On April 2, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company focused on revolutionizing product discovery and development in multiple life-science based industries, reported that it has filed its annual report on Form 20-F for the fiscal year ended December 31, 2020 with the U.S. Securities and Exchange Commission (the "SEC") (Press release, Evogene, APR 2, 2021, View Source [SID1234577547]).

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The annual report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC website at View Source as well as via the Company’s website at View Source The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to the Company Media Contact: [email protected].

On April 2, 2021 Taiho Oncology, Inc. reported that Phase 2 clinical data, along with preclinical and Phase 1 clinical data for futibatinib (TAS-120) will be presented during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 Week 1, taking place virtually from April 10-15, 2021 (Press release, Taiho, APR 2, 2021, View Source [SID1234577548]). Futibatinib is a covalently-binding FGFR inhibitor being investigated for the potential treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions. Key presentations include:

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Primary results of phase 2 FOENIX-CCA2: the irreversible FGFR1-4 inhibitor futibatinib in intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements: Lipika Goyal, MD, MPhil, Massachusetts General Hospital Cancer Center (Presentation Number CT010). Results will be shared online as an oral plenary presentation from 2:00 – 3:45 PM ET on April 11, 2021.
Acquired resistance to ATP-competitive and irreversible FGFR inhibitors (FGFRi’s): A library-based approach: Hiroshi Sootome, MS, Manager, Translational Research Planning & Management group, Taiho Pharmaceutical Co., Ltd. (1117). Results will be shared online as a poster presentation from 8:30 AM – 11:59 PM ET on April 10, 2021.
Effect of futibatinib on QT/QTc interval: a randomized, controlled, double-blind study: Ikuo Yamamiya, PhD, Associate Director, Bioanalytics & DMPK, Taiho Oncology, Inc. (CT128). Results will be shared online as a poster presentation from 8:30 AM – 11:59 PM ET on April 10, 2021.
Evaluation of potential drug-drug interactions (DDIs) between futibatinib and CYP3A inhibitors/inducers, CYP3A substrates, or proton pump inhibitors (PPIs): Ikuo Yamamiya, PhD, Associate Director, Bioanalytics & DMPK, Taiho Oncology, Inc. (CT125). Results will be shared online as a poster presentation from 8:30 AM – 11:59 PM ET on April 10, 2021.
Please visit Taiho Oncology’s virtual Medical Booth when the exhibit opens on April 10, 2021.

"We are pleased to present these clinical and pre-clinical data for futibatinib in patients with advanced intrahepatic cholangiocarcinoma (iCCA) who have failed at least one line of therapy, including primary results from the Phase 2 FOENIX-CCA2 trial," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "These data add to the body of evidence for futibatinib and support this investigational compound as a potential treatment option for patients with iCCA whose disease has progressed following previous therapies."

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for futibatinib for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions, in February 2021 based on efficacy and safety results from the FOENIX-CCA2 study. The FDA Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma in May 2018.

About Futibatinib (TAS-120)
Futibatinib (TAS-120) is an investigational, oral, potent, selective, and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies. Futibatinib selectively and irreversibly binds to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations.

About Cholangiocarcinoma
Cholangiocarcinoma (CCA), also known as bile duct cancer, is not common. About 8,000 people in the U.S. are diagnosed with CCA each year.1 This includes both intrahepatic (inside the liver) and extrahepatic (outside the liver) cancers. CCA can occur at younger ages, but it is seen mainly in older people. The average age of people in the U.S. diagnosed with cancer of the intrahepatic bile ducts is 70, and for cancer of the extrahepatic bile ducts it is 72.1 The five-year survival rates of intrahepatic CCA (all SEER stages combined) is 9%.2

The main treatment for CCA is surgery. Radiation therapy and chemotherapy may be used if the cancer cannot be entirely removed with surgery and in cases where the edges of the tissues removed at the operation show cancer cells (also called a positive margin). Both stage III and stage IV cancers cannot be completely removed surgically. Currently, standard treatment options are limited to radiation, palliative therapy, liver transplantation, surgery, chemotherapy and interventional radiology.3

On April 1, 2021 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the fourth quarter ended December 31, 2020, and earlier today reported preliminary topline data (Press release, Delcath Systems, APR 1, 2021, View Source [SID1234577495]). The company will host its quarterly call at 8:00am ET today, with a primary focus on discussing the preliminary top line data.

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Recent Business Highlights

During and since the fourth quarter of 2020, the company:

Reported positive preliminary results from the FOCUS Clinical Trial (NCT02678572) for Patients with Hepatic Dominant Ocular Melanoma treated with HEPZATO based on an analysis of currently evaluable patients. The preliminary analysis included 87% of treated patients and final results are expected later in the year. The primary endpoint, overall response rate (ORR), as determined by an independent review committee, exceeded the prespecified threshold for success. Additionally, both prespecified ORR and Progression Free Survival comparative analyses against the best alternative care arm demonstrated a statistically significant improvement. The safety profile was consistent with the safety profile of CHEMOSAT treatment described in previous European single-center and multi-center publications with no new safety signals observed in this patient population.

Initiated a consulting engagement to select a portfolio of follow-on indications which will maximize the value of the HEPZATO Kit and CHEMOSAT platform.

Completed an underwritten public offering of common stock at a price of $13.25 per share yielding $22.2 million in gross proceeds.

Strengthened the executive team with the appointment of Gerard Michel as Chief Executive Officer and Kevin Muir as Vice President of Commercial Operations.

"The fourth quarter marked the start of a critical transformation for Delcath," said Gerard Michel, CEO of Delcath. "Since October, we have attracted new investors, strengthened the management team and, most importantly, released preliminary results from the FOCUS trial which, as of this compilation, suggests a significant improvement in the benefit risk ratio versus an earlier generation of Delcath’s proprietary percutaneous hepatic perfusion system. We look forward to continued progress in 2021, as we prepare both to file an NDA in early 2022 and expand the development of HEPZATO into additional areas of high unmet need."

Fourth Quarter 2020 Financial Results:

Income Statement Highlights.

Product revenue for the three months ended December 31, 2020 was approximately $379 thousand, compared to $398 thousand for the prior year period from our sales of CHEMOSAT procedures in Europe. Selling, general and administrative expenses were approximately $4.5 million compared to $2.1 million in the prior year quarter. Research and development expenses for the quarter were $2.7 million compared to $2.7 million in the prior year quarter. Total operating expenses for the quarter were $7.3 million compared with $4.8 million in the prior year quarter.

We recorded a net loss for the three months ended December 31, 2020, of $7.0 million, compared to a net income of $12.5 million for the same period in 2019.

Balance Sheet Highlights.

At December 31, 2020, we had cash, cash equivalents and restricted cash totaling $28.8 million, as compared to cash, cash equivalents and restricted cash totaling $10.2 million at December 31, 2019. During the three months ended December 31, 2020 and December 31, 2019, we used $4.6 million and $5.4 million, respectively, of cash in our operating activities.

Conference Call Information

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On April 1, 2021 City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that it will extend its leading-edge cancer expertise to South America via an education agreement with Hospital Israelita Albert Einstein, a top cancer center in Latin America (Press release, City of Hope, APR 1, 2021, View Source [SID1234577511]).

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The three-year agreement calls for City of Hope to share its specialized cancer expertise with Hospital Israelita Albert Einstein’s oncology residents and clinical staff. City of Hope will provide educational experiences and host multidisciplinary tumor boards. Both institutions will explore potential innovative collaborations in precision oncology and research.

"This agreement marks another milestone moment, allowing City of Hope to extend its mission to eliminate cancer to a new continent," said Harlan Levine, M.D., president of strategy and business ventures at City of Hope, which is headquartered near Los Angeles.

"Hospital Israelita Albert Einstein has an exceptional medical team," Levine added. "City of Hope will offer our best-in-class expertise as a comprehensive cancer center to both their residents in training and clinical staff. We hope to collaborate with our Latin American colleagues to improve cancer care outcomes not only in São Paulo, but also throughout Brazil and Latin America."

Among other services, City of Hope will provide a virtual multidisciplinary tumor board that will initially focus on gastrointestinal, genitourinary, lung and brain cancers. Hospital Israelita Albert Einstein physicians will share specific patient cases with complex issues involving molecular diagnostics, immunotherapy and innovations in cancer care delivery for review and discussion. City of Hope will also provide educational webinars and offer professional training on topics such as genetic testing, supportive care services and nursing.

Sidney Klajner, M.D., Ph.D., president of Hospital Israelita Albert Einstein, said, "We will incorporate City of Hope’s multidisciplinary approach to oncology precision medicine to address the cancer burden in Brazil. Together with City of Hope, we hope to collaborate on molecular diagnostics and innovative care advancements for the benefit of patients in Latin American and beyond."

Hospital Israelita Albert Einstein has been ranked as the best hospital in Latin America by the America Economia Business Intelligence Unit for 12 years in a row. Additionally, it is positioned 36th overall globally and 21st for specialized oncology on Newsweek’s ranking of the World’s Best Hospitals 2021.

This collaborative agreement was made possible through efforts by City of Hope’s Center for International Medicine (CIM), which seeks to collaborate with international organizations to improve cancer and diabetes care for more people worldwide. CIM works with governments, hospitals, private companies and investors, and offers a range of services in the areas of clinical research and innovation, education and professional development.

On April 1, 2021 Inspyr Therapeutics, Inc. (OTC:NXPX), a pharmaceutical company focused on the research and development of novel targeted precision therapeutics for the treatment of cancer, reported its financial results and business update for the fourth quarter and full year 2020 ended December 31, 2020 (Press release, Inspyr Therapeutics, APR 1, 2021, View Source [SID1234577496]).

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Business Highlights

In October 2020, we announced that the company would strengthen its strategic collaboration with Ridgeway Therapeutics by reacquiring its novel immune-oncology precision targeting platform for the treatment of cancer through the cancellation of our prior licensing agreement.
As of March 30, 2021, we have 24 issued patents in our intellectual property portfolio for 22 jurisdictions in potential future commercial markets including the United States, Europe, the United Kingdom, Asia, and other geographies.
The company is currently preparing an investigational new drug (IND) application, for its lead asset, RT-AR001, an adenosine A2B receptor antagonist. The company plans to provide an update on RT-AR001’s clinical development in the second half of 2021 after its pre-IND meeting with the U.S. Food and Drug Administration (FDA).
Financial Highlights

Cash and restricted cash was $0.4 million and $0.02 million at December 31, 2020 and 2019, respectively. As of December 31, 2020 and 2019, there was no cash over the federally insured limit.
Operating expenses was $2.5 million and $0.06 million at December 31, 2020 and 2019, respectively. The increase was mostly due to the $2.0 million associated with the licensing cost of the adenosine portfolio.
Research and development (R&D) expenses incurred were $0.02 million and $0.04 million for the years ended December 31, 2020 and 2019, respectively.