Chimerix Reports First Quarter 2020 Financial Results and Provides Operational Update
May 07 2020 - 7:00AM
Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on
accelerating the development of medicines to treat cancer and other
serious diseases, today reported financial results for the first
quarter ended March 31, 2020 and provided an operational update.
“Responding to the COVID-19 global pandemic, we recently
announced our accelerated program for dociparstat sodium (DSTAT) to
combat acute lung injury (ALI) in COVID-19 patients,” stated Mike
Sherman, Chief Executive Officer of Chimerix. “As we've learned
more about the manifestations of COVID-19 and how it causes death
in the most serious cases, it has become clear that DSTAT’s
mechanisms may be uniquely positioned to address multiple aspects
of the virus’ progression, including ALI and coagulative disorders
that have led to a number of other conditions, including
amputations, pulmonary embolisms and stroke. As a result, DSTAT has
the potential to prevent the disease progression necessitating the
use of mechanical ventilation, improve survival and potentially
accelerate recovery.”
“Given the urgent need for effective treatments for COVID-19
related ALI, we expect to begin dosing patients in this Phase 2/3
clinical trial this month, with data from the first safety cohort
from the Phase 2 portion of the study to be available in the second
half of this year.
“The COVID-19 pandemic has also highlighted the importance of
our global preparedness for a variety of viral outbreaks. Chimerix
has been at the forefront of these measures working with the U.S.
government to develop brincidofovir (BCV) for smallpox. Preparing
BCV for the U.S. Strategic National Stockpile (SNS) is a critical
element to protect the population from this deadly virus, whether a
potential outbreak occurs naturally or through a bioterror attack.
To that end, we were very pleased to receive the U.S. Food and Drug
Administration’s (FDA) clearance to initiate a rolling New Drug
Application (NDA) for BCV as a medical countermeasure for smallpox.
We look forward to finalizing our submission mid-year and to a
potential procurement contract to enable the addition of BCV to the
SNS,” added Mr. Sherman.
Recent Highlights
- Received clearance from the FDA for a rolling submission of its
NDA for the approval of BCV as a medical countermeasure for
smallpox
- Received clearance from the FDA to initiate a Phase 2/3 Study
of DSTAT in ALI patients with COVID-19
- Received clearance from the FDA to initiate a Phase 3 trial of
DSTAT in Acute Myeloid Leukemia (AML) based on review of final
protocol.
Expected Upcoming Milestones
- Completion of NDA submission of BCV mid-2020
- Completion of Phase 2 portion of DSTAT trial in COVID-19 in
second half of 2020
- Initiation of Phase 3 trial of DSTAT in first line AML
- Potential procurement agreement for BCV prior to FDA decision
on smallpox NDA
- FDA decision on BCV smallpox NDA in 2021
- Completion of manufacturing of approximately $100 million of
BCV product for SNS by mid-2021.
The company previously announced a plan to initiate a Phase 3
clinical study of DSTAT for the treatment of AML in 2020 and has
subsequently announced its delay due to the ongoing COVID-19
pandemic. The Company’s current operational focus is on
executing the DSTAT study in ALI patients with COVID-19. Next steps
on the proposed AML study will be determined in the coming
months.
First Quarter 2020 Financial Results
Chimerix reported a net loss of $10.4 million, or $0.17 per
basic and diluted share, for the first quarter of 2020.
During the same period in 2019, Chimerix recorded a net loss of
$17.7 million, or $0.35 per basic and diluted share.
Revenues for the first quarter of 2020 decreased to $1.2
million, compared to $2.4 million for the same period in 2019.
Research and development expenses decreased to $8.9 million for
the first quarter of 2020, compared to $13.5 million for the same
period in 2019.
General and administrative expenses decreased to $3.2 million
for the first quarter of 2020, compared to $7.7 million for the
same period in 2019.
Loss from operations was $10.9 million for the first quarter of
2020, compared to a loss from operations of $18.8 million for the
same period in 2019.
Chimerix's balance sheet at March 31, 2020 included $103.0
million of capital available to fund operations, no debt, and
approximately 61.9 million outstanding shares of common
stock. The Company expects to end the year with approximately
$70 million in cash and cash equivalents at the end of 2020.
About Chimerix
Chimerix is a development-stage biopharmaceutical company
dedicated to accelerating the advancement of innovative medicines
that make a meaningful impact in the lives of patients living with
cancer and other serious diseases. Its two clinical-stage
development programs are dociparstat sodium (DSTAT) and
brincidofovir (BCV).
Dociparstat sodium is a potential first-in-class
glycosaminoglycan compound derived from porcine heparin that has
low anticoagulant activity. In vitro and in vivo animal model data
support DSTAT’s potential to reduce the inflammation and cellular
infiltration associated with acute lung injury and address
coagulation disorders associated with COVID-19 pathology (HMGB1 and
PF4). Separately, DSTAT inhibits the activities of several key
proteins implicated in the viability of AML blasts and leukemic
stem cells in the bone marrow during chemotherapy (e.g., CXCL12,
selectins, HMGB1, elastase). Randomized AML Phase 2
data suggest that DSTAT may also accelerate platelet recovery
post-chemotherapy via inhibition of PF4, a negative regulator of
platelet production that impairs platelet recovery following
chemotherapy. The company is conducting a randomized,
double-blind, placebo-controlled, Phase 2/3 trial to determine the
safety and efficacy of DSTAT in adults with severe COVID-19 who are
at high risk of respiratory failure. The Phase 2 portion of the
study will enroll 24 subjects to confirm the maximum safe dose and
will then expand by an additional 50 patients (74 total) at the
selected dose. A formal analysis of all endpoints, including
supportive biomarkers will be performed at the conclusion of the
Phase 2 portion of the study. Contingent upon positive results, the
Phase 3 portion of the study will enroll approximately 450
subjects.
BCV is an antiviral drug candidate in development as a medical
countermeasure for smallpox. For further information, please visit
the Chimerix website, www.chimerix.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks and uncertainties that could cause actual
results to differ materially from those projected. Forward-looking
statements include those relating to, among other things, the
mechanism of action of DSTAT and its potential in ALI patients with
COVID-19; Chimerix’s ability to develop DSTAT, including the
initiation of a Phase 2/3 clinical trial for DSTAT as a potential
treatment for ALI associated with COVID-19; Chimerix’s ability to
submit and/or obtain regulatory approvals for DSTAT and BCV; and
the timing and receipt of a potential procurement contract for BCV
in smallpox. Among the factors and risks that could cause actual
results to differ materially from those indicated in the
forward-looking statements are risks that DSTAT may not achieve the
endpoints of the Phase 2/3 clinical trial; risks that DSTAT or BCV
may not obtain regulatory approval from the FDA or such approval
may be delayed or conditioned; risks that development activities
related to DSTAT may not be completed on time or at all; risks
that Chimerix may not receive a procurement contract for
BCV for smallpox in a timely manner or at all; Chimerix’s reliance
on a sole source third-party manufacturer for drug supply; risks
that ongoing or future trials may not be successful or replicate
previous trial results, or may not be predictive of real-world
results or of results in subsequent trials; risks and uncertainties
relating to competitive products and technological changes that may
limit demand for our drugs; risks that our drugs may be precluded
from commercialization by the proprietary rights of third parties;
and additional risks set forth in the Company's filings with the
Securities and Exchange Commission. These forward-looking
statements represent the Company's judgment as of the date of this
release. The Company disclaims, however, any intent or obligation
to update these forward-looking statements.
CONTACT:Investor
Relations:
Michelle LaSpaluto919 972-7115ir@chimerix.com
Will O’ConnorStern Investor
Relationswill@sternir.com 212-362-1200
Media ContactDavid SchullRusso
Partners858-717-2310David.Schull@russopartnersllc.com
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|
CHIMERIX, INC. |
CONSOLIDATED BALANCE SHEETS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
March, 31 |
|
December 31, |
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
24,553 |
|
|
$ |
16,901 |
|
|
Short-term investments, available-for-sale |
|
|
78,469 |
|
|
|
96,574 |
|
|
Accounts receivable |
|
|
1,079 |
|
|
|
1,233 |
|
|
Prepaid expenses and other current assets |
|
|
2,639 |
|
|
|
3,385 |
|
|
|
Total current assets |
|
|
106,740 |
|
|
|
118,093 |
|
Property and equipment, net of accumulated depreciation |
|
|
435 |
|
|
|
540 |
|
Operating lease right-of-use assets |
|
|
578 |
|
|
|
709 |
|
Other long-term assets |
|
|
16 |
|
|
|
34 |
|
|
|
|
Total assets |
|
$ |
107,769 |
|
|
$ |
119,376 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
1,124 |
|
|
$ |
2,398 |
|
|
Accrued liabilities |
|
|
5,556 |
|
|
|
6,830 |
|
|
|
Total current liabilities |
|
|
6,680 |
|
|
|
9,228 |
|
Lease-related obligations |
|
|
48 |
|
|
|
196 |
|
|
|
|
Total liabilities |
|
|
6,728 |
|
|
|
9,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 shares authorized at
March 31, 2020 and |
|
|
|
|
|
|
|
|
|
|
December 31, 2019; no shares issued and outstanding as of March 31,
2020 and |
|
|
- |
|
|
|
- |
|
|
|
December 31, 2019 |
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par value, 200,000,000 shares authorized at
March 31, 2020 and |
|
|
|
|
|
|
|
|
|
|
December 31, 2019; 61,930,339 and 61,590,013 shares issued and
outstanding as of |
|
|
|
|
|
|
|
|
|
|
March 31, 20120 and December 31, 2019, respectively |
|
|
62 |
|
|
|
62 |
|
|
Additional paid-in capital |
|
|
780,248 |
|
|
|
778,693 |
|
|
Accumulated other comprehensive (loss) gain, net |
|
|
(11 |
) |
|
|
35 |
|
|
Accumulated deficit |
|
|
(679,258 |
) |
|
|
(668,838 |
) |
|
|
Total stockholders’ equity |
|
|
101,041 |
|
|
|
109,952 |
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
107,769 |
|
|
$ |
119,376 |
|
|
|
|
|
|
|
|
|
CHIMERIX, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
Revenues: |
|
|
|
|
|
Contract revenue |
|
$ |
1,171 |
|
|
$ |
2,356 |
|
|
Licensing revenue |
|
|
70 |
|
|
|
- |
|
|
|
Total revenues |
|
|
1,241 |
|
|
|
2,356 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
|
8,949 |
|
|
|
13,515 |
|
|
General and administrative |
|
|
3,205 |
|
|
|
7,686 |
|
|
|
Total operating expenses |
|
|
12,154 |
|
|
|
21,201 |
|
|
|
|
Loss from operations |
|
|
(10,913 |
) |
|
|
(18,845 |
) |
Other income: |
|
|
|
|
|
Interest income and other, net |
|
|
493 |
|
|
|
1,152 |
|
|
|
|
|
Net loss |
|
|
(10,420 |
) |
|
|
(17,693 |
) |
Other comprehensive loss: |
|
|
|
|
|
Unrealized (loss) gain on debt investments, net |
|
|
(46 |
) |
|
|
140 |
|
|
|
|
|
Comprehensive loss |
|
$ |
(10,466 |
) |
|
$ |
(17,553 |
) |
Per share information: |
|
|
|
|
|
Net loss, basic and diluted |
|
$ |
(0.17 |
) |
|
$ |
(0.35 |
) |
|
Weighted-average shares outstanding, basic and diluted |
|
61,742,035 |
|
|
|
50,887,221 |
|
|
|
|
|
|
|
|
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