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Chimerix Reports First Quarter 2020 Financial Results and Provides Operational Update
“Responding to the COVID-19 global pandemic, we recently announced our accelerated program for dociparstat sodium (DSTAT) to combat acute lung injury (ALI) in COVID-19 patients,” stated
“Given the urgent need for effective treatments for COVID-19 related ALI, we expect to begin dosing patients in this Phase 2/3 clinical trial this month, with data from the first safety cohort from the Phase 2 portion of the study to be available in the second half of this year.
“The COVID-19 pandemic has also highlighted the importance of our global preparedness for a variety of viral outbreaks.
- Received clearance from the FDA for a rolling submission of its NDA for the approval of BCV as a medical countermeasure for smallpox
- Received clearance from the FDA to initiate a Phase 2/3 Study of DSTAT in ALI patients with COVID-19
- Received clearance from the FDA to initiate a Phase 3 trial of DSTAT in Acute Myeloid Leukemia (AML) based on review of final protocol.
Expected Upcoming Milestones
- Completion of NDA submission of BCV mid-2020
- Completion of Phase 2 portion of DSTAT trial in COVID-19 in second half of 2020
- Initiation of Phase 3 trial of DSTAT in first line AML
- Potential procurement agreement for BCV prior to FDA decision on smallpox NDA
- FDA decision on BCV smallpox NDA in 2021
- Completion of manufacturing of approximately
$100 millionof BCV product for SNS by mid-2021.
The company previously announced a plan to initiate a Phase 3 clinical study of DSTAT for the treatment of AML in 2020 and has subsequently announced its delay due to the ongoing COVID-19 pandemic. The Company’s current operational focus is on executing the DSTAT study in ALI patients with COVID-19. Next steps on the proposed AML study will be determined in the coming months.
First Quarter 2020 Financial Results
Revenues for the first quarter of 2020 decreased to
Research and development expenses decreased to
General and administrative expenses decreased to
Loss from operations was
Dociparstat sodium is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity. In vitro and in vivo animal model data support DSTAT’s potential to reduce the inflammation and cellular infiltration associated with acute lung injury and address coagulation disorders associated with COVID-19 pathology (HMGB1 and PF4). Separately, DSTAT inhibits the activities of several key proteins implicated in the viability of AML blasts and leukemic stem cells in the bone marrow during chemotherapy (e.g., CXCL12, selectins, HMGB1, elastase). Randomized AML Phase 2 data suggest that DSTAT may also accelerate platelet recovery post-chemotherapy via inhibition of PF4, a negative regulator of platelet production that impairs platelet recovery following chemotherapy. The company is conducting a randomized, double-blind, placebo-controlled, Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at high risk of respiratory failure. The Phase 2 portion of the study will enroll 24 subjects to confirm the maximum safe dose and will then expand by an additional 50 patients (74 total) at the selected dose. A formal analysis of all endpoints, including supportive biomarkers will be performed at the conclusion of the Phase 2 portion of the study. Contingent upon positive results, the Phase 3 portion of the study will enroll approximately 450 subjects.
BCV is an antiviral drug candidate in development as a medical countermeasure for smallpox. For further information, please visit the
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, the mechanism of action of DSTAT and its potential in ALI patients with COVID-19; Chimerix’s ability to develop DSTAT, including the initiation of a Phase 2/3 clinical trial for DSTAT as a potential treatment for ALI associated with COVID-19; Chimerix’s ability to submit and/or obtain regulatory approvals for DSTAT and BCV; and the timing and receipt of a potential procurement contract for BCV in smallpox. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that DSTAT may not achieve the endpoints of the Phase 2/3 clinical trial; risks that DSTAT or BCV may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that development activities related to DSTAT may not be completed on time or at all; risks that Chimerix may not receive a procurement contract for BCV for smallpox in a timely manner or at all; Chimerix’s reliance on a sole source third-party manufacturer for drug supply; risks that ongoing or future trials may not be successful or replicate previous trial results, or may not be predictive of real-world results or of results in subsequent trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for our drugs; risks that our drugs may be precluded from commercialization by the proprietary rights of third parties; and additional risks set forth in the Company's filings with the
Stern Investor Relations
|CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share data)|
|Cash and cash equivalents||$||24,553||$||16,901|
|Short-term investments, available-for-sale||78,469||96,574|
|Prepaid expenses and other current assets||2,639||3,385|
|Total current assets||106,740||118,093|
|Property and equipment, net of accumulated depreciation||435||540|
|Operating lease right-of-use assets||578||709|
|Other long-term assets||16||34|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||6,680||9,228|
|Additional paid-in capital||780,248||778,693|
|Accumulated other comprehensive (loss) gain, net||(11||)||35|
|Total stockholders’ equity||101,041||109,952|
|Total liabilities and stockholders’ equity||$||107,769||$||119,376|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except share and per share data)|
| Three Months Ended
|Research and development||8,949||13,515|
|General and administrative||3,205||7,686|
|Total operating expenses||12,154||21,201|
|Loss from operations||(10,913||)||(18,845||)|
|Interest income and other, net||493||1,152|
|Other comprehensive loss:|
|Unrealized (loss) gain on debt investments, net||(46||)||140|
|Per share information:|
|Net loss, basic and diluted||$||(0.17||)||$||(0.35||)|
|Weighted-average shares outstanding, basic and diluted||61,742,035||50,887,221|
Source: Chimerix, Inc.