On November 5, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter ended September 30, 2026.

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"CAR T has transformed what’s possible in medicine, but toxicity and treatment complexity have kept its full potential out of reach for too many patients," said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. "We believe 2027 will be an important year for cema-cel and the field, with upcoming ALPHA3 data expected to provide important insights into the potential for CAR T to be integrated into existing practice patterns, earlier in the course of a patient’s disease and closer to where they receive care. At the same time, our ALLO-329 data set to be released next week will begin to address an equally important question in autoimmune disease: whether we can deliver meaningful clinical benefit with less reliance on chemotherapy-based conditioning. Both programs reflect our conviction that the future of CAR T will be shaped not only by what these therapies can do, but by how we make them more accessible and practical for patients."

Cema-Cel: Pivotal ALPHA3 Trial in 1L Consolidation in LBCL
Cemacabtagene ansegedleucel (cema-cel) is being evaluated in ALPHA3, the first pivotal, randomized trial in LBCL designed to assess whether minimal residual disease (MRD)-guided treatment following first-line therapy can delay or prevent clinical relapse.

Enrollment momentum continues, supported by expanded site participation, increasing MRD screening activity, strong investigator engagement, and brisk enrollment in the Asia-Pacific region following the positive interim futility analysis reported earlier this year. The growing ALPHA3 network includes community oncology practices, where the majority of patients with LBCL receive treatment, reinforcing the potential for cema-cel to expand CAR T access beyond traditional treatment centers.

Early clinical experience has demonstrated the feasibility of outpatient cema-cel administration, including at community practices with limited or no prior CAR T experience. Together with the integration of MRD testing to identify patients at risk of relapse, these findings support the potential for ALPHA3 to establish a new treatment paradigm that brings CAR T earlier in the course of disease and closer to where patients receive care.

The Company continues to anticipate its next clinical update in mid-2027, with trial enrollment expected to be completed by year-end 2027.

Cema-Cel: Advancing Commercial Readiness and Patient Access
As the ALPHA3 program advances, Allogene has begun laying the groundwork for potential commercialization of cema-cel, with an early focus on payer coverage, reimbursement and treatment-site readiness to support broader patient access. To lead these efforts, the Company appointed Rocio Manghani, MPH, as Vice President, Market Access, Evidence & Strategy. Ms. Manghani brings extensive cell therapy commercialization experience from Kite, Gamida Cell and Orca Bio, including expertise in payer coverage, reimbursement, evidence generation and launch operations. Her appointment underscores Allogene’s commitment to addressing access barriers early and preparing to bring CAR T to patients where they receive care.

Further informing this strategy, an abstract accepted for online publication in November in connection with the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and in the supplemental issue of Blood will highlight findings from a survey of 152 U.S. hematologists and oncologists examining barriers to CAR T adoption and opportunities to expand access through allogeneic therapy.

Building on these insights, Allogene plans to host an in-person event at ASH (Free ASH Whitepaper) exploring how cema-cel could help overcome longstanding barriers to CAR T adoption. The discussion will explore how earlier intervention guided by MRD testing, combined with the potential for treatment in community practices, could expand access to CAR T. Additional event details will be announced at a later date.

ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease
ALLO-329 is a next-generation, dual-targeting anti-CD19/CD70 AlloCAR T product incorporating the Company’s proprietary Dagger technology. The product was designed to address allogeneic rejection by targeting activated CD70-positive patient T cells, with the goal of optimizing the benefit-risk profile while reducing or eliminating the need for conventional chemotherapy-based lymphodepletion (LD).

The ongoing Phase 1 RESOLUTION trial is a dose-escalation study evaluating ALLO-329 across multiple autoimmune indications, including systemic sclerosis (scleroderma), idiopathic inflammatory myopathies (myositis) or systemic lupus erythematosus (lupus). The trial incorporates a parallel evaluation of three conditioning approaches: no LD, cyclophosphamide alone and fludarabine plus cyclophosphamide. The design of RESOLUTION is intended to help distinguish the contribution of ALLO-329 from that of chemotherapy-based conditioning and inform selection of a treatment regimen that minimizes the burden and toxicity of LD without compromising efficacy.

Allogene will present updated clinical and translational data from RESOLUTION at the 2026 American College of Rheumatology (ACR) Convergence on November 9, 2026. The presentation will build upon the published nine-patient abstract with an expanded patient population, longer follow-up and results across three dose levels and three LD approaches.

The expanded dataset will provide a more comprehensive assessment of ALLO-329’s emerging safety and efficacy, with a focus on scleroderma, while offering new insights into the relationship between conditioning intensity and treatment response. Enrollment and dose escalation continue as the Company evaluates additional dose levels and conditioning approaches to inform selection of a potential Phase 2 regimen.

Allogene will host a webinar on November 9, 2026, at 6:00 a.m. PT/9:00 a.m. ET to review the updated clinical and translational findings, prior to the ACR poster presentation later that day.

Next-Generation Pipeline: Advancing the Dagger Platform
Allogene will highlight its leadership in allogeneic CAR T at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, November 4-8, 2026, through two invited presentations and a preclinical poster showcasing the breadth and continued evolution of its platform.

On November 5, Jeff McLeroy, M.D., Vice President, Head of Safety and Pharmacovigilance, discussed clinical findings from the Phase 1 TRAVERSE trial of ALLO-316 in renal cell carcinoma, including evidence of durable responses, CAR T expansion and tumor infiltration in patients with advanced disease. On November 6, Dr. Roberts will present Allogene’s broader vision for allogeneic CAR T as a platform designed to improve patient access across oncology and autoimmune disease, highlighting the Company’s clinical programs and the potential to bring cell therapy into more treatment settings.

Complementing these presentations, the Company will present preclinical data evaluating a novel off-the-shelf DLL3/CD70 dual CAR T product candidate for small cell lung cancer and other neuroendocrine tumors. The findings suggest that careful selection of the genomic location for site-specific-integration of the CAR can improve CAR T cell performance in controlling tumors. Confirming and extending observations presented earlier this year with BCMA, the data show pairing the DLL3 CAR with a CAR targeting CD70 can enhance resistance to immune-mediated rejection, illustrating that Dagger technology can be coupled with other CARs. These findings reinforce the potential of the Dagger technology as a versatile foundation for Allogene’s next-generation pipeline, supporting the development of off-the-shelf CAR T therapies across additional targets for both hematological and solid tumors as well as autoimmune disease.

2026 Third Quarter Financial Results

Research and development expenses were $41.9 million for the third quarter of 2026, which includes $2.9 million of non-cash stock-based compensation expense.
General and administrative expenses were $12.9 million for the third quarter of 2026, which includes $4.2 million of non-cash stock-based compensation expense.
Net loss for the third quarter of 2026 was $50.4 million, or $0.15 per share, including non-cash stock-based compensation expense of $7.0 million.
The Company had $388.9 million in cash, cash equivalents, and investments as of September 30, 2026.

Based on its cash, cash equivalents, and investments as of September 30, 2026, the Company continues to project its cash runway into 2029. Guidance for operating expense in 2026 is expected to be approximately $165 million. GAAP Operating Expenses are expected to be approximately $225 million, including estimated non-cash stock-based compensation expense of approximately $35 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, NOV 5, 2026, View Source [SID1234674349])

On November 5, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported financial results for the third quarter ended September 30, 2026, and highlighted recent business progress.

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"During the third quarter, we made significant progress with VS-7375, our potential best-in-class oral KRAS G12D (ON/OFF) inhibitor. Our first U.S. clinical data established a new monotherapy efficacy benchmark in metastatic pancreatic cancer and showed early but encouraging antitumor activity in colorectal and lung cancers, all driven by KRAS G12D, while continuing to demonstrate a manageable safety and tolerability profile without many of the on-target toxicities associated with pan-RAS approaches. Following alignment with the FDA, we plan to open our Phase 3 TARGET-D 301 trial in first-line KRAS G12D-driven metastatic pancreatic cancer by the end of the year. We also expect to engage with the FDA before year-end on Phase 3 trial designs in colorectal and lung cancers. We believe VS-7375 has transformative potential for patients with KRAS G12D-driven cancers and remain focused on advancing our pivotal programs in 2027," said Dan Paterson, president and chief executive officer at Verastem Oncology. "Demand for AVMAPKI FAKZYNJA CO-PACK remained steady during the third quarter, with strong refill rates generating $24.0 million in net product revenue. We remain confident in the long-term opportunity and anticipate a more gradual sales ramp given the episodic nature of treatment persistence in this rare disease. The FDA has accepted our NDA for the new blister pack, to further support patient convenience and adherence, and granted priority review with a decision anticipated by February 2027."

Third Quarter 2026 and Recent Updates

AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets)

AVMAPKI FAKZYNJA CO-PACK generated net product revenue of $24.0 million for the third quarter of 2026. Strong refill growth drove revenue, partially offset by fewer new patient starts due to seasonal headwinds, the implementation of recent commercial team changes, and evolving patterns of off-label use.
On October 14, the Company communicated that the U.S. Food and Drug Administration (FDA) had accepted the New Drug Application (NDA) for the AVMAPKI FAKZYNJA CO-PACK Blister Pack, granting it Priority Review with an FDA decision by February 7, 2027. The Company believes the new package presentation is an important step in further supporting patient convenience and adherence.
In October, new data from the Company’s Phase 2 RAMP 201 clinical trial of avutometinib plus defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC) were presented at the International Gynecologic Cancer Society (IGCS) 2026 Annual Global Meeting. The RAMP 201 molecular profiling analysis showed clinically meaningful activity in KRAS wild-type recurrent LGSOC, including overall response rates (ORR) of 22% in patients with NRAS- or BRAF-mutated tumors and 18% in patients with KRAS/NRAS/BRAF triple wild-type tumors. Additionally, an external control arm analysis of RAMP 201 showed higher weighted ORR and statistically significant improvements in progression free survival (PFS) versus conventional care in both KRAS-mutated and KRAS wild-type subgroups.
In September, the Company announced that two-year results evaluating the efficacy and safety of AVMAPKI FAKZYNJA CO-PACK in women with recurrent LGSOC from the RAMP 201 study were published online and in the October print issue of Gynecologic Oncology, the official journal of the Society of Gynecologic Oncology (SGO). In the updated analysis, with ongoing patients presenting a median follow-up of 24.9 months, efficacy measures, including median duration of response and median PFS, and safety, are consistent with the primary analysis, which was conducted more than 13 months prior.
In July, updated data from the RAMP 201 Japan study were presented at the Annual Meeting of the Japanese Society of Gynecologic Oncology and demonstrated consistent pharmacokinetics (PK), efficacy, and safety profile with the RAMP 201 study.
Expected Key Milestones:

FDA decision on NDA submitted for the AVMAPKI FAKZYNJA CO-PACK Blister Pack by February 7, 2027.
Report a topline readout of the primary endpoint in the RAMP 301 trial of avutometinib plus defactinib in patients with recurrent LGSOC in mid-2027.
Continue to pursue regulatory paths for potential expansion of recurrent LGSOC into Europe and Japan.
VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor in Advanced Solid Tumors

In October, the Company reported initial efficacy and updated safety and tolerability data for VS-7375 in pancreatic, lung, and colorectal cancers from the ongoing Phase 1/2 TARGET-D 101 clinical development program.
In metastatic pancreatic ductal adenocarcinoma (mPDAC), VS-7375 900 mg once daily (QD) monotherapy achieved a confirmed objective response rate (cORR) of 50% (4/8) in the second line (2L) setting, a 41% cORR (9/22) in 2L or later (2L+) setting, including two complete responses, one confirmed and one unconfirmed (treatment ongoing), and 36% cORR (5/14) in the third and fourth line (3L/4L) settings. The disease control rate (DCR) was 86%, and the six-month landmark PFS rate was 67%.
VS-7375 600 mg QD monotherapy achieved a cORR of 43% (10/23) in 2L+ non-small cell lung cancer (NSCLC). In preliminary first line (1L) data, VS-7375 600 mg QD in combination with standard-of-care (SoC) carboplatin, pemetrexed, and pembrolizumab achieved an ORR of 75% (6/8) in 1L KRAS G12D adenocarcinoma of the lung. The 900 mg QD dose level is currently being evaluated in the TARGET-D 202 Phase 2 registration-directed advanced NSCLC trial.
In early data in 3L+ metastatic colorectal cancer (mCRC), VS-7375 900 mg in combination with anti-EGFR therapy achieved an ORR of 33% (2/6; one confirmed and one unconfirmed response).
Across TARGET-D 101 monotherapy and combination cohorts, VS-7375 demonstrated a favorable and manageable safety profile at both the 600 mg (n=73) and 900 mg dose levels (n=48), with no clinically significant cumulative toxicities observed. At 900 mg once daily, the adverse event-related discontinuation rate was 2%, median relative dose intensity was 97%, and treatment-related adverse events (TRAEs) were primarily low-grade gastrointestinal events; Grade 3 TRAEs occurred in 10% of patients. Combination regimens with SoC therapies were generally consistent with the safety profiles of the individual agents, with no new or meaningful overlapping toxicities observed.
In October, the Company also shared that it had reached alignment with the FDA on the design of TARGET-D 301, a three-arm Phase 3 pivotal trial in 1L mPDAC evaluating VS-7375 900 mg in combination with anti-EGFR therapy (chemotherapy-free option) and VS-7375 900 mg in combination with gemcitabine and nab-paclitaxel versus investigator’s choice of SoC chemotherapy.
In July, the Company announced the first patients were dosed in both the TARGET-D 203 CRC and the TARGET-D 202 NSCLC clinical trials. Together with the previously announced dosing of the first patient in the TARGET-D 201 mPDAC trial in June, enrollment is ongoing across all three TARGET-D registration-directed Phase 2 studies.
Expected Key Milestones:

Plan to meet with the FDA before the end of the year to review Phase 3 pivotal trial designs in 1L mCRC (TARGET-D 303) and 1L advanced NSCLC (TARGET-D 302).
Expect to complete enrollment in the TARGET-D 201 (PDAC) and TARGET-D 203 (CRC) Phase 2 trials by the end of 2026; TARGET-D 202 (NSCLC) expected in Q2 2027.
Plan to report mature data from the TARGET-D 101 mCRC cohort evaluating VS-7375 900 mg in combination with anti-EGFR therapy in Q1 2027 to allow for additional patient follow-up.
Plan to report initial data from the TARGET-D 101 mPDAC cohort evaluating VS-7375 600 mg plus cetuximab in early 2027, with the data intended for presentation at a medical meeting.
Plan to open the TARGET-D 301 1L mPDAC trial by year-end 2026. Plan to enroll the first patient in the CRC and NSCLC Phase 3 pivotal trials in the first half of 2027.
Expect to report initial data from the 1L mPDAC combination with gemcitabine/Nab-paclitaxel in early Q2 2027, with the data intended for presentation at a medical meeting.
Plan to report initial Phase 2 data from TARGET-D 201 in 2L PDAC in Q2 2027; expect to report initial data from TARGET-D 202 in 2L NSCLC and TARGET-D 203 in 2L CRC in 2H 2027. Data from all three trials are intended for presentation at a medical meeting.
Corporate Updates

In October, Verastem announced the appointment of Michael P. Bailey as President and Chief Executive Officer (CEO), effective January 1, 2027. The CEO transition follows the planned retirement of Daniel Paterson, who will step down as President and CEO and continue to serve on the Company’s Board of Directors and as an advisor to the Company.
In October, Verastem strengthened its balance sheet by raising gross proceeds of approximately $250 million in a public offering of 30,937,500 shares of its common stock and pre-funded warrants to purchase 312,503 shares of its common stock.
Verastem selected a second program to advance under its research collaboration with GenFleet; a previously selected third program has been discontinued due to technical futility, and the targets for both programs remain undisclosed. Separately, the companies amended their August 2023 agreement. Under the new terms Verastem will lead Investigational New Drug-enabling studies and clinical development outside of China for the second program while allowing GenFleet the option to retain China rights based on Phase 1 safety data from the ex-China study. The financial terms of the original agreement have been amended with Verastem having no additional near-term payment for gaining rights to the second program, with future success-based milestone payments tied to achieving clinical regulatory, and sales milestones.
In September, Verastem received the 2026 Industry Innovation and Rare Impact Award from the National Organization for Rare Disorders (NORD) and was listed by Fierce Healthcare as a 2026 Fierce 50 honoree in the Breakthrough category, both awards recognizing the innovation behind the first FDA-approved treatment specifically for adults with KRAS-mutated recurrent LGSOC.
Third Quarter 2026 Financial Results

Verastem Oncology ended the third quarter of 2026 with cash, cash equivalents, and investments of $172.8 million, inclusive of the $50.0 million non-dilutive royalty financing arrangement that closed on August 28, 2026. On a pro forma basis, taking into account the $250.0 million of gross proceeds raised in a follow-on offering in October, cash and cash equivalents were $422.8 million as of September 30, 2026. Based on Verastem’s cash position, gross proceeds from the October financing, and expected revenues from AVMAPKI FAKZYNJA CO-PACK sales, Verastem believes it has the capital to fund its operating plan into the first half of 2028, including the initiation of three pivotal Phase 3 studies in PDAC, CRC, and NSCLC.

Net product revenue for the three months ended September 30, 2026 (2026 Quarter) was $24.0 million, compared to $11.2 million in net product revenue recognized for the three months ended September 30, 2025 (2025 Quarter). Total operating expenses for the 2026 Quarter were $99.2 million, compared to $52.0 million for the 2025 Quarter. Cost of sales was $3.9 million for the 2026 Quarter, compared to $2.0 million for the 2025 Quarter.

Research & development expenses for the 2026 Quarter were $68.8 million, compared to $29.0 million for the 2025 Quarter. The increase of $39.8 million, or 137%, was primarily due to increased costs for investigator fees, drug substance and drug product manufacturing costs, contract research organization costs, and personnel costs, including non-cash stock-based compensation.

Selling, general & administrative expenses for the 2026 Quarter were $26.5 million, compared to $21.0 million for the 2025 Quarter. The increase of $5.5 million, or 26%, was primarily due to higher costs for personnel, including non-cash stock-based compensation, and commercial operations.

Net loss (GAAP basis) for the 2026 Quarter was $74.7 million, or $0.74 per share (basic and diluted), compared to $98.5 million, or $1.35 per share (basic and diluted) for the 2025 Quarter.

Non-GAAP adjusted net loss for the 2026 Quarter was $72.8 million, or $0.72 per share (basic), compared to non-GAAP adjusted net loss of $39.1 million, or $0.53 per share (basic), for the 2025 Quarter. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.

Conference Call and Webcast

Verastem will host a conference call and webcast today at 4:30 p.m. ET to review the third quarter 2026 financial results and recent business updates. To access the live audio webcast of the call, along with accompanying slides, please visit the "Events & Presentations" page in the Investor section of the Company’s website, View Source A replay of the webcast will be archived and available following the event.

(Press release, Verastem, NOV 5, 2026, View Source [SID1234674348])

On November 5, 2026 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported third quarter 2026 results and provided a corporate update.

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"During the last quarter we reached alignment with the U.S. Food and Drug Administration (FDA) on the protocol for a Phase 3 study of our lead therapeutic candidate, efzofitimod, in pulmonary sarcoidosis patients with restrictive lung disease, a major form of interstitial lung disease (ILD) with a high unmet medical need," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We believe the efzofitimod program is well-positioned, considering the late-stage development status in an indication with a multi-billion-dollar global market opportunity, and have determined that at this time the best way for us to advance efzofitimod is to prioritize strategic partnerships."

Third Quarter 2026 and Subsequent Period Highlights

Reached alignment with the FDA on the protocol for a global Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease. The Company recently initiated study-related activities for the trial and is prioritizing strategic partnerships and/or licensing arrangements in order to advance the Phase 3 study beyond the completion of the initial study-related activities.
Completed enrollment in the Phase 2 EFZO-CONNECT study of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc)-related ILD (SSc-ILD). Full study results are expected in the second quarter of 2027. These will include data for multiple study endpoints, including the modified Rodnan Skin Score, skin histopathology, gene expression profiling, immune biomarkers, forced vital capacity, and an exposure response analysis.
Published the results of the Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis in The Lancet Respiratory Medicine. The peer-reviewed publication reinforces efzofitimod’s differentiated profile and potential to advance pulmonary sarcoidosis care. The publication is available on the Company’s website.
Published a manuscript demonstrating the mechanism of action and anti-fibrotic effects of ATYR0101 in the Journal of Biological Chemistry. ATYR0101 is a fusion protein that interacts with latent transforming growth factor beta binding protein 1 (LTBP-1) through a unique way that presents a differentiated approach to targeting fibrosis. The publication is available on the Company’s website.
Announced a research collaboration for pediatric osteosarcoma with Montefiore Einstein involving preclinical studies of ATYR2810, the Company’s monoclonal antibody that targets the neuropilin-2 (NRP2) receptor. The collaboration is to further the development and testing of ATYR2810 in an aggressive cancer where NRP2 is implicated.
Third Quarter 2026 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of September 30, 2026, were $50.3 million. Based on its current cash and operating expense forecast and plans, the Company anticipates that this cash position will be sufficient to fund the Company’s current operations into late 2028.
R&D Expenses: Research and development expenses were $10.4 million for the third quarter 2026, which consisted primarily of costs for the Phase 2 EFZO-CONNECT study and research and development costs for the Company’s preclinical product candidates.
G&A Expenses: General and administrative expenses were $8.3 million for the third quarter 2026.
About Efzofitimod

Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr recently initiated study-related activities for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

(Press release, aTyr Pharma, NOV 5, 2026, View Source [SID1234674347])

On November 5, 2026 GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its third quarter 2026 financial results1 and provides a corporate update.

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Cash and Revenue

Cash position
As of September 30, 2026, the Company’s cash and cash equivalents amounted to €95.6 million compared with €113.8 million as of June 30, 2026, and €101.1 million as of December 31, 2025.

In 2026, cash consumption was primarily driven by research and development activities across our Acute-on-Chronic Liver Failure (ACLF) franchise programs, notably NTZ/G1090N, SRT-015, CLM-022 and VS-02 HE, as well as our GNS561 program in cholangiocarcinoma (CCA). Cash consumption was partially offset by two significant cash inflows during the first half of 2026: (i) the second €30.0 million tranche received under the royalty financing agreement and (ii) the receipt of the first commercial milestone from Ipsen totaling €17.0 million ($20.0 million), which had been recognized in 2025 and was received in cash in 2026.

Cash runway
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 and support general corporate purposes. Beyond this period, as sales of elafibranor increase, we expect related cash flows to become an increasingly important source of funding, with the objective of ultimately financing our operations and future development through cash generated by the business. This is based on current assumptions and programs and does not include exceptional events. In particular, this assumes (i) the continued commercial performance of Iqirvo (elafibranor) and resulting royalties, (ii) the expectation to receive significant commercial milestones under the Ipsen Agreement, (iii) maintaining operating expenses at levels broadly consistent with current expectations, (iv) the development of revenues from our diagnostic activities, and (v) the possibility to draw down, if needed, the third and final installment of the Royalty Financing agreement.

Revenue

Revenue Nine-months ended
(In € thousands) 30/09/2025 30/09/2026
Royalty revenue 12,596 36,308
Milestone revenue 26,556 0
Other revenue 81 125
Total 39,233 36,433
Royalty revenue

Virtually all royalty revenue is derived from worldwide sales of Ipsen’s Iqirvo2 (elafibranor) under the Ipsen Agreement. These are utilized to repay the Group’s Royalty Financing agreement. Year-over-year growth for the periods presented was 188%, reflecting accelerating U.S. sales and strong performance across Europe and other markets.

Milestone revenue

On May 20, 2025, GENFIT announced that Ipsen’s Iqirvo (elafibranor) was granted pricing and reimbursement in Italy for Primary Biliary Cholangitis (PBC), the third major European country to do so in addition to the UK and Germany. This third approval triggered a milestone payment of €26.5 million under GENFIT’s Licensing and Collaboration Agreement with Ipsen, due upon pricing and reimbursement of Iqirvo (elafibranor) in three major European markets.

Year-over-year revenue comparisons should consider the timing of milestone payments. Revenue for the nine months ended September 30, 2025 included a milestone payment, while no milestone revenue was recognized in the nine months ended September 30, 2026. Additional milestone revenue may however be recognized in future periods.

Corporate update

Elafibranor in cholestatic liver diseases

Primary Biliary Cholangitis (PBC) – Iqirvo net sales reached €109.4 million in Q3 2026, compared with €48.6 million in Q3 2025, representing 125.4% year-over-year growth at constant exchange rates (CER). For the first nine months of 2026, net sales reached €282.6 million, versus €107.4 million over the same period in 2025, representing 170.8% growth at CER.3 Iqirvo is leading growth within Rare Disease, Ipsen’s fastest-growing franchise. Earlier in July, Ipsen upgraded its peak sales estimates from €500 million to €1 billion in PBC. This revision followed Ipsen’s announcement on July 13, 20264, that the primary endpoint of alkaline phosphatase (ALP) normalization had been achieved in 85% of patients treated with Iqirvo (elafibranor), compared with 23% of patients receiving placebo at Week 52, in the Phase 3 ELSPIRE study.

Next steps: Following positive results of the ELSPIRE study, regulatory submission is underway for PBC label update. Ipsen intends to publish its full-year results and fourth-quarter sales on February 11, 2027.

Primary Sclerosing Cholangitis (PSC) – Phase 3 ELASCOPE study launched early 2026 is still ongoing. The market opportunity in PSC is estimated to be comparable in size to the second‑line PBC market. Subject to successful development and regulatory approval of elafibranor in this indication, GENFIT would be eligible to receive additional milestone payments as well as incremental double‑digit royalties.

Next steps: Data readout expected around 2031.
Non-invasive diagnostic technology in Metabolic dysfunction‑Associated SteatoHepatitis (MASH)
Medicare reimbursement for Labcorp’s NASHnext2 test (based on GENFIT’s NIS technology) became effective in August 2026 (under the Clinical Laboratory Fee Schedule) for patients meeting coverage criteria. GENFIT believes broader reimbursement by private payers, if obtained, could support accelerated adoption of its technology over time. Further market expansion could also be supported by a potential future In Vitro Diagnostics (IVD) launch, which may facilitate deployment across a wider range of healthcare settings.

In September, based on intention-to-diagnose data collected across key specialties, increasing disease prevalence, and a staged commercialization strategy spanning Laboratory Developed Tests (LDT) and IVD, IQVIA estimated that U.S. peak annual sales of products using GENFIT’s technology could exceed $1.5 billion by 2033, with annual testing volume in the U.S. reaching more than 7 million tests.5

GENFIT is engaging with stakeholders at AASLD The Liver Meeting 2026 (November 5-9) to raise awareness of the evolving evidence supporting non-invasive approaches to identifying patients with at-risk MASH, including its NIS Technology.

Next steps: GENFIT intends to outline its industrial strategy for the development and large-scale commercialization of an IVD kit based on its NIS Technology toward year-end. Subject to successful development, regulatory approval, partner execution and market adoption, GENFIT believes a potential commercial launch from 2028 could contribute to a meaningful acceleration in NIS-related revenues over time.
R&D pipeline

Nangibotide to be evaluated in Phase 2 in ACLF – In summer 2026, GENFIT acquired the nangibotide program, a differentiated late-stage asset targeting the TREM-1 pathway. Phase 2 development is supported by efficacy signals observed across three prior Phase 2 clinical trials in septic shock and Covid19, including statistically significant improvements in mortality and SOFA score in selected analyses, together with a favorable safety and tolerability profile across more than 400 exposed subjects.

Next steps: Nangibotide is expected to enter a Phase 2 study in ACLF by year-end, with data readout targeted in the second half of 2027.

Nitazoxanide to be evaluated in Phase 2 in ACLF – Positive Phase 1 data reported in early 2026 confirmed the favorable safety profile of NTZ and demonstrated multi‑modal biological activity, supporting its continued clinical development across the ACLF disease continuum. In March 2026, FDA granted Orphan Drug Designation for NTZ for the treatment of ACLF.

Next steps: The proof‑of‑concept study initiated in the third quarter of 2026 is expected to deliver data in mid-2027.

GNS561 to be evaluated in Phase 2 in combination, in KRAS mutated CCA – Encouraging preliminary data from the ongoing Phase 1b study evaluating GNS561 in combination with a MEK inhibitor in KRAS-mutated CCA were disclosed in December 2025 and June 2026, leading to the expansion of the study into additional cohorts.

Next steps: Additional Phase 1b data expected by year-end; Phase 2 initiation on track by year-end, with data readout targeted for the second half of 2027.

Research programs in ACLF and CCA – GENFIT is directing its capital and development resources towards the programs with the strongest translational rationale and clinical potential.

Next steps: Further details will be provided as and when these programs advance into clinical development.

(Press release, Genfit, NOV 5, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-third-quarter-2026-financial-information-and [SID1234674346])

On November 5, 2026 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company developing novel multispecific immuno-oncology therapeutics, reported an important clinical development milestone for mipletamig: a substantial reduction in infusion-related reactions (IRRs) following successive refinements to its priming-dose regimen. The improvement builds on mipletamig’s already favorable safety and tolerability profile, including encouraging cytokine release syndrome (CRS) findings observed throughout its clinical development. Mipletamig data will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 68th Annual Meeting in New Orleans, Louisiana from December 12-15, 2026.

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The ongoing RAINIER dose optimization study has demonstrated encouraging clinical activity and a favorable safety and tolerability profile for mipletamig, including favorable findings related to cytokine release syndrome (CRS). Building on these results, Aptevo has further improved tolerability through refinements to the priming-dose regimen, substantially reducing infusion-related reactions (IRRs) during initial treatment. The Company believes this achievement is a key part of creating an optimized dose that delivers safety, tolerability and efficacy, consistent with the objectives of its discussions with the U.S. Food and Drug Administration (FDA), as it prepares for Phase 2 development.

Mipletamig is being evaluated in combination with standard-of-care venetoclax and azacitidine in patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. The Company expects to complete the current study by year-end 2026.

"We have made substantial progress in improving mipletamig’s tolerability for patients with frontline AML," said Dirk Huebner, M.D., Chief Medical Officer of Aptevo Therapeutics. "Mipletamig has demonstrated a differentiated safety and tolerability profile, and successive refinements to the priming-dose regimen have substantially reduced the occurrence of infusion-related reactions. Reducing these reactions matters to patients: it has the potential to make treatment easier to tolerate and limit complications that can disrupt care. These findings are an important part of our preparations for the next stage of clinical development."

A Targeted Improvement with Meaningful Patient Benefits

Infusion-related reactions can occur during or after intravenous treatment and may include fever, chills, rash or nausea. Although often manageable, these reactions can be uncomfortable for patients and, depending on their severity, may require additional medical intervention, treatment interruptions or discontinuation.

This is particularly relevant in frontline AML, where patients who are unfit for intensive chemotherapy are often older or have additional health conditions that make treatment tolerability especially important.

Mipletamig’s priming-dose regimen gradually introduces treatment before escalation to higher doses. Aptevo has refined this approach over the course of RAINIER to reduce treatment-related reactions during early dosing, building on the favorable tolerability observations previously reported for mipletamig.

Successive refinements to the initial dosing regimen have been associated with substantial reductions in the occurrence of treatment-related reactions, including IRRs. For patients, fewer treatment-related reactions may mean a more comfortable and predictable treatment experience, less need for additional medical intervention and fewer disruptions during treatment. These considerations are especially important for patients with frontline AML, who may be older or have other health conditions.

Building on an Already Favorable Safety Profile

Mipletamig has demonstrated an encouraging safety and tolerability profile throughout its clinical development, including highly favorable findings related to cytokine release syndrome (CRS), a potentially serious inflammatory reaction associated with certain immune-based cancer therapies.

The latest refinements to mipletamig’s priming-dose regimen build on that foundation by substantially reducing infusion-related reactions during initial treatment. Together, these findings underscore Aptevo’s continued focus on optimizing treatment tolerability while advancing mipletamig as a potential addition to the frontline AML standard of care.

Together, these observations reinforce Aptevo’s focus on improving the patient treatment experience as it optimizes mipletamig for combination therapy. Reducing treatment-related reactions could lessen interruptions that interfere with care and help preserve patients’ opportunity to receive treatment and potentially benefit from it.

Making the Case in Frontline AML

The dosing refinement adds to a growing body of clinical evidence supporting mipletamig’s potential as an addition to the current frontline AML standard of care.

Aptevo has previously reported encouraging clinical activity in the RAINIER study, including remission responses in patients with TP53-mutated AML, a high-risk population with historically poor outcomes. The Company has also reported that patients initially considered unfit for intensive chemotherapy have advanced to allogeneic stem cell transplantation, a potentially curative treatment option.

These findings support the continued evaluation of mipletamig in combination with venetoclax and azacitidine, with the goal of improving outcomes beyond those achieved with the current standard-of-care doublet.

The refined priming-dose regimen strengthens the tolerability component of mipletamig’s development profile. While these findings do not establish improved efficacy or treatment persistence, reducing reactions that can interrupt therapy is clinically meaningful and may lessen a potential obstacle to continued treatment.

Advancing Toward Phase 2 Development

The substantial reductions in IRRs and CRS observed following successive priming-dose refinements represent important progress in Aptevo’s preparation for Phase 2 development.

These observations add to the clinical evidence informing dose selection and upcoming regulatory discussions, reflecting Aptevo’s continued focus on improving tolerability while evaluating mipletamig’s therapeutic potential in frontline AML.

The Company continues to evaluate clinical activity, safety and tolerability in RAINIER and expects to complete the current study by year-end 2026, conduct regulatory interactions and initiate Phase 2 development in 2027.

Aptevo’s objective remains to develop mipletamig as an effective, well-tolerated addition to the current frontline AML standard of care, offering patients the potential for better outcomes without unnecessarily increasing the burden of treatment.

About Mipletamig

Aptevo’s wholly owned lead proprietary drug candidate, mipletamig, is being evaluated for the treatment of AML. Mipletamig is designed to redirect the patient’s immune system to destroy leukemic cells and leukemic stem cells expressing CD123, which is overexpressed on leukemic stem cells and AML blasts. Mipletamig is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. Mipletamig is purposefully designed to reduce the likelihood and severity of cytokine release syndrome by using the CRIS-7-derived CD3 binding pathway, an approach that differentiates Aptevo from competitors.

(Press release, Aptevo Therapeutics, NOV 5, 2026, View Source [SID1234674345])