Chemomab Therapeutics Ltd. quarterly report, Q2 FY2021

Chemomab Therapeutics Ltd. — Q2 2021 Form 10-Q

Reporting period: Quarter and six months ended June 30, 2021. Financial statements are unaudited and presented in U.S. dollars unless otherwise noted. Chemomab is a clinical-stage biotechnology company; the March 2021 merger with Anchiano was accounted for as a reverse recapitalization, with Chemomab Ltd. as the accounting acquirer.

Business context and operating results

The company is developing CM-101, a CCL24-targeting antibody, for inflammatory and fibrotic diseases. Its lead programs include Phase 2 studies in primary sclerosing cholangitis (PSC) and non-alcoholic steatohepatitis (NASH); management expected to initiate a systemic sclerosis (SSc) Phase 2 study early the following year.

Chemomab had generated no revenue and reported no gross profit; margins are therefore not applicable. It remains loss-making, with research and development and general and administrative expenses as its principal operating costs.

MetricQ2 2021Q2 2020Six months 2021Six months 2020
RevenueNoneNoneNoneNone
Research and development expense$1.307m$0.847m$2.464m$2.399m
General and administrative expense$1.446m$0.254m$1.988m$0.406m
Net loss$2.770m$1.081m$4.474m$2.776m
Net loss per ordinary share$0.013$0.008$0.024$0.021

Financial position and cash flows

  • At June 30, 2021, cash and cash equivalents were $45.396m and short-term bank deposits were $21.524m, totaling approximately $66.9m. Total assets were $70.518m; total liabilities were $2.479m, including $0.392m of operating lease liabilities. The filing reports no borrowings.
  • Accumulated deficit was $28.169m; shareholders’ equity was $68.039m.
  • For the six months, operating cash use was $6.900m, investing cash use was $20.605m, and financing cash inflow was $61.227m. Cash, cash equivalents and restricted cash rose $33.722m to $45.449m.
  • Contractual commitments totaled $6.705m, including $3.546m for 2022 and $2.598m for 2023.

Material changes and financing

  • Q2 R&D expense rose 54% year over year, which management attributed primarily to increased clinical and preclinical activity. First-half R&D rose 3%.
  • Q2 G&A expense increased $1.192m to $1.446m; first-half G&A increased $1.582m to $1.988m. Management cited merger-related costs and the costs of becoming a public company.
  • Net loss increased 156% year over year in Q2 and 61% for the first half. First-half operating cash use increased $4.114m year over year.
  • The March merger and concurrent private placement brought approximately $45.5m in gross proceeds; the placement included warrants exercisable at $17.35 per ADS that could provide approximately $4.5m if fully exercised. A separate ATM facility authorized sales of up to $75m; through June 30, the company sold 699,806 ADSs for $15.9m gross.

Outlook, risks and unusual items

  • Management said existing cash resources were expected to fund projected cash requirements approximately through mid-2023. The company nevertheless expects to need substantial additional financing and had no commitments for future external funding. Additional equity financing could dilute shareholders; debt could increase fixed obligations and impose covenants.
  • Management expected R&D expenses to increase substantially as programs advance, and G&A expenses to rise to support development and public-company requirements.
  • COVID-19 disrupted trial sites, delayed PSC enrollment and affected recruitment rates. The company expanded recruiting to additional territories; further disruption and patient withdrawals remained possible.
  • Other notable items included the $1m sale of Anchiano’s pan-RAS and PDE10/β-catenin programs and a July 2021 shareholder-approved increase of 540,000 ADSs in the 2015 plan’s authorized shares.
  • No material change to previously disclosed risk factors was reported. Management said disclosure controls were effective as of June 30, 2021; internal-control procedures were being strengthened following the merger, with management’s assessment planned for the 2021 annual report.

Important facts for investors to verify

  • Whether cash use, clinical-trial spending and recruitment progress remain consistent with the stated mid-2023 runway, and how the company may finance operations thereafter.
  • Current status, timing and enrollment of the PSC and NASH trials and the planned SSc study, including any continuing COVID-19 effects.
  • Remaining ATM capacity, subsequent ADS sales, potential dilution from outstanding warrants and options, and the effect of the expanded 2015 plan.
  • Whether contractual commitments or other contingencies have changed since June 30, 2021; the filing reports no currently pending legal matter expected to have a material adverse effect.