On May 12, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported financial results for the first quarter ended Mar. 31 and provided operational updates, including measures taken by the company in response to the COVID-19 pandemic (Press release, Turning Point Therapeutics, MAY 12, 2020, View Source [SID1234564374]).

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"In reflecting on the past quarter of events, I want to acknowledge and thank the dedicated health care providers worldwide who have been treating patients during this unprecedented time," said Athena Countouriotis, M.D., president and chief executive officer. "As we have adapted to manage our business, we are appreciative of their efforts for the health and well-being of patients.

"Despite a very challenging environment in the first quarter, I am pleased with our recent Fast Track designation for repotrectinib based on Phase 1 TRIDENT-1 ROS1+ TKI Naïve NSCLC data which included an update to the duration of response, duration of treatment, and new progression free survival data; and the progress our team made advancing our programs, including our global registrational Phase 2 clinical study of repotrectinib. Site activations continued, with enrollment progressing across our four ongoing clinical trials.

"As it relates to COVID-19, we took action during the first quarter to implement multiple steps in response to the pandemic, including remote site activation and data monitoring; enabling patients to have routine tests conducted closer to home and allowing sites to evaluate certain patients remotely, in compliance with their local procedures. We are also evaluating additional sites for participation in our TRIDENT-1 study.

"Despite these interventions, we have more recently started to experience delays in trial site initiations and patient enrollment within the Phase 2 TRIDENT-1 study. We are also closely watching the progress in our other studies and believe the extent of the impact on our pipeline will depend on the continued duration and severity of the pandemic.

"We continue to anticipate providing data updates from our registrational Phase 2 TRIDENT-1 and TPX-0022 trials in the second half of 2020. For TRIDENT-1, we are currently monitoring the overall study conduct and data collection to be in a position to potentially provide this update in the third quarter. We anticipate the update will include preliminary efficacy and safety data from approximately 30 to 40 patients across multiple Phase 2 cohorts, including registrational and exploratory cohorts. For TPX-0022 we anticipate our update will be primarily a safety update as well as any early efficacy signals as we continue through our dose escalation cohorts."

First quarter and recent highlights include:

The company announced today that repotrectinib has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of ROS1-positive advanced non-small cell lung cancer (NSCLC) patients who have not been previously treated with a ROS1 tyrosine kinase inhibitor (TKI). In January, repotrectinib was granted Fast Track designation for the treatment of ROS1-positive advanced NSCLC patients who had been previously treated with one prior line of platinum-based chemotherapy and one prior line of a ROS1 TKI, a setting where there are currently no approved targeted therapies.

Fast Track Designation granted in ROS1+ TKI-naive patients. In the Phase 1 portion of TRIDENT-1, utilizing the 22 July 2019 data cut-off date with a median follow-up of 20.1 months (range: 5.3 to 24.9+), repotrectinib demonstrated a confirmed overall response rate (ORR) by blinded independent central review (BICR) of 91 percent (N=11, 95% CI: 59–100) in patients with ROS1+ advanced NSCLC who are ROS1 TKI-naïve. Repotrectinib demonstrated a median duration of response (DOR) of 23.1 months (95% CI: 5.6–NR) (based on Kaplan-Meier estimation). The probability of patients with a DOR ≥ 9 months, ≥ 12 months and ≥ 18 months was 78 percent, 65 percent, and 65 percent, respectively. Also, repotrectinib showed a median progression-free survival (PFS) of 24.6 months (95% CI: 7.2–NR). With an additional 8.5 months of follow-up as of 6 April 2020, 4 of the 5 responding patients remained in a PR (partial response) per physician assessment data since the 22 July 2019 data cutoff and the duration of treatment ranged from 9.2 to 34.2+ months with 7 of the total 11 (64%) patients remaining on repotrectinib.
All 7 (64%) remain on treatment for more than 17 months,
6 (55%) on treatment for more than 24 months, and
3 (27%) on treatment for more than 30 months at the time of the analysis

Repotrectinib has demonstrated CNS activity among patients with ROS1+ advanced NSCLC who are ROS1 TKI-naïve, with an intracranial objective response rate (IC-ORR) of 100% (3 of 3 patients, 95% CI: 29–100) with durations of response, as of the 22 July 2019 data cut-off, of 14.8+, 17.6+ and 23.1 months. All three of these patients remain on treatment, as of 6 April 2020, for 26.0+, 28.5+ and 34.2+ months.

Ongoing site activations and enrollment in the Phase 2 registrational portion of the TRIDENT-1 study of repotrectinib, with approximately 50 percent of planned sites now active in 11 countries. The study is now planned at up to 120 global sites with enrollment of approximately 320 ROS1-positive advanced non-small cell lung cancer (NSCLC) and NTRK-positive advanced solid tumor patients.

Ongoing progress in the Phase 1/2 open-label study to assess repotrectinib in pediatric patients with ALK-, NTRK- or ROS1-positive advanced solid tumors; the Phase 1 study of TPX-0022, Turning Point’s MET/CSF1R/SRC inhibitor; and Phase 1/2 study of TPX-0046, Turning Point’s RET/SRC inhibitor. Both the TPX-0022 and TPX-0046 trials continue dose escalation based on real time pharmacokinetic data evaluation and enrollment includes both TKI-naïve and -pretreated patients across both studies.

Acceptance of multiple abstracts for poster presentations at the ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper) virtual annual meetings. The ASCO (Free ASCO Whitepaper) presentation is expected to highlight preclinical data for TPX-0046 and the AACR (Free AACR Whitepaper) presentations are planned to highlight preclinical repotrectinib combination data and TPX-0131 preclinical data.

Recent publication in the AACR (Free AACR Whitepaper) journal Clinical Cancer Research of repotrectinib preclinical data and patient case studies from the Phase 1 portion of TRIDENT-1. The publication highlighted potent antitumor activity of repotrectinib in treatment-naïve and solvent-front mutation ROS1-rearranged NSCLC. In addition, repotrectinib demonstrated significant reduction of brain lesions in an intracranial tumor model.
First Quarter Financial Update
Operating expenses for the first quarter totaled $62.6 million, which included $38.4 million in non-cash stock-based compensation expense. The non-cash stock-based compensation expenses included a one-time charge of $31.4 million associated with previously disclosed modifications to the vesting of existing stock options, pursuant to the transition agreement with the company’s scientific founder. Excluding this one-time charge, non-GAAP operating expenses in the first quarter totaled $31.2 million compared to GAAP operating expenses of $14.1 million in the first quarter of 2019 and $23.1 million in the fourth quarter of 2019. Primary drivers of the year-over-year increase were investments made to develop repotrectinib, TPX-0022 and TPX-0046, as well as personnel expenses.

Cash, cash equivalents and marketable securities at Mar. 31 totaled $380.8 million, a decrease of $28.4 million from Dec. 31, 2019. The company projects its cash position funds current operations into 2022.

Upcoming Milestones
Key milestones anticipated through 2020 include:

Presenting preclinical data for TPX-0046, the company’s novel RET/SRC inhibitor, as a poster presentation during the ASCO (Free ASCO Whitepaper) virtual annual meeting on May 29.

Presenting preclinical repotrectinib combination data and preclinical data for TPX-0131, the company’s novel ALK inhibitor, during the AACR (Free AACR Whitepaper) virtual annual meeting in late June.

Early interim data from initial patients in the TRIDENT-1 Phase 2 study during the second half of the year. The company anticipates this update will include preliminary efficacy and safety data from approximately 30 to 40 patients across multiple Phase 2 cohorts, including registrational and exploratory cohorts.

Early interim data from initial patients treated with TPX-0022 during the second half of the year.

Submitting the IND for TPX-0131 by early 2021.
Webcast and Conference Call
Turning Point will webcast its Quarterly Update Conference Call today, May 12 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 6135289. A replay will be available through the "Investors" section of www.tptherapeutics.com.

On May 12, 2020 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported financial results for the quarter ended March 31, 2020 (Press release, Sun BioPharma, MAY 12, 2020, View Source [SID1234557900])

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First-Line Combination Pancreatic Cancer moves into expansion phase prior to COVID-19 pause During the first quarter of 2020, the Company completed enrollment in an added fourth cohort that was intended to study a dose schedule more conveniently aligned with the standard gemcitabine and nab-paclitaxel regimen, and immediately began enrollment of subjects in the expansion phase of this clinical trial. This trial, a Phase 1a/1b combination of SBP-101 with gemcitabine and nab-paclitaxel in patients previously untreated for metastatic pancreatic ductal adenocarcinoma ("PDA"), is being conducted at sites in the United States and Australia.

In early April 2020, as a result of the impact of the COVID-19 pandemic on the conduct of clinical trials around the world, the Company announced a pause in enrollment of new patients. Patients already enrolled in the clinical trial continue to be treated, and the Company intends to resume recruitment in the near future.

"We continue to monitor the situation in communities where our trial is in progress," noted Michael Cullen, MD, Executive Chairman, President and CEO. "We expect to resume enrollment in the second quarter; that timeline is dependent on the course of the pandemic.

" Financial Results for the Three months ending March 31, 2020

Operating Results

General and administrative ("G&A") expenses increased 54.5% to $468,000 in the first quarter of 2020, up from $303,000 in the first quarter of 2019. The increase is due to resumption of normal salary levels following a voluntary reduction of salaries for a part of the first quarter of 2019, in addition to higher stock compensation and legal expenses. Research and development ("R&D") expenses increased 70.9% to $598,000 in the first quarter of 2020, up from $350,000 in the first quarter of 2019, primarily due to an increase in clinical trial costs.

Other net expenses were $824,000 and $999,000 for the three months ended March 31, 2020 and 2019, respectively. The net expense in the quarter ended March 31, 2020 is composed primarily of a foreign currency exchange loss on the intercompany receivable balance. The net expense in the quarter ended March 31, 2019 is primarily the amortization of debt discount on convertible notes sold in December 2018 and January 2019, all of which converted into equity securities in 2019.

Net loss in the first quarter of 2020 was $1.8 million, or $0.27 per diluted share, compared to a net loss of $1.6 million, or $0.31 per diluted share, in the first quarter of 2019.

Balance Sheet and Cash Flow Total cash was $1.3 million and $2.4 million as of March 31,2020 and December 31, 2019, respectively. Total current assets were $2.1 million and $3.1 million as of March 31, 2020, and December 31, 2019, respectively. Current liabilities decreased to $1.4 million as of March 31, 2020, compared to $1.8 million as of December 31, 2019, primarily as a result of payments made on vendor balances.

Net cash used in operating activities was $1.1 million in the three months ended March 31, 2020, compared to $0.8 million in the same period of the prior year. The net cash used in each of these periods primarily reflected the net loss for these periods and was partially offset by the effects of changes in operating assets and liabilities.

About SBP-101
SBP-101 is a first-in-class, proprietary, polyamine analogue designed to induce polyamine metabolic inhibition (PMI), exploiting a high affinity for the compound specific to the exocrine pancreas and pancreatic ductal adenocarcinoma. Sun BioPharma originally licensed SBP-101 from the University of Florida Research Foundation in 2011. The molecule has shown signals of efficacy in US and Australian metastatic pancreatic cancer patients, demonstrating complementary activity with an existing FDA-approved chemotherapy regimen. SBP-101 is expected to differ from current pancreatic cancer therapies in that it does not appear to exacerbate the typical adverse events of bone marrow suppression and peripheral neuropathy. Management believes that SBP-101 may effectively treat patients with primary and metastatic pancreatic cancer, and may be effective in combination with other agents, and in other types of cancer. The safety and PMI profile demonstrated in Sun BioPharma’s current clinical trialsupport evaluation of the compound in a randomized clinical trial.

On May 12, 2020 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, reported financial results for the first quarter ended March 31, 2020, and provided a corporate update (Press release, Black Diamond Therapeutics, MAY 12, 2020, View Source [SID1234557641]).

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"We are pleased with our first quarter progress which included advancing the Phase 1/2 clinical trial of our lead product candidate BDTX-189 and completing our successful initial public offering," said David M. Epstein, Ph.D., President and CEO. "All companies are being impacted by the COVID-19 pandemic and Black Diamond is no exception. Our priority is the safety and well-being of our patients, as well as employees and their families, and we have adjusted our operations accordingly. We have also put in place contingency plans and additional resources from third-party service providers to minimize the impact on our business and strategy. We believe we are well positioned not only to execute on the clinical development of BDTX-189 as planned, but also to continue to invest in our proprietary MAP platform and to progress our early stage pipeline of small molecule, tumor-agnostic precision medicine programs. We will continue to closely monitor the global COVID-19 situation and its impact on our business as it evolves."

Recent Developments
•In February 2020, Black Diamond completed an initial public offering (IPO) pursuant to which it issued and sold 12,174,263 shares of common stock, including full exercise of the underwriters’ over-allotment option, resulting in gross proceeds of $231.3 million before deducting underwriting discounts and commissions and other offering expenses.
•Black Diamond continued to enroll and dose patients in the Phase 1 portion of a Phase 1/2 clinical trial of BTDX-189 (MasterKey-01; NCT04209465) and expects to complete the Phase 1 portion of the trial by the first half of 2021. BDTX-189 is Black Diamond’s mutation spectrum-selective, oral, irreversible small molecule inhibitor product candidate, which targets cancer-causing driver mutations in human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR) that have not yet been drugged.
•Black Diamond continued to advance its program in glioblastoma multiforme (GBM) toward nomination of a development candidate targeting a range of driver mutations in GBM, as well as its earlier-stage programs derived from the Company’s Mutation-Allostery-Pharmacology (MAP) platform.
•Black Diamond implemented risk mitigation measures and adjusted operations in response to the COVID-19 pandemic.
Financial Highlights
•Black Diamond ended the first quarter of 2020 with $357.2 million in cash and cash equivalents, which included net proceeds from the Company’s IPO of $212.1 million, compared to $44.7 million for the first quarter of 2019. Net cash used in operations was $11.3 million for the first quarter of 2020 compared to $6.9 million for the first quarter of 2019.
•Research and development (R&D) expenses were $7.4 million for the first quarter of 2020 compared to $3.0 million for the first quarter of 2019. The increase in R&D expenses was primarily related to an increase in headcount, preclinical development, and advancement of the BDTX-189 Phase 1/2 clinical trial.
•General and administrative (G&A) expenses were $5.5 million for the first quarter of 2020 compared to $0.8 million for the first quarter of 2019. The increase in G&A expenses was primarily due to an increase in personnel and costs associated with operations as a public company.

Upcoming Events
•The Company will present a poster about the MasterKey-01 Phase 1/2 clinical trial design at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program:
◦Abstract Title: Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies (Abstract TPS3665; Poster 395)
◦Poster Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
•David M. Epstein, Ph.D., President and CEO, is scheduled to present at the following upcoming conferences:
◦Bank of America Global Research Health Care Conference 2020, on Tuesday, May 12, 2020, at 4:20 PM ET
◦Jefferies Global Healthcare Conference, on Wednesday, June 3, 2020, at 1:30 PM ET
◦BMO 2020 Prescriptions for Success Healthcare Virtual Conference, on Tuesday, June 23, 2020

On May 11, 2020, Galera Therapeutics, Inc. (the "Company") and Clarus IV Galera Royalty AIV, L.P. (the "Purchaser") reported that it entered into Amendment No. 1 (the "Amendment") to the Amended and Restated Purchase and Sale Agreement, dated November 14, 2018, by and among the Company, the Purchaser and the other parties thereto (the "Royalty Agreement"), which was filed as Exhibit 10.1 to the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on October 11, 2019 (Filing, 8-K, Galera Therapeutics, MAY 12, 2020, View Source [SID1234557640]). The Purchaser is affiliated with Blackstone Life Sciences ("Blackstone"), successor in interest to Clarus Ventures.

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Under the Royalty Agreement, Blackstone previously agreed to pay the Company, in the aggregate, up to $80.0 million (the "Royalty Purchase Price"), in four tranches of $20.0 million each upon the achievement of specified clinical milestones in the Company’s Phase 3 ROMAN Trial. The Amendment increased the Royalty Purchase Price by $37.5 million to a total of $117.5 million by increasing the fourth tranche from $20.0 million to $37.5 million (the "Fourth Milestone Tranche") and adding a new $20.0 million tranche upon the achievement of an additional clinical enrollment milestone (the "New Milestone Tranche").

Pursuant to the Royalty Agreement, as amended by the Amendment, in connection with the payment of each tranche of the Royalty Purchase Price, the Company has agreed to sell, convey, transfer and assign to Blackstone all of its right, title and interest in a high single-digit percentage of (i) worldwide net sales of avasopasem and GC4711 (the "Products") and (ii) all amounts received by the Company or its affiliates, licensees and sublicensees with respect to Product-related damages (collectively, the "Product Payments") during the Royalty Period. The Royalty Period means, on a Product-by-Product and country-by-country basis, the period of time commencing on the commercial launch of such Product in such country and ending on the latest to occur of (i) the 12th anniversary of such commercial launch, (ii) the expiration of all valid claims of the Company’s patents covering such Product in such country, and (iii) the expiration of regulatory data protection or market exclusivity or similar regulatory protection afforded by the health authorities in such country, to the extent such protection or exclusivity effectively prevents generic versions of such Product from entering the market in such country.

The amended Royalty Agreement will remain in effect until the date on which the aggregate amount of the Product Payments paid to Blackstone exceeds a fixed single-digit multiple of the actual amount of the Royalty Purchase Price received by the Company, unless earlier terminated pursuant to the mutual written agreement of the Company and Blackstone.

On May 11, 2020, as partial consideration for the Amendment, the Company and the Purchaser entered into a warrant purchase agreement (the "Purchase Agreement") pursuant to which the Company issued two warrants (the "Warrants") to the Purchaser to purchase an aggregate of 550,661 shares (the "Warrant Shares") of the Company’s common stock, par value $0.001 per share ("Common Stock"), at an exercise price equal to $13.62 per share, subject to customary adjustments for stock splits, stock combinations and similar transactions. The first warrant is exercisable for 256,975 of the Warrant Shares and will become exercisable on payment of the Fourth Milestone Tranche and the second warrant is exercisable for 293,686 of the Warrant Shares and will become exercisable on payment of the New Milestone Tranche. The Warrants expire six years after the initial exercise date of each respective warrant.

Under the Purchase Agreement, the Company has provided the Purchaser with customary "piggyback" registration rights, allowing the Purchaser to include the Warrant Shares in certain "shelf" or "resale" registration statements of the Company filed under the Securities Act of 1933, as amended (the "Securities Act"), subject to certain limitations. The Purchase Agreement contains customary indemnification and procedural terms.

The issuance of the Warrants is exempt from registration pursuant to Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder, as a transaction by an issuer not involving a public offering. The Purchaser has acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends have been affixed to the securities issued in this transaction.

On May 12, 2020 Invivoscribe reported that their LeukoStrat CDx FLT3 Mutation Assay was submitted to regulatory authorities in China in April in support of the Astellas New Drug Application (NDA) submission of XOSPATA (gilteritinib) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation (Press release, Invivoscribe Technologies, MAY 12, 2020, View Source [SID1234557639]). Invivoscribe also announced expansion of its wholly-owned company, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd., adding laboratory testing services to support clinical trials and pharmaceutical partners.

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Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Astellas as the companion diagnostic supporting use of gilteritinib to treat adult patients with relapsed/ refractory FLT3-mutated AML.

"This is an announcement of two significant milestones: Submission of our LeukoStrat CDx Assay to the NMPA, and the expansion of our laboratory network into China. The submission itself is a milestone that builds on the LeukoStrat CDx FLT3 Mutation Assay as the international gold standard signal ratio assay for comprehensive assessment of activating mutations in the FLT3 gene; one of the most important biomarkers in AML", said Jeffrey Miller, Invivoscribe’s CSO and CEO. "Further, the expansion of our company to include a laboratory was done to provide comprehensive test support for our partners conducting trials in China. Testing will include simultaneous assessment of minimal residual disease by both flow cytometry and next-generation sequencing technologies conducted on exactly the same subject specimen. These paired analyses have been requested by regulatory authorities and partners, but have been missing in clinical studies. Invivoscribe’s LabPMM laboratories will bring this long-desired capability to fruition in our laboratories in China, Japan, Europe, and the US."

The LeukoStrat CDx FLT3 Mutation Assay is the only internationally standardized signal ratio assay that identifies both ITD and TKD mutations of the FLT3 biomarker. It has been approved as a companion diagnostic by regulatory authorities in the US, Australia, and Japan, and is available as a CE-marked kit in Europe and Switzerland. The LeukoStrat CDx FLT3 Mutation Assay served as the companion diagnostic in the ADMIRAL, RATIFY and QuANTUM-R clinical trials, which supported approvals of gilteritinib (XOSPATA), midostaurin (RYDAPT) and quizartinib (VANFLYTA). The assay is available both as a service and as a kit. LeukoStrat CDx FLT3 Mutation Assay test services are available from LabPMM locations in Japan, Germany, and the United States.