On May 8, 2026 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, reported its financial and operating results for the first quarter ended March 31, 2026, and provided a business update.

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Recent Progress and Upcoming Catalysts:

TTI-109 (Healthy Volunteer Study): Study ongoing with topline data anticipated in June 2026. The Company plans to announce the clinical development strategy based on these results.
TTI-101 (HCC – REVERT LIVER CANCER study): Phase 1b/2 trial remains on track to report topline results in 2H 2026.
TTI-101 (IPF – REVERT IPF study additional analyses): Phase 2 trial showed that TTI-101 was associated with a 9.4% baseline-weighted reduction in fibrosis score compared to 2.4% for placebo. Treatment with TTI-101 was also associated with a 4.5-fold greater decline in IL-6, a central STAT3-driven inflammatory cytokine.

Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "We are approaching a key inflection point with topline data from our next-generation STAT3 inhibitor, TTI-109, expected in June. These results are expected to inform our future clinical development strategy."

"TTI-109 is designed to build on the preclinical and clinical activity observed with TTI-101 while potentially offering improved tolerability through its prodrug profile and enabling broader development across inflammatory and proliferative diseases driven by STAT3."

"In parallel, we remain on track to report topline data from our ongoing Phase 2 REVERT LIVER CANCER trial in the second half of this year. Prior interim findings demonstrated clinically meaningful activity across treatment settings, and we look forward to evaluating the full dataset."

"We continue to make significant progress advancing both programs, providing line of sight to two near-term value inflection points," Dr. Alibhai concluded.

Key Upcoming Milestones:

June 2026: TTI-109 Phase 1 healthy volunteer topline data and clinical development strategy
2H 2026: TTI-101 Phase 1b/2 HCC topline data

First Quarter 2026 Financial Results

Research and development expenses for the three months ended March 31, 2026, were $4.9 million as compared to $3.1 million for the comparable period in 2025. The increase was primarily driven by higher TTI-109 developmental costs, partly offset by declining clinical costs associated with TTI-101.

General and administrative expenses were $2.1 million for the three months ended March 31, 2026, as compared to $1.2 million for the three months ended March 31, 2025. The increase was primarily driven by higher personnel costs, including stock-based compensation, and professional fees, including costs associated with being a publicly traded company.

Net loss for the three months ended March 31, 2026, was $6.8 million, as compared to a net loss of $9.6 million for the comparable period in 2025.

Basic and diluted net loss per share attributable to common shareholders for the three months ended March 31, 2026, were a net loss of $(0.73), compared to a net loss of $(3.72) for the comparable period in 2025.

Cash, cash equivalents and short-term investments as of March 31, 2026, were $25.0 million, as compared to $30.8 million as of December 31, 2025. Tvardi anticipates that its current cash runway is sufficient to fund operations, as currently planned, through clinical readouts and into the fourth quarter of 2026.

(Press release, Tvardi Therapeutics, MAY 8, 2026, View Source [SID1234665402])

On May 8, 2026 CG Oncology, Inc. (NASDAQ: CGON) reported financial results for the first quarter ended March 31, 2026, and provided business updates.

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"We have successfully completed non-clinical and clinical modules for our first BLA submission. The remaining CMC module is progressing as planned, and we are on track to finalize our submission in the fourth quarter 2026. We are pleased to provide this additional guidance on expected BLA completion following focused filing discussions with FDA. Manufacturing inspection readiness activities continue to progress, including our commitment to sustainable long-term supply. The quality and execution of the rolling BLA has been a top priority for us, and we are confident that we are taking all appropriate measures to ensure a successful package. This has been a tremendous undertaking, and I am extremely proud of the team for their unwavering commitment," stated Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology.

"We look forward to a number of meaningful near-term milestones for CG, including anticipated topline data from the Phase 3 PIVOT-006 trial in intermediate-risk NMIBC in the coming months, as well as the first results from the Phase 2 CORE-008 Cohort CX in high-risk BCG-exposed and BCG-unresponsive patients, to be presented at AUA."

Corporate Highlights

CORE-008 Cohort CX data podium and poster presentation at the Society of Urologic Oncology (SUO) session at the American Urological Association (AUA) 2026 Annual Meeting on May 16.
Title: First Results from CORE-008 Cohort CX- Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec with Gemcitabine in Patients with High-Risk BCG-Exposed or BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Strengthened Executive Leadership Team with the addition of life-science executive Jim DeTore.
In April 2026, the Company appointed Jim DeTore to Chief Financial Officer. Jim brings over 30 years of life sciences expertise including executive leadership roles at Neurogastrx, Inc., Bluebird Bio, and Proteostasis Therapeutics, in each case leading the company’s financing and investor relations strategies, helping to raise over a billion dollars in equity capital. He also served as vice president of corporate finance at Ironwood Pharmaceuticals where he worked directly on several debt and equity transactions, including the company’s initial public offering. Jim received his M.B.A. and bachelor’s degree in finance from Northeastern University in Boston.

Anticipated 2026 Milestones

CORE-008 Cohort CX (HR BCG-exposed and BCG-unresponsive NMIBC): First results from the Phase 2 clinical trial of the combination of cretostimogene with gemcitabine in 1H’26
PIVOT-006 (intermediate-risk NMIBC): Phase 3 topline data in 1H’26
Completion of BLA submission in initial indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in 4Q’26
BOND-003 Cohort C (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), and CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1), durability data in 2026
First Quarter Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were $1.1 billion, compared with $742.2 million as of December 31, 2025. The March 31, 2026, cash includes net proceeds of approximately $391.4 million from a total of 6,941,407 shares sold through the Company’s at-the-market (ATM) facility in Q1 based on reverse inquiries from existing and new, high-quality funds. The Company anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations through 2029.
Research and Development (R&D) Expenses: R&D expenses were $43.7 million for the first quarter of 2026, as compared to $27.5 million for the prior year period. The increase was primarily due to an increase in clinical trial expenses, including CMC costs, and an increase in compensation costs due to increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $20.8 million for the first quarter of 2026, as compared to $14.8 million for the prior year period. The increase was primarily attributed to an increase in personnel-related expenses, including compensation costs from increased headcount, and an increase in professional and consulting fees.
Net Loss: Net loss was $60.2 million, or $(0.71) per share, for the first quarter of 2026, as compared to a net loss of $34.5 million, or $(0.45) per share, for the prior year period.

About Cretostimogene Grenadenorepvec

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 600 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a multi-cohort Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

(Press release, CG Oncology, MAY 8, 2026, View Source [SID1234665401])

On May 8, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the completion of enrollment in its ReSTART pivotal trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), a U.S. multicenter study evaluating the efficacy and safety of intratumoral Alpha DaRT for the treatment of patients with recurrent cutaneous squamous cell carcinoma (cSCC). This is the first U.S. pivotal clinical study of Alpha Tau to have completed enrollment, representing a landmark milestone in the Company’s journey towards potential FDA PMA approval of Alpha DaRT in this indication.

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Uzi Sofer, CEO of Alpha Tau, stated, "The completion of enrollment in the ReSTART pivotal trial is a watershed moment for Alpha Tau. Skin cancer was the very first clinical application of Alpha DaRT, and it has served as the cornerstone of our entire clinical development strategy. The years of evidence we have generated across multiple countries and numerous patients have consistently demonstrated the strength of our intratumoral radiotherapeutic approach – providing the foundation not only for this pivotal study, but also for our expanding clinical programs in additional indications. Completing enrollment in our first-ever U.S. pivotal trial – the study designed to support our first potential FDA approval – brings us closer than ever to potential commercialization. We look forward to continued progress on our modular PMA submission and to ultimately bringing Alpha DaRT to market."

A pivotal study is a definitive clinical trial designed to provide the primary evidence of a medical product’s safety and efficacy upon which the FDA relies when evaluating whether to grant market approval. The completion of enrollment in the ReSTART trial marks a critical transition from patient recruitment to follow-up and data maturation, bringing Alpha Tau one step closer to a potential commercial approval of Alpha DaRT in the United States.

The ReSTART trial is a prospective, multicenter, single-arm, open-label pivotal study which enrolled 88 patients with biopsy-proven recurrent cSCC who have failed at least first-line standard-of-care therapy and who are not indicated for surgery or conventional treatment, and for whom no curative systemic treatment is available. The study’s co-primary endpoints are the objective response rate (ORR) based on confirmed best overall response, and the duration of response (DOR) at six months from the initial observation of response. Secondary endpoints include progression-free survival and overall survival at one year, overall duration of response, local control, and quality of life. With enrollment now complete, the study will proceed through its follow-up period to allow for assessment of these primary and secondary endpoints.

Cutaneous squamous cell carcinoma is the second most common form of skin cancer, with an incidence that continues to rise globally. While surgical excision effectively treats the majority of cSCC cases, a meaningful subset of patients develops recurrent disease that can no longer be managed with surgery or conventional treatments. For these patients there remains a significant unmet need for effective, well-tolerated treatments. Alpha DaRT, designed to deliver a targeted intratumoral radiotherapeutic treatment directly to the tumor, seeks to offer a new approach for this underserved population.

The ReSTART pivotal study builds on a robust foundation of clinical evidence generated through multiple skin cancer studies conducted in Israel, Italy and France, as well as a pilot study in the U.S. Together, clinicians in these studies have treated hundreds of tumors and have consistently observed promising efficacy and favorable safety of Alpha DaRT. Alpha Tau has received Breakthrough Device Designation from the FDA for Alpha DaRT in the treatment of recurrent cSCC, and submitted the first module of its modular PMA application in January 2026.

Robert B. Den, MD, Chief Medical Officer of Alpha Tau, stated, "Alpha DaRT’s journey in skin cancer has spanned years and continents. It began with foundational studies in Israel and Italy, expanded to France, and progressed to a pilot study in the United States – each study building upon the last and reinforcing the clinical evidence behind this technology. The ReSTART pivotal study, with a very large patient population of 88, represents the most rigorous evaluation of Alpha DaRT to date, and I want to express my sincere gratitude to all of the principal investigators who recruited patients into this trial. Their belief in the potential of Alpha DaRT to make a real difference for patients with recurrent cSCC – patients who have exhausted surgical and other curative options – has been instrumental in reaching this milestone. It is their commitment to clinical excellence and to their patients that brought us to this point."

Liron Dimnik, VP Clinical Affairs at Alpha Tau, commented, "Completing enrollment in a multicenter pivotal trial is an enormous operational undertaking, and I am incredibly proud of the team that made it happen. I want to thank our clinical operations team at Alpha Tau, who worked tirelessly to ensure that every aspect of the study – from site activation to data quality to regulatory compliance – was executed to the highest standards. I also want to recognize the physicians, study coordinators and site teams at every participating center, whose day-to-day dedication to patient care and protocol adherence is the backbone of any successful clinical trial. We now transition into the follow-up phase with confidence, knowing that the foundation we have built together is strong."

About the ReSTART Trial

The ReSTART trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) is a prospective, multicenter, single-arm, open-label pivotal clinical study evaluating the efficacy and safety of intratumoral Alpha DaRT for the treatment of patients with recurrent cutaneous squamous cell carcinoma (cSCC) who have failed at least first-line standard-of-care therapy and are not indicated for surgery or conventional treatment. The study enrolled 88 patients across clinical centers in the United States, Israel, and Canada. The co-primary endpoints are the objective response rate (ORR) based on confirmed best overall response and the duration of response (DOR) at six months from the initial observation of response. Secondary endpoints include progression-free survival and overall survival at one year, overall duration of response, local control, and quality of life. Alpha DaRT has received Breakthrough Device Designation from the FDA for this indication, and the Company submitted the first module of its modular pre-market approval (PMA) application in January 2026. Additional information about the trial can be found at View Source

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal intratumoral treatment of solid tumors. Alpha DaRT sources are inserted directly into the tumor, where they release short-lived therapeutic particles that disperse locally with the goal of destroying the tumor. Since the therapeutic effect is confined to a short distance, Alpha DaRT aims to mainly affect the tumor and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, MAY 8, 2026, View Source [SID1234665400])

On May 8, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported that it will host a conference call and webcast on Monday, May 11, 2026 at 8:30am ET to discuss interim clinical data from the first three patients treated in its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma (GBM), also known as the REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial.

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Conference Call and Webcast Details

Date: Monday, May 11, 2026
Time: 8:30am ET
Web Access: View Source
An archived webcast will be available following the event.

About the REGAIN Study

The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the trial can be found at View Source

(Press release, Alpha Tau Medical, MAY 8, 2026, https://www.globenewswire.com/news-release/2026/05/08/3291131/0/en/alpha-tau-to-host-conference-call-to-discuss-interim-results-from-first-three-patients-treated-for-recurrent-glioblastoma.html [SID1234665399])

On May 8, 2026 Ensoma, an in vivo cellular engineering company with a mission to advance the future of medicine through one-time therapies, reported the presentation of initial clinical data from the first participant dosed in its Phase 1/2 trial of EN-374 for the treatment of X-linked chronic granulomatous disease (X-CGD) at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 29th Annual Meeting, taking place May 11-15 in Boston. The data represent the first reported clinical experience with in vivo hematopoietic stem cell (HSC)-directed therapy, from which the patient has the potential to create a continuous source of therapeutic immune and blood cells to treat disease.

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"We are excited to discuss encouraging initial safety data from the first participant in our Phase 1/2 clinical trial of EN-374 for X-CGD, the first-ever in vivo HSC gene insertion therapy in the clinic. While these are early data from a single participant, they mark an important first step in evaluating a new approach to engineering hematopoietic stem cells directly in vivo, and we look forward to continuing to assess safety and potential markers of clinical activity as the study progresses," said Jim Burns, CEO of Ensoma. "Additional ASGCT (Free ASGCT Whitepaper) presentations include promising developments with both Ensoma’s viral vector technology and our approach to producing cancer-killing immune cells. Together, these data advance our goal of bringing the power of in vivo HSC engineering to patients and treating genetic diseases and cancer with a potentially continuous supply of engineered immune and blood cells."

Oral Presentations:

Title: First in vivo hematopoietic stem cell (HSC) gene addition clinical trial: Initial results from EN-374-101 in X-linked chronic granulomatous disease (X-CGD)
Presentation Date/Time: Friday, May 15, 8:00-9:45 a.m. ET
Location: Westin Seaport Commonwealth Ballroom ABC (Concourse level)
Presenter: Ahmad Rayes, M.D., University of Utah
Key Highlights:

Treatment, including HSC mobilization, gene therapy infusion, short-course immune prophylaxis and three cycles of enrichment, was well tolerated
Adverse events (AEs) were all low-grade. There were no serious AEs or dose-limiting toxicities
Follow-up to assess potential efficacy is ongoing and will be reported at a later date
Title: Discovery and development of engineered neutralizing antibody-evading helper-dependent adenovirus capsids as candidates for in vivo gene therapy
Presentation Date/Time: Wednesday, May 13, 11:15-11:30 a.m. ET
Location: Westin Seaport Commonwealth Ballroom ABC (Concourse Level)
Presenter: Marcin Maziarz, Ph.D., Ensoma
Data Summary:

Engineered series of hexon-modified helper-dependent adenovirus (HDAd) capsids designed to evade pre-existing Ad5 neutralizing antibodies (NAbs), a known barrier to gene delivery
Identified an optimized capsid variant (HDAdGen2) that demonstrated evasion of NAbs in human sera
HDAdGen2 maintained transduction efficiency comparable to the standard HDAd5/35++ vector in vitro and in vivo
Findings suggest potential to improve gene delivery in patients with pre-existing immunity to Ad5
Supports continued advancement of optimized capsids for in vivo gene therapy applications
Poster Presentation:

Title: An in vivo engineered and lineage-restricted multiplexed CAR-M, -NK, and -T cell therapy mounts robust solid tumor control in pre-clinical models
Poster Presentation Date/Time: Wednesday, May 13, 5:00-6:30 p.m. ET
Location: MCEC Exhibit and Poster Hall (Halls B2-C, Exhibit level)
Presenter: Yiwen Zhao, Ph.D., Ensoma
Data Summary:

Designed lineage-restricted regulatory elements to drive CAR expression selectively in myeloid, NK and T cell populations
Observed durable HER2+ tumor control and prolonged survival in treated animals compared to controls in preclinical models
Maintained normal hematopoiesis and immune cell differentiation following HSC engineering
Supports potential of a multi-lineage, in vivo-generated cell therapy approach for solid tumors
Additionally, Drew Dietz, M.D., Vice President and Head of Clinical Research & Development at Ensoma, will speak during a scientific symposia session. Details are as follows:

Title: Adenoviral vectors and in vivo selection: Designing clinical strategies for durable benefit
Session Date/Time: Friday, May 15, 11:07-11:33 a.m. ET

About EN-374

EN-374 is a first-in-class in vivo hematopoietic stem cell (HSC)-directed therapy for X-CGD that employs virus-like particles (VLPs) to deliver payloads having a CYBB transgene to HSCs. Neutrophils arising from the engineered HSC then express the protein product of the CYBB transgene. In this way, EN-374 is designed to restore function of the infection-fighting NADPH oxidase enzyme complex critical for immune defense in humans. In preclinical studies, EN-374 demonstrated therapeutic levels of restoration of CYBB gene expression and NADPH oxidase activity in circulating neutrophils. EN-374 represents the first in vivo HSC-directed therapy for X-CGD, building on a mechanism that has been validated ex vivo. The Phase 1/2 study is an open-label, multicenter clinical trial in the US and UK evaluating the safety, tolerability, pharmacodynamics and efficacy biomarkers of EN-374, with the goal of identifying a dose for further clinical development in X-CGD.

(Press release, Ensoma, MAY 8, 2026, View Source [SID1234665398])