Core Insights - Chemomab Therapeutics is advancing its clinical-stage monoclonal antibody, nebokitug (CM-101), as a potential treatment for systemic sclerosis (SSc), a severe autoimmune disease lacking approved therapies [1][3][12] - New data supporting nebokitug's efficacy will be presented at the CORA 2025 conference, reinforcing its role in targeting CCL24, a key driver of SSc pathology [1][6][12] Company Overview - Chemomab Therapeutics is focused on developing innovative therapeutics for fibro-inflammatory diseases, with nebokitug being a first-in-class dual activity monoclonal antibody that neutralizes CCL24 [12] - The company has received FDA and EMA Orphan Drug designations for nebokitug in the treatment of primary sclerosing cholangitis (PSC) and systemic sclerosis, along with FDA Fast Track status for PSC [12] Disease Context - Systemic sclerosis (SSc) is characterized by extensive tissue fibrosis and microvascular injury, making it one of the most lethal systemic connective tissue diseases, with no approved disease-modifying therapies available [2][8] - Current estimates suggest approximately 100,000 SSc patients in the U.S., predominantly affecting women aged 30 to 50 [8] Clinical Evidence - Extensive preclinical studies indicate that blocking CCL24 with nebokitug reduces inflammatory and fibrotic injuries associated with SSc, including lung, skin, and vascular damage [2][3] - A recent peer-reviewed study found that higher serum CCL24 levels correlate with severe SSc manifestations and predict pulmonary function deterioration [4] Ongoing Research - The upcoming presentation at CORA 2025 will detail a study assessing nebokitug's effects on immune cells in SSc, further validating the therapeutic rationale for targeting CCL24 [3][6] - Positive results from the Phase 2 SPRING trial in PSC have strengthened the rationale for evaluating nebokitug in SSc, demonstrating its dual anti-inflammatory and anti-fibrotic mechanisms [5][12]

Core Insights - Chemomab Therapeutics has successfully completed an FDA End-of-Phase 2 meeting, establishing a clear pathway for potential regulatory approval of nebokitug for the treatment of primary sclerosing cholangitis (PSC) without the need for liver biopsies or confirmatory studies [1][4][3] - The company is on track to release clinical data from the SPRING trial open label extension in the first quarter of 2025, and discussions with potential strategic partners are ongoing [1][5][3] Clinical Development - The Phase 2 SPRING trial for nebokitug demonstrated a favorable safety profile and met its primary endpoint, with significant improvements in multiple secondary efficacy endpoints for patients with moderate/advanced PSC [3][4][7] - The FDA has aligned with Chemomab on a single pivotal Phase 3 trial design that focuses on clinical event-driven endpoints, which is expected to streamline the regulatory approval process [3][4][5] Financial Performance - For the full year ended December 31, 2024, Chemomab reported a net loss of $13.9 million, a decrease from a net loss of $24.2 million in 2023 [11][18] - Research and development expenses for 2024 were $11.3 million, down from $18.4 million in 2023, reflecting reduced clinical costs as the Phase 2 trial neared completion [8][11] Cash Position - As of December 31, 2024, Chemomab had cash, cash equivalents, and short-term bank deposits totaling $14.3 million, down from $19.9 million at the end of 2023, with a cash runway expected to last through the first quarter of 2026 [6][11] Strategic Outlook - The company is actively assessing various strategic paths forward and has received interest from potential partners following the positive FDA meeting [3][5] - Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations, positioning it as a promising candidate for addressing the unmet needs in PSC treatment [13]

Core Insights - Chemomab Therapeutics has successfully aligned with the FDA on a single Phase 3 registration study for its lead product candidate, nebokitug, aimed at treating primary sclerosing cholangitis (PSC) [2][3] - The Phase 3 trial design provides regulatory clarity and eliminates the need for liver biopsies or additional confirmatory studies, focusing on clinically relevant endpoints associated with PSC disease progression [3][5] - Nebokitug is a first-in-class dual activity monoclonal antibody that neutralizes CCL24, showing promise in treating PSC and other fibro-inflammatory diseases [7][11] Group 1: Trial Design and Objectives - The Phase 3 trial is a randomized placebo-controlled study with a 2:1 active to placebo ratio, enrolling approximately 350 PSC patients [6] - The primary endpoint is the time-to-first clinical event, which includes various adverse events related to PSC progression, such as acute cholangitis and liver transplantation [6][4] - The trial aims to collect sufficient clinical events to demonstrate statistically significant changes between treatment and placebo arms, with an estimated two-year timeline for participants to experience a clinically meaningful event without intervention [6][4] Group 2: Regulatory and Strategic Developments - The FDA's agreement on the trial design marks a significant milestone, providing a streamlined path to potential full regulatory approval based on a single pivotal trial [3][5] - The company is actively engaging with potential strategic partners while preparing for the Phase 3 program, which could launch before the end of the year [3][5] - The trial's design is similar to oncology registration trials, focusing on disease progression-related events, which may allow for broader labeling compared to symptom-related endpoints [5][6] Group 3: Clinical Background and Need - PSC is a rare and debilitating liver disease with no FDA-approved therapies, affecting an estimated 30,000 patients in the U.S. and 80,000 worldwide [8] - The disease is characterized by inflammation and fibrosis of the bile ducts, leading to severe complications such as liver failure and increased cancer risk [8] - There is a high unmet medical need for effective treatments to address PSC symptoms and slow disease progression, highlighting the importance of nebokitug's development [8][11]

Core Insights - Chemomab Therapeutics Ltd. is a clinical stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases with high unmet need [3] - The company will present at the virtual Oppenheimer 35 Annual Healthcare Life Sciences Conference on February 11, 2025, with a live webcast available for 90 days [1][2] Company Overview - Chemomab is developing CM-101, a first-in-class dual activity monoclonal antibody that neutralizes the soluble protein CCL24, which plays a role in fibrosis and inflammation [3] - CM-101 has shown a favorable safety profile and potential to treat multiple severe fibro-inflammatory diseases, with positive results reported from four clinical trials [3] - The company anticipates achieving a clear FDA registrational pathway for the planned Phase 3 pivotal trial of CM-101 in primary sclerosing cholangitis (PSC) and reporting data from the SPRING trial open label extension in early 2025 [3] - CM-101 has received FDA and EMA Orphan Drug and FDA Fast Track designations for PSC treatment [3] - The program for systemic sclerosis treatment is Phase 2-ready with an open U.S. IND [3]

Core Insights - Chemomab Therapeutics Ltd. announced positive results from its Phase 2 SPRING trial for CM-101 in patients with primary sclerosing cholangitis (PSC), demonstrating anti-fibrotic, anti-inflammatory, and anti-cholestatic activity [1][5][6] Study Details - The Phase 2 SPRING trial involved 76 PSC patients receiving two doses of CM-101 (10 mg/kg and 20 mg/kg) every three weeks for 15 weeks [3] - The trial included a double-blinded, placebo-controlled design, focusing on patients who completed all doses and the week 15 visit [2][3] Efficacy and Safety - CM-101 met its primary endpoint with a favorable safety profile, showing mild to moderate adverse events similar to the placebo group [4] - Significant improvements were observed in liver stiffness, ELF scores, PRO-C3 levels, liver biochemistries, total bilirubin levels, and pruritus scores in CM-101 treated patients compared to placebo [4][5] Future Development - Chemomab plans to advance CM-101 into a registrational trial and expects to meet with the FDA by the end of 2024 to discuss the trial design [6][7] - An open-label extension of the Phase 2 SPRING trial is ongoing, with results anticipated in the first quarter of 2025 [7] Company Background - Chemomab is a clinical-stage biotechnology company focused on developing therapeutics for fibroinflammatory diseases, with CM-101 being a first-in-class monoclonal antibody targeting CCL24 [9] - The company has received FDA and EMA Orphan Drug designations and FDA Fast Track status for CM-101 in PSC [9]

Group 1 - Chemomab Therapeutics reported earnings per share of -26 cents for the second quarter of 2024 [1] - The company did not report any revenue for the quarter [1]

[Interim Condensed Consolidated Financial Statements](index=1&type=section&id=Interim%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited interim condensed consolidated financial statements and their accompanying notes [Interim Condensed Consolidated Balance Sheets](index=2&type=section&id=Interim%20Condensed%20Consolidated%20Balance%20Sheets) The balance sheet reflects a decrease in total assets and shareholders' equity by June 30, 2024, primarily driven by reduced cash and accumulated deficit Consolidated Balance Sheet Highlights (in USD thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 5,036 | 9,292 | | Total current assets | 13,455 | 20,897 | | Total assets | 14,544 | 22,151 | | **Liabilities & Equity** | | | | Total current liabilities | 4,308 | 4,838 | | Total liabilities | 4,559 | 5,154 | | Accumulated deficit | (96,177) | (88,678) | | Total shareholders' equity | 9,985 | 16,997 | | **Total liabilities and shareholders' equity** | **14,544** | **22,151** | - The number of authorized ordinary shares increased from **650,000,000** to **4,650,000,000** between December 31, 2023, and June 30, 2024, with issued and outstanding shares also increasing from **284.1 million** to **287.2 million**[2](index=2&type=chunk) [Interim Condensed Consolidated Statements of Operations](index=5&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Operations) The company significantly reduced its net loss for the six months ended June 30, 2024, primarily driven by substantial decreases in operating expenses Statement of Operations Summary (in USD thousands) | Metric | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | | Research and development | 6,080 | 11,907 | | General and administrative | 1,736 | 5,337 | | **Total operating expenses** | **7,816** | **17,244** | | Net loss for the period | 7,499 | 16,723 | | Basic and diluted loss per Ordinary Share | $0.026 | $0.076 | Quarterly Statement of Operations Summary (in USD thousands) | Metric | Three months ended June 30, 2024 | Three months ended June 30, 2023 | | :--- | :--- | :--- | | Research and development | 2,928 | 5,020 | | General and administrative | 840 | 3,175 | | **Total operating expenses** | **3,768** | **8,195** | | Net loss for the period | 3,631 | 7,970 | | Basic and diluted loss per Ordinary Share | $0.013 | $0.036 | [Interim Condensed Consolidated Statements of Changes in Equity](index=6&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) Shareholders' equity decreased significantly in the first half of 2024, primarily due to the net loss, partially offset by share-based compensation and issuances Changes in Equity for Six Months Ended June 30, 2024 (in USD thousands) | Description | Amount | | :--- | :--- | | Balance as of January 1, 2024 | 16,997 | | Share-based compensation | 355 | | Issuance of shares | 132 | | Net loss for the period | (7,499) | | **Balance as of June 30, 2024** | **9,985** | Changes in Equity for Six Months Ended June 30, 2023 (in USD thousands) | Description | Amount | | :--- | :--- | | Balance as of January 1, 2023 | 36,223 | | Share-based compensation | 1,123 | | Issuance of shares, net | 1,368 | | Net loss for the period | (16,723) | | **Balance as of June 30, 2023** | **21,991** | [Interim Condensed Consolidated Statements of Cash Flow](index=8&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flow) Operating cash outflow significantly decreased for the six months ended June 30, 2024, with overall cash and equivalents declining to **$5.1 million** Cash Flow Summary (in USD thousands) | Cash Flow Activity | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | (7,191) | (14,672) | | Net cash provided by investing activities | 2,801 | 10,164 | | Net cash provided by financing activities | 132 | 1,368 | | **Decrease in cash, cash equivalents and restricted cash** | **(4,258)** | **(3,140)** | | Cash, cash equivalents and restricted cash at end of period | 5,110 | 10,456 | [Notes to the Interim Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Interim%20Condensed%20Consolidated%20Financial%20Statements) These notes provide essential context to the financial statements, detailing the company's operational status, accounting policies, contingencies, and subsequent financing events [Note 1 - General](index=9&type=section&id=Note%201%20-%20General) This note outlines Chemomab's status as a clinical-stage biotech, its reliance on shareholder funding, and its projected cash runway through early 2026 - The company is a clinical-stage biotech without approved products and relies on shareholder funding for its operations[14](index=14&type=chunk)[15](index=15&type=chunk) - Management believes that after a July 2024 fundraising, its existing liquidity will fund operations through the beginning of 2026[15](index=15&type=chunk) - Under an 'At the Market' (ATM) agreement with Roth Capital, the company sold **1,954,455** ADSs for net proceeds of **$1.674 million** between October 2023 and June 2024[16](index=16&type=chunk) [Note 2 - Basis of Presentation and Significant Accounting Policies](index=10&type=section&id=Note%202%20-%20Basis%20of%20Presentation%20and%20Significant%20Accounting%20Policies) This note confirms the unaudited interim financial statements adhere to U.S. GAAP and SEC rules, with no significant accounting policy changes since 2023 - The financial statements are unaudited and prepared in accordance with U.S. GAAP and SEC rules for interim reporting[18](index=18&type=chunk) - The preparation of financial statements requires management to make estimates and assumptions, and actual results could differ[19](index=19&type=chunk) [Note 3 - Contingencies](index=10&type=section&id=Note%203%20-%20Contingencies) This note details an ongoing dispute with the Israeli Tax Authority regarding a VAT audit for 2017-2022, which the company has appealed to district court - The company is in an ongoing dispute with the Israeli Tax Authority (ITA) over a VAT audit for 2017-2022, and has appealed the ITA's assessment to the Israeli district court[20](index=20&type=chunk)[21](index=21&type=chunk) [Note 4 - Subsequent events](index=11&type=section&id=Note%204%20-%20Subsequent%20events) This note discloses a significant private placement completed on July 30, 2024, raising **$10.0 million** through the sale of ADSs and pre-funded warrants - On July 30, 2024, the company closed a private placement, selling **$10.0 million** of its ADSs and pre-funded warrants to new and existing investors[23](index=23&type=chunk)

──Reported Positive Phase 2 Results Demonstrating Safety and Anti-Fibrotic, Anti-Inflammatory and AntiCholestatic Activity across Multiple Components of Primary Sclerosing Cholangitis (PSC)── ──Establishes Clinical Proof-of-Concept for Disease-Modifying Potential of CM-101 and Provides Foundation for Advancing to PSC Phase 3 Pivotal Trial── ──Completed PIPE Financing Including Major New and Existing Investors that Extends Cash Runway Through Beginning of 2026── ──On Track to Achieve Key Clinical Milestones ...

TEL AVIV, Israel, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab" or the "Company"), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced the company will issue a press release reporting its second quarter 2024 financial results and providing a business update on August 21, 2024, at 7:00 am Eastern Time. Investors who would like to discuss the financial results or business updat ...

— HBM Healthcare Investments, OrbiMed and Sphera Biotech Master Fund LP Participated in the Financing that Extends Cash Runway Potentially to the Beginning of 2026— —Chemomab is Well-Positioned to Achieve Key Clinical Milestones in Q1 2025 While Continuing to Advance Its Discussions with Potential Partners Based on Positive Phase 2 Results— TEL AVIV, Israel, July 30, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab" or the "Company"), a clinical stage biotechnology company devel ...