On September 24, 2026 Amberstone Biosciences, Inc., a preclinical-stage oncology company developing pH-gated, tumor-activated T-cell engagers (TCEs), reported a collaboration and license agreement with Shanghai Henlius Biotech, Inc., a commercial-stage biopharmaceutical company (2696.HK). Under the agreement, Amberstone will work with Henlius to apply its proprietary T-MATE (Tumor Microenvironment Activated ThErapeutics) platform technology to generate preclinical candidates against up to two targets selected by Henlius. Henlius will lead subsequent research, development, manufacturing, and commercialization activities worldwide.

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T-cell engagers redirect a patient’s T cells to kill cancer cells, but their development in solid tumors has been constrained by cytokine release syndrome and on-target, off-tumor toxicity. T-MATE is designed to address these limitations through reversible pH gating, reducing T-cell activation in the circulation and healthy tissues while retaining therapeutic activity across a broad range of pH conditions found in solid tumors. Preclinical studies have shown potent tumor-cell killing under tumor-like pH conditions with markedly reduced activity at physiological pH. Amberstone’s self-developed lead T-MATE TCE asset is expected to enter clinical development in the first half of 2027.

Under the agreement, Amberstone will receive an upfront payment and research funding, and is eligible to receive up to US$440 million in potential development, regulatory, and sales milestones for each target, plus tiered royalties on net sales.

(Press release, Amberstone Biosciences, SEP 24, 2026, View Source [SID1234671059])

On September 24, 2026 Earendil Labs, an AI-powered biotechnology company advancing next-generation biologics, reported a research collaboration with Genentech, a member of the Roche Group, to discover and develop multiple therapeutic bispecific antibody programs in oncology.

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Under the collaboration, Earendil Labs will lead antibody discovery and research through the early clinical development stage for antibody programs directed to certain pre-agreed target combinations. Genentech will assume responsibility for subsequent global clinical development and commercialization of such antibody programs arising from the collaboration. The transaction is subject to customary closing conditions.

As part of the agreement:

Earendil Labs will receive a $55 million upfront payment
The total potential value of the collaboration, including upfront, development, regulatory and sales milestone payments, is in excess of $1.5 billion.
Earendil Labs is also eligible to receive tiered royalties on net product sales.
Jian Peng, PhD, CEO of Earendil Labs, said: "Genentech is a pioneer in defining modern biologics cancer medicine. Earendil Labs is building an AI-driven high-throughput biology platform that effectively integrates AI directly into biologics research and development—from predictive protein modeling and generative protein design to rapid experimental validation. By combining our platform with Genentech’s deep expertise in oncology drug development, we aim to accelerate the creation of differentiated bispecific antibodies and translate them into new medicines."

Zhenping Zhu, MD, PhD, President & co-CEO of Earendil Labs, added: "Despite many major advances in targeted cancer therapies and immunotherapies, there still exists a significant unmet medical need as many cancer patients develop drug resistance or relapse. Tumor growth and metastasis depend on multiple and interactive biological pathways, making it especially challenging for therapies directed at a single mechanism to achieve durable benefit. Bispecific antibodies offer the potential to address complementary disease biology within a single medicine. Through this strategic collaboration, we strive to discover and advance meaningful new treatment options for patients expeditiously."

"Bispecific antibodies have reframed how we approach treatment precision in oncology," said Boris L. Zaïtra, Head of Roche Corporate Business Development. "In cancers where patients face high relapse rates and limited options, bispecific antibodies support our commitment to delivering innovative, targeted therapies. Partnering with companies such as Earendil Labs allows us to push the boundaries of scientific innovation to meet patients’ critical unmet needs in oncology."

(Press release, Earendil Labs, SEP 24, 2026, View Source [SID1234671058])

On September 24, 2026 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage ultra-rare rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2026.

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Tumor HI

upLIFT, a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment of tumor HI, is ongoing.
Enrollment is in progress and topline results are expected before the end of 2026.
In June 2026, the Company shared positive interim data from the upLIFT study, announcing that of the 8 participants enrolled, 6 had already met the responder criterion for the study’s primary endpoint within the 8-week pivotal treatment phase. Each of these 6 participants also achieved a complete discontinuation of intravenous glucose requirements with the administration of ersodetug. Since the time of this announcement, the seventh participant has also met the responder criterion for the study’s primary endpoint.
One of the 8 enrolled participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status (ECOG 4). The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition, so the participant is being counted as a non-responder for purposes of assessing the primary endpoint.
In June 2026 at the Annual Meeting of the Endocrine Society (ENDO), Rezolute delivered a poster presentation highlighting favorable outcomes from a case series report of 9 patients with refractory hypoglycemia due to malignant insulinoma and non-islet cell tumors (tumor HI), demonstrating that 75% of the patients receiving IV dextrose/total parenteral nutrition (TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN.
The outcomes of this case series were also recently published in manuscript form in The Journal of Clinical Endocrinology & Metabolism (JCEM), titled Ersodetug for refractory hypoglycemia due to malignant insulin-secreting tumors.

Congenital HI

In September 2026, the Company provided an update that data from the Phase 3 sunRIZE study in congenital HI, which did not meet its primary endpoint, remains under review with the U.S. Food and Drug Administration (FDA or Agency).
In June 2026, the Company provided additional study data for the Agency’s independent review, including source and analysis datasets and summary results from a substantial number of pre-specified, post-hoc, and sensitivity analyses with a focus on continuous glucose monitoring (CGM) based glucose outcomes from the pivotal portion of the study.
The open-label extension (OLE) phase of the sunRIZE study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in the use of background standard of care therapies.
Rezolute will continue to await feedback and reserves the ability to request a formal meeting under a regulatory timeline, as needed.
In June 2026 at ENDO, Rezolute delivered three data presentations focused on congenital HI.
In an oral presentation, Huseyin Demirbilek, M.D., Professor, Department of Pediatric Endocrinology, Hacettepe University Faculty of Medicine, Ankara, Turkey, and Principal Investigator of the Phase 3 sunRIZE study, reviewed previously reported results from the study.
Two poster presentations highlighted results from systematic analyses of natural history and adverse neurologic and health-economic outcomes resulting from congenital HI, using a meta-analysis of the literature as well as a claims-based approach to quantifying congenital HI complications, respectively.

Fourth Quarter and Full Year Fiscal 2026 Financial Results

Cash, cash equivalents and investments in marketable securities were $107.8 million as of June 30, 2026, compared with $167.9 million as of June 30, 2025.

Research and development (R&D) expenses were $14.9 million for the fourth quarter of fiscal 2026, compared with $20.9 million for the same period a year ago. Full fiscal year 2026 R&D expenses were $53.8 million, compared to $61.5 million in fiscal year 2025. The decrease from fiscal year 2025 to fiscal year 2026 was primarily due to decreased manufacturing costs for ersodetug, partially offset by increased employee-related stock-based compensation expense. R&D expenses include $6.5 million of share-based compensation expense for the fiscal year 2026, compared with $3.5 million for fiscal year 2025.

General and administrative (G&A) expenses were $6.7 million for the fourth quarter of fiscal 2026, compared with $5.0 million for the same period a year ago. Full fiscal year 2026 G&A expenses were $29.2 million, compared to $18.4 million in fiscal year 2025. The increase was primarily attributable to increased employee-related stock-based compensation expense, and an increase in professional fees in preparation for future ersodetug commercial activities. G&A expenses include $8.0 million of share-based compensation expense for fiscal 2026, compared with $3.6 million for fiscal year 2025.

Net loss was $20.5 million for the fourth quarter of fiscal 2026 compared with a net loss of $24.4 million for the same period a year ago. Full year fiscal 2026 net loss was $77.6 million compared to net loss of $74.4 million for the fiscal year 2025.

About Ersodetug

Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from pancreatic insulin or paraneoplastic IGF-2 secretion and from entero-incretin pathways, it has the potential to be universally effective at treating refractory hypoglycemia due to any form of hyperinsulinism (HI), including congenital HI, tumor HI (insulinoma, non-islet cell tumors) or bariatric/non-bariatric gastrointestinal surgery hypoglycemia. Ersodetug for the treatment of HI is investigational. Statements about safety and efficacy have not been approved by any health authority.

(Press release, Rezolute, SEP 24, 2026, View Source [SID1234671057])

On September 24, 2026 Celularity Inc. (Nasdaq: CELU) ("Celularity" or the "Company"), a regenerative and cellular medicine company, reported an initial closing generating over $10 million in gross cash proceeds from a private placement of senior secured convertible notes and warrants. The closing is part of a broader recapitalization plan contemplating up to $25 million in new cash investment, including the initial closing, and the restructuring of approximately $3 million in existing indebtedness.

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The financing follows significant operating improvements, including a reduction in monthly cash burn of more than $1 million, personnel optimization and a sharper allocation of resources toward revenue-generating opportunities. With a lower operating cost base, purpose-built manufacturing infrastructure and existing cenplacel-L inventory that management estimates represents approximately $40 million in potential sales value, Celularity is focused on converting its scientific and manufacturing assets into revenue and sustained growth.

The Company also announced the appointment of Philip A. Barach to its Board of Directors, bringing financial expertise and an emphasis on capital allocation, operating accountability and stockholder returns.

"We have built substantial scientific and manufacturing capabilities, and we are taking decisive action to translate those investments into commercial results," said Robert J. Hariri, M.D., Ph.D., Chairman and Chief Executive Officer. "Our lower cost structure, existing cellular product inventory and purpose-built manufacturing facility provide a powerful foundation for growth. This financing supports our ambition to expand revenue-producing relationships, increase utilization of our manufacturing capabilities and pursue opportunities across cellular and regenerative medicine and complementary longevity therapeutics. Our objective is to build a business that can help advance human healthspan while delivering lasting value to stockholders."

"Extending healthy human life is an extraordinary opportunity, and Celularity has spent years building capabilities to help address it," added Peter H. Diamandis, M.D., Co-Founder and Director of Celularity. "The next phase is about translating that foundation into scale by connecting our science with market access, expanding productive partnerships and making our infrastructure an engine of growth. I’m pleased to welcome Philip to the Board and look forward to James joining us as we work to realize that potential."

A Lower Cost Base and a Sharper Focus on Returns

Celularity has implemented substantial budgetary improvements, reduced monthly cash burn by more than $1 million and optimized personnel and spending around its strategic priorities. These actions are designed to make invested capital go further and strengthen the Company’s ability to translate additional revenue into improved operating performance.

Building on these operating improvements and anticipated revenue growth, Celularity expects to achieve positive monthly operating cash flow by the end of the first quarter of 2027. This outlook reflects management’s expectations for increased manufacturing revenue, deployment of existing cellular product inventory and continued control of operating expenses.

"Since my initial investment, Celularity has demonstrated the willingness to make difficult operating decisions and reduce its monthly cash burn, enabling the Company to concentrate resources on bolstering revenue generation," said Philip A. Barach. "That progress was a catalyst for my additional investment and my agreement to join the Board. I see an opportunity to pair a leaner operating structure with substantial scientific and manufacturing assets to build a stronger, more valuable company. My focus will be on directing capital toward the most compelling opportunities and holding the business accountable for measurable results."

Expanding Manufacturing Relationships

The Company’s growth strategy centers on turning its existing scientific and manufacturing assets into revenue-producing partnerships. Its collaboration with MuseCell Innovations Pte. Ltd. ("MCI") illustrates that strategy, establishing U.S. manufacturing capabilities for the Dezawa MuseCell platform and related products at Celularity’s Florham Park facility. The relationship provides an opportunity to increase facility utilization, generate manufacturing revenue and build a foundation for broader commercial expansion. Celularity intends to pursue additional relationships that similarly put its existing infrastructure and expertise to productive use while maintaining a disciplined approach to capital investment.

Approximately $40 Million in Potential Sales From Existing cenplacel-L Inventory

Celularity currently holds inventory of cenplacel-L, its investigational placenta-derived allogeneic cell therapy, that management estimates represents approximately $40 million in potential sales value. The Company intends to pursue deployment through commercial relationships in permissive jurisdictions where supply and use are legally authorized, subject to applicable local regulatory requirements.

This existing inventory provides a tangible foundation for the Company’s domestic and international growth strategy. Celularity aims to convert that inventory into revenue while expanding relationships that can support recurring demand and broader utilization of its manufacturing capabilities.

Transaction Summary

The transaction combines a private placement of senior secured convertible notes and accompanying warrants with the restructuring of existing indebtedness. The initial closing generated over $10 million in gross cash proceeds, before transaction expenses and repayment of existing indebtedness.

The notes mature 24 months after their respective issuance dates and bear interest at 10% per annum, compounded annually. Notes issued at the initial closing are initially convertible into Class A common stock at $1.50 per share. Accompanying five-year warrants are initially exercisable at $1.50 per share and provide eleven warrant shares for every twenty shares initially issuable upon conversion of the notes.

Conversion and exercise prices are subject to adjustment, and issuances remain subject to applicable ownership limitations and Nasdaq stockholder approval requirements. Additional closings are subject to the applicable investor election procedures and other conditions specified in the definitive agreements. The full recapitalization amount includes potential future funding that has not yet been received, and there can be no assurance that additional closings will occur.

In connection with the transaction, Philip A. Barach is to join Robert J. Hariri and Peter H. Diamandis on a newly constituted five-member Board of Directors, with two additional directors to be announced at a later date. The appointments remain subject to applicable requirements, including completion of the Rule 14f-1 information statement process.

Odeon Capital Group LLC acted as placement agent in connection with the initial closing of the private placement.

Further details regarding the financing, restructured indebtedness, Board arrangements and related agreements will be included in a Current Report on Form 8-K.

The securities have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption. This release does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sale in a jurisdiction where such offer, solicitation or sale would be unlawful.

(Press release, Celularity, SEP 24, 2026, View Source;id=409780&p=2454974&I=1206939-c7Z3G6f3m8 [SID1234671056])

On September 24, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that an abstract about molecular profiling and tumor biomarker analysis from the Phase 2 RAMP 201 clinical trial of avutometinib plus defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC) has been selected for a late-breaking oral presentation at the International Gynecologic Cancer Society (IGCS) 2026 Annual Global Meeting, taking place October 1–3, 2026, in Montreal, Canada.

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Additionally, previously reported results from the Phase 2 RAMP 201J study in Japanese patients with recurrent low-grade serous ovarian cancer has also been selected as a seminal oral presentation. Presentation details for all accepted late breaking, seminal, and regular abstracts are listed below and available on the IGCS Annual Global Meeting web site.

Session: Rapid Orals – Rare Gynecologic Tumors Master Session
Title: Molecular Profiling and Tumor Biomarker Analysis of RAMP 201, A Study Demonstrating Efficacy of Avutometinib in Combination with Defactinib in Recurrent Low-Grade Serous Ovarian Cancer
LBA Abstract #: 1016
Presenter: Susana N. Banerjee, MBBS, MA, FRCP, PhD, The Royal Marsden NHS Foundation Trust, London
Date and Time: Friday, October 2, 2026, 10:30 – 11:30​ a.m. ET

Session: Rapid Orals – Rare Gynecologic Tumors Master Session
Title: Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC): A Phase II Study in Japanese Patients (RAMP 201J)
Seminal Abstract #: 1236
Presenter: Shogo Shigeta, M.D., Tohoku University School of Medicine, Tokyo
Date and Time: Friday, October 2, 2026, 10:30 – 11:30​ a.m. ET

Session: Poster Rounds with the Professor
Title: Efficacy of Avutometinib and Defactinib vs Conventional Care in Low-Grade Serous Ovarian Cancer (LGSOC): An External Control Arm Analysis
Abstract and Poster #: 1253/PPD077 (Read the abstract here)
Presenter: Rachel Grisham, M.D., Memorial Sloan Kettering Cancer Center, New York, NY
Date and Time: Friday, October 2, 2026, 2:25 – 2:30 p.m. ET

About RAMP 201
RAMP 201 (ENGOTov60/GOG3052/NCRI) (NCT04625270) was an adaptive, two-part multicenter, parallel cohort, randomized, open-label Phase 2 registration-directed trial evaluating the efficacy and safety of avutometinib alone and in combination with defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC). The first part of the trial (Part A) determined the selection of the go-forward regimen, which was the combination of avutometinib and defactinib versus avutometinib alone, based on overall response rates. The expansion phases of the trial (Parts B and C) evaluated the safety and efficacy of the go-forward regimen of avutometinib 3.2 mg twice weekly and defactinib 200 mg twice daily. The Part D portion of the trial evaluated a low dose of the combination to inform individualized dose reduction.

About Low-Grade Serous Ovarian Cancer (LGSOC)
LGSOC is a rare ovarian cancer that is insidious and persistent. LGSOC is distinct and different from high-grade serous ovarian cancer (HGSOC) and requires different treatment. LGSOC is highly recurrent and less sensitive to chemotherapy compared to HGSOC. Approximately 6,000-8,000 women in the U.S. and 80,000 worldwide are living with this disease. LGSOC affects younger women with bimodal peaks of diagnosis at ages between 20-30 and 50-60 and has a median survival of approximately ten years. Approximately 70 percent of LGSOC shows RAS pathway-associated mutations, and 30 percent of people with LGSOC have a KRAS mutation. The majority of patients report a negative impact of LGSOC on their mental and physical health, fertility, and long-term quality of life.

About AVMAPKI and FAKZYNJA Combination Therapy
AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.

The U.S. Food and Drug Administration (FDA) approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. In June 2026, Verastem provided updated results on the Phase 1/2 RAMP 205 trial (NCT05669482), which is evaluating avutometinib plus defactinib in combination with standard-of-care chemotherapy as a first-line treatment for patients with advanced pancreatic cancer. Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use.

AVMAPKI FAKZYNJA CO-PACK U.S. Indication

Indication

AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

Warnings and Precautions

Ocular Toxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold AVMAPKI FAKZYNJA CO-PACK for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue AVMAPKI FAKZYNJA CO-PACK for any grade 4 toxicity.
Serious Skin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARSs) occurred. Adhere to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity, tolerability and duration.
Hepatotoxicity: Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and persistence of abnormality.
Rhabdomyolysis: Monitor creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and duration of the adverse reaction.
Embryo-Fetal Toxicity: AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Adverse Reactions

The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.

Drug Interactions

Strong and moderate CYP3A4 inhibitors: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.
Strong and moderate CYP3A4 inducers: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.
Warfarin: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin.
Gastric acid reducing agents: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with proton pump inhibitors (PPIs) or H2 receptor antagonists. If use of an acid-reducing agent cannot be avoided, administer FAKZYNJA 2 hours before or 2 hours after the administration of a locally acting antacid.
Use in Specific Populations

Lactation: Advise not to breastfeed.
Fertility: May impair fertility in males and females.

(Press release, Verastem, SEP 24, 2026, View Source [SID1234671055])