Grace Therapeutics agrees to private placement, expects about $13.8 million net proceeds

Grace Therapeutics, Inc. (Nasdaq: GRCE) agreed on February 10, 2025 to sell common stock, pre-funded warrants and common warrants to institutional and accredited investors in a private placement. The company expects net proceeds of about $13.8 million after fees and expenses, and it expects to close on February 11, 2025, subject to customary conditions. The terms are in a Form 8-K filed the same day.

The terms and the dilution

Under two securities purchase agreements, one involving a placement agent and one not, Grace agreed to sell 3,252,132 shares of common stock at $3.395 each. It also agreed to sell pre-funded warrants for up to 1,166,160 shares, priced at the share price less $0.0001, each exercisable at $0.0001 and immediately exercisable.

Each share and each pre-funded warrant comes with a common warrant. The common warrants cover an aggregate of 4,418,292 shares, or pre-funded warrants in their place. Each has an exercise price of $3.395 per share, or $3.3949 per pre-funded warrant. The company sells the common warrants at $0.125 each, a price included in the offering price. They are immediately exercisable and expire on the earlier of the 60th day after the FDA approves the New Drug Application for GTx-104 and September 25, 2028.

Holders can choose a limit of 4.99% or 9.99% of outstanding common stock on exercise. They can raise or lower that limit, up to 19.99%, on 61 days' notice. The securities are sold without registration under Section 4(a)(2) of the Securities Act and Rule 506.

For a period after closing, the company may not, with some exceptions, issue new common stock or equivalents, effect a reverse stock split or file a new registration statement. That restriction runs until the later of 90 days after closing and 30 days after the resale registration statement becomes effective.

Who is involved

TD Securities (USA) LLC acted as placement agent and receives customary placement fees on sales to some of the investors. The 8-K does not name any other placement agent, underwriter or financial adviser, and it does not name legal counsel to Grace or to the investors.

Grace signed a registration rights agreement to register the shares and warrant shares for resale. It must use reasonable best efforts to have the registration statement declared effective as promptly as possible. Missing the filing and effectiveness deadlines may subject the company to damages.

The trial, reported the same day

In the same 8-K, the company reported topline results from its Phase 3 STRIVE-ON safety trial of GTx-104, an injectable nimodipine for intravenous infusion in aneurysmal subarachnoid hemorrhage. The company says the trial met its primary endpoint and provided evidence of clinical benefit compared with orally administered nimodipine. The press release describes the trial as pivotal.

The trial was randomized but open-label, with 50 patients on GTx-104 and 52 on oral nimodipine. The primary endpoint was the number of patients with at least one episode of clinically significant hypotension reasonably considered to be caused by the drug. The release reports that in 28% of GTx-104 patients and 35% of those on oral nimodipine, which it calls a 19% reduction, and it gives no p-value. Chief Medical Officer Dr. Loch MacDonald said the trial was "not designed or powered to demonstrate efficacy." That is the company's own limit on the benefit claim. The company said it intends to submit its NDA in the first half of 2025.

The company and what comes next

Grace, formerly Acasti Pharma Inc., describes itself as a late-stage biopharmaceutical company with candidates for rare and orphan diseases. GTx-104 is the lead candidate. Chief Executive Officer Prashant Kohli signed the 8-K.

The company's next step is the NDA. It needs that filing, and FDA review after it, before GTx-104 can be sold, and the warrants' expiry depends on FDA approval. Until then, the placement's $13.8 million in net proceeds is the cash the company says it is raising. The 8-K does not give the company's cash balance, so the proceeds cannot be set against the cash it already holds.

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