COMPASS Pathways announces pricing of public offering

London, UK – 30 April 2021

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the pricing of its public offering of 4,000,000 American Depositary Shares (“ADSs”) representing 4,000,000 ordinary shares at a public offering price of $36.00 per ADS for total gross proceeds of $144.0 million. All ADSs sold in the offering were offered by COMPASS. The offering is expected to close on or about 4 May 2021, subject to the satisfaction of customary closing conditions. In addition, COMPASS has granted the underwriters a 30-day option to purchase up to an additional 600,000 ADSs at the public offering price, less underwriting discounts and commissions.

Cowen, Evercore ISI and Berenberg are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. and BTIG, LLC are acting as lead managers for the offering.

A registration statement relating to the offering has been filed with, and declared effective by, the US Securities and Exchange Commission (“SEC”). The offering will be made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, telephone: (888) 474-0200, or email: ecm.prospectus@evercore.com; or Berenberg Capital Markets LLC, Attention: Investment Banking, 1251 Avenue of the Americas, 53rd Floor, New York, New York 10020, or by telephone at +1 (646) 949-9000, or by e-mail at prospectusrequests@berenberg-us.com. For the avoidance of doubt, such prospectus will not constitute a “prospectus” for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and will not have been reviewed by any competent authority in any EU member state or the UK.

Important information

This press release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

For readers in the European Economic Area (“EEA”) and the UK

In any EEA member state and the UK (each, a “Relevant State”), this press release and any offering are only addressed to and directed at persons who are qualified investors (“Qualified Investors”) in that Relevant State within the meaning of the Prospectus Regulation. The term “Prospectus Regulation” means Regulation (EU) 2017/1129.

For readers in the UK

In the UK, this press release, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended (the “FSMA”), and any offering are only addressed to and directed at Qualified Investors (i) who are investment professionals as described in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), (ii) persons and entities who fall within Article 49(2)(a) to (d) of the Order, or (iii) to whom it may otherwise lawfully be communicated (all such persons being referred to as “relevant persons”).

This press release must not be acted on or relied on (i) in the UK, by persons who are not relevant persons, and (ii) in any EEA member state, by persons who are not Qualified Investors. Any investment or investment activity to which this press release relates is available only to and will only be engaged with (i) in the UK, relevant persons, and (ii) in any EEA member state, Qualified Investors. This press release does not contain an offer or constitute any part of an offer to the public within the meaning of sections 85 and 102B of the FSMA or otherwise.

About COMPASS Pathways

COMPASS Pathways (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 are currently conducting 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, US. Our vision is a world of mental wellbeing.

Forward-looking statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, express or implied statements relating to, among other things, COMPASS’s ability to complete the proposed offering and its anticipated use of  proceeds. Forward-looking statements are based on COMPASS’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the satisfaction of customary closing conditions and the completion of the offering, and the risks inherent in mental health care clinical trials. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the offering to be filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and COMPASS undertakes no duty to update such information except as required under applicable law.

Enquiries:

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

COMPASS Pathways launches proposed public offering

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the launch of a proposed public offering of 4,000,000 American Depositary Shares (“ADSs”), each representing one ordinary share.

Each of the ADSs is being offered by COMPASS. COMPASS expects to grant the underwriters a 30-day option to purchase up to an additional 600,000 ADSs. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

Cowen, Evercore ISI and Berenberg are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. and BTIG, LLC are acting as lead managers for the offering.

The proposed offering will be made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, telephone: (888) 474-0200, or email: ecm.prospectus@evercore.com; or Berenberg Capital Markets LLC, Attention: Investment Banking, 1251 Avenue of the Americas, 53rd Floor, New York, New York 10020, or by telephone at +1 (646) 949-9000, or by e-mail at prospectusrequests@berenberg-us.com. For the avoidance of doubt, such prospectus will not constitute a “prospectus” for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and will not have been reviewed by any competent authority in any EU member state or the UK.

Important information

A registration statement relating to these securities has been filed with the US Securities and Exchange Commission (the “SEC”), but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

For readers in the European Economic Area (“EEA”) and the UK

In any EEA member state and the UK (each, a “Relevant State”), this press release and any offering are only addressed to and directed at persons who are qualified investors (“Qualified Investors”) in that Relevant State within the meaning of the Prospectus Regulation. The term “Prospectus Regulation” means Regulation (EU) 2017/1129.

For readers in the UK

In the UK, this press release, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended (the “FSMA”), and any offering are only addressed to and directed at Qualified Investors (i) who are investment professionals as described in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), (ii) persons and entities who fall within Article 49(2)(a) to (d) of the Order, or (iii) to whom it may otherwise lawfully be communicated (all such persons being referred to as “relevant persons”).

This press release must not be acted on or relied on (i) in the UK, by persons who are not relevant persons, and (ii) in any EEA member state, by persons who are not Qualified Investors. Any investment or investment activity to which this press release relates is available only to and will only be engaged with (i) in the UK, relevant persons, and (ii) in any EEA member state, Qualified Investors. This press release does not contain an offer or constitute any part of an offer to the public within the meaning of sections 85 and 102B of the FSMA or otherwise.

About COMPASS Pathways

COMPASS 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 are currently conducting 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, US. Our vision is a world of mental wellbeing.

Forward-looking statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, express or implied statements relating to, among other things, COMPASS’s ability to complete the proposed offering and its anticipated use of proceeds. Forward-looking statements are based on COMPASS’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the satisfaction of customary closing conditions and the completion of the offering, and the risks inherent in mental health care clinical trials. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the offering to be filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and COMPASS undertakes no duty to update such information except as required under applicable law.

Enquiries:

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

New England Journal of Medicine publishes exploratory study showing signals of positive activity in COMP360 psilocybin compared with escitalopram for major depressive disorder

Study concludes that psilocybin findings should be explored further in larger studies

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, welcomed a study published in the New England Journal of Medicine (NEJM) yesterday, which showed signals of positive activity in COMP360 psilocybin compared with the standard antidepressant escitalopram, for major depressive disorder (MDD).

The study was designed and conducted by a research team at Imperial College London, using COMPASS’s COMP360 psilocybin.

This was an exploratory, randomised, double-blind clinical study. Its aim was to compare the efficacy and mechanisms of action of psilocybin with a six-week course of escitalopram, a selective serotonin reuptake inhibitor (SSRI), for MDD.

The study included 59 participants; 30 were randomly assigned to the psilocybin arm, and 29 to the escitalopram arm. Participants in the psilocybin arm received two doses of 25mg psilocybin three weeks apart, with psychological support delivered prior to, during and after each psilocybin administration, plus six weeks of daily placebo capsules. The escitalopram arm received two doses of 1mg psilocybin (presumed negligible effect) three weeks apart, with equivalent psychological support to the psilocybin arm, plus six weeks of daily escitalopram capsules, 10mg for the first three weeks titrated to 20mg for the following three weeks.

The study authors, from Imperial College London, noted that the study was not powered to detect a difference between psilocybin and escitalopram. As reported in the NEJM, the primary efficacy measure, the change from baseline in the self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16) total score at six weeks, did not show a significant difference between the two groups, with a two point difference favouring the psilocybin group compared with the escitalopram group. This trend favouring psilocybin was present from week one.

Secondary outcomes including clinician-rated depression scales, response and remission, signalled the antidepressant effects of both agents; psilocybin showed numerical advantages on clinical measures compared with escitalopram. On the clinician-rated depression scales, the change from baseline at week six on the Montgomery-Asberg Depression Rating Scale (MADRS), showed a 7.2 point treatment difference favouring psilocybin, while the Hamilton Depression Rating Scale (HAM-D-17) showed a 5.3 point treatment difference favouring psilocybin. Response rates (a 50% or greater reduction on the QIDS-SR-16 total score from baseline) at week six were 70.2% for the psilocybin arm compared with 48.0% for the escitalopram arm, and remission rates (defined as a QIDS-SR-16 total score ≤5) at week six were 57.1% and 29.1%, respectively. Similar patterns favouring psilocybin were found in other secondary endpoints measuring work and social functioning, anxiety, avoidance, anhedonia, and wellbeing. Such secondary endpoints were uncorrected for multiplicity.

Adverse event rates and severity were largely comparable across conditions. Adverse events in the psilocybin arm were typically transient, occurring and resolving within 24 hours of dosing days, with the most commonly reported adverse event being transient headaches. No Serious Adverse Events were reported.

“In a field of research where it is very difficult to separate treatments in head-to-head comparative efficacy trials, this study found signals favouring psilocybin therapy over escitalopram. This is an encouraging investigator-initiated study that supports the need for additional clinical investigations in larger, well-powered studies to more accurately determine the efficacy of COMP360 psilocybin in MDD”, said George Goldsmith, CEO and Co-founder of COMPASS Pathways. “At COMPASS, we are already committed to a full clinical development programme of psilocybin therapy in treatment-resistant depression, and we know there is much more work to be done so that we can bring evidence-based innovation to patients who have run out of options in a number of mental health illnesses.”

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 are currently conducting 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, USA. Our vision is a world of mental wellbeing.

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 efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s business strategy and goals, COMPASS’s ability to continue to advance its research, including COMP360, and COMPASS’s expectations regarding the benefits of its psilocybin therapy, including COMP360. 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.

Enquiries

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

COMPASS Pathways plc to participate in 20th Annual Needham Virtual Healthcare Conference

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that George Goldsmith, Chairman, CEO and Co‑founder, and Lars Wilde, President, Chief Business Officer, and Co‑founder, will present a corporate update at 8:00am ET on 15 April at the 20th Annual Needham Virtual Healthcare Conference. Members of the COMPASS management team will also be holding 1:1 investor meetings.

A live audio webcast of the presentation will be available on the “Events” page of the Investors section of the COMPASS website. A replay of the webcast will be available for 30 days following the event. For more information, please visit ir.compasspathways.com.

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 are currently conducting 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, USA. Our vision is a world of mental wellbeing.

Contacts:

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

COMPASS Pathways appoints Wayne J Riley MD to its Board of Directors

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it has appointed Wayne J Riley MD to its Board of Directors.

Dr Riley is President of the State University of New York (SUNY) Downstate Health Sciences University, Brooklyn, where he holds tenured professorships in internal medicine, and health policy and management. A primary care physician and an academic, he has more than 25 years of experience encompassing clinical and academic medicine, research programme oversight, biotechnology, primary care, public health, healthcare management and policy, healthcare quality, academic health science centre administration, and government service.

“We are delighted to welcome Wayne to the COMPASS Board,” said George Goldsmith, CEO and Co-founder of COMPASS Pathways. “He has dedicated his career to patients and to improving healthcare services. At COMPASS, we want to transform the patient experience in mental health care and to give people options. We look forward to benefitting from Wayne’s breadth of expertise as we continue to advance our evidence-based research and to work towards our vision of a world of mental wellbeing.”

Dr Riley said, “I am honoured to join the Board of COMPASS Pathways at this critical time when it is more important than ever to develop novel, effective treatments for depression and other mental health conditions. I look forward to working with the Board and the management team and contributing to advancing COMPASS’s quest to improve the lives of millions of patients worldwide.”

In addition to his position at SUNY Downstate Health Sciences University, Dr Riley is also Chairman of the Board of the New York Academy of Medicine, an elected member of the US National Academy of Medicine, a Commissioner of the US Medicare Payment Advisory Commission, and President of the Society of Medical Administrators. He is a President Emeritus of the American College of Physicians (ACP).

Dr Riley is a member of the Board of Directors of HCA Healthcare Inc, a learning health system comprising 180 hospitals and more than 2,000 sites of care in the US and in the UK, where he serves as Chair of the Patient Safety & Quality Committee and a member of the Audit & Compliance and Nominating & Corporate Governance Committees. He previously served as a Director of Vertex Pharmaceuticals. He holds a BA from Yale University, an MPH from the Tulane University School of Public Health and Tropical Medicine, an MD from the Morehouse School of Medicine, and an MBA from Rice University.

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 are currently conducting 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, 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”, “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, COMPASS’s business strategy and goals, COMPASS’s ability to continue to advance its research, and COMPASS’s expectations regarding the benefits of its psilocybin therapy. 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.

Enquiries:

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

COMPASS Pathways granted two US patents

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it has been granted two new patents by the US Patent and Trademark Office (USPTO). These patents cover oral formulations of COMPASS’s synthetic psilocybin in the treatment of major depressive disorder (MDD), which includes treatment-resistant depression (TRD).

US Patent No 10,954,259 was granted on 23 March 2021, with claims to COMPASS’s high-purity crystalline psilocybin (including the form used in its synthetic formulation, COMP360), pharmaceutical formulations containing crystalline psilocybin and methods of treating MDD with the crystalline psilocybin.

US Patent No 10,947,257 was granted on 16 March 2021, with claims to oral dosage forms of crystalline psilocybin and methods of treating MDD with the oral dosage forms.

“These patents are a critical milestone in our efforts to establish a new evidence-based option to help patients with depression in the US,” said George Goldsmith, CEO and Co-founder of COMPASS Pathways. “Through these grants, the USPTO has recognised our innovations. These decisions enable us to continue to do the highest quality clinical research and bring potentially life-changing care to patients who might benefit from this therapy.”

COMPASS’s first US patent, No 10,519,175, was granted in December 2019 and covers the use of formulations of COMPASS’s high-purity crystalline psilocybin in psilocybin therapy for patients with TRD.

COMP360 is being investigated in a phase IIb clinical trial of psilocybin therapy for TRD. COMPASS received Breakthrough Therapy designation from the US FDA for this application in 2018. Data from the phase IIb trial is expected in late 2021.

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 are currently conducting 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, 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”, “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, COMPASS’s business strategy and goals, the benefits of additional patent protection to help achieve these goals, and COMPASS’s expectations regarding the benefits of its psilocybin therapy. 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.

Enquiries:

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

COMPASS Pathways plc announces financial results and business highlights for fourth quarter and year-end 2020

Highlights include continued progress with phase IIb psilocybin therapy clinical trial, launch of first Centre of Excellence, and expansion of Discovery Center

 

  • Phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD) on track to report data by end of 2021
  • First Centre of Excellence, a research facility and innovation lab, established at Sheppard Pratt (Baltimore, Maryland, US)
  • Discovery Center expanded into network of world-leading scientists developing new optimised psychedelic compounds
  • Conference call today at 1.00pm GMT (8.00am ET)

 

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the fourth quarter and year-end 2020 and gave an update on recent progress across its business.

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “Mental health is an urgent crisis and this has only been exacerbated by the COVID-19 pandemic. At COMPASS we remain committed to transforming mental health care and helping patients who are suffering and aren’t helped by existing treatments. Our phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression is actively recruiting and we plan to report data from this trial at the end of the year. We are also continuing preclinical research into new indications, new compounds and new technologies, working with partners through our Centre of Excellence, our Discovery Center, and a number of investigator-initiated studies, as well as developing a strong team.”

Business highlights

  • Continued progress with phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD)
    – On track to report data end of 2021
    – New site added in London, UK, bringing trial to 22 sites in 10 countries
    – Working closely with all sites to assess the ongoing COVID-19 situation and COMPASS will always prioritise the safety of patients and teams
    – Paper on therapist training programme published in Frontiers in Psychiatry in February, setting out formal and scalable methodology for psychological support in psilocybin therapy
    – Breakthrough Therapy designation awarded by US FDA in 2018
  • Signal-generating, exploratory psilocybin therapy research underway in a range of indications
    – COMPASS has the right to exclusively license new IP generated through these investigator-initiated studies
  • Launch of first Centre of Excellence at Sheppard Pratt, Baltimore
    – Centres of Excellence are research facilities and innovation labs that COMPASS anticipates will model the ”clinic of the future”, showcasing the most advanced thinking in science, therapy, technology and design
    – Centres of Excellence should generate evidence to shape therapy models in mental health care, train and certify therapists, conduct clinical trials including proof-of-concept studies, and prototype digital solutions to improve patient experience
    – Initial research focused on COMP360 psilocybin therapy, which is already being used in two investigator-initiated studies looking at severe treatment-resistant depression and bipolar type II depression
  • Expansion of Discovery Center in the US
    – Discovery Center expanded beyond initial sponsored research agreement with University of the Sciences (Philadelphia, PA) to include collaborations with world-leading scientists from laboratories at UC San Diego, School of Medicine, and Medical College of Wisconsin, in a virtual network
    – Focus on development of new optimised psychedelic compounds targeting the 5-HT2A receptor
    – COMPASS is exclusive licensee for all new compounds generated

Financial highlights

  • Net loss for the three months ended 31 December 2020 was $18.8 million, or $0.52 loss per share (after including non-cash share-based compensation expense of $1.4 million), compared with $7.6 million, or $0.90 loss per share, during the same period in 2019 (after including non-cash share-based compensation expense of $0.8 million)
  • The net loss for the 12 months ended 31 December 2020 was $60.3 million, or $3.55 loss per share (after including non-cash share-based compensation expense of $18.0 million), compared with $19.6 million, or $2.62 loss per share, during the same period in 2019 (after including non-cash share-based compensation expense of $3.3 million)
  • Research & development expenses (R&D) were $4.5 million for the three months ended 31 December 2020, compared with $4.6 million during the same period in 2019. R&D expenses were $23.4 million for the 12 months ended 31 December 2020, compared with $12.6 million during the same period in 2019, reflecting increased investment in the ongoing phase IIb COMP360 psilocybin therapy clinical programme for TRD
  • General and administrative expenses (G&A) were $7.0 million for the three months ended 31 December 2020, compared with $2.8 million during the same period in 2019. Of the increase, $0.5 million was related to share-based compensation expenses. G&A expenses were $28.0 million for the 12 months ended 31 December 2020, compared with $8.6 million during the same period in 2019. Of this increase, $10.2 million was related to share-based compensation expenses
  • Cash and cash equivalents were $190.3 million as of 31 December 2020, compared with $196.5 million at 30 September 2020

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm GMT (8.00am ET) on 9 March 2021. The call can be accessed by dialling (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 5558345.

The call will also be webcast on the investors section of the COMPASS Pathways website (ir.compasspathways.com) 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 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting 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, US. Our vision is a world of mental wellbeing.

 

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, COMPASS’s business strategy and goals, and COMPASS’s expectations regarding its ongoing preclinical work and clinical trials, including the timing of the release of clinical data. 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, +1 401-290-7324

COMPASS Pathways plc to announce fourth quarter and full year end results

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the fourth quarter and year ended 31 December 2020, and provide an update on recent business developments, on 9 March 2021.

The management team will host a conference call at 1:00pm GMT (8.00am ET) on 9 March. The call can be accessed by dialling (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 5558345.

The call will also be webcast on the Investors section of the COMPASS Pathways website. The webcast will be 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 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting 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, US. Our vision is a world of mental wellbeing. www.compasspathways.com

 

Enquiries:

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

COMPASS Pathways plc to participate in Cowen’s 41st Annual Health Care Conference

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that members of its management team will participate in Cowen’s 41st Annual Health Care Conference. George Goldsmith, Chairman, CEO and Co‑founder, will participate in the Neuropsych Panel discussion at 1:20pm ET on 1 March.

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 are currently conducting 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, US. Our vision is a world of mental wellbeing. www.compasspathways.com

Enquiries:

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

COMPASS Pathways expands its Discovery Center through new collaborations with world-leading scientists

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it has expanded its Discovery Center, through collaborations with world-leading laboratories at UC San Diego, School of Medicine, and Medical College of Wisconsin (MCW). Adam Halberstadt PhD, Associate Professor, Psychiatry, UC San Diego, and John D McCorvy PhD, Assistant Professor, Department of Cell Biology, Neurobiology and Anatomy, MCW, and their teams, will join Jason Wallach PhD, Assistant Professor of Pharmaceutical Sciences, University of the Sciences (Philadelphia), at the Discovery Center, a group of researchers working together, virtually.

The COMPASS Discovery Center was established in August 2020 through a sponsored research agreement between COMPASS and University of the Sciences. It is led by Jason Wallach’s laboratory at University of the Sciences and is now expanding its research network across the US, with Adam Halberstadt in San Diego, and John McCorvy in Wisconsin. The scientists intend to develop new, optimised psychedelic compounds to address unmet medical need. COMPASS will be the exclusive licensee for all new compounds generated.

Adam Halberstadt PhD is an expert on the behavioural neuropharmacology of psychedelics. He leads a team studying how psychedelics interact with serotonin systems and the implications for psychedelic therapy. Dr Halberstadt was the co-editor of the book Behavioural Neurobiology of Psychedelic Drugs and developed an efficient, automated head-twitch response preclinical assay that is now helping to expedite the screening of novel psychedelic compounds.

John McCorvy PhD is a 5-HT receptor pharmacologist and expert in G protein-coupled receptor (GPCR) signalling. His lab at MCW studies multiple aspects of GPCR signalling elicited by psychedelic, antipsychotic and antidepressant drugs. This work includes the importance of functional selectivity, whereby different drugs bind to the same receptor to cause different effects. He will be conducting detailed pharmacological characterisations of new compounds.

Jason Wallach PhD, who is leading the work at the Discovery Center, is a leading chemist and pharmacologist who studies a broad range of psychoactive compounds, including psychedelic and dissociative drugs. He said, “Psilocybin and other psychedelic compounds have shown promise for helping people suffering with mental health challenges, such as treatment-resistant depression. The Discovery Center is investigating whether similar compounds could have superior properties to psilocybin. We are looking for the next generation of compounds that might make a difference to patients. I’m honoured to be collaborating with Dr Halberstadt and Dr McCorvy, who bring increased breadth and depth of expertise to our research.”

Lars Wilde, Chief Business Officer and Co-founder, COMPASS Pathways, said, “This is a really exciting collaboration with three of the world’s most eminent scientists in psychedelic research. The Discovery Center will focus on preclinical research of novel psychedelic compounds addressing significant unmet need in a number of mental health indications. We believe that this will enable us to build a broad portfolio that will ultimately help patients and bring us closer to our vision of a world of mental wellbeing.”

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 are currently conducting 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, 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”, “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. 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, the risk that 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, the risk that results of preclinical studies may not be predictive of the results of clinical trials, and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s Prospectus filed with the US Securities and Exchange Commission (SEC) on 21 September 2020 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, +1 401-290-7324