert in rare cancers and complex tumours, Gustave Roussy treats all cancers at all stages of life. It offers its patients personalised care that combines innovation and humanity, taking into account both care and the physical, psychological and social quality of life. With 4,100 employees at two sites, Villejuif and Chevilly-Larue, Gustave Roussy brings together the expertise essential for high-level cancer research; 32% of treated patients are included in clinical studies. To find out more about Gustave Roussy and follow the Institute’s news: www.gustaveroussy.fr/en, X, Facebook, LinkedIn, Instagram and Bluesky.

About Charité – Universitätsmedizin Berlin:

With more than 100 departments and institutes across four campuses and 3,293 beds, Charité – Universitätsmedizin Berlin is one of Europe’s largest university medical centers. At Charité, the areas of research, teaching, and medical and patient care are closely interconnected. Averaging about 20,600 employees Charité-wide and some 24,300 across the entire group of companies, Berlin’s university medicine organization remained one of the capital city’s largest employers in 2024. Charité is a leader in diagnosis and treatment of particularly severe, complex, and rare diseases and health conditions. A medical school and university medical center in one, Charité enjoys an outstanding reputation worldwide, combining first-class patient care with excellence in research and innovation, state-of-the-art teaching, and high-quality training and education. Everything Charité does revolves around people and their health. Charité pursues translational research in which scientific findings are applied to prevention, diagnostics, and treatment and clinical observations inform new approaches in research in turn. At Charité, the goal is to actively help shape the medicine of the future to benefit patients. www.charite.de/en/

Contacts

Press contacts:

Owkin

malika.labou-ext@owkin.com
+33 6 64 15 45 62

Gustave Roussy

Claire Parisel & Leona Pinto

presse@gustaveroussy.fr
+33 1 42 11 50 59

+33 1 42 11 63 59

Charité – Universitätsmedizin Berlin

Dr. Anne Rediger

Referentin Pressearbeit

+49 30 450 570 400

presse@charite.de

SINOVAC Announces Receipt of Nasdaq Notice of Delisting and Intention to Appeal

SINOVAC Announces Receipt of Nasdaq Notice of Delisting and Intention to Appeal




SINOVAC Announces Receipt of Nasdaq Notice of Delisting and Intention to Appeal

BEIJING–(BUSINESS WIRE)–Sinovac Biotech Ltd. (Nasdaq: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, announced today that on November 12, 2025, it received a delisting determination letter (the “Staff Determination”) from the Nasdaq Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, unless the Company timely requests a hearing before the Nasdaq Hearing Panel, which the Company intends to do, the Company’s securities would be subject to suspension and delisting from Nasdaq at the opening of business on November 21, 2025 as a result of the Company’s non-compliance with Nasdaq Listing Rule 5250(c)(1) (the “Listing Rule”) for its failure to timely file its annual report on Form 20-F for the year ended December 31, 2024 (the “2024 Annual Report”) by the Extension Deadline (defined below).

The Company previously disclosed in the Notification of Late Filing on Form 12b-25, filed with the U.S. Securities and Exchange Commission on April 29, 2025, that it was unable to timely file the 2024 Annual Report due to Grant Thornton Zhitong Certified Public Accountants LLP’s resignation on April 15, 2025 as the Company’s independent registered public accounting firm. As the Company subsequently disclosed on May 23, 2025, Nasdaq granted the Company a period of 60 calendar days from the date of the initial notification on May 16, 2025 for failure to timely file the 2024 Annual Report to submit a plan to regain compliance, and subject to acceptance of such plan, a period of 180 calendar days from the prescribed due date of the 2024 Annual Report, or until November 11, 2025 (the “Extension Deadline”), to file the 2024 Annual Report to regain compliance with the Listing Rule.

As the Company announced on October 24, 2025, it has engaged UHY LLP as its independent registered public accounting firm and the Company is working diligently with UHY LLP to be able to file the 2024 Annual Report as soon as possible to regain compliance with the Listing Rule.

The Company intends to appeal the Staff Determination to enable UHY LLP sufficient time to audit the financial statements required to file the 2024 Annual Report. The Company’s request for a hearing before the Nasdaq Hearing Panel to appeal the Staff Determination must be made on or before November 19, 2025. The hearing request will automatically stay the suspension of the Company’s securities for a period of 15 days from the date of the request. The Company also intends to seek a further stay of any suspension or delisting action pending the hearing process.

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.

SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, etc.

The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under “Category 1 Preventative Biological Products” and commercialized in China in 2016. In 2022, SINOVAC’s Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.

SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.

SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. Such statements are based upon current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, including without limitation risks, uncertainties and factors related to the completion of the audits of required fiscal periods, completion and filing of the 2024 Annual Report, decisions from the Nasdaq Hearing Panel and actions taken to regain compliance with the Listing Rule, all of which are difficult to predict and many of which are beyond the Company’s or Board’s control, which may cause actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company and Board do not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

Contacts

Media Contact
FGS Global

Email: sinovac@fgsglobal.com

Investor Contact
Sinovac Biotech Ltd.

Email: ir@sinovac.com

Bristol Myers Squibb Announces Accepted Amounts and Pricing Terms of its Tender Offers

Bristol Myers Squibb Announces Accepted Amounts and Pricing Terms of its Tender Offers




Bristol Myers Squibb Announces Accepted Amounts and Pricing Terms of its Tender Offers

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) (“Bristol Myers Squibb”), today announced the accepted amounts and pricing terms of the previously announced tender offers to purchase for cash its outstanding notes listed in the tables below.


The outstanding debt securities listed in (i) the first table below labeled “Pool 1” are referred to collectively as the “Pool 1 Notes” and (ii) the second table below labeled “Pool 2” are referred to collectively as the “Pool 2 Notes.” The Pool 1 Notes and the Pool 2 Notes are referred to collectively as the “Notes” and each series of Notes is referred to as a “series.” We refer to each offer to purchase a series of Notes for cash as an “Offer,” the offers to purchase the Pool 1 Notes collectively as the “Pool 1 Offers,” the offers to purchase the Pool 2 Notes collectively as the “Pool 2 Offers,” and all the offers to purchase Notes are referred to collectively as the “Offers.”

As previously announced, Bristol Myers Squibb (i) decreased the maximum aggregate purchase price of the Pool 1 Notes it will accept for purchase from the previously announced amount of $4,000,000,000 to an amount sufficient (the “Amended Pool 1 Maximum”) to accept for purchase all Pool 1 Notes that were validly tendered and not validly withdrawn prior to the Early Tender Deadline and (ii) increased the maximum aggregate purchase price of the Pool 2 Notes it will accept for purchase from the previously announced amount of $3,000,000,000 to an amount sufficient (the “Amended Pool 2 Maximum”) to accept for purchase all Pool 2 Notes with an acceptance priority level at 1 through 4 (as set forth in the second table below) that were validly tendered and not validly withdrawn prior to the Early Tender Deadline as well as up to $250,000,000 in principal amount of Bristol Myers Squibb’s 5.900% Notes due 2033 (the “2033 Notes”). The Amended Pool 1 Maximum and Amended Pool 2 Maximum have now been established as approximately $3.99 billion and $3.51 billion, respectively.

The tables below indicate, among other things, the aggregate principal amount of Notes tendered as of 5:00 p.m. (New York City time) on November 17, 2025, (the “Early Tender Deadline”) and accepted in each Offer, the Offer Yield (each as defined below), the proration factor, if any, and the total consideration for each $1,000 principal amount of each series of Notes validly tendered at or prior to the Early Tender Deadline and accepted for purchase (the “Total Consideration”), as calculated at 10:00 a.m. (New York City time) today, November 18, 2025 in accordance with the terms of the Offer to Purchase dated November 3, 2025 (as amended or supplemented from time to time, the “Offer to Purchase”).

Since all of the Pool 1 Notes, and all of the Pool 2 Notes with an acceptance priority level at 1 through 4 that were validly tendered and not validly withdrawn prior to the Early Tender Deadline have been accepted for purchase by Bristol Myers Squibb, no proration procedures will be required for the Pool 1 Notes and the Pool 2 Notes with an acceptance priority level at 1 through 4. Since the aggregate principal amount of 2033 Notes exceeds $250,000,000, Bristol Myers has accepted the 2033 Notes on a prorated basis in accordance with the terms and conditions of the Offer to Purchase. No Pool 2 Notes with an acceptance priority level at 6 through 9, as set forth in the second table below, have been accepted for purchase. Bristol Myers Squibb has accepted Notes for purchase according to the Acceptance Priority Procedures and the terms and conditions described in the Offer to Purchase. Holders of Notes (each, a “Holder” and collectively, “Holders”) validly tendered at or prior to the Early Tender Deadline that are accepted for purchase by Bristol Myers Squibb will receive the applicable Total Consideration, in cash. As described in the Offer to Purchase, Notes tendered and not accepted for purchase will be promptly returned to the tendering Holder’s account.

Pool 1

Offers to purchase for cash up to the Amended Pool 1 Maximum of the securities listed in the priority order below.

Acceptance Priority Level

Title of Security

CUSIP /ISIN Number(s)

Principal Amount Outstanding

Principal Amount Tendered and Not Withdrawn as of the Early Tender Deadline

Principal Amount Accepted

Approximate Proration Factor

Offer Yield(1)

Total Consideration(2)

1

4.950% Notes due 2026

110122ED6/ US110122ED68

$1,000,000,000

$360,004,000

$360,004,000

100%

4.026%

$1,002.16

2

3.200% Notes due 2026

110122CN6/ US110122CN68/ 110122CA4/ US110122CA48/ U11009BA1/ USU11009BA16

$1,749,998,000

$529,929,000

$529,929,000

100%

3.823%

$996.51

3

4.900% Notes due 2027

110122EE4/ US110122EE42

$1,000,000,000

$519,484,000

$519,484,000

100%

3.748%

$1,013.07

4

3.900% Notes due 2028

110122DE5/ US110122DE50/ 110122BQ0/ US110122BQ09/ U11009AQ7/ USU11009AQ76

$1,456,162,000

$560,147,000

$560,147,000

100%

3.756%

$1,002.75

5

4.900% Notes due 2029

110122EF1/ US110122EF17

$1,750,000,000

$1,023,313,000

$1,023,313,000

100%

3.770%

$1,033.46

6

3.400% Notes due 2029

110122CP1/ US110122CP17/ 110122CB2/ US110122CB21/ U11009BB9/ USU11009BB98

$2,399,977,000

$972,783,000

$972,783,000

100%

3.820%

$985.66

(1) The “Offer Yield” is equal to the sum of (i) the applicable Reference Yield (as defined in the Offer to Purchase), which is based on the bid-side price of the applicable Reference U.S. Treasury Security (as specified in the Offer to Purchase), plus (ii) the applicable Fixed Spread (as specified in the Offer to Purchase).

(2) Includes the Early Tender Premium (as defined in the Offer to Purchase). Payable per each $1,000 principal amount of each specified series of Notes validly tendered at or prior to the Early Tender Deadline and accepted for purchase.

Pool 2

Offers to purchase for cash up to the Amended Pool 2 Maximum of the securities listed in the priority order below.

Acceptance Priority Level

Title of Security

CUSIP / ISIN Number(s)

Principal Amount Outstanding

Principal Amount Tendered and Not Withdrawn as of the Early Tender Deadline

Principal Amount Accepted

Approximate Proration Factor

Offer Yield(1)

Total Consideration(2)

1

6.875% Debenture due 2097

110122AC2/ US110122AC22

$62,417,000

$6,178,000

$6,178,000

100%

6.125%

$1,120.71

2

6.400% Notes due 2063

110122EC8/ US110122EC85

$1,250,000,000

$879,216,000

$879,216,000

100%

5.575%

$1,129.13

3

6.250% Notes due 2053

110122EB0/ US110122EB03

$1,250,000,000

$811,465,000

$811,465,000

100%

5.425%

$1,117.14

4

5.650% Notes due 2064

110122EL8/

US110122EL84

$1,750,000,000

$1,309,768,000

$1,309,768,000

100%

5.575%

$1,011.67

5

5.900% Notes due 2033

110122DZ8/ US110122DZ89

$1,000,000,000

$493,578,000

$250,000,000

50.84%

4.333%

$1,102.12

6

5.750% Notes due 2031

110122DY1/ US110122DY15

$1,000,000,000

$412,855,000

$0

7

5.550% Notes due 2054

110122EK0/ US110122EK02

$2,750,000,000

$1,917,650,000

$0

8

5.200% Notes due 2034

110122EH7/ US110122EH72

$2,500,000,000

$1,468,075,000

$0

9

5.100% Notes due 2031

110122EG9/ US110122EG99

$1,250,000,000

$666,525,000

$0

(1) The “Offer Yield” is equal to the sum of (i) the applicable Reference Yield (as defined in the Offer to Purchase), which is based on the bid-side price of the applicable Reference U.S. Treasury Security (as specified in the Offer to Purchase), plus (ii) the applicable Fixed Spread (as specified in the Offer to Purchase).

(2) Includes the Early Tender Premium (as defined in the Offer to Purchase). Payable per each $1,000 principal amount of each specified series of Notes validly tendered at or prior to the Early Tender Deadline and accepted for purchase.

The withdrawal rights for the Offers expired at 5:00 p.m. (New York City time) on November 17, 2025. As previously announced, all conditions of the Offers were deemed satisfied or waived by Bristol Myers Squibb by the Early Tender Deadline and Bristol Myers Squibb has elected to exercise its Early Settlement Right (as defined in the Offer to Purchase). The Early Settlement Date (as defined in the Offer to Purchase) will occur on November 20, 2025. The Offers will each expire at 5:00 p.m. (New York City time) on December 3, 2025, unless extended or earlier terminated by Bristol Myers Squibb. However, since the aggregate principal amount of Pool 1 Notes and Pool 2 Notes validly tendered and not validly withdrawn at or prior to the Early Tender Deadline met or exceeded the Amended Pool 1 Maximum and Amended Pool 2 Maximum, respectively, Bristol Myers Squibb expects that there will be no Final Settlement Date (as defined in the Offer to Purchase) and no tenders of Notes after the Early Tender Deadline will be accepted for purchase by Bristol Myers Squibb.

The Total Consideration that will be paid on the Early Tender Deadline for each series of Notes accepted for purchase does not include a cash payment equal to accrued and unpaid interest on such Notes to, but not including, the Early Settlement Date. For the avoidance of doubt, interest will cease to accrue on the Early Settlement Date for all Notes accepted in the Offers. Under no circumstances will any interest be payable to Holders because of any delay on the part of Global Bondholder Services Corporation, as the tender agent and information agent, The Depository Trust Company or any other party in the transmission of funds to Holders. See the Offer to Purchase for additional information.

All Notes accepted in the Offers will be cancelled and retired and will no longer remain outstanding obligations of Bristol Myers Squibb.

Bristol Myers Squibb has retained Citigroup Global Markets Inc., Deutsche Bank Securities Inc., Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC as lead dealer managers, BofA Securities, Inc., Barclays Capital Inc., J.P. Morgan Securities LLC and Wells Fargo Securities, LLC as dealer managers and Academy Securities, Inc. as a co-dealer manager for the Offers. Questions regarding terms and conditions of the Offers should be directed to Citigroup Global Markets Inc. at (800) 558-3745 (toll-free) or (212) 723-6106 (collect) or Deutsche Bank Securities Inc. at (866) 627-0391 (toll-free) or (212) 250-2955 (collect) or Goldman Sachs & Co. LLC at (800) 828-3182 (toll-free) or (212) 357-1452 (collect) or Morgan Stanley & Co. LLC at (800) 624-1808 (toll-free) or (212) 761-1057 (collect). Global Bondholder Services Corporation is acting as the tender agent and the information agent for the Offers (the “Tender and Information Agent”).

Offer and Distribution Restrictions

This announcement is for informational purposes only. This announcement is not an offer to sell or purchase, a solicitation of an offer to sell or purchase, or the solicitation of tenders with respect to any of Notes described herein. The Offers are being made solely pursuant to the Offer to Purchase. The Offers are not being made to Holders of Notes in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction. In any jurisdiction in which the securities laws or blue sky laws require the Offers to be made by a licensed broker or dealer, the Offers will be deemed to be made on behalf of Bristol Myers Squibb by the dealer managers or one or more registered brokers or dealers that are licensed under the laws of such jurisdiction.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain forward-looking statements regarding, among other things, the timing, terms, conditions and other aspects of the Offers. You can identify these forward-looking statements by the fact that they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of, among other things, the Offers, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. No forward-looking statement can be guaranteed.

Forward-looking statements are based on current expectations and projections about Bristol Myers Squibb’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them, that are difficult to predict, may be beyond its control and could cause its future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. Such risks, uncertainties and other matters include, but are not limited to: general market conditions which might affect the Offers; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; and access to capital markets.

Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in its Annual Report on Form 10-K for the year ended December 31, 2024, as updated by the subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC. The forward-looking statements included in this press release are made only as of the date of this press release and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

About Bristol Myers Squibb: Transforming Patients’ Lives Through Science

At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve.

corporatefinancial-news

Contacts

Media Relations:
media@bms.com

Investor Relations:
investor.relations@bms.com

Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)

Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)




Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)

– REDEMPLO is the first and only FDA-approved medicine to be studied in patients with genetically confirmed and clinically diagnosed FCS

– People living with FCS have extremely high triglyceride levels and a substantially higher risk of acute pancreatitis and related long-term complications, often resulting in a reduced quality of life

– The FDA approval is based on positive results from the Phase 3 PALISADE study where REDEMPLO significantly reduced triglycerides from baseline and lowered the numerical incidence of acute pancreatitis compared to placebo

– Arrowhead will host a conference call and webcast today at 1:30 p.m. ET

PASADENA, Calif.–(BUSINESS WIRE)–$arwr–Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has approved REDEMPLO (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. REDEMPLO is the first and only FDA-approved siRNA medicine for people living with FCS and can be self-administered at home with a simple subcutaneous injection once every three months. REDEMPLO utilizes the proprietary and differentiated Targeted RNAi Molecule (TRiM™) platform and is Arrowhead’s first FDA-approved medicine, marking a major milestone for the company as it transitions into commercial-stage.




“The FDA approval of REDEMPLO is a transformational milestone for Arrowhead. This is a proud moment for all those involved in the discovery and development process and represents new hope for the estimated 6,500 people in the U.S. living with genetic or clinical FCS. This approval, and subsequent launch, marks the beginning of a new chapter in our journey—one rooted in our unwavering commitment to delivering life-changing therapies to patients with serious diseases,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. “REDEMPLO also represents the first FDA-approval for a medicine that leverages Arrowhead’s proprietary and differentiated Targeted RNAi Molecule (TRiM™) platform. Arrowhead continues to lead the field in innovation, with the TRiM™ platform now potentially capable of delivering siRNA to seven different cell types in the body and the potential to simultaneously silence the expression of two genes in one molecule. The breadth of this technology with our growing commercial capabilities dramatically expands the diseases we can potentially address and the number of lives we can change.”

The FDA approval was supported by clinical data from the Phase 3 PALISADE study, a randomized, double-blind, placebo-controlled trial in adults with clinically diagnosed or genetically confirmed FCS. The PALISADE study met its primary endpoint and all multiplicity-controlled key secondary endpoints, including demonstrating significant reductions in triglycerides and APOC3. In PALISADE, 25 mg REDEMPLO achieved deep and durable reductions in triglycerides, with a median change from baseline of -80% versus -17% in the pooled placebo group, and a lower numerical incidence of acute pancreatitis compared with placebo.

Lindsey Sutton Bryan, co-founder and co-president of the FCS Foundation added, “Today’s approval marks a pivotal moment for people living with familial chylomicronemia syndrome and the physicians who support them. Because FCS symptoms are mostly invisible, this community historically has been often overlooked and misunderstood, making their journey to effective treatment especially difficult. We’re grateful to Arrowhead for listening to patients and caregivers and incorporating their lived experiences into the development of this transformative therapy. Plozasiran offers real hope for a better future and shows what’s possible when innovation is driven by empathy and collaboration addressing patients in need.”

The most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and > 5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction. The US approved package insert contains no contraindications, warnings, or precautions associated with the use of REDEMPLO.

The efficacy and safety results from the PALISADE study were presented at the European Society of Cardiology (ESC) Congress 2024 and the American Heart Association Scientific Sessions 2024 (AHA24) and simultaneously published in The New England Journal of Medicine and Circulation, respectively. ESC, AHA24, and other plozasiran presentations may be accessed on the Events and Presentations page in the Investors section of the Arrowhead website.

Underscoring the company’s commitment to improving patient outcomes, ensuring access for patients, and providing value to the health system, Arrowhead is developing best-in-class solutions for the FCS community. Arrowhead is launching Rely On REDEMPLO, a patient support program providing support services and resources for patients at each stage of the treatment journey with REDEMPLO, including financial assistance options for eligible patients.

REDEMPLO will be available in the U.S. before the end of the year.

REDEMPLO was granted Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation by the FDA for the treatment of patients with FCS and was granted Orphan Medicinal Product Designation by the European Medicines Agency for the treatment of patients with FCS.

Webcast and Conference Call and Details

Arrowhead will host a conference call and webcast to discuss the REDEMPLO FDA approval today at 1:30 p.m. ET.

A live webcast may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call.

About FCS

Familial chylomicronemia syndrome (FCS) is a severe and rare disease leading to extremely high triglyceride (TG) levels, typically over 880 mg/dL. Such severe elevations can lead to various serious signs and symptoms including acute and potentially fatal pancreatitis, chronic abdominal pain, diabetes, hepatic steatosis, and cognitive issues. Currently, there are limited therapeutic options to adequately treat FCS.

About the PALISADE Phase 3 Study

The PALISADE study (NCT05089084) was a Phase 3 placebo-controlled study to evaluate the efficacy and safety of plozasiran in adults with genetically confirmed or clinically diagnosed FCS. The primary endpoint of the study was percent change from baseline in fasting TG versus placebo at Month 10. A total of 75 subjects distributed across 39 different sites in 18 countries were randomized to receive 25 mg plozasiran, 50 mg plozasiran, or matching placebo once every three months. Participants who completed the randomized period were eligible to continue in a 2-part extension period, where all participants receive plozasiran.

About REDEMPLO® (plozasiran)

REDEMPLO (plozasiran) is approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce triglycerides for adults with Familial Chylomicronemia Syndrome (FCS). REDEMPLO is an siRNA therapeutic designed to suppress the production of apoC-III, a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is the first and only siRNA FDA-approved treatment studied in both genetically confirmed and clinically diagnosed patients living with FCS.

For more information about REDEMPLO, visit Our Medicines.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None.

ADVERSE REACTIONS

Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and >5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction.

Please see full Prescribing Information for REDEMPLO®.

About Plozasiran

Plozasiran is a first-in-class investigational RNA interference (RNAi) therapeutic designed to reduce production of apolipoprotein C-III (apoC-III) which is a component of triglyceride rich lipoproteins (TRLs) and a key regulator of triglyceride metabolism. ApoC-III increases triglyceride levels in the blood by inhibiting breakdown of TRLs by lipoprotein lipase and uptake of TRL remnants by hepatic receptors in the liver. The goal of treatment with plozasiran is to reduce the level of apoC-III, thereby reducing triglycerides and restoring lipids to more normal levels.

In addition to the FDA approval of REDEMPLO as an adjunct to diet to reduce triglycerides for adults with Familial Chylomicronemia Syndrome, plozasiran has been submitted to additional global regulatory authorities for review and marketing authorization. Plozasiran is also being investigated in the SHASTA-3, SHASTA-4, and SHASTA-5 Phase 3 studies in patients with severe hypertriglyceridemia and the MUIR Phase 3 study in patients with mixed hyperlipidemia.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline, products or product candidate or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about our beliefs and expectations regarding the long-term impacts of REDEMPLO (plozasiran) on patient health and the health care system; our beliefs and expectations regarding the pricing, value, or expected timing for availability of our drugs and drug candidates; and our believes and expectations around the potential uses and value of the TRiM™ platform. These statements are based upon our current expectations and speak only as of the date hereof. Actual results or outcomes may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties the safety and efficacy of our products and product candidates, pricing and reimbursement decisions related to our products, demand for our products, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

Contacts

Arrowhead Pharmaceuticals, Inc.

Vince Anzalone, CFA

626-304-3400

ir@arrowheadpharma.com

Investors:
LifeSci Advisors, LLC

Brian Ritchie
212-915-2578

britchie@lifesciadvisors.com

Media:
HAVAS PR

Erick Edwing

941-468-7534

Erick.edwing@havasred.com

Lifordi Immunotherapeutics Secures Strategic Investment from Sanofi Ventures and Additional Capital from Existing Investors

Lifordi Immunotherapeutics Secures Strategic Investment from Sanofi Ventures and Additional Capital from Existing Investors




Lifordi Immunotherapeutics Secures Strategic Investment from Sanofi Ventures and Additional Capital from Existing Investors

Company Raised $112 Million to Date and is on Track to Generate Initial Clinical Data by Year End

BURLINGTON, Mass.–(BUSINESS WIRE)–#ADCs–Lifordi Immunotherapeutics, Inc., a clinical-stage biotech company developing antibody-drug conjugates (ADCs) for the treatment of autoimmune and inflammatory disorders, today announced a strategic investment from Sanofi Ventures, the venture arm of global healthcare leader Sanofi, and funding from existing investors ARCH Ventures, 5AM Ventures, and Atlas Venture. The new funds bring the total raised to $112 million and support an ongoing Phase 1 study in Rheumatoid Arthritis (RA) designed to evaluate LFD-200, an ADC delivering a potent glucocorticoid (GC) directly to immune cells. It also provides for Chemistry Manufacturing and Controls (CMC) preparations to ensure that Phase 2 clinical supply is available without incurring an unnecessary delay. As part of the investment, Christopher Gagliardi, Ph.D., Principal at Sanofi Ventures, will join as an observer on Lifordi’s Board of Directors.


“Sanofi has demonstrated a strong commitment to invest in new treatments for autoimmune and inflammatory diseases, and we are fortunate to have this support from Chris and the Sanofi Ventures team alongside our current investors to advance LFD-200 and our targeted ADC delivery pipeline for immune-mediated conditions,” said Arthur Tzianabos, Ph.D., President & Chief Executive Officer. “Enrollment and dosing in our Phase 1 study of LFD-200 in RA is progressing as planned, and we look forward to sharing initial data from healthy participants in the coming months.”

“We continue to search for new approaches to improve the treatment of autoimmune and inflammatory diseases and were intrigued by Lifordi’s targeted ADC approach to deliver glucocorticoids without toxicity,” said Christopher Gagliardi, Ph.D. “Once we met the team and did our due diligence on the proof-of-concept data in multiple animal models of autoimmune disease together with extensive nonclinical studies, we made the decision to invest in Lifordi now. This enables Sanofi to share our expertise and experiences to help guide LFD-200 through clinical studies and support pipeline development using this approach to deliver other drug payloads, such as ASOs or siRNAs.”

Lifordi’s Phase 1 clinical trial is currently enrolling and dosing healthy participants. The study is designed to evaluate the safety and efficacy of LFD-200, and initial healthy participant data will include both safety and pharmacodynamic measures. Following single and multiple ascending dosing (SAD/MAD studies), the Company plans to evaluate LFD-200 in patients with moderate to severe rheumatoid arthritis. Lifordi recently presented non-clinical data at the American College of Rheumatology (ACR) 2025 meeting showing that clinically relevant doses of LFD-200 given subcutaneously every 7 days for 13 weeks maintained glucocorticoid exposure in immune cells without evidence of systemic toxicity. By harnessing the efficacy of GCs while limiting the toxicity, LFD-200 has the potential to solve the problem that has limited the broad and long-term use of GCs for the past 75 years.

About Lifordi

Lifordi Immunotherapeutics, Inc. is a clinical-stage biotechnology company leading the way by leveraging the success of antibody-drug conjugates (ADCs) to develop treatments for autoimmune and inflammatory disorders. The Company’s lead ADC, LFD-200, is in a Phase 1 clinical trial. Preclinical studies demonstrated efficacy in multiple disease models by targeting myeloid and lymphoid cells using a highly internalized cell surface membrane protein (VISTA). Lifordi has also applied its novel drug delivery platform to other diverse payloads, such as small molecules, antisense oligonucleotides (ASOs) and siRNA. As experienced drug developers in immunology and inflammatory diseases, together with expert clinical advisors, a strong partnering track record, and funding from ARCH Venture Partners, 5AM Ventures, and Atlas Venture, Lifordi is committed to changing how immune and inflammatory diseases are treated. For more information, please visit www.lifordi.com.

About Sanofi Ventures

Sanofi Ventures is the corporate venture capital arm of Sanofi, investing globally in early-stage biotech and digital health companies aligned with Sanofi’s mission to chase the miracles of science. Areas of focus include immunology, oncology, rare diseases, vaccines, and digital innovation.

Contacts

Theresa McNeely

Chief Communications Officer

tmcneely@lifordi.com
(508) 523-9511

CELFULL Showcases Aging Intervention Technology at SupplySide Global to Lead New Trends 2026

CELFULL Showcases Aging Intervention Technology at SupplySide Global to Lead New Trends 2026




CELFULL Showcases Aging Intervention Technology at SupplySide Global to Lead New Trends 2026

LAS VEGAS–(BUSINESS WIRE)–The recently concluded SupplySide Global 2025 was hailed as “the best ever” by a senior dietary supplement expert, who highlighted bioavailability as the defining frontier for health supplements in 2026. As “high content” gives way to “high absorption,” CELFULL – a clinically driven anti-aging health brand – unveiled Celfavor NADH, a controlled-release microsphere technology that elevates nutrient absorption to an unprecedented level, which is of epoch-making significance.




This innovative ingredient, formulated using the company’s proprietary Celfavor™ active delivery technology, establishes a new benchmark in stability and bioavailability for the highly labile NADH molecule.

As a critical coenzyme involved in cellular energy production and defense against oxidative stress, NADH has historically posed significant formulation challenges due to its inherent instability, typically degrading substantially within months under ambient conditions.

The novel microsphere delivery system employed in Celfavor™ NADH effectively shields the NADH from exposure to oxygen, moisture, and light, extending its room-temperature shelf life to an unprecedented 36 months—more than six times that of conventional NADH formulations.

Furthermore, the technology ensures near-complete preservation of NADH in gastric acid over a period of up to four hours, facilitating targeted release and optimal absorption in the intestinal tract.

“Celfavor™ NADH represents a milestone advancement in NADH innovation. Comprehensive testing, conducted both internally and through independent third-party laboratories including SGS, confirms that no currently available NADH ingredient on the market achieves comparable stability in gastric conditions alongside efficient intestinal release,” stated Dr. Juliane Hitzel, Research Lead at CELFULL.

The ingredient is free from gluten, lactose, and genetically modified organisms (GMOs), and is manufactured through a sustainable green biosynthesis process. It is protected by seven internationally granted invention patents.

Additionally, the Celfavor™ platform enables the precise co-formulation of NADH with other bioactive compounds such as vitamins and peptides, opening new possibilities for advanced nutraceutical formulations targeting energy metabolism, cognitive functions.

Industry observers note that more companies like CELFULL—those that continue to invest in R&D and expand their product and service ecosystems—are well positioned to drive the next phase of development with high-quality, high-efficiency and naturally derived ingredients and solutions.

Contacts

Company: CELFULL

Contact: Maggie Jane

Email: maggie@celfull.com
Website: www.celfull.com