Zentalis Pharmaceuticals Reports Second Quarter 2021 Financial Results and Operational Update
August 12 2021 - 7:00AM
Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage
biopharmaceutical company focused on discovering and developing
small molecule therapeutics targeting fundamental biological
pathways of cancers, today announced financial results for the
second quarter ended June 30, 2021 and highlighted recent corporate
accomplishments.
“We have had an extremely productive second quarter, marked by
significant clinical and regulatory advances that were outlined in
our mid-year review in June. The data presented continue to support
our candidates’ potential for best-in-class positioning – both as
monotherapies and in combinations – for an array of
difficult-to-treat cancers,” commented Dr. Anthony Sun, Chairman
and Chief Executive Officer of Zentalis. “Of note, our lead
candidate, ZN-c3, demonstrated additional deepening and durable
tumor responses, and based on this maturing data presented in June,
we have identified potential accelerated approval paths for this
candidate in USC and a biomarker-driven setting, with the Phase 2
trial in USC already underway.”
Continued Dr. Sun, “Furthermore, this momentous period for
Zentalis was reinforced by the completion of a recent upsized
public offering in which we raised approximately $173 million in
gross proceeds. This financing ensures we are well-positioned to
fund all upcoming key milestones, with the goal of delivering
differentiated cancer treatments to patients globally.”
Program Highlights:
- In June 2021, Zentalis hosted a mid-year update webcast,
providing key clinical and regulatory updates across its pipeline.
Clinical highlights from the update included: five confirmed
Partial Responses (PRs) and one unconfirmed PR in the Phase 1
monotherapy trial of ZN-c3 in a range of heavily pre-treated solid
tumors; plans for two potentially registrational trials for ZN-c3
in USC and a biomarker-driven setting; an oral dose of 50 mg QD
demonstrating a Clinical Benefit Rate of 40% in the Phase 1
monotherapy trial of ZN-c5 in ER+/HER2- breast cancer. For more
information on the clinical results reported, click here.
- In July 2021, the Company dosed the first patient in a Phase 2
trial of ZN-c3 in women with recurrent or persistent USC. Following
an end-of-Phase 1 meeting, the U.S. Food and Drug Administration
(FDA) agreed in principle that ZN-c3 has the potential for an
accelerated approval pathway based on the Phase 2 global study
design in USC.
- In June 2021, the Company received orphan drug and rare
pediatric disease designations from the FDA for ZN-c3 in
combination with chemotherapy for the treatment of osteosarcoma.
Zentalis expects to initiate a Phase 1/2 trial in 3Q
2021.
- In April 2021, Zentalis reported initial results from the Phase
1 portion of a Phase 1/2 trial of ZN-c3 in advanced solid tumors in
a late-breaking session at the AACR Annual Meeting, which was
further discussed at a webcast event with Key Opinion Leaders.
- In April 2021, Zentalis entered into a Clinical Trial
Collaboration and Supply Agreement with GSK to investigate the
combination of ZN-c3 and niraparib, GSK’s poly (ADP-ribose)
polymerase (PARP) inhibitor, in patients with advanced epithelial
ovarian cancer. The Company expects to initiate a Phase 1b trial
with this combination in the second half of 2021.
Zentera Highlights:
- In July 2021, Zentera, a Shanghai-based clinical-stage
biopharmaceutical company formed by Zentalis, announced the
completion of a $75 million Series B financing. The proceeds will
be used to advance the clinical development of three
Zentalis-discovered candidates, ZN-c3, ZN-c5 and ZN-d5, in China,
in addition to business development opportunities for pipeline
expansion.
- As of July 2021, Zentera had received CTA acceptances in China
for ZN-c3, ZN-c3 in combination, ZN-c5 and ZN-d5. Two clinical
trials are ongoing with plans to initiate one more trial by
year-end 2021.
Corporate Highlights:
- In July 2021, Zentalis closed an underwritten public offering
of 3,565,000 shares of its common stock at a public offering price
of $48.50 per share. The total gross proceeds were approximately
$172.9 million, before deducting underwriting discounts and
commissions and offering expenses payable by Zentalis.
Second Quarter 2021 Financial Results
- Cash and Marketable Securities Position: As of
June 30, 2021, Zentalis had cash, cash equivalents and marketable
securities of $250.9 million. We believe that our existing cash,
cash equivalents and marketable securities as of June 30, 2021,
together with the net proceeds from our July 2021 follow-on
offering, will enable us to fund our operating expenses and capital
expenditure requirements into the third quarter of 2023.
- Research and Development Expenses: Research
and development expenses for the three months ended June 30, 2021
were $44.8 million, compared to $17.5 million for the three months
ended June 30, 2020. The increase of $27.3 million was primarily
due to increases in external research and development expenses
related to our lead product candidates, as we advanced our Phase
1/2 clinical trials for ZN-c3 and ZN-c5. In addition, in the three
months ended June 30, 2021, we conducted additional preclinical
studies, incurred additional manufacturing costs, and incurred
increased costs for study and lab materials.
- General and Administrative Expenses: General
and administrative expenses for the three months ended June 30,
2021 were $10.4 million, compared to $9.9 million during the three
months ended June 30, 2020. This increase of $0.5 million was
primarily attributable to an increase of $2.0 million in
employee-related and supply costs, partially offset by a reduction
in allocable overhead facility expenses.
- Net Loss: Net loss was $55.1 million for three
months ended June 30, 2021, compared to $27.3 million for the three
months ended June 30, 2020. The $27.8 million increase in net loss
was primarily the result of the increases in research and
development and general and administrative expenses discussed
above.
- Impact from COVID-19 Pandemic: Though the
impact of the COVID-19 pandemic to our business and operating
results presents additional uncertainty and cannot be predicted
with confidence, we continue to use the best information available
to inform our critical accounting estimates.
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. The Company
is developing a broad pipeline of potentially best-in-class
oncology candidates, which include ZN-c3, a WEE1 inhibitor for
advanced solid tumors, ZN-c5, an oral selective estrogen receptor
degrader (SERD) for ER+/HER2- breast cancer, ZN-d5, a BCL-2
inhibitor for hematologic malignancies, and ZN-e4, an EGFR
inhibitor for non-small cell lung carcinoma (NSCLC). 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
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 without limitation statements regarding our expectations
surrounding the development, potential, safety, efficacy, and
regulatory and clinical progress of our product candidates in the
Unites States and globally, plans and timing for the initiation of
and the release of data from our clinical trials and our ability to
meet other key milestones, activities in connection with our
collaboration with Tempus, the anticipated impact of the COVID-19
pandemic on our business and operating results, our participation
in upcoming events and presentations, and the sufficiency of our
cash and cash equivalents. 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: the COVID-19 pandemic has adversely impacted and may
continue to adversely impact our business, including our
preclinical studies and clinical trials; 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 substantial
dependence on the success of our lead product candidate; failure to
identify additional product candidates and develop or commercialize
marketable products; the early stage of our development efforts;
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
significant costs as a result of operating as a public company.
These and other important factors discussed under the caption “Risk
Factors” in our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2021 filed with the U.S. Securities and Exchange
Commission (SEC) and our other filings with the SEC could cause
actual results to differ materially from those indicated by the
forward-looking statements made in this press release. 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.
Investor Contact:Gitanjali JainSolebury
Troutgogawa@soleburytrout.com
Media Contact:Julia DeutschSolebury
Troutjdeutsch@soleburytrout.com
Zentalis Pharmaceuticals,
Inc.Condensed Consolidated Statements of
Operations(Unaudited)(In
thousands, except per unit and per share amounts)
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Operating
Expenses |
|
|
|
|
|
|
|
Research and development |
$ |
44,770 |
|
|
$ |
17,452 |
|
|
$ |
83,164 |
|
|
$ |
30,710 |
|
General and administrative |
10,362 |
|
|
9,924 |
|
|
22,315 |
|
|
13,065 |
|
Total operating expenses |
55,132 |
|
|
27,376 |
|
|
105,479 |
|
|
43,775 |
|
Operating loss |
(55,132 |
) |
|
(27,376 |
) |
|
(105,479 |
) |
|
(43,775 |
) |
Other Income
(Expense) |
|
|
|
|
|
|
|
Investment and other income, net |
115 |
|
|
84 |
|
|
214 |
|
|
248 |
|
Other expense |
(139 |
) |
|
— |
|
|
(183 |
) |
|
— |
|
Net loss before income taxes |
(55,017 |
) |
|
(27,292 |
) |
|
(105,265 |
) |
|
(43,527 |
) |
Income tax expense |
45 |
|
|
— |
|
|
241 |
|
|
— |
|
Net loss |
(55,062 |
) |
|
(27,292 |
) |
|
(105,506 |
) |
|
(43,527 |
) |
Net loss attributable to
noncontrolling interests |
(488 |
) |
|
(435 |
) |
|
(1,031 |
) |
|
(544 |
) |
Net loss attributable to
Zentalis |
$ |
(54,574 |
) |
|
$ |
(26,857 |
) |
|
$ |
(104,475 |
) |
|
$ |
(42,983 |
) |
Net loss per common share
outstanding, basic and diluted |
$ |
(1.34 |
) |
|
$ |
(0.78 |
) |
|
$ |
(2.58 |
) |
|
$ |
(2.53 |
) |
Common shares used in computing
net loss per share, basic and diluted |
40,738 |
|
|
34,353 |
|
|
40,549 |
|
|
16,978 |
|
Zentalis Pharmaceuticals, Inc.
Selected Condensed Consolidated Balance Sheet
Data(Unaudited)(In
thousands)
|
As of June 30, |
|
As of December 31, |
|
2021 |
|
2020 |
Cash, cash equivalents and marketable securities |
$ |
250,900 |
|
|
$ |
338,505 |
|
Working capital (1) |
225,872 |
|
|
316,503 |
|
Total assets |
283,962 |
|
|
365,555 |
|
Total liabilities |
36,353 |
|
|
32,178 |
|
Total Zentalis equity |
$ |
247,609 |
|
|
$ |
333,377 |
|
|
|
|
|
(1) The Company
defines working capital as current assets less current
liabilities. |
|
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