CI
CohBar, Inc. (CWBR)·Q3 2022 Earnings Summary
Executive Summary
- Q3 2022 maintained operational focus on advancing CB5138-3 for IPF; management reiterated the IND timeline for 2H 2023, contingent on identifying a formulation that mitigates injection-site aggregation issues .
- Cash and investments were $18.3M, quarterly cash burn was ~$1.9M, and management guided runway through Q4 2023 (extended from “into 2H 2023” in Q2), with no debt .
- CohBar executed a 1-for-30 reverse stock split on Sept 23, regaining compliance with Nasdaq’s $1 minimum bid price, improving access to capital and potential institutional interest .
- No revenue; net loss improved year over year; EPS comparability affected by the reverse split (Q3 post-split vs prior quarters pre-split) .
- Near-term catalysts: formulation in vivo results and target engagement data (management “hoping” by year-end), and progress toward IND submission for CB5138-3; risks centered on formulation iteration potentially impacting timeline and exposure .
What Went Well and What Went Wrong
What Went Well
- CB5138-3 IND timeline reiterated (2H 2023), with newer formulations showing improved in vitro aggregation profile under physiological stress; animal testing underway to validate in vivo performance .
- Capital markets actions: reverse split completed; Nasdaq compliance regained, supporting liquidity and institutional access. “By implementing the reverse split, we have maintained our listing on the NASDAQ Exchange…” .
- Operating discipline: reduced R&D and G&A vs prior year; net loss narrowed year over year. “We continue to operate the company in a prudent financial manner…” .
What Went Wrong
- Formulation setbacks: Interim formulations that looked promising in vitro still aggregated/gelled in vivo, causing local deposition at injection sites; prompted additional formulation iterations .
- Continued pre-revenue profile with reliance on cash runway and capital market access; micro-cap market turbulence noted by management as a headwind .
- EPS comparability and dilution optics complicated by reverse split; investors should note pre/post-split share counts when assessing per-share trends .
Financial Results
Income Statement Summary (no revenue; expenses and loss)
Note: Q1/Q2 EPS reflect pre-split share counts (~86.7M and ~87.0M avg shares), Q3 reflects post-split (~2.90M avg shares) .
Balance Sheet / Liquidity
KPIs
Versus Estimates
Wall Street consensus via S&P Global was unavailable for CWBR at the time of analysis; no estimate comparisons could be made.
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “Assuming that these formulations meet our in vivo performance targets, we remain on track to file our IND in the second half of 2023.” — CEO, Q3 prepared remarks .
- “We ended Q3 2022 with $18.3 million in cash and investments… we estimate that we have sufficient capital to finance our operations through the fourth quarter of 2023.” — CFO, Q3 prepared remarks .
- “By implementing the reverse split, we have maintained our listing on the NASDAQ Exchange, which affords us greater access to capital… and an increased chance of attracting high-quality institutional investors and commercial partners.” — CEO, Q3 prepared remarks .
- “This past year has been a challenging one… turbulence in the capital markets… disproportionate impact on micro-cap biotech companies.” — CEO, Q3 prepared remarks .
- “We now expect data on both… target engagement and improved formulations in the near future…” — CEO, Q3 prepared remarks .
Q&A Highlights
- Timing of formulation/target engagement data: Management is “hoping” for near-year-end readouts but emphasized dependence on CROs; exact timing uncertain .
- IND timeline risk management: Management reiterated the IND timing depends on next data set; if further formulation work is required, timeline impact will depend on proximity to performance targets and specific data outcomes .
- Clarifications: Process is iterative; manufacturing for contemplated formulations not expected to be atypical or a significant hurdle .
Estimates Context
- Wall Street consensus (S&P Global) for Q3 2022 revenue and EPS was unavailable for CWBR at the time of analysis; therefore, we cannot assess beats/misses versus consensus. Estimate comparisons are omitted accordingly.
- Implication: With no revenue and evolving share count due to the reverse split, per-share optics are less comparable; investors should focus on cash runway, burn, and clinical milestone timing .
Key Takeaways for Investors
- IND timeline maintained for CB5138-3 (2H 2023) but contingent on successfully mitigating injection-site aggregation; near-term formulation data is the critical catalyst. A positive in vivo performance in animals would likely de-risk the path to IND .
- Runway extended to Q4 2023 with lower Q3 burn (~$1.9M); funding risk moderated in the near term, but progress remains sensitive to capital market conditions and potential partnership milestones .
- Reverse split and regained Nasdaq compliance should help sustain listing and potentially expand the investor base; reduces near-term listing risk and supports optionality for future financing .
- Expense discipline evident (R&D/G&A down YoY); focus remains on CB5138-3 preclinical derisking and target engagement work, which may inform biomarker selection and Phase 2 design .
- Trading setup: Watch for any company updates on animal testing of new formulations and preliminary receptor screen results (management “hoping” by year-end); either update could drive stock volatility given the binary nature of formulation success .
- Medium-term thesis: If CB5138-3 advances to IND on schedule and Phase 1 initiates quickly thereafter, IPF’s sizable market and need for better-tolerated therapies underpin strategic value; partnership for CB4211 remains a call option on NASH/obesity .
- Risk factors: Additional formulation iterations may be needed; timeline sensitivity remains. Pre-revenue profile and micro-cap biotech market turbulence can amplify funding and execution risk .