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 first
quarter ended March 31, 2017.
“We have made meaningful progress advancing both the
short-course oral brincidofovir program and the first of several
confirmatory studies of IV brincidofovir. The single ascending dose
study of IV brincidofovir (BCV) demonstrated with the first dose of
10 mg that we can achieve the plasma exposures that previously
showed antiviral activity in the SUPPRESS and AdVise studies, but
without the previously noted gastrointestinal (GI) limitations,”
said M. Michelle Berrey, MD, MPH, President and CEO of
Chimerix. “These results together with the multiple-dose
studies in healthy subjects and in infected populations will inform
the planned pivotal pediatric trial for IV BCV, the MVP-Peds Study
(Multi-Viral Prevention in Pediatric Allogeneic Transplant
Recipients), which we hope to initiate in 2018. We look
forward to advancing this important program to bring brincidofovir
to immunocompromised patients suffering with these life-threatening
viral
infections."
Recent Highlights and Program Updates:
Full Data from Phase 1 Dose Escalation Study of
Intravenous Brincidofovir in Healthy Subjects Reported
Data from all four cohorts of the Phase 1 study of IV BCV were
presented at the recent Investor Event held on April 27, 2017. In
this study a total of 40 healthy subjects were randomized to
receive a single dose of either IV BCV or IV placebo in one of four
cohorts. IV BCV 10 mg achieved comparable plasma exposure to that
achieved with the oral BCV 100 mg dose. There were no
drug-related adverse events (AEs) reported in either the 10 mg or
25 mg cohorts; this dose range is likely to be selected for future
studies for treatment of adenovirus and prevention of
cytomegalovirus and other DNA viruses based on the antiviral
activity demonstrated with oral BCV 100 mg.
Doses higher than those currently being explored for the above
indications (“supratherapeutic”) of IV BCV (50 mg given over two
hours in Cohort 3, 50 mg given over four hours in Cohort 4) were
also administered to evaluate the potential effects of BCV on QT
interval and other safety parameters. A majority of the AEs
reported were mild and self-limited. Four subjects in Cohort 3
reported drug-related AEs: one drug-related GI AE, two subjects
with a mild headache, and one subject reported pain and irritation
at the IV infusion site. In Cohort 4, five subjects reported
nine drug-related AEs: three subjects with GI AEs, two subjects
with headache, and one subject with reversible elevations of liver
transaminases reported as an AE.
Therapeutic doses of IV BCV were thus very well tolerated, and
no new adverse events were identified with the IV formulation of
BCV compared with the large safety database for oral BCV.
Clinical Development of BCV Continues
Following discussions with European regulators, Chimerix plans
to initiate the AdAPT trial (Adenovirus after Allogeneic Pediatric
Transplantation, previously referred to as “Study 999”) with
short-course oral BCV later this year in Europe, and possibly in
the US. AdAPT will recruit approximately 140 patients.
Children who have received a T-cell depleted allogeneic HCT with
confirmed AdV viral DNA loads greater than 1000 c/ml in plasma
within 100 days from transplant will be randomized to receive oral
BCV or local standard of care which is predominantly off-label
cidofovir. The study builds on the scientific understanding
from multiple previous trials of BCV in patients with
life-threatening AdV infection, and will provide comparative data
on short-course oral BCV compared with currently available
treatment. If positive, data from AdAPT could enable regulatory
approval in Europe for oral BCV.
Following on the encouraging data from the single ascending dose
study of IV BCV, Chimerix plans to initiate a multiple ascending
dose study of IV BCV in healthy subjects, and a second study to
generate multiple-dose PK and safety data in virally infected
patients. These data are intended to inform the planned pivotal
study of Multi-Viral Prevention of DNA viral infections in
pediatric HCT recipients (MVP-Peds). Subject to the
successful completion of the multiple ascending dose study,
Chimerix intends to initiate the MVP-Peds study during 2018.
Development of BCV for smallpox continues in collaboration with
the Biomedical Advanced Research and Development
Authority (BARDA). Following completion of a planned second
animal efficacy study, Chimerix plans to meet with
the FDA to discuss any additional required data for a
regulatory decision.
Investor Event
On April 27, 2017, Chimerix hosted an Investor Event that
featured keynote presentations from Thomas Lion, MD, PhD, Professor
and Medical Director of the Children's Cancer Research Institute
(Vienna, Austria), who discussed the rapidly changing field of
adenovirus infections in immunocompromised patients, and
highlighted the need for new therapeutic options that can
facilitate viral control during periods of severe
immunosuppression. Dr. Lion presented research showing that
adenovirus often reactivates in the gut and that early treatment
can lead to significantly improved outcomes. Joshua Hill, MD,
Associate in the Vaccine and Infectious Disease Division at the
Fred Hutchinson Cancer Research Center (Seattle, Washington) shared
his research on the frequency of multiple viral infections in both
adult and pediatric transplant recipients. Dr. Hill showed
that 90% of the predominately adult allogeneic HCT recipients whose
samples were tested at their center had evidence of at least one
DNA virus, and two-thirds had two or more DNA viruses. Of the
HCT recipients who reactivated CMV, more than three-quarters had at
least one other DNA virus identified and were at an increased risk
of death. These data demonstrate a need for novel strategies
to prevent multiple DNA viral infections and their negative impact
on patient outcomes. Genovefa Papanicolaou, MD,
Infectious Disease Specialist at Memorial Sloan Kettering Cancer
Center (New York, NY) also spoke of her experiences with multiple
DNA viruses in her allogeneic transplant recipients, which
corroborated Dr. Hill’s data.
First Quarter 2017 Financial Results
Chimerix reported a net loss of $17.8 million,
or $0.38 per basic and diluted share, for the first
quarter of 2017. During the same period in
2016, Chimerix recorded a net loss of $26.3 million,
or $0.57 per basic and diluted share.
Revenues for the first quarter of 2017 decreased to $1.1
million, compared to $1.2 million for the same
period in 2016.
Research and development expenses decreased to $12.7
million for the first quarter of 2017, compared to $20.9
million for the same period in 2016.
General and administrative expenses decreased to $6.6
million for the first quarter of 2017, compared to $6.9
million for the same period in 2016.
Loss from operations was $18.3 million for the first
quarter of 2017, compared to a loss from operations of $26.6
million for the same period in 2016.
Chimerix's balance sheet at March 31,
2017 included $264.7 million of capital available to
fund operations, no debt, and approximately 46.7 million
outstanding shares of common stock.
Today's Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to
discuss first 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 3258363.
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 ChimerixChimerix 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. Chimerix recently announced 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
herpesviruses 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, 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) |
|
|
March 31, |
|
December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
ASSETS |
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
21,866 |
|
|
$ |
51,463 |
|
|
Short-term investments, available-for-sale |
|
|
139,829 |
|
|
|
180,558 |
|
|
Accounts receivable |
|
|
811 |
|
|
|
1,599 |
|
|
Prepaid expenses and other current assets |
|
|
2,391 |
|
|
|
2,845 |
|
|
Total current assets |
|
|
164,897 |
|
|
|
236,465 |
|
Long-term
investments |
|
|
104,884 |
|
|
|
47,407 |
|
Property
and equipment, net of accumulated depreciation |
|
|
2,567 |
|
|
|
2,843 |
|
Other
long-term assets |
|
|
59 |
|
|
|
55 |
|
|
Total
assets |
|
$ |
272,407 |
|
|
$ |
286,770 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
2,813 |
|
|
$ |
3,890 |
|
|
Accrued liabilities |
|
|
5,819 |
|
|
|
6,215 |
|
|
Total current liabilities |
|
|
8,632 |
|
|
|
10,105 |
|
Lease-related obligations |
|
|
401 |
|
|
|
441 |
|
|
Total
liabilities |
|
|
9,033 |
|
|
|
10,546 |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 shares authorized
at March 31, 2017 and |
|
|
|
|
|
December 31, 2016; no shares issued and outstanding as of March
31, 2017 and |
|
|
|
|
|
|
December 31, 2016 |
|
|
— |
|
|
|
— |
|
|
Common stock, $0.001 par value, 200,000,000 shares authorized
at March 31, 2017 and |
|
|
|
December 31, 2016; 46,651,793 and 46,522,475 shares issued and
outstanding as of |
|
|
|
|
|
|
March 31, 2017 and December 31, 2016, respectively |
|
|
47 |
|
|
|
46 |
|
|
Additional paid-in capital |
|
|
696,995 |
|
|
|
692,422 |
|
|
Accumulated other comprehensive loss, net |
|
|
(109 |
) |
|
|
(440 |
) |
|
Accumulated deficit |
|
|
(433,559 |
) |
|
|
(415,804 |
) |
|
Total stockholders’ equity |
|
|
263,374 |
|
|
|
276,224 |
|
|
Total
liabilities and stockholders’ equity |
|
$ |
272,407 |
|
|
$ |
286,770 |
|
|
CHIMERIX, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
Three Months Ended March
31, |
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
Contract revenue |
|
$ |
1,078 |
|
|
$ |
1,228 |
|
|
Operating expenses: |
|
|
Research and development |
|
|
12,742 |
|
|
|
20,936 |
|
|
|
General and administrative |
|
|
6,596 |
|
|
|
6,924 |
|
|
|
Total operating expenses |
|
|
19,338 |
|
|
|
27,860 |
|
|
|
Loss from operations |
|
|
(18,260 |
) |
|
|
(26,632 |
) |
|
Interest income |
|
|
506 |
|
|
|
372 |
|
|
|
Net loss |
|
|
(17,754 |
) |
|
|
(26,260 |
) |
|
Other comprehensive loss: |
|
|
|
|
|
|
Unrealized gain on investments, net |
|
|
331 |
|
|
|
421 |
|
|
|
Comprehensive loss |
|
$ |
(17,423 |
) |
|
$ |
(25,839 |
) |
|
Per
share information: |
|
|
|
|
|
|
Net loss, basic and diluted |
|
$ |
(0.38 |
) |
|
$ |
(0.57 |
) |
|
|
Weighted-average shares outstanding, basic and diluted |
|
|
46,573,394 |
|
|
|
46,184,134 |
|
|
|
|
|
|
|
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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