Chemomab Therapeutics gibt Finanzergebnisse für das erste Quartal 2022 bekannt und gibt Unternehmensaktualisierungen bekannt

— Das Unternehmen veranstaltet heute, am 12. Mai um 8:00 Uhr ET, eine Telefonkonferenz für Investoren —

, /PRNewswire/ — Chemomab Therapeutics, Ltd. (Nasdaq: CMMB ), ein Biotechnologieunternehmen in der klinischen Phase, das sich auf die Entdeckung und Entwicklung innovativer Therapeutika für fibrotische und entzündliche Erkrankungen mit hohem ungedecktem Bedarf konzentriert, gab heute Finanz- und Betriebsergebnisse für das erste Quartal zum 31. März 2022 bekannt und legte ein Unternehmen vor aktualisieren.

“Während des Quartals haben wir weiterhin gute Fortschritte bei der Verfeinerung und Umsetzung von Überarbeitungen unseres klinischen Programms CM-101 gemacht, die darauf abzielen, das Gesamtentwicklungsrisiko zu verringern, die erhaltenen klinischen Daten zu maximieren, um die klinische Entscheidungsfindung zu erleichtern, und kritische Daten zu generieren, um den Fortschritt bis zur Registrierung zu unterstützen Studien”, sagte Dale Pfost, PhD, Chief Executive Officer von Chemomab. „Wir erweitern unsere Bemühungen bei primär sklerosierender Cholangitis (PSC) mit einer erweiterten klinischen Studie, die Patienten aus neuen Zentren in den USA und Europa rekrutiert und gleichzeitig eine wichtige Dosisfindungskomponente und eine Open-Label-Erweiterung hinzufügt. Wir werden eine Zwischenanalyse der derzeit in die PSC-Studie aufgenommenen Dosiskohorte zur Bewertung der Sicherheit und zur Bestätigung der geplanten Stichprobenumfänge für die CM-101-Dosiskohorten.

Dr. Pfost fügte hinzu: „Bei systemischer Sklerose (SSc) erwarten wir, dass das überarbeitete Studiendesign der Phase 2 einen beschleunigten Weg zu Proof-of-Concept-Daten ermöglicht und vor allem zusätzliche Informationen über die Aktivität von CM-101 bei der Modifizierung der Haut-, Lungen- und vaskuläre Pathophysiologie bei SSc-Patienten. Wir konzipieren diese Studie mit der Unterstützung wichtiger SSc-Meinungsführer und sind auf dem besten Weg, die Studie bis Ende des Jahres zu starten. Ich freue mich auch, Ihnen mitteilen zu können, dass wir sie jetzt abgeschlossen haben Aufnahme in unsere Phase-2-Studie zu Sicherheit, Pharmakokinetik und Biomarker-Leberfibrose, mit endgültigen Ergebnissen gegen Ende des Jahres erwartet.Wir setzen unser Kapital weiterhin effizient ein und freuen uns darauf, diesen Sommer weitere Einzelheiten zu unseren Fortschritten bei den PSC- und SSc-Phase-2-Studien bekannt zu geben. “

Aktuelle Höhepunkte:

• Ernennung zu Jack Lawler zum Vice President of Global Clinical Development Operations. Herr Lawler, der in den USA ansässig ist, bringt dem Unternehmen mehr als 20 Jahre vielfältige Erfahrung in der globalen klinischen Arzneimittelentwicklung mit.




• Chief Scientific Officer Dr. Adi Mor präsentierte auf der alle zwei Jahre stattfindenden International Rheumatology Conference in Israel „Blockierung von CCL24, einem neuartigen Ziel, das Entzündungsfibrose und Endothelschäden reguliert, zeigt vielversprechendes Potenzial als Behandlung für systemische Sklerose“. Studiendaten aus experimentellen Modellen und Patientenproben zeigten, dass CCL24, das Ziel von CM-101, in Haut- und Serumproben von Patienten mit diffusem SSc im Vergleich zu gesunden Personen überexprimiert wird. CCL24-Spiegel korrelierten auch mit fibrotischen Biomarkern und dem Fortschreiten der Krankheit. In einem experimentellen Mausmodell von SSc reduzierte CM-101 die Haut- und Lungenfibrose erheblich.




• Professor Francesco Del Galdo von der University of Leeds stellte auf dem 7. Systemic Sclerosis World Congress „CCL24 as a Marker of Worse Prognosis in diffuse cutan SSc: a Promising Novel Biological Target“ vor. Die Ergebnisse von Professor Del Galdo unterstützen die Rolle von CCL24 als potenzielles therapeutisches Ziel, indem sie erhöhte Serumspiegel von CCL24 bei Patienten mit diffusem kutanem SSc nachweisen. Hohe CCL24-Serumspiegel korrelierten mit der Krankheitsaktivität und einer schlechteren Prognose, was sich in einer hohen fibrotischen Aktivität und einer Verschlechterung der Lungenfunktion im Laufe der Zeit in einer Längsschnitt-Patientenkohorte widerspiegelte.




• Teilnahme an der 32. jährlichen Oppenheimer Healthcare Conference




• 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.