On February 26, 2026 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three and twelve months ended December 31, 2025, and highlighted recent corporate updates.

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"As demonstrated in today’s release, we are entering 2026 with exceptional momentum. The fourth quarter delivered the strongest results in the history of Heron’s Acute Care franchise, underscoring the success of the strategic decisions we implemented to unlock the full potential of these assets," said Craig Collard, Chief Executive Officer of Heron. "The milestones achieved in 2025, particularly for ZYNRELEF – including enhanced distributor‑partner incentives, the seamless completion of the Vial Access Needle transition, and CMS approval of a product‑specific J‑Code – are already accelerating adoption and strengthening our competitive position in a large and underpenetrated market."

"With a more powerful commercial engine, expanding demand signals, and improved reimbursement clarity, we believe Heron is well‑positioned for continued share gains and meaningful revenue expansion in 2026 and beyond."

Financial Guidance for 2026

Item
2026 Full-Year Guidance for Net Revenue and Adjusted EBITDA
(in millions)
Net Revenue $173 to $183 million
Adjusted EBITDA $10 to $20 million

Business Highlights

– Heron’s Acute Care franchise delivered revenue growth of 57.3% year-over-year in Q4 2025 and 65.1% year-over-year for 2025 compared to 2024, reflecting continued commercial acceleration.

– ZYNRELEF Updates:

The permanent, product specific J-Code (J0668) for ZYNRELEF, granted by the Centers for Medicare and Medicaid Services ("CMS"), was approved effective October 1, 2025 – streamlining reimbursement and improving billing clarity across payer types and settings of care.
Transition to the Vial Access Needle is complete, optimizing product preparation, handling, and operating field sterility with ZYNRELEF in hospitals and ambulatory surgical centers across the U.S.
Through aligned partnerships with leading distributors, we are broadening account access and elevating education around ZYNRELEF’s differentiated clinical profile, driving durable surgeon adoption and expansion of use.
Development of the proposed Prefilled Syringe market presentation is progressing and, if successful, FDA approval is anticipated in mid-to-late 2027.

– APONVIE Updates:

Inclusion of APONVIE (aprepitant) Injectable Emulsion in the Newly Released Fifth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting ("PONV"), highlighting the clinical impact of aprepitant, use of multimodal PONV prophylaxis, and expanding recognition of the need for long-acting antiemetic coverage.
CMS has granted a permanent, product specific J-Code (J8502) for APONVIE.
Fully dedicated sales team, launched in Q3 2025, is gaining significant momentum in both expanding formulary access and driving successful utilization of APONVIE.

– Oncology Updates:

The Oncology franchise continues to deliver a strong revenue base, generating over $105 million in 2025 net revenue despite complex market dynamics.

– Cash, cash equivalents, and short-term investments were $46.6 million as of December 31, 2025.

Net Revenue Performance – Twelve Months Ended December 31 (in thousands)

2025 2024 Dollar Change Percentage Change

Acute Care $49,643 $30,064 $19,579 65.1%
APONVIE $11,571 $4,518 $7,053 156.1%
ZYNRELEF $38,072 $25,546 $12,526 49.0%

Oncology $105,261 $114,221 $(8,960) (7.8%)
CINVANTI $96,758 $100,079 $(3,321) (3.3%)
SUSTOL $8,503 $14,142 $(5,639) (39.9%)

Total Net Revenue $154,904 $144,285 $10,619 7.4%

Net Revenue Performance – Three Months Ended December 31 (in thousands)
(unaudited)

2025 2024 Dollar Change Percentage Change

Acute Care $16,344 $10,389 $5,955 57.3%
APONVIE $3,814 $1,932 $1,882 97.4%
ZYNRELEF $12,530 $8,457 $4,073 48.2%

Oncology $24,244 $30,392 $(6,148) (20.2%)
CINVANTI $22,917 $26,873 $(3,956) (14.7%)
SUSTOL $1,328 $3,519 $(2,191) (62.3%)

Total Net Revenue $40,588 $40,781 $(193) (0.5%)

Conference Call and Webcast

Heron will host a conference call and live webcast on Thursday, February 26, 2026, at 8:30 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. The investor presentation to be used for the conference call and webcast can be accessed from Heron’s website prior to the conference call and webcast. An archive of the teleconference, webcast, and investor presentation will also be made available on Heron’s website for sixty days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About APONVIE for Prevention of Postoperative Nausea and Vomiting ("PONV") Prevention

APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023.

Please see full prescribing information at www.APONVIE.com.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

Please see full prescribing information at www.SUSTOL.com.

(Press release, Heron Therapeutics, FEB 26, 2026, View Source [SID1234663076])

On February 26, 2026 GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its fourth quarter 2025 revenues and cash position results1 and provides a corporate update.

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I. Cash position

As of December 31, 2025, the Company’s cash and cash equivalents amounted to €101.1 million compared with €81.8 million as of December 31, 2024 and €119.0 million as of September 30, 2025.

In 2025, cash utilization is mainly the result of our research and development efforts in our Acute on-Chronic Liver Failure (ACLF) franchise (notably VS-01, NTZ/G1090N, SRT-015, CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma (CCA). Cash utilization is offset notably by the €26.55 million milestone received in July 2025 (invoiced in May 2025) upon pricing and reimbursement approval of Iqirvo (elafibranor) in Italy, the third major European country to do so, as part of our long-term strategic partnership with Ipsen (the "Ipsen Agreement") signed in December 2021.

In January 2026, GENFIT exercised its option to receive (and did in fact receive) the second installment of the Royalty Financing agreement totaling €30.0 million. Both this amount, as well as the first commercial milestone of €17.0 million ($20.0 million) that GENFIT will receive as part of the Ipsen Agreement, are not included in cash and cash equivalents as of December 31, 2025.

We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the end of 2028, enabling the Company to further develop its R&D pipeline focused on ACLF and support general corporate purposes. This is based on current assumptions and programs and does not include exceptional events. This estimation assumes (i) our expectation to receive significant future commercial milestone revenue pursuant to the Ipsen Agreement and Ipsen meeting its sales-based thresholds and (ii) drawing down the third and final, optional installment under the Royalty Financing agreement.

Revenue
Revenues for 2025 amounted to €65.4 million compared to €67.0 million for the same period in 2024.

Revenue Year ended
(in € millions) 31/12/2024 31/12/2025
Royalty revenue 2.7 21.8
Milestone revenue 48.7 43.6
Revenue initially deferred from the Licensing Agreement (Ipsen) 15.3 -
Revenue from the Part B Transition Services Agreement (Ipsen) 0.1 -
Other revenue 0.2 -
TOTAL 67.0 65.4
Royalty revenue is entirely attributable to worldwide sales of Iqirvo (elafibranor), which amounted to $208 million in 2025.

Milestone revenue in 2025 is comprised of two milestones:

GENFIT’s first commercial milestone of €17.0 million ($20.0 million) after Ipsen’s Iqirvo exceeded the $200 million threshold in its first full year of net sales, and
GENFIT’s milestone of €26.55 million upon pricing and reimbursement approval of Iqirvo (elafibranor) in Italy, the third major European country to do so.
II. Corporate update and program highlights

Acute On-Chronic Liver Failure (ACLF)

The key highlight for this pipeline segment in the fourth quarter 2025 was the progress of our lead program, G1090N, which generated preliminary Phase 1 data readout showing a safety profile and a robust anti-Inflammatory activity evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors. As communicated earlier, GENFIT will engage with regulatory authorities to determine the best approach for progressing to a Phase 2 proof-of-concept in inflammatory conditions such as ACLF, where systemic immune dysregulation is a critical driver of disease progression.

Other assets developed to address the unmet medical need in ACLF continued their preclinical evaluation during the fourth quarter of 2025 to fully assess their potential before advancing into clinical development.

Cholangiocarcinoma (CCA)

The main highlight in this indication in the fourth quarter of 2025 was the highly encouraging early data delivered from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA, positioning this novel combination as a potential new therapeutic approach for difficult-to-treat cancers. Phase 1b dose escalation continues as planned to confirm the activity signal, with new data for next patient cohorts and recommended Phase 2 combination doses expected in the first half of 2026. Phase 2 initiation remains targeted for the second half of 2026.

Ipsen’s Iqirvo (elafibranor) in Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC)

PBC: Iqirvo’s net sales for the fourth quarter 2025 amounted to $88 million, bringing full-year 2025 sales to $208 million, triggering the first commercial milestone payment to GENFIT one year ahead of schedule.

PSC: Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial, addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties.

(Press release, Genfit, FEB 26, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-fourth-quarter-2025-financial-information-and [SID1234663075])

On February 26, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

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"We solidified our leadership position and proved the strength of Syndax’s R&D and commercial capabilities in 2025, achieving our third FDA approval and successfully launching two first- and best-in-class medicines. We reached thousands of patients with Revuforj and Niktimvo and generated over $275 million in 2025 sales, rapidly advancing the company towards profitability," said Michael A. Metzger, Chief Executive Officer. "With strong momentum and multiple growth drivers for both products, including increasing uptake of Revuforj in R/R NPM1m AML and the post-transplant setting, Syndax is well positioned for continued growth in 2026 and beyond."

Mr. Metzger continued, "We’ve also made excellent progress advancing our development programs designed to further unlock multi-billion-dollar opportunities for both our medicines. We are positioned to be first to frontline AML with a menin inhibitor, and to expand our impact on chronic GVHD and other fibrotic diseases through CSF-1R inhibition. Earlier this year, we completed enrollment in our Phase 2 IPF trial and remain on track for topline data later this year which could further unlock Niktimvo’s potential as a novel antifibrotic."

Recent Business Highlights and Anticipated Milestones

Revuforj (revumenib)

Achieved $44.2 million in Revuforj net revenue in the fourth quarter of 2025, a 38% increase over the third quarter of 2025. Revuforj net revenue for the full year 2025 totaled $124.8 million.
Observed continued acceleration in demand following the FDA’s approval on October 24, 2025, of Revuforj for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 mutation (NPM1m) in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. Total Revuforj prescriptions in the fourth quarter of 2025 were approximately 1,150, an approximate 35% increase over the third quarter of 2025.
Initiated REVEAL-ND, a Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with intensive chemotherapy in newly diagnosed patients with NPM1m AML in November 2025. The trial has dual primary endpoints of measurable residual disease (MRD) negative complete remission (CR) and event free survival (EFS) to support the potential for accelerated approval and full approval, respectively.
Received the ‘Best New Drug’ award for Revuforj at the Scrip Awards in December 2025. The award recognizes excellence in pharmaceutical development and the drug that represents the best therapeutic advance in its area.
Highlighted the company’s leadership in menin inhibition with the presentation of 12 revumenib abstracts, including three oral presentations, at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025. The presentations reported compelling results with revumenib in multiple acute leukemia subtypes across the R/R, frontline, and post-stem cell transplant maintenance setting.
The data presented included the first real-world evidence for a menin inhibitor. The results showed an overall response rate (ORR) of 77% (10/13), a measurable residual disease (MRD) negativity rate of 75% (9/12), and favorable tolerability among primarily R/R NPM1m, KMT2Ar, and NUP98r acute leukemia patients who received revumenib in combination with standard of care therapies or as a monotherapy outside of a clinical trial.
Multiple clinical trials evaluating revumenib across the acute leukemia treatment continuum are ongoing, such as:
EVOLVE-2: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed NPM1m (primary efficacy analysis population) and KMT2Ar AML patients who are unfit for intensive chemotherapy. The trial is being conducted in collaboration with the HOVON network, a leading cooperative clinical trial group with extensive experience studying novel therapies for hematologic malignancies.
REVEAL-ND: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with intensive chemotherapy in newly diagnosed NPM1m AML patients.
SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with newly diagnosed and R/R AML or mixed-lineage acute leukemia (MPAL) harboring either NPM1m, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center. New data presented at the 2025 ASH (Free ASH Whitepaper) Annual Meeting from the first cohort of newly diagnosed patients showed a complete remission (CR) rate of 76% (16/21), an ORR of 86% (18/21), and a MRD negativity rate among responders of 100% (18/18).
Intensive chemotherapy: Two ongoing Phase 1 trials evaluating the combination of revumenib with intensive chemotherapy (7+3) in newly diagnosed NPM1m or KMT2Ar acute leukemia patients. Preliminary data presented from both trials at the 2025 ASH (Free ASH Whitepaper) Annual Meeting showed that the safety profile of the combination was consistent with the profile for intensive chemotherapy alone, along with high rates of response and MRD negativity.
BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed older adults (≥60 years) with NPM1m or KMT2Ar AML. The trial is being conducted as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial. Data presented at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress and simultaneously published in the Journal of Clinical Oncology showed a CR rate of 67% (29/43), an ORR of 88% (38/43), and a MRD negativity rate of 100% (37/37) among responders.
Post-transplant maintenance: A Phase 1 trial evaluating the safety and preliminary efficacy of revumenib as post-transplant maintenance after hematopoietic stem cell transplant (HSCT) in patients with KMT2Ar or NPM1m acute leukemia. The trial is being conducted by investigators from the City of Hope Medical Center.
Break Through Cancer: A Phase 2 trial studying whether the combination of revumenib and venetoclax can eliminate MRD in patients with AML and extend progression-free survival. The trial is being conducted by Break Through Cancer, a collaboration between leading U.S. cancer research centers.
INTERCEPT: A Phase 1 trial evaluating the use of novel therapies, including revumenib, to target MRD and early relapse in AML. The trial is being conducted by the Australasian Leukaemia and Lymphoma Group as part of the INTERCEPT AML master clinical trial.
The Company expects to present additional revumenib data at major medical meetings throughout 2026, including additional real-world evidence and data from the frontline and post-HSCT maintenance setting.
The Company expects the RAVEN trial to initiate in the second half of 2026. RAVEN is a Phase 2 collaborative trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed KMT2Ar patients who would be considered eligible, or fit, for intensive chemotherapy.

Niktimvo (axatilimab-csfr)

Achieved $56.0 million in Niktimvo net revenue in the fourth quarter of 2025, a 22% increase over the third quarter of 2025. Niktimvo net revenue for the full year 2025 totaled $151.6 million. Syndax and Incyte are co-commercializing Niktimvo. Syndax records 50% of the Niktimvo net commercial profit, defined as net product revenue minus the cost of sales and commercial expenses. Syndax’s share of the Niktimvo product contribution, reported as collaboration revenue, was $19.4 million and $42.4 million in the fourth quarter and full year 2025, respectively.
Presented data from 11 axatilimab abstracts, including three oral presentations, at the 2025 ASH (Free ASH Whitepaper) Annual Meeting. The abstracts highlighted the potential for axatilimab to provide long-term benefit in recurrent or refractory chronic graft-versus-host disease (GVHD) and the tolerability of axatilimab with ruxolitinib in newly diagnosed chronic GVHD.
Presented data from nine axatilimab abstracts, including one oral presentation, at the Tandem Meetings (Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR) in February 2026. The data presented included a comprehensive analysis of axatilimab in patients with chronic GVHD-related bronchiolitis obliterans syndrome (BOS) in two clinical studies. The results show clinical and symptom responses across a spectrum of lung involvement.
Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed chronic GVHD patients are ongoing, including:
A Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥ 12 years of age with newly diagnosed chronic GVHD.
A pivotal Phase 3, randomized, double-blind, placebo-controlled, multi-center trial of axatilimab in combination with corticosteroids in patients ≥ 12 years of age with newly diagnosed chronic GVHD.
Completed enrollment in MAXPIRe, a Phase 2, 26-week randomized, double-blinded, placebo-controlled trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis (IPF) in the first quarter of 2026. The Company expects to report topline data in the fourth quarter of 2026.

Fourth Quarter and Full Year 2025 Financial Results

As of December 31, 2025, Syndax had cash, cash equivalents, and short-term investments of $394.1 million and 87.7 million common shares and prefunded warrants outstanding.

Total revenue for the fourth quarter of 2025 was $68.7 million, which consisted of $44.2 million in Revuforj net revenue, $19.4 million in Niktimvo collaboration revenue, and $5.1 million in milestone, license and royalty revenue. Total revenue for the full year 2025 was $172.4 million, which consisted of $124.8 million in Revuforj net revenue, $42.4 million in Niktimvo collaboration revenue, and $5.1 million in milestone, license and royalty revenue. The Niktimvo collaboration revenue is derived from the $151.6 million in Niktimvo net revenue that was previously reported by the Company’s partner Incyte for the full year 2025. Syndax records 50% of the Niktimvo net commercial profit, defined as net revenue (recorded by Incyte) minus the cost of sales and commercial expenses.

Fourth quarter 2025 research and development expenses increased to $78.6 million from $65.5 million for the comparable prior year period, and for the full year 2025 increased to $258.8 million compared to $241.6 million for 2024. The year-over-year increase was primarily due to increased clinical, medical, and employee-related expenses.

Fourth quarter 2025 selling, general and administrative expenses increased to $49.9 million from $37.7 million for the comparable prior year period, and for the full year 2025 increased to $179.7 million compared to $120.9 million for 2024. The year-over-year increase was primarily due to increased employee-related expenses and increased sales and marketing expenses related to the U.S. commercial launches of Revuforj and Niktimvo.

For the three months ended December 31, 2025, Syndax reported a net loss attributable to common stockholders of $68.0 million, or $0.78 per share, compared to a net loss attributable to common stockholders of $94.2 million, or $1.10 per share, for the comparable prior year period. For the year ended December 31, 2025, Syndax reported a net loss attributable to common stockholders of $285.4 million or $3.29 per share, compared to a net loss attributable to common stockholders of $318.8 million or $3.72 per share for the comparable prior year period.

Financial Guidance

For the full year of 2026, the Company expects total research and development plus selling, general and administrative expenses to be approximately $400 million, excluding the impact of $50 million in estimated non-cash stock compensation expense.

Syndax expects that its operating expense base will remain stable over the next couple of years. As a result, Syndax expects that its cash, cash equivalents and short-term investments, combined with its anticipated product revenue, collaboration revenue and interest income, will enable the Company to reach profitability.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, February 26, 2026.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following:

Conference ID: Syndax4Q25
Domestic Dial-in Number: (800) 590-8290
International Dial-in Number: (240) 690-8800
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

About Revuforj (revumenib)

Revuforj (revumenib) is an oral, first-in-class menin inhibitor that is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients one year and older. Revuforj is also indicated for the treatment of R/R acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options.

Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML.

Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation and Breakthrough Therapy Designation for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement.

About Niktimvo (axatilimab-csfr)

Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD, including a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774). Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

(Press release, Syndax, FEB 26, 2026, View Source [SID1234663073])

On February 26, 2026 GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its fourth quarter 2025 revenues and cash position results1 and provides a corporate update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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I. Cash position

As of December 31, 2025, the Company’s cash and cash equivalents amounted to €101.1 million compared with €81.8 million as of December 31, 2024 and €119.0 million as of September 30, 2025.

In 2025, cash utilization is mainly the result of our research and development efforts in our Acute on-Chronic Liver Failure (ACLF) franchise (notably VS-01, NTZ/G1090N, SRT-015, CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma (CCA). Cash utilization is offset notably by the €26.55 million milestone received in July 2025 (invoiced in May 2025) upon pricing and reimbursement approval of Iqirvo (elafibranor) in Italy, the third major European country to do so, as part of our long-term strategic partnership with Ipsen (the "Ipsen Agreement") signed in December 2021.

In January 2026, GENFIT exercised its option to receive (and did in fact receive) the second installment of the Royalty Financing agreement totaling €30.0 million. Both this amount, as well as the first commercial milestone of €17.0 million ($20.0 million) that GENFIT will receive as part of the Ipsen Agreement, are not included in cash and cash equivalents as of December 31, 2025.

We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the end of 2028, enabling the Company to further develop its R&D pipeline focused on ACLF and support general corporate purposes. This is based on current assumptions and programs and does not include exceptional events. This estimation assumes (i) our expectation to receive significant future commercial milestone revenue pursuant to the Ipsen Agreement and Ipsen meeting its sales-based thresholds and (ii) drawing down the third and final, optional installment under the Royalty Financing agreement.

Revenue
Revenues for 2025 amounted to €65.4 million compared to €67.0 million for the same period in 2024.

Revenue Year ended
(in € millions) 31/12/2024 31/12/2025
Royalty revenue 2.7 21.8
Milestone revenue 48.7 43.6
Revenue initially deferred from the Licensing Agreement (Ipsen) 15.3 -
Revenue from the Part B Transition Services Agreement (Ipsen) 0.1 -
Other revenue 0.2 -
TOTAL 67.0 65.4
Royalty revenue is entirely attributable to worldwide sales of Iqirvo (elafibranor), which amounted to $208 million in 2025.

Milestone revenue in 2025 is comprised of two milestones:

GENFIT’s first commercial milestone of €17.0 million ($20.0 million) after Ipsen’s Iqirvo exceeded the $200 million threshold in its first full year of net sales, and
GENFIT’s milestone of €26.55 million upon pricing and reimbursement approval of Iqirvo (elafibranor) in Italy, the third major European country to do so.
II. Corporate update and program highlights

Acute On-Chronic Liver Failure (ACLF)

The key highlight for this pipeline segment in the fourth quarter 2025 was the progress of our lead program, G1090N, which generated preliminary Phase 1 data readout showing a safety profile and a robust anti-Inflammatory activity evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors. As communicated earlier, GENFIT will engage with regulatory authorities to determine the best approach for progressing to a Phase 2 proof-of-concept in inflammatory conditions such as ACLF, where systemic immune dysregulation is a critical driver of disease progression.

Other assets developed to address the unmet medical need in ACLF continued their preclinical evaluation during the fourth quarter of 2025 to fully assess their potential before advancing into clinical development.

Cholangiocarcinoma (CCA)

The main highlight in this indication in the fourth quarter of 2025 was the highly encouraging early data delivered from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA, positioning this novel combination as a potential new therapeutic approach for difficult-to-treat cancers. Phase 1b dose escalation continues as planned to confirm the activity signal, with new data for next patient cohorts and recommended Phase 2 combination doses expected in the first half of 2026. Phase 2 initiation remains targeted for the second half of 2026.

Ipsen’s Iqirvo (elafibranor) in Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC)

PBC: Iqirvo’s net sales for the fourth quarter 2025 amounted to $88 million, bringing full-year 2025 sales to $208 million, triggering the first commercial milestone payment to GENFIT one year ahead of schedule.

PSC: Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial, addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties.

(Press release, Genfit, FEB 26, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-fourth-quarter-2025-financial-information-and [SID1234663070])

On February 26, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

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"I am extremely proud of the progress the Fate team delivered in 2025, including bringing to fruition the treatment of FT819 off-the-shelf CAR T cells as outpatient therapy, eliminating the need for extended hospital stay requirements seen today with other CAR T-cell programs, which now uniquely expands autoimmune patient access, including in underserved regions, while significantly improving health system economics," said Bob Valamehr, M.B.A., Ph.D., President and Chief Executive Officer of Fate Therapeutics. "I’m also pleased to note that we are continuing to progress towards the commencement of our first planned Phase 2 clinical trial in lupus nephritis, and we are actively recruiting patients in the Phase 1 basket study of FT819 across the U.S., U.K. and E.U., with the ultimate goal to advance FT819 to commercialization in various autoimmune diseases. Last year’s accomplishments are further highlighted by strong fourth-quarter clinical site activation, accelerated patient enrollment, expansion of FT819 into additional autoimmune diseases, the advancement of our next generation CAR T-cell programs, and continuation of our scientific leadership through quality conference presentations and manuscript publications. Importantly, additional clinical signals across autoimmune disease and in oncology without the use of conditioning chemotherapy are further validating the breadth of our platform. We have a well-capitalized balance sheet ensuring runway through 2027 and believe we are uniquely positioned to drive long-term value creation."

Clinical Development & Program Updates

FT819 Off-the-Shelf CAR T-cell Program in Autoimmune Disease for Broad Patient Accessibility

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population.

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FT819-102 Phase 1 clinical trial now enrolling in 16 clinical sites across the U.S., U.K. and E.U. The Company’s ongoing multi-center, Phase 1 clinical trial of FT819 (NCT06308978) is designed to evaluate the safety, pharmacokinetics, and efficacy of a single dose of FT819 following either i) Regimen A, a fludarabine (flu)-free less-intensive conditioning regimen, consisting of either bendamustine alone or cyclophosphamide alone, or ii) Regimen B, added to maintenance therapy without the use of conditioning chemotherapy. The disease indications in the basket study include systemic lupus erythematosus (SLE), anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc).
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Fifteen SLE patients across the two regimens have been treated, as of February 25th;
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Four SSc patients have also been treated in the two regimens as of February 25th, with the first SSc patient treated with FT819 and less-intensive conditioning chemotherapy (Regimen A) exhibiting improvements in health assessment questionnaire (HAQ), clinician global assessment (CGA), patient global assessment (PtGA) and modified Rodnan skin score (mRSS) at the 3-month follow-up, as of February 9th data cut off; and
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One IIM patient has also been treated, as of February 25th.
Clinical site expansion and enrollment across the study indications continue to accelerate with a focus on bringing on-demand accessibility of FT819 and outpatient treatment to community hospitals and infusion centers. The Company expects to provide clinical, regulatory, and operational updates in the second half of 2026.

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Successfully treated patients in FT819-102 clinical trial as outpatient treatment. This achievement represents a major clinical milestone: the successful dosing of autoimmune patients with FT819 off-the-shelf CAR T-cell therapy in an outpatient setting, without the need for extended hospitalization and observation. By eliminating the need for extended hospitalization and reducing or eliminating the use of conditioning chemotherapy, FT819 removes key logistical and clinical barriers that have limited autoimmune patient access to CAR T-cell therapies, facilitating broad patient access to such potentially transformative medicine.
This unique ability for outpatient treatment of CAR T cells in autoimmune disease reflects meaningful clinical progress. Enabling a feasible treatment option in community hospital-based settings and plans for treatment in infusion centers has the potential to expand access to FT819 off-the-shelf CAR T cells to a broader patient population, facilitate service to underserved regions, reduce burden on healthcare infrastructure, and improve the scalability and practical delivery of CAR T-cell therapy.

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Data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrate meaningful and durable clinical responses, broad accessibility, and favorable safety profile of FT819 in SLE. At the 2025 ASH (Free ASH Whitepaper) Annual Meeting, the Company reported that 12 patients had been treated in the FT819-101 Phase 1 study, and provided clinical data for 10 patients with greater than 1 month follow-up as of a data cut off date of October 22, 2025, showing progressive and durable reductions in disease activity, including mean SLEDAI-2K score reductions of up to 78% by six months from the dose level 2 (DL2) cohort, complete renal responses in lupus nephritis, and sustained B-cell depletion with immune cell remodeling. FT819 was well tolerated with no dose limiting toxicities, no immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD), and only low-grade incidences of cytokine release syndrome (CRS), supporting outpatient, on-demand treatment.

Next-generation off-the-Shelf CAR T-cell Program with Novel Sword & Shield Technology Designed to Eliminate the Need for Conditioning Chemotherapy

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Preclinical data demonstrates potent activity and functional persistence of FT836 across a broad array of cancers. FT836 is the Company’s multipoint-edited CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB). The expression of MICA/B cell-surface proteins is induced by cellular stress or malignant transformation and is detectable across many types of cancer cells with limited expression on healthy tissue. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual meeting held in November 2025, the Company presented preclinical data showing FT836 exhibited potent and durable CAR-dependent antigen-driven proliferation with robust activity across diverse solid tumors and that FT836 can be combined with standard of care chemotherapy to induce MICA/B surface expression for enhanced target recognition and additive antitumor activity. In addition, the Company presented immunohistochemistry analysis showing that MICA/B is expressed throughout tumor tissue in biopsy samples obtained from patients with various cancers, including colorectal cancer. FT836 is also the Company’s first product candidate to incorporate the novel Sword & ShieldTM technology, which utilizes the Company’s novel alloimmune defense receptor (ADR) alongside CD58 knockout (KO), to both target and evade host alloreactive immune cells for a comprehensive strategy to avoid the need for conditioning chemotherapy. In January 2025, the Company secured a $4 million award from the California Institute of Regenerative Medicine (CIRM) to support IND-enabling activities for FT836.

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FT836 demonstrates clinical activity in CRC without the use of conditioning chemotherapy. In July, the FDA allowed the Company’s investigational new drug (IND) application to initiate Phase 1 clinical testing of FT836 off-the-shelf CAR T cells. The Phase 1 study is designed to assess the safety and activity of FT836 as monotherapy and in combination with standard of care therapies without administration of conditioning chemotherapy for the treatment of advanced solid tumors. The Company has now treated three colorectal cancer (CRC) patients with FT836 at DL1 of 300 million cells, given on Days 1 and 15, with the first dose requiring 24-hour hospitalization and the second dose being given as outpatient. FT836 was well-tolerated with no ICANS, GvHD, CRS or dose-limiting toxicities reported at DL1, supporting its potential as a broadly accessible treatment with a favorable safety profile. As of the January 23rd 2026 data cut off, one of the three CRC patients treated in combination with cetuximab at DL1, a heavily pretreated 45 year old male who was refractory to cetuximab and had received 7 prior lines of therapy, demonstrated early evidence of anti-tumor activity, including a greater than 50% reduction in carcinoembryonic antigen (CEA) levels and significant reduction in lactate dehydrogenase (LDH) levels at Day 29 post treatment, with tumor reduction seen across all target lesions of approximately 20% decrease in the sum of diameters at the 46-day evaluation scan. Notably, these observations were achieved without conditioning chemotherapy, a capability of FT836 attributed to its Sword and ShieldTM Technology. The clinical response is assessed on Day 56 and the patient is under consideration for a second treatment cycle. The ongoing clinical protocol trial is open to enrollment for treatment of patients with breast, colorectal, ovarian, head and neck, endometrial, gastric/gastroesophageal junction, and non-small cell lung cancers. The Company expects to provide additional clinical data updates in the second half of 2026.

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FT839 preclinical data presented at 2025 ASH (Free ASH Whitepaper) Annual Meeting demonstrates broad targeting capacity across autoimmune diseases and hematologic malignancies withoutthe need for conditioning chemotherapy. FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate that is designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and the second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is the second program to contain the Company’s Sword and ShieldTM technology. At the 2025 ASH (Free ASH Whitepaper) Annual Meeting, the Company presented preclinical data demonstrating the ability of FT839, with its dual-CAR mechanism and unique ability to synergize with monoclonal antibodies and T-cell engagers through its incorporated hnCD16 Fc receptor and CD3 fusion receptor, respectively, to specifically eliminate a variety of pathogenic immune cell types without requiring conditioning chemotherapy, suggesting its potential to broadly treat complex autoimmune diseases and hematologic malignancies. The Company has created the FT839 master cell bank and is completing IND-enabling activities to support initial clinical investigation of FT839 for the treatment of autoimmune diseases and hematologic malignancies in 2026.

Fourth Quarter 2025 Financial Results

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Cash & Investment Position: Cash, cash equivalents, and investments as of December 31, 2025 were $205.1 million.
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Total Revenue: Revenue was $1.4 million for the fourth quarter of 2025, which was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the Company’s collaboration with Ono Pharmaceutical.
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Total Operating Expenses: Total operating expenses were $36.1 million for the fourth quarter of 2025, including research and development expenses of $25.4 million and general and administrative expenses of $10.7 million. Such amount included $5.5 million of non-cash stock-based compensation expense.
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Shares Outstanding: As of December 31, 2025, common shares outstanding were 115.4 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares.

(Press release, Fate Therapeutics, FEB 26, 2026, View Source [SID1234663069])