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Chemomab Therapeutics Announces Year End and Fourth Quarter 2024 Financial Results and Provides a Corporate Update

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Chemomab Therapeutics reported successful completion of FDA End-of-Phase 2 Meeting for nebokitug (CM-101) in Primary Sclerosing Cholangitis (PSC). The company achieved alignment with FDA on a streamlined pathway to potential regulatory approval through a single pivotal Phase 3 trial, without requiring liver biopsies or confirmatory studies.

The Phase 2 SPRING trial met its primary endpoint, demonstrating favorable safety profile. Patients with moderate/advanced disease showed improvements across multiple secondary efficacy endpoints. The company selected the 20mg/kg dose for the Phase 3 trial based on observed dose-dependent responses.

Financial highlights for 2024:

  • Cash position: $14.3 million as of December 31, 2024
  • R&D expenses: $11.3 million for full year (down from $18.4 million in 2023)
  • G&A expenses: $3.4 million (decreased from $7.1 million in 2023)
  • Net loss: $13.9 million ($0.04 per share)

The company completed a $10 million private placement in July 2024 with participation from OrbiMed, HBM Partners, and Sphera Biotech Master Fund. Current cash runway extends through Q1 2026.

Chemomab Therapeutics ha riportato il completamento con successo della riunione di fine fase 2 con la FDA per nebokitug (CM-101) nella colangite sclerosante primaria (PSC). L'azienda ha raggiunto un allineamento con la FDA su un percorso semplificato verso una potenziale approvazione regolatoria attraverso un singolo studio pivotale di fase 3, senza la necessità di biopsie epatiche o studi di conferma.

Lo studio di fase 2 SPRING ha raggiunto il suo obiettivo primario, dimostrando un profilo di sicurezza favorevole. I pazienti con malattia moderata/avanzata hanno mostrato miglioramenti in diversi endpoint secondari di efficacia. L'azienda ha selezionato la dose di 20 mg/kg per lo studio di fase 3 in base alle risposte osservate dipendenti dalla dose.

Risultati finanziari per il 2024:

  • Posizione di cassa: 14,3 milioni di dollari al 31 dicembre 2024
  • Spese R&S: 11,3 milioni di dollari per l'intero anno (in calo rispetto ai 18,4 milioni di dollari nel 2023)
  • Spese G&A: 3,4 milioni di dollari (diminuzione rispetto ai 7,1 milioni di dollari nel 2023)
  • Perdita netta: 13,9 milioni di dollari (0,04 dollari per azione)

L'azienda ha completato un collocamento privato di 10 milioni di dollari a luglio 2024 con la partecipazione di OrbiMed, HBM Partners e Sphera Biotech Master Fund. La attuale liquidità disponibile si estende fino al primo trimestre del 2026.

Chemomab Therapeutics informó sobre la finalización exitosa de la reunión de fin de fase 2 con la FDA para nebokitug (CM-101) en colangitis esclerosante primaria (PSC). La compañía logró un alineamiento con la FDA sobre un camino simplificado hacia una posible aprobación regulatoria a través de un único ensayo pivotal de fase 3, sin requerir biopsias hepáticas ni estudios de confirmación.

El ensayo de fase 2 SPRING cumplió su objetivo principal, demostrando un perfil de seguridad favorable. Los pacientes con enfermedad moderada/avanzada mostraron mejoras en múltiples puntos finales secundarios de eficacia. La compañía seleccionó la dosis de 20 mg/kg para el ensayo de fase 3 en base a las respuestas observadas dependientes de la dosis.

Aspectos financieros para 2024:

  • Posición de efectivo: 14.3 millones de dólares al 31 de diciembre de 2024
  • Gastos de I+D: 11.3 millones de dólares para el año completo (a la baja desde 18.4 millones de dólares en 2023)
  • Gastos G&A: 3.4 millones de dólares (disminución desde 7.1 millones de dólares en 2023)
  • Pérdida neta: 13.9 millones de dólares (0.04 dólares por acción)

La compañía completó una colocación privada de 10 millones de dólares en julio de 2024 con la participación de OrbiMed, HBM Partners y Sphera Biotech Master Fund. La actual liquidez se extiende hasta el primer trimestre de 2026.

Chemomab Therapeutics는 1차 경화성 담관염(PSC)에 대한 nebokitug (CM-101)의 FDA 2상 종료 회의 성공적 완료를 보고했습니다. 이 회사는 간 생검이나 확인 연구 없이 단일 주요 3상 시험을 통해 잠재적인 규제 승인을 위한 간소화된 경로에 대해 FDA와 일치했습니다.

2상 SPRING 시험은 주요 목표를 달성했으며, 안전성 프로필이 우수함을 입증했습니다. 중등도/진행성 질환 환자들은 여러 보조 효과성 지표에서 개선을 보였습니다. 이 회사는 관찰된 용량 의존적 반응에 따라 3상 시험을 위한 20mg/kg 용량을 선택했습니다.

2024년 재무 하이라이트:

  • 현금 보유: 2024년 12월 31일 기준 1430만 달러
  • 연구개발 비용: 연간 1130만 달러 (2023년 1840만 달러에서 감소)
  • 일반관리 비용: 340만 달러 (2023년 710만 달러에서 감소)
  • 순손실: 1390만 달러 (주당 0.04 달러)

회사는 2024년 7월에 OrbiMed, HBM Partners 및 Sphera Biotech Master Fund의 참여로 1000만 달러의 사모 배치를 완료했습니다. 현재 현금 유동성은 2026년 1분기까지 연장됩니다.

Chemomab Therapeutics a annoncé l'achèvement réussi de la réunion de fin de phase 2 avec la FDA pour nebokitug (CM-101) dans la cholangite sclérosante primitive (PSC). L'entreprise a obtenu un alignement avec la FDA sur un chemin simplifié vers une approbation réglementaire potentielle via un essai pivot de phase 3, sans nécessiter de biopsies hépatiques ni d'études de confirmation.

L'essai de phase 2 SPRING a atteint son objectif principal, démontrant un profil de sécurité favorable. Les patients atteints de maladies modérées/avancées ont montré des améliorations dans plusieurs critères d'efficacité secondaires. L'entreprise a sélectionné la dose de 20 mg/kg pour l'essai de phase 3 en fonction des réponses observées dépendantes de la dose.

Points financiers pour 2024:

  • Position de trésorerie : 14,3 millions de dollars au 31 décembre 2024
  • Dépenses R&D : 11,3 millions de dollars pour l'année complète (en baisse par rapport à 18,4 millions de dollars en 2023)
  • Dépenses G&A : 3,4 millions de dollars (en baisse par rapport à 7,1 millions de dollars en 2023)
  • Perte nette : 13,9 millions de dollars (0,04 dollar par action)

L'entreprise a réalisé un placement privé de 10 millions de dollars en juillet 2024 avec la participation d'OrbiMed, HBM Partners et Sphera Biotech Master Fund. La liquidité actuelle s'étend jusqu'au premier trimestre 2026.

Chemomab Therapeutics berichtete über den erfolgreichen Abschluss des FDA-Ende-Phase-2-Meetings für nebokitug (CM-101) bei primärer sklerosierender Cholangitis (PSC). Das Unternehmen erzielte eine Übereinstimmung mit der FDA über einen vereinfachten Weg zu einer potenziellen behördlichen Genehmigung durch eine einzige entscheidende Phase-3-Studie, ohne dass Leberbiopsien oder Bestätigungsstudien erforderlich sind.

Die Phase-2-SPRING-Studie erreichte ihr Hauptziel und zeigte ein günstiges Sicherheitsprofil. Patienten mit moderater/fortgeschrittener Erkrankung zeigten Verbesserungen in mehreren sekundären Wirksamkeitsendpunkten. Das Unternehmen wählte die Dosis von 20 mg/kg für die Phase-3-Studie basierend auf den beobachteten dosisabhängigen Reaktionen.

Finanzielle Höhepunkte für 2024:

  • Liquiditätsposition: 14,3 Millionen Dollar zum 31. Dezember 2024
  • F&E-Ausgaben: 11,3 Millionen Dollar für das gesamte Jahr (rückläufig von 18,4 Millionen Dollar im Jahr 2023)
  • Allgemeine und administrative Ausgaben: 3,4 Millionen Dollar (gesunken von 7,1 Millionen Dollar im Jahr 2023)
  • Nettverlust: 13,9 Millionen Dollar (0,04 Dollar pro Aktie)

Das Unternehmen schloss im Juli 2024 eine Privatplatzierung in Höhe von 10 Millionen Dollar mit Beteiligung von OrbiMed, HBM Partners und Sphera Biotech Master Fund ab. Der aktuelle Cash-Bestand reicht bis zum ersten Quartal 2026.

Positive
  • FDA agreement on streamlined Phase 3 pathway without need for liver biopsies
  • Successful Phase 2 SPRING trial results with positive safety profile
  • Secured $10M financing from notable investors
  • Reduced operating expenses: R&D down 39% and G&A down 52% year-over-year
  • Cash runway extended through Q1 2026
Negative
  • Net loss of $13.9M in 2024
  • Cash position decreased from $19.9M to $14.3M year-over-year

Insights

Chemomab's year-end results reveal a biotech efficiently managing its runway while advancing its lead asset through critical regulatory milestones. With $14.3 million in cash (down from $19.9 million year-over-year), the company has extended its operations through Q1 2026, bolstered by a strategic $10 million private placement that attracted both existing investors like OrbiMed and new backers including HBM Partners.

The financial discipline is evident in their significant cost reductions - R&D expenses decreased 38.6% year-over-year to $11.3 million, while G&A expenses dropped 52.1% to $3.4 million. These efficiencies translated to a narrowed annual net loss of $13.9 million, a 42.6% improvement from 2023's $24.2 million loss.

What's particularly compelling is how Chemomab has parlayed these cost controls into achieving a potentially accelerated regulatory pathway for nebokitug in PSC - a rare liver disease with no FDA-approved treatments. The FDA agreement on a streamlined Phase 3 program without requiring liver biopsies or confirmatory studies represents significant regulatory de-risking. For a micro-cap biotech with a $30.5 million market cap, securing this regulatory clarity dramatically enhances their strategic optionality, including partnership potential that could provide non-dilutive capital to fund the Phase 3 program.

Chemomab's Phase 2 SPRING trial results represent a potential breakthrough in the PSC treatment landscape. The company has secured the most streamlined regulatory pathway I've seen for a PSC candidate - a single pivotal Phase 3 trial based on clinical events rather than complex surrogate endpoints that have plagued previous PSC trials. This approach mirrors successful oncology drug approval pathways and directly addresses the FDA's increasing focus on clinically meaningful outcomes.

The Phase 2 data showing improvements across fibrotic, inflammatory and cholestatic biomarkers in moderate/advanced PSC patients is particularly significant. Previous PSC candidates have typically shown effects on individual markers, but nebokitug's broader impact across disease mechanisms suggests a potential disease-modifying effect rather than just symptomatic management.

The CCL24 mechanism represents a novel approach targeting a specific chemokine that appears central to the fibro-inflammatory processes in PSC. The published proteomics research and confirmatory scientific studies strengthen the biological rationale. With the planned Open Label Extension data coming this quarter, we'll gain critical insights into longer-term treatment effects and durability of response.

From a competitive standpoint, nebokitug is well-positioned as potentially the first-to-market therapy for PSC, a devastating liver disease with no FDA-approved treatments. The regulatory clarity achieved through their End-of-Phase 2 meeting substantially de-risks the development pathway compared to competitors still working through earlier clinical stages or more complex trial designs.

Completed Successful FDA End-of-Phase 2 Meeting Following Positive Nebokitug Phase 2 SPRING Trial Results in Primary Sclerosing Cholangitis (PSC)

Achieved Alignment with FDA on Clear and Efficient Pathway to Potential Regulatory Approval for the Treatment of PSC with No Liver Biopsies or Confirmatory Studies Needed; Nebokitug Positioned to Potentially Become the First FDA-Approved Treatment for PSC

On Track for Releasing Clinical Data from SPRING Trial Open Label Extension in First Quarter 2025─

─Discussions with Potential Strategic Partners Ongoing

TEL AVIV, Israel, March 03, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq:CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced financial and operating results for the full year and fourth quarter ended December 31, 2024, and provided a corporate update.

“The past year has been a transformative period for both Chemomab and the PSC field,” said Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab. “Following rapid enrollment in our nebokitug (CM-101) Phase 2 SPRING trial in patients with PSC, we were able to report topline results in July, approximately six months ahead of schedule. We and our PSC expert advisers view these Phase 2 data as the strongest in PSC to date. Nebokitug achieved the SPRING trial primary endpoint, demonstrating a favorable safety profile. Additionally, patients treated with nebokitug who had moderate/advanced disease showed improvements in multiple secondary efficacy endpoints encompassing the fibrotic, inflammatory and cholestatic aspects of PSC. This is the first time that an investigational drug for PSC has shown improvements across such a wide range of highly relevant disease markers. These promising results set the stage for our FDA End-of-Phase 2 meeting. We recently reported the positive results of that meeting and outlined the design for a single pivotal Phase 3 trial for nebokitug in PSC, which provides us with a clear and streamlined pathway to potential regulatory approval.”

Dr. Mor continued, “We were very pleased by FDA’s positive and collaborative spirit at the meeting and their stated commitment to facilitating the advancement of effective new therapies for PSC. We aligned on a full regulatory approval program for nebokitug using a single pivotal Phase 3 trial based on well-characterized clinical events that are associated with disease progression in PSC. Neither liver biopsies nor additional confirmatory studies will be needed. The design is similar to the approach used in oncology trials and is both feasible and efficient. Importantly, use of a clinical event-driven endpoint helps derisk the Phase 3 trial, since key publications have linked the type of improvements in PSC biomarkers seen in nebokitug-treated patients in the SPRING trial with decreases in clinical events.”

Dr. Mor added, “We continue to assess a variety of potential strategic paths forward. The recent positive developments have been of keen interest to potential strategic partners and active discussions are advancing following FDA’s regulatory guidance. At the same time, we are laying the foundation for beginning the Phase 3 trial, leveraging the strong relationships our clinical team developed with global PSC centers during the SPRING study. We believe that nebokitug could become the first FDA-approved therapy for PSC, addressing the tremendous unmet need in this devastating, often lethal disease. We look forward to reporting data from the SPRING trial Open Label Extension later this quarter.”

2024 and Recent Highlights:

  • On February 19, 2025, Chemomab reported that the International Nonproprietary Names (INN) program of the World Health Organization had assigned the INN designation nebokitug to the company’s lead product candidate CM-101.
  • On February 19, 2025, Chemomab announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and alignment with FDA on the design of a Phase 3 registration study for nebokitug for the treatment of PSC. The design provides clarity on a streamlined path to full regulatory approval based on a single pivotal trial that does not require liver biopsies or confirmatory studies. The primary endpoint measures time-to-first clinical event and encompasses multiple clinical events associated with disease progression. Key publications have shown that the reductions in PSC biomarkers seen in the nebokitug Phase 2 SPRING trial are associated with reductions in clinical events, increasing confidence in the relevance of this approach for the nebokitug Phase 3 trial. The company is sharing the Phase 3 design in active discussions with potential strategic partners while laying the groundwork for initiating the Phase 3 program.
  • On January 13, 2025, a new peer-reviewed publication in the journal Cells further confirmed the key role of the soluble protein CCL24 in driving the fibro-inflammatory pathologies underlying PSC, systemic sclerosis and other fibrotic diseases. The review describes the pivotal role CCL24 plays in initiating and advancing fibrotic processes, highlighting its impact on fibrotic, immune and vascular pathways. It also presented preclinical and clinical evidence supporting the therapeutic potential of blocking CCL24 with agents like nebokitug in diseases that involve excessive inflammation and fibrosis.
  • On November 19, 2024, Chemomab reported that data from its Phase 2 SPRING trial in patients with PSC was presented at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2024. In an oral, late-breaking presentation, Professor Christopher Bowlus, MD, a SPRING trial investigator and Professor and Chief of the Division of Gastroenterology and Hepatology at the University of California Davis School of Medicine, discussed data from the double-blind, placebo-controlled portion of the Phase 2 trial.
  • On July 30, 2024, Chemomab announced the closing of a private placement that resulted in gross proceeds of approximately $10 million to the company. Existing investors such as OrbiMed and new investors including HBM Partners and Sphera Biotech Master Fund participated in the financing.
  • On July 25, 2024, Chemomab reported positive topline results from the nebokitug Phase 2 SPRING trial in patients with PSC. Nebokitug met the primary study endpoint, demonstrating a favorable safety profile and nebokitug-treated patients with moderate/advanced disease showed improvements on a wide range of disease-related secondary endpoints, including liver stiffness, liver fibrosis biomarkers, such as the Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels; total bilirubin and liver function tests; pruritus (itch) and markers of inflammation. Dose-dependent responses were observed for multiple disease-related biomarkers. A consistent pattern of greater improvement on the secondary endpoints was observed in the study arm receiving the 20mg/kg dose of nebokitug. This dose has been selected for the active treatment arm of the Phase 3 trial.
  • On June 18, 2024, Chemomab announced new scientific publications had been published in the peer-reviewed journals International Journal of Molecular Science and Drug Safety that reinforced the clinical potential of nebokitug in PSC.
  • On June 6, 2024, Chemomab presented new scientific and clinical data at EASL 2024 and at a Gordon Research Conference supporting the clinical potential of nebokitug as a novel treatment for PSC. The findings helped elucidate nebokitug’s mode of action in liver fibrosis and could help in characterizing its anti-fibrotic drug effects.
  • On April 18, 2024, Chemomab announced the publication of a new study in the journal Arthritis Care and Research that confirms the key role of CCL24 in systemic sclerosis. The longitudinal study of more than 200 SSc patients showed that elevated levels of serum CCL24 are associated with increased mortality and disease severity across the fibrotic and vascular manifestations of the disease.
  • On April 10, 2024, Chemomab hosted an expert PSC webinar featuring Christopher Bowlus, MD, of UC Davis Health; Ricky Safer, founder and CEO of PSC Partners Seeking a Cure and Massimo Pinzani, MD, PhD, of the UCL Institute for Liver and Digestive Health and UPMC ISMETT.
  • In March, 2024, Chemomab reported that the European Patent Office had granted a new patent for nebokitug, covering the use of nebokitug and sequence-related anti-CCL24 antibodies for the treatment of liver diseases, such as PSC. In February, new patents were granted in Brazil and Israel.
  • On January 30, 2024, Chemomab reported publication of new proteomics research in the peer-reviewed journal Cells. The proteomic analyses of human samples highlighted the unique role of CCL24 in activating key PSC-related disease mechanisms and further confirmed the potential of nebokitug as a promising treatment for PSC.
  • On January 3, 2024, Chemomab announced early completion of patient enrollment in the nebokitug Phase 2 PSC SPRING trial and moved up the expected topline data readout to midyear 2024.

Full Year and Fourth Quarter 2024 Financial Highlights:

  • Cash Position: Cash, cash equivalents and short-term bank deposits were $14.3 million as of December 31, 2024 compared to $19.9 million as of December 31, 2023. The current cash runway is expected to take the Company through the first quarter of 2026.
  • Research and Development (R&D) Expenses: R&D expenses were $2.4 million for the fourth quarter and $11.3 million for the full year ended December 31, 2024, compared to $3.1 million and $18.4 million for the respective periods in 2023. The decrease in R&D expenses in the fourth quarter of 2024 compared to the fourth quarter of 2023 primarily resulted from decreased clinical costs as the company’s nebokitug Phase 2 PSC trial was nearing completion.
  • General and Administrative (G&A) Expenses: G&A expenses were $0.8 million for the fourth quarter and $3.4 million for the full year ended December 31, 2024, compared to $0.8 million and $7.1 million for the fourth quarter and full year in 2023. The decrease in G&A expenses reflected selected reductions in headcount and reductions in share-based payments and recruitment costs.
  • Net Loss: Net loss was $3.0 million, or a net loss of less than $0.01 per basic and diluted Ordinary Share, for the fourth quarter and $13.9 million, or a net loss of $0.04 per basic and diluted Ordinary Share, for the full year ended December 31, 2024, compared to a net loss of $3.4 million, or a net loss of $0.01 per basic and diluted share, for the fourth quarter of 2023, and $24.2 million, or a net loss of $0.10 per basic and diluted Ordinary Share, for the full year ended December 31, 2023. 

The weighted average number of Ordinary Shares outstanding, basic and diluted was 324,649,751 (equal to 16,232,489 ADSs) for the year ended December 31, 2024, and 234,998,859 (equal to 11,749,943 ADSs) for the year ended December 31, 2023, respectively.

For further details on the company’s financial results for the year ended December 31, 2024, please refer to the company’s annual report on Form 20-F, which will be filed with the SEC in March, 2025.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially,” “will” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the risk that certain acknowledgements from the End-of-Phase 2 (EOP2) meeting with the FDA in connection with PSC regulatory approval will not materialize into a pathway for regulatory approval; that certain conclusions and assumptions drawn from the EOP2 meeting with the FDA discussed in the press release will prove incorrect and adversely affect the ability for nebokitug to become an FDA fully approved therapy; the risk that the full data set from the nebokitug study or data generated in further clinical trials of nebokitug will not be consistent with the topline results of the nebokitug Phase 2 PSC trial; failure to obtain, or delays in obtaining, regulatory approvals for nebokitug in the U.S., Europe or other territories; failure to successfully commercialize nebokitug, if approved by applicable regulatory authorities, in the U.S., Europe or other territories, or to maintain U.S., European or other territory regulatory approval for nebokitug if approved; uncertainties in the degree of market acceptance of nebokitug by physicians, patients, third-party payors and others in the healthcare community; nebokitug development of unexpected safety or efficacy concerns related to nebokitug; failure to successfully conduct future clinical trials for nebokitug, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that the Company's clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of nebokitug for commercial or clinical needs, to conduct the Company's clinical trials; changes in laws and regulations applicable to the Company's business and failure to comply with such laws and regulations; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; and uncertainties with respect to the Company's need and ability to access future capital; and the intensity and duration of the current war in Israel, and its impact on our operations in Israel. These risks are not exhaustive. You should carefully consider the risks and uncertainties described in the “Risk Factors” sections of our 20-F for the year ended December 31, 2023. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release. Before you invest, you should read the documents we have filed and will file with the SEC for more complete information about us. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities law of any such state or jurisdiction.

About Chemomab Therapeutics Ltd.
Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed nebokitug (CM-101), a first-in-class dual activity monoclonal antibody that neutralizes CCL24 and has demonstrated disease-modifying potential. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile and has been generally well-tolerated, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of nebokitug in patients. Based on recent positive data from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC), the company is preparing for potential initiation of a PSC nebokitug Phase 3 trial. The design calls for a single pivotal study based on a clinical event primary endpoint that provides a clear and streamlined pathway to potential regulatory approval. Data from the SPRING trial open label extension will be reported in the first quarter of 2025. Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations for the treatment of PSC. Chemomab’s nebokitug program for the treatment of systemic sclerosis has an open U.S. IND. For more information, visit: chemomab.com.

Contacts:

Media and Investors:
Barbara Lindheim
Consulting Vice President, Investor & Public Relations, Strategic Communications
Phone: +1 917-355-9234
barbara.lindheim@chemomab.com
IR@chemomab.com

Chemomab Therapeutics Ltd. and its subsidiaries
Consolidated Balance Sheets as of
In USD thousands (except share and per share amounts)
  December 31,
 December 31,
  2024
 2023
Assets     
      
Current assets     
Cash and cash equivalents 6,071  9,292 
Short-term bank deposit 8,195  10,492 
Restricted cash 76  76 
Other receivables and prepaid expenses 1,698  1,037 
    
Total current assets 16,040  20,897 
    
Non-current assets   
Long-term prepaid expenses 385  559 
Property and equipment, net 250  303 
Operating lease right-of-use assets 289  392 
    
Total non-current assets 924  1,254 
    
Total assets 16,964  22,151 
    
Current liabilities   
Trade payables 666  516 
Accrued expenses 1,563  3,423 
Employee and related expenses 874  823 
Operating lease liabilities 115  76 
    
Total current liabilities 3,218  4,838 
    
Non-current liabilities   
Non-current operating lease liabilities 209  316 
       
Total non-current liabilities 209  316 
Commitments and contingent liabilities   
    
Total liabilities 3,427  5,154 
    
Shareholders' equity   
Ordinary Shares no par value - Authorized: 4,650,000,000 and 650,000,000 Ordinary shares as of December 31, 2024, and December 31, 2023 , respectively   
Issued and outstanding: 377,132,220, and284,094,700 Ordinary shares as of December 31, 2024 and 2023, respectively -  - 
Additional paid-in capital 116,160  105,675 
Accumulated deficit (102,623) (88,678)
    
Total shareholders’ equity 13,537  16,997 
    
Total liabilities and shareholders’ equity 16,964  22,151 
       

(*) 1 American Depositary Share (ADS) represents 20 Ordinary Shares

 

Consolidated Statements of Operations
In USD thousands (except share and per share amounts)
  Three months
Ended
December 31
 Three months
Ended
December 31
 Year Ended
December
31,

 Year Ended
December
31,

     
     
  2024 2023 2024 2023
  Unaudited
 Unaudited Unaudited Audited
Operating expenses     
      
Research and development 2,411  3,097  11,327  18,381 
      
General and administrative 802  751  3,412  7,078 
      
Total operating expenses 3,213  3,848  14,739  25,459 
      
Financing income, net (250) (431) (794) (1,238)
      
Net loss for the year 2,963  3,417  13,945  24,221 
             
Basic and diluted loss per Ordinary Share 0.008  0.013  0.043  0.103 
             
Weighted average number of Ordinary Shares outstanding, basic, and diluted 377,132,220  260,274,470  324,649,751  234,998,859 
             

(*) 1 American Depositary Share (ADS) represents 20 Ordinary Shares


FAQ

What were the key results of Chemomab's (CMMB) Phase 2 SPRING trial for nebokitug in PSC?

The trial met its primary safety endpoint and showed improvements in multiple secondary endpoints including liver stiffness, fibrosis biomarkers, liver function tests, and pruritus in moderate/advanced disease patients.

How much did Chemomab (CMMB) raise in their July 2024 private placement?

Chemomab raised approximately $10 million through a private placement with investors including OrbiMed, HBM Partners, and Sphera Biotech Master Fund.

What is the current cash runway for Chemomab (CMMB) as of Q4 2024?

The company's cash position of $14.3 million is expected to fund operations through the first quarter of 2026.

What is the Phase 3 trial design agreed upon with FDA for nebokitug in PSC?

A single pivotal trial using clinical event-driven endpoints, without requiring liver biopsies or confirmatory studies, using the 20mg/kg dose.

Chemomab Therapeutics Ltd

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