On November 29, 2022 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancers, bacteria and viruses reported that it has released the Company’s unaudited 3Q2022 condensed interim consolidated Financial Statements ("Financial Statements") (Press release, Theralase, NOV 29, 2022, View Source [SID1234624554]).

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!

Financial Highlights:

(1)Other represents gain from legal settlement, (gain) loss on foreign exchange, interest accretion on lease liabilities and interest income
Total revenue increased 43%, year over year and is primarily attributed to the anticipated Canadian and US economic recovery from the COVID-19 pandemic in 2020 and 2021.

Cost of sales for the nine-month period ended September 30, 2022 was $389,232 or 48% of revenue resulting in a gross margin of $423,766 or 52% of revenue. In comparison, the cost of sales in 2021 was $317,397 or 56% of revenue resulting in a gross margin of $249,415 or 44% of revenue. Cost of sales is represented by the following costs: raw materials, subcontracting, direct and indirect labour and the applicable share of manufacturing overhead.

Selling expenses for the nine-month period ended September 30, 2022, decreased to $238,904, from $271,708 in 2021, a 12% decrease. The decrease in selling expenses is primarily attributed to the COVID-19 pandemic, resulting in reduced advertising (51%), and salaries (15%).

Administrative expenses for the nine-month period ended September 30, 2022, decreased to $1,068,979 from $1,211,834 in 2021, a 12% decrease. The decrease in administrative expenses is primarily attributed to decreased spending on professional fees (28%) and insurance (12%). Stock based compensation expense decreased 62% in 2022 due to a reduction in stock options granted.

Net research and development expenses for the nine-month period ended September 30, 2022, increased to $3,464,664 from $2,036,415 in 2021, a 70% increase. The increase in research and development expenses is primarily attributed to the costs related to the Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study II"). Research and development expenses represented 73% of the Company’s operating expenses and represents investment into the research and development of the Company’s Anti-Cancer Therapy ("ACT") technology.

The net loss for the nine-month period ended September 30, 2022 was $4,352,100, which included $391,321 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss in 2021 of $3,129,731 which included $486,010 of net non-cash expenses. The ACT division represented $3,820,222 of this loss (88%) for the nine-month period ended September 30, 2022.

The increase in net loss is primarily attributed to increased spending in research and development expenses in Study II.

Operational Highlights:

1.)Non-Brokered Private Placement. On September 22, 2022, the Company completed a financing by way of a non-brokered private placement, where 10,000,000 units were issued at a price of $0.25 per unit for gross proceeds of $2,500,000. Each unit consisted of 1 common share and 1 non-transferable common share purchase warrant. Each whole warrant entitles the holder thereof to acquire 1 common share at a price of $0.35, expiring on September 22, 2024. An aggregate of 2,400,000 units, representing gross proceeds of $600,000, were issued to certain insiders of the Corporation.

On November 17, 2022, the Company completed a financing by way of a non-brokered private placement, where 1,000,000 units were issued at a price of $0.25 per unit for gross proceeds of $250,000. Each unit consisted of 1 common share and 1 non-transferable common share purchase warrant. Each whole warrant entitles the holder thereof to acquire 1 common share at a price of $0.35, expiring on November 17, 2024. An aggregate of 511,000 units, representing gross proceeds of $127,750, were issued to certain insiders of the Corporation.

2.)Break Through Designation Update. In 2021, Theralase completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 assessments for 25 patients, expected in 4Q2022, subject to the CSS’s availability to complete all required assessments and biostatistical review and analysis.

3.)COVID-19 Pandemic Update. In the ACT division, the Company continues to experience delays in patient enrollment and treatment rates in Study II due to the ongoing COVID-19 pandemic; however, these rates have improved as Canada and the US commence their recovery from the business and economic impacts of the COVID-19 pandemic.

4.)Clinical study site status and update. To date, Study II has provided the primary study treatment for 51 patients (including three patients from the Phase Ib NMIBC Clinical Study treated at the Therapeutic Dose for a total of 54 patients.

An analysis of Evaluable Patients (defined as patients who have been evaluated by the principal investigator and thus excludes data pending), in Study II provides the following interim analysis (including three patients from the Phase Ib NMIBC Clinical Study treated at the Therapeutic Dose):

Note: The Primary Objective CR is determined at any point in time (defined above under Study II Objectives). CR was achieved as follows: 23 patients at 90 days, 1 patient at 180 days and 2 patients at 270 days.

Note: Indeterminate Response ("IR"), previously referred to as Partial Response, is defined as patients assessed with negative cystoscopy and suspicious or positive urine cytology.

The clinical data to date demonstrates a strong initial CR (53%) and a strong duration of that response for 450 days (28%).

In accordance with the FDA’s 2018 guidelines to industry, the patients who have achieved an Indeterminate Response ("IR") are being further assessed via Computerized Tomography ("CT") scan and/or biopsy of the prostatic urethra to determine if upper tract Urothelial Cell Carcinoma ("UCC") or prostatic urethra UCC can be detected to allow these patients to be re-categorized as CR.

Note: The current interim data analysis presented above, should be read with caution, as the clinical data is interim in its presentation, has not been formally reviewed by Health Canada and/or the FDA, as Study II is ongoing and new clinical data collected may or may not continue to support the current trends, with significant data still pending.

5.)Additional cancer indications. The Company has demonstrated significant anti-cancer efficacy of Rutherrin, when activated by laser light or radiation treatment across numerous preclinical models; including: Glio Blastoma Multiforme ("GBM") and Non-Small Cell Lung Cancer ("NSCLC"). The Company has commenced Non – Good Laboratory Practices ("GLP") toxicology studies with Rutherrin in animals to help determine the maximum recommended human dose of the drug, when administered systemically into the human body, via intravenous injections. Theralase plans to commence GLP toxicology studies in animals in 4Q2022.

6.)COVID-19 Research Update. In February 2022 Theralase reported that Public Health Agency of Canada had demonstrated that light-activated TLD-1433, was effective in rapidly inactivating the SARS-CoV-2 virus by up to 99.99%, compared to control in an in vitro study. Further research is required to confirm these findings.

In July 2022, Theralase executed a Testing and Technical Services Agreement ("TTSA") with the National Research Council of Canada ("NRC") to produce inactivated SARS-CoV-2 virus using Theralase’s patented PDC and proprietary TLC-3000B medical laser system technology. This inactivated virus will be used to create a vaccine to vaccinate animals to determine the immunogenicity effects of the TLD-1433 SARS-CoV-2 (COVID-19) vaccine and assess its efficacy in protecting the animals from contracting SARS-CoV-2 during SARS-CoV-2 challenge.

Theralase is currently designing and developing a new proprietary light activation platform; specifically, the TLC-3000B, to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. The TLC-3000B is expected to be completed for use by PHAC and NRC in 1Q2023.

The above results and completion of the TLC-3000B will lay the groundwork for the next phase of the CRA and TTSA, which is evaluating the Theralase COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, at two world class laboratories, when exposed to the virus, which is expected to commence in 1Q2023 and be completed by 1Q2024.

Note: The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 coronavirus.

About Study II

Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 Clinical Study Sites ("CSS") located in Canada and the United States.

About TLD-1433

TLD-1433 is a patented PDC with over 10 years of published peer reviewed preclinical research and is currently under investigation in Study II.

On November 29, 2022 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s lead program, batiraxcept, for treatment of patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have progressed after 1 or 2 prior lines of systemic therapy that include both immuno-oncology (IO)-based and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapies (either in combination or sequentially) (Press release, Aravive, NOV 29, 2022, View Source [SID1234624553]).

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!

Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need. Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug’s development plan, including the design of the proposed clinical trials, use of biomarkers and the extent of data needed to support approval. Drugs with Fast Track Designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.

The Fast Track Designation was based on new data submitted to the agency from the P1b clear cell renal cell cancer (ccRCC) study (AVB500-RCC-003; NCT04300140). As of September 26, 2022, 26 previously treated (second line or greater) patients with ccRCC have been treated with batiraxcept in the Phase 1b portion of a Phase 1b/2 trial at doses of 15 mg/kg (n=16) and 20 mg/kg (n=10), plus cabozantinib 60 mg daily. There were no dose limiting toxicities observed at either dose. Clinical data from this study demonstrate that batiraxcept has the potential to increase the clinical activity of cabozantinib in patients with metastatic ccRCC who have progressed following IO- and VEGF-TKI-based therapies (N=14 of the 26 patients) as the Objective Response Rate (ORR) was 57% and median Progression-Free Survival (PFS) was 11.4 months in this population.

"The majority of patients with kidney cancer develop resistance to frontline treatment and there is a clinical need for novel agents to improve upon treatment options in the refractory setting," said Kathryn Beckermann, M.D., Ph.D., Assistant Professor, Division of Hematology and Oncology, Vanderbilt University Medical Center, and lead investigator for the trial. "Response rates to single agent targeted kinase inhibitors are approximately 30% with a PFS of approximately 7 months. The early data seen with batiraxcept including biomarker development, response rate, and progression-free survival are promising."

"A review of the literature suggests that the clinical activity of cabozantinib is lower in those patients who have progressed following a VEGF-TKI-based therapy compared to patients who have progressed on IO or IO/IO therapy. Since preclinical data published by Xiao in 20191 observed that batiraxcept may restore TKI sensitivity, it makes sense that the combination of batiraxcept and cabozantinib may exhibit its greatest impact in those patients who have failed prior VEGF-TKI therapies," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "Understanding the P1b ccRCC data has allowed us to identify the most appropriate patient population in which to evaluate batiraxcept in combination with cabozantinib and potentially the quickest path to approval in this population with an unmet medical need."

On November 29, 2022 Kineta, Inc. ("Kineta" or the "Company"), a clinical-stage biotechnology company focused on developing next-generation immunotherapies to address cancer immune resistance, reported that the Company will present at the JMP Securities Hematology and Oncology Summit, a virtual investor event to be held from December 6-7, 2022 (Press release, Kineta, NOV 29, 2022, View Source;utm_medium=rss&utm_campaign=kineta-to-participate-in-jmp-securities-hematology-and-oncology-summit-2 [SID1234624552]). Shawn Iadonato, Ph.D., Kineta’s Chief Executive Officer, will present a corporate update and overview of KVA12123 (formerly referred to as KVA12.1), Kineta’s VISTA blocking immunotherapy. Kineta’s management team will also be available for virtual one-on-one meetings during the conference. For more information on the conference or to register, visit: View Source

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 copy of the presentation will be available on the Kineta website under Events & Presentations after the conference on December 6, 2022: View Source

The summit will feature industry experts revisiting important takeaways from the recent European Society for Medical Oncology Immuno-Oncology Congress (ESMO) (Free ESMO Whitepaper) and Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting and offer the latest perspectives on developing therapeutics for solid tumors and hematological malignancies.

On November 29, 2022 NETRIS Pharma, a clinical-stage private biopharmaceutical company developing a new class of drugs based on dependence receptor biology, reported dosing of the first patient in the ImmunoNET trial (Press release, Netris Pharma, NOV 29, 2022, View Source [SID1234624551]). ImmunoNET is a multicenter, open-label, proof of concept phase II trial designed to assess the clinical and biological activity of NETRIS Pharma’s first drug candidate, NP137, as add-on therapy in patients with advanced/metastatic solid tumors treated by standard immunotherapies.

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 enrollment of the first patient in ImmunoNET is a new clinical milestone for NETRIS Pharma. Immune-checkpoint inhibitors have revolutionized the treatment of cancer, yet the vast majority of patients do not respond or transiently respond to these immunotherapies. Based on a unique mode of action of NP137 and biomarker studies conducted in Phase 1, we believe we can enlarge the fraction of responding patients and potentially prevent resistance," said Patrick Mehlen, CEO of NETRIS Pharma. "ImmunoNET has been specifically designed by clinicians to provide new solutions for patients suffering from resistance to immune-checkpoint inhibitors."

The study will enroll up to 90 patients suffering from solid-tumor cancers, including Head and Neck, Melanoma, Non-Small Cell Lung Cancer, Urothelial and other tumor types. These patients will be classified according to their responses to immunotherapy, in 3 arms: (1) patients under stable disease after 12 weeks under standard PD-1/PD-L1 therapy; (2) patients with radiological progression; and (3) patients with radiological progression following an initial objective response according to RECIST V1.1, with clinical benefit according to RECIST.

"Despite some remarkable results with the use of immunotherapy, which have become the new standard of care in various oncology indications, many patients are experiencing an absence of response or immune resistance," said Jérome Fayette, clinical oncologist at Center Léon Bérard and Principal Investigator of this Investigator Initiated Trial conducted in collaboration with several key clinical centers in France. "We look forward to measure the potential benefit of NP137 on patients partially or not responding from immunotherapy."

"NETRIS Pharma is grateful to the EU Innovation Council and SME’s Executive Agency (EISMEA) for participating in the funding of this trial after having been selected as one of the most innovative project in Europe in December 2021 under the EIC accelerator Instrument program," added Christophe Guichard, CFO of NETRIS Pharma.

On November 29, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported a portfolio prioritization designed to optimize the development of programs at or nearing clinical development, continue investments in our core research platforms and innovation, and maintain a strong balance sheet with an expected cash runway into 2025 (Press release, Sana Biotechnology, NOV 29, 2022, View Source [SID1234624550]). The resulting changes include focusing its second HIP-modified allogeneic CAR T program on targeting CD22 for CD19 CAR T failures, halting further internal investment in its SC187 program (cardiomyocytes for heart failure), and stage-gating certain platform investments based upon clinical progress in humans. The prioritization and restructuring reduced the company’s headcount by approximately 15%, which gives the company the expected runway to invest in its key clinical programs over the next several years. Timelines for the company’s lead programs, including time to IND and clinical data, are not expected to be impacted.

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 are making significant progress with our platforms to address two of the fundamental opportunities to enable greater utilization of cell engineering to treat serious diseases – overcoming immune rejection of allogeneic cells and in vivo delivery of gene modification reagents in a cell-specific manner. We look forward to generating human proof of concept starting next year and are positioning the company to invest fully based upon the clinical data," said Steve Harr, Sana’s President and CEO. "Losing talented and valued colleagues is painful, and we thank them for their contributions to Sana’s mission. Prioritization is important, and we will continue to make decisions based upon internal data, external evolution of the field, and the company’s needed capabilities to deliver on the promise of our pipeline with important medicines for patients."

Select Program Review

SC291 (HIP-modified, CD19-targeted allogeneic CAR T) – Sana remains on track to file an IND this year with initial clinical data expected in 2023. Preclinical data continue to highlight the potential for the HIP platform to hide our allogeneic cells from immune detection, creating the potential for longer CAR T cell persistence and higher durable complete response rates in cancer patients. The company intends to study this therapy in a number of B cell malignancies.

SC263 (HIP-modified, CD22-targeted allogeneic CAR T) – Sana expects to file an IND in 2023. Over 50% of patients treated with approved autologous CD19-targeted CAR T cell products either relapse after a complete response or never reach a complete response. CD22, which is also a B cell surface protein, has emerged as a target to address patients that fail to achieve durable complete responses with a CD19-directed CAR T therapy. The CD22-directed CAR construct we are developing has led to a complete response in over 50% of treated CD19-failure patients. SC263 incorporates this clinically-validated CAR with T cells manufactured using our HIP platform. This therapy has the potential to treat patients with B cell malignancies who have failed previous CAR T therapies.

SG295 (in vivo CAR T with CD8-targeted fusogen delivery of a CD19-targeted CAR) – Sana remains on track to file an IND in 2023. This program has the potential to generate CAR T cells in vivo (inside the patient), eliminating the need for conditioning chemotherapy and complex CAR T cell manufacturing. The company expects to study this therapy in patients with B cell malignancies.

SC451 (HIP-modified, stem-cell derived pancreatic islet cell therapy for patients with type 1 diabetes) – Sana remains on track to file an IND in 2024. Preclinical data continue to highlight the potential for HIP modifications to allow these cells to evade both allogeneic and autoimmune rejection in type 1 diabetes. The goal of this therapy is to transplant hypoimmune islet cells with no immunosuppression into patients with type 1 diabetes so that these cells produce insulin in a physiologic manner in response to glucose.

SC255 (HIP-modified, BCMA-targeted allogeneic CAR T) – Sana expects to file an IND in 2024 to treat multiple myeloma. BCMA has been validated as a target for autologous CAR T therapy in relapsed and/or refractory multiple myeloma. This program will incorporate a clinically-validated CAR and T cells manufactured using our HIP platform, with the goal of offering greater persistence of CAR T cells and the scalable manufacturing of our allogeneic process for patients with multiple myeloma.

SC379 (stem-cell derived GPCs) – The glial progenitor cell (GPC) program aims to deliver healthy allogeneic GPCs, the precursors to both astrocytes and oligodendrocytes. This program has the potential to treat myelin and glial-based disorders, which represent a broad group of debilitating neurological disorders, including genetic disorders of dysfunctional oligodendrocyte or astrocyte production and more common diseases such as progressive multiple sclerosis. The company’s goal is to begin GLP toxicology studies in 2023.

SG418 (Fusogen HSC program) – Sana is developing a hematopoietic stem cell (HSC)-targeted fusosome with the ability to deliver gene editing material in vivo to repair genetic abnormalities such as those that cause sickle cell disease and beta-thalassemia. The company’s goal is for preclinical proof of concept in 2023.