Nadofaragene firadenovec-vncg

Brings nearly three decades of leadership spanning NMIBC, corporate strategy and business development to help advance NDV-01 and support the Company's long-term growth and value creation. CORAL GABLES, Fla., July 28, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced the appointment of Bipin Dalmia, PhD, MBA, as Chief Business Officer. Bipin will lead Relmada's corporate strategy, commercial planning, and business development activities, reporting directly to Chief Executive Officer Sergio Traversa. Bipin Dalmia joins Relmada with nearly three decades of biopharmaceutical leadership, combining extensive experience in corporate strategy and business development with deep expertise in non-muscle invasive bladder cancer (NMIBC). As the Company advances NDV-01, its novel sustained-release intravesical therapy for patients with NMIBC, Bipin’s appointment reflects Relmada's rapid evolution toward late-stage development and its commitment to building the commercial and strategic capabilities needed to maximize the value of NDV-01. "Bipin combines a deep understanding of the evolving NMIBC treatment and competitive landscape, with exceptional experience in helping bring the first FDA-approved intravesical gene therapy to bladder cancer patients. His experience and perspective will be invaluable in helping us maximize the clinical, commercial and long-term potential of NDV-01," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. "In addition to advancing NDV-01, Bipin's experience in corporate strategy, business development and value creation will strengthen Relmada as we evaluate opportunities to maximize long-term shareholder value." "I am excited to join Relmada at such an important stage in the Company's evolution. What drew me to this opportunity was the chance to help realize the full potential of NDV-01. The NMIBC treatment landscape is entering a period of rapid innovation, yet patients continue to face significant unmet needs. NDV-01’s differentiated product profile and encouraging clinical data generated to date position it to become a best-in-class intravesical therapy across the NMIBC disease spectrum," said Bipin Dalmia, Chief Business Officer. "I look forward to working alongside the outstanding Relmada team to help advance the next phase of NDV-01's development and, if successful, bring this innovative therapy to patients as quickly as possible.” About Bipin Dalmia, PhD, MBA Bipin Dalmia is a senior biopharmaceutical executive with nearly three decades of leadership roles across corporate strategy, portfolio management, commercial planning, business development and M&A in biotechnology, specialty pharmaceuticals, and global pharmaceutical companies. Most recently, he served as Senior Vice President, Global Head of Portfolio Strategy & Business Development at Ferring Pharmaceuticals, where he established and led this new global function. During his 14-year tenure at Ferring, in addition to global business development leadership, he led the company's Uro-Oncology Franchise, including the U.S. launch and global lifecycle and manufacturing strategy for ADSTILADRIN® – the first FDA-approved intravesical gene therapy for BCG-unresponsive NMIBC patients. Beyond ADSTILADRIN, Bipin led and completed more than 20 strategic licensing, partnership and M&A transactions across multiple therapeutic areas, modalities and development stages, while strengthening the company's portfolio management and capital allocation capabilities. Prior to Ferring, Bipin held business development leadership positions at Biolex Therapeutics and earlier served in strategy, new product planning and business development roles at Syngenta and Novartis. He began his career as a research scientist. He currently serves on the Board of Directors of Ferring Ventures S.A. and on the Board of Directors of FinVector Oy. Bipin Dalmia holds a PhD and an MS in Chemical Engineering from Iowa State University and an MBA from Drake University. About Relmada Therapeutics, Inc. Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development with the potential to address significant unmet needs. For more information, visit www.relmada.com Forward-Looking Statements: The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Relmada’s product candidates to fail to progress, potential for Phase 2 NDV-01 data to fail to continue to deliver positive results supporting further development, potential for clinical trials to fail to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of interim or top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to continue to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone, or that future NDV-01 and/or sepranolone clinical results will be acceptable to the FDA, failure to secure adequate NDV-01 and/or sepranolone drug supply, failure of pending patent applications to result in issued patents, or issued patents being challenged and invalidated by third parties or not providing us with any competitive advantages, the Company’s cash runway and sufficiency of the Company’s cash resources and uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein are not a complete list. Investor Contact:Brian RitchieLifeSci Advisorsbritchie@lifesciadvisors.com Media Inquiries:Corporate Communicationsmedia@relmada.com

TMX NewsfileMay 29, 2026 5:04 PM EDT Theralase® Provides an Update on its Phase II Bladder Cancer Clinical Study Toronto, Ontario–(Newsfile Corp. – May 29, 2026) – Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) (“Theralase®” or the “Company“), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of various cancer, bacteria and viruses has released the Company’s unaudited interim consolidated financial statements for the three-month period ended March 31st, 2026 (“Financial Statements“). Theralase® will be hosting a conference call on June 9th at 11:00 am ET, which will include a presentation of the financial and operational results for the quarter ended March 31st, 2026. To ensure Theralase® has time to address questions during the call, please e-mail them in advance to mperraton@theralase.com. An archived version will be available on the website following the conference call. Table 1: Financial Summary for the Quarter Ended March 31st To view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2786/299492_1988af03149dd9a6_001full.jpg Financial Highlights: For the Quarter ended March 31st, 2026 (All funds in Canadian Dollars): Total revenue increased to $132,634 from $91,190 for the same period in 2025, a 45% increase. Cost of sales for the three-month period ended March 31st, 2026, was $68,250 (51% of revenue) resulting in a gross margin of $64,382 (49% of revenue). In comparison, the cost of sales for the same period in 2025 was $77,896 (85% of revenue) resulting in a gross margin of $13,294 (15% of revenue). Selling expenses decreased to $66,534 from $68,143 for the same period in 2025, a 2% decrease. The decrease in selling expenses is primarily a result of decreased spending on advertising (64%) and travel (38%). Administrative expenses for three-month period ended March 31st, 2026, decreased to $463,553 from $555,074 for the same period in 2025, a 16% decrease. The decrease in administrative expenses is primarily a result of decreased spending on insurance (20%) and professional fees (45%). Net research and development expenses for the three-month period ended March 31st, 2026, decreased to $564,724 from $877,670 for the same period in 2025, a 36% decrease. The decrease in research and development expenses is attributed to a decrease in costs for Study II patient enrollment and treatment, as the clinical study reaches completion. Research and development expenses represented 52% of the Company’s operating expenses and represent investment into the research and development of the Company’s Drug Division. The net loss for the three-month period ended March 31st, 2026, was $1,031,785, which included $172,118 of net non-cash expenses (i.e.: amortization, stock-based compensation expense). This compared to a net loss for the same period in 2025 of $1,471,250, which included $254,523 of net non-cash expenses. The Drug Division represented $803,352 (78%) of this loss. The decrease in net loss is primarily attributed to decreased spending on research and development expenses in Study II, as the clinical study reaches completion. Operational Highlights: Collaborative Clinical Development Agreement On January 12th, 2026, the Company announced that it had entered into a collaborative clinical development agreement dated January 9th, 2026 with Ferring Pharmaceuticals, expanding the Company’s existing Phase II NMIBC clinical program (NCT03945162) through the addition of a new cohort evaluating Ruvidar® (TLD-1433) in combination with 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 disease (±Ta/T1) (“Study II“). Under the terms of the agreement, the Company will remain the sponsor of the study, with both parties providing clinical oversight through a joint development committee. The new cohort is expected to be enrolled and treated initially in the United States and, subject to written agreement, may expand into Canada or other jurisdictions. Study II Interim Clinical Data Cohort 1 Theralase® has completed enrollment in Study II, with the Clinical Study Sites (“CSSs“) enrolling and providing the primary Study Procedure to 92 patients. Additional patients may be enrolled, until all CSSs have been closed to enrollment. According to the clinical study design, a patient is considered to have completed Study II, if they received the Study Procedure and have been assessed by the Principal Investigator (“PI“) for up to 15 months or they have been prematurely removed from the clinical study by the PI for failure to respond or failure to comply with the clinical study design. According to this definition, 82 patients have completed Study II (with 10 patients on study pending clinical data), resulting in the following interim clinical data in support of the Study II endpoints: A total of 92 patients have been enrolled and treated in the study. Of these patients, 81% were ≥ 65 years of age, 81% male and 83% white. Tumour stage was distributed as follows: pure 81% CIS; 12% CIS + T1; and 7% CIS + Ta. 98% were classified as BCG-Unresponsive with 2% BCG-Intolerant. The median number of BCG instillations was 15.5. As of May 29th, 2026, 89 patients have been assessed for response outcomes, evaluable for the primary endpoint analysis. Primary Endpoint Performance (Complete Response at any Point in Time) The primary endpoint of Study II is the achievement of Complete Response (“CR“) at any point in time following administration of the Study Procedure. Interim analysis demonstrates that 65.2% (58 out of 89) evaluable patients achieved CR. Table 2: Primary Endpoint Performance Approximately, 2 out of 3 patients diagnosed with BCG-Unresponsive NMIBC CIS (with or without Ta/T1) achieved a CR following treatment with the Theralase® Study Procedure. Secondary Endpoint Performance (Duration of CR – 12 Months) The secondary endpoint evaluates the sustainability of CR at 12 months, after initial CR determination (450 days post-treatment). Among patients evaluable for durability of response, 40.4% (21 of 52 evaluable patients) maintained a CR at 450 days. Table 3: Secondary Endpoint Performance Tertiary Endpoint Performance (Safety) The tertiary endpoint is defined as patients who have a Serious Adverse Event (“SAE“) ≥ 4 directly caused by the Study Drug or Study Device, which did not resolve within 450 days. Theralase® and the independent Data Safety Monitoring Board believes all SAEs reported to date are unrelated or unlikely related to the Study Drug or Study Device. The tertiary endpoint assesses the safety profile of the Study Procedure. Treatment Emergent Adverse Events (“TEAEs“) were noted, but did not meet the SAE criteria. TEAEs included urinary frequency (65%), hematuria (62.5%) and urinary urgency (53.8%), which resolved within 1 month of treatment. There have been 24 SAEs reported: 1 x Grade I, 3 x Grade II, 13 x Grade III, 5 x Grade IV (all resolved between 1 to 82 days) and 2 x Grade V (Unlikely Related to the Study Drug, Study Device or Study Procedure). A high majority of SAEs were not treatment related and none were directly related to the Study Drug or Study Device. Table 4: Tertiary Endpoint Performance Duration of CR – Extended Time Points Patients who have completed the study were followed for up to 3 years after initial treatment at extended time points. Table 5: Duration of CR at Extended Time Points One patient demonstrated CR for 7 years, after one Study Procedure. On Kaplan-Meier analysis, if CR is obtained, the long term estimated probability of remaining cancer free at 1, 2 and 3 years is 48.6%, 34.5% and 25.4%, respectively. Figure 1: Kaplan-Meier Curve To view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2786/299492_1988af03149dd9a6_003full.jpg Figure 2: Swimmer’s Plot To view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2786/299492_figure2.jpg Figure 3: Patient Population To view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2786/299492_1988af03149dd9a6_007full.jpg Regulatory Pathway, Commercialization Strategy and FDA Guidance If approved by Health Canada and the FDA, the clinical data collected from Study II represents a transformative therapeutic option for patients diagnosed with BCG-Unresponsive NMIBC CIS, who would otherwise face radical cystectomy (surgical removal of the bladder). The Theralase® procedure has demonstrated a robust CR and sustained durability of that response, with the majority of patients receiving only a single procedure. Following the completion of patient follow-up and final clinical data analysis, Theralase® intends to submit a New Drug Application (“NDA“) to Health Canada and the United States Food and Drug Administration (“FDA“) in 3Q2026, under a rolling review, with regulatory decisions anticipated in 1H2027. Cohort 2 Theralase®, in conjunction with Ferring Pharmaceutical, subject to FDA approval, is preparing to launch a combinational clinical study to investigate the safety and efficacy of combining light-activated Ruvidar® with Adstiladrin. It is anticipated that the complementary mechanisms of action (Ruvidar® targets bladder cancer cells directly, Adstiladrin® targets health bladder cells to produce Interferon to stimulate the innate and adaptive immune system) will provide a strong additive effect in the treatment of patients being treated for BCG-Unresponsive NMIBC CIS. In the procedure, patients will be treated with Ruvidar® (1 hour of drug instillation, approximately 1 hour of light activation), then at another visit, they will be treated with Adstiladrin® (1 hour procedure), both in outpatient procedures. Under the clinical protocol, the patient may receive up to 4 treatments of Adstiladrin®. The presiding uro-oncologist will have the option to deliver an additional re-induction Study Procedure, if the patient recurs. The patient will be followed for 15 months after initial Study Procedure and up to 3 years for post-study follow-up. Commercialization and Strategic Partnerships In parallel with the finalization of Study II, Theralase® is actively pursuing commercialization opportunities and strategic partnerships to support the global marketing and distribution of Ruvidar®. The Company is interested in engaging in discussions with pharmaceutical companies across multiple geographic regions regarding: Licensing arrangements for Ruvidar® in the treatment of BCG-Unresponsive NMIBC CIS in various geographic territories Collaborative clinical research initiatives focused on the application of light-activated Ruvidar® for broader NMIBC indications Collaborative clinical research combining Ruvidar®, with other FDA-approved drugs to enhance treatment efficacy About Study II:Study II utilizes the therapeutic dose of the patented drug, Ruvidar® (TLD-1433) activated by the patented study device, the TLC-3200 Medical Laser System. Study II has enrolled and treated 92 BCG-Unresponsive NMIBC CIS patients in 11 clinical study sites located in Canada and the United States. About Theralase® Technologies Inc.:Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses. Additional information is available at www.theralase.com and www.sedarplus.ca 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 StatementsThis 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 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; access to sufficient capital to fund the Company’s operations is available on terms that are commercially favorable to the Company or at all; the Company’s small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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)www.theralase.com Kristina Hachey, CPAChief Financial Officer X 224khachey@theralase.com To view the source version of this press release, please visit https://www.newsfilecorp.com/release/299492