On August 10, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that presentations at the upcoming 2021 Society of Neuro-Oncology (SNO) Conference on Brain Metastases, to be held in a virtual format from August 19 to 20, 2021 (Press release, Blue Earth Diagnostics, AUG 10, 2021, View Source [SID1234586256]). The conference, the Third Annual Conference on Brain Metastases, is conducted by SNO and the American Association of Neurological Surgeons (AANS)/CNS Section on Tumors. Details of the presentations to be given by Blue Earth Diagnostics and its collaborators are listed below.

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Note: 18F-fluciclovine, under the tradename Axumin (fluciclovine F 18) injection, is an FDA-approved and commercially available molecular imaging radiopharmaceutical for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The safety and efficacy of 18F-fluciclovine PET imaging for the detection of recurrent brain metastases has not been established.

Highlighted 18F-Fluciclovine Scientific Presentations

All 2021 SNO Conference on Brain Metastases presentations are available beginning 11:00 a.m. ET, Thursday, August 19, 2021.

Title:

Trial in Progress: A Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine PET in Detecting Recurrent Brain Metastases after Radiation Therapy (PURSUE)
Presenter: Rupesh Kotecha, MD, Baptist Health South Florida, Miami, FL, USA
Abstract:

TRLS-01

Title:

Trial in Progress: A Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine PET in Detecting Recurrent Brain Metastases after Radiation Therapy (REVELATE)
Presenter: Alain Chaglassian, MD, Blue Earth Diagnostics Inc., Burlington, MA
Abstract:

TRLS-02
Blue Earth Diagnostics invites participants at the SNO Conference on Brain Metastases 2021 to attend the presentations above. For more information about the meeting, please see the online program here.

Blue Earth Diagnostics has two clinical studies underway to investigate the use of 18F-fluciclovine PET in the detection of recurrent brain metastases. The Phase 2 PURSUE trial is designed to establish image interpretation criteria for 18F-fluciclovine PET in detecting recurrent brain metastases. REVELATE is a Phase 3 study designed to evaluate its diagnostic performance in the detection of recurrent brain metastases in patients previously treated with radiation therapy. Further information about these trials, including a current list of clinical trial sites, can be found on www.clinicaltrials.gov (PURSUE, NCT04410367; REVELATE, NCT04410133).

About 18F-Fluciclovine PET

18F-Fluciclovine PET is a novel diagnostic imaging radiopharmaceutical for PET imaging to visualize the increased amino transport that occurs in malignant tumors. It consists of a synthetic amino acid that is preferentially taken up by cancer cells compared with surrounding normal tissues and is labeled with the radioisotope 18F for PET imaging. 18F-Fluciclovine is under investigation by Blue Earth Diagnostics for potential use for the detection of recurrent brain metastases in adult patients who have previously undergone radiation therapy. 18F-Fluciclovine was invented at Emory University, in Atlanta, Ga., with much of the fundamental clinical development carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Blue Earth Diagnostics licensed 18F-fluciclovine from GE Healthcare and is investigating the molecule for other potential cancer indications, including in neuro-oncology.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On August 10, 2021 TYME Technologies, Inc. (Nasdaq: TYME) (the "Company" or "TYME"), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported financial and operating results for its fiscal first quarter ended June 30, 2021 (Press release, TYME, AUG 10, 2021, View Source [SID1234586255]).

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Fiscal First Quarter 2022 Business and Recent Highlights:

Completed strategic review and identified clinical priorities with a focus on metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative ("HR+/HER2-") breast cancer, second-line pancreatic cancer and sarcomas as well as biomarker and mechanism of action ("MOA") studies.
Granted U.S. patent claims covering use of tyrosine-based drug delivery method to treat cancer. This early-stage technology, if proven, could provide TYME an opportunity to expand its current cancer-metabolism based approach with a drug delivery platform that aims to deliver toxic therapies in a targeted manner to offer improved safety and efficacy for a range of anticancer drugs.
Commenced a comprehensive biomarker initiative across several leading institutions, including Mayo Clinic and Georgetown University and the global drug development company Evotec. These studies have the potential to provide valuable information to help guide our future clinical development. In April 2021, Mayo Clinic established multiple human pancreatic organoid models.
Presented interim clinical data from the Phase II HopES Sarcoma trial at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") General Meeting. The Company expects enrollment of this trial to be completed this fiscal year.
Strengthened leadership team with the appointments of biopharmaceutical veterans, Dr. Jan M. Van Tornout as Acting Chief Medical Officer, and Frank Porfido as Chief Financial Officer.
"It was an active and productive fiscal first quarter at TYME. Having completed our comprehensive strategic review, we believe we are now better positioned with a more diversified pipeline and larger addressable market opportunities. We welcomed Dr. Van Tornout and Mr. Porfido to the leadership team and look forward to their contributions as we embark on a host of promising clinical initiatives. Importantly, we have been able to implement these strategies without increasing our projected clinical spend," stated Richie Cunningham, Chief Executive Officer of TYME.

"Looking ahead, we believe the recently granted patent on our drug delivery technology and the announcement of the Phase II OASIS breast cancer trial with Georgetown University are exciting opportunities for TYME that help position us for meaningful achievements ahead," concluded Cunningham.

First Quarter Fiscal 2022 Financial Results

As of the first quarter ended June 30, 2021, the Company had approximately $101.5 million in cash and marketable securities, compared to $107.5 million as of the fourth quarter ended March 31, 2021. In the first quarter, the Company invested approximately $74.1 million in a portfolio of highly liquid investments and marketable securities with the primary objectives of preserving capital and diversifying risk, while maintaining sufficient liquidity to meet cash flow requirements.

TYME’s operational cash burn rate for the first quarter of fiscal year 2022 was $6.0 million compared to $5.2 million for the fourth quarter of fiscal year 2021 and $6.7 million for the first quarter of fiscal 2021. The burn rate was below the Company’s previous projections and reflects expenses associated with ongoing clinical trials in pancreatic cancer (Precision Promise) and sarcoma cancers (HopES), as well as reduced costs associated with our discontinued pancreatic cancer trial, TYME-88-Panc Part II.

Based on the Company’s active clinical trials including OASIS, our new investigator-initiated open-label Phase II breast cancer trial, ongoing and close out costs related to our discontinued pancreatic cancer study, the upcoming pre-clinical studies in biomarker and mechanism of action research of SM-88 and TYME-19 pre-clinical studies; TYME continues to anticipate that its quarterly cash usage or "cash burn rate" will range from $6.0 to $8.0 million per quarter for the remainder of fiscal year 2022.

Net loss was $5.9 million for the first quarter ended June 30, 2021, or a net loss per basic and diluted share of ($0.03), as compared to a net loss of $8.8 million for the first quarter ended June 30, 2020, or a net loss per basic and diluted share of ($0.07). The decrease was substantially due to the year over year variance in the change in value of the warrant liability compared to prior years’ gain on the warrant exchange and decreased operating costs. The reduction in operating costs primarily reflected lower ongoing trial costs and employee related expenses. Adjusted net loss for the three months ended June 30, 2021, was $6.0 million, or an adjusted net loss per share of ($0.03), compared to adjusted net loss of $6.7 million, or an adjusted net loss per share of ($0.05), for the three months ended June 30, 2020, after adjusting for the change in fair value of warrant liability, amortization of employees, directors and consultants stock options, and the prior year’s gain on warrant exchange. Adjusted net loss and adjusted net loss per share are non-GAAP measures. See "Use of Non-GAAP Measures" below for a reconciliation to the comparable GAAP measures.

TYME has reported its full financial results for the quarter ended June 30, 2021 in the Company’s Form 10-Q filed with the Securities and Exchange Commission ("SEC"). TYME’s 10-Q is located in the SEC filings section of the Company’s website.

The webcast will be accessible on the Events & Presentations page of the Investors section of the TYME website, tymeinc.com, and will be archived for 90 days following the event.

Use of Non-GAAP Measures

Adjusted net loss and adjusted net loss per share as presented in this report are non-GAAP measures. The adjustments relate to the change in fair value of warrant liability, amortization of employees, directors and consultants stock options and gain on warrant exchange. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles ("Non-GAAP Measures"). In the reconciliation tables that follow, we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures, net loss and net loss per share. These items are adjusted because they are not operational or because they are significant noncash charges and management believes these adjustments are meaningful to understanding the Company’s performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP. Our definitions of adjusted net loss and adjusted loss per share may not be comparable to similar measures reported by other companies.

On August 10, 2021 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported its second quarter 2021 financial results and provides a business update (Press release, Pulmatrix, AUG 10, 2021, View Source [SID1234586254]).

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"We have made steady progress across our pipeline in the second quarter," said Ted Raad, Chief Executive Officer of Pulmatrix. "Recent toxicology data from PUR1800 suggests the potential to expand into indications that require chronic dosing. We look forward to presenting topline data from the fully enrolled, ongoing Phase 1b study of PUR1800 in Q1 2022. We are also rapidly advancing towards the clinic with PUR3100 in acute migraine. We believe that our strong cash position allows us to advance our pipeline through major data milestones into 2023."

Second Quarter and Recent Highlights:

PUR1800

Completed enrollment in ongoing Phase 1b clinical study of PUR1800 in acute exacerbations in COPD (AECOPD). Study endpoints include safety, tolerability, and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect.
PUR1800 Phase 1b top-line data is expected in Q1 2022.
Results from 6-month rat and 9-month dog toxicology results demonstrate no progression of 28-day findings, suggesting potential for chronic dosing of PUR1800 in indications beyond AECOPD including, but not limited to, steroid resistant asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).
The Company estimates an approximate peak net revenue opportunity of $2.4B in AECOPD1, due to the significant unmet need beyond standard of care oral steroids and/or antibiotic therapy. Expansion to chronic indications should further broaden the market potential of PUR1800.
PUR3100

14-day toxicology results for PUR3100, Pulmatrix’s dry powder iSPERSE formulation of dihydroergotamine (DHE) for pulmonary delivery to treat acute migraine are expected in Q3 2021.
IND filing planned in Q4 2021, with a Phase 1/ Phase 2 clinical study start date anticipated in Q1 2022. Data from this proof-of-concept study are expected in Q4 2022.
Pulmazole

Pulmatrix notified Cipla Technologies LLC (Cipla) that it is in material breach of the Development and Commercialization Agreement (the Cipla Agreement) in May 2021. The Company continues to seek Cipla’s reaffirmation of all of its obligations under the Cipla Agreement and, in the absence of such reaffirmation, to pursue all available remedies.
1 Market research and analysis from ClearView Healthcare Partners

Financials

As of June 30, 2021, Pulmatrix had $56.9 million in cash and cash equivalents, compared to $31.7 million for the year ended December 31, 2020.

Revenue for the second quarter of 2021 was $2.2 million, compared to $3.5 million for the same period in 2020. The revenue for the second quarter of 2021 was the result of the collaboration and licensing agreements with Cipla and JJEI.

Research and development expense was $4.5 million in the second quarter of 2021 compared to $3.2 million for the same period in 2020. The increase year–over-year was primarily attributable to increased preclinical and manufacturing costs related to the PUR3100 project partially offset by decreased spend on the Pulmazole clinical trial.

General and administrative expense was $1.6 million for the second quarter of 2021 compared to $1.5 million for the same period in 2020. The increase year–over-year was primarily attributable to increase legal, patent, ad public company costs partially offset by decreased employment costs.

Net loss was $3.9 million for the second quarter of 2021 compared to a net loss of $1.2 million for the same period of 2020. The $2.7 million increase in net loss year-over-year was due to increased spend for preclinical and manufacturing expenses on the PUR3100 program and reduced revenue recognized that related to the Pulmazole program.

On August 10, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company, reported that the company has expanded its research collaboration with The Ohio State University (OSU) to deepen the understanding of the immune mechanisms of sarcoid granuloma formation and identify potential biomarkers of efficacy for the company’s lead therapeutic candidate, ATYR1923, which is currently in clinical development for the treatment of pulmonary sarcoidosis (Press release, aTyr Pharma, AUG 10, 2021, View Source [SID1234586253]). The research will be conducted in the laboratory of Elliott Crouser, M.D., Professor of Pulmonology, Critical Care and Sleep Medicine at OSU. Dr. Crouser specializes in sarcoidosis research and treatment and will serve as the principal investigator.

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The collaboration, which expands upon a successful pilot proof-of-concept study, will assess the effect of ATYR1923 on sarcoid granuloma formation in vitro in blood samples taken from sarcoidosis patients. The study will focus on identifying the relevant immune mechanisms triggered in granuloma formation and analyze promising biomarkers predictive of strong granuloma formation in order to assess whether they could be used as predictive biomarkers for treatment selection or treatment response to ATYR1923.

"We look forward to working with aTyr on this important initiative to expand the current understanding of the underlying mechanisms involved in pulmonary sarcoidosis, particularly the formation of granulomas. This work has the potential to identify promising biomarkers that may be used to predict treatment response, including to ATYR1923. Current treatment options for pulmonary sarcoidosis are limited, and the ability to determine a patient population that may benefit from a potential treatment such as ATYR1923 presents the opportunity to take a much-needed step forward in managing this disease," said Dr. Crouser.

"We are very pleased to expand this research collaboration with OSU and Dr. Crouser. This collaboration will build upon the successful findings from research conducted with Dr. Crouser that were recently accepted to be presented at the upcoming European Respiratory Society International Congress in September, which demonstrate the ability of a splice variant of histidyl-tRNA synthetase, the active portion of ATYR1923, to disrupt sarcoid granuloma formation in vitro — a hallmark of this debilitating disease," said Sanjay Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "The research generated from this collaboration may help direct us to biomarkers indicative of a population that may be sensitive to treatment with ATYR1923, which could lead to improved patient outcomes."

Sarcoidosis is an inflammatory disease characterized by the formulation of granulomas, clumps of inflammatory cells, in one or more organs of the body. Sarcoidosis in the lungs is called pulmonary sarcoidosis and occurs in more than 90% of all sarcoidosis patients. Approximately 150,000 to 200,000 Americans live with pulmonary sarcoidosis and the prognosis ranges from benign and self-limiting to chronic, debilitating disease, permanent loss of lung function and death. Current treatment options include corticosteroids and other immunosuppressive therapies, which have limited efficacy and are associated with serious side-effects when used long-term that many patients cannot tolerate.

Dr. Crouser received his medical degree from the Medical College of Ohio at Toledo, OH. He completed an internship, residency and fellowship at The Ohio State University Wexner Medical Center in Columbus, OH. He is board certified in Internal Medicine with subspecialty certifications in Pulmonary Disease and Critical Care. He is a leader in sarcoidosis research and treatment and currently serves as the Chair of the Foundation for Sarcoidosis Research’s Scientific Advisory Board. In 25 years, his laboratory has contributed to the publication of more than 100 peer-reviewed manuscripts, including the first clinical practice guidelines for sarcoidosis, which were endorsed by the American Thoracic Society in 2020. Ohio State’s Sarcoidosis Specialty Clinic was named a Center of Excellence in 2020 by the World Association of Sarcoidosis and Other Granulomatous Disorders.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with severe inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr has completed enrollment in a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetic profile of multiple doses of ATYR1923. Proof-of-mechanism for ATYR1923 was established in a Phase 2 clinical trial in COVID-19 patients with severe respiratory complications, which demonstrated that ATYR1923 reduced inflammatory cytokine levels in patients consistent with preclinical models, including cytokines that are implicated in sarcoidosis and other forms of interstitial lung disease.

On August 10, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported financial results and operational updates for the second quarter ended June 30, 2021 (Press release, Turning Point Therapeutics, AUG 10, 2021, View Source [SID1234586251]).

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"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 (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 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 (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 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 (Free AACR Whitepaper) 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 (Free AACR Whitepaper)-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 (Free AACR Whitepaper)-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.