1. DURHAM, N.C., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, announced today the pricing of its underwritten public offering of 11,765,000 shares of its common stock at a price to the public of $8.50 per share. All of the shares to be sold in the offering are being sold by Chimerix. The gross proceeds to Chimerix from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be $100.0 million. In addition, Chimerix has granted the underwriters a 30-day option to purchase up to an additional 1,764,750 shares of common stock at the public offering…

    DURHAM, N.C., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, announced today the pricing of its underwritten public offering of 11,765,000 shares of its common stock at a price to the public of $8.50 per share. All of the shares to be sold in the offering are being sold by Chimerix. The gross proceeds to Chimerix from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be $100.0 million. In addition, Chimerix has granted the underwriters a 30-day option to purchase up to an additional 1,764,750 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about January 25, 2021.

    Chimerix intends to use the net proceeds from the proposed offering to fund the clinical development of its product candidates, commercial pre-launch activities and general corporate purposes.

    Jefferies and Cowen are acting as joint bookrunning managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering and JonesTrading is acting as co-manager for the offering.

    The securities described above are being offered by Chimerix pursuant to a shelf registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC) (File No. 333-244146). A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at ; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    About Chimerix

    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. Our three most advanced clinical-stage development programs are, brincidofovir (BCV), ONC201 and dociparstat sodium (DSTAT). 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. ONC201 is currently in a registrational clinical trial for recurrent H3 K27M-mutant glioma and a confirmatory response rate assessment is expected later this year. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia and as a potential treatment for acute lung injury in COVID-19 patients.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements relating to Chimerix's expectations of market conditions and the satisfaction of customary closing conditions related to the public offering, the expected closing of the offering and the anticipated use of proceeds therefrom. The inclusion of forward-looking statements should not be regarded as a representation by Chimerix that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Chimerix's business, including, without limitation: the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering, the risks and uncertainties inherent in Chimerix's business, including risks that the current Phase 2 clinical trial data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of Chimerix's acquisition of Oncoceutics, Inc. may not be realized; DSTAT and BCV may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; 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 Chimerix's drugs; risks that Chimerix's drugs may be precluded from commercialization by the proprietary rights of third parties; and the other risks described in Chimerix's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Chimerix undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof.

    CONTACT:

    Investor Relations:

    Michelle LaSpaluto

    919 972-7115





    Will O'Connor

    Stern Investor Relations

    212-362-1200





    Media:

    David Schull

    Russo Partners

    858-717-2310



    Primary Logo

    View Full Article Hide Full Article
  2. DURHAM, N.C., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, announced today that it intends to offer and sell, subject to market and other conditions, up to $75,000,000 of shares of its common stock in an underwritten public offering. In addition, Chimerix expects to grant the underwriters a 30-day option to purchase up to an additional $11,250,000 of shares of common stock. All of the shares to be sold in the offering are to be sold by Chimerix. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Chimerix intends to use…

    DURHAM, N.C., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, announced today that it intends to offer and sell, subject to market and other conditions, up to $75,000,000 of shares of its common stock in an underwritten public offering. In addition, Chimerix expects to grant the underwriters a 30-day option to purchase up to an additional $11,250,000 of shares of common stock. All of the shares to be sold in the offering are to be sold by Chimerix. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Chimerix intends to use the net proceeds from the proposed offering to fund the clinical development of its product candidates, commercial pre-launch activities and for general corporate purposes.

    Jefferies and Cowen are acting as joint bookrunning managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering and JonesTrading is acting as co-manager for the offering.

    The securities described above are being offered by Chimerix pursuant to a shelf registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC) (File No. 333-244146). The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at ; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at . Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    About Chimerix

    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. Our three most advanced clinical-stage development programs are, brincidofovir (BCV), ONC201 and dociparstat sodium (DSTAT). 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. ONC201 is currently in a registrational clinical trial for recurrent H3 K27M-mutant glioma and a confirmatory response rate assessment is expected later this year. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia and as a potential treatment for acute lung injury in COVID-19 patients.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on the company's current beliefs and expectations.  Such forward-looking statements include, but are not limited to, statements relating to the offering, including the timing and size of the offering and the anticipated use of proceeds therefrom and the grant of the option to purchase additional shares. The inclusion of forward-looking statements should not be regarded as a representation by Chimerix that any of its plans will be achieved. Many factors may cause differences between current expectations and actual results, including market conditions and the satisfaction of customary closing conditions related to the proposed offering. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Chimerix's business, including, without limitation: the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering, the risks and uncertainties inherent in Chimerix's business, including risks that the current Phase 2 clinical trial data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of Chimerix's acquisition of Oncoceutics, Inc. may not be realized; DSTAT and BCV may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; 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 Chimerix's drugs; risks that Chimerix's drugs may be precluded from commercialization by the proprietary rights of third parties; and the other risks described in the Chimerix's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Chimerix undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof.



    CONTACT:

    Investor Relations:        

    Michelle LaSpaluto

    919 972-7115

     



    Will O'Connor

    Stern Investor Relations

    212-362-1200

     



    Media:

    David Schull

    Russo Partners

    858-717-2310

     



    Primary Logo

    View Full Article Hide Full Article
  3. ONC201 Registrational Trial for Recurrent H3 K27M-mutant Glioma

    Compelling Response Rates to Date; Defined Regulatory Path to Registration

    Pivotal Data Anticipated in 2021 to Support Potential Registration, Addressing an Estimated Market Opportunity of Greater than $500 Million

    Management to Host Conference Call at 8:30 a.m. ET Today

    DURHAM, N.C., Jan. 08, 2021 (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 the Company has acquired Oncoceutics, Inc., a privately-held, clinical-stage biotechnology company developing imipridones, a novel class of compounds. Oncoceutics' lead product candidate…

    ONC201 Registrational Trial for Recurrent H3 K27M-mutant Glioma

    Compelling Response Rates to Date; Defined Regulatory Path to Registration

    Pivotal Data Anticipated in 2021 to Support Potential Registration, Addressing an Estimated Market Opportunity of Greater than $500 Million

    Management to Host Conference Call at 8:30 a.m. ET Today

    DURHAM, N.C., Jan. 08, 2021 (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 the Company has acquired Oncoceutics, Inc., a privately-held, clinical-stage biotechnology company developing imipridones, a novel class of compounds. Oncoceutics' lead product candidate, ONC201, has been shown in clinical testing to selectively induce cell death in multiple cancer types. ONC201 is currently in a registrational clinical trial for recurrent H3 K27M-mutant glioma and a confirmatory response rate assessment is expected in 2021.

    ONC201 is an orally administered small molecule dopamine receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP) agonist in late-stage clinical development for recurrent gliomas that harbor the H3 K27M mutation. Recurrent glioma is a form of brain cancer with a particularly poor prognosis having a median overall survival of approximately eight months. Recurrent pediatric patients, with cancer that carries the H3 K27M mutation, have an even worse prognosis with median overall survival of approximately four months. Compelling responses at this stage of disease are rare and lack durability. Patients with this mutation are considered grade IV by the World Health Organization, regardless of underlying histology or age. Initial evaluation of data from the full 50-subject registration cohort, which remains subject to full maturation and confirmation by Blinded Independent Central Review (BICR), indicate a compelling and particularly durable single agent Overall Response Rate (ORR) of at least 20% as assessed by Response Assessment in Neuro-Oncology-High Grade Glioma (RANO-HGG). The final confirmatory data analysis is expected in 2021.

    "Patients with H3 K27M-mutant glioma are in desperate need of better therapeutic alternatives," said Dr. Patrick Wen, Director, Center for Neuro-Oncology at the Dana-Farber Cancer Institute and professor of Neurology at Harvard Medical School. "The tumor responses and safety profile we have observed with ONC201 in this devastating disease are compelling and I look forward to the possibility of accelerating its delivery to patients."

    "Glioma remains one of the highest areas of unmet need in oncology where even first-line radiation therapy, as well as temozolomide in eligible patients, is not meaningfully effective and subsequent therapies are considered palliative. Further, there are no molecularly-targeted therapies for patients which harbor the H3 K27M mutation in this life-limiting disease. Given the urgent need and based on discussions with the FDA, there is a potential accelerated path to approval based on overall response. With a registration cohort of patients fully enrolled, treated, and preliminary data in hand, ONC201 offers an exciting near-term opportunity to quickly bring a potentially life-saving therapy and hope to patients with limited or no options," said Mike Sherman, Chief Executive Officer of Chimerix. "Our team is uniquely positioned to advance ONC201 given our considerable experience bringing targeted oncology products through the regulatory process."

    "Oncoceutics represents a transformative acquisition for Chimerix, positioning the company with five assets across all stages of development and delivering on our goal to focus on oncology opportunities, complementing our Phase 3 study in acute myeloid leukemia with DSTAT.

    With the upcoming Prescription Drug User Fee Act (PDUFA) date of April 7, 2021 for brincidofovir in smallpox and the confirmatory response rate assessment of ONC201 in 2021, we expect these near-term milestones to accelerate delivery of two new therapies in areas of particularly high unmet need," concluded Mr. Sherman.

    "We are thrilled to join the Chimerix team to help accelerate ONC201 to glioma patients in urgent need of effective treatments. Chimerix has the leadership and resources to bring this program successfully through to approval and to further develop other promising assets in the Oncoceutics pipeline," said Lee Schalop, M.D., Chief Executive Officer of Oncoceutics. "This acquisition builds upon the vision of my co-founder Wolfgang Oster, M.D., Ph.D., scientific founder Wafik El-Deiry, M.D., Ph.D., FACP and all the employees at Oncoceutics in developing a therapy for patients for which there is no available treatment."  

    Clinical Development Plan for ONC201 in H3 K27M-mutant Glioma

    The current Phase 2 clinical program for ONC201 includes a 50 subject registration cohort comprised of patients greater than 2 years of age with recurrent diffuse midline glioma that harbor the H3 K27M mutation, that have measurable disease, received radiation at least 90 days prior to enrollment and displayed evidence of progressive disease, and certain other criteria. This registration cohort is comprised of patients from multiple clinical trials and has completed enrollment. A BICR analysis is expected to take place in 2021 which, if favorable, may form the basis for regulatory approval of ONC201 in the United States. A BICR of the first 30 patients was completed and presented at the Society of Neuro-Oncology meeting held in November 2020. ONC201 has demonstrated a favorable safety profile with a database of over 350 treated patients. ONC201 has been generally well tolerated during extended periods of administration and the most commonly reported adverse events (AEs) were nausea/vomiting, fatigue and decreased lymphocyte counts.  

    The FDA has granted ONC201 Fast Track Designation for the treatment of adult recurrent H3 K27M-mutant high-grade glioma, Rare Pediatric Disease Designation for treatment of H3 K27M-mutant glioma, and Orphan Drug Designations for the treatment of glioblastoma and for the treatment of malignant glioma.

    Over 300 subjects with recurrent high-grade gliomas, including gliomas with H3 K27M mutations, have been treated with ONC201 across three company-sponsored studies and an expanded access program.

    Transaction Terms

    Under the terms of the acquisition, Chimerix will pay Oncoceutics shareholders $78 million, of which $39 million is payable in Chimerix stock and $39 million is payable in cash, subject to certain customary adjustments. The payment of $39 million in cash is split $25 million at closing and $14 million on the first anniversary of closing. Oncoceutics shareholders will also potentially earn development, regulatory and sales milestones totaling up to $360 million across three development programs and royalties on combined sales of ONC201 and ONC206 of 15% up to $750 million in annual revenue and 20% above $750 million in annual revenue.

    The Boards of Directors of both companies have approved the transaction and the transaction closed simultaneously with execution of definitive agreements on January 7, 2021.

    Cooley LLP served as legal advisor to Chimerix. Evercore and Morgan Lewis served as exclusive financial advisor and legal advisor, respectively, to Oncoceutics. Spring Mountain Capital is the lead Oncoceutics investor.

    Conference Call and Webcast

    Chimerix will host a conference call and live audio webcast today at 8:30 a.m. ET. Slides that support the conference call are available in the Investors section of the Chimerix website, www.chimerix.com. 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 1877809.  

    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 Oncoceutics

    Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of compounds called imipridones that selectively induce cell death in cancer cells. ONC201 is an orally active small molecule DRD2 antagonist and ClpP agonist in late-stage clinical development for H3 K27M-mutant glioma with additional indications under clinical investigation. ONC206 is the second clinical-stage imipridone that is under clinical investigation for central nervous system tumors. The company has received grant support from NCI, FDA, The Musella Foundation, Michael Mosier Defeat DIPG Foundation, Dragon Master Foundation, The ChadTough Foundation, the National Brain Tumor Society, and a series of private and public partnerships.

    About Chimerix

    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. 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 the 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 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 timing of the confirmatory response rate assessment for ONC201; the sufficiency of the data from the current Phase 2 clinical trial of ONC201 to support accelerated regulatory approval; the anticipated benefits of Chimerix's acquisition of Oncoceutics; the completion of a Phase 3 study in acute myeloid leukemia with DSTAT and Chimerix's ability to obtain regulatory approval for its clinical candidates, including ONC201 and BCV. 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 Phase 2 clinical trial data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of the acquisition of Oncoceutics may not be realized; BCV may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; 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





    Will O'Connor

    Stern Investor Relations

    212-362-1200





    Media:

    David Schull

    Russo Partners

    858-717-2310



    Primary Logo

    View Full Article Hide Full Article
  4. DURHAM, N.C., Jan. 06, 2021 (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 participate in a pre-recorded presentation at the H.C. Wainwright BioConnect 2021 Conference made available on Monday, January 11, 2021 at 7:00 a.m. ET.

    An 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 Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that…

    DURHAM, N.C., Jan. 06, 2021 (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 participate in a pre-recorded presentation at the H.C. Wainwright BioConnect 2021 Conference made available on Monday, January 11, 2021 at 7:00 a.m. ET.

    An 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 Chimerix

    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. 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 the 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 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 obtain regulatory approval for BCV; the timing and receipt of a potential procurement contract for BCV in smallpox; and the timing of enrollment in the DSTAT trial for AML. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that BCV may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that Chimerix will not obtain a procurement contract for BCV in smallpox in a timely manner or at all; risks related to the timing and conduct of the DSTAT trial for AML; 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

     



    Will O'Connor

    Stern Investor Relations

    212-362-1200

      



    Primary Logo

    View Full Article Hide Full Article
  5. DURHAM, N.C., Dec. 07, 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 the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for brincidofovir (BCV) as a medical countermeasure for smallpox. The FDA granted Priority Review and set an action date of April 7, 2021 under the Prescription Drug User Fee Act (PDUFA).

    Brincidofovir, an investigational therapy, is a nucleotide analog lipid-conjugate that has demonstrated antiviral activity as a medical countermeasure against smallpox under the FDA's Animal Efficacy Rule, which allows for testing of investigational…

    DURHAM, N.C., Dec. 07, 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 the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for brincidofovir (BCV) as a medical countermeasure for smallpox. The FDA granted Priority Review and set an action date of April 7, 2021 under the Prescription Drug User Fee Act (PDUFA).

    Brincidofovir, an investigational therapy, is a nucleotide analog lipid-conjugate that has demonstrated antiviral activity as a medical countermeasure against smallpox under the FDA's Animal Efficacy Rule, which allows for testing of investigational drugs in animal models to support effectiveness in diseases which are not ethical or feasible to study in humans.

    Chimerix has developed BCV as a potential medical countermeasure for smallpox under an ongoing collaboration and funding provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, under ongoing contract number HHSO100201100013C.

    The FDA's acceptance of the NDA indicates the application is sufficiently complete to permit a substantive review. A Priority Review designation accelerates the FDA's review time from 10 months to a goal of six months and is granted to drugs that may offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. At this time, the FDA is not planning to hold an advisory committee meeting to discuss this application.

    "Our team has continued to execute extremely well in collaboration with BARDA to advance this program," said Mike Sherman, Chief Executive Officer of Chimerix. "As we've observed in recent months, the threat of serious viral infections requires robust pandemic plans to protect the population and our economy. With BCV, we hope to provide that protection from smallpox, and look forward to working with BARDA on next steps in making this countermeasure available to patients in advance of an outbreak."

    About Chimerix

    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. 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 the 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 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 obtain regulatory approval for 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 BCV may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; 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

    Will O'Connor

    Stern Investor Relations

    212-362-1200



    Media:

    David Schull

    Russo Partners

    858-717-2310



    Primary Logo

    View Full Article Hide Full Article
  6. 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 Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make…

    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 Chimerix

    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. 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



    Will O'Connor

    Stern Investor Relations

    212-362-1200



    Media:

    David Schull

    Russo Partners

    858-717-2310

     

    Primary Logo

    View Full Article Hide Full Article
  7. 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…

    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 2021

    Third Quarter 2020 Financial Results

    Chimerix 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 Webcast

    Chimerix 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 Chimerix

    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. 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 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 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





    Will O'Connor

    Stern Investor Relations

    212-362-1200





    Media:

    David Schull

    Russo Partners

    858-717-2310

     
    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 
                 

    Primary Logo

    View Full Article Hide Full Article
  8. 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…

    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 Chimerix

    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. 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 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. 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





    Will O'Connor

    Stern Investor Relations

    212-362-1200





    Media:

    David Schull

    Russo Partners

    858-717-2310

    Primary Logo

    View Full Article Hide Full Article
  9. Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company focused on developing next-generation biologics for the restoration of cellular integrity of damaged tissues, has appointed M. Michelle Berrey, M.D., M.P.H. and Annamaria T. Kausz, M.D., M.S. as members of the company's Board of Directors.

    "We are delighted to welcome Drs. Berrey and Kausz to our Board of Directors. Each brings a wealth of expertise in medical and regulatory strategy, drug development, commercialization and corporate financing," said William Golden, Founder, Chairman and CEO of Noveome.

    "Both Drs. Berrey and Kausz are joining Noveome at a crucial time as we continue our work to advance ST266 for the treatment of ophthalmology indications including persistent…

    Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company focused on developing next-generation biologics for the restoration of cellular integrity of damaged tissues, has appointed M. Michelle Berrey, M.D., M.P.H. and Annamaria T. Kausz, M.D., M.S. as members of the company's Board of Directors.

    "We are delighted to welcome Drs. Berrey and Kausz to our Board of Directors. Each brings a wealth of expertise in medical and regulatory strategy, drug development, commercialization and corporate financing," said William Golden, Founder, Chairman and CEO of Noveome.

    "Both Drs. Berrey and Kausz are joining Noveome at a crucial time as we continue our work to advance ST266 for the treatment of ophthalmology indications including persistent corneal epithelial defects, and systemic inflammation including the cytokine storm often seen in COVID-19."

    Dr. Berrey has over 25 years of combined industry and clinical experience. She is a seasoned industry executive with a proven track record in first-in-class therapeutics targeting viral diseases. Currently, Dr. Berrey serves on the Scientific Advisory Board for ViiV/GSK, and is on the Executive Committee and Board of the NC Biotechnology Center. Dr. Berrey was most recently president and CEO at Chimerix (NASDAQ:CMRX) and previously served as Chief Medical Officer at Pharmasset (acquired by Gilead Sciences (NASDAQ: GILD) and Vice President of Clinical Development for Antivirals and Metabolic Diseases at GlaxoSmithKline (NYSE:GSK). Throughout her career she has focused on diseases threatening the most immunocompromised patient populations. Dr. Berrey holds an M.P.H. from Emory University and an M.D. from the Medical College of Georgia.

    "It's exciting to join the Board of a company like Noveome, rooted in novel science that is unlocking the vast potential of a multi-targeted secretome such as ST266," said Dr. Berrey. "I look forward to working together with the Noveome management team as we aim to improve clinical outcomes in a range of complex diseases."

    Dr. Kausz brings 14 years of experience in drug development and regulatory strategy across several disease areas and all phases of development, including post-marketing. She led the successful filing of two new drug approvals in the U.S. and E.U for renal and metabolic indications, and supported their commercial launch in the U.S. Dr. Kausz is currently the Chief Medical Officer of Allena Pharmaceuticals (NASDAQ:ALNA), where she was instrumental in securing agreement with the FDA on an accelerated approval strategy for a novel indication using a novel endpoint, led several clinical trials, and supported financing activities. Dr. Kausz also serves on the Board of Directors for the Kidney Health Initiative (KHI). She previously held various clinical development roles at EMD-Serono, Keryx, Reata, and AMAG. Dr. Kausz has an M.D. from the University of Virginia and an M.S. in Epidemiology with a concentration in Biostatistics from the University of Washington.

    "It is an honor to join the Noveome Board and I look forward to working with leadership on regulatory strategy, evaluation of indication expansion and business development opportunities," said Dr. Kausz. "ST266 has exciting potential to address the challenges of severe inflammatory responses that can occur in a wide range of indications, and I am eager to help advance Noveome's programs."

    About ST266

    ST266 is a cell-free biologic made by culturing a novel population of human amnion-derived cells. Through a proprietary culturing method, these cells produce an array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation.

    About Noveome Biotherapeutics, Inc.

    Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection as well as the post-COVID-19 symptoms experienced by many COVID-19 patients. Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). ST266 is also being evaluated in a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye. Noveome is currently planning follow-up clinical studies to characterize the efficacy and safety of ST266 further for the treatment of PEDs and a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients. For more information, visit www.noveome.com.

    View Full Article Hide Full Article
  10. DURHAM, N.C., Sept. 10, 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 management will participate in the following investor conferences in September:

    • H.C. Wainwright 22nd Annual Global Investment Conference: Chimerix will present a corporate overview on Monday, September 14 at 1:00 p.m. ET and participate in investor meetings.
    • Cantor Fitzgerald Virtual Healthcare Conference: Management will participate in investor meetings on Wednesday, September 16.

    A live audio webcast of the H.C. Wainwright conference presentation will be available on the Investor Relations section of Chimerix's website at ir.chimerix.com…

    DURHAM, N.C., Sept. 10, 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 management will participate in the following investor conferences in September:

    • H.C. Wainwright 22nd Annual Global Investment Conference: Chimerix will present a corporate overview on Monday, September 14 at 1:00 p.m. ET and participate in investor meetings.
    • Cantor Fitzgerald Virtual Healthcare Conference: Management will participate in investor meetings on Wednesday, September 16.

    A live audio webcast of the H.C. Wainwright conference 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 Chimerix

    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. 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 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. 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





    Will O'Connor

    Stern Investor Relations

    212-362-1200

    Media:

    David Schull

    Russo Partners

    858-717-2310

     

    Primary Logo

    View Full Article Hide Full Article
  11. – Completion of BCV NDA Rolling Submission Planned for Third Quarter 2020 –

     Currently Enrolling Phase 2/3 Study of DSTAT in Patients with COVID-19;
     Phase 2 Enrollment Completion Expected in Fourth Quarter

    Startup Activities for DSTAT Phase 3 AML Study Initiated;
      Site Activation Expected Early 2021 –

    – Conference Call at 8:30 a.m. ET Today –

    DURHAM, N.C., Aug. 10, 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 second quarter ended June 30, 2020 and provided an operational update.

    Mike Sherman, Chief Executive Officer of Chimerix, commented, "Our enthusiasm for the…

    – Completion of BCV NDA Rolling Submission Planned for Third Quarter 2020 –

     Currently Enrolling Phase 2/3 Study of DSTAT in Patients with COVID-19;

     Phase 2 Enrollment Completion Expected in Fourth Quarter

    Startup Activities for DSTAT Phase 3 AML Study Initiated;

      Site Activation Expected Early 2021 –

    – Conference Call at 8:30 a.m. ET Today –

    DURHAM, N.C., Aug. 10, 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 second quarter ended June 30, 2020 and provided an operational update.

    Mike Sherman, Chief Executive Officer of Chimerix, commented, "Our enthusiasm for the potential of dociparstat sodium (DSTAT) to treat COVID-19 patients continues to grow as new data emerges on the role of high mobility group box 1 (HMGB1) which has recently been correlated with disease severity and survival.  DSTAT's key targets include both HMGB1 and platelet factor 4 (PF4). Inhibition of HMGB1 and PF4 with DSTAT could substantially address the excessive inflammation and coagulation disorders observed in these patients. We are currently enrolling our Phase 2/3 study of DSTAT as a treatment for acute lung injury (ALI) in patients with COVID-19 and expect to complete Phase 2 enrollment in the fourth quarter of 2020. We have also resumed work on our DSTAT program for the treatment of acute myeloid leukemia (AML) and now expect site activation for the Phase 3 study to begin in early 2021."

    Mr. Sherman continued, "With the recent additions of Dr. Allen Melemed as Chief Medical Officer and Caryn Barnett as Vice President of Clinical Operations, we have continued to enhance our strong leadership team. Both executives bring decades of successful drug development expertise to Chimerix as we advance our pipeline." 

    "Importantly, we are in the midst of our rolling submission of the New Drug Application (NDA) for the approval of brincidofovir (BCV) as a medical countermeasure for smallpox and expect to complete it by the end of the third quarter. The COVID-19 pandemic has highlighted the importance of preparedness to treat future viral outbreaks, especially those as deadly as smallpox, and we look forward to a possible BCV regulatory approval and a potential procurement contract for the U.S. Strategic National Stockpile (SNS)," concluded Mr. Sherman.

    Recent Highlights

    • Began rolling NDA submission for the approval of BCV as a medical countermeasure for smallpox
    • Initiated enrollment in Phase 2/3 trial of DSTAT in ALI patients with COVID-19

    Expected Upcoming Milestones

    • Completion of NDA submission of BCV in third quarter 2020
    • Completion of enrollment of Phase 2 portion of DSTAT trial in COVID-19 in fourth quarter of 2020
    • Initiate Phase 3 AML trial in early 2021
    • Potential procurement agreement for BCV prior to FDA decision on smallpox NDA 
    • FDA decision on BCV smallpox NDA in 2021
    • Completion of BCV drug product manufacturing to support a potential shipment to the SNS of up to $100 million in 2021

    Second Quarter 2020 Financial Results

    Chimerix reported a net loss of $10.0 million, or $0.16 per basic and diluted share, for the second quarter of 2020.  During the same period in 2019, Chimerix recorded a net loss of $17.7 million, or $0.35 per basic and diluted share.

    Revenues for the second quarter of 2020 were $1.4 million, equal to the same period of 2019.

    Research and development expenses decreased to $8.6 million for the second quarter of 2020, compared to $13.8 million for the same period in 2019.

    General and administrative expenses decreased to $3.1 million for the second quarter of 2020, compared to $6.3 million for the same period in 2019.

    Loss from operations was $10.3 million for the second quarter of 2020, compared to a loss from operations of $18.7 million for the same period in 2019.

    Chimerix's balance sheet at June 30, 2020, included $96 million of capital available to fund operations, no debt and approximately 62.2 million outstanding shares of common stock.  The Company reaffirms its previous cash balance forecast of approximately $70 million at the end of 2020.

    Conference Call and Webcast

    Chimerix will host a conference call and live audio webcast to discuss second 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 3334648.

    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 Chimerix

    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. Its two clinical-stage drug candidates 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.  Inhibition of HMGB1 may be a primary anti-inflammatory target for DSTAT. HMGB1 induces downstream proinflammatory cytokines, including but not limited to, IL-6, TNF-α, monocyte chemoattractant protein-1 (MCP-1) and macrophage inflammatory protein-1α (MIP-1α), all of which are elevated in COVID-19.  DSTAT also binds to and inhibits the activity of PF4 which appears to play a significant role in the coagulation disorders observed in severe 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 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 ongoing Phase 2/3 clinical trial for DSTAT as a potential treatment for ALI associated with COVID-19, and the site activation of the Phase 3 clinical trial for DSTAT for the treatment of AML; 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 in its  clinical trials; risks that DSTAT and 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 associated with entering in to a  procurement agreement for BCV on expected terms 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



    Will O'Connor

    Stern Investor Relations

    212-362-1200



    Media:

    David Schull

    Russo Partners

    858-717-2310



    CHIMERIX, INC. 
    CONSOLIDATED BALANCE SHEETS 
    (in thousands, except share and per share data) 
    (unaudited) 
             
         June 30, December 31, 
          2020   2019  
    ASSETS     
    Current assets:     
     Cash and cash equivalents $53,501  $16,901  
     Short-term investments, available-for-sale  42,449   96,574  
     Accounts receivable  367   1,233  
     Prepaid expenses and other current assets  2,578   3,385  
      Total current assets  98,895   118,093  
    Property and equipment, net of accumulated depreciation  338   540  
    Operating lease right-of-use assets  2,414   709  
    Other long-term assets  26   34  
       Total assets $101,673  $119,376  
             
    LIABILITIES AND STOCKHOLDERS' EQUITY     
    Current liabilities:     
     Accounts payable $1,425  $2,398  
     Accrued liabilities  4,811   6,830  
      Total current liabilities  6,236   9,228  
    Lease-related obligations  2,302   196  
       Total liabilities  8,538   9,424  
             
    Stockholders' equity:     
     Preferred stock, $0.001 par value, 10,000,000 shares authorized at June 30, 2020 and     
      December 31, 2019; no shares issued and outstanding as of June 30, 2020 and     
      December 31, 2019;       
     Common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2020 and    
      December 31, 2019; 62,172,418 and 61,590,013 shares issued and outstanding as of    
      June 30, 2020 and December 31, 2019, respectively  62   62  
     Additional paid-in capital  782,217   778,693  
     Accumulated other comprehensive gain, net  130   35  
     Accumulated deficit  (689,274)  (668,838) 
      Total stockholders' equity  93,135   109,952  
       Total liabilities and stockholders' equity $101,673  $119,376  
             



    CHIMERIX, INC. 
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS 
    (in thousands, except share and per share data) 
    (unaudited) 
                  
           Three Months Ended June 30, Six Months Ended June 30, 
           2020   2019   2020   2019  
    Revenues:         
     Contract revenue $1,396  $1,438  $2,567  $3,794  
     Licensing revenue  6   -   76   -  
      Total revenues  1,402   1,438   2,643   3,794  
    Operating expenses:         
     Research and development  8,578   13,827   17,527   27,342  
     General and administrative  3,110   6,312   6,315   13,998  
      Total operating expenses  11,688   20,139   23,842   41,340  
       Loss from operations  (10,286)  (18,701)  (21,199)  (37,546) 
    Other income:         
     Interest income and other, net  270   1,051   763   2,203  
        Net loss  (10,016)  (17,650)  (20,436)  (35,343) 
    Other comprehensive loss:         
     Unrealized gain on debt investments, net  141   77   95   217  
        Comprehensive loss $(9,875) $(17,573) $(20,341) $(35,126) 
    Per share information:         
     Net loss, basic and diluted $(0.16) $(0.35) $(0.33) $(0.69) 
     Weighted-average shares outstanding, basic and diluted 62,042,778   51,130,104   61,892,407   51,009,935  
                  

     

    Primary Logo

    View Full Article Hide Full Article
  12. DURHAM, N.C., Aug. 03, 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 Monday, August 10, 2020 at 8:30 a.m. ET to report financial results for the second quarter ended June 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 3334648. 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…

    DURHAM, N.C., Aug. 03, 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 Monday, August 10, 2020 at 8:30 a.m. ET to report financial results for the second quarter ended June 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 3334648. 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 Chimerix

    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. 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 complications.  DSTAT is being studies in a Phase 2/3 trial to assess safety and efficacy in adults with acute lung injury with underlying severe COVID-19 infection.  A Phase 3 trial protocol to study DSTAT in acute myeloid leukemia (AML) has been agreed to with the US Food and Drug Administration (FDA). 

    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 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; Chimerix's ability to develop DSTAT, including the initiation of a Phase 3 trial in AML and the ongoing 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 its clinical trials; 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; 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





    Will O'Connor

    Stern Investor Relations

    212-362-1200





    Media:

    David Schull

    Russo Partners

    858-717-2310

    Primary Logo

    View Full Article Hide Full Article
  13. DURHAM, N.C., June 22, 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 the appointment of Allen Melemed, M.D., M.B.A., as Chief Medical Officer.

    "We are delighted to welcome Dr. Melemed as a key member of our management team. We look forward to leveraging his considerable clinical and regulatory experience as a distinguished pharmaceutical executive. His vast experience bringing oncology therapeutics through development and approval across multiple modalities will be invaluable as we initiate our dociparstat sodium (DSTAT) Phase 3 trial in first line acute myeloid leukemia (AML), our ongoing Phase 2/3…

    DURHAM, N.C., June 22, 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 the appointment of Allen Melemed, M.D., M.B.A., as Chief Medical Officer.

    "We are delighted to welcome Dr. Melemed as a key member of our management team. We look forward to leveraging his considerable clinical and regulatory experience as a distinguished pharmaceutical executive. His vast experience bringing oncology therapeutics through development and approval across multiple modalities will be invaluable as we initiate our dociparstat sodium (DSTAT) Phase 3 trial in first line acute myeloid leukemia (AML), our ongoing Phase 2/3 trial to combat acute lung injury (ALI) in COVID-19 patients, and finalize our rolling New Drug Application (NDA) for brincidofovir (BCV) as a medical countermeasure for smallpox," said Mike Sherman, Chief Executive Officer of Chimerix.

    "I am particularly pleased to be joining Chimerix at such an important juncture in its growth trajectory. DSTAT's potential to improve survival in newly-diagnosed AML patients is critically important in a disease where five-year survival rates remain far too low, particularly in older populations.  Furthermore, DSTAT's broad mechanism to manage inflammation and hematologic disorders offers promise to treat ALI in COVID-19 patients and underpins its mechanism of action in ALI beyond the current pandemic. I look forward to working with the team to advance our pipeline of important therapies and to bringing these life-saving treatments to patients in need," said Dr. Melemed.

    Dr. Melemed joins Chimerix from Eli Lilly and Company, where he spent more than 20 years dedicated to the clinical development and approval of oncology medicines across a broad range of tumor types including VERZENIO®, CYRAMZA®, LARTRUVO® , ALIMTA®  and RETEVMO® among others. Most recently, he served as a Distinguished Medical Fellow and Senior Director of Regulatory Affairs Oncology, North America. In addition to his role at Eli Lilly, Dr. Melemed was an attending physician in pediatric oncology at Indiana University (IU) School of Medicine, Riley Children's Hospital from 1996 to 2012.

    Dr. Melemed holds a B.S. in Genetics and Cell Biology from the University of Minnesota and a M.D. from the University of Minnesota School of Medicine. In addition, he completed his residency in pediatrics at the University of Wisconsin, Madison and fellowship in pediatric hematology/oncology at IU School of Medicine. He earned an M.B.A. from the University of Chicago Booth School of Business. Dr. Melemed has authored dozens of scientific and clinical publications.

    About Chimerix

    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. Its two clinical-stage development programs are DSTAT and BCV.

    Dociparstat sodium is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that may be dosed at much higher levels without triggering bleeding complications. In vitro and in vivo animal model data support DSTAT's potential to reduce the inflammation and cellular infiltration associated with ALI and address coagulation disorders associated with COVID-19 pathology of high mobility group box 1 (HMGB1) and platelet factor 4 (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 Chimerix website, www.chimerix.com.

    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; Chimerix's ability to develop DSTAT, including the initiation of a Phase 3 trial in AML and the ongoing 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 its clinical trials; 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; 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





    Will O'Connor

    Stern Investor Relations

    212-362-1200





    Media:

    David Schull

    Russo Partners

    858-717-2310

    Primary Logo

    View Full Article Hide Full Article
  14. DURHAM, N.C., June 18, 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 Company management, including Mike Sherman, Chief Executive Officer, and Mike Andriole, Chief Business and Financial Officer, will participate in a fireside chat at the H.C. Wainwright Virtual Fireside Chat Series on Thursday, June 25, 2020 at 12:05 p.m. ET.

    A live audio webcast of the chat 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 Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating…

    DURHAM, N.C., June 18, 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 Company management, including Mike Sherman, Chief Executive Officer, and Mike Andriole, Chief Business and Financial Officer, will participate in a fireside chat at the H.C. Wainwright Virtual Fireside Chat Series on Thursday, June 25, 2020 at 12:05 p.m. ET.

    A live audio webcast of the chat 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 Chimerix

    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. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).

    Dociparstat sodium is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that may be dosed at much higher levels without triggering bleeding complications. 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 Chimerix website, www.chimerix.com.

    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 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; 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





    Will O'Connor

    Stern Investor Relations



    212-362-1200

    Media Contact

    David Schull

    Russo Partners

    858-717-2310

    Primary Logo

    View Full Article Hide Full Article
  15. DURHAM, N.C., May 28, 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 Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 9:30 a.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 Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful…

    DURHAM, N.C., May 28, 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 Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 9:30 a.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 Chimerix

    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. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).

    Dociparstat sodium is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that may be dosed at much higher levels without triggering bleeding complications. 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 Chimerix website, www.chimerix.com.

    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 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; 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
     

    Will O'Connor
    Stern Investor Relations

    212-362-1200

    Media Contact
    David Schull
    Russo Partners
    858-717-2310

    Primary Logo

    View Full Article Hide Full Article
  16. RESEARCH TRIANGLE PARK, N.C. , May 19, 2020 (GLOBE NEWSWIRE) -- Asklepios BioPharmaceutical, Inc. (AskBio), a leading, clinical-stage adeno-associated virus (AAV) gene therapy company, today announced the appointment of Tim Trost as Chief Financial Officer. Mr. Trost is a highly accomplished CFO with more than 25 years of experience building, managing and financing emerging life sciences companies.

    Prior to joining AskBio, Mr. Trost most recently served as CFO at Chimerix (NASDAQ:CMRX), where he took the company through its IPO and four follow-on financings. Previous to Chimerix, he was CFO at Argos Therapeutics, a venture-backed immunotherapy company that ultimately also went public. Prior to that, he was CFO at InteCardia, a venture-backed…

    RESEARCH TRIANGLE PARK, N.C. , May 19, 2020 (GLOBE NEWSWIRE) -- Asklepios BioPharmaceutical, Inc. (AskBio), a leading, clinical-stage adeno-associated virus (AAV) gene therapy company, today announced the appointment of Tim Trost as Chief Financial Officer. Mr. Trost is a highly accomplished CFO with more than 25 years of experience building, managing and financing emerging life sciences companies.

    Prior to joining AskBio, Mr. Trost most recently served as CFO at Chimerix (NASDAQ:CMRX), where he took the company through its IPO and four follow-on financings. Previous to Chimerix, he was CFO at Argos Therapeutics, a venture-backed immunotherapy company that ultimately also went public. Prior to that, he was CFO at InteCardia, a venture-backed cardiac imaging company, where he played a key role in negotiating and executing the sale of the company to a NASDAQ-listed entity. Previous to InteCardia, Mr. Trost served as CFO of Coastal Physician Group (NYSE:DR), a contract provider of emergency room physicians, after having joined the company as Vice President of Corporate Development. His earlier career included positions as Vice President of Finance at Morganite North America and Senior Manager at PwC.

    "Tim's financial and strategic leadership experience, as well as his track record of financing clinical-stage biotech companies, will be critical as we enter our next phase of growth that includes expansion of our AAV manufacturing and clinical programs," said Sheila Mikhail, JD, MBA, AskBio CEO. "On behalf of our growing team, I welcome Tim and look forward to his contributions."

    Mr. Trost holds a degree in accounting from the University of Illinois at Urbana-Champaign and is a Certified Public Accountant.

    About AskBio
    Founded in 2001, Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held, clinical-stage gene therapy company dedicated to improving the lives of children and adults with genetic disorders. AskBio's gene therapy platform includes an industry-leading proprietary cell line manufacturing process called Pro10™ and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. An early innovator in the space, AskBio holds more than 500 patents in areas such as AAV production and chimeric and self-complementary capsids. AskBio has a portfolio of clinical programs across a range of indications that includes therapeutics for Pompe disease, limb-girdle muscular dystrophy 2i/R9 and congestive heart failure, as well as out-licensed clinical indications for hemophilia (Chatham Therapeutics acquired by Takeda) and Duchenne muscular dystrophy (Bamboo Therapeutics acquired by Pfizer). Learn more at https://www.askbio.com or follow us on LinkedIn.

    Contact:
    Robin Fastenau
    Vice President, Communications
    +1 984.275.2705
    

    Primary Logo

    View Full Article Hide Full Article
  17. DURHAM, N.C., May 07, 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 first quarter ended March 31, 2020 and provided an 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 Mike Sherman, Chief Executive Officer of Chimerix. "As we've learned more about the manifestations of COVID-19 and how it causes death in the most serious cases, it has become clear that DSTAT's mechanisms may be uniquely positioned to address multiple aspects…

    DURHAM, N.C., May 07, 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 first quarter ended March 31, 2020 and provided an 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 Mike Sherman, Chief Executive Officer of Chimerix. "As we've learned more about the manifestations of COVID-19 and how it causes death in the most serious cases, it has become clear that DSTAT's mechanisms may be uniquely positioned to address multiple aspects of the virus' progression, including ALI and coagulative disorders that have led to a number of other conditions, including amputations, pulmonary embolisms and stroke. As a result, DSTAT has the potential to prevent the disease progression necessitating the use of mechanical ventilation, improve survival and potentially accelerate recovery."

    "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. Chimerix has been at the forefront of these measures working with the U.S. government to develop brincidofovir (BCV) for smallpox. Preparing BCV for the U.S. Strategic National Stockpile (SNS) is a critical element to protect the population from this deadly virus, whether a potential outbreak occurs naturally or through a bioterror attack. To that end, we were very pleased to receive the U.S. Food and Drug Administration's (FDA) clearance to initiate a rolling New Drug Application (NDA) for BCV as a medical countermeasure for smallpox. We look forward to finalizing our submission mid-year and to a potential procurement contract to enable the addition of BCV to the SNS," added Mr. Sherman.

    Recent Highlights

    • 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 million of 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

    Chimerix reported a net loss of $10.4 million, or $0.17 per basic and diluted share, for the first quarter of 2020.  During the same period in 2019, Chimerix recorded a net loss of $17.7 million, or $0.35 per basic and diluted share.

    Revenues for the first quarter of 2020 decreased to $1.2 million, compared to $2.4 million for the same period in 2019.

    Research and development expenses decreased to $8.9 million for the first quarter of 2020, compared to $13.5 million for the same period in 2019.

    General and administrative expenses decreased to $3.2 million for the first quarter of 2020, compared to $7.7 million for the same period in 2019.

    Loss from operations was $10.9 million for the first quarter of 2020, compared to a loss from operations of $18.8 million for the same period in 2019.

    Chimerix's balance sheet at March 31, 2020 included $103.0 million of capital available to fund operations, no debt, and approximately 61.9 million outstanding shares of common stock.  The Company expects to end the year with approximately $70 million in cash and cash equivalents at the end of 2020.

    About Chimerix

    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. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).

    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 Chimerix website, www.chimerix.com.

    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 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
     

    Will O'Connor
    Stern Investor Relations
      
    212-362-1200

    Media Contact
    David Schull
    Russo Partners
    858-717-2310
     

     
     
    CHIMERIX, INC.
    CONSOLIDATED BALANCE SHEETS
    (in thousands, except share and per share data)
    (unaudited)
                   
              March, 31   December 31,
                2020       2019  
    ASSETS        
    Current assets:        
      Cash and cash equivalents   $ 24,553     $ 16,901  
      Short-term investments, available-for-sale     78,469       96,574  
      Accounts receivable     1,079       1,233  
      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  
          Total assets   $ 107,769     $ 119,376  
                   
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    Current liabilities:        
      Accounts payable   $ 1,124     $ 2,398  
      Accrued liabilities     5,556       6,830  
        Total current liabilities     6,680       9,228  
    Lease-related obligations     48       196  
          Total liabilities     6,728       9,424  
                           
    Stockholders' equity:                
      Preferred stock, $0.001 par value, 10,000,000 shares authorized at March 31, 2020 and                
        December 31, 2019; no shares issued and outstanding as of March 31, 2020 and     -       -  
        December 31, 2019                
      Common stock, $0.001 par value, 200,000,000 shares authorized at March 31, 2020 and                
        December 31, 2019; 61,930,339 and 61,590,013 shares issued and outstanding as of                
        March 31, 20120 and December 31, 2019, respectively     62       62  
      Additional paid-in capital     780,248       778,693  
      Accumulated other comprehensive (loss) gain, net     (11 )     35  
      Accumulated deficit     (679,258 )     (668,838 )
        Total stockholders' equity     101,041       109,952  
          Total liabilities and stockholders' equity   $ 107,769     $ 119,376  
                   


    CHIMERIX, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (in thousands, except share and per share data)
    (unaudited)
                     
                 Three Months Ended March 31,
                  2020       2019  
    Revenues:        
      Contract revenue   $ 1,171     $ 2,356  
      Licensing revenue     70       -  
        Total revenues     1,241       2,356  
    Operating expenses:        
      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 )
    Other income:        
      Interest income and other, net     493       1,152  
            Net loss     (10,420 )     (17,693 )
    Other comprehensive loss:        
      Unrealized (loss) gain on debt investments, net     (46 )     140  
            Comprehensive loss   $ (10,466 )   $ (17,553 )
    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  
                     

    Primary Logo

    View Full Article Hide Full Article
  18. FDA Clearance to Proceed with Phase 2/3 Randomized, Double-Blind, Placebo Controlled Study

    Mechanisms of Action May Address Overactive Inflammatory Response, Including Underlying Causes of Blood Coagulation Disorders Associated with COVID-19

    Company to Host Conference Call Today at 8:30 a.m. ET

    DURHAM, N.C., April 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 the Company's initiation of a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI). 

    DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential…

    FDA Clearance to Proceed with Phase 2/3 Randomized, Double-Blind, Placebo Controlled Study

    Mechanisms of Action May Address Overactive Inflammatory Response, Including Underlying Causes of Blood Coagulation Disorders Associated with COVID-19

    Company to Host Conference Call Today at 8:30 a.m. ET

    DURHAM, N.C., April 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 the Company's initiation of a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI). 

    DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding complications compared to commercially available forms of heparin.1

    "Given the severity of the COVID-19 pandemic, we have evaluated many potential targets to address the clinical manifestations associated with severe COVID-19,"said Joseph Lasky, M.D., Professor of Medicine, Pulmonary and Critical Care Section Chief, John W. Deming, M.D. Endowed Chair in Internal Medicine at Tulane University Medical School.  "Based on the literature, we believe DSTAT has the potential to reduce the excessive inflammation, immune cell infiltration and hypercoagulation associated with poor outcomes in patients with severe COVID-19 infection."

    "DSTAT is well-suited to unlock the anti-inflammatory properties of heparin as it may be dosed at much higher levels than any available form of heparin without triggering bleeding complications," said Mike Sherman, Chief Executive Officer of Chimerix. "We had planned to evaluate DSTAT in several indications of high unmet need, including ALI from different causes. The pandemic intensified our focus on ALI associated with COVID-19. Our team has worked closely with critical care physicians treating COVID-19 patients and with the U.S. Food and Drug Administration (FDA) to develop a Phase 2/3 protocol to determine if DSTAT can reduce the need for mechanical ventilation and improve the rate of survival in patients with severe COVID-19 infection."

    Phase 2/3 Study Design

    The study is a 1:1 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. Eligible subjects will be those with confirmed COVID-19 who require hospitalization and supplemental oxygen therapy. The primary endpoint of the study is the proportion of subjects who survive and do not require mechanical ventilation through day 28. Additional endpoints include time to improvement as assessed by the National Institute of Allergy and Infectious Disease ordinal scale, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality, and changes in key biomarkers (e.g. interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), high mobility group box 1 (HMGB1), C-reactive protein and d-dimer). 

    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.

    Clinical Rationale for DSTAT in COVID-19 Patients with ALI

    The clinical manifestations of COVID-19 range from mild, self-limited respiratory tract illness to severe alveolar damage and progressive respiratory failure, multiple organ failure, and death. Mortality in COVID-19 is associated with severe pulmonary disease and coagulation disorders such as disseminated intravascular coagulation (DIC).2,3   

    The mechanistic rationale supporting DSTAT's potential in ALI patients with COVID-19 is two-fold:

    • Potential to decrease inflammation/immune cell infiltration in COVID-19 patients with ALI:
      • A primary anti-inflammatory effect of DSTAT is mediated by inhibition of HMGB1 activity. HMGB1 induces downstream proinflammatory cytokines, including but not limited to, IL-6, TNF-α, monocyte chemoattractant protein-1 (MCP-1) and macrophage inflammatory protein-1α (MIP-1α), all of which are elevated in COVID-19.1,4-6
         
      • Infiltration of monocytes and other immune cells into inflamed lung tissue is a key pathogenic driver of ALI.7  DSTAT reduces lung infiltration by immune cells in ALI, likely by inhibition of MCP-1 and other ligands involved in migration of monocytes, neutrophils and other effector cells that promote hyperinflammation in the lungs.1,8
         
    • Potential to alleviate the underlying causes of coagulation disorders by inhibiting HMGB1 and platelet factor 4 (PF4) activities:
      • Two recent studies have identified a high neutrophil/lymphocyte ratio and low platelet counts as clinically relevant indicators of disease severity and mortality in COVID-19.9,10 Neutrophils are early responders to infection capable of extruding granular and nuclear contents to produce neutrophil extracellular traps (NETs). NETs may be beneficial (e.g., by trapping pathogens); however, excessive neutrophils and NET release can be pathogenic.11 HMGB1 promotes NETs which may drive hypercoagulation by providing a substrate for platelet aggregation and upregulating tissue factor on endothelial cells.12  Activated platelets in turn release PF4, which further exacerbates inflammation.13  DSTAT's inhibition of inflammatory drivers of coagulation (e.g., PF4 and HMGB1) has the potential to prevent and treat  coagulation disorders observed in COVID-19.1,14,15            

    In a recent Phase 2 Acute Myeloid Leukemia (AML) study DSTAT was well tolerated with adverse events similar across DSTAT and control groups.  DSTAT is an investigational agent, not yet licensed or approved for use. 

    Conference Call and Webcast

    Chimerix will host a conference call and live audio webcast 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 8263766.

    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 Chimerix

    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. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).

    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. 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 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.  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 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; and Chimerix's ability to submit and/or obtain regulatory approvals for DSTAT. 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 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; 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


    Will O'Connor
    Stern Investor Relations

    212-362-1200

    Media:
    David Schull
    Russo Partners
    858-717-2310
     

    note: DSTAT may be referred to as 2-O,3-O desulfated heparin, ODSH or CX-01 in these references.

    1. Rao, Narayanam V., et al. "Low Anticoagulant Heparin Targets Multiple Sites of Inflammation, Suppresses Heparin-Induced Thrombocytopenia, and Inhibits Interaction of RAGE with Its Ligands." American Journal of Physiology - Cell Physiology, vol. 299, no. 1, July 2010, doi:10.1152/ajpcell.00009.2010.
    2. Zhou, Fei, et al. "Clinical Course and Risk Factors for Mortality of Adult Inpatients with COVID-19 in Wuhan, China: A Retrospective Cohort Study." The Lancet, vol. 6736, no. 20, Elsevier Ltd, 2020, pp. 1–9, doi:10.1016/s0140-6736(20)30566-3.
    3. Tang, Ning, et al. "Anticoagulant Treatment Is Associated with Decreased Mortality in Severe Coronavirus Disease 2019 Patients with Coagulopathy." Journal of Thrombosis and Haemostasis, Wiley, Mar. 2020, doi:10.1111/jth.14817.
    4. Kim, Sodam, et al. "Signaling of High Mobility Group Box 1 (HMGB1) through Toll-like Receptor 4 in Macrophages Requires CD14." Molecular Medicine, vol. 19, no. 1, Mol Med, 2013, pp. 88–98, doi:10.2119/molmed.2012.00306.
    5. Huang, Chaolin, et al. "Clinical Features of Patients Infected with 2019 Novel Coronavirus in Wuhan, China." The Lancet, vol. 395, no. 10223, 2020, pp. 497–506, doi:10.1016/S0140-6736(20)30183-5.
    6. Herold, Tobias, et al. "Level of IL-6 Predicts Respiratory Failure in Hospitalized Symptomatic COVID-19 Patients." MedRxiv, Cold Spring Harbor Laboratory Press, Apr. 2020, p. 2020.04.01.20047381, doi:10.1101/2020.04.01.20047381.
    7. Thompson, B. Taylor, et al. "Acute Respiratory Distress Syndrome." New England Journal of Medicine, vol. 377, no. 6, Massachussetts Medical Society, 10 Aug. 2017, pp. 562–72, doi:10.1056/NEJMra1608077.
    8. Sharma, Lokesh, et al. "Partially-Desulfated Heparin Improves Survival in Pseudomonas Pneumonia by Enhancing Bacterial Clearance and Ameliorating Lung Injury." Journal of Immunotoxicology, vol. 11, no. 3, 2014, pp. 260–67, doi:10.3109/1547691X.2013.839587.
    9. Liu, Jingyuan, et al. "Neutrophil-to-Lymphocyte Ratio Predicts Severe Illness Patients with 2019 Novel Coronavirus in the Early Stage." MedRxiv, vol. 807, Cold Spring Harbor Laboratory Press, Feb. 2020, p. 2020.02.10.20021584, doi:10.1101/2020.02.10.20021584.
    10. Lippi, Giuseppe, et al. "Thrombocytopenia Is Associated with Severe Coronavirus Disease 2019 (COVID-19) Infections: A Meta-Analysis." Clinica Chimica Acta, vol. 2019, Elsevier LTD, 2020, doi:10.1016/j.cca.2020.03.022.
    11. Porto, Bárbara Nery, and Renato Tetelbom Stein. "Neutrophil Extracellular Traps in Pulmonary Diseases: Too Much of a Good Thing?" Frontiers in Immunology, vol. 7, no. Aug, 2016, pp. 1–13, doi:10.3389/fimmu.2016.00311.
    12. Tadie, Jean Marc, et al. "HMGB1 Promotes Neutrophil Extracellular Trap Formation through Interactions with Toll-like Receptor 4." American Journal of Physiology - Lung Cellular and Molecular Physiology, vol. 304, no. 5, Am J Physiol Lung Cell Mol Physiol, 2013, doi:10.1152/ajplung.00151.2012.
    13. Bdeir, Khalil, et al. "Platelet-Specific Chemokines Contribute to the Pathogenesis of Acute Lung Injury." American Journal of Respiratory Cell and Molecular Biology, vol. 56, no. 2, 2017, pp. 261–70, doi:10.1165/rcmb.2015-0245OC.
    14. Kowalska, M. Anna, et al. "Modulation of Protein c Activation by Histones, Platelet Factor 4, and Heparinoids: New Insights into Activated Protein C Formation." Arteriosclerosis, Thrombosis, and Vascular Biology, vol. 34, no. 1, Arterioscler Thromb Vasc Biol, Jan. 2014, pp. 120–26, doi:10.1161/ATVBAHA.113.302236.
    15. Krauel, Krystin, et al. "Heparin-Induced Thrombocytopenia: In Vitro Studies on the Interaction of Dabigatran, Rivaroxaban, and Low-Sulfated Heparin, with Platelet Factor 4 and Anti-PF4/Heparin Antibodies." Blood, vol. 119, no. 5, 2012, pp. 1248–55, doi:10.1182/blood-2011-05-353391.             

    Primary Logo

    View Full Article Hide Full Article
  19. DURHAM, N.C., April 28, 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 the Company has received clearance from the U.S. Food and Drug Administration (FDA) for a rolling submission of its New Drug Application (NDA) for the approval of brincidofovir (BCV) as a medical countermeasure for smallpox. The Company intends to begin the rolling NDA submission for BCV in May 2020 with completion targeted for mid-2020. Chimerix is developing BCV as a potential medical countermeasure for smallpox under an ongoing collaboration and funding provided by the Biomedical Advanced Research and Development Authority…

    DURHAM, N.C., April 28, 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 the Company has received clearance from the U.S. Food and Drug Administration (FDA) for a rolling submission of its New Drug Application (NDA) for the approval of brincidofovir (BCV) as a medical countermeasure for smallpox. The Company intends to begin the rolling NDA submission for BCV in May 2020 with completion targeted for mid-2020. Chimerix is developing BCV as a potential medical countermeasure for smallpox under an ongoing collaboration and funding provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, under ongoing USG Contract No HHSO10201100013C.

    "The value of being prepared for viral outbreaks has never been clearer. The potential for engineered or naturally occurring resistance to the currently approved therapy has made the development of BCV imperative," stated Mike Sherman, Chief Executive Officer of Chimerix. "The clearance to begin the rolling submission of the NDA for BCV is an important milestone for both the company and BARDA as it brings us one step closer to realizing the mandate of Project Bioshield. Our NDA preparation is already in process and we look forward to working with BARDA on a potential procurement contract in advance of FDA approval."

    In a lethal model, BCV when administered at varying times post-infection demonstrated a statistically significant survival advantage relative to placebo. This observation was consistent throughout all time points.

    About Chimerix

    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. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).

    Dociparstat sodium is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity but retains the ability to inhibit 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 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 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 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 submit and/or obtain regulatory approvals for BCV; and Chimerix's ability to enter into a procurement contract for BCV as a medical countermeasure. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that BCV may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; 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 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

    Will O'Connor
    Stern Investor Relations

    212-362-1200

     

    Primary Logo

    View Full Article Hide Full Article
  20. DURHAM, N.C., Feb. 26, 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 at the Cowen and Company 40th Annual Health Care Conference on Wednesday, March 4, 2020 at 8:40 a.m. ET in Boston, MA.

    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 Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a…

    DURHAM, N.C., Feb. 26, 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 at the Cowen and Company 40th Annual Health Care Conference on Wednesday, March 4, 2020 at 8:40 a.m. ET in Boston, MA.

    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 Chimerix

    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 Company's two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).

    Dociparstat sodium is a potential first-in-class glycosaminoglycan compound 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, elastase). 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 survival endpoints 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 an antiviral drug candidate in development as a medical countermeasure for smallpox. For further information, please visit the Chimerix website, www.chimerix.com.

    CONTACT:
    Investor Relations:
    Michelle LaSpaluto
    919 972-7115


    Will O'Connor
    Stern Investor Relations

    212-362-1200

    Primary Logo

    View Full Article Hide Full Article
  21. - Successful DSTAT End of Phase 2 Meeting with FDA Confirms Phase 3 Readiness; First Patient Visit Expected mid-2020 in 1L AML -

    - Brincidofovir pre-NDA Meeting Scheduled with FDA, on Track for mid-2020 NDA Filing -

    – Conference Call at 8:30 a.m. ET Today –

    DURHAM, N.C., Feb. 25, 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 fourth quarter and full-year ended December 31, 2019 and provided an operational update.

    "The transformation and progress we made in 2019 has laid the foundation for Chimerix to achieve a number of value-creating milestones in 2020," said Mike Sherman…

    - Successful DSTAT End of Phase 2 Meeting with FDA Confirms Phase 3 Readiness; First Patient Visit Expected mid-2020 in 1L AML -

    - Brincidofovir pre-NDA Meeting Scheduled with FDA, on Track for mid-2020 NDA Filing -

    – Conference Call at 8:30 a.m. ET Today –

    DURHAM, N.C., Feb. 25, 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 fourth quarter and full-year ended December 31, 2019 and provided an operational update.

    "The transformation and progress we made in 2019 has laid the foundation for Chimerix to achieve a number of value-creating milestones in 2020," said Mike Sherman, Chief Executive Officer of Chimerix. "The team has continued to execute extremely well as we plan to file our first New Drug Application (NDA) for brincidofovir (BCV) as a medical countermeasure for smallpox and advance our promising dociparstat sodium (DSTAT) program into pivotal Phase 3 clinical development as a front-line treatment for acute myeloid leukemia (AML)."

    Fourth Quarter and Recent Highlights

    Phase 3 Pivotal Trial of DSTAT in Front-line AML Patients

    Chimerix recently conducted an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) related to the Company's development of DSTAT in AML. Following that meeting, Chimerix incorporated FDA's feedback on key elements of the Phase 3 clinical trial and has since submitted a full protocol for final FDA review.   Chimerix plans to initiate a Phase 3 trial mid-year of DSTAT in combination with standard chemotherapy (cytarabine plus anthracycline, or "7+3") in newly diagnosed AML patients.

    The proposed Phase 3 trial will be a randomized, double-blind trial of approximately 570 newly diagnosed AML patients. The trial will include patients 60 years of age or older who have an intermediate or adverse genetic risk profile.  It will also include patients between 18 and 60 years of age who have an adverse genetic risk profile. Patients will be randomized 1:1 to receive DSTAT in combination with standard of care cytarabine plus anthracycline (7+3) induction and cytarabine consolidation chemotherapy or to receive standard of care (7+3) induction and consolidation chemotherapy alone.  Patients with FLT-3 mutations will be allowed in the study and will be eligible to receive midostaurin.

    The primary endpoint of the proposed trial will be overall survival (OS). In addition, FDA has indicated that event-free survival (EFS), using complete response with hematologic recovery to define induction success (CR), is acceptable as an endpoint for regulatory approval. Other endpoints to be evaluated in the proposed trial include minimal residual disease (MRD), relapse-free survival (RFS), time to hematologic recovery, and induction response. 

    In order to supplement the previously reported data from the pilot and Phase 2 trials and provide additional evidence of DSTAT's mechanism of action, the proposed Phase 3 trial includes an early assessment of comparative CR and MRD rates among the first 80 evaluable patients. This data is expected to be unblinded, reported publicly, and available for ongoing analysis of later endpoints. Prior to potential unblinding, this data will be reviewed by an independent Data Monitoring Committee (DMC).  The DMC will have the discretion to maintain blinding of the data from this early assessment in the event the DSTAT arm shows exceptional advantages to the control arm on CR and/or MRD, at certain pre-specified thresholds, which would allow inclusion of these patients in the final analysis.   

    The Company expects to incur approximately $15 million in clinical trial expenses up to and including this early assessment.

    BCV as a Medical Countermeasure for Smallpox

    In January, Chimerix presented data in support of BCV as a potential treatment for smallpox at the 2020 American Society for Microbiology (ASM) Biothreats Meeting in Arlington, Virginia. The presentation highlighted independent experiments performed in two lethal animal models of smallpox. In these studies, either rabbits or mice were inoculated with rabbitpox or ectromelia (mousepox) virus, respectively, to determine the survival benefit conferred by BCV treatment in animals acutely infected with these orthopoxviruses. Animals were randomized to receive either placebo or BCV at varying time intervals post infection. In both studies, animals that received BCV, even when administered late post-infection, demonstrated a statistically significant survival advantage relative to placebo.

    Data from these studies are intended to address the requirement under the FDA Animal Efficacy Rule for two different animal models of efficacy. 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 the efficacy of investigational drugs in animal models for diseases which cannot be evaluated in human clinical studies.

    In cooperation with BARDA, Chimerix has scheduled a pre-NDA meeting with FDA to review the final efficacy and safety data in preparation to submit an NDA.  Pending the outcome of this meeting, Chimerix intends to submit a BCV NDA for smallpox in mid-2020. The Company's operating and manufacturing plan assumes entering into a procurement contract with BARDA in 2020 and preparation for delivery of BCV into the Strategic National Stockpile in 2021.

    Fourth Quarter 2019 Financial Results

    Chimerix's balance sheet at December 31, 2019 included $113.5 million of capital available to fund operations, no debt, and approximately 61.6 million outstanding shares of common stock.

    Chimerix reported a net loss of $3.5 million, or $0.06 per basic and diluted share, for the fourth quarter of 2019. During the same period in 2018, Chimerix recorded a net loss of $15.0 million, or $0.29 per basic and diluted share. 

    Revenues for the fourth quarter of 2019 increased to $6.8 million, compared to $4.9 million for the same period in 2018.

    Research and development expenses decreased to $7.5 million for the three-month period ended December 31, 2019, compared to $15.3 million for the same period in 2018. 

    General and administrative expenses decreased to $3.1 million for the fourth quarter of 2019, compared to $5.0 million for the same period in 2018.

    Loss from operations was $3.9 million for the fourth quarter of 2019, compared to a loss from operations of $15.4 million for the same period in 2018.

    Full Year 2019 Financial Results

    Chimerix reported a net loss of $112.6 million, or $2.03 per basic and diluted share, for the year ended December 31, 2019. For the year ended December 31, 2018, Chimerix recorded a net loss of $69.5 million, or $1.43 per basic and diluted share. 

    Revenues for 2019 increased to $12.5 million, compared to $7.2 million in 2018.

    Research and development expenses decreased to $42.3 million for the year ended December 31, 2019, compared to $55.2 million for the year ended December 31, 2018.

    General and administrative expenses decreased to $21.2 million for the year ended December 31, 2019, compared to $23.6 million for the year ended December 31, 2018.

    Chimerix recorded acquired-in-process research and development expenses of $65.0 million for the year ended December 31, 2019 related to the Cantex transaction. 

    Loss from operations was $116.0 million for the year ended December 31, 2019, compared to a loss from operations of $71.6 million for the year ended December 31, 2018.

    Conference Call and Webcast

    Chimerix will host a conference call and live audio webcast to discuss fourth quarter and full-year 2019 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 1397800.

    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 Chimerix

    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 Company's two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).

    Dociparstat sodium is a potential first-in-class glycosaminoglycan compound 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, elastase).  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 survival  endpoints 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 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 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 develop DSTAT and BCV, including the initiation of a Phase 3 clinical trial for DSTAT; Chimerix's ability to submit and/or obtain regulatory approvals for DSTAT and BCV; and Chimerix's ability to enter into a procurement contract for BCV as a medical countermeasure. 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 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 or BCV may not be completed on time 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; risks related to procurement of BCV for the treatment of smallpox 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


    Will O'Connor
    Stern Investor Relations

    212-362-1200

    CHIMERIX, INC.
    CONSOLIDATED BALANCE SHEETS
    (in thousands, except share and per share data)
     
           
      December 31,   December 31,
        2019       2018  
    ASSETS      
    Current assets:      
    Cash and cash equivalents $ 16,901     $ 81,106  
    Short-term investments, available-for-sale   96,574       105,424  
    Accounts receivable   1,233       330  
    Prepaid expenses and other current assets   3,385       2,598  
    Total current assets   118,093       189,458  
    Property and equipment, net of accumulated depreciation   540       1,210  
    Operating lease right-of-use assets   709       -  
    Other long-term assets   34       46  
    Total assets $ 119,376     $ 190,714  
           
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable $ 2,398     $ 4,691  
    Accrued liabilities   6,830       8,275  
    Total current liabilities   9,228       12,966  
    Lease-related obligations   196       144  
    Total liabilities   9,424       13,110  
           
    Stockholders' equity:      
    Preferred stock, $0.001 par value, 10,000,000 shares authorized at December 31, 2019 and 2018; no shares issued and outstanding as of December 31, 2019 and 2018   -       -  
    Common stock, $0.001 par value, 200,000,000 shares authorized at December 31, 2019 and 2018; 61,590,013 and 50,735,279 shares issued and outstanding as of December 31, 2019 and 2018, respectively   62       51  
    Additional paid-in capital   778,693       733,907  
    Accumulated other comprehensive loss, net   35       (92 )
    Accumulated deficit   (668,838 )     (556,262 )
    Total stockholders' equity   109,952       177,604  
    Total liabilities and stockholders' equity $ 119,376     $ 190,714  
           


    CHIMERIX, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (in thousands, except share and per share data)
     
                   
       Three Months Ended December 31,   Years Ended December 31,
        2019       2018       2019       2018  
    Revenues:              
    Contract revenue $ 1,852     $ 4,864     $ 7,604     $ 7,216  
    Licensing revenue   4,915       -       4,915       -  
    Total revenues   6,767       4,864       12,519       7,216  
    Operating expenses:              
    Research and development   7,493       15,276       42,288       55,239  
    General and administrative   3,147       5,007       21,169       23,582  
    Acquired in-process research and development   -       -       65,045       -  
    Total operating expenses   10,640       20,283       128,502       78,821  
    Loss from operations   (3,873 )     (15,419 )     (115,983 )     (71,605 )
    Other income:              
    Interest income and other, net   370       463       3,407       2,131  
    Net loss   (3,503 )     (14,956 )     (112,576 )     (69,474 )
    Other comprehensive loss:              
    Unrealized (loss) gain on investments, net   (55 )     569       127       871  
    Comprehensive loss $ (3,558 )   $ (14,387 )   $ (112,449 )   $ (68,603 )
    Per share information:              
    Net loss, basic and diluted $ (0.06 )   $ (0.29 )   $ (2.03 )   $ (1.43 )
    Weighted-average shares outstanding, basic and diluted   61,385,616       50,722,655       55,501,973       48,593,435  
                   

    Primary Logo

    View Full Article Hide Full Article
  22. DURHAM, N.C., Feb. 24, 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 the appointment of Pratik S. Multani, M.D., to its Board of Directors, effective immediately. Dr. Multani currently serves as Chief Medical Officer of ORIC Pharmaceuticals. He replaces Jim Daly, who recently stepped down from the Board of Directors.

    ‘We are thrilled to welcome Pratik to our Board of Directors. His significant experience advancing oncology products from the clinic through regulatory approval will be a valuable resource as we advance DSTAT in newly diagnosed acute myeloid leukemia patients," said Mike Sherman, President…

    DURHAM, N.C., Feb. 24, 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 the appointment of Pratik S. Multani, M.D., to its Board of Directors, effective immediately. Dr. Multani currently serves as Chief Medical Officer of ORIC Pharmaceuticals. He replaces Jim Daly, who recently stepped down from the Board of Directors.

    ‘We are thrilled to welcome Pratik to our Board of Directors. His significant experience advancing oncology products from the clinic through regulatory approval will be a valuable resource as we advance DSTAT in newly diagnosed acute myeloid leukemia patients," said Mike Sherman, President and Chief Executive Officer of Chimerix. "We also thank Jim for his considerable contribution to Chimerix over the last six years, particularly in supporting our recent re-positioning of the company, and wish him well in all of his future endeavors."

    "I am delighted to be joining the Chimerix Board of Directors at this exciting stage of the company's development. I look forward to working with my fellow directors to guide Chimerix as we strive to bring life-saving therapies to patients battling cancer and other serious diseases," said Dr. Multani.

    Prior to joining ORIC, Dr. Multani served as Chief Medical Officer of Ignyta, which was acquired by Roche in 2017. Prior to Ignyta, Dr. Multani was Chief Medical Officer of Fate Therapeutics, and prior to that held multiple leadership positions at Kalypsys, Kanisa, and Salmedix. Dr. Multani started his biotech career at Biogen Idec, where he was involved with the development of both Zevalin and Rituxan for treatment of Non-Hodgkin Lymphoma.

    Earlier in his career, Dr. Multani held academic and clinical positions at Harvard Medical School and at Massachusetts General Hospital. His postdoctoral training included a fellowship in hematology and oncology at Dana-Farber Cancer Institute and an internship and residency in Internal Medicine at Massachusetts General Hospital. Dr. Multani received an M.D. from Harvard Medical School and an M.S. in clinical epidemiology from Harvard School of Public Health.

    About Chimerix

    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 compound 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 acute myeloid leukemia (AML) blasts and leukemic stem cells in the bone marrow during chemotherapy (e.g., CXCL12, selectins, HMGB1, elastase). 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 event-free survival (EFS) and overall survival (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 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 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 development of DSTAT in newly diagnosed acute myeloid leukemia patients. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that development activities related to DSTAT may not be completed on time or at all; 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


    Will O'Connor
    Stern Investor Relations

    212-362-1200

     

    Primary Logo

    View Full Article Hide Full Article
  23. DURHAM, N.C., Feb. 18, 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 Tuesday, February 25, 2020 at 8:30 a.m. ET to report financial results for the fourth quarter and full-year ended December 31, 2019, 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 1397800. A live audio webcast of the call will also be available on the Investors' section of the Company's website, www.chimerix.com

    DURHAM, N.C., Feb. 18, 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 Tuesday, February 25, 2020 at 8:30 a.m. ET to report financial results for the fourth quarter and full-year ended December 31, 2019, 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 1397800. 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 Chimerix

    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 compound 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, elastase).  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 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 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 develop BCV as a medical countermeasure for smallpox; Chimerix's ability to submit and/or obtain regulatory approvals for BCV; and Chimerix's ability to enter into a procurement contract for BCV as a medical countermeasure. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that BCV may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that development activities related to BCV may not be completed on time 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; risks related to procurement of brincidofovir for the treatment of smallpox 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


    Will O'Connor
    Stern Investor Relations

    212-362-1200

    Primary Logo

    View Full Article Hide Full Article
  24. DURHAM, N.C., Jan. 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 announces that data in support of brincidofovir (BCV) as a potential treatment for smallpox were highlighted in an oral presentation and poster at the 2020 American Society for Microbiology (ASM) Biothreats Meeting taking place January 28-30, 2020 in Arlington, Virginia. Chimerix is developing BCV as a medical countermeasure against smallpox.

    The poster titled, "Brincidofovir Treatment Efficacy in Two Well Characterized Orthopoxvirus Infection Models of Smallpox," can be accessed on the Investor page of the Chimerix corporate website.   

    Independent…

    DURHAM, N.C., Jan. 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 announces that data in support of brincidofovir (BCV) as a potential treatment for smallpox were highlighted in an oral presentation and poster at the 2020 American Society for Microbiology (ASM) Biothreats Meeting taking place January 28-30, 2020 in Arlington, Virginia. Chimerix is developing BCV as a medical countermeasure against smallpox.

    The poster titled, "Brincidofovir Treatment Efficacy in Two Well Characterized Orthopoxvirus Infection Models of Smallpox," can be accessed on the Investor page of the Chimerix corporate website.   

    Independent experiments were performed in two lethal animal models of smallpox. In these studies, either rabbits or mice were inoculated with rabbitpox or ectromelia virus, respectively, to determine the survival benefit of BCV in animals acutely infected with these orthopoxviruses. These animal models are being studied in connection with the FDA Animal Rule to determine the utility of BCV as a medical countermeasure against the human orthopoxvirus disease, smallpox. Animals were randomized to receive either placebo or BCV treatment at varying intervals post infection. In both studies, animals that received BCV, regardless of time post-infection, demonstrated a statistically significant survival advantage relative to placebo.

    Based on the increased survival evident in both studies, the authors concluded, "These studies show that treatment with BCV post exposure results in a statistically significant survival benefit in two well-characterized orthopoxvirus infection models for smallpox. These studies also provide a scientific rationale for therapeutic intervention with BCV in the event of a smallpox outbreak when vaccination is contraindicated or when diagnosis follows the appearance of clinical signs and symptoms."

    "We are delighted to present the data from these two confirmatory trials that demonstrate BCV's significant survival benefit in both orthopoxvirus infection models of smallpox. These compelling data underscore the potentially life-saving benefit of BCV and support the rationale for the Biomedical Advanced Research and Development Authority (BARDA) to stockpile BCV as a countermeasure in the event of a smallpox outbreak," said Mike Sherman, President and Chief Executive Officer of Chimerix. 

    "We continue to look forward to conducting a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and to our planned submission of applications for approval of BCV in mid-2020," added Mr. Sherman. 

    About Chimerix

    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 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 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 develop BCV as a medical countermeasure for smallpox; Chimerix's ability to submit and/or obtain regulatory approvals for BCV; and Chimerix's ability to enter into a procurement contract for BCV as a medical countermeasure. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that BCV may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that development activities related to BCV may not be completed on time 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; risks related to procurement of brincidofovir for the treatment of smallpox 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


    Will O'Connor
    Stern Investor Relations

    212-362-1200

    Primary Logo

    View Full Article Hide Full Article
  25. DURHAM, N.C., Dec. 10, 2019 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that data relating to its dociparstat sodium (DSTAT) program, formerly known as CX-01, were presented at the 61st American Society of Hematology Annual Meeting, in Orlando, FL.

    The poster, titled "Updated Study Results for CX-01, an Inhibitor of CXCL12/CXCR4, With Azacitidine for the Treatment of Hypomethylating Agent Refractory AML and MDS," was presented by Eric Huselton, M.D., Assistant Professor of Medicine at the University of Rochester on December 9, 2019.

    As reported in the published study abstract, 20 patients with refractory…

    DURHAM, N.C., Dec. 10, 2019 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that data relating to its dociparstat sodium (DSTAT) program, formerly known as CX-01, were presented at the 61st American Society of Hematology Annual Meeting, in Orlando, FL.

    The poster, titled "Updated Study Results for CX-01, an Inhibitor of CXCL12/CXCR4, With Azacitidine for the Treatment of Hypomethylating Agent Refractory AML and MDS," was presented by Eric Huselton, M.D., Assistant Professor of Medicine at the University of Rochester on December 9, 2019.

    As reported in the published study abstract, 20 patients with refractory myelodysplastic syndrome (MDS) (n = 9) or refractory acute myeloid leukemia (AML) (n = 11) were enrolled of which 15 were considered evaluable for response with a bone marrow biopsy after cycle 2. Patients received a 7-day continuous infusion of DSTAT (CX-01) at a dose of 0.25 mg/kg/hour, and azacitidine 75 mg/m2 daily days 1-7, in 28-day cycles.  The primary objective of this trial was to assess the overall response rate. Half of the patients had high risk cytogenetic abnormalities and 3 had TP53 mutations.  Patients had a median of 2 prior lines of therapy (range 1-3) with median of 6 prior cycles of hypomethylating agent (HMA) therapy (range 4-20).  Only 4 patients had a confirmed response to prior HMA therapy.

    The 15 evaluable patients received a median of 3 cycles of CX-01 and azacitidine (range 2-9).  Of 15 evaluable patients, there was 1 CR (complete remission) and 3 bone marrow CRs (mCR, with incomplete peripheral blood count recovery), 9 stable disease, and 2 progressive disease for an overall response rate of 27%. Of the 3 patients with a mCR after cycle 2, two had hematologic improvement of their neutrophil and platelet counts, respectively, by the end of cycle 4.  A patient with stable disease also had hematologic improvement in platelets. 

    The median overall survival of evaluable patients was 221 days. The median overall survival was not significantly different between AML patients at 221 days and MDS patients at 248 days.

    "Following a minimum of 4 cycles of prior HMA therapy, one would not expect to observe response to subsequent HMA therapy," said Dr. Huselton. "These results demonstrate DSTAT's potential to improve HMA therapy outcomes in terms of both response and overall survival."

    "DSTATs mechanism of action is intended to enhance patient benefit when combined with an active agent, so to observe these results in HMA-refractory patients is promising. In addition to our planned Phase 3 pivotal trial in newly diagnosed AML, this study highlights the potential to develop DSTAT to enhance the benefit of multiple therapies such as azacitidine, in AML and MDS in both front-line and recurrent settings," said Mike Sherman, Chief Executive Officer of Chimerix.     

    About Chimerix

    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 Chimerix website,www.chimerix.com

    CONTACT:

    Investor Relations:
    Michelle LaSpaluto
    919-972-7115

    Will O'Connor
    Stern Investor Relations
    212-362-1200

    Primary Logo

    View Full Article Hide Full Article
  26. – 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 8:30 a.m. ET Today –

    DURHAM, N.C., Nov. 05, 2019 (GLOBE NEWSWIRE) -- Chimerix, Inc. (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, 2019 and provided an operational update.

    "The progress we have made over the last several months has positioned us well for the balance…

    – 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 8:30 a.m. ET Today –

    DURHAM, N.C., Nov. 05, 2019 (GLOBE NEWSWIRE) -- Chimerix, Inc. (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, 2019 and provided an operational update.

    "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 Mike Sherman, President and Chief Executive Officer of Chimerix. "As we look toward 2020, we expect to achieve several key milestones, including a meeting with U.S. regulatory authorities to confirm our pivotal study protocol for dociparstat sodium (DSTAT) in first-line acute myeloid leukemia (AML), initiation of that important study mid-year, submission of the marketing application for brincidofovir (BCV) as a medical countermeasure for smallpox, and a potential procurement contract with BARDA to enable the addition of BCV to the U.S. Strategic National Stockpile. Importantly, while there have been several recent approvals of targeted therapies in AML, the overall five-year survival rate of roughly 10% in older patients remains low. With DSTAT, our aim is to meaningfully improve first-line therapy results in order to deliver long-term, durable responses for patients."

    Third Quarter and Recent Highlights

    Final Analysis of Randomized Trial of DSTAT in Front-line AML Patients

    In July, Chimerix entered into a License and Development Agreement with Cantex Pharmaceuticals, Inc. (Cantex) pursuant to which Chimerix acquired exclusive worldwide rights to develop and commercialize DSTAT for any and all uses. DSTAT is a 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). DSTAT has received Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration for the treatment of AML.

    In October 2019, Chimerix presented final results from the recently completed Phase 2b, randomized controlled trial of DSTAT in AML. The study evaluated DSTAT (4 mg/kg intravenous (IV) bolus followed by either 0.125 or 0.25 mg/kg/hr continuous IV infusion for 7 days) in combination with standard 7+3 chemotherapy versus chemotherapy alone in 75 subjects, greater than 60 years of age, with newly diagnosed AML. An analysis of the intent-to-treat (ITT) population in this study indicated that patients receiving DSTAT 0.25 mg/kg/hr exhibited improved hazard ratios for event-free survival (EFS, 0.67), overall survival (OS, 0.68) and relapse free-survival (RFS, 0.45) when compared to control patients. Complete response rates (CR/CRi) were similar between the arms. An analysis of subjects meeting the likely target inclusion criteria for the Phase 3 study, which excludes patients with favorable cytogenetics or secondary AML, showed improved observed hazard ratios for DSTAT 0.25 mg/kg/hr versus control for EFS (0.58), OS (0.51), and RFS (0.39).

    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 FDA in early 2020.

    BCV for Smallpox

    Chimerix intends to conduct a pre-NDA meeting with the FDA in the first quarter of 2020 and submit marketing applications for BCV in mid-2020, contingent upon final audited results of the animal efficacy studies and the finalization of animal PK analysis necessary to bridge to a recommended human dose. Earlier this year Chimerix reported statistically significant and clinically meaningful reduction in mortality from GLP mousepox and rabbitpox studies. Data from these studies are intended to address the requirement under the FDA's Animal Efficacy Rule for two different animal models of efficacy.

    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 SymBio Pharmaceuticals for BCV

    In September, Chimerix entered into an exclusive global license agreement with SymBio Pharmaceuticals, Ltd. (SymBio), under which SymBio has exclusively licensed the worldwide rights to develop, manufacture and commercialize BCV in all human indications, excluding the prevention and treatment of orthopoxviruses, including smallpox. Moving forward, SymBio will be responsible for all future development, commercialization and manufacturing associated with BCV in those licensed indications.

    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.

    Chimerix recorded acquired-in-process research and development expenses of $65.0 million for the third quarter of 2019 related to the Cantex transaction. 

    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.

    Chimerix's balance sheet at September 30, 2019 included $116.7 million of capital available to fund operations, no debt, and approximately 61.4 million outstanding shares of common stock. The Company reaffirms its previous guidance of approximately $110 million in cash and cash equivalents at the end of 2019. 

    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.

    About Chimerix

    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 Chimerix website, www.chimerix.com 

    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 SymBio Pharmaceuticals or Cantex Pharmaceuticals, including any statements related to DSTAT; Chimerix's ability to develop disease modifying and potentially curative treatments for diseases, including AML and smallpox; and, Chimerix's ability to submit for marketing authorization or enter into a procurement contract for BCV as a medical countermeasure. 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 benefits of the agreements with Cantex or SymBio may never be realized; 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 or BCV may not be completed on time or at all; Chimerix's reliance on a sole source third-party manufacturers for drug supply; risks that ongoing or future clinical trials may not be successful or replicate previous clinical trial results, or may not be predictive of real-world results or of results in subsequent clinical 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; risks related to procurement of brincidofovir for the treatment of smallpox 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

    Will O'Connor
    Stern Investor Relations
    212-362-1200


    CHIMERIX, INC.
    CONSOLIDATED BALANCE SHEETS
    (in thousands, except share and per share data)
    (unaudited)
                   
              September 30,   December 31,
                2019       2018  
    ASSETS        
    Current assets:        
      Cash and cash equivalents   $ 19,349     $ 81,106  
      Short-term investments, available-for-sale     97,366       105,424  
      Accounts receivable     1,822       330  
      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  
          Total assets   $ 127,751     $ 190,714  
                   
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    Current liabilities:        
      Accounts payable   $ 3,477     $ 4,691  
      Accrued liabilities     11,957       8,275  
        Total current liabilities     15,434       12,966  
    Lease-related obligations     369       144  
          Total liabilities     15,803       13,110  
                   
    Stockholders' equity:        
      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 )
      Accumulated deficit     (665,335 )     (556,262 )
        Total stockholders' equity     111,948       177,604  
          Total liabilities and stockholders' equity   $ 127,751     $ 190,714  
                   


     
    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,
                  2019       2018       2019       2018  
    Contract revenue   $ 1,958     $ 369     $ 5,752     $ 2,352  
    Operating expenses:                
      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  
            Net loss     (73,730 )     (16,079 )     (109,073 )     (54,518 )
    Other comprehensive loss:                
      Unrealized (loss) gain on debt investments, net     (36 )     180       182       302  
            Comprehensive loss   $ (73,766 )   $ (15,899 )   $ (108,891 )   $ (54,216 )
    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  
                             

     

     

    Primary Logo

    View Full Article Hide Full Article
  27. DURHAM, N.C., Nov. 04, 2019 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that management will present at two upcoming investor conferences in November.

    • Credit Suisse 28th Annual Healthcare Conference on Wednesday, November 13 at 11:30 a.m. MT in Scottsdale, AZ
    • Jefferies 2019 London Healthcare Conference on Wednesday, November 20 at 6:00 p.m. GMT in London, UK

    A live audio webcast of each presentation will be available on the Investor Relations section of Chimerix's website at ir.chimerix.com, where they will be archived for approximately 90 days.

    About Chimerix

    Chimerix is a development-stage biopharmaceutical…

    DURHAM, N.C., Nov. 04, 2019 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that management will present at two upcoming investor conferences in November.

    • Credit Suisse 28th Annual Healthcare Conference on Wednesday, November 13 at 11:30 a.m. MT in Scottsdale, AZ
    • Jefferies 2019 London Healthcare Conference on Wednesday, November 20 at 6:00 p.m. GMT in London, UK

    A live audio webcast of each presentation will be available on the Investor Relations section of Chimerix's website at ir.chimerix.com, where they will be archived for approximately 90 days.

    About Chimerix

    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 Chimerix website, www.chimerix.com.

    CONTACT:

    Investor Relations:
    Michelle LaSpaluto
    919-972-7115

    Will O'Connor
    Stern Investor Relations
    212-362-1200

    Primary Logo

    View Full Article Hide Full Article
  28. Includes All Human Indications Excluding Prevention and Treatment of Smallpox

    Chimerix to Receive up to $180 Million in Potential Clinical, Regulatory, and Commercial Milestones and is Eligible for Double Digit Royalties

    DURHAM, N.C., Sept. 30, 2019 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), 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, today announces an exclusive global license agreement with SymBio Pharmaceuticals, Ltd (SymBio), under which SymBio has exclusively licensed the worldwide rights to develop, manufacture and commercialize brincidofovir in all human indications…

    Includes All Human Indications Excluding Prevention and Treatment of Smallpox

    Chimerix to Receive up to $180 Million in Potential Clinical, Regulatory, and Commercial Milestones and is Eligible for Double Digit Royalties

    DURHAM, N.C., Sept. 30, 2019 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), 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, today announces an exclusive global license agreement with SymBio Pharmaceuticals, Ltd (SymBio), under which SymBio has exclusively licensed the worldwide rights to develop, manufacture and commercialize brincidofovir in all human indications, excluding the prevention and treatment of smallpox. Moving forward, SymBio will be responsible for all future development and commercialization as well as manufacturing costs associated with brincidofovir in the licensed indications.

    Under the terms of the agreement, Chimerix will receive an upfront payment of $5 million plus potential clinical, regulatory and commercial milestones of up to $180 million. In addition, Chimerix is eligible to receive double digit royalties on net sales of brincidofovir worldwide.
                       
    "This transaction marks an important corporate milestone for Chimerix, as we have transitioned our focus to the final stage of development of brincidofovir as a medical countermeasure for smallpox and to the Phase 3 development of dociparstat sodium (CX-01) in front-line therapy for acute myeloid leukemia (AML). AML remains an area of significant unmet need in which five-year survival rates are less than 30%," said Mike Sherman, President and Chief Executive Officer of Chimerix. "The structure of this agreement with SymBio allows Chimerix shareholders to participate in the value of ongoing development of brincidofovir through potential future milestone payments and royalties."

    "Furthermore, SymBio's success in transitioning to a commercial-stage biotechnology company, while simultaneously developing a pipeline of novel molecules in oncology and virology, illustrates the strength of their capability and capacity. SymBio is well positioned to explore worldwide development of brincidofovir beyond smallpox and we are excited by the promise of this partnership," continued Mr. Sherman.

    Locust Walk acted as exclusive transaction advisor and Cooley LLP acted as legal counsel to Chimerix.

    About Chimerix
    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. Dociparstat sodium is an investigational product targeting multiple proteins involved in cancer cell resistance to chemotherapy under development for the treatment of acute myeloid leukemia and other hematologic malignancies. Brincidofovir (BCV, CMX001) is an anti-viral drug candidate in development as a medical countermeasure for smallpox. For further information, please visit the Chimerix website, www.chimerix.com.

    About SymBio Pharmaceuticals Limited
    SymBio Pharmaceuticals Limited was established in March, 2005 by Fuminori Yoshida who previously served concurrently as Corporate VP of Amgen Inc. and founding President of Amgen Japan. In May, 2016 SymBio incorporated its wholly-owned subsidiary in the U.S., SymBio Pharma USA, Inc. (Headquarters: Menlo Park, California, President: Mr. Fuminori Yoshida). SymBio's underlying corporate mission is to "deliver hope to patients in need" as it aspires to be a leading global specialty biopharmaceutical company dedicated to addressing underserved medical needs.

    Forward-Looking Statements
    This press release includes 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 potential benefits to be derived from the license agreement with SymBio Pharmaceuticals, Ltd., including statements related to the activity profile and opportunities for potential development of brincidofovir (BCV); Chimerix's ability to develop disease modifying and potentially curative treatments for diseases, including smallpox and AML.  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 benefits of the agreement with SymBio may never be realized; risks that BCV or dociparstat sodium may not obtain regulatory approval from the FDA or foreign regulatory authorities or such approval may be delayed or conditioned; risks that development activities related to BCV or dociparstat sodium may not be completed on time or at all; risks that ongoing or future clinical trials may not be successful or replicate previous clinical trial results, or may not be predictive of real-world results or of results in subsequent clinical trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for dociparstat sodium or BCV; risks that dociparstat sodium or BCV 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


    Will O'Connor
    Stern Investor Relations

    212-362-1200 

    Primary Logo

    View Full Article Hide Full Article
  29. DURHAM, N.C., Sept. 27, 2019 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX) today announced that Mike Sherman, Chief Executive Officer, will present a corporate overview at the upcoming 2019 Cantor Global Healthcare Conference on Thursday, October 3, 2019 at 8:20 a.m. ET in New York City.

    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 Chimerix

    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. Dociparstat sodium (CX-01) is an investigational…

    DURHAM, N.C., Sept. 27, 2019 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX) today announced that Mike Sherman, Chief Executive Officer, will present a corporate overview at the upcoming 2019 Cantor Global Healthcare Conference on Thursday, October 3, 2019 at 8:20 a.m. ET in New York City.

    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 Chimerix

    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. Dociparstat sodium (CX-01) is an investigational product targeting multiple proteins involved in cancer cell resistance to chemotherapy under development for the treatment of acute myeloid leukemia and other hematologic malignancies. Brincidofovir (BCV, CMX001) is an anti-viral drug candidate in development as a medical countermeasure for smallpox. For further information, please visit the Chimerix website, www.chimerix.com.

    CONTACT:
    Investor Relations:                            
    Michelle LaSpaluto
    919 972-7115


    Will O'Connor
    Stern Investor Relations

    212-362-1200

    Primary Logo

    View Full Article Hide Full Article