On November 21, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that financial results for the three and nine months ended September 30, 2022 and provides a business update (Press release, Biocept, NOV 21, 2022, View Source [SID1234624307]).

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!

"Our third quarter financial results reflect solid increases in CNSide orders, up 8% sequentially and 176% year-over-year," said Samuel D. Riccitelli, Biocept’s Chairman, and interim President and CEO. "We are executing well on our strategy to generate further evidence to secure higher reimbursement for CNSide and support its adoption into clinical care guidelines. The first site in our FORESEE clinical trial is now open for patient enrollment and we expect at least one additional site to be cleared for enrollment in the coming months. We recently announced our participation in an investigator-initiated study with leading breast cancer oncologists at the University of California San Francisco aimed at learning more about how metastatic breast cancer develops and progresses. I’m also pleased that at last week’s Society for Neuro-Oncology annual meeting three posters featuring CNSide were presented by prominent neuro-oncologists."

Third Quarter Financial Results

Net revenues for the third quarter of 2022 were $5.6 million, which included $4.7 million in RT-PCR COVID-19 test revenue. This compared with net revenues for the third quarter of 2021 of $17.5 million, which included $16.5 million in RT-PCR COVID-19 test revenue.

Biocept accessioned 49,874 commercial samples during the third quarter of 2022, compared with 152,796 commercial samples during the third quarter of 2021, with the decline due primarily to lower RT-PCR COVID-19 testing volume. The average value per commercial accession for the third quarter of 2022 was $111, compared with $114 for the third quarter of 2021, with the decrease due to payor mix.

Cost of revenues for the third quarter of 2022 was $5.8 million, compared with $11.3 million for the prior-year period, with the decrease primarily related to lower RT-PCR COVID-19 testing volume.

Research and development (R&D) expenses for the third quarter of 2022 were $1.4 million compared with $1.3 million for the third quarter of 2021. General and administrative (G&A) expenses for the third quarter of 2022 were $3.0 million, compared with $3.5 million for the third quarter of 2021, with the decrease primarily due to lower stock-based compensation and lower headcount. Sales and marketing expenses for the third quarter of 2022 were $1.0 million, compared with $1.9 million for the third quarter of 2021, with the decrease due primarily to a reduction in sales commissions expense.

Net loss attributable to common stockholders for the third quarter of 2022 was $5.5 million, or ($0.33) per share on 17.0 million weighted-average shares outstanding. This compares with net loss attributable to common stockholders for the third quarter of 2021 of $0.6 million, or ($0.04) per share on 15.4 million weighted-average shares outstanding.

Nine Month Financial Results

Net revenues for the first nine months of 2022 were $36.1 million, compared with $47.3 million for the first nine months of 2021.

Operating expenses for the first nine months of 2022 were $49.5 million, and included cost of revenues of $24.1 million, R&D expenses of $4.9 million, G&A expenses of $14.2 million, of which $3.5 million are non-recurring, and sales and marketing expenses of $6.3 million. Operating expenses for the first nine months of 2021 were $46.9 million, and included cost of revenues of $27.7 million, R&D expenses of $3.5 million, G&A expenses of $9.9 million and sales and marketing expenses of $5.8 million.

Net loss attributable to common stockholders for the first nine months of 2022 was $13.6 million, or ($0.80) per share on 16.9 million weighted-average shares outstanding. This compares with net income attributable to common stockholders for the first nine months of 2021 of $0.1 million, or $0.01 per diluted share on 14.3 million weighted-average shares outstanding.

Biocept reported cash as of September 30, 2022 of $18.0 million, compared with $28.9 million as of December 31, 2021.

Conference Call and Webcast

Biocept will hold a conference call on Monday, November 28, 2022 beginning at 4:00 p.m. Eastern time to discuss these results and answer questions. Participants can pre-register for the conference call here. Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the call start time.

The conference call can be accessed at the time of the live call by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4109 for international callers. A live webcast of the conference call will be available here.

A replay of the call will be available for 48 hours following its conclusion and can be accessed by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers or (412) 317-0088 for international callers. Please use event passcode 9945142. A replay of the webcast will be available for 90 days.

On November 21, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematological and solid cancers and other serious diseases, reported an update on recent interactions with the U.S. Food and Drug Administration (FDA) relating to the company’s Biologics License Application (BLA) for omidubicel, the company’s advanced cell therapy candidate for allogeneic hematopoietic stem cell transplant (Press release, Gamida Cell, NOV 21, 2022, View Source [SID1234624306]).

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 part of its ongoing BLA review, FDA issued an information request and viewed the data in the response as a major amendment, resulting in an extension of the omidubicel Prescription Drug User Fee Act (PDUFA) date from January 30, 2023 to May 1, 2023. The agency also rescheduled Gamida Cell’s late-cycle meeting to the first quarter of 2023.

The data FDA requested were laboratory results for intermediate time points for patients enrolled in the Phase 3 study. These additional data provided by Gamida Cell to FDA are consistent with prior data submissions.

"We appreciate the FDA’s collaboration as they conduct their review of omidubicel," said Abigail "Abbey" Jenkins, Gamida Cell’s President and Chief Executive Officer. "If approved, omidubicel will be the first and only advanced cell therapy for patients with blood cancer in need of an allogeneic stem cell transplant. We are committed to bringing this potentially transformative therapy forward as quickly as possible."

About Omidubicel

Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit View Source

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

On November 21, 2022 Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, reported that Daphne Karydas, Chief Operating Officer and Chief Financial Officer of Flare Therapeutics, will present a company overview at 9:30 a.m. ET on Thursday, December 1, 2022 at the Piper Sandler 34th Annual Healthcare Conference being held in New York, NY (Press release, Flare Therapeutics, NOV 21, 2022, View Source [SID1234624304]).

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!

On November 21, 2022 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders with high unmet need, reported that Gaurav Shah, M.D., Chief Executive Officer, will participate in a fireside chat at the 5th Annual Evercore ISI HealthCONx Conference on Tuesday, November 29, 2022, at 3:30 p.m. ET (Press release, Rocket Pharmaceuticals, NOV 21, 2022, View Source [SID1234624303]).

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!

A live audio webcast of the presentation will be available under "Events" in the Investors section of the Company’s website at View Source The webcast replay will be available on the Rocket website following the conference.

On November 21, 2022 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared Legend Biotech’s Investigational New Drug (IND) application to proceed with the clinical development of LB2102, an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adult patients with extensive stage small cell lung cancer (SCLC) (Press release, Legend Biotech, NOV 21, 2022, View Source [SID1234624302]).

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!

LB2102 is designed to selectively target delta-like ligand 3 (DLL-3), a ligand that is highly restricted to various malignancies, including SCLC, large cell neuroendocrine carcinoma (LCNEC), certain other neuroendocrine tumors and some prostate cancers. DLL-3 has also been linked to tumor growth, migration and invasion.1

The Phase 1, first-in-human, open-label clinical study is designed to evaluate the safety and preliminary efficacy of LB2102 in subjects with extensive stage SCLC and patients with LCNEC, as well as to determine the recommended dose for Phase 2.

"Lung cancer is a debilitating disease that often spreads quickly. On average, only seven percent of patients with SCLC are alive five years after receiving their diagnosis," said Lida Pacaud, M.D., Vice-President of Clinical Development at Legend Biotech. "We are eagerly awaiting the start of this Phase 1 trial, and we hope that the study will provide much needed insight into the potential of this investigational CAR-T therapy."

About Small Cell Lung Cancer

Lung cancer is a leading cause of cancer deaths, contributing to 25 percent of all cancer-related fatalities annually in the United States.2 Small cell lung cancer (SCLC) is the most aggressive, and accounts for roughly 10-15 percent of lung cancer cases in the United States.3,4 An estimated 30,000 to 35,000 people are newly diagnosed with the disease each year.4 This cancer becomes more difficult to treat once it has spread and becomes extensive stage SCLC. Approximately 60 to 70 percent of SCLC patients are diagnosed with metastatic SCLC.3,5