Chimerix Announces Third Quarter 2013 Financial Results
Business Highlights
-- Brincidofovir for the Prevention of Cytomegalovirus (CMV) Infection
-
Chimerix initiated the Phase 3 SUPPRESS trial of brincidofovir for the prevention of CMV in recipients of hematopoietic cell transplants (HCT), also known as bone marrow transplants. CMV, a double-stranded DNA (dsDNA) virus, causes life-threatening infections in patients whose immune systems are compromised after receiving a transplant or other therapies. Enrollment of the planned 450 subjects is on track to deliver pivotal data in mid-2015. Positive results from SUPPRESS would be supportive of Accelerated Approval of brincidofovir for the prevention of CMV, the first approval of an antiviral for the prevention of CMV in HCT recipients. -
Results from Study 201, a Phase 2 study that evaluated brincidofovir for the prevention of CMV in 230 HCT recipients, were published in the
September 26, 2013 issue of theNew England Journal of Medicine . This publication highlights the importance of brincidofovir and its potential to change the standard of care in this area of high unmet medical need.
-- Brincidofovir as Preemptive Therapy for Adenovirus (AdV)
-
Data from Study 202, a Phase 2 study of brincidofovir as a preemptive therapy for AdV infection, were presented during an oral, late-breaker session at the
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in September 2013. The results showed potential clinical benefit in reducing progression to AdV disease and all-cause mortality. The rates of adverse events leading to discontinuation were the same between the brincidofovir and placebo cohorts, and there were no new safety findings for brincidofovir. -
The Company is in discussions with key opinion leaders and the
U.S. Food and Drug Administration (FDA) regarding next steps for the AdV program and brincidofovir's overall pediatric program.
-- Issuance of Additional Composition of Matter Patent Covering Brincidofovir
-
The United States Patent and Trademark Office issued U.S. Patent No. 8,569,321 to
Chimerix covering a method of synthesis and a morphic form of brincidofovir. With the addition of this most recent patent, composition of matter coverage for brincidofovir in the U.S. is expected to extend toAugust 2031 .
-- Secondary Public Offering of Common Stock
-
Chimerix completed a secondary public offering of 2,476,995 shares of common stock held by certain existing stockholders onOctober 23 , 2013. Chimerix did not issue any shares of common stock and received no proceeds in connection with this offering. The principal purposes of the offering were to facilitate an orderly distribution of shares and increase the Company's public float.
"During the third quarter,
"The rate of non-relapse mortality is approximately 20% in the first year following HCT, caused by post-transplant complications, including viral, bacterial and fungal infections and graft failure. Based on the positive Phase 2 study results of brincidofovir and the study design for SUPPRESS, we are optimistic about the likelihood of positive results from the trial and the potential for brincidofovir to bring meaningful benefit to patients," said
Third Quarter 2013 Financial Results
Revenues for the third quarter of 2013 decreased to
Research and development expenses decreased to
General and administrative expenses increased to
Loss from operations was
Interest expense was
Today's Conference Call and Webcast
A live audio webcast of the call will also be available on the Investors section of
About Brincidofovir (CMX001)
Following positive Phase 2 results, in the third quarter of 2013
About the Phase 3 SUPPRESS Trial
SUPPRESS is designed to demonstrate the efficacy and safety of brincidofovir for the prevention of CMV infection versus a placebo control, as no therapy is currently approved for the prevention of CMV in HCT recipients. The primary endpoint for SUPPRESS is the rate of clinically significant CMV infection through the first 24 weeks post-transplant. The trial is powered to detect a relative 50% decrease in clinically significant CMV infection in subjects receiving brincidofovir versus those receiving placebo. Secondary endpoints in the SUPPRESS trial include clinical and virologic evidence of dsDNA viral infections, including AdV, BKV and other herpesviruses such as HHV-6 and varicella zoster virus that contribute to morbidity and mortality in the first year following HCT.
SUPPRESS is anticipated to enroll approximately 450 HCT recipients who are at increased risk of CMV infection, with approximately 300 subjects receiving 100 mg twice weekly brincidofovir and 150 receiving placebo (2-to-1 ratio). Approximately 40 transplant centers will participate in SUPPRESS. Dosing of study drug will begin shortly after subjects receive their transplant, and will not require evidence of stem cell "engraftment" (evidence of production of blood cells by the new transplant), a safety precaution incorporated in the Phase 2 trial of brincidofovir and other recent trials of investigational antivirals for CMV prevention. Enrolled subjects will continue on brincidofovir or placebo through Week 14 post-transplant, the period of highest risk for viral reactivation. Subjects will continue to be monitored for evidence of CMV and other dsDNA viral infections through Week 24 post-transplant.
Data from SUPPRESS are anticipated in mid-2015 and, if positive, may support Accelerated Approval of brincidofovir for the prevention of CMV infection.
About Cytomegalovirus (CMV) and Double-Stranded DNA (dsDNA) Viruses
CMV is a member of the herpesvirus family and is the most common infectious pathogen in transplant recipients. A majority of adults in the US have been exposed to CMV, generally in childhood, with lifelong viral latency established following resolution. In healthy individuals with a functioning immune system, CMV remains dormant throughout life. A functioning immune system protects an infected individual against future exposure to CMV but does not clear the virus from their body. In immunocompromised individuals with weakened immune systems, such as transplant recipients, CMV often reactivates during the post-transplant period when the immune system is rebuilding itself. No therapies are approved for the prevention of CMV in HCT recipients. Currently available systemic anti-CMV agents can be effective against CMV; however, their use is limited by significant toxicities, including bone marrow suppression and renal impairment, and these therapies are only approved for certain solid organ transplant patient populations. CMV infection is known to correlate with progression to CMV disease and death. CMV itself is immunosuppressive and reactivation of the virus can predispose a patient to other opportunistic viral infections in addition to fungal and bacterial infections.
About
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 likelihood of positive results from the SUPPRESS trial, the efficacy of brincidofovir and its ability to provide a broad spectrum of antiviral activity, and the positive impact of brincidofovir on transplant recipients. Risks that contribute to the uncertain nature of the forward-looking statements include: the success of the SUPPRESS trial; the demonstrated efficacy of brincidofovir in the SUPPRESS trial;
|
|
||
| BALANCE SHEETS | ||
| (in thousands, except share and per share data) | ||
| (unaudited) | ||
| September 30, 2013 | December 31, 2012 | |
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 115,891 | $ 19,906 |
| Short-term investments, available-for-sale | 1,004 | 9,849 |
| Accounts receivable | 190 | 783 |
| Prepaid and other current assets | 2,683 | 983 |
| Deferred financing costs, current portion | 20 | 33 |
| Total current assets | 119,788 | 31,554 |
| Property and equipment, net of accumulated depreciation | 335 | 407 |
| Deposits | 20 | 22 |
| Deferred financing costs, less current portion | 15 | 48 |
| Total assets | $ 120,158 | $ 32,031 |
| Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | ||
| Current liabilities: | ||
| Accounts payable | $ 1,770 | $ 1,964 |
| Accrued liabilities | 1,601 | 906 |
| Loan payable, current portion | 5,597 | 4,753 |
| Total current liabilities | 8,968 | 7,623 |
| Other long-term liabilities | 345 | 337 |
| Loan payable, less current portion | 5,715 | 9,867 |
| Redeemable convertible preferred stock warrant liability | -- | 7,512 |
| Total liabilities | 15,028 | 25,339 |
| Redeemable convertible preferred stock | -- | 107,723 |
| Stockholders' equity (deficit): | ||
|
Common stock, |
26 | 3 |
| Additional paid-in capital | 259,661 | -- |
| Accumulated other comprehensive loss | -- | (2) |
| Accumulated deficit | (154,557) | (101,032) |
| Total stockholders' equity (deficit) | 105,130 | (101,031) |
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ 120,158 | $ 32,031 |
|
|
||||
| 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, | |||
| 2013 | 2012 | 2013 | 2012 | |
| Revenues: | ||||
| Contract revenue | $ 912 | $ 3,411 | $ 3,491 | $ 12,694 |
| Collaboration and licensing revenue | -- | 17,445 | -- | 17,445 |
| Total revenues | 912 | 20,856 | 3,491 | 30,139 |
| Operating expenses: | ||||
| Research and development | 5,319 | 7,748 | 18,379 | 23,823 |
| General and administrative | 2,029 | 1,836 | 5,753 | 4,956 |
| (Loss) income from operations | (6,436) | 11,272 | (20,641) | 1,360 |
| Other expense: | ||||
| Interest expense, net | (270) | (130) | (1,041) | (367) |
| Fair value adjustments to warrant liability | -- | -- | (6,590) | (1,073) |
| Net (loss) income | (6,706) | 11,142 | (28,272) | (80) |
| Other comprehensive gain (loss): | ||||
| Unrealized gain (loss) on securities available-for-sale | 1 | (3) | 3 | 4 |
| Comprehensive (loss) income | $ (6,705) | $ 11,139 | $ (28,269) | $ (76) |
| Per share information: | ||||
| Net (loss) income per common share, basic | $ (0.26) | $ 6.70 | $ 3.69 | $ (1.82) |
| Weighted-average shares outstanding, basic | 25,866,109 | 1,529,442 | 16,911,592 | 1,524,489 |
| Net (loss) income per common share, diluted | $ (0.26) | $ 0.11 | $ (3.69) | $ (1.82) |
| Weighted-average shares outstanding, diluted | 25,866,109 | 52,933,956 | 16,911,592 | 1,524,489 |
|
|
||
| STATEMENTS OF CASH FLOWS | ||
| (in thousands) | ||
| (unaudited) | ||
| Nine Months Ended September 30, | ||
| 2013 | 2012 | |
| Operating activities: | ||
| Net loss | $ (28,272) | $ (80) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation | 197 | 210 |
| Non-cash interest expense | 46 | 175 |
| Amortization/accretion of premium/discount on investments | 416 | 29 |
| Share-based compensation costs | 2,853 | 1,133 |
| Fair value measurement of redeemable convertible preferred stock warrant liability | 6,590 | 1,073 |
| Changes in operating assets and liabilities: | ||
| Accounts receivable | 593 | 3,155 |
| Prepaid expenses and other current assets and deposits | (1,698) | 171 |
| Accounts payable and accrued liabilities | 501 | (3,093) |
| Net cash (used) provided in operating activities | (18,774) | 2,773 |
| Investing Activities: | ||
| Purchase of property and equipment | (125) | (120) |
| Purchase of short-term investments | (1,852) | -- |
| Sales of short-term investments | 750 | -- |
| Maturities of short-term investments | 9,758 | 5,893 |
| Net cash provided by investing activities | 8,531 | 5,773 |
| Financing Activities: | ||
| Proceeds from exercise of stock options | 582 | 8 |
| Proceeds from exercise of warrant | 1,537 | -- |
| Proceeds from loan payable | -- | 15,000 |
| Proceeds from initial public offering, net of offering costs | 107,634 | -- |
| Debt discount | -- | (75) |
| Repayment of loan payable | (3,525) | (2,600) |
| Deferred financing costs | -- | (24) |
| Net cash provided by financing activities | 106,228 | 12,309 |
| Increase in cash and cash equivalents | 95,985 | 20,855 |
| Cash and cash equivalents, beginning of period | 19,906 | 13,607 |
| Cash and cash equivalents, end of period | $ 115,891 | $ 34,462 |
| Supplemental cash flow information: | ||
| Interest payments | $ 862 | $ 170 |
CONTACT: CHIMERIX CONTACT:
Joseph T. Schepers
Executive Director, Investor Relations
and Corporate Communications
jschepers@chimerix.com
919-287-4125
Source: News Provided by Acquire Media