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 Ascendo Biotechnology reported that it has successfully completed an oversubscribed financing round, supported by a strong group of institutional investors, including Taiwania Capital Management Corporation (TaiAx Life Science Fund, L.P.), Yuanta Venture Capital Co., Ltd., Maxpro Investment Co., Ltd., Chenghan Investment Co., Ltd, Darly2 Venture, lnc., TECO Capital Investment Co., Ltd, Industrial Technology Investment Corporation (ITIC), Beiley Biofund Inc., Chang Hwa Bank Venture Capital Co., Ltd., and First Venture Capital Co., Ltd.

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This strong investor support reflects growing confidence in our differentiated approach to targeting innate immune checkpoints, a novel strategy aimed at addressing significant unmet needs in oncology and autoimmune diseases, where current therapies remain limited in efficacy.

Ascendo Biotechnology was founded by Dr. Yen-Ta Lu, a physician from Mackay Memorial Hospital. Our core technologies originate from Taiwan-based clinical and translational research, forming the foundation of our proprietary innate immune checkpoint platform.

Proceeds from this financing will be used to advance our lead program, ASD141, through key clinical milestones in its Phase I trial and to prepare for Phase II development. In parallel, we will also advance IND-enabling studies for ASD001.

ASD141 has demonstrated encouraging early clinical signals, including immune cell activation observed at low- and mid-dose levels, with multiple patients achieving stable disease. As dose escalation continues, we aim to further validate its therapeutic potential and explore its ability to expand response rates beyond current immunotherapy limitations.

We look forward to continuing our clinical progress and advancing global collaborations and licensing discussions to accelerate the development of our pipeline.

We sincerely thank our investors and partners for their support as we move into the next phase of growth.

(Press release, Ascendo Biotechnology, MAY 8, 2026, View Source [SID1234665310])

On May 8, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported a significant advancement in its intellectual property portfolio with the issuance of a Hong Kong patent covering its proprietary method of reconstituting liposomal Annamycin.

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The newly granted patent (No. 40073244), titled "Method of Reconstituting Liposomal Annamycin," extends protection through June 25, 2040, further reinforcing Moleculin’s long-term global exclusivity strategy. The invention is jointly owned with The University of Texas System.

This patent represents an impactful layer of protection around Moleculin’s lead asset, Annamycin, at a time when the global oncology market continues to seek improved treatment options. By securing rights in Hong Kong, an influential gateway to broader Asian markets, Moleculin is strategically positioning itself in one of the fastest-growing regions for cancer therapeutics.

"This patent issuance is a meaningful step forward in fortifying the global intellectual property foundation for Annamycin," said Walter Klemp, President and Chief Executive Officer of Moleculin. "This level of patent protection is made all the more important given the expected timing of our first Phase 3 clinical data release later this quarter. As we continue advancing clinical development, protecting our formulation technology is essential to unlocking long-term value and supporting future commercialization efforts worldwide."

The Hong Kong patent approval builds on Moleculin’s expanding global intellectual property portfolio, which includes allowed, issued or granted patents in the United States, Australia, Canada, China, Europe, India, Israel, Japan, Mexico, Singapore, and Taiwan, further strengthening protection of Annamycin.

Annamycin is Moleculin’s lead product candidate designed to avoid cardiotoxicity, avoid multidrug resistance and cross-resistance, and improve tissue/organ distribution when compared with currently prescribed anthracyclines. Annamycin’s unique multilamellar lipid-based delivery system is intended to further enhance these characteristics.

(Press release, Moleculin, MAY 8, 2026, View Source [SID1234665386])

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 7, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported an update following the recent Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel) held by our partner Pierre Fabre Pharmaceuticals, Inc. (PFP).

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PFP, with Atara’s support, had a productive meeting with the FDA and discussed a potential path forward to resubmitting the tab-cel BLA. The FDA agreed that a single arm study using an appropriate historical control applicable to the trial population, conducted in a pre-specified manner, could serve as an adequate and well controlled study and provide safety and efficacy data in support of a future marketing application of tab-cel for the proposed indication. PFP has indicated they intend to submit an updated dataset with additional patients and longer follow up from the pivotal Phase 3 single arm ALLELE study of tabelecleucel in adults and children two years of age and older with R/R EBV+ PTLD following solid organ transplant or hematopoietic cell transplant as well as supportive data, as a part of the resubmission plan being defined with the FDA.

"We are grateful to the agency for engaging in a collaborative conversation with our partners, Pierre Fabre, and us. We appreciate the FDA’s continued engagement with PFP and Atara, and we believe the Type A Meeting provided helpful alignment on the regulatory framework to resubmit," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We will continue to support Pierre Fabre as it prepares the resubmission and anticipate providing a further regulatory update in the third quarter."

(Press release, Atara Biotherapeutics, MAY 7, 2026, View Source [SID1234665311])