On November 21, 2022 Researchers at the University of Wisconsin–Madison, the first U.S. clinical evaluation site for GE Healthcare’s industry-first silicon-based photon counting CTi, reported that it will begin human scanning using the device, which is engineered with Deep Silicon detectors with the goal of greatly enhancing imaging capabilities to help clinicians improve patient outcomes across oncology, cardiology, neurology, and other clinical CT applications (Press release, GE Healthcare, NOV 21, 2022, View Source [SID1234624309]).

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!

The collaboration comes nearly one year after GE Healthcare announced its first clinical evaluation site at Karolinska Institute and MedTechLabs in Sweden. Since then, the company has made rapid progress in enhancing the developing technology, building a new system prototype to include:

A larger detector with the possible goal of enabling quicker scan times as well as expanding coverage;
ECG-gated cardiac scan capabilities designed for coronary artery imaging; and
Faster acquisition speed with the intent to reduce the likelihood of blurred images due to motionii.
"Photon counting CT has promise to embody the best of CT imaging available to date," explains Dr. Meghan G Lubner, professor of radiology at the UW School of Medicine and Public Health. "This technology has the potential to expand the scope of current indications by combining refined energy resolved data, high spatial resolution, reduced noise and improved soft tissue contrast. We are working with GE Healthcare by testing their novel photon counting solutions in human subjects to assess issues ranging from improving commonly encountered CT image quality limitations to evaluating whether previously out of reach clinical questions can now feasibly be answered."

Photon counting CT could potentially advance the capabilities of CT, including the visualization of minute details of organ structures, improved tissue characterization, more accurate material density measurement (or quantification) and lower radiation dose.

GE Healthcare is pursuing a unique approach to photon counting CT, which may enable higher spatial and spectral resolution at the same time, thanks to several advantages provided by Deep Silicon detectors, including: the detector’s material purity, innovative geometric design, and true multi-bin technologies for high performance spectral imaging. As such, the research being done at UW–Madison will assist GE Healthcare in better understanding the heights of these unique capabilities.

"Photon counting detectors push CT technology forward in two major ways: better spatial resolution and better contrast resolution," shares Tim Szczykutowicz, Ph.D., associate professor radiology at the school. Szczykutowicz is also affiliated with the Departments of Medical Physics and Biomedical Engineering. "I think for CT, photon counting is undoubtedly the next big thing. We are a part of the process of evaluating and developing this unique approach to photon counting based on Deep Silicon technology."

UW–Madison will facilitate human subject research and produce technical feedback to test and advance GE Healthcare’s photon counting CT technology with Deep Silicon. The study will assess reconstruction methods, image presentation workflows, and clinical benefits for specific pathologies and disease types to determine how to best optimize photon counting CT with Deep Silicon detectors to enable better visualization and utilization.

"Innovation requires close collaboration between medical technology innovators and academia," concludes Jean-Luc Procaccini, President & CEO, Molecular Imaging & Computed Tomography, GE Healthcare. "We are thrilled to deliver our newest prototype to our long-time collaborators at UW–Madison and UW Health. Together with UW, Karolinska Institute and MedTechLabs, we are advancing a cutting-edge technology with the potential to provide clinicians and patients with more information sooner – all with the goal of helping to improve patient outcomes."

On November 21, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will present at the 34th Annual Piper Sandler Healthcare Conference on Wednesday, November 30, 2022 at 1:30 p.m. Eastern Time in New York, NY (Press release, Personalis, NOV 21, 2022, View Source [SID1234624308]).

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 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!