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 third
quarter ended September 30, 2023, and provided a corporate update.
“With the recent oral presentation of our Phase 2 monotherapy
clinical results at ESMO in Madrid, we are already experiencing
increased awareness of and interest in our OPERA-01 Phase 3
monotherapy clinical trial,” said Sean P. Bohen, M.D., Ph.D.,
President and Chief Executive Officer of Olema Oncology. “Our Phase
2 study of palazestrant in combination with ribociclib is now
rapidly enrolling and we look forward to presenting new
palazestrant combination data at SABCS in December, including a
Poster Spotlight Discussion for our interim Phase 2 palbociclib
combination clinical results. We are proud of the advancements we
are making across our business, and as we progress our CERAN and
KAT6 programs we remain focused on defining the next generation of
targeted therapies for women’s cancers.”
Recent Corporate Highlights
- OPERA-01, Olema’s first pivotal Phase 3 clinical trial testing
palazestrant as a monotherapy in second- and third-line metastatic
breast cancer is ongoing, including clinical site activation and
first patient expected to be enrolled in the fourth quarter.
- Presented 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. Results demonstrated that, across all 86 heavily pretreated
patients, the median progression-free survival (PFS) was 4.6 months
with a clinical benefit rate (CBR) of 40%; in patients with ESR1
mutations at baseline, the median PFS was 5.6 months with a CBR of
52%. In a subset analysis of 49 second- or third-line patients with
or without prior chemotherapy, the median PFS was 7.2 months and
CBR was 48% across all patients, and the median PFS was 7.3 months
and CBR was 59% in ESR1-mutant patients. Study results support
continued development of palazestrant in the OPERA-01 monotherapy
Phase 3 pivotal trial.
- Announced the appointment of Mr. Scott Garland, who brings more
than 30 years of biopharmaceutical industry experience with deep
commercial and executive leadership expertise, to Olema’s Board of
Directors.
- Announced the expansion of Olema’s clinical collaboration with
Novartis Institutes for BioMedical Research, Inc. (Novartis),
increasing the size of the ongoing Phase 1/2 clinical study testing
palazestrant in combination with ribociclib to approximately 60
patients.
- Presented new preclinical data regarding the discovery of novel
compounds targeting KAT6, an epigenetic target that is dysregulated
in breast and other cancers, at the 2023 AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics, demonstrating anti-tumor activity in preclinical
models of ER+ breast cancer.
- Completed a combined financing for up to $180 million including
an equity private placement of approximately $130 million of common
stock as well as a new senior secured credit facility with an
aggregate principal amount of up to $50 million with Silicon Valley
Bank, $25 million of which is currently available.
Upcoming Milestones
- Present palazestrant interim Phase 1b/2 clinical study results
in combination with CDK4/6 inhibitor, palbociclib, as a Poster
Spotlight Discussion at the 2023 San Antonio Breast Cancer
Symposium (SABCS) in December 2023.
- Present palazestrant interim Phase 1b clinical study results in
combination with CDK4/6 inhibitor, ribociclib, at SABCS.
- Present trial-in-progress poster for OPERA-01, a randomized,
open-label, Phase 3, study of palazestrant vs. standard-of-care
treatment for ER+/HER2- advanced or metastatic breast cancer after
endocrine and CDK4/6 inhibitor therapy, at SABCS, which will
provide details on the trial design, inclusion/exclusion criteria,
and trial endpoints.
Third Quarter 2023 Financial Results
Cash, cash equivalents and marketable securities as of September
30, 2023, were $276.9 million.
Net loss for the quarter ended September 30, 2023, was $21.5
million, as compared to $22.7 million for the same period of the
prior year. The decrease in net loss was primarily related to
decreased spending on general and administrative activities, and
higher interest income earned from the marketable securities, which
were offset by increased spending on clinical operations and
development-related activities as Olema continues to advance
palazestrant into late-stage clinical trials.
GAAP research and development (R&D) expenses were $19.5
million for the quarter ended September 30, 2023, as compared to
$17.6 million for the quarter ended September 30, 2022. The
increase was primarily a result of increased spending on clinical
operations and development-related activities as Olema continues to
advance palazestrant into late-stage clinical development.
Non-GAAP R&D expenses were $16.7 million for the quarter
ended September 30, 2023, excluding $2.8 million non-cash
stock-based compensation expense. Non-GAAP R&D expenses were
$14.8 million for the quarter ended September 30, 2022, excluding
$2.8 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 $3.9
million for the quarter ended September 30, 2023, as compared to
$5.6 million for the quarter ended September 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.
Non-GAAP G&A expenses were $2.6 million for the quarter
ended September 30, 2023, excluding $1.3 million non-cash
stock-based compensation expense. Non-GAAP G&A expenses were
$4.1 million for the quarter ended September 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 3 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 initiation and
enrollment for potential clinical studies and for results of
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 help define the next generation of
targeted therapies for women’s cancers, palazestrant’s
combinability with other drugs, the capabilities of Olema’s board
of directors, and Olema’s preclinical program, including the
potential beneficial characteristics of its KAT6 inhibitor
compounds and its applicability to breast and other cancers.
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 September 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) |
|
|
|
|
|
|
|
|
September 30, |
December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
276,901 |
|
|
$ |
204,421 |
|
Total assets |
|
|
292,799 |
|
|
|
215,645 |
|
Total current liabilities |
|
|
15,966 |
|
|
|
16,549 |
|
Total liabilities |
|
|
17,665 |
|
|
|
18,099 |
|
Total stockholders’ equity |
|
|
275,134 |
|
|
|
197,546 |
|
Total liabilities and stockholders’ equity |
|
$ |
292,799 |
|
|
$ |
215,645 |
|
|
|
|
|
|
Olema Pharmaceuticals, Inc. |
Condensed Consolidated Statements of
Operations |
(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development (1) |
$ |
19,453 |
|
|
$ |
17,627 |
|
|
$ |
60,268 |
|
|
$ |
60,690 |
|
General and administrative (2) |
|
3,889 |
|
|
|
5,595 |
|
|
|
14,277 |
|
|
|
19,079 |
|
Total operating expenses |
|
23,342 |
|
|
|
23,222 |
|
|
|
74,545 |
|
|
|
79,769 |
|
Loss from operations |
|
(23,342 |
) |
|
|
(23,222 |
) |
|
|
(74,545 |
) |
|
|
(79,769 |
) |
Other income (expense): |
|
|
|
|
|
Interest income |
|
1,919 |
|
|
|
622 |
|
|
|
4,774 |
|
|
|
1,255 |
|
Other expense |
|
(79 |
) |
|
|
(120 |
) |
|
|
(112 |
) |
|
|
(94 |
) |
Total other income |
|
1,840 |
|
|
|
502 |
|
|
|
4,662 |
|
|
|
1,161 |
|
Net loss |
$ |
(21,502 |
) |
|
$ |
(22,720 |
) |
|
$ |
(69,883 |
) |
|
$ |
(78,608 |
) |
Net loss per share, basic and diluted |
$ |
(0.48 |
) |
|
$ |
(0.57 |
) |
|
$ |
(1.66 |
) |
|
$ |
(1.97 |
) |
Weighted average shares used to compute net loss per share, basic
and diluted |
|
44,977,161 |
|
|
|
40,036,201 |
|
|
|
41,999,978 |
|
|
|
39,930,418 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP
Information |
(In thousands) |
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
(1) Research and development reconciliation |
|
|
|
|
|
GAAP research and development |
$ |
19,453 |
|
|
$ |
17,627 |
|
|
$ |
60,268 |
|
|
$ |
60,690 |
|
Less: share-based compensation expense |
|
2,801 |
|
|
|
2,812 |
|
|
|
8,858 |
|
|
|
9,088 |
|
Non-GAAP research and development |
$ |
16,652 |
|
|
$ |
14,815 |
|
|
$ |
51,410 |
|
|
$ |
51,602 |
|
|
|
|
|
|
|
(2) General and administrative reconciliation |
|
|
|
|
|
GAAP general and administrative |
$ |
3,889 |
|
|
$ |
5,595 |
|
|
$ |
14,277 |
|
|
$ |
19,079 |
|
Less: share-based compensation expense |
|
1,304 |
|
|
|
1,463 |
|
|
|
4,047 |
|
|
|
4,880 |
|
Non-GAAP general and administrative |
$ |
2,585 |
|
|
$ |
4,132 |
|
|
$ |
10,230 |
|
|
$ |
14,199 |
|
|
|
|
|
|
|
IR Contact:Geoffrey Mogilner, Vice President, Investor Relations
and Communicationsir@olema.com
Media Contact:Ignacio Guerrero-Ros, Ph.D., Russo
Partners646-942-5604ignacio.guerrero-ros@russopartnersllc.com
Olema Pharmaceuticals (NASDAQ:OLMA)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Olema Pharmaceuticals (NASDAQ:OLMA)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024