Chemomab Therapeutics(US:CMMB)2022-11-09 16:00Product Development - Chemomab is focused on developing CM-101, a monoclonal antibody targeting CCL24, for treating fibrotic and inflammatory diseases with high unmet needs [61]. - CM-101 is currently in Phase 2 clinical trials for primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc), with an expected increase in study size to 93 patients [64][67]. - The PSC trial will include a dose-finding component with cohorts of 5 mg/kg, 10 mg/kg, and 20 mg/kg, and an open-label extension phase lasting 48 weeks [67]. - An interim safety analysis for the PSC trial is expected to be completed by the end of 2023, which will support the evaluation of the higher 20 mg/kg dose [68]. - The company plans to finalize the design of a Phase 2 trial in SSc and expects to launch it around the end of 2022 [70]. Financial Performance - The company has not generated any revenue to date and does not expect to until regulatory approval and commercialization of a product candidate [77]. - The net loss for the three months ended September 30, 2022, was $8.1 million, compared to a net loss of $3.0 million for the same period in 2021, representing an increase of $5.1 million, or 172% [85]. - The net loss for the nine months ended September 30, 2022, was $19.4 million, compared to a net loss of $7.4 million for the same period in 2021, representing an increase of $11.9 million, or 160% [85]. - Net cash used in operating activities for the nine months ended September 30, 2022, increased by $5.2 million, or 55%, compared to the same period in 2021, primarily related to the increase in net loss [97]. - The company's accumulated deficit at September 30, 2022, was $55.5 million, with cash, cash equivalents, and short-term deposits totaling approximately $46.5 million [92]. Expenses - Research and development expenses are anticipated to increase substantially as the company advances its product candidates, particularly in later-stage clinical trials [81]. - For the three months ended September 30, 2022, research and development expenses increased by approximately $3.9 million, or 265%, compared to the same period in 2021, primarily due to increased clinical and preclinical activities [86]. - For the nine months ended September 30, 2022, research and development expenses rose by approximately $7.1 million, or 180%, compared to the same period in 2021, also driven by increased clinical and preclinical activities [87]. - General and administrative expenses are expected to rise due to increased headcount and activities related to supporting research and development, as well as expanding presence in the U.S. [83]. - General and administrative expenses for the three months ended September 30, 2022, increased by approximately $1.5 million, or 106%, compared to the same period in 2021, mainly due to increased salaries and related benefits expenses [88]. - General and administrative expenses for the nine months ended September 30, 2022, increased by approximately $5.4 million, or 160%, compared to the same period in 2021, primarily due to non-cash share-based expenses and increased salaries [89]. Capital and Funding - A shelf registration statement was filed for the issuance of up to $200 million in securities, with an ATM facility allowing for the sale of up to $75 million in ADSs [72]. - As of June 30, 2021, the company sold 699,806 ADSs for approximately $15.9 million under the sales agreement [72]. - The company's contractual commitments at September 30, 2022, totaled $9.5 million, with $1.9 million due in the remainder of 2022 and $6.9 million in 2023 [100]. Accounting and Valuation - The fair value of options granted as equity awards is estimated using a Black-Scholes options pricing model, with significant assumptions including share price, expected volatility, and expected option term [108]. - The expected volatility is estimated based on the volatility of similar companies in the biotechnology sector, as the company lacks specific historical volatility information [108]. - The risk-free interest rate used in the model is based on the yield from governmental zero-coupon bonds with an equivalent term [108]. - The expected option term for employee and director grants is calculated using the "simplified" method, while grants to non-employees are based on the contractual term [108]. - The company has historically not paid dividends and has no plans to issue dividends in the future [108]. - The company is classified as an emerging growth company and is not required to provide certain market risk disclosures [110]. - Recent accounting pronouncements are discussed in the Summary of Significant Accounting Policies in the 2021 Annual Report [109].