On May 13, 2021 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrosis-related diseases with high unmet need, reported financial and operating results for the first quarter ended March 31, 2021 and provided a business update (Press release, Anchiano Therapeutics, MAY 13, 2021, View Source [SID1234579844]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This quarter has been truly exciting for Chemomab as we accessed the public markets and began to trade on the Nasdaq exchange, successfully closed on a private offering of $45 million, announced positive data from our Phase Ib study in NAFLD, and initiated a Phase IIa study in PSC." said Dr. Adi Mor, CEO of Chemomab. "We also started treating patients in our Phase IIa liver fibrosis trial with our subcutaneous formulation of CM-101 and will look to build upon our substantial progress and positive momentum in the coming quarters with the initiation of our additional planned Phase II study of CM-101 in Systemic Sclerosis (SSc). CM-101 is a very promising therapy with the potential to treat multiple severe and life-threatening inflammatory and fibrotic diseases. With a strong financial position, and our unique development track record we believe we are well positioned to continue to advance our pipeline and execute our important milestones this year."

First Quarter and Recent Highlights

·Announced positive results from its Phase Ib SPARK study evaluating CM-101 in nonalcoholic fatty liver disease (NAFLD) patients. The SPARK study was a double-blind, placebo-controlled study designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of CM-101 in NAFLD patients with normal liver function. In this study repeated CM-101 administrations were found to be safe and well-tolerated for both tested doses when administered as intravenous (IV) infusion or subcutaneous (SC) injection. No safety signals or unexpected adverse events were observed for CM-101 in either the IV or SC formulation and all reported adverse events were mild or moderate in intensity. Exploratory analysis of multiple pharmacodynamic parameters, including measurement of collagen turnover and fibrotic biomarkers, demonstrated that CM-101 treatment resulted in reduction of fibrotic and fibrogenesis markers compared to no change or slight elevation in the placebo treated group. In addition, there was a reduction in liver stiffness measured by FibroScanTM in the CM-101 treated group.

·Enrolled the first patient in its Phase IIa SPRING clinical trial of CM-101 for the treatment of patients with primary sclerosing cholangitis (PSC). The SPRING study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the mechanism of action, safety, pharmacokinetics and pharmacodynamic effects, as well as the antifibrotic effect of IV CM-101 in PSC patients. The trial will enroll and randomize up to 45 patients and is anticipated to complete enrollment by early 2022 with data expected in 1H 2022.

·Enrolled the first patient in its Phase IIa SPLASH clinical trial of CM-101 for the treatment of patients with nonalcoholic steatohepatitis (NASH). The SPLASH study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the mechanism of action, safety, pharmacokinetics and pharmacodynamic effects, as well as the anti-fibrotic effects of SC CM-101 in NASH patients with fibrosis stage F2-F3. The trial will enroll 40 patients and is anticipated to complete enrollment by the end of 2021 with data expected in 1H 2022.

·Completed a merger with Anchiano Therapeutics Ltd, and began trading on the Nasdaq Capital Market exchange under the symbol "CMMB" on March 17, 2021.

·Completed the successful pricing of a private placement of $45 million into the combined company led by new and certain existing investors including Cormorant Asset Management, OrbiMed, Peter Thiel, Christian Angermayer’s Presight Capital and Apeiron Investment Group, as well as other healthcare-focused and institutional investors.

·Strengthened its Board of Directors with the appointment of four new directors: Dr. Alan Moses, Dr. Claude Nicaise, Mr. Joel Maryles, and Mr. Neil Cohen. Dr. Stephen Squinto remains as Chairman of Chemomab’s Board, with Dr. Adi Mor and Dr. Nissim Darvish continuing in their roles as Directors.

Upcoming Milestones:

Chemomab is advancing in parallel three Phase 2 clinical trials with CM-101 in three distinct fibrotic indications; Systemic Sclerosis (SSc) is planned to be initiated by the end of 2021, and clinical readouts from the ongoing clinical trials in PSC and NASH are expected during 2022.

First Quarter 2021 Financial Highlights

·Cash and cash equivalents as of March 31, 2021 were $58.2 million which includes $45.5 million of gross proceeds from the private placement completed on March 22, 2021.

·Research and Development expenses for the three months ended March 31, 2021 were $1.2 million, compared to $1.6 million for the three months ended March 31, 2020. The decrease of $0.4 million was primarily related to a decrease in expenses to sub-contractors.

·General and administrative expenses were $0.5 million for the three months ended March 31, 2021, compared to $0.1 million for the three months ended March 31, 2020. The increase of $0.4 million was primarily related to merger related expenses.

·Net loss for the three months ended March 31, 2021 and 2020 was $1.7 million.

On May 13, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, reported encouraging interim Phase 1 data from the Company’s off-the-shelf, iPSC-derived natural killer (NK) cell programs in relapsed / refractory acute myeloid leukemia (AML) (Press release, Fate Therapeutics, MAY 13, 2021, View Source [SID1234579910]). The ongoing Phase 1 dose-escalation study of FT516 as monotherapy is currently enrolling patients in the third dose cohort (900 million cells per dose), with three patients treated in the first dose cohort (90 million cells per dose) and six patients treated in the second dose cohort (300 million cells per dose). The Phase 1 dose-escalation study of FT538 as monotherapy is currently ongoing, with three patients treated in the first dose cohort (100 million cells per dose).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As of the data cutoff date of April 16, 2021, five of 12 patients had achieved an objective response with complete leukemic blast clearance in the bone marrow (FT516 [n=9]: 3 complete remission with incomplete hematologic recovery [CRi], 1 morphologic leukemia-free state [MLFS]; FT538 [n=3]: 1 CRi). Of the four patients achieving a CRi, one patient successfully proceeded to allogeneic stem cell transplant and the other three patients remained on-study and in remission without further therapeutic intervention, two of whom remained in remission having been on-study for more than six months. Clinical assessments were based on the 2017 European LeukemiaNet (ELN) response criteria (Blood (2017) 129 (4): 424–447).

Importantly, no dose-limiting toxicities, and no cases of any grade of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease, were observed. Patients had received a median of three prior lines of therapy, with 11 of 12 patients refractory to their last prior therapy. At baseline prior to conditioning chemotherapy, 11 of 12 patients had significant hematopoietic impairment, with both neutrophil counts below 1,000/µL and platelet counts below 100,000/µL.

"We are highly encouraged by these Phase 1 data in patients with relapsed / refractory AML, which clearly indicate that off-the-shelf, iPSC-derived NK cells administered as monotherapy in the outpatient setting were well-tolerated, and have the potential to induce complete leukemic blast clearance in the bone marrow and confer durable remissions without further therapeutic intervention. Complete leukemic blast clearance in the bone marrow is essential as recent studies in relapsed / refractory AML have shown that this clinical outcome results in a statistically-significant improvement in patient survival," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Additionally, we are excited that a patient receiving FT538 in the initial dose escalation cohort achieved a complete remission with incomplete hematologic recovery, and that FT538 continued to be detected in the peripheral blood at Day 8 post-infusion. This suggests that the additional engineered functionality of FT538 can augment NK cell pharmacokinetics without the need for exogenous cytokine support during patient treatment."

FT516 Phase 1 Study
FT516 is an investigational, universal, off-the-shelf NK cell cancer immunotherapy derived from a clonal engineered master induced pluripotent stem cell (iPSC) line. The Phase 1 clinical trial in relapsed / refractory AML is assessing FT516 administered as monotherapy. Up to two cycles of treatment are administered, with each cycle consisting of three days of conditioning chemotherapy followed by three weekly doses of FT516, with IL-2 cytokine support after each FT516 dose. FT516 may be administered in the outpatient setting with no requirement for inpatient monitoring during the treatment period.

Three patients in the first dose cohort of 90 million cells per dose and six patients in the second dose cohort of 300 million cells per dose were assessed for safety and activity (see Table 1). Of the nine patients, eight had adverse molecular risk based on the 2017 ELN risk category and eight patients were refractory to their last prior therapy. Patients had received a median of three prior lines of therapy. At baseline prior to conditioning chemotherapy, all nine patients were significantly cytopenic, with eight patients having neutrophil counts below 1,000/µL and nine patients having platelet counts below 100,000/µL, and the median bone marrow leukemic blast percentage was 39%.

Safety Data
No dose-limiting toxicities, and no cases of any grade of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease, were observed. The multi-dose treatment schedule was well-tolerated with no treatment discontinuations due to adverse events. Three patients experienced Grade 3 febrile neutropenia, and no other FT516-related Grade 3 or greater adverse events were reported by investigators. In addition, no evidence of anti-product T- or B-cell mediated host-versus-product alloreactivity was detected, supporting the potential to safely administer up to six doses of FT516 in the outpatient setting without the need for patient matching.

Activity Data
Six of nine relapsed / refractory AML patients showed anti-leukemic activity as evidenced by on-treatment reduction in bone marrow blasts, with four patients achieving an objective response with complete clearance of leukemic blasts in the bone marrow. Three of these four responders achieved a best overall response of CRi based on 2017 ELN response criteria, including two patients in the second dose cohort (Table 1: Subjects 1006 and 1007), each of whom had ongoing remission without further therapeutic intervention at six months’ follow-up, and one patient in the first dose cohort (Table 1: Subject 1001) who successfully proceeded to allogeneic stem cell transplant.

FT538 Phase 1 Study
FT538 is an investigational, universal, off-the-shelf NK cell cancer immunotherapy derived from a clonal master iPSC line engineered with three functional components designed to enhance innate immunity. The Phase 1 clinical trial in relapsed / refractory AML is assessing FT538 administered as monotherapy. Up to two cycles of treatment are administered, with each cycle consisting of three days of conditioning chemotherapy followed by three weekly doses of FT538 without IL-2 cytokine support. FT538 may be administered in the outpatient setting with no requirement for inpatient monitoring during the treatment period.

Three patients were enrolled in the first dose cohort of 100 million cells per dose, two of whom were evaluable for safety and anti-leukemic activity and one patient who discontinued from the study prior to completion of the first treatment cycle due to clinical evidence of failure to respond to therapy (see Table 2). Of the two evaluable patients, one patient had adverse molecular risk based on the 2017 ELN risk category. Both patients had received at least three prior lines of therapy, were refractory to their last prior therapy, and were significantly cytopenic with neutrophil counts below 1,000/µL and platelet counts below 100,000/µL at baseline prior to conditioning chemotherapy.

Safety Data
No dose-limiting toxicities, and no cases of any grade of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease, were observed. The multi-dose treatment schedule was well-tolerated with no FT538-related Grade 3 or greater adverse events reported by investigators. In addition, no evidence of anti-product T- or B-cell mediated host-versus-product alloreactivity was detected, supporting the potential to safely administer up to six doses of FT538 in the outpatient setting without the need for patient matching.

Activity Data
Both evaluable patients showed anti-leukemic activity as evidenced by on-treatment reduction in bone marrow blasts. One patient (Table 2: Subject 1003), who was refractory to their two most recent prior therapies (an investigational CD33-targeted tri-specific NK cell engager [TriKE], followed by glasdegib in combination with low-dose cytarabine), achieved a CRi based on 2017 ELN response criteria at the end of the first treatment cycle and remained on-study. FT538 was detected in the peripheral blood at Day 8 prior to administration of the second dose in both patients.

CRi (Complete Remission with incomplete hematologic recovery) = Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; recovery of either neutrophils to ≥1,000/µL or platelets to ≥100,000/µL
MLFS (Morphologic Leukemia-free State) = Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; residual neutropenia (<1,000/µL) and residual thrombocytopenia (<100,000/µL)
PD = Progressive Disease
SD = Stable Disease
As of April 16, 2021 database entry. Data subject to source document verification.
a Subject 1001 received 2 of 3 doses of FT538 in the first treatment cycle and discontinued from study due to evidence of non-response to therapy.

Today’s Webcast
The Company will host a live audio webcast today, Thursday, May 13, 2021 at 5:00 p.m. ET to review the relapsed / refractory AML treatment landscape and discuss interim Phase 1 clinical data for the Company’s FT516 and FT538 off-the-shelf, iPSC-derived NK cell programs. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On May 13, 2021 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported its financial results for the first quarter ended March 31, 2021 (Press release, HTG Molecular Diagnostics, MAY 13, 2021, View Source [SID1234579926]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Business Highlights

● Released a second technical white paper (White Paper Two) characterizing the company’s planned transcriptome panel using the HTG EdgeSeq technology. White Paper Two, among other things, compares the performance and feasibility of a prototype of HTG’s planned transcriptome panel to RNA sequencing (RNA-Seq) across multiple cancer indications. White Paper Two also demonstrates the feasibility and expected performance of the transcriptome panel, including:

○ Ability to differentiate samples based on gene expression profiles;
○ Repeatability amongst replicates from multiple cancer indications with archived samples;
○ Accuracy of differential expression analysis using a direct comparison to RNA-Seq;
○ Potential as a robust alternative to RNA-Seq for gene expression profiling while maintaining the advantages of the HTG EdgeSeq technology.

With the feasibility testing for all elements of the panel’s design complete, the company is now in the optimization phase of development, working to further improve the panel’s design, workflow, and robustness. Having completed our final round of probe quality control testing, defined our quality control metric strategy and finalized the reagent formulation during the quarter, we have ordered our final probe pool for the panel. Final panel design lock is anticipated in the second quarter of 2021 followed by formal panel design verification with initial commercialization anticipated by the third quarter of 2021.

● Increased participation in the company’s transcriptome panel Early Adopter Program (EAP), refining study details with over 25 collaborators to date, including those in both academia and pharma. The EAP allows a select group of customers access to the initial transcriptome panel for use in their laboratories or through services performed by HTG prior to commercial launch of the panel.

"Our team continues to be very optimistic about the launch of the transcriptome panel using our HTG EdgeSeq technology," said John Lubniewski, President and CEO of HTG. "Data published in our second white paper highlight the potential of this panel as a robust, clinically deployable alternative to RNA-Seq for gene expression profiling. We believe the benefits of our HTG EdgeSeq technology and the transcriptome panel, including ease of use, cost savings, turnaround time and broad applicability, will make this a very attractive alternative for gene expression profiling applications. We continue to meet our development milestones and look forward to providing updates on our progress in the coming months."

"In the fourth quarter of 2020, our base business showed signs of recovery after experiencing a substantial impact from COVID-19 in the second and third quarters of 2020. The reopening process stalled again in the first quarter of 2021 in Europe and our pharmaceutical company customers have continued a slow return to pre-COVID-19 clinical trial levels. We are hopeful of a return to pre-COVID revenue levels as vaccinations become more widely available and business continues to normalize," Mr. Lubniewski continued.

First Quarter 2021 Financial Highlights:

Total revenue for the first quarter ended March 31, 2021 was $1.4 million, compared with $2.2 million for the same period in 2020. HTG believes the decrease in revenue is a result of the impact of the COVID-19 pandemic requiring the closure of customer facilities, causing a significant reduction in oncology-related clinical trial activity or limiting the ability of our customers to operate at pre-pandemic levels.

Product and product-related services revenue was $1.4 million, compared with $2.0 million for the same period in 2020. Throughout the pandemic, HTG’s ability to ship instruments and consumables to customer facilities and the ability of its customers to prepare and ship samples to HTG’s VERI/O laboratory for processing has been limited.

There was no collaborative development services revenue for the quarter ended March 31, 2021, compared with $0.2 million for the same period in 2020, reflecting the completion of remaining tasks under existing arrangements. The company has ongoing sales efforts to identify and contract new programs in this area.

Net loss from operations for the first quarter ended March 31, 2021 was $4.6 million, compared with $5.4 million for the same period in 2020. Net loss per share was $(0.80) for the quarter ended March 31, 2021 compared with $(1.27) for the same period in 2020.

Cash, cash equivalents and short-term available-for-sale securities totaled $30.8 million as of March 31, 2021, with current liabilities of approximately $8.3 million and non-current liabilities of $11.5 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

On May 13, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, Precision Biosciences, MAY 13, 2021, View Source [SID1234579942]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the first quarter, we have worked diligently to advance our ARCUS-based in vivo gene editing and allogeneic CAR T pipelines," commented Matt Kane, CEO and co-founder of Precision BioSciences. "In April, we seized the opportunity to reacquire all global rights previously granted to Servier for our CAR T programs, including PBCAR0191 and PBCAR19B. We believe that this repurchase, alongside our maturing datasets, will allow us to take full advantage of our CAR T programs as they progress through clinical development."

"We are on track to initiate the Phase 1 study of our PBCAR19B this month, our first candidate incorporating immune evading stealth cell technology as an alternative potential path to deeper and more durable responses. This will precede multiple anticipated clinical and research milestones across our portfolio in 2021, including interim updates from all three clinical-stage CAR T programs: PBCAR0191, PBCAR20A, and PBCAR269A. Additionally, we look forward to providing an update on our in vivo gene editing pipeline mid-year," concluded Mr. Kane.

Recent Developments and Upcoming Milestones:

Allogeneic CAR T Portfolio:

Reacquired Global Development and Commercialization Rights from Servier: In April 2021, Precision announced that it had entered into a Program Purchase Agreement to reacquire all global development and commercialization rights for all CAR T partnered programs covered under its Development and Commercial License Agreement with Servier. This includes its two CD19-targeting allogeneic CAR T candidates, PBCAR0191 and PBCAR19B stealth cell, plus four additional CAR T targets identified by Servier in 2020.

Under the terms of the Program Purchase Agreement, Precision paid $1.25 million in cash to Servier and agreed to waive earned, but as-yet unpaid milestones totaling $18.75 million that would have otherwise been payable to Precision. Servier is also eligible to receive milestones and low- to mid-single-digit royalties subject to product development achievement.

PBCAR0191: Precision has continued to advance its Phase 1/2a study of PBCAR0191 in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). Since the December 2020 interim data update, additional patients have been dosed with PBCAR0191 following enhanced lymphodepletion (eLD)1. Precision will continue to monitor the results for durability from this eLD regimen and expects to report updated interim results in June at ASCO (Free ASCO Whitepaper) 2021.

PBCAR19B: Precision has begun adding clinical trial sites for its Phase 1 study of PBCAR19B, the Company’s next generation, stealth cell, allogeneic CAR T candidate for patients with CD19-positive malignancies such as those with R/R NHL. The study is expected to begin by the end of May 2021. PBCAR19B will be administered at flat dose levels, beginning at 2.7 × 108 cells, with the ability to dose up to 8.1 × 108 cells per patient, following standard lymphodepletion2. The primary objective of the study is to identify the maximum tolerated dose and any dose-limiting toxicities.

PBCAR20A: Precision continues to enroll patients in its Phase 1/2a clinical trial of PBCAR20A, its anti-CD20 CAR T therapy for patients with R/R NHL, including patients with R/R chronic lymphocytic leukemia or R/R small lymphocytic lymphoma. In February 2021, the study began enrolling patients into dose level 3, a fixed dose of 480 × 106 cells with a max dose of 6.0 × 106 cells/kg. Precision expects to provide an interim update for the PBCAR20A study in 2021.

PBCAR269A: Precision continues to enroll patients in its Phase 1/2a study of PBCAR269A, its CAR T candidate targeting B-cell maturation antigen (BCMA) for the treatment of R/R multiple myeloma, for which Precision has received Fast Track Designation and Orphan Drug Designation from the FDA. In February 2021, the study began enrolling patients into its highest dose cohort, dose level 3 at 6.0 × 106 cells/kg and Precision expects to provide an interim update in 2021. Precision also expects to initiate the combination arm of its ongoing Phase 1/2a clinical study with PBCAR269A and nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor, in the first half of 2021.

PBCAR269B: In April 2021, Precision introduced PBCAR269B, a next-generation, BCMA-targeted candidate incorporating stealth cell technology, for treatment of R/R multiple myeloma. Precision is conducting IND-enabling studies for PBCAR269B and expects to file an IND application in early 2022.

In Vivo Gene Correction Portfolio:

Genome Editing Research Collaboration with Eli Lilly: In January 2021, Precision announced the closing of its agreement with Eli Lilly. Under the agreement, Precision will develop up to six in vivo therapies for genetic disorders using ARCUS, with an initial focus on Duchenne muscular dystrophy and two other undisclosed gene targets.

PH1: Pre-clinical research continues to progress with Precision’s wholly-owned in vivo gene correction program using its ARCUS genome editing technology to knock out the HAO1 gene as a potential one-time treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disease. The Company expects to provide an update in mid-2021.

Corporate:

Executive Leadership: In April 2021, Precision announced that it has initiated a CEO transition plan for Co-Founder and Chief Executive Officer, Matt Kane. Mr. Kane is expected to continue in his current leadership capacity until his successor has been identified. He will also serve as an advisor for a period of time after the next CEO is hired ensuring a smooth transition.

Precision also announced the appointment of Alan List, M.D. as the Company’s Chief Medical Officer and a member of the senior leadership team. Dr. List is a world-renowned hematologist with extensive academic and clinical experience in the research and development of hematology and oncology products.

Board of Directors: Precision announced that it has strengthened its Board of Directors with the appointment of Stanley R. Frankel, M.D., a hematologist-oncologist with extensive academic and industry experience in the research, clinical development, and commercialization of immuno-oncology and cellular therapies. Dr. Frankel was most recently the Senior Vice President, Cellular Therapy Development at Bristol-Myers Squibb (BMS). Prior to the BMS acquisition of Celgene, he was Corporate Vice President, Head, Immuno-Oncology & Cellular Therapy, Clinical Research and Development Head, Cell Therapy Clinical Center of Excellence at Celgene.

Elo Life Systems:

Corporate Structure: In January 2021, Precision disclosed its intention to spin out its wholly-owned subsidiary, Elo Life Systems. Precision is continuing to explore its strategic options, and expects to complete any such spinout, sale or other treatment of Elo in 2021.

Quarter Ended March 31, 2021 Financial Results

Cash and Cash Equivalents: As of March 31, 2021, Precision had approximately $193.5 million in cash and cash equivalents, which includes the $100 million upfront cash payment and equity investment of $35 million received from Eli Lilly in January 2021. The Company expects that existing cash and cash equivalents, expected operational receipts, and available credit will be sufficient to fund its operating expenses and capital expenditure requirements into 2023.

Revenues: Total revenues for the first quarter ended March 31, 2021 were $16.3 million, as compared to $7.0 million for the same period in 2020.

Research and Development Expenses: Research and development expenses were $25.6 million for the quarter ended March 31, 2021, as compared to $24.9 million for the same period in 2020.

General and Administrative Expenses: General and administrative expenses were $9.5 million for the quarter ended March 31, 2021, as compared to $9.6 million for the same period in 2020.

Net Loss: Net loss was $18.7 million, or $(0.33) per share, for the quarter ended March 31, 2021, as compared to a net loss of $26.8 million, or $(0.52) per share, for the same period in 2020.

On May 13, 2021 Genetron Holdings Limited ("Genetron Health" or the "Company", NASDAQ:GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, reported a strategic partnership with Siemens Healthineers at the China Medical Equipment Fair (Press release, Genetron Health Technologies, MAY 13, 2021, View Source [SID1234579960]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This partnership aims to promote large scale application of Genetron’s S5 platform and lung cancer 8-gene IVD assay in Chinese hospitals, in order to provide non-small cell lung cancer (NSCLC) patients with efficient and accurate personalized diagnosis and treatment guidance. The companies also plan to work together to standardize cancer molecular testing in hospitals.

Representing Genetron Health at the signing ceremony in Shanghai were Co-founder and CEO Sizhen Wang, and Vice President Zhaohui Yin. Elisabeth Staudinger, President of Siemens Healthineers Asia Pacific, and Guo Yiming, Vice President of Siemens Healthineers Laboratory Diagnostic System, Greater China Region, also attended the event.

"Genetron Health focuses on the innovation, clinical transformation and commercialization of cancer genomics technologies. Both our lab developed test (LDT) and in vitro diagnostic (IVD) products’ business models have been progressing well," said Sizhen Wang, Co-founder and CEO of Genetron Health. "We are pleased to collaborate with Siemens Healthineers for our S5 instrument and lung 8 IVD assay, which helps diagnose and treat cancer patients. We also expect this partnership to help standardize cancer molecular testing in China, and reach more patients in need," Wang said.

"As a global leader in healthcare technology, Siemens Healthineers stays committed to addressing the needs of patients. To help Chinese cancer patients access quality care, we are not only introducing cutting-edge testing analyzers and reagents to China, but are also working with local innovators to offer personalized diagnostics. We are excited to forge a strategic partnership with Genetron Health, an industry leading precision oncology platform company. Meanwhile, we expect to push forward precision care in the field of lung cancer, therefore contributing to the vision of a Healthy China," said Guo Yiming, Vice President of Laboratory Diagnostics, Siemens Healthineers Greater China.

At present, lung cancer is one of the most serious diseases in China, placing the highest amongst morbidity and mortality rankings of all cancer types. In China, 787,000 cases of lung cancer are diagnosed every year, with about 631,000 deaths [1] caused annually as well. NSCLC is the most common type of lung cancer. In recent years, with the development of more advanced diagnostics and the emergence of targeted drugs, more NSCLC patients have been able to receive quicker and more accurate treatment. As the "first step" of targeted therapy for lung cancer, cancer molecular gene detection is the key to guided clinical treatment and drug applications. The U.S. National Comprehensive Cancer Network (NCCN) Guidelines for NSCLC also recommend that molecular testing of lung cancer-related genes be used to guide targeted therapies for NSCLC patients. Accurate lung cancer gene detection for NSCLC patients can help clinicians opt for more precise treatment.

Based on Genetron Health’s One-Step Seq technology (Chinese invention patent ZL 201710218529.4), the lung cancer 8-gene IVD assay can detect many mutations and fusions across 8 different genes at once, for targeted therapy selection in NSCLC. The assay can offer patients rapid and accurate molecular typing, medication guidance and drug resistance monitoring. Combined with Genetron S5, it offers advantages in detection efficiency, ease of use, economic cost, sample size, and can achieve a two-day turnaround time. It is suitable for independent clinical molecular testing in Chinese hospitals at all levels.

[1] Zheng R., Sun K., Zhang S., et al. Report of cancer epidemiology in China, 2015, Chinese Journal of Oncology, 2019, 41(1):19-28.