Turning Point Therapeutics Reports Second-Quarter Financial Results, Provides Operational Updates
- Early Interim Data from Registrational Phase 2 TRIDENT-1 Study of Lead Drug Candidate Repotrectinib Anticipated in Third Quarter
- Four Clinical Studies of Three Drug Candidates Ongoing; Early Interim TPX-0022 Data Anticipated in Fourth Quarter
- Cash, Cash Equivalents, and
Marketable Securitiesof $710 MillionExpected to Fund Current Operations into 2023
“We achieved many important milestones since our first quarter update in May, including advancing our pipeline of four drug candidates, sharing our preclinical combination data for repotrectinib in KRAS cancer models, raising gross proceeds of
“Turning to the second half of 2020, we remain focused on advancing our pipeline, as we continue to navigate the COVID-19 pandemic and monitor its impact to our timelines. For the TRIDENT-1 Phase 2 registrational study of repotrectinib, site activations and enrollment have improved since our last update in May, and we are planning to report early interim data from the study in the third quarter. Our goal is to achieve full global site activation in the TRIDENT-1 study in early 2021.
“Overall, I am pleased with how our team has adapted and advanced our clinical development during these challenging times and I want to again thank the dedicated health care providers worldwide who continue to treat patients suffering from COVID-19.”
Second quarter and recent highlights include:
- Progress in the TRIDENT-1 Phase 2 registrational study of repotrectinib, where the company anticipates reporting early interim data in the third quarter. The preliminary efficacy and safety data by physician assessment are expected to be from 30 to 40 patients across multiple Phase 2 cohorts, including registrational and exploratory cohorts. The company’s goal is to achieve full site activation in the study in early 2021.
- Three additional trials ongoing, including the Phase 1/2 open-label study to assess repotrectinib in pediatric patients with ALK-, NTRK- or ROS1-positive advanced solid tumors; the Phase 1 study of TPX-0022, Turning Point’s MET/CSF1R/SRC inhibitor; and the Phase 1/2 study of TPX-0046, Turning Point’s RET/SRC inhibitor.
- Completing an exclusive license agreement with
Zai Labfor the development and commercialization of repotrectinib in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Zai Lab obtained exclusive rights to develop and commercialize repotrectinib in Greater China and Turning Point Therapeutics will receive a $25 million upfront payment, with the potential to receive up to an additional $151 million in development, regulatory and sales-based milestone payments. Turning Point will also be eligible to receive mid-to-high teen royalties based on annual net sales of repotrectinib in Greater China.
- Appointing Andrew Partridge as executive vice president and chief commercial officer. Mr. Partridge has more than 20 years of global pharmaceutical sales and marketing experience leading more than 20 commercial launches across multiple indications, including oncology, hematology and rare diseases.
Second Quarter Financial Update
Operating expenses for the second quarter totaled
Excluding a one-time non-cash stock-based compensation charge in the first quarter of
Cash, cash equivalents and marketable securities at June 30 totaled
Key milestones anticipated into early 2021 include:
- Early interim data from approximately 30 to 40 patients across multiple TRIDENT-1 Phase 2 cohorts in the third quarter.
- Additional preclinical data highlighting the potential for repotrectinib to increase the effectiveness of KRAS-G12C inhibitors in the fourth quarter.
- Early interim data from initial patients treated with TPX-0022 in the fourth quarter.
- Submitting the IND for TPX-0131 by early 2021.
- Early interim data from initial patients treated with TPX-0046 in early 2021
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 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 and SRC, 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 in IND-enabling studies. 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.
Non-GAAP Financial Measures
In addition to the financial results that are provided in accordance with accounting principles generally accepted in
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. 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’ development programs and clinical trials including the Phase 2 TRIDENT-1 clinical study, the Phase 1/2 pediatric clinical study of repotrectinib, the Phase 1 clinical study of TPX-0022 and the Phase 1/2 clinical study of TPX-0046, plans regarding future clinical trials and regulatory submissions, the regulatory approval path for repotrectinib, the potential to receive milestone and royalty payments from Zai Lab, 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’ filings with the
|Balance Sheet Data|
|Balance Sheet Data:|
|Cash, cash equivalents, and marketable securities||$||710,430||$||409,151|
|Total stockholders' equity||710,827||404,351|
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
|Three Months Ended
||Six Months Ended
|Research and development||$||24,154||$||13,711||$||46,923||$||24,162|
|General and administrative||8,578||4,743||48,435||8,357|
|Total operating expenses||32,732||18,454||95,358||32,519|
|Loss from operations||(32,732||)||(18,454||)||(95,358||)||(32,519||)|
|Other income, net||1,239||1,312||3,147||1,830|
|Unrealized gain on marketable securities, net of tax||1,063||345||747||345|
|Net loss per share, basic and diluted||$||(0.82||)||$||(0.70||)||$||(2.47||)||$||(2.19||)|
|Weighted-average common shares outstanding, basic and diluted||38,603,236||24,479,767||37,261,296||14,004,957|
|Reconciliation of GAAP to Non-GAAP Financial Results|
|Three Months Ended
||Six Months Ended
|GAAP Loss from operations||$||(32,732||)||$||(18,454||)||$||(95,358||)||$||(32,519||)|
|Share-based compensation expense (1)||–||–||31,405||–|
|Non-GAAP Loss from operations||$||(32,732||)||$||(18,454||)||$||(63,953||)||$||(32,519||)|
(1) During the first quarter of 2020, the Company recognized in non-cash stock-based compensation expense a one-time charge of
Source: Turning Point Therapeutics, Inc.