Can-Fite(CANF)
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Can-Fite Granted Brazilian Patent for Treatment of Sexual Dysfunction
Globenewswire· 2025-12-26 12:00
Core Insights - Can-Fite BioPharma Ltd. has received a patent from the Brazilian Patent Office for the use of A3 Adenosine Receptor Agonists in treating sexual dysfunction, enhancing its intellectual property portfolio in a significant pharmaceutical market [1][3] Group 1: Patent and Market Implications - The granted patent provides protection in Brazil for Can-Fite's proprietary A3AR agonists, which is crucial as Brazil is one of the largest pharmaceutical markets in Latin America with increasing demand for innovative sexual health therapies [1][2] - The patent validates the therapeutic versatility of A3 adenosine receptor agonists and may lead to future commercialization opportunities in Latin America [3] Group 2: Company Overview and Drug Development - Can-Fite is an advanced clinical stage drug development company targeting multi-billion-dollar markets in cancer, liver, and inflammatory diseases [4] - The company's lead drug candidate, Piclidenoson, has reported topline results in a Phase III trial for psoriasis and is advancing in other trials for hepatocellular carcinoma and pancreatic cancer [4] - Can-Fite's drug candidate Namodenoson has received Orphan Drug Designation in the U.S. and Europe and is being evaluated in multiple clinical trials [4]
UiPath, Ramaco Resources And 3 Stocks To Watch Heading Into Wednesday - Citius Pharmaceuticals (NASDAQ:CTXR)
Benzinga· 2025-12-24 05:07
Group 1 - UiPath Inc. will join the S&P Midcap 400, replacing Synovus Financial Corp., effective January 2, 2026, leading to a 6.8% increase in shares to $17.05 in after-hours trading [1] - Agios Pharmaceuticals Inc. received FDA approval for AQVESME™ for treating anemia in adults with alpha- or beta-thalassemia, but shares fell 1.4% to $24.59 [1] - Can Fite Biopharma announced a 1-for-3,000 reverse share split, resulting in a 28.8% drop in shares to $0.17 in after-hours trading [1] - Citius Pharmaceuticals reported a quarterly loss of 11 cents per share, better than the expected loss of 43 cents, causing shares to surge 22.1% to $1.27 [1] - Ramaco Resources announced a $100 million stock repurchase plan, leading to a 7.1% increase in shares to $18.09 in after-hours trading [1]
Can-Fite Announces Reverse Split of its Ordinary Shares and ADS Ratio Change
Globenewswire· 2025-12-23 21:46
Core Viewpoint - Can-Fite BioPharma Ltd. has announced a 1-for-3,000 reverse split of its ordinary shares, which will take effect on January 2, 2026, with the first trading of the consolidated shares on January 5, 2026 [1][4]. Share Structure Changes - Each outstanding 3,000 pre-split ordinary shares will combine into one new ordinary share automatically, with no action required from shareholders [2]. - The ratio of ordinary shares underlying the Company's American Depositary Shares (ADSs) will change from 1 ADS representing 300 ordinary shares to 1 ADS representing 2 ordinary shares, effective January 5, 2026 [2][3]. - The total number of outstanding ordinary shares will decrease from 42 billion to 14 million as a result of the reverse split [4]. Impact on ADS Holders - For ADS holders, the ratio change equates to a one-for-twenty ADS split, requiring the exchange of every 20 ADSs for one new ADS [3]. - No fractional new ADSs will be issued; instead, fractional entitlements will be aggregated and sold, with net cash proceeds distributed to ADS holders [6]. Ownership and Voting Power - The reverse split and ADS ratio change will not affect shareholders' percentage ownership or voting power, aside from minimal effects from fractional shares [5]. Market Expectations - The ADS price is expected to increase proportionally due to the change in the ADS ratio, although there is no assurance that the price will be equal to or greater than twenty times the pre-split price [7]. Company Overview - Can-Fite BioPharma Ltd. is focused on developing small-molecule drugs for oncological and inflammatory diseases, with its lead drug candidate, Piclidenoson, in Phase III trials for psoriasis [8]. - The company is also advancing Namodenoson, which is in various stages of trials for liver cancer and has received Orphan Drug Designation in the U.S. and Europe [8].
Can-Fite Provides Update on Clinical and Financial Status
Globenewswire· 2025-12-16 14:19
Core Insights - Can-Fite BioPharma Ltd. is advancing its clinical development activities and financial status, focusing on proprietary small-molecule drugs for oncological and inflammatory diseases [1] Clinical Development - Can-Fite is enrolling patients in a pivotal Phase III clinical study for Namodenoson, targeting advanced hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 liver function, addressing a significant unmet medical need [2] - An interim analysis for the Phase III study of Namodenoson is expected in Q4 2026, with potential eligibility for conditional regulatory approval from the FDA and EMA based on positive results [2] - A Phase IIb clinical study of Namodenoson for metabolic dysfunction-associated steatohepatitis (MASH) is ongoing, following positive Phase IIa trial results [3] - Namodenoson is also being evaluated in a Phase IIa study for pancreatic cancer, with data expected in Q2 2026 [4] - Can-Fite is conducting a pivotal Phase III clinical study for Piclidenoson in psoriasis, with interim analysis data anticipated in Q2 2026 [5] - The company has developed a Phase II study protocol for Lowe Syndrome, planning to submit it to regulatory authorities in Italy and EMA in Q1 2026 [5] Financial Status - As of June 30, 2025, Can-Fite had cash and cash equivalents of $6.45 million, and raised $5 million from a public offering in July 2025, followed by an additional $2.2 million through an ATM facility in November 2025 [6] Company Strategy - The company aims to address significant unmet medical needs with orally administered drug candidates, with ongoing pivotal studies in liver cancer and psoriasis, alongside mid-stage programs in MASH and pancreatic cancer [7] - Can-Fite's lead drug candidate, Piclidenoson, is positioned in multi-billion-dollar markets for cancer, liver, and inflammatory diseases, with a strong safety profile demonstrated in over 1,600 patients [8]
Can-Fite’s Latest Developments of its Advanced Stage Drug Pipeline will be Presented at Noble Capital Markets 21st Annual Emerging Growth Equity Conference
Globenewswire· 2025-11-26 12:00
Core Insights - Can-Fite BioPharma Ltd. is advancing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, with CEO Motti Farbstein scheduled to present at NobleCon21 on December 3, 2025 [1][2] Company Overview - Can-Fite BioPharma Ltd. is an advanced clinical stage drug development company with a platform technology aimed at addressing multi-billion-dollar markets in cancer, liver, and inflammatory disease treatment [4] - The lead drug candidate, Piclidenoson, has reported topline results in a Phase III trial for psoriasis and has commenced a pivotal Phase III trial [4] - The liver drug, Namodenoson, is being evaluated in multiple trials, including a Phase III trial for hepatocellular carcinoma (HCC) and has received Orphan Drug Designation and Fast Track Designation from the U.S. FDA [4] - CF602, the third drug candidate, has shown efficacy in treating erectile dysfunction, with all drugs demonstrating an excellent safety profile in over 1,600 patients [4] Financial Agreements - Can-Fite has secured numerous out-licensing and global distribution agreements valued at up to $130 million for pharmaceutical indications and an additional up to $325 million for veterinary indications [2]
Can-Fite to Advance New Veterinary Partnership Opportunities for Namodenoson at the BioFIT 2025 Conference
Globenewswire· 2025-11-24 12:00
Core Insights - Can-Fite BioPharma is advancing its veterinary oncology pipeline with Namodenoson, a Phase III cancer drug, targeting a market projected to reach $3.1 billion by 2030 [1] - The company is also developing Piclidenoson for osteoarthritis in pets, with clinical studies showing efficacy in dogs, representing a $3 billion market [1] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [4] - The company's lead drug candidate, Piclidenoson, has reported topline results in a Phase III trial for psoriasis and is in a pivotal Phase III trial [4] - Namodenoson is being evaluated in multiple clinical trials, including a Phase III trial for hepatocellular carcinoma and a Phase II study for pancreatic cancer [4] Upcoming Events - Can-Fite will participate in BioFIT 2025, a major European life sciences conference, to explore collaboration opportunities for Namodenoson [1][2] - The company aims to establish a second veterinary partnership focused on Namodenoson during the conference [2] Strategic Partnerships - Previous participation at BioFIT led to a successful partnership with Vetbiolix for Piclidenoson, potentially worth $325 million in royalty revenues for Can-Fite [2] - Can-Fite plans to hold partnering meetings with major animal health companies, including Elanco Animal Health and Zoetis, to discuss collaboration for Namodenoson [3]
Can-Fite's CF602 Erectile Dysfunction Treatment Receives Notice of Patent Allowance in Brazil
Globenewswire· 2025-11-20 12:00
Core Insights - Can-Fite BioPharma's CF602 targets erectile dysfunction (ED) in diabetic patients and non-responders to existing medications, addressing a significant unmet need in a $3.2 billion market [1][2][3] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [1][5] - The company has received a Notice of Allowance for its patent application in Brazil, expanding intellectual property protection for CF602 beyond the U.S. and Europe [2] Market Context - The current ED market is valued at $3.2 billion, with standard treatments like Viagra and Cialis effective for approximately 65%-70% of patients [2] - An estimated 30%-35% of ED patients are non-responders to these treatments, and around 16 million men with diabetes are contraindicated from using them [2] Product Details - CF602 is an A3 adenosine receptor (A3AR) allosteric modulator that enhances receptor activity and avoids desensitization, potentially offering a new treatment option for ED [4] - Preclinical studies indicate that CF602 can improve erectile function and vascular health in diabetic models, showing promise for restoring muscle collagen and endothelial function [3][4] Clinical Development - Can-Fite's lead drug candidate, Piclidenoson, is in Phase III trials for psoriasis, while Namodenoson is being evaluated for hepatocellular carcinoma and other cancers [5] - CF602 is positioned as a third drug candidate with demonstrated efficacy in treating erectile dysfunction [5]
Can-Fite: 9-Year Survival with Complete Cure in an Advanced Liver Cancer Patient Treated with Namodenoson
Globenewswire· 2025-11-18 12:00
Core Insights - Can-Fite BioPharma Ltd. announced a patient treated with Namodenoson has achieved an overall survival of 9 years with a complete response to treatment [1][2] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [1][7] - The company is advancing its lead drug candidate, Namodenoson, which is currently in a pivotal Phase III clinical study for advanced hepatocellular carcinoma (HCC) [3][7] Clinical Development - Namodenoson has shown promising results in a completed Phase II study, with a patient remaining cancer-free for 9 years [2][4] - The drug is being evaluated in multiple clinical trials, including a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH) and a Phase IIa study in pancreatic cancer [6][7] - The U.S. FDA and European Medicines Agency have granted Namodenoson Orphan Drug status and Fast Track status for HCC treatment [3][7] Market Potential - The global market for HCC treatments is projected to reach $6.1 billion by 2027 for the G8 countries, driven by the need for effective and safe treatment options [5] - Liver cancer accounts for over 700,000 deaths globally each year, highlighting the urgent need for new therapies [5] Drug Mechanism - Namodenoson is a small orally bioavailable drug that selectively binds to the A3 adenosine receptor (A3AR), which is highly expressed in diseased cells, contributing to its excellent safety profile [6]
Can-Fite Reports Complete Resolution of Esophageal Varices in Decompensated Cirrhosis Patient Treated with Namodenoson
Globenewswire· 2025-09-15 11:00
Core Insights - Can-Fite BioPharma Ltd. announced a significant clinical finding regarding Namodenoson, which has led to the complete resolution of esophageal varices in a patient with decompensated liver cirrhosis, indicating a potential disease-modifying effect [1][2][3] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [1][8] - The company is currently advancing its lead drug candidate, Namodenoson, which is in a Phase III clinical trial for hepatocellular carcinoma (HCC) and has shown promise in treating other conditions [5][9] Clinical Development - Namodenoson is being evaluated in multiple clinical trials, including a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH) and a Phase IIa study in pancreatic cancer [7][9] - The drug has been granted Orphan Drug Designation in the U.S. and Europe, as well as Fast Track Designation for HCC treatment by the FDA [9] Market Context - In 2017, approximately 10.6 million people globally were affected by decompensated cirrhosis, highlighting the urgent need for effective treatments [6] - The U.S. market for liver cirrhosis treatment is projected to reach around $15 billion by 2030, indicating a significant growth opportunity for Can-Fite's products [6]
Can-Fite(CANF) - 2025 Q2 - Quarterly Report
2025-08-28 12:49
[Condensed Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's financial position shows a decrease in total assets and shareholders' equity, primarily driven by reduced short-term deposits and accumulated deficit [Assets](index=2&type=section&id=Assets) The company's total assets decreased from $9,120 thousand as of December 31, 2024, to $7,720 thousand as of June 30, 2025, primarily driven by a reduction in short-term deposits and cash and cash equivalents | ASSETS (U.S. dollars in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $6,454 | $4,825 | | Short-term investment | $2 | $5 | | Short term deposits | $- | $3,057 | | Prepaid expenses and other current assets | $1,168 | $1,095 | | **Total current assets** | **$7,624** | **$8,982** | | Operating lease right of use assets | $91 | $111 | | Property, plant and equipment, net | $5 | $27 | | **Total non-current assets** | **$96** | **$138** | | **Total assets** | **$7,720** | **$9,120** | - Total assets decreased by **$1,400 thousand (15.3%)** from December 31, 2024, to June 30, 2025[4](index=4&type=chunk) - Short-term deposits decreased significantly from **$3,057 thousand to $0**, while cash and cash equivalents increased by **$1,629 thousand**[4](index=4&type=chunk) [Liabilities and Shareholders' Equity](index=3&type=section&id=Liabilities%20and%20Shareholders'%20Equity) Total liabilities decreased slightly, while shareholders' equity saw a notable reduction, primarily due to the accumulated deficit from net losses, despite increases in additional paid-in capital from share issuances | LIABILITIES AND SHAREHOLDERS' EQUITY (U.S. dollars in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------------------- | :------------ | :---------------- | | Trade payables | $1,152 | $618 | | Current maturity of operating lease liability | $57 | $53 | | Deferred revenues (current) | $405 | $405 | | Other accounts payable | $506 | $976 | | **Total current liabilities** | **$2,120** | **$2,052** | | Long - term operating lease liability | $33 | $51 | | Deferred revenues (non-current) | $1,383 | $1,581 | | **Total long-term liabilities** | **$1,416** | **$1,632** | | **Total liabilities** | **$3,536** | **$3,684** | | Additional paid-in capital | $174,294 | $170,670 | | Accumulated other comprehensive income | $1,127 | $1,127 | | Accumulated deficit | $(171,237) | $(166,361) | | **Total shareholders' equity** | **$4,184** | **$5,436** | | **Total liabilities and shareholders' equity** | **$7,720** | **$9,120** | - Total shareholders' equity decreased by **$1,252 thousand (23.0%)** from December 31, 2024, to June 30, 2025[7](index=7&type=chunk) - Additional paid-in capital increased by **$3,624 thousand**, while the accumulated deficit worsened by **$4,876 thousand**[7](index=7&type=chunk) [Condensed Consolidated Statements of Net Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Net%20Loss) The company reported an increased net loss for the six months ended June 30, 2025, driven by higher operating expenses despite reduced revenues [Operating Results](index=4&type=section&id=Operating%20Results) The company experienced an increased net loss for the six months ended June 30, 2025, compared to the same period in 2024, driven by higher research and development and general and administrative expenses, despite a decrease in revenues | (U.S. dollars in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Revenues | $202 | $316 | | Research and development expenses | $(3,034) | $(2,885) | | General and administrative expenses | $(2,066) | $(1,525) | | Operating loss | $(4,898) | $(4,094) | | Financial income, net | $22 | $137 | | Net loss | $(4,876) | $(3,957) | | Basic and diluted net loss per share | $(0.00) | $(0.00) | | Weighted average number of ordinary shares | 3,411,909,670 | 1,821,304,184 | - Net loss increased by **$919 thousand (23.2%)** from **$3,957 thousand** in H1 2024 to **$4,876 thousand** in H1 2025[9](index=9&type=chunk) - Revenues decreased by **$114 thousand (36.1%)** year-over-year[9](index=9&type=chunk) - Research and development expenses increased by **$149 thousand (5.2%)**, and general and administrative expenses increased by **$541 thousand (35.5%)**[9](index=9&type=chunk) [Condensed Consolidated Statements of Changes in Shareholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity) Total shareholders' equity decreased due to net loss, partially offset by capital raised from various share issuances during the period [Equity Changes](index=5&type=section&id=Equity%20Changes) Total shareholders' equity decreased from $5,436 thousand at January 1, 2025, to $4,184 thousand at June 30, 2025, primarily due to the net loss, partially offset by proceeds from share issuances | (U.S. dollars in thousands) | Ordinary shares (Number) | Additional paid-in capital | Accumulated other comprehensive income | Accumulated deficit | Total shareholders' equity | | :-------------------------- | :----------------------- | :------------------------- | :------------------------------------- | :------------------ | :------------------------- | | Balance as of January 1, 2025 | 2,983,181,793 | $170,670 | $1,127 | $(166,361) | $5,436 | | Net loss | - | - | - | $(4,876) | $(4,876) | | Issuance of ordinary shares and warrants, net | 750,000,000 | $2,548 | | | $2,548 | | Issuance of ordinary shares due to ATM, net | 204,225,600 | $825 | - | - | $825 | | Share-based payments | 30,000,000 | $251 | - | - | $251 | | Balance as of June 30, 2025 | 3,967,407,393 | $174,294 | $1,127 | $(171,237) | $4,184 | - Total ordinary shares outstanding increased significantly from **2,983,181,793** at January 1, 2025, to **3,967,407,393** at June 30, 2025, due to various issuances[12](index=12&type=chunk) - Additional paid-in capital increased by **$3,624 thousand** during the six months ended June 30, 2025, from share issuances and share-based payments[12](index=12&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash and cash equivalents increased significantly, driven by financing activities, which compensated for continued cash usage in operations [Cash Flow Activities](index=6&type=section&id=Cash%20Flow%20Activities) The company's cash and cash equivalents increased significantly in the first half of 2025, primarily due to substantial cash inflows from financing activities, which offset the continued net cash used in operating activities | (U.S. dollars in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(4,752) | $(4,036) | | Net cash provided by investing activities | $2,999 | $4,496 | | Net cash provided by financing activities | $3,373 | $- | | Exchange differences on balances of cash and cash equivalents | $9 | $(19) | | Increase in cash and cash equivalents | $1,629 | $441 | | Cash and cash equivalents at the beginning of the period | $4,825 | $4,278 | | Cash and cash equivalents at the end of the period | $6,454 | $4,719 | - Net cash used in operating activities increased by **$716 thousand (17.7%)** year-over-year[15](index=15&type=chunk) - Net cash provided by financing activities was **$3,373 thousand** in H1 2025, compared to **$0** in H1 2024, primarily from issuance of ordinary shares and warrants[17](index=17&type=chunk) - Cash and cash equivalents at period end increased to **$6,454 thousand** in H1 2025 from **$4,719 thousand** in H1 2024[17](index=17&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations of the company's accounting policies, financial statement line items, and significant events [NOTE 1: General Information and Going Concern](index=8&type=section&id=NOTE%201%3A%20General%20Information%20and%20Going%20Concern) Can-Fite Biopharma Ltd. is a clinical-stage biopharmaceutical company developing small molecule therapeutic products. The company's financial statements are prepared assuming a going concern, despite a history of net losses and negative operating cash flows, which raised substantial doubt. Management's plans to alleviate this doubt include reducing non-essential expenses, deferring R&D programs, and seeking additional financing - Can-Fite Biopharma Ltd. is a clinical-stage biopharmaceutical company focused on developing orally bioavailable small molecule therapeutic products for conditions like psoriasis, liver cancer, MASH, pancreatic cancer, and erectile dysfunction, utilizing the A3AR therapeutic target[19](index=19&type=chunk) - Substantial doubt about the company's ability to continue as a going concern was raised due to net losses of **$4,876 thousand** (H1 2025) and **$3,957 thousand** (H1 2024), net operating cash outflows of **$4,752 thousand** (H1 2025) and **$4,036 thousand** (H1 2024), and reliance on additional financing[20](index=20&type=chunk)[21](index=21&type=chunk) - Management's plans to address going concern include reducing non-essential expenses, deferring/reprioritizing R&D programs, and raising additional funds through equity or debt financings, or strategic partnerships[22](index=22&type=chunk)[25](index=25&type=chunk) [NOTE 2: Significant Accounting Policies](index=10&type=section&id=NOTE%202%3A%20Significant%20Accounting%20Policies) This section details the company's revenue recognition policies, specifically regarding contract balances and remaining performance obligations, and outlines recently issued accounting pronouncements that have not yet been adopted - Contract liabilities, representing amounts received for which revenue has not yet been recognized, amounted to **$1,788 thousand** as of June 30, 2025, down from **$1,986 thousand** as of December 31, 2024[29](index=29&type=chunk) - The aggregate amount of transaction price allocated to remaining performance obligations was **$1,788 thousand** as of June 30, 2025, with **22%** expected to be recognized as revenue over the next 12 months and the remainder over the following 3.5 years[30](index=30&type=chunk) - The company is evaluating the impact of recently issued accounting pronouncements, ASU 2023-09 (Income Taxes) effective January 1, 2025, and ASU 2024-03 (Income Statement - Expense Disaggregation) effective after December 15, 2026[30](index=30&type=chunk)[31](index=31&type=chunk) [NOTE 3: Fair Value Measurements](index=11&type=section&id=NOTE%203%3A%20Fair%20Value%20Measurements) The company measures its short-term investment at fair value, classifying it as Level 1 due to the use of quoted prices in active markets for identical assets - The company's short-term investment, consisting of an equity investment in a publicly traded company, is classified within **Level 1** of the fair value hierarchy[33](index=33&type=chunk) Fair Value Measurements (U.S. dollars in thousands) | Description | Fair value (June 30, 2025) | Level 1 (June 30, 2025) | Fair value (December 31, 2024) | Level 1 (December 31, 2024) | | :------------------ | :------------------------- | :---------------------- | :----------------------------- | :-------------------------- | | Short-term investment | $2 | $2 | $5 | $5 | [NOTE 4: Earnings Per Share](index=11&type=section&id=NOTE%204%3A%20Earnings%20Per%20Share) Basic and diluted net loss per share remained at $(0.00) for both periods, despite a significant increase in the weighted average number of ordinary shares outstanding, as all outstanding share options and warrants were anti-dilutive | (U.S. dollars in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Net loss applicable to shareholders | $(4,876) | $(3,957) | | Weighted average shares used in computing basic and diluted net loss per share | 3,411,909,670 | 1,821,304,184 | | Net loss per share, basic and diluted | $(0.00) | $(0.00) | - The weighted average number of ordinary shares used in computing basic and diluted net loss per share increased by **87.3%** from **1,821,304,184** in H1 2024 to **3,411,909,670** in H1 2025[36](index=36&type=chunk) - All outstanding share options and warrants (excluding prefunded warrants) were excluded from diluted EPS calculation as they were anti-dilutive for both periods[37](index=37&type=chunk) [NOTE 5: Contingent Liabilities and Commitments](index=12&type=section&id=NOTE%205%3A%20Contingent%20Liabilities%20and%20Commitments) The company has a patent license agreement with Leiden University for compounds including CF602, which involves various royalty payments based on milestones, net sales, and sublicensing, with no material accrual recorded as of June 30, 2025 - The company holds an exclusive license from Leiden University for patents of several compounds, including CF602, in certain territories[39](index=39&type=chunk) - Commitments include a one-time **€25 thousand** concession commission, annual royalties of **€10 thousand** until clinical trials commence, **2%-3%** of net sales, and milestone-based royalties up to **€850 thousand** (e.g., **€50k** for Phase I, **€100k** for Phase II, **€200k** for Phase III, **€500k** for marketing approval)[41](index=41&type=chunk) - A **10%** royalty rate applies if the agreement is sublicensed to another company[41](index=41&type=chunk) [NOTE 6: Shareholders' Equity Details](index=13&type=section&id=NOTE%206%3A%20Shareholders'%20Equity%20Details) This section details significant changes in shareholders' equity, including multiple share issuances through registered direct offerings and ATM programs, an increase in authorized share capital, and the adoption of new share option plans, alongside a summary of outstanding warrants - In April 2025, the company completed a registered direct offering of **750,000,000 ordinary shares** at **$0.004 per share**, generating approximately **$3,000 thousand** in gross proceeds, and issued warrants to the placement agent[43](index=43&type=chunk)[44](index=44&type=chunk)[47](index=47&type=chunk) - During January through June 2025, the company issued **204,225,600 ordinary shares** for net proceeds of **$825 thousand** through its ATM program[47](index=47&type=chunk) - The authorized share capital was increased by **10,000,000,000 ordinary shares** on June 30, 2025, bringing the total authorized to **20,000,000,000 ordinary shares**[47](index=47&type=chunk) Share-based expenses recognized (U.S. dollars in thousands) | (U.S. dollars in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Research and development | $30 | $34 | | General and administrative | $221 | $159 | | **Total** | **$251** | **$193** | Outstanding Warrants to Purchase Ordinary Shares (as of June 30, 2025) | Issuance date | Number of outstanding Warrants | Exercise price per warrant | | :------------ | :----------------------------- | :------------------------- | | January 2020 | 23,838,038 | $0.12 | | December 2021 | 10,500,000 | $0.07 | | January 2023 | 28,636,500 | $0.02 | | November 2023 | 771,366,900 | $0.00 | | August 2024 | 1,774,285,800 | $0.01 | | April 2025 | 52,500,000 | $0.01 | | **Total** | **2,661,127,238** | | [NOTE 7: Segment Reporting](index=16&type=section&id=NOTE%207%3A%20Segment%20Reporting) The company operates as a single operating segment, with the CEO serving as the chief operating decision maker who reviews consolidated financial information to allocate resources and assess performance - The company's business is comprised of **one operating segment**[54](index=54&type=chunk) - The Chief Executive Officer (CEO) acts as the chief operating decision maker (CODM) and reviews financial information on a consolidated basis to measure segment profit or loss, allocate resources, and assess performance[54](index=54&type=chunk) [NOTE 8: Subsequent Events](index=17&type=section&id=NOTE%208%3A%20Subsequent%20Events) Subsequent to the balance sheet date, in July 2025, the company completed a public offering, raising significant gross proceeds and issuing ordinary shares, pre-funded warrants, and common warrants, along with incurring issuance costs - On July 28, 2025, the company completed a public offering, raising aggregate gross proceeds of **$5,000 thousand** (approximately **$4,200 thousand** net of issuance costs)[55](index=55&type=chunk) - The July 2025 Offering included the issuance of **375,000,000 ordinary shares**, **7,083,333 pre-funded warrants** (to purchase up to **2,124,999,900 ordinary shares**), and **16,666,666 common warrants** (to purchase up to **4,999,999,800 ordinary shares**)[55](index=55&type=chunk) - The pre-funded warrants are immediately exercisable at a nominal exercise price (**$0.001 per ADS**), and common warrants have an exercise price of **$0.002 per share** (**$0.60 per ADS**) and expire on the two-year anniversary of issuance[56](index=56&type=chunk) - The company incurred an aggregate issuance cost of **$760 thousand** for the July 2025 Offering and issued warrants to the placement agent[57](index=57&type=chunk)