Chimerix(US:CMRX)2024-05-01 12:36Financial 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].