On November 30, 2020Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamicCompounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancers released its audited annual consolidated 3Q2020 financial statement (Press release, Theralase, NOV 30, 2020, View Source [SID1234571971]).

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Other represents (Gain) Loss on foreign exchange, interest accretion on lease liabilities and interest income
Total revenue remained predominantly flat, year over year, and is primarily attributed to the COVID-19 pandemic as most health care practitioners elected to temporarily close their practices and place any purchasing decisions on temporary or permanent hold.

Cost of sales for the nine-month period ended September 30, 2020 was $383,990 which included a one-time provision for inventory of $77,075 resulting in an adjusted cost of sales of $306,915 or 58% of revenue with an adjusted gross margin of $220,559 or 42% of revenue. The gross margin increase, as a percentage of sales, year over year, is attributed to eliminating non-essential personnel leading to decreased production salaries, attributed to the COVID-19 pandemic for the TLC-1000 and TLC-2000 product lines

The decrease in selling expenses year over year is primarily due to the restructuring of the Canadian and US sales and marketing departments, resulting in the resignation and/or termination of certain non-essential sales and marketing personnel and significantly reduced travel expenditures due to the COVID-19 pandemic.

The decrease in administrative expenses year over year is primarily attributed to decreased spending on general and administrative expenses, director and advisory fees and administrative salaries due to the COVID-19 pandemic, resulting in the termination of certain non-essential administrative personnel.

Net research and development expenses increased year over year primarily due to increased expenses for operating Study II. Research and development expenses represented 64% of the Company’s operating expenses for the nine-month period ended September 30, 2020 and represent investment into the research and development of the Company’s ACT technology.

The net loss for the nine-month period ended September 30, 2020 was $4,715,771 which included $921,448 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss for the same period in 2019 of $4,399,045 which included $341,548 of net non-cash expenses. The ACT division represented $3,641,470 of this loss (77%) for the nine-month period ended September 30, 2020.

The increase in net loss is primarily attributed to the following:

Operational Highlights:

FDA Fast Track. On November 23, 2020, the FDA granted Theralase Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase will have access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with TLC-3200, to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with Bacillus Calmette-Guerin ("BCG") – Unresponsive Non- Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS"), with or without papillary Ta or T1 tumors. FTD can lead to an Accelerated Approval ("AA"), Break Through Designation ("BTD") and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.
COVID-19 Pandemic Update. In the ACT division, all Canadian Clinical Study Sites ("CSS") have re-commenced new patient enrollment and treatment in Study II as of September 24, 2020. The CSSs placed themselves on temporary hold due to the COVID-19 between March 20, 2020 to August 12, 2020 and September 24, 2020. In the CLT division, the Company continues to experience variations in sales and the timing of these sales due to the ongoing COVID-19 pandemic and has taken actions to reduce expenses by eliminating non-essential personnel and imposing a temporary hiring freeze, to be lifted, subject to the Canadian and United States economies demonstrating recovery from COVID-19.
Clinical study site status. The Company has successfully launched four CSSs and is preparing to launch a fifth Canadian CSS later in the year. The Company is in advanced discussions to launch a number of U.S. based CSS, subject to the United States economy recovering from the COVID-19 pandemic. The U.S. based Trial Management Organization is supporting the of launch 4 to 5 CSSs in 4Q2020 with potential to commence Study II patient enrollment and treatment as early as 1Q2021.
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 2021.
COVID-19 Research Update. The Company’s PDC technology was proven to be effective in the destruction of Influenza H1N1 and Zika viruses at low nanomolar concentrations. These studies were expanded to include coronavirus Bio Safety Level ("BSL") 2. As a note, COVID-19 is caused by coronavirus (BSL-3), not coronavirus (BSL-2). A new assay was established to measure coronavirus destruction and using this new assay the Theralase PDC technology was able to destroy coronavirus (BSL-2) with drug doses 5 times lower than what was used to kill Influenza H1N1 and Zika viruses. These drug doses demonstrated a 99.995% destruction rate of the BSL-2 coronavirus and are significantly lower than those used by the Company to treat cancers; hence considered safe for human use. Coronaviruses are considered similar in their structure and these new results strongly suggest that Theralase’s PDC will be highly effective against the SARS-CoV-2 (BSL-3) virus responsible for COVID-19. Theralase plans to commence an in-vivo small animal study later this year at another facility equipped to handle SARS-CoV-2 viruses (BSL-3) and if successful commence human clinical studies in 2021, subject to the availability of suitable financing.*
* 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 (0.70 mg/cm2) of TLD-1433 and is focused on the enrollment and treatment of approximately 100 BCG-Unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the US.

Study II has a:

Primary endpoint of efficacy (defined by Complete Response ("CR") at any point in time
Secondary endpoint of duration of CR at 360 days post-initial CR (approximately 450 days post initial Study treatment, assuming CR is achieved at the 90 day assessment)
Tertiary endpoint of safety measured by incidence and severity of Adverse Events ("AEs") grade 4 or higher that do not resolve within 450 days post-initial treatment
The FDA, in its 2018 guidance to industry has stated that, "For single-arm trials of patients with BCG-unresponsive disease, the FDA defines a CR as at least one of the following:

Negative cystoscopy and negative (including atypical) urine cytology
Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
For intravesical therapies without systemic toxicity, the FDA includes, in the definition of a CR, negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative.
Intravesical instillation does not deliver the investigational drug to the upper tract or prostatic urethra; therefore, the development of disease in these areas cannot be attributed to a lack of activity of the investigational drug. Thus, sponsors can consider patients with new malignant lesions of the upper tract or prostatic urethra, who have received intravesical therapy to have achieved a CR in the primary analysis; however, sponsors should record these lesions and conduct sensitivity analyses in which these patients are not considered to have achieved a CR."1

On November 30, 2020 GENFIT (Nasdaq and Euronext: GNFT) a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, today announces that (Press release, Genfit, NOV 30, 2020, View Source [SID1234571969]):

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•the reverse book building process for the partial buyback of GENFIT’s 6,081,081 convertible bonds maturing in October 2022 ("OCEANEs") achieved satisfactory results and ended on November 27, 2020 (COB) as planned;

•the Bond Purchase Agreements from investors having tendered their OCEANEs will be collected as quickly as possible and once the process is completed, GENFIT will communicate the final results of the partial buyback.

On November 30, 2020 Mersana Therapeutics, Inc. (Nasdaq: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the appointment of Arvin Yang, M.D., Ph.D., as Senior Vice President and Chief Medical Officer effective immediately (Press release, Mersana Therapeutics, NOV 30, 2020, View Source [SID1234571968]). Dr. Yang succeeds Dirk Huebner, M.D., who has stepped down as Chief Medical Officer but will remain with the Company until January 15, 2021, to assist with a smooth transition.

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"We are excited to welcome Arvin to our leadership team as we enter this next crucial and exciting stage for Mersana," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "Arvin’s deep experience in leading late-stage global registration trials combined with his early stage and immuno-oncology experience will be instrumental in guiding the advancement of XMT-1536 into the planned fast-to-market registration-enabling study as well as driving the rest of Mersana’s first-in-class innovative pipeline."

Dr. Yang spent over a decade at Bristol Myers Squibb in various roles with increasing responsibility for the clinical development of oncology and immuno-oncology therapies. Most recently, he was Vice President and Head of Clinical Hematology, where he was responsible for the clinical development of the late stage hematology pipeline. Before that, he was Vice President and Development Lead for Melanoma and GU cancers, and played a critical role in the global approval of nivolumab and nivolumab plus ipilimumab combinations in a number of indications. Earlier, he was responsible for the nivolumab and ipilimumab life-cycle clinical development plans including those in gynecological cancers. Finally, he has held leadership roles overseeing a pipeline of early clinical programs as well as roles in medical affairs. Dr. Yang received his M.D. and Ph.D. from Rutgers Robert Wood Johnson Medical School and completed training in internal medicine at Beth Israel Deaconess, Harvard Medical School and in oncology at Memorial Sloan-Kettering Cancer Center.

"Mersana’s XMT-1536 is poised to make a meaningful difference for people living with ovarian cancer. I am excited about the opportunity to work with the talented Mersana team to bring this important medicine to patients," said Dr. Yang. "I am equally excited about the potential of the NaPi2b target in non-small cell lung cancer adenocarcinoma, Mersana’s robust pipeline of early-stage candidates developed using innovative and differentiated ADC platforms, and the potential of these candidates to make a significant impact in the lives of people living with cancer."

"I would also like to take this opportunity to thank Dirk for his many contributions at Mersana. Over the past two years, Dirk has played a significant role in bringing XMT-1536 to proof of concept in ovarian cancer and in building a strong clinical development team. I wish him all the best in his future endeavors," added Anna Protopapas.

On November 30, 2020 Istari Oncology, Inc., a clinical-stage biotechnology company, reported the first patient was dosed in the LUMINOS-101 Phase 2 clinical trial, assessing the safety and efficacy of PVSRIPO in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda) in patients with recurrent glioblastoma multiforme (rGBM) (Press release, Istari Oncology, NOV 30, 2020, View Source [SID1234571967]).

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PVSRIPO is a novel viral immunotherapy that activates a patient’s innate and adaptive immunity to facilitate a targeted anti-tumor immune response. The study seeks to determine whether PVSRIPO and pembrolizumab will be able to generate anti-tumor response in patients with rGBM, given their complimentary mechanisms of action.

"The initiation of this Phase 2 trial represents a significant milestone in the advancement of PVSRIPO and our quest to treat this formidable opponent," said Matt Stober, President and Chief Executive Officer at Istari Oncology. "Currently the treatment options for patients with rGBM are limited and outcomes are grim, so following the encouraging results of our Phase 1 trial, we are eager to see the effectiveness of PVSRIPO in combination with pembrolizumab."

"Combining PVSRIPO’s ability to generate antitumor immune response with a checkpoint inhibitor holds the promise of more effective therapy for this devastating disease," said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. "Achieving rapid disease control is critical in patients with rGBM, one of the most aggressive and treatment-refractory tumors."

LUMINOS-101 is a Phase 2, single arm trial (clinicaltrials.gov NCT04479241) in patients with rGBM that aims to characterize the safety, tolerability and initial efficacy of PVSRIPO intratumoral infusion followed by intravenous pembrolizumab 14 to 28 days later, and every three weeks thereafter.

LUMINOS-101 follows a Phase 1 trial of PVSRIPO in rGBM, conducted at the Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, that found survival rates were significantly higher in rGBM patients who received an intratumoral infusion of PVSRIPO compared to similar patients receiving standard treatment. Overall survival among patients who received PVSRIPO plateaued at 21 percent, 24 to 36 months after injection based on a publication of the interim trial results (Desjardins, et al., 2018 NEJM). The overall survival rate was sustained at 36 months in these patients. A multicenter Phase 2 study of PVSRIPO in patients with rGBM (n=120) completed enrollment in June 2020; follow-up of those patients is ongoing.

The Phase 2 LUMINOS-101 trial will be conducted across multiple research sites, including Ohio State University Comprehensive Cancer Center, University of California San Francisco, Baptist MD Anderson Cancer Center, Duke University Medical Center, Oregon Health and Science University and University Hospitals Seidman Cancer Center (UHSCC) in Cleveland, Ohio. The first patient has been dosed at UHSCC, which treated seven patients with rGBM as part of the previous Phase 2 trial.

"The Phase 1 trial of PVSRIPO yielded survival rates like we’ve never seen before," says Andrew E. Sloan, MD, FACS, Director of the Brain Tumor & Neuro-Oncology Center and the Center of Excellence in Translational Neuro-Oncology at UH Seidman Cancer Center and UH Neurological Institute, and Professor and Vice Chairman, Department of Neurosurgery at Case Western Reserve University School of Medicine. "Glioblastoma is one of the most aggressive tumors known to man. Following the encouraging results of PVSRIPO to date, we are very interested to see if those results improve further in combination with pembrolizumab."

For more information about Istari Oncology and their ongoing clinical trials, visit istarioncology.com.

About PVSRIPO
PVSRIPO is a virus based on the live attenuated Sabin type 1 polio vaccine that has been genetically modified for safety. Unlike other viral immunotherapies, PVSRIPO has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via sublethal infection of antigen presenting cells in the tumor, which unleashes an inflammatory cascade resulting in sustained systemic antitumor immunity. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma.

About Glioblastoma
Glioblastoma is the most common and aggressive form of brain cancer, comprising 52% of patients with primary brain tumors. There are approximately 13,000 patients diagnosed with GBM in the United States annually and approximately 18,000 in the European Union. Despite aggressive treatment, survival for newly diagnosed glioblastoma patients is usually less than 20 months, and for patients with recurrence, which occurs in 98% of patients, survival is usually less than 12 months.

On November 30, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) and Viracta Therapeutics, Inc., a privately held precision oncology company targeting virus-associated malignancies, reported they have entered into a definitive merger agreement (the "Merger Agreement") pursuant to which Viracta will combine with Sunesis in an all-stock transaction (the "Merger") (Press release, Sunesis, NOV 30, 2020, View Source [SID1234571965]). The merged company will focus on the advancement and expansion of Viracta’s clinical stage, precision oncology pipeline targeting virus-associated malignancies, including Viracta’s lead program for the treatment of Epstein-Barr virus (EBV)-positive relapsed/refractory lymphomas. Upon completion of the Merger, the combined company will operate under the name Viracta Therapeutics, Inc. and intends to be listed on the Nasdaq Global Market under the ticker symbol "VIRX."

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Viracta recently completed a $40 million Series E Preferred Stock equity financing led by aMoon, Israel’s leading healthtech and life sciences venture fund, with participation from Taiwania Capital Management, Latterell Venture Partners, LifeSci Venture Partners and other existing investors.

Concurrent with the execution of the Merger Agreement, Viracta entered into an agreement for the sale of common stock in a private placement with an investor syndicate of institutional accredited investors led by BVF Partners L.P., with participation from aMoon, Ridgeback Capital Management, Surveyor Capital (a Citadel company), Logos Capital, Samsara Biocapital, Sectoral Asset Management, Janus Henderson Investors, LifeSci Venture Partners, and Serrado Capital LLC, as well as other institutional investors. The private placement is expected to result in gross proceeds to Viracta of approximately $65 million prior to the close of the Merger, subject to customary conditions. Upon the close of the Merger and related financing, the total cash balance of the combined company is expected to be approximately $120 million with an expected cash runway into 2024.

Viracta’s lead program evaluates the all-oral combination of nanatinostat, its proprietary investigational drug, and valganciclovir in a Phase 2 clinical trial for the treatment of EBV-positive relapsed/refractory lymphomas. There are currently no approved therapies for EBV-associated cancers, which are responsible for over 140,000 deaths each year. Viracta’s precision oncology and biomarker-driven combination product candidate targets EBV-positive cancer cells with an inducible synthetic lethality approach. Viracta plans to initiate a registration trial for the treatment of EBV-positive lymphoma in the first half of 2021, and also plans to initiate a Phase 1b/2 trial in EBV-positive solid tumors in 2021.

"This is a transformational event for Viracta, and I am very pleased to see the company brought forward into the public market," said Roger Pomerantz, M.D., F.A.C.P., Chairman of the Board of Directors of Viracta. "Importantly, Viracta’s novel approach to targeting viral latency represents a completely new medical modality in the landscape of precision oncology, and today is the beginning of an important and exciting new phase in the company’s evolution. EBV-induced malignancies are a high unmet medical need area, and the patients are waiting for novel therapies."

"After a thorough evaluation of strategic alternatives, the Board of Directors of Sunesis believes this merger is in the best interest of Sunesis’ stockholders and has the potential to deliver near- and long-term value," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "This transaction will provide the resources for the combined company to leverage Viracta’s scientific platform and pipeline to treat a range of virus-associated cancers and other serious diseases. Viracta shares our mission to develop important new targeted treatments for patients living with cancer, and we are enthusiastic about the prospect of carrying on that mission."

Ivor Royston, M.D., President and Chief Executive Officer of Viracta added, "The merger and our private financings represent a significant step in Viracta’s growth as a late-stage development company. Our ongoing Phase 2 clinical trial for the treatment of EBV-positive lymphomas has produced encouraging efficacy and safety, and these transactions provide meaningful capital as we advance this program towards registration and expand our clinical pipeline. We look forward to building upon our clinical and corporate momentum to create shareholder and patient value, as we advance our important work to address the significant unmet needs in virus-associated malignancies."

About the Merger

Under the terms of the Merger Agreement, pending stockholder approval of the transaction, Viracta will merge with a wholly owned subsidiary of Sunesis, and stockholders of Viracta will receive shares of newly issued Sunesis common stock. Viracta stockholders are expected to own approximately 86% and Sunesis stockholders will own approximately 14% of the combined company on a fully diluted basis using the treasury stock method. The percentage of the combined company that Sunesis stockholders will own as of the close of the Merger may be subject to adjustment based on Sunesis’ net cash.

The Merger Agreement has been unanimously approved by the Board of Directors of each company. The transaction is expected to close in the first quarter of 2021, subject to approvals by stockholders of each company and other customary closing conditions.

MTS Health Partners, L.P. is serving as the financial advisor to Sunesis, and Cooley LLP is serving as legal counsel to Sunesis. SVB Leerink LLC and Evercore Group LLC served as placement agents in Viracta’s private financings. Wilson Sonsini Goodrich & Rosati is serving as legal counsel to Viracta.

Management and Organization

The combined company will be led by Viracta’s current management team and will be headquartered in Cardiff, California. The Board of Directors is expected to consist of seven members, including six members from Viracta’s board and one member from Sunesis’ board.

Conference Call and Webcast Information

Sunesis and Viracta will host a conference call and webcast today at 8:30 a.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 5742158. To access the live webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com, or the "News/Media" section of the Viracta website at www.viracta.com. The webcast will be recorded and available for replay on the respective company’s website for two weeks.