CMRX Chimerix Inc.

5.9
-0.33  -5%
Previous Close 6.23
Open 6.07
52 Week Low 3.38
52 Week High 11.5696
Market Cap $512,488,313
Shares 86,862,426
Float 62,981,761
Enterprise Value $435,119,913
Volume 589,005
Av. Daily Volume 892,591
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Upcoming Catalysts

Drug Stage Catalyst Date
DSTAT (CX-01) - (DASH AML)
Acute Myeloid Leukemia (AML)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ONC201
H3 K27M-mutant Glioma
Phase 2
Phase 2
Phase 2 data demonstrated an ORR of 20%, median duration of response was 11.2 months and the median time to response was 8.3 months. Also PFS reached a 35% and 30% at 6 and 12 months respectively, OS 57% at 12 months, noted November 19, 2021.
DSTAT
Acute lung injury (ALI) in COVID-19
Phase 2
Phase 2
Phase 2 initial data released May 6, 2021. One patients died in DSTAT arm.
ONC201
Neuroendocrine Tumors
Phase 2
Phase 2
Phase 2 ASCO abstract noted ORR 5/10 (50%).
TEMBEXA (brincidofovir)
Smallpox
Approved
Approved
FDA approval announced June 4, 2021.
Oral Brincidofovir - AdAPT Study
Allogeneic hematopoietic stem cell transplant (HCT) recipients with adenovirus (AdV)
Phase 2
Phase 2
Phase 2 trial discontinued - May 9, 2019.
Brincidofovir - SUPPRESS
Cytomegalovirus (CMV) infection following an allogeneic hematopoietic stem cell transplant (HSCT)
Phase 3
Phase 3
Phase 3 endpoints not met December 2015
IV Brincidofovir
Adult allo-HCT recipients with Adenovirus
Phase 2
Phase 2
Phase 2 trial discontinued - May 9, 2019.
Brincidofovir - SURPASS
Cytomegalovirus (CMV) infection
Phase 3
Phase 3
Phase 3 discontinued following poor data from SUPPRESS trial
Brincidofovir - SUSTAIN
Cytomegalovirus (CMV) infection
Phase 3
Phase 3
Phase 3 discontinued following poor data from SUPPRESS trial
Brincidofovir - Advise trial
Adenovirus Infection
Phase 3
Phase 3
Phase 3 interim analysis released May 2016. Final data released February 22, 2017.

Latest News

  1. – Plenary Session Presentation on Saturday, November 20 –

    – Company to Host Conference Call at 8:30 a.m. ET on Monday, November 22 –

    DURHAM, N.C., Nov. 19, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the presentation of positive data from its 50-patient efficacy analysis of ONC201 for the treatment of recurrent H3 K27M-mutant diffuse midline glioma. ONC201 is an orally administered small molecule dopamine receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP) agonist for the treatment of recurrent gliomas that harbor the H3 K27M- mutation.

    These data will be…

    – Plenary Session Presentation on Saturday, November 20 –

    – Company to Host Conference Call at 8:30 a.m. ET on Monday, November 22 –

    DURHAM, N.C., Nov. 19, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the presentation of positive data from its 50-patient efficacy analysis of ONC201 for the treatment of recurrent H3 K27M-mutant diffuse midline glioma. ONC201 is an orally administered small molecule dopamine receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP) agonist for the treatment of recurrent gliomas that harbor the H3 K27M- mutation.

    These data will be presented by Isabel Arrillaga-Romany, MD, PhD, Director of Neuro-Oncology Clinical Trials, Massachusetts General Hospital Cancer Center tomorrow, November 20, 2021, during a plenary session at the Society for Neuro-Oncology (SNO) Annual Meeting in Boston, MA. In addition, Dr. Arrillaga-Romany will join management for a conference call on Monday, November 22, 2021 to give an additional overview of the data.

    Key Data Highlights

    ONC201 monotherapy exhibited durable and clinically meaningful efficacy in recurrent H3 K27M-mutant diffuse midline glioma (DMG) patients:

    • Response Assessment in Neuro-Oncology Criteria for High Grade Gliomas (RANO-HGG) criteria assessed by dual reader blinded independent central review (BICR)
      • Overall response rate (ORR): 20% (95% CI: 10 – 34%); including one complete response
      • Median duration of response (DOR): 11.2 months (95% CI: 3.8 – not reached)
      • Median time to response: 8.3 months (range: 1.9 – 15.9)
      • Disease control rate (DCR): 40% (95% CI: 26 – 55%)
      • Progression-free survival (PFS): 35% (95% CI: 21 – 49%) at 6 months; 30% (95% CI: 17 – 44%) at 12 months
    • Response Assessment in Neuro-Oncology Criteria for Low Grade Gliomas (RANO-LGG) criteria assessed by dual reader BICR
      • ORR 26% (95% CI: 15 – 40%)
    • Among evaluable patients (those receiving at least 4mg of dexamethasone daily at baseline), 46.7% achieved at least a 50% confirmed reduction in corticosteroid dose
    • Among evaluable patients (those with a baseline performance status (KPS/LPS) score of 80 or lower), 20.6% achieved a confirmed improvement, indicative of improved quality of life.
    • Overall survival
      • 12 months: 57% (95% CI: 41 – 70%)
      • 24 months: 35% (95% CI: 21 – 49%)

    "The ONC201 data to be presented at SNO show impressive and consistent results in a disease where life expectancy is exceedingly limited. There currently are no effective therapeutic options for patients with recurrent disease after radiation other than palliation. ONC201 results are particularly notable in light of extended wash-out periods required to ensure isolation of ONC201 single agent effect. It sets the stage for future study of ONC201 earlier in treatment," said Mike Sherman, Chief Executive Officer of Chimerix. "This mutation is considered high grade regardless of histology when present in diffuse midline gliomas and yet the consistency in response between RANO-HGG and -LGG criteria is important in that responses in both enhancing and non-enhancing measures of disease confer benefit to patients. Importantly, tumor responses were quite durable and associated with other measures of clinical benefit including sustained reduction in corticosteroid use, performance status improvement, and survival beyond 24 months. In fact, 11 of the 12 evaluable RANO responders (HGG or LGG) also had accompanying corticosteroid reduction or performance status improvement. In the context of an oral therapy that has demonstrated an attractive safety profile in prior reports, we are very excited about the potential of ONC201 to help children and adult patients."

    "Given the very limited treatment options for patients with recurrent H3 K27M-mutant glioma, we are encouraged by the durable tumor regressions seen in some patients treated with ONC201," said Dr. Arrillaga-Romany.

    This cohort was comprised of the first 50 patients enrolled across five ONC201 clinical studies who met specific criteria based on feedback from the FDA. These patients were two years of age or older, had a measurable diffuse midline glioma with the H3 K27M- mutation, and had evidence of disease progression following prior therapy with at least radiation completed at least 90 days prior to enrollment.  

    One serious adverse event was attributed by an investigator as possibly related to ONC201. Full safety data collection and analysis for this cohort is ongoing. Prior safety review of ONC201 identified the most commonly reported adverse events as nausea/vomiting, fatigue and decreased lymphocyte counts.  

    The U.S. Food and Drug Administration (FDA) granted ONC201 Fast Track Designation for the treatment of adult recurrent H3 K27M-mutant HGG, 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.

    Chimerix plans to meet with the FDA in 2022 following completion of ongoing chemistry, manufacturing and controls (CMC) clinical pharmacology studies and natural disease history evaluation.

    About Recurrent H3 K27M-mutant Glioma

    Recurrent H3 K27M-mutant glioma is a brain cancer with a particularly poor prognosis. Pediatric patients with recurrent glioma that carries the H3 K27M mutation have an even worse prognosis. Diffuse midline gliomas with this mutation are classified as Grade IV by the World Health Organization. Grade IV gliomas represent the highest grade with the worst prognosis.

    Conference Call and Webcast

    Chimerix will host a conference call and live audio webcast to discuss these data on Monday, November 22 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 9048088. The call will reference slides that can be accessed on our website under the investor tab.

    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 biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. In June 2021, the U.S. Food and Drug Administration granted approval of TEMBEXA for the treatment of smallpox as a medical countermeasure. The Company has two other advanced clinical-stage development programs, ONC201 and dociparstat sodium (DSTAT). ONC201 is in development for recurrent H3 K27M-mutant glioma. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia.

    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 status of Chimerix's oncology programs, and the results of the 50-patient efficacy analysis of ONC201. 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 clinical study data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of the acquisition of Oncoceutics may not be realized; the ability to generate positive results in a Phase 3 study in acute myeloid leukemia and subsequent approval for DSTAT; risks that Chimerix will not obtain a procurement contract for TEMBEXA 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



    Primary Logo

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  2. DURHAM, N.C., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX),a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced that Mike Sherman, Chief Executive Officer of Chimerix, will participate in a pre-recorded presentation at the Jefferies London Healthcare Conference that will be made available on Thursday, November 18, 2021 at 3:00 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 biopharmaceutical company whose mission is to develop medicines that…

    DURHAM, N.C., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX),a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced that Mike Sherman, Chief Executive Officer of Chimerix, will participate in a pre-recorded presentation at the Jefferies London Healthcare Conference that will be made available on Thursday, November 18, 2021 at 3:00 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 biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. In June 2021, the U.S. Food and Drug Administration granted approval of TEMBEXA for the treatment of smallpox as a medical countermeasure. The Company has two other advanced clinical-stage development programs, ONC201 and dociparstat sodium (DSTAT). ONC201 is in development for recurrent H3 K27M mutant glioma. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia.

    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
  3. DURHAM, N.C., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced upcoming data presentations at the Society for Neuro-Oncology (SNO) Annual Meeting 2021, which will be held in Boston, MA from November 19-21, 2021.

    Details for the late-breaking plenary oral presentation are as follows:

    Title: Clinical efficacy of ONC201 in recurrent H3 K27M-mutant diffuse midline glioma patients
    Abstract Number: LTBK-05
    Date and Time: November 20, 2021 from 9:37 a.m. – 9:50 a.m. ET
    Presenter: Isabel Arrillaga-Romany, M.D., Ph. D., Massachusetts General Hospital

    Details for additional oral…

    DURHAM, N.C., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced upcoming data presentations at the Society for Neuro-Oncology (SNO) Annual Meeting 2021, which will be held in Boston, MA from November 19-21, 2021.

    Details for the late-breaking plenary oral presentation are as follows:

    Title: Clinical efficacy of ONC201 in recurrent H3 K27M-mutant diffuse midline glioma patients

    Abstract Number: LTBK-05

    Date and Time: November 20, 2021 from 9:37 a.m. – 9:50 a.m. ET

    Presenter: Isabel Arrillaga-Romany, M.D., Ph. D., Massachusetts General Hospital

    Details for additional oral and poster presentations are as follows:

    Title: Single agent activity of ONC201 in non-midline H3 K27M-mutant diffuse gliomas

    Abstract Number: CTNI-27

    Date and Time: November 19, 2021 from 7:30 p.m. - 9:30 p.m. ET

    Presenter: Yazmin Odia, M.D., M.S., FAAN, Miami Cancer Institute

    Title: Safety of ONC201 administered two consecutive days per week in pediatric H3 K27M-mutant glioma patients

    Abstract Number: CTNI-36

    Date and Time: November 19, 2021 from 7:30 p.m. - 9:30 p.m. ET

    Presenter: Sharon L. Gardner, M.D., New York University School of Medicine

    Title: Dual metabolic reprogramming by ONC201/TIC10 and 2-Deoxyglucose has a strong antiproliferative effect on medulloblastoma cells

    Abstract Number: EXTH-68

    Date and Time: November 19, 2021 from 7:30 p.m. - 9:30 p.m. ET

    Presenter: Georg Karpel-Massler, M.D., Ph.D., Ulm University

    Title: Induction of Synthetic Lethality by Activation of Mitochondrial ClpP and Inhibition of HDAC1/2 in Glioblastoma

    Abstract Number: TAMI-17

    Date and Time: November 19, 2021 from 7:30 p.m. - 9:30 p.m. ET

    Presenter: Trang T. Nguyen, Ph.D., Columbia University

    Title: Harnessing Cellular Stress for Immune Targeting of DIPGs

    Abstract Number: EXTH-30

    Date and Time: November 19, 2021 from 7:30 p.m. - 9:30 p.m. ET

    Presenter: Donghang Cheng, Ph.D., University of Texas MD Anderson Cancer Center

    Title: Serial plasma and CSF cell-free tumor DNA (cf-tDNA) tracking in diffuse midline glioma patients undergoing treatment with ONC201

    Abstract Number: BIOM-28

    Date and Time: November 21, 2021 from 11:35 a.m. – 11:45 a.m. ET

    Presenter: Evan Cantor, M.D., J.D., Washington University at St. Louis

    About Chimerix

    Chimerix is a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. In June 2021, the U.S. Food and Drug Administration granted approval of TEMBEXA for the treatment of smallpox as a medical countermeasure. The Company has two other advanced clinical-stage development programs, ONC201 and dociparstat sodium (DSTAT). ONC201 is in development for recurrent H3 K27M mutant glioma. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia.

    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
  4. – Announced Positive Topline Results from ONC201 in Recurrent H3 K27M-mutant Glioma –

    U.S. Food and Drug Administration (FDA) Published Article Summarizing Benefit-Risk Assessment of TEMBEXA for the Treatment of Smallpox –

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

    DURHAM, N.C., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today reported financial results for the third quarter ended September 30, 2021 and provided an operational update.

    "We are pleased with the progress we have made in 2021 towards advancing our pipeline and validating our imipridone programs. Today…

    – Announced Positive Topline Results from ONC201 in Recurrent H3 K27M-mutant Glioma –

    U.S. Food and Drug Administration (FDA) Published Article Summarizing Benefit-Risk Assessment of TEMBEXA for the Treatment of Smallpox –

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

    DURHAM, N.C., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today reported financial results for the third quarter ended September 30, 2021 and provided an operational update.

    "We are pleased with the progress we have made in 2021 towards advancing our pipeline and validating our imipridone programs. Today, we announced positive topline results from the BICR of the ONC201 50 patient cohort in recurrent H3 K27M-mutant glioma, furthering our conviction that this program has the potential to significantly improve the standard of care for these patients with severe unmet medical need," said Mike Sherman, Chief Executive Officer of Chimerix. "As we look to the balance of the year, we plan to continue to advance our clinical programs and expect to complete TEMBEXA® manufacturing for initial potential stockpiling in support of U.S. national preparedness."

    Recent Highlights

    ONC201 for Recurrent H3 K27M-mutant Glioma

    Earlier today, Chimerix reported topline data from the 50-patient cohort of ONC201 for the treatment of recurrent H3 K27M-mutant glioma. ONC201 is an orally administered small molecule dopamine receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP) agonist for the treatment of recurrent gliomas that harbor the H3 K27M mutation.

    According to a blinded independent central review (BICR) of the registration cohort, the overall response rate (ORR) was 20.0% (95% confidence interval (CI):10.0-33.7%) as determined by Response Assessment in Neuro-Oncology Criteria for High Grade Gliomas (RANO-HGG). The median duration of response was 11.2 months (95% CI: 3.8 – not reached) and the median time to response was 8.3 months.   Prior review of ONC201 identified the most commonly reported adverse events as nausea/vomiting, fatigue and decreased lymphocyte counts.   Additional supportive data, including measures of other forms of clinical benefit and survival analysis will be presented at the Society for Neuro-Oncology (SNO) Annual Meeting November 19-21, 2021.

    TEMBEXA for Smallpox

    In June, the FDA granted TEMBEXA tablets and oral suspension approval for the treatment of smallpox. TEMBEXA is approved for adult and pediatric patients and is the first and only smallpox therapy approved for neonates. The oral suspension formulation is particularly important for patients who have difficulty swallowing due to age or medical status.

    TEMBEXA potentially fills an important role as a treatment countermeasure to smallpox; it has a differentiated mechanism of action, a relatively high barrier to resistance and available evidence suggests it can be used in patients who have received the other FDA approved smallpox antiviral treatment. In September, an article was published in the peer review journal, Antiviral Research, providing a thorough assessment of TEMBEXA as a medical counter measure for smallpox.   The article can be accessed here.

    By year-end, Chimerix expects to complete initial TEMBEXA drug product manufacturing in order to execute first shipments to the strategic national stockpile in response to a potential procurement contract to support national preparedness in the United States.

    DSTAT for AML

    Chimerix continues enrollment in the Phase 3 Dociparstat in AML with Standard Chemotherapy (DASH AML) study of DSTAT for the treatment of AML. The multicenter, randomized, double-blind, placebo-controlled, parallel-group study is being conducted to evaluate the efficacy and safety of DSTAT in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly diagnosed AML patients. Chimerix expects to unblind data following enrollment of the first 80 evaluable patients in this study to assess complete response rates and minimal residual disease rates between the study arm and the control arm.   To date, enrollment of this study has proceeded more slowly than expected due to hospital staffing shortages related to COVID-19. We expect to complete enrollment of the first 80 evaluable patients in the second half of 2022.  

    Third Quarter 2021 Financial Results

    Chimerix reported a net loss of $18.6 million, or $0.21 per basic and diluted share, for the third quarter of 2021. During the same period in 2020, Chimerix recorded a net loss of $11.4 million, or $0.18 per basic and diluted share.

    Revenues for the third quarter of 2021 decreased to $0.1 million, compared to $1.6 million for the same period in 2020.

    Research and development expenses increased to $13.8 million for the third quarter of 2021, compared to $10.0 million for the same period in 2020 driven primarily by the expanded pipeline associated with the acquisition of Oncoceutics, Inc in January 2021.

    General and administrative expenses increased to $4.9 million for the third quarter of 2021, compared to $3.2 million for the same period in 2020.

    Chimerix's balance sheet as of September 30, 2021, included approximately $125 million of capital available to fund operations, $14.0 million in a note payable related to the Oncoceutics transaction and approximately 86.8 million outstanding shares of common stock.

    In accordance with the terms of the merger agreement between Chimerix and Oncoceutics, Inc., the achievement of the 20% ORR via BICR will result in a success milestone payment of $20 million to the former Oncoceutics, Inc. shareholders to be paid prior to year-end.

    Conference Call and Webcast

    Chimerix will host a conference call and live audio webcast to discuss third quarter 2021 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 5935686.

    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 biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. In June 2021, the U.S. Food and Drug Administration granted approval of TEMBEXA for the treatment of smallpox as a medical countermeasure. The Company has two other advanced clinical-stage development programs, ONC201 and dociparstat sodium (DSTAT). ONC201 is in development for recurrent H3 K27M-mutant glioma. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia.

    About TEMBEXA

    TEMBEXA is an oral antiviral formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. TEMBEXA is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug's efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals.

    TEMBEXA (brincidofovir) is a nucleotide analog lipid-conjugate designed to mimic a natural monoacyl phospholipid to achieve effective intracellular concentrations of the active antiviral metabolite, cidofovir diphosphate. Cidofovir diphosphate exerts its orthopoxvirus antiviral effects by acting as an alternate substrate inhibitor for viral DNA synthesis mediated by viral DNA polymerase.

    IMPORTANT SAFETY INFORMATION Including BOXED WARNING

    WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION



    An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease.

    WARNINGS AND PRECAUTIONS

    Elevations in Hepatic Transaminases and Bilirubin: May cause increases in serum transaminases (ALT or AST) and serum bilirubin. Monitor liver laboratory parameters before and during treatment.

    Diarrhea and Other Gastrointestinal Adverse Events: Diarrhea and additional gastrointestinal adverse events including nausea, vomiting, and abdominal pain may occur. Monitor patients, provide supportive care, and if necessary, do not give the second and final dose of TEMBEXA.

    Coadministration with Related Products: TEMBEXA should not be co-administered with intravenous cidofovir.

    Carcinogenicity: TEMBEXA is considered a potential human carcinogen. Do not crush or divide TEMBEXA tablets and avoid direct contact with broken or crushed tablets or oral suspension.

    Male Infertility: Based on testicular toxicity in animal studies, TEMBEXA may irreversibly impair fertility in individuals of reproductive potential.

    ADVERSE REACTIONS

    Common adverse reactions (adverse events assessed as causally related by the investigator in ≥ 2% of subjects) experienced in the first 2 weeks of dosing with TEMBEXA were diarrhea, nausea, vomiting and abdominal pain.

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    Based on findings from animal reproduction studies, TEMBEXA may cause fetal harm when administered to pregnant individuals. Pregnancy testing should be performed before initiation of TEMBEXA in individuals of childbearing potential to inform risk. An alternative therapy should be used to treat smallpox during pregnancy, if feasible.

    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, results from the BICR of the 50- patient cohort of ONC201 for the treatment of recurrent H3 K27M-mutant glioma, the status of Chimerix's oncology programs, and the manufacturing, potential benefits and government procurement of TEMBEXA. 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 clinical study data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of the acquisition of Oncoceutics may not be realized; the ability to generate positive results in a Phase 3 study in acute myeloid leukemia and subsequent approval for DSTAT; risks that Chimerix will not obtain a procurement contract for TEMBEXA in smallpox in a timely manner or at all; Chimerix's current BCV manufacturing efforts may not satisfy the requirements of any procurement award; 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

    CHIMERIX, INC. 
    CONSOLIDATED BALANCE SHEETS 
    (in thousands, except share and per share data) 
    (unaudited) 
             
         September 30, December 31, 
          2021   2020  
    ASSETS     
    Current assets:     
     Cash and cash equivalents $26,174  $46,989  
     Short-term investments, available-for-sale  96,384   31,973  
     Accounts receivable  53   340  
     Inventories  1,595   -  
     Prepaid expenses and other current assets  4,327   2,356  
      Total current assets  128,533   81,658  
    Long-term investments  2,035   -  
    Property and equipment, net of accumulated depreciation  264   214  
    Operating lease right-of-use assets  2,509   2,825  
    Other long-term assets  60   26  
       Total assets $133,401  $84,723  
             
    LIABILITIES AND STOCKHOLDERS' EQUITY     
    Current liabilities:     
     Accounts payable $1,792  $1,283  
     Accrued liabilities  10,498   7,250  
     Note payable  14,000   -  
      Total current liabilities  26,290   8,533  
    Lease-related obligations  2,525   2,814  
       Total liabilities  28,815   11,347  
             
    Stockholders' equity:     
     Preferred stock, $0.001 par value, 10,000,000 shares authorized at September 30, 2021 and    
      December 31, 2020; no shares issued and outstanding as of September 30, 2021 and     
      December 31, 2020  -   -  
     Common stock, $0.001 par value, 200,000,000 shares authorized at September 30, 2021 and   
      December 31, 2020; 86,848,426 and 62,816,039 shares issued and outstanding as of     
      September 30, 2021 and December 31, 2020, respectively  87   63  
     Additional paid-in capital  950,597   785,673  
     Accumulated other comprehensive loss, net  -   -  
     Accumulated deficit  (846,098)  (712,360) 
      Total stockholders' equity  104,586   73,376  
       Total liabilities and stockholders' equity $133,401  $84,723  
             



    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, 
           2021   2020   2021   2020  
    Revenues:         
     Contract revenue $105  $1,591  $1,928  $4,158  
     Licensing revenue  2   18   5   94  
      Total revenues  107   1,609   1,933   4,252  
    Operating expenses:         
     Research and development  13,820   10,018   39,480   27,545  
     General and administrative  4,887   3,151   13,431   9,466  
     Acquired in-process research and development  -   -   82,890   -  
      Total operating expenses  18,707   13,169   135,801   37,011  
       Loss from operations  (18,600)  (11,560)  (133,868)  (32,759) 
    Other income:         
     Interest income and other, net  40   149   130   912  
        Net loss  (18,560)  (11,411)  (133,738)  (31,847) 
    Other comprehensive loss:         
     Unrealized gain (loss) on debt investments, net  11   (97)  -   (2) 
        Comprehensive loss $(18,549) $(11,508) $(133,738) $(31,849) 
    Per share information:         
     Net loss, basic and diluted $(0.21) $(0.18) $(1.59) $(0.51) 
     Weighted-average shares outstanding, basic and diluted 86,335,357   62,242,456   84,277,555   62,009,941  
                  



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  5. – Blinded Independent Central Review (BICR) of ONC201 Cohort Reported 20.0% Objective Response Rate (ORR) by RANO-HGG Criteria –

    – Compelling Durability of Responses with 11.2 Month Median Duration of Response (mDOR) in Addition to an 8.3 Month Median Time to Response (mTTR) –

    – Additional Data to be Presented at the Society for Neuro-Oncology (SNO) Annual Meeting –

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

    DURHAM, N.C., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today reported positive topline data from its 50-patient efficacy analysis of ONC201 for the treatment of recurrent…

    – Blinded Independent Central Review (BICR) of ONC201 Cohort Reported 20.0% Objective Response Rate (ORR) by RANO-HGG Criteria –

    – Compelling Durability of Responses with 11.2 Month Median Duration of Response (mDOR) in Addition to an 8.3 Month Median Time to Response (mTTR) –

    – Additional Data to be Presented at the Society for Neuro-Oncology (SNO) Annual Meeting –

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

    DURHAM, N.C., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today reported positive topline data from its 50-patient efficacy analysis of ONC201 for the treatment of recurrent H3 K27M-mutant glioma. ONC201 is an orally administered small molecule dopamine receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP) agonist for the treatment of recurrent gliomas that harbor the H3 K27M mutation.

    "These results are exciting, especially for this patient population with no good systemic therapeutic options," said Dr. Isabel Arrillaga-Romany, MD, PhD, Director of Neuro-Oncology Clinical Trials, Massachusetts General Hospital Cancer Center. "The durability of responses in patients we would otherwise expect to progress rapidly is compelling."

    "These data confirm our expectations for the potential benefit for patients with this devastating disease," said Mike Sherman, Chief Executive Officer of Chimerix. "We look forward to sharing additional data at the SNO conference later this month. The durability of responses are complemented by the consistency of data across other clinical endpoints. We believe this represents an attractive risk – benefit for patients who otherwise receive palliative care. On behalf of the entire Chimerix team, we thank the clinical collaborators and their patients who participated in our clinical trials with the hope of improving not only their own outcomes, but also the outcomes of future patients. None of the progress we have made would be possible without their support."  

    An efficacy analysis by blinded independent central review (BICR) of the registration cohort determined the overall response rate (ORR) to be 20.0% (95% Confidence Interval (CI): 10.0-33.7%) as determined by Response Assessment in Neuro-Oncology Criteria for High Grade Gliomas (RANO-HGG). The median duration of response (mDOR) was 11.2 months (95% CI: 3.8 - not reached) and the median time to response (mTTR) was 8.3 months.

    The cohort for a potential registration of ONC201 was comprised of the first 50 patients enrolled across five ONC201 clinical studies who met certain criteria. These patients were two years of age or older, had measurable diffuse midline glioma, their tumor harbored the H3 K27M mutation and had evidence of disease progression following prior therapy with at least radiation completed at least 90 days prior to enrollment, among certain other criteria.  

    The full BICR analysis will be presented at the Society for Neuro-Oncology (SNO) Annual Meeting on November 20, 2021. The plenary presentation will include additional supporting evidence of disease control, clinical benefit, including neurological improvements as measured by performance status, reduction in the use of corticosteroids, and an analysis of overall survival.

    One serious adverse event was attributed by an investigator as possibly related to ONC201. Full safety data collection and analysis for this cohort is ongoing. Prior safety review of ONC201 identified the most commonly reported adverse events as nausea/vomiting, fatigue and decreased lymphocyte counts.  

    The FDA 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.

    The Company plans to meet with the U.S. Food and Drug Administration in 2022 following completion of ongoing chemistry, manufacturing and controls (CMC) clinical pharmacology studies and natural disease history evaluation.

    About Recurrent H3 K27M-mutant Glioma

    Recurrent high-grade glioma is a form of brain cancer with a particularly poor prognosis. Pediatric patients with recurrent glioma that carries the H3 K27M mutation have an even worse prognosis. Gliomas with this mutation are considered Grade IV by the World Health Organization regardless of patient age.

    Conference Call and Webcast

    Chimerix will host a conference call and live audio webcast to discuss these data along with third quarter 2021 financial results 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 5935686.

    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 biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. In June 2021, the U.S. Food and Drug Administration granted approval of TEMBEXA for the treatment of smallpox as a medical countermeasure. The Company has two other advanced clinical-stage development programs, ONC201 and dociparstat sodium (DSTAT). ONC201 is in development for recurrent H3 K27M mutant glioma. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia.

    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 status of Chimerix's oncology programs, and the potential benefits and government procurement of TEMBEXA. 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 clinical study data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of the acquisition of Oncoceutics may not be realized; the ability to generate positive results in a Phase 3 study in acute myeloid leukemia and subsequent approval for DSTAT; risks that Chimerix will not obtain a procurement contract for TEMBEXA 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



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