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Chimerix(CMRX) - 2023 Q4 - Annual Results
2024-02-28 16:00
Will O'Connor Stern Investor Relations 212-362-1200 Will@sternir.com CHIMERIX, INC. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) | --- | --- | --- | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-----------------|-------|------------| | | | December \n2023 | | 31, ...
Chimerix(CMRX) - 2023 Q4 - Annual Report
2024-02-28 16:00
36 In addition, there are risks involved with both establishing our own sales and marketing capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and time-consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily inc ...
Chimerix(CMRX) - 2023 Q3 - Earnings Call Transcript
2023-11-02 18:50
Financial Data and Key Metrics Changes - The company ended the third quarter with $217 million in cash and equivalents, aligning with previous guidance of approximately $200 million by year-end [22] - The company continues to expect its cash balance to support operations into the end of 2026 and through expected clinical endpoints [10] Business Line Data and Key Metrics Changes - The ACTION study of ONC201 has 113 sites open across 12 countries, exceeding the prior guidance of 100 sites by September 30 [19] - Enrollment in the ACTION study is progressing, with first and second interim overall survival data expected in 2025 [19] Market Data and Key Metrics Changes - The company has seen strong engagement in Europe, evidenced by rapid site activations, while Canada has been slower due to regulatory factors [53] - The company participated in the European Association for Neuro-Oncology Conference, which saw record attendance and increased site activity post-conference [5][4] Company Strategy and Development Direction - The company is preparing for the potential commercialization of ONC201 and is finalizing the recruitment of a Chief Commercial Officer [8] - The company is focused on advancing ONC201 and exploring business development opportunities to broaden its pipeline [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing ACTION study and the potential of ONC201 as a first-in-class therapy for H3 K27M-mutant glioma [13] - The management highlighted the importance of in-person medical conferences for driving engagement and awareness in the neuro-oncology community [5] Other Important Information - The company has approved protocol amendments for ONC206 dose escalation studies, allowing for a more intense dosing schedule [9] - A recent publication in Cancer Discovery supports the efficacy of ONC201 in frontline settings, showing a survival rate of 21.7 months for treated patients compared to 12 months for those who did not receive the treatment [12][11] Q&A Session Summary Question: When is full enrollment expected for the ACTION study? - Management has not provided specific guidance but expects first interim efficacy data in the first half of 2025, suggesting a similar timeline for full enrollment [29] Question: What is the status of ONC206 enrollment? - There are three separate arms ongoing in the Phase I studies, and management expects enrollment to be completed in the first half of 2024, with safety data likely released first [31][32] Question: How long has the GBM patient been on ONC206 therapy? - The patient has been on study for about 1.5 years and has graduated to dose level 4, showing a durable response [36] Question: What data will be presented at the upcoming SNO conference? - Management expects at least three oral presentations on ONC201, focusing on its role as a combinatorial backbone in DMG and associated safety and outcomes [39] Question: What is the expected expense trajectory for the next few quarters? - The company anticipates a similar cash burn rate of approximately $15 million to $17 million per quarter, with a potential uptick in expenses as preparations for commercialization begin [76][78]
Chimerix(CMRX) - 2023 Q3 - Quarterly Report
2023-11-01 16:00
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 CHIMERIX, INC. (Exact Name of Registrant as Specified in Its Charter) Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerate ...
Chimerix(CMRX) - 2023 Q2 - Earnings Call Transcript
2023-08-05 17:10
Chimerix, Inc. (NASDAQ:CMRX) Q2 2023 Earnings Conference Call August 3, 2023 8:30 AM ET Company Participants Michelle Laspaluto - Vice President of Strategic Planning and Investor Relations Mike Andriole - President and CEO Josh Allen - Chief Technology Officer Allen Melemed - Chief Medical Officer Conference Call Participants Kevin Strang - Jefferies Naureen Quibria - Capital One Joel Beatty - Baird Ed White - H.C. Wainwright Soumit Troy - Jones Trading Joseph Thome - TD Cowen Operator Good morning, ladies ...
Chimerix(CMRX) - 2023 Q2 - Earnings Call Presentation
2023-08-05 14:12
• Baseline Performance Status ≥60 • Corticosteroids stable or decreasing for at least 3 days prior to baseline scan • Excluded: DIPG, primary spinal tumors, atypical and non-astrocytic hist., leptomeningeal spread, CSF dissemination -100 • Responses require both imaging and clinical criteria -75 | --- | --- | --- | --- | --- | --- | --- | --- | |-----------------------------------------------|-------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ...
Chimerix(CMRX) - 2023 Q2 - Quarterly Report
2023-08-02 16:00
Financial Performance - Total revenues for the three months ended June 30, 2023, were $26,000, a decrease from $440,000 in the same period of 2022[28]. - Total revenues for the six months ended June 30, 2023, were $309,000, down from $455,000 in the same period of 2022, reflecting a decrease of 32.2%[28]. - The company reported a gross profit of $26,000 for the three months ended June 30, 2023, compared to $341,000 for the same period in 2022[28]. - The net loss for the three months ended June 30, 2023, was $18,576,000, compared to a net loss of $23,468,000 for the same period in 2022, indicating an improvement of 20.3%[28]. - Net loss for the six months ended June 30, 2023, was $39,948,000, compared to a net loss of $48,235,000 for the same period in 2022, representing a 17.5% improvement[32]. - The company reported a comprehensive loss of $19,158,000 for the three months ended June 30, 2023, compared to a comprehensive loss of $23,463,000 for the same period in 2022, an improvement of 18.5%[28]. Expenses - Research and development expenses for the six months ended June 30, 2023, were $35,748,000, a decrease of 3.6% compared to $37,087,000 for the same period in 2022[28]. - Research and development expenses for the three months ended June 30, 2023, were $16,926,000, compared to $18,047,000 for the same period in 2022, a reduction of 6.2%[28]. - Total operating expenses for the six months ended June 30, 2023, were $45,875,000, down from $48,559,000 in the same period of 2022, reflecting a 5.5% reduction[28]. - General and administrative expenses for the three months ended June 30, 2023, were $4,448,000, down from $5,840,000 in the same period of 2022, a decrease of 23.8%[28]. Cash and Assets - Cash and cash equivalents as of June 30, 2023, were $20,099,000, down from $25,842,000 at the end of 2022, indicating a decrease of 22.5%[26]. - Total assets as of June 30, 2023, were $241,085,000, a decrease from $279,341,000 at the end of 2022, representing a decline of 13.7%[26]. - The company had total stockholders' equity (deficit) of $224,112,000 as of June 30, 2023, compared to $256,857,000 at the end of 2022, indicating a decrease of 12.8%[30]. - The accumulated deficit as of June 30, 2023, was $753,377,000, an increase from $713,429,000 as of December 31, 2022[30]. - Cash flows used in operating activities for the six months ended June 30, 2023, were $36,567,000, compared to $34,007,000 for the same period in 2022, showing an increase of 7.5%[32]. Company Information - Chimerix, Inc. is a Delaware corporation and has obtained a registered trademark for Chimerix® in the United States[38]. - The company is classified as a smaller reporting company and has not elected to use the extended transition period for complying with new financial accounting standards[36]. - The common stock of Chimerix, Inc. is traded on The Nasdaq Global Market under the symbol CMRX[36].
Chimerix(CMRX) - 2023 Q1 - Earnings Call Transcript
2023-05-06 21:41
Financial Data and Key Metrics Changes - For Q1 2023, the company reported a net loss of $21.4 million, an improvement from a net loss of $24.8 million in Q1 2022 [17] - Research and development expenses decreased to $18.8 million in Q1 2023 from $19 million in the same period in 2022 [17] - General and administrative expenses slightly increased to $5.7 million in Q1 2023 compared to $5.6 million in Q1 2022 [17] - The company ended Q1 2023 with approximately $246 million in cash and equivalents, with a projected year-end cash of around $200 million sufficient to fund operations into 2027 [18][19] Business Line Data and Key Metrics Changes - The ACTION study is progressing with regulatory approval in nine countries, including recent approval from the European Union [10] - The company is on track for the first efficacy analysis of the ACTION study in early 2025, which will include an overall survival assessment [10] - The dose escalation for ONC206 is expected to complete by the first half of 2024, with ongoing studies indicating potential for broader patient populations [15][19] Market Data and Key Metrics Changes - The company anticipates that approximately two-thirds of patients in the ACTION study will come from the U.S. or North America, with the potential for more than 120 global sites for patient enrollment [24][38] - The company has seen positive feedback and higher-than-expected interest in participation from sites in Europe, which may accelerate patient enrollment [38] Company Strategy and Development Direction - The company is focusing on expanding the potential market for ONC206 beyond H3K27M glioblastoma, with preclinical data suggesting broader activity [33] - The company aims to leverage findings from recent studies to inform future development strategies for both ONC201 and ONC206, particularly in indications exhibiting loss of H3K27 trimethyl [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing trials and the potential for ONC201 and ONC206, highlighting the significance of recent findings related to H3K27 trimethyl loss [11][14] - The company is preparing for a quick submission following the ACTION study, with a focus on maintaining capital efficiency and exploring additional investment opportunities [17][19] Other Important Information - The company is actively collecting tissue and blood samples from patients to support additional molecular assays and studies [45][46] - The financial impact of a previously announced reduction in force is expected to take effect in the current quarter [17] Q&A Session Summary Question: What is the expected split between U.S. and outside U.S. sites for the ACTION study? - Management estimates that most patients will come from the U.S. or North America, approximately two-thirds, with the potential for more than 120 global sites [24] Question: What is the timing for the PFS readout in relation to the OS assessment? - The PFS readout is expected to occur after the initial OS assessment, likely still during 2025 [26] Question: What are the ultimate market opportunities for ONC206 compared to ONC201? - ONC206 has demonstrated activity in non-H3K27M glioblastoma, suggesting a potential market that is significantly larger than that for ONC201 [28][33] Question: Can you provide more details on the future data updates for ONC206? - The focus will be on safety and the ability to escalate dosing safely, with potential efficacy signals expected to emerge as the study progresses [35]
Chimerix(CMRX) - 2023 Q1 - Quarterly Report
2023-05-03 16:00
Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share CMRX The Nasdaq Global Market Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨ Indi ...
Chimerix(CMRX) - 2022 Q4 - Earnings Call Transcript
2023-03-02 15:36
Chimerix, Inc. (NASDAQ:CMRX) Q4 2022 Earnings Conference Call March 2, 2023 8:30 AM ET Company Participants Michelle LaSpaluto - Vice President-Strategic Planning and Investor Relations Mike Sherman - President and Chief Executive Officer Josh Allen - Chief Technology Officer of Imipridones Mike Andriole - Chief Financial and Business Officer Allen Melemed - Chief Medical Officer Conference Call Participants Kevin Strang - Jefferies Joseph Thome - TD Cowen Naureen Quibria - Capital One Securities Soumit Roy ...