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GCAR and Purdue Pharma L.P. Announce Initiation of Tinostamustine in GBM AGILE Trial

On April 8, 2026 The Global Coalition for Adaptive Research (GCAR) and Purdue Pharma L.P. (Purdue) reported the activation of investigational tinostamustine in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447), a pioneering, international adaptive platform trial designed to accelerate the identification of effective treatments for glioblastoma (GBM). Tinostamustine will be evaluated for the treatment of adult patients with newly diagnosed GBM across GBM AGILE. It will also be studied in a cohort of patients with recurrent GBM at select GBM AGILE sites.

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GBM is the most common and aggressive form of primary brain cancer. Treatment options remain limited and patient outcomes have seen minimal improvement over the past several decades.

GBM AGILE is a seamless phase 2/3 study conducted under a master protocol enabling multiple therapies or combinations of therapies from different pharmaceutical companies to be evaluated simultaneously against a shared control arm. With its innovative design and efficient operational infrastructure, data from GBM AGILE can potentially be used as the foundation for a new drug application (NDA) and registrations to the U.S. FDA and other health authorities. Since its launch in 2019, GBM AGILE has evaluated multiple investigational therapies and has screened over 2,600 patients at approximately 60 trial locations in six countries.

Dr. John de Groot, Neuro-Oncology Division Chief, Department of Neurosurgery, University of California, San Francisco and Dr. Shiao-Pei Weathers, Brain Tumor Section Chief, Department of Neuro-Oncology, University of Texas MD Anderson Cancer Center, are serving as the Principal Investigators for tinostamustine’s evaluation in GBM AGILE. Dr. Timothy Cloughesy, Director, Neuro-Oncology Program and Distinguished Professor of Neurology at the University of California, Los Angeles, is the Global Principal Investigator for the overall study.

"Glioblastoma remains one of the most aggressive and difficult-to-treat cancers we encounter in clinical practice," said Dr. John de Groot. "There is a pressing need to explore novel mechanisms of action in well-designed studies. GBM AGILE’s adaptive platform design allows us to rigorously evaluate promising therapies like tinostamustine while generating high-quality data efficiently. The addition of tinostamustine strengthens our ability to investigate new approaches that may improve outcomes for patients with GBM."

"Despite advances in oncology, outcomes for patients with glioblastoma remain poor," said Dr. Shiao-Pei Weathers. "Participating in a global study like GBM AGILE gives patients access to innovative investigational therapies that would otherwise not be available outside of a clinical trial. The inclusion of tinostamustine offers hope and reflects the ongoing commitment to expanding meaningful treatment opportunities for this devastating disease."

Tinostamustine is a first-in-class, new chemical entity that combines two potentially synergistic mechanisms of action: bifunctional DNA alkylating activity, which triggers apoptosis, and pan histone deacetylase inhibition (or HDAC inhibition), which in addition to improving alkylating agent access to DNA, has been shown to disrupt oncogenic signaling pathways and enhance immune recognition of tumor cells. This dual mechanism may be particularly relevant in aggressive and treatment-resistant cancers like GBM, where both genomic instability and epigenetic dysregulation drive disease progression. Tinostamustine has the potential to be a first-line treatment and is being investigated in patients with newly diagnosed GBM as an adjuvant therapy following standard treatment with surgery, chemotherapy and radiation, as well as in a limited cohort for patients in whom the disease has recurred following initial treatment.

"We are pleased to initiate the evaluation of tinostamustine in GBM AGILE, an innovative adaptive trial designed to efficiently determine whether promising therapies like tinostamustine can provide meaningful benefit to patients with glioblastoma," said Dr. Julie Ducharme, Vice President and Chief Scientific Officer, Purdue. "Encouraging findings from prior clinical studies support continued investigation, and we look forward to advancing the development of tinostamustine for this devastating disease, where significant unmet need remains."

"Activation of the first trial sites represents the culmination of years of hard work and dedication, scientific rigor, and partnership," said Dr. Craig Landau, President and CEO, Purdue. "It underscores our determination to apply sustained scientific and clinical investment to help deliver new treatments patients urgently need."

"At GCAR, our mission is to rethink how therapies are developed for aggressive cancers like glioblastoma," said Dr. Meredith Buxton, CEO and President, GCAR. "Through master protocols and adaptive platform trials, we aim to streamline evaluation and accelerate decision-making. Our collaboration to evaluate tinostamustine represents an important step toward rapidly advancing new treatments in GBM AGILE and bringing new hope to patients."

(Press release, Purdue Pharma, APR 8, 2026, View Source [SID1234664247])

Cue Biopharma to Receive $7.5 Million Preclinical Milestone Payment from Boehringer Ingelheim Collaboration and License Agreement

On April 8, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage memory T cell subsets to deplete pathogenic B cells for the potential treatment of autoimmune and inflammatory diseases, reported that it will receive a $7.5 million preclinical milestone payment under its collaboration and license agreement with Boehringer Ingelheim following Boehringer Ingelheim’s selection and approval of its first compound for lead optimization. The Company expects to receive the payment in May 2026.

"We are very pleased to have achieved this critical preclinical milestone through our strategic research collaboration with Boehringer Ingelheim," said Lucinda Warren, interim president and chief executive officer of Cue Biopharma. "This is a very exciting time for the Company as we progress our lead autoimmune asset, CUE-401, toward the clinic and reach this important milestone in our collaboration with Boehringer Ingelheim to further develop CUE-501, a bispecific molecule intended for autoimmune and inflammatory diseases."

Under the terms of the collaboration and license agreement with Boehringer Ingelheim, Cue Biopharma’s technology will be leveraged to further research and advance the development of the candidate molecule. The terms of the multi-year collaboration also include the ability of the parties to expand research and development into various B cell targeting bispecifics encompassing autoimmune diseases.

Pursuant to the terms of the collaboration, Cue Biopharma is also eligible to earn, in addition, up to approximately $337.5 million in additional research, development and commercial milestone-based payments as well as royalty payments on net sales.

(Press release, Cue Biopharma, APR 8, 2026, View Source [SID1234664246])

Kyntra Bio to Present at the 25th Annual Needham Virtual Healthcare Conference

On April 8, 2026 Kyntra Bio (Nasdaq: KYNB) reported that the Company will present at the 25th Annual Needham Virtual Healthcare Conference being held April 13-16, 2026.

Thane Wettig, Chief Executive Officer of Kyntra Bio, will deliver a company presentation on Monday, April 13, 2026, at 1:30 PM EDT. A live webcast of the presentation will be available here.

Kyntra Bio’s management team will be available for one-on-one meetings during the conference. Interested investors should contact their representative at Needham. A replay of the presentation will be posted, when available, to the Kyntra Bio website on the Events & Presentations page of the Investors and Media section for 90 days.

(Press release, Kyntra Bio, APR 8, 2026, View Source [SID1234664245])

Entry into a Material Definitive Agreement

On April 8, 2026, Phio Pharmaceuticals Corp. (the "Company") entered into an At The Market Offering Agreement (the "Sales Agreement") with H.C. Wainwright & Co., LLC, as sales agent (the "Sales Agent"), pursuant to which the Company may offer and sell, from time to time, through the Sales Agent, shares of the Company’s common stock, par value $0.0001 per share (the "Shares"). The offering and sale of up to $6,360,000 of the Shares pursuant to the Sales Agreement is being registered under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-279557), which was declared effective by the Securities and Exchange Commission ("SEC") on July 1, 2024, which includes a base prospectus, and an accompanying prospectus supplement filed with the SEC on April 8, 2026.

Subject to the terms and conditions of the Sales Agreement, the Sales Agent will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company provided the Sales Agent with customary indemnification rights and contribution rights, including for liabilities under the Securities Act, and the Sales Agent will be entitled to a commission of 3.0% of the gross proceeds from each sale of the Shares. In addition, the Company agreed to reimburse certain expenses incurred by the Sales Agent in connection with the Sales Agreement, including up to $75,000 for reasonable and documented fees and expenses incurred by the Sales Agent’s legal counsel in connection with entering into the transactions contemplated by the Sales Agreement, excluding periodic due diligence fees as set forth in the Sales Agreement.

Sales of the Shares, if any, under the Sales Agreement may be made in transactions that are deemed to be "at the market offerings" as defined in Rule 415(a)(4) under the Securities Act. The Company will designate the parameters for the sale of Shares, if any, including the number of Shares to be issued, the time period during which sales are requested to be made, limitations on the number of Shares that may be sold on any trading day and any minimum price below which sales may not be made. The Company has no obligation to sell any of the Shares and may at any time suspend offers under the Sales Agreement or terminate the Sales Agreement. The Sales Agent is not obligated to purchase any Shares on a principal basis pursuant to the Sales Agreement, except as otherwise specifically agreed by the Sales Agent and the Company in a separate agreement. No assurance can be given that any Shares will be sold under the Sales Agreement, or if such sales occur, no assurance can be given as to the price or number of Shares that will be sold, or the dates on which any such sales will take place.

The Sales Agreement contains customary representations, warranties and agreements by the Company, indemnification obligations of the Company and the Sales Agent and other obligations of the parties.

The information set forth herein shall not constitute an offer to sell or the solicitation of any offer to buy the Shares, nor shall there be an offer, solicitation or sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

This description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 1.01. The legal opinion of Hogan Lovells US LLP relating to the Shares being offered pursuant to the Sales Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

(Filing, Phio Pharmaceuticals, APR 8, 2026, View Source [SID1234664244])

UroGen Launches LG-UTUC Luminaries Initiative Recognizing Excellence and Leadership in Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer

On April 8, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the launch of its "LG-UTUC Luminaries" initiative, recognizing clinicians and institutions demonstrating leadership, expertise, and a commitment to advancing low‑grade upper tract urothelial cancer (LG‑UTUC) care.

LG‑UTUC is a rare form of cancer affecting an estimated 6,000-7,000 patients each year in the U.S., which represents approximately 40% of patients diagnosed in the U.S. annually with UTUC. While typically noninvasive, it often recurs and may require repeated endoscopic procedures or radical surgery to remove the kidney and ureter, underscoring a continued need for guideline-recommended kidney‑sparing care approaches.

"Through the LG-UTUC Luminaries initiative, we are honored to recognize the clinicians and institutions redefining what is possible for patients living with LG-UTUC," said Liz Barrett, President and Chief Executive Officer of UroGen. "By elevating these leaders, we aim to inspire broader adoption of evidence-based, kidney-sparing care, strengthen collaboration across the urology community, and accelerate progress toward a future where patients with this highly recurrent disease have better outcomes and a better care experience."

The LG-UTUC Luminaries initiative recognizes clinicians and institutions working to achieve excellence in LG-UTUC care. Honorees have extensive experience with LG-UTUC and are actively involved in treatment, research, and peer-to-peer education. Institutional recipients are distinguished by established, guideline-aligned care pathways spanning diagnosis, treatment, and long-term surveillance, as well as strong commitments to physician training, research participation, and comprehensive patient support.

UroGen recognizes Saum Ghodoussipour, MD, Director, Bladder and Urothelial Cancer Program, Rutgers Cancer Institute, and Associate Professor of Surgery, Rutgers Robert Wood Johnson Medical School, as the first recipient of this flagship LG-UTUC Luminaries recognition—an honor that will continue to be presented to physicians and institutions dedicated to helping shape the future of kidney-sparing management in LG-UTUC.

"I’m truly honored to receive this recognition," said Dr. Saum Ghodoussipour, Director of the Bladder and Urothelial Cancer Program at Rutgers Cancer Institute and Associate Professor of Surgery at Rutgers Robert Wood Johnson Medical School, NJ. "This distinction reflects the dedication of our entire multidisciplinary team at Rutgers Cancer Institute, whose commitment to advancing education, research, and patient-centered care continues to drive progress for individuals living with LG-UTUC. I’d especially like to recognize Dr. Vignesh Packiam, Director of Clinical and Translational Research in Urologic Oncology and Associate Professor of Surgery at Rutgers Robert Wood Johnson Medical School, whose leadership and contributions have been instrumental in shaping our program. Together, we remain committed to improving outcomes through collaboration, innovation, and a steadfast focus on our patients."

About the LG-UTUC Luminaries Initiative
The LG-UTUC Luminaries initiative is UroGen’s effort to recognize and collaborate with leading clinicians and institutions advancing care for patients with low-grade upper tract urothelial cancer. By highlighting clinical leadership and fostering collaboration across the urology community, the initiative supports continued progress in kidney-sparing care and efforts to improve outcomes in this rare and highly recurrent disease.

(Press release, UroGen Pharma, APR 8, 2026, View Source [SID1234664243])