On March 28, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, in collaboration with Mayo Clinic Comprehensive Cancer Center, reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard Esophagus test that is currently in development for the detection of esophageal adenocarcinoma (EAC) and its precursors, including Barrett’s esophagus (BE) (Press release, Exact Sciences, MAR 28, 2024, View Source [SID1234641561]). Findings from the test’s algorithm training and testing were recently published in the Clinical Gastroenterology and Hepatology journal.

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EAC is the most common form of esophageal cancer in the U.S. with incidence having increased significantly over the past few decades compared to other, more common types of cancer where rates have either declined or remained flat due to advanced technologies in screening.3,4 The majority of EAC cases are diagnosed in advanced stages, with early EAC typically having no signs or symptoms, making screening in high-risk populations a critical need.5 There are approximately 30 million people in the U.S. who are at high-risk for EAC and should be screened.6

"Esophageal adenocarcinoma (EAC) is quickly becoming one of the deadliest cancers, with over 80% of patients dying within five years of diagnosis.7 Barrett’s esophagus (BE) is the only known precursor to EAC and patients with BE have an increased risk of progressing to EAC if not caught early. Standard methods of screening can be invasive and costly for patients, which is why there has been a recent push to change the screening guidelines to include non-endoscopic tests," said Prasad G. Iyer, MD, Professor of Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic Comprehensive Cancer Center. "In collaborating with Exact Sciences, we are able to study the potential of a minimally invasive, non-endoscopic screening tool currently in development in patients at higher risk for EAC. Our algorithm training and testing study accomplishes the next critical step for the accurate, non-endoscopic detection of BE/EAC."

The study used an encapsulated sponge collection device to collect esophageal specimens from 352 participants in the training set and 125 participants in the test set. These were then blindly assayed for methylated DNA markers (MDMs). Cross-validation of the three-MDM panel demonstrated an overall sensitivity of 82% (CI, 68% to 94%) for BE detection at 90% specificity (CI, 79% to 98%) in the training set and 88% sensitivity (CI, 78% to 94%) at 84% specificity (CI, 70% to 93%) in the test set. In both training and test sets, sensitivity was 100% for EAC and BE with high grade dysplasia (HGD) – both treatment-eligible subsets. The collection method was generally well tolerated by study participants and was conducive to office-based implementation.

"In esophageal cancer, earlier screening and detection will provide an important advance, as we have seen in other cancers. While many experts recommend that people with chronic reflux disease and at least one other risk factor be screened for Barrett’s esophagus, only a small number of eligible patients undergo screening currently,"8 said Paul Limburg, Chief Medical Officer of Screening, Exact Sciences. "At Exact Sciences, our work has always focused on the latest innovations in screening and testing to help patients and clinicians have accurate, less invasive, and cost-effective options. We are collaborating with Mayo Clinic to continue the development of the Oncoguard Esophagus test as a minimally invasive solution for earlier detection of EAC and its precursors."

The Oncoguard Esophagus test is currently under development and features of the test described above are outlining current development goals. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA) or any other national regulatory authority.

Mayo Clinic and Dr. Iyer have a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

On March 28, 2024 Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, reported that it will showcase significant contributions in preclinical and translational oncology research at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024 meeting (Press release, Crown Bioscience, MAR 28, 2024, View Source [SID1234641560]). Highlighting its latest research, the company will present ten posters covering a broad spectrum of data from the company’s R&D program.

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The data presented will cover a range of innovative techniques in oncology and immuno-oncology drug discovery and development. Posters featured at AACR (Free AACR Whitepaper) include:

The in-depth Characterization of Acute Myeloid Leukemia Patient-Derived Xenograft (PDX) Models with Hotspot Gene Mutations for Therapeutic Evaluation.

The development of an Integrated Pipeline for Immuno-Oncology Drug Testing, using patient-derived tumor organoids with a reconstituted tumor microenvironment and fresh ex vivo patient tissue cultures, aiming to enhance therapeutic evaluation and drug development efficiency with translational patient-derived systems.

The utilization of Large Panel Organoid Drug Testing Combined with Biomarker Analysis, set to deliver insights into mechanisms of action and boost efficiency within the drug development pipeline.

Research on KRAS Inhibitors and PARP Inhibitor-Induced Resistant PDX Ovarian Cancer Models further expands on the knowledge base of drug resistance patterns in cancer while also assessing innovative therapeutic approaches for targeting mutated tumors, including combination therapy.

SynAI, an adaptive AI-driven platform for in silico drug synergism screening, optimizes the exploration of compound interactions in early-stage cancer drug development.

Magnetic Resonance Imaging and Bioluminescence Imaging for Evaluating Tumor Burden in Orthotopic Glioblastoma, merging digital technology with cancer research to forecast a new era of therapeutic strategy development.
Abstracts for all ten poster presentations can be found on a dedicated page, Crown Bioscience AACR (Free AACR Whitepaper) posters 2024. Following the show, all will be available for download.

Attendees are encouraged to visit Booth #1717 to learn more about these studies and talk to Crown Bioscience’s scientists to gain deeper insights into the platforms and services on offer to advance oncology research.

On March 28, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the successful completion of a $101 million placement to institutional investors ("Placement") and the institutional component (the "Institutional Entitlement Offer") of the approximate $20 million pro rata accelerated non-renounceable entitlement offer to existing eligible Clarity shareholders in Australia and New Zealand ("Entitlement Offer") (the Entitlement Offer and the Placement, collectively the "Offer") (Press release, Clarity Pharmaceuticals, MAR 28, 2024, View Source [SID1234641559]).

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The Placement and Institutional Entitlement Offer closed on Tuesday, 26 March 2024. The offer price per new fully paid ordinary share in Clarity ("New Share") to be issued under the Offer is $2.55 per New Share ("Offer Price").

Bell Potter ("Underwriter") is the sole underwriter and is acting as joint lead manager with Wilsons Corporate Finance ("Joint Lead Managers"), with Lander & Rogers the Australian legal adviser.

COMPLETION OF PLACEMENT AND INSTITUTIONAL ENTITLEMENT OFFER
The Placement will result in the issue of approximately 39.5 million New Shares at the Offer Price, raising approximately $101 million. Approximately 3.7 million New Shares will be issued to successful applicants under the Institutional Entitlement Offer at the Offer Price, raising approximately $9 million. The Placement and Institutional Entitlement Offer were well supported by new and existing institutional investors, including specialist healthcare investors.

As outlined in the Company’s announcement on Tuesday, 26 March 2024, funds raised under the Offer will be used to advance Clarity’s clinical portfolio and strengthen its balance sheet. The amounts raised will fund the development of Clarity’s clinical portfolio of products, SAR-bisPSMA, SAR-Bombesin and SARTATE, as the Company progresses towards a number of clinical trial milestones. Please refer to Clarity’s investor presentation for further details.

As a result of the successful completion of the Placement and Institutional Entitlement Offer, Clarity’s ordinary shares (the "Shares") are expected to recommence normal trading on an ex-entitlement basis from the opening of the market on Thursday, 28 March 2024.

New Shares subscribed for under the Institutional Entitlement Offer and Placement are expected to be settled on Friday, 5 April 2024, to be issued and commence trading on ASX on Monday, 8 April 2024. New Shares issued pursuant to the Institutional Entitlement Offer and Placement will rank equally with existing Shares on issue with effect from their date of issue.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented: "It is great to see the incredible response to the capital raising from existing and new shareholders alike, and we thank our shareholders for their continued support in building Clarity into an Australian life sciences success story. The total of $121 million significantly strengthens our balance sheet to over $150 million and allows us to continue to progress all of our products through their respective clinical trials. This is the first capital raising after the completion of the Company’s record $92 million IPO capital raising on the ASX in August 2021 and we are now very well positioned to maximise the value of our Company in what has become one of the most exciting areas of the pharmaceutical industry, radiopharmaceuticals.

"While big pharmaceutical companies are on the hunt for new clinical-stage radiopharmaceutical assets, we continue to differentiate from the current generation of products. What makes Clarity stand out from a myriad of other radiopharmaceuticals is not only the remarkable data on all three of our Targeted Copper Theranostic (TCT) products in clinical development to date, but also TCTs’ ability to resolve the logistical and manufacturing limitations of the current generation of products and expand the field into the large oncology market. TCTs are scalable, sustainable and dependable, removing reliance on the antiquated fleet of nuclear reactors and short shelf life products.

"Once again, we thank our shareholders for their support, and welcome our new shareholders to the Clarity story. We look forward to further updating our shareholders shortly on the continued progress of our therapy and diagnostic programs as we head towards our ultimate goal of better treating children and adults with cancer."

RETAIL ENTITLEMENT OFFER
Eligible Retail Shareholders (defined below) who have a registered address in Australia or New Zealand as at 7.00pm (Sydney time) on Thursday, 28 March 2024 (the "Record Date") are invited to participate in the retail component of the Entitlement Offer at the Offer Price (the "Retail Entitlement Offer").

Eligible Retail Shareholders are shareholders on the Record Date who are already registered as holders of Shares at the Record Date and:

have a registered address on the Clarity register of members which is in Australia or New Zealand;
are not in the United States nor acting for the account or benefit of a person in the United States;
were not invited to participate in the Institutional Entitlement Offer and were not treated as an ineligible institutional shareholder under the Institutional Entitlement Offer (other than as nominee or custodian, in each case in respect of other underlying holdings); and
are eligible under all applicable securities laws to receive an offer under the Retail Entitlement Offer (the "Eligible Retail Shareholders").
The Retail Entitlement Offer will raise up to approximately $11 million. The Retail Entitlement Offer is expected to open on Thursday, 4 April 2024 and close at 5.00pm (Sydney time) on Friday, 19 April 2024 (the "Retail Entitlement Offer Period").

Further information will be sent to Eligible Retail Shareholders via a shareholder letter to be dispatched on or around Thursday, 4 April 2024 and further information will also be available in the offer booklet for the Retail Entitlement Offer (the "Retail Offer Booklet") which is expected to be lodged with ASX and made available on the ASX website (www.asx.com.au) on or around Thursday, 4 April 2024.

The Retail Offer Booklet and accompanying personalised entitlement and acceptance form ("Application Form") will contain instructions for Eligible Retail Shareholders on how they can apply for New Shares as part of the Retail Entitlement Offer.

Application Forms and payments are due by no later than 5.00pm (Sydney time) on Friday, 19 April 2024 unless otherwise extended at the discretion of Clarity’s Board of Directors and in compliance with ASX Listing Rules.

Shortfall
If there is any shortfall under the Retail Entitlement Offer which is not acquired by the Underwriter (i.e. if the Underwriting Agreement were to be terminated), Clarity’s directors reserve the right to place any or all of the shortfall to one or more investors within three months of the closing date of the Retail Entitlement Offer, at the directors’ discretion and at a price not less than the Offer Price.

Indicative Timetable
Event Date (2024)
Results of Placement and Institutional Entitlement Offer announced; Trading Halt ceases 28 March
Record Date for the Retail Entitlement Offer 7.00pm, 28 March
Retail Entitlement Offer materials dispatched to Eligible Retail Shareholders 4 April
Retail Entitlement Offer opens 4 April
Placement and Institutional Entitlement Offer settlement date 5 April
Issue and quotation of New Shares under Placement and Institutional Entitlement Offer 8 April
Retail Entitlement Offer closes (Retail Closing Date) 5:00pm, 19 April
Announcement of results of the Retail Entitlement Offer 24 April
Settlement of New Shares issued under the Retail Entitlement Offer 26 April
Issue of New Shares under the Retail Entitlement Offer 29 April
Quotation and trading commence on a normal settlement basis 30 April
The above timetable is indicative only (except where historical) and subject to change. All times and dates refer to Sydney time. Subject to the ASX Listing Rules, Clarity in conjunction with the Joint Lead Managers reserves the right to vary any or all of these dates, including the Retail Closing Date, without prior notice or consultation with you. Any extension of the Retail Closing Date will have a consequential effect on the anticipated date for issue of the New Shares under the Retail Entitlement Offer. The Directors also reserve the right not to proceed with the whole or part of any of the Offer at any time prior to allotment of the New Shares. In that event, the relevant Application Monies will be returned without interest.

Shareholder Enquiries
Eligible Retail Shareholders who have questions relating to the Retail Entitlement Offer should call Clarity’s share registry, Link Market Services Limited, on 1300 494 861 (within Australia) or + 61 1300 494 861 (from outside Australia) from 8.30am to 5.30pm (Sydney time) Monday to Friday during the Retail Entitlement Offer Period.

Further information in relation to the Placement and the Entitlement Offer is set out in an investor presentation which Clarity filed with the ASX on Tuesday, 26 March 2024. The investor presentation contains important information including key risks and assumptions and foreign selling restrictions with respect to the Placement.

ADDITIONAL INFORMATION
This announcement has been authorised and approved by the Board of Directors of Clarity for lodgement with ASX.

All the amounts are in Australian dollars unless otherwise indicated.

On March 28, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update (Press release, Candel Therapeutics, MAR 28, 2024, View Source [SID1234641558]).

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"2023 was a significant year for Candel with two additional FDA Fast Track Designations for CAN-2409 for non-small cell lung cancer and borderline resectable pancreatic cancer, and most recently Candel received FDA Fast Track Designation for CAN-3110 for recurrent high-grade glioma in February of 2024. We are also excited that initial results in CAN-3110’s ongoing phase 1b clinical trial were published in the high-impact scientific journal, Nature," said Paul Peter Tak, MD PhD FMedSci, President and CEO of Candel. "Further, initial patient data showed improved survival after experimental treatment with Candel’s investigational viral multimodal immunotherapies, as compared to standard of care, in non-small cell lung cancer (CAN-2409), pancreatic cancer (CAN-2409), and high-grade glioma (CAN-3110)."

Dr. Tak continued, "In 2024, we are expecting six data readouts across our three platforms, which include novel clinical and biomarker data in lung cancer, pancreatic cancer, and brain cancer, and a potentially registrational phase 3 clinical trial in prostate cancer. We look forward to sharing additional updates in the year ahead."

Fourth Quarter 2023 & Recent Highlights

o
CAN-2409 – Pancreatic Cancer

▪
Announced initial positive interim data from our randomized phase 2 clinical trial of CAN-2409 in non-metastatic pancreatic cancer which showed prolonged and sustained survival, robust activation of immune response after dosing of CAN-2409, and a favorable tolerability profile.

▪
U.S. Food and Drug Administration (FDA) granted Fast Track Designation for CAN-2409 plus prodrug (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma to improve overall survival (OS).
o
CAN-3110 – Recurrent High-Grade Glioma (HGG)
▪
The results from the ongoing first-in-human phase 1b clinical trial of CAN-3110 in recurrent high-grade glioma, showing extended survival associated with immune activation, were published online on October 18, 2023, in Nature.
▪
FDA granted Fast Track Designation to CAN-3110 for the treatment of patients with recurrent high-grade glioma (HGG) to improve OS.
o
enLIGHTEN Discovery Platform CAN-2409 – Pancreatic Cancer

▪
Presented encouraging preclinical data from the first experimental candidate from its discovery pipeline, Alpha 201-macro-1, at both the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and the International Oncolytic Virus Conference (IOVC) in November 2023. This investigational, locally delivered, biological oncolytic therapeutic, which is designed to interfere with the CD47/SIRP1a pathway, demonstrated better inhibition of tumor growth, when compared to systemic anti-CD47 antibody therapy, in a mouse model of breast cancer.

▪
Announced an upcoming "late-breaking" poster presentation at the 2024 AACR (Free AACR Whitepaper) Annual Meeting unveiling the second drug candidate from the enLIGHTEN Discovery Platform.

Anticipated Milestones

o
New preclinical data on the second drug candidate from the enLIGHTEN Discovery Platform to be presented at the 2024 AACR (Free AACR Whitepaper) Annual Meeting taking place April 5-10, 2024
o
Phase 2 topline OS data for CAN-2409 in NSCLC expected in Q2 2024
o
Phase 2 updated OS data for CAN-2409 in borderline resectable pancreatic cancer expected in Q2 2024
o
Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer expected in Q4 2024
o
Phase 3 topline data for CAN-2409 in localized intermediate/high-risk prostate cancer expected in Q4 2024

Financial Results for the Year and Fourth Quarter Ended December 31, 2023

Research and Development Service Revenue, related party: Research and development service revenue, related party, for each of the quarter and full year ended December 31, 2023 was $0, as compared to $31,000 and $125,000 for the quarter and full year ended December 31, 2022.

Research and Development Expenses: Research and development expenses were $7.3 million for the fourth quarter of 2023 compared to $5.0 million for the fourth quarter of 2022, and $24.5 million for the full year 2023 compared to $20.8 million for the full year 2022. The increase was primarily due to manufacturing and regulatory activities in support of the Company’s CAN-2409 programs, stock compensation costs, and impairment of fixed assets. Research and development expenses included non-cash stock compensation expense of $0.5 million and $1.3 million for the fourth quarter and full year of 2023, respectively, as compared to a non-cash stock compensation expense of $0.2 million and $0.8 million for the fourth quarter and full year of 2022.

General and Administrative Expenses: General and administrative expenses were $3.1 million for the fourth quarter of 2023 compared to $3.2 million for the fourth quarter of 2022, and $13.9 million for the full year 2023 compared to $14.1 million for the full year 2022. The decrease was primarily due to lower insurance and recruiting costs, which were partially offset by increased employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $0.5 million and $1.7 million for the fourth quarter and full year of 2023, respectively, as compared to a non-cash stock compensation expense of $0.4 million and $1.5 million for the fourth quarter and full year of 2022.

Net Loss: Net loss for the fourth quarter of 2023 was $11.1 million compared to a net loss of $5.1 million for the fourth quarter of 2022, and included net other expense of $0.8 million and net other income $3.0 million, respectively. The change from net other income in the fourth quarter of 2022 to net other expense in the fourth quarter of 2023 was primarily related to the change in the fair value of the Company’s warrant liability. Net loss for the full year 2023 was $37.9 million compared to a net loss of $18.8 million for the full year 2022, and included net other income of $0.5 million and $15.9 million, respectively, related primarily to the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents as of December 31, 2023 were $35.4 million, as compared to $70.1 million as of December 31, 2022. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the fourth quarter of 2024.

On March 28, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported financial results and clinical updates for the twelve months ended December 31, 2023 (Press release, Can-Fite BioPharma, MAR 28, 2024, View Source [SID1234641557]).

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Recent Clinical & Development Milestones Achieved

Namodenoson Drug Candidate:

1. Ewopharma recently acquired marketing rights for Namodenoson in the treatment of pancreatic carcinoma This adds up to an out licensing agreement that Can-Fite signed with Switzerland-based Ewopharma in 2021, for exclusive distribution of both Piclidenoson and Namodenoson in Central Eastern European (CEE) countries (Piclidenoson for the treatment of psoriasis and Namodenoson for the treatment of liver cancer and NASH). Under the terms of the distribution agreement, Ewopharma AG paid Can-Fite an upfront payment of US$2.25 million with up to an additional US$40.45 million, payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. Recently, Ewopharma AG exercised its right to expand the distribution agreement to include the indication of pancreatic cancer and the transaction terms of the distribution agreement are applicable to such indication.

2. Can-Fite Broadens its Strong Intellectual Property (IP) for NASH (MASH): Received Patent Allowance in Canada

Can-Fite received a Notice of Allowance from the Canadian Intellectual Property Office for its patent application titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation". This invention addresses the use of Namodenoson for the reduction of liver fat in patients with NASH a clinical indication that is being developed by Can-Fite. In a successfully concluded Phase IIa study, Namodenoson, one of the Company’s two drugs in advanced clinical development, reduced liver fat content, showed anti-inflammatory effects manifested by a significant decrease in the liver enzymes ALT & AST, and decreased body weight in patients with NASH. A Company-sponsored study for Namodenoson for this indication is currently enrolling patients for a Phase IIb study which will include 140 patients, in whom liver pathology is the primary endpoint. Patent has already been issued in other major markets including the U.S., EU, Japan and China.

Piclidenoson Drug Candidate:

Positive Data from the COMFORT-1 Phase III Psoriasis Study Published in a Top Scientific Journal The Journal of the European Academy of Dermatology and Venereology (EADV) published an article titled "Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT-1)". EADV is a top ranked peer reviewed journal (impact factor 9.2) that publishes articles on clinical and basic science topics in dermatology. The article’s first author, Dr. K.A Papp, is an internationally renowned key opinion leader in the psoriasis field and was the engine for some registered drugs on the market for this devastating skin disease. The EADV article presents the safety and efficacy of Piclidenoson in the randomized, placebo- and active-controlled, double-blind Phase III COMFORT-1 trial. As previously reported, the study met its primary endpoint which was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI-75) at Week 16 (3 mg BID dose: PASI 75 rate of 9.7% vs. 2.6% for Piclidenoson vs. placebo, p=0.037). Piclidenoson’s efficacy continued to increase throughout the study period in a linear manner with an excellent safety and tolerability profile. Currently, Piclidenoson is being evaluated in COMFORT-2 a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

"Our advanced-stage pipeline continues to achieve milestones, with Piclidenoson and Namodenoson both positioned as potentially safe and effective treatments for the oncological diseases liver cancer & pancreatic carcinoma and the inflammatory and metabolic diseases psoriasis and NASH. We anticipate additional clinical progress and new out licensing deals in this year," stated Can-Fite CEO Motti Farbstein.

Financial Results

Revenues for the year ended December 31, 2023 were $0.74 million, a decrease of $0.07 million, or 8.6%, compared to $0.81 million for the year ended December 31, 2022. The decrease in revenues was mainly due to the recognition a lower portion of advance payments received under the Ewopharma distribution agreement entered in 2021 and 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 year ended December 31, 2023 were $5.98 million, a decrease of $1.78 million, or 22.9%, compared to $7.76 million for the year ended December 31, 2022. Research and development expenses for the year ended December 31, 2023 comprised primarily of expenses associated with the completion of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for NASH. The decrease is primarily due to a decrease in expenses associated with Piclidenosnon.

General and administrative expenses were $2.95 million for the year ended December 31, 2023 a decrease of $0.19 million, or 6.05%, compared to $3.14 million for the year ended December 31, 2022. The decrease is primarily due to the decrease in directors and officer’s insurance policy premium. We expect that general and administrative expenses will remain at the same level through 2024.

Financial income (expense), net for the year ended December 31, 2023 aggregated $0.56 million compared to financial expense, net of $(0.07) for the year ended December 31, 2022. The decrease in financial expense, net was mainly due to increase interest from deposits and reduction in expenses related to the revaluation of our short-term investment.

Net loss for the year ended December 31, 2023 was $7.63 million compared with a net loss of $10.17 million for the same period in 2022. The decrease in net loss for the year ended December 31, 2023 was primarily attributable to the decrease in research and development expenses and in general and administrative expenses.

As of December 31, 2023, Can-Fite had cash and cash equivalents and short term deposits of $8.90 million as compared to $7.98 million at December 31, 2022. The decrease in cash during the year ended December 31, 2023 is due to the ongoing operations of the Company which was offset by the Company’s financing during January 2023 and exercise of certain warrants during November 2023.

The Company’s consolidated financial results for the year ended December 31, 2023 are presented in accordance with US GAAP Reporting Standards.

More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at View Source as well as via the Company’s investor relations 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 Can-Fite Investor Relations at 26 Ben Gurion Street, Ramat Gan, 5257346, Israel or by phone at +972-3-9241114.