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, 2018.
“Throughout the second quarter of 2018, we continued to make
steady progress advancing our novel antivirals across a number of
important clinical studies. Our lead product candidate,
brincidofovir (BCV), is moving forward as a treatment for
life-threatening adenovirus infection in the AdAPT study, which we
expect to be fully enrolled in 2019. We are opening
sites for our Phase 2 studies for intravenous (IV) BCV in the
United States and Europe. In addition to brincidofovir, we are
advancing CMX521 in the clinic for the treatment and prevention of
norovirus supported by results from a single dose study in healthy
subjects and strong preclinical data,” said M. Michelle
Berrey, MD, MPH, President and Chief Executive Officer of
Chimerix.
Corporate Highlights
Addressed Congressional Subcommittee in Support of
Reauthorization of the Pandemic and All-Hazards Preparedness Act
(PAHPA)
In June, Dr. Berrey delivered remarks before the House Committee
on Energy and Commerce Subcommittee on Health at a hearing titled
“Examining the Reauthorization of the Pandemic and All-Hazards
Preparedness Act” in Washington, D.C. The purpose of the hearing
was to reauthorize certain programs under the Pandemic and
All-Hazards Preparedness Act (PAHPA), which originally passed in
2006 and seeks to improve the United States’ public health and
medical preparedness and response capabilities for emergencies,
whether deliberate, accidental or natural.
Program Updates
Oral BCVThe AdAPT study (Adenovirus after
Allogeneic Pediatric Transplantation) is open for enrollment in the
United States (US), the United Kingdom (UK), and Europe. Four
of nine planned countries are currently undergoing regulatory or
central ethics review; additional sites in the US, UK and Europe
are also in the process of opening for enrollment.
IV BCV Phase 2 Studies Initiating in the US, UK and
EuropeThe Company is opening sites in the US, UK and
Europe for enrollment in IV BCV Phase 2 studies in adult
hematopoietic cell transplant recipients with adenovirus. Chimerix
anticipates interim data in the second half of 2018.
Received Orphan Drug Designation for Brincidofovir for
the Treatment of Smallpox
In June, Chimerix announced that the US Food and Drug
Administration (FDA) granted Orphan Drug Designation for
brincidofovir for the treatment of smallpox. The Orphan Drug
Designation program provides orphan status to drugs and biologics
which are defined as those intended for the safe and effective
treatment, diagnosis or prevention of rare diseases and disorders
that affect fewer than 200,000 people in the United States.
Orphan Drug Designation provides manufacturers with many
benefits, including a waiver of the FDA Prescription Drug User
Fee Act.
Chimerix intends to submit marketing applications for smallpox
following the completion of the rabbit and mouse efficacy
studies.
Presented Preclinical CMX521 Data at 31st International
Conference on Antiviral Research (ICAR)
In June, Chimerix presented results from preclinical studies
supporting clinical evaluation of CMX521, the first clinical-stage
direct-acting antiviral specifically for the treatment and
prevention of norovirus. CMX521 showed activity in
vitro against all strains of norovirus tested, suggesting
broad efficacy against human noroviruses and supporting the ongoing
Phase 1 study. These data were presented in oral and poster
presentations at the 31st International Conference on Antiviral
Research (ICAR) in Porto, Portugal.
In late 2017, Chimerix initiated a first-time-in-human Phase 1
study of CMX521 to evaluate the pharmacokinetics, safety and
tolerability of CMX521 in healthy adult subjects. The first
presentation of clinical data on CMX521 will be in September at the
European Society for Clinical Virology in Athens, Greece.
Second Quarter 2018 Financial Results
Chimerix reported a net loss of $18.6 million,
or $0.39 per basic and diluted share, for the second
quarter of 2018. During the same period in
2017, Chimerix recorded a net loss of $16.7 million,
or $0.36 per basic and diluted share.
Revenues for the second quarter of 2018 increased to $1.2
million, compared to $0.7 million for the same
period in 2017.
Research and development expenses increased to $13.7
million for the second quarter of 2018, compared to $11.6
million for the same period in 2017.
General and administrative expenses increased to $6.7
million for the second quarter of 2018, compared to $6.3
million for the same period in 2017.
Loss from operations was $19.2 million for the second
quarter of 2018, compared to a loss from operations of $17.2
million for the same period in 2017.
Chimerix's balance sheet at June 30,
2018 included $195.7 million of capital available to
fund operations, no debt, and approximately 47.9 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 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 2976768.
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 Brincidofovir
Chimerix's lead product candidate, brincidofovir, is a
nucleotide analog that has 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 a low risk of nephrotoxicity.
Brincidofovir has received Fast Track designation from
the FDA and Orphan Medicinal Product Designation from
the European Commission for adenovirus, cytomegalovirus,
and smallpox.
About CMX521
CMX521 is a nucleoside antiviral identified from
the Chimerix Chemical Library as a potential treatment and/or
prevention for norovirus, the most common cause of acute
gastroenteritis worldwide. An ongoing Phase 1 study is evaluating
the pharmacokinetics, safety and tolerability of CMX521.
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 and compound library have produced brincidofovir (BCV,
CMX001); CMX157, which was licensed to ContraVir
Pharmaceuticals; and CMX521, the first clinical-stage direct-acting
antiviral for the treatment and prevention of norovirus. For
further information, please
visit Chimerix's website, www.chimerix.com.
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 our current or future clinical trials of
brincidofovir may not be successful, 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.
Similar risks and uncertainties apply to the Company’s development
of CMX521.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.
CONTACT:Investor
Relations:
Michelle LaSpaluto (919) 972-7115 ir@chimerix.com or Will
O’Connor Stern Investor Relations Will@sternir.com (212)
362-1200
Media: Laurie Masonson W2O
Grouplmasonson@w2group.com (917) 459-6164
CHIMERIX, INC. |
|
CONSOLIDATED BALANCE SHEETS |
|
(in thousands, except share and per share
data) |
|
(unaudited) |
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
27,447 |
|
|
$ |
18,548 |
|
|
Short-term investments, available-for-sale |
|
|
147,316 |
|
|
|
132,972 |
|
|
Accounts
receivable |
|
|
219 |
|
|
|
1,682 |
|
|
Prepaid
expenses and other current assets |
|
|
3,329 |
|
|
|
3,331 |
|
|
Total
current assets |
|
|
178,311 |
|
|
|
156,533 |
|
|
Long-term
investments |
|
|
21,115 |
|
|
|
76,731 |
|
|
Property and equipment,
net of accumulated depreciation |
|
|
1,502 |
|
|
|
1,894 |
|
|
Other long-term
assets |
|
|
52 |
|
|
|
72 |
|
|
Total
assets |
|
$ |
200,980 |
|
|
$ |
235,230 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
|
$ |
1,426 |
|
|
$ |
3,812 |
|
|
Accrued
liabilities |
|
|
7,976 |
|
|
|
9,384 |
|
|
Total
current liabilities |
|
|
9,402 |
|
|
|
13,196 |
|
|
Lease-related
obligations |
|
|
185 |
|
|
|
224 |
|
|
Total
liabilities |
|
|
9,587 |
|
|
|
13,420 |
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
Preferred
stock, $0.001 par value, 10,000,000 shares authorized at June 30,
2018 and |
|
|
|
|
|
December
31, 2017; no shares issued and outstanding as of June 30, 2018
and |
|
December
31, 2017 |
|
|
— |
|
|
|
— |
|
|
Common
stock, $0.001 par value, 200,000,000 shares authorized at June 30,
2018 and |
|
December
31, 2017; 47,855,025 and 47,505,532 shares issued and outstanding
as |
|
|
|
|
|
of June
30, 2018 and December 31, 2017, respectively |
|
|
48 |
|
|
|
47 |
|
|
Additional paid-in capital |
|
|
717,414 |
|
|
|
709,514 |
|
|
Accumulated other comprehensive loss, net |
|
|
(842 |
) |
|
|
(963 |
) |
|
Accumulated deficit |
|
|
(525,227 |
) |
|
|
(486,788 |
) |
|
Total
stockholders’ equity |
|
|
191,393 |
|
|
|
221,810 |
|
|
Total
liabilities and stockholders’ equity |
|
$ |
200,980 |
|
|
$ |
235,230 |
|
|
|
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, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
Contract
revenue |
|
$ |
1,193 |
|
|
$ |
675 |
|
|
$ |
1,983 |
|
|
$ |
1,753 |
|
|
Operating
expenses: |
|
Research
and development |
|
|
13,712 |
|
|
|
11,636 |
|
|
|
28,071 |
|
|
|
24,378 |
|
|
General
and administrative |
|
|
6,650 |
|
|
|
6,284 |
|
|
|
13,388 |
|
|
|
12,880 |
|
|
Total
operating expenses |
|
|
20,362 |
|
|
|
17,920 |
|
|
|
41,459 |
|
|
|
37,258 |
|
|
Loss from
operations |
|
|
(19,169 |
) |
|
|
(17,245 |
) |
|
|
(39,476 |
) |
|
|
(35,505 |
) |
|
Other (expense)
income: |
|
|
|
|
|
|
|
|
|
Unrealized loss on equity investment |
|
|
(78 |
) |
|
|
- |
|
|
|
(212 |
) |
|
|
- |
|
|
Interest
income |
|
|
634 |
|
|
|
565 |
|
|
|
1,249 |
|
|
|
1,071 |
|
|
Net loss |
|
|
(18,613 |
) |
|
|
(16,680 |
) |
|
|
(38,439 |
) |
|
|
(34,434 |
) |
|
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on investments, net |
|
|
225 |
|
|
|
(1,366 |
) |
|
|
122 |
|
|
|
(1,035 |
) |
|
Comprehensive loss |
|
$ |
(18,388 |
) |
|
$ |
(18,046 |
) |
|
$ |
(38,317 |
) |
|
$ |
(35,469 |
) |
|
Per share
information: |
|
|
|
|
|
|
|
|
|
Net loss,
basic and diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.81 |
) |
|
$ |
(0.74 |
) |
|
Weighted-average shares outstanding, basic and diluted |
|
|
47,811,552 |
|
|
|
46,863,753 |
|
|
|
47,725,209 |
|
|
|
46,719,367 |
|
|
|
|
|
|
|
Chimerix (NASDAQ:CMRX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Chimerix (NASDAQ:CMRX)
Historical Stock Chart
From Apr 2023 to Apr 2024