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
second quarter ended June 30, 2023, and provided a corporate
update.
“Olema is on track to deliver on significant milestones this
year, including initiating our first pivotal Phase 3 trial,
OPERA-01, which will test palazestrant (OP-1250) as a monotherapy
in the second- and third-line metastatic setting, as well as
presenting new data from our ongoing monotherapy and combination
clinical studies,” said Sean P. Bohen, M.D., Ph.D., President and
Chief Executive Officer of Olema Oncology. “We are actively engaged
in start-up activities for our OPERA-01 Phase 3 clinical trial,
with enrollment expected to begin in the fourth quarter. Among
other upcoming milestones, we look forward to presenting our mature
Phase 2 monotherapy data as part of an oral presentation at the
ESMO Congress in Madrid in October. Our goal with palazestrant
remains to significantly improve upon current standard-of-care
endocrine therapy as the backbone treatment for metastatic breast
cancer.”
Recent Corporate Highlights
- Presented interim Phase 1b/2
clinical study results of palazestrant in combination with a CDK4/6
inhibitor (palbociclib) at the 2023 European Society for Medical
Oncology (ESMO) Breast Cancer Annual Congress in Berlin, Germany.
Results demonstrated no dose-limiting toxicities and no observed
drug-drug interaction, with an overall tolerability profile of the
combination consistent with the FDA-approved label of palbociclib
plus an endocrine agent.
- Presented trials-in-progress poster
from the ongoing Phase 1b/2 dose escalation and dose expansion
study of palazestrant in combination with CDK4/6 inhibitor,
ribociclib, or PI3Ka inhibitor, alpelisib, at the 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Upcoming Milestones
- Present palazestrant Phase 2 monotherapy clinical study results
as an oral presentation at the European Society for Medical
Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 22,
2023.
- Present palazestrant interim Phase 1b/2 clinical study results
in combination with CDK4/6 inhibitor, palbociclib, in the fourth
quarter of 2023.
- Present palazestrant interim Phase 1b clinical study results in
combination with CDK4/6 inhibitor, ribociclib, in the fourth
quarter of 2023.
- Initiate OPERA-01, Olema’s first pivotal Phase 3 clinical
trial, testing palazestrant as a monotherapy in second- and
third-line metastatic breast cancer, anticipated in the fourth
quarter of 2023.
Second Quarter 2023 Financial Results
Cash, cash equivalents and marketable securities as of June 30,
2023, were $167.4 million, a reduction of approximately $18.6
million from the quarter ended March 31, 2023. Olema anticipates
that this balance will be sufficient to fund operations into the
second quarter of 2025.
Net loss for the quarter ended June 30, 2023, was $20.1 million,
as compared to $32.9 million for the same period of the prior year.
The decrease in net loss was primarily related to decreased
spending on discovery research activities including a one-time
upfront payment of $8.0 million to Aurigene Pharmaceuticals in June
2022 pursuant to the exclusive global license agreement entered
into in June 2022 between the Company and Aurigene Pharmaceuticals
(the Aurigene Agreement), and general and administrative activities
including a reduction in corporate- and legal-related costs, which
were primarily offset by increased spending on clinical development
and operations-related activities as we continue to advance
palazestrant into late-stage clinical development.
GAAP research and development (R&D) expenses were $18.0
million for the quarter ended June 30, 2023, as compared to $27.1
million for the quarter ended June 30, 2022. The decrease was
primarily due to decreased spending on (i) preclinical research
programs, which included the $8.0 million upfront payment in
connection with the Aurigene Agreement incurred and paid in June
2022, (ii) clinical pharmacology-related costs, and (iii)
personnel-related expenses, which primarily related to lower
headcount as a result of the restructuring and portfolio
prioritization during the first quarter of 2023, and a decrease of
approximately $0.2 million in non-cash stock-based compensation
expense. Total decreases were primarily offset by increased
spending on clinical operations-related activities as we continue
to advance palazestrant into late-stage clinical trials.
Non-GAAP R&D expenses were $15.0 million for the quarter
ended June 30, 2023, excluding $3.0 million non-cash stock-based
compensation expense. Non-GAAP R&D expenses were $23.8 million
for the quarter ended June 30, 2022, excluding $3.2 million
non-cash stock-based compensation expense. A reconciliation of GAAP
to non-GAAP financial measures used in this press release can be
found in the tables below.
GAAP general and administrative (G&A) expenses were $3.6
million for the quarter ended June 30, 2023, as compared to $6.2
million for the quarter ended June 30, 2022. The decrease in
G&A expenses was primarily due to decreased spending on (i)
corporate- and legal-related costs, and (ii) personnel-related
expenses, primarily due to lower headcount as a result of the
restructuring and portfolio prioritization, and a decrease of
approximately $0.3 million in non-cash stock-based compensation
expense.
Non-GAAP G&A expenses were $2.4 million for the quarter
ended June 30, 2023, excluding $1.2 million non-cash stock-based
compensation expense. Non-GAAP G&A expenses were $4.7 million
for the quarter ended June 30, 2022, excluding $1.5 million
non-cash stock-based compensation expense. A reconciliation of GAAP
to non-GAAP financial measures used in this press release can be
found in the tables below.
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, palazestrant (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. Palazestrant 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. For
more information, please visit us at www.olema.com, or follow us on
Twitter and LinkedIn.
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 Olema’s financial condition and resources,
results of operations, cash position, the sufficiency of the
initiation and timeline of Olema’s pivotal Phase 3 monotherapy
clinical trial (OPERA-01), the timelines for potential clinical
study results and clinical trials of palazestrant (OP-1250) as a
monotherapy and in combination trials, potential beneficial
characteristics, safety, tolerability, efficacy and therapeutic
effects of palazestrant, the potential of palazestrant to
significantly improve endocrine therapy for women living with
ER+/HER2- metastatic breast cancer, and palazestrant’s
combinability with other drugs. 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 Quarterly Report on
Form 10-Q for the quarter ended June 30, 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) |
|
|
|
|
|
|
June
30, |
December 31, |
|
|
|
2023 |
|
2022 |
|
|
|
|
Cash, cash
equivalents and marketable securities |
|
$ |
167,444 |
$ |
204,421 |
Total assets |
|
|
177,624 |
|
215,645 |
Total
current liabilities |
|
|
14,831 |
|
16,549 |
Total
liabilities |
|
|
16,041 |
|
18,099 |
Total
stockholders’ equity |
|
|
161,583 |
|
197,546 |
Total liabilities and stockholders’ equity |
|
$ |
177,624 |
$ |
215,645 |
|
|
|
|
|
|
Olema
Pharmaceuticals, Inc. |
Condensed
Consolidated Statements of Operations |
(In
thousands, except share and per share data) |
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and
development (1) |
$ |
17,989 |
|
$ |
27,054 |
|
|
$ |
40,815 |
|
$ |
43,063 |
|
General and
administrative (2) |
|
3,612 |
|
|
6,239 |
|
|
|
10,388 |
|
|
13,484 |
|
Total
operating expenses |
|
21,601 |
|
|
33,293 |
|
|
|
51,203 |
|
|
56,547 |
|
Loss from
operations |
|
(21,601 |
) |
|
(33,293 |
) |
|
|
(51,203 |
) |
|
(56,547 |
) |
Other
income: |
|
|
|
|
|
Interest
income |
|
1,550 |
|
|
415 |
|
|
|
2,855 |
|
|
633 |
|
Other
(expense) income |
|
(44 |
) |
|
20 |
|
|
|
(33 |
) |
|
26 |
|
Total other
income |
|
1,506 |
|
|
435 |
|
|
|
2,822 |
|
|
659 |
|
Net loss |
$ |
(20,095 |
) |
$ |
(32,858 |
) |
|
$ |
(48,381 |
) |
$ |
(55,888 |
) |
Net loss per
share, basic and diluted |
$ |
(0.49 |
) |
$ |
(0.82 |
) |
|
$ |
(1.20 |
) |
$ |
(1.40 |
) |
Weighted
average shares used to compute net loss per share, basic and
diluted |
|
40,720,294 |
|
|
39,918,219 |
|
|
|
40,470,041 |
|
|
39,876,650 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP
Information |
(In thousands) |
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
(1)
Research and development reconciliation |
|
|
|
|
|
GAAP
research and development |
$ |
17,989 |
|
$ |
27,054 |
|
|
$ |
40,815 |
|
$ |
43,063 |
|
Less:
share-based compensation expense |
|
2,969 |
|
|
3,211 |
|
|
|
6,057 |
|
|
6,278 |
|
Non-GAAP research and development |
$ |
15,020 |
|
$ |
23,843 |
|
|
$ |
34,758 |
|
$ |
36,785 |
|
|
|
|
|
|
|
(2)
General and administrative reconciliation |
|
|
|
|
|
GAAP general
and administrative |
$ |
3,612 |
|
$ |
6,239 |
|
|
$ |
10,388 |
|
$ |
13,484 |
|
Less:
share-based compensation expense |
|
1,201 |
|
|
1,517 |
|
|
|
2,743 |
|
|
3,415 |
|
Non-GAAP general and administrative |
$ |
2,411 |
|
$ |
4,722 |
|
|
$ |
7,645 |
|
$ |
10,069 |
|
|
|
|
|
|
|
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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