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GH Research PLC (Nasdaq: GHRS) has launched an underwritten public offering in the United States of $150 million of ordinary shares. The company said in its offering document that it intends to use the net proceeds to strategically invest in research, clinical, and technical development of current and/or additional product candidates, working capital, capital expenditures, and general corporate purposes. The stock was falling over 8% on the news of the offering.

As of September 2024, GH Research had $193 million in cash but expects that by the end of December, the cash will likely be roughly $182 million. The company has an accumulated deficit of $97 million.

GH Research’s focus is on developing novel and proprietary mebufotenin therapies for the treatment of patients with treatment-resistant depression (TRD). Its portfolio currently includes GH001, a proprietary inhalable mebufotenin product candidate and GH002, its proprietary intravenous mebufotenin product candidate. Mebufotenin, also known as 5-MeO-NMT (5-Methoxy-N-Methyltryptamine), is a naturally occurring tryptamine alkaloid. It is structurally related to 5-MeO-DMT (5-Methoxy-Dimethyltryptamine) but differs in having only one methyl group on the amine rather than two.

GH001 delivers positive results

“While GH001 is currently delivered via a vaporization device produced by a third party, we are developing a proprietary aerosol delivery device, which is currently in clinical investigation,” read the company’s offering document. “We have completed two Phase 1 healthy volunteer clinical trials for GH001 (GH001-HV-101 and GH001-HV-103), in which administration of GH001 via inhalation was observed to be well tolerated at the investigated single dose levels and in an individualized dosing regimen (IDR), with intra-subject dose escalation within a single day. We have also completed a Phase 1/2 clinical trial in patients with TRD (GH001-TRD-102) and have recently completed the double-blind phase of a randomized, double-blind, placebo-controlled phase 2b trial in patients with TRD (GH001-TRD-201). Based on observed clinical activity in these clinical trials, we believe that administration of GH001 has the potential to induce ultra-rapid remissions as measured by the Montgomery–Åsberg Depression Rating Scale, or MADRS.”

The company reported this week that it met its primary endpoint as GH001 led to an ultra-rapid anti-depressant effect with a significant placebo-adjusted MADRS reduction from a baseline of -15.5 on Day 8 (p<0.0001).

“Patients treated with GH001 experienced a difference of -15.5 points in MADRS score at Day 8 compared to placebo, which is truly remarkable,” said Professor Michael E. Thase, MD, Professor of Psychiatry, Perelman School of Medicine, University of Pennsylvania. “Most TRD patients have not benefited from a number of established treatment options and this illness frequently imposes years of insurmountable mental suffering and disabling effects on social and vocational functioning. A novel treatment with such a large and rapid effect, particularly one that may require only infrequent, short 1-3 hours clinic visits, has the potential to be a practice changing treatment.”