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Chimerix Announces Third Quarter 2019 Financial Results and Provides Operational Update
– Final Data from Phase 2 Randomized Trial of DSTAT in First-line AML Support Enhanced Durability of Response, Event-free Survival and Overall Survival Benefit –
– End of Phase 2 Meeting for Dociparstat (DSTAT) and Pre-NDA Meeting for Brincidofovir (BCV) Anticipated during First Quarter 2020 –
– Conference Call at
“The progress we have made over the last several months has positioned us well for the balance of the year and beyond. We have successfully transitioned our clinical pipeline to deliver a number of near-term, value-creating milestones,” said
Third Quarter and Recent Highlights
Final Analysis of Randomized Trial of DSTAT in Front-line AML Patients
Combination treatment with 7+3 chemotherapy and DSTAT did not show significant added toxicity at the 0.125 or 0.25 mg/kg/hr doses. The most common serious adverse event in the DSTAT arm was febrile neutropenia. DSTAT also showed signs of accelerating platelet and neutrophil recovery following chemotherapy, consistent with the reported DSTAT inhibition of platelet factor 4, a negative regulator of platelet production that impairs platelet recovery following chemotherapy.
Chimerix plans to initiate a Phase 3 clinical trial of DSTAT for the treatment of AML in mid-2020 subject to discussions with
BCV for Smallpox
Chimerix intends to conduct a pre-NDA meeting with the
Chimerix is collaborating with the Biomedical Advanced Research and Development Authority (BARDA) for the development of BCV as a potential medical countermeasure for smallpox. This rule allows for testing of investigational drugs in animal models to support the effectiveness of the drug in diseases for which human clinical studies are not ethical or feasible.
Exclusive Global License Agreement with
Under the terms of the agreement, Chimerix received an upfront payment of $5 million with the potential to receive future clinical, regulatory and commercial milestone payments of up to $180 million. In addition, Chimerix is eligible to receive low double-digit royalty payments on net sales of BCV worldwide.
Third Quarter 2019 Financial Results
Chimerix reported a net loss of $73.7 million, or $1.26 per basic and diluted share, for the third quarter of 2019. During the same period in 2018, Chimerix recorded a net loss of $16.1 million, or $0.33 per basic and diluted share.
Revenues for the third quarter of 2019 increased to $2.0 million, compared to $0.4 million for the same period in 2018.
Research and development expenses decreased to $7.5 million for the third quarter of 2019, compared to $11.9 million for the same period in 2018.
General and administrative expenses decreased to $4.0 million for the third quarter of 2019, compared to $5.2 million for the same period in 2018.
Loss from operations was $74.6 million for the third quarter of 2019, compared to a loss from operations of $16.7 million for the same period in 2018.
Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to discuss third quarter 2019 results and provide a business update today at 8:30 a.m. ET. To access the live conference call, please dial 877-354-4056 (domestic) or 678-809-1043 (international) at least five minutes prior to the start time and refer to conference ID 1693898.
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 website approximately two hours after the event.
Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. The two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).
Dociparstat sodium is a potential first-in-class glycosaminoglycan biologic derived from porcine heparin that has low anticoagulant activity but retains the ability to inhibit activities of several key proteins implicated in the retention and viability of AML blasts and leukemic stem cells in the bone marrow during chemotherapy (e.g., CXCL12, selectins, HMGB1). Mobilization of AML blasts and leukemic stem cells from the bone marrow has been associated with enhanced chemosensitivity and may be a primary mechanism accounting for the observed increases in EFS and OS in Phase 2 with DSTAT versus placebo. Randomized Phase 2 data suggest that DSTAT may also accelerate platelet recovery post-chemotherapy via inhibition of platelet factor 4, a negative regulator of platelet production that impairs platelet recovery following chemotherapy. BCV is a lipid conjugate DNA polymerase inhibitor 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, Chimerix’s ability to deliver near-term, value-creating milestones; the potential benefits to be derived from the License and Development Agreement with
Stern Investor Relations
|CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share data)|
|September 30,||December 31,|
|Cash and cash equivalents||$||19,349||$||81,106|
|Short-term investments, available-for-sale||97,366||105,424|
|Prepaid expenses and other current assets||7,432||2,598|
|Total current assets||125,969||189,458|
|Property and equipment, net of accumulated depreciation||910||1,210|
|Operating lease right-of-use assets||836||-|
|Other long-term assets||36||46|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||15,434||12,966|
|Preferred stock, $0.001 par value, 10,000,000 shares authorized at September 30, 2019 and|
|December 31, 2018; no shares issued and outstanding as of September 30, 2019 and|
|December 31, 2018||—||—|
|Common stock, $0.001 par value, 200,000,000 shares authorized at September 30, 2019 and|
|December 31, 2018; 61,382,263 and 50,735,279 shares issued and outstanding as of|
|September 30, 2019 and December 31, 2018, respectively||61||51|
|Additional paid-in capital||777,133||733,907|
|Accumulated other comprehensive loss, net||89||(92||)|
|Total stockholders’ equity||111,948||177,604|
|Total liabilities and stockholders’ equity||$||127,751||$||190,714|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except share and per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||7,453||11,892||34,795||39,963|
|General and administrative||4,024||5,187||18,022||18,575|
|Acquired in-process research and development||65,045||-||65,045||-|
|Total operating expenses||76,522||17,079||117,862||58,538|
|Loss from operations||(74,564||)||(16,710||)||(112,110||)||(56,186||)|
|Other (expense) income:|
|Interest income and other, net||834||631||3,037||1,668|
|Other comprehensive loss:|
|Unrealized (loss) gain on debt investments, net||(36||)||180||182||302|
|Per share information:|
|Net loss, basic and diluted||$||(1.26||)||$||(0.33||)||$||(2.04||)||$||(1.14||)|
|Weighted-average shares outstanding, basic and diluted||58,457,110||48,172,354||53,519,207||47,875,895|
Source: Chimerix, Inc.