On May 5, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the first quarter ended March 31, 2026, and provided a review of recent program and corporate developments.

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"We continue to make strong progress across the portfolio, completing enrollment in our Phase 3 trial of bitopertin in EPP and remaining on track to report topline data in the fourth quarter of 2026. We were also pleased to have our Phase 2 data for DISC-0974 in MF anemia selected for oral presentation at ASCO (Free ASCO Whitepaper), while continuing to advance multiple additional clinical trials across our pipeline," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "Together, these milestones reflect the strength of our execution and position us to deliver multiple important catalysts in the second half of this year."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

Completed enrollment of Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP, with topline data expected Q4 2026; study size was expanded to 183 patients due to patient and physician demand
Following completion of APOLLO, expect to submit a response to the CRL and receive an FDA decision by mid-2027
Type A meeting with the US FDA to review approach for resubmission scheduled for Q2 2026
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Updated data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) to be shared in an oral presentation at ASCO (Free ASCO Whitepaper) in June covering N=61 patients with data through April 27, 2026
Topline data from the RALLY-MF study to be shared in Q4 2026, with an end of Phase 2 meeting with the FDA expected to occur by end of year
Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Progressing ongoing Phase 2 study in patients with polycythemia vera and Phase 1b study in patients with sickle cell disease with initial data expected in Q4 2026
First Quarter 2026 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $730.2 million as of March 31, 2026, which are expected to fund operational plans into 2029.
Research and Development Expenses: R&D expenses were $45.9 million for the three months ended March 31, 2026, as compared to $27.8 million for the three months ended March 31, 2025. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 and DISC-3405 programs, and increased headcount.
Selling, General and Administrative Expenses: SG&A expenses were $23.6 million for the three months ended March 31, 2026, as compared to $12.2 million for the three months ended March 31, 2025. The increase in SG&A expenses was primarily due to increased headcount and establishing infrastructure to support potential commercialization.
Net Loss: Net loss was $63.5 million for the three months ended March 31, 2026, as compared to $34.1 million for the three months ended March 31, 2025. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

(Press release, Disc Medicine, MAY 5, 2026, View Source [SID1234665114])

On May 5, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentation at the BofA Securities 2026 Healthcare Conference at 2:20 p.m. PT on Tuesday, May 12, 2026. The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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The webcast will be accessible on the Investor Relations page of Sana’s website at View Source A replay of the presentation will be available at the same location for 30 days following the conference.

(Press release, Sana Biotechnology, MAY 5, 2026, View Source [SID1234665130])

On May 5, 2026 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company reported the initiation of a global, multi-center clinical trial. The Company has also submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), marking a key milestone in Senhwa’s global clinical development.

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The study will evaluate Senhwa’s first-in-class investigational drug, Pidnarulex (CX-5461), in combination with BeOne Medicines’ marketed PD-1 inhibitor, tislelizumab, across multiple advanced or metastatic solid tumors, including pancreatic cancer, colorectal cancer, and melanoma—areas with significant unmet medical needs. The global multi-center design is expected to accelerate clinical validation while enhancing the asset’s visibility, supporting future out-licensing and commercialization opportunities.

The Company aims to leverage combination therapy approaches to enter the rapidly expanding immuno-oncology market and build sustainable long-term growth momentum.

CX-5461 features a differentiated dual mechanism of action. In addition to inhibiting ribosomal RNA synthesis and suppressing tumor cell proliferation, it stabilizes G-quadruplex structures, inducing DNA damage and activating the cGAS–STING pathway. This unique mechanism not only confers direct anti-tumor activity but also enhances tumor immunogenicity, creating strong synergy with immune checkpoint inhibitors. Preclinical and translational studies have demonstrated that CX-5461 can effectively remodel the tumor microenvironment, increase tumor-infiltrating lymphocytes (TILs), and upregulate PD-L1 expression. These findings suggest its potential to overcome resistance and improve response rates in patients with limited benefit from current immunotherapies, positioning CX-5461 as a promising backbone agent in combination immunotherapy strategies.

According to market research analyses, the global cancer immunotherapy market exceeded US$150 billion in 2025 and is projected to grow at a double-digit compound annual growth rate, potentially surpassing US$300 billion by 2035. Within this expanding landscape, combination therapies have emerged as a central focus for the pharmaceutical industry, serving as a key driver for lifecycle extension and next-generation revenue growth.

At the same time, the pharmaceutical sector is facing increasing pressure from patent expirations of blockbuster drugs, driving strong demand for innovative assets with differentiated mechanisms and clinical potential. Strategic licensing and M&A activities have become primary pathways for large pharmaceutical companies to secure high-value pipeline assets, intensifying competition for early-stage opportunities.

Against this backdrop, the current clinical trial is expected to serve as a critical validation point for CX-5461. Pending positive efficacy and safety outcomes, the asset has the potential to attract strong interest from global pharmaceutical companies for licensing or acquisition, significantly enhancing its commercial prospects and overall market value.

(Press release, Senhwa Biosciences, MAY 5, 2026, View Source [SID1234665149])

On May 5, 2026 Electra Therapeutics, a clinical stage biotechnology company pioneering therapies against novel targets for diseases in immunology and cancer, reported dosing of the first patient in a Phase 1 study of ipsoprubart (ELA026) in patients with T cell malignancies. Ipsoprubart, a first-in-class monoclonal antibody targeting signal regulatory proteins (SIRP) on immune cells, is designed to selectively deplete pathological T cells and myeloid cells, with the potential to inhibit tumor growth and survival through both direct tumor cell elimination and tumor microenvironment modulation.

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Initial evidence of anti-tumor activity in lymphoma, including T cell malignancies, was observed in a Phase 1b study of ipsoprubart in secondary hemophagocytic lymphohistiocytosis (sHLH), in patients whose disease was triggered by the underlying lymphoma. These findings supported advancement into a dedicated study in T cell malignancies, extending the clinical program for ipsoprubart beyond the ongoing pivotal study in sHLH. The Phase 1 study in T cell malignancies will evaluate safety and efficacy in patients treated with ipsoprubart monotherapy. T cell malignancies are a group of rare, aggressive lymphomas and leukemias arising from mature or immature T lymphocytes. More than 13,000 patients in the US are diagnosed annually with T cell malignancies and have limited effective treatment options that provide durable disease control.

"Our team has pioneered SIRP targeting as a therapeutic approach to selectively deplete pathological immune cells," said Kathy Dong, PharmD, MBA, President and CEO of Electra Therapeutics. "We are excited to follow the science and expand into T cell malignancies, where new treatment approaches are needed for patients and ipsoprubart has shown promising potential."

The open-label Phase 1 study will enroll adults with relapsed or ​refractory T cell malignancies. Patients may receive up to six cycles (24 weeks) of treatment with ipsoprubart. The study consists of two parts: Part 1 will enroll up to 24 patients to identify up to two dosing regimens with acceptable safety profiles; Part 2 will further evaluate these regimens in expansion cohorts. The primary endpoint is safety, including drug-related toxicities and treatment-emergent adverse events. Secondary endpoints include overall response rate, duration of response, and disease control rate. Additional details are available on clinicaltrials.gov (NCT07465835).

"The initiation of this study reflects strong interest from clinical investigators who were highly encouraged by the anti-tumor effect observed within weeks of treatment with ipsoprubart in the Phase 1b study in sHLH," said Kim‑Hien Dao, DO, PhD, Chief Medical Officer of Electra Therapeutics. "Patients with relapsed or refractory T cell malignancies have limited treatment options and poor outcomes. The promising activity observed in heavily treated patients, including responses to ipsoprubart monotherapy, supports our further evaluation in this setting."

Clinical Data for Ipsoprubart (ELA026) in Lymphomas, Including T Cell Malignancies
Anti-tumor activity of ipsoprubart in lymphoma was observed in a Phase 1b study in sHLH, including in patients whose disease was triggered by T cell malignancies. Among eight patients with lymphoma-associated sHLH, six of whom had T cell malignancies as the underlying trigger, the objective tumor response rate was 100% (8/8), with a complete response rate of 88% (7/8), including one durable complete response achieved with ipsoprubart monotherapy in a T cell lymphoma patient refractory to more than five lines of prior therapy. These findings were first reported in a presentation titled "ELA026, a Monoclonal Antibody Targeting SIRP‑expressing Myeloid Cells and T Lymphocytes, Demonstrates Broad Anti-Tumor Activity in Patients with Lymphoma" at the International Conference on Malignant Lymphoma in 2025.

(Press release, Electra Therapeutics, MAY 5, 2026, View Source [SID1234665115])

On May 5, 2026 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage biotechnology company, reported that the first patient was dosed in Study FTH-PIK-101 (NCT07558733), a Phase 1b/2 trial of PIKTOR in patients with HR+/HER2- advanced breast cancer. PIKTOR, an investigational, all-oral combination of serabelisib and sapanisertib, is designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway through PI3K-alpha and dual mTORC1/2 targeting, and became Sensei’s lead program after the company acquired Faeth Therapeutics in February 2026.

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Patients with HR+/HER2- advanced breast cancer whose tumors stop responding to current therapies have few effective options, particularly when their cancer is driven by the PI3K/AKT/mTOR signaling pathway, a network of growth and survival signals that is altered in approximately half of HR+/HER2- cases.¹ Study FTH-PIK-101, titled "Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients with HR+/HER2- Advanced or Metastatic Breast Cancer," is evaluating PIKTOR across HR+/HER2-advanced breast cancer patients, regardless of mutational status.

The study is a multi-center, dose-escalation Phase 1b/2 trial evaluating sapanisertib and serabelisib (PIKTOR) in combination with fulvestrant and/or other anticancer therapies in patients with HR+/HER2- advanced or metastatic breast cancer.

Approved drugs that target this pathway each block only one component, which often allows the cancer to reroute its growth signals through the parts that remain active. PIKTOR takes a different approach, combining two oral drugs, serabelisib (which blocks PI3K-alpha) and sapanisertib (which blocks mTORC1 and mTORC2), to target multiple nodes of the pathway simultaneously.

PIKTOR has already been tested in cancer patients. In a completed investigator-initiated Phase 1b study (NCT03154294), patients with advanced breast, endometrial and ovarian tumors who had failed an average of four prior treatments and were largely out of standard options received PIKTOR plus paclitaxel. Nearly half responded (47% overall response rate, n=15). Among patients whose tumors carried PI3K pathway mutations, 71% responded. Three patients had complete responses, all in endometrial cancer.² Sapanisertib in combination with fulvestrant has also shown activity in HR+/HER2- advanced breast cancer in an earlier Phase 2 study.³

"In our earlier trial, patients who had exhausted multiple lines of therapy, including chemotherapy, responded to the PIKTOR plus paclitaxel combination, and several had complete responses," said Anand Parikh, Chief Operating Officer of Sensei Biotherapeutics. "PIK-101 now takes that same oral combination into breast cancer, where a large share of tumors carry the pathway alterations that PIKTOR is designed to target."

As part of its broader clinical development program for PIKTOR, Sensei is also conducting Study FTH-PIK-201, an ongoing multicenter, open-label, single-arm Phase 2 study (n≈40) in patients with advanced endometrial cancer.

(Press release, Sensei Biotherapeutics, MAY 5, 2026, View Source [SID1234665131])