Appendix 4E Preliminary Final Report Year Ended 31 December 2023

Kabir Nath, Chief Government Officer, mentioned, “We proceed to progress our two part 3 trials of COMP360 in treatment-resistant melancholy with top-line information anticipated this yr and subsequent. Whereas our total Section 3 trial completion stays on observe with the ‘006 examine anticipated in mid-2025, we’re experiencing some enrollment delays within the ‘005 trial, leading to a slight delay to our steering for that trial. In parallel, we’re actively making ready for commercialization and have commenced quite a lot of collaborations with psychological well being suppliers within the US to grasp the affected person care expertise and to research fashions for the supply of scalable COMP360 psilocybin remedy inside varied care settings, if authorised by the FDA. We’re additionally excited to supply a full information set from our part 2 examine in people residing with post-traumatic stress dysfunction this Spring after an preliminary security information readout late final yr.”

Enterprise highlights

COMP360 psilocybin remedy in treatment-resistant melancholy (TRD):

• Section 3 program underway, composed of two pivotal trials with an built-in, long-term outcomes part
  • Pivotal trial 1 (COMP 005): single dose monotherapy, n=255, top-line information anticipated in fourth quarter 2024
  • Pivotal trial 2 (COMP 006): fastened repeat dose monotherapy, n=568, top-line information anticipated in mid-2025
  • Lengthy-term follow-up in every trial will generate information on period of response and potential impact of retreatment

Extra COMP360 growth actions:

• Analysis collaborations with Greenbrook TMS and Hackensack Meridian Well being launched to discover and develop a number of potential business supply templates for COMP360 psilocybin remedy if authorised
• Section 2 examine in sufferers with post-traumatic stress dysfunction (PTSD) preliminary security information reported, COMP360 properly tolerated, full information set anticipated in Spring 2024
• Section 2 examine in anorexia nervosa ongoing
• Publication of outcomes of COMP360 remedy in bipolar II melancholy revealed in JAMA Psychiatry displaying a big variety of sufferers expertise reduction from their bipolar II melancholy signs after a single 25mg dose of COMP360 psilocybin remedy

Management Replace

• Teri Loxam to start out as Chief Monetary Officer on March 1, 2024

Monetary highlights

• Internet loss for the yr ended December 31, 2023, was $118.5 million, or $2.32 loss per share (together with non-cash share-based compensation expense of $17.3 million), in contrast with $91.5 million, or $2.16 loss per share, throughout the identical interval in 2022 (together with non-cash-share-based compensation expense of $13.1 million).
• Internet loss for the three months ended December 31, 2023, was $32.5 million, or $0.53 loss per share (together with non-cash share-based compensation expense of $4.2 million), in contrast with $30.9 million, or $0.73 loss per share, throughout the identical interval in 2022 (together with non-cash-share-based compensation expense of $3.3 million).
• Analysis and growth (R&D) bills have been $87.5 million for the yr ended December 31, 2023, in contrast with $65.1 million throughout the identical interval in 2022. Of this enhance, $14.0 million associated to a rise in exterior growth bills as we proceed to research COMP360 psilocybin remedy in scientific trials and preclinical research. An extra $6.9 million and $1.6 million have been attributable to personnel bills and non-cash share-based compensation respectively, to assist the enlargement of the digital, preclinical and scientific groups in late 2022 and 2023. Different bills elevated by $0.1 million.
• R&D bills have been $27.1 million for the three months ended December 31, 2023, in contrast with $19.8 million throughout the identical interval in 2022. Of this enhance, $3.6 million associated to a rise in exterior growth bills as we proceed to research COMP360 psilocybin remedy in scientific trials and preclinical research. An extra $2.1 million was attributable to personnel bills as a consequence of elevated headcount.  Different bills elevated by $1.2 million, which primarily associated to a rise in exterior consulting charges and non-cash share-based compensation elevated by $0.4 million.
• Normal and administrative (G&A) bills have been $49.4 million for the yr ended December 31, 2023, in contrast with $45.4 million throughout the identical interval in 2022. The rise was partially attributable to a rise of $2.6 million in non-cash share-based compensation, with an additional enhance of $2.0 million and $1.0 million in services and different bills and personnel bills respectively. The will increase have been partially offset by a lower of $1.6 million in authorized {and professional} charges.
• G&A bills have been $11.3 million for the three months ended December 31, 2023, in contrast with $12.4 million throughout the identical interval in 2022. This was attributable to a lower of $1.5 million in personnel bills, partially offset by a rise of $0.5 million in non-cash share-based compensation. There was an additional lower of $0.1 million in authorized {and professional} charges.
• Money and money equivalents have been $220.2 million as of December 31, 2023, in contrast with $143.2 million as of December 31, 2022
• Long run debt was $28.8 million as of December 31, 2023, in contrast with $0 million as of December 31, 2022
• Extra $31.4 million web money raised up to now in first quarter of 2024

Monetary Steerage
First quarter 2024 web money utilized in working actions is anticipated to be within the vary of $17 million to $23 million. This vary consists of the quantity receivable in respect of the 2022 R&D tax credit score within the UK, confirmed by HMRC to be paid in full, however the timing for which is unsure. The total-year 2024 web money utilized in working actions is anticipated to be within the vary of $110 million to $130 million. The money place at December 31, 2023, along with the web money raised up to now within the first quarter, is anticipated to be adequate to fund working bills and capital expenditure necessities into late 2025.

Convention name
The Compass Pathways administration workforce will host a convention name at 8.00am ET (1:00pm UK) on February 29, 2024.
Please register upfront here to entry the decision and procure an area or toll-free telephone quantity and private pin.
A reside webcast of the decision might be out there on Compass Pathway’s web site at: Fourth Quarter 2023 Financial Results . The webcast will even be out there on the Investors section of the Compass Pathways web site. The webcast might be archived for 30 days. The decision will even be webcast on the Compass Pathways web site and archived for 30 days. For extra data, please go to the Compass Pathways web site (ir.compasspathways.com).

About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a psychological well being care firm devoted to accelerating affected person entry to evidence-based innovation in psychological well being. Our focus is on bettering the lives of those that are struggling with psychological well being challenges and who usually are not helped by present remedies. We’re pioneering the event of a brand new mannequin of psilocybin remedy, by which our proprietary formulation of artificial psilocybin, COMP360, is run together with psychological assist. COMP360 has been designated a Breakthrough Remedy by the U.S. Meals and Drug Administration (FDA) and has acquired Progressive Licensing and Entry Pathway (ILAP) designation within the UK for treatment-resistant melancholy (TRD). Now we have commenced a part 3 scientific program of COMP 360 psilocybin remedy in TRD, the biggest randomised, managed, double-blind psilocybin remedy scientific program ever carried out. Beforehand, we accomplished a part 2b examine with prime line information displaying a statistically important (p www.compasspathways.com

Availability of different details about COMPASS Pathways
Traders and others ought to notice that we talk with our traders and the general public utilizing our web site (www.compasspathways.com), our investor relations web site (ir.compasspathways.com), and on social media (LinkedIn), together with however not restricted to investor shows and investor reality sheets, US Securities and Trade Fee filings, press releases, public convention calls and webcasts. The knowledge that we submit on these channels and web sites could possibly be deemed to be materials data. In consequence, we encourage traders, the media, and others thinking about us to overview the knowledge that’s posted on these channels, together with the investor relations web site, frequently. This record of channels could also be up to date every now and then on our investor relations web site and should embody extra social media channels. The contents of our web site or these channels, or another web site which may be accessed from our web site or these channels, shall not be deemed included by reference in any submitting underneath the Securities Act of 1933.

Ahead-looking statements
This press launch incorporates forward-looking statements throughout the that means of the Personal Securities Litigation Reform Act of 1995, as amended. In some circumstances, forward-looking statements might be recognized by terminology reminiscent of “could”, “would possibly”, “will”, “may”, “would”, “ought to”, “anticipate”, “intend”, “plan”, “goal”, “anticipate”, “consider”, “ponder”, “estimate”, “predict”, “potential”, “proceed” and “ongoing,” or the detrimental of those phrases or different comparable terminology, though not all forward-looking statements comprise these phrases. Ahead-looking statements embody specific or implied statements referring to, amongst different issues, COMPASS’s monetary steering, Compass’s enterprise technique and targets, its expectations and projections concerning the firm’s future money wants and monetary outcomes, the anticipated proceeds to be acquired from the pending train of warrants issued within the personal placement and future workout routines, if any, of remaining warrants issued within the personal placement; Compass’s plans and expectations concerning its part 3 trials in TRD, together with its expectations that the part 3 pivotal program is on observe and the time intervals throughout which the outcomes of the 2 Section 3 trials will change into out there, the potential for these part 3 trials or different trials to assist regulatory filings and approvals, the protection or efficacy of its investigational COMP360 psilocybin remedy, together with for remedy of TRD, PTSD, anorexia nervosa, and bipolar II melancholy, Compass’s expectations concerning its ongoing preclinical work and scientific trials, growth efforts and innovation labs and Compass’s plans, expectations and talent to attain its targets associated to the analysis collaboration agreements with Greenbrook TMS and Hackensack Meridian Well being. The forward-looking statements on this press launch are neither guarantees nor ensures, and you shouldn’t place undue reliance on these forward-looking statements as a result of they contain identified and unknown dangers, uncertainties, and different elements, lots of that are past Compass’s management and which may trigger precise outcomes, ranges of exercise, efficiency or achievements to vary materially from these expressed or implied by these forward-looking statements.

These dangers, uncertainties, and different elements embody, amongst others: we would require substantial extra funding to attain our enterprise targets, together with to repay the time period mortgage facility, and if we’re unable to acquire this funding when wanted and on acceptable phrases, we could possibly be pressured to delay, restrict or terminate our product growth efforts; the supply of future tranches underneath the time period mortgage facility relies, partially, on the approval of the lender, achievement of sure milestones and different elements; the danger that the pending warrant workout routines for about $9.0 million in proceeds is not going to settle; scientific growth is prolonged and outcomes are unsure, and subsequently our part 3 scientific trials in TRD and our different scientific trials could also be delayed or terminated; full outcomes from the part 2 examine in post-traumatic stress dysfunction or outcomes from future research is probably not in keeping with the preliminary 24-hour security information; our efforts to acquire advertising and marketing approval from the relevant regulatory authorities in any jurisdiction for COMP360 or any of future product candidates could also be unsuccessful; our growth efforts and our enterprise technique to arrange analysis services and innovation labs includes important prices and sources and could also be unsuccessful; the danger that our analysis collaborations is not going to proceed or is not going to achieve success, together with the danger that Greenbrook TMS’s willingness or potential to finish its obligations underneath the analysis collaboration could also be adversely affected by enterprise mixtures, restructurings or different company transactions, worsening of its monetary place or important modifications in Greenbrook TMS’s technique and our efforts to acquire protection and reimbursement for our investigational COMP360 psilocybin remedy, if authorised, could also be unsuccessful; and people dangers and uncertainties described underneath the heading “Threat Components” in Compass’s most up-to-date annual report on Kind 10-Okay or quarterly report on Kind 10-Q and in different studies we’ve filed with the U.S. Securities and Trade Fee (“SEC”) , which can be found on the SEC’s web site at www.sec.gov. Besides as required by regulation, Compass disclaims any intention or duty for updating or revising any forward-looking statements contained on this press launch within the occasion of latest data, future developments or in any other case. These forward-looking statements are based mostly on Compass’s present expectations and converse solely as of the date hereof.

Enquiries
Media: Amy Lawrence, amy@compasspathways.com, +44 7813 777 919
Traders: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

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