UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
September 18, 2013
Date of Report (Date of earliest event reported)
|
Chimerix, Inc. | ||
| (Exact name of registrant as specified in its charter) | ||
|
Delaware |
001-35867 |
33-0903395 |
| (State or other jurisdiction | (Commission File Number) | (IRS Employer Identification No.) |
| of incorporation) | ||
2505 Meridian Parkway, Suite 340 Durham, NC |
| |
| (Address of principal executive offices) | (Zip Code) | |
| Registrant’s telephone number, including area code: (919) 806-1074 | ||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 8.01 | Other Events. |
On September 18, 2013, in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference, we announced that Kenneth I. Moch, President and CEO of Chimerix, will be presenting at the 20th Annual BioCentury “NewsMakers in the Biotech Industry” Conference on Friday, September 27, 2013 at 10:30 a.m. EDT at the Millennium Broadway Hotel in New York City. An audio webcast of the presentation will be available on the Investor Relations section of Chimerix's website at http://ir.chimerix.com/events.cfm.
Also in the attached press release, the Company announced that Chimerix management hosted an analyst/investor presentation to provide an update on the clinical development of brincidofovir on September 17, 2013. A webcast of the meeting and accompanying slide presentations are available on the Investor Relations section of Chimerix's website at http://ir.chimerix.com/events.cfm.
The information in this Item 8.01 and the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 8.01 and the attached Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit No. | Description | |
| 99.1 | Press Release of Chimerix, Inc. dated September 18, 2013. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Chimerix, Inc. | ||||
| Dated: September 18, 2013 | ||||
| By: | /s/ Timothy W. Trost | |||
| Timothy W. Trost | ||||
| Senior Vice President, Chief Financial Officer and Corporate Secretary | ||||
INDEX TO EXHIBITS
| Exhibit No. | Description | |
| 99.1 | Press Release of Chimerix, Inc. dated September 18, 2013. |
Exhibit 99.1
Chimerix to Present at the 20th Annual BioCentury NewsMakers Conference
Brincidofovir (CMX001) Analyst/Investor Update Presentation Available
on Chimerix Website
DURHAM, NC, September 18, 2013 – Chimerix, Inc. (NASDAQ: CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced today that Kenneth I. Moch, President and CEO of Chimerix, will be presenting at the 20th Annual BioCentury “NewsMakers in the Biotech Industry” Conference on Friday, September 27, 2013 at 10:30 a.m. EDT at the Millennium Broadway Hotel in New York City. An audio webcast of the presentation will be available on the Investor Relations section of Chimerix's website at http://ir.chimerix.com/events.cfm.
Brincidofovir (CMX001) Analyst/Investor Update Presentation Available on Website
Chimerix management hosted an analyst/investor presentation to provide an update on the clinical development of brincidofovir on September 17, 2013. The presentation included a review of results from Chimerix’s exploratory Phase 2 study evaluating brincidofovir in hematopoietic cell transplant (HCT) recipients with early adenovirus (AdV) infection, presented by Dr. Michael Grimley, Associate Professor of Clinical Pediatrics in the Division of Bone Marrow Transplant and Immune Deficiency at Cincinnati Children’s Hospital Medical Center, and the lead investigator in the Phase 2 study. In addition, Dr. Atul Humar, Professor in the Department of Medicine, Division of Infectious Diseases and Multi-Organ Transplantation at Toronto General Hospital reviewed the recently updated Consensus Guidelines for management of infectious complications including CMV in solid organ transplant recipients.
A webcast of the meeting and accompanying slide presentations are available on the Investor Relations section of Chimerix's website at http://ir.chimerix.com/events.cfm.
About Brincidofovir (CMX001)
Brincidofovir is an investigational oral nucleotide analog lipid-conjugate that has shown broad-spectrum antiviral activity against all five families of dsDNA viruses that affect humans, including herpesviruses such as CMV, adenoviruses, polyomaviruses such as BK virus, papillomaviruses, and orthopoxviruses. Brincidofovir has a favorable safety and tolerability profile, with no evidence of kidney or bone marrow toxicity in over 900 patients dosed with brincidofovir for prevention, preemptive therapy, or treatment of dsDNA viruses that cause disease in humans.
In a Phase 2 trial of 230 HCT recipients, brincidofovir demonstrated potential clinical utility in prevention of CMV infection. In this same CMV trial, brincidofovir-treated subjects had improvements in kidney function and hematuria (blood in the urine) when compared to placebo-treated subjects, suggesting that brincidofovir may reduce BKV-associated bladder and renal damage.
On September 9, 2013, Chimerix announced the initiation of its Phase 3 SUPPRESS trial evaluating brincidofovir 100 mg BIW for the prevention of CMV in HCT recipients.
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
About Hematopoietic Cell Transplantation (HCT)
HCT is a medical procedure performed most frequently to treat patients with certain cancers of the blood and bone marrow, such as multiple myeloma or leukemia, or genetic diseases. For these patients, replacement of the blood forming system is the best therapeutic alternative. Because of chemotherapy and immunosuppressants that are used before, during and after the procedure, patients are highly susceptible to viral, bacterial and fungal infections. These infectious complications are a significant cause of morbidity and mortality following HCT.
About Chimerix
Chimerix, a biopharmaceutical company based in Durham, NC, is committed to the discovery, development and commercialization of novel, oral antiviral therapeutics designed to transform patient care in areas of high unmet medical need. Chimerix's proprietary lipid technology has given rise to two clinical-stage nucleotide analog lipid-conjugates, brincidofovir (CMX001) and CMX157, which have demonstrated the potential for enhanced activity and safety in convenient, orally administered dosing regimens. Brincidofovir has shown broad-spectrum activity against dsDNA viruses, including herpesviruses, adenoviruses and polyomaviruses. On September 9, 2013, Chimerix announced the initiation of its Phase 3 SUPPRESS trial evaluating brincidofovir 100 mg BIW for the prevention of CMV in HCT recipients. Chimerix's second product candidate, CMX157, an oral nucleotide analog for the treatment of HIV infection, was licensed to Merck in July 2012.
# # #
CHIMERIX CONTACT:
Joseph T. Schepers
Executive Director, Investor Relations and Corporate Communications
jschepers@chimerix.com
919-287-4125
MEDIA CONTACT:
Tony Plohoros
tplohoros@6degreespr.com
908-940-0135
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |