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.

"It is crucial that we understand how different mental health service providers are positioned to deliver COMP360 psilocybin treatment to patients, should it receive FDA approval," said Kabir Nath, CEO of Compass Pathways. "By joining forces with MHS, Compass will have the opportunity to learn from a leading provider of innovative behavioral health care for people living with treatment-resistant depression and other difficult-to-treat mental health conditions."

The collaboration with MHS will include an in-depth information exchange on Compass's potential delivery model for investigational COMP360 psilocybin treatment, and how it might fit into a healthcare delivery system similar to MHS. Compass and MHS will chart the depression and TRD patient pathway and investigate challenges with the current patient care experience, including potential approaches to address these. MHS will complete training and learning sessions on Compass's psychological support model and therapist training program and conduct research to better understand therapist training needs. Compass and MHS will exchange information on model treatment rooms, site activation services, and coding and reimbursement considerations related to psychedelic treatments.

"There are millions of people in the US living with depression for whom existing treatments do not work," said John Minahan, CEO of Mindful Health Solutions. "Part of MHS's mission is to make innovative treatments accessible to everyone who may benefit from them. As such, we are proud to collaborate with Compass Pathways and to contribute to learning how COMP360 psilocybin treatment may be most effectively delivered to patients, if approved for TRD."

Compass has previously announced research collaboration agreements with Greenbrook TMS, a leading provider of interventional psychiatric treatments such as transcranial magnetic stimulation; Hackensack Meridian Health, a leading not-for-profit health care organization and the largest, most comprehensive and truly integrated network in New Jersey, addressing the full continuum of care for people living with TRD; and Journey Clinical, a leading psychedelic-assisted psychotherapy platform with the largest network of licensed therapists focused on psychedelics in the US.

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 living 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 U.S. 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 COMP360 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 .

About Mindful Health Solutions

Mindful Health Solutions (mindfulhealthsolutions.com) is a leading provider of innovative behavioral health care in the US, with a focus on emerging psychedelic research, precision medicine, and cutting-edge treatment protocols such as transcranial magnetic stimulation, esketamine, and IV Ketamine for patients living with TRD and other serious mental illnesses. MHS operates over 20 outpatient clinics located across California, Washington, Texas, and Georgia. MHS has a team of psychiatrists, therapists and nurse practitioners focused on helping patients get the help they need. They are dedicated to improving patients' lives, especially those suffering from depression.

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", "should", "expect", "intend", "plan", "believe", "estimate", "predict", "possible", "potential" 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 investigational COMP360 psilocybin treatment as a treatment for treatment-resistant depression, post-traumatic stress disorder or anorexia nervosa, the potential for the pivotal phase 3 program or other trials to support regulatory filings and approvals, Compass's business strategy and goals, Compass's plans, expectations and ability to achieve its goals related to this research collaboration agreement and its other research collaborations; Compass's ability to continue to advance its research, obtain regulatory approval or develop plans to bring COMP360 psilocybin treatment to patients, and Compass's expectations regarding the benefits of its investigational 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 Compass's clinical trials may be delayed or terminated; the results early-stage clinical trials of investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; 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; Compass's efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any of future product candidates may be unsuccessful; Compass's efforts to obtain coverage and reimbursement for its investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that this research collaboration with Mindful Health or one or more of our previously announced research collaborations will not continue or will not achieve the expected benefits; uncertainties regarding the ability to develop a scalable and cost-effective delivery model for COMP360 psilocybin treatment; the risk that market adoption and access to COMP360 psilocybin treatment, if approved, may be limited 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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	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)

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

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