Exhibit 99.1
Contact:
Adam D. Levy, Ph.D., M.B.A.
ir@tptherapeutics.com
858-867-6366
TURNING POINT THERAPEUTICS REPORTS FOURTH-QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS, PROVIDES OPERATIONAL UPDATES
SAN DIEGO, February 28, 2022 – 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 fourth quarter and year ended December 31, 2021, and provided operational updates.
“We are encouraged by the progress made during 2021 and into the first two months of 2022,” said Athena Countouriotis, M.D., President and CEO. “We look forward to sharing topline ORR and DOR data for our lead investigational therapy repotrectinib in patients with ROS1-positive NSCLC and completing a pre-NDA meeting with the FDA in the second quarter. Supported by our strong financial position, with approximately $1 billion in cash at the end of 2021, we continue to invest in our clinical programs and our research engine, while we also consider opportunities to bring in external innovation where there's a strategic fit.”
Fourth quarter and recent operational highlights include:
REPOTRECTINIB, ROS1/TRK INHIBITOR
ELZOVANTINIB (TPX-0022), MET/SRC/CSF1R INHIBITOR
TPX-0046, RET INHIBITOR
TPX-0131, ALK INHIBITOR
DISCOVERY
Upcoming Milestones
Key milestones anticipated in 2022 include:
Repotrectinib
Elzovantinib
TPX-0131
Discovery
Fourth Quarter and Full-Year 2021 Financial Results
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, visit www.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 annual report on Form 10-K filed with the SEC on February 28, 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) |
|
|
| December 31, |
|
| December 31, |
|
| ||
|
| 2021 |
|
| 2020 |
|
| ||
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
| $ | 981,582 |
|
| $ | 1,122,508 |
|
|
Working capital |
|
| 945,373 |
|
|
| 1,106,287 |
|
|
Total assets |
|
| 1,003,463 |
|
|
| 1,136,713 |
|
|
Accumulated deficit |
|
| (516,727 | ) |
|
| (280,176 | ) |
|
Total stockholders' equity |
| $ | 954,425 |
|
| $ | 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 December 31, |
|
| Year Ended December 31, | |||||||||||||||
|
| 2021 |
|
| 2020 |
|
| 2021 |
|
| 2020 |
|
| |||||||
Revenue |
| $ | - |
|
| $ | - |
|
| $ | 30,829 |
|
| $ | 25,000 |
|
| |||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Research and development |
|
| 58,177 |
|
|
| 34,275 |
|
|
| 192,979 |
|
|
| 113,411 |
|
| |||
General and administrative |
|
| 20,464 |
|
|
| 13,664 |
|
|
| 75,850 |
|
|
| 73,425 |
|
| |||
Total operating expenses |
|
| 78,641 |
|
|
| 47,939 |
|
|
| 268,829 |
|
|
| 186,836 |
|
| |||
Loss from operations |
|
| (78,641 | ) |
|
| (47,939 | ) |
|
| (238,000 | ) |
|
| (161,836 | ) |
| |||
Other income, net |
|
| 192 |
|
|
| 563 |
|
|
| 1,449 |
|
|
| 4,544 |
|
| |||
Net loss |
|
| (78,449 | ) |
|
| (47,376 | ) |
|
| (236,551 | ) |
|
| (157,292 | ) |
| |||
Unrealized loss on marketable securities |
|
| (1,258 | ) |
|
| (203 | ) |
|
| (1,483 | ) |
|
| (62 | ) |
| |||
Comprehensive loss |
| $ | (79,707 | ) |
| $ | (47,579 | ) |
| $ | (238,034 | ) |
| $ | (157,354 | ) |
| |||
Net loss per share, basic and diluted |
| $ | (1.58 | ) |
| $ | (1.02 | ) |
| $ | (4.80 | ) |
| $ | (3.85 | ) |
| |||
Weighted-average common shares outstanding, basic and diluted |
|
| 49,498,541 |
|
|
| 46,588,835 |
|
|
| 49,264,549 |
|
|
| 40,843,782 |
|
|