Charbone Hydrogen secures warrant proceeds, extends expiry dates, and grants stock options

Charbone Hydrogen secures warrant proceeds, extends expiry dates, and grants stock options

Charbone Hydrogen Corporation (TSX-V:CH, OTCQB:CHHYF) announced $371,150 from warrant exercises expiring in late 2024 and early 2025.

The company is extending the expiry dates of 9.98M warrants to February 28, 2025, and lowering their exercise price from $0.20 to $0.125, with TSX approval.

Charbone also granted 1.75M stock options to team members, priced at $0.15, exercisable from December 2024.

Updates to its private placement include insider participation of 1.26M units by CFO Benoit Veilleux and Director Mena Beshay, with finders’ warrants exercisable at $0.05 for 12 months.

New Food and Drug Administration (FDA) guidance on accelerated approval for drugs targeting “serious conditions” appears to be a positive move for rare diseases, analysts at Jefferies believe.

The FDA earlier this month published the draft guidance on its policies and procedures for the accelerated approval (AA) pathway for drugs for serious conditions that fulfil an unmet medical need. 

The analysts wrote that it is notable that both the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have jointly published the guidance. 

They wrote,

Historically, the two divisions have been known to be less aligned,

The 2024 FDA guidance on AA builds on prior guidance from 2014 but places more emphasis on a few important changes, Jefferies highlighted.

The agency encourages early communication with sponsors, ideally as early as post-Phase 1, regarding the eligibility of drugs for AA. This signals a more collaborative approach from the FDA, the analysts believe.

For rare diseases, the FDA has introduced the Rare Disease Endpoint Advancement Pilot Program, allowing sponsors to propose surrogate or intermediate endpoints, which highlights the agency’s willingness to work closely with developers in these areas.

Additionally, the FDA is now more open to considering a broader range of evidence, such as preclinical animal models and epidemiological data, when evaluating drugs for AA.

However, the guidance also notes that AA is not suitable for every serious disease, especially if there is insufficient evidence to support a surrogate endpoint or if confirmatory trials are “infeasible.”

Furthermore, the FDA has the authority to withdraw AA status if post-marketing requirements are not fulfilled, such as failing to complete confirmatory trials or if the drug turns out to be unsafe or ineffective.

The analysts wrote,

The FDA serves as the gatekeeper for drug approvals, so a more amenable FDA means decreased regulatory risk, which then could mean valuation upside due to a higher probability of success,

“In our view, all indication areas theoretically stand to benefit, though we think the rare disease space seems like a prime beneficiary, and not just gene therapies for rare diseases either.”

They pointed to several notable rare disease programs, including Dyne Therapeutics and Sarepta Therapeutics Inc (NASDAQ:SRPT).

Dyne is pursuing accelerated approval pathways for treatments targeting Myotonic dystrophy type 1 and Duchenne Muscular Dystrophy (DMD), while Sarepta has already received accelerated approval for its gene therapy Elevidys for DMD and is looking to extend this approach to other diseases like Limb-Girdle Muscular Dystrophy.

Analysts wrote,

These programs are relatively early in development yet sponsors are actively discussing with the FDA already, corroborating the FDA’s statement that early interactions are important to discuss the potential eligibility of an AA, including the proposed surrogate/intermediate endpoints, study designs, and confirmatory trial plans,

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Charbone Hydrogen secures warrant proceeds, extends expiry dates, and grants stock options, source