Finanças dos EUA

Chemomab Therapeutics anuncia resultados financeiros do primeiro trimestre de 2022 e fornece atualização corporativa


— Empresa sediará teleconferência para investidores hoje, 12 de maio às 8h ET —


, /PRNewswire/ — Chemomab Therapeutics, Ltd. . (Nasdaq: CMMB ), uma empresa de biotecnologia de estágio clínico focada na descoberta e desenvolvimento de terapias inovadoras para doenças fibróticas e inflamatórias com alta necessidade não atendida, anunciou hoje os resultados financeiros e operacionais do primeiro trimestre encerrado em 31 de março de 2022 e forneceu uma visão corporativa atualizar.


“Durante o trimestre, continuamos a fazer um bom progresso no refinamento e implementação de revisões em nosso programa clínico CM-101 com o objetivo de diminuir o risco geral de desenvolvimento, maximizar os dados clínicos obtidos para facilitar a tomada de decisões clínicas e gerar dados críticos para apoiar o avanço para o registro testes”, disse Dale Pfost, PhD, CEO da Chemomab. “Estamos expandindo nossos esforços em colangite esclerosante primária (PSC) com um ensaio clínico ampliado que está recrutando pacientes de novos locais nos EUA e na Europa, ao mesmo tempo em que adicionamos um importante componente de descoberta de dose e uma extensão aberta. análise provisória da coorte de dose atualmente matriculada no estudo PSC para avaliar a segurança e confirmar os tamanhos de amostra planejados para as coortes de dose de CM-101.


Dr. Pfost acrescentou: “Na esclerose sistêmica (ES), esperamos que o projeto revisado do estudo de Fase 2 permita um caminho acelerado para dados de prova de conceito e, mais importante, forneça informações adicionais sobre a atividade do CM-101 na modificação do fisiopatologia da pele, pulmão e vascular observada em pacientes com ES. Estamos projetando este estudo com a ajuda dos principais líderes de opinião da ES e estamos a caminho de lançá-lo até o final do ano. Também tenho o prazer de informar que concluímos inscrição em nosso estudo de fibrose hepática de segurança, farmacocinética e biomarcador de Fase 2, com leituras finais esperadas para o final do ano. Continuamos a usar nosso capital de forma eficiente e esperamos fornecer mais detalhes sobre nosso progresso com os ensaios PSC e SSc Fase 2 neste verão. “


Destaques recentes:



  • Nomeado Jack Lawler Vice-Presidente de Operações de Desenvolvimento Clínico Global. O Sr. Lawler, que está sediado nos Estados Unidos, traz para a empresa mais de 20 anos de experiência global diversificada no desenvolvimento de medicamentos clínicos.

  • O Diretor Científico Dr. Adi Mor apresentou “Blocking CCL24, um novo alvo que regula a fibrose da inflamação e os danos endoteliais, mostra um potencial promissor como tratamento para a Esclerose Sistêmica” na Conferência Internacional de Reumatologia bienal em Israel. Dados de estudos de modelos experimentais e amostras de pacientes demonstraram que CCL24, o alvo para CM-101, é superexpresso em amostras de pele e soro de pacientes com ES difusa em comparação com indivíduos saudáveis. Os níveis de CCL24 também se correlacionaram com biomarcadores fibróticos e progressão da doença. Em um modelo experimental de camundongo de ES, o CM-101 reduziu profundamente a fibrose da pele e do pulmão.

  • O professor Francesco Del Galdo da Universidade de Leeds apresentou “CCL24 como marcador de pior prognóstico na ES cutânea difusa: um novo alvo biológico promissor” no 7º Congresso Mundial de Esclerose Sistêmica. Os achados do professor Del Galdo apoiam o papel do CCL24 como potencial alvo terapêutico, demonstrando níveis séricos elevados de CCL24 em pacientes com ES cutânea difusa. Níveis séricos elevados de CCL24 foram correlacionados com a atividade da doença e pior prognóstico, refletido pela alta atividade fibrótica e deterioração da função pulmonar ao longo do tempo em uma coorte longitudinal de pacientes.

  • Participou da 32ª Conferência Anual Oppenheimer Healthcare

  • At the Cantor Fitzgerald Rare Orphan Disease Summit, Dr. Adi Mor described how Chemomab’s CM-101 “pipeline in a product” strategy offers important synergies and efficiencies in the drug development process.


First Quarter 2022 Financial Highlights



  • Cash Position: Cash and cash equivalents were $57.5 million as of March 31, 2022, compared to $61.2 million as of December 31, 2021.

  • Research and Development (R&D) Expenses: R&D expenses were $2.7 million for the first quarter ended March 31, 2022, compared to $1.2 million for the same quarter in 2021.

  • General and Administrative (G&A) Expenses: G&A expenses were $2.6 million for the first quarter ended March 31, 2022, compared to $0.5 million for the same quarter in 2021. The current quarter figure includes a $0.9 million non-cash stock-based compensation payment.

  • Net Loss: Net loss was $5.1 million, or a net loss of $0.02 per basic and diluted share, for the first quarter ended March 31, 2022, compared to $1.7 million, or a net loss of $0.01 per basic and diluted share, for the quarter ended March 31, 2021. The weighted average number of Ordinary Shares outstanding, basic and diluted were 228,090,300 (equal to 11,404,515 American Depository Shares) and 156,751,771 (equal to 7,837,589 American Depository Shares) for the quarters ended March 31, 2022, and March 31, 2021, respectively.


For further details on the company’s financial results for the quarter ended March 31, 2022, refer to the Form 10-Q, which will be filed with the SEC today, May 12, 2022.


Conference Call
Chemomab management will host a conference call for investors today, Thursday, May 12, 2022, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by clicking this Webcast link to access the live webcast or replay, or by dialing 877-407-9208 (in the U.S.) or 201-493-6784 (outside the U.S. and in Israel) and entering passcode 13728593. Ask for the Chemomab conference call. The call also will be webcast live on the company’s website at https://investors.chemomab.com/events


A replay of the call will be available on the company website for 90 days at www.chemomab.com.


About Chemomab Therapeutics Ltd.
Chemomab is a clinical-stage biotechnology company focusing on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need. Based on the unique and pivotal role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody designed to bind and block CCL24 activity. CM-101 has demonstrated the potential to treat multiple severe and life-threatening fibrotic and inflammatory diseases. It is currently in Phase 2 trials for primary sclerosing cholangitis and liver fibrosis, with a Phase 2 trial in systemic sclerosis expected to begin in late 2022.


For more information on Chemomab, visit chemomab.com.


Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements include, among other things, statements regarding the clinical development pathway for CM-101; the future operations of Chemomab and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones; the nature, strategy and focus of Chemomab; the development and commercial potential and potential benefits of any product candidates of Chemomab; and that the product candidates have the potential to address high unmet needs of patients with serious fibrosis-related diseases and conditions. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Chemomab’s current expectations. Forward-looking statements involve risks and uncertainties. Because such statements deal with future events and are based on Chemomab’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Chemomab could differ materially from those described in or implied by the statements in this presentation, including: risks related to Chemomab’s ability to effectively implement the revised clinical strategy and its ability to achieve the anticipated results; risks related to the projections and associated benefits in pursuing the contemplated changes to the clinical strategy; risks associated with the ongoing transitions of certain of our executive officers, including Chemomab’s new Chief Executive Officer; the uncertain and time-consuming regulatory approval process; risks related to Chemomab’s ability to correctly manage its operating expenses and its expenses; Chemomab’s plans to develop and commercialize its product candidates, focusing on CM-101; the timing of initiation of Chemomab’s planned clinical trials; the timing of the availability of data from Chemomab’s clinical trials including any potential delays associated with Chemomab’s contemplated revised clinical strategy; the timing of any planned investigational new drug application or new drug application; Chemomab’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Chemomab’s product candidates; Chemomab’s commercialization, marketing and manufacturing capabilities and strategy; Chemomab’s ability to protect its intellectual property position; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. Additional risks and uncertainties relating to Chemomab’s and its business can be found under the caption “Risk Factors” and elsewhere in Chemomab’s filings and reports with the SEC. Chemomab expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Chemomab’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except to the extent required by applicable law.


Contacts:


Investor Relations:
Irina Koffler
LifeSci Advisors, LLC
Phone: +1 917-734-7387
[email protected]


Chemomab Therapeutics:
Barbara Lindheim
Consulting Vice President
Investor & Public Relations,
Strategic Communications
Phone: +1 917-355-9234
[email protected]


Condensed Consolidated Balance Sheets


In USD thousands (except share amounts)








March 31,


December 31,






2022


2021


Assets




Unaudited


Audited










Current assets








Cash and cash equivalents




13,827


15,186


Short term bank deposits




43,579


45,975


Other receivables and prepaid expenses




1,934


1,527










Total current assets




59,340


62,688










Non-current assets








Long term prepaid expenses




864


908


Property and equipment, net




358


357


Restricted cash




85


55


Operating lease right-of-use assets




309


345


Total non-current assets




1,616


1,665










Total assets




60,956


64,353










Current liabilities








Trade payables




1,487


1,336


Accrued expenses




1,248


555


Employee and related expenses




666


653


Operating lease liabilities




116


106










Total current liabilities




3,517


2,650










Non-current liabilities








Operating lease liabilities – long term




203


237










Total non-current liabilities




203


237










Commitments and contingent liabilities
















Total liabilities




3,720


2,887










Shareholders’ equity








Ordinary shares no par value – Authorized: 650,000,000 shares as of March 31, 2022 and as of December 31, 2021;


Issued and outstanding: 228,090,300 ordinary shares as of March 31, 2022 and as of December 31, 2021




























Additional paid in capital




98,513


97,639


Accumulated deficit




(41,277)


(36,173)










Total shareholders’ equity




57,236


61,466


Total liabilities and shareholders’ equity




60,956


64,353


Condensed Consolidated Interim Statements of Operations (Unaudited)


In USD thousands






Three months


Three months




Ended


Ended




March 31,


March 31,




2022


2021






Operating expenses












Research and development


2,745


1,157








General and administrative


2,575


542








Total operating expenses


5,320


1,699








Financing expenses (income), net


(216)


5






Net loss for the period


5,104


1,704














Basic and diluted loss per Ordinary Share*


0.022


0.011








Weighted average number of Ordinary Shares outstanding,
basic, and diluted*


228,090,300


156,751,771


* Number of shares has been retroactively adjusted based on the equivalent number of shares received by the accounting acquirer’s shareholders in the reverse recapitalization transaction.


SOURCE Chemomab Therapeutics, Ltd.



Dr. Pfost acrescentou: “Na esclerose sistêmica (ES), esperamos que o projeto revisado do estudo de Fase 2 permita um caminho acelerado para dados de prova de conceito e, mais importante, forneça informações adicionais sobre a atividade do CM-101 na modificação do fisiopatologia da pele, pulmão e vascular observada em pacientes com ES. Estamos projetando este estudo com a ajuda dos principais líderes de opinião da ES e estamos a caminho de lançá-lo até o final do ano. Também tenho o prazer de informar que concluímos inscrição em nosso estudo de fibrose hepática de segurança, farmacocinética e biomarcador de Fase 2, com leituras finais esperadas para o final do ano. Continuamos a usar nosso capital de forma eficiente e esperamos fornecer mais detalhes sobre nosso progresso com os ensaios PSC e SSc Fase 2 neste verão. “

Source: https://www.prnewswire.com/news-releases/chemomab-therapeutics-announces-first-quarter-2022-financial-results-and-provides-corporate-update-301545733.html

Previous
Finanças dos EUABOOM: Despertou a Disney (Groomers) Enfrentando um Desastre Financeiro Enquanto a Reação Anti-Acordar se Encaixa Contra Ele | As grandes empresas inevitavelmente têm dezenas de métricas que usam para avaliar o desempenho delas. Elementos como segurança no local de trabalho, índices de satisfação do cliente e resultados de pesquisas de engajamento de funcionários são apenas alguns exemplos do que uma grande corporação pode rastrear para garantir que as coisas estejam indo na direção certa. Uma empresa acordada, como | A primeira página do Tea Party. | Lentamente, nossas liberdades estão sendo lascadas com a justificativa do tipo "Sabemos melhor..." como seu martelo e cinzel.
Next
Finanças dos EUAInscreva-se para ler | Financial Times

Similar Posts

Leave a Reply