COMPASS Pathways plc announces financial results and business highlights for the third quarter 2021

Highlights:

Positive topline results from phase IIb COMP360 psilocybin therapy trial for treatment-resistant depression; rapid and sustained response for patients receiving a single 25mg dose of COMP360 psilocybin with psychological support
Launch of phase II study of COMP360 psilocybin therapy for PTSD
Positive signals from Maryland Oncology Hematology open-label investigator initiated study of COMP360 psilocybin therapy for depression in cancer
Acquisition of IP portfolio of novel psychedelic compounds and prodrugs
Hamilton Morris appointed full-time consultant
New US composition patent granted for crystalline psilocybin
Conference call today at 1:00pm UK (8:00am ET)

COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the third quarter 2021 and gave an update on recent progress across its business.

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, "With the positive topline results from our COMP360 psilocybin therapy phase IIb trial, we are one step closer to potentially providing a much-needed therapeutic option to patients suffering with treatment-resistant depression. At the same time, we are making great progress in broadening our pipeline – we are beginning a phase II COMP360 psilocybin therapy trial for PTSD, and we have acquired a large portfolio of new compounds and IP, working with Matthias Grill PhD. Our goal remains the same - to transform mental health care and bring options to the millions of patients who currently don't have many."

Business highlights

Positive topline results from groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD); data shared in separate press release published today

Continued investment in the expansion of COMPASS portfolio with addition of phase II trial of COMP360 psilocybin therapy in post-traumatic stress disorder (PTSD)
- 20 patient, fixed dose, open-label trial to begin at The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London

Promising data from open-label investigator-initiated study of COMP360 psilocybin therapy for depression in cancer, conducted and reported by Maryland Oncology Hematology at the Aquilino Cancer Center (Rockville, MD)
- Showed feasibility of simultaneous psilocybin administration in small groups, with 1:1 support
- Remission in major depression symptoms for 15 of the 30 patients, sustained for eight-week follow-up
- COMP360 psilocybin found to be generally well-tolerated with no treatment-related serious adverse events

Acquisition of intellectual property (IP) portfolio including patent applications covering a variety of psychedelic and empathogenic substances
- IP developed with Dr Matthias Grill, founder and CEO of MiHKAL GmbH in Basel, Switzerland
- Working with Dr Grill on exclusive research project to develop new product candidates

Hamilton Morris, research scientist and filmmaker, appointed full-time consultant
- Researching new psychedelic compounds that could be developed into therapies in areas of unmet mental health need

New US patent granted
- Claims covering alternative crystalline psilocybin not used in COMP360
- Portfolio of nine granted patents, including four in the US, two in the UK, one in Germany, two in Hong Kong

Financial highlights

Net loss for the three months ended 30 September 2021 was $15.8 million or $0.38 loss per share (after including non-cash share-based compensation expense of $2.3 million), compared with $16.7 million or $1.30 loss per share during the same period in 2020 (after including non-cash-share-based compensation expense of $5.2 million).

Net loss for the nine months ended 30 September 2021 was $46.1 million, or $1.17 loss per share (after including non-cash share-based compensation expense of $5.9 million), compared with $41.5 million, or $3.90 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $16.6 million).

Research & development (R&D) expenses were $12.2 million for the three months ended 30 September 2021, compared with $6.9 million during the same period in 2020. Of this increase, $6.2 million reflected increased development activities, including hiring additional staff, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. There was a reduction of $0.9 million in non-cash share-based compensation expense compared with the same period in the prior year.

R&D expenses were $30.4 million for the nine months ended 30 September 2021, compared with $18.8 million during the same period in 2020. Of this increase, $14.3 million reflected increased development activities, including hiring additional staff, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. There was a reduction of $2.7 million in non-cash share-based compensation expense compared with the same period in the prior year.

G&A expenses were $9.6 million for the three months ended 30 September 2021, compared with $6.6 million during the same period in 2020. The increase was attributable to a reduction of $2.0 million in non-cash share-based compensation, offset against an increase of $2.5 million, $0.7 million and $1.8 million, respectively, in personnel expenses, legal and professional fees, and facilities and other expenses.

G&A expenses were $24.5 million for the nine months ended 30 September 2021, compared with $21.1 million during the same period in 2020. The increase was attributable to a reduction of $8.0 million in non-cash share-based compensation, offset against an increase of $5.8 million, $0.8 million and $4.9 million, respectively, in personnel expenses, legal and professional fees, and facilities and other expenses.

Cash and cash equivalents were $294.0 million as of 30 September 2021, compared with $196.5 million at 30 September 2020.

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm UK (8.00am ET) on 9 November 2021. The call can be accessed by dialing (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 34908054.

The call will be accompanied by a presentation which will be available on the COMPASS Pathways website (ir.compasspathways.com). The call will also be webcast on the website and archived for 30 days.

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 is investigational and 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. We are headquartered in London, UK, with offices in New York and San Francisco in the US. 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 "may", "might", "will", "could", "would", "should", "expect", "plan", "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, COMPASS's business strategy and goals, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, 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, the future accessibility of COMP360 psilocybin therapy, COMPASS's ability to continue to advance its research, including COMP360, COMPASS's expectations regarding the benefits of its psilocybin therapy, including COMP360 and COMPASS's ability to advance new psychedelic compounds in other areas of unmet mental health need. 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 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.

Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7423


COMPASS PATHWAYS PLC
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)

	September 30,		December 31,
	2021		2020
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	293,959	$	190,327
Restricted cash	104		29
Prepaid expenses and other current assets	18,733		12,048
Total current assets	312,796		202,404
Investment	521		529
Property and equipment, net	355		245
Deferred tax assets	852		221
Other assets	219		57
Total assets	$	314,743	$	203,456
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable	$	2,742	$	2,747
Accrued expenses and other liabilities	6,581		4,148
Total current liabilities	9,323		6,895
Total liabilities	9,323		6,895

Commitments and contingencies (Note 13)
SHAREHOLDERS' EQUITY:
Ordinary shares, £0.008 par value; 41,731,180 and 35,930,331 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020, respectively	431		367
Deferred shares, £21,921.504 par value; one share authorized, issued and outstanding at September 30, 2021 and December 31, 2020	28		28
Additional paid-in capital	441,135		279,480
Accumulated other comprehensive income	7,817		14,585
Accumulated deficit	(143,991)		(97,899)
Total shareholders' equity	305,420		196,561
Total liabilities and shareholders' equity	$	314,743	$	203,456


COMPASS PATHWAYS PLC
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
OPERATING EXPENSES:
Research and development	$	12,197	$	6,875	$	30,434	$	18,822
General and administrative	9,571		6,607		24,464		21,052
Total operating expenses	21,768		13,482		54,898		39,874
LOSS FROM OPERATIONS:	(21,768)		(13,482)		(54,898)		(39,874)
OTHER INCOME (EXPENSE), NET:
Other income, net	—		109		2		302
Foreign exchange gains (losses)	3,364		(4,331)		2,171		(3,252)
Fair value change of convertible notes	—		—		—		(1,031)
Fair value change of convertible notes - due to a related party	—		—		—		(723)
Benefit from R&D tax credit	2,618		1,092		6,733		3,175
Total other income (expense), net	5,982		(3,130)		8,906		(1,529)
Loss before income taxes	(15,786)		(16,612)		(45,992)		(41,403)
Income tax expense	(63)		(82)		(100)		(125)
Net loss	(15,849)		(16,694)		(46,092)		(41,528)
Other comprehensive (loss) income:
Foreign exchange translation adjustment, net after tax	(8,401)		4,806		(6,768)		3,773
Comprehensive loss	$	(24,250)	$	(11,888)	(52,860)		$	(37,755)
Net loss per share attributable to ordinary shareholders—basic and diluted	$	(0.38)	$	(1.30)	$	(1.17)	$	(3.90)
Weighted average ordinary shares outstanding—basic and diluted	41,708,220		12,834,889		39,378,824		10,638,738

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Compass Pathways CMPS:US Psychedelics Investing

Seelos Announces Postponement of its Annual Meeting of Stockholders

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its 2024 Annual Meeting of Stockholders (the "Annual Meeting"), which was originally scheduled to be held on September 27, 2024 has been postponed. The Annual Meeting is now scheduled to be held virtually, via live webcast at www.virtualshareholdermeeting.comSEEL2024 on Friday, October 25, 2024 at 8:00 a.m., Eastern Time . The record date for the Annual Meeting August 19, 2024 is unchanged and applies to the postponed Annual Meeting.

The Annual Meeting has been postponed due to an anticipated lack of quorum, and to provide further time to solicit proxies from the Company's stockholders. Seelos' Board of Directors unanimously recommends that you vote FOR the Board of Director nominees and FOR all other proposals identified in the Company's proxy statement for the Annual Meeting. Stockholders who have already cast their votes do not need to take any action, unless they wish to change or revoke their prior proxy or voting instructions, and their votes will be counted at the postponed Annual Meeting. For stockholders who have not yet cast their votes, we urge them to vote their shares now, so they can be tabulated prior to the postponed Annual Meeting.

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.

For more information, please visit our website: https://seelostherapeutics.com , the content of which is not incorporated herein by reference.

IMPORTANT ADDITIONAL INFORMATION

Seelos has filed a definitive proxy statement with the Securities and Exchange Commission (the "SEC") on August 20, 2024 . STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED BY SEELOS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ANY SOLICITATION. Stockholders may obtain a free copy of the proxy statement and the other relevant materials, and any other documents filed by Seelos with the SEC, at the SEC's web site at http://www.sec.gov or on the "SEC Filings" section of Seelos' website at https://seelostherapeutics.com .

Participants in the Solicitation

Seelos, its directors and executive officers and other members of management and employees will be participants in the solicitation of proxies with respect to a solicitation by Seelos. Information about Seelos' executive officers and directors, including information regarding the direct or indirect interests, by security holdings or otherwise, is available in Seelos' definitive proxy statement for its Annual Meeting, which was filed with the SEC on August 20, 2024 . To the extent holdings by our directors and executive officers of Seelos securities reported in the proxy statement for the Annual Meeting have changed, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4 or 5 filed with the SEC. These documents are or will be available free of charge at the SEC's website at http://www.sec.gov .

Forward-Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements related to Seelos for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not receiving stockholder approval of any of the proposals to be presented at the Annual Meeting, the risks related to raising capital to fund its development plans and ongoing operations and risks related to Seelos' current stock price, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023 , subsequent Quarterly Reports on Form 10-Q, including Seelos' Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 . 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
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

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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Seelos Therapeutics Announces 1-for-16 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-16 reverse stock split of its outstanding shares of common stock, to be effective as of 12: 01 a.m. Eastern Time on Friday September 27, 2024.

The Company's common stock, par value $0.001 , will begin trading on a reverse stock split-adjusted basis at the opening of the market on Friday, September 27, 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, 81577F 406. 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. The reverse stock split was approved by the Company's Board of Directors pursuant to Section 78.207 of the Nevada Revised Statutes and was effectuated by the filing of a Certificate of Change with office of the Nevada Secretary of State.

At the effective time of the reverse split, every sixteen (16) issued and outstanding shares of the Company's common stock will be combined automatically into one (1) 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 any 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 50,000,000 shares to 3,125,000 shares and the ownership percentage of each stockholder will remain unchanged other than as a result of the rounding 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 9.2 million to approximately 581 thousand.

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

View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-announces-1-for-16-reverse-stock-split-302257773.html

SOURCE Seelos Therapeutics, Inc.

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US Food and Drug Administration website on a phone screen.

FDA Finds Kratom Capsules Safe, but Questions About Concentrated Forms Remain

An initial US Food and Drug Administration (FDA) study on kratom, a plant-based substance long consumed in Southeast Asia, has found that the compound appears safe when used in capsule form, even at high doses.

However, a Tuesday (September 17) Bloomberg article notes that the FDA's research did not include kratom-infused drinks or concentrates, which are more common in the US and may carry different risks.

Kratom, a botanical product derived from the leaves of Mitragyna speciosa, has been used in Southeast Asia for centuries, with users traditionally chewing the leaves for its mind-altering effects.

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Compass Pathways to participate in three investor conferences in September

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in the following September investor conferences:

Morgan Stanley 22nd Annual Global Healthcare Conference: fireside chat at 7:45 am ET on September 4, 2024, and host investor meetings
H. C. Wainwright 26th Annual Global Investment Conference: fireside chat at 9:30 am ET on September 10, 2024, and host investor meetings
Cantor Global Healthcare Conference: fireside chat at 2:30 pm ET on September 17, 2024, and host investor meetings

A live audio webcast of these events will be accessible from the "Events" page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event.

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COMPASS Pathways to participate in Canaccord Genuity 44th Annual Growth Conference

A live audio webcast of this event will be accessible from the "Events" page of the Investors section of the Compass website. A replay of this webcast will be accessible for 30 days following such event. For more information, please visit investor section of compasspathways.com.

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COMPASS Pathways plc announces financial results and business highlights for the third quarter 2021

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