On August 10, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, and Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported a multi-part collaboration including: a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from BeOne with any of Revolution Medicines’ four clinical RAS(ON) inhibitors, and a separate regional rights agreement granting BeOne exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Clinical collaboration will explore potential targeted combination approaches for patients with RAS-addicted cancers

Potential drug combinations for development as part of the clinical collaboration will include certain BeOne assets and Revolution Medicines’ four clinical RAS(ON) inhibitors: daraxonrasib, a RAS(ON) multi-selective inhibitor; zoldonrasib, a RAS(ON) G12D-selective inhibitor; elironrasib, a RAS(ON) G12C-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor. Planned combination studies include: BeOne’s MTA-cooperative PRMT5 inhibitor, BGB-58067, and an EGFR x MET x MET trispecific antibody, BG-T187, with either daraxonrasib or zoldonrasib.

Regional rights agreement leverages BeOne’s established R&D and commercial expertise and Revolution Medicines’ clinical stage RAS(ON) inhibitor portfolio

Under the regional rights agreement, Revolution Medicines has granted BeOne exclusive rights in select Asian markets to develop and commercialize or solely commercialize, depending on the market, these four clinical-stage RAS(ON) inhibitors. Revolution Medicines is eligible to receive development and sales milestone payments and tiered royalties on net sales in the partnered region. Revolution Medicines retains development and commercial rights to all its assets outside of the licensed territory, including Japan and South Korea. As part of this multi-part arrangement, BeOne will fund and conduct a global registrational Phase 3 study for one of Revolution Medicines RAS(ON) inhibitors using BeOne’s differentiated, fully in-house development superhighway, while Revolution Medicines continues to advance a broad range of global registrational studies across its portfolio.

John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:
"We are pleased to enter this collaboration with Revolution Medicines, which gives BeOne the opportunity to evaluate combinations between assets from our oncology pipeline and four promising RAS(ON) inhibitors from Revolution Medicines. In parallel, the regional rights transaction allows us to use our global development superhighway capabilities and established commercial presence, with the goal of bringing more medicines to patients with difficult-to-treat cancers."

Mark A. Goldsmith, M.D., Ph.D., CEO and Chairman of Revolution Medicines, said:
"This arrangement with BeOne reflects our commitment to advancing RAS(ON) inhibitors for patients with RAS-addicted cancers around the world, including in regions where we have not previously had a presence, while exploring novel combination strategies that may further expand their potential impact. BeOne brings additional established global oncology development capabilities and a strong regional commercial footprint that can help us broaden the reach of our innovative RAS(ON) inhibitors as part of our ambitious global strategy."

(Press release, BeOne Medicines, AUG 10, 2026, View Source [SID1234669916])

On August 10, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the first patient has been dosed in a Phase II clinical study (AK146D1-202) evaluating AK146D1, the Company’s internally developed TROP2/Nectin-4 bispecific antibody-drug conjugate (bsADC), in combination with ivonescimab (the Company’s PD-1/VEGF bispecific antibody), for the treatment of advanced breast cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

This study aims to explore the potential of Akeso’s "IO2.0 + ADC2.0" regimen in advanced breast cancer, with a particular focus on first-line treatment of HR+/HER2- breast cancer and triple-negative breast cancer (TNBC).

Breast cancer is the second most common malignancy worldwide, with approximately 2.3 million new cases diagnosed annually. Advances in molecular subtype-guided precision medicine—including targeted therapies, immunotherapies, and ADCs—have improved outcomes for patients with certain subtypes. Nevertheless, substantial opportunities remain to enhance both efficacy and safety. Persistent challenges such as resistance in later-line settings, limited availability of effective agents, and marked tumor heterogeneity continue to create significant and urgent unmet clinical needs. These include the limited efficacy of immuno-oncology approaches in PD-L1-negative patients and in those who develop resistance to anti-PD-1 therapy, as well as the safety constraints of ADCs that restrict both therapeutic benefit and the number of treatment lines that can be administered. Exploring novel targets, optimizing combination strategies, and identifying predictive biomarkers for efficacy and resistance remain critical priorities in breast cancer research.

Ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, has shown strong clinical results compared to PD-1 inhibitor-based therapies across multiple Phase III studies. AK146D1 is a next-generation ADC candidate that has demonstrated potent antitumor activity and a favorable safety profile in early clinical studies. The combination of AK146D1 and ivonescimab has the potential to improve clinical efficacy while maintaining a manageable safety profile, potentially expanding treatment options for patients with advanced breast cancer.

Guided by its IO2.0 + ADC2.0 strategy, Akeso is driving the continuous evolution of treatment paradigms for major malignancies such as non-small cell lung cancer and breast cancer.

In the immuno-oncology field, Akeso has two approved bispecific antibodies for cancer treatment. The Company is actively evaluating ivonescimab and cadonilimab in combination with its proprietary next-generation ADC candidates. Increasingly, global partners recognize both ivonescimab and cadonilimab as preferred agents for combination regimens and breakthrough therapy explorations across a wide spectrum of tumor types.

In the ADC space, Akeso has built a differentiated pipeline of next-generation candidates, including AK146D1, AK138D1, AK157D1, and AK158D1 (a bispecific ADC), which are currently in clinical development. These agents are designed to address the narrow therapeutic window and safety limitations commonly associated with first-generation ADCs.

Building on the encouraging Phase II clinical data of ivonescimab in breast cancer, a Phase III study evaluating an ivonescimab-based combination as first-line treatment for TNBC is currently underway. In addition to AK146D1, Akeso is also conducting a Phase Ib/II study of its next-generation HER3 ADC (AK138D1) in combination with ivonescimab.

Akeso’s IO2.0 + ADC2.0 strategy utilizes multi-target and multi-mechanism combinations to harness the synergistic advantages of its pipeline assets. The Company is building a broad portfolio of combination therapies across multiple subtypes and treatment lines in major cancers. This approach seeks to improve clinical outcomes, address resistance challenges, and provide more effective treatment options for patients with advanced breast cancer.

Looking ahead, Akeso continues to advance additional IO2.0 + ADC2.0 combination therapies across a growing range of high incidence tumor indications.

About AK146D1 (TROP2/Nectin4 Bispecific ADC)

AK146D1 is an innovative bispecific antibody-drug conjugate (bsADC) developed by Akeso. It is composed of a bispecific antibody that simultaneously targets TROP2 and Nectin4, conjugated via a cleavable MC-AAA linker (maleimide-alanine-alanine-alanine) to the topoisomerase I inhibitor DXd.

Early research results indicate that AK146D1 for injection demonstrates potent biological activity and a favorable safety profile. A Phase II clinical study evaluating AK146D1 in combination with cadonilimab and ivonescimab for the treatment of multiple solid tumors is currently underway. This study represents an important component of Akeso’s IO2.0 + ADC2.0 strategy.

(Press release, Akeso Biopharma, AUG 10, 2026, View Source;adc2-0-strategy-first-patient-dosed-in-phase-ii-study-of-trop2nectin-4-bispecific-adc-ak146d1-combined-with-ivonescimab-in-breast-cancer-302846851.html [SID1234669915])

On August 10, 2026 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported that the U.S. Food and Drug Administration (FDA) has approved Labcorp’s PGDx elio tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma with certain BRAF variants who may benefit from treatment with FDA-approved targeted therapiesi.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Addressing a Critical Need in Advanced Melanoma
Melanoma is the deadliest form of skin cancer, with a five‑year survival rate of just 16% for patients diagnosed with stage IV disease. However, targeted therapies are an important treatment option for patients with advanced melanoma whose tumors have a BRAF alteration. As a companion diagnostic, PGDx elio tissue complete CDx helps clinicians identify which melanoma patients carry these BRAF V600E/K variants and may benefit from treatment with FDA-approved BRAF inhibitors and BRAF/MEK inhibitor combination regimens.

"Advanced melanoma is an extremely aggressive and life‑threatening cancer, but targeted treatments are offering real hope for patients," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "Labcorp’s FDA‑approved companion diagnostic improves access to these therapies by allowing clinicians to confirm which patients may be eligible for and can start receiving those treatments as soon as possible."

A Comprehensive and Scalable Testing Solution
Labcorp’s PGDx elio tissue complete CDx is approved for use by qualified healthcare professionals across hospitals and clinical laboratories, supporting broader patient access to high-quality molecular testing. As a kit-based solution, the companion diagnostic can be implemented directly within hospitals and health systems, expanding access to testing while enabling organizations to retain samples and data that may inform future clinical research.

The addition of Labcorp’s PGDx elio tissue complete CDx reflects the continued expansion of Labcorp’s precision medicine portfolio, which includes comprehensive tissue- and liquid-based oncology diagnostics designed to support personalized care. For more information about PGDx elio tissue complete or Labcorp’s oncology solutions, visit View Source

(Press release, LabCorp, AUG 10, 2026, View Source [SID1234669914])

On August 10, 2026 Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported financial results for the second quarter ended June 30, 2026, and provided a review of recent accomplishments and anticipated upcoming developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "What excites me most about Biohaven today is that we’re no longer talking about scientific promise—we’re watching new therapeutic approaches begin to work in patients. This year we’ve crossed important milestones across our portfolio, including advancing BHV-1300 into pivotal development for Graves’ disease and generating compelling patient data from both our Graves’ disease and IgA nephropathy programs. We believe our MoDE and TRAP platforms are doing something fundamentally different: selectively removing the proteins that drive disease while preserving normal immune function. If these data continue to translate into larger studies, extracellular protein degradation has the potential to reshape how autoimmune diseases are treated."

Dr. Coric continued, "Opakalim represents another example of our commitment to solving difficult biological problems with precision. For decades, patients with epilepsy have often had to choose between seizure control and living with burdensome central nervous system side effects like somnolence, dizziness, and cognitive impairment. Our goal is to change that equation. Across studies to date, opakalim has consistently demonstrated the potential to deliver meaningful seizure reduction with a differentiated tolerability profile from existing therapies. As we approach our pivotal readout later this year, we believe we have the opportunity to introduce an important new treatment option for patients who deserve both seizure control and the ability to fully participate in their everyday lives."

Second Quarter 2026 and Recent Business Highlights

Presented new patient data from the MoDE platform in Graves’ disease; initiated pivotal study: In May 2026, the Company presented new clinical data from an ongoing Phase 1b study of BHV-1300 in patients with Graves’ disease. In the study, weekly administration of BHV-1300 1000 mg subcutaneously achieved mean reductions of pathogenic TSHR-IgG1 autoantibodies of greater than 80% by week 12 in patients with Graves’ hyperthyroidism. Among participants with elevated thyroid hormones despite concurrent anti-thyroid drug therapy, normalization of free T4 occurred at a median of 3 weeks, and normalization of free T3 occurred at a median of 5 weeks after the first administration of BHV-1300. To date, BHV-1300 has been safe and well-tolerated through 12 weeks of dosing, with most AEs mild and self-resolving, no SAEs, no clinically significant increases in cholesterol or ALT/AST/bilirubin, no clinically significant reductions in albumin, and no clinically significant reductions in IgG3, IgA, IgE, or IgM relative to baseline. Based upon these Phase 1b results, we have initiated a pivotal trial of BHV-1300 in Graves’ disease and expect to pursue additional follow-on studies in other autoimmune diseases. The Phase 3 study is designed to evaluate the ability of BHV-1300 to rapidly and selectively eliminate disease-causing autoantibodies while preserving the remainder of the immune system.
Presented additional patient data supporting the TRAP degrader platform in IgA nephropathy: In May 2026, the Company reported updated Phase 1b data from our ongoing study of BHV-1400 in patients with IgAN. BHV-1400 administered subcutaneously achieved mean reductions of pathogenic Gd-IgA1 of greater than 60% within 48 hours and approximately 70% within the first month of dosing. These reductions were deeper than those reported for BAFF/APRIL inhibitors, APRIL inhibitors, and CD38 inhibitors at comparable early time points. Reductions in Gd-IgA1 were associated with increases in eGFR, decreases in spot UPCR, and resolution of hematuria. Effects were selective, with no clinically significant reductions in other immunoglobulins (IgA, IgG, IgE, or IgM). To date, BHV-1400 has been safe and well-tolerated throughout one month of dosing, with most AEs mild and self-resolving, no SAEs, and no clinically significant increases in ALT, AST, or bilirubin. A pivotal study is expected to initiate in 2H 2026.
Continued advancement of Biohaven’s extracellular degrader pipeline: Biohaven continues to expand its leadership in extracellular targeted protein degradation with multiple MoDE and TRAP programs advancing across autoimmune diseases. In addition to ongoing development of BHV-1300 in Graves’ disease and BHV-1400 in IgA nephropathy, the Company continues advancing additional degrader candidates targeting IgG4-mediated disease, PLA2R autoantibodies, pro-insulin autoantibodies and other pathogenic extracellular proteins, broadening the potential impact of its proprietary platform.
Presented clinical data update with opakalim (BHV-7000) across multiple epilepsy types: In May 2026 at the Company’s annual R&D Day, the Company reported new clinical data for opakalim, a selective Kv7 activator, demonstrating durable seizure control and a differentiated tolerability profile across multiple epilepsy populations. In a proof-of-concept study in idiopathic generalized epilepsy (IGE), with a time-to-event design, the median time to the second generalized tonic-clonic seizure was 141 days with opakalim versus 47 days with placebo, with 33% of treated participants completing the 24-week double-blind period without a second seizure. Updated data from the ongoing open-label extension study in focal epilepsy showed that 54% of participants achieved a ≥50% reduction in seizure frequency over any consecutive six-month treatment period (n>100), while opakalim continued to demonstrate a favorable safety profile with a low incidence of CNS adverse events. Topline results from the Phase 2/3 RISE3 trial in focal epilepsy are expected during 2H 2026.
Continued advancement of Biohaven’s oncology portfolio: In July 2026, the Company announced that new data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, will be presented at the ESMO (Free ESMO Whitepaper) Congress 2026. The new Phase 1 data will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven’s R&D Day in May 2026 and will include signals of clinical activity demonstrated in the ongoing Phase 1, open-label, dose-escalation study of BHV-1530 in patients with advanced solid tumors. The data from May 27, 2026, showed early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. The Company also announced a new clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with Libtayo. This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven’s oncology pipeline.
Completed enrollment in Phase 2 obesity study with taldefgrobep alfa: Taldefgrobep alfa targets the myostatin/activin pathway with the goal of producing high-quality weight loss while preserving lean muscle mass. Unlike therapies designed primarily to maximize weight reduction, Biohaven believes preservation of skeletal muscle may translate into greater metabolic health, improved physical function, and more durable long-term treatment outcomes.
Reported first-in-human (FIH) dosing of oral PKM2 modulator, BHV-8100, targeting metabolic restoration and immunomodulation: In June 2026, the Company announced the initiation of FIH dosing for BHV-8100, its oral, brain-penetrant pyruvate kinase M2 isoform (PKM2) modulator. PKM2 modulation offers a potential new paradigm for treating large, underserved, and high-value indications in neurology, ophthalmology, and immunology and exhibits robust beneficial effects across a spectrum of preclinical models of Alzheimer’s, and multiple sclerosis, specifically by restoring metabolic deficits, reducing inflammation and neurodegeneration, and enhancing remyelination.
Advanced Parkinson’s disease program with BHV-8000: Enrollment continues in the Company’s global pivotal Phase 2/3 study evaluating BHV-8000, its orally administered, brain-penetrant, highly selective TYK2/JAK1 inhibitor for early Parkinson’s disease. BHV-8000 is designed to modulate neuroinflammation, a central driver of disease progression, and peripheral immune dysregulation.
Expected Upcoming Milestones:

We believe Biohaven is well positioned to achieve significant milestones in the second half of 2026 across numerous programs:

Selective Kv7 Ion Channel Activator (Opakalim):

Continue two Phase 2/3 studies in focal epilepsy; topline results for the first study expected in 2H 2026.
Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa):

Completed enrollment in Phase 2 study in obesity in 1Q 2026.
Lead TRAP and MoDE Extracellular Protein Degraders (BHV-1400 and BHV-1300)

BHV-1300: Continue enrolling patients in ongoing Phase 3 study in Graves’ disease following June 2026 study initiation. The study is a randomized, double-blind, placebo-controlled study in approximately 300 adults with Graves’ hyperthyroidism evaluating normalization of T3, T4, and TSH at 26 weeks absent an antithyroid drug.
BHV-1400: Pivotal study initiation in IgAN study targeted for 2H 2026.
Capital Position:

Cash, cash equivalents, marketable securities and restricted cash as of June 30, 2026, totaled approximately $270.5 million.

Second Quarter 2026 Financial Highlights:

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $100.8 million for the three months ended June 30, 2026, compared to $184.4 million for the three months ended June 30, 2025. The decrease of $83.6 million was primarily due to decreases in direct program spend and preclinical spend in 2026 as compared to the same period in the prior year. The decrease in direct program spend was largely due to our strategic reprioritization of programs, which was implemented in the fourth quarter of 2025, as well as one-time developmental milestones recorded during the three months ended June 30, 2025 of $15.0 million and $10.0 million for our BHV-8000 and BHV-1530 programs, respectively. Non-cash share-based compensation expense was $12.0 million for the three months ended June 30, 2026, a decrease of $1.1 million as compared to the same period in 2025.

General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $24.1 million for the three months ended June 30, 2026, compared to $27.3 million for the three months ended June 30, 2025. The decrease of $3.2 million was primarily due to decreased legal costs and employee costs, including non-cash share based compensation expense. Non-cash share-based compensation expense was $7.2 million for the three months ended June 30, 2026, a decrease of $0.5 million as compared to the same period in 2025.

Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $12.0 million for the three months ended June 30, 2026, compared to other income, net of $13.8 million for the three months ended June 30, 2025. The decrease of $25.8 million was primarily due to increased non-cash losses during the three months ended June 30, 2026 related to changes in fair value of our notes payable liability under the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the NPA), and gains recorded during the three months ended June 30, 2025 for the non-cash changes in fair value of our forward contracts and derivative liabilities recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment).

Net Loss: Biohaven reported a net loss for the three months ended June 30, 2026 of $137.3 million, or $0.91 per share, compared to $198.1 million, or $1.94 per share, for the same period in 2025. Non-GAAP adjusted net loss for the three months ended June 30, 2026 was $118.1 million, or $0.78 per share, compared to $166.4 million, or $1.63 per share, for the same period in 2025. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

(Press release, Biohaven Pharmaceutical, AUG 10, 2026, View Source [SID1234669912])

On August 10, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the second quarter 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Our team is executing on our goals of beginning clinical studies soon for both SC451 in type 1 diabetes and SG293 in non-Hodgkin lymphoma," said Steve Harr, President and Chief Executive Officer. "Proof of concept data for these programs, including the recent update for UP421 in The New England Journal of Medicine and for an SG293 surrogate at the ASGCT (Free ASGCT Whitepaper) meeting, are encouraging. If all goes as we anticipate, we expect to gain valuable insight into the clinical profiles and potential of both SC451 and SG293 over the next 6-9 months, and we look forward to sharing our progress."

Corporate Highlights

Continued progress toward beginning clinical trials for SC451 and SG293

SC451, an O-negative, hypoimmune (HIP)-modified, iPSC-derived pancreatic islet cell therapy which uses the same HIP technology as UP421, is being developed as a one-time treatment for patients with type 1 diabetes with a goal of long-term normal blood glucose without the need for any insulin therapy or immunosuppression. Sana is conducting activities to prepare for SC451 investigational new drug application (IND) submission and Phase 1/2 trial start, including near-term completion of GLP toxicology studies, advancement of SC451 technology transfer to the contract manufacturer, and clinical trial readiness. Sana expects to file an IND and begin a Phase 1/2 clinical trial for SC451 as early as this year.
SG293 is a CD8-targeted fusosome that delivers the genetic material to make CD19-directed CAR T cells. SG293 has been designed to minimize potential toxicities related to in vivo CAR T cells, including peri-infusion reactions and off-target delivery to tissues such as the liver. Preclinical data presented at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting demonstrate that a SG293 surrogate, which is active in non-human primates, achieves cell-specific delivery and deep B cell depletion – as measured by depletion in circulating and lymph node B cells as well as a phenotypic reset when B cells return – in non-human primates without the use of any lymphodepleting chemotherapy. Sana expects to generate first-in-human data for SG293 in non-Hodgkin lymphoma as early as this year. If successful, the company intends to expand clinical development into B cell-mediated autoimmune diseases as well.

Shared updated, positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with HIP technology, into a patient with type 1 diabetes without the use of any immunosuppression.

UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator.
Results of the study through 14 months after cell transplantation demonstrated the survival and function of pancreatic beta cells in a patient as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increased with mixed meal tolerance tests (MMTT) performed over the course of the study, consistent with insulin secretion in response to a meal. Fasting and MMTT-stimulated C-peptide levels at month 14 were comparable to those observed in the first six months of the study. PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm. The study has identified no safety issues, and the HIP-modified islet cells have evaded immune detection.
Announced that The New England Journal of Medicine published a peer-reviewed Letter to the Editor titled "Long-Term Survival of Hypoimmune Allogeneic Islets without Immunosuppression" (DOI: 10.1056/NEJMc2604408), which discusses 14-month results from this study.
14-month data from the study were presented at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting in July 2026, and additional data from the IST will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 on October 2.

Announced strategic collaboration with Mayo Clinic to advance development of SC451, a HIP-modified, induced pluripotent stem cell (iPSC)-derived pancreatic islet cell therapy for type 1 diabetes.

The purpose of the collaboration is to draw on Mayo Clinic’s multidisciplinary expertise to accelerate the development, validation, and standardization of protocols and processes for SC451, supporting safe, scalable, and consistent delivery across diverse clinical environments.
In connection with the collaboration, Mayo Clinic made a $25.0 million equity investment in the company, reflecting a shared commitment to advancing innovative approaches aimed at improving care for patients with type 1 diabetes.

Advanced preclinical pipeline

SG227, a CD8-targeted fusosome that delivers the genetic material to make BCMA-directed CAR T cells, is being developed as a potential treatment for patients with multiple myeloma. SG227 delivers a BCMA CAR that has been validated in the autologous CAR T setting for patients with multiple myeloma in a product that is currently approved in China. Sana is preparing to begin clinical testing as early as mid-2027, contingent upon the early clinical profile of SG293.

Raised aggregate net proceeds of $93.3 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and Mayo Clinic investment in the second quarter; expected cash runway into mid-2027.

Raised net proceeds of $93.3 million in the second quarter from sales of common stock through Sana’s ATM and equity financing.

Second Quarter 2026 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2026 were $160.5 million compared to $138.4 million as of December 31, 2025. The increase of $22.1 million was primarily due to net proceeds from equity financings of $93.3 million, partially offset by cash used in operations of $70.2 million and cash used for the purchase of property and equipment of $1.9 million.
Research and Development Expenses: For the three and six months ended June 30, 2026, research and development expenses, inclusive of non-cash expenses, were $30.7 million and $59.4 million, respectively, compared to $29.8 million and $67.0 million for the same periods in 2025. The increase of $0.9 million for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to increased research, laboratory, and clinical development costs for our SC451 and SG293 programs and increased third-party manufacturing costs at contract development and manufacturing organizations (CDMOs) for our SC451 and SG293 programs, partially offset by lower personnel and other facility and allocated costs. The decrease of $7.6 million for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to lower personnel-related expenses, including non-cash stock-based compensation, lower facility and other allocated costs, and decreased third-party manufacturing costs at CDMOs due to costs incurred in the first half of 2025 for the suspended allogeneic CAR T programs that did not recur in 2026. These decreases were partially offset by increased third-party manufacturing costs at CDMOs for our SC451 and SG293 programs. Research and development expenses include non-cash stock-based compensation of $3.2 million and $6.3 million for the three and six months ended June 30, 2026, respectively, compared to $4.2 million and $8.8 million for the same periods in 2025.
Research and Development Related Success Payments and Contingent Consideration: For the three and six months ended June 30, 2026, Sana recognized non-cash expenses of $23.9 million and $32.3 million, respectively, compared to $10.3 million and $12.2 million for the same periods in 2025, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities may fluctuate significantly with changes to the probabilities of achieving clinical development or regulatory milestones with respect to a fusosome product candidate, and Sana’s market capitalization and stock price.
General and Administrative Expenses: General and administrative expenses for the three and six months ended June 30, 2026, inclusive of non-cash expenses, were $10.8 million and $22.2 million, respectively, compared to $10.3 million and $21.8 million for the same periods in 2025. The increases for each of the three and six months ended June 30, 2026 and 2025 were primarily due to increases in facility and other allocated costs. General and administrative expenses include non-cash stock-based compensation of $2.2 million and $4.7 million for the three and six months ended June 30, 2026, respectively, compared to $2.4 million and $4.8 million for the same periods in 2025.
Impairment of Long-Lived Assets: For each of the three and six months ended June 30, 2025, non-cash impairment of long-lived assets was $44.6 million. There was no impairment of long-lived assets for the three and six months ended June 30, 2026. The non-cash impairment in 2025 was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. In the second quarter of 2025, because of increased availability of manufacturing capacity at third-party CDMOs for cell and gene therapy products, together with progress in understanding our near-term manufacturing needs, we determined that CDMOs could meet our manufacturing requirements. Accordingly, we suspended further build-out of our internal manufacturing capabilities and continue to rely on CDMOs to meet our manufacturing needs at present.
Net Loss: Net loss for the three and six months ended June 30, 2026 was $63.6 million, or $0.22 per share, and $110.8 million, or $0.39 per share, respectively, compared to $93.8 million, or $0.39 per share, and $143.2 million, or $0.60 per share, for the same periods in 2025.

(Press release, Sana Biotechnology, AUG 10, 2026, View Source [SID1234669911])