Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing
novel antivirals to address unmet medical needs, today reported
financial results and provided a corporate update for the second
quarter ended June 30, 2017.
“Throughout the second quarter, we continued to make steady
progress as we advance brincidofovir for the benefit of
immunocompromised patients,” said M. Michelle Berrey, MD, MPH,
President and Chief Executive Officer of Chimerix. “We are pleased
by the enrollment in our multiple ascending dose study of IV BCV,
the results of which will inform the next phase of
development.”
“Our efforts in the first half of 2017 position us to achieve
important milestones throughout the remainder of the year. We look
forward to data from AdVance, our study of the natural history and
outcomes of AdV infection in HCT recipients in Europe, including
the use of off-label agents. We plan to initiate the AdAPT
trial of oral brincidofovir for the treatment of adenovirus
infection later this year,” continued Dr. Berrey.
Recent Highlights and Program Updates:
Initiated Multiple Ascending Dose Study of IV
Brincidofovir
Chimerix commenced dosing in the multiple ascending dose (MAD)
study of intravenous (IV) brincidofovir (BCV) in healthy subjects.
This study is designed to evaluate the safety, tolerability and
pharmacokinetics associated with multiple doses of IV BCV given
once or twice weekly in healthy subjects. Data from this study will
inform the continued development of this new formulation toward the
planned Multi-Viral Prevention study of DNA viral infections in
pediatric stem cell transplant recipients (MVP-Peds).
Additional Pipeline Updates
Study start-up activities are on-track for AdAPT, or Adenovirus
after Allogeneic Pediatric Transplantation, previously referred to
as Study 999. The Company is in active discussions with
regulators on the final study design and intends to initiate AdAPT
with short-course oral BCV later this year as previously
communicated.
Development of BCV as a potential countermeasure for smallpox
continues in collaboration with the Biomedical Advanced Research
and Development Authority (BARDA). On Friday, Chimerix received
correspondence from the FDA that indicated the Company will need to
conduct a second rabbitpox study. The Company plans to seek
clarification and is committed to work with the FDA and BARDA to
gain agreement on next steps.
Chimerix anticipates initiation of a first-time-in-human
(FTIH) study for CMX521 later this year. Identified from the
Chimerix Chemical Library, CMX521 is a nucleoside analog, which
targets the norovirus polymerase, a part of the virus which is
required for viral replication and is common to all viral strains,
including genetically diverse norovirus strains that have been
associated with outbreaks.
Second Quarter 2017 Financial Results
Chimerix reported a net loss of $16.7 million,
or $0.36 per basic and diluted share, for the second
quarter of 2017. During the same period in
2016, Chimerix recorded a net loss of $18.1 million,
or $0.39 per basic and diluted share.
Revenues for the second quarter of 2017 decreased to $0.7
million, compared to $1.8 million for the same
period in 2016.
Research and development expenses decreased to $11.6
million for the second quarter of 2017, compared to $13.8
million for the same period in 2016.
General and administrative expenses decreased to $6.3
million for the second quarter of 2017, compared to $6.6
million for the same period in 2016.
Loss from operations was $17.2 million for the second
quarter of 2017, compared to a loss from operations of $18.5
million for the same period in 2016.
Chimerix's balance sheet at June 30,
2017 included $251.5 million of capital available to
fund operations, no debt, and approximately 47.0 million
outstanding shares of common stock.
Today's Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to
discuss second quarter 2017 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 54730100.
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 dedicated to
discovering, developing and commercializing medicines that improve
outcomes for immunocompromised patients. Chimerix's proprietary
lipid conjugate technology has produced brincidofovir (BCV,
CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals;
and earlier-stage compounds. In addition, Chimerix has in
early-stage development a new clinical candidate, CMX521, for the
treatment and/or prevention of norovirus. For further information,
please visit Chimerix's website, www.chimerix.com.
About Brincidofovir
Chimerix's lead product candidate, brincidofovir, is a
nucleotide analog that has shown in vitro antiviral
activity against all five families of DNA viruses that affect
humans, including the herpes viruses and adenoviruses.
Brincidofovir has a high barrier to resistance, no myelosuppression
and low risk of nephrotoxicity. Brincidofovir has received Fast
Track designation from the FDA for adenovirus, CMV and
smallpox. Brincidofovir has also received Orphan Medicinal Product
Designation from the European Commission for the treatment of
adenovirus and for the prevention of CMV disease, and the Committee
for Orphan Medicinal Products has issued a positive opinion for an
Orphan Designation for the treatment of smallpox.
Forward-Looking Statements This press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that are subject
to risks, uncertainties and other factors, including the
possibility that there may not be a viable continued development
path for brincidofovir, that FDA and other regulatory
authorities may not approve brincidofovir or brincidofovir-based
regimens, that CMX521 may not demonstrate expected activity against
norovirus, and that marketing approvals, if granted, may have
significant limitations on their use. As a result, brincidofovir
may never be successfully commercialized. In
addition, Chimerix may be unable to file for regulatory
approval for brincidofovir with other regulatory authorities. These
risks, uncertainties and other factors could cause actual results
to differ materially from those expressed or implied by such
forward-looking statements. Risks are described more fully in the
Company's filings with the Securities and Exchange Commission,
including without limitation the Company's most recent Quarterly
Report on Form 10-Q 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. The Company 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, INC. |
CONSOLIDATED BALANCE SHEETS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
June 30, |
|
December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
ASSETS |
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
23,891 |
|
|
$ |
51,463 |
|
|
Short-term
investments, available-for-sale |
|
|
124,637 |
|
|
|
180,558 |
|
|
Accounts
receivable |
|
|
- |
|
|
|
1,599 |
|
|
Prepaid
expenses and other current assets |
|
|
3,148 |
|
|
|
2,845 |
|
|
Total
current assets |
|
|
151,676 |
|
|
|
236,465 |
|
Long-term
investments |
|
|
103,643 |
|
|
|
47,407 |
|
Property
and equipment, net of accumulated depreciation |
|
|
2,306 |
|
|
|
2,843 |
|
Other
long-term assets |
|
|
51 |
|
|
|
55 |
|
|
Total assets |
|
$ |
257,676 |
|
|
$ |
286,770 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
|
$ |
1,609 |
|
|
$ |
3,890 |
|
|
Accrued
liabilities |
|
|
6,159 |
|
|
|
6,215 |
|
|
Total
current liabilities |
|
|
7,768 |
|
|
|
10,105 |
|
Lease-related obligations |
|
|
246 |
|
|
|
441 |
|
|
Total liabilities |
|
|
8,014 |
|
|
|
10,546 |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred
stock, $0.001 par value, 10,000,000 shares authorized at June 30,
2017 and |
|
|
|
|
|
December
31, 2016; no shares issued and outstanding as of June 30, 2017
and |
|
|
|
|
|
|
December
31, 2016 |
|
|
— |
|
|
|
— |
|
|
Common
stock, $0.001 par value, 200,000,000 shares authorized at June 30,
2017 and |
|
|
|
December
31, 2016; 47,042,762 and 46,522,475 shares issued and outstanding
as of |
|
|
|
|
|
|
June 30,
2017 and December 31, 2016, respectively |
|
|
47 |
|
|
|
46 |
|
|
Additional
paid-in capital |
|
|
701,329 |
|
|
|
692,442 |
|
|
Accumulated
other comprehensive loss, net |
|
|
(1,475 |
) |
|
|
(440 |
) |
|
Accumulated
deficit |
|
|
(450,239 |
) |
|
|
(415,804 |
) |
|
Total
stockholders’ equity |
|
|
249,662 |
|
|
|
276,244 |
|
|
Total liabilities and
stockholders’ equity |
|
$ |
257,676 |
|
|
$ |
286,790 |
|
|
CHIMERIX, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
Three Months Ended June
30, |
|
Six Months Ended June
30, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
Contract revenue |
|
$ |
675 |
|
|
$ |
1,841 |
|
|
$ |
1,753 |
|
|
$ |
3,069 |
|
Operating expenses: |
|
|
Research
and development |
|
|
11,636 |
|
|
|
13,759 |
|
|
|
24,378 |
|
|
|
34,695 |
|
|
General and
administrative |
|
|
6,284 |
|
|
|
6,607 |
|
|
|
12,880 |
|
|
|
13,531 |
|
|
Total
operating expenses |
|
|
17,920 |
|
|
|
20,366 |
|
|
|
37,258 |
|
|
|
48,226 |
|
|
Loss from
operations |
|
|
(17,245 |
) |
|
|
(18,525 |
) |
|
|
(35,505 |
) |
|
|
(45,157 |
) |
Interest Income |
|
|
565 |
|
|
|
377 |
|
|
|
1,071 |
|
|
|
749 |
|
|
Net
loss |
|
|
(16,680 |
) |
|
|
(18,148 |
) |
|
|
(34,434 |
) |
|
|
(44,408 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
Unrealized
(loss) gain on investments, net |
|
|
(1,366 |
) |
|
|
75 |
|
|
|
(1,035 |
) |
|
|
496 |
|
|
Comprehensive loss |
|
$ |
(18,046 |
) |
|
$ |
(18,073 |
) |
|
$ |
(35,469 |
) |
|
$ |
(43,912 |
) |
Per
share information: |
|
|
|
|
|
|
|
|
|
Net loss,
basic and diluted |
|
$ |
(0.36 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.74 |
) |
|
$ |
(0.96 |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
46,863,753 |
|
|
|
46,214,086 |
|
|
|
46,719,367 |
|
|
|
46,199,110 |
|
|
|
|
|
|
|
|
|
CONTACT:
Investor Relations:
ir@chimerix.com
or
Will O’Connor
Stern Investor Relations
Will@sternir.com
212-362-1200
Media:
Becky Vonsiatsky
W2O Group
bvonsiatsky@w2ogroup.com
413-478-2003
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