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 fourth quarter and full year ended December 31, 2023, and
provided a corporate update.
“In 2023 we demonstrated the unique opportunity ahead for
palazestrant to make a meaningful impact on improving treatment
options for women with ER+/HER2- breast cancer. We believe
palazestrant’s activity on both wild-type and ESR1-mutant breast
cancer, and its ability to safely combine with ribociclib, result
in a highly differentiated profile amongst this emerging new class
of estrogen receptor-targeting therapies,” said Sean P. Bohen,
M.D., Ph.D., President and Chief Executive Officer of Olema
Oncology. “We have recently completed enrollment in our 60-patient
Phase 2 study of 120 mg palazestrant in combination with 600 mg
ribociclib, and we are looking forward to sharing an update on this
study at the 2024 ESMO Breast Cancer Annual Congress. Beyond
palazestrant, we recently declared a development candidate for our
KAT6 program, OP-3136, and we are advancing towards an IND filing
by the end of this year. Our mission at Olema is to improve the
lives of women living with cancer and we are very pleased with the
progress we are making.”
Recent Corporate
Highlights
- Presented interim clinical results of palazestrant in
combination with CDK4/6 inhibitors ribociclib and palbociclib at
the 2023 San Antonio Breast Cancer Symposium (SABCS), showing no
significant drug-drug interaction, no dose-limiting toxicities and
a tolerability profile consistent with the FDA-approved labels of
ribociclib or palbociclib plus an endocrine therapy.
- Presented palazestrant monotherapy Phase 2 clinical results at
the European Society for Medical Oncology (ESMO) Congress 2023 in
Madrid, Spain, as an oral presentation demonstrating compelling
activity in both wild-type and ESR1-mutant tumor types.
- Initiated OPERA-01, our pivotal Phase 3 monotherapy clinical
trial in the second- and third-line setting of ER+/HER2- advanced
or metastatic breast cancer, including dosing first patients and
activating multiple trial sites globally.
- 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 the expansion of Olema's clinical collaboration with
Novartis Institutes for BioMedical Research, Inc. (Novartis),
increasing the size of the ongoing Phase 1/2 clinical study testing
palazestrant in combination with ribociclib to approximately 60
patients. This study is fully enrolled.
- Completed a combined financing for up to $180 million including
an equity private placement of approximately $130 million of common
stock as well as a new senior secured credit facility with an
aggregate principal amount of up to $50 million with Silicon Valley
Bank (SVB), $25 million of which is currently available.
Upcoming Milestones
- Present interim Phase 2 clinical results of palazestrant in
combination with ribociclib at ESMO Breast Cancer Annual Congress
2024, May 15-17, 2024, in Berlin, Germany.
- Initiate Phase 1b/2 clinical study of palazestrant in
combination with mTOR inhibitor, everolimus, in Q3 2024.
- File an Investigational New Drug, or IND, application with the
FDA for OP-3136, a KAT6 inhibitor, in late 2024, and advance
clinical development.
- Prepare for pivotal Phase 3 first-line trial in combination
with CDK4/6 inhibitor, ribociclib.
Fourth Quarter and Full-Year 2023 Financial
Results
Cash, cash equivalents and marketable securities as of December
31, 2023, were $261.8 million.
Net loss was $26.8 million and $96.7 million for the quarter and
year ended December 31, 2023, respectively, as compared to $26.2
million and $104.8 million for the quarter and year ended December
31, 2022, respectively. The increase in net loss for the fourth
quarter was primarily related to increased spending on clinical
operations and development-related activities, including
personnel-related expenses, as Olema continues to advance
palazestrant into late-stage clinical trials. This increase was
offset by decreased spending on general and administrative
activities and higher interest income earned from marketable
securities. The decrease in net loss for the full year 2023 was
primarily due to higher interest income earned from marketable
securities.
GAAP research and development (R&D) expenses were $25.9
million and $86.1 million for the quarter and year ended December
31, 2023, respectively, as compared to $21.6 million and $82.3
million for the quarter and year ended December 31, 2022,
respectively. The increase in R&D expenses was primarily a
result of increased spending on clinical operations and
development-related activities including personnel-related costs as
Olema continues to advance palazestrant into late-stage clinical
development, which were offset by decreased spending on
research-related activities.
Non-GAAP R&D expenses were $23.0 million and $74.4 million
for the quarter and year ended December 31, 2023, respectively,
excluding $2.9 million and $11.8 million non-cash stock-based
compensation expense, respectively. Non-GAAP R&D expenses were
$18.2 million and $69.8 million for the quarter and year ended
December 31, 2022, respectively, excluding $3.4 million and $12.5
million non-cash stock-based compensation expense, respectively. 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 and $18.8 million for
the quarter and year ended December 31, 2023, respectively, as
compared to $5.6 million and $24.7 million for the quarter and year
ended December 31, 2022, respectively. The decrease in G&A
expenses was primarily due to decreased spending on corporate- and
legal-related costs, and personnel-related expenses.
Non-GAAP G&A expenses were $3.1 million and $13.3 million
for the quarter and year ended December 31, 2023, respectively,
excluding $1.4 million and $5.5 million non-cash stock-based
compensation expense respectively. Non-GAAP G&A expenses were
$4.1 million and $18.3 million for the quarter and year ended
December 31, 2022, excluding $1.5 million and $6.4 million non-cash
stock-based compensation expense, respectively. A reconciliation of
GAAP to non-GAAP financial measures used in this press release can
be found at the end of this press release.
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 activity 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 currently being
evaluated both as a single agent in an ongoing Phase 3 clinical
trial, OPERA-01, and in Phase 2 combination studies with CDK4/6
inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor
(alpelisib). 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. 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,” “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 Olema’s financial
condition and resources, results of operations, cash position, the
timeline of Olema’s pivotal Phase 3 monotherapy clinical trial
(OPERA-01), 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,
potential beneficial characteristics, including but not limited to
safety, tolerability, efficacy and therapeutic effects of
palazestrant, the potential of palazestrant to improve treatment
options or outcomes for women living with ER+/HER2- breast cancer,
palazestrant’s combinability with other drugs, and the sufficiency
and timing of Olema’s preclinical program, including the potential
beneficial characteristics of its KAT6 inhibitor compounds, its
applicability to breast and other cancers and the timing of a
potential IND application. 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 Annual Report on Form
10-K for the year ended December 31, 2023, 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) |
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
261,807 |
|
|
$ |
204,421 |
|
Total assets |
|
|
276,945 |
|
|
|
215,645 |
|
Total
current liabilities |
|
|
21,621 |
|
|
|
16,549 |
|
Total
liabilities |
|
|
23,050 |
|
|
|
18,099 |
|
Total
stockholders’ equity |
|
|
253,895 |
|
|
|
197,546 |
|
Total liabilities and stockholders’ equity |
|
$ |
276,945 |
|
|
$ |
215,645 |
|
|
|
|
|
|
|
|
|
|
|
Olema
Pharmaceuticals, Inc. |
Condensed
Consolidated Statements of Operations |
(In
thousands, except share and per share data) |
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and development (1) |
$ |
25,872 |
|
|
$ |
21,584 |
|
|
$ |
86,140 |
|
|
$ |
82,274 |
|
General and
administrative (2) |
|
4,544 |
|
|
|
5,635 |
|
|
|
18,821 |
|
|
|
24,714 |
|
Total
operating expenses |
|
30,416 |
|
|
|
27,219 |
|
|
|
104,961 |
|
|
|
106,988 |
|
Loss from
operations |
|
(30,416 |
) |
|
|
(27,219 |
) |
|
|
(104,961 |
) |
|
|
(106,988 |
) |
Other income
(expense): |
|
|
|
|
|
Interest
income |
|
3,551 |
|
|
|
973 |
|
|
|
8,325 |
|
|
|
2,228 |
|
Other income
(expense): |
|
93 |
|
|
|
67 |
|
|
|
(19 |
) |
|
|
(27 |
) |
Total other
income |
|
3,644 |
|
|
|
1,040 |
|
|
|
8,306 |
|
|
|
2,201 |
|
Net loss |
$ |
(26,772 |
) |
|
$ |
(26,179 |
) |
|
$ |
(96,655 |
) |
|
$ |
(104,787 |
) |
Net loss per
share, basic and diluted |
$ |
(0.49 |
) |
|
$ |
(0.65 |
) |
|
$ |
(2.14 |
) |
|
$ |
(2.62 |
) |
Weighted
average shares used to compute net loss per share, basic and
diluted |
|
54,783,945 |
|
|
|
40,188,466 |
|
|
|
45,247,098 |
|
|
|
39,995,460 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP
Information |
(In thousands) |
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
(1)
Research and development reconciliation |
|
|
|
|
|
GAAP
research and development (3) |
$ |
25,872 |
|
|
$ |
21,584 |
|
|
$ |
86,140 |
|
|
$ |
82,274 |
|
Less:
share-based compensation expense |
|
2,911 |
|
|
|
3,374 |
|
|
|
11,769 |
|
|
|
12,462 |
|
Non-GAAP research and development |
$ |
22,961 |
|
|
$ |
18,210 |
|
|
$ |
74,371 |
|
|
$ |
69,812 |
|
|
|
|
|
|
|
(2)
General and administrative reconciliation |
|
|
|
|
|
GAAP general
and administrative |
$ |
4,544 |
|
|
$ |
5,635 |
|
|
$ |
18,821 |
|
|
$ |
24,714 |
|
Less:
share-based compensation expense |
|
1,440 |
|
|
|
1,487 |
|
|
|
5,487 |
|
|
|
6,367 |
|
Non-GAAP general and administrative |
$ |
3,104 |
|
|
$ |
4,148 |
|
|
$ |
13,334 |
|
|
$ |
18,347 |
|
|
|
|
|
|
|
(3) Research and
development expenses for the twelve-months ended December 31, 2022
include an $8.0 million upfront 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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