Olema Pharmaceuticals, Inc. (“Olema”, “Olema Oncology”,
Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused
on the discovery, development and commercialization of targeted
therapies for women’s cancers, today reported financial results for
the first quarter ended March 31, 2024, and provided a corporate
update.
“Our mission at Olema is uniquely focused on advancing the
standard of care for women living with cancer,” said Sean P. Bohen,
M.D., Ph.D., President and Chief Executive Officer of Olema
Oncology. “We are excited for the achievements we are making both
with palazestrant, our oral complete ER antagonist program, and now
with our KAT6 inhibitor program, OP-3136. We believe palazestrant
has the potential to become the backbone endocrine
therapy-of-choice for advanced or metastatic breast cancer, and we
look forward to presenting new clinical data in combination with
ribociclib at the 2024 ESMO Breast Cancer Annual Congress later
this month.”
First Quarter 2024
Highlights
- Completed enrollment of 60-patient Phase 1b/2 studies of
palazestrant (OP-1250) in combination with each of ribociclib and
palbociclib.
- Nominated OP-3136, an orally bioavailable KAT6 inhibitor, as a
development candidate. OP-3136 demonstrated potent anti-tumor
activity alone and in combination with both palazestrant and CDK4/6
inhibitors in preclinical ER+ breast cancer models.
- Announced publication of data in Molecular Cancer Therapeutics
describing the design, discovery and optimization of
palazestrant.
Upcoming Milestones
- Present interim Phase 1b/2 clinical results of palazestrant in
combination with ribociclib at ESMO Breast Cancer Annual Congress
2024, May 15-17, 2024, in Berlin, Germany.
- Present trial-in-progress poster on OPERA-01, a pivotal Phase 3
monotherapy clinical trial in the second- and third-line setting of
ER+/HER2- advanced or metastatic breast cancer, at the 2024 ASCO
Annual Meeting, May 31-June 4, 2024, in Chicago, IL.
- Initiate Phase 1b/2 clinical study of palazestrant in
combination with mTOR inhibitor, everolimus, in Q3 2024.
- File an Investigational New Drug (IND), application with the
U.S. Food and Drug Administration (FDA) for OP-3136 in late 2024
and advance clinical development.
First Quarter 2024 Financial Results
Cash, cash equivalents and marketable securities as of March 31,
2024, were $249.0 million.
Net loss for the quarter ended March 31, 2024, was $31.0
million, as compared to $28.3 million for the quarter March 31,
2023. The increase in net loss for the first quarter was primarily
related to increased spending on research and clinical
development-related activities as a result of late-stage clinical
trials for palazestrant and the advancement of our KAT6 inhibitor
program. This increase was offset by decreased spending on general
and administrative activities and higher interest income earned
from marketable securities.
GAAP research and development (R&D) expenses were $29.9
million for the quarter ended March 31, 2024, as compared to $22.8
million for the quarter ended March 31, 2023. The increase in
R&D expenses was primarily related to a $5.0 million milestone
payment incurred in connection with the exclusive global license
agreement entered into in June 2022 between Olema and Aurigene
(Aurigene Agreement) associated with the advancement of our KAT6
inhibitor program, and increased spending on clinical
development-related activities, as we continue to advance
palazestrant into late-stage clinical trials. The increase was
offset by decreased spending on clinical pharmacology studies and
nonclinical research programs and a one-time restructuring charge
recorded in the first quarter of 2023.
Non-GAAP R&D expenses were $26.5 million for the quarter
ended March 31, 2024, which included a $5.0 million milestone
payment in connection to the Aurigene Agreement and excluded $3.4
million non-cash stock-based compensation expense. Non-GAAP R&D
expenses were $19.7 million for the quarter ended March 31, 2023,
excluding $3.1 million non-cash stock-based compensation expense. A
reconciliation of GAAP to non-GAAP financial measures used in this
press release can be found at the end of this press release.
GAAP G&A expenses were $4.5 million for the quarter ended
March 31, 2024, as compared to $6.8 million for the quarter ended
March 31, 2023. The decrease in G&A expenses was primarily due
to decreased spending on corporate- and legal-related costs, and
personnel-related expenses, including a one-time restructuring
charge recorded in the first quarter of 2023.
Non-GAAP G&A expenses were $3.0 million for the quarter
ended March 31, 2024, excluding $1.5 million non-cash stock-based
compensation expense. Non-GAAP G&A expenses were $5.2 million
for the quarter ended March 31, 2023, excluding $1.5 million
non-cash stock-based compensation expense. A reconciliation of GAAP
to non-GAAP financial measures used in this press release can be
found at the end of this press release.
ESMO Breast Cancer Investor Conference Call
Olema will host a webcast and conference call for analysts and
investors to review the data being presented at ESMO Breast Cancer
Annual Congress 2024 on Wednesday, May 15, 2024, at 8:00 a.m. ET
(2:00 p.m. CEST). Please register for the webcast by visiting the
Investors & Media section of Olema’s website at olema.com.
About Palazestrant (OP-1250)
Palazestrant (OP-1250) is a novel, orally-available small
molecule with dual activity as both a complete estrogen receptor
(ER) antagonist (CERAN) and selective ER degrader (SERD). It is
currently being investigated in patients with recurrent, locally
advanced or metastatic ER-positive (ER+), human epidermal growth
factor receptor 2-negative (HER2-) breast cancer. In clinical
studies, palazestrant completely blocks ER-driven transcriptional
activity in both wild-type and mutant forms of metastatic ER+
breast cancer and has demonstrated anti-tumor efficacy along with
attractive pharmacokinetics and exposure, favorable tolerability,
CNS penetration, and combinability with CDK4/6 inhibitors.
Palazestrant has been granted U.S. Food and Drug Administration
(FDA) Fast Track designation for the treatment of ER+/HER2-
metastatic breast cancer that has progressed following one or more
lines of endocrine therapy with at least one line given in
combination with a CDK4/6 inhibitor. It is being evaluated both as
a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and
in Phase 1/2 combination studies with CDK4/6 inhibitors
(palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an
mTOR inhibitor (everolimus). For more information, please visit
www.opera01study.com.
About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company
committed to transforming the standard of care and improving
outcomes for women living with cancer. Olema is advancing a
pipeline of novel therapies by leveraging our deep understanding of
endocrine-driven cancers, nuclear receptors, and mechanisms of
acquired resistance. In addition to our lead product candidate,
palazestrant (OP-1250), a proprietary, orally-available complete
estrogen receptor (ER) antagonist (CERAN) and a selective ER
degrader (SERD), Olema is developing a potent KAT6 inhibitor
(OP-3136). Olema is headquartered in San Francisco and has
operations in Cambridge, Massachusetts. For more information,
please visit us at www.olema.com.
Non-GAAP Financial Information
The results presented in this press release include both GAAP
information and non-GAAP information. As used in this release,
non-GAAP R&D expense is defined by Olema as GAAP R&D
expense excluding stock-based compensation expense, and non-GAAP
G&A expense is defined by Olema as GAAP G&A expense
excluding stock-based compensation expense. We use these non-GAAP
financial measures to evaluate our ongoing operations and for
internal planning and forecasting purposes. We believe that
non-GAAP financial information, when taken collectively, may be
helpful to investors because it provides consistency and
comparability with past financial performance. However, non-GAAP
financial information is presented for supplemental informational
purposes only, has limitations as an analytical tool, and should
not be considered in isolation or as a substitute for financial
information presented in accordance with GAAP. Other companies,
including companies in our industry, may calculate similarly titled
non-GAAP measures differently or may use other measures to evaluate
their performance, all of which could reduce the usefulness of our
non-GAAP financial measures as tools for comparison. Investors are
encouraged to review the related GAAP financial measures and the
reconciliation of these non-GAAP financial measures to their most
directly comparable GAAP financial measures and not rely on any
single financial measure to evaluate our business.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Words such as
“anticipate,” "believe,” “could,” “expect,” “goal,” “may,”
“potential,” "upcoming," “will” and similar expressions (as well as
other words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These statements include those related to the timelines for
initiation and enrollment for potential clinical studies and for
results of clinical trials of palazestrant (OP-1250) as a
monotherapy and in combination trials, timings of presentations at
conferences and conference calls, Olema’s financial condition and
resources, results of operations, cash position, potential
beneficial characteristics, including but not limited to safety,
tolerability, activity, efficacy and therapeutic effects of
palazestrant, the potential of palazestrant to advance the standard
of care for women living with cancer or become the backbone
endocrine therapy-of-choice for advanced or metastatic breast
cancer, palazestrant’s combinability with other drugs, the
initiation of a phase 1b/2 clinical study of palazestrant in
combination with everolimus and timing thereof, and the sufficiency
and timing of Olema’s preclinical program, including the potential
beneficial characteristics of its KAT6 inhibitor compounds and the
timing of a potential IND application for OP-3136. Because such
statements deal with future events and are based on Olema’s current
expectations, they are subject to various risks and uncertainties,
and actual results, performance or achievements of Olema could
differ materially from those described in or implied by the
statements in this press release. These forward-looking statements
are subject to risks and uncertainties, including, without
limitation, those discussed in the section titled “Risk Factors” in
Olema’s Quarterly Report on Form 10-Q for the quarter ended March
31, 2024, and future filings and reports that Olema makes from time
to time with the U.S. Securities and Exchange Commission. Except as
required by law, Olema assumes no obligation to update these
forward-looking statements, including in the event that actual
results differ materially from those anticipated in the
forward-looking statements.
|
Olema Pharmaceuticals, Inc. |
Condensed Consolidated Balance Sheets Data |
(in thousands) |
|
|
|
|
|
|
March 31, |
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
248,977 |
|
$ |
261,807 |
|
Total assets |
|
|
263,694 |
|
|
276,945 |
|
Total current liabilities |
|
|
26,224 |
|
|
21,621 |
|
Total liabilities |
|
|
27,376 |
|
|
23,050 |
|
Total stockholders’ equity |
|
|
236,318 |
|
|
253,895 |
|
Total liabilities and stockholders’ equity |
|
$ |
263,694 |
|
$ |
276,945 |
|
Olema Pharmaceuticals, Inc. |
Condensed Consolidated Statements of
Operations |
(In thousands, except share and per share
data) |
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
Operating expenses: |
|
|
|
Research and development (1) |
|
$ |
29,883 |
|
$ |
22,826 |
|
General and administrative (2) |
|
|
4,456 |
|
|
6,776 |
|
Total operating expenses |
|
|
34,339 |
|
|
29,602 |
|
Loss from operations |
|
|
(34,339 |
) |
|
(29,602 |
) |
Other income: |
|
|
|
Interest income |
|
|
3,352 |
|
|
1,305 |
|
Other income |
|
|
17 |
|
|
11 |
|
Total other income |
|
|
3,369 |
|
|
1,316 |
|
Net loss |
|
$ |
(30,970 |
) |
$ |
(28,286 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.56 |
) |
$ |
(0.70 |
) |
Weighted average shares used to compute net loss per share, basic
and diluted |
|
|
55,574,324 |
|
|
40,354,493 |
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP
Information |
(In thousands) |
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
(1) Research and development reconciliation |
|
|
|
GAAP research and development (3) |
|
$ |
29,883 |
|
$ |
22,826 |
|
Less: share-based compensation expense |
|
|
3,412 |
|
|
3,088 |
|
Non-GAAP research and development |
|
$ |
26,471 |
|
$ |
19,738 |
|
|
|
|
|
(2) General and administrative reconciliation |
|
|
|
GAAP general and administrative |
|
$ |
4,456 |
|
$ |
6,776 |
|
Less: share-based compensation expense |
|
|
1,497 |
|
|
1,542 |
|
Non-GAAP general and administrative |
|
$ |
2,959 |
|
$ |
5,234 |
|
|
|
|
|
(3) Research and development expenses for the three-months ended
March 31, 2024 include a $5.0 million milestone payment in
connection to the Aurigene Agreement. |
|
IR and Media Contact:Geoffrey Mogilner, Vice President, Investor
Relations and Communicationsir@olema.com
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