Chimerix Reports Third Quarter 2024 Financial Results and Provides Operational Update
Chimerix (NASDAQ: CMRX) reported Q3 2024 financial results with a net loss of $22.9 million ($0.26 per share), compared to $24.0 million ($0.27 per share) in Q3 2023. Research and development expenses increased to $19.6 million from $17.4 million year-over-year, while general and administrative expenses decreased to $5.2 million from $9.3 million.
The company's Phase 3 ACTION study for dordaviprone remains on track with first interim Overall Survival data expected in Q3 2025. The Independent Data Monitoring Committee recommended continuing the study as planned. Chimerix ended Q3 with $152.4 million in available capital and plans to submit a New Drug Application for Provisional Approval in Australia in the coming months.
Chimerix (NASDAQ: CMRX) ha riportato i risultati finanziari del terzo trimestre 2024 con una perdita netta di $22,9 milioni ($0,26 per azione), rispetto ai $24,0 milioni ($0,27 per azione) del terzo trimestre 2023. Le spese per ricerca e sviluppo sono aumentate a $19,6 milioni da $17,4 milioni rispetto all'anno precedente, mentre le spese generali e amministrative sono diminuite a $5,2 milioni da $9,3 milioni.
Lo studio di Fase 3 ACTION per il dordaviprone procede come previsto, con i primi dati intermedi sulla sopravvivenza complessiva attesi nel terzo trimestre 2025. Il Comitato Indipendente per il Monitoraggio dei Dati ha raccomandato di continuare lo studio come pianificato. Chimerix ha chiuso il terzo trimestre con $152,4 milioni di capitale disponibile e prevede di presentare una Richiesta di Nuovo Farmaco per Approvazione Provvisoria in Australia nei prossimi mesi.
Chimerix (NASDAQ: CMRX) reportó los resultados financieros del tercer trimestre de 2024 con una pérdida neta de $22.9 millones ($0.26 por acción), en comparación con $24.0 millones ($0.27 por acción) en el tercer trimestre de 2023. Los gastos de investigación y desarrollo aumentaron a $19.6 millones desde $17.4 millones año tras año, mientras que los gastos generales y administrativos disminuyeron a $5.2 millones desde $9.3 millones.
El estudio de Fase 3 ACTION de la empresa para el dordaviprone sigue en marcha, con los primeros datos interinos sobre la Supervivencia General esperados para el tercer trimestre de 2025. El Comité Independiente de Monitoreo de Datos recomendó continuar el estudio según lo planeado. Chimerix cerró el tercer trimestre con $152.4 millones en capital disponible y planea presentar una Solicitud de Nuevo Medicamento para Aprobación Provisional en Australia en los próximos meses.
Chimerix (NASDAQ: CMRX)는 2024년 3분기 재무 결과를 발표하였으며, 순손실은 $22.9백만 ($0.26 주당)이며, 이는 2023년 3분기의 $24.0백만 ($0.27 주당)과 비교됩니다. 연구 및 개발 비용은 연간 $17.4백만에서 $19.6백만으로 증가하였고, 일반 및 관리 비용은 $9.3백만에서 $5.2백만으로 감소하였습니다.
회사의 dordaviprone에 대한 3상 ACTION 연구는 계획대로 진행 중이며, 최초의 중간 전체 생존 데이터는 2025년 3분기에 예상됩니다. 독립 데이터 모니터링 위원회는 연구를 계획대로 계속할 것을 권장했습니다. Chimerix는 3분기를 $152.4백만의 자본으로 마감하였으며, 향후 몇 달 내에 호주에서의 임시 승인을 위한 새로운 약물 신청을 제출할 계획입니다.
Chimerix (NASDAQ: CMRX) a annoncé les résultats financiers du troisième trimestre 2024 avec une perte nette de $22,9 millions ($0,26 par action), contre $24,0 millions ($0,27 par action) au troisième trimestre 2023. Les dépenses de recherche et développement ont augmenté à $19,6 millions contre $17,4 millions d'une année sur l'autre, tandis que les dépenses générales et administratives ont diminué à $5,2 millions contre $9,3 millions.
L'étude de phase 3 ACTION de l'entreprise pour le dordaviprone reste sur la bonne voie, avec les premières données intermédiaires sur la survie globale attendues au troisième trimestre 2025. Le Comité Indépendant de Surveillance des Données a recommandé de poursuivre l'étude comme prévu. Chimerix a terminé le troisième trimestre avec $152,4 millions de capital disponible et prévoit de soumettre une Demande de Nouveau Médicament pour Approbation Provisoire en Australie dans les mois à venir.
Chimerix (NASDAQ: CMRX) hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht, mit einem Nettoverlust von $22,9 Millionen ($0,26 pro Aktie), verglichen mit $24,0 Millionen ($0,27 pro Aktie) im dritten Quartal 2023. Die Forschungs- und Entwicklungskosten stiegen im Jahresvergleich auf $19,6 Millionen von $17,4 Millionen, während die allgemeinen und Verwaltungskosten auf $5,2 Millionen von $9,3 Millionen sanken.
Die Phase-3-Studie ACTION des Unternehmens für dordaviprone liegt im Zeitplan, mit den ersten vorläufigen Daten zur Gesamtüberlebensrate, die im dritten Quartal 2025 erwartet werden. Das unabhängige Datenüberwachungskomitee empfahl, die Studie wie geplant fortzusetzen. Chimerix schloss das dritte Quartal mit $152,4 Millionen an verfügbarem Kapital ab und plant, in den kommenden Monaten einen Antrag auf bedingte Zulassung für ein neues Medikament in Australien einzureichen.
- Strong cash position of $152.4 million with no outstanding debt
- Reduction in G&A expenses from $9.3M to $5.2M year-over-year
- Positive IDMC safety review recommendation for Phase 3 ACTION study
- Alignment with TGA for Provisional Approval submission in Australia
- Net loss of $22.9 million in Q3 2024
- Increased R&D expenses to $19.6M from $17.4M year-over-year
Insights
The Q3 2024 results show mixed financial performance. The company reported a
The Phase 3 ACTION study for dordaviprone remains on track, with first interim data expected Q3 2025. The potential provisional approval pathway in Australia could accelerate commercialization timeline to end-2025. However, meaningful revenue generation still appears distant and ongoing R&D expenses will continue to impact cash burn.
The development pipeline shows promising progress. Dordaviprone's unique mechanism targeting H3 K27M-mutant diffuse glioma represents a first-in-class opportunity. The IDMC's safety review recommendation to continue the trial as planned, particularly at higher dosing frequency, provides confidence in the drug's safety profile.
ONC206's early safety data across 80+ patients is encouraging, showing mostly mild to moderate adverse events even at escalated doses. The 10x greater potency compared to dordaviprone and broader potential applications beyond CNS tumors suggest significant pipeline value. The completion of dose escalation studies in 2024 and response data in H1 2025 will be critical milestones.
– Phase 3 ACTION Study On-Track with First Interim Overall Survival Data Expected Third Quarter 2025 –
– IDMC Recommends Continuing Conduct of ACTION Study As-Is Following Preplanned Safety Review –
– Alignment with TGA to Submit Dordaviprone for Provisional Approval in Australia –
– Conference Call at 8:30 a.m. ET Today –
DURHAM, N.C., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today reported financial results for the third quarter ended September 30, 2024 and provided an operational update.
“We have sustained execution of the Phase 3 ACTION study and continue to be encouraged by the safety profile of dordaviprone following the Independent Data Monitoring Committee’s (IDMC) preplanned safety review which recommended continuing study conduct as-is, including at the more intense twice per week dose. Additionally, the Therapeutic Goods Administration (TGA) has granted orphan drug designation to dordaviprone, and we have alignment to file a New Drug Application (NDA) for Provisional Approval in Australia which we expect to occur in the coming months,” said Mike Andriole, Chief Executive Officer of Chimerix. “As we complete the dordaviprone NDA and look toward the balance of the year, we also expect to complete enrollment in a Phase 1 dose escalation study of ONC206 as we consider future development scenarios for this program.”
“In addition, we were delighted to announce the promotion of Dr. Josh Allen to the role of Chief Scientific Officer this quarter. Josh has been instrumental in the discovery and development of the imipridone class of compounds and expect his broad expertise in cancer biology and strong business acumen will underpin Chimerix early phase development for years to come,” added Mr. Andriole.
Dordaviprone (ONC201)
Dordaviprone, a first-in-class imipridone, has the potential to be the first treatment approved for H3 K27M-mutant diffuse glioma. It is an oral small molecule that crosses the blood-brain barrier and selectively binds to the mitochondrial protease ClpP and the dopamine receptor D2 (DRD2). Dordaviprone's unique mechanism of action includes alterations of key epigenetic modifications such as reversal of H3 K27me3-loss which is the hallmark of H3 K27M-mutant gliomas.
Dordaviprone is being evaluated in the Phase 3 ACTION trial that is currently enrolling H3 K27M-mutant diffuse glioma patients at over 145 sites in 15 countries. Chimerix expects interim OS data in the third quarter of 2025. For more information on the ACTION trial, please visit www.clinicaltrials.gov
Earlier this year, Chimerix initiated the evaluation process for dordaviprone to be considered for Provisional Registration in Australia. The Provisional Registration process is a three-step process which begins with a Pre-Submission Meeting evaluating current data, as well as other program features, including the status of pivotal studies. The second step, the Provisional Determination Application, was approved during the third quarter 2024, as was the application for Orphan Drug Designation in Australia. The final step is the NDA submission for Provisional Registration which is expected to occur in the coming months with potential commercial availability as soon as year-end 2025.
ONC206
The imipridone ONC206 is a second generation ClpP agonist and DRD2 antagonist which also crosses the blood-brain barrier and is 10x more potent in vitro than dordaviprone. It has demonstrated monotherapy anti-cancer activity in vivo in central nervous system (CNS) tumor models, as well as in vivo solid tumors models outside of the CNS. The two Phase 1 dose escalation trials conducted in partnership with the Pacific Pediatric Neuro-Oncology Consortium (PNOC) and the National Institutes of Health (NIH) have enrolled over 80 pediatric and adult patients with unselected CNS tumors, with no dose limiting toxicity observed to date.
The safety profile of ONC206 has been consistent across both pediatric and adult populations, with the majority of treatment-related adverse events being mild to moderate, including fatigue, lymphocyte count decrease and vomiting. No significant change in the overall safety profile has been reported to date as dosing has escalated and intensified in frequency from once per week to twice per day on three consecutive days per week. Completion of enrollment in the remaining dose escalation cohorts is expected to occur in 2024.
Assessment of objective responses in patients where a monotherapy treatment effect can be reliably evaluated is ongoing in dose cohorts at or above target exposure thresholds. The company expects to assess any objective responses in the first half of 2025, allowing sufficient time for response onset and confirmation in current and future dose cohorts.
Additionally, ONC206 nonclinical studies remain ongoing to identify candidate oncology indications and biomarkers to inform future development plans.
Corporate
In September 2024, Chimerix promoted Joshua E. Allen, PhD, to the role of Chief Scientific Officer after previously serving as Chief Technology Officer. Dr. Allen co-discovered the anti-cancer activity of ONC201 and co-invented the imipridone class of compounds. He has continuously advanced the research and development of dordaviprone from academic discovery to its registration program, along with the creation and clinical introduction of biologically distinct derivatives. He received his Ph.D. in Biochemistry and Molecular Biophysics from the University of Pennsylvania. Several research publications, patents, grants, and awards reflect his scientific and entrepreneurial efforts in oncology, including recognition on the Forbes 30 under 30 list. Prior to joining Chimerix, Dr. Allen served as Chief Scientific Officer at Oncoceutics.
Third Quarter 2024 Financial Results
Chimerix reported a net loss of
Research and development expenses increased to
General and administrative expenses decreased to
Chimerix’s balance sheet at September 30, 2024 included
Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to discuss third quarter 2024 financial results and provide a business update today at 8:30 a.m. ET. To access the live conference call, please dial 646-307-1963 (domestic) or 800-715-9871 (international) at least five minutes prior to the start time and refer to conference ID 6580777. A live audio webcast of the call will also be available on the Investors section of Chimerix’s website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event.
About Chimerix
Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company’s most advanced clinical-stage development program, dordaviprone (ONC201), is in development for H3 K27M-mutant diffuse glioma. The Company is conducting Phase 1 dose escalation studies of ONC206 to evaluate safety and PK data.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, expectations regarding interim OS data from the ACTION study, plans for Provisional Registration and commercialization in Australia, expectations regarding completion of enrollment and assessment of responses in the ONC206 dose escalation trials, and the characteristics and development of ONC206. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks related to the ability to obtain and maintain accelerated approval; risks related to the timing, completion and outcome of the Phase 3 ACTION study of ONC201; risks associated with repeating positive results obtained in prior preclinical or clinical studies in future studies; risks related to the clinical development of our clinical candidates; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
CONTACT:
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) | |||||||||
(unaudited) | |||||||||
September 30, | December 31, | ||||||||
2024 | 2023 | ||||||||
ASSETS | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 23,645 | $ | 27,661 | |||||
Short-term investments, available-for-sale | 112,585 | 155,174 | |||||||
Accounts receivable | 155 | 4 | |||||||
Prepaid expenses and other current assets | 4,517 | 6,271 | |||||||
Total current assets | 140,902 | 189,110 | |||||||
Long-term investments | 16,201 | 21,657 | |||||||
Property and equipment, net of accumulated depreciation | 281 | 224 | |||||||
Operating lease right-of-use assets | 1,089 | 1,482 | |||||||
Other long-term assets | 195 | 301 | |||||||
Total assets | $ | 158,668 | $ | 212,774 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 5,340 | $ | 2,851 | |||||
Accrued liabilities | 16,904 | 15,592 | |||||||
Total current liabilities | 22,244 | 18,443 | |||||||
Line of credit commitment fee | - | 125 | |||||||
Lease-related obligations | 644 | 1,177 | |||||||
Total liabilities | 22,888 | 19,745 | |||||||
Stockholders’ equity: | |||||||||
Preferred stock, | |||||||||
December 31, 2023; no shares issued and outstanding as of September 30, 2024 and | |||||||||
December 31, 2023; no shares issued and outstanding as of September 30, 2024 and | - | - | |||||||
Common stock, | |||||||||
December 31, 2023; 89,936,053 and 88,929,300 shares issued and outstanding as of | |||||||||
September 30, 2024 and December 31, 2023, respectively | 90 | 89 | |||||||
Additional paid-in capital | 996,389 | 988,457 | |||||||
Accumulated other comprehensive gain, net | 258 | 7 | |||||||
Accumulated deficit | (860,957 | ) | (795,524 | ) | |||||
Total stockholders’ equity | 135,780 | 193,029 | |||||||
Total liabilities and stockholders’ equity | $ | 158,668 | $ | 212,774 | |||||
CHIMERIX, INC. | ||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Revenues: | ||||||||||||||||
Contract and grant revenue | $ | 26 | $ | 11 | $ | 155 | $ | 271 | ||||||||
Licensing revenue | - | - | - | 49 | ||||||||||||
Total revenues | 26 | 11 | 155 | 320 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 19,646 | 17,396 | 56,918 | 53,144 | ||||||||||||
General and administrative | 5,173 | 9,304 | 15,252 | 19,431 | ||||||||||||
Total operating expenses | 24,819 | 26,700 | 72,170 | 72,575 | ||||||||||||
Loss from operations | (24,793 | ) | (26,689 | ) | (72,015 | ) | (72,255 | ) | ||||||||
Other income: | ||||||||||||||||
Interest income and other, net | 1,914 | 2,703 | 6,582 | 8,321 | ||||||||||||
Net loss | (22,879 | ) | (23,986 | ) | (65,433 | ) | (63,934 | ) | ||||||||
Other comprehensive loss: | ||||||||||||||||
Unrealized gain (loss) on debt investments, net | 466 | 188 | 251 | (288 | ) | |||||||||||
Comprehensive loss | $ | (22,413 | ) | $ | (23,798 | ) | $ | (65,182 | ) | $ | (64,222 | ) | ||||
Per share information: | ||||||||||||||||
Net loss, basic and diluted | $ | (0.26 | ) | $ | (0.27 | ) | $ | (0.73 | ) | $ | (0.72 | ) | ||||
Weighted-average shares outstanding, basic and diluted | 89,701,117 | 88,620,666 | 89,531,017 | 88,500,813 | ||||||||||||
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