ORIC Pharmaceuticals Reports First Quarter 2024 Financial Results and Operational Updates
May 06 2024 - 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,
2024.
“In the first quarter of 2024, we continued
making steady progress across our clinical and preclinical
programs, while also strengthening our cash position and runway,”
said Jacob M. Chacko, M.D., president and chief executive officer.
“Most recently, we announced the selection of provisional
recommended phase 2 doses for ORIC-114 that confirm its wide
therapeutic index, and we initiated three expansion cohorts in
patients with EGFR/HER2 mutated non-small cell lung cancer,
including those with active, untreated CNS metastases. For
ORIC-944, we presented clinical and preclinical data that further
reinforce its promise as a potential best-in-class treatment option
for prostate cancer based upon its superior drug properties and
clinical half-life versus competitor PRC2 inhibitors. We are laser
focused on flawless execution as we continue to advance these two
programs towards the initiation of registrational studies, which we
anticipate in the second half of 2025.”
First Quarter 2024 and Other Recent
Highlights
ORIC-114: a brain
penetrant, orally bioavailable, irreversible EGFR/HER2
inhibitor
- Announced the completion of the
dose escalation portion of the Phase 1b trial of ORIC-114 and the
selection of the provisional recommended phase 2 doses.
- Announced first patients dosed
across three expansion cohorts in the Phase 1b trial of ORIC-114 in
patients with mutated non-small cell lung cancer (NSCLC), including
EGFR exon 20 insertion (EGFR exon 20 inhibitor naïve), HER2 exon 20
insertion, and EGFR atypical mutations.
- Initiated an extension cohort to
evaluate ORIC-114 for the treatment of patients with first-line,
treatment-naïve EGFR exon 20 insertion NSCLC.
- Expect to report updated Phase 1b
data in the first half of 2025.
ORIC-944: a potent and
selective allosteric inhibitor of PRC2
- Reported initial Phase 1b
monotherapy data for ORIC-944 in metastatic prostate cancer
supporting advancement into combination development and
demonstrating the potential as a best-in-class PRC2 inhibitor,
including a clinical half-life of ~20 hours, no signs of CYP
autoinduction that was observed with first-generation PRC2
inhibitors, robust target engagement, and a well-tolerated safety
profile.
- Presented preclinical data at the
2024 AACR Annual Meeting demonstrating superior preclinical drug
properties and synergy data in prostate cancer models, reinforcing
the promise of ORIC-944 as a potential best-in-class treatment for
combination with AR inhibitors.
- Proceeding with combination of
ORIC-944 with AR inhibitor(s) in metastatic prostate cancer and
expect to provide a program update in mid-2024.
ORIC-533: a highly
potent, orally bioavailable small molecule inhibitor of
CD73
- The company is completing a Phase
1b trial and plans to pursue strategic partnership for combination
studies.
Discovery Pipeline:
- Presented at the 2024 AACR annual
meeting the first preclinical data on ORIC-613, a potential first-
and best-in-class development candidate selectively inhibiting
PLK4.
Corporate Highlights:
- Strengthened cash position and
runway with a $125 million private placement financing from new and
existing healthcare specialist funds in January 2024.
First Quarter 2024 Financial
Results
- Cash, Cash Equivalents and
Investments: Cash, cash equivalents and investments
totaled $331.5 million as of March 31, 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 $22.0 million for the three months ended March 31, 2024,
compared to $19.5 million for the three months ended March 31,
2023, an increase of $2.4 million. The increase was 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 of
$0.7 million.
- G&A
Expenses: General and administrative (G&A)
expenses were $7.0 million for the three months ended March
31, 2024, compared to $6.2 million for the three months ended
March 31, 2023, an increase of $0.9 million. The increase was
primarily due to higher personnel costs, including additional
non-cash stock-based compensation of $0.7 million.
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 designed to selectively target EGFR and HER2
with high potency against exon 20 insertion 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; ORIC-114, ORIC-944 and ORIC-533 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; 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 6, 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) |
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
|
(unaudited) |
|
|
|
|
Assets |
|
Current assets: |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
316,778 |
|
|
$ |
208,187 |
|
Prepaid expenses and other current assets |
|
7,305 |
|
|
|
4,410 |
|
Total current assets |
|
324,083 |
|
|
|
212,597 |
|
|
|
|
|
|
|
Long-term investments |
|
14,694 |
|
|
|
26,852 |
|
Property and equipment, net |
|
2,801 |
|
|
|
2,862 |
|
Other assets |
|
9,208 |
|
|
|
9,696 |
|
Total assets |
$ |
350,786 |
|
|
$ |
252,007 |
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
2,988 |
|
|
$ |
944 |
|
Accrued liabilities |
|
12,222 |
|
|
|
19,514 |
|
Total current liabilities |
|
15,210 |
|
|
|
20,458 |
|
|
|
|
|
|
|
Other long-term liabilities |
|
6,931 |
|
|
|
7,461 |
|
Total liabilities |
|
22,141 |
|
|
|
27,919 |
|
|
|
|
|
|
|
Total stockholders'
equity |
|
328,645 |
|
|
|
224,088 |
|
Total liabilities and stockholders' equity |
$ |
350,786 |
|
|
$ |
252,007 |
|
|
|
|
|
|
|
|
|
ORIC PHARMACEUTICALS, INC.STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(Unaudited)(in thousands, except share and per
share amounts) |
|
|
Three Months
EndedMarch 31, |
|
|
2024 |
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
21,960 |
|
|
$ |
19,516 |
|
General and administrative |
|
7,030 |
|
|
|
6,162 |
|
Total operating expenses |
|
28,990 |
|
|
|
25,678 |
|
Loss from operations |
|
(28,990 |
) |
|
|
(25,678 |
) |
|
|
|
|
|
|
Other income, net |
|
3,979 |
|
|
|
1,733 |
|
Net loss |
$ |
(25,011 |
) |
|
$ |
(23,945 |
) |
Other comprehensive (loss)
income: |
|
|
|
|
|
Unrealized (loss) gain on investments |
|
(420 |
) |
|
|
792 |
|
Comprehensive loss |
$ |
(25,431 |
) |
|
$ |
(23,153 |
) |
Net loss per share, basic and
diluted |
$ |
(0.37 |
) |
|
$ |
(0.53 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
67,349,551 |
|
|
|
45,090,166 |
|
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