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, 2023, and provided a corporate update.
“We are on track for the initiation of our first pivotal Phase 3
clinical trial in the second half of this year,” said Sean P.
Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema
Oncology. “Our ongoing Phase 2 studies continue to generate data in
support of our underlying thesis that OP-1250 has the potential to
become a best-in-class complete estrogen receptor antagonist and
improve upon the current standard of care in the treatment of
ER+/HER2- metastatic breast cancer. We look forward to presenting
our next clinical update at the 2023 ESMO Breast Cancer Annual
Congress in mid-May, and we believe we are well-positioned to
achieve our goal to significantly improve endocrine therapy for
women living with breast cancer.”
Anticipated Upcoming Milestones
- Present interim Phase 2 clinical study results of OP-1250 in
combination with CDK4/6 inhibitor (palbociclib) at the 2023 ESMO
Breast Cancer Annual Congress in Berlin, Germany, in a poster
presentation on May 12, 2023.
- Present trials-in-progress clinical study overview of OP-1250
in combination with ribociclib or alpelisib in a poster
presentation at the 2023 ASCO Annual Meeting, June 2-6, 2023, in
Chicago, IL.
- Initiate a pivotal Phase 3 monotherapy clinical trial in the
second- and third-line setting of ER+/HER2- advanced or metastatic
breast cancer in the second half of 2023.
- Present Phase 2 monotherapy clinical study results in the
second half of 2023.
- Present Phase 1b clinical study results of OP-1250 in
combination with CDK4/6 inhibitor (ribociclib) in the second half
of 2023.
First Quarter 2023 Financial Results
Cash, cash equivalents and marketable securities as of March 31,
2023, were $186.0 million. Olema anticipates that this balance will
be sufficient to fund operations into 2025.
Net loss for the quarter ended March 31, 2023, was $28.3
million, as compared to $23.0 million for the same period of the
prior year. The increase in net loss related primarily to Olema’s
continued investment in OP-1250, increased spending on research and
development (R&D) activities, and personnel-related costs,
including a one-time restructuring charge of $2.8 million. The
increase in R&D spending was partially offset by a decrease in
general and administrative (G&A) costs.
GAAP R&D expenses were $22.8 million for the quarter ended
March 31, 2023, as compared to $16.0 million for the quarter ended
March 31, 2022. The increase in R&D expenses was primarily
related to increases in advancing ongoing clinical studies of
OP-1250 and associated manufacturing costs, nonclinical research
and discovery program activities, and personnel-related expenses,
including a one-time restructuring charge of $1.8 million.
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. Non-GAAP R&D expenses were $12.9 million
for the quarter ended March 31, 2022, 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 $6.8 million for the quarter ended
March 31, 2023, as compared to $7.2 million for the quarter ended
March 31, 2022. The decrease in G&A expenses was primarily due
to lower corporate costs, and personnel-related expenses, including
non-cash stock-based compensation expense. The decrease in spending
was partially offset by a one-time restructuring charge of $1.0
million.
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. Non-GAAP G&A expenses were $5.3 million
for the quarter ended March 31, 2022, excluding $1.9 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.
About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of
targeted therapies for women’s cancers. Olema’s lead product
candidate, OP-1250, is a proprietary, orally-available small
molecule with dual activity as both a complete estrogen receptor
(ER) antagonist (CERAN) and a selective ER degrader (SERD). It is
currently being evaluated both as a single agent in an ongoing
Phase 2 clinical trial, and in combination with CDK4/6 inhibitors
(palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in
patients with recurrent, locally advanced or metastatic ER-positive
(ER+), human epidermal growth factor receptor 2-negative (HER2-)
breast cancer. OP-1250 has been granted 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. Olema
is headquartered in San Francisco and has operations in Cambridge,
Massachusetts.
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 non-cash 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,” “expect,” “will,” “may,” “goal,” “potential” 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 company’s financial condition, results
of operations, cash position, the sufficiency of the company’s
financial resources, potential beneficial characteristics, safety,
tolerability, efficacy and therapeutic effects of OP-1250, the
potential of OP-1250 to become a best-in-class treatment option for
ER+/HER2- metastatic breast cancer or significantly improve
endocrine therapy for women living with ER+/HER2- metastatic breast
cancer, OP-1250’s combinability with other drugs, and the timelines
for potential clinical study results and clinical trials of OP-1250
as a monotherapy and in combination trials. 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-Q for the quarter ended March 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 or to update the reasons if 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, |
|
|
|
2023 |
|
2022 |
|
|
|
|
Cash, cash
equivalents and marketable securities |
|
$ |
185,954 |
$ |
204,421 |
Total assets |
|
|
195,768 |
|
215,645 |
Total
current liabilities |
|
|
19,410 |
|
16,549 |
Total
liabilities |
|
|
20,793 |
|
18,099 |
Total
stockholders’ equity |
|
|
174,975 |
|
197,546 |
Total liabilities and stockholders’ equity |
|
$ |
195,768 |
$ |
215,645 |
|
|
|
|
Olema
Pharmaceuticals, Inc. |
Condensed
Consolidated Statements of Operations |
(In thousands,
except share and per share data) |
|
|
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
Operating
expenses: |
|
|
Research and
development (1) |
$ |
22,826 |
|
|
$ |
16,009 |
|
General and
administrative (2) |
|
6,776 |
|
|
|
7,245 |
|
Total
operating expenses |
|
29,602 |
|
|
|
23,254 |
|
Loss from
operations |
|
(29,602 |
) |
|
|
(23,254 |
) |
Other
income: |
|
|
Interest
income |
|
1,305 |
|
|
|
218 |
|
Other
income |
|
11 |
|
|
|
6 |
|
Total other
income |
|
1,316 |
|
|
|
224 |
|
Net loss attributable to common stockholders |
$ |
(28,286 |
) |
|
$ |
(23,030 |
) |
Net loss per
share attributable to common stockholders, basic and diluted |
$ |
(0.70 |
) |
|
$ |
(0.58 |
) |
Weighted
average shares used to compute net loss per share attributable to
common stockholders, basic and diluted |
|
40,354,493 |
|
|
|
39,834,619 |
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP
Information |
(In thousands) |
|
|
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
(1)
Research and development reconciliation |
|
|
GAAP
research and development |
$ |
22,826 |
|
|
$ |
16,009 |
|
Less:
share-based compensation expense |
|
3,088 |
|
|
|
3,067 |
|
Non-GAAP research and development |
$ |
19,738 |
|
|
$ |
12,942 |
|
|
|
|
(2)
General and administrative reconciliation |
|
|
GAAP general
and administrative |
$ |
6,776 |
|
|
$ |
7,245 |
|
Less:
share-based compensation expense |
|
1,542 |
|
|
|
1,898 |
|
Non-GAAP general and administrative |
$ |
5,234 |
|
|
$ |
5,347 |
|
|
|
|
IR Contact:Shane Kovacs, Chief Operating and Financial
Officerir@olema.com
Media Contact:Ignacio Guerrero-Ros, Ph.D., Russo
Partners646-942-5604ignacio.guerrero-ros@russopartnersllc.com
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