Chimerix's NDA for Dordaviprone is under FDA review, with Jazz Pharmaceuticals set to acquire Chimerix in 2025.
Quiver AI Summary
Chimerix, a biopharmaceutical company, announced that the New Drug Application (NDA) for its drug Dordaviprone, aimed at treating recurrent H3 K27M-mutant diffuse glioma, is under review with a Prescription Drug User Fee Act (PDUFA) action date set for August 18, 2025. The company has also revealed that it is being acquired by Jazz Pharmaceuticals, a deal expected to close in the second quarter of 2025. In its financial report for the fourth quarter and full year of 2024, Chimerix reported a net loss of $23 million for the quarter and $88.4 million for the year, with increased research and development expenses attributed to preparations for the drug’s commercial launch. As the acquisition process proceeds, Chimerix will not host a conference call to discuss its earnings results.
Potential Positives
- FDA acceptance of the dordaviprone New Drug Application (NDA) as a significant milestone, potentially improving treatment options for patients with H3 K27M-mutant diffuse glioma.
- Pending acquisition by Jazz Pharmaceuticals, valued at approximately $935 million, which could enhance Chimerix's resources and capabilities for drug development and commercialization.
- Chimerix's strong balance sheet with $140.1 million in capital available to fund operations and no outstanding debt, positioning the company well for upcoming initiatives and developments.
Potential Negatives
- Chimerix reported a net loss of $88.4 million for the full year 2024, which represents an increase from the net loss of $82.1 million in 2023, indicating ongoing financial challenges.
- Research and development expenses rose to $74.6 million for the year ended December 31, 2024, compared to $68.8 million in 2023, reflecting increased investment but also potentially unsustainable operational expenditure.
- The decision not to hold a conference call to discuss the fourth quarter and full year 2024 earnings may indicate a lack of transparency or confidence in the financial results presented.
FAQ
What is the NDA for Dordaviprone?
The NDA for Dordaviprone is for treating recurrent H3 K27M-mutant diffuse glioma, currently under FDA review.
When is the PDUFA action date for Dordaviprone?
The PDUFA action date for Dordaviprone is set for August 18, 2025.
What was Chimerix's financial status for Q4 2024?
Chimerix reported a net loss of $23.0 million for Q4 2024 and had $140.1 million in capital available.
When is the expected closing date for the Jazz acquisition of Chimerix?
The acquisition of Chimerix by Jazz Pharmaceuticals is expected to close in the second quarter of 2025.
What were the research expenses for Chimerix in 2024?
Chimerix reported research and development expenses of $74.6 million for the full year 2024.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$CMRX Insider Trading Activity
$CMRX insiders have traded $CMRX stock on the open market 8 times in the past 6 months. Of those trades, 0 have been purchases and 8 have been sales.
Here’s a breakdown of recent trading of $CMRX stock by insiders over the last 6 months:
- MICHAEL T. ANDRIOLE (PRESIDENT AND CEO) has made 0 purchases and 2 sales selling 9,720 shares for an estimated $42,918.
- MICHELLE LASPALUTO (CHIEF FINANCIAL OFFICER) has made 0 purchases and 2 sales selling 3,275 shares for an estimated $14,367.
- ALLEN S. MELEMED (CHIEF MEDICAL OFFICER) sold 3,065 shares for an estimated $13,798
- DAVID JAKEMAN (VP OF FINANCE AND ACCOUNTING) has made 0 purchases and 2 sales selling 3,100 shares for an estimated $12,829.
- MICHAEL ALBERT ALRUTZ (SVP AND GENERAL COUNSEL) sold 1,600 shares for an estimated $7,226
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$CMRX Hedge Fund Activity
We have seen 30 institutional investors add shares of $CMRX stock to their portfolio, and 46 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- DEERFIELD MANAGEMENT COMPANY, L.P. (SERIES C) added 3,771,342 shares (+inf%) to their portfolio in Q4 2024, for an estimated $13,124,270
- ROSALIND ADVISORS, INC. added 3,050,000 shares (+inf%) to their portfolio in Q4 2024, for an estimated $10,614,000
- MARSHALL WACE, LLP added 2,057,864 shares (+1318.5%) to their portfolio in Q4 2024, for an estimated $7,161,366
- MONACO ASSET MANAGEMENT SAM removed 1,400,782 shares (-33.2%) from their portfolio in Q4 2024, for an estimated $4,874,721
- ACUITAS INVESTMENTS, LLC removed 796,401 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $2,771,475
- ADAGE CAPITAL PARTNERS GP, L.L.C. removed 600,000 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $2,088,000
- RENAISSANCE TECHNOLOGIES LLC removed 518,941 shares (-38.7%) from their portfolio in Q4 2024, for an estimated $1,805,914
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
New Drug Application (NDA) for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma Under Review with Prescription Drug User Fee Act (PDUFA) Action Date of August 18, 2025
Acquisition of Chimerix by Jazz Pharmaceuticals (Jazz) Expected to Close in Second Quarter of 2025
DURHAM, N.C., March 21, 2025 (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 fourth quarter and full-year ended December 31, 2024.
"The recent FDA acceptance of the dordaviprone NDA marks an important milestone for Chimerix and offers renewed hope for patients diagnosed with this life-threatening cancer," said Mike Andriole, Chief Executive Officer of Chimerix. “Our mission to bring dordaviprone to patients globally is greatly enhanced by the pending acquisition of Chimerix by Jazz. We continue to prepare to bring dordaviprone to patients in need as quickly as possible."
Fourth Quarter 2024 Financial Results
Chimerix’s balance sheet at December 31, 2024 included $140.1 million of capital available to fund operations, no outstanding debt, and approximately 92.2 million outstanding shares of common stock.
Chimerix reported a net loss of $23.0 million, or $0.25 per basic and diluted share, for the fourth quarter of 2024, compared to a net loss of $18.2 million, or $0.20 per basic and diluted share for the fourth quarter of 2023.
Research and development expenses increased to $17.7 million for the fourth quarter of 2024, compared to $15.6 million for the same period in 2023.
General and administrative expenses increased to $7.0 million for the fourth quarter of 2024, compared to $5.2 million for the same period in 2023. The increase was mainly due to increased spending on commercial launch preparations.
Full Year 2024 Financial Results
Chimerix reported a net loss of $88.4 million, or $0.99 per basic and diluted share, for the year ended December 31, 2024 compared to a net loss of $82.1 million, or $0.93 per basic and diluted share for the year ended December 31, 2023.
Research and development expenses increased to $74.6 million for the year ended December 31, 2024, compared to $68.8 million for the year ended December 31, 2023.
General and administrative expenses decreased to $22.2 million for the year ended December 31, 2024, compared to $24.6 million for the year ended December 31, 2023.
Transaction with Jazz
On March 5, 2025, Chimerix and Jazz announced that the companies have entered into a definitive merger agreement under which Jazz has agreed to acquire Chimerix for $8.55 per share in cash, for a total consideration of approximately $935 million. The transaction is expected to close in the second quarter of 2025, subject to customary closing conditions, including the tender of a majority of the outstanding shares of Chimerix’s voting common stock and other conditions.
In light of the pending acquisition by Jazz, Chimerix will not hold a conference call to discuss its fourth quarter and full year 2024 earnings.
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, is in development for H3 K27M-mutant 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: Jazz’s proposed acquisition of Chimerix, the anticipated occurrence, manner and timing of the proposed tender offer, the closing of the proposed acquisition and the prospective benefits of the proposed acquisition; the initial potential PDUFA timing; and other statements that are not historical facts. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are: uncertainties as to the timing of the tender offer; uncertainties as to how many of Chimerix’s stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay, or refuse to grant approval for the consummation of the transaction (or only grant approval subject to adverse conditions or limitations); the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the possibility that the transaction does not close; the risk that competing offers or acquisition proposals will be made; the effects of the transaction on relationships with employees, customers, suppliers, other business partners or governmental entities; significant transaction costs; the risk of litigation and/or regulatory actions related to the proposed acquisition; effectively launching and commercializing products and product candidates such as dordaviprone, if approved; the successful completion of development and regulatory activities with respect to dordaviprone; obtaining and maintaining adequate coverage and reimbursement; the time-consuming and uncertain regulatory approval process, including the risk that Chimerix’s NDA for dordaviprone seeking accelerated approval for treatment of H3 K27M-mutant diffuse glioma in adult and pediatric patients with progressive disease following prior therapy may not be approved by FDA in a timely manner or at all; the costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients, including with respect to current and planned future clinical trials of dordaviprone; global economic, financial, and healthcare system disruptions; 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
[email protected]
[email protected]
CHIMERIX, INC. | ||||||||||||
CONSOLIDATED BALANCE SHEETS | ||||||||||||
(in thousands, except share and per share data) | ||||||||||||
December 31, | December 31, | |||||||||||
2024 | 2023 | |||||||||||
ASSETS | ||||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | $ | 31,049 | $ | 27,661 | ||||||||
Short-term investments, available-for-sale | 100,594 | 155,174 | ||||||||||
Accounts receivable | 57 | 4 | ||||||||||
Prepaid expenses and other current assets | 4,251 | 6,271 | ||||||||||
Total current assets | 135,951 | 189,110 | ||||||||||
Long-term investments | 8,475 | 21,657 | ||||||||||
Property and equipment, net of accumulated depreciation | 417 | 224 | ||||||||||
Operating lease right-of-use assets | 951 | 1,482 | ||||||||||
Other long-term assets | 214 | 301 | ||||||||||
Total assets | $ | 146,008 | $ | 212,774 | ||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||||
Current liabilities: | ||||||||||||
Accounts payable | $ | 3,938 | $ | 2,851 | ||||||||
Accrued liabilities | 19,933 | 15,592 | ||||||||||
Total current liabilities | 23,871 | 18,443 | ||||||||||
Line of credit commitment fee | - | 125 | ||||||||||
Lease-related obligations | 458 | 1,177 | ||||||||||
Total liabilities | 24,329 | 19,745 | ||||||||||
Stockholders’ equity: | ||||||||||||
Preferred stock, $0.001 par value, 10,000,000 shares authorized at December 31, 2024 and | ||||||||||||
2023; no shares issued and outstanding as of December 31, 2024 and 2023 | - | - | ||||||||||
Common stock, $0.001 par value, 200,000,000 shares authorized at December 31, 2024 and | ||||||||||||
2023; 92,209,175 and 88,929,300 shares issued and outstanding as of December 31, 2024 | ||||||||||||
and 2023, respectively | 92 | 89 | ||||||||||
Additional paid-in capital | 1,005,475 | 988,457 | ||||||||||
Accumulated other comprehensive gain, net | 23 | 7 | ||||||||||
Accumulated deficit | (883,911 | ) | (795,524 | ) | ||||||||
Total stockholders’ equity | 121,679 | 193,029 | ||||||||||
Total liabilities and stockholders’ equity | $ | 146,008 | $ | 212,774 | ||||||||
CHIMERIX, INC. | |||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||||||
Three Months Ended
December 31, |
Years Ended
December 31, |
||||||||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||||||||
Revenues: | |||||||||||||||||||||
Contract and grant revenue | $ | 57 | $ | 4 | $ | 212 | $ | 275 | |||||||||||||
Licensing revenue | - | - | - | 49 | |||||||||||||||||
Total revenues | 57 | 4 | 212 | 324 | |||||||||||||||||
Operating expenses: | |||||||||||||||||||||
Research and development | 17,656 | 15,644 | 74,574 | 68,788 | |||||||||||||||||
General and administrative | 6,953 | 5,170 | 22,205 | 24,601 | |||||||||||||||||
Total operating expenses | 24,609 | 20,814 | 96,779 | 93,389 | |||||||||||||||||
Loss from operations | (24,552 | ) | (20,810 | ) | (96,567 | ) | (93,065 | ) | |||||||||||||
Other income: | |||||||||||||||||||||
Interest income and other, net | 1,598 | 2,649 | 8,180 | 10,970 | |||||||||||||||||
Net loss | (22,954 | ) | (18,161 | ) | (88,387 | ) | (82,095 | ) | |||||||||||||
Other comprehensive (loss) income: | |||||||||||||||||||||
Unrealized (loss) income on investments, net | (235 | ) | 632 | 16 | 344 | ||||||||||||||||
Comprehensive loss | $ | (23,189 | ) | $ | (17,529 | ) | $ | (88,371 | ) | $ | (81,751 | ) | |||||||||
Per share information: | |||||||||||||||||||||
Net loss, basic and diluted | $ | (0.25 | ) | $ | (0.20 | ) | $ | (0.99 | ) | $ | (0.93 | ) | |||||||||
Weighted-average shares outstanding, basic and diluted | 90,261,484 | 88,910,300 | 89,699,074 | 88,604,026 |