On February 27, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported an update to its financial outlook and raises its 2020 financial guidance (Press release, Ligand, FEB 27, 2020, View Source [SID1234554866]). Ligand now expects 2020 total revenues to be approximately $133 million and diluted EPS to be $3.62, up from previous guidance for total revenues of approximately $128 million and diluted EPS of $3.45. This increase is due to higher material sales of Ligand’s Captisol technology as a result of multiple recent orders for Captisol to be used with the investigational compound remdesivir. Material sales for 2020 are now expected to be approximately $40 million, up from previous guidance of approximately $35 million.

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This updated financial guidance continues to include the contribution from the core assets and business of Icagen, Inc. (Icagen). This acquisition was announced on February 11, 2020, is subject to certain closing conditions, including a vote of Icagen stockholders, and is expected to close in April 2020.

"Ligand’s Captisol technology has enabled several ground-breaking medicines, and we are now seeing partners increase their orders in support of clinical studies of the antiviral drug remdesivir, which is being actively assessed for the treatment of the new strain of the coronavirus, COVID-19," said John Higgins, Chief Executive Officer of Ligand. "We have invested significantly in the Captisol technology and supply chain over the years to enable the development and manufacture of important medicines that address significant medical needs. We stand ready to fulfill additional future orders of Captisol for use in formulating remdesivir, as needed."

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Amgen’s KYPROLIS, Baxter International’s NEXTERONE, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA and Melinta Therapeutics’ BAXDELA and Sage Therapeutics’ ZULRESSO. There are many Captisol-enabled products currently in various stages of development.

On February 27, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the fourth quarter and year ended December 31, 2019 and provided a corporate update (Press release, Jounce Therapeutics, FEB 27, 2020, View Source [SID1234554864]).

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"On the heels of a year of significant clinical progress in 2019, we have set the pace for a robust 2020 with the advancement of our vopratelimab Phase 2 studies, the ongoing EMERGE trial and the upcoming SELECT trial. The recent announcement of the TISvopra biomarker for patient selection in SELECT is a testament to our Translational Science Platform and further emphasizes our vision of bringing the right immunotherapy to the right patients," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "With two of our programs, vopratelimab and JTX-4014, in clinical trials, along with the advancement of our potential first-in-class monoclonal antibody, JTX-1811, into IND enabling activities, we are continuing to establish our differentiated approach to immunotherapy and clinical trial design. We look forward to executing on several key milestones in 2020 across our growing pipeline."

Pipeline Update and Highlights:
Vopratelimab

Established two development paths for vopratelimab program: In early 2019, Jounce announced two development paths for vopratelimab, which are now represented by two distinct and independent Phase 2 clinical trials, EMERGE and SELECT. Both trials are based on the biology related to the pharmacodynamic biomarker, ICOS hi CD4 T cells, which emerge in the blood of patients due to vopratelimab and not PD-1 inhibitors and are associated with clinical benefit.
— Enrollment on track in Phase 2 EMERGE trial: EMERGE trial enrollment in non-small cell lung cancer (NSCLC) remains on track, and Jounce expects to report preliminary efficacy and related biomarker data in the second half of 2020.
— Identified the baseline TISvopra biomarker: In February 2020, Jounce presented new data announcing the identification of the predictive biomarker associated with vopratelimab patient selection, known as TISvopra, which will be used in the upcoming SELECT trial to select patients more likely to develop ICOS hi CD4 T cells and experience clinical benefit in the presence of vopratelimab. The TISvopra biomarker is a baseline RNA signature with a threshold optimized for the prediction of the emergence of ICOS hi CD4 T cells and is expected to predict for both vopratelimab and PD-1 activity.
— Announced trial design for upcoming Phase 2 SELECT trial: In January 2020, Jounce announced the trial design for SELECT, a randomized, ex-U.S. trial that will evaluate vopratelimab and JTX-4014, a PD-1 inhibitor, in patients with second line, PD-1 inhibitor naive NSCLC. Jounce expects to enroll approximately 75 patients, who will be selected using the TISvopra biomarker. Jounce expects to initiate the Phase 2 SELECT trial in mid-2020 and report interim clinical data in 2021.
JTX-4014

Established JTX-4014 as combination agent for Phase 2 SELECT trial: Based on the results of the Phase 1 JTX-4014 trial announced in November 2019, Jounce plans to use JTX-4014 as the PD-1 inhibitor in combination with its other product candidates beginning with the upcoming Phase 2 SELECT trial.
Presented safety and preliminary efficacy data from Phase 1 trial at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting: In November 2019, Jounce presented safety and preliminary efficacy data from the Phase 1 trial of JTX-4014 at SITC (Free SITC Whitepaper) demonstrating anti-tumor activity with an overall RECIST 1.1 response rate of 16.7% (3/18), one complete response, two partial responses and a disease control rate of 44.4% (8/18) in patients with advanced refractory solid tumor malignancies and an average of over four lines of prior therapies. JTX-4014 was found to have an acceptable safety profile in this trial.
JTX-1811

Named JTX-1811 as next development candidate from Translational Science Platform: In December 2019, JTX-1811 was selected as the next development candidate to emerge from Jounce’s Translational Science Platform. JTX-1811 is a monoclonal antibody designed to selectively deplete immuno-suppressive T regulatory cells. Jounce will present additional preclinical data at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and expects to file an Investigational New Drug (IND) application in the first half of 2021.
Research Collaborations and Partnerships:

Established research collaboration with NanoString Technologies to support the application of TISvopra in Phase 2 SELECT trial: In January 2020, Jounce entered into a new research collaboration with NanoString Technologies for the application of the TISvopra biomarker, including the optimized selection threshold in the SELECT trial. The TISvopra clinical trial assay will be implemented on the nCounter Dx Analysis System.
Updated strategic collaboration with Celgene Corporation: In July 2019, Jounce and Celgene entered into a mutual agreement to terminate their broad strategic collaboration established in 2016. As a result, Jounce owns all global rights to its current pipeline, including vopratelimab, JTX-4014, JTX-1811 and all discovery-stage assets. Separately, Celgene obtained exclusive worldwide licensing rights to JTX-8064, a potential first-in-class antibody that targets the LILRB2 receptor on macrophages. Under the terms of the new license agreement, Jounce received a $50.0 million non-refundable license fee and is eligible to receive up to $480.0 million from Celgene in development, regulatory and commercial milestone payments, as well as royalties from potential worldwide sales.
Fourth Quarter and Full Year 2019 Financial Results:

Cash position: As of December 31, 2019, cash, cash equivalents and investments were $170.4 million, compared to $195.9 million as of December 31, 2018. The decrease in cash, cash equivalents and investments was primarily due to operating costs incurred during the year, offset by the $50.0 million license fee received in July 2019 pursuant to Jounce’s JTX-8064 license agreement with Celgene.
License and collaboration revenue: No license and collaboration revenue was recognized during the fourth quarter of 2019, compared to $20.1 million for the same period in 2018. License and collaboration revenue was $147.9 million for the full year 2019, compared to $65.2 million for the full year 2018. License and collaboration revenue recognized during 2019 was comprised of $50.0 million of cash revenue related to Jounce’s JTX-8064 license agreement with Celgene and $97.9 million of non-cash revenue recognition relating to the $225.0 million upfront payment received from Celgene in July 2016. License and collaboration revenue recognized during 2018 was comprised solely of non-cash revenue recognition related to the July 2016 upfront payment.
Research and development expenses: Research and development expenses were $16.6 million for both the fourth quarter of 2019 and 2018. Research and development expenses were $67.1 million for the full year 2019, compared to $70.1 million for the full year 2018. The decrease in research and development expenses for the full year 2019 was primarily due to $6.0 million of decreased manufacturing and IND-enabling expenses as well as $0.9 million of decreased lab consumable costs. These decreases were partially offset by $3.1 million of increased employee compensation costs.
General and administrative expenses: General and administrative expenses were $6.9 million for the fourth quarter of 2019, compared to $6.6 million for the same period in 2018 and $27.9 million for the full year 2019, compared to $26.4 million for the full year 2018. The increase in general and administrative expenses for both the fourth quarter of 2019 and the full year 2019 was primarily attributable to increased employee compensation costs.
Net (loss) income: Net loss was $22.7 million for the fourth quarter of 2019, or a basic and diluted net loss per share of $0.68. Net loss was $2.0 million for the same period in 2018, or a basic and diluted net loss per share of $0.06. Net income was $56.8 million for the full year 2019, resulting in basic net income per share of $1.72 and diluted net income per share of $1.66. Net loss was $27.4 million for the full year 2018, or a basic and diluted net loss per share of $0.84. Net income recognized for the full year 2019 was primarily attributable to $147.9 million of license and collaboration revenue recognized under Jounce’s agreements with Celgene.
Financial Guidance:
Based on its current operating and development plans, Jounce expects gross cash burn on operating expenses and capital expenditures for the full year 2020 to be approximately $80.0 million to $95.0 million. Jounce will no longer provide license and collaboration revenue guidance as potential future payments under the JTX-8064 license agreement with Celgene are royalty- and milestone-based.

Given the strength of its balance sheet, Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the end of 2021.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 7889239. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

On February 27, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported operational highlights and financial results for the fourth quarter and year ended December 31, 2019 (Press release, Intellia Therapeutics, FEB 27, 2020, View Source [SID1234554863]).

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"In 2019, we advanced our full-spectrum strategy, guiding both our in vivo and ex vivo lead programs toward the clinic. We also continued to build on our genome editing and delivery capabilities to enable a rapid succession of candidates," said Intellia President and Chief Executive Officer, John Leonard, M.D. "We are off to a productive start in 2020. We announced the nomination of NTLA-5001, a WT1-directed TCR-T cell therapy for the treatment of AML, and plan to select our third development candidate in the first half of this year, which will be for the treatment of HAE. In addition, in the second half of the year, we expect to begin dosing ATTR patients with NTLA-2001, a potential single-course treatment for ATTR patients. This is anticipated to be the first-ever systemically delivered CRISPR/Cas9-based therapy to enter the clinic, representing an important milestone in our mission to deliver potentially curative therapies from our proprietary modular platform."

2019 and Recent Operational Highlights

ATTR Program: Intellia remains on track to submit an investigational new drug (IND) application in mid-2020 for its lead in vivo candidate, NTLA-2001, for the treatment of transthyretin amyloidosis (ATTR). In December 2019, Intellia completed a 12-month durability study of its lead lipid nanoparticle (LNP) formulation in support of NTLA-2001, maintaining an average reduction of >95% of serum transthyretin (TTR) protein and sustained liver genome editing after a single dose in non-human primates (NHPs). NTLA-2001 is anticipated to be the first systemically delivered CRISPR/Cas9 therapy to enter the clinic, and Intellia expects to dose the first patients in the second half of 2020. NTLA-2001 is part of a co-development/co-promotion (Co/Co) agreement between Intellia, which is the lead development and commercialization party, and Regeneron Pharmaceuticals, Inc. (Regeneron).
AML Program: In January 2020, Intellia announced NTLA-5001 as its first engineered T cell therapy development candidate for the treatment of acute myeloid leukemia (AML). NTLA-5001 utilizes a T cell receptor (TCR)-directed approach to target the Wilms’ Tumor 1 (WT1) intracellular antigen to develop a broadly applicable treatment for AML patients, regardless of mutational background of a patient’s leukemia. At the recent Keystone Symposia’s Engineering the Genome Conference, the Company presented data in support of NTLA-5001, demonstrating that the selection of a naturally-occurring, high-affinity TCR, in combination with Intellia’s CRISPR-enabled engineering and targeted insertion, results in an engineered T cell capable of specific and potent killing of primary AML blasts. Importantly, data presented showed that CRISPR-enabled engineering overcomes certain key challenges of traditional TCR approaches, such as mispairing between therapeutic and endogenous TCR, therefore creating a more homogenous T cell product. The engineered T cell carrying the therapeutic TCR also exhibited no detectable off-target reactivity to bone marrow cells. The Company plans to submit an IND application for NTLA-5001 in the first half of 2021. Additional efforts are underway to evaluate the potential use of the WT1-directed TCR construct to treat other tumor types, including solid tumors.
HAE Program: In January 2020, Intellia announced hereditary angioedema (HAE) as its third development program. Building on the modular LNP delivery platform developed in the ATTR program, the Company aims to knock out the kallikrein B1 (KLKB1) gene with a single course of treatment to reduce the spontaneous activation of biological pathways responsible for generating bradykinin and thereby ameliorate the frequency and intensity of HAE attacks. At the recent Keystone Conference, the Company reported results from an ongoing NHP study, which demonstrated a 90% reduction in kallikrein activity sustained for at least five months following a single dose. The reduction of kallikrein activity observed in this study corresponds to the reduced enzymatic levels in patients that meaningfully impact HAE attack rates (Source: Banerji et al., NEJM, 2017). Intellia expects to select its development candidate in the first half of 2020. Intellia’s KLKB1 HAE program is subject to an option by Regeneron to enter into a Co/Co agreement prior to the initiation of IND-enabling studies, with Intellia as the lead party.
Modular Platform: Intellia continued to progress differentiated genome editing and delivery strategies, including targeted insertion and consecutive editing, across its in vivo and ex vivo efforts. These platform capabilities enable the removal and/or restoration of a gene’s function in developing treatments for life-threatening diseases. In 2019, the Company demonstrated the first CRISPR-mediated, targeted transgene insertion in the liver of NHPs. The targeted insertion of the Factor 9 gene generated circulating human Factor IX protein at or above normal levels. Additionally, Intellia presented the first demonstration of a consecutive in vivo gene knockout followed by a targeted insertion in an alpha-1 antitrypsin deficiency (AATD) mouse model. The consecutive edits led to >98% reduction of the disease-causing protein and sustained restoration of the normal protein to therapeutically relevant circulating levels throughout the study. The Company continues to advance these platform capabilities and leverage them to develop the next wave of in vivo and ex vivo clinical candidates.
Board of Directors Update: Dr. Frank Verwiel was elected Chairman of the Board of Directors in February 2020, succeeding Perry Karsen, who will remain a member of the Board.
Upcoming Milestones

The Company has set forth the following for pipeline progression:

ATTR:
Submit IND application for NTLA-2001 in mid-2020
Dose first patients in 2H 2020
AML:
Submit IND application for NTLA-5001 in 1H 2021
HAE:
Nominate a development candidate in 1H 2020
R&D Advancements:
Present preclinical data at upcoming scientific conferences in 2020
Upcoming Event

The Company will participate in the following investor event during the first quarter of 2020:

Barclays Capital Global Healthcare Conference, March 10, Miami
Fourth Quarter and Full Year 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $284.5 million as of December 31, 2019, compared to $314.1 million as of December 31, 2018. The decrease was driven by cash used to fund operations of approximately $124.9 million, which was offset in part by $72.3 million of net equity proceeds raised from the Company’s "At the Market" (ATM) offerings, $9.0 million of funding received under the Novartis collaboration, $9.9 million of ATTR cost reimbursements made by Regeneron, and $4.2 million in proceeds from employee-based stock plans.
Collaboration Revenue: Collaboration revenue increased by approximately $3.1 million to $10.9 million during the fourth quarter of 2019, compared to $7.9 million during the fourth quarter of 2018. The increase in collaboration revenue in 2019 was primarily driven by amounts recognized under the Company’s ATTR Co/Co agreement with Regeneron. As previously disclosed, Regeneron funded approximately 50% of the development costs for the ATTR program throughout 2019. Starting in June 2020, Regeneron will share approximately 25% of worldwide development costs and commercial profits for the ATTR program.
R&D Expenses: Research and development expenses increased by $11.8 million to $31.7 million during the fourth quarter of 2019, compared to $19.9 million during the fourth quarter of 2018. This increase was mainly due to IND-enabling activities for NTLA-2001, research efforts supporting the selection of NTLA-5001 and the expansion of the Company’s research and development team.
G&A Expenses: General and administrative expenses increased by $0.3 million to $9.0 million during the fourth quarter of 2019, compared to $8.7 million during the fourth quarter of 2018. This increase was driven primarily by employee-related expenses.
Net Loss: The Company’s net loss was $28.3 million for the fourth quarter of 2019, compared to $19.1 million during the fourth quarter of 2018.
Financial Guidance

Intellia expects that its cash, cash equivalents and marketable securities as of December 31, 2019 will enable the Company to fund its anticipated operating expenses and capital expenditure requirements at least through the end of 2021. This expectation excludes any strategic use of capital not currently in the Company’s base-case planning assumptions.

Conference Call to Discuss Fourth Quarter and Full Year 2019 Earnings

The Company will discuss these results on a conference call today, February 27, 2020, at 8 a.m. ET.

To join the call:

U.S. callers should dial 1-877-317-6789 and use conference ID# 10138773, approximately five minutes before the call.
International callers should dial 1-412-317-6789 and use conference ID# 10138773, approximately five minutes before the call.
A replay of the call will be available through the Events and Presentations page of the Investor Relations section on Intellia’s website, beginning on February 27, 2020 at 12 p.m. ET.

On February 27, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has entered into a common stock purchase agreement (the "Agreement") of up to $30 million with Aspire Capital Fund, LLC ("Aspire Capital") (Press release, Curis, FEB 27, 2020, View Source [SID1234554861]).

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Under the terms of the Agreement, Aspire Capital has made an initial investment of $3 million via purchase of 2,693,965 common shares of Curis. In addition, Aspire Capital has committed to purchasing up to $27 million of common shares of Curis, at Curis’ request from time to time during a 30-month period at prices based on the market price at the time of each sale, subject to certain limits. There are no warrants, derivatives, or other share classes associated with this Agreement. Curis will control the timing and amount of the further sale of its common shares to Aspire Capital.

"We are excited to enter into this transaction with Aspire Capital, a long-term, healthcare-focused institutional investor," said James Dentzer, President and Chief Executive Officer of Curis. "This facility is expected to provide us with a flexible, efficient capital source to advance the clinical development of our novel, targeted cancer therapeutics, including fimepinostat, a small molecule dual inhibitor of PI3K/HDAC and suppressor of MYC; CA-4948, an IRAK4 kinase inhibitor and first in class suppressor of the TLR pathway and CI-8993, a first in class VISTA antagonist."

"Curis’ pipeline of novel, targeted cancer therapies and immunotherapies, bolstered by the recent addition of CI-8993, addresses therapeutics areas with significant unmet medical need and patient burden," stated Steven G. Martin, Managing Member of Aspire Capital Partners, LLC. "Aspire is pleased to support Curis at this transformational time and looks forward to this long-term partnership with the Curis team."

Proceeds will be used by Curis for general corporate purposes, including research and development, clinical trial activity and working capital. There are no restrictions on future financings and there are no financial covenants, participation rights, rights of first refusal, or penalties in the Agreement. Curis has the right to terminate the Agreement at any time without any additional cost or penalty.

As consideration for Aspire Capital’s obligation under the Agreement, Curis issued 646,551 common shares to Aspire Capital as a commitment fee. Curis also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the Agreement. A complete and detailed description of the Agreement and the related Registration Rights Agreement is set forth in Curis’ Current Report on the Form 8-K filed today with the U.S. Securities and Exchange Commission (SEC).

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On February 27, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biopharmaceutical company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported new pre-clinical findings in connection with its on-going collaboration with Univo Pharmaceuticals (TASE:UNVO), demonstrating CBD’s robust anti-neoplastic effect in pre-clinical studies against liver cancer (Press release, Can-Fite BioPharma, FEB 27, 2020, View Source [SID1234554860]). The studies were carried out on human liver cancer cells and utilized cannabinoid fractions enriched for CBD, in nano and pico molar concentrations. Marked inhibition of Hep-3b, liver cancer cell proliferation was noted and was mediated via the A3 adenosine receptor, the target of Can-Fite’s drug platform.

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Can-Fite is greatly encouraged and sees clinical potential in treating patients with minute CBD dosages which are effective and at the same time may minimize potential adverse effects. Based on this approach, an expansion of the agreement with Univo Pharmaceuticals has been entered into to allow the testing of minute CBD concentrations/dosages in combination with Namodenoson on liver cancer and additional oncological indications. As part of the expansion, Can-Fite will fund the research and development activities for the two new indications, to be jointly performed, for an amount of US$200,000 per indication.

Dr. Michael Silverman, M.D., Can Fite Medical Director, commented on the new findings, "Many of the liver cancer patients are already treated with cannabinoids for management of constitutional symptoms such as anorexia, nausea, and fatigue. These novel findings of anti-cancer cell effects found with minute dosages of CBD may open up new avenues of utilizing cannabinoids to treat cancer patients while minimizing adverse effects."

According to Adroit Market Research, the medical cannabis market is projected to grow at a CAGR of 29% to $56.7 billion by 2026.