TURNING POINT THERAPEUTICS REPORTS THIRD-QUARTER FINANCIAL RESULTS, PROVIDES OPERATIONAL UPDATES
SAN DIEGO, November 9, 2021 - Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today reported financial results for the third quarter ended September 30, 2021 and provided operational updates.
"We are encouraged by the progress made across our pipeline, including recent preliminary data presented for repotrectinib and elzovantinib at the AACR-NCI-EORTC meeting," said Athena Countouriotis, M.D., president and CEO. "We look forward to multiple anticipated upcoming FDA interactions including a pre-NDA meeting for repotrectinib in ROS1-positive non-small cell lung cancer."
Third quarter and recent highlights include:
REPOTRECTINIB, ROS1/TRK INHIBITOR
The company anticipates discussing next steps towards registration of repotrectinib in patients with NTRK-positive TKI-pretreated advanced solid
The safety analysis from 301 treated patients from the pooled Phase 1 and Phase 2 portions of TRIDENT-1 across all cohorts demonstrated that repotrectinib was generally well tolerated, with the majority of treatment related adverse events reported as grade 1 or 2.
ELZOVANTINIB (TPX-0022), MET/SRC/CSF1R INHIBITOR
Patient screening at the intermediate dose level (60 mg QD to 60 mg BID) is ongoing and the company plans to enroll at least six to 10 patients at this dose level and provide data from this dose level to the FDA, with the intention of revising the SHIELD-1 study into a potentially registrational Phase 1/2 study and initiating the Phase 2 portion in 2022. The company also continues to enroll patients in the Phase 1 dose expansion portion of the study at 40 mg QD to 40 mg BID.
TPX-0046, RET INHIBITOR
TPX-0131, ALK INHIBITOR
DISCOVERY
Third Quarter Financial Results
Webcast and Conference Call
Turning Point will webcast its Quarterly Update Conference Call today, November 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 3118428. A replay will be available 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 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; 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. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visitwww.tptherapeutics.com.
Forward Looking Statements
Statements 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 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. 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 November 9, 2021. 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) |
September 30, | December 31, | |||
2021 | 2020 | |||
Balance Sheet Data: | ||||
Cash, cash equivalents, and marketable securities | $ | 1,036,014 | $ | 1,122,508 |
Working capital | 1,008,388 | 1,106,287 | ||
Total assets | 1,058,985 | 1,136,713 | ||
Accumulated deficit | (438,278 | ) | (280,176 | ) |
Total stockholders' equity | $ | 1,017,337 | $ | 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 September 30, | Nine Months Ended September 30, | |||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||
Revenue | $ | 460 | $ | 25,000 | $ | 30,829 | $ | 25,000 | ||||
Operating expenses: | ||||||||||||
Research and development | 48,889 | 32,213 | 134,802 | 79,136 | ||||||||
General and administrative | 18,224 | 11,326 | 55,386 | 59,761 | ||||||||
Total operating expenses | 67,113 | 43,539 | 190,188 | 138,897 | ||||||||
Loss from operations | (66,653 | ) | (18,539 | ) | (159,359 | ) | (113,897 | ) | ||||
Other income, net | 328 | 834 | 1,257 | 3,981 | ||||||||
Net loss | (66,325 | ) | (17,705 | ) | (158,102 | ) | (109,916 | ) | ||||
Unrealized (loss) / gain on marketable securities, net of tax | (18 | ) | (606 | ) | (225 | ) | 141 | |||||
Comprehensive loss | $ | (66,343 | ) | $ | (18,311 | ) | $ | (158,327 | ) | $ | (109,775 | ) |
Net loss per share, basic and diluted | $ | (1.34 | ) | $ | (0.42 | ) | $ | (3.21 | ) | $ | (2.82 | ) |
Weighted-average common shares outstanding, basic and diluted | 49,426,496 | 42,185,824 | 49,185,693 | 38,914,789 |
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Turning Point Therapeutics Inc. published this content on 09 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 November 2021 21:17:01 UTC.