On August 8, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, reported financial results for the quarter ended June 30, 2022 and provided operational updates (Press release, Turning Point Therapeutics, AUG 8, 2022, View Source [SID1234617849]).

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"We are pleased with our continued pipeline advancement and expansion," said Athena Countouriotis, M.D., President and CEO. "We look forward to a productive second half of the year, with multiple data readouts and continued regulatory progress."

Second quarter and recent operational highlights include:

REPOTRECTINIB:

Announced receipt of positive feedback from the FDA at a pre-NDA meeting completed during the second quarter. The feedback focused on the proposed patient follow-up within the ROS1-positive advanced NSCLC patient cohorts of the ongoing TRIDENT-1 registrational study. The purpose of the pre-NDA meeting was to discuss the company’s planned NDA for repotrectinib for the treatment of ROS1+ advanced NSCLC. The FDA agreed with the company’s plan to provide data for ROS1+ TKI-naïve and TKI-pretreated advanced NSCLC patients with at least six months of follow-up from the first post-baseline scan at the time of NDA submission.
Received Breakthrough Therapy designation (BTD) from the FDA for repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with one ROS1 tyrosine kinase inhibitor and who have not received prior platinum-based chemotherapy. This represents the eighth regulatory designation granted by the FDA for repotrectinib.
ELZOVANTINIB:

Initiated the Phase 1b/2 SHIELD-2 combination study of elzovantinib and aumolertinib in EGFR mutant MET-amplified advanced non-small cell lung cancer. The combination of elzovantinib and aumolertinib is being studied in patients with EGFR mutant MET-amplified advanced NSCLC who have progressed following treatment with osimertinib. The study will evaluate the safety, tolerability and preliminary efficacy of the combination regimen.
TPX-4589

Initiated patient dosing in the third dosing level cohort in the Phase 1 study of TPX-4589. TPX-4589 is a potentially first-in-class anti-Claudin18.2 antibody drug conjugate (ADC) that suppresses cell proliferation of gastric and pancreatic cell lines with nanomolar potency in preclinical models. It is currently being studied in two ongoing Phase 1 studies in patients with advanced solid tumors.
BUSINESS DEVELOPMENT:

Announced a strategic research and development alliance with The University of Texas MD Anderson Cancer Center to expand the evaluation of repotrectinib and elzovantinib. The planned focus of the alliance includes monotherapy and potential combinations with other agents – including chemotherapy, immunotherapies and other targeted agents.
Entered into an exclusive license agreement with LaNova Medicines Limited to develop and commercialize LM-302, now known as TPX-4589, a novel antibody drug conjugate targeting Claudin18.2, in the United States and rest of the world excluding Greater China and South Korea. Claudin18.2 is a protein expressed in many gastrointestinal cancers, including gastric, gastroesophageal junction and pancreatic cancer. TPX-4589 is currently in Phase 1 clinical trials in both the United States and China.
Announced a definitive merger agreement with Bristol Myers Squibb to acquire Turning Point Therapeutics for $76.00 per share. The transaction was unanimously approved by both the Bristol Myers Squibb and Turning Point Therapeutics Boards of Directors and is anticipated to close during the third quarter of 2022.
Upcoming Milestones

REPOTRECTINIB

Present detailed study results, including intracranial activity, from the ROS1-positive advanced NSCLC cohorts of the TRIDENT-1 study at a medical conference in the second half of 2022.
Provide a clinical data update from the NTRK+ advanced solid tumor cohorts from TRIDENT-1 in the second half of 2022.
ELZOVANTINIB

Initiate the Phase 2 portion of the SHIELD-1 study in the second half of 2022, pending FDA feedback on data from the intermediate dose level.
Provide a clinical data update from the Phase 1 SHIELD-1 study in the second half of 2022.
TPX-0131

Provide early interim data from initial patients treated in the dose-finding portion of the FORGE-1 study in the fourth quarter of 2022 or early 2023.
TPX-4589

Present preclinical data at a medical conference by early 2023.
Provide additional guidance on clinical development plan by early 2023.
DISCOVERY

Nominate 2 development candidates in the second half of 2022.
Provide details on the other 2 GTPase signaling discovery programs in the second half of 2022.
Second Quarter 2022 Financial Results

Revenue: Revenue recognized during the second quarter of 2022 was $0.1 million from the sale of clinical supply to Zai Lab (Shanghai) Co. Ltd. (Zai), compared to $5.2 million during the second quarter of 2021, consisting of $5.0 million earned upon the achievement of development milestones under the license agreement with Zai regarding repotrectinib and $0.2 million from the sale of clinical supply to Zai.

R&D Expenses: Research and development expenses were $86.8 million for the second quarter of 2022 compared to $44.7 million for the second quarter of 2021. Primary drivers of the year-over-year increase were investments made to develop repotrectinib, discovery efforts and personnel expenses. In addition, R&D expenses for the second quarter of 2022 included an upfront payment of $25.0 million to LaNova for the in-licensing of its intellectual property that has not yet achieved regulatory approval.

G&A Expenses: General and administrative expenses were $37.7 million for the second quarter of 2022 compared to $17.2 million for the second quarter of 2021. G&A expenses for the second quarter of 2022 included approximately $17.7 million of transaction costs incurred in connection with the pending acquisition by Bristol Myers Squibb.

Net Loss: Net loss was $123.1 million for the second quarter of 2022 compared to net loss of $56.3 million for the second quarter of 2021.

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2022 totaled $818.3 million, reflecting a net decrease of approximately $99.9 million from March 31, 2022.