Chimerix (NASDAQ:CMRX), a biopharmaceutical company
whose mission it is to develop medicines that meaningfully improve
and extend the lives of patients facing deadly diseases, today
reported financial results for the first quarter ended March 31,
2022 and provided an operational update.
“As announced earlier today, the sale of TEMBEXA® to Emergent
BioSolutions, Inc. (Emergent) significantly strengthens our balance
sheet at a time when access to capital within the industry is at a
historic premium. With Emergent’s expertise in global biodefense
and our participation in future economics, this program is
positioned to maximize value. We will now focus on developing a
potentially life altering drug for glioma patients that harbor the
H3 K27M mutation who have no other alternatives,” said Mike
Sherman, Chief Executive Officer of Chimerix. “Securing $225
million in an upfront payment with the possibility of additional
milestones and royalties solidifies our ability to fund development
of ONC201 and the imipridone platform without the uncertainty that
arises from contracting with government entities.”
“We continue our engagement with the U.S. Food and Drug
Administration (FDA) regarding the development of ONC201. While we
have not yet requested formal feedback on a potential NDA
submission for accelerated approval, communication from the FDA
makes it clear that the potential for accelerated approval is more
challenging than previously anticipated. This is consistent with
the evolving policy the agency has expressed towards single arm
studies, generally. As such, we are prioritizing the initiation of
a randomized Phase 3 study by year-end. Given the strength of the
data already presented and the extent of the unmet patient need, we
still believe an accelerated approval is possible and plan to
complete the work already underway to support a potential NDA
submission,” added Mr. Sherman.
“Following an internal review of our pipeline, we will no longer
be investing in the DSTAT program. This narrower focus of
development resources will ensure we optimize our execution in
bringing ONC201 to patients as quickly as possible,” concluded Mr.
Sherman.
Recent Highlights
Emergent Acquires Worldwide Rights to
TEMBEXA
Today, Chimerix announced entering into an agreement with
Emergent for the sale of TEMBEXA worldwide rights for $225 million
upfront and additional milestones of up to $100 million to be paid
contingent upon the execution of additional procurement awards from
Biomedical Advanced Research and Development Authority (BARDA)
following the base period. The closing payment and the milestone
payments may be adjusted based on actual procurement value.
Chimerix is also eligible to receive up to $12.5 million in
regulatory milestones associated with the SymBio Pharmaceuticals
Ltd. brincidofovir partnership to be assumed by Emergent. Chimerix
may also earn a 20% royalty on future gross profit of TEMBEXA in
the United States associated with volumes above 1.7 million
treatment courses of therapy during the exclusivity period of
TEMBEXA. Outside of the United States, the agreement also allows
Chimerix to earn a 15% royalty on all gross profit associated with
TEMBEXA sales during the exclusivity period of TEMBEXA on a
market-to-market basis.
Subject to the satisfaction or waiver of the closing conditions,
the companies expect the transaction may close as early as the
second quarter of 2022. Chimerix is currently in negotiation with
BARDA on the terms of a TEMBEXA procurement contract. Chimerix will
continue to lead this negotiation until its conclusion. Entry into
a TEMBEXA procurement contract with BARDA is a closing condition to
the acquisition agreement with Emergent.
The FDA granted TEMBEXA tablets and oral suspension approval for
the treatment of smallpox. TEMBEXA is approved for adult and
pediatric patients and is the first and only smallpox therapy
approved for neonates.
ONC201 for Recurrent H3 K27M-mutant Glioma
ONC201 is an orally administered small molecule dopamine
receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP)
agonist for the treatment of recurrent gliomas that harbor the H3
K27M mutation.
The FDA had previously requested that Chimerix
conduct a retrospective Natural Disease History (NDH) study of
recurrent H3 K27M-mutant glioma. More recently, Chimerix was
informed that the FDA no longer expects to rely on the outcome of a
NDH study to inform a regulatory decision given the limitations
inherent in NDH studies. Therefore, the Company plans to limit
further investment in this study and will disclose the findings at
a later date.
The Company plans to initiate a Phase 3 study of
ONC201 in patients who harbor the H3 K27M-mutation. This study is
designed to serve as the basis for either a confirmatory approval
or first approval. Final study design and protocols are under
review. Once agreement has been reached with the FDA, the Company
will announce the final clinical design and timeline. While
acknowledging the new regulatory sentiment with respect to
single-arm data to support accelerated approval, the Company
continues work to complete the safety database, clinical
pharmacology studies and other items to support a possible
regulatory filing for accelerated approval.
In November, Chimerix reported data from the 50-patient cohort
of ONC201 for the treatment of recurrent H3 K27M-mutant glioma at
the Society for Neuro-Oncology (SNO) Annual Meeting. According to a
BICR of the registration cohort, the overall response rate (ORR)
was 20.0% (95% confidence interval (CI):10.0-33.7%) as determined
by Response Assessment in Neuro-Oncology Criteria for High Grade
Gliomas (RANO-HGG). The median duration of response was 11.2 months
(95% CI: 3.8 – not reached) in addition to the median time to
response of 8.3 months. The proportion of patients achieving either
a RANO-HGG and/or RANO-LGG response was 30% (95% CI: 17.9 – 44.6%).
One serious adverse event considered possibly ONC201-related by
investigator was reported; however, the event was considered
unlikely ONC201-related by sponsor assessment.
The FDA granted ONC201 Fast Track Designation for the treatment
of adult recurrent H3 K27M-mutant HGG, Rare Pediatric Disease
Designation for treatment of H3 K27M-mutant glioma, and Orphan Drug
Designations for the treatment of glioblastoma and malignant
glioma.
CMX521
In March, Chimerix presented a Late Breaking Oral presentation
of CMX521 at the International Conference of Antiviral Research
(ICAR). Promising preclinical efficacy data from the CMX521 program
as a potential prophylactic and treatment of SARS-CoV-2 (COVID-19)
infection was generated through a collaboration between Chimerix
and the Rapidly Emerging Antiviral Drug Development Initiative
(READDI) at the University of North Carolina at Chapel Hill (UNC).
READDI is a global public-private partnership founded at UNC by the
UNC Eshelman School of Pharmacy, UNC School of Medicine, Gilling
School of Global Public Health, Eshelman Institute for Innovation
and the Structural Genomics Consortium. Development remains ongoing
with this collaboration.
First Quarter 2022 Financial Results
Chimerix reported a net loss of $24.8 million, or $0.28 per
basic and diluted share, for the first quarter of 2022. During the
same period in 2021, Chimerix recorded a net loss of $97.4 million,
or $1.21 per basic and diluted share.
Revenues for the first quarter of 2022 decreased to $15,000,
compared to $1.4 million for the same period in 2021. This
difference was driven by a lack of BARDA reimbursement revenue in
2022 versus 2021 for TEMBEXA development.
Research and development expenses increased to $19.0 million for
the first quarter of 2022, compared to $11.9 million for the same
period in 2021 driven primarily by higher investments in ONC201 and
ONC206 compared to the same period last year.
General and administrative expenses increased to $5.6 million
for the first quarter of 2022, compared to $4.1 million for the
same period in 2021.
Chimerix recorded acquired in-process research and
development expenses of $82.9 million for the first
quarter of 2021 related to the acquisition of Oncoceutics,
Inc.
Loss from operations was $24.8 million for the first quarter of
2022, compared to a loss from operations of $97.5 million for the
same period in 2021 driven by the first quarter 2021 in-process
research and development charge of $82.9 million related to the
acquisition of Oncoceutics, Inc.
Chimerix's balance sheet at March 31, 2022 included $53.4
million of capital available to fund operations, approximately 87.4
million outstanding shares of common stock and no outstanding debt
as the $14 million note related to the purchase price of
Oncoceutics from January 2021 was repaid in the first quarter of
2022.
Chimerix expects to execute the transaction with Emergent as
early as the second quarter of 2022 with payment of $225 million
payable at closing.
Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to
discuss first quarter 2022 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 3535104.
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 biopharmaceutical company with a mission to
develop medicines that meaningfully improve and extend the lives of
patients facing deadly diseases. The Company’s most advanced
clinical-stage development program, ONC201, is in development for
H3 K27M-mutant glioma.
Forward-Looking StatementsThis 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 execution of a
procurement contract for TEMBEXA and the amount and timing of
TEMBEXA shipment into the SNS; the sale of our TEMBEXA program and
related assets to Emergent, which is subject to certain closing
conditions which may not be completed on a timely basis, if at all;
risks associated with the receipt of future milestone payments and
royalty payments under the Emergent transaction, if completed; the
timing and nature of regulatory submissions for ONC201; and results
from the BICR of the 50- patient cohort of ONC201 for the treatment
of recurrent H3 K27M-mutant glioma. Among the factors and risks
that could cause actual results to differ materially from those
indicated in the forward-looking statements are risks that Chimerix
will not obtain a procurement contract for TEMBEXA in smallpox in a
timely manner, on favorable terms, or at all; risks that the
initial delivery or any subsequent deliveries of TEMBEXA will not
occur as planned, or at all; risks that the current pre-clinical or
clinical study data for ONC201 or CMX521 will not support
accelerated, or any, regulatory approval; the anticipated benefits
of the acquisition of Oncoceutics or the sale of our TEMBEXA
program to Emergent may not be realized; risks that Chimerix’s
current BCV manufacturing efforts may not satisfy the requirements
of any procurement award; risks that 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.comWill O’ConnorStern Investor
Relations212-362-1200will@sternir.com
CHIMERIX,
INC. |
|
CONSOLIDATED
BALANCE SHEETS |
|
(in
thousands, except share and per share data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March,
31 |
|
December
31, |
|
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
31,957 |
|
|
$ |
15,397 |
|
|
|
Short-term investments, available-for-sale |
|
|
21,421 |
|
|
|
72,970 |
|
|
|
Inventories |
|
|
3,406 |
|
|
|
2,760 |
|
|
|
Prepaid expenses and other current assets |
|
|
5,766 |
|
|
|
4,678 |
|
|
|
|
Total current assets |
|
|
62,550 |
|
|
|
95,805 |
|
|
Long-term investments |
|
|
- |
|
|
|
2,022 |
|
|
Property and equipment, net of accumulated depreciation |
|
|
229 |
|
|
|
253 |
|
|
Operating lease right-of-use assets |
|
|
2,298 |
|
|
|
2,404 |
|
|
Other long-term assets |
|
|
439 |
|
|
|
56 |
|
|
|
|
|
Total
assets |
|
$ |
65,516 |
|
|
$ |
100,540 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,494 |
|
|
$ |
2,788 |
|
|
|
Accrued liabilities |
|
|
11,718 |
|
|
|
13,108 |
|
|
|
Note payable |
|
|
- |
|
|
|
14,000 |
|
|
|
|
Total current liabilities |
|
|
15,212 |
|
|
|
29,896 |
|
|
Loan Fees |
|
|
250 |
|
|
|
- |
|
|
Lease-related obligations |
|
|
2,256 |
|
|
|
2,392 |
|
|
|
|
|
Total
liabilities |
|
|
17,718 |
|
|
|
32,288 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 shares authorized at
March 31, 2022 and |
|
|
|
|
|
|
|
December 31, 2021; no shares issued and outstanding as of March 31,
2022 and |
|
|
|
|
|
|
|
December 31, 2021; no shares issued and outstanding as of March 31,
2022 and |
|
|
- |
|
|
|
- |
|
|
|
Common stock, $0.001 par value, 200,000,000 shares authorized at
March 31, 2022 and |
|
|
|
|
|
|
|
December 31, 2021; 87,436,180 and 86,884,266 shares issued and
outstanding as of |
|
|
|
|
|
|
|
March 31, 2022 and December 31, 2021, respectively |
|
|
87 |
|
|
|
87 |
|
|
|
Additional paid-in capital |
|
|
958,147 |
|
|
|
953,782 |
|
|
|
Accumulated other comprehensive loss, net |
|
|
(73 |
) |
|
|
(21 |
) |
|
|
Accumulated deficit |
|
|
(910,363 |
) |
|
|
(885,596 |
) |
|
|
|
Total stockholders’ equity |
|
|
47,798 |
|
|
|
68,252 |
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
65,516 |
|
|
$ |
100,540 |
|
|
|
|
|
|
|
|
|
|
|
CHIMERIX,
INC. |
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
|
(in
thousands, except share and per share data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
Revenues: |
|
|
|
|
|
|
Contract and grant revenue |
|
$ |
- |
|
|
$ |
1,433 |
|
|
|
Licensing revenue |
|
|
15 |
|
|
|
2 |
|
|
|
|
Total revenues |
|
|
15 |
|
|
|
1,435 |
|
|
|
Cost of goods sold |
|
|
114 |
|
|
|
- |
|
|
|
|
Gross Profit |
|
|
(99 |
) |
|
|
1,435 |
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
19,040 |
|
|
|
11,862 |
|
|
|
General and administrative |
|
|
5,632 |
|
|
|
4,136 |
|
|
|
Acquired in-process research and development |
|
|
- |
|
|
|
82,890 |
|
|
|
|
Total operating expenses |
|
|
24,672 |
|
|
|
98,888 |
|
|
|
|
|
Loss from operations |
|
|
(24,771 |
) |
|
|
(97,453 |
) |
|
Other income: |
|
|
|
|
|
|
Interest income and other, net |
|
|
4 |
|
|
|
38 |
|
|
|
|
|
|
Net
loss |
|
|
(24,767 |
) |
|
|
(97,415 |
) |
|
Other comprehensive loss: |
|
|
|
|
|
|
Unrealized loss on debt investments, net |
|
|
(52 |
) |
|
|
(43 |
) |
|
|
|
|
|
Comprehensive loss |
|
$ |
(24,819 |
) |
|
$ |
(97,458 |
) |
|
Per share information: |
|
|
|
|
|
|
Net loss, basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(1.21 |
) |
|
|
Weighted-average shares outstanding, basic and diluted |
|
87,088,804 |
|
|
|
80,204,094 |
|
|
|
|
|
|
|
|
|
|
|
|
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