Turning Point Therapeutics Reports Second-Quarter Financial Results, Provides Operational Updates
August 09 2021 - 4:02PM
Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision
oncology company developing next-generation therapies that target
genetic drivers of cancer, today reported financial results and
operational updates for the second quarter ended June 30, 2021.
“Our team made strong progress advancing our 4 clinical drug
candidates in 5 ongoing clinical trials as well as our research
programs with the first 2 development candidates targeted in the
second half of 2022,” said Athena Countouriotis, M.D., president
and CEO. “In our clinical programs, we are pleased with ongoing
enrollment in our pivotal TRIDENT-1 study of repotrectinib. In
addition, we recently initiated the Phase 1 expansion cohorts in
our SHIELD-1 study of TPX-0022 and just last week were granted Fast
Track designation for TPX-0022 in certain gastric cancer
indications. We look forward to multiple data updates from our
clinical studies at medical conferences during the fourth
quarter.”
Second quarter and recent highlights
include:
REPOTRECTINIB, ROS1/TRK Inhibitor
- Enrollment of approximately 300 patients in the Phase 1 and 2
portions of the TRIDENT-1 study, including more than 50 patients in
the ROS1-positive TKI-naïve advanced non-small cell lung cancer
(NSCLC) patient cohort (EXP-1). Enrollment in the EXP-1 cohort is
ongoing to provide continued access to new patients.
- Acceptance of TRIDENT-1 clinical data for presentation at the
2021 AACR-NCI-EORTC International Conference on Molecular Targets
and Cancer Therapeutics in October.
- Acceptance of initial clinical data from the ongoing Phase 1/2
CARE study in pediatric and young adult patients with advanced
solid tumors harboring ALK, ROS1 or NTRK alterations for an oral
presentation at the 53rd Congress of the International Society of
Paediatric Oncology (SIOP) in October.
- First patients dosed in China in the TRIDENT-1 study as part of
the company’s partnership with Zai Lab to develop repotrectinib in
greater China. Achievement of the milestones resulted in revenue of
$5 million to Turning Point under its collaboration agreement with
Zai Lab.
TPX-0022, MET/ SRC/CSF1R Inhibitor
- Selection of the likely recommended Phase 2 dose (RP2D) in the
ongoing Phase 1 SHIELD-1 study of TPX-0022, Turning Point’s MET,
SRC and CSF1R inhibitor, and initiation of Phase 1 expansion
cohorts. Subject to feedback from the U.S. Food and Drug
Administration (FDA) at an end of Phase 1 meeting in the third
quarter, including agreement on the RP2D, the company plans to
revise the study into a potentially registrational Phase 1/2 and
proceed into the Phase 2 portion.
- Acceptance of SHIELD-1 clinical data for presentation at the
2021 AACR-NCI-EORTC International Conference on Molecular Targets
and Cancer Therapeutics in October.
- Orphan Drug Designation granted by the FDA for the treatment of
patients with gastric cancer, including gastroesophageal junction
adenocarcinoma (GEJ).
- Fast Track Designation granted by the FDA for the treatment of
patients with MET amplified advanced or metastatic gastric cancer
or GEJ adenocarcinoma after prior chemotherapy.
TPX-0046, RET Inhibitor
- Progress in the ongoing dose-finding portion of the Phase 1/2
SWORD-1 study, where the company continues to evaluate multiple
doses and schedules to further characterize the pharmacokinetics,
safety, and efficacy profile before determining the RP2D.
TPX-0131, ALK Inhibitor
- Ongoing patient dosing in the Phase 1/2 FORGE-1 study of
TPX-0131 in locally advanced or metastatic TKI-pretreated
ALK-positive NSCLC. The study endpoints include safety and
tolerability, determination of the recommended Phase 2 dose,
pharmacokinetics, and any early signals of efficacy.
- Publication of preclinical data in the AACR Journal of
Molecular Cancer Therapeutics showing TPX-0131 to be potent against
a wide range of ALK resistant mutations, including G1202R, L1196M
and multiple compound mutations.
Discovery
- Advancing four internal discovery programs targeting aberrant
GTPase signaling known to drive genomically defined cancers with
significant unmet medical need. The most advanced programs target
KRAS G12D and the p21 activated kinase, or “PAK” family. Turning
Point is targeting 2 development candidates in the second half of
2022 with a goal to achieve at least one new IND per year beginning
in 2023.
Second Quarter Financial Results
- Revenue: Revenue of $5.2 million recognized during the
quarter was driven primarily by milestones earned from Zai Lab
(Shanghai) Co. Ltd. under the company’s license agreement for
repotrectinib in Greater China. Revenue for the first half of 2021
totaled $30.4 million.
- R&D Expenses: Research and development expenses were
$44.7 million in the quarter, compared to $24.2 million in the
second quarter of 2020. The $20.5 million increase was primarily
driven by the year-over-year increase in investments to develop
repotrectinib, TPX-0022, TPX-0046 and TPX-0131, discovery efforts
and personnel expenses. R&D expenses for the first half of 2021
totaled $85.9 million.
- G&A Expenses: General and administrative expenses were
$17.2 million compared to $8.6 million in the second quarter of
2020, primarily related to higher personnel expenses from an
increase in head count and professional services. G&A expenses
for the first half of 2021 totaled $37.2 million.
- Net Income/Loss: Net loss was $56.3 million compared to a
net loss of $31.5 million for the second quarter of 2020. Net loss
for the first half of 2021 was $91.8 million.
- Cash position: Cash, cash equivalents and marketable securities
at June 30, 2021 totaled approximately $1.1 billion. Net cash used
during the first half of 2021 was $44.7 million. Turning Point
projects its cash position funds current operations into 2024.
Upcoming Milestones Key milestones anticipated
in the second half of 2021 include:
Repotrectinib
- Initiate the first cohort of a multi-arm Phase 1b/2 TRIDENT-2
combination study in patients with KRAS mutant G12D advanced solid
tumors in the third quarter
- Provide a clinical data update by physician assessment from
multiple ROS1 and NTRK patient cohorts of the Phase 2 TRIDENT-1
study at the AACR-NCI-EORTC conference in October
- Report initial clinical data from the ongoing Phase 1/2 CARE
study in pediatric and young adult patients in an oral presentation
at the 53rd SIOP Congress in October
TPX-0022
- Provide a clinical data update across multiple tumor types and
MET genetic alterations from the Phase 1 dose finding portion of
the SHIELD-1 study at the AACR-NCI-EORTC conference in October
- Initiate the Phase 2 portion of the SHIELD-1 study, pending FDA
feedback, in the fourth quarter
- Initiate the Phase 1b/2 SHIELD-2 study of TPX-0022 in
combination with an epidermal growth factor receptor (EGFR)
targeted therapy in the fourth quarter
Webcast, Conference Call, Upcoming Investor
ConferencesTurning Point will webcast its Quarterly Update
Conference Call today, Aug. 9 at 4:30 p.m. ET/1:30 p.m. PT. Dr.
Countouriotis will host the call, which will be accessible through
the "Investors" section of tptherapeutics.com or by dialing (877)
388-2118 (in the United States) or (470) 495-9489 (outside the
U.S.) using conference ID 4029189. A replay will be available
through the "Investors" section of www.tptherapeutics.com.
Dr. Countouriotis will also participate in a targeted oncology
panel discussion at the 2021 Wedbush Pacgrow Virtual Healthcare
Conference on Aug. 10 at 10:55 a.m. ET, and a “fireside chat”
question-and-answer session at the 41st Annual Canaccord Genuity
Growth Conference on Aug. 11 at 4 p.m. ET. Both sessions will be
accessible through the "Investors" section of
www.tptherapeutics.com.
About Turning Point Therapeutics Inc.Turning
Point Therapeutics is a clinical-stage precision oncology
company with a pipeline of internally discovered 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 pretreated patients. The
company’s pipeline of drug candidates also includes TPX-0022,
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; and 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. Turning Point’s next-generation kinase inhibitors are
designed to bind to their targets with greater precision and
affinity than existing therapies, with a novel, compact structure
that has demonstrated an ability to potentially overcome treatment
resistance common with other kinase inhibitors. 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. Such
forward-looking statements include statements regarding, among
other things, the efficacy, safety and therapeutic potential of
Turning Point Therapeutics’ drug candidates, repotrectinib,
TPX-0022, TPX-0046 and TPX-0131, 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 strength of Turning Point Therapeutics’ balance sheet and the
adequacy of cash on hand. Because such statements are subject to
risks and uncertainties, actual results may differ materially from
those expressed or implied by such forward-looking statements.
Words such as “plans”, “will”, “believes,” “anticipates,”
“expects,” “intends,” “goal,” “potential” and similar expressions
are intended to identify 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’s business and the other risks
described in Turning Point Therapeutics’ Quarterly Report on Form
10-Q for the quarter ended June 30, 2021 and other filings with the
SEC. 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, |
|
|
|
|
|
2021 |
|
|
2020 |
|
|
| Balance Sheet
Data: |
|
|
|
|
|
|
|
|
|
| Cash, cash equivalents, and
marketable securities |
|
$ |
1,077,806 |
|
|
$ |
1,122,508 |
|
|
| Working capital |
|
|
1,059,525 |
|
|
|
1,106,287 |
|
|
| Total assets |
|
|
1,102,920 |
|
|
|
1,136,713 |
|
|
| Accumulated deficit |
|
|
(371,953 |
) |
|
|
(280,176 |
) |
|
| Total stockholders'
equity |
|
$ |
1,067,507 |
|
|
$ |
1,109,898 |
|
|
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, |
|
|
| |
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
| Revenue |
|
$ |
5,164 |
|
|
$ |
- |
|
|
$ |
30,369 |
|
|
$ |
- |
|
|
| Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
44,650 |
|
|
|
24,154 |
|
|
|
85,913 |
|
|
|
46,923 |
|
|
|
General and administrative |
|
|
17,171 |
|
|
|
8,578 |
|
|
|
37,162 |
|
|
|
48,435 |
|
|
| Total operating expenses |
|
|
61,821 |
|
|
|
32,732 |
|
|
|
123,075 |
|
|
|
95,358 |
|
|
| Loss from operations |
|
|
(56,657 |
) |
|
|
(32,732 |
) |
|
|
(92,706 |
) |
|
|
(95,358 |
) |
|
| Other income, net |
|
|
384 |
|
|
|
1,239 |
|
|
|
929 |
|
|
|
3,147 |
|
|
| Net loss |
|
|
(56,273 |
) |
|
|
(31,493 |
) |
|
|
(91,777 |
) |
|
|
(92,211 |
) |
|
|
Unrealized gain / (loss) on marketable securities, net of tax |
|
|
(22 |
) |
|
|
1,063 |
|
|
|
(208 |
) |
|
|
747 |
|
|
| Comprehensive loss |
|
$ |
(56,295 |
) |
|
$ |
(30,430 |
) |
|
$ |
(91,985 |
) |
|
$ |
(91,464 |
) |
|
| Net loss per share, basic and
diluted |
|
$ |
(1.14 |
) |
|
$ |
(0.82 |
) |
|
$ |
(1.87 |
) |
|
$ |
(2.47 |
) |
|
| Weighted-average common shares
outstanding, basic and diluted |
|
|
49,204,425 |
|
|
|
38,603,236 |
|
|
|
49,063,298 |
|
|
|
37,261,296 |
|
|
Contact: Jim
Mazzolajim.mazzola@tptherapeutics.com858-342-8272
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