Olema Oncology Reports Second Quarter 2021 Financial Results and Provides Corporate Update
August 10 2021 - 4:05PM
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 provided an update on recent company
developments and reported second quarter financial results for the
period ended June 30, 2021.
“We made important progress in the second quarter of 2021 as we
advanced the clinical development of our lead candidate, OP-1250,
an investigational complete estrogen receptor (ER) antagonist
(CERAN), and strengthened our corporate foundation to ensure that
we have the talent and resources in place to support our future
success,” said Sean P. Bohen, M.D., Ph.D., President and Chief
Executive Officer of Olema Oncology. “We have seen robust
enrollment in the ongoing Phase 1/2 clinical trial of OP-1250 and
look forward to sharing interim dose-escalation data at a medical
meeting in the fourth quarter of this year.”
Corporate Highlights and Anticipated
Milestones
- Significant progress advancing the Phase 1/2 clinical trial of
OP-1250 in patients with metastatic, ER+ / HER2- breast cancer. As
of June 4, 2021, 28 patients have been enrolled across five
dose-escalation cohorts. OP-1250 has demonstrated oral
bioavailability and a dose-proportional pharmacokinetic profile
consistent with predictions from Olema nonclinical models. A
maximum tolerated dose has not been identified. The Company plans
to present interim safety, tolerability, pharmacokinetic and
initial efficacy data at a medical meeting in the fourth quarter of
2021, pending abstract acceptance.
- Advance into monotherapy dose expansion in the second half of
2021.
- Initiate a Phase 1b clinical trial
of OP-1250 in combination with a CDK4/6 inhibitor in the first
quarter of 2022.
Second Quarter 2021 Financial Highlights
- Cash, cash equivalents and marketable securities as of June 30,
2021 were $318.1 million. Olema anticipates that this cash balance
will be sufficient to fund operations through the end of 2023.
- Research and development (R&D) expenses were $11.9 million
for the quarter ended June 30, 2021, compared to $1.9 million for
the same period of the prior year. The increase in R&D expenses
was primarily due to increased expenditures to advance the Phase
1/2 clinical trial of OP-1250, the increase in nonclinical
development activities, higher personnel-related expenses as
headcount grew to support the advancement of the clinical and
nonclinical programs, and higher non-cash stock-based compensation
expenses.
- General and administrative (G&A) expenses were $4.6 million
for the quarter ended June 30, 2021, compared to $0.5 million for
the same period of the prior year. The increase in G&A expenses
was primarily due to higher personnel-related expenses associated
with increases in the number of G&A personnel supporting the
growth of the organization, public company-related expenses and
other corporate costs, and non-cash share-based compensation
expenses.
- Net loss for the quarter ended June 30, 2021 was $16.4 million,
compared to $2.5 million for the same period of the prior
year.
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 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.
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, including timelines related to data presentation, trial
initiation and advancement, and enrollment, 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 Quarterly Report on Form
10-Q for the quarter ended June 30, 2021 to be filed on August 10,
2021 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) |
|
June
30, |
December 31, |
|
2021 |
2020 |
|
(Unaudited) |
(Audited) |
Cash, cash equivalents and marketable securities |
$ |
318,144 |
$ |
338,549 |
Total assets |
$ |
322,230 |
$ |
342,722 |
Total
liabilities |
$ |
8,146 |
$ |
4,585 |
Total
stockholders’ equity |
$ |
314,084 |
$ |
338,137 |
Total liabilities and stockholders’ equity |
$ |
322,230 |
$ |
342,722 |
|
|
|
Olema
Pharmaceuticals, Inc. |
Condensed
consolidated statements of operations and comprehensive
loss |
(In thousands,
except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
(Unaudited) |
|
(Unaudited) |
Operating
expenses: |
|
|
|
|
|
Research and
development |
$ |
11,910 |
|
|
$ |
1,947 |
|
|
$ |
22,602 |
|
|
$ |
2,742 |
|
General and
administrative |
|
4,612 |
|
|
|
539 |
|
|
|
9,370 |
|
|
|
787 |
|
Total
operating expenses (1) |
|
16,522 |
|
|
|
2,486 |
|
|
|
31,972 |
|
|
|
3,529 |
|
Loss from
operations |
|
(16,522 |
) |
|
|
(2,486 |
) |
|
|
(31,972 |
) |
|
|
(3,529 |
) |
Other
(expense) income: |
|
|
|
|
|
Interest
income |
|
117 |
|
|
|
33 |
|
|
|
228 |
|
|
|
36 |
|
Interest
expense |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(653 |
) |
Other income
(expense) |
|
(1 |
) |
|
|
- |
|
|
|
(1 |
) |
|
|
- |
|
Total other
income (expense), net |
|
116 |
|
|
|
33 |
|
|
|
227 |
|
|
|
(617 |
) |
Net loss |
$ |
(16,406 |
) |
|
$ |
(2,453 |
) |
|
$ |
(31,745 |
) |
|
$ |
(4,146 |
) |
Net loss per
share, basic and diluted |
$ |
(0.42 |
) |
|
$ |
(0.95 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.60 |
) |
Weighted
average shares used to compute net loss per share, basic and
diluted |
|
39,415,330 |
|
|
|
2,593,316 |
|
|
|
39,370,809 |
|
|
|
2,593,316 |
|
|
|
|
|
|
|
(1) Total operating
expenses includes the following non-cash stock-based compensation
expenses: |
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
(Unaudited) |
|
(Unaudited) |
Research and
development |
$ |
2,288 |
|
|
$ |
103 |
|
|
$ |
4,022 |
|
|
$ |
103 |
|
General and
administrative |
|
1,633 |
|
|
|
51 |
|
|
|
3,107 |
|
|
|
51 |
|
|
$ |
3,921 |
|
|
$ |
154 |
|
|
$ |
7,129 |
|
|
$ |
154 |
|
|
|
|
|
|
|
Contact:Eva StroynowskiVice President,
Communications and Investor Relationseva@olema.com
Olema Pharmaceuticals (NASDAQ:OLMA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Olema Pharmaceuticals (NASDAQ:OLMA)
Historical Stock Chart
From Jul 2023 to Jul 2024