Two thirds of physicians surveyed believe psilocybin therapy has potential benefit for patients with treatment-resistant depression

London, UK and New York, US, 19 January 2022

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, and Sermo, a global leader in physician insights, today announced findings from a survey of Sermo physician members that showed two thirds (66%) of doctors surveyed believe psilocybin therapy has potential therapeutic benefit for patients with treatment-resistant depression (TRD).

More than 320 million people globally suffer with major depressive disorder (MDD) i the leading cause of disability worldwide and one of the fastest growing mental health illnesses ii . About a third of these patients 100 million people aren't helped by existing therapies and suffer with TRD iii .

Psilocybin therapy is an approach being investigated for the treatment of mental health challenges, including TRD. It combines the pharmacological effects of a synthesised version of psilocybin, a psychoactive substance that is an active ingredient in some species of mushrooms, with psychological support ^iv .

The survey of 259 Sermo member physicians, sponsored by COMPASS, was conducted in November 2021 and completed by participants from the US, the UK, France, Italy, Denmark, Spain and the Netherlands. Doctors were asked their views on the future of psychiatric therapy and the potential role of psilocybin therapy.

Key survey findings:

66% of doctors surveyed believe psilocybin therapy has potential benefit for patients with TRD
50% would prescribe psilocybin therapy, if it was approved; 32% are undecided
The greatest potential advantages to psilocybin treatment are believed to be: improved efficacy in treatment-resistant conditions (30%), rapid onset of action (26%), and different mechanism of action from existing therapies (19%)
The greatest potential barriers to treatment were cited as: needing a dedicated space for six to eight hours (28%), lack of trained therapists in a new model of psychological support (21%), and office infrastructure (15%)
Opinions on the optimal setting for psilocybin administration varied by region: 50% of European respondents said hospital; 42% of US respondents said specialised network of centres
Physicians also noted the need to educate healthcare professionals on the potential benefits of psilocybin therapy and on how to incorporate the therapy into their practice, if approved

"Severe mental illnesses, such as treatment-resistant depression, have affected too many people in society for too long. Physicians are looking for new approaches to accelerate the healing process, particularly for patients for whom current therapies have failed," said Murali Doraiswamy MBBS, FRCP, Professor of Psychiatry and Behavioural Sciences at Duke University School of Medicine, and an advisor to Sermo.

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: "These findings underline the fact that physicians need more options in helping patients suffering with treatment-resistant depression. COMPASS is developing COMP360 psilocybin therapy through a rigorous programme of research in the hope that we can offer just such an option. It's very encouraging to see that so many doctors see the potential that psilocybin could have and these insights will help us to understand how to introduce COMP360 psilocybin, with psychological support, into medical systems, if approved."

-Ends-

Survey methodology

The survey was designed to assess attitudes towards the use of psilocybin therapy in general, in psychiatry. The survey was conducted online via Sermo's RealTime platform and the random sample of physicians received compensation for their time and expertise. Survey limitations include sampling bias, inability to deduce causality from opinion polls, confounding variables not measured, and other factors.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care 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 therapy, 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), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p 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 "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "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 psilocybin therapy, including COMP360, as a treatment for depression, COMPASS's business strategy and goals, including its ability to launch and commercialise products, COMPASS's expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS's ability to continue to advance its research or develop plans to bring its product candidates to patients, including COMP360, clinicians' perceptions of the potential advantages and efficacy of COMP360 in relation to other available therapies, including any new therapies that may be approved for the indications we are investigating, and COMPASS's expectations regarding the benefits of psilocybin therapy and the effectiveness of its executive team. 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: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading "Risk Factors" in COMPASS's annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the 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.

About Sermo

Sermo turns physician experience, expertise, and observations into actionable insights for the global healthcare community. Engaging with more than 1.3 million HCPs across 150 countries, the company provides physicians with a social platform and unique community that fosters impactful peer-to-peer collaboration & discussions about issues that are important to them and their patients. Sermo offers on demand access to physicians via a suite of proprietary technology to provide business intelligence that benefits pharmaceutical, healthcare partners, and the medical community at large. To learn more, visit www.sermo.com .

Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

ⁱ WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf [Accessed 21 October 2021]
ⁱⁱ WHO (2012). Depression: A Global Crisis [Online]. Available at: https://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf [Accessed 21 October 2021]
ⁱⁱⁱ Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388
^iv Ross et al, 2016; Griffiths et al, 2016; Carhart-Harris et al, 2016

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Compass Pathways CMPS:US Psychedelics Investing

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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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	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)

Two thirds of physicians surveyed believe psilocybin therapy has potential benefit for patients with treatment-resistant depression

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