Zentalis Pharmaceuticals Reports Third Quarter 2023 Financial Results and Operational Updates
06 11월 2023 - 9:18PM
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 quarter ended September 30, 2023, and highlighted recent
corporate accomplishments.
“We are executing on our fast-to-market strategy for our
potentially first-in-class and best-in-class WEE1 inhibitor,
azenosertib, while also laying the groundwork for the franchise
opportunity we see for azenosertib across multiple tumor types,”
said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis.
“Azenosertib continues to show very encouraging monotherapy
anti-tumor activity, safety and tolerability in both ovarian cancer
and uterine serous carcinoma. We are executing our clinical
strategy to advance this high-potential asset to patients with
ovarian cancer and uterine serous carcinoma as quickly as possible
and expand into additional indications where WEE1 inhibition has
the potential to improve outcomes for patients. By focusing our
team and resources on the advancement of azenosertib, Zentalis is
targeting the submission of the first NDA for azenosertib in a
gynecologic malignancy in 2026.”
“This quarter we are also executing on our succession plan for
Chief Scientific Officer, which will see our Chief Translational
Officer, Mark Lackner, succeed our co-founder, Kevin Bunker, at the
end of the year,” said Dr. Blackwell. “Kevin’s passion for
discovering promising oncology drugs is a cornerstone of our
culture and led to four of our product candidates advancing into
the clinic, including azenosertib. I want to thank Kevin for his
immense contributions to Zentalis and to the cancer patients we
serve.”
“Since joining Zentalis last year, Mark has put together a
talented translational team and has spearheaded our biomarker
enrichment strategies for azenosertib,” continued Dr. Blackwell.
“Mark’s appointment as Chief Scientific Officer sees our
translational and discovery efforts brought under a single
umbrella, which puts us in a strong position as we continue to
advance azenosertib through the clinic while supporting robust
preclinical drug discovery efforts.”
Program Updates and Highlights
- Azenosertib monotherapy
program. Today, 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 has increased by nearly 5 months
and the median progression free survival (mPFS) has increased to
6.5 months. With additional safety-evaluable patients and follow-up
since June, azenosertib continues to demonstrate a favorable safety
and tolerability profile that is similar to or better than approved
ovarian cancer products, supporting its continued advancement.
- Azenosertib development
strategy. Azenosertib is currently being evaluated in more
than 10 ongoing and planned clinical trials as a monotherapy and in
combinations with compelling scientific rationales across a broad
array of tumor types. The Company is on track to submit its first
New Drug Application (NDA) for azenosertib in a gynecologic
malignancy in 2026. The Company has revised its strategy in
platinum sensitive ovarian cancer (PSOC) and plans to evaluate
azenosertib in PSOC in the first-line (1L) maintenance setting in
the clinic. This strategy allows for the opportunity to benefit a
larger segment of patients with ovarian cancer and fill a gap in
the treatment paradigm since the standard of care in the 1L
maintenance setting is evolving and fewer options are available.
The Company plans to provide additional details on this trial in
the second half of 2024, and anticipates initiating enrollment in
2025.
- Presentation at the
American Association for Cancer Research (AACR) Special Conference:
Ovarian Cancer. In October, the Company presented a poster
presentation titled “Cyclin E1 Positive Staining Is Frequent and
Independent of Prior Platinum Treatment in High Grade Serous
Ovarian Cancer” at the AACR Special Conference: Ovarian Cancer in
Boston. To review the data in more detail, click here.
- ZN-d5 + azenosertib in
relapsed or refractory acute myeloid leukemia (R/R AML).
Zentalis is the only company known to have both a WEE1 inhibitor,
azenosertib, and a BCL-2 inhibitor, ZN-d5, in clinical development.
The Company is evaluating the combination of these promising
product candidates in a Phase 1/2 trial in heavily pretreated
patients with R/R AML based on strong preclinical data
demonstrating highly synergistic anti-leukemia activity of this
combination. The Company updated guidance for sharing initial data
from this trial to the second half of 2024.
- ZN-d5 in relapsed or
refractory light chain amyloidosis (R/R AL amyloidosis).
Dose escalation is complete in the Phase 1 trial of ZN-d5 as a
monotherapy in R/R AL amyloidosis. A preliminary efficacy signal
was observed in patients with R/R AL amyloidosis with a hematologic
response rate of 40% in patients treated with at least 400 mg daily
of ZN-d5. ZN-d5 was well tolerated with few treatment-related
adverse events. The proposed monotherapy dose has been identified
as 800 mg daily. The Company does not plan to develop ZN-d5 further
for this indication in order to focus its resources on the
azenosertib franchise opportunity, including the azenosertib +
ZN-d5 combination.
Corporate Highlight
- Today, the Company announced that Mark Lackner, Ph.D., Chief
Translational Officer, Head of Biomarker Strategy, will succeed
co-founder, Kevin Bunker, Ph.D., as Chief Scientific Officer at the
end of the year. Dr. Bunker will continue his service to the
Company as an advisor following the transition. Dr. Lackner joined
Zentalis in October 2022. Prior to Zentalis, Dr. Lackner served as
Senior Vice President, Head of Biology and Translational Sciences
at IDEAYA Biosciences, where he successfully led biology efforts
contributing to three small molecule development candidates and
established a strong translational team that led to the discovery
of a novel combination biomarker strategy. Previously, Dr. Lackner
worked at Genentech for over a decade, holding multiple roles of
increasing responsibility that culminated in serving as the Head of
Genentech Oncology Early Stage Biomarker Group. During this tenure,
he led multiple research teams in developing and incorporating
predictive biomarker strategies across all phases of clinical
trials and managed a diverse biomarker portfolio spanning targeted
therapies, immuno-oncology agents and antibody drug
conjugates.
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
Third Quarter 2023 Financial Results
- Cash and Marketable
Securities Position: As of September 30, 2023, Zentalis
had cash, cash equivalents and marketable securities of $516.6
million. The Company believes that its existing cash, cash
equivalents and marketable securities as of September 30, 2023 will
be sufficient to fund its operating expenses and capital
expenditure requirements into 2026.
- Research and Development
Expenses: Research and development (R&D) expenses for
the quarter ended September 30, 2023 were $46.8 million, compared
to $42.2 million for the quarter ended September 30, 2022. The
increase of $4.6 million was primarily attributable to $3.2 million
of costs shared with Zentera in the prior period, a $2.6 million
increase related to personnel expenses, of which $1.4 million
related to non-cash stock-based compensation expense, and $0.8
million related to consulting costs. These increases were partially
offset by decreases of $1.3 million and $0.7 million in facility
expenses and clinical expenses, respectively.
- General and Administrative
Expenses: General and administrative (G&A) expenses
for the quarter ended September 30, 2023 were $16.0 million,
compared to $12.0 million during the quarter ended September 30,
2022. This increase of $4.0 million was primarily attributable to a
$2.9 million increase in personnel expenses, of which $2.2 million
related to non-cash stock-based compensation expense, and a $1.1
million increase related to facilities and outside services.
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 and homologous recombination deficient tumors. 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 the Company to
execute on its fast-to-market strategy for azenosertib; the
potential to build a meaningful franchise around azenosertib;
opportunities with azenosertib across multiple tumor types; our
plans to submit an NDA for azenosertib in a gynecologic malignancy
and the timing thereof; our plans to evaluate azenosertib in PSOC
in the 1L maintenance setting in the clinic, and the timing
thereof; the potential for azenosertib to benefit a larger segment
of patients with ovarian cancer and fill a gap in the treatment
paradigm; 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; our plans to execute on a
succession plan for our Chief Scientific Officer; and the Company’s
cash runway. The terms “anticipate,” “believe,” “continue,”
“designed,” “milestone,” “on track,” “opportunity,” “plan,”
“potential,” “projected,” “promising,” “strategy,” “support,”
“target,” “to,” “will” 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:Katie Beach OltsikEvoke
CanaleKatherine.Beach@evokegroup.com
Zentalis Pharmaceuticals, Inc. |
Condensed Consolidated Statements of
Operations |
(Unaudited) |
(In thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating
Expenses |
|
|
|
|
|
|
|
Research and development |
$ |
46,765 |
|
|
$ |
42,181 |
|
|
$ |
138,033 |
|
|
$ |
132,118 |
|
Acquired in-process research and
development |
|
— |
|
|
|
— |
|
|
|
45,568 |
|
|
|
— |
|
General and administrative |
|
15,953 |
|
|
|
12,012 |
|
|
|
47,986 |
|
|
|
43,415 |
|
Total operating expenses |
|
62,718 |
|
|
|
54,193 |
|
|
|
231,587 |
|
|
|
175,533 |
|
Operating loss |
|
(62,718 |
) |
|
|
(54,193 |
) |
|
|
(231,587 |
) |
|
|
(175,533 |
) |
Other Income
(Expense) |
|
|
|
|
|
|
|
Investment and other income,
net |
|
7,209 |
|
|
|
1,905 |
|
|
|
15,769 |
|
|
|
2,755 |
|
Net loss before income taxes |
|
(55,509 |
) |
|
|
(52,288 |
) |
|
|
(215,818 |
) |
|
|
(172,778 |
) |
Income tax expense (benefit) |
|
31 |
|
|
|
(159 |
) |
|
|
(466 |
) |
|
|
(109 |
) |
Loss on equity method
investment |
|
— |
|
|
|
2,371 |
|
|
|
16,014 |
|
|
|
9,460 |
|
Net loss |
|
(55,540 |
) |
|
|
(54,500 |
) |
|
|
(231,366 |
) |
|
|
(182,129 |
) |
Net loss attributable to
noncontrolling interests |
|
(12 |
) |
|
|
(99 |
) |
|
|
(92 |
) |
|
|
(294 |
) |
Net loss attributable to
Zentalis |
$ |
(55,528 |
) |
|
$ |
(54,401 |
) |
|
$ |
(231,274 |
) |
|
$ |
(181,835 |
) |
Net loss per share outstanding,
basic and diluted |
$ |
(0.79 |
) |
|
$ |
(0.96 |
) |
|
$ |
(3.64 |
) |
|
$ |
(3.56 |
) |
Common shares used in computing
net loss per share, basic and diluted |
|
70,612 |
|
|
|
56,807 |
|
|
|
63,601 |
|
|
|
51,098 |
|
|
|
|
|
|
|
|
|
Zentalis Pharmaceuticals, Inc. |
Selected Condensed Consolidated Balance Sheet
Data |
(Unaudited) |
(In thousands) |
|
|
|
|
|
|
|
As of September 30, |
|
As of December 31, |
|
|
2023 |
|
2022 |
Cash, cash equivalents and
marketable securities |
|
$ |
516,637 |
|
$ |
437,371 |
Working capital (1) |
|
|
469,346 |
|
|
395,286 |
Total assets |
|
|
585,715 |
|
|
539,310 |
Total liabilities |
|
|
103,818 |
|
|
105,286 |
Total Zentalis equity |
|
$ |
481,897 |
|
$ |
434,024 |
|
|
|
|
|
(1) The Company
defines working capital as current assets less current
liabilities. |
|
|
Zentalis Pharmaceuticals (NASDAQ:ZNTL)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Zentalis Pharmaceuticals (NASDAQ:ZNTL)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024