Announcement • Apr 13

Turning Point Therapeutics, Inc. Announces Positive Topline Results from the Registrational TRIDENT-1 Study Across All Four ROS1-Positive Advanced Non-Small Cell Lung Cancer Cohort

Turning Point Therapeutics, Inc. announced positive topline results from the registrational TRIDENT-1 study across all four ROS1-positive advanced non-small cell lung cancer (NSCLC) cohorts, as reported by Blinded Independent Central Review (BICR). The primary objective of the TRIDENT-1 study is to determine the cORR based on BICR as assessed by RECIST 1.1, and the key secondary objectives include duration of response (DOR), progression free survival (PFS) and intracranial activity. The dataset utilizes a February 11, 2022 data cutoff date. The safety analysis included 380 treated patients from the pooled Phase 1 and Phase 2 portions of TRIDENT-1 across all cohorts, of which 287 patients were treated at the Phase 2 dose. The efficacy analyses included pooled patients from Phase 1 across all dose levels with an identified ROS1 fusion by next generation sequencing at baseline and Phase 2 patients. All patients received at least one dose of repotrectinib with at least four months of follow-up, and the majority of responders had at least six months of DOR follow-up. Pooled Phase 1 and Phase 2 Topline Efficacy Analyses by BICR: ROS1-positive TKI-Naïve NSCLC (EXP-1; n=71 (8 from Phase 1 and 63 from Phase 2)): In the ROS1-positive TKI-naïve advanced NSCLC population (EXP-1: n=71), the cORR was 79% (n=56/71; 95% CI: 68, 88), with 4 patients (6%) achieving a complete response (CR) and 52 patients (73%) achieving a partial response (PR). The cORR does not include one patient in an unconfirmed partial response (uPR) with tumor regression of -38% on the last scan, who remained on treatment awaiting the next scan as of the data cutoff date. DOR ranged from 1.4+ to 35.1+ months with probability of patients in a response at 6, 9, 12 and 18 months, utilizing a Kaplan-Meier analysis, with a median duration of follow-up of 10.2 months. PFS ranged from 0+ to 40.4+ months with probability of patients remaining progression free at 6, 9, 12 and 18 months, utilizing a Kaplan-Meier analysis, with a median duration of follow-up of 10.8 months. ROS1-positive TKI-Pretreated NSCLC (EXP-2, EXP-3, and EXP-4; n=100): In the ROS1-positive advanced NSCLC population pretreated with one prior TKI and prior platinum-based chemotherapy (EXP-2: n=26 (3 from Phase 1 and 23 from Phase 2)), the cORR was 42% (n=11/26; 95% CI: 23, 63), with 1 patient (4%) achieving a CR and 10 patients (38%) achieving a PR. Duration of response ranged from 3.6 to 18.3+ months. In the ROS1-positive advanced NSCLC population pretreated with two prior TKIs without prior chemotherapy (EXP-3: n=18 (1 from Phase 1 and 17 from Phase 2)), the cORR was 28% (n=5/18; 95% CI: 10, 54), with 1 patient (6%) achieving a CR and 4 patients (22%) achieving a PR. Duration of response ranged from 1.9+ to 20.3+ months. In the ROS1-positive advanced NSCLC population pretreated with one prior TKI without prior chemotherapy (EXP-4: n=56 (3 from Phase 1 and 53 from Phase 2)), the cORR was 36% (n=20/56; 95% CI: 23, 50), with 4 patients (7%) achieving a CR and 16 patients (30%) achieving a PR. The cORR does not include two patients with an uPR who both had tumor regressions of -47% on their last scans, both of whom remained on treatment awaiting their next scans as of the data cutoff date. Duration of response ranged from 1.9+ to 17.8 months. Across the ROS1-positive TKI-pretreated advanced NSCLC population (EXP-2, EXP-3 and EXP-4), 17 patients had an identified ROS1 G2032R solvent front mutation detected, of which the cORR was 59% (n=10/17; 95% CI: 33, 82), with 1 patient (6%) achieving a CR and 9 patients (53%) achieving a PR. Duration of response ranged from 1.9+ to 20.3+ months. TRIDENT-1 Topline Safety Analyses: Repotrectinib was generally well tolerated in a total of 380 patients with a safety and tolerability profile that was consistent with previously reported findings. The most commonly reported treatment emergent adverse event remained dizziness (61% all grade), of which 76% of patients who reported dizziness had a maximum severity of grade 1. The safety profile was comparable among the 287 patients who were treated at the Phase 2 dose. As previously guided, the company anticipates discussing the topline BICR data with the U.S. Food and Drug Administration (FDA) at a pre-NDA meeting this quarter.

Announcement • Mar 03

Turning Point Therapeutics, Inc. Provides Operational and Clinical Updates

Turning Point Therapeutics, Inc. announced that progress in the Phase 2 TRIDENT-1 registrational study of lead drug candidate repotrectinib, where the company in January reported updated interim findings in patients with ROS1-positive TKI-naïve non-small cell lung cancer (NSCLC). As of the Dec. 31, 2020 data cutoff date in 15 patients enrolled in the Phase 2 portion of the TRIDENT-1 study, the preliminary efficacy analysis showed a confirmed objective response rate (ORR) by physician assessment of 93% (95% CI: 68-100), and in 22 patients pooled from the Phase 1 (dosed at or above the Phase 2 dose) and Phase 2 portions, the confirmed ORR was 91% (95% CI: 71-99). As of an Oct. 30, 2020 data cutoff date, the interim safety update in a total of 185 patients from the Phase 1 and Phase 2 portions of the study showed repotrectinib was generally well tolerated. Strong enrollment in the TRIDENT-1 study during the fourth quarter and into 2021, with Turning Point now anticipating enrollment in cohort 1 (EXP-1) to reach 50 patients pooled from the Phase 1 and Phase 2 portions of the study in the second quarter of 2021. The company plans to discuss next steps towards registration of repotrectinib in this patient population at a Type B meeting with the Food and Drug Administration (FDA), also anticipated in the second quarter. In addition, enrollment in the other cohorts within TRIDENT-1 continues to progress, and it is the company’s goal to provide an enrollment and clinical data update for other cohorts in the study in the second half. Breakthrough Therapy Designation (BTD) granted by the FDA for the treatment of patients with ROS1-positive metastatic NSCLC who have not been treated with a ROS1 tyrosine kinase inhibitor. BTD is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. Plans to present additional preclinical data highlighting repotrectinib’s combination potential in KRAS-mutant disease at a medical conference in the second quarter of 2021. Progress toward initiating the first cohort in the multi-arm Phase 1b/2 TRIDENT-2 repotrectinib combination study in KRAS-mutant solid tumors in mid-2021. TPX-0022, MET/SRC/CSF1R Inhibitor: Progress in the Phase 1 SHIELD-1 study of TPX-0022, Turning Point’s MET, SRC and CSF1R inhibitor, where initial data reported in October 2020 highlighted preliminary clinical activity, including objective responses across multiple tumor types and a generally well-tolerated safety profile. The company continues to enroll patients in the Phase 1 study and is currently evaluating multiple doses and schedules to further characterize the pharmacokinetics, safety and efficacy profile before ultimately determining a recommended Phase 2 dose (RP2D), anticipated in the second quarter. Turning Point plans to proceed directly into Phase 1 dose expansion in multiple patient cohorts after determining RP2D. Additional clinical data update from the Phase 1 dose finding portion of SHIELD-1 planned in the second half of 2021. The company also plans to discuss the ongoing study with the FDA with the goal to modify the study into a registrational Phase 1/2 design and initiate the Phase 2 portion in the second half, pending FDA feedback. TPX-0046, RET Inhibitor: Progress in the Phase 1 dose finding study of TPX-0046, a novel RET inhibitor, where the company continues to evaluate multiple doses and schedules to further characterize the pharmacokinetics, safety, and efficacy profile. Turning Point plans to provide preliminary data in the second quarter of 2021, which will focus primarily on safety and any early signals of efficacy from initial patients. TPX-0131, ALK Inhibitor: Approval by the Australian Ethics Committee of the Phase 1/2 clinical study of TPX-0131 focused on ALK-positive TKI-pretreated advanced NSCLC patients. Study initiation is anticipated in the second quarter of 2021. IND submission to the FDA on track for March for TPX-0131, Turning Point’s fourth drug candidate, which has a compact macrocyclic structure that has been shown in preclinical studies to potently inhibit wildtype ALK and numerous ALK mutations, and in in-vivo studies has shown significant brain tissue penetration after repeat oral dosing supporting the potential to cross the blood-brain barrier. Presentation of additional preclinical data highlighting the profile of TPX-0131 at a medical conference in the second quarter of 2021. Key milestones anticipated in 2021 include: Repotrectinib: Reach enrollment of 50 patients pooled from the Phase 1 and Phase 2 portions of the TRIDENT-1 study in the ROS1-positive TKI-naïve NSCLC patient cohort (EXP-1) in second quarter. Discuss next steps towards registration of repotrectinib in patients with ROS1-positive TKI-naïve NSCLC at a Type B meeting with the FDA in the second quarter. Initiate the first cohort of a multi-arm Phase 1b/2 TRIDENT-2 combination study in patients with KRAS-mutant solid tumors mid-year. Provide an enrollment and clinical data update in other cohorts of the Phase 2 TRIDENT-1 study in the second hal .TPX-0046: Report early interim data from initial patients enrolled in the dose finding portion of the TPX-0046 Phase 1 study in the second quarter. TPX-0022: Provide a clinical data update from the Phase 1 dose finding portion of the SHIELD-1 study in the second half. Initiate the Phase 2 portion of the SHIELD-1 study of TPX-0022, pending FDA feedback, in the second half. Initiate the Phase 1b/2 SHIELD-2 study of TPX-0022 in combination with an epidermal growth factor receptor (EGFR) targeted therapy in the second halTPX-0131. Submit the IND for TPX-0131 in the first quarter. Initiate the Phase 1/2 clinical study of TPX-0131 focused on ALK-positive TKI-pretreated advanced NSCLC patients in the second quarte. Preclinical/Research: Present multiple preclinical data presentations in the second quarter. Outline research strategy in the second half, including focus and anticipated timeline to development candidates.

Total Shareholder Yield	-0.4%
Future Dividend Yield	0%
Dividend Growth	n/a
Next dividend pay date	n/a
Ex dividend date	n/a
Dividend per share	n/a
Payout ratio	n/a

Segment	Dividend Yield
Company (TPTX)	n/a
Market Bottom 25% (US)	1.3%
Market Top 25% (US)	4.2%
Industry Average (Biotechs)	2.3%
Analyst forecast (TPTX) (up to 3 years)	0%

Data	Last Updated (UTC time)
Company Analysis	2022/08/17 04:31
End of Day Share Price	2022/08/16 00:00
Earnings	2022/06/30
Annual Earnings	2021/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Alec Stranahan	BofA Global Research
Arlinda Lee	Canaccord Genuity
Silvan Tuerkcan	Citizens JMP Securities, LLC

This company has been acquired

Turning Point Therapeutics Dividends and Buybacks

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Key information

Recent dividend and buyback updates

Recent updates

Turning Point Therapeutics, Inc.(NasdaqGS:TPTX) dropped from NASDAQ Composite Index

Turning Point Therapeutics, Inc. Announces Executive Changes

Consensus forecasts updated

Turning Point Therapeutics, Inc. Provides Operational and Clinical Update

Second quarter 2022 earnings: EPS and revenues miss analyst expectations

Executive VP & CFO recently sold US$89k worth of stock

Bristol Myers U.S., German antitrust filings for Turning Point expected very soon - report

Turning Point Therapeutics, Inc.(NasdaqGS:TPTX) dropped from NASDAQ Biotechnology Index

Price target decreased to US$79.50

Price target decreased to US$87.71

Bristol-Myers Squibb Company (NYSE:BMY) entered into a definitive merger agreement to acquire Turning Point Therapeutics, Inc. (NasdaqGS:TPTX) for $3.8 billion.

Consensus forecasts updated

Turning Point Therapeutics, Inc. Announces Appointment of Steve Sabus as Chief Commercial Officer, Effective as of May 31, 2022

Price target decreased to US$105

Turning Point Therapeutics Granted Breakthrough Therapy Designation for Repotrectinib Treatment in Patients With One Prior ROS1 Tyrosine Kinase Inhibitor and no Prior Chemotherapy

Turning Point Therapeutics, Inc., Annual General Meeting, Jun 16, 2022

High number of new and inexperienced directors

Turning Point Therapeutics, Inc. Announces Positive Topline Results from the Registrational TRIDENT-1 Study Across All Four ROS1-Positive Advanced Non-Small Cell Lung Cancer Cohort

Turning Point Therapeutics, Inc. Appoints Brian Sun as Senior Vice President and General Counsel, Effective April 11, 2022

We Think Turning Point Therapeutics (NASDAQ:TPTX) Can Afford To Drive Business Growth

Turning Point Therapeutics, Inc. Announces the Resignation of Siegfried Reich as Executive Vice President and Chief Scientific Officer

Full year 2021 earnings: EPS exceeds analyst expectations

Price target decreased to US$119

Turning Point Therapeutics, Inc. Announces Retirement of Annette North as Executive Vice President, General Counsel and Corporate Secretary, Effective March 4, 2022

President recently sold US$108k worth of stock

Turning Point Therapeutics, Inc. Announces FDA Clearance of Investigational New Drug Application for Combination of Elzovantinib and Aumolertinib in Egfr Mutant Met-Amplified Non-Small Cell Lung Cancer

Turning Point Therapeutics, Inc. Provides Updates and Anticipates 2022 Clinical and Discovery Pipeline Milestones

Turning Point Therapeutics, Inc. Announces Regulatory Updates for Its Lead Drug Candidate, Repotrectinib, ROS1/TRK Inhibitor, and for Elzovantinib (TPX-0022), Its Drug Candidate Targeting MET, CSF1R and SRC

Companies Like Turning Point Therapeutics (NASDAQ:TPTX) Are In A Position To Invest In Growth

The Take On Turning Point Therapeutics

Price target decreased to US$134

Turning Point Therapeutics Announces Early Clinical Data for Repotrectinib in NTRK Fusion-Positive Advanced Solid Tumors Selected for Late-Breaker Plenary Presentation at 2021 AACR-NCI-EORTC Conference

Executive VP exercised options and sold US$630k worth of stock

Turning Point Therapeutics Initiates TRIDENT-2 Clinical Study Investigating Repotrectinib-Trametinib Combination in KRAS G12D Mutated Advanced Solid Tumors

Consensus revenue estimates increase to US$30.4m

Industry Analysts Just Made A Sizeable Upgrade To Their Turning Point Therapeutics, Inc. (NASDAQ:TPTX) Revenue Forecasts

Turning Point Therapeutics (NASDAQ:TPTX) Is In A Strong Position To Grow Its Business

Executive VP & Chief Commercial Officer recently sold US$140k worth of stock

Chairman of the Board recently bought US$163k worth of stock

Turning Point Therapeutics, Inc. Grants FDA Orphan Drug Designation for TPX-0022 in Gastric Cancer

Executive VP exercised options and sold US$900k worth of stock

Senior VP of Finance & Administration and Principal Accounting Officer has left the company

Consensus forecasts updated

Turning Point Therapeutics, Inc. (NASDAQ:TPTX) Just Reported First-Quarter Earnings: Have Analysts Changed Their Mind On The Stock?

Turning Point Therapeutics, Inc. Appoints Brian Baker as the Interim Principal Financial Officer

Turning Point Therapeutics, Inc. Announces Executive Changes, Effective March 31, 2021

Analysts update estimates

New 90-day low: US$103

Earnings beat expectations, revenue disappoints

Turning Point Therapeutics, Inc. Provides Operational and Clinical Updates

Have Insiders Been Selling Turning Point Therapeutics, Inc. (NASDAQ:TPTX) Shares This Year?

Turning Point Therapeutics, Inc. to Report Q4, 2020 Results on Mar 01, 2021

President exercised options and sold US$8.1m worth of stock

New 90-day high: US$140

Price target raised to US$160

Turning Point Therapeutics Reports Updated Interim Data from Registrational Phase 2 Trident-1 Study of Repotrectinib in Patients With ROS1-Positive TKI-Naïve Non-Small Cell Lung Cancer

Analysts' Revenue Estimates For Turning Point Therapeutics, Inc. (NASDAQ:TPTX) Are Surging Higher

Price target raised to US$141

We're Not Worried About Turning Point Therapeutics' (NASDAQ:TPTX) Cash Burn

Turning Point Therapeutics, Inc. Announces the Following 2021 Milestone Targets for Its Pipeline

New 90-day high: US$131

Executive VP & Chief Medical Officer exercised options and sold US$657k worth of stock

Is Turning Point Therapeutics, Inc. (NASDAQ:TPTX) Trading At A 48% Discount?

New 90-day high: US$126

Analysts update estimates

Turning Point Therapeutics, Inc. Announces the Resignation of Carl Gordon from the Board of Directors of the Company

Analysts update estimates

Revenue beats expectations, earnings disappoint

Price target raised to US$92.11

New 90-day high: US$92.56

Turning Point Therapeutics Announces Updated Interim Clinical Data of Repotrectinib in Advanced ROS1+ Non-Small Cell Lung Cancer

Stability and Growth of Payments

Dividend Yield vs Market

Earnings Payout to Shareholders