Triple Hair Expands Global Phase III Program for TH07 with Launch of 500-Patient Trial in India

• Phase III trial in India expected to enroll 500 male patients with androgenic alopecia
• Study forms part of Triple Hair’s coordinated international Phase III program for TH07
• Harmonized clinical design supports development of a robust global data package and enhances strategic relevance across major commercial markets

MONTRÉAL — Triple Hair Group Inc. (“Triple Hair” or the “Company”), a company specializing in the development of innovative treatments for androgenic alopecia (pattern baldness), today announced the initiation of its Phase III clinical trial in India evaluating TH07, the Company’s patented prescription topical treatment for male pattern hair loss.

The India Phase III study is expected to enroll 500 male patients and represents a significant step in Triple Hair’s broader coordinated international development program for TH07. Following the recent dosing of the first patient in Canada, the launch of this trial further underscores Triple Hair’s disciplined global strategy. Designed within a harmonized clinical framework, the study is intended to contribute to a robust and comparable global data package, strengthening the positioning of TH07 across major commercial markets. Together with the ongoing Canadian Phase III trial, Triple Hair’s international late-stage program is expected to evaluate TH07 in approximately 920 male patients.

“Advancing TH07 into Phase III in India marks an important milestone in our global development strategy,” said Jean-Philippe Gravel, CEO of Triple Hair. “We are executing a disciplined international clinical program designed to generate meaningful safety and efficacy data, support future regulatory and partnering discussions, and position TH07 as a globally relevant late-stage asset in androgenic alopecia.”

Triple Hair is working with experienced clinical partners and investigators in both Canada and India to support efficient execution of its Phase III program.

Mr. Sanjeev Jain, MD, Akums Drugs & Pharmaceuticals Ltd., added: “We are proud to partner with Triple Hair in advancing TH07 into Phase III in India. This collaboration reflects a shared commitment to innovation, scientific rigor, and delivering high-quality, reliable healthcare solutions. At Akums, our focus remains on enabling partners with world-class manufacturing and support while ensuring the highest standards of quality, safety, and compliance. We are committed to contributing meaningfully to this program, strengthening our partnership with Triple Hair and supporting its continued progress through collaborative excellence.”

TH07 is Triple Hair’s patented topical formulation being developed for the treatment of male androgenic alopecia, a condition affecting hundreds of millions of men worldwide. Through its harmonized international Phase III strategy, the Company aims to generate a clinical data package of meaningful scale and quality to support future discussions with global strategic partners, investors and other stakeholders.

The Company believes that expanding Phase III development into India enhances the breadth, comparability and overall strategic value of its program. By combining international scale with a harmonized development framework, Triple Hair is advancing TH07 as a differentiated late-stage asset with potential relevance across multiple markets.

“Our focus is on disciplined execution and long-term value creation,” added Gravel. “We believe that scale, harmonization and international clinical breadth are critical to building a development program that resonates with strategic partners and supports future commercialization opportunities.”

About TH07
TH07 is a patented prescription triple-combination topical therapy that combines minoxidil, finasteride and latanoprost, three pharmacologically active agents that target distinct biological pathways involved in androgenic alopecia.

The therapy is designed to address multiple mechanisms associated with hair loss by:

• stimulating hair follicle activity,
• reducing androgen-mediated follicle miniaturization, and
• supporting prolonged hair growth cycles.

By integrating these complementary mechanisms in a single topical formulation, TH07 is designed to simultaneously target several key drivers of hair loss.

TH07 has previously demonstrated encouraging results in earlier clinical studies, where 82% of participants experienced positive outcomes ranging from moderate to dense hair regrowth, supporting its continued development in Phase III evaluation.

About Akums Drugs & Pharmaceuticals Ltd.
Akums Drugs & Pharmaceuticals Ltd. is India’s largest Contract Development and Manufacturing Organization (CDMO), delivering end-to-end pharmaceutical development and manufacturing solutions across a wide spectrum of dosage forms and therapeutic areas. Backed by 4,000+ commercialized formulations, a workforce of over 17,000 professionals, and state-of-the-art manufacturing facilities, the Company offers integrated services spanning formulation development, large-scale manufacturing, and regulatory support.

Akums partners with leading pharmaceutical and healthcare companies across India and 60+ international markets, ensuring consistent quality, scalability, and compliance with global standards. With a strong focus on innovation, quality, and regulatory excellence, Akums continues to strengthen its global footprint across pharmaceuticals, APIs, nutraceuticals, and dermatology products.

About Triple Hair
Triple Hair Group Inc. is a Canadian biotechnology company focused on the development of innovative therapies for androgenic alopecia, a condition affecting hundreds of millions of men and women worldwide.

The global hair-loss treatment market was valued at approximately US$8.8 billion in 2023 and is projected to reach over US$16 billion by 2030, reflecting the significant demand for safe and effective treatment options.

Triple Hair’s lead product candidate, TH07, is a patented prescription topical therapy currently in Phase III clinical development.

For more information, visit the Company’s website, at www.triplehair.ca/investors.

Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, statements regarding the initiation, timing, conduct, enrollment, execution, completion and results of clinical trials, the therapeutic potential of TH07, the market opportunity for TH07, the strategic relevance of the Company’s development program, future regulatory pathways, partnering opportunities, financing activities, and potential commercialization. Forward-looking statements are based on management’s current expectations and assumptions and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to clinical trial initiation, site activation, patient recruitment, dosing, regulatory interactions, data outcomes, safety observations, market conditions, financing needs, and the Company’s ability to execute its business strategy. Readers are cautioned not to place undue reliance on these forward-looking statements. Triple Hair undertakes no obligation to update any forward-looking statements except as required by applicable law.

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Contacts

Triple Hair Group
Jean-Philippe Gravel
President and CEO
[email protected]

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