On March 16, 2020 Helix BioPharma Corp. (TSX: "HBP"), a an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, reported its financial results for the fiscal second quarter ended January 31, 2020 (Press release, Helix BioPharma, MAR 16, 2020, View Source [SID1234555605]).

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OVERVIEW
The Company reported a consolidated net loss and total comprehensive loss, including non-controlling interest of $2,255,000 ($0.02 loss per common share) and $4,466,000 ($0.04 loss per common share), respectively for the three and six-month period ended January 31, 2020. For the three and six-month periods ended January 31, 2019, consolidated net loss and total comprehensive loss including non-controlling interest totalled $1,908,000 ($0.02 loss per common share) and $3,287,000 ($0.03 loss per common share), respectively.

To-date in fiscal 2020, the Company has raised gross proceeds totaling approximately $16,000,000 and as a result, no longer faces a working capital deficiency. In addition, the Company during the fiscal year, to-date has divested a 49% percent stake in its Polish subsidiary and is working on divesting the remaining 51% before the end of the Company’s fiscal 2020 year-end while retaining licensing agreements for future royalties and milestones payments.

The Company has also been in discussions with various capital market firms, both in the U.S. and Canada, with the goal of raising additional capital to further advance the Company’s clinical development programs and to qualify for a NASDAQ listing.

Patient enrollment and screening commenced on the LDOS006 Phase Ib/II clinical study in the U.S. for the treatment of patients with previously treated advanced pancreatic cancer. Two patients have been enrolled to-date. The Phase Ib portion of the study involves three dose escalating cohorts enrolling a total of nine (9) patients. The Phase II portion of the study will enroll an additional eleven (11) patients depending on meeting safety and efficacy criteria. The Company’s other clinical studies for non-small cell lung cancer are in the following stages of development.

LDOS001 clinical study has completed enrollment and the Company is working on finalizing data for reporting while LDOS003 is in the last cohort of the study’s dose escalation phase. Research and development L-DOS47 research and development expenses for the three and six-month periods ended January 31, 2020 totalled $1,332,000 and $2,453,000, respectively (January 31, 2019-$788,000 and $1,649,000, respectively).

L-DOS47 research and development expenditures relate primarily to the Company’s LDOS001 Phase I clinical study in the U.S., the LDOS003 Phase II clinical study in Poland and the Ukraine and the Company’s newly approved LDOS006 Phase Ib/II clinical study in the U.S. The increase in L-DOS47 expenditures in Q2 fiscal 2020 when compared to Q2 fiscal 2019 reflects an increase of approximately $350,000 in L-DOS47 manufacturing activity to produce additional drug substance in addition to increased spend of approximately $295,000 in the Company’s newly launched pancreatic clinical study in the U.S.

The Company commenced enrollment in the new pancreatic clinical study in December 2019. For the six-month period ending Q2 2020 when compared to the six-moth period ended Q2 2019 the increase in spending mainly reflects the increase in cost associated with the commencement of the new pancreatic clinical trial in the U.S. Preclinical V-DOS47 research and development expenses for the three and six-month periods ended January 31, 2020 and 201 totalled $69,000 and $180,000, respectively (January 31, 2019-$102,000 and $232,000, respectively).

The Company’s wholly owned subsidiary in Poland has a grant funding agreement with the Polish National Centre for Research and Development ("PNCRD") for research and development expenditures associated with V-DOS47. In the three and sixmonth period ended January 31, 2020, the Company’s Polish subsidiary received grant funding of $132,000 and $159,000, respectively (January 31, 2019-$87,000 and $222,000, respectively), from the PNCRD. CAR-T research and development expenses for both the three and six-month periods ended January 31, 2020 totalled $nil, respectively (January 31, 2019-$333,000, respectively). The Company’s collaboration with ProMab Biotechnologies Inc. has been impacted by the Coronavirus pandemic and as such certain planned activities have been deferred. Trademark and patent related expenses for the three and six-month periods ended January 31, 2020 totalled $85,000 and $238,000, respectively (January 31, 2019-$43,000 and $68,000, respectively). The Company continues to ensure it adequately protects its intellectual property. Stock based compensation expense for the three and six-month periods ended January 31, 2020 totalled $40,000 and $79,000, respectively (January 31, 2019-$nil and $nil, respectively). The amount represents the expense associated with the vesting of stock options that were granted in May 2019, over their vesting period. Operating, general and administration Operating, general and administration expenses for the three and six-month periods ended January 31, 2020 totalled $654,000 and $1,363,000, respectively ($533,000 and $906,000 respectively for the three and six-month periods ended January 31, 2019). The increase is mainly the result of higher expenses associated with various third-party advisor services such as investor and media relations, legal, business development activities and investment banking services. The Company has been in discussion with various advisory groups as it pursues a listing on a recognized U.S. stock exchange, like the Nasdaq.

LIQUIDITY AND CAPITAL RESOURCES
The Company reported a consolidated net loss and total comprehensive loss including non-controlling interest of $2,255,000 for the three-month period ended January 31, 2020 (January 31, 2019-$1,908,000) and $4,466,000 for the six-month period ended January 31, 2020 (January 31, 2019-$3,287,000). As at January 31, 2020 the Company had working capital of $873,000, shareholders’ equity of $1,088,000 and a deficit of $175,938,000. As at July 31, 2019 the Company had a working capital deficiency of $3,534,000, shareholders’ deficiency of $3,281,000 and a deficit of $171,531,000.

The Company experienced a working capital deficiency for several fiscal quarters, until August 21, 2019 when the Company closed a private placement financing for gross proceeds of $7,000,005 which included a disposition of a 25% stake in the Company’s Polish subsidiary. Subsequent to the August 21, 2019 private placement and as of March 12, 2020, the Company raised an additional $9.000,000. To-date in fiscal 2020 the Company has raised a total of $16,000,000.

As previously disclosed, the Company intends to fully divest its remaining 51.0% interest in its Polish subsidiary to raise additional capital to further fund the Company’s clinical development programs for future royalties and milestone payments.

In addition, the Company has been in discussions with various capital market firms, both in the U.S. and Canada, with the goal of raising additional capital to qualify the Company for a listing on a U.S. stock exchange such as NASDAQ in order to further advance the Company’s clinical development programs.

The Company’s cash reserves of $2,094,000 as at January 31, 2020 in addition to the subsequent private placement the Company closed on March 12, 2020 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, and nor are they sufficient to see planned research and development initiatives through to completion. Though the funds raised have materially assisted the Company in dealing with its working capital deficiency, additional funds are required to advance the Company’s clinical and preclinical programs and deal with working capital requirements To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, primarily through the issuance of equity securities of the Company, to be critical for its development needs. 4

The Company’s condensed unaudited interim consolidated statement of net loss and comprehensive loss for the three and six-month periods ending January 31, 2020 and 2019 and the condensed unaudited interim consolidated statement of cash flows for the six-month periods ending January 31, 2020 and 2019 are summarized below:
Consolidated Statements of Net Loss and Comprehensive Loss Consolidated Statements of Cash Flows (thousand $, except for per share data) (thousand $) 2020 2019 2020 2019 2020 2019

The Company’s condensed unaudited interim consolidated financial statements and management’s discussion and analysis will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website.

On March 16, 2020 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, reported financial results for the year ended December 31, 2019 and highlighted recent achievements (Press release, Immunic, MAR 16, 2020, View Source [SID1234555621]).

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"In addition to the closing of our stock-for-stock exchange transaction with Vital Therapies, Inc., which provided our Nasdaq listing and a significant capital infusion, 2019 was punctuated by the attainment of other important milestones," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Most notably, we completed enrollment for our phase 2 EMPhASIS trial of our lead compound, IMU-838, for patients with relapsing-remitting multiple sclerosis (RRMS), roughly nine months ahead of our initial plan. With preclinical data showing a solidly superior profile compared to DHODH inhibitor, teriflunomide, IMU-838 holds promise as an important new, best-in-class oral therapy for RRMS and other underserved immunologic diseases. We anticipate reporting top-line results in the third quarter of this year and believe that positive data could allow us to move quickly into a pivotal phase 3 trial.

"We also reported progress for IMU-838 in moderate-to-severe ulcerative colitis (UC) and primary sclerosing cholangitis (PSC), with a positive phase 2 interim dosing analysis in UC and the initiation of our investigator-sponsored, phase 2 trial in PSC, led by the Mayo Clinic. Given that the interim dosing analysis from the CALDOSE-1 study in patients with UC showed that it was likely not ineffective at the lowest 10 mg dose and that none of the three dose levels revealed unacceptable intolerance, the trial was expanded to 240 patients and top-line data is expected in the fourth quarter of 2021."

Dr. Vitt continued, "Our earlier stage programs have also advanced, with the dosing of healthy volunteers in several dose cohorts in our phase 1 trial of IMU-935, a potentially best-in-class inverse agonist of RORγt. Additionally, we plan to complete the preclinical and manufacturing activities required in order to initiate phase 1 clinical studies of IMU-856, during the first half of this year, having just announced in January 2020 the exercise of our option for the exclusive worldwide license to IMU-856 from Daiichi Sankyo, Co., Ltd. We are highly encouraged by the data we have generated thus far for our programs, most especially for IMU-838, and look forward to additional success in 2020."

Recent Highlights

January 2020: Exercised option from Daiichi Sankyo Co., Ltd. for the exclusive worldwide license to a group of compounds, designated by Immunic as IMU-856, aimed at restoring intestinal barrier function.
December 2019: Presented data, for the first time, on IMU-856, at the Crohn’s and Colitis Foundation IBD Innovate Conference. The presentation highlighted preclinical data indicating that the compound potentially restores intestinal barrier function without impairing the immune system. This represents a new and possibly disruptive approach for the treatment of intestinal diseases.
November 2019: Expanded the Board of Directors to seven members with the appointment of biotechnology executive Barclay "Buck" A. Phillips.
October 2019: Expanded the Board of Directors to six members with the appointment of industry veteran Tamar Howson.
October 2019: Announced early completion of patient enrollment (nine months ahead of initial schedule) for the phase 2 EMPhASIS trial of IMU-838, for the treatment of RRMS.
Upcoming Anticipated Clinical Milestones

Top-line data from the phase 2 EMPhASIS trial in RRMS is expected to be available in the third quarter of 2020.
Completion of the preclinical and manufacturing activities that are necessary for the initiation of phase 1 clinical studies of IMU-856 is expected during the first half of 2020.
The current, single ascending dose trial of IMU-935 is planned to be followed by a phase 1 multiple ascending dose trial in healthy volunteers and a phase 1 trial in patients with mild-to-moderate psoriasis; both are expected to start during the first half of this year.
Top-line data from the phase 2 CALDOSE-1 trial in UC is expected to be available during the fourth quarter of 2021.
Financial and Operating Results

Research and Development (R&D) Expenses were $22.5 million for the year ended December 31, 2019, compared to $9.6 million for the same period during 2018, an increase of $12.9 million. The increase is primarily due to (i) higher external development costs for the company’s IMU-838 program for the phase 2 clinical trial in patients with RRMS and UC and preparation costs related to the phase 2 clinical trial for patients with Crohn’s disease totaling $8.3 million, (ii) an increase of drug supply costs to support clinical trials of IMU-838 totaling $1.5 million, (iii) a contingent payment under the asset purchase agreement with 4SC AG settled in stock valued at $1.5 million, (iv) external R&D costs related to the company’s IMU-856 program of $1.1 million and (v) $0.5 million related to increases across numerous categories.
General and Administrative (G&A) Expenses were $14.5 million for the year ended December 31, 2019, compared to $2.4 million for the same period during 2018, an increase of $12.1 million. The increase is primarily due to (i) one-time costs related to the stock-for-stock exchange transaction completed on April 12, 2019 with Vital Therapies, including $6.4 million of stock-based compensation for executives, key employees and members of the board and $1.7 million of investment banking and legal fees, (ii) $2.6 million related to becoming a public company, including directors and officers liability insurance, audit and legal fees and personnel costs for executives and staff in the U.S. corporate headquarters, (iii) $0.5 million related to travel and (iv) $0.9 million related to increases across numerous categories.
Other Income for the year ended December 31, 2019 was $2.1 million compared to $450,000 for the same period of 2018, an increase of $1.6 million. The increase is primarily attributable to a $0.9 million year-over-year increase in reimbursement of research and development expenses in connection with the option and license agreement with Daiichi Sankyo Co., Ltd., the $0.3 million as a result of the sale of certain of Vital Therapies’ clinical development-related assets and related intellectual property, $0.3 million related to research and development tax incentives for clinical trials in Australia and $0.1 million related to interest income.
Net Loss for year ended December 31, 2019 was approximately $34.9 million, or $4.52 per basic and diluted share, based on 7,722,269 weighted average common shares outstanding, compared to a net loss of approximately $11.5 million, or $13.63 per basic and diluted share, based on 846,953 weighted average common shares outstanding for the year ended December 31, 2018. Substantially all of the company’s operating losses resulted from expenses incurred in connection with its R&D programs and from G&A costs associated with operations.
Cash and Cash Equivalents, as of December 31, 2019, of $29.4 million, is expected to fund the company’s operations into the first quarter of 2021.

On March 16, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Leap Therapeutics, MAR 16, 2020, View Source [SID1234555606]).

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Leap Highlights:

·Entered into an exclusive option and licence agreement with BeiGene, Ltd. for the clinical development and commercialization of DKN-01, Leap’s anti-Dickkopf-1 (DKK1) antibody, in Asia (excluding Japan), Australia, and New Zealand
·Completed a $27 million equity financing with BeiGene, Perceptive Advisors, and a lead institutional investor
·Presented final data from its Phase 1/2 clinical trial of DKN-01 plus Keytruda (pembrolizumab) in patients with advanced or recurrent esophagogastric cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Gastrointestinal Cancers Symposium
·Presented updated data from its Phase 2 clinical trial of DKN-01 as monotherapy and in combination with paclitaxel chemotherapy in patients with advanced gynecological malignancies at the 2019 International Gynecologic Cancer Society Annual Global Meeting and at the Society of Gynecologic Oncology 50th Annual Meeting on Women’s Cancer
·Announced investigator-initiated study of DKN-01 in patients with DKK1+ advanced prostate cancer
·Announced investigator-initiated study of DKN-01 plus Opdivo (nivolumab) in patients with advanced biliary tract cancer that is partially supported by Bristol-Myers Squibb
·Announced investigator-initiated study of DKN-01 plus Tecentriq (atezolizumab) in patients with advanced esophagogastric cancer that is funded by Roche

"We ended 2019 having made significant progress in the clinical development of DKN-01 as both a monotherapy and in combination with other therapies as a treatment for cancer. We’ve generated an abundance of data that continues to demonstrate DKN-01’s activity against multiple difficult-to-treat tumor types," said Christopher K. Mirabelli, Ph.D., President and Chief Executive Officer of Leap. "We’ve carried this momentum into the new year, having achieved our top corporate goal of securing a strategic partner for development of DKN-01 in the Asia-Pacific region. We look forward to working with BeiGene to bring DKN-01 to patients in this geographic area where the incidence of esophagogastric cancer is highly prevalent and to develop DKN-01 in combination with tizlelizumab, their anti-PD-1 antibody."

Business Update

·Leap and BeiGene Sign Exclusive Option and License Agreement for DKN-01 – Leap and BeiGene announced an exclusive option and license agreement for the clinical development and commercialization of DKN-01. Under the terms of the agreement, Leap will receive an upfront cash payment of $3 million from BeiGene in exchange for granting BeiGene an option to an exclusive license to develop and commercialize DKN-01 in Asia (excluding Japan), Australia, and New Zealand, and will be eligible to receive an additional payment from BeiGene upon BeiGene’s exercise of the option following initial proof-of-concept studies. Leap will retain exclusive rights for the development, manufacturing, and commercialization of DKN-01 for the rest of the world. Additionally, Leap is eligible to receive payments from BeiGene based upon the achievement of certain development, regulatory, and sales milestones for a total deal value of up to $132 million, together with tiered royalties on any product sales of DKN-01 in the licensed territory.

·Leap Completes $27 Million Equity Financing with BeiGene, Perceptive Advisors and another institutional investor – In connection with the licensing agreement with BeiGene, Leap has also entered into a securities purchase agreement to issue and sell in a private placement 1,421,801 shares of Series A mandatorily convertible preferred stock to a lead institutional investor and 1,137,442 shares of Series B mandatorily convertible preferred stock to BeiGene and Perceptive Advisors. On March 5, 2020, the Leap stockholders approved the conversion of the Series A preferred stock into a pre-funded warrant to purchase 14,413,902 shares of common stock and the conversion of the Series B preferred stock into 11,531,133 shares of common stock. Each investor also received a warrant to purchase an equal number of shares at an exercise price of $2.11 per share.

DKN-01 Clinical Update

DKN-01 is a humanized monoclonal antibody targeting the DKK1 protein, a Wnt pathway modulator. DKN-01, as a single agent, has achieved partial responses in three different cancer indications. In combination with immune checkpoint inhibitors and with chemotherapy, DKN-01 has achieved overall response rates and survival data that is greater than the historical benchmarks, particularly in biomarker targeted patient populations.

·ESOPHAGOGASTRIC CANCER (EGC): Leap completed a multi-part Phase 1/2 clinical study of DKN-01 as a monotherapy and in combination with paclitaxel or KEYTRUDA (pembrolizumab) in advanced EGC. Two DKN-01 monotherapy patients experienced partial responses (PRs) by central imaging assessment, one of whom had previously been treated with prior immunotherapies, including an anti-PD-L1 antibody, was on therapy for one year. Six additional monotherapy patients were determined to have had a best response of stable disease (SD). The combination of DKN-01 and pembrolizumab in gastroesophageal junction cancer (GEJ) and gastric cancer (GC) patients demonstrated improved outcomes in DKK1-high patients and who had not previously been treated with PD-1/PD-L1 therapy. DKK1-high patients experienced over 22 weeks median progression-free survival (PFS) and nearly 32 weeks overall survival (OS), with a 50% overall response rate (ORR) and 80% disease control rate (DCR) in ten evaluable patients. DKK1-low patients experienced nearly 6 weeks median PFS and over 17 weeks OS, with a 20% DCR in 15 evaluable patients.

As part of the collaboration with BeiGene, Leap plans to study the combination of DKN-01 and BeiGene’s anti-PD-1 antibody, tislelizumab and will evaluate approximately 40 DKK1-high patients with second-line GC or GEJ. In addition, Leap plans to evaluate the combination of DKN-01 with tislelizumab and chemotherapy in approximately 20 patients with first-line GC/GEJ. These clinical trials are expected to initiate in the first half of 2020.

·GYNECOLOGICAL CANCERS: The ongoing Phase 2 clinical study of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers has recently completed patient enrollment. As of September 2019, twenty-two patients who had previously received one to ten lines of therapy have been enrolled to receive DKN-01 monotherapy. In the cohort of sixteen monotherapy patients with epithelial endometrial cancer with identified Wnt signaling mutations, one patient had a complete response and one patient had a partial response, seven patients had a best response of SD, and seven patients had progressive disease. Patient follow-up is continuing in this study, which has been expanded to include focused cohorts of patients with carcinosarcoma.

In light of the global emergency of the new coronavirus, COVID-19, the Society of Gynecologic Oncology will not conduct its 2020 Annual Meeting on Women’s Cancer, previously scheduled for March 28-31, 2020, in Toronto, Canada. Leap is currently awaiting additional information about the oral presentation that was to be made at the conference and evaluating other data presentation opportunities for the study in gynecologic cancers.

Selected Year-End and Fourth Quarter 2019 Financial Results

Net loss was $32.9 million for the year ended December 31, 2019, compared to $23.1 million for the year ended December 31, 2018. This increase was primarily due to increased research and development expenses and a change in warrant liability accounting.

Research and development expenses were $24.4 million for the full year 2019, compared to $21.8 million for the same period in 2018. This increase was primarily due to increased full-year clinical trial costs due to increased patient enrollment, payroll and stock-based compensation expense, offset by reduced manufacturing expenses of our clinical product candidates and consulting expenses. Research and development expenses were $5.7 million for the fourth quarter of 2019, compared to $6.9 million for the same period in 2018. This decrease was primarily due to reduced clinical trial costs in the fourth quarter of 2019 resulting from the maturing of our clinical trials and from lower manufacturing and consulting expenses.

General and administrative expenses were $9.1 million for the full year 2019, compared to $8.9 million for the same period in 2018. General and administrative expenses were $2.6 million for the fourth quarter of 2019, compared to $2.1 million for the same period in 2018. These increases were due to increases in performance-based and stock-based compensation expense.

Cash, cash equivalents and marketable securities totaled $3.9 million at December 31, 2019. Research and development incentive receivables totaled $0.2 million. Subsequent to the financial year end, Leap completed a $27.0 million private placement and received $3.0 million from the agreement with BeiGene.

On March 16, 2020 EnGeneIC Limited, a clinical-stage biopharmaceutical company advancing its proprietary EDV nanocell platform for targeted cyto-immunotherapy in cancer, reported that the prestigious peer-reviewed journal Cancer Cell has published a scientific paper, authored by EnGeneIC’s research team, entitled "Cyto-Immuno-Therapy for Cancer: A Pathway Elicited by Tumor-Targeted, Cytotoxic Drug-Packaged Bacterially Derived Nanocell (Press release, EnGeneIC, MAR 16, 2020, View Source [SID1234555622])." The paper describes how the EnGeneIC Dream Vector (EDV) technology stimulates both an innate and an adaptive immune response and creates a dual method of action that could result in long-term survival. Additionally, Cancer Cell will display the EDV’s immunotherapy mechanism of action as this month’s cover art.

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The immuno-oncology field has been focused largely on chimeric antigen receptor T-cell (CAR-T) therapies or checkpoint inhibitors, both designed to enable cytotoxic T-cells to target cancer cells. However, research shows that T-cells are only part of the story. Achieving a robust anti-tumor immune response requires the stimulation of several different types of immune cells. The EnGeneIC research paper describes how the company’s targeted EDV nanocells combine cytotoxicity by virtue of their chemotherapy payload, and at the same time incite a totally novel and more complete anti-tumor immune response. The EDVs stimulate an innate immune response by activating macrophages, natural killer cells and dendritic cells with a subsequent adaptive immune response resulting from recruitment of specific CD8+ tumor killing T-cells into the tumor microenvironment. This work paves the way for treatment of even drug-resistant, end-stage cancers across many tumor types with little or no toxicity, and for a fraction of the cost compared to other immunotherapies capable of treating only a limited number of cancer indications.

Himanshu Brahmbhatt, Ph.D., co-Chief Executive of EnGeneIC and the study’s senior author, stated, "The EnGeneIC team is excited by the publication of its latest scientific paper in Cancer Cell. For the first time, we show that one therapeutic has the ability to carry a toxic payload to kill cancer cells and also jump-start the depleted immune system. This two-prong attack is showing preliminary success in early human trials."

Clinical trials are now underway in Australia evaluating EDV in multiple cancer indications, including pancreatic cancer patients with stage IV disease who have exhausted curative treatment options. The trial also has a second all-comers cohort for patients suffering with a variety of other a late-stage EGFR-expressing solid tumors.

Dr. Brahmbhatt continued, "EDV treatment is not a piecemeal approach to cancer – all the key immune cells required for an assault on the tumor are stimulated. When we depleted each of these cell types, the anti-tumor effect was diminished. As well as delineating the novel mechanism of action in mouse models of cancer, our paper describes two patients who responded with an anti-tumor immune response. We look forward to advancing the development of our EDV nanocell technology platform to bring hope to those patients most in need."

The Cancer Cell article is available to view at the following link: View Source

On March 16, 2020 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has already enrolled seven patients for the compassionate use program for Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, MAR 16, 2020, View Source [SID1234555573]). Results of treatment in this patient group indicate that Namodenoson was found to have a good safety profile and was well tolerated, with no severe adverse events reported. Can-Fite’s compassionate use program is managed by Dr. Salomon Stemmer, a key opinion leader in the field of liver cancer, and Professor at the Institute of Oncology, Rabin Medical Center, Israel.

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The Company also reports that an additional two patients from the former Phase II study are still undergoing Namodenoson treatment, each with an overall survival of more than 2.5 years.

Recently, the Company successfully concluded an End-of-Phase II meeting with the FDA which agreed with Can-Fite’s proposed pivotal Phase III trial design of Namodenoson for the treatment of patients with advanced HCC, with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval. In addition, the Company also submitted a Phase III protocol and Registration Plan to the European Medicines Agency (EMA) for Namodenoson and expects to receive a response from the EMA in the next few weeks. Can-Fite plans to work concurrently with the two agencies, the FDA and EMA, with the expectation to register the drug in parallel upon successful conclusion of the Phase III study.

"We are grateful to Dr. Stemmer for leading this compassionate use program, making Namodenoson available to patients who have exhausted all other treatment options. Based on the encouraging results of our recent Phase II trial, in which Namodenoson demonstrated clinical benefits in patients with underlying CPB7 cirrhosis, Can-Fite is committed to providing Namodenoson to fulfill the unmet medical need in this population," stated Can-Fite CEO Dr. Pnina Fishman.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.