TPTX Turning Point Therapeutics Inc.

76.12
-2.54  -3%
Previous Close 78.66
Open 79.17
52 Week Low 59.73
52 Week High 141.3
Market Cap $3,761,181,412
Shares 49,407,966
Float 41,021,238
Enterprise Value $2,826,490,437
Volume 106,505
Av. Daily Volume 303,581
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Upcoming Catalysts

Drug Stage Catalyst Date
Repotrectinib (TPX-0005) - TRIDENT-1
Non-small-cell lung cancer (NSCLC) and solid tumors
Phase 2
Phase 2
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TPX-0022 ( SHIELD-1)
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Repotrectinib (TPX-0005) - TRIDENT-2
KRAS mutant NSCLC
Phase 2
Phase 2
Phase 2 initiation announced August 16, 2021.
TPX-0022 (SHIELD-2)
Phase 1/2
Phase 1/2
Phase 1b/2 trial to be initiated 4Q 2021.
TPX-0131 - FORGE-1
Non-small cell lung cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial initiation announced April 12, 2021.
TPX-0046
RET-altered NSCLC
Phase 1/2
Phase 1/2
Phase 1/2 interim data noted 3/14 partial responses - April 5, 2021.

Latest News

  1. SAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced a late-breaker abstract of early clinical data by physician assessment for repotrectinib in NTRK-positive TKI-naïve and TKI-pretreated advanced solid tumor cohorts of TRIDENT-1 has been accepted for oral presentation in a plenary session at the Virtual International Conference on Molecular Targets and Cancer Therapeutics hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) on Oct. 7-10.

    In addition to the…

    SAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced a late-breaker abstract of early clinical data by physician assessment for repotrectinib in NTRK-positive TKI-naïve and TKI-pretreated advanced solid tumor cohorts of TRIDENT-1 has been accepted for oral presentation in a plenary session at the Virtual International Conference on Molecular Targets and Cancer Therapeutics hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) on Oct. 7-10.

    In addition to the late-breaker abstract, two additional abstracts have been selected for presentation at the meeting:

    • Repotrectinib clinical data by physician assessment from the ROS1-positive non-small cell lung cancer TKI-pretreated cohorts (EXP-2, EXP-3 and EXP-4) of TRIDENT-1; and



    • TPX-0022 clinical data by physician assessment from the Phase 1 dose finding portion of SHIELD-1 in patients with advanced solid tumors harboring genetic alterations in MET.

    About Turning Point Therapeutics Inc.

    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, 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, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer. 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.

    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. 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 SEC, including its quarterly report on Form 10-Q filed with the SEC on August 9, 2021. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Contact:

    Scott Lipman

    ir@tptherapeutics.com 

    858-876-3985



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  2. SAN DIEGO, Sept. 01, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced that President and CEO Athena Countouriotis, M.D., will participate in the Wells Fargo Virtual Healthcare Conference on Sept. 9 and the H.C. Wainwright 23rd Annual Global Investment Conference on Sept. 13.

    Dr. Countouriotis is scheduled to present a company overview and participate in a question-and-answer session at 2:00 p.m. ET on Sept. 9 and present a company overview at 7:00 a.m. ET on Sept. 13. Both sessions will be accessible via webcast through the Investors page of www.tptherapeutics.com.

    About Turning Point Therapeutics

    SAN DIEGO, Sept. 01, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced that President and CEO Athena Countouriotis, M.D., will participate in the Wells Fargo Virtual Healthcare Conference on Sept. 9 and the H.C. Wainwright 23rd Annual Global Investment Conference on Sept. 13.

    Dr. Countouriotis is scheduled to present a company overview and participate in a question-and-answer session at 2:00 p.m. ET on Sept. 9 and present a company overview at 7:00 a.m. ET on Sept. 13. Both sessions will be accessible via webcast through the Investors page of www.tptherapeutics.com.

    About Turning Point Therapeutics Inc.

    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 pretreated 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, 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, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer. 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.

    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. 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 SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Contact:

    Scott Lipman

    ir@tptherapeutics.com

    858-876-3985



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  3. SAN DIEGO, Aug. 16, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced initiation of the first cohort of its Phase 1b/2 TRIDENT-2 combination study of lead investigational drug repotrectinib. The initial cohort will investigate repotrectinib in combination with MEK-inhibitor trametinib in KRAS G12D mutated advanced solid tumors.

    "We are pleased to initiate the TRIDENT-2 study and explore a potential new treatment option for patients with KRAS-driven solid tumors," said Mohammad Hirmand, executive vice president and chief medical officer. "With preclinical studies demonstrating repotrectinib's ability…

    SAN DIEGO, Aug. 16, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced initiation of the first cohort of its Phase 1b/2 TRIDENT-2 combination study of lead investigational drug repotrectinib. The initial cohort will investigate repotrectinib in combination with MEK-inhibitor trametinib in KRAS G12D mutated advanced solid tumors.

    "We are pleased to initiate the TRIDENT-2 study and explore a potential new treatment option for patients with KRAS-driven solid tumors," said Mohammad Hirmand, executive vice president and chief medical officer. "With preclinical studies demonstrating repotrectinib's ability to inhibit JAK2, SRC and FAK, our goal is to help improve the effectiveness of KRAS-targeting agents by suppressing known pathways of tumor resistance."

    The Phase 1b portion of the study will examine the safety, tolerability, pharmacokinetics, and any early signals of efficacy of repotrectinib in combination with trametinib in patients with KRAS G12D mutated advanced solid tumors. After determination of a recommended Phase 2 combination dose, the study includes a Phase 2 dose expansion portion with the primary endpoint of objective response rate.

    Results from preclinical studies presented at the 2021 American Association for Cancer Research annual meeting found that repotrectinib in combination with trametinib was more effective than single-agent trametinib in patient-derived KRAS mutant G12D lung cancer models. The repotrectinib-trametinib combination suppressed a broad range of downstream mutant KRAS G12D signaling, increased cell cycle arrest and induction of apoptosis, and was more active in multiple KRAS G12D dependent models compared to either single-agent treatment. 

    The frequently mutated Kirsten Rat Sarcoma (KRAS) viral oncogene is associated with a broad range of human cancers, including approximately 30% of non-small cell lung, 40% of colorectal and more than 90% of pancreatic cancers. KRAS G12D mutations are known to occur across multiple tumors types, including an estimated 30% of pancreatic, 15% of colorectal and 5% of both endometrial and non-small cell lung cancers.

    Therapeutic targeting of KRAS has proven challenging, in part due to resistance and adaptive upregulation of alternative signaling pathways that promote tumor cell survival, as well as concurrent secretion of various cytokines and growth factors.

    About Turning Point Therapeutics Inc.

    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, 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, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer. 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.

    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 repotrectinib, the results, conduct, progress and timing of Turning Point Therapeutics' pre-clinical studies and clinical trials and plans regarding future clinical trials. 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 SEC, including its quarterly report on Form 10-Q filed with the SEC on August 9, 2021. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Contact:

    Scott Lipman

    ir@tptherapeutics.com

    858-876-3985

     



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  4. SAN DIEGO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced the U.S. Food and Drug Administration (FDA) granted a sixth regulatory designation to lead drug candidate, repotrectinib.

    The Fast-Track designation was granted for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) who have been previously treated with one prior ROS1 tyrosine kinase inhibitor (TKI) and who have not received prior platinum-based chemotherapy.

    "We are pleased to receive our fourth Fast-Track designation and sixth overall regulatory designation for repotrectinib as we continue…

    SAN DIEGO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced the U.S. Food and Drug Administration (FDA) granted a sixth regulatory designation to lead drug candidate, repotrectinib.

    The Fast-Track designation was granted for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) who have been previously treated with one prior ROS1 tyrosine kinase inhibitor (TKI) and who have not received prior platinum-based chemotherapy.

    "We are pleased to receive our fourth Fast-Track designation and sixth overall regulatory designation for repotrectinib as we continue to work toward our goal of getting this ROS1 targeted therapy to patients quickly," said Athena Countouriotis, M.D., president and chief executive officer. "We continue to believe repotrectinib has the potential to be a best-in-class treatment for patients with ROS1-positive advanced non-small cell lung cancer or NTRK-positive advanced solid tumors and now have multiple regulatory designations in both the TKI-naïve and TKI-pretreated ROS1 patient populations."

    Repotrectinib was previously granted Breakthrough Therapy designation in ROS1- positive metastatic NSCLC patients who have not been treated with a ROS1 tyrosine kinase inhibitor, as well as three Fast-Track designations in ROS1-positive advanced NSCLC patients who are ROS1 TKI naïve, ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI, and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments.

    About Fast-Track Designation

    Fast-Track is an FDA program intended to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need.

    A drug candidate that receives Fast-Track designation may be eligible for:

    • More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
    • More frequent written communication with the FDA;
    • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
    • Rolling submission of a New Drug Application (NDA) for review by FDA.

    About Turning Point Therapeutics Inc.

    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, 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, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer. 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.

    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 repotrectinib, the potential benefits of Fast Track Designation and the regulatory approval path for repotrectinib. 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 SEC, including its quarterly report on Form 10-Q filed with the SEC on August 9, 2021. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Contact:

    Jim Mazzola

    jim.mazzola@tptherapeutics.com

    858-342-8272



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    • Phase 1/2 TRIDENT-1 Enrollment Reaches Approximately 300 Patients, Including More than 50 in the ROS1-Positive TKI-naïve NSCLC Cohort (EXP-1)

    • TPX-0022 Granted Fast Track Designation in MET Amplified Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction (GEJ) Adenocarcinoma after Prior Chemotherapy

    • SHIELD-1 Phase 1 Expansion Cohorts Initiated

    • TRIDENT-1, SHIELD-1 and CARE Studies Accepted for Clinical Data Presentations at Medical Conferences in October

    • Four Discovery Research Programs Ongoing with First 2 Development Candidates Targeted in 2H 2022; Goal to Achieve At Least 1 New IND Every Year Beginning in 2023

    • Cash, Cash Equivalents, and Marketable Securities of $1.1 Billion Expected to Fund Current Operations into 2024

    SAN DIEGO, Aug…

    • Phase 1/2 TRIDENT-1 Enrollment Reaches Approximately 300 Patients, Including More than 50 in the ROS1-Positive TKI-naïve NSCLC Cohort (EXP-1)



    • TPX-0022 Granted Fast Track Designation in MET Amplified Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction (GEJ) Adenocarcinoma after Prior Chemotherapy



    • SHIELD-1 Phase 1 Expansion Cohorts Initiated



    • TRIDENT-1, SHIELD-1 and CARE Studies Accepted for Clinical Data Presentations at Medical Conferences in October



    • Four Discovery Research Programs Ongoing with First 2 Development Candidates Targeted in 2H 2022; Goal to Achieve At Least 1 New IND Every Year Beginning in 2023



    • Cash, Cash Equivalents, and Marketable Securities of $1.1 Billion Expected to Fund Current Operations into 2024

    SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today reported financial results and operational updates for the second quarter ended June 30, 2021.

    "Our team made strong progress advancing our 4 clinical drug candidates in 5 ongoing clinical trials as well as our research programs with the first 2 development candidates targeted in the second half of 2022," said Athena Countouriotis, M.D., president and CEO. "In our clinical programs, we are pleased with ongoing enrollment in our pivotal TRIDENT-1 study of repotrectinib. In addition, we recently initiated the Phase 1 expansion cohorts in our SHIELD-1 study of TPX-0022 and just last week were granted Fast Track designation for TPX-0022 in certain gastric cancer indications. We look forward to multiple data updates from our clinical studies at medical conferences during the fourth quarter."

    Second quarter and recent highlights include:

    REPOTRECTINIB, ROS1/TRK Inhibitor

    • Enrollment of approximately 300 patients in the Phase 1 and 2 portions of the TRIDENT-1 study, including more than 50 patients in the ROS1-positive TKI-naïve advanced non-small cell lung cancer (NSCLC) patient cohort (EXP-1). Enrollment in the EXP-1 cohort is ongoing to provide continued access to new patients.



    • Acceptance of TRIDENT-1 clinical data for presentation at the 2021 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October.



    • Acceptance of initial clinical data from the ongoing Phase 1/2 CARE study in pediatric and young adult patients with advanced solid tumors harboring ALK, ROS1 or NTRK alterations for an oral presentation at the 53rd Congress of the International Society of Paediatric Oncology (SIOP) in October.



    • First patients dosed in China in the TRIDENT-1 study as part of the company's partnership with Zai Lab to develop repotrectinib in greater China. Achievement of the milestones resulted in revenue of $5 million to Turning Point under its collaboration agreement with Zai Lab.

    TPX-0022, MET/ SRC/CSF1R Inhibitor

    • Selection of the likely recommended Phase 2 dose (RP2D) in the ongoing Phase 1 SHIELD-1 study of TPX-0022, Turning Point's MET, SRC and CSF1R inhibitor, and initiation of Phase 1 expansion cohorts. Subject to feedback from the U.S. Food and Drug Administration (FDA) at an end of Phase 1 meeting in the third quarter, including agreement on the RP2D, the company plans to revise the study into a potentially registrational Phase 1/2 and proceed into the Phase 2 portion.



    • Acceptance of SHIELD-1 clinical data for presentation at the 2021 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October.



    • Orphan Drug Designation granted by the FDA for the treatment of patients with gastric cancer, including gastroesophageal junction adenocarcinoma (GEJ).



    • Fast Track Designation granted by the FDA for the treatment of patients with MET amplified advanced or metastatic gastric cancer or GEJ adenocarcinoma after prior chemotherapy.

    TPX-0046, RET Inhibitor

    • Progress in the ongoing dose-finding portion of the Phase 1/2 SWORD-1 study, where the company continues to evaluate multiple doses and schedules to further characterize the pharmacokinetics, safety, and efficacy profile before determining the RP2D.

    TPX-0131, ALK Inhibitor

    • Ongoing patient dosing in the Phase 1/2 FORGE-1 study of TPX-0131 in locally advanced or metastatic TKI-pretreated ALK-positive NSCLC. The study endpoints include safety and tolerability, determination of the recommended Phase 2 dose, pharmacokinetics, and any early signals of efficacy.



    • Publication of preclinical data in the AACR Journal of Molecular Cancer Therapeutics showing TPX-0131 to be potent against a wide range of ALK resistant mutations, including G1202R, L1196M and multiple compound mutations.

    Discovery

    • Advancing four internal discovery programs targeting aberrant GTPase signaling known to drive genomically defined cancers with significant unmet medical need. The most advanced programs target KRAS G12D and the p21 activated kinase, or "PAK" family. Turning Point is targeting 2 development candidates in the second half of 2022 with a goal to achieve at least one new IND per year beginning in 2023.

    Second Quarter Financial Results

    • Revenue: Revenue of $5.2 million recognized during the quarter was driven primarily by milestones earned from Zai Lab (Shanghai) Co. Ltd. under the company's license agreement for repotrectinib in Greater China. Revenue for the first half of 2021 totaled $30.4 million.



    • R&D Expenses: Research and development expenses were $44.7 million in the quarter, compared to $24.2 million in the second quarter of 2020. The $20.5 million increase was primarily driven by the year-over-year increase in investments to develop repotrectinib, TPX-0022, TPX-0046 and TPX-0131, discovery efforts and personnel expenses. R&D expenses for the first half of 2021 totaled $85.9 million.



    • G&A Expenses: General and administrative expenses were $17.2 million compared to $8.6 million in the second quarter of 2020, primarily related to higher personnel expenses from an increase in head count and professional services. G&A expenses for the first half of 2021 totaled $37.2 million.



    • Net Income/Loss: Net loss was $56.3 million compared to a net loss of $31.5 million for the second quarter of 2020. Net loss for the first half of 2021 was $91.8 million.



    • Cash position: Cash, cash equivalents and marketable securities at June 30, 2021 totaled approximately $1.1 billion. Net cash used during the first half of 2021 was $44.7 million. Turning Point projects its cash position funds current operations into 2024.

    Upcoming Milestones

    Key milestones anticipated in the second half of 2021 include:

    Repotrectinib

    • Initiate the first cohort of a multi-arm Phase 1b/2 TRIDENT-2 combination study in patients with KRAS mutant G12D advanced solid tumors in the third quarter



    • Provide a clinical data update by physician assessment from multiple ROS1 and NTRK patient cohorts of the Phase 2 TRIDENT-1 study at the AACR-NCI-EORTC conference in October



    • Report initial clinical data from the ongoing Phase 1/2 CARE study in pediatric and young adult patients in an oral presentation at the 53rd SIOP Congress in October

    TPX-0022

    • Provide a clinical data update across multiple tumor types and MET genetic alterations from the Phase 1 dose finding portion of the SHIELD-1 study at the AACR-NCI-EORTC conference in October



    • Initiate the Phase 2 portion of the SHIELD-1 study, pending FDA feedback, in the fourth quarter



    • Initiate the Phase 1b/2 SHIELD-2 study of TPX-0022 in combination with an epidermal growth factor receptor (EGFR) targeted therapy in the fourth quarter

    Webcast, Conference Call, Upcoming Investor Conferences

    Turning Point will webcast its Quarterly Update Conference Call today, Aug. 9 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Countouriotis will host the call, which will be accessible through the "Investors" section of tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside the U.S.) using conference ID 4029189. A replay will be available through the "Investors" section of www.tptherapeutics.com.

    Dr. Countouriotis will also participate in a targeted oncology panel discussion at the 2021 Wedbush Pacgrow Virtual Healthcare Conference on Aug. 10 at 10:55 a.m. ET, and a "fireside chat" question-and-answer session at the 41st Annual Canaccord Genuity Growth Conference on Aug. 11 at 4 p.m. ET. Both sessions will be accessible through the "Investors" section of www.tptherapeutics.com.

    About Turning Point Therapeutics Inc.

    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 pretreated 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, 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, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer. 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.

    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' research and development programs and clinical trials, plans regarding future data presentations, clinical trials, regulatory meetings and regulatory submissions, the regulatory approval path for repotrectinib, and 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' Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    TURNING POINT THERAPEUTICS, INC. 
    Balance Sheet Data 
    (In thousands)

    (unaudited)
     



      June 30,  December 31,  
      2021  2020  
    Balance Sheet Data:         
    Cash, cash equivalents, and marketable securities $1,077,806  $1,122,508  
    Working capital  1,059,525   1,106,287  
    Total assets  1,102,920   1,136,713  
    Accumulated deficit  (371,953)  (280,176) 
    Total stockholders' equity $1,067,507  $1,109,898  

    TURNING POINT THERAPEUTICS, INC.

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands, except share and per share amounts)

    (unaudited)

      Three Months Ended

    June 30,
      Six Months Ended June 30,



      
      2021  2020  2021  2020  
    Revenue $5,164  $-  $30,369  $-  
    Operating expenses:                 
    Research and development  44,650   24,154   85,913   46,923  
    General and administrative  17,171   8,578   37,162   48,435  
    Total operating expenses  61,821   32,732   123,075   95,358  
    Loss from operations  (56,657)  (32,732)  (92,706)  (95,358) 
    Other income, net  384   1,239   929   3,147  
    Net loss  (56,273)  (31,493)  (91,777)  (92,211) 
    Unrealized gain / (loss) on marketable securities, net of tax  (22)  1,063   (208)  747  
    Comprehensive loss $(56,295) $(30,430) $(91,985) $(91,464) 
    Net loss per share, basic and diluted $(1.14) $(0.82) $(1.87) $(2.47) 
    Weighted-average common shares outstanding, basic and diluted  49,204,425   38,603,236   49,063,298   37,261,296  

    Contact:

    Jim Mazzola

    jim.mazzola@tptherapeutics.com

    858-342-8272

     



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