Finanza USA

Chemomab Therapeutics annuncia i risultati finanziari del primo trimestre 2022 e fornisce aggiornamenti aziendali


— La società ospiterà una teleconferenza per gli investitori oggi, 12 maggio alle 8:00 ET —


, /PRNewswire/ — Chemomab Therapeutics, Ltd . (Nasdaq: CMMB ), una società di biotecnologie in fase clinica focalizzata sulla scoperta e lo sviluppo di terapie innovative per malattie fibrotiche e infiammatorie con elevati bisogni insoddisfatti, ha annunciato oggi i risultati finanziari e operativi per il primo trimestre terminato il 31 marzo 2022 e ha fornito un aggiornare.


“Durante il trimestre abbiamo continuato a fare buoni progressi nel perfezionamento e nell’implementazione delle revisioni del nostro programma clinico CM-101 volte a ridurre il rischio di sviluppo complessivo, massimizzare i dati clinici ottenuti per facilitare il processo decisionale clinico e generare dati critici per supportare l’avanzamento alla registrazione prove”, ha affermato Dale Pfost, PhD, amministratore delegato di Chemomab. “Stiamo ampliando i nostri sforzi nella colangite sclerosante primitiva (PSC) con uno studio clinico allargato che sta reclutando pazienti da nuovi siti negli Stati Uniti e in Europa, aggiungendo al contempo un importante componente di determinazione della dose e un’estensione in aperto. analisi ad interim della coorte di dose attualmente arruolata nello studio PSC per valutare la sicurezza e confermare le dimensioni del campione pianificate per le coorti di dose CM-101.


Il Dr. Pfost ha aggiunto: “Nella sclerosi sistemica (SSc), ci aspettiamo che il progetto di sperimentazione di Fase 2 rivisto consenta un percorso accelerato verso i dati di prova del concetto e, soprattutto, fornisca ulteriori informazioni sull’attività di CM-101 nel modificare il fisiopatologia cutanea, polmonare e vascolare osservata nei pazienti con SSc. Stiamo progettando questo studio con l’assistenza dei principali opinion leader del SSc e siamo sulla buona strada per avviare lo studio entro la fine dell’anno. Sono inoltre lieto di comunicare che ora abbiamo completato iscrizione al nostro studio di fase 2 sulla sicurezza, farmacocinetica e biomarcatori sulla fibrosi epatica, con letture finali previste per la fine dell’anno.Continuiamo a utilizzare il nostro capitale in modo efficiente e non vediamo l’ora di fornire ulteriori dettagli sui nostri progressi con gli studi di fase 2 PSC e SSc questa estate. “


In evidenza recenti:



  • Nominato Jack Lawler Vice President of Global Clinical Development Operations. Il Sig. Lawler, che ha sede negli Stati Uniti, porta l’azienda con oltre 20 anni di esperienza nello sviluppo di farmaci clinici clinici globali diversificati.

  • Il Direttore Scientifico Dr. Adi Mor ha presentato “Bloccare CCL24, un nuovo bersaglio che regola la fibrosi infiammatoria e il danno endoteliale, mostra un potenziale promettente come trattamento per la sclerosi sistemica” alla conferenza biennale internazionale di reumatologia in Israele. I dati dello studio provenienti da modelli sperimentali e campioni di pazienti hanno dimostrato che CCL24, l’obiettivo per CM-101, è sovraespresso in campioni di pelle e siero di pazienti con SSc diffusa rispetto a individui sani. I livelli di CCL24 erano anche correlati ai biomarcatori fibrotici e alla progressione della malattia. In un modello sperimentale murino di SSc, CM-101 ha ridotto profondamente la fibrosi cutanea e polmonare.

  • Il Professor Francesco Del Galdo dell’Università di Leeds ha presentato “CCL24 as a Marker of Worse Prognosis in diffuse cutanee SSc: a Promising Novel Biological Target” al 7th Systemic Sclerosis World Congress. I risultati del professor Del Galdo supportano il ruolo di CCL24 come potenziale bersaglio terapeutico, dimostrando livelli sierici elevati di CCL24 nei pazienti con SSc cutaneo diffuso. Livelli sierici elevati di CCL24 erano correlati con l’attività della malattia e una prognosi peggiore, come evidenziato dall’elevata attività fibrotica e dal deterioramento della funzione polmonare nel tempo in una coorte di pazienti longitudinali.

  • Ha partecipato alla 32a conferenza annuale di 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.



Il Dr. Pfost ha aggiunto: “Nella sclerosi sistemica (SSc), ci aspettiamo che il progetto di sperimentazione di Fase 2 rivisto consenta un percorso accelerato verso i dati di prova del concetto e, soprattutto, fornisca ulteriori informazioni sull’attività di CM-101 nel modificare il fisiopatologia cutanea, polmonare e vascolare osservata nei pazienti con SSc. Stiamo progettando questo studio con l’assistenza dei principali opinion leader del SSc e siamo sulla buona strada per avviare lo studio entro la fine dell’anno. Sono inoltre lieto di comunicare che ora abbiamo completato iscrizione al nostro studio di fase 2 sulla sicurezza, farmacocinetica e biomarcatori sulla fibrosi epatica, con letture finali previste per la fine dell’anno.Continuiamo a utilizzare il nostro capitale in modo efficiente e non vediamo l’ora di fornire ulteriori dettagli sui nostri progressi con gli studi di fase 2 PSC e SSc questa estate. “

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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