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.

On November 30, 2020 ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported that it will host a live conference call and webcast on Monday, December 7, 2020, at 8:00 a.m. ET to highlight several presentations at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, including data on its lead candidate loncastuximab tesirine (Lonca) for the treatment of relapsed of refractory diffuse large B-cell lymphoma and updated preliminary data from a pivotal Phase 2 trial of camidanlumab tesirine (Cami) in Hodgkin lymphoma (Press release, ADC Therapeutics, NOV 30, 2020, View Source [SID1234571964]).

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The event will feature a presentation from key opinion leader Mehdi Hamadani, MD, Professor of Internal Medicine at the Medical College of Wisconsin, Division of Hematology and Oncology.

To access the conference call, please dial (833) 303-1198 (domestic) or +1 914 987-7415 (international) and provide the pin number 1486164. A live webcast of the presentation will be available on the Investors section of the ADC Therapeutics website at www.adctherapeutics.com. The archived webcast will be available on the ADC Therapeutics website after the completion of the event.

On November 30, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that $25 million in milestones have been achieved under its exclusive global collaboration and license agreement with Incyte for retifanlimab, an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012) (Press release, MacroGenics, NOV 30, 2020, View Source [SID1234571951]). The milestones were triggered by clinical and regulatory activities related to the further advancement of the molecule, including the recent initiation of POD1UM-303, Incyte’s Phase 3 global study in patients with metastatic squamous cell anal carcinoma (SCAC).

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MacroGenics and Incyte have each established multiple development programs for retifanlimab, evaluating the anti-PD-1 molecule either as monotherapy or in combination with other agents. Incyte is conducting clinical trials that are potentially registration-enabling for patients with metastatic non-small cell lung cancer, SCAC, microsatellite instability high endometrial cancer and Merkel cell carcinoma. MacroGenics is conducting a potentially registration-enabling study of retifanlimab in combination with margetuximab, an investigational Fc-engineered, anti-HER2 mAb, in HER2-positive gastric cancer.

"We are excited to see the continued advancement of the development of retifanlimab across a broad set of monotherapy and combination regimens," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We look forward to continued progress on this program over the coming months."

Under the collaboration agreement with Incyte, MacroGenics is eligible to receive up to a total of $365 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the molecule.

On November 30, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the nine months ended September 30, 2020 (Press release, Can-Fite BioPharma, NOV 30, 2020, View Source [SID1234571950]).

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Clinical Developments and Corporate Highlights for the Third Quarter and Recent Weeks Include:

Positive Interim Analysis in Phase III Comfort Trial of Piclidenoson in the Treatment of Psoriasis – The Independent Data Monitoring Committee (IDMC) for Can-Fite’s Phase III trial of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis recommended the Company continue the study with the original sample size and drop one dose group based on the positive data from its interim analysis. While the interim data continue to be blinded to Can-Fite, the Company considers the IDMC’s recommendations highly encouraging. As the optimal dose has been identified, Can-Fite believes the study can be concluded earlier than originally planned. The majority of costs associated with the Phase III Comfort study have been previously paid. Piclidenoson is out-licensed for the indication of psoriasis in nine countries through agreements that include milestone payments and royalties on revenues upon regulatory approval.

Data from the Interim Analysis of the Acrobat Rheumatoid Arthritis Study – The IDMC recommended not to continue this study. The Company conducted a detailed analysis which showed that although Piclidenoson efficacy was significantly superior to placebo, the study missed the primary endpoint which was non-inferiority vs. the comparator methotrexate. The Company decided to stop this Phase III study and to focus on the developments that showed promising data including psoriasis, NASH and liver cancer.

Phase II COVID-19 IND Application for Piclidenoson Approved by FDA – The U.S. Food and Drug Administration (FDA) issued a "safe to proceed" notice for Can-Fite’s Investigational New Drug (IND) application for a Phase II study of Piclidenoson in the treatment COVID-19. The 28-day study will enroll 40 patients hospitalized with "moderate" COVID-19 per U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. The randomized, double blind study will evaluate patients who will receive Piclidenoson in addition to standard supportive care, as compared to patients who receive standard supportive care with placebo. The Company expects to commence patient enrollment in Q4 2020.

Namodenoson Abstract of Phase II Data Selected as ‘Best of The Liver Meeting’ in the NASH Category of the American Association of Liver Diseases (AASLD) – Dr. Rifaat Safadi, Principal Investigator of Can-Fite’s Phase II study of Namodenoson in the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) delivered a late-breaking oral presentation at the prestigious American Association for the Study of Liver Diseases (AASLD) conference, The Liver Meeting Digital Experience 2020. Presenting to the world’s leading scientists and health care professionals committed to preventing and curing liver diseases, Dr. Safadi concluded that "Namodenoson’s very impressive study data may result in a promising drug for the treatment of NAFLD/NASH due to the combination of good efficacy and favorable safety." Can-Fite’s presentation was selected as ‘Best of The Liver Meeting’ in the NAFLD/NASH category. This selection is a singular honor and indicates the high level with which the AASLD review committee regards Can-Fite’s research.

Patent Protecting Namodenoson in Treatment of NASH Approved in Europe – A patent titled "An A3 Adenosine Receptor For Use In Treating Ectopic Fat Acculturation" was issued to Can-Fite by the European Patent Office. The patent’s claims include use of the A3 adenosine receptor (A3AR), the target of Can-Fite’s platform technology, in reducing ectopic fat accumulation particularly in fatty liver as manifested in NAFLD and NASH.

Completed Development of Assay to Identify Clinically Active Cannabis Derived Compounds – Can-Fite completed the development of a biological cell-based in vitro assay which can identify clinically active cannabis derived compounds that bind to and activate A3AR, the target of Can-Fite’s platform technology. In addition to using this assay in the development of its own cannabis derived compound-based therapeutics, Can-Fite plans to market the assay on a ‘fee for service’ basis to researchers and other cannabis companies worldwide.

"We are very pleased with the results of the IDMC’s interim analysis and recommendation for our Phase III psoriasis study. Piclidenoson has a clear value proposition in the psoriasis market we believe, based on its demonstrated safety and efficacy to date, and the benefit of being an oral drug among a growing number of injectable biologics. Oral drugs are cost effective and more convenient for the patient. Both of these factors are preferred by psoriasis patients based on a 2018 study published in an industry journal," stated Can-Fite CEO Dr. Pnina Fishman. "This quarter we anticipate enrolling the first COVID-19 patient in our U.S. FDA Phase II study. Piclidenoson’s anti-inflammatory and anti-viral properties make it a promising candidate in the fight against this pandemic. We are also very encouraged by the level of interest in Namodenoson in the treatment of NAFLD/NASH from the scientific and business communities."

Financial Results

Revenues for the nine months ended September 30, 2020 were $0.61 million compared with $1.84 million for the same period of 2019. The decrease in revenues was mainly due to the recognition of a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.

Research and development expenses for the nine months ended September 30, 2020 were $9.05 million compared with $7.01 million for the same period of 2019. Research and development expenses for the nine months ended September 30, 2020 comprised primarily of expenses associated with the Phase II studies for Namodenoson in the treatment of NASH and HCC, as well as expenses for ongoing Phase III studies of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis. The increase is primarily due to increased costs associated with the accelerating rate of absorption of patients for the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis and for psoriasis during this period.

General and administrative expenses were $2.14 million for the nine months ended September 30, 2020 compared to $2.22 million for the same period in 2019. The decrease is primarily due to a decrease in professional services and travel expenses which was partly offset by an increase in salaries and related benefits and insurance expenses.

Financial expenses, net for the nine months ended September 30, 2020 was $0.22 million compared to $0.44 million for the same period in 2019. The decrease in financial expenses, net is mainly due to fair value revaluation of the investment in Wize Pharma Inc’s shares which is classified under short term investment.

Can-Fite’s net loss for the nine months ended September 30, 2020 was $10.81 million compared with a net loss of $7.84 million for the same period in 2019. As of September 30, 2020, Can-Fite had cash and cash equivalents of $10.22 million as compared to $2.69 million at December 31, 2019. The increase in cash during the nine months ended September 30, 2020 is due to an aggregate of $17.68 million net proceeds received through a warrant exercise transaction in January 2020, a public offering in February 2020, partial exercises in March, April and May 2020 of warrants issued in the February 2020 public offering, and a registered direct offering in June and July 2020 which was offset by net cash used in operating activity of $10.16 million.

The Company’s consolidated financial results for the nine months ended September 30, 2020 are presented in accordance with US GAAP Reporting Standards.

Conference Call

Management will host a conference call today, November 30, 2020 at 9:15 a.m. ET. Investors in the U.S. are invited to dial 877-423-9813. International investors may dial 201-689-8573. The conference ID is 13713545. Investors may also participate via webcast: View Source

A replay of the webcast will be archived on Can-Fite’s website for a period of time. 

On November 30, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that the Company will host a conference call and live audio webcast on Saturday, December 5, 2020, at 2:00 p.m. ET (Press release, IGM Biosciences, NOV 30, 2020, https://igmbio.com/2020/11/30/igm-biosciences-to-host-conference-call-and-webcast-to-review-igm-2323-data-presented-at-the-62nd-annual-ash-meeting/ [SID1234571949]). The event will take place following a poster presentation featuring the first clinical data from the Company’s Phase 1 trial evaluating IGM-2323 at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

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The conference call may be accessed by dialing (866) 649-1996 (domestic) or (409) 217-8769 (international) and referring to conference ID 1141638. A live webcast of the presentation will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.