ORIC® Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Updates
12 Novembre 2024 - 10:05PM
ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage
oncology company focused on developing treatments that address
mechanisms of therapeutic resistance, today reported financial
results and operational updates for the quarter ended September 30,
2024.
“We are encouraged by the growing evidence
supporting the potential best-in-class profiles of ORIC-114 and
ORIC-944, and we continue to steadily advance both programs towards
the initiation of registrational studies next year,” said Jacob M.
Chacko, M.D., president and chief executive officer. “Preclinical
data presented at the ENA conference highlighted ORIC-114's
potential for superior potency and selectivity in targeting EGFR
exon 20 insertions and other atypical mutations, building on
previously reported clinical data in NSCLC patients. For ORIC-944,
the clinical trial collaboration and supply agreements we secured
with Bayer and Johnson and Johnson have helped us further advance
our combination studies in prostate cancer. We remain laser-focused
on execution across our clinical and preclinical pipeline and look
forward to reporting updated data in 2025.”
Third Quarter 2024 and Other Recent
Highlights:
ORIC-114: a brain
penetrant, orally bioavailable, irreversible EGFR/HER2
inhibitor
- Presented preclinical data
demonstrating potential best-in-class properties, including potency
and selectivity, of ORIC-114 to treat NSCLC harboring EGFR exon 20
insertions and other atypical mutations at the EORTC-NCI-AACR
Symposium on Molecular Targets and Cancer Therapeutics.
- Expect to report updated Phase 1b
data in the first half of 2025.
ORIC-944: a potent and
selective allosteric inhibitor of PRC2
- Initiated dosing of ORIC-944 in
combination with NUBEQA® (darolutamide) and in combination with
ERLEADA® (apalutamide) in the ongoing Phase 1b trial for prostate
cancer in first half of 2024.
- Entered into clinical trial
collaboration and supply agreements with Bayer and Johnson &
Johnson to support the ongoing Phase 1b trial of ORIC-944 in
combinations with AR inhibitors for the treatment of prostate
cancer.
Corporate Highlights:
- Expanded the leadership team with
the appointment of industry veteran Keith Lui as Senior Vice
President of Commercial and Medical Affairs.
Third Quarter 2024 Financial
Results
- Cash, Cash Equivalents and
Investments: Cash, cash equivalents and investments
totaled $282.4 million as of September 30, 2024, which the
company expects will be sufficient to fund its operating plan into
late 2026.
- R&D
Expenses: Research and development (R&D) expenses
were $31.2 million for the three months ended September 30, 2024,
compared to $22.4 million for the three months ended September 30,
2023, an increase of $8.8 million. For the nine months ended
September 30, 2024, R&D expenses were $82.1 million, compared
to $60.7 million for the nine months ended September 30, 2023, an
increase of $21.4 million. The increases were due to a net increase
in external expenses related to the advancement of product
candidates and discovery programs, as well as higher personnel
costs, including additional non-cash-stock-based compensation.
- G&A
Expenses: General and administrative (G&A)
expenses were $7.1 million for the three months ended
September 30, 2024, compared to $6.3 million for the three
months ended September 30, 2023, an increase of $0.8 million. For
the nine months ended September 30, 2024, G&A expenses were
$21.2 million, compared to $18.7 million for the nine months ended
September 30, 2023, an increase of $2.6 million. The increases were
primarily due to higher personnel costs, including additional
non-cash stock-based compensation.
About ORIC Pharmaceuticals,
Inc. ORIC Pharmaceuticals is a clinical stage
biopharmaceutical company dedicated to improving patients’ lives
by Overcoming Resistance In Cancer. ORIC’s
clinical stage product candidates include (1) ORIC-114, a brain
penetrant inhibitor that selectively targets EGFR exon 20, HER2
exon 20 and EGFR atypical mutations, being developed across
multiple genetically defined cancers, (2) ORIC-944, an allosteric
inhibitor of the polycomb repressive complex 2 (PRC2) via the EED
subunit, being developed for prostate cancer, and (3) ORIC-533, an
orally bioavailable small molecule inhibitor of CD73, a key node in
the adenosine pathway believed to play a central role in resistance
to chemotherapy- and immunotherapy-based treatment regimens, being
developed for multiple myeloma. Beyond these three product
candidates, ORIC® is also developing multiple precision medicines
targeting other hallmark cancer resistance mechanisms. ORIC has
offices in South San Francisco and San Diego, California. For more
information, please go to www.oricpharma.com, and follow us
on X or LinkedIn.
Cautionary Note Regarding
Forward-Looking StatementsThis press release contains
forward-looking statements as that term is defined in Section 27A
of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Statements in this press release that are not
purely historical are forward-looking statements. Such
forward-looking statements include, among other things, statements
regarding the continued clinical development of ORIC-114 and
ORIC-944; statements regarding the potential best-in-class
properties of ORIC-114; ORIC-114 clinical outcomes, which may
materially change as patient enrollment continues or more patient
data become available; the development plans and timelines for
ORIC-114, ORIC-944 and ORIC’s other product candidates; the
potential advantages of ORIC-114, ORIC-944 and ORIC’s other product
candidates and programs; plans underlying ORIC’s clinical trials
and development; anticipated program milestones, including timing
of program and data updates and the initiation of registrational
studies; the period over which ORIC estimates its existing cash,
cash equivalents and investments will be sufficient to fund its
current operating plan; and statements by the company’s chief
executive officer. Words such as “believes,” “anticipates,”
“plans,” “expects,” “intends,” “will,” “goal,” “potential” and
similar expressions are intended to identify forward-looking
statements. The forward-looking statements contained herein are
based upon ORIC’s current expectations and involve assumptions that
may never materialize or may prove to be incorrect. Actual results
could differ materially from those projected in any forward-looking
statements due to numerous risks and uncertainties, including but
not limited to: risks associated with the process of discovering,
developing and commercializing drugs that are safe and effective
for use as human therapeutics and operating as an early clinical
stage company; ORIC’s ability to develop, initiate or complete
preclinical studies and clinical trials for, obtain approvals for
and commercialize any of its product candidates; changes in ORIC’s
plans to develop and commercialize its product candidates; the
potential for clinical trials of ORIC’s product candidates to
differ from preclinical, initial, interim, preliminary or expected
results; negative impacts of health emergencies, economic
instability or international conflicts on ORIC’s operations,
including clinical trials; the risk of the occurrence of any event,
change or other circumstance that could give rise to the
termination of ORIC’s license and collaboration agreements or its
clinical trial collaboration and supply agreements; the potential
market for ORIC’s product candidates, and the progress and success
of competing therapeutics currently available or in development;
ORIC’s ability to raise any additional funding it will need to
continue to pursue its business and product development plans;
regulatory developments in the United States and foreign countries;
ORIC’s reliance on third parties, including contract manufacturers
and contract research organizations; ORIC’s ability to obtain and
maintain intellectual property protection for its product
candidates; the loss of key scientific or management personnel;
competition in the industry in which ORIC operates; general
economic and market conditions; and other risks. Information
regarding the foregoing and additional risks may be found in the
section titled “Risk Factors” in ORIC’s Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission (the “SEC”)
on November 12, 2024, and ORIC’s future reports to be filed with
the SEC. These forward-looking statements are made as of the date
of this press release, and ORIC assumes no obligation to update the
forward-looking statements, or to update the reasons why actual
results could differ from those projected in the forward-looking
statements, except as required by law.
Contact:Dominic Piscitelli,
Chief Financial
Officerdominic.piscitelli@oricpharma.cominfo@oricpharma.com
ORIC PHARMACEUTICALS, INC.CONDENSED
BALANCE SHEETS(in thousands, except share and per share
amounts) |
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
|
(unaudited) |
|
|
|
|
Assets |
|
Current assets: |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
272,369 |
|
|
$ |
208,187 |
|
Prepaid expenses and other current assets |
|
7,059 |
|
|
|
4,410 |
|
Total current assets |
|
279,428 |
|
|
|
212,597 |
|
|
|
|
|
|
|
Long-term investments |
|
9,998 |
|
|
|
26,852 |
|
Property and equipment, net |
|
3,091 |
|
|
|
2,862 |
|
Other assets |
|
9,553 |
|
|
|
9,696 |
|
Total assets |
$ |
302,070 |
|
|
$ |
252,007 |
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
4,249 |
|
|
$ |
944 |
|
Accrued liabilities |
|
16,999 |
|
|
|
19,514 |
|
Total current liabilities |
|
21,248 |
|
|
|
20,458 |
|
|
|
|
|
|
|
Other long-term liabilities |
|
6,828 |
|
|
|
7,461 |
|
Total liabilities |
|
28,076 |
|
|
|
27,919 |
|
|
|
|
|
|
|
Total stockholders'
equity |
|
273,994 |
|
|
|
224,088 |
|
Total liabilities and stockholders' equity |
$ |
302,070 |
|
|
$ |
252,007 |
|
ORIC PHARMACEUTICALS, INC.STATEMENTS OF
OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited)(in thousands, except
share and per share amounts) |
|
|
Three Months
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
31,202 |
|
|
$ |
22,388 |
|
|
$ |
82,102 |
|
|
$ |
60,691 |
|
General and administrative |
|
7,116 |
|
|
|
6,294 |
|
|
|
21,223 |
|
|
|
18,661 |
|
Total operating expenses |
|
38,318 |
|
|
|
28,682 |
|
|
|
103,325 |
|
|
|
79,352 |
|
Loss from operations |
|
(38,318 |
) |
|
|
(28,682 |
) |
|
|
(103,325 |
) |
|
|
(79,352 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
3,752 |
|
|
|
3,204 |
|
|
|
11,785 |
|
|
|
6,985 |
|
Net loss |
$ |
(34,566 |
) |
|
$ |
(25,478 |
) |
|
$ |
(91,540 |
) |
|
$ |
(72,367 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on investments |
|
978 |
|
|
|
198 |
|
|
|
464 |
|
|
|
922 |
|
Comprehensive loss |
$ |
(33,588 |
) |
|
$ |
(25,280 |
) |
|
$ |
(91,076 |
) |
|
$ |
(71,445 |
) |
Net loss per share, basic and
diluted |
$ |
(0.49 |
) |
|
$ |
(0.44 |
) |
|
$ |
(1.32 |
) |
|
$ |
(1.46 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
70,542,684 |
|
|
|
57,402,226 |
|
|
|
69,417,672 |
|
|
|
49,424,418 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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