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Core Insights - Chimerix, a biopharmaceutical company, focuses on developing medicines to improve and extend the lives of patients with deadly diseases [1][3] - The CEO, Mike Andriole, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 6, 2024 [1] - The company's leading clinical-stage program, ONC201, targets H3 K27M-mutant glioma [3] Company Information - Chimerix is dedicated to creating impactful treatments for patients facing severe health challenges [3] - The company has a significant focus on advancing its clinical-stage development programs [3]

Financial Data and Key Metrics Changes - The company reported a net loss of $21.9 million or $0.25 per basic and diluted share for Q1 2024, compared to a net loss of $21.4 million or $0.24 per share in Q1 2023 [39] - Research and development expenses remained flat at $18.8 million compared to the same period in 2023, while general and administrative expenses decreased to $5.5 million from $5.7 million [39][39] Business Line Data and Key Metrics Changes - The Phase 1 evaluation of ONC206 is on track, with dose escalation studies completed without limiting safety signals, now moving to an intensified dose schedule [2][3] - The ACTION study, which is central to the company's strategy, is progressing with steady state accrual and is expected to provide the first interim readout next year [8] Market Data and Key Metrics Changes - The company is exploring global registration pathways for dordaviprone (ONC201) to accelerate access, particularly in Australia, where a provisional registration process is underway [81][82] - The company anticipates that the filing for provisional registration in Australia could be submitted by the end of 2024, with potential commercial availability in 2026 [89] Company Strategy and Development Direction - The primary strategic focus for the company this year is the continued enrollment in the Phase 3 ACTION study, which addresses a significant unmet need in neuro-oncology [77][79] - The company is preparing development strategies for ONC206, with expectations to share details before the end of the year as they approach a Phase 2 investment decision [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile and therapeutic window of ONC206, indicating that the ongoing studies are expected to yield promising results [10][12] - The company remains disciplined in financial management, with a cash balance sufficient to support operations into Q4 2026 [38] Other Important Information - The company has $188.2 million in capital available to fund operations and no outstanding debt, positioning it as one of the most capital-efficient Phase 3 companies in its peer group [13] - The company is leveraging clinical experience from dordaviprone to inform the development of ONC206, focusing on tumors that do not harbor the H3 K27M mutation [11][12] Q&A Session Summary Question: Enrollment for the Phase 3 ACTION study - Management confirmed that the additional five sites added were part of the initial tranche and are strategically located to optimize enrollment, with expectations for the first interim overall survival (OS) data in 2025 [16][24] Question: Filing application submission to the Australia TGA - Management discussed the gating factors for the application, indicating that the submission is not contingent on Phase 3 trial data but rather on ensuring the trial is well underway [17][47] Question: Commercial opportunity in Australia - Management expressed optimism regarding the commercial potential in Australia, highlighting the efficient network in the neuro-oncology community and the potential for in-country collaborations [49][50] Question: Future studies for ONC206 - Management indicated that both adult and pediatric trials for ONC206 are proceeding in parallel, with expectations to report safety and pharmacokinetic data from both studies [51][51] Question: Overlap between H3 K27M and BRAF alteration - Management clarified that H3 K27M does not co-occur with other actionable mutations, and the focus remains on the frontline setting for the Phase 3 trial [64][64]

Financial Performance - The Company reported total share-based compensation expense of $2.749 million for the three months ended March 31, 2024, compared to $4.363 million for the same period in 2023, reflecting a decrease of approximately 37%[152]. - For the three months ended March 31, 2024, the company reported no revenue compared to $0.3 million for the same period in 2023, a decrease of 100%[181]. - Total revenues for the three months ended March 31, 2023, were $283,000, a decrease of 100% compared to the previous year[210]. - Net loss for the three months ended March 31, 2023, was $21,372,000, a decrease of 2.3% compared to the previous year[210]. - Net cash used in operating activities was $17,518,000, an improvement from $22,225,000 in the same period last year[218]. - Net cash provided by investing activities was $8,675,000, down from $12,135,000 year-over-year[218]. Research and Development - Research and development expenses for the three months ended March 31, 2024, amounted to $1.870 million, down from $2.312 million in the same period of 2023, indicating a reduction of about 19%[152]. - Total research and development expenses for the three months ended March 31, 2024, were $18.844 million, slightly up from $18.822 million in the same period of 2023[204]. - Direct research and development expenses were $10.692 million for the three months ended March 31, 2024, compared to $11.260 million in the same period of 2023, a decrease of 5%[204]. - The company incurred significant research and development expenses related to the continued development of imipridone compounds, including ONC206 and ONC212[181]. - The ACTION trial for dordaviprone is currently enrolling 450 patients across 135 sites in 13 countries, with interim overall survival analyses expected in 2025[188]. - The company is working towards Provisional Registration for dordaviprone in Australia, with a potential filing around year-end and possible commercial availability in 2026[189]. - ONC212 has completed IND-enabling toxicology studies and is being explored pre-clinically in collaboration with MD Anderson Cancer Center and Brown University[192]. - The Company expects to report preliminary safety and pharmacokinetic data for ONC206 in mid-2024, which is currently in Phase 1 dose escalation trials[164]. Revenue and Funding - The Company generated modest, non-recurring revenue from product sales, with total revenue primarily derived from government grants and collaboration agreements since inception, except for 2022[168]. - An upfront cash payment of approximately $238 million was received from Emergent BioSolutions as part of an asset sale, with potential additional milestone payments of up to $124 million[169]. - The company has a deferred revenue balance of $0.1 million related to cost-plus-fixed-fee grants as of March 31, 2024, with no grant revenue recognized for the same period[200]. Stock and Equity - As of March 31, 2024, the Company has 1.8 million shares available for purchase under the Employee Stock Purchase Plan (ESPP)[150]. - The Company maintains a 2013 Equity Incentive Plan with 0.5 million shares reserved for future issuance as of March 31, 2024[149]. Regulatory and Market Risks - The company faces risks related to obtaining regulatory approvals, which could impact revenue generation and profitability[275]. - Clinical trials for product candidates may face delays, increased costs, and potential suspension due to various factors, impacting the approval process and market entry[277][279][280]. - The company relies on third parties for the development of companion diagnostics for dordaviprone, which may affect FDA approval and marketing authorization if not successfully obtained[282]. Financial Position and Control - The company has recorded a full valuation allowance against its deferred tax assets due to a history of cumulative losses, indicating uncertainty in future profitability[155]. - The company has a secured revolving loan facility of up to $50 million, with no amounts drawn as of March 31, 2024[215]. - The Loan Agreement was amended to extend the term to September 30, 2026, and increase the unused line fee on the unused portion[215]. - There have been no material changes to the internal control over financial reporting during Q1 2024 that could affect the company's financial reporting[285]. Strategic Initiatives - The company is conducting a review of potential transaction opportunities to build its product candidate pipeline, including licensing, mergers, or acquisitions[197]. - The company has not marketed or sold any of its current product candidates, indicating a focus on development[272].

[Chimerix First Quarter 2024 Financial Results and Operational Update](index=1&type=section&id=Chimerix%20First%20Quarter%202024%20Financial%20Results%20and%20Operational%20Update) [Operational Update](index=1&type=section&id=Operational%20Update) Chimerix is advancing its lead drug candidate, dordaviprone, and second-generation drug, ONC206, alongside a Board of Directors change [Dordaviprone (ONC201)](index=1&type=section&id=Dordaviprone%20(ONC201)) The company is advancing the Phase 3 ACTION study for dordaviprone and pursuing a provisional registration pathway in Australia - The Phase 3 ACTION study is enrolling **450 patients** across 135 sites in 13 countries to evaluate dordaviprone for H3 K27M-mutant glioma[20](index=20&type=chunk) - Key data readouts for the ACTION study are expected with interim Overall Survival (OS) data in **2025** and final OS data in **2026**[3](index=3&type=chunk)[19](index=19&type=chunk) - Chimerix is advancing dordaviprone in Australia's Provisional Registration process after a positive Pre-Submission Meeting with the TGA[1](index=1&type=chunk)[21](index=21&type=chunk) [ONC206](index=2&type=section&id=ONC206) ONC206 is progressing in Phase 1 trials for CNS tumors, with preliminary safety and pharmacokinetic data expected in mid-2024 - ONC206 is a second-generation ClpP agonist and DRD2 antagonist being evaluated in Phase 1 dose escalation trials for CNS tumors[3](index=3&type=chunk)[29](index=29&type=chunk) - To date, ONC206 has been **generally well tolerated** with no dose-limiting toxicities reported in ongoing Phase 1 studies[3](index=3&type=chunk)[9](index=9&type=chunk) - Preliminary safety and pharmacokinetic (PK) data from the Phase 1 studies are expected to be reported starting in **mid-2024**[3](index=3&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) The company appointed Marc D Kozin to its Board of Directors and announced the retirement of Patrick Machado - Marc D. Kozin was appointed to the Company's Board of Directors in **March 2024**[13](index=13&type=chunk) - Patrick Machado will retire from the Board in **June 2024** after ten years of service[13](index=13&type=chunk) [First Quarter 2024 Financial Results](index=2&type=section&id=First%20Quarter%202024%20Financial%20Results) The company reported a Q1 2024 net loss of $21.9 million with stable operating expenses and ended the quarter with $188.2 million in capital [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Chimerix reported a Q1 2024 net loss of $21.9 million, slightly increased from Q1 2023, with stable R&D and G&A expenses Q1 2024 vs Q1 2023 Financial Highlights (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total Revenues | $0 | $283 | | R&D Expenses | $18,844 | $18,822 | | G&A Expenses | $5,546 | $5,679 | | Loss from Operations | $(24,390) | $(24,218) | | Net Loss | $(21,869) | $(21,372) | | Net Loss per Share | $(0.25) | $(0.24) | - The company ended Q1 2024 with **$188.2 million in capital** available to fund operations and **no outstanding debt**[24](index=24&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) The balance sheet shows total assets of $194.0 million as of March 31, 2024, with the statement of operations detailing the net loss Consolidated Balance Sheet Summary (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total Assets** | **$194,042** | **$212,774** | | Total Current Assets | $163,032 | $189,110 | | **Total Liabilities** | **$19,940** | **$19,745** | | Total Current Liabilities | $18,935 | $18,443 | | **Total Stockholders' Equity** | **$174,102** | **$193,029** | Consolidated Statement of Operations Summary (in thousands) | Account | Three Months Ended March 31, 2024 | | :--- | :--- | | Total Revenues | $0 | | Total Operating Expenses | $24,390 | | Loss from Operations | $(24,390) | | Net Loss | $(21,869) | [Other Information](index=3&type=section&id=Other%20Information) This section provides details on the investor conference call, forward-looking statements, and a company overview [Conference Call and Webcast](index=3&type=section&id=Conference%20Call%20and%20Webcast) Chimerix held a conference call and webcast to discuss Q1 2024 financial results and provide a business update - A conference call and webcast were held at 8:30 a.m. ET on **May 1, 2024**, to discuss Q1 2024 results and provide a business update[32](index=32&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) The press release contains forward-looking statements regarding drug development and regulatory approvals that are subject to risks - The report contains forward-looking statements concerning regulatory applications, the ACTION study, and ONC206 development, which are subject to risks[6](index=6&type=chunk) [About Chimerix](index=3&type=section&id=About%20Chimerix) Chimerix is a biopharmaceutical company focused on developing medicines for deadly diseases like H3 K27M-mutant glioma - Chimerix is a biopharmaceutical company whose lead clinical program, ONC201, is in development for H3 K27M-mutant glioma[25](index=25&type=chunk)

– Dordaviprone (ONC201) ACTION Study Progressing; Reiterates Expectations for Interim Overall Survival (OS) Data in 2025 and Final OS Data in 2026 – – No Dose Limiting Toxicity in ONC206 Phase 1 Studies to Date, Preliminary Phase 1 Safety and Pharmacokinetic (PK) Data Expected This Summer – – Company to Advance Dordaviprone in Provisional Registration Process Following Positive Interaction with Therapeutic Goods Administration (TGA) in Australia – – Conference Call at 8:30 a.m. ET Today – DURHAM, N.C., Ma ...

DURHAM, N.C., April 24, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced that it will host a live conference call and audio webcast on Wednesday, May 1, 2024 at 8:30 a.m. ET to report financial results for the first quarter ended March 31, 2024, and to provide a business overview. To access the live conference call, please dial (646) 307-1963 (d ...

DURHAM, N.C., March 21, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the appointment of Marc D. Kozin as the newest member of the Company's Board of Directors. In addition, Patrick Machado has announced his retirement from the Chimerix Board effective at the Company's 2024 Annual Meeting of Stockholders in June, after ten years of service. " ...

onurdongel Topline Summary Chimerix, Inc (NASDAQ:CMRX) is a microcap biotech stock focused mainly on development of novel treatments for subsets of high-grade glioma, a form of brain cancer, as well as other therapies. While they have the same serious risks of pipeline failure that all developmental biotechs carry, the fact that they have double their market cap in assets and a 2+ year runway gives a lot of fuel for the investment thesis. For the conservative investor, I don't think there's enough here ...

Financial Data and Key Metrics Changes - The company ended 2023 with over $204 million in capital, demonstrating disciplined fiscal management throughout the year [1] - For Q4 2023, the company reported a net loss of $18.2 million or $0.20 per share, an improvement from a net loss of $21 million or $0.24 per share in Q4 2022 [80] - The total net burn for the year was approximately $61.5 million, averaging over $15 million per quarter, with expectations that the cash balance will support operations into Q4 2026 [81] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $15.6 million in Q4 2023 from $19.3 million in Q4 2022, primarily due to workforce reduction costs related to the divestiture of TEMBEXA [2] - General and administrative expenses remained flat at $5.2 million compared to $5.3 million in the same period last year [2] Market Data and Key Metrics Changes - The company is currently operating in 13 countries and has opened over 130 sites, with plans to expand into additional high-demand regions such as Brazil, Argentina, Hong Kong, and Singapore [95][42] - There is a high demand for the ONC201 program, with patients traveling internationally to participate in the study, indicating a significant unmet need in the market [58][41] Company Strategy and Development Direction - The company remains focused on advancing the Phase 3 ACTION study of ONC201 and completing ONC206 dose escalation studies, with a strong emphasis on disciplined execution and urgency [26][49] - The management team is committed to maximizing future growth potential for both patients and shareholders, with strategic additions to the team aimed at enhancing operational capabilities [36][48] - The company plans to use gated milestones to guide commercial efforts and ensure timely and cost-effective preparations for potential commercialization [92] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the future impact of the company on patients, emphasizing the resilience of patients and families involved in studies [39] - The company is encouraged by early indicators of enrollment trends and is optimistic about the potential for pivotal data in 2024 [28][43] - There is an acknowledgment of the challenges in the neuro-oncology field, but management remains motivated by the demand for new solutions in high-grade glioma treatment [40][46] Other Important Information - The company is assessing the feasibility of expanding the ACTION study into regions with high demand, ensuring that any expansion is prudent and efficient [101] - The recent publication of ONC201 Phase 2 data has accelerated awareness of the program, particularly outside the U.S., which is expected to aid enrollment efforts [57] Q&A Session Summary Question: Can you provide an update on ONC206 Phase 1 dose escalation and safety data? - Management indicated that they are progressing through dose levels and expect to reach level 11 by mid-year, with plans to report safety and PK data [71][85] Question: How is the company addressing geographic differences in patient care? - Management stated that they are carefully evaluating new site expansions and ensuring that enrollment criteria are sufficient to streamline processes across different regions [79] Question: What is the company's strategy for commercialization in international markets? - The company sees the majority of value for ONC201 in the U.S. and is prepared to commercialize efficiently, while also considering partnerships in challenging markets like Europe [108][109]