Olema Oncology Reports First Quarter 2022 Financial Results and Provides Corporate Update
May 09 2022 - 4:30PM
Olema Pharmaceuticals, Inc. (“Olema” or “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 first quarter financial results
for the period ended March 31, 2022 and provided a business update.
“Following the successful completion of the Phase 1a dose
escalation portion of our trial for OP-1250 late last year, we are
pleased with the continued robust enrollment we are achieving
across our development program. Both our Phase 1/2 monotherapy
expansion study and the Phase 1b combination trial with palbociclib
are advancing, and we expect to initiate additional combination
trials later this year. In parallel, we plan to evaluate OP-1250’s
potential in the treatment of patients with ER+/HER2+ breast cancer
and CNS metastases, an important and underserved patient population
with limited treatment options,” said Sean P. Bohen, M.D.,
Ph.D., President and Chief Executive Officer of Olema Oncology.
“Our knowledge and clinical experience with OP-1250 is rapidly
expanding. We are fortunate to be supported by both a strong team
and balance sheet as we approach potential near-term value drivers
for our business. We look forward to presenting updated clinical
data later this year.”
Recent Corporate Highlights
- Achieved target enrollment of 30 patients in Phase 1b
monotherapy dose expansion at 60 mg and 120 mg dose levels (N=15
per cohort).
- Enrolled initial dose cohorts in the dose escalation portion of
the Phase 1b combination study with palbociclib and dose escalation
of OP-1250 continues.
- Presented two posters at the
American Association for Cancer Research (AACR) Annual Meeting,
held April 8-13, 2022. Data presented showed that 10 mg/kg OP-1250,
a complete estrogen receptor (ER) antagonist (CERAN), alone or in
combination with palbociclib, substantially inhibits primary tumor
growth in an endocrine-resistant breast cancer model with ERα Y537S
mutation. A second poster showed that OP-1250 is able to
effectively reverse estradiol-induced transcriptional changes
associated with the activated estrogen receptor in two ER+ cell
lines, MCF7 and CAMA-1.
Anticipated Milestones
- Select the Recommended Phase 2 Dose (RP2D) for OP-1250 in the
second quarter of 2022, followed by initiation of the Phase 2
portion of the trial. Phase 2 will include enrollment across three
cohorts: patients with measurable disease (N=50), patients with
non-measurable disease (N=15) and patients with CNS metastasis
(N=15).
- Initiate additional Phase 1b combination studies with CDK4/6
and PI3Kα inhibitors in 2022.
- Initiate Phase 1b study of OP-1250 in patients with ER+/HER2+
breast cancer and CNS metastases in the second half of 2022.
- Present updated monotherapy and initial combination data for
OP-1250.
Financial
Results
- Cash, cash equivalents and marketable securities as of March
31, 2022, were $267.9 million. Olema anticipates that this balance
will be sufficient to fund operations into 2024.
- Net loss for the quarter ended March 31, 2022, was $23.0
million, compared to $15.3 million for the same period of the prior
year. The increase in net loss related primarily to Olema’s
continued investment in OP-1250, and an increase in general and
administrative (G&A) costs.
- GAAP research and development (R&D) expenses were $16.0
million for the quarter ended March 31, 2022, compared to $10.7
million for the same period of the prior year. The increase in
R&D expenses was primarily related to the advancement of the
development program for OP-1250, increase in nonclinical
development activities, and higher personnel-related expenses,
including non-cash stock-based compensation expenses. 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. Non-GAAP R&D expenses were $9.0 million for the
quarter ended March 31, 2021, excluding $1.7 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 news release.
- GAAP G&A expenses were $7.2 million for the quarter ended
March 31, 2022, as compared to $4.8 million for the same period of
the prior year. The increase in G&A expenses was primarily
related to higher personnel-related expenses, including non-cash
stock-based compensation expenses, and other corporate costs.
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. Non-GAAP G&A expenses were $3.3 million
for the quarter ended March 31, 2021, excluding $1.5 million
non-cash stock-based compensation expense.
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 an orally-available small molecule with
combined activity as both a complete estrogen receptor (ER)
antagonist (CERAN) and a selective ER degrader (SERD). It is
currently being evaluated as a single agent in an ongoing Phase 1/2
clinical trial, and in Phase 1b combination with palbociclib, in
patients with recurrent, locally advanced, or metastatic
ER-positive (ER+), human epidermal growth factor receptor
2-negative (HER2-) breast cancer. 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 research and development expense is defined by Olema as
GAAP research and development expense excluding stock-based
compensation expense, and non-GAAP general and administrative
expense is defined by Olema as GAAP general and administrative
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,” “expect,” “intend,” “will,” “may,” “goal,”
“estimate,” “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 development of
OP-1250, both as a monotherapy and in combination trials, including
timelines related to data presentation, trial initiation and
advancement, and enrollment, the beneficial characteristics,
safety, efficacy and therapeutic effects of OP-1250, as well as the
sufficiency of our financial resources. 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, the risk that Olema’s ongoing or future clinical
studies in humans may show that OP-1250 is not a tolerable and
effective treatment for breast cancer and other risks and
uncertainties affecting Olema, as well as those discussed in the
section titled “Risk Factors” in Olema’s Annual Report on Form 10-Q
for the quarter ended March 31, 2022 to be filed on May 9, 2022 and
future filings and reports that Olema makes from time to time with
the United States 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, |
|
|
2022 |
2021 |
|
|
(Unaudited) |
(*) |
Cash, cash equivalents and marketable securities |
|
$ |
267,867 |
$ |
287,250 |
Total assets |
|
$ |
277,418 |
$ |
295,945 |
Total
current liabilities |
|
$ |
10,168 |
$ |
9,019 |
Total
liabilities |
|
$ |
12,328 |
$ |
11,377 |
Total
stockholders’ equity |
|
$ |
265,090 |
$ |
284,568 |
Total liabilities and stockholders’ equity |
|
$ |
277,418 |
$ |
295,945 |
(*) Derived
from audited financial statements |
|
|
|
|
|
|
|
Olema
Pharmaceuticals, Inc. |
Consolidated
Statements of Operations and Comprehensive Loss |
(In thousands,
except share and per share data) |
|
|
|
|
Three Months Ended March 31, |
|
|
2022 |
|
|
2021 |
|
|
(Unaudited) |
|
|
|
Operating
expenses: |
|
|
Research and
development (1) |
$ |
16,009 |
|
$ |
10,692 |
|
General and
administrative (2) |
|
7,245 |
|
|
4,758 |
|
Total
operating expenses |
|
23,254 |
|
|
15,450 |
|
Loss from
operations |
|
(23,254 |
) |
|
(15,450 |
) |
Other
income: |
|
|
Interest
income |
|
218 |
|
|
111 |
|
Other
income |
|
6 |
|
|
- |
|
Total other
income |
|
224 |
|
|
111 |
|
Net loss |
$ |
(23,030 |
) |
$ |
(15,339 |
) |
Net loss per
share attributable to common stockholders, basic and diluted |
$ |
(0.58 |
) |
$ |
(0.39 |
) |
Weighted
average shares used to compute net loss per share attributable to
common stockholders, basic and diluted |
|
39,834,619 |
|
|
39,325,793 |
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP
Information |
(In thousands) |
|
|
|
|
Three Months Ended March 31, |
|
|
2022 |
|
|
2021 |
|
|
(Unaudited) |
(1)
Research and development reconciliation |
|
|
GAAP
research and development |
$ |
16,009 |
|
$ |
10,692 |
|
Less:
share-based compensation expense |
|
3,067 |
|
|
1,734 |
|
Non-GAAP research and development |
$ |
12,942 |
|
$ |
8,958 |
|
|
|
|
(2)
General and administrative reconciliation |
|
|
GAAP general
and administrative |
$ |
7,245 |
|
$ |
4,758 |
|
Less:
share-based compensation expense |
|
1,898 |
|
|
1,474 |
|
Non-GAAP general and administrative |
$ |
5,347 |
|
$ |
3,284 |
|
|
|
|
Contact:
Eva Stroynowski
Vice President, Communications and Investor Relations
eva@olema.com
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