Chimerix Reports Second Quarter 2023 Financial Results and Provides Operational Update
03 August 2023 - 9:00PM
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 second quarter ended June 30, 2023 and provided an
operational update.
"I am thrilled to begin leading the organization during such a
pivotal time in Chimerix’s history and in the field of
neuro-oncology, where several genetically defined programs have
advanced the field recently. During the second quarter, our team
has been laser focused on site activation and enrollment of the
Phase 3 ACTION study which now includes 77 sites enrolling patients
across 11 countries and an enrollment rate that remains on track
for the first interim overall survival analysis in early 2025. We
are incredibly grateful to the neuro-oncology community which is
eagerly supporting the ACTION study in order to advance the
treatment for patients with this cancer. H3 K27M-mutant glioma is
estimated to occur in 5,000 people annually in the major global
markets,” said Mike Andriole, Chief Executive Officer of
Chimerix.
“Furthermore, dose escalation for our second-generation
compound, ONC206, continues and completion is expected in the first
half of 2024. There have been no dose limiting toxicities
identified during dose escalation thus far and we are now exploring
a more intense dose and schedule with the goal of identifying
additional signals of activity,” added Mr.
Andriole.
ONC201 for Treatment of H3 K27M-Mutant Diffuse
Glioma
The Phase 3 ACTION trial is currently enrolling patients at 77
sites in 11 countries and remains on track to report interim data
in early 2025.
The ACTION trial is enrolling patients shortly after they have
completed standard of care front-line radiation therapy. The study
is designed to enroll 450 patients randomized 1:1:1 to receive
ONC201 at one of two dosing frequencies or placebo. Participants
will be randomized to receive 625mg of ONC201 once per week (the
Phase 2 dosing regimen), 625mg twice per week on two consecutive
days or placebo. The dose will be scaled by body weight for
patients <52.5kg. Overall survival (OS) will be assessed for
efficacy at three alpha-allocated timepoints: two interim
assessments by the Independent Data Monitoring Committee (IDMC) at
164 events and 246 events, respectively, and a final assessment at
327 events. The final progression-free survival (PFS) analysis will
be performed after 286 events, with progression assessed using RANO
HGG criteria by blinded independent central review (BICR).
Secondary endpoints include corticosteroid response, performance
status response, change from baseline in quality of life (QoL)
assessments and change from baseline in neurologic function as
assessed by the Neurologic Assessment in Neuro-Oncology (NANO)
scale.
ONC206
ONC206 is a second generation DRD2 antagonist and ClpP agonist
that has demonstrated monotherapy anti-cancer activity in
pre-clinical models. Phase I dose escalation trials continue at the
National Institutes of Health (NIH) and the Pacific Pediatric
Neuro-Oncology Consortium (PNOC). In March 2023, the Company
reported an investigator-assessed response in a patient with
recurrent glioblastoma without the H3K27M-mutation. The patient has
continued to respond and remains on treatment, receiving increasing
doses as part of the dose escalation. To date, ONC206 is generally
well tolerated with a similar safety profile in adults and
pediatrics. No dose limiting toxicities have been identified to
date. The dose escalation trials are transitioning to intensify
dosing from a once weekly dosing to a more frequent dose schedule
to increase the duration of therapeutic exposure.
Second Quarter 2023 Financial Results
Chimerix reported a net loss of $18.6 million, or $0.21 per
basic and diluted share, for the second quarter of 2023. During the
same period in 2022, Chimerix recorded a net loss of $23.5 million,
or $0.27 per basic and diluted share.
Research and development expenses decreased to $16.9 million for
the second quarter of 2023, compared to $18.0 million for the same
period in 2022.
General and administrative expenses decreased to $4.4 million
for the second quarter of 2023, compared to $5.8 million for the
same period in 2022.
Chimerix’s balance sheet at June 30, 2023 included $233.0
million of capital available to fund operations, approximately 88.6
million outstanding shares of common stock and no outstanding
debt.
Conference Call and Webcast Chimerix will host
a conference call and live audio webcast to discuss second quarter
2023 financial results and provide a business update today at 8:30
a.m. ET. To access the live conference call, please dial
646-307-1963 (domestic) or 800-715-9871 (international) at least
five minutes prior to the start time and refer to conference ID
8015897. 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 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 probability of
success of the Phase 3 ACTION study, the potential filing and
approval of an NDA for ONC201 and subsequent commercial
opportunity, the implications of the monotherapy radiographic
partial response observed during ONC206 dose escalation, the
ability to reproduce clinical and pre-clinical findings, and
projections regarding funding and timing of future data readouts.
Among the factors and risks that could cause actual results to
differ materially from those indicated in the forward-looking
statements are risks related to the timing, completion and outcome
of the Phase 3 ACTION study of ONC201; risks associated with
repeating positive results obtained in prior preclinical or
clinical studies in future studies; risks related to the clinical
development of ONC206; 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.
CONTACTS:
Michelle LaSpaluto919 972-7115ir@chimerix.com
Will O’ConnorStern Investor
Relations212-362-1200will@sternir.com
CHIMERIX,
INC. |
|
CONSOLIDATED
BALANCE SHEETS |
|
(in
thousands, except share and per share data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
|
|
2023 |
|
2022 |
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
20,099 |
|
|
$ |
25,842 |
|
|
|
Short-term investments, available-for-sale |
|
|
185,657 |
|
|
|
191,492 |
|
|
|
Accounts receivable |
|
|
26 |
|
|
|
1,040 |
|
|
|
Prepaid expenses and other current assets |
|
|
5,735 |
|
|
|
9,764 |
|
|
|
|
Total current assets |
|
|
211,517 |
|
|
|
228,138 |
|
|
Long-term investments |
|
|
27,258 |
|
|
|
48,626 |
|
|
Property and equipment, net of accumulated depreciation |
|
|
256 |
|
|
|
227 |
|
|
Operating lease right-of-use assets |
|
|
1,728 |
|
|
|
1,964 |
|
|
Other long-term assets |
|
|
326 |
|
|
|
386 |
|
|
|
|
|
Total assets |
|
$ |
241,085 |
|
|
$ |
279,341 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,823 |
|
|
$ |
3,034 |
|
|
|
Accrued liabilities |
|
|
13,518 |
|
|
|
17,381 |
|
|
|
|
Total current liabilities |
|
|
15,341 |
|
|
|
20,415 |
|
|
Line of credit commitment fee |
|
|
125 |
|
|
|
250 |
|
|
Lease-related obligations |
|
|
1,507 |
|
|
|
1,819 |
|
|
|
|
|
Total liabilities |
|
|
16,973 |
|
|
|
22,484 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 shares authorized at
June 30, 2023 and |
|
|
|
|
|
|
|
December 31, 2022; no shares issued and outstanding as of June 30,
2023 and |
|
|
|
|
|
|
|
December 31, 2022 |
|
|
- |
|
|
|
- |
|
|
|
Common stock, $0.001 par value, 200,000,000 shares authorized at
June 30, 2023 and |
|
|
|
|
|
|
|
December 31, 2022; 88,583,567 and 88,054,127 shares issued and
outstanding as of |
|
|
|
|
|
|
|
June 30, 2023 and December 31, 2022, respectively |
|
|
89 |
|
|
|
88 |
|
|
|
Additional paid-in capital |
|
|
978,213 |
|
|
|
970,535 |
|
|
|
Accumulated other comprehensive loss, net |
|
|
(813 |
) |
|
|
(337 |
) |
|
|
Accumulated deficit |
|
|
(753,377 |
) |
|
|
(713,429 |
) |
|
|
|
Total stockholders’ equity |
|
|
224,112 |
|
|
|
256,857 |
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
241,085 |
|
|
$ |
279,341 |
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
|
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues: |
|
|
|
|
|
|
|
|
|
Contract and grant revenue |
|
$ |
26 |
|
|
$ |
- |
|
|
$ |
260 |
|
|
$ |
- |
|
|
Licensing revenue |
|
|
- |
|
|
|
440 |
|
|
|
49 |
|
|
|
455 |
|
|
|
Total revenues |
|
|
26 |
|
|
|
440 |
|
|
|
309 |
|
|
|
455 |
|
|
Cost of goods sold |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
114 |
|
|
|
Gross Profit |
|
|
26 |
|
|
|
440 |
|
|
|
309 |
|
|
|
341 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
16,926 |
|
|
|
18,047 |
|
|
|
35,748 |
|
|
|
37,087 |
|
|
General and administrative |
|
|
4,448 |
|
|
|
5,840 |
|
|
|
10,127 |
|
|
|
11,472 |
|
|
|
Total operating expenses |
|
|
21,374 |
|
|
|
23,887 |
|
|
|
45,875 |
|
|
|
48,559 |
|
|
|
|
Loss from operations |
|
|
(21,348 |
) |
|
|
(23,447 |
) |
|
|
(45,566 |
) |
|
|
(48,218 |
) |
Other income (loss): |
|
|
|
|
|
|
|
|
|
Interest income and other, net |
|
|
2,772 |
|
|
|
(21 |
) |
|
|
5,618 |
|
|
|
(17 |
) |
|
|
|
|
Net loss |
|
|
(18,576 |
) |
|
|
(23,468 |
) |
|
|
(39,948 |
) |
|
|
(48,235 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on debt investments, net |
|
|
(582 |
) |
|
|
5 |
|
|
|
(476 |
) |
|
|
(47 |
) |
|
|
|
|
Comprehensive loss |
|
$ |
(19,158 |
) |
|
$ |
(23,463 |
) |
|
$ |
(40,424 |
) |
|
$ |
(48,282 |
) |
Per share information: |
|
|
|
|
|
|
|
|
|
Net loss, basic and diluted |
|
$ |
(0.21 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.45 |
) |
|
$ |
(0.55 |
) |
|
Weighted-average shares outstanding, basic and diluted |
|
88,583,567 |
|
|
|
87,436,180 |
|
|
|
88,439,894 |
|
|
|
87,263,452 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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