Grace Therapeutics raised $10M in a private placement, selling 4.76M shares at $2.10. Proceeds extend cash runway to 2028 and fund dual-source manufacturing for GTx-104 NDA resubmission.
Alpha Score of 49 reflects weak overall profile with strong momentum, poor value, moderate quality. Based on 3 of 4 signals – score is capped at 90 until remaining data ingests.
Grace Therapeutics priced a $10 million private placement on Tuesday, selling 4.76 million shares at $2.10 each to new and existing institutional investors. The biopharma company expects the financing to close on Aug. 6 and said the proceeds, combined with existing cash, extend its cash runway to the end of 2028.
The company plans to use the net proceeds to support manufacturing and regulatory work for GTx-104, its injectable nimodipine formulation for aneurysmal subarachnoid hemorrhage. The FDA issued a Complete Response Letter earlier this year, flagging chemistry and manufacturing controls issues at the current contract manufacturer along with several non-clinical items.
Grace Therapeutics is pursuing a dual-source manufacturing strategy. A technology transfer to a second, U.S.-based contract manufacturer is underway. The timing of the New Drug Application resubmission will depend on which facility reaches readiness first: the U.S. site, which requires a full CMC package supported by 12 months of stability data, or the current manufacturer, if it successfully remediates its FDA compliance issues sooner.
The company said it is also working to address the remaining CMC and non-clinical items from the CRL. Manufacturing readiness, rather than those items, is expected to be the primary driver of the resubmission schedule, the company said. The FDA has said it will not approve the NDA while the current facility remains in an unacceptable compliance status.
GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower pharmacokinetic variability compared to oral nimodipine capsules, according to the company. The FDA granted Orphan Drug Designation, which provides seven years of marketing exclusivity post-launch if certain conditions are met at NDA approval.
Craig-Hallum acted as sole placement agent for the private placement. The shares were priced at-the-market under Nasdaq rules and have not been registered under the Securities Act. The company agreed to file a registration statement with the SEC registering the resale of the shares.
Drafted by a large language model from the source reporting linked above, then screened by automated publishing checks. It is not read by a journalist before publication. Some articles cite our Alpha Score. Verify prices and figures against the original source. Educational coverage, not personalized advice.