PRESS RELEASES<< Back
Chimerix Reports Second Quarter 2021 Financial Results and Provides Operational Update
– Blinded Independent Central Review (BICR) of ONC201 Registration Cohort in Recurrent H3 K27M-mutant Glioma Expected in Fourth Quarter 2021 –
– Conference Call at 8:30 a.m. ET Today –
“We made considerable progress throughout the first half of 2021, highlighted by the acquisition of
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 approved smallpox antiviral treatment. By year-end,
Imipridones and ONC201
Chimerix’s acquisition of Oncoceutics, Inc., expands the Company’s oncology franchise with a late-stage, novel class of small molecule anti-cancer compounds. Oncoceutics’ lead product candidate, ONC201, has been shown in clinical testing to selectively induce tumor cell death in multiple cancer types.
The BICR of radiographic imaging will enable clinical efficacy analyses of the first 50 patients with recurrent H3-K27M-mutant diffuse midline glioma who received single agent ONC201. These analyses will include overall response rate and key supportive endpoints, such as durability of response and other measures of clinical benefit. If favorable, these data may form the basis for an NDA submission seeking accelerated approval of ONC201 in
In addition, a Phase 1 clinical trial for ONC206, our second imipridone product candidate, and IND-enabling work for our third imipridone candidate, ONC212, remain ongoing.
DSTAT for AML
Expected 2021 Milestones
- Negotiation of a smallpox procurement agreement for TEMBEXA
- Completion of TEMBEXA drug product manufacturing to support potential shipments up to
$100 millionfor U.S.national preparedness
- Efficacy analysis by blinded independent central review of 50-subject registration cohort of ONC201 in recurrent H3 K27M-mutant glioma
Second Quarter 2021 Financial Results
Revenues for the second quarter of 2021 decreased to
Research and development expenses increased to
General and administrative expenses increased to
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, the status of Chimerix’s oncology programs, and the 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
|CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share data)|
|Cash and cash equivalents||$||25,445||$||46,989|
|Short-term investments, available-for-sale||106,584||31,973|
|Prepaid expenses and other current assets||4,185||2,356|
|Total current assets||136,250||81,658|
|Property and equipment, net of accumulated depreciation||298||214|
|Operating lease right-of-use assets||2,612||2,825|
|Other long-term assets||30||26|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||24,922||8,533|
|Additional paid-in capital||946,612||785,673|
|Accumulated other comprehensive loss, net||(11||)||-|
|Total stockholders’ equity||119,149||73,376|
|Total liabilities and stockholders’ equity||$||146,725||$||84,723|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except share and per share data)|
| Three Months Ended
||Six Months Ended
|Research and development||13,798||8,578||25,660||17,527|
|General and administrative||4,408||3,110||8,544||6,315|
|Acquired in-process research and dvelopment||-||-||82,890||-|
|Total operating expenses||18,206||11,688||117,094||23,842|
|Loss from operations||(17,815||)||(10,286||)||(115,268||)||(21,199||)|
|Interest income and other, net||52||270||90||763|
|Other comprehensive loss:|
|Unrealized gain (loss) on debt investments, net||32||141||(11||)||95|
|Per share information:|
|Net loss, basic and diluted||$||(0.21||)||$||(0.16||)||$||(1.38||)||$||(0.33||)|
|Weighted-average shares outstanding, basic and diluted||86,255,836||62,042,778||83,231,600||61,892,407|
Source: Chimerix, Inc.