Chimerix (NASDAQ:CMRX), today reported financial results for
the second quarter ended June 30, 2019 and provided an
operational update.
“We were delighted to announce our acquisition of exclusive
worldwide rights to a Phase 3 ready program in oncology. We are
particularly pleased to have so rapidly sourced this promising
oncology product candidate, as it allows us to focus our efforts on
moving quickly into Phase 3 development of CX-01 in front-line
therapy for acute myeloid leukemia (AML), an area where there are
limited front-line treatment options. CX-01 has shown
compelling activity across multiple endpoints in first-line AML
patients in combination with back-bone chemotherapy regimen,
whereas most recent advances in AML have been in genetically
defined patient populations, or in relapsed/refractory patients,”
stated Mike Sherman, Chief Executive Officer of Chimerix. “The
mechanisms of action for CX-01 also create the opportunity to
develop the therapy for the treatment of a number of other
challenging hematologic malignancies, where there are significant
market opportunities.”
“In addition, we are looking forward to filing a New Drug
Application (NDA) for brincidofovir next year for the treatment of
smallpox, as we believe this offers a significant opportunity to be
an important medical countermeasure for our national strategic
stockpile, and potential non-dilutive funding for the company,”
continued Mr. Sherman.
Second Quarter and Recent Highlights
CX-01 for Acute Myeloid Leukemia
In July, Chimerix announced the completion of an exclusive
worldwide license of CX-01 from Cantex Pharmaceuticals, Inc.
Chimerix intends to move quickly into Phase 3 development of
CX-01 for the treatment of Acute Myeloid Leukemia (AML) in the
first-line setting.
CX-01 (dociparstat sodium) is an investigational product derived
from unfractionated heparin with very low anticoagulant activity.
CX-01 targets key protein pathways important for AML blast cell
migration to the bone marrow and retention of these cells in the
marrow where they are protected from chemotherapy. CX-01 also binds
with proteins involved in chemotherapy resistance and the delay in
platelet recovery after chemotherapy. Together, these activities
are understood to sensitize AML blasts to chemotherapy and improve
clinical responses.
Chimerix plans to initiate a Phase 3 clinical trial of CX-01 for
the treatment of AML in mid-2020 subject to discussions with
FDA.
CX-01 has received Fast Track and Orphan Drug Designations from
the U.S. Food and Drug Administration for the treatment
of AML.
Brincidofovir (BCV) for Smallpox
Data from Chimerix’s completed mouse ectromelia and rabbitpox
studies are intended to address the requirement under the FDA’s
Animal Efficacy Rule for two different animal models of efficacy.
Positive overall survival results in both animal models were
announced earlier this year. Contingent upon final audited results
of the animal efficacy studies, along with finalizing the animal PK
analysis necessary to bridge to a recommended human dose, Chimerix
intends to submit marketing applications in 2020.
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 of investigational drugs in animal models to support the
effectiveness of the drug in diseases in which human clinical
studies are not ethical or feasible.
Second Quarter 2019 Financial Results
Chimerix reported a net loss of $17.7 million, or $0.35 per
basic and diluted share, for the second quarter of 2019.
During the same period in 2018, Chimerix recorded a net loss of
$18.6 million, or $0.39 per basic and diluted share.
Revenues for the second quarter of 2019 increased to $1.4
million, compared to $1.2 million for the same period in 2018.
Research and development expenses increased to $13.8 million for
the second quarter of 2019, compared to $13.7 million for the same
period in 2018.
General and administrative expenses decreased to $6.3 million
for the second quarter of 2019, compared to $6.7 million for the
same period in 2018.
Loss from operations was $18.7 million for the second quarter of
2019, compared to a loss from operations of $19.2 million for the
same period in 2018.
As of June 30, 2019, Chimerix had approximately $158.4 million
of capital available to fund operations. The Company has no debt
and approximately 51.2 million outstanding shares of common
stock. Following the recent transaction with Cantex
Pharmaceuticals, Chimerix expects to end 2019 with approximately
$105 million in capital to fund operations. This amount reflects
payments related to the upfront payment associated with the
in-license of CX-01, development costs of CX-01, and the Company’s
previously announced corporate restructuring expenses of $3.2
million related to the close-out of oral and intravenous BCV
clinical trials and $3.3 million in severance costs.
About CX-01
CX-01 (dociparstat sodium) is an investigational product derived
from unfractionated heparin with very low anticoagulant activity.
CX-01 targets key protein pathways important for AML blast
cell migration to the bone marrow and retention of these cells in
the marrow where they are protected from chemotherapy. CX-01 also
binds with proteins involved in chemotherapy resistance and the
delay in platelet recovery after chemotherapy. Together, these
activities are understood to sensitize AML blasts to chemotherapy
and improve clinical responses. These mechanisms of action support
the potential for development in myelodysplastic syndrome, multiple
myeloma, and lymphomas.
About Brincidofovir
Chimerix's antiviral product candidate, brincidofovir, is a
nucleotide analog that has 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. Brincidofovir has Orphan Drug Designation for
smallpox.
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. CX-01 (dociparstat sodium) is an
investigational product targeting multiple proteins involved in
cancer cell resistance to chemotherapy under development for the
treatment of acute myeloid leukemia and other hematologic
malignancies. Brincidofovir (BCV, CMX001) is an anti-viral 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 includes 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 submission of marketing applications for BCV for the
treatment of smallpox, the potential benefits to be derived from
the license agreement with Cantex Pharmaceuticals, including
statements related to the activity profile and opportunities for
potential development of CX-01; Chimerix’s ability to develop
disease modifying and potentially curative treatments for diseases,
including AML. Among the factors and risks that could cause
actual results to differ materially from those indicated in the
forward-looking statements are risks that the benefits of the
agreement with Cantex may never be realized; risks that our product
candidates may not obtain regulatory approval from the FDA or such
approval may be delayed or conditioned; risks that development
activities related to our product candidates may not be completed
on time or at all; Chimerix’s reliance on sole source third-party
manufacturers for our product candidates; risks that ongoing or
future clinical trials may not be successful or replicate previous
clinical trial results, or may not be predictive of real-world
results or of results in subsequent clinical trials; risks and
uncertainties relating to competitive products and technological
changes that may limit demand for our product candidates; risks
that our product candidates 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 LaSpaluto
919 972-7115 ir@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) |
(unaudited) |
|
|
June 30, |
|
December 31, |
|
|
2019 |
|
|
|
2018 |
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
|
Cash and cash
equivalents |
$ |
21,644 |
|
|
$ |
81,106 |
|
|
Short-term
investments, available-for-sale |
|
136,755 |
|
|
|
105,424 |
|
|
Accounts
receivable |
|
774 |
|
|
|
330 |
|
|
Prepaid expenses
and other current assets |
|
2,200 |
|
|
|
2,598 |
|
|
|
Total current
assets |
|
161,373 |
|
|
|
189,458 |
|
Property and
equipment, net of accumulated depreciation |
|
1,054 |
|
|
|
1,210 |
|
Operating lease
right-of-use assets |
|
969 |
|
|
|
- |
|
Other long-term
assets |
|
45 |
|
|
|
46 |
|
|
|
|
Total assets |
$ |
163,441 |
|
|
$ |
190,714 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
|
Accounts
payable |
$ |
1,832 |
|
|
$ |
4,691 |
|
|
Accrued
liabilities |
|
11,954 |
|
|
|
8,275 |
|
|
|
Total current
liabilities |
|
13,786 |
|
|
|
12,966 |
|
Lease-related
obligations |
|
537 |
|
|
|
144 |
|
|
|
|
Total liabilities |
|
14,323 |
|
|
|
13,110 |
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
Preferred stock,
$0.001 par value, 10,000,000 shares authorized at June 30, 2019
and |
|
|
|
|
|
December 31, 2018;
no shares issued and outstanding as of June 30, 2019 and |
|
|
|
December 31,
2018 |
|
— |
|
|
|
— |
|
|
Common stock,
$0.001 par value, 200,000,000 shares authorized at June 30, 2019
and |
|
|
|
December 31, 2018;
51,230,916 and 50,735,279 shares issued and outstanding as of |
|
|
|
|
|
June 30,
2019 and December 31, 2018, respectively |
|
51 |
|
|
|
51 |
|
|
Additional paid-in
capital |
|
740,547 |
|
|
|
733,907 |
|
|
Accumulated other
comprehensive loss, net |
|
125 |
|
|
|
(92 |
) |
|
Accumulated
deficit |
|
(591,605 |
) |
|
|
(556,262 |
) |
|
|
Total
stockholders’ equity |
|
149,118 |
|
|
|
177,604 |
|
|
|
|
Total liabilities and
stockholders’ equity |
$ |
163,441 |
|
|
$ |
190,714 |
|
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, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Contract
revenue |
$ |
1,438 |
|
|
$ |
1,193 |
|
|
$ |
3,794 |
|
|
$ |
1,983 |
|
Operating
expenses: |
|
|
Research and
development |
|
13,827 |
|
|
|
13,712 |
|
|
|
27,342 |
|
|
|
28,071 |
|
|
General and
administrative |
|
6,312 |
|
|
|
6,650 |
|
|
|
13,998 |
|
|
|
13,388 |
|
|
Total operating
expenses |
|
20,139 |
|
|
|
20,362 |
|
|
|
41,340 |
|
|
|
41,459 |
|
|
|
|
Loss from
operations |
|
(18,701 |
) |
|
|
(19,169 |
) |
|
|
(37,546 |
) |
|
|
(39,476 |
) |
Other
(expense) income: |
|
|
|
|
|
|
|
|
Unrealized loss on
equity investment |
|
(22 |
) |
|
|
(78 |
) |
|
|
(30 |
) |
|
|
(212 |
) |
|
Interest income
and other, net |
|
1,073 |
|
|
|
634 |
|
|
|
2,233 |
|
|
|
1,249 |
|
|
|
|
|
Net loss |
|
(17,650 |
) |
|
|
(18,613 |
) |
|
|
(35,343 |
) |
|
|
(38,439 |
) |
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
Unrealized gain on
debt investments, net |
|
77 |
|
|
|
225 |
|
|
|
217 |
|
|
|
122 |
|
|
|
|
|
Comprehensive loss |
$ |
(17,573 |
) |
|
$ |
(18,388 |
) |
|
$ |
(35,126 |
) |
|
$ |
(38,317 |
) |
Per share
information: |
|
|
|
|
|
|
|
|
Net loss, basic
and diluted |
$ |
(0.35 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.81 |
) |
|
Weighted-average
shares outstanding, basic and diluted |
|
51,130,104 |
|
|
|
47,811,552 |
|
|
|
51,009,935 |
|
|
|
47,725,209 |
|
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