On May 12, 2020 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the quarter ended March 31, 2020 (Press release, Adaptive Biotechnologies, MAY 12, 2020, View Source [SID1234557598]).

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"Adaptive’s immune medicine platform was built to decode the specific immune response to any disease, which we are now applying in full force to COVID-19," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "Importantly, we are able to do this while maintaining focus on our current products and future pipeline."

Recent Highlights

Revenue of $20.9 million for the first quarter of 2020, representing a 65% increase over the corresponding period in 2019

Clinical tests for clonoSEQ increased 75% to 3,518 clinical tests in the first quarter of 2020, compared to the first quarter 2019

Extended existing partnership with Microsoft to decode the adaptive immune response to COVID-19 and potentially develop an improved diagnostic; data to be made publicly available

Announced strategic partnership with Amgen to leverage Adaptive’s immune medicine platform to discover and develop therapeutic antibodies for COVID-19

Executed South San Francisco lease expansion to construct personalized cell therapy prototyping lab for Genentech collaboration

First Quarter 2020 Financial Results

Revenue was $20.9 million for the quarter ended March 31, 2020, representing a 65% increase from the first quarter in the prior year. Sequencing revenue was $9.5 million for the quarter, representing a 56% increase from the first quarter in the prior year. Development revenue increased to $11.4 million for the quarter, representing a 74% increase from the first quarter in the prior year.

Operating expenses were $55.5 million for the first quarter of 2020, compared to $32.7 million in the first quarter of the prior year, representing an increase of 70%.

Net loss was $31.4 million for the first quarter of 2020, compared to $18.4 million for the same period in 2019.

Adjusted EBITDA (non-GAAP) was a loss of $28.0 million for the first quarter of 2020, compared to a loss of $15.2 million for the first quarter of the prior year.

Cash, cash equivalents and marketable securities was $655.8 million as of March 31, 2020.

2020 Financial Guidance

Given the ongoing uncertainty of the scope, duration and impact of the COVID-19 pandemic, Adaptive Biotechnologies is withdrawing its previously announced annual revenue guidance for 2020, which was issued on February 26, 2020.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its first quarter financial results after market close on Tuesday, May 12, 2020 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On May 12, 2020 Sutro Biopharma, Inc. (Nasdaq: STRO), a clinical stage drug discovery, development and manufacturing company focused on deploying its proprietary integrated cell-free protein synthesis platform, XpressCF, to create a broad variety of optimally designed, next-generation protein therapeutics initially for cancer and autoimmune disorders, reported the pricing of an underwritten public offering of 11,000,000 shares of its common stock at a price to the public of $7.75 per share (Press release, Sutro Biopharma, MAY 12, 2020, View Source [SID1234557630]). The gross proceeds from this offering are expected to be approximately $85.3 million, before deducting underwriting discounts and commissions and other offering expenses payable by Sutro. Sutro has also granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of common stock in connection with the public offering. All of the shares of common stock are being offered by Sutro. The offering is expected to close on or about May 14, 2020, subject to the satisfaction of customary closing conditions.

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Cowen, Piper Sandler and Wells Fargo Securities are acting as joint book-running managers in the offering.

Sutro intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and marketable securities, to fund the continued clinical development of STRO-001 and STRO-002 and the remainder to fund the further development of its technology platform, including manufacturing, to broaden its pipeline of product candidates, and for working capital and general corporate purposes.

The shares are being offered by Sutro pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering have been filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, and when available, the final prospectus supplement, may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001, by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Sutro, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the first quarter 2020 and business highlights, including an update on its progress with fadraciclib, Cyclacel’s novel CDK inhibitor (Press release, Cyclacel, MAY 12, 2020, View Source [SID1234557599]). The Company’s net loss applicable to common shareholders for the three months ended March 31, 2020 was $1.3 million. As of March 31, 2020, cash and cash equivalents totaled $8.9 million. Following net proceeds of $18.4 million from an equity financing in April 2020, pro forma cash and cash equivalents total $27.3 million. Based on current spending, the Company estimates it has sufficient resources to fund planned operations, including research and development, to the end of 2022.

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"The global pandemic is creating uncertainty in every business sector and it is clear that we need novel, science-based solutions to emerge from the crisis," said Spiro Rombotis, President and Chief Executive Officer. "While our priorities are ensuring patient safety and addressing our social responsibility, we remain committed to our business strategy of building an innovative pipeline addressing the rising problem of cancer resistance. Fadraciclib is establishing a leadership position among MCL1 suppressing compounds in clinical development. We are encouraged by observations of deep response and prolonged stable disease with tumor shrinkage in both intravenous schedules tested this far. Importantly, initial clinical data with oral fadraciclib show concordance with intravenous pharmacokinetics. After strengthening our balance sheet, we will now turn our attention to executing a precision medicine strategy to evaluate fadraciclib in patients with solid tumors and achieve our other clinical milestones through late 2022."

Key Corporate Highlights

·In light of the pandemic caused by the novel coronavirus and to ensure the health and wellbeing of our employees, patients and the communities we serve, we have redesigned our work flow and business processes in line with current standards and government recommendations. In addition, we are working hard to provide uninterrupted clinical supplies and maintain the integrity of our clinical research. At present, we have not experienced recruitment delays, and our clinical investigators continue to screen and enroll patients. As the future course of the pandemic is uncertain, we will continue to closely monitor developments.

·CYC065-01 Phase 1 part 2 single agent i.v. – We have previously reported that a heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib at 213mg. This patient continues on therapy and reduction in her target tumor lesions is 79% after nine months. An additional patient with cyclin E amplified ovarian cancer achieved stable disease with 29% tumor shrinkage after approximately four months at 213mg. Based on data thus far, we are designing a Phase 1/2 precision medicine study to further evaluate fadraciclib as monotherapy and in combinations in patients with advanced solid tumors.

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¨ 1 James Lindsay Place, Dundee, DD1 5JJ, UK Tel +44 1382 206 062 Fax +44 1382 206 067

www.cyclacel.com – [email protected]

·CYC065-01 Phase 1 part 3 single agent p.o. – Initial data from an oral capsule formulation of fadraciclib given once daily to three patients with advanced solid tumors demonstrated a predictable pharmacokinetic profile closely overlapping the intravenous form with encouraging exposure levels.

·CYC065-03 Phase 1 fadraciclib i.v. and venetoclax p.o. in AML/MDS – We have dosed 11 heavily pretreated patients with relapsed/refractory (R/R) AML in five dose levels up to 200 mg/m2 of fadraciclib in combination with the venetoclax. Evidence of anticancer activity has been observed in multiple patients with blast reductions in peripheral blood. Preclinical data in AML suggest that targeting both MCL1 and BCL2 may be more beneficial than inhibiting either protein alone.

·CYC065-02 Phase 1 fadraciclib i.v. and venetoclax p.o. in CLL – We have dosed 5 patients with R/R CLL in four dose levels up to 150 mg/m2 of fadraciclib in combination with venetoclax. Evidence of anticancer activity has been observed in two patients who achieved MRD negativity on the combination. Preclinical data suggest that targeting both BCL2 and MCL1 in CLL may be more beneficial than single agent treatment in this setting as well.

·CYC682-11 Phase 1 part 2 sapacitabine p.o. and venetoclax p.o. – We have enrolled 12 patients in two dose cohorts in our DNA Damage Response (DDR) program evaluating an oral combination of sapacitabine and venetoclax in patients with R/R AML/MDS. Sapacitabine is a nucleoside analogue that is active in AML and MDS R/R to prior therapy such as cytarabine or hypomethylating agents. Preclinical data demonstrated synergy of sapacitabine with BCL2 inhibition, which may offer an effective, oral treatment regimen for patients who have failed front-line therapy.

·CYC140-01 Phase 1 CYC140 i.v. – We have enrolled 5 patients in our first-in-human, dose escalation study evaluating CYC140 in patients with advanced leukemias. CYC140 is a small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers.

·COVID-19 Collaboration – We entered into an agreement with The University of Edinburgh to evaluate the potential of our CDK inhibitors, fadraciclib and seliciclib, for reducing runaway inflammation and subsequent lung injury in patients with COVID-19 disease.

More information on our clinical trials can be found at www.clinicaltrials.gov.

Key Business Objectives

·Report updated fadraciclib Phase 1 safety and efficacy data with frequent i.v. dosing schedule in patients with advanced solid cancers;
·Report initial safety and PK data from Phase 1 study of fadraciclib oral formulation;
·Treat first patient in fadraciclib Phase 1/2 precision medicine study;
·Report initial data from fadraciclib-venetoclax Phase 1 study in R/R AML/MDS & CLL;
·Report initial data from sapacitabine-venetoclax Phase 1 study in R/R AML/MDS;
·Report initial data from CYC140 Phase 1 first-in-human study in R/R leukemias; and
·Report data from Phase 1b/2 sapacitabine-olaparib IST in BRCA mutant metastatic breast cancer when reported by the investigators.

Financial Highlights

As of March 31, 2020, cash and cash equivalents totaled $8.9 million, compared to $11.9 million as of December 31, 2019. The decrease of $3.0 million was primarily due to net cash used in operating activities of $2.8 million and $0.1 million of net cash used in financing activities. There were no revenues for each of the three months ended March 31, 2020 and 2019.

Research and development expenses were $1.1 million for the three months ended March 31, 2020 as compared to $1.0 million for the same period in 2019. Research and development expenses relating to transcriptional regulation increased by almost $0.3 million for the three months ended March 31, 2020 as we continue to progress the clinical evaluation of fadraciclib.

General and administrative expenses for the three months ended March 31, 2020 were $1.3 million, compared to $1.2 million for the same period of the previous year.

Total other income, net, for the three months ended March 31, 2020 was $0.9 million, compared to $0.1 million for the same period of the previous year. The increase of $0.8 million for the three months ended March 31, 2020 is primarily related to income received under an Asset Purchase Agreement with Thermo Fisher Scientific Inc.

United Kingdom research & development tax credits were $0.3 million for each of the three months ended March 31, 2020 and 2019.

Net loss for the three months ended March 31, 2020 was $1.2 million, compared to $1.8 million for the same period in 2019.

The Company raised net proceeds of approximately $18.4 million from an equity financing in April 2020.

The Company estimates that cash resources of $8.9 million as of March 31, 2020 together with the $18.4 million net proceeds from the April 2020 financing will fund currently planned programs through 2022.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 4198767.

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On May 12, 2020 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that management will present at the Bank of America 2020 Health Care Conference on Thursday, May 14 at 4:20 p.m. ET (Press release, Sangamo Therapeutics, MAY 12, 2020, View Source [SID1234557615]).

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The audio presentation will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.