PRESS RELEASES<< Back
Chimerix Reports Third Quarter 2021 Financial Results and Provides Operational Update
– Announced Positive Topline Results from ONC201 in Recurrent H3 K27M-mutant Glioma –
– Conference Call at 8:30 a.m. ET Today –
“We are pleased with the progress we have made in 2021 towards advancing our pipeline and validating our imipridone programs. Today, we announced positive topline results from the BICR of the ONC201 50 patient cohort in recurrent H3 K27M-mutant glioma, furthering our conviction that this program has the potential to significantly improve the standard of care for these patients with severe unmet medical need,” said
ONC201 for Recurrent H3 K27M-mutant Glioma
According to a blinded independent central review (BICR) of the registration cohort, the overall response rate (ORR) was 20.0% (95% confidence interval (CI):10.0-33.7%) as determined by Response Assessment in Neuro-Oncology Criteria for High Grade Gliomas (RANO-HGG). The median duration of response was 11.2 months (95% CI: 3.8 – not reached) and the median time to response was 8.3 months. Prior review of ONC201 identified the most commonly reported adverse events as nausea/vomiting, fatigue and decreased lymphocyte counts. Additional supportive data, including measures of other forms of clinical benefit and survival analysis will be presented at the
TEMBEXA for Smallpox
In June, the FDA granted TEMBEXA tablets and oral suspension approval for the treatment of smallpox. TEMBEXA is approved for adult and pediatric patients and is the first and only smallpox therapy approved for neonates. The oral suspension formulation is particularly important for patients who have difficulty swallowing due to age or medical status.
TEMBEXA potentially fills an important role as a treatment countermeasure to smallpox; it has a differentiated mechanism of action, a relatively high barrier to resistance and available evidence suggests it can be used in patients who have received the other FDA approved smallpox antiviral treatment. In September, an article was published in the peer review journal,
DSTAT for AML
Third Quarter 2021 Financial Results
Revenues for the third quarter of 2021 decreased to
Research and development expenses increased to
General and administrative expenses increased to
In accordance with the terms of the merger agreement between
Conference Call and Webcast
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
TEMBEXA is an oral antiviral formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. TEMBEXA is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals.
TEMBEXA (brincidofovir) is a nucleotide analog lipid-conjugate designed to mimic a natural monoacyl phospholipid to achieve effective intracellular concentrations of the active antiviral metabolite, cidofovir diphosphate. Cidofovir diphosphate exerts its orthopoxvirus antiviral effects by acting as an alternate substrate inhibitor for viral DNA synthesis mediated by viral DNA polymerase.
IMPORTANT SAFETY INFORMATION Including BOXED WARNING
|WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION
An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease.
WARNINGS AND PRECAUTIONS
Elevations in Hepatic Transaminases and Bilirubin: May cause increases in serum transaminases (ALT or AST) and serum bilirubin. Monitor liver laboratory parameters before and during treatment.
Diarrhea and Other Gastrointestinal Adverse Events: Diarrhea and additional gastrointestinal adverse events including nausea, vomiting, and abdominal pain may occur. Monitor patients, provide supportive care, and if necessary, do not give the second and final dose of TEMBEXA.
Coadministration with Related Products: TEMBEXA should not be co-administered with intravenous cidofovir.
Carcinogenicity: TEMBEXA is considered a potential human carcinogen. Do not crush or divide TEMBEXA tablets and avoid direct contact with broken or crushed tablets or oral suspension.
Male Infertility: Based on testicular toxicity in animal studies, TEMBEXA may irreversibly impair fertility in individuals of reproductive potential.
Common adverse reactions (adverse events assessed as causally related by the investigator in ≥ 2% of subjects) experienced in the first 2 weeks of dosing with TEMBEXA were diarrhea, nausea, vomiting and abdominal pain.
USE IN SPECIFIC POPULATIONS
Based on findings from animal reproduction studies, TEMBEXA may cause fetal harm when administered to pregnant individuals. Pregnancy testing should be performed before initiation of TEMBEXA in individuals of childbearing potential to inform risk. An alternative therapy should be used to treat smallpox during pregnancy, if feasible.
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, results from the BICR of the 50- patient cohort of ONC201 for the treatment of recurrent H3 K27M-mutant glioma, the status of Chimerix’s oncology programs, and the manufacturing, potential benefits and government procurement of TEMBEXA. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that the current clinical study data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of the acquisition of Oncoceutics may not be realized; the ability to generate positive results in a Phase 3 study in acute myeloid leukemia and subsequent approval for DSTAT; risks that
|CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share data)|
|Cash and cash equivalents||$||26,174||$||46,989|
|Short-term investments, available-for-sale||96,384||31,973|
|Prepaid expenses and other current assets||4,327||2,356|
|Total current assets||128,533||81,658|
|Property and equipment, net of accumulated depreciation||264||214|
|Operating lease right-of-use assets||2,509||2,825|
|Other long-term assets||60||26|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||26,290||8,533|
|Additional paid-in capital||950,597||785,673|
|Accumulated other comprehensive loss, net||-||-|
|Total stockholders’ equity||104,586||73,376|
|Total liabilities and stockholders’ equity||$||133,401||$||84,723|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except share and per share data)|
| Three Months Ended
||Nine Months Ended
|Research and development||13,820||10,018||39,480||27,545|
|General and administrative||4,887||3,151||13,431||9,466|
|Acquired in-process research and development||-||-||82,890||-|
|Total operating expenses||18,707||13,169||135,801||37,011|
|Loss from operations||(18,600||)||(11,560||)||(133,868||)||(32,759||)|
|Interest income and other, net||40||149||130||912|
|Other comprehensive loss:|
|Unrealized gain (loss) on debt investments, net||11||(97||)||-||(2||)|
|Per share information:|
|Net loss, basic and diluted||$||(0.21||)||$||(0.18||)||$||(1.59||)||$||(0.51||)|
|Weighted-average shares outstanding, basic and diluted||86,335,357||62,242,456||84,277,555||62,009,941|
Source: Chimerix, Inc.