- Conference Call at 8:30 a.m. ET Today
-
Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing
novel antivirals to address life-threatening viral infections,
today reported financial results and provided a corporate update
for the third quarter ended September 30, 2018.
“We have made important progress throughout the year that we
believe will position Chimerix for several transformational
catalysts in 2019. We expect AdAPT to fully enroll in 2019
and provide data in 2020. Data from our Phase 2 studies of IV
BCV should inform the design and doses of BCV in other viral
infections such as BK virus and HHV-6. Results from our pivotal
animal studies supporting BCV for smallpox are anticipated in
2019. Finally, our financial position remains strong,
providing the capital needed to advance our clinical programs for
BCV and CMX521,” said M. Michelle Berrey, MD, MPH, President
and Chief Executive Officer of Chimerix.
Recent Highlights and Program Updates:
Detailed AdVance Data Presented at IDWeek
At IDWeek 2018 in early October, Chimerix presented the full
analysis of multiple measures of adenovirus (AdV) viral load
dynamics from the AdVance study. AdVance was the first large,
multi-center study of AdV incidence, natural history, management
and clinical outcomes in allogeneic hematopoietic cell transplant
(allo-HCT) recipients.
The analysis considered six different dynamic measures
of AdV viral load and their association with all-cause
mortality. Importantly, all measures were
independently associated with mortality, including the viral burden
measured as time-averaged area-under-the-curve for AdV viral load
over 16 weeks (AAUC0-16). As with many viral infections,
peak viral load and the duration of the high viral load were both
predictors of poor clinical outcomes. The
area-under-the-curve includes both measures: viral peak and
persistence. As the primary endpoint in the ongoing AdAPT
study, the company believes AdV AAUC0-16 is thus likely to reflect
the superior antiviral effect of oral brincidofovir (BCV) compared
with current standard of care and may also demonstrate the improved
short-term outcomes in subjects who are treated with oral BCV.
Data from Multiple Ascending Dose Study of IV
Brincidofovir Presented at IDWeek
Chimerix presented data from the company’s Phase 1 study
evaluating the safety and pharmacokinetics (PK) of multiple
ascending doses (MAD) of intravenous (IV) BCV in healthy adult
subjects. These data were presented at IDWeek 2018.
The study evaluated the safety and PK of four doses of IV BCV in
27 healthy individuals who were randomized 3:1 to receive IV
BCV or placebo in sequential cohorts of escalating doses.
Individuals receiving IV BCV were given a 10 mg dose in
a two-hour infusion twice a week for two weeks or a 20 mg dose in
either a one- or two-hour infusion once a week for four weeks.
Twice weekly doses of IV BCV at 10 mg provided similar blood
levels of the drug as the oral BCV 100 mg dose previously studied
in late-stage clinical trials, with no reported diarrhea or other
gastrointestinal adverse events.
Preclinical Data Demonstrating Antiviral Activity of BCV
Against Polyomavirus Presented at Kidney Week 2018
Chimerix announced data from two preclinical studies which
assessed the in vivo antiviral activity of BCV against
polyomavirus. These data were presented at the American
Society of Nephrology’s Kidney Week 2018 in San Diego, CA.
The two studies evaluated BCV’s effect against Murine Polyoma
Virus (MuPyV), a mouse polyomavirus closely related to the human BK
virus. In these studies, mice with MuPyV were treated with
BCV either 24 hours after being infected or prophylactically for a
full week prior to infection. Data from the two studies show
that BCV demonstrated significant antiviral activity against MuPyV
and showed no safety signals across BCV doses administered.
In mice treated after infection with MuPyV, BCV delivered via
intraperitoneal injection once daily, twice weekly or once weekly
reduced kidney viral loads by 100-fold relative to placebo.
These data along with data from the company’s ongoing Phase 2
studies of IV BCV are expected to inform the dose regimen for the
company’s planned Phase 2/3 studies.
Program Updates
Oral BCV
The AdAPT Study (Adenovirus after Allogeneic Pediatric
Transplantation) is open for enrollment in the United States (US)
and Europe. All targeted countries and clinical sites are
anticipated to be open for enrollment by the end of 2018.
Chimerix anticipates completing enrollment in 2019 and
obtaining results from the 16‑week primary endpoint in 2020;
however, this forecast will likely be updated once the company has
several months of data on the enrollment rate from a majority of
planned clinical centers.
IV BCV Phase 2 Studies Continue to Initiate in the US
and Europe
Sites in the US and Europe continue to open for enrollment in
our IV BCV Phase 2 studies in adult allo-HCT recipients with AdV.
The company anticipates interim data in 2019. Building
on the recently-presented data from IV BCV in healthy adults, the
safety and BCV levels in patients, together with AdV viral decay
curves, will inform the design of future Phase 2/3 studies.
Final Animal Studies for Brincidofovir for the Treatment
of Smallpox
Chimerix recently initiated the adjunct rabbit study and
anticipates initiating the pivotal mouse efficacy study in
2019. Data from both animal efficacy models are expected in
2019. Chimerix intends to submit marketing applications for
oral BCV for smallpox following the completion of the rabbit and
mouse efficacy studies.
CMX521 for Norovirus
In September 2018, Chimerix presented data on
CMX521 at the European Society for Clinical Virology in Athens,
Greece. The data presented included:
- No safety concerns were identified with single oral doses of
CMX521 up to 2400 mg the top dose tested
- CMX521 plasma exposures increased in a less-than-proportional
manner with escalating single oral dose administration
Clinical testing of CMX521 is ongoing in conjunction with in
vitro studies in cultured human intestinal cells and recently
described animal models of norovirus to assess antiviral
efficacy.
Third Quarter 2018 Financial Results
Chimerix reported a net loss of $16.1 million, or $0.33 per
basic and diluted share, for the third quarter of 2018.
During the same period in 2017, Chimerix recorded a net loss
of $17.3 million, or $0.37 per basic and diluted share.
Revenues for the third quarter of 2018 decreased to $0.4
million, compared to $0.9 million for the same period in
2017.
Research and development expenses decreased to $11.9 million for
the third quarter of 2018, compared to $12.2 million for the same
period in 2017.
General and administrative expenses decreased to $5.2 million
for the third quarter of 2018, compared to $6.7 million for the
same period in 2017.
Loss from operations was $16.7 million for the third quarter of
2018, compared to a loss from operations of $17.9 million for the
same period in 2017.
Chimerix's balance sheet at September 30, 2018 included $193.8
million of capital available to fund operations, no debt, and
approximately 50.6 million outstanding shares of common stock.
Today's Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to
discuss third 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 4646308.
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 for cytomegalovirus (CMV) and smallpox.
Brincidofovir has also received Orphan Medicinal Product
Designation from the European Commission for the treatment of
adenovirus, for the prevention of CMV disease, and for the
treatment of smallpox, and Orphan Drug Designation from the FDA for
the treatment of 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/or 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 the 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) 972-7115ir@chimerix.com or Will O’Connor Stern Investor
RelationsWill@sternir.com (212) 362-1200
Media: Laurie MasonsonW2O Grouplmasonson@w2group.com(917)
459-6164
| CHIMERIX, INC. |
| CONSOLIDATED BALANCE SHEETS |
| (in thousands, except share and per share
data) |
| (unaudited) |
| |
| |
September 30, |
|
December 31, |
| |
2018 |
|
2017 |
|
ASSETS |
|
|
|
| Current assets: |
|
|
|
| Cash and cash
equivalents |
$ |
22,991 |
|
|
$ |
18,548 |
|
|
Short-term investments, available-for-sale |
|
160,367 |
|
|
|
132,972 |
|
| Accounts
receivable |
|
332 |
|
|
|
1,682 |
|
| Prepaid
expenses and other current assets |
|
3,028 |
|
|
|
3,331 |
|
| Total
current assets |
|
186,718 |
|
|
|
156,533 |
|
| Long-term
investments |
|
10,564 |
|
|
|
76,731 |
|
| Property and equipment,
net of accumulated depreciation |
|
1,363 |
|
|
|
1,894 |
|
| Other long-term
assets |
|
51 |
|
|
|
72 |
|
| Total
assets |
$ |
198,696 |
|
|
$ |
235,230 |
|
| |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
| Current
liabilities: |
|
|
|
| Accounts
payable |
$ |
1,609 |
|
|
$ |
3,812 |
|
| Accrued
liabilities |
|
7,776 |
|
|
|
9,384 |
|
| Total
current liabilities |
|
9,385 |
|
|
|
13,196 |
|
| Lease-related
obligations |
|
167 |
|
|
|
224 |
|
| Total
liabilities |
|
9,552 |
|
|
|
13,420 |
|
| |
|
|
|
| Stockholders’
equity: |
|
|
|
| Preferred
stock, $0.001 par value, 10,000,000 shares authorized at September
30, 2018 and December 31, 2017; no shares issued and outstanding as
of September 30, 2018 and December 31, 2017 |
|
— |
|
|
|
— |
|
| Common
stock, $0.001 par value, 200,000,000 shares authorized at September
30, 2018 and December 31, 2017; 50,627,237 and 47,505,532
shares issued and outstanding as of September 30, 2018 and December
31, 2017, respectively |
|
51 |
|
|
|
47 |
|
|
Additional paid-in capital |
|
731,060 |
|
|
|
709,514 |
|
|
Accumulated other comprehensive loss, net |
|
(661 |
) |
|
|
(963 |
) |
|
Accumulated deficit |
|
(541,306 |
) |
|
|
(486,788 |
) |
| Total
stockholders’ equity |
|
189,144 |
|
|
|
221,810 |
|
| Total
liabilities and stockholders’ equity |
$ |
198,696 |
|
|
$ |
235,230 |
|
| |
| CHIMERIX, INC. |
| CONSOLIDATED 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, |
| |
2018 |
|
2017 |
|
2018 |
|
2017 |
| Contract
revenue |
$ |
369 |
|
|
$ |
897 |
|
|
$ |
2,352 |
|
|
$ |
2,650 |
|
| Operating
expenses: |
|
| Research
and development |
|
11,892 |
|
|
|
12,157 |
|
|
|
39,963 |
|
|
|
36,535 |
|
| General
and administrative |
|
5,187 |
|
|
|
6,650 |
|
|
|
18,575 |
|
|
|
19,530 |
|
| Total
operating expenses |
|
17,079 |
|
|
|
18,807 |
|
|
|
58,538 |
|
|
|
56,065 |
|
| Loss from
operations |
|
(16,710 |
) |
|
|
(17,910 |
) |
|
|
(56,186 |
) |
|
|
(53,415 |
) |
| Other (expense)
income: |
|
|
|
|
|
|
|
|
Unrealized loss on equity investment |
|
(99 |
) |
|
|
- |
|
|
|
(311 |
) |
|
|
- |
|
| Interest
income |
|
730 |
|
|
|
598 |
|
|
|
1,979 |
|
|
|
1,669 |
|
|
Net loss |
|
(16,079 |
) |
|
|
(17,312 |
) |
|
|
(54,518 |
) |
|
|
(51,746 |
) |
| Other
comprehensive loss: |
|
|
|
|
|
|
|
|
Unrealized gain (loss) on investments, net |
|
180 |
|
|
|
(6 |
) |
|
|
302 |
|
|
|
(1,041 |
) |
|
Comprehensive loss |
$ |
(15,899 |
) |
|
$ |
(17,318 |
) |
|
$ |
(54,216 |
) |
|
$ |
(52,787 |
) |
| Per share
information: |
|
|
|
|
|
|
|
| Net loss,
basic and diluted |
$ |
(0.33 |
) |
|
$ |
(0.37 |
) |
|
$ |
(1.14 |
) |
|
$ |
(1.10 |
) |
|
Weighted-average shares outstanding, basic and diluted |
|
48,172,354 |
|
|
|
47,065,756 |
|
|
|
47,875,895 |
|
|
|
46,836,099 |
|
| |
|
|
|
|
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