Devonian Health Group Gets Health Canada Authorization for Radiodermatitis Trial

Devonian Health Group Gets Health Canada Authorization for Radiodermatitis Trial

Devonian Health Group’s last published cash balance was C$0.7 million, as of April 30. On Tuesday, Health Canada authorized the company to run a 150-patient, double-blind trial in women receiving radiotherapy for breast cancer. The US listing and public offering Devonian has pursued since July was once expected to start trading on August 21. It still has no date.

Devonian Receives Health Canada Authorization for a 150-Patient Trial

Devonian Health Group Inc. (TSXV: GSD) (OTCQB: DVHGF) announced on October 20 that Health Canada has authorized a 150-patient, randomized, double-blind, multicenter study of a new topical formulation containing Thykamine 0.1%. The target is radiodermatitis, the skin injury caused by radiation therapy, in adult women being treated for breast cancer. Double-blind means neither patients nor investigators know who is applying which cream. Thykamine is the lead product of Devonian’s botanical drug platform.

The condition is common. Citing a 2023 systematic review by the Multinational Association of Supportive Care in Cancer, the company’s release puts it at up to 95% of patients receiving external beam radiation, ranging from redness and itching to painful moist peeling and, in severe cases, ulceration. The same review counted 149 randomized trials of preventive or treatment approaches and found the evidence behind many of them limited and inconsistent.

Authorization lets the study proceed. It is not permission to market the formulation, a point Devonian makes itself.

How Devonian’s Thykamine 0.1% Study Is Designed

Patients will be randomized one-to-one to the Thykamine 0.1% formulation or to Glaxal Base cream as the comparator, applied three times a day during radiotherapy and for five weeks after it ends. Treatment runs roughly eight to nine weeks per patient, depending on the radiotherapy schedule.

The primary endpoint is time to Grade 2 or higher radiodermatitis, assessed on standardized clinical severity criteria. Secondary endpoints cover the incidence of Grade 2 or higher reactions, patient-reported pain, patient satisfaction and adverse events. Devonian describes the goal as preventing or delaying clinically significant skin reactions.

This specific formulation has no disclosed clinical data. Devonian says it differs from the formulation used in its earlier Phase II atopic dermatitis study and was designed for skin exposed to radiation. The rationale it offers rests on preclinical work, including lab experiments in skin models and dermal fibroblasts, which are cell and tissue studies rather than results in people. Efficacy and safety in this indication, the release states, remain to be established.

No phase number is assigned to the study in the release. There is also no date for the first patient, no site count and no readout timeline.

Devonian Weighs a Medical-Device Route for the Formulation

The other half of the announcement is regulatory. Devonian intends to explore a medical-device regulatory pathway for this formulation, while pursuing conventional drug development for other Thykamine programs, including atopic dermatitis.

The company’s argument is that a device route could shorten timelines and cut development costs, giving it a commercial foothold in supportive cancer care. That is Devonian’s framing, not a regulator’s. Its own forward-looking statements say there is no assurance the formulation will qualify for device classification at all, or that the pathway would save time or money if it did.

Devonian said it will evaluate the opportunity in Canada and in other major markets, naming the United States and Europe.

Devonian’s NYSE American Listing Still Has No Trading Date

Devonian first announced a proposed NYSE American listing with a concurrent US public offering on July 27, working with ThinkEquity. On August 18, it said its shares could begin trading under the symbol “DHGR” as early as August 21. That date passed without trading.

In an October 16 update, Devonian said it remains committed to the listing, while both the trading start date and the offering closing date are undetermined. The deal remains subject to market conditions and to approvals from NYSE American LLC and the TSXV, and the company stays listed on the TSXV in the meantime.

The trial authorization and the listing are separate matters. Tuesday’s news does not settle when, or whether, the US offering closes.

Devonian Reported C$0.7 Million in Cash at April 30

Devonian’s third-quarter results, published June 29, showed cash and cash equivalents of C$0.7 million at April 30, 2026, against C$7 million at July 31, 2025. Operating activities used C$8.4 million over those nine months, partly offset by C$2 million from two private placements and C$0.2 million from warrant exercises. The company reported no debt.

Much of the change traces to a business Devonian is leaving behind. The nine-month net loss of C$5.7 million included a C$6.5 million drop in gross margin, tied to Dexlansoprazole sales that appeared only in the prior-year period, after the related distribution agreement expired. The third-quarter loss alone was C$1.9 million.

Devonian’s draft US registration statement submitted to the SEC in May says its ability to continue as a going concern depends on raising capital and securing strategic alliances and licensing agreements. Going-concern language means a company’s ability to keep operating depends on outcomes not yet secured.

The fiscal year ended July 31, 2026. Audited annual figures that would update the April cash number had not been published as of this writing, and no updated cash runway was identified in the sources reviewed.

Devonian’s Trial Start and US Listing Dates Remain Undisclosed

Devonian has not disclosed a first-patient date for the 150-patient radiodermatitis study; its October 20 release lists clinical site activation and research ethics requirements among the next steps. The company’s October 16 update described both the NYSE American trading start date and the offering close as undetermined. Audited results for the fiscal year ended July 31, 2026 had not been released as of October 22.

Sources

Editorial Disclosure

This article is based entirely on publicly available information, including company press releases distributed by PR Newswire and Newswire.ca and a filing on SEC EDGAR. The security discussed is Devonian Health Group Inc. (TSXV: GSD) (OTCQB: DVHGF). The proposed NYSE American symbols “DHGR” (common shares) and “DHGR WS” (warrants) are not trading as of publication. aktiego.com has not received any compensation from Devonian Health Group, its management, investor relations representatives, or any third party. No staff member or principal of aktiego.com holds a position in this security at the time of publication.

Thykamine 0.1% is an investigational formulation and has not been approved by Health Canada, the FDA, or any other regulatory authority for any indication. Health Canada’s authorization permits the study to be conducted; per the company’s own disclosure, it does not authorize marketing or commercialization. The study has not enrolled a disclosed first patient, and the release assigns it no phase number, site count, or readout date.

The scientific rationale cited for this formulation is preclinical, including in vitro work in skin models and dermal fibroblasts. No clinical data for this formulation in radiodermatitis has been disclosed, and the company states that efficacy and safety in this indication remain to be established.

The potential medical-device regulatory pathway is Devonian’s own stated intention and framing, not a confirmed regulatory classification. The company discloses that there is no assurance the formulation will qualify as a medical device or that such a pathway would shorten timelines or reduce costs.

The proposed NYSE American listing and concurrent US public offering have no determined trading or closing date, remain subject to market conditions and to NYSE American LLC and TSXV approvals, and may not be completed. If completed, the offering would involve the issuance of new common shares and warrants, which would be dilutive to existing shareholders. The October 20 trial authorization is separate from, and does not resolve, the status of that offering.

Devonian reported cash and cash equivalents of C$0.7 million as of April 30, 2026, the most recent figure published; audited results for the fiscal year ended July 31, 2026 had not been released as of publication, and no updated cash runway was identified in the sources reviewed. The company’s May 29, 2026 draft registration statement filed with the SEC states that its ability to continue as a going concern depends on raising capital and securing strategic alliances and licensing agreements. Devonian completed two private placements in the nine months ended April 30, 2026. Neither the TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of Devonian’s press releases, per the company’s own standard disclosure.

Small cap and micro-cap stocks listed on the CSE, TSX, TSXV, and Nasdaq are speculative investments carrying significant risk including potential total loss of capital. Coverage on aktiego.com is provided for informational and educational purposes only. aktiego.com is not a registered investment advisor. Nothing in this article constitutes financial, investment, or professional advice. Readers are encouraged to conduct their own due diligence and consult a qualified financial advisor before making any investment decisions. For more information please see our full DISCLAIMER.

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