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Oral Presentation at AASLD The Liver Meeting® 2024 Highlights Broad Clinical Activity of Chemomab's CM-101 Across Multiple Biomarkers and Its Disease-Modifying Potential in Primary Sclerosing Cholangitis
GlobeNewswire News Room· 2024-11-19 12:00
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]
CMMB Stock Earnings: Chemomab Therapeutics Reported Results for Q2 2024
Investor Place· 2024-08-21 15:52
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]
Chemomab Therapeutics(CMMB) - 2024 Q2 - Quarterly Report
2024-08-21 11:00
[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)
Chemomab Therapeutics Announces Second Quarter 2024 Financial Results and Provides Corporate Update
GlobeNewswire News Room· 2024-08-21 11:00
──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 ...
Chemomab Therapeutics to Report Second Quarter 2024 Financial Results and Provide a Business Update
GlobeNewswire News Room· 2024-08-12 11:00
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 ...
Chemomab Therapeutics Announces Closing of $10 Million Private Placement
GlobeNewswire News Room· 2024-07-30 13:00
— 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 ...
Chemomab Therapeutics Regains Compliance With Nasdaq Minimum Bid Price Requirement
Newsfilter· 2024-07-26 11:00
On July 23, 2024, Nasdaq provided confirmation to the Company that for the 10 consecutive business days preceding receipt of the letter, from July 9, 2024 to July 22, 2024, the closing bid price of the ADSs was $1.00 or greater, that the Company has hence regained compliance with Listing Rule 5550(a)(2) and that the matter is now closed. About Chemomab Therapeutics Ltd. Chemomab had previously announced on November 6, 2023, that it was notified by Nasdaq that it was not in compliance with the minimum bid pr ...
Chemomab Therapeutics Announces $10 Million Private Placement
Newsfilter· 2024-07-25 11:38
Core Viewpoint - Chemomab Therapeutics Ltd. has announced a private investment in public equity (PIPE) expected to generate approximately $10 million in gross proceeds, which will extend its cash runway to fund operations through early 2026, one year longer than previously projected [3][4]. Funding and Use of Proceeds - The net proceeds from the PIPE will be utilized alongside existing cash to support the development of CM-101, as well as for general corporate purposes and working capital [2][4]. - The PIPE involves the sale of 4,188,867 American Depositary Shares (ADSs) at a price of $1.235 per share, reflecting the average share price over the last four trading days [4]. Company Overview - Chemomab is a clinical-stage biotechnology company focused on developing therapeutics for fibro-inflammatory diseases with significant unmet needs [12]. - The company has developed CM-101, a monoclonal antibody targeting CCL24, which has shown a favorable safety profile in clinical trials and is positioned to treat various severe fibro-inflammatory diseases [12]. Clinical Development - Chemomab has reported positive results from four clinical trials of CM-101, including a Phase 2 trial for primary sclerosing cholangitis and a Phase 2a trial for liver fibrosis [12]. - The CM-101 program for systemic sclerosis is ready for Phase 2 trials with an open U.S. IND [12].
Chemomab Therapeutics Announces $10 Million Private Placement
GlobeNewswire News Room· 2024-07-25 11:38
The PIPE included participation from both new investors, including HBM Healthcare Investments and Sphera Biotech Master Fund LP, and existing investors. Chemomab expects that the net proceeds from the PIPE will extend its cash runway to fund its operations through the beginning of 2026, an extension of approximately one year from current projections, which should fund the Company for approximately one year after the completion of two major milestones expected in early 2025. Forward Looking Statements About ...
Chemomab Therapeutics Announces Positive Phase 2 Trial Results: CM-101 Achieves Primary and Secondary Endpoints Demonstrating Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Effects in Patients with Primary Sclerosing Cholangitis
Newsfilter· 2024-07-25 11:00
Core Insights - Chemomab Therapeutics reported positive topline results from the Phase 2 SPRING trial for its monoclonal antibody CM-101 in patients with primary sclerosing cholangitis (PSC), achieving its primary endpoint of safety and tolerability while demonstrating significant anti-fibrotic, anti-inflammatory, and anti-cholestatic effects [2][3][5] Company Overview - Chemomab is a clinical-stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases with high unmet medical needs, particularly targeting CCL24 to address fibrosis and inflammation [26] Clinical Trial Results - The Phase 2 SPRING trial involved 76 patients treated with either 10 mg/kg or 20 mg/kg of CM-101 every three weeks over 15 weeks, with a focus on safety and a range of secondary efficacy endpoints [3][20] - CM-101 demonstrated statistically significant improvements in liver stiffness, total bilirubin, liver function tests, and pruritis, marking it as the first investigational drug to show such effects in PSC [3][5][8][13][14] - Improvements in liver stiffness were observed as early as 15 weeks, with a notable reduction in total bilirubin levels indicating its anti-cholestatic activity [3][13] Safety Profile - CM-101 exhibited a favorable safety profile, with adverse events primarily being mild to moderate, including fatigue, headache, and pruritis, distributed similarly between treatment and placebo groups [7][8] Future Plans - The company is preparing for an End-of-Phase 2 meeting with the FDA to discuss the trial results and the design of a proposed Phase 3 trial for accelerated approval, with plans to initiate the trial in 2025 [17] - An ongoing Open Label Extension (OLE) portion of the SPRING trial allows patients to receive CM-101 for an additional 33 weeks, with results expected in the first quarter of 2025 [18] Market Context - PSC is a rare, progressive liver disease with no approved therapies, affecting an estimated 30,000 patients in the U.S. and 80,000 worldwide, highlighting the significant unmet medical need for effective treatments [21]