Turning Point Therapeutics Reports Second Quarter 2019 Financial and Operational Results
- FDA Accepts Repotrectinib Recommended Phase 2 Dose Regimen for Registrational TRIDENT-1 Study
- Two Abstracts Selected for Presentation at the European Society for Medical Oncology (
ESMO) Annual Congress Highlighting Clinical Data for Repotrectinibin ROS1 and TRK patients, and Preclinical Data for RET/SRC Inhibitor TPX-0046
- Phase 1 Study Initiated for Drug Candidate TPX-0022, a Novel MET/CSF1R/SRC Inhibitor
- Yi Larson Hired as Executive Vice President, Chief Financial Officer
- Cash, Cash Equivalents, and
Marketable Securitiesof $250 MillionFunds Operations into the Second Half of 2021
“During the second quarter of 2019 – our first quarter as a public company – we achieved a number of key milestones, including a successful public stock offering, our first oral presentation at
“Looking ahead to the second half of the year, I am very pleased to have
The Phase 2 portion of the TRIDENT-1 study was initiated in June and will be conducted at approximately 100 global sites with planned enrollment of approximately 310 ROS1-positive and NTRK-positive non-small cell lung cancer (NSCLC) and other solid tumor patients.
Other second quarter 2019 and recent highlights include:
- Oral presentation of positive interim data from the Phase 1 portion of the TRIDENT-1 study at the
American Society of Clinical Oncology( ASCO) Annual Meeting. Among the findings as of a March 4data cut-off, data by blinded independent central review (BICR) with more than 16 months of median follow up showed in TKI-naïve ROS1+ patients a confirmed overall response rate (ORR) of 82 percent across seven dose levels, and 83 percent at a dose of 160 mg and above. The median duration of response was not yet met. In addition, confirmed ORR by BICR in ROS1+ patients pretreated with one prior TKI was 39 percent across seven dose levels and 55 percent at 160 mg and above. In patients with a documented G2032R solvent front mutation, the confirmed ORR was 40 percent. The overall safety profile showed repotrectinib continued to be generally well tolerated, with 45 percent of patients (n=15 of 33) remaining on treatment and 12 of the 15 patients remaining on repotrectinib for greater than 12 months as of the data cut-off.
- Presentation of four preclinical studies at the
American Association for Cancer Research(AACR) Annual Conference, including two studies highlighting the preclinical potency of repotrectinib and two studies highlighting the ability of TPX-0022, the company’s investigational MET/CSF1R/SRC inhibitor, to potently inhibit MET-driven cancer cells, modulate the tumor microenvironment and demonstrate tumor regression and tumor growth inhibition.
- Initiation of a Phase 1 first-in-human, open-label clinical study of TPX-0022 for patients with advanced solid tumors harboring genetic alterations in MET following
FDAclearance of the investigational new drug (IND) application. FDAapproval of an investigational device exemption (IDE) for the diagnostic assay being used in the registrational Phase 2 portion of TRIDENT-1 study of repotrectinib. The assay is intended to identify patients with ROS1, NTRK1-3 or ALK gene fusions in advanced solid tumors.
- Completion of the company’s initial public stock offering at
$18per share, raising net proceeds of $175 million.
- The appointment of
Yi Larsonas executive vice president and chief financial officer, who will join the company on August 26from Goldman Sachs & Co.where she most recently served as a managing director in Healthcare Investment Banking.
- The addition of
Patrick Machado, J.D., and Carol Gallagher, Pharm.D., both 20+ year biotech leaders to the company’s board of directors.
Second Quarter Financial Update
Operating expenses during the second quarter were $18.5 million compared to $14.1 million in the first quarter and
Turning Point expects expenses will increase through the year as it activates sites for its Phase 2 study of repotrectinib and Phase 1 study of TPX-0022. In addition, the company plans to initiate up to two additional clinical trials in 2019, including the Phase 1/2 study of repotrectinib in pediatric and young adult patients with advanced solid tumors with NTRK, ALK, or ROS1 alterations and, pending submission and subsequent IND clearance, a Phase 1 study of TPX-0046 in patients with advanced solid tumors with oncogenic RET genetic alterations.
Cash, cash equivalents and marketable securities at June 30 totaled
Anticipated milestones for the second half of 2019, include:
- Submission of an IND for TPX-0046, and pending IND clearance, initiation of the Phase 1 clinical study.
- Presentation at
ESMOof an update from the ongoing TRIDENT-1 Phase 1 study of repotrectinib, which will include additional follow-up since the last data cut-off and a limited number of new patients.
- Presentation at
ESMOof preclinical data for Turning Point’s pre-IND novel RET/SRC inhibitor TPX-0046. The presentation will build on prior preclinical work against proxy molecules with new preclinical potency data.
- Initiation of a Phase 1 clinical study of repotrectinib in pediatric and young adult patients with advanced solid tumors with NTRK, ALK, or ROS1 alterations.
- Nomination of a development candidate from a series of Turning Point designed ALK inhibitors.
Webcast and Conference Call
Turning Point will webcast its Quarterly Update Conference Call today,
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 Phase 1/2 TRIDENT-1 clinical study and the Phase 1 clinical study of TPX-0022, 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
|Turning Point Therapeutics, Inc.|
|Condensed Balance Sheets|
|(In thousands, except share amounts)|
|June 30,||December 31,|
|Cash and cash equivalents||$||78,781||$||101,029|
|Marketable securities, available for sale||171,389||–|
|Prepaid expenses and other current assets||4,998||494|
|Total current assets||255,168||101,523|
|Property and equipment, net||954||1,000|
|Right-of-use assets from operating leases||1,250||–|
|Deferred financing costs||–||684|
|Liabilities, convertible preferred stock, and stockholders' equity (deficit)|
|Accrued expenses and other current liabilities||1,992||2,415|
|Current portion of operating lease liabilities||138||–|
|Total current liabilities||7,888||5,322|
|Other long-term liabilities||260||–|
|Operating lease liabilities, net of current portion||1,382||448|
|Commitments and contingencies|
|Convertible preferred stock, $0.0001 par value; 0 shares issued and outstanding as of
June 30, 2019 and 65,423,901 shares issued and outstanding as of December 31,
2018; aggregate liquidation preference of $0 and $146,460 as of June 30, 2019 and
December 31, 2018, respectively
|Stockholders' equity (deficit):|
|Common stock, $0.0001 par value; 200,000,000 shares authorized as of June 30, 2019
and 104,000,000 shares authorized as of December 31, 2018; 31,297,423 shares
issued and outstanding as of June 30, 2019; 3,411,516 shares issued and outstanding
at December 31, 2018
|Additional paid-in capital||328,978||2,346|
|Accumulated other comprehensive income||345||–|
|Total stockholders’ equity (deficit)||247,915||(48,406||)|
|Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)||$||257,445||$||103,280|
|Turning Point Therapeutics, Inc.|
|Condensed Statements of Operations and Comprehensive Loss|
|(In thousands, except share and per share amounts)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$||13,711||$||4,369||$||24,162||$||8,713|
|General and administrative||4,743||803||8,357||1,319|
|Total operating expenses||18,454||5,172||32,519||10,032|
|Loss from operations||(18,454||)||(5,172||)||(32,519||)||(10,032||)|
|Other comprehensive income:|
|Unrealized gain on marketable securities, net of tax||345||–||345||–|
|Net loss per share, basic and diluted||$||(0.70||)||$||(1.49||)||$||(2.19||)||$||(2.89||)|
|Weighted-average common shares outstanding, basic and diluted||24,479,767||3,380,899||14,004,957||3,374,787|
Source: Turning Point Therapeutics, Inc.