UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 9, 2021, Turning Point Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the third quarter ended September 30, 2021 and providing a corporate update. A copy of this press release is furnished herewith as Exhibit 99.1.
The information contained in this Current Report on Form 8-K under this Item 2.02, and Exhibit 99.1 hereto are being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by the Company, under the Securities Act of 1933, as amended, unless specifically identified as being incorporated therein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit Number |
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Description |
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99.1 |
Press release issued by Turning Point Therapeutics, Inc. on November 9, 2021 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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TURNING POINT THERAPEUTICS, INC. |
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Date: |
November 9, 2021 |
By: |
/s/ Annette North |
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Annette North |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact:
Adam Levy
ir@tptherapeutics.com
858-867-6366
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, 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 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 |
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(In thousands) (unaudited) |
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September 30, |
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December 31, |
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2021 |
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2020 |
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Balance Sheet Data: |
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Cash, cash equivalents, and marketable securities |
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$ |
1,036,014 |
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$ |
1,122,508 |
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Working capital |
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1,008,388 |
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1,106,287 |
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Total assets |
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1,058,985 |
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1,136,713 |
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Accumulated deficit |
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(438,278 |
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(280,176 |
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Total stockholders' equity |
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$ |
1,017,337 |
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$ |
1,109,898 |
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TURNING POINT THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Revenue |
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$ |
460 |
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$ |
25,000 |
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$ |
30,829 |
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$ |
25,000 |
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Operating expenses: |
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Research and development |
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48,889 |
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32,213 |
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134,802 |
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79,136 |
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General and administrative |
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18,224 |
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11,326 |
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55,386 |
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59,761 |
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Total operating expenses |
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67,113 |
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43,539 |
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190,188 |
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138,897 |
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Loss from operations |
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(66,653 |
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(18,539 |
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(159,359 |
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(113,897 |
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Other income, net |
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328 |
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834 |
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1,257 |
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3,981 |
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Net loss |
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(66,325 |
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(17,705 |
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(158,102 |
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(109,916 |
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Unrealized (loss) / gain on marketable securities, net of tax |
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(18 |
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(606 |
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(225 |
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141 |
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Comprehensive loss |
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$ |
(66,343 |
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$ |
(18,311 |
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$ |
(158,327 |
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$ |
(109,775 |
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Net loss per share, basic and diluted |
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$ |
(1.34 |
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$ |
(0.42 |
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$ |
(3.21 |
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$ |
(2.82 |
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Weighted-average common shares outstanding, basic and diluted |
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49,426,496 |
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42,185,824 |
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49,185,693 |
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38,914,789 |
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