Chimerix Reports Second Quarter 2022 Financial Results and Provides Operational Update
– ONC201 Phase 3 ACTION Study Planned to Initiate This Year –
–~$32M in Revenue from International TEMBEXA Agreements Recently Recognized–
– Conference Call at 4:30 p.m. ET Today –
“We are pleased to announce the design of Phase 3 study of ONC201 for the treatment of H3 K27M mutant glioma (the ACTION study), following feedback from the
"The study will evaluate the weekly dose of ONC201 used across many clinical studies where durable tumor response has been observed in the relapsed setting. In addition, a twice per week dosing schedule will also be evaluated. This capitalizes on the safety profile of this agent and has the potential to bolster efficacy. The design positions the study to have multiple ways to achieve success,” said Dr. Timothy Cloughesy, M.D., Professor of Neurology and Molecular and Medical Pharmacology at the
"Our center is excited to participate in the upcoming ACTION Study. We expect several factors to favorably impact enrollment, including the combined RANO-HGG/LGG response rate of 30% observed after treatment with ONC201 in the relapse setting, the durability of those responses, the 2:1 ratio of patients to receive ONC201, and the sequencing of treatment to begin shortly after completion of radiation,” said Dr. Isabel Arrillaga-Romany, MD, PhD, Director of Neuro-Oncology Clinical Trials,
Phase 3 ACTION Study of ONC201 for Treatment of H3 K27M-mutant Glioma
The ACTION study is a randomized, double-blind, placebo-controlled, multicenter international study in newly diagnosed diffuse glioma patients whose tumor harbors an H3 K27M-mutation. Treatment with ONC201 will occur shortly after completion of radiation therapy. The study is designed to enroll 450 patients randomized 1:1:1 to receive ONC201 at one of two dosing frequencies or placebo. Activation of sites is expected to begin by year-end and continue into the first half of next year.
Participants will be randomized to receive 625mg of ONC201 once per week, 625mg twice per week on two consecutive days or placebo. The dose will be scaled by body weight for pediatric patients.
The primary endpoint of the study is overall survival (OS). The study will also evaluate progression free survival (PFS) with alpha control for both OS and PFS endpoints. OS will be assessed for efficacy at three alpha-allocated timepoints: two interim assessments by the Independent Data Monitoring Committee (IDMC) at 164 events and 246 events, respectively, and a final assessment at 327 events. The final PFS analysis will be performed after 286 events, with progression assessed using RANO HGG criteria by blinded independent central review (BICR). Secondary endpoints include corticosteroid response, performance status response, change from baseline in quality of life (QoL) assessments and change from baseline in neurologic function as assessed by the Neurologic Assessment in Neuro-Oncology (NANO) scale.
Participants in the study must have a Karnofsky or Lansky performance status, a measure of patients’ ability to perform ordinary tasks, of >70 at time of randomization. Key exclusion criteria are the presence of a primary spinal tumor, diffuse intrinsic pontine glioma, evidence of leptomeningeal spread of disease or cerebrospinal fluid dissemination.
Stratification factors include age (<21 years, >21 years), and an assessment of risk factors including tumor location, tumor size, and number of tumors.
The study will take place at up to 120 sites in
In May, Chimerix entered into an agreement with Emergent BioSolutions (EBS) for the sale of worldwide rights to TEMBEXA for $225 million upfront, potential additional milestones of up to $112.5 million and additional double-digit royalties on gross profit internationally and on gross profit associated with volumes greater than 1.7 million treatment courses in the
Negotiations with BARDA for the procurement of TEMBEXA into the Strategic National Stockpile are now in the final stages.
ONC206 is a second generation imipridone where pre-clinical models indicate potentially improved, anti-cancer activity relative to ONC201. ONC206 is currently being evaluated in Phase I dose escalation trials in partnership with the
ONC212, which targets GPR132 and ClpP, is in ongoing IND-enabling toxicology studies which are expected to be completed in Q4 2022 with a decision to enter clinical studies expected in 1H 2023. ONC212 is being explored pre-clinically in hematological malignancies, including AML, in partnership with
Development of CMX521 remains ongoing as a potential prophylactic and treatment of SARS-CoV-2 (COVID-19) infection in collaboration with the Rapidly Emerging Antiviral Drug Development Initiative (READDI) at the
Second Quarter 2022 Financial Results
Revenues for the second quarter of 2022 and 2021 were
Research and development expenses increased to
General and administrative expenses increased to
Loss from operations was
Chimerix’s balance sheet at
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
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, ONC201, is in development for H3 K27M-mutant glioma.
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, consummation of the Transaction, including, as a result of failing to satisfy the closing conditions to the Transaction; the satisfaction of any closing conditions in a timely manner or at all, including, without limitation; the execution of a procurement contract for TEMBEXA; the timing of the initiation of the Phase 3 clinical development of ONC201; and Chimerix’s financial strength. 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 Transaction will not be completed as planned;
|CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share data)|
|Cash and cash equivalents||$||28,086||$||15,397|
|Short-term investments, available-for-sale||14,705||72,970|
|Prepaid expenses and other current assets||3,853||4,678|
|Total current assets||50,770||95,805|
|Property and equipment, net of accumulated depreciation||205||253|
|Operating lease right-of-use assets||2,189||2,404|
|Other long-term assets||399||56|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||23,271||29,896|
|Additional paid-in capital||961,740||953,782|
|Accumulated other comprehensive loss, net||(68||)||(21||)|
|Total stockholders’ equity||27,928||68,252|
|Total liabilities and stockholders’ equity||$||53,563||$||100,540|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except share and per share data)|
| Three Months Ended
||Six Months Ended
|Contract and grant revenue||$||-||$||390||$||-||$||1,823|
|Cost of goods sold||-||-||114||-|
|Research and development||18,047||13,798||37,087||25,660|
|General and administrative||5,840||4,408||11,472||8,544|
|Acquired in-process research and dvelopment||-||-||-||82,890|
|Total operating expenses||23,887||18,206||48,559||117,094|
|Loss from operations||(23,447||)||(17,815||)||(48,218||)||(115,268||)|
|Other (loss) income:|
|Interest income and other, net||(21||)||52||(17||)||90|
|Other comprehensive loss:|
|Unrealized gain (loss) on debt investments, net||5||32||(47||)||(11||)|
|Per share information:|
|Net loss, basic and diluted||$||(0.27||)||$||(0.21||)||$||(0.55||)||$||(1.38||)|
|Weighted-average shares outstanding, basic and diluted||87,436,180||86,255,836||87,263,452||83,231,600|
Source: Chimerix, Inc.