Zentalis Pharmaceuticals Reports First Quarter 2024 Financial Results and Operational Progress
May 07 2024 - 7:00AM
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 quarter ended March 31, 2024, and highlighted recent
corporate accomplishments. "Zentalis continues to advance towards a
catalyst-rich period during the second half of 2024 and into 2025,
with a clear path to demonstrating the clinical profile of
azenosertib, our potentially first-in-class and best-in-class WEE1
inhibitor, across various tumor types," said Kimberly Blackwell,
M.D., Chief Executive Officer. "We believe that the data emerging
this year and next have the potential to establish azenosertib’s
monotherapy activity, differentiated safety and efficacy profile,
and its ability to address significant unmet need for patients with
serious gynecological cancers. Our clinical development plan
remains on track as we work to bring azenosertib to patients living
with gynecological cancers and other solid tumors.”
Program Updates and
Highlights
-
Phase 1 azenosertib clinical data in osteosarcoma to be
presented at ASCO. In accordance with the Company’s
guidance, Phase 1 results of azenosertib in combination with
gemcitabine in adult and pediatric patients with relapsed or
refractory (R/R) osteosarcoma will be presented in a poster session
at the 2024 American Society of Clinical Oncology (ASCO) Annual
Meeting.
-
Azenosertib preclinical data at AACR. On April 9,
2024, Zentalis presented preclinical data demonstrating that
azenosertib exerts synergistic anti-tumor activity with KRASG12C
inhibitors at the American Association of Cancer Research (AACR)
Annual Meeting. This research supports azenosertib’s potential to
be highly synergistic in combination with KRAS targeted cancer
therapeutics, creating an additional large opportunity to combine
with other standard of care targeted agents.
-
Azenosertib development continues to progress on track
across gynecological and other 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 (PSOC), uterine serous carcinoma (USC),
BRAF mutant metastatic colorectal cancer, and other solid tumors.
In addition, the Company is evaluating azenosertib and its BCL-2
inhibitor (ZN-d5) in patients with R/R acute myeloid leukemia
(AML).
Corporate Updates
- On April 5, 2024, Cam Gallagher was
appointed interim Chief Financial Officer while the Company
conducts a search for a new Chief Financial Officer.
Anticipated Upcoming Milestones
- 1H 2024
- Presentation of final results of Phase 1 (ZN-c3-003)
azenosertib + chemotherapy (gemcitabine) trial in R/R osteosarcoma
at 2024 ASCO Annual Meeting
- 2H 2024
- Presentation of final results of Phase 1b (ZN-c3-001)
azenosertib monotherapy trial in solid tumors
- Topline data from Phase 1/2 MAMMOTH (ZN-c3-006) azenosertib +
PARP inhibitor (niraparib) and azenosertib monotherapy trial in
platinum resistant ovarian cancer in partnership with GSK
- Presentation of initial data from Phase 1 (ZN-c3-016)
azenosertib + BEACON regimen (encorafenib + cetuximab) trial in
BRAF mutant metastatic colorectal cancer in partnership with
Pfizer
- Initial data from Phase 1 (ZN-d5-004C) azenosertib + ZN-d5
trial in R/R AML
- Additional details on design of planned registration-enabling
trial of azenosertib in PSOC in the 1L maintenance setting
- 1H 2025
- Topline data from registration-enabling Phase 2 DENALI study
(ZN-c3-005) of azenosertib monotherapy in platinum resistant
high-grade serous ovarian cancer
- 2H 2025
- Topline data from registration-enabling Phase 2 TETON study
(ZN-c3-004) of azenosertib monotherapy in recurrent or persistent
USC
- 2025
- Initiate registration-enabling trial of azenosertib in PSOC in
the 1L maintenance setting
- 2026
- First NDA for azenosertib in a
gynecologic malignancy
First Quarter 2024 Financial Results
- Cash,
Cash Equivalents and Marketable Securities Position: As of
March 31, 2024, Zentalis had cash, cash equivalents and marketable
securities of $489.0 million, which includes $56.7 million
representing the March 31, 2024 fair value of Immunome common stock
received by the Company as part of its upfront payment for the
out-licensing of its ROR1 antibody-drug conjugate (ADC) product
candidate and ADC platform in January 2024. The Company believes
that its existing cash, cash equivalents and marketable securities
(excluding the Immunome stock) as of March 31, 2024 will be
sufficient to fund its operating expenses and capital expenditure
requirements into mid-2026.
- Research
and Development Expenses: Research and development
(R&D) expenses for the three months ended March 31, 2024, were
$49.6 million, compared to $48.6 million for the three months ended
March 31, 2023. The increase of $1.0 million was primarily due to
increases of $2.4 million and $2.2 million from drug product and
clinical expense, respectively. We also saw increases of $0.7
million and $0.7 million from consulting and R&D cost sharing,
respectively. These increases were partially offset by a decrease
of $4.7 million in overhead allocations and a $0.3 million decrease
of personnel expense.
- General and Administrative
Expenses: General and administrative expenses for the
three months ended March 31, 2024, were $15.7 million, compared to
$16.4 million during the three months ended March 31, 2023. This
decrease of $0.7 million was primarily attributable to $0.8 million
and $0.7 million decreases in depreciation and other expenses,
respectively. This was partially offset by $0.8 million increase
related to personnel expense, of which $0.2 million is from
non-cash stock-based compensation expense.
About AzenosertibAzenosertib is
a novel, selective, and orally bioavailable inhibitor of WEE1
currently being evaluated as a monotherapy and combination clinical
studies in ovarian cancer and additional tumor types. WEE1 acts as
a master regulator of the G1-S and G2-M cell cycle checkpoints,
through negative regulation of both CDK1 and CDK2, to prevent
replication of cells with damaged DNA. By inhibiting WEE1,
azenosertib enables cell cycle progression, despite high levels of
DNA damage, thereby resulting in the accumulation of DNA damage and
leading to mitotic catastrophe and cancer cell death.
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 address significant unmet need
for patients with serious gynecological cancers; the broad
franchise potential of azenosertib; our anticipated milestones and
the timing thereof, including plans and timing to share multiple
data readouts in gynecological and other cancer types; the
potential for data emerging this year and next to establish
azenosertib’s monotherapy activity, differentiated safety and
efficacy profile; our plans to present Phase 1 azenosertib clinical
data in osteosarcoma at the 2024 ASCO Annual Meeting; the potential
for azenosertib to be highly synergistic in combination with KRAS
targeted cancer therapeutics, creating an additional large
opportunity to combine with other standard of care agents; our
plans with respect to the development of our product candidates,
including azenosertib and ZN-d5; the potential benefits of our
product candidatesand the Company’s cash runway. The terms
“advancing,” “anticipate,” “believe,” “continue,” “milestone,” “on
track,” “plan,” “potential,” “projected,” “progress,” “strategy,”
“will,” “work to bring,” 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.
Contact:Elizabeth Pingpank
Hickinehickin@zentalis.com860-463-0469
Zentalis Pharmaceuticals,
Inc.Consolidated Statements of
Operations(In thousands, except per share
amounts)
|
|
|
|
|
Three Months Ended March 31, |
|
2024 |
|
2023 |
License Revenue |
$ |
40,560 |
|
|
$ |
- |
|
Operating
Expenses |
|
|
|
Research and development |
|
49,585 |
|
|
|
48,584 |
|
General and administrative |
|
15,740 |
|
|
|
16,369 |
|
Total operating expenses |
|
65,325 |
|
|
|
64,953 |
|
Loss from operations |
|
(24,765 |
) |
|
|
(64,953 |
) |
Other Income
(Expense) |
|
|
|
Investment and other income,
net |
|
34,948 |
|
|
|
4,109 |
|
Net income (loss) before income
taxes |
|
10,183 |
|
|
|
(60,844 |
) |
Income tax expense |
|
143 |
|
|
|
108 |
|
Loss on equity method
investment |
|
- |
|
|
|
2,310 |
|
Net income (loss) |
|
10,040 |
|
|
|
(63,262 |
) |
Net loss attributable to
noncontrolling interests |
|
(28 |
) |
|
|
(43 |
) |
Net income (loss) attributable to
Zentalis |
$ |
10,068 |
|
|
$ |
(63,219 |
) |
Earnings per share |
|
|
|
Basic |
$ |
0.14 |
|
|
$ |
(1.07 |
) |
Diluted |
$ |
0.14 |
|
|
$ |
(1.07 |
) |
Weighted average common shares
outstanding |
|
|
|
Basic |
|
70,898 |
|
|
|
59,277 |
|
Diluted |
|
71,192 |
|
|
|
59,277 |
|
|
Zentalis Pharmaceuticals, Inc. |
Selected Condensed Consolidated Balance Sheet
Data |
(In thousands) |
|
|
|
|
|
|
|
As of March 31, |
|
As of December 31, |
|
|
|
2024 |
|
|
2023 |
Cash, cash equivalents and
marketable securities |
|
$ |
488,984 |
|
$ |
482,919 |
Working capital (1) |
|
|
449,008 |
|
|
427,351 |
Total assets |
|
|
557,479 |
|
|
551,688 |
Total liabilities |
|
|
98,708 |
|
|
114,297 |
Total Zentalis equity |
|
$ |
458,771 |
|
$ |
437,391 |
|
|
|
|
|
(1) The Company
defines working capital as current assets less current
liabilities. |
|
|
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