Olema Oncology Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
February 28 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 financial results for the
fourth quarter and full year ended December 31, 2021 and provided a
business update.
“2021 was a transformative year for Olema. Our team made
important progress against our strategic goals, culminating in the
presentation of strong proof-of-concept data for OP-1250 in ER+ /
HER2- breast cancer. The initial data, demonstrating OP-1250’s
attractive pharmacokinetics, favorable tolerability and encouraging
anti-tumor activity in a heavily pretreated patient population,
validate OP-1250’s potential to become the endocrine therapy of
choice for ER+ breast cancer. We are now actively expanding our
clinical study enrollment and expect to be in a position to present
more data later this year,” said Sean P. Bohen, M.D., Ph.D.,
President and Chief Executive Officer of Olema Oncology.
“Importantly, we entered 2022 with a strong balance sheet, and as
we continue to build our team and grow our capabilities, we are
well positioned to advance our clinical development program and
discovery efforts.”
Recent Corporate Highlights
- Presented interim Phase 1a dose escalation data for OP-1250
from the ongoing Phase 1/2 clinical study. The initial data provide
strong proof-of-concept supporting OP-1250’s potential as a
once-daily oral monotherapy in women with recurrent, locally
advanced, or metastatic ER+ / HER2- breast cancer, with OP-1250
demonstrating highly attractive pharmacokinetics, favorable
tolerability, and clear efficacy signals in a heavily pretreated
patient population.
- Initiated monotherapy dose expansion at 60 mg and 120 mg dose
levels. Each cohort will enroll approximately 15 patients with
measurable disease, and findings will help inform the selection of
a recommended Phase 2 dose (RP2D). Enrollment remains on track to
complete in the first quarter of 2022.
- Initiated Phase 1b combination study with palbociclib, a CDK4/6
inhibitor. The dose escalation portion of the combination trial
includes a starting dose of 30 mg OP-1250 once-daily and follows a
standard 3+3 design.
- Presented nonclinical data on OP-1250 in a poster session at
the San Antonio Breast Cancer Symposium (SABCS), held December
7-10, 2021. Data presented showed that the addition of OP-1250 to
anti-HER2 agents, trastuzumab and tucatinib, improved the
inhibition of tumor growth in nonclinical models of ER+ / HER2+
breast cancer.
- Appointed Naseem Zojwalla, M.D., as Olema’s new Chief Medical
Officer. Dr. Zojwalla joins Olema from Turning Point Therapeutics
and brings significant leadership in clinical development,
operations and regulatory experience. Former CMO Pamela Klein,
M.D., continues to work with Olema in a strategic advisory capacity
and as a newly appointed member of the company’s Scientific
Advisory Board.
- In December 2021, Olema was added to the NASDAQ
Biotechnology Index® (Nasdaq: NBI).
Anticipated Milestones
- Select the Recommended Phase 2 Dose (RP2D) for OP-1250 and
initiate Phase 2 in the first half of 2022. The Phase 2 study
includes 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 in 2022.
- Sean Bohen, M.D., Ph.D., President and CEO of Olema Oncology,
is scheduled to present at the 42nd Annual Cowen Healthcare
Conference on Monday, March 7, 2022, at 2:50 PM ET.
Fourth Quarter and Full Year 2021 Financial
Results
- Cash, cash equivalents and
marketable securities as of December 31, 2021, were $287.3 million.
Olema anticipates that this balance will be sufficient to fund
operations into 2024.
- Net loss was $21.6 million and $71.1 million for the quarter
and year ended December 31, 2021, respectively, as compared to
$10.1 million and $22.1 million for the quarter and year ended
December 31, 2020, respectively. The increase in net loss related
primarily to Olema’s continued investment in OP-1250, and an
increase in general and administrative (G&A) infrastructure
costs.
- GAAP research and development (R&D) expenses were $16.0
million and $51.1 million for the quarter and year ended December
31, 2021, respectively, as compared to $6.3 million and $13.7
million for the quarter and year ended December 31, 2020,
respectively. The increase in R&D expenses was primarily
related to the advancement of the ongoing Phase 1/2 clinical trial
of OP-1250, increase in nonclinical development activities, higher
personnel-related expenses and higher non-cash stock-based
compensation expenses. Non-GAAP R&D expenses were $13.1 million
and $41.8 million for the quarter and year ended December 31, 2021,
respectively, excluding $2.9 million and $9.3 million non-cash
stock-based compensation expense respectively. Non-GAAP R&D
expenses were $4.8 million and $11.7 million for the quarter and
year ended December 31, 2020, respectively, excluding $1.5 million
and $2.0 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
news release.
- GAAP G&A expenses were $5.8 million and $20.4 million for
the quarter and year ended December 31, 2021, respectively, as
compared to $3.8 million and $7.8 million for the quarter and year
ended December 31, 2020, respectively. The increase in G&A
expenses was primarily related to an increase in personnel, public
company-related expenses, other corporate costs and higher non-cash
stock-based compensation expenses. Non-GAAP G&A expenses were
$4.1 million and $13.8 million for the quarter and year ended
December 31, 2021, respectively, excluding $1.7 million and $6.6
million non-cash stock-based compensation expense respectively.
Non-GAAP G&A expenses were $3.0 million and $6.7 million for
the quarter and year ended December 31, 2020, excluding $0.9
million and $1.1 million non-cash stock-based compensation expense
respectively.
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 and Olema being well
positioned to advance its clinical development program and
discovery efforts. 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-K for the year ended December 31, 2021 to be filed on February
28, 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) |
|
December 31, |
December 31, |
|
2021 |
2020 |
|
(Audited) |
(Audited) |
Cash, cash equivalents and marketable securities |
$ |
287,250 |
$ |
338,549 |
Total assets |
$ |
295,945 |
$ |
342,722 |
Total
current liabilities |
$ |
9,019 |
$ |
4,585 |
Total
liabilities |
$ |
11,377 |
$ |
4,585 |
Total
stockholders’ equity |
$ |
284,568 |
$ |
338,137 |
Total liabilities and stockholders’ equity |
$ |
295,945 |
$ |
342,722 |
|
|
|
Olema
Pharmaceuticals, Inc. |
Consolidated
Statements of Operations and Comprehensive Loss |
(In thousands,
except share and per share data) |
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2021 |
|
|
2020 |
|
|
|
2021 |
|
|
2020 |
|
|
(Unaudited) |
|
(Audited) |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and
development (1) |
$ |
15,975 |
|
$ |
6,289 |
|
|
$ |
51,100 |
|
$ |
13,704 |
|
General and
administrative (2) |
|
5,782 |
|
|
3,842 |
|
|
|
20,391 |
|
|
7,824 |
|
Total
operating expenses |
|
21,757 |
|
|
10,131 |
|
|
|
71,491 |
|
|
21,528 |
|
Loss from
operations |
|
(21,757 |
) |
|
(10,131 |
) |
|
|
(71,491 |
) |
|
(21,528 |
) |
Other income
(expense): |
|
|
|
|
|
Interest
income |
|
109 |
|
|
- |
|
|
|
442 |
|
|
60 |
|
Interest
expense |
|
- |
|
|
- |
|
|
|
- |
|
|
(653 |
) |
Other income
(expense) |
|
10 |
|
|
- |
|
|
|
(47 |
) |
|
- |
|
Total other
income (expense), net |
|
119 |
|
|
- |
|
|
|
395 |
|
|
(593 |
) |
Net loss |
$ |
(21,638 |
) |
$ |
(10,131 |
) |
|
$ |
(71,096 |
) |
$ |
(22,121 |
) |
Repurchase and retirement of Series A and Series A-1 convertible
preferred stock |
|
- |
|
|
- |
|
|
|
- |
|
|
(1,869 |
) |
Net loss
attributable to common stockholders |
$ |
(21,638 |
) |
$ |
(10,131 |
) |
|
$ |
(71,096 |
) |
$ |
(23,990 |
) |
Net loss per
share attributable to common stockholders, basic and diluted |
$ |
(0.54 |
) |
$ |
(0.50 |
) |
|
$ |
(1.80 |
) |
$ |
(3.42 |
) |
Weighted
average shares used to compute net loss per share attributable to
common stockholders, basic and diluted (3) |
|
39,742,723 |
|
|
20,155,342 |
|
|
|
39,524,272 |
|
|
7,021,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP
Information |
(In thousands) |
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2021 |
|
|
2020 |
|
|
|
2021 |
|
|
2020 |
|
|
(Unaudited) |
|
(Unaudited) |
(1)
Research and development reconciliation |
|
|
|
|
|
GAAP
research and development |
$ |
15,975 |
|
$ |
6,289 |
|
|
$ |
51,100 |
|
$ |
13,704 |
|
Less: share-based compensation expense |
|
2,919 |
|
|
1,475 |
|
|
- |
|
9,346 |
|
|
1,970 |
|
Non-GAAP research and development |
$ |
13,056 |
|
$ |
4,814 |
|
$ |
- |
$ |
41,754 |
|
$ |
11,734 |
|
|
|
|
|
|
|
(2)
General and administrative reconciliation |
|
|
|
|
|
GAAP general
and administrative |
$ |
5,782 |
|
$ |
3,842 |
|
$ |
- |
$ |
20,391 |
|
$ |
7,824 |
|
Less:
share-based compensation expense |
|
1,708 |
|
|
867 |
|
|
- |
|
6,567 |
|
|
1,108 |
|
Non-GAAP general and administravie |
$ |
4,074 |
|
$ |
2,975 |
|
$ |
- |
$ |
13,824 |
|
$ |
6,716 |
|
|
|
|
|
|
|
(3) The weighted
average shares used to compute net loss attributable to common
stockholders include the weighted average effects of the conversion
of all outstanding convertible preferred stock into 23,765,065
shares of common stock of the company and the sale of 12,650,000
common shares in connection with the company's November 2020
initial public offering. |
Contact:
Eva Stroynowski
Vice President, Communications and Investor Relations
eva@olema.com
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