ORIC® Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Updates
May 05 2025 - 4:05PM
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 March 31,
2025.
“In the first quarter, we made significant
progress across our pipeline, announced focused registrational
development plans for our two lead programs, extended our cash
runway, and accelerated key corporate milestones,” stated Jacob M.
Chacko, M.D., president and chief executive officer. “Looking
ahead, we expect to share multiple clinical data updates across
both programs over the next fifteen months. We remain on track to
initiate the first Phase 3 trial of ORIC-944 in mCRPC in the first
half of 2026, with registrational development of ORIC-114 in
first-line NSCLC expected to begin later that year.”
First Quarter 2025 and Other Recent
Highlights
ORIC-944: a potent and
selective allosteric inhibitor of PRC2
- Reported encouraging early safety
and efficacy data in ongoing dose escalation trial for ORIC-944 in
combination with apalutamide in patients with metastatic castration
resistant prostate cancer (mCRPC).
- Presented preclinical ORIC-944 data
demonstrating synergistic activity and improved progression-free
survival (PFS) when combined with androgen receptor pathway
inhibitors (ARPIs) in models of prostate cancer at the 2025 AACR
Annual Meeting.
- Announced updated program milestones
and development plans to initiate first Phase 3 registrational
trial for ORIC-944 in mCRPC in 1H 2026.
ORIC-114: a brain
penetrant, orally bioavailable, irreversible EGFR/HER2
inhibitor
- Announced a clinical trial
collaboration and supply agreement with Johnson & Johnson and
initiated a trial to evaluate ORIC-114 in combination with
subcutaneous (SC) amivantamab for the 1L treatment of patients with
non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion
mutations.
- Announced updated program
milestones and registrational development plans to focus ORIC-114
in 1L NSCLC and plans to initiate first Phase 3 trial in 2026.
Corporate Highlights:
- Extended projected cash runway into
2027 (from previous guidance of late 2026), and
accelerated/augmented corporate milestones, based upon favorable
enrollment and focused registrational clinical development plans
for two lead programs.
Anticipated Program
Milestones:
ORIC anticipates the following upcoming
milestones:
- ORIC-944 (mCRPC):
- 1H 2025: Combination dose
escalation data with AR inhibitors(s)
- 2H 2025: Updated combination dose
escalation data with AR inhibitors(s)
- 4Q 2025 / 1Q 2026: Combination dose
optimization data with AR inhibitor(s)
- ORIC-114 (NSCLC):
- 2H 2025: 1L EGFR exon 20, 2L EGFR
exon 20, 2L+ HER2 exon 20 and 2L+ EGFR atypical data
- Mid-2026: 1L EGFR exon 20
combination with SC amivantamab and 1L EGFR atypical data
First Quarter 2025 Financial
Results
- Cash, Cash Equivalents and
Investments: Cash, cash equivalents and investments
totaled $223.8 million as of March 31, 2025, which is expected
to fund the current operating plan into 2027.
- R&D
Expenses: Research and development (R&D) expenses
were $24.6 million for the three months ended March 31, 2025,
compared to $22.0 million for the three months ended March 31,
2024, an increase of $2.7 million. The increase was due to a net
increase in external expenses related to the advancement of product
candidates, as well as higher personnel costs, including additional
non-cash stock-based compensation.
- G&A
Expenses: General and administrative (G&A)
expenses were $8.1 million for the three months ended March
31, 2025, compared to $7.0 million for the three months ended
March 31, 2024, an increase of $1.0 million. The increase was
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-944, an
allosteric inhibitor of the polycomb repressive complex 2 (PRC2)
via the EED subunit, being developed for prostate cancer, and (2)
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. Beyond these two
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-944 and
ORIC-114; the potential of ORIC-944 and ORIC-114; clinical
outcomes, which may materially change as patient enrollment
continues or more patient data become available; advantages of
ORIC-944 in preclinical models, including synergies with ARPIs and
improved PFS; the development plans and timelines for ORIC-944,
ORIC-114 and ORIC’s other programs; plans underlying ORIC’s
clinical trials and development; anticipated program milestones,
including timing of program and data updates and the initiation of
registrational trials; 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 May 5, 2025, 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) |
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
|
(unaudited) |
|
|
|
|
Assets |
|
Current assets: |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
203,723 |
|
|
$ |
255,960 |
|
Prepaid expenses and other current assets |
|
7,710 |
|
|
|
6,290 |
|
Total current assets |
|
211,433 |
|
|
|
262,250 |
|
|
|
|
|
|
|
Long-term investments |
|
20,039 |
|
|
|
— |
|
Property and equipment, net |
|
3,021 |
|
|
|
2,924 |
|
Other assets |
|
8,365 |
|
|
|
8,968 |
|
Total assets |
$ |
242,858 |
|
|
$ |
274,142 |
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
5,160 |
|
|
$ |
1,548 |
|
Accrued liabilities |
|
12,457 |
|
|
|
23,298 |
|
Total current liabilities |
|
17,617 |
|
|
|
24,846 |
|
|
|
|
|
|
|
Other long-term liabilities |
|
5,503 |
|
|
|
6,174 |
|
Total liabilities |
|
23,120 |
|
|
|
31,020 |
|
|
|
|
|
|
|
Total stockholders'
equity |
|
219,738 |
|
|
|
243,122 |
|
Total liabilities and stockholders' equity |
$ |
242,858 |
|
|
$ |
274,142 |
|
|
|
|
|
|
|
|
|
ORIC PHARMACEUTICALS, INC.STATEMENTS OF
OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited)(in thousands, except
share and per share amounts) |
|
|
Three Months
EndedMarch 31, |
|
|
2025 |
|
|
2024 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
24,640 |
|
|
$ |
21,960 |
|
General and administrative |
|
8,078 |
|
|
|
7,030 |
|
Total operating expenses |
|
32,718 |
|
|
|
28,990 |
|
Loss from operations |
|
(32,718 |
) |
|
|
(28,990 |
) |
|
|
|
|
|
|
Other income, net |
|
2,697 |
|
|
|
3,979 |
|
Net loss |
$ |
(30,021 |
) |
|
$ |
(25,011 |
) |
Other comprehensive loss: |
|
|
|
|
|
Unrealized loss on investments |
|
(170 |
) |
|
|
(420 |
) |
Comprehensive loss |
$ |
(30,191 |
) |
|
$ |
(25,431 |
) |
Net loss per share, basic and
diluted |
$ |
(0.42 |
) |
|
$ |
(0.37 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
71,040,580 |
|
|
|
67,349,551 |
|
|
|
|
|
|
|
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