Ferring Pharmaceuticals and Theralase® Technologies Announce Clinical Development Agreement to Investigate Combination Therapy in Bladder Cancer

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PARSIPPANY, N.J.--(BUSINESS WIRE)--Jan 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, has 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 exerts 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., MSc, FRCS (C), Vice President and Global Medical Director for Uro-Oncology, Ferring Pharmaceuticals.

Roger DuMoulin-White, BSc, 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 IINCT03945162, 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. Visithttp://www.fda.gov/medwatchor 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 www.theralase.com and www.sedarplus.ca.

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 www.ferringusa.com, call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X.

References:

1. Urology Care Foundation. Non-muscle Invasive Bladder Cancer. https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer. Accessed November 2025.
2. National Cancer Institute. Cancer Statistics. https://www.cancer.gov/about-cancer/understanding/statistics. Accessed November 2025.
3. American Cancer Society. Cancer Facts & Figures 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf. Accessed November 2025.
4. 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. https://pubmed.ncbi.nlm.nih.gov/34511303/. Accessed November 2025.
5. 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. https://pubmed.ncbi.nlm.nih.gov/38392073/. Accessed November 2025.
6. National Comprehensive Cancer Network. Bladder Cancer (Version 2.2025). https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed November 2025.
7. ADSTILADRIN in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Gov Identifier: NCT02773849. https://clinicaltrials.gov/ct2/show/NCT02773849. Accessed November 2025.
8. 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. https://www.auajournals.org/doi/full/10.1097/JU.0000000000004020. Accessed November 2025.

Additional information:

• Healthcare Providers: If you are interested in ordering ADSTILADRIN, please sign up for information and updates at www.ADSTILADRINHCP.com.
• Patients and Consumers: For more information about ADSTILADRIN, please visit www.ADSTILADRIN.com, or call 1-888-FERRING (888-337-7464), and select option number one.

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KEYWORD: NEW JERSEY UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH PHARMACEUTICAL CLINICAL TRIALS ONCOLOGY

SOURCE: Ferring Pharmaceuticals

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PUB: 01/12/2026 07:00 AM/DISC: 01/12/2026 07:00 AM

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