Turning Point Therapeutics Reports Third Quarter 2019 Financial and Operational Results
- Registrational Phase 2 Study of Repotrectinib Ongoing
- Phase 1/2 Clinical Studies of RET/SRC Inhibitor TPX-0046 and Repotrectinib in Pediatric Patients On Track to Initiate in 2019
Mohammad Hirmand, M.D. Named Executive Vice President and Chief Medical Officer, Effective Dec. 2
- Cash, Cash Equivalents, and
Marketable Securitiesof $424 MillionExpected to Fund Operations Beyond 2021
President and Chief Executive Officer
“Beyond this clinical progress, we raised net proceeds of
“As I look ahead to the remainder of the year, we are focused on the execution of our ongoing clinical studies and the continued development of our pipeline, including our combination strategy with repotrectinib and selection of a candidate from our ALK program.”
Third quarter 2019 and recent highlights include:
- Continuing site activations and enrollment in the Phase 2 registrational portion of the TRIDENT-1 study of repotrectinib. The study is planned to be conducted at approximately 100 global sites with enrollment of approximately 310 patients, including ROS1-positive advanced non-small cell lung cancer (NSCLC) and NTRK-positive advanced solid tumor patients.
FDAclearance at the end of September of the investigational new drug application for TPX-0046, a novel RET/SRC inhibitor, with an anticipated initiation of the Phase 1/2 clinical study in 2019. The open-label study is planned to enroll approximately 50 patients in the Phase 1 dose escalation portion and approximately 300 patients in the Phase 2 expansion portion to evaluate the safety profile and preliminary efficacy.
- Ongoing progress enrolling patients in the Phase 1 study of TPX-0022, Turning Point’s MET/CSF1R/SRC inhibitor. The study is designed to evaluate the overall safety, tolerability, pharmacokinetics (PK), and preliminary efficacy in a standard dose escalation design, followed by dose expansion once the recommended Phase 2 dose is determined. Total enrollment for both portions of the study is anticipated to be approximately 120 patients.
- Reporting and subsequently presenting at the
European Society for Medical Oncology( ESMO) annual congress updated interim data from the Phase 1 portion of the TRIDENT-1 study of repotrectinib in ROS1-positive NSCLC patients. As of a July 22data cut-off, the data showed a 91 percent confirmed overall response rate (cORR) in TKI-naive patients, a 39 percent cORR in patients treated with one prior TKI across all dose levels and a 55 percent cORR in patients treated with one prior TKI at the Phase 2 dose of 160 mg or above. Among patients treated with known solvent front mutations after crizotinib, the cORR was 43 percent. The safety profile remained consistent with prior updates, and 45 percent of ROS-positive NSCLC patients remained on treatment, including two for more than 24 months as of the data cut-off.
- Reporting and presenting at
ESMOpreclinical data for TPX-0046, demonstrating potent inhibition of wildtype and mutated RET kinases as compared to proxy chemical compounds for investigational RET inhibitors, LOXO-292 and BLU-667. In cellular assays, TPX-0046 showed comparable potency against wildtype KIF5B-RET and stronger potency against the G810R solvent front mutation.
- Completing a follow-on public stock offering of 4.5 million shares of common stock, resulting in net proceeds of
Mohammad Hirmand, M.D. as executive vice president and chief medical officer (CMO), effective Dec. 2. Dr. Hirmand has more than 20 years of biotechnology clinical development experience, most recently as CMO of Peloton Therapeutics, which was acquired by Merckin July. Prior to joining Peloton in 2017, Dr. Hirmand served as CMO of Medivation through its acquisition by Pfizer.
“Mohammad is a strategic leader with a strong background in oncology drug development, including early and late-stage clinical development and multiple drug approvals,” said Dr. Countouriotis. “He will be a valuable addition to our leadership team as we advance our three drug candidates in clinical studies, including our TRIDENT-1 global registrational study underway for repotrectinib.”
Third Quarter Financial Update
Operating expenses during the third quarter were
For the nine months year-to-date, operating expenses totaled
Net cash used in operating activities during the nine months ended
Cash, cash equivalents and marketable securities at Sept. 30 totaled
Anticipated milestones for the remainder of 2019 include:
Progressin site activations and patient enrollment in clinical studies of three drug candidates to advance the company’s wholly owned and internally discovered pipeline of kinase inhibitors;
- Initiation of a Phase 1/2 clinical study of TPX-0046 in patients with RET-altered NSCLC, thyroid cancer and other advanced solid tumors;
- Initiation of a Phase 1/2 clinical study of repotrectinib in pediatric patients with advanced ALK-, NTRK- and ROS1-positive tumors;
- Further advancement of the company’s pipeline with the nomination of a development candidate from a series of Turning Point designed ALK inhibitors;
- Advancing preclinical proof of concept for the company’s combination strategy for repotrectinib.
Webcast and Conference Call
Turning Point will webcast its Quarterly Update Conference Call today,
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 program, repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is currently being studied in a registrational Phase 2 study, 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 currently being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; and TPX-0046, targeting RET and SRC, which is planned for study in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET. Turning Point’s 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 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 and TPX-0046, the results, conduct, progress and timing of Turning Point Therapeutics’ development programs and clinical trials including the TRIDENT-1 clinical study, the Phase 1 clinical study of TPX-0022 and the Phase1/2 clinical study of TPX-0046, plans regarding future clinical trials, the regulatory approval path for repotrectinib, 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, and the other risks described in Turning Point Therapeutics’ filings with the
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||16,640||$||5,129||$||40,802||$||13,841|
|General and administrative||5,500||1,000||13,857||2,319|
|Total operating expenses||22,140||6,129||54,659||16,160|
|Loss from operations||(22,140||)||(6,129||)||(54,659||)||(16,160||)|
|Other comprehensive income:|
|Unrealized gain (loss) on marketable securities, net of tax||(24||)||–||322||-|
|Net loss per share, basic and diluted||$||(0.63||)||$||(1.77||)||$||(2.54||)||$||(4.66||)|
|Weighted-average common shares outstanding, basic and diluted||32,312,814||3,394,423||20,178,979||3,381,404|
Condensed Balance Sheets
(In thousands, except share amounts)
|September 30,||December 31,|
|Cash and cash equivalents||$||172,421||$||101,029|
|Prepaid expenses and other current assets||5,795||494|
|Total current assets||429,370||101,523|
|Property and equipment, net||2,184||1,000|
|Right-of-use assets from operating leases||4,761||–|
|Deferred financing costs||–||684|
|Liabilities, convertible preferred stock, and stockholders' equity (deficit)|
|Accrued expenses and other current liabilities||2,950||2,415|
|Current portion of operating lease liabilities||1,175||–|
|Total current liabilities||11,720||5,322|
|Operating lease liabilities, net of current portion||4,144||448|
|Commitments and contingencies (Note 7)|
|Convertible preferred stock||–||145,916|
|Total stockholders’ equity (deficit)||420,524||(48,406||)|
|Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)||$||436,388||$||103,280|
Source: Turning Point Therapeutics, Inc.