Zentalis Pharmaceuticals Reports Full Year 2023 Financial Results and Operational Updates
27 Febrero 2024 - 6:00AM
Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage
biopharmaceutical company discovering and developing clinically
differentiated small molecule therapeutics targeting fundamental
biological pathways of cancers, today announced financial results
for the year ended December 31, 2023, and highlighted recent
corporate accomplishments.
"Zentalis is making remarkable progress in advancing our
clinical development program for azenosertib, our potentially
groundbreaking WEE1 inhibitor, across various tumor types," stated
Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. "In
November 2023, we disclosed promising clinical data demonstrating
the potential of azenosertib as an effective monotherapy in ovarian
cancer and uterine serous carcinoma. Our team is diligently
executing a clinical strategy, which is firmly on track, designed
to rapidly bring this promising therapeutic option to patients with
gynecological cancers that continue to have a poor prognosis based
on currently available treatment options. We anticipate an exciting
and data-rich period ahead during the remainder of 2024 and into
2025 where we plan to share multiple clinical datasets to help
further demonstrate the potential of azenosertib in multiple cancer
types as a monotherapy and in combination."
Program Updates and Highlights
- Azenosertib
development program updates. In November 2023, the Company
announced an updated analysis of the ongoing Phase 1 clinical trial
of azenosertib as a monotherapy in solid tumors (ZN-c3-001), which
continued to show anti-tumor activity with intermittent dosing. In
the same population of 19 platinum resistant or refractory ovarian
cancer and uterine serous carcinoma (USC) patients that were
included in the data reported on June 6, 2023, the objective
response rate (ORR) was 37%. Median follow-up had increased and the
median progression free survival (mPFS) had increased to 6.5
months. The Company also disclosed in November 2023, that, with
additional safety-evaluable patients and follow-up, azenosertib
continued to demonstrate a favorable safety and tolerability
profile similar to or better than approved ovarian cancer products.
(Link)
- Azenosertib
development continues to progress across a broad array of tumor
types. Azenosertib is being evaluated in more than 10
ongoing and planned clinical trials as a monotherapy and in
combinations supported by compelling scientific rationales across a
broad array of tumor types, including platinum resistant ovarian
cancer (PROC), platinum sensitive ovarian cancer (PROC), BRAF
mutant metastatic colorectal cancer, and other solid tumors. In
addition, the Company is evaluating azenosertib and its BCL-2
inhibitor in patients with relapsed or refractory Acute Myeloid
Leukemia (AML).
- On track to
disclose multiple clinical data readouts during 2024 and
2025 (anticipated milestones noted below) and on track to submit
its first New Drug Application (NDA) for azenosertib in a
gynecologic malignancy in 2026.
Corporate Updates
- Strengthened
Leadership Team with the addition of Diana Hausman, M.D. as Chief
Medical Officer, and Kyle Rasbach, Ph.D., Pharm.D. as Chief
Business Officer. Dr. Hausman is an oncologist with
extensive experience in all aspects of drug development and
clinical strategy, including over a decade of experience as a Chief
Medical Officer at various biopharma companies. During her career,
she has contributed to the development of multiple cancer
therapeutics, including small molecules, antibody drug conjugates,
and immunotherapies. Dr. Rasbach joins from Eventide Asset
Management, where he was a Portfolio Manager for Eventide’s
healthcare and life sciences strategies, a Managing Director for
Eventide Ventures, and a Senior Research Analyst for other Eventide
investments. He previously held investment management and equity
research roles at several other firms. (Link)
- Strengthened
balance sheet with licensing of ROR1 antibody drug conjugate and
proprietary technology platform to Immunome. Under the
terms of the transaction, in January 2024 Zentalis received an
up-front payment of $35 million in cash and Immunome common stock
and remains eligible to receive up to $275 million of milestone
payments and mid-to-high single-digit royalties. (Link)
- Hosted a
webcast with gynecologic oncology academic expert highlighting the
strength of the emerging clinical profile for
azenosertib. On November 10, 2023,
Zentalis participated in a webcast with Joyce F. Liu, M.D., MPH, to
discuss azenosertib ovarian cancer clinical data. (Link)
Anticipated Upcoming Milestones
- 1H 2024
- Final results of Phase 1 azenosertib + chemotherapy
(gemcitabine) trial in osteosarcoma (ZN-c3-003)
- 2H 2024
- Final results of Phase 1b azenosertib monotherapy trial in
solid tumors (ZN-c3-001)
- Topline data from Phase 1/2 azenosertib + PARP inhibitor
(niraparib) and azenosertib monotherapy trial in platinum resistant
ovarian cancer in partnership with GSK (MAMMOTH, ZN-c3-006)
- Initial data from Phase 1 azenosertib + BEACON regimen
(encorafenib + cetuximab) trial in BRAF mutant metastatic
colorectal cancer in partnership with Pfizer (ZN-c3-016)
- Initial data from Phase 1 of azenosertib + ZN-d5 trial in R/R
AML (ZN-d5-004C)
- Additional details on planned clinical trial of azenosertib in
PSOC in the 1L maintenance setting
- 1H 2025
- Topline data from Phase 2 azenosertib monotherapy trial in
platinum resistant high-grade serous ovarian cancer (DENALI,
ZN-c3-005)
- 2H 2025
- Topline data from Phase 2 azenosertib monotherapy trial in
recurrent or persistent USC (TETON, ZN-c3-004)
- 2025
- Initiate clinical trial of azenosertib in PSOC in the 1L
maintenance setting
- 2026
- First NDA for azenosertib in a gynecologic malignancy
Full Year 2023 Financial Results
- Cash, Cash Equivalents and
Marketable Securities Position: As of December 31, 2023,
Zentalis had cash, cash equivalents and marketable securities of
$482.9 million. The Company believes that its existing cash, cash
equivalents and marketable securities as of December 31, 2023 will
be sufficient to fund its operating expenses and capital
expenditure requirements into 2026. The December 31, 2023 cash,
cash equivalents and marketable securities balance does not reflect
the up-front payment from Immunome of $35 million in cash and
Immunome stock, which was received in January 2024, as the
Company’s agreement was executed and announced in January
2024.
- Research and Development
Expenses: Research and development (R&D) expenses for
the year ended December 31, 2023 were $189.6 million, compared to
$172.7 million for the year ended December 31, 2022. The increase
of $16.9 million was primarily due to a $7.5 million increase in
expense relating to our cost sharing relationship with Zentera that
was terminated in June 2023, a $7.4 million increase related to
personnel expenses, of which $5.8 million related to non-cash
stock-based compensation expense, a $2.8 million increase in
facilities and overhead expenses and a $2.8 million increase in
consulting expense. These increases were partially offset by
decreases of $2.8 million and $0.9 million in collaborations
expense and supplies/other expenses, respectively.
- General and Administrative Expenses: General
and administrative expenses for the year ended December 31, 2023
were $64.4 million, compared to $54.6 million during the year ended
December 31, 2022. The increase of $9.8 million was primarily
attributable to a $4.9 million non-cash operating lease impairment
charge, a $5.1 million increase related to personnel expenses, of
which $3.7 million related to non-cash stock-based compensation
expense, and $1.4 million related to outside services. This was
partially offset by a $1.6 million decrease in facilities and
overhead and other expense.
About AzenosertibAzenosertib is a potentially
first-in-class and best-in-class small molecule WEE1 inhibitor in
development for the treatment of cancer. Inhibition of WEE1, a DNA
damage response kinase, drives cancer cells into mitosis without
being able to repair damaged DNA, resulting in cell death.
Currently, there are no FDA-approved WEE1 inhibitors, and
azenosertib has been designed for superior selectivity and
pharmacokinetic properties. Azenosertib is being developed in
therapeutic areas of high unmet need and is being evaluated as a
monotherapy, in combination with chemotherapy, and in combination
with molecularly targeted agents.
About Zentalis Pharmaceuticals
Zentalis® Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company discovering and developing clinically
differentiated small molecule therapeutics targeting fundamental
biological pathways of cancers. The Company’s lead product
candidate, azenosertib (ZN-c3), is a potentially first-in-class and
best-in-class WEE1 inhibitor for advanced solid tumors and
hematologic malignancies. Azenosertib is being evaluated as a
monotherapy and in combination across multiple clinical trials and
has broad franchise potential. In clinical trials, azenosertib has
been well tolerated and has demonstrated anti-tumor activity as a
single agent across multiple tumor types and in combination with
several chemotherapy backbones. As part of its azenosertib clinical
development program, the Company is exploring enrichment strategies
targeting tumors of high genomic instability, such as Cyclin E1
positive tumors, homologous recombination deficient tumors and
tumors with oncogenic driver mutations. The Company is also
leveraging its extensive experience and capabilities across cancer
biology and medicinal chemistry to advance its research on protein
degraders. Zentalis has operations in both New York and San
Diego.
For more information, please visit www.zentalis.com. Follow
Zentalis on X/Twitter at @ZentalisP and on LinkedIn
at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including statements regarding the potential for azenosertib to be
first-in-class and best-in-class; the potential for azenosertib to
be groundbreaking across various tumor types; the broad franchise
potential of azenosertib; our plans to share multiple clinical
datasets to demonstrate the potential of azenosertib in multiple
cancer types as a monotherapy and in combination, and the timing
thereof; our plans to submit an NDA for azenosertib in a
gynecologic malignancy and the timing thereof; the potential for us
to receive milestone payments from the Immunome licensing
agreement; our plans with respect to the development of our product
candidates, including azenosertib and ZN-d5; our plans and timing
for the initiation of and the release of data from our clinical
trials and our ability to meet other key milestones; the potential
benefits of azenosertib, including the potential benefits of the
design thereof, the value potential of the asset, and the potential
to improve outcomes for patients; and the Company’s cash runway.
The terms “advancing,” “anticipate,” “believe,” “continue,”
“designed,” “evaluating,” “milestone,” “on track,” “ongoing,”
“plan,” “potential,” “projected,” “progress,” “promising,”
“strategy,” and similar references are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. These statements are
neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements, including,
but not limited to, the following: our limited operating history,
which may make it difficult to evaluate our current business and
predict our future success and viability; we have and expect to
continue to incur significant losses; our need for additional
funding, which may not be available; our plans, including the costs
thereof, of development of any diagnostic tools; our substantial
dependence on the success of our lead product candidates; the
outcome of preclinical testing and early trials may not be
predictive of the success of later clinical trials; failure to
identify additional product candidates and develop or commercialize
marketable products; potential unforeseen events during clinical
trials could cause delays or other adverse consequences; risks
relating to the regulatory approval process or ongoing regulatory
obligations; failure to obtain U.S. or international marketing
approval; our product candidates may cause serious adverse side
effects; inability to maintain our collaborations, or the failure
of these collaborations; our reliance on third parties; effects of
significant competition; the possibility of system failures or
security breaches; risks relating to intellectual property; our
ability to attract, retain and motivate qualified personnel, and
risks relating to management transitions; significant costs as a
result of operating as a public company; and the other important
factors discussed under the caption “Risk Factors” in our most
recently filed periodic report on Form 10-K or 10-Q and subsequent
filings with the U.S. Securities and Exchange Commission (SEC) and
our other filings with the SEC. Any such forward-looking statements
represent management’s estimates as of the date of this press
release. While we may elect to update such forward-looking
statements at some point in the future, we disclaim any obligation
to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis
and/or its affiliates. All website addresses and other links in
this press release are for information only and are not intended to
be an active link or to incorporate any website or other
information into this press release. Comparisons of our product
candidates to other agents in this press release are not
head-to-head.
Contact:Carlo Tanzi, Ph.D.Kendall Investor
Relationsctanzi@kendallir.com
Zentalis Pharmaceuticals, Inc.Consolidated
Statements of Operations(In thousands, except per
share amounts) |
|
|
Year endedDecember 31, |
|
2023 |
|
2022 |
|
2021 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
Research and development |
$189,590 |
|
|
$172,734 |
|
|
$175,601 |
|
|
Zentera in-process research and development |
45,568 |
|
|
- |
|
|
- |
|
|
General and administrative |
64,351 |
|
|
54,553 |
|
|
40,941 |
|
|
Total operating expenses |
299,509 |
|
|
227,287 |
|
|
216,542 |
|
|
Loss from operations |
(299,509 |
) |
|
(227,287 |
) |
|
(216,542 |
) |
|
Other Income (Expense) |
|
|
|
|
|
|
|
|
|
Investment and other income, net |
22,617 |
|
|
5,987 |
|
|
401 |
|
|
Gain on deconsolidation of Zentera |
— |
|
|
— |
|
|
51,582 |
|
|
Net loss before income taxes |
(276,892 |
) |
|
(221,300 |
) |
|
(164,559 |
) |
|
Income tax expense (benefit) |
(601 |
) |
|
(469 |
) |
|
(297 |
) |
|
Loss on equity method investment |
16,014 |
|
|
16,282 |
|
|
1,831 |
|
|
Net loss |
(292,305 |
) |
|
(237,113 |
) |
|
(166,093 |
) |
|
Net loss attributable to noncontrolling interests |
(114 |
) |
|
(307 |
) |
|
(7,368 |
) |
|
Net loss attributable to Zentalis |
$(292,191 |
) |
|
$(236,806 |
) |
|
$(158,725 |
) |
|
Net loss per common share outstanding, basic and diluted |
$(4.47 |
) |
|
$(4.48 |
) |
|
$(3.72 |
) |
|
Common shares used in computing net loss per share, basic and
diluted |
65,409 |
|
|
52,857 |
|
|
42,688 |
|
|
|
Zentalis Pharmaceuticals, Inc. |
Selected Condensed Consolidated Balance Sheet
Data |
|
(In thousands) |
|
|
December 31, |
|
2023 |
|
2022 |
|
Cash, cash equivalents and marketable securities |
$482,919 |
|
$437,371 |
|
Working capital (1) |
427,351 |
|
395,286 |
|
Total assets |
551,688 |
|
539,310 |
|
Total liabilities |
114,297 |
|
105,286 |
|
Total Zentalis equity |
$437,391 |
|
$434,024 |
|
|
(1) The Company
defines working capital as current assets less current
liabilities. |
Zentalis Pharmaceuticals (NASDAQ:ZNTL)
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Zentalis Pharmaceuticals (NASDAQ:ZNTL)
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