NeonMind Publicizes Determination to Search A Purchaser For Drug Growth Program

George Goldsmith, Govt Chairman of COMPASS Pathways, stated, “With the announcement of our pivotal Section 3 COMP360 program design for treatment-resistant melancholy, we’re one other necessary step nearer to our aim of bringing COMP360 psilocybin remedy to the big variety of sufferers who are usually not at the moment served by current therapies and urgently want new therapy choices. We’re additionally thrilled with the publication of the COMP360 Section 2b trial in The New England Journal of Medication , the world’s main peer-reviewed medical publication, reinforcing the rigour and scale of this research.”

Kabir Nath, Chief Govt Officer, added, “The COMP360 Section 3 pivotal program in treatment-resistant melancholy is designed to generate the proof required for regulatory approval and to make sure industrial success by way of integration into healthcare programs. We’re on monitor to start out the Section 3 program this yr and we’re making regular progress towards establishing the complete world footprint for this program, which incorporates actively initiating new websites and coaching therapists. We’re additionally advancing the opposite necessary components of our enterprise which can be tied to the COMP360 program, particularly industrial and digital, which we featured in our latest Capital Markets Day presentation. Past this Section 3 program, we proceed to increase our medical growth of COMP360 psilocybin remedy with ongoing Section 2 trials in anorexia nervosa and PTSD.”

Enterprise highlights

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

• Section 3 program on monitor to begin in 2022
• Program composed of two pivotal trials and one long-term outcomes research
  • Pivotal trial 1 (COMP 005): single dose monotherapy, n=378
    • High line knowledge anticipated finish 2024
  • Pivotal trial 2 (COMP 006): mounted repeat dose monotherapy, n=568
    • High line knowledge anticipated mid 2025
  • Objective is to supply the proof wanted for FDA approval and payor reimbursement
  • A number of medical websites have been initiated
• Section 2b trial printed in The New England Journal of Medication
• Section 2b long-term observe up research full
  • Outcomes supportive of Section 3 program design

Further COMP360 growth actions:

• Section 2 trials in anorexia nervosa ongoing throughout 4 world-leading analysis institutes within the UK and US (College of California San Diego College of Medication, Sheppard Pratt, King’s School London and Columbia College Medical Middle)
• Section 2 trial in post-traumatic stress dysfunction (PTSD) ongoing at Mt. Sinai Hospital in New York Metropolis and King’s School London
• Investigator-led research in adults with autism spectrum dysfunction (ASD) launched, the primary ever mechanistic research of psilocybin in autistic adults, co-sponsored by Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s School London and South London and Maudsley NHS Basis Belief
• 10 granted patents issued up to now masking composition, formulation and methodology of use
• Investigator-initiated research underway throughout quite a few further indications

Monetary highlights

• Web loss for the three months ended 30 September 2022 was $18.4 million, or $0.43 loss per share (together with non-cash share-based compensation expense of $3.5 million), in contrast with $15.8 million or $0.38 loss per share, throughout the identical interval in 2021 (together with non-cash-share-based compensation expense of $2.3 million).
• Web loss for the 9 months ended 30 September 2022 was $60.6 million, or $1.43 loss per share (together with non-cash share-based compensation expense of $9.8 million), in contrast with $46.1 million or $1.17 loss per share, throughout the identical interval in 2021 (together with non-cash-share-based compensation expense of $5.9 million).
• Analysis and growth (R&D) bills have been $14.0 million for the three months ended 30 September 2022, in contrast with $12.2 million throughout the identical interval in 2021. Of this enhance, $1.1 million was attributable to a rise in different bills, which primarily associated to a rise in exterior consulting bills. An additional $0.8 million and $0.6 million have been attributable to personnel bills and non-cash share-based compensation respectively, as a consequence of elevated headcount. Exterior growth bills decreased by $0.8 million total, primarily attributable to decreased medical trial bills that are anticipated to extend considerably within the close to future because the Section 3 program initiates.
• R&D bills have been $45.3 million for the 9 months ended 30 September 2022, in contrast with $30.4 million throughout the identical interval in 2021. Of this enhance, $5.1 million pertains to a rise in personnel bills, as a consequence of elevated headcount. $4.5 million pertains to a rise in exterior growth bills because the Firm continues to analyze COMP360 psilocybin remedy in medical and pre-clinical trials. An additional $2.7 million was attributable to elevated different bills primarily associated to a rise in exterior consulting bills. As well as, non-cash share-based compensation elevated by $2.5 million, as a consequence of elevated headcount.
• Basic and administrative (G&A) bills have been $11.6 million for the three months ended 30 September 2022 in contrast with $9.6 million throughout the identical interval in 2021. The rise was attributable to a rise of $0.6 million in authorized {and professional} charges. An additional enhance of $0.6 million and $0.4 million was attributable to non-cash share-based compensation and personnel bills respectively, as a consequence of elevated headcount. There was an extra enhance of $0.4 million in amenities and different bills.
• G&A bills have been $33.0 million for the 9 months ended 30 September 2022 in contrast with $24.5 million throughout the identical interval in 2021. The rise was attributable to a rise of $3.7 million in authorized {and professional} charges. An additional $2.1 million and $1.4 million have been attributable to personnel bills and non-cash share-based compensation respectively, as a consequence of elevated headcount. There was an extra enhance of $1.2 million in amenities and different bills.
• Money and money equivalents have been $173.1 million as of 30 September 2022, in contrast with $273.2 million as of 31 December 2021.

Convention name
The COMPASS Pathways administration workforce will host a convention name at 8.00am ET (12.00pm UK) on 3 November 2022.
Please register upfront right 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: Third Quarter 2022 Monetary Outcomes .
The webcast may even be out there on the Buyers part of the COMPASS Pathways web site. The webcast might be archived for 30 days.
The decision may 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 are usually not helped by present therapies. 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 help. COMP360 has been designated a Breakthrough Remedy by the US Meals and Drug Administration (FDA) and has acquired Progressive Licensing and Entry Pathway (ILAP) designation within the UK, for treatment-resistant melancholy (TRD). We now have accomplished a section 2b medical trial of psilocybin remedy for TRD, in 22 websites throughout Europe and North America and we’re getting ready to begin a section 3 program by the top of 2022. This section 2b trial was the biggest randomised, managed, double-blind psilocybin remedy medical trial ever performed, and our topline knowledge confirmed a statistically vital (p www.compasspathways.com .

Availability of different details about COMPASS Pathways
Buyers and others ought to notice that we talk with our buyers 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 displays and investor truth sheets, US Securities and Trade Fee filings, press releases, public convention calls and webcasts. The knowledge that we put up on these channels and web sites may very well be deemed to be materials data. Consequently, we encourage buyers, the media, and others desirous about us to overview the data that’s posted on these channels, together with the investor relations web site, regularly. This checklist of channels could also be up to date sometimes on our investor relations web site and should embrace further social media channels. The contents of our web site or these channels, or every other web site which may be accessed from our web site or these channels, shall not be deemed integrated by reference in any submitting underneath the Securities Act of 1933.

Ahead-looking statements
This press launch accommodates forward-looking statements inside the that means of the Personal Securities Litigation Reform Act of 1995, as amended. In some circumstances, forward-looking statements will be recognized by terminology similar to “could”, “would possibly”, “will”, “might”, “would”, “ought to”, “count on”, “intend”, “plan”, “goal”, “anticipate”, “imagine”, “ponder”, “estimate”, “predict”, “potential”, “proceed” and “ongoing,” or the detrimental of those phrases or different comparable terminology, though not all forward-looking statements include these phrases. Ahead-looking statements embrace categorical or implied statements referring to, amongst different issues, COMPASS’s enterprise technique and objectives, the anticipated timing for beginning our Section 3 medical program of COMP360 psilocybin remedy in TRD and anticipated timing for finishing our Section 3 program and offering top-line knowledge, the protection or efficacy of its investigational COMP360 psilocybin remedy, together with for therapy of TRD, anorexia nervosa or PTSD, and COMPASS’s expectations concerning its ongoing preclinical work and medical trials, growth efforts and innovation labs. 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, a lot of that are past COMPASS’s management and which might 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 embrace, amongst others: preclinical and medical growth is prolonged and unsure, and due to this fact our preclinical research and medical trials could also be delayed or terminated, or could by no means advance to or within the clinic; our growth efforts and our enterprise technique to arrange analysis amenities and innovation labs will contain vital prices and assets and could also be unsuccessful; and people dangers and uncertainties described underneath the heading “Danger Components” in COMPASS’s most up-to-date annual report on Kind 10-Ok or quarterly report on Kind 10-Q and in different stories we’ve got 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 accountability 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 primarily based on COMPASS’s present expectations and converse solely as of the date hereof.

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

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COMPASS PATHWAYS PLC
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