Zentalis Pharmaceuticals Reports Second Quarter 2023 Financial Results and Operational Updates
09 Agosto 2023 - 8:00AM
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 June 30, 2023, and highlighted recent
corporate accomplishments.
“We have strong azenosertib data that creates the potential to
build a meaningful franchise around this exciting product candidate
with the possibility of near-, mid- and long-term opportunities
across multiple tumor types,” said Kimberly Blackwell, M.D., Chief
Executive Officer of Zentalis. “As a monotherapy, azenosertib
achieved an objective response rate of 36.8% in ovarian cancer and
uterine serous carcinoma patients who received intermittent dosing.
Azenosertib plus chemotherapy combinations also demonstrated
positive results in women facing heavily pretreated ovarian cancer.
Taking these results together, we believe there is the potential
for azenosertib to transform the standard of care for patients with
ovarian and uterine cancers, and ultimately other solid tumors. We
are well positioned to advance this program with a strong cash
position resulting from our recent offering that extended our cash
runway and will sustain our corporate and clinical strategy for the
next several years.”
WEE1 Inhibitor (Azenosertib) Program
Highlights
- Identified monotherapy
recommended Phase 2 dose (RP2D) and reported positive safety and
efficacy data. Based on encouraging Phase 1 dose
optimization clinical data, the Company identified 400 mg daily
(QD) on a 5 days on 2 days off (5:2) administration schedule as the
monotherapy RP2D. Intermittent dosing more than doubled steady
state drug exposure to achieve an objective response rate (ORR) of
36.8% in ovarian cancer and uterine serous carcinoma (USC)
patients, while maintaining safety and improving tolerability in
comparison to continuous dosing. For a more detailed summary of the
Phase 1 monotherapy dose optimization data, click here. To listen
to a replay of the call, click here.
- Presented positive azenosertib + chemotherapy
combination data at the 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting. The Company presented positive data
from its Phase 1b chemotherapy combination trial in
platinum-resistant ovarian cancer at the ASCO Annual Meeting in
Chicago on June 5, 2023. Azenosertib was well tolerated in
combination with multiple types of chemotherapy and demonstrated
strong anti-tumor activity, with noteworthy improvements in ORRs
and median progression free survival (mPFS) in all patients,
especially those with Cyclin E1+ tumors, a subgroup recognized to
have a poor prognosis and relatively poor outcomes following
chemotherapy. Azenosertib combined with paclitaxel resulted in an
ORR of 50.0% and mPFS of 7.4 months. An ORR of 35.7% and mPFS of
10.4 months was observed in azenosertib combined with carboplatin.
Zentalis is preparing for a Phase 3 trial of azenosertib using
intermittent dosing in combination with chemotherapy in Cyclin E1+
platinum-sensitive ovarian cancer. To review the Phase 1b results
in more detail, click here.
- Biomarker enrichment strategies. Zentalis is
exploring biomarker enrichment strategies for azenosertib targeting
tumors of high genomic instability, such as Cyclin E1+ tumors and
homologous recombination deficient tumors. In April 2023, the
Company presented preclinical data supporting the rationale for the
Cyclin E1 enrichment strategy at the American Association for
Cancer Research (AACR) Annual Meeting 2023.
Corporate Highlights
- In August 2023, the Company announced the appointment of
Kimberly Freeman as Chief Strategy Officer. In this role, she will
support and implement Zentalis’ long-term portfolio strategy. Ms.
Freeman joins Zentalis with over 25 years of clinical development
and strategic leadership experience, including deep expertise in
oncology, particularly in gynecologic malignancies and the DNA
damage response (DDR) pathway. Ms. Freeman brings an outstanding
track record of building and executing drug development and
franchise strategies that will be invaluable to the Company as it
seeks to capitalize on the significant opportunity with azenosertib
across a broad array of tumor types.
- In June 2023, the Company closed an underwritten public
offering of 11,032,656 shares of its common stock at a public
offering price of $22.66 per share. The total gross proceeds were
approximately $250.0 million.
- In May 2023, the Company appointed Diana Hausman, M.D., to its
Board of Directors. Dr. Hausman is an oncologist with extensive
experience in all aspects of drug development, including
development and implementation of clinical strategy. Dr. Hausman is
currently serving as Chief Medical Officer of Link
Immunotherapeutics. Dr. Hausman previously served as Chief Medical
Officer of Lengo Therapeutics, Zymeworks and Oncothyreon. Prior to
Oncothyreon, Dr. Hausman held positions of increasing
responsibility at ZymoGenetics, Berlex Laboratories and Immunex.
Dr. Hausman currently serves on the Board of Directors of
Immuneering.
- In May 2023, the Company announced that it had appointed Funda
Meric-Bernstam, M.D., a widely recognized Phase 1 trial expert and
experimental therapeutics researcher in oncology, to its Scientific
Advisory Board. Dr. Meric-Bernstam is the Chair of the Department
of Investigational Cancer Therapeutics -- the Phase 1 Program at
The University of Texas MD Anderson Cancer Center. Her clinical
research is focused on novel therapeutics, novel combination
therapies and biomarkers to predict and monitor drug response.
Second Quarter 2023 Financial Results
- Cash and Marketable Securities Position: As of
June 30, 2023, Zentalis had cash, cash equivalents and marketable
securities of $553.0 million. The Company believes that its
existing cash, cash equivalents and marketable securities as of
June 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 three months ended June
30, 2023 were $42.7 million, compared to $43.8 million for the
three months ended June 30, 2022. The decrease of $1.1 million was
primarily due to $1.7 million in decreased collaboration costs, a
$1.1 million decrease related to clinical trials and R&D
supplies, and a $0.6 million reduction in personnel and related
expense. These decreases were partially offset by a $1.5 million
increase in Zentera Therapeutics cost sharing and a $0.8 million
increase in consulting and other expense.
- General and Administrative Expenses: General
and administrative expenses for the three months ended June 30,
2023 were $15.7 million, compared to $19.6 million during the three
months ended June 30, 2022. This decrease of $3.9 million was
primarily attributable to a $4.2 million decrease in non-cash,
stock-based compensation expense and a $0.8 million decrease
related to other personnel expenses. These decreases were partially
offset by an increase of $0.8 million in allocated overhead
expenditures and a $0.3 million increase in outside services and
other costs.
- Zentera-Related Expenses: On June 15, 2023,
the Company announced that it had regained worldwide development
and commercialization rights to azenosertib, ZN-d5 and ZN-c5 as a
result of the termination of its collaboration with Zentera
Therapeutics in certain Asian countries, including China. In
connection with the Zentera termination, the Company incurred
one-time expenses totaling $45.6 million.
About Azenosertib Azenosertib 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 PharmaceuticalsZentalis®
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company
focused on discovering and developing small molecule therapeutics
targeting fundamental biological pathways of cancers. Utilizing its
Integrated Discovery Engine, the Company is developing a focused
pipeline of potentially best-in-class oncology candidates, which
include azenosertib (ZN-c3), a WEE1 inhibitor for advanced solid
tumors, ZN-d5, a BCL-2 inhibitor for hematologic malignancies and
related disorders, and a heterobifunctional degrader of BCL-xL for
solid and hematological malignancies. 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 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 to build a meaningful
franchise around azenosertib; opportunities with azenosertib across
multiple tumor types; the potential for azenosertib to transform
the standard of care for patients with ovarian and uterine cancers,
and potentially other solid tumors; the potential benefits of
azenosertib, including the potential benefits of the design
thereof; and the Company’s cash runway. The terms “believe,”
“designed,” “opportunity,” “potential,” “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.
Dr. Meric-Bernstam receives compensation as a member of the
Zentalis Scientific Advisory Board, and this financial relationship
has been disclosed to MD Anderson’s Conflict of Interest Committee
in accordance with its institutional policy.
Contact:
Katie Beach Oltsik Evoke
CanaleKatherine.Beach@evokegroup.com
Zentalis Pharmaceuticals, Inc. |
Condensed Consolidated Statements of
Operations |
(Unaudited) |
(In thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating Expenses |
|
|
|
|
|
|
|
Research
and development |
$42,684 |
|
|
$43,825 |
|
|
$91,268 |
|
|
$89,937 |
|
Zentera
in-process research and development |
|
45,568 |
|
|
|
— |
|
|
|
45,568 |
|
|
|
— |
|
General
and administrative |
|
15,664 |
|
|
|
19,636 |
|
|
|
32,033 |
|
|
|
31,403 |
|
Total
operating expenses |
|
103,916 |
|
|
|
63,461 |
|
|
|
168,869 |
|
|
|
121,340 |
|
Operating loss |
|
(103,916 |
) |
|
|
(63,461 |
) |
|
|
(168,869 |
) |
|
|
(121,340 |
) |
Other Income (Expense) |
|
|
|
|
|
|
|
Investment and other income, net |
|
4,451 |
|
|
|
424 |
|
|
|
8,560 |
|
|
|
850 |
|
Net loss
before income taxes |
|
(99,465 |
) |
|
|
(63,037 |
) |
|
|
(160,309 |
) |
|
|
(120,490 |
) |
Income
tax expense (benefit) |
|
(605 |
) |
|
|
17 |
|
|
|
(497 |
) |
|
|
50 |
|
Loss on
equity method investment |
|
13,704 |
|
|
|
5,338 |
|
|
|
16,014 |
|
|
|
7,089 |
|
Net
loss |
|
(112,564 |
) |
|
|
(68,392 |
) |
|
|
(175,826 |
) |
|
|
(127,629 |
) |
Net loss
attributable to noncontrolling interests |
|
(37 |
) |
|
|
(35 |
) |
|
|
(80 |
) |
|
|
(195 |
) |
Net loss
attributable to Zentalis |
$(112,527 |
) |
|
$(68,357 |
) |
|
$(175,746 |
) |
|
$(127,434 |
) |
Net loss
per common share outstanding, basic and diluted |
$(1.85 |
) |
|
$(1.34 |
) |
|
$(2.93 |
) |
|
$(2.64 |
) |
Common
shares used in computing net loss per share, basic and diluted |
|
60,790 |
|
|
|
51,117 |
|
|
|
60,038 |
|
|
|
48,197 |
|
Zentalis Pharmaceuticals, Inc. |
Selected Condensed Consolidated Balance Sheet
Data |
(Unaudited) |
(In thousands) |
|
|
|
|
|
|
|
As of June 30, |
|
As of December 31, |
|
|
|
2023 |
|
|
2022 |
Cash, cash equivalents and
marketable securities |
|
$552,986 |
|
$437,371 |
Working capital (1) |
|
|
512,170 |
|
|
395,286 |
Total assets |
|
|
621,444 |
|
|
539,310 |
Total liabilities |
|
|
98,162 |
|
|
105,286 |
Total Zentalis equity |
|
$523,282 |
|
$434,024 |
|
|
|
|
|
(1) The Company
defines working capital as current assets less current
liabilities. |
|
|
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