Financial Data and Key Metrics - Cash used in operations in Q3 2024 was $22.2 million, including a $13.6 million R&D tax credit received in full during the quarter Excluding the tax credit, cash used in operations would have been $35.8 million, within the guidance range of $32 million to $38 million [24] - Cash and cash equivalents stood at $207 million as of September 30, 2024, compared to $228.6 million at the end of Q2 2024 [25] - Debt under the Hercules loan facility was $29.8 million at the end of Q3 2024 [25] - The company expects net cash used in operations to increase to between $37 million and $43 million in Q4 2024, resulting in full-year 2024 cash usage between $114 million and $120 million [24] Business Line Data and Key Metrics - The company is focusing on completing its Phase III trials for COMP360, with significant resources dedicated to ensuring successful recruitment and trial integrity [8][10] - The COMP005 trial, a 52-week study, is now expected to disclose 6-week data in Q2 2025 due to recruitment challenges [8] - The COMP006 trial, with a 26-week blinded portion, is expected to disclose data in the second half of 2026 [16] - The company is reducing its workforce by approximately 30% and externalizing non-COMP360 preclinical efforts to preserve cash and focus on COMP360 trials [26] Market Data and Key Metrics - The company is preparing for the commercialization of COMP360, focusing on establishing billing codes, DEA rescheduling, and health economics research [19] - Strategic collaborations with interventional psychiatry networks are providing insights into optimizing patient flow and scaling the COMP360 operating model [20] - There is significant enthusiasm among healthcare providers for COMP360, with a focus on managing demand and monitoring requirements similar to Spravato [21] Company Strategy and Industry Competition - The company is prioritizing the completion of its Phase III trials for COMP360, with a focus on maintaining trial integrity and ensuring regulatory success [8][16] - COMPASS Pathways is the first company to conduct large-scale psychedelic trials, facing unique challenges due to the complexity of the trials and lack of prior comparable Phase III timelines [9] - The company is leveraging insights from the Lykos AdCom and FDA feedback to refine its regulatory strategy and maintain blinding in its trials [13][14] Management Commentary on Operating Environment and Future Outlook - Management acknowledges the challenges in recruitment and trial complexity but remains confident in the potential impact of COMP360 for patients with treatment-resistant depression (TRD) [16][29] - The company is taking steps to preserve cash, including workforce reduction and externalizing digital tools, to ensure sufficient runway into 2026 [26] - Management emphasizes the importance of maintaining the integrity of the trials and the potential for COMP360 to be a paradigm-changing treatment for TRD [17][29] Other Important Information - The company is exploring externalizing its digital tools and technology to a new company established by its co-founders, with a final decision expected by Q1 2025 [26] - The restructuring and cost-cutting measures are expected to extend the company's cash runway and ensure focus on COMP360's success [26][28] Q&A Session Summary Question: Was the decision to move the top-line readout made after additional FDA correspondence or a face-to-face meeting? [30] - Answer: The decision was made internally by COMPASS out of caution, influenced by observations from the Lykos process and the need to maintain blinding in the 006 trial [31] Question: How do trial recruitment complexities impact real-world use of COMP360? [33] - Answer: Clinical trial settings differ from commercial settings, but the company is learning from trial sites and collaborations to optimize patient flow for commercialization [34][35] Question: Has the regulatory strategy changed for COMP005 and COMP006? [39] - Answer: No changes to the regulatory strategy, with both trials still needed for filing [40] Question: How is the washout of antidepressant medications affecting enrollment? [41] - Answer: The washout rate is over 90%, with no significant logistical obstacles observed [42] Question: What is the expected cash runway given the trial delays? [45] - Answer: The company has $207 million in cash, expected to last into 2026, with restructuring savings aimed at offsetting increased trial costs [45] Question: What needs to be done between final data readouts and launch? [47] - Answer: Focus areas include increasing TRD awareness, educating on COMP360 data, state rescheduling, optimizing patient flow, and preparing for payer discussions [54] Question: Will data from both COMP005 and COMP006 be needed for the NDA submission? [68] - Answer: Yes, data from both trials will be required, and an advisory committee is expected given the Schedule 1 status of the product [69] Question: What is considered a positive outcome in terms of MADRS improvement in Phase III TRD trials? [73] - Answer: Success is defined as detecting a clinically relevant difference in TRD, with adequate power in the studies to show such differences [77] Question: Are dropout rates tracking as expected, and is the company adding patients? [78] - Answer: Attrition rates are below plan, and no changes to sample size are being made [78] Question: What percentage of trial participants will have completed 26 weeks at the 6-week data announcement? [79] - Answer: The company has always guided for releasing 6-week data for COMP005, with no change in this approach [80] Question: Does the Phase III program provide enough data for pretreatment schedules and pricing? [81] - Answer: The company believes the Phase III program will provide important data relevant to payers and dosing schedules [82]

Compass Pathways Announces Third Quarter 2024 Financial Results and Business Updates • Top-line COMP005 data for COMP360 phase 3 pivotal program in treatment-resistant depression now expected in second quarter 2025 • COMP006 data will now be announced after 26-week time point, expected in the second half of 2026 • Strategic reorganization to focus all efforts on COMP360 program resulting in reduction of workforce of approximately 30% • Cash position of $207 million • Conference call on October 31 at 8:00 am ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of Each Class Trading Symbol Name of each exchange on which registered American Depositary Shares, each representing one ordinary share, par value of £0.008 per shareCMPS Nasdaq Global Select Market Form 10-Q ⊠ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ...

imagedepotpro/iStock via Getty Images Listen here or on the go via Apple Podcasts and Spotify Jason Najum has covered the psychedelic space for a long time and contextualizes recent news around the FDA, MDMA, PTSD and Lykos Therapeutics (1:35). Recent news a blessing in disguise for Cybin, COMPASS Pathways and MindMed (14:30)? Trial data and cash in the bank are top signifiers of success (22:35). How Atai fell behind and dropped out of the conversation (24:00). Upcoming catalysts - patience required (26:35) ...

COMPASS Pathways plc (NASDAQ:CMPS) Q2 2024 Earnings Conference Call August 1, 2024 8:00 AM ET Company Participants Stephen Schultz - SVP, IR Kabir Nath - CEO Guy Goodwin - Chief Medical Officer Teri Loxam - CFO Conference Call Participants Ritu Baral - TD Cowen Leonid Timashev - RBC Capital Markets Charles Duncan - Cantor Vikram Purohit - Morgan Stanley Gavin Clark-Gartner - Evercore ISI Sumant Kulkarni - Canaccord Genuity Tom Shrader - BTIG Elemer Piros - Rodman Operator Good day, ladies and gentlemen, and ...

Financial Performance - Net loss for Q2 2024 was $38.1 million, or $0.56 loss per share, compared to $28.3 million, or $0.62 loss per share, in Q2 2023[7] - Net loss for the six months ended June 30, 2024, was $73.288 million, compared to $52.543 million in the same period in 2023[21] - Net loss per share for the six months ended June 30, 2024, was $1.11, compared to $1.19 in 2023[20] - Comprehensive loss for the six months ended June 30, 2024, was $73.243 million, compared to $52.404 million in 2023[21] Operating Expenses - Research and development expenses for Q2 2024 were $29.1 million, up from $19.8 million in Q2 2023, primarily due to advancing COMP360 phase 3 clinical trials[7] - General and administrative expenses for Q2 2024 were $14.3 million, up from $12.8 million in Q2 2023, primarily due to increased personnel expenses[7] - Total operating expenses for the six months ended June 30, 2024, increased to $81.895 million from $64.452 million in 2023[22] - Research and development expenses for the six months ended June 30, 2024, rose to $53.970 million from $38.853 million in 2023[22] - General and administrative expenses for the six months ended June 30, 2024, increased to $27.925 million from $25.599 million in 2023[22] Cash and Debt Position - Cash position of $228.6 million as of June 30, 2024[1] - Long-term debt as of June 30, 2024, was $29.4 million, compared to $28.8 million as of December 31, 2023[7] - Full-year 2024 net cash used in operating activities expected to be in the range of $110 million to $130 million[8] Clinical Trials and Research - Top-line COMP005 data for COMP360 phase 3 pivotal program in treatment-resistant depression expected in Q4 2024[1] - COMP360 phase 2 study in post-traumatic stress disorder showed meaningful and sustained symptom improvement in 22 patients with no serious adverse events reported[4] Tax and Other Financial Items - Benefit from R&D tax credit for the six months ended June 30, 2024, was $6.810 million, slightly down from $6.836 million in 2023[22] - Interest income for the six months ended June 30, 2024, surged to $4.668 million from $1.342 million in 2023[22] - Foreign exchange losses for the six months ended June 30, 2024, were $558,000, compared to gains of $4.061 million in 2023[22] Shareholder Information - Weighted average ordinary shares outstanding for the six months ended June 30, 2024, increased to 66,296,658 from 44,153,772 in 2023[20] Leadership Changes - Gino Santini to join Board of Directors as Chairman effective September 3, 2024[5] - Lori Englebert appointed as Chief Commercial Officer in July 2024[6]

| --- | --- | |-------|-------------------------------------------------------------------------------------| | | UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 | | | Form 10-Q | ⊠ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001 ...

Top-line COMP005 data for COMP360 phase 3 pivotal program in treatment-resistant depression expected in fourth quarter 2024 Gino Santini to join Board of Directors as Chairman Lori Englebert named new Chief Commercial Officer Cash position of $228.6 million Conference call August 1 at 8:00 am ET (1:00 pm UK) LONDON and NEW YORK, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental he ...

The management team will host a conference call at 8:00 am ET (1:00 pm UK) on August 1, 2024. To access the call, please register in advance here to obtain a local or toll-free phone number and your personal pin. About Compass Pathways Availability of other information about Compass Pathways LONDON, July 24, 2024 (GLOBE NEWSWIRE) -- Compass Pathways plc (NASDAQ:CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will ...

Lori's appointment follows that of Teri Loxam as Chief Financial Officer in March 2024 and Dr. Michael Gold as Chief Research & Development Officer in May 2024. All three executive team members bring decades of successful strategic leadership and highly relevant experience in drug development. Forward-looking statements Enquiries LONDON, June 26, 2024 (GLOBE NEWSWIRE) -- Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in ...