Dordaviprone

Chimerix began attracting deal interest in its experimental brain tumor treatment about 18 months before it signed a $935 million cash exit to Jazz Pharmaceuticals earlier this month, according to a Friday regulatory filing . The filing highlights the broad interest that Chimerix was able to garner for dordaviprone, a potential first-ever medicine for H3 K27M-mutant diffuse glioma. Chimerix nabbed the asset as part of its Oncoceutics acquisition in 2021. The small molecule, also known as ONC201, is up for an FDA approval decision by Aug. 18. An undisclosed global biopharma company approached Chimerix in August 2023 about a potential ex-US licensing deal for the investigational drug. That initial confidentiality agreement with “Party A” kickstarted a year and a half of discussions between the North Carolina biotech and more than half a dozen other unnamed drugmakers interested in dordaviprone, according to the Friday filing. Jazz ultimately won with its $8.55 per-share cash offer. Jazz’s approach began in December 2024 , when its head of corporate development reached out to Chimerix a few days after the biotech said it was seeking accelerated approval of dordaviprone. A week later, on Dec. 19, Party A said it would be willing to acquire dordaviprone and related assets for $350 million upfront plus an additional $100 million if the FDA approved the medicine. The deal terms weren’t good enough, Chimerix replied. A month later, Party A came back and said it would be willing to acquire all of Chimerix for $6.50 per share, plus contingent payments if the biotech reached certain FDA and sales milestones. Meanwhile, Party F asked whether a $5 per-share offer was “attractive.” Chimerix’s financial advisor, Centerview, told the company it had already gotten a higher offer from another bidder. Over the next few weeks, Parties F, E and others dropped out of the discussions. Party F cited “perceived risks around Chimerix’s ongoing Phase 3 ACTION Study,” and Party E cited its “challenges in assessing risk in neuro-oncology,” according to Friday’s regulatory document. For its part, Jazz’s interest began at $5.50 per share on Feb. 6, plus various contingent value rights upon FDA approval, European reimbursement approvals and net sales milestones. Then, on Feb. 18, Chimerix said the FDA accepted its NDA with priority review status. Chimerix CEO Mike Andriole had already telephoned that message to Jazz CEO Bruce Cozadd and a Party A “senior executive” four days before. Weeks later, Jazz revised its proposal to $8.55 per share in cash, removing the riskiness of contingent value rights, which sometimes don’t come to fruition for acquired companies’ shareholders. On that same day, March 3, Party A said it would offer $7.50 per share upfront and a $2 per-share CVR if Chimerix snagged full FDA approval for dordaviprone by Aug. 31, 2032. But the CVR wouldn’t be payable if the Phase 3 trial failed or if Chimerix got a complete response letter from the FDA. In the end, Jazz beat Party A.

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 ResultsChimerix’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 ResultsChimerix 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 JazzOn 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’ConnorStern Investor Relations 212-362-1200ir@chimerix.comwill@sternir.com Source: Chimerix, Inc.