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 fourth
quarter and full-year ended December 31, 2019 and provided an
operational update.
“The transformation and progress we made in 2019 has laid the
foundation for Chimerix to achieve a number of value-creating
milestones in 2020,” said Mike Sherman, Chief Executive Officer of
Chimerix. “The team has continued to execute extremely well as we
plan to file our first New Drug Application (NDA) for brincidofovir
(BCV) as a medical countermeasure for smallpox and advance our
promising dociparstat sodium (DSTAT) program into pivotal Phase 3
clinical development as a front-line treatment for acute myeloid
leukemia (AML).”
Fourth Quarter and Recent Highlights
Phase 3 Pivotal Trial of DSTAT in Front-line AML Patients
Chimerix recently conducted an end of Phase 2 meeting with the
U.S. Food and Drug Administration (FDA) related to the Company’s
development of DSTAT in AML. Following that meeting, Chimerix
incorporated FDA’s feedback on key elements of the Phase 3 clinical
trial and has since submitted a full protocol for final FDA
review. Chimerix plans to initiate a Phase 3 trial
mid-year of DSTAT in combination with standard chemotherapy
(cytarabine plus anthracycline, or “7+3”) in newly diagnosed AML
patients.
The proposed Phase 3 trial will be a randomized, double-blind
trial of approximately 570 newly diagnosed AML patients. The trial
will include patients 60 years of age or older who have an
intermediate or adverse genetic risk profile. It will also
include patients between 18 and 60 years of age who have an adverse
genetic risk profile. Patients will be randomized 1:1 to receive
DSTAT in combination with standard of care cytarabine plus
anthracycline (7+3) induction and cytarabine consolidation
chemotherapy or to receive standard of care (7+3) induction and
consolidation chemotherapy alone. Patients with FLT-3
mutations will be allowed in the study and will be eligible to
receive midostaurin.
The primary endpoint of the proposed trial will be overall
survival (OS). In addition, FDA has indicated that event-free
survival (EFS), using complete response with hematologic recovery
to define induction success (CR), is acceptable as an endpoint for
regulatory approval. Other endpoints to be evaluated in the
proposed trial include minimal residual disease (MRD), relapse-free
survival (RFS), time to hematologic recovery, and induction
response.
In order to supplement the previously reported data from the
pilot and Phase 2 trials and provide additional evidence of DSTAT’s
mechanism of action, the proposed Phase 3 trial includes an early
assessment of comparative CR and MRD rates among the first 80
evaluable patients. This data is expected to be unblinded, reported
publicly, and available for ongoing analysis of later endpoints.
Prior to potential unblinding, this data will be reviewed by an
independent Data Monitoring Committee (DMC). The DMC will
have the discretion to maintain blinding of the data from this
early assessment in the event the DSTAT arm shows exceptional
advantages to the control arm on CR and/or MRD, at certain
pre-specified thresholds, which would allow inclusion of these
patients in the final analysis.
The Company expects to incur approximately $15 million in
clinical trial expenses up to and including this early
assessment.
BCV as a Medical Countermeasure for Smallpox
In January, Chimerix presented data in support of BCV as a
potential treatment for smallpox at the 2020 American Society
for Microbiology (ASM) Biothreats Meeting in Arlington,
Virginia. The presentation highlighted independent experiments
performed in two lethal animal models of smallpox. In these
studies, either rabbits or mice were inoculated with rabbitpox or
ectromelia (mousepox) virus, respectively, to determine the
survival benefit conferred by BCV treatment in animals acutely
infected with these orthopoxviruses. Animals were randomized to
receive either placebo or BCV at varying time intervals post
infection. In both studies, animals that received BCV, even when
administered late post-infection, demonstrated a statistically
significant survival advantage relative to placebo.
Data from these studies are intended to address the requirement
under the FDA Animal Efficacy Rule for two different animal models
of efficacy. Chimerix is collaborating with the Biomedical Advanced
Research and Development Authority (BARDA) for the development of
BCV as a potential medical countermeasure for smallpox. This rule
allows for testing the efficacy of investigational drugs in animal
models for diseases which cannot be evaluated in human clinical
studies.
In cooperation with BARDA, Chimerix has scheduled a pre-NDA
meeting with FDA to review the final efficacy and safety data in
preparation to submit an NDA. Pending the outcome of this
meeting, Chimerix intends to submit a BCV NDA for smallpox in
mid-2020. The Company’s operating and manufacturing plan assumes
entering into a procurement contract with BARDA in 2020 and
preparation for delivery of BCV into the Strategic National
Stockpile in 2021.
Fourth Quarter 2019 Financial Results
Chimerix's balance sheet at December 31,
2019 included $113.5 million of capital available to
fund operations, no debt, and approximately 61.6 million
outstanding shares of common stock.
Chimerix reported a net loss of $3.5 million,
or $0.06 per basic and diluted share, for the fourth
quarter of 2019. During the same period in
2018, Chimerix recorded a net loss of $15.0 million,
or $0.29 per basic and diluted share.
Revenues for the fourth quarter of 2019 increased to $6.8
million, compared to $4.9 million for the same
period in 2018.
Research and development expenses decreased to
$7.5 million for the three-month period
ended December 31, 2019, compared to $15.3 million for
the same period in 2018.
General and administrative expenses decreased to $3.1
million for the fourth quarter of 2019, compared to $5.0
million for the same period in 2018.
Loss from operations was $3.9 million for the fourth
quarter of 2019, compared to a loss from operations of $15.4
million for the same period in 2018.
Full Year 2019 Financial Results
Chimerix reported a net loss of $112.6 million,
or $2.03 per basic and diluted share, for the year
ended December 31, 2019. For the year ended December 31,
2018, Chimerix recorded a net loss of $69.5 million,
or $1.43 per basic and diluted share.
Revenues for 2019 increased to $12.5 million, compared
to $7.2 million in 2018.
Research and development expenses decreased to $42.3
million for the year ended December 31, 2019, compared
to $55.2 million for the year ended December 31,
2018.
General and administrative expenses decreased to $21.2
million for the year ended December 31, 2019, compared
to $23.6 million for the year ended December 31,
2018.
Chimerix recorded acquired-in-process research and
development expenses of $65.0 million for the year ended
December 31, 2019 related to the Cantex transaction.
Loss from operations was $116.0 million for the year
ended December 31, 2019, compared to a loss from
operations of $71.6 million for the year
ended December 31, 2018.
Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to
discuss fourth quarter and full-year 2019 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 1397800.
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 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. The Company’s 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 but retains the ability to inhibit
activities of several key proteins implicated in the retention and
viability of AML blasts and leukemic stem cells in the bone marrow
during chemotherapy (e.g., CXCL12, selectins, HMGB1,
elastase). Mobilization of AML blasts and leukemic stem cells
from the bone marrow has been associated with enhanced
chemosensitivity and may be a primary mechanism accounting for the
observed increases in survival endpoints in Phase 2 with
DSTAT versus placebo. Randomized Phase 2 data suggest that DSTAT
may also accelerate platelet recovery post-chemotherapy via
inhibition of platelet factor 4, a negative regulator of platelet
production that impairs platelet recovery following chemotherapy.
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,
Chimerix’s ability to develop DSTAT and BCV, including the
initiation of a Phase 3 clinical trial for DSTAT; Chimerix’s
ability to submit and/or obtain regulatory approvals for DSTAT and
BCV; and Chimerix’s ability to enter into a procurement contract
for BCV as a medical countermeasure. 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 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 or BCV may not be completed on time 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; risks related to procurement
of BCV for the treatment of smallpox 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 LaSpaluto
919 972-7115ir@chimerix.com Will O’Connor Stern Investor Relations
will@sternir.com 212-362-1200
CHIMERIX, INC. |
CONSOLIDATED BALANCE SHEETS |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2019 |
|
|
|
2018 |
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
16,901 |
|
|
$ |
81,106 |
|
Short-term investments, available-for-sale |
|
96,574 |
|
|
|
105,424 |
|
Accounts receivable |
|
1,233 |
|
|
|
330 |
|
Prepaid expenses and other current assets |
|
3,385 |
|
|
|
2,598 |
|
Total current assets |
|
118,093 |
|
|
|
189,458 |
|
Property and equipment, net of accumulated depreciation |
|
540 |
|
|
|
1,210 |
|
Operating lease right-of-use assets |
|
709 |
|
|
|
- |
|
Other long-term assets |
|
34 |
|
|
|
46 |
|
Total assets |
$ |
119,376 |
|
|
$ |
190,714 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,398 |
|
|
$ |
4,691 |
|
Accrued liabilities |
|
6,830 |
|
|
|
8,275 |
|
Total current liabilities |
|
9,228 |
|
|
|
12,966 |
|
Lease-related obligations |
|
196 |
|
|
|
144 |
|
Total liabilities |
|
9,424 |
|
|
|
13,110 |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value, 10,000,000 shares authorized at
December 31, 2019 and 2018; no shares issued and outstanding as of
December 31, 2019 and 2018 |
|
- |
|
|
|
- |
|
Common stock, $0.001 par value, 200,000,000 shares authorized at
December 31, 2019 and 2018; 61,590,013 and 50,735,279 shares issued
and outstanding as of December 31, 2019 and 2018, respectively |
|
62 |
|
|
|
51 |
|
Additional paid-in capital |
|
778,693 |
|
|
|
733,907 |
|
Accumulated other comprehensive loss, net |
|
35 |
|
|
|
(92 |
) |
Accumulated deficit |
|
(668,838 |
) |
|
|
(556,262 |
) |
Total stockholders’ equity |
|
109,952 |
|
|
|
177,604 |
|
Total liabilities and stockholders’ equity |
$ |
119,376 |
|
|
$ |
190,714 |
|
|
|
|
|
CHIMERIX, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
Contract revenue |
$ |
1,852 |
|
|
$ |
4,864 |
|
|
$ |
7,604 |
|
|
$ |
7,216 |
|
Licensing revenue |
|
4,915 |
|
|
|
- |
|
|
|
4,915 |
|
|
|
- |
|
Total revenues |
|
6,767 |
|
|
|
4,864 |
|
|
|
12,519 |
|
|
|
7,216 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
7,493 |
|
|
|
15,276 |
|
|
|
42,288 |
|
|
|
55,239 |
|
General and administrative |
|
3,147 |
|
|
|
5,007 |
|
|
|
21,169 |
|
|
|
23,582 |
|
Acquired in-process research and development |
|
- |
|
|
|
- |
|
|
|
65,045 |
|
|
|
- |
|
Total operating expenses |
|
10,640 |
|
|
|
20,283 |
|
|
|
128,502 |
|
|
|
78,821 |
|
Loss from operations |
|
(3,873 |
) |
|
|
(15,419 |
) |
|
|
(115,983 |
) |
|
|
(71,605 |
) |
Other income: |
|
|
|
|
|
|
|
Interest income and other, net |
|
370 |
|
|
|
463 |
|
|
|
3,407 |
|
|
|
2,131 |
|
Net loss |
|
(3,503 |
) |
|
|
(14,956 |
) |
|
|
(112,576 |
) |
|
|
(69,474 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
Unrealized (loss) gain on investments, net |
|
(55 |
) |
|
|
569 |
|
|
|
127 |
|
|
|
871 |
|
Comprehensive loss |
$ |
(3,558 |
) |
|
$ |
(14,387 |
) |
|
$ |
(112,449 |
) |
|
$ |
(68,603 |
) |
Per share information: |
|
|
|
|
|
|
|
Net loss, basic and diluted |
$ |
(0.06 |
) |
|
$ |
(0.29 |
) |
|
$ |
(2.03 |
) |
|
$ |
(1.43 |
) |
Weighted-average shares outstanding, basic and diluted |
|
61,385,616 |
|
|
|
50,722,655 |
|
|
|
55,501,973 |
|
|
|
48,593,435 |
|
|
|
|
|
|
|
|
|
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