Turning Point Therapeutics Reports Second-Quarter 2022 Financial Results, Provides Operational Updates
August 08 2022 - 4:17PM
Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage
precision oncology company designing and developing novel targeted
therapies for cancer treatment, today reported financial results
for the quarter ended June 30, 2022 and provided operational
updates.
“We are pleased with our continued pipeline
advancement and expansion,” said Athena Countouriotis, M.D.,
President and CEO. “We look forward to a productive second half of
the year, with multiple data readouts and continued regulatory
progress.”
Second quarter and recent operational
highlights include:
REPOTRECTINIB:
- Announced receipt of positive feedback from the FDA at a
pre-NDA meeting completed during the second quarter. The feedback
focused on the proposed patient follow-up within the ROS1-positive
advanced NSCLC patient cohorts of the ongoing TRIDENT-1
registrational study. The purpose of the pre-NDA meeting was to
discuss the company’s planned NDA for repotrectinib for the
treatment of ROS1+ advanced NSCLC. The FDA agreed with the
company’s plan to provide data for ROS1+ TKI-naïve and
TKI-pretreated advanced NSCLC patients with at least six months of
follow-up from the first post-baseline scan at the time of NDA
submission.
- Received Breakthrough Therapy designation (BTD) from the FDA
for repotrectinib for the treatment of patients with ROS1-positive
metastatic NSCLC who have been previously treated with one ROS1
tyrosine kinase inhibitor and who have not received prior
platinum-based chemotherapy. This represents the eighth regulatory
designation granted by the FDA for repotrectinib.
ELZOVANTINIB:
- Initiated the Phase 1b/2 SHIELD-2 combination study of
elzovantinib and aumolertinib in EGFR mutant MET-amplified advanced
non-small cell lung cancer. The combination of elzovantinib and
aumolertinib is being studied in patients with EGFR mutant
MET-amplified advanced NSCLC who have progressed following
treatment with osimertinib. The study will evaluate the safety,
tolerability and preliminary efficacy of the combination
regimen.
TPX-4589
- Initiated patient dosing in the third dosing level cohort in
the Phase 1 study of TPX-4589. TPX-4589 is a potentially
first-in-class anti-Claudin18.2 antibody drug conjugate (ADC) that
suppresses cell proliferation of gastric and pancreatic cell lines
with nanomolar potency in preclinical models. It is currently being
studied in two ongoing Phase 1 studies in patients with advanced
solid tumors.
BUSINESS DEVELOPMENT:
- Announced a strategic research and development alliance with
The University of Texas MD Anderson Cancer Center to expand the
evaluation of repotrectinib and elzovantinib. The planned focus of
the alliance includes monotherapy and potential combinations with
other agents – including chemotherapy, immunotherapies and other
targeted agents.
- Entered into an exclusive license agreement with LaNova
Medicines Limited to develop and commercialize LM-302, now known as
TPX-4589, a novel antibody drug conjugate targeting Claudin18.2, in
the United States and rest of the world excluding Greater China and
South Korea. Claudin18.2 is a protein expressed in many
gastrointestinal cancers, including gastric, gastroesophageal
junction and pancreatic cancer. TPX-4589 is currently in Phase 1
clinical trials in both the United States and China.
- Announced a definitive merger agreement with Bristol Myers
Squibb to acquire Turning Point Therapeutics for $76.00 per share.
The transaction was unanimously approved by both the Bristol Myers
Squibb and Turning Point Therapeutics Boards of Directors and is
anticipated to close during the third quarter of 2022.
Upcoming Milestones
REPOTRECTINIB
- Present detailed study results, including intracranial
activity, from the ROS1-positive advanced NSCLC cohorts of the
TRIDENT-1 study at a medical conference in the second half of
2022.
- Provide a clinical data update from the NTRK+ advanced solid
tumor cohorts from TRIDENT-1 in the second half of 2022.
ELZOVANTINIB
- Initiate the Phase 2 portion of the SHIELD-1 study in the
second half of 2022, pending FDA feedback on data from the
intermediate dose level.
- Provide a clinical data update from the Phase 1 SHIELD-1 study
in the second half of 2022.
TPX-0131
- Provide early
interim data from initial patients treated in the dose-finding
portion of the FORGE-1 study in the fourth quarter of 2022 or early
2023.
TPX-4589
- Present preclinical data at a medical conference by early
2023.
- Provide additional guidance on clinical development plan by
early 2023.
DISCOVERY
- Nominate 2 development candidates in the second half of
2022.
- Provide details on the other 2 GTPase signaling discovery
programs in the second half of 2022.
Second Quarter 2022 Financial
Results
- Revenue: Revenue recognized during the second quarter of 2022
was $0.1 million from the sale of clinical supply to Zai Lab
(Shanghai) Co. Ltd. (Zai), compared to $5.2 million during the
second quarter of 2021, consisting of $5.0 million earned upon the
achievement of development milestones under the license agreement
with Zai regarding repotrectinib and $0.2 million from the sale of
clinical supply to Zai.
- R&D Expenses: Research and development expenses were $86.8
million for the second quarter of 2022 compared to $44.7 million
for the second quarter of 2021. Primary drivers of the
year-over-year increase were investments made to develop
repotrectinib, discovery efforts and personnel expenses. In
addition, R&D expenses for the second quarter of 2022 included
an upfront payment of $25.0 million to LaNova for the in-licensing
of its intellectual property that has not yet achieved regulatory
approval.
- G&A Expenses: General and administrative expenses were
$37.7 million for the second quarter of 2022 compared to $17.2
million for the second quarter of 2021. G&A expenses for the
second quarter of 2022 included approximately $17.7 million of
transaction costs incurred in connection with the pending
acquisition by Bristol Myers Squibb.
- Net Loss: Net loss was $123.1 million for the second quarter of
2022 compared to net loss of $56.3 million for the second quarter
of 2021.
- Cash Position: Cash, cash equivalents and marketable securities
as of June 30, 2022 totaled $818.3 million, reflecting a net
decrease of approximately $99.9 million from March 31, 2022.
About Turning Point Therapeutics
Inc.Turning Point Therapeutics is a clinical-stage
precision oncology company with a pipeline of investigational drugs
designed to address key limitations of existing cancer therapies.
The company’s lead drug candidate, repotrectinib, is a
next-generation kinase inhibitor targeting the ROS1 and TRK
oncogenic drivers of non-small cell lung cancer and advanced solid
tumors. Repotrectinib, which is being studied in a registrational
Phase 2 study in adults and a Phase 1/2 study in pediatric
patients, has shown antitumor activity and durable responses among
kinase inhibitor treatment-naïve and pre-treated patients. The
company’s pipeline of drug candidates also includes elzovantinib,
targeting MET, CSF1R and SRC, which is being studied in a Phase 1
trial of patients with advanced or metastatic solid tumors
harboring genetic alterations in MET; TPX-0046, targeting RET,
which is being studied in a Phase 1/2 trial of patients with
advanced or metastatic solid tumors harboring genetic alterations
in RET; TPX-0131, a next-generation ALK inhibitor, which is being
studied in a Phase 1/2 trial of previously treated patients with
ALK-positive advanced or metastatic non-small cell lung cancer; and
TPX-4589 (LM-302), a novel ADC targeting Claudin18.2 which is being
studied in a Phase 1 study in gastrointestinal cancers. The company
is driven to develop therapies that mark a turning point for
patients in their cancer treatment. For more information,
visit www.tptherapeutics.com.
Forward Looking
StatementsStatements contained in this press release
regarding matters that are not historical facts are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as “plans”,
“will”, “believes,” “anticipates,” “expects,” “intends,” “goal,”
“potential” and similar expressions are intended to identify
forward-looking statements. Such forward-looking statements include
statements regarding, among other things, the efficacy, safety and
therapeutic potential of Turning Point Therapeutics’ drug
candidates, repotrectinib, elzovantinib, TPX-0046, TPX-0131, and
TPX-4589, the results, conduct, progress and timing of Turning
Point Therapeutics’ research and development programs and clinical
trials, plans regarding future data presentations, clinical trials,
regulatory meetings and regulatory submissions, the regulatory
approval path for repotrectinib, and the closing and proposed
timing of the pending acquisition by Bristol Myers Squibb. Because
such statements are subject to risks and uncertainties, actual
results may differ materially from those expressed or implied by
such forward-looking statements. These forward-looking statements
are based upon Turning Point Therapeutics’ current expectations and
involve assumptions that may never materialize or may prove to be
incorrect. Actual results could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
risks and uncertainties associated with Turning Point Therapeutics’
business in general, risks and uncertainties related to the impact
of the COVID-19 pandemic to Turning Point Therapeutics’ business
and the other risks described in Turning Point Therapeutics’
filings with the Securities and Exchange Commission (SEC),
including its quarterly report on Form 10-Q filed with
the SEC on August 8, 2022. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Turning Point
Therapeutics undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
TURNING POINT THERAPEUTICS, INC.
Balance Sheet Data(In
thousands)(unaudited)
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
2022 |
|
|
2021 |
|
Balance Sheet
Data: |
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
$ |
818,286 |
|
|
$ |
981,582 |
|
Working capital |
|
782,244 |
|
|
|
945,373 |
|
Total assets |
|
843,335 |
|
|
|
1,003,463 |
|
Accumulated deficit |
|
(714,260 |
) |
|
|
(516,727 |
) |
Total stockholders'
equity |
$ |
793,022 |
|
|
$ |
954,425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TURNING POINT THERAPEUTICS,
INC.Statements of Operations and Comprehensive
Loss(In thousands, except share and per share
amounts)(unaudited)
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue |
$ |
119 |
|
|
$ |
5,164 |
|
|
$ |
548 |
|
|
$ |
30,369 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
86,788 |
|
|
|
44,650 |
|
|
|
141,838 |
|
|
|
85,913 |
|
General and administrative |
|
37,695 |
|
|
|
17,171 |
|
|
|
58,009 |
|
|
|
37,162 |
|
Total operating expenses |
|
124,483 |
|
|
|
61,821 |
|
|
|
199,847 |
|
|
|
123,075 |
|
Loss from operations |
|
(124,364 |
) |
|
|
(56,657 |
) |
|
|
(199,299 |
) |
|
|
(92,706 |
) |
Other income, net |
|
1,276 |
|
|
|
384 |
|
|
|
1,766 |
|
|
|
929 |
|
Net loss |
|
(123,088 |
) |
|
|
(56,273 |
) |
|
|
(197,533 |
) |
|
|
(91,777 |
) |
Unrealized loss on marketable securities |
|
(1,522 |
) |
|
|
(22 |
) |
|
|
(5,640 |
) |
|
|
(208 |
) |
Comprehensive loss |
$ |
(124,610 |
) |
|
$ |
(56,295 |
) |
|
$ |
(203,173 |
) |
|
$ |
(91,985 |
) |
Net loss per share, basic and
diluted |
$ |
(2.48 |
) |
|
$ |
(1.14 |
) |
|
$ |
(3.98 |
) |
|
$ |
(1.87 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
49,702,860 |
|
|
|
49,204,425 |
|
|
|
49,657,426 |
|
|
|
49,063,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact: Adam D. Levy, Ph.D.,
M.B.A.ir@tptherapeutics.com858-867-6366
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