
CEO: "2023 is the most important year in Seelos' history thus far."
CEO: "2023 is the most important year in Seelos' history thus far."
Filament is actively pursuing partnerships for development and testing of its compounds.
The company will focus on psychedelics.
The company's net loss ticked down after March labor cuts.
Psychedelic drug company Compass Pathways plc (Nasdaq: CMPS) reported its financial results for the first quarter of 2023 and gave an update on recent progress across its business. Compass Pathways has no revenue at this time to report. It had a net loss of $24.2 million, or $0.57 loss per share (including non-cash share-based compensation expense of $4.1 million), compared with $21.2 million or $0.50 loss per share, during the same period in 2022.
Kabir Nath, Chief Executive Officer, said, “Our phase 3 pivotal trials in treatment-resistant depression are now underway and on track, with treatment being administered to patients across numerous sites. This is significant progress, indicating that with the necessary approvals and licenses in place, these sites can now focus completely on training and recruitment. We have also made important progress in laying the commercial groundwork for COMP360, with the recent acceptance by the American Medical Association of a CPT III code to describe the support services required in its administration. It has been a quarter of steady, strong progress, including productive, ongoing dialogue about the design of our pivotal trials with FDA.”
The company said it ints quarterly filing,
We believe that our existing cash and cash equivalents, together with the net proceeds from sales of the Company’s ADSs through May 10, 2023, will be sufficient for us to fund our operating expenses and capital expenditure requirements for at least the next twelve months.
The company had cash and cash equivalents of $117.1 million at the end of the quarter versus $143.2 at the end of 2022. Second quarter 2023 net cash used in operating activities is expected to be in the range of $22 million to $30 million and the full-year 2023 to be in the range of $85 million to $110 million. An additional $26.9 million in net cash was raised through the ATM facility to date in the second quarter.
The company said in its earnings statement, “We will need substantial additional funding to complete the development and commercialization of our Phase 3 clinical program, and our Phase 2 studies in anorexia nervosa and PTSD. Further, changing circumstances, some of which may be beyond our control, such as heightened or fluctuating inflation and interest rates, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurance that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all.” The future viability of the company is dependent on its ability to raise additional capital to finance its operations.
Compass said it has incurred total net losses of $24.2 million and $21.2 million for the three months ended March 31, 2023 and 2022, respectively. As of March 31, 2023, it had an accumulated deficit of $285.4 million.
Compass reported R&D expenses were $19.0 million versus $15.4 million during the same period in 2022. The company said the increase was due to $1.4 million in external development expenses as the company continues to investigate COMP360 psilocybin therapy in clinical and pre-clinical trials. $1.2 million due to an increase in personnel expenses, due to increased headcount. A further $0.6 million was attributable to an increase in other expenses primarily related to an increase in external consulting expenses. In addition, non-cash share-based payment compensation increased by $0.5 million, due primarily to increased headcount.
G&A expenses were $12.8 million versus $10.1 million during the same period in 2022. The increase was attributable to an increase of $2.2 million in personnel expenses, due to increased headcount. $0.9 million relates to an increase in facilities and other expenses. A further $0.5 million was attributable to an increase in non-cash share-based compensation, due primarily to increased headcount. This was partially offset by a decrease of $0.9 million in legal and professional fees.
Compass gave investors an update on its drug pipeline for COMP360 psilocybin therapy in treatment-resistant depression (TRD). The Phase 3 program underway, composed of two pivotal trials with an integrated, long-term outcomes component:
Psychedelic biotech company GH Research PLC (Nasdaq: GHRS) reported financial results for the first quarter that ended March 31, 2023. The company has no revenue at this time but did state that it has cash, and cash equivalents of $246.1 million down from $251.7 million at the end of 2022. The company said, “We believe that our existing cash, cash equivalents, other financial assets, and marketable securities will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2026.”
R&D expenses were $7.3 million for the quarter versus $4.7 million for the same quarter in 2022. The increase was primarily due to increased activities relating to our technical development and clinical trials and increases in employee expenses to support these activities. G&A expenses were $3.1 million for the quarter versus $3.3 million for the same quarter in 2022. The decrease was primarily due to lower insurance costs offset by an increase in professional costs, as well as increased employee expenses.
The company noted that its inhalable mebufotenin (5-MeO-DMT) product candidate GH001 is currently being investigated in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). “We expect to recruit approximately 80 patients for this trial across several European countries. The primary objective is to determine the efficacy of our single-day individualized dosing regimen (IDR) of GH001 compared with placebo in improving depressive symptoms as assessed by the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) at the end of the 7-day double-blind phase,” said the company’s statement.
The company said that its randomized, double-blind, placebo-controlled, dose-ranging clinical pharmacology trial of GH002, the mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach, in healthy volunteers (GH002-HV-105) is expected to be completed in the fourth quarter of 2023.
GH Research went on to say, “We have recently filed 19 new international patent applications, which claim priority to earlier filings, further expanding our patent portfolio, which relates to various aspects of mebufotenin (5-MeO-DMT) use in a therapeutic context, including but not limited to the use of mebufotenin (5-MeO-DMT) for treatment of various disorders when administered by inhalation, or by nasal, buccal, sublingual, intravenous, intramuscular or subcutaneous routes.”
In preclinical models, Lucid-MS has been shown to prevent a hallmark pathology feature of MS.
Parties exchanged legal barbs over religious freedom and the Controlled Substances Act.
Both parties accused each other of not understanding FDA processes.
The company asked its shareholders to reject a slate of directors offered up by FCM MM Holdings.
Unpack the industry with the daily cannabis newsletter for business leaders.
Unpack the industry with the daily cannabis newsletter for business leaders.