Opinion paper calls for clarity on the definition of "psychedelic-assisted therapy" using psilocybin

Leading psychiatrists and researchers examine common assumptions about the term "psychedelic-assisted psychotherapy" and the role of psychotherapy when evaluating psilocybin treatment.
Authors highlight the need for clarity in terminology and definition to accurately assess the efficacy and safety of psilocybin treatment.

COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the publication of a paper in the American Journal of Psychiatry that examines the definition of "psychedelic-assisted psychotherapy" using psilocybin and offers a new way of thinking about and describing this potential new treatment in psychiatry. The article is authored by leading psychiatrists and researchers, including COMPASS's Chief Medical Officer, Dr. Guy Goodwin, and Co-founder and COMPASS board member, Dr. Ekaterina Malievskaia.

Psychedelic drugs, such as psilocybin, can produce a powerful experience for patients, and are being studied to understand their potential in several mental health conditions, including treatment-resistant depression. This potential new treatment is often referred to as "psychedelic-assisted psychotherapy" or "psychedelic-assisted therapy." The authors of the paper examine the definitions as they relate to psilocybin treatment and offer these primary conclusions:

Psychological support is an essential element of psilocybin treatment but is not an independent psychotherapy as commonly understood . Psychological support is provided to patients to help them prepare for their experience and to safeguard them throughout the treatment. The intense psychedelic states associated with psilocybin are largely incompatible with simultaneous evidence-based psychotherapy. A therapist is present during the administration of psilocybin treatment to provide non-directive support, not to interpret the experience. This has been the case in virtually all the formal historical clinical trials of psilocybin.
More research is needed to understand how to optimize psilocybin treatment. The first steps have been taken to create a safe and effective framework for psilocybin treatment to advance through the regulatory process. If psilocybin treatment is approved by regulatory authorities, this baseline standard of care could be built upon by researchers interested in exploring further therapeutic developments.
Clarity on terminology is needed to better define psilocybin treatment. For patients to access a new treatment, it must first be approved by regulatory bodies such as the US Food and Drug Administration and the European Medicines Agency. Regulators evaluate and approve investigational medicinal products based on safety, quality and efficacy. They have not historically evaluated or regulated psychotherapy. To achieve regulatory approval, the drug effect needs to be established unambiguously in clinical trials, which is only possible if any psychological support is not an alternative treatment in itself and is applied in a consistent way. As such, there is a need for clarity on how this type of treatment is characterized. In this case of psilocybin administration with psychological support, the authors suggest using the term "psilocybin treatment."

Dr. Goodwin said, "The evidence we have seen from the most rigorous studies of psilocybin treatment to date, suggests that the efficacy of the treatment comes primarily from the drug itself, while psychological support is essential for safeguarding patients. This clarity is important in the assessment of efficacy and safety of psilocybin, alongside standardized psychological support. Our ongoing phase 3 program of COMP360 psilocybin treatment for treatment-resistant depression aims to generate additional evidence in the context of this efficacy and safety assessment."

About COMPASS Pathways
COMPASS Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

We have commenced a phase 3 clinical program of COMP 360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p

COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. www.compasspathways.com .

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website ( www.compasspathways.com ), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "aim", "may", "will", "could", "should", "expect", "intend", "believe", "predict", "possible", "potential", "suggest", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of its investigational COMP360 psilocybin treatment, including for treatment of TRD and other mental health conditions, COMPASS's expectations regarding its ongoing preclinical work and clinical trials and development efforts, the potential for COMPASS's pivotal phase 3 program or other trials to support regulatory filings and approvals and COMPASS's expectations regarding the benefits of its COMP360 psilocybin treatment. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: clinical development is lengthy and outcomes are uncertain, and therefore our clinical trials may be delayed or terminated; the possibility of unfavorable results from additional clinical trials of COMP360 psilocybin treatment or from subsequent analysis of existing data or new data received from additional ongoing and future studies of COMP360 psilocybin treatment; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any of future product candidates may be unsuccessful and those risks and uncertainties described under the heading "Risk Factors" in COMPASS's most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov . Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS's current expectations and speak only as of the date hereof.

Enquiries

Media: Amy Lawrence, media@compasspathways.com, +44 7813 777 919

Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

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Seelos Therapeutics Announces 1-for-8 Reverse Stock Split

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its Board of Directors approved a 1-for-8 reverse stock split of its outstanding shares of common stock, to be effective as of 12:01 a.m. Eastern Time on Thursday May 16, 2024.

The Company's common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on Thursday, May 16, 2024 . Following the reverse stock split, the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "SEEL" with the new CUSIP number, 81577F307. The reverse stock split is intended for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market.

At the effective time of the reverse split, every 8 issued and outstanding shares of the Company's common stock will be converted automatically into one share of the Company's common stock without any change in the par value per share. No fractional shares will be issued in connection with the reverse stock split, and fractional shares resulting from the reverse stock split will be rounded up to the nearest whole share. The reverse stock split will reduce the number of authorized shares of the Company's common stock from 400,000,000 shares to 50,000,000 shares and the ownership percentage of each stockholder will remain unchanged other than as a result of fractional shares. In addition, the reverse stock split will apply to the Company's common stock issuable upon the exercise of the Company's outstanding warrants and stock options, with proportionate adjustments to be made to the exercise prices thereof and under the Company's equity incentive plans, as applicable.

The reverse stock split will reduce the number of issued and outstanding shares of the Company's common stock from approximately 17.4 million to approximately 2.2 million.

About Seelos Therapeutics:

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

Forward-Looking Statements:

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the reverse stock split and the timing thereof, the potential impact of the reverse split on the bid price of the Company's common stock, the potential for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market and the expected number of shares of common stock to be outstanding following the reverse stock split. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties involved include those associated with general economic and market conditions, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information

Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 ^nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

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SOURCE Seelos Therapeutics, Inc.

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Compass Pathways Announces First Quarter 2024 Financial Results and Business Highlights

COMP360 phase 3 pivotal program in treatment-resistant depression (TRD) on track for top-line COMP005 trial data in fourth quarter 2024, COMP006 trial top-line data expected mid-2025
Compass announces positive phase 2 COMP360 data in post-traumatic stress disorder (PTSD)
Michael Gold to join Compass as Head of R&D
Compass enters into additional commercial collaborations, including with Reliant Medical Group, part of Optum Care
Cash position of $262.9 million at March 31, 2024
Conference call May 8 at 8:00 am ET (1:00 pm UK)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2024 and provided an update on recent business progress.

Kabir Nath, Chief Executive Officer, said, "We were pleased to see the positive results from the phase 2 PTSD study, a condition with significant unmet need and limited therapeutic options for the people who live with it. PTSD is a logical extension for COMP360 psilocybin treatment as there is significant overlap in patients living with treatment-resistant depression and PTSD. These strong data enable us to explore the optimal path forward to advance clinical development in PTSD alongside our phase 3 pivotal program in TRD, which is on track for initial data this year. We also continue to prepare for commercialization of COMP360 in TRD if approved by the FDA and have established collaborations with important mental health providers in the US to investigate models for the delivery of COMP360 psilocybin treatment at scale in diverse care settings."

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Compass Pathways announces durable improvement in symptoms through 12 weeks in open-label phase 2 study of COMP360 psilocybin in post-traumatic stress disorder

Study met primary safety endpoint; administration was well tolerated, with no serious adverse events observed
Early and clinically meaningful improvement from baseline in mean CAPS-5 total score (29.5 point reduction at week 12), with change from baseline in mean SDS total score (14.4 point reduction at week 12)
81.8% response (reduction of ≥ 15 points in CAPS-5 score), 63.6% remission (total CAPS-5 ≤ 20) rates at week 4 with 77.3% response and 54.5% remission at week 12
Measures of symptom scores relative to baseline improved following a single 25mg dose administered with psychological support (n=22)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today announced top-line results from an open-label phase 2 study evaluating the safety and tolerability of investigational COMP360 psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD). The study met its primary safety endpoint and available secondary efficacy endpoints. Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life. Administration of COMP360 was well-tolerated, with a safety profile consistent with previous studies.

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Compass Pathways establishes research collaboration with Mindful Health Solutions to inform the development of a scalable and cost-effective delivery model for investigational COMP360 psilocybin treatment

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Mindful Health Solutions (MHS), one of the US's leading providers of innovative behavioral health care, today announced that they have entered into a research collaboration agreement to inform the development of a scalable and cost-effective delivery model for COMP360 psilocybin treatment, if approved for treatment-resistant depression (TRD). This is the latest of several collaborations for Compass, intended to better understand a range of potential approaches to deliver COMP360 to patients in different care settings.

MHS offers comprehensive mental health care services for patients living with TRD and other mental health conditions. They focus on early adoption of advanced, interventional treatment options, as part of a long-term, holistic care model that includes medication management and psychotherapy. MHS operates over 20 outpatient clinics located across California, Washington, Texas, and Georgia.

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	March 31,		December 31,
	2024		2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	262,888	$	220,198
Restricted cash	389		440
Prepaid income tax	1,123		1,123
Prepaid expenses and other current assets	31,115		39,535
Total current assets	295,515		261,296
NON-CURRENT ASSETS:
Operating lease right-of-use assets	3,722		4,306
Deferred tax assets	3,659		3,336
Long-term prepaid expenses and other assets	6,097		7,049
Total assets	$	308,993	$	275,987
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable	$	9,342	$	5,892
Accrued expenses and other liabilities	7,680		11,301
Operating lease liabilities - current	2,380		2,411
Total current liabilities	19,402		19,604
NON-CURRENT LIABILITIES
Long-term debt	29,090		28,757
Operating lease liabilities - non-current	1,339		1,882
Total liabilities	49,831		50,243
SHAREHOLDERS' EQUITY:
Ordinary shares, £0.008 par value; 68,342,534 and 61,943,471 shares authorized, issued and outstanding at March 31, 2024 and December 31, 2023, respectively	699		635
Additional paid-in capital	690,222		621,645
Accumulated other comprehensive loss	(16,962)		(16,926)
Accumulated deficit	(414,797)		(379,610)
Total shareholders' equity	259,162		225,744
Total liabilities and shareholders' equity	$	308,993	$	275,987

	Three months ended March 31,
	2024		2023
OPERATING EXPENSES:
Research and development	$	24,901	$	19,035
General and administrative	13,672		12,753
Total operating expenses	38,573		31,788
Loss from operations	(38,573)		(31,788)
OTHER INCOME, NET:
Other income, net	2,388		709
Interest expense	(1,098)		—
Foreign exchange (losses) gains	(783)		2,685
Benefit from R&D tax credit	3,101		4,316
Total other income, net	3,608		7,710
Loss before income taxes	(34,965)		(24,078)
Corporate income tax expense	(222)		(130)
Net loss	$	(35,187)	$	(24,208)

Net loss per share attributable to ordinary shareholders—basic and diluted	$	(0.55)	$	(0.57)
Weighted average ordinary shares outstanding—basic and diluted	64,222,178		42,725,863

Net loss	$	(35,187)	$	(24,208)
Other comprehensive loss:
Foreign exchange translation adjustment	(36)		(578)
Comprehensive loss	$	(35,223)	$	(24,786)

Opinion paper calls for clarity on the definition of "psychedelic-assisted therapy" using psilocybin

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