COMPASS Pathways Q3 2023 Results: Cash Injection To Sustain Phase 3 Psilocybin Program

COMPASS Pathways plc CMPS, the London-headquartered psychedelics biotech company reported financial results for the third quarter 2023 ended September 30, showing: 

• Cash and cash equivalents of $248.0 million as of Sept. 30, 67% more than that held on last quarter’s closing (June 30,) and 73% than by Dec. 31, 2022.

• Long-term debt of $28.4 million, vs. $28.1 million by June 30 and $0 million by Dec. 2022.

See COMPASS full Q2 results.

• Three and nine month net loss of $33.4 million (or $0.67 per share) and $85.9 million (or $1.81 per share), representing 81.5% and 42.2% increases from the comparable periods in 2022 -$18.4 million (or $0.43 per share) and $60.6 million (or $1.43 per share), respectively.

• Three and nine month R&D expenses of $21.5 million and $60.4 million respectively, a 53.6% and 33.3% rises as per the comparable 2022 periods ($14.0 million and $45.3 million, respectively.)

• Three and nine month general and administrative expenses of $12.5 million and $38.1 million respectively, 7.7% and 15.5% increases from the same periods in 2022 ($11.6 million and $33.0 million, respectively.)

The company’s recent “selected” private placement involved the issuance and sale of a total 16,076,750 American Depositary Shares (ADSs) and warrants to purchase up to 16,076,750 ADSs (titled the PIPE Warrants) at $7.78 each, plus accompanying warrant to purchase one ADS. 

At closing, COMPASS received $125 million in gross proceeds, with final net proceeds totaling $116.9 million. Up to an extra $160 million in gross proceeds would be available at investors discretion. 

The transaction, along with an up to $50 million term loan facility and the sale of shares under the ATM facility, has provided a runway extension to late 2025.

CEO Kabir Nath said the August financing provides “a strong financial foundation” allowing the company to move forward “confidently” with its clinical programs and studies toward a potential New Drug Application (NDA) filing with the FDA.

“We also continue to invest in our pre-commercial work to ensure we are prepared for a successful COMP360 launch, if approved,” Nath added.

Pipeline Features 

Synthetic psilocybin therapeutic COMP360 has received FDA’s designation of Breakthrough Therapy as well as U.K.’s Innovative Licensing and Access Pathway (ILAP), both for Treatment-Resistant Depression (TRD). 

Reportedly the largest ever randomized, controlled, double-blind psilocybin treatment clinical program, COMPASS’ Phase 3 clinical program of COMP360 for TRD is underway. “On track” and progressing, CEO Nath announced the company received a new authorization to begin recruitment “in a number of European clinical trial sites.” 

Composed of two pivotal trials with an integrated long-term outcomes component, the first (COMP 005) administers a single dose monotherapy in 255 TRD participants. Topline data is expected within the summer of 2024.

The second (COMP 006) is a fixed repeat dose monotherapy regimen, administered in 568 TRD  participants. Topline data is expected within mid-2025.

The company expects long-term follow up in each trial will generate data on duration of response and potential effect of retreatment.

Meanwhile, COMP360 is being assessed for two additional conditions, PTSD (Phase 2 trial with topline data expected by the end of 2023) and anorexia nervosa (ongoing Phase 2 trial.)

Additionally, there’s been some managerial changes, including Daphne Karydas’ appointment to the board of directors and Mary-Rose Hughes’ as interim CFO following Mike Falvey’s departure.

Photo: Benzinga edit with photo by anaterate and sergeitokmakov on Pixabay.