Finanzas de EE. UU.

Chemomab Therapeutics anuncia los resultados financieros del primer trimestre de 2022 y brinda actualización corporativa


— La empresa realizará una conferencia telefónica para inversores hoy, 12 de mayo a las 8:00 a. m., hora del este —


, /PRNewswire/ — Chemomab Therapeutics, Ltd . (Nasdaq: CMMB ), una compañía de biotecnología en etapa clínica enfocada en el descubrimiento y desarrollo de terapias innovadoras para enfermedades fibróticas e inflamatorias con una gran necesidad insatisfecha, anunció hoy los resultados financieros y operativos del primer trimestre finalizado el 31 de marzo de 2022 y proporcionó un informe corporativo actualizar.


“Durante el trimestre continuamos logrando un buen progreso en el perfeccionamiento e implementación de revisiones a nuestro programa clínico CM-101 con el objetivo de disminuir el riesgo general de desarrollo, maximizar los datos clínicos obtenidos para facilitar la toma de decisiones clínicas y generar datos críticos para respaldar el avance hacia el registro. ensayos”, dijo Dale Pfost, PhD, director ejecutivo de Chemomab. “Estamos ampliando nuestros esfuerzos en la colangitis esclerosante primaria (PSC) con un ensayo clínico ampliado que está reclutando pacientes de nuevos sitios en los EE. UU. y Europa, al tiempo que agrega un componente importante de búsqueda de dosis y una extensión abierta. Realizaremos un análisis intermedio de la cohorte de dosis actualmente reclutada en el estudio PSC para evaluar la seguridad y confirmar los tamaños de muestra previstos para las cohortes de dosis de CM-101.


El Dr. Pfost agregó: “En la esclerosis sistémica (SSc), esperamos que el diseño revisado del ensayo de Fase 2 permita un camino acelerado hacia los datos de prueba de concepto y, lo que es más importante, brinde información adicional sobre la actividad de CM-101 en la modificación del fisiopatología cutánea, pulmonar y vascular observada en pacientes con SSc. Estamos diseñando este ensayo con la ayuda de líderes de opinión clave de SSc y estamos en camino de lanzar el ensayo a finales de año. También me complace informar que ahora hemos completado inscripción en nuestro estudio de seguridad, farmacocinética y biomarcadores de fibrosis hepática de Fase 2, y se espera que las lecturas finales estén cerca de fin de año. Seguimos utilizando nuestro capital de manera eficiente y esperamos brindar más detalles sobre nuestro progreso con los ensayos de Fase 2 de PSC y SSc este verano. “


Destacados recientes:



  • Nombrado a Jack Lawler Vicepresidente de Operaciones de Desarrollo Clínico Global. El Sr. Lawler, que reside en los EE. UU., aporta a la compañía más de 20 años de diversa experiencia en el desarrollo de fármacos clínicos globales.

  • El director científico, el Dr. Adi Mor, presentó “Blocking CCL24, un nuevo objetivo que regula la inflamación, la fibrosis y el daño endotelial, muestra un potencial prometedor como tratamiento para la esclerosis sistémica” en la Conferencia internacional bienal de reumatología en Israel. Los datos del estudio de modelos experimentales y muestras de pacientes demostraron que CCL24, el objetivo de CM-101, se sobreexpresa en muestras de piel y suero de pacientes con SSc difusa en comparación con individuos sanos. Los niveles de CCL24 también se correlacionaron con los biomarcadores fibróticos y la progresión de la enfermedad. En un modelo de ratón experimental de SSc, CM-101 redujo profundamente la piel y la fibrosis pulmonar.

  • El profesor Francesco Del Galdo de la Universidad de Leeds presentó “CCL24 como marcador de peor pronóstico en SSc cutánea difusa: un objetivo biológico novedoso y prometedor” en el 7º Congreso Mundial de Esclerosis Sistémica. Los hallazgos del profesor Del Galdo respaldan el papel de CCL24 como un objetivo terapéutico potencial, demostrando niveles séricos elevados de CCL24 en pacientes con SSc cutánea difusa. Los niveles séricos altos de CCL24 se correlacionaron con la actividad de la enfermedad y un peor pronóstico, como se refleja en la alta actividad fibrótica y el deterioro de la función pulmonar a lo largo del tiempo en una cohorte longitudinal de pacientes.

  • Participó en la 32.ª Conferencia Anual de Atención Médica de Oppenheimer

  • 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.



El Dr. Pfost agregó: “En la esclerosis sistémica (SSc), esperamos que el diseño revisado del ensayo de Fase 2 permita un camino acelerado hacia los datos de prueba de concepto y, lo que es más importante, brinde información adicional sobre la actividad de CM-101 en la modificación del fisiopatología cutánea, pulmonar y vascular observada en pacientes con SSc. Estamos diseñando este ensayo con la ayuda de líderes de opinión clave de SSc y estamos en camino de lanzar el ensayo a finales de año. También me complace informar que ahora hemos completado inscripción en nuestro estudio de seguridad, farmacocinética y biomarcadores de fibrosis hepática de Fase 2, y se espera que las lecturas finales estén cerca de fin de año. Seguimos utilizando nuestro capital de manera eficiente y esperamos brindar más detalles sobre nuestro progreso con los ensayos de Fase 2 de PSC y SSc este verano. “

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

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