Nadofaragene firadenovec-vncg

The collaborative clinical study will evaluate ADSTILADRIN® (nadofaragene firadenovec-vncg) in combination with the investigational drug Ruvidar ® (TLD-1433) in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer carcinoma in-situ with or without papillary disease (±Ta/T1). Combination therapy aims to offer a complementary approach that may provide additional treatment options for patients with NMIBC. Collaboration reflects the shared commitment of Ferring and Theralase® to advance treatment options for NMIBC patients. Toronto, Ontario--(News - January 12, 2026) - Ferring Pharmaceuticals and Theralase ® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) are pleased to announce that they have entered into a collaborative clinical development agreement (" Agreement "), on January 9, 2026. The Agreement builds on Theralase®'s existing clinical program ( NCT03945162 ) with a new cohort investigating Theralase®'s investigational light-activated small molecule Ruvidar ® (TLD-1433) in combination with Ferring's intravesical non-replicating gene therapy ADSTILADRIN (nadofaragene firadenovec-vncg) for adult patients diagnosed with high-risk Bacillus Calmette-Guérin (" BCG ")-unresponsive Non-Muscle Invasive Bladder Cancer (" NMIBC ") Carcinoma In-Situ (" CIS ") with or without papillary tumors ( ± Ta/T1). Under the terms of the Agreement, Theralase® will remain the sponsor of the study, with both parties providing clinical overview of the new cohort through a joint development committee. The new cohort will be enrolled and treated in the United States and then subject to written agreement may expand into Canada or other countries. "The introduction of ADSTILADRIN, as the first intravesical gene therapy, filled a critical unmet need for patients with BCG-unresponsive NMIBC who faced limited treatment options and needed an alternative to invasive bladder removal surgery," said Ashish Kamat, MD, MBBS, Endowed Professor of Urologic Oncology (Surgery) and Cancer Research at University of Texas MD Anderson Cancer Center, Houston, Texas and President of the International Bladder Cancer Group. "As the BCG-unresponsive treatment paradigm continues to evolve, the combination of complementary therapies may offer additional treatment options to definitive therapy. This new study offers an opportunity to explore the possibility of enhancing efficacy and durability of response with a combination of a promising, investigational light-activated small molecule with the leading gene therapy in NMIBC." The collaboration between Ferring and Theralase® underscores their shared commitment to advancing innovative therapies for patients with BCG-unresponsive bladder cancer. The new cohort of patients will explore the potential benefit of combining two innovative and complementary mechanisms of action. ADSTILADRIN is the first and only intravesical gene therapy approved by the U.S. Food and Drug Administration (" FDA ") for high-risk BCG-unresponsive NMIBC CIS with or without papillary tumors ( ± Ta/T1) that delivers the human interferon alpha-2b gene directly to bladder cells, prompting local secretion of interferon that exert multiple anticancer and immunomodulatory effects. Ruvidar® is an investigational small molecule that penetrates cancer cell walls and, upon light activation, delivers targeted cytotoxic effects to destroy cancer cells, while inducing immunogenic cell death, stimulating both innate and adaptive immune responses. "Underscoring our ambition to establish ADSTILADRIN as the backbone therapy in NMIBC, this collaborative clinical study with Theralase® aims to explore whether combination approaches can further enhance patient outcomes, building on the strong foundation ADSTILADRIN has established in treating this challenging disease," said Daniel Shoskes, M.D., M.Sc, FRCS (C), Vice President and Global Medical Director for Uro-Oncology, Ferring Pharmaceuticals. Roger DuMoulin-White, B.Sc, P.Eng, Pro.Dir, President, Chief Executive Officer and Chairman of the Board of Theralase®, added, "We are honored to collaborate with Ferring, a worldwide leader in uro-oncology with deep expertise in bladder cancer treatment. As we approach completion of our clinical study and regulatory submissions for Ruvidar®, this partnership provides the perfect opportunity to investigate whether we can deliver even greater benefits to patients through innovative combinational approaches." Study Details In Study II NCT03945162 , Theralase® is clinically investigating light-activated Ruvidar® in the treatment of patients diagnosed with BCG-unresponsive NMIBC CIS (Study II). Theralase® has enrolled and successfully treated 88 out of a planned 90 patients in Study II and plans to complete enrollment and treatment of the remaining 2 patients by 1Q2026 with follow-up completed by 2Q2027. In the Collaborative Clinical Study , Theralase® will apply to the FDA to add a new cohort to Study II. This cohort will be treated with Theralase®'s lead small molecule, light-activated Ruvidar®, followed by treatment with Ferring's FDA-approved ADSTILADRIN. About NMIBC NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall. 1 In the United States, bladder cancer is the sixth most common cancer, 2 fourth among men, 3 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025. 3 Historically, 75% of bladder cancer presents as NMIBC. 4 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease. 5 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network (" NCCN ") guidelines recommend cystectomy (partial or complete removal of the bladder). 6 About Ruvidar ® Ruvidar® (TLD-1433) is a small molecule, able to be activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of various cancers, bacteria and viruses. About ADSTILADRIN ADSTILADRIN (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk BCG-unresponsive NMIBC CIS with or without papillary tumors ( ± Ta/T1). It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder's cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body's own natural defenses against the cancer. ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC, who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849 and final five-year follow-up analysis published in The Journal of Urology ). 7-8 INDICATION ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors ( ± Ta/T1). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product. WARNINGS AND PRECAUTIONS: Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy. Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals. DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use or oral administration. USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose. ADVERSE REACTIONS: The most common (>10%) adverse reactions; including, laboratory abnormalities (>15%), were increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition (urination urgency), increased creatinine, hematuria (blood in urine), decreased phosphate, chills, pyrexia (fever) and dysuria (painful urination). You are encouraged to report negative side effects of prescription drugs to FDA. Visit or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING. Please click to see the full Prescribing Information . About Theralase® Technologies Inc. Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and drug-activated small molecule compounds and their associated formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses, with minimal impact on surrounding healthy tissue. Additional information is available at and . About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately-owned, specialty, biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees. For more information, please visit , call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn and X . References: Urology Care Foundation. Non-muscle Invasive Bladder Cancer. . Accessed November 2025. National Cancer Institute. Cancer Statistics. . Accessed November 2025. American Cancer Society. Cancer Facts & Figures 2025. . Accessed November 2025. Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer. Eur Urol. 2022 Jan;81(1):75-94. Lidagoster S, et al. BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. Curr Oncol. 2024 Feb 16;31(2):1063-1078. National Comprehensive Cancer Network. Bladder Cancer (Version 2.2025). . Accessed November 2025. ADSTILADRIN in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Gov Identifier: NCT02773849. . Accessed November 2025. Narayan VM, Boorjian SA, Alemozaffar M, et al. Efficacy of intravesical nadofaragene firadenovec for patients with Bacillus Calmette-Guérin-unresponsive nonmuscle-invasive bladder cancer: 5-year follow-up from a phase 3 trial. J Urol. 2024;212(1):1-12. . Accessed November 2025 Additional information: Healthcare Providers: If you are interested in ordering ADSTILADRIN, please sign up for information and updates at . Patients and Consumers: For more information about ADSTILADRIN, please visit , or call 1-888-FERRING (888-337-7464), and select option number one. Media: Members of the press can contact Carol Ready , Director, Brand Communications, by phone at (973) 765-7307, or email at carol.ready@ferring.com . Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Statements This news release contains Forward-Looking Statements (" FLS ") within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words " may , " should ", " will ", " anticipates ", " believes ", " plans ", " expects ", " estimate ", " potential for " and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals. These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure the regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; the risk that access to sufficient capital to fund the Company's operations may not be available on terms that are commercially favorable to the Company or at all; the risk that the Company's small molecule and drug formulations may not be effective against the diseases tested in its clinical studies; the risk that the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company's ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict. Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS. Although the FLS contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these FLS. All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such FLS. For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies . For More Information: 1.866.THE.LASE (843.5273) 416.699.LASE (5273) Kristina Hachey, CPA Chief Financial Officer X 224 khachey@theralase.com To view the source version of this press release, please visit

ImmunityBio's Anktiva helped 92.2% of evaluated patients avoid a cystectomy at 12 months post-treatment, the company reported. Armed with new three-year data demonstrating the benefits of Anktiva in a specific patient subset, ImmunityBio is proving its bladder cancer med is still one to watch as it competes with heavy hitters from Merck and Johnson & Johnson.Last year, the company won a long-sought FDA approval for its drug—used alongside the Bacillus Calmette-Guérin (BCG) vaccine—to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. That nod set up a showdown with Merck’s Keytruda and Ferring Pharmaceuticals’ gene therapy Adstiladrin. More recently, the competition has amped up, with Johnson & Johnson’s Inlexzo hitting the scene and putting pressure on IL-15 receptor agonist Anktiva.Not deterred by the expanding competitive landscape, ImmunityBio is using new data from the company’s Quilt-3.032 study to flesh out Anktiva’s benefits in patients with BCG-unresponsive high-grade papillary-only NMIBC. Papillary tumors and CIS are the two clonally linked subtypes of NMIBC, ImmunityBio explained in a Dec. 16 press release. Across the 80 high-grade papillary-only NMIBC patients evaluated in cohort B of the company’s Quilt-3.032 trial, the disease-free survival (DFS) rate came out to 58.2% at one year and 38.2% by year three.Disease-specific survival (DSS) outcomes told a bit of a different story, however, with 98.7% of patients alive at one year and 96% at three years. The DSS endpoint tracks how long patients survive without dying specifically from the disease being studied. DFS, meanwhile, tracks how long patients survive without any signs or symptoms of the disease, according to the National Cancer Institute.All told, 94.9% of patients had survived without disease progression at one year, as did 83.1% of the cohort's participants at the three-year mark, according to ImmunityBio. The trial also tracked cystectomy avoidance rates, which determined that 92.2% of patients didn’t need a cystectomy at one year. At three years, the number was 81.8%. A cystectomy is a bladder removal procedure that’s typically the go-to response for bladder cancer that doesn’t respond to treatment. The results, which are published in The Journal of Urology’s January 2026 print edition, suggest a “potential paradigm change in the treatment of BCG-unresponsive high-grade papillary-only NMIBC,” ImmunityBio’s founder, chairman and global chief scientific and medical officer, Patrick Soon-Shiong, M.D., said in the release, adding that the 12-month and 36-month outcomes are “higher than those reported for other investigational therapies in this patient population.”“The evidence that CIS and papillary disease are clonally linked, combined with the Quilt-3.032 findings showing long-term cystectomy avoidance, sustained avoidance of progression to muscle-invasive disease, and 96% bladder cancer-specific survival at three years, supports the consideration that Anktiva plus BCG addresses the unmet need for patients with papillary disease alone who face the prospect of total radical cystectomy following failure of BCG therapy,” Soon-Shiong added.ImmunityBio’s efforts to expand into the papillary-only population have been up in the air since the FDA responded to its March bid for a papillary disease indication with a refusal-to-file letter, leaving the company “shocked” by what it described as the agency’s “inconsistent response.”Since holding a type A meeting with the FDA in June, the drugmaker has been reevaluating its approach for the filing, it said in an August earnings release. Either way, the race is on in this indication, with J&J recently reporting its own data from a cohort of its phase 2b Inlexo study. Out of 52 patients with the papillary disease subtype, J&J found a one-year DFS rate of 74.3% and progression-free survival of 95.6%, while 92.3% of patients didn’t need a radical cystectomy. After laying off workers to save costs in the wake of Anktiva’s approval last year, ImmunityBio saw strong sales growth to $31.8 million during the third quarter of this year, with Anktiva drawing “continued strong demand,” CEO Richard Adcock said. At the time, Adcock said a study of Anktiva in BCG-naïve patients was “enrolling well,” giving the company confidence in its hopes of expanding the drug’s reach to an “even broader population of bladder cancer patients in the near future.”