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Chimerix, Inc. (CMRX)

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Previous Close3.6900
Open3.7300
Bid3.4500 x 1300
Ask0.0000 x 1800
Day's Range3.7000 - 3.8200
52 Week Range1.1900 - 3.8900
Volume121,974
Avg. Volume412,515
Market Cap238.635M
Beta (5Y Monthly)1.80
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
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  • Chimerix to Present at Credit Suisse 29th Annual Healthcare Conference
    GlobeNewswire

    Chimerix to Present at Credit Suisse 29th Annual Healthcare Conference

    DURHAM, N.C., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that Mike Sherman, Chief Executive Officer, will present a corporate overview and program update at the Credit Suisse 29th Annual Healthcare Conference on Thursday, November 12, 2020 at 4:15 p.m. ET. A live audio webcast of the presentation will be available on the Investor Relations section of Chimerix's website at ir.chimerix.com, where it will be archived for approximately 90 days.About ChimerixChimerix 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. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).DSTAT is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that, compared to commercially available forms of heparin, may be dosed at higher levels without associated bleeding-related complications. DSTAT is being studied in a Phase 2/3 trial to assess safety and efficacy in adults with acute lung injury with underlying COVID-19. A Phase 3 trial protocol to study DSTAT in acute myeloid leukemia has been developed in alignment with the US Food and Drug Administration (FDA) and site activation is expected in early 2021. BCV is an antiviral drug candidate in development as a medical countermeasure for smallpox and is currently under review for regulatory approval in the United States. For further information, please visit the Chimerix website, www.chimerix.com.CONTACT:Investor Relations:         Michelle LaSpaluto 919 972-7115 ir@chimerix.com Will O’Connor Stern Investor Relations 212-362-1200 will@sternir.com Media: David Schull Russo Partners 858-717-2310 David.Schull@russopartnersllc.com

  • Chimerix Reports Third Quarter 2020 Financial Results and Provides Operational Update
    GlobeNewswire

    Chimerix Reports Third Quarter 2020 Financial Results and Provides Operational Update

    – Completed Rolling NDA Submissions for Both BCV Tablet and Suspension Formulations as Medical Countermeasure for Smallpox –– First Patient Visit for DSTAT Phase 3 AML Study Expected in Early 2021 –– Company Well Capitalized Through Several Expected Upcoming Milestones –– Conference Call at 8:30 a.m. ET Today –DURHAM, N.C., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today reported financial results for the third quarter ended September 30, 2020 and provided an operational update.“Throughout the third quarter we continued to make significant progress across a number of key initiatives,” said Mike Sherman, Chief Executive Officer of Chimerix. “Of particular note was the completion of our rolling submissions to the U.S. Food and Drug Administration (FDA) for the approval of brincidofovir (BCV) as a medical countermeasure for smallpox. This milestone brings us one step closer to the company’s first regulatory approval and to securing a potential procurement contract with BARDA to supply the U.S. Strategic National Stockpile (SNS), which we expect to take place around the time of a potential FDA approval. In addition, we expect to be notified of our Prescription Drug User Fee Act (PDUFA) date relating to these submissions before the end of the year.”“In addition, we expect to initiate our Phase 3 study of DSTAT for the treatment of acute myeloid leukemia (AML) in early 2021. We were particularly encouraged by a recent meta-analysis of 11,151 patients covering 81 separate studies published in the Journal of the American Medical Association Oncology (Short, et al) in which a link was suggested between minimal residual disease (MRD) status and outcomes in patients with AML. Specifically, this large cohort meta-analysis showed that MRD-negative AML patients experience superior disease-free survival and overall survival rates when compared to patients that are MRD-positive (average hazard ratios of 0.37 and 0.36, for overall survival and disease-free survival respectively). The study suggests that evaluation of MRD status in AML patients may allow for an earlier assessment of therapeutic effects and could lead to acceleration in the development of novel AML therapeutics. This meta-analysis underscores the importance of the MRD assessment that we will undertake following the first 80 evaluable patients in our Phase 3 study in order to better interpret the relapse-free survival and overall survival advantages observed with DSTAT in our smaller Phase 2 study.”  “Due to the complex and rapidly changing landscape of the current pandemic, we cannot predict when we will complete enrollment in our Phase 2 trial of DSTAT in acute lung injury (ALI) in COVID-19 but do anticipate sharing initial topline data in the first quarter of 2021,” concluded Mr. Sherman.   Recent Highlights * Completed the rolling NDA submissions for BCV tablets and for BCV suspension as a medical countermeasure for smallpox * Published manuscript in Advances in Therapy, titled "Design and Rationale of a Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study Evaluating Dociparstat in Acute Lung Injury Associated with Severe COVID-19.” * Presented data in support of the multi-stage modeling and simulation approach used to determine BCV dosing for the treatment of smallpox in humans at the World Health Organization Advisory Committee on Variola Virus Research Expected Upcoming Milestones * FDA notification during the fourth quarter of 2020 regarding the acceptance of the BCV NDA submissions and assignment of a PDUFA date * Initiation of Phase 3 trial of DSTAT in first line AML in early 2021 * Potential procurement agreement for BCV around the time of FDA decision on smallpox NDA  * FDA decision on BCV smallpox NDA in 2021 * Completion of Phase 2 trial of DSTAT in COVID-19 related ALI in 2021 * Completion of BCV drug product manufacturing to support potential shipments to the SNS of up to $100 million in 2021Third Quarter 2020 Financial ResultsChimerix reported a net loss of $11.4 million, or $0.18 per basic and diluted share, for the third quarter of 2020. During the same period in 2019, Chimerix recorded a net loss of $73.7 million, or $1.26 per basic and diluted share.Revenues for the third quarter of 2020 decreased to $1.6 million, compared to $2.0 million for the same period in 2019.Research and development expenses increased to $10.0 million for the third quarter of 2020, compared to $7.5 million for the same period in 2019. The increase was driven by clinical trial expenses associated with the development of DSTAT.General and administrative expenses decreased to $3.2 million for the third quarter of 2020, compared to $4.0 million for the same period in 2019.Loss from operations was $11.6 million for the third quarter of 2020, compared to a loss from operations of $74.6 million for the same period in 2019, which included $65 million associated with the licensing of DSTAT in that period.Chimerix's balance sheet at September 30, 2020 included $87.8 million of capital available to fund operations, no debt, and approximately 62.6 million outstanding shares of common stock.Conference Call and WebcastChimerix will host a conference call and live audio webcast to discuss third quarter 2020 financial 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 6085937.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.About ChimerixChimerix 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. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).DSTAT is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that, compared to commercially available forms of heparin, may be dosed at higher levels without associated bleeding-related complications. DSTAT is being studied in a Phase 2/3 trial to assess safety and efficacy in adults with acute lung injury with underlying COVID-19. A Phase 3 trial protocol to study DSTAT in acute myeloid leukemia has been developed in alignment with the US Food and Drug Administration (FDA) and first patient visit is expected in early 2021. BCV is an antiviral drug candidate developed as a potential medical countermeasure for smallpox and is currently under review for regulatory approval in the United States. For further information, please visit the Chimerix website, www.chimerix.com.Forward Looking StatementsThis 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 obtain regulatory approval for BCV; the timing and receipt of a potential procurement contract for BCV in smallpox; and the initiation, progress and results of the Phase 3 clinical trial of DSTAT in AML and the Phase 2/3 clinical trial of DSTAT in ALI associated with COVID-19. 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 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 DSTAT may not achieve the endpoints of its clinical trials; risks that Chimerix will not obtain a procurement contract for BCV in 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 Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.CONTACT: Investor Relations:         Michelle LaSpaluto 919 972-7115 ir@chimerix.com Will O’Connor Stern Investor Relations 212-362-1200 will@sternir.com Media: David Schull Russo Partners 858-717-2310 David.Schull@russopartnersllc.com  CHIMERIX, INC. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) (unaudited)               September 30, December 31,       2020   2019  ASSETS     Current assets:      Cash and cash equivalents $38,130  $16,901   Short-term investments, available-for-sale  49,635   96,574   Accounts receivable  378   1,233   Prepaid expenses and other current assets  2,100   3,385    Total current assets  90,243   118,093  Property and equipment, net of accumulated depreciation  291   540  Operating lease right-of-use assets  2,943   709  Other long-term assets  27   34     Total assets $93,504  $119,376           LIABILITIES AND STOCKHOLDERS' EQUITY     Current liabilities:      Accounts payable $880  $2,398   Accrued liabilities  6,532   6,830    Total current liabilities  7,412   9,228  Lease-related obligations  2,923   196     Total liabilities  10,335   9,424           Stockholders’ equity:      Preferred stock, $0.001 par value, 10,000,000 shares authorized at September 30, 2020 and     December 31, 2019; no shares issued and outstanding as of September 30, 2020 and      December 31, 2019;  —   —   Common stock, $0.001 par value, 200,000,000 shares authorized at September 30, 2020 and     December 31, 2019; 62,629,722 and 61,590,013 shares issued and outstanding as of      September 30, 2020 and December 31, 2019, respectively  63   62   Additional paid-in capital  783,758   778,693   Accumulated other comprehensive gain, net  33   35   Accumulated deficit  (700,685)  (668,838)   Total stockholders’ equity  83,169   109,952     Total liabilities and stockholders’ equity $93,504  $119,376           CHIMERIX, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (unaudited)                      Three Months Ended September 30, Nine Months Ended September 30,        2020   2019   2020   2019  Revenues:          Contract revenue $1,591  $1,958  $4,158  $5,752   Licensing revenue  18   -   94   -    Total revenues  1,609   1,958   4,252   5,752  Operating expenses:          Research and development  10,018   7,453   27,545   34,795   General and administrative  3,151   4,024   9,466   18,022   Acquired in-process research and development  -   65,045   -   65,045    Total operating expenses  13,169   76,522   37,011   117,862     Loss from operations  (11,560)  (74,564)  (32,759)  (112,110) Other income:          Interest income and other, net  149   834   912   3,037      Net loss  (11,411)  (73,730)  (31,847)  (109,073) Other comprehensive loss:          Unrealized (loss)/gain on debt investments, net  (97)  (36)  (2)  182      Comprehensive loss $(11,508) $(73,766) $(31,849) $(108,891) Per share information:          Net loss, basic and diluted $(0.18) $(1.26) $(0.51) $(2.04)  Weighted-average shares outstanding, basic and diluted 62,242,456   58,457,110   62,009,941   53,519,207

  • Chimerix to Report Third Quarter 2020 Financial Results and Provide an Operational Update on November 5, 2020
    GlobeNewswire

    Chimerix to Report Third Quarter 2020 Financial Results and Provide an Operational Update on November 5, 2020

    DURHAM, N.C., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that it will host a live conference call and audio webcast on Thursday, November 5, 2020 at 8:30 a.m. ET to report financial results for the third quarter ended September 30, 2020, and to provide a business overview.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 6085937. A live audio webcast of the call will also be available on the Investors’ section of the Company's website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event.About ChimerixChimerix 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. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).DSTAT is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that, compared to commercially available forms of heparin, may be dosed at higher levels without associated bleeding-related complications. DSTAT is being studied in a Phase 2/3 trial to assess safety and efficacy in adults with acute lung injury with underlying COVID-19. A Phase 3 trial protocol to study DSTAT in acute myeloid leukemia has been agreed to with the US Food and Drug Administration (FDA) and site activation is expected in early 2021. BCV is an antiviral drug candidate in development as a medical countermeasure for smallpox. For further information, please visit the Chimerix website, www.chimerix.com.Forward Looking StatementsThis 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. Factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.CONTACT:Investor Relations: Michelle LaSpaluto 919 972-7115 ir@chimerix.com Will O’Connor Stern Investor Relations 212-362-1200 will@sternir.com Media: David Schull Russo Partners 858-717-2310 David.Schull@russopartnersllc.com