Company Highlights Significant Regulatory, Clinical and Strategic Progress Across SkinJect® and Teverelix® Programs and a Strengthened Financial Position Supporting Continued Pipeline Execution and Expansion

PHILADELPHIA, PA / ACCESS Newswire / August 12, 2026 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, today reported financial results for the three and six months ended June 30, 2026, and provided a corporate update highlighting significant regulatory, clinical and strategic achievements across its development portfolio.

During the second quarter of 2026, Medicus continued to advance its transition into a diversified clinical-stage biotechnology company with meaningful progress and significant strengthening of its financial position to support execution across its growing pipeline.

During and subsequent to the quarter, the Company achieved several important regulatory milestones, including FDA "Study May Proceed" authorization for the registrational SkinJect® program in Gorlin Syndrome and Institutional Review Board (IRB) authorization and positive FDA feedback for optimized Teverelix® Phase 2 study in acute urinary retention. The company also received authorization from UAE Department of Health (DOH) to initiate genomics-enabled PRECISION-E2 study evaluating Teverelix® in women with symptomatic endometriosis.

We believe that these achievements further position Medicus as a diversified clinical-stage biotech/life sciences company with two differentiated therapeutic platforms, multiple anticipated clinical and regulatory catalysts, and a disciplined strategy focused on advancing innovative therapies towards late-stage development and commercialization.

Management Commentary

"The second quarter of 2026 marked a defining period for Medicus as we successfully advanced both of our lead therapeutic platforms into their next stages of clinical and regulatory development, while strengthening our balance sheet and financial flexibility," stated Dr. Raza Bokhari, Medicus Executive Chairman and CEO. "We believe Medicus is well positioned with two differentiated programs advancing towards late-stage development, each addressing significant commercial opportunities through distinct regulatory pathways and multiple anticipated value-creating milestones. We remain focused on disciplined execution, regulatory excellence and strategic growth as we continue building long-term shareholder value."

Financial Highlights (Q2 2026)

During the second quarter of 2026, the Company significantly strengthened its financial position through multiple financing initiatives, including utilization of its expanded At-the-Market ("ATM") equity program and completion of a new secured financing facility. Year to date, the Company has raised ~$40 million in equity and/or debt financing.

These initiatives enhanced the Company's liquidity and financial flexibility to support continued advancement of its expanding clinical development programs. Nonetheless, substantial doubt exists regarding the Company's ability to continue as a going concern without additional financing.

As disclosed in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, financial results include:

Cash, cash equivalents and restricted cash: $25.2 million as of June 30, 2026.
Cash and cash equivalents: $15.2 million as of June 30, 2026 (vs. $9.7 million as of June 30, 2025).
Operating expenses (loss from operations): $11.5 million (vs. $6.0 million in Q2 2025).
General and administrative expenses: $6.6 million (vs. $4.6 million in Q2 2025).
Research and development expenses: $4.9 million (vs. $1.4 million in Q2 2025).
Net loss: $11.7 million (vs. $6.2 million in Q2 2025).
Net loss per share: $0.21 (vs. $0.43 in Q2 2025).

The Company's complete unaudited financial statements and results of operations for the quarter ended June 30, 2026, are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 12, 2026.

Second Quarter 2026 Operational Highlights

During the second quarter of 2026 and subsequent to quarter end, Medicus achieved significant regulatory, clinical and strategic milestones across both of its lead therapeutic platforms while strengthening its financial position and advancing long-term corporate objectives.

SkinJect® Platform (Dermatologic Oncology / Rare Disease)

During and subsequent to the quarter, the Company:

Reported additional pre-specified analyses from the completed Phase 2 SKNJCT-003 study demonstrating positive dose response and clinically meaningful clinical and histological clearance rates of 64% and 55%, respectively, with the 200 µg SkinJect® dose.
Received FDA "Study May Proceed" authorization permitting initiation of the Company's registrational SKNJCT-005 study to evaluate use of SkinJect® for patients with Gorlin Syndrome.
Strengthened the Company's Gorlin Syndrome development program through continued collaboration with the Gorlin Syndrome Alliance and clinical investigators.
Advanced regulatory initiatives supporting the Company's rare disease development strategy.

Collectively, these achievements position SkinJect® to advance the Company's FDA 505(b)(2) regulatory strategy supporting future registration of SkinJect®.

Teverelix® Platform (Urology, Oncology and Women's Health):

During and subsequent to the quarter, the Company:

Received Institutional Review Board (IRB) authorization and positive FDA feedback for its optimized Phase 2 study evaluating Teverelix® to prevent relapse of acute urinary retention.
Received UAE Department of Health (DOH) authorization to initiate PRECISION-E2 genomics-enabled Phase 2 study evaluating Teverelix® in women with symptomatic endometriosis.
Appointed Dr. Faisal Mehmud, Chief Executive Officer of Antev Limited, a subsidiary of the Company, in addition to his role as the Chief Medical Officer of the Company to further align the scientific, clinical and operational leadership.

These milestones further expand the clinical development strategy for Teverelix® across multiple therapeutic indications and reinforce the Company's commitment to precision medicine and disciplined clinical execution.

Corporate Development and Strategic Initiatives:

During and subsequent to the quarter, Medicus also advanced initiatives, aimed at fostering long-term growth and shareholder value. The Company evaluated strategic acquisition, licensing and partnering opportunities aligned with the Company's multi-asset biotechnology strategy.

Anticipated Clinical, Regulatory and Strategic Milestones:

The Company expects the coming quarters to be marked by continued execution across both therapeutic platforms, with multiple anticipated clinical and regulatory milestones and strategic partnering discussions across both core programs, especially SkinJect®. The Company expects potential expansion of strategic collaborations and licensing discussions as well as continued execution of financing strategies supporting advancement of the Company's expanding clinical pipeline.

For further information contact:

Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.com

About Medicus Pharma Ltd.

Medicus Pharma Ltd. (NASDAQ:MDCX) is a precision-guided biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutic assets. The Company is actively engaged in multiple countries across three continents.

The Company's current key therapeutic assets are:

SkinJect®, a novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) and Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome.

Teverelix®, a next-generation GnRH antagonist, is a product under clinical development for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, and endometriosis.

Medicus' strategy is to advance select programs through Phase 2 proof-of-concept, key clinical and regulatory inflection points that substantially reduce development risk and increase attractiveness to potential pharmaceutical partners. By generating decision-grade clinical, regulatory and operational datasets, the Company seeks to create opportunities for strategic collaborations, regional licensing transactions and broader commercialization partnerships with established pharmaceutical companies. As data matures across its programs, Medicus intends to continue building differentiated development packages designed to maximize asset value while maintaining capital efficiency and development focus.

Cautionary Notice on Forward-Looking Statements

Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the development of SkinJect® and the potential benefits thereof for those suffering with Gorlin Syndrome, Antev's future, the development of Teverelix® and expectations concerning, future outcomes relating to, the development, advancement and commercialization of Teverelix® for AURr, cardiovascular high-risk advanced prostate cancer, women's health indications like endometriosis, and the potential market opportunities related thereto and the Company's potential expansion of strategic collaborations, licensing discussions and financing strategies to advance its clinical pipeline. Forward-looking statements are often but not always, identified by the use of such terms as "may", "on track", "aim", "might", "will", "will likely result", "could," "designed," "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target", "potential" or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's annual report on form 10-K for the year ended December 31, 2025, and in the Company's other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

SOURCE: Medicus Pharma Ltd.

View the original press release on ACCESS Newswire