On December 1, 2020 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of oncolytic virus-based immunotherapies for cancer, reported that it has been granted a new patent from the European Patent Office (EPO) (Press release, Calidi Biotherapeutics, DEC 1, 2020, View Source [SID1234572049]). European Patent Number 3209382, "Combination Immunotherapy Approach for Treatment of Cancer," secures Calidi’s proprietary technology platform, Supernova 1 (SNV1), composed of the oncolytic agent, CAL1 vaccinia virus, loaded into allogeneic, adipose-derived mesenchymal stem cells (AD-MSC).

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!

"We’re very excited to be granted this European Patent to protect our innovative immunotherapy product and combination approach abroad," said Allan J. Camaisa, CEO and Chairman of Calidi Biotherapeutics. "This new patent provides considerable opportunity for the expansion of Calidi’s years of research into the profound oncolytic potential of SNV1."

Pre-clinical data has shown Calidi’s SVN1 product to shield the viral payload of CAL1 vaccinia virus from the patient’s immune system, supporting efficient delivery to tumor sites and effectively potentiating oncolytic viruses.

"Our talented, seasoned team of doctors and scientists have exerted years of intensive research and groundbreaking work to produce Calidi’s SVN1 technology," said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi Biotherapeutics. "This patent represents the culmination of their impressive expertise, dedication, and passion."

As of the EP Grant Date, November 25, 2020, the European Patent covers Calidi’s combination immunotherapy approach and SNV1 product in 37 contracting European countries. Earlier in the year, the patent was also granted in Canada, Russia, Singapore, Australia, and New Zealand.

On December 1, 2020 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported it will host an analyst and investor event on Wednesday, December 16, 2020 at 10:00 am ET (Press release, Sierra Oncology, DEC 1, 2020, View Source [SID1234572067]). The event will feature three leading myelofibrosis experts:

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!

Jean-Jacques Kiladjian, MD, PhD, Saint-Louis Hospital; Paris Diderot University
Ruben Mesa, MD, Director of the Mays Cancer Center, home to UT Health San Antonio, MD Anderson Cancer Center
Srdan Verstovsek, MD, PhD, University of Texas; MD Anderson Cancer Center
The call will include an overview of momelotinib data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, a panel discussion moderated by Barbara Klencke, MD, Chief Development Officer of Sierra Oncology, and an open question & answer session with attendees.

Analyst & Investor Event and Webcast Information

Date and Time: Wednesday, December 16, 2020, 10:00 am ET

To register, please click here.

The presentation will be webcast live, and an archive of the presentation will be accessible after the event through the Sierra Oncology website: www.SierraOncology.com.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 inhibitor currently under investigation for the treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is driven by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. Top-line data are anticipated in H1 2022. The U.S. Food & Drug Administration has granted Fast Track designation for momelotinib.

On December 1, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that it will host a key opinion leader (KOL) call on MB-106 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma on Wednesday, December 9, 2020, at 1:00 p.m. EST (Press release, Mustang Bio, DEC 1, 2020, View Source [SID1234572035]).

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 call will feature presentations by KOLs Mazyar Shadman, M.D., M.P.H., Fred Hutchinson Cancer Research Center ("Fred Hutch"), and Brian Till, M.D., Fred Hutch, who will discuss the interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphoma that the company is developing in collaboration with Fred Hutch. Data from this study have been selected for a poster presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

During the call, Drs. Shadman and Till will also discuss the modified cell manufacturing process that was co-developed by Fred Hutch and Mustang Bio, as well as the correlative science observed in the study to date. The Mustang team will then give a corporate update on its pipeline and future plans. Following the formal presentations, the Mustang team, along with Drs. Till and Shadman, will be available for questions.

To register for the call, please click here.

About Dr. Shadman
Mazyar Shadman, M.D., M.P.H., is an associate professor at the University of Washington (UW) and Fred Hutch. He is a hematologic malignancies expert who specializes in treating patients with lymphoma / chronic lymphocytic leukemia (CLL). He is involved in clinical trials using novel therapeutic agents, immunotherapy (CAR T cell), and stem cell transplant for treatment of lymphoid malignancies with a focus on CLL. He also studies the clinical outcomes of patients using institutional and collaborative retrospective cohort studies. Dr. Shadman received his M.D. from Tehran University in Iran. He finished internal medicine internship and residency training at the Cleveland Clinic in Cleveland, Ohio. He completed his training in hematology and medical oncology fellowships at UW and Fred Hutch. Dr. Shadman also earned an M.P.H. degree from UW and was a fellow for National Cancer Institute’s cancer research training program at Fred Hutch, where he studies cancer epidemiology.

About Dr. Till
Brian Till, M.D., is an Associate Professor in the Clinical Research Division of Fred Hutch and Department of Medicine at UW. His laboratory focuses on developing chimeric antigen receptor (CAR)-based immunotherapies for non-Hodgkin lymphoma and understanding why CAR T cell therapies work for some patients but not for others. He led the first published clinical trial testing CAR T cells as a treatment for lymphoma patients. Dr. Till also has a clinical practice treating patients with lymphoma and attends on the stem cell transplantation and immunotherapy services at the Seattle Cancer Care Alliance.

On December 1, 2020 Cellaria Inc (Wakefield, MA, USA) and the Spring Lab, Northeastern University, reported the successful receipt of a National Institutes of Health (NIH) R01 grant to extend and advance the application of innovative new photomedicine-based therapies for hard-to-treat cancers (Press release, Cellaria, DEC 1, 2020, View Source [SID1234572050]). The grant highlights the close working relationship of the two organizations and will provide $3.2M funding to develop precision therapeutics closely tailored to the requirements of specific patient populations. Cellaria’s contribution to the partnership is next generation, patient-derived, customized cell models that boost the effectiveness of in vitro studies, helping researchers to identify where the technology can have the most impact. Dr Bryan Spring, Assistant Professor of Biomedical Physics credits Cellaria with a vital role in accelerating his research.

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!

"We’ve demonstrated proof of concept and seen significant interest from clinicians," said Dr Spring. "However, we initially targeted just a single ovarian cancer biomarker. To capture the heterogeneity of the disease and efficiently study multiple biomarkers we needed to upgrade our cell models. Developing new models in-house would have taken years and instead we chose to work with Cellaria. This has really accelerated progress by providing rapid access to rigorously characterized cell models for specific molecular subtypes and patient populations."

Dr Spring’s research focuses on the use of antibody-photosensitizer conjugates to make cancer cells susceptible to light-induced destruction, targeting microscopic cancer cell deposits left behind by conventional therapies. Primary areas of application are pancreatic and ovarian cancer. With these cancers, cells left behind by surgery and other conventional therapies can metastasize in the peritoneal cavity and abdomen, attacking other organs and increasing the severity of the disease. The new NIH research grant is entitled "Multiplexed and dynamically targeted photoimmunotherapy of heterogeneous, chemoresistant micrometastases guided by online in vivo optical imaging of cell-surface biomarkers."

Cellaria provides cell models, complete with comprehensive omics data, that help the researchers to determine which biomarkers are most actionable when it comes to targeting drug resistant cells and applying the photomedicine. These cell models robustly represent the full heterogeneity of the cancers, which is essential for the development of precision therapies. Dr Spring has been using Powder, a high grade serous ovarian cancer cell model developed from the carcinoma of a 65 – 69 Caucasian, stage IV patient. New models for pancreatic cancer have recently been added to the Cellaria portfolio. All have a robustly authenticated lineage and are provided with protocols to maintain specific biomarker expression. Cellaria’s unrivalled expertise in cell line growth, stabilization and characterization underpin the company’s ability to supply customised models that enable researchers to identify the specific biomarkers of most relevance to their work.

"Cellaria have all the -omics in place and are highly responsive in terms of refining models to our requirements," said Dr Spring. "The Cellaria team are experts in their field and great to work with. The bottom line is that via this collaboration we get to concentrate on our science, rather than the tools we need to support it, which is just as we prefer it."

On December 1, 2020 CollPlant (NASDAQ: CLGN), a regenerative and aesthetics medicine company, reported financial results for the third quarter ended September 30, 2020 and provided an update on the Company’s business developments (Press release, CollPlant, DEC 1, 2020, View Source [SID1234572068]). Certain metrics, including those expressed on an adjusted basis, are non-GAAP measures. See "Use of Non-GAAP Measures" below.

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!

CollPlant reported revenues of $4.1 million for the third quarter of 2020, a 511% increase from the $679,000 recorded in the third quarter of 2019. The Company ended the third quarter of 2020 with $5.0 million in cash and cash equivalents. Comprehensive income for the third quarter of 2020 was $703,000 on a GAAP basis, or adjusted comprehensive income of $1.1 million, on a non-GAAP basis.

"We are very pleased with the progress of our collaboration with United Therapeutics which started with lungs and is now expanding to cover kidneys, a second lifesaving organ. The $3 million payment for the option exercise which contributed to our profitability in the third quarter of 2020 is part of a larger agreement signed in October 2018 that includes upfront and milestone payments plus royalties," stated Yehiel Tal, CollPlant’s Chief Executive Officer.

"We continue to advance our medical aesthetics line with next-generation, regenerative, photocurable dermal fillers which we believe will yield skin rejuvenation inclusive of the ability to inject into deep wrinkles, as well as other key attributes. During the third quarter of 2020 we shared updates on our photocurable dermal fillers and on our breast implant product pipeline, at the exclusive Science of Aging Virtual Symposium 2020."

"Furthermore, we are moving forward with a development program of an antiviral agent for the potential treatment of COVID-19. We got promising preclinical data showing our platform technology significantly inhibited avian coronavirus infectivity. The data indicated our formulation that is comprised of rhCollagen imbedded with silver nanoparticles (AgNP), targets viral load in COVID-19 patients, thereby potentially assisting the body’s immune system to combat viral infection, reduce transmission rates between people, and ultimately reduce the percentage of patients who need to be treated in critical care settings," Mr. Tal concluded.

Financial Results

Third Quarter 2020 Financial Results on U.S. GAAP basis ("GAAP")

Revenues for the three months ended September 30, 2020 increased by 511% to $4.1 million, compared to $679,000 in the third quarter of 2019. Revenues were derived mainly from sales of CollPlant’s BioInk for the development of 3D bioprinting of human organs, the exercise of an option by United Therapeutics for licensing CollPlant technology to print kidneys, and from sales of rhCollagen for medical aesthetics product development.

Cost of revenue was $1.4 million in the three months ended September 30, 2020, an increase of 123% compared to $645,000 in the same period in 2019. The increase is primarily related to royalties payments to the Israel Innovation Authority on revenue from licensing CollPlant’s technology to United Therapeutics for printing of kidneys.

The Company’s gross profit for the three months ended September 30, 2020 increased by $2.7 million to $2.7 million, or 65% of revenues, in the third quarter of 2020, compared to $34,000, or 5% of revenues in the third quarter of 2019.

Total operating expenses for the three months ended September 30, 2020 were $2.0 million, an increase of 11% compared to $1.8 million in the third quarter of 2019. The increase is primarily related to share-based compensation expenses for options grant.

Operating profit for the three months ended September 30, 2020 was $734,000, compared to an operating loss of $1.7 million in the third quarter of 2019.

Financial expense, net for the three months ended September 30, 2020 was $31,000 compared to $1.4 million in the third quarter of 2019. Financial expense in the three months ended September 30, 2020 and September 30, 2019 mainly derived from non-cash exchange differences of operating lease liabilities under ASC 842, and re-evaluation of financial instruments.

Comprehensive income for the third quarter of 2020 was $703,000, or $0.10 per share, compared to a comprehensive loss of $3.2 million, or $0.68 per share, for the third quarter of 2019.

Cash used in operating activities during the nine months ended September 30, 2020 was $2.9 million compared to $4.1 million in the nine months ended September 30, 2019. As of September 30, 2020, cash and cash equivalents totaled $5.0 million.

Cash used in investing activities during the nine months ended September 30, 2020 was $378,000 compared to $1.2 million in the nine months ended September 30, 2019. The decrease is mainly attributable to costs incurred in the establishment in 2019 of CollPlant’s new HQ and R&D center in Rehovot, Israel.

Cash provided by financing activities during the nine months ended September 30, 2020 was $4.5 million, of which $4.4 million are attributable to proceeds from issuance of shares in a private placement in February 2020. Cash provided in the nine months ended September 30, 2019 by financing activities amounted to $5.4 million, and are attributed to proceeds from funding in September 2019.

Third Quarter 2020 Financial Results on Non-U.S. GAAP Basis ("non-GAAP")

On a non-GAAP basis, the operating expenses for the third quarter of 2020 were $1.6 million, a decrease of $106,000 compared to $1.7 million for the third quarter of 2019.

Comprehensive income for the third quarter of 2020 was $1.1 million, or $0.16 per share, compared to comprehensive loss of $1.8 million, or $0.38 per share, for the third quarter of 2019.

Non-GAAP measures exclude certain non-cash expenses. The table on page 10 includes a reconciliation of the Company’s GAAP results to non-GAAP results. The reconciliation reflects non-cash expenses in the amount of $397,000 with respect to (i) change in fair value of financial instruments, (ii) share-based compensation to employees, directors and consultants and (iii) change of operating lease accounts, including related financial expenses.

Use of Non-GAAP Measures

This press release contains certain non-GAAP financial measures for operating costs and expenses, operating loss, comprehensive loss and basic and diluted comprehensive loss per share that exclude the effects of non-cash expense for fair market value attributed to change in fair value of financial instruments, share-based compensation to employees, directors and consultants, and change in operating lease accounts. Management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company’s performance that enhances management’s and investors’ ability to evaluate the Company’s operating costs, comprehensive loss and loss per share, and to compare them to historical Company results.

The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company’s business internally and therefore decided to make these non-GAAP adjustments available to investors. The non-GAAP financial measures used by the Company in this press release may be different from the measures used by other companies.

For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" table on page 10 in this press release. This accompanying table on page 10 has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.

The Company’s consolidated financial results as of, and for the nine months ended, September 30, 2020 are presented in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP").