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
August 14, 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 2.02 Results of Operations and Financial Condition.
On August 14, 2013, we announced our financial results for the second quarter ended June 30, 2013 in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 2.02 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 2.02 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 7.01 Regulation FD Disclosure.
On August 14, 2013, we announced top line data from our exploratory Phase 2 study of CMX001 as preemptive therapy for adenovirus infection and the acceptance of the proof-of-concept data as an oral late-breaker presentation at the upcoming 53rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy meeting, in the press release attached hereto as Exhibit 99.2 and incorporated herein by reference.
The information in this Item 7.01 and the attached Exhibit 99.2 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 7.01 and the attached Exhibit 99.2 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 August 14, 2013. | |
| 99.2 | Press Release of Chimerix, Inc. dated August 14, 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: August 14, 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 August 14, 2013. | |
| 99.2 | Press Release of Chimerix, Inc. dated August 14, 2013. |
Chimerix Announces Second Quarter 2013 Financial Results
Management to Host Conference Call Today at 8:30 a.m. ET
DURHAM, NC, August 14, 2013 – Chimerix, Inc. (NASDAQ: CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today reported financial results for the quarter ended June 30, 2013.
Business Highlights
| · | Phase 3 SUPPRESS trial of CMX001 for the prevention of cytomegalovirus (CMV) in hematopoietic cell transplant (HCT) recipients is on track to begin dosing in the third quarter of 2013 |
| · | Announced top line data from Study 202 of CMX001 as a preemptive therapy for adenovirus (AdV) infection in HCT recipients (premarket today in a separate release) |
| · | Announced that data from AdV Study 202 has been accepted for late-breaker presentation at upcoming 53rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) on September 10th (premarket today in a separate release) |
| · | Extended contract with the Biomedical Advanced Research and Development Authority (BARDA) into the first option segment providing up to $5 million for the continued development of CMX001 as a potential medical countermeasure against smallpox |
| · | Elected Rodman L. Drake to the Board of Directors |
“Chimerix is well-positioned to achieve significant milestones in the second half of 2013, including dosing the first patient in our Phase 3 SUPPRESS trial of CMX001 for the prevention of cytomegalovirus infection in hematopoietic cell transplant recipients,” said Kenneth I. Moch, President and CEO of Chimerix. “We believe CMX001 offers the potential to provide a new standard of care for these immunocompromised patients and we are excited to further advance this broad-spectrum antiviral through continued clinical development.”
Second Quarter 2013 Financial Results
Chimerix reported a net loss of $12.5 million, or $0.91 per share, for the second quarter of 2013, compared to a net loss of $4.3 million, or $3.44 per share, for the second quarter of 2012.
Revenues for the second quarter of 2013 decreased to $808,000, compared to $6.2 million for the same period in 2012, based primarily on the completion of the base segment of Chimerix’s contract with BARDA in the second quarter of 2013.
Research and development expenses decreased to $6.3 million for the second quarter of 2013, compared to $9.1 million for the same period in 2012, driven primarily by the completion of the base segment of Chimerix’s contract with BARDA in the second quarter of 2013 offset by a one-time non-cash compensation expense related to restricted stock units (RSUs) that vested upon completion of Chimerix’s initial public offering (IPO).
General and administrative expenses increased to $2.2 million for the second quarter of 2013, compared to $1.5 million for the same period in 2012, primarily related to the vesting of RSUs, as described above.
Loss from operations increased to $7.7 million for the second quarter of 2013, compared to $4.4 million for the same period in 2012. The increase in loss from operations in the second quarter of 2013 primarily relates to the completion of the base segment of Chimerix’s contract with BARDA combined with a one-time non-cash compensation expense based on vesting RSUs, as described above.
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
Interest expense was $415,000 in the second quarter of 2013, compared to $128,000 in the same period in 2012, based on the larger outstanding loan balance following a draw-down of $12.0 million of venture debt in the third quarter of 2012.
Fair value adjustment to the warrant liability increased to $4.4 million in the second quarter of 2013, compared to an add back of $226,000 in the same period of 2012, due to an increase of non-cash expense related to the periodic revaluation of Chimerix’s warrant liability. This increase was primarily attributable to the significant increase in the market price of Chimerix’s common stock in the second quarter of 2013 related to its IPO.
Chimerix’s balance sheet at June 30, 2013 included $123.0 million in cash, cash equivalents and short-term investments, $12.7 million in debt and 25.8 million outstanding shares of common stock.
Today’s Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to discuss its second quarter 2013 accomplishments and 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 28537322.
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, 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 lipid acyclic nucleotide phosphonates, CMX001 and CMX157, which have demonstrated the potential for enhanced activity and safety in convenient, orally administered dosing regimens. CMX001 has shown broad-spectrum activity against double-stranded DNA viruses, including all of the herpesviruses, adenoviruses and polyomaviruses. Chimerix anticipates beginning the Phase 3 SUPPRESS trial in the third quarter of 2013 for the prevention of CMV infection in HCT recipients. Chimerix’s second product candidate, CMX157, an oral nucleotide analog lipid-conjugate for the treatment of HIV infection, was licensed to Merck in July 2012.
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Chimerix’s ability to meet milestones in the second half of 2013, the timing for initiating the Phase 3 SUPPRESS trial, the efficacy of CMX001 and its ability to provide a broad spectrum of antiviral activity and the positive impact of CMX001 on transplant recipients. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Chimerix’s estimates regarding its ability to initiate the SUPPRESS trial; the success of SUPPRESS and Phase 2 trials, the demonstrated efficacy of CMX001 in the SUPPRESS trial and Phase 2 trials; Chimerix’s financial position; and regulatory developments in the United States and foreign countries. Other risks and uncertainties affecting Chimerix are described more fully in Chimerix’s filings with the Securities and Exchange Commission, including without limitation its most recently filed Quarterly Report on Form 10-Q and its most recently filed reports on Form 8-K, and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Chimerix undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CHIMERIX CONTACTS:
Rebecca Heath, 919.972.7124
Elizabeth Kelly, 919.972.7109
MEDIA CONTACT:
Tony Plohoros
908.940.0135
tplohoros@6degreespr.com
INVESTOR CONTACT:
Lilian Stern
212.362.1200
lilian@sternir.com
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
| CHIMERIX, INC. |
| BALANCE SHEETS |
| (in thousands, except share and per share data) |
| (unaudited) |
| June 30, 2013 | December 31, 2012 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 115,438 | $ | 19,906 | ||||
| Short-term investments, available-for-sale | 7,595 | 9,849 | ||||||
| Accounts receivable | 83 | 783 | ||||||
| Prepaid and other current assets | 3,034 | 983 | ||||||
| Deferred financing costs, current portion | 20 | 33 | ||||||
| Total current assets | 126,170 | 31,554 | ||||||
| Property and equipment, net of accumulated depreciation | 342 | 407 | ||||||
| Deposits | 22 | 22 | ||||||
| Deferred financing costs, less current portion | 20 | 48 | ||||||
| Total assets | $ | 126,554 | $ | 32,031 | ||||
| Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 995 | $ | 1,964 | ||||
| Accrued liabilities | 1,471 | 906 | ||||||
| Loan payable, current portion | 5,584 | 4,753 | ||||||
| Total current liabilities | 8,050 | 7,623 | ||||||
| Other long-term liabilities | 341 | 337 | ||||||
| Loan payable, less current portion | 7,119 | 9,867 | ||||||
| Redeemable convertible preferred stock warrant liability | - | 7,512 | ||||||
| Total liabilities | 15,510 | 25,339 | ||||||
| Redeemable convertible preferred stock | - | 107,723 | ||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, $0.001 par value, 200,000,000 and 89,700,000 shares authorized at June 30, 2013 and December 31, 2012, respectively; 25,779,445 and 1,533,996 shares issued and outstanding as of June 30, 2013 and December 31, 2012, respectively | 26 | 3 | ||||||
| Additional paid-in capital | 258,870 | - | ||||||
| Accumulated other comprehensive loss | (1 | ) | (2 | ) | ||||
| Accumulated deficit | (147,851 | ) | (101,032 | ) | ||||
| Total stockholders’ equity (deficit) | 111,044 | (101,031 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | $ | 126,554 | $ | 32,031 | ||||
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
| CHIMERIX, INC. |
| 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, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Revenues: | ||||||||||||||||
| Contract revenue | $ | 808 | $ | 6,205 | $ | 2,579 | $ | 9,283 | ||||||||
| Total revenues | 808 | 6,205 | 2,579 | 9,283 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 6,276 | 9,082 | 13,059 | 16,075 | ||||||||||||
| General and administrative | 2,188 | 1,545 | 3,725 | 3,120 | ||||||||||||
| Loss from operations | (7,656 | ) | (4,422 | ) | (14,205 | ) | (9,912 | ) | ||||||||
| Other expense: | ||||||||||||||||
| Interest expense, net | (415 | ) | (128 | ) | (771 | ) | (237 | ) | ||||||||
| Fair value adjustments to warrant liability | (4,388 | ) | 226 | (6,590 | ) | (1,073 | ) | |||||||||
| Net loss | (12,459 | ) | (4,324 | ) | (21,566 | ) | (11,222 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain on securities available-for-sale | 1 | - | 1 | 4 | ||||||||||||
| Comprehensive loss | $ | (12,458 | ) | $ | (4,324 | ) | $ | (21,565 | ) | $ | (11,218 | ) | ||||
| Net loss | (12,459 | ) | (4,324 | ) | (21,566 | ) | (11,222 | ) | ||||||||
| Accretion of redeemable convertible preferred stock | (8,582 | ) | (900 | ) | (34,108 | ) | (1,800 | ) | ||||||||
| Net loss attributable to common shareholders | $ | (21,041 | ) | $ | (5,224 | ) | $ | (55,674 | ) | $ | (13,022 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss per common share, basic and diluted | $ | (0.91 | ) | $ | (3.44 | ) | $ | (4.50 | ) | $ | (8.58 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 23,067,201 | 1,518,753 | 12,360,125 | 1,518,112 | ||||||||||||
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
| CHIMERIX, INC. |
| STATEMENTS OF CASH FLOWS |
| (in thousands) |
| (unaudited) |
| Six Months Ended June 30, | ||||||||
| 2013 | 2012 | |||||||
| Operating activities: | ||||||||
| Net loss | $ | (21,566 | ) | $ | (11,222 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 135 | 141 | ||||||
| Non-cash interest expense | 224 | 54 | ||||||
| Amortization/accretion of premium/discount on investments | 149 | 29 | ||||||
| Share-based compensation costs | 2,589 | 539 | ||||||
| Fair value measurement of redeemable convertible preferred stock warrant liability | 6,590 | 1,073 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 700 | 692 | ||||||
| Prepaid expenses and other current assets and deposits | (2,051 | ) | 779 | |||||
| Accounts payable and accrued liabilities | (400 | ) | (1,672 | ) | ||||
| Net cash used in operating activities | (13,630 | ) | (9,587 | ) | ||||
| Investing Activities: | ||||||||
| Purchase of property and equipment | (70 | ) | (41 | ) | ||||
| Purchase of short-term investments | (1,851 | ) | - | |||||
| Maturities of short-term investments | 3,957 | 5,894 | ||||||
| Net cash provided by investing activities | 2,036 | 5,853 | ||||||
| Financing Activities: | ||||||||
| Proceeds from exercise of stock options | 55 | 2 | ||||||
| Proceeds from exercise of warrant | 1,537 | - | ||||||
| Proceeds from loan payable | - | 3,000 | ||||||
| Proceeds from initial public offering, net of offering costs | 107,634 | - | ||||||
| Debt discount | - | (15 | ) | |||||
| Repayment of loan payable | (2,100 | ) | (2,600 | ) | ||||
| Deferred financing costs | - | (24 | ) | |||||
| Net cash provided by financing activities | 107,126 | 363 | ||||||
| Increase (decrease) in cash and cash equivalents | 95,532 | (3,371 | ) | |||||
| Cash and cash equivalents, beginning of period | 19,906 | 13,607 | ||||||
| Cash and cash equivalents, end of period | $ | 115,438 | $ | 10,236 | ||||
| Supplemental cash flow information: | ||||||||
| Interest payments | $ | 505 | $ | 107 | ||||
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
Chimerix
Announces Top Line Data from CMX001 Phase 2
Adenovirus Study and Late-Breaker Presentation at ICAAC
| · | Encouraging results from the first proof-of-concept study for adenovirus infection support continued clinical development of CMX001 as a first-in-class broad-spectrum antiviral for prevention of double-stranded DNA viral infections |
| · | Data accepted for oral late-breaker presentation at the ICAAC Annual Meeting on September 10th |
DURHAM, NC, August 14, 2013 – Chimerix, Inc. (Nasdaq: CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced top line data from the exploratory Phase 2 study of CMX001 as preemptive therapy for adenovirus (AdV) infection, the first interventional trial in AdV infection. In this trial in allogeneic hematopoietic cell transplant (HCT) recipients, the 100 mg dose given twice weekly (BIW) demonstrated decreased levels of AdV viremia and showed a potential benefit in reducing both progression to AdV disease and all-cause mortality, compared to subjects who received placebo or CMX001 given once weekly (QW). Planned intent-to-treat analyses as well as exploratory analyses in specific patient groups were consistent in trends favoring the CMX001 BIW regimen over placebo, although statistical significance was not established in this exploratory study.
Chimerix also announced the acceptance of the proof-of-concept data as an oral late-breaker presentation at the upcoming 53rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting being held in Denver, CO on September 10-13, 2013.
“These proof of concept data will provide critical information regarding the factors that predict an increased risk of AdV infection and the natural history of AdV infection that too often leads to devastating morbidity and mortality in children and adults who have undergone an allogeneic stem cell transplant. Importantly, we will have additional insights into the potential use of CMX001 to decrease progression of AdV disease and overall mortality for recipients of allogeneic transplants,” said M. Michelle Berrey, MD, MPH, Chief Medical Officer at Chimerix.
AdV, a double-stranded DNA (dsDNA) virus, causes respiratory infections including the common cold in healthy individuals. However, in patients with a compromised immune system such as those who have recently undergone bone marrow or organ transplants, AdV infections have a high mortality rate. Because no antiviral is approved for use in AdV infection and based on the potential for antiviral activity from in vitro data, CMX001 was made available through an open-label protocol for exploratory use in over 100 patients with life-threatening AdV infections. Results were presented at the European BMT Meeting (Grimley et. al., EBMT April 2013), providing initial data on survival and decreased levels of AdV viremia (virus in the blood) following treatment with CMX001.
Chimerix’s blinded, placebo-controlled proof-of-concept trial, Study 202, assessed the use of CMX001 at an earlier stage of AdV infection, when patients had detectable viremia but before the appearance of symptoms of disease. Pediatric and adult patients who had recently undergone HCT and were found to have viremia without symptoms of AdV disease were randomized to one of three dosing regimens: CMX001 BIW, CMX001 QW, or placebo. The primary endpoint was a composite of progression to symptomatic AdV disease or an increase of at least 10-fold in the levels of AdV in the blood. Forty-eight pediatric and adult subjects were randomized into the trial beginning in June 2011.
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
Top line safety and efficacy results support the continued development of CMX001 100 mg BIW as prevention for dsDNA viral infections including AdV and cytomegalovirus (CMV):
| · | CMX001 100 mg BIW decreased levels of AdV viremia and showed a potential benefit in reducing both progression to AdV disease and all-cause mortality, compared to subjects who received placebo or CMX001 given QW. Planned intent-to-treat analyses as well as exploratory analyses in specific groups of patients were consistent in trends favoring the CMX001 BIW regimen over placebo, although statistical significance was not established in this exploratory study. |
| · | No new safety concerns were identified, and no changes were deemed necessary to the protocol already in place for the Phase 3 SUPPRESS trial for the prevention of CMV infection. CMX001 BIW is the investigational regimen in SUPPRESS, which is anticipated to begin dosing later this quarter. |
Full results from the Phase 2 AdV study have been accepted for oral late-breaker presentation at ICAAC on September 10, 2013. Michael Grimley, MD, from Cincinnati Children’s Hospital, Cincinnati, OH, who served as the Primary Investigator for Study 202, will give the presentation on behalf of his fellow investigators and Chimerix entitled “The First Interventional Trial for Adenovirus (AdV): Brincidofovir1 (CMX001) for AdV in HCT.”
Chimerix intends to review the Study 202 data with the U.S. Food and Drug Administration in the fourth quarter of 2013, in the context of a Pediatric Plan for CMX001.
“These data are another milestone in support of our goal to develop CMX001 as the first broad-spectrum antiviral for prevention,” said Kenneth I. Moch, President and CEO of Chimerix. “We look forward to initiating the Phase 3 SUPPRESS trial later this quarter.”
1On May 29, 2013, Chimerix was informed by The Council of United States Adopted Names (USAN) that “brincidofovir” has been adopted as the generic name for CMX001.
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, CMX001 and CMX157, which have demonstrated the potential for enhanced activity and safety in convenient, orally administered dosing regimens. CMX001 has shown broad-spectrum activity against double-stranded DNA viruses, including herpesviruses, adenoviruses and polyomaviruses. Chimerix's second product candidate, CMX157, an oral nucleotide analog for the treatment of HIV infection, was licensed to Merck in July 2012.
About CMX001
CMX001 is an investigational oral nucleotide analog lipid-conjugate that has shown broad-spectrum antiviral activity against all five families of dsDNA viruses that effect humans, including herpesviruses such as CMV, adenoviruses, polyomaviruses such as BK virus (BKV), papillomaviruses, and orthopoxviruses. In a Phase 2 trial of 230 HCT recipients, CMX001 demonstrated potential clinical utility in prevention of CMV infection. In this same CMV trial, CMX001-treated subjects had improvements in kidney function and hematuria (blood in the urine) when compared to placebo-treated subjects, suggesting that CMX001 may reduce BKV-associated bladder and renal damage. Chimerix anticipates beginning the Phase 3 SUPPRESS trial in the third quarter of 2013 for the prevention of CMV infection in HCT recipients. CMX001 has an emerging favorable safety and tolerability profile and has shown no evidence of kidney or bone marrow toxicity.
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the continued development of CMX001 as prevention for dsDNA viral infections including CMV and AdV, Chimerix’s timing for initiating the Phase 3 SUPPRESS trial, the efficacy of CMX001 and its ability to provide a broad spectrum of antiviral activity and the positive impact of CMX001 on transplant recipients. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Chimerix’s estimates regarding the continued development of CMX001 based on the Study 202 results; the accuracy of Chimerix’s estimates regarding the timing for initiating the SUPPRESS trial; the success of SUPPRESS and Phase 2 trials, the demonstrated efficacy of CMX001 in the SUPPRESS trial and Phase 2 trials; and regulatory developments in the United States and foreign countries. Other risks and uncertainties affecting Chimerix are described more fully in Chimerix’s filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q, its most recently filed reports on Form 8-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Chimerix undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
# # #
CHIMERIX CONTACTS:
Rebecca Heath, 919.972.7124
Elizabeth Kelly, 919.972.7109
MEDIA CONTACT:
Tony Plohoros
908.940.0135
tplohoros@6degreespr.com
INVESTOR CONTACT:
Lilian Stern
212.362.1200
lilian@sternir.com
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |