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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)

MetricQ1 2022Q2 2022Q3 2022
Revenues ($USD)$0 $0 $0
Research & Development ($USD)$1,506,308 $1,186,900 $1,037,111
General & Administrative ($USD)$1,744,918 $1,556,785 $1,433,699
Total Operating Expenses ($USD)$3,251,226 $2,743,685 $2,470,810
Operating Loss ($USD)$(3,251,226) $(2,743,685) $(2,470,810)
Interest Income ($USD)$3,173 $18,717 $78,902
Net Loss ($USD)$(3,261,773) $(2,724,968) $(2,391,908)
Diluted EPS ($)$(0.04) $(0.03) $(0.82) (post-split)

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

MetricQ1 2022Q2 2022Q3 2022
Cash & Cash Equivalents ($USD)$1,563,984 $2,878,147 $4,211,379
Investments ($USD)$21,963,818 $17,219,179 $14,128,120
Cash + Investments ($USD)$23.5M $20.1M $18.3M
Total Assets ($USD)$24,226,899 $21,456,932 $19,292,616
Total Stockholders’ Equity ($USD)$23,003,101 $20,713,089 $18,746,117
DebtNone outstanding in Q3 (no debt)

KPIs

KPIQ1 2022Q2 2022Q3 2022
Quarterly Cash Burn (approx.)~$3.1M ~$3.5M ~$1.9M
Non-cash expense included in net loss~$0.5M ~$0.5M ~$0.4M
Weighted Avg Shares (Basic & Diluted)86,726,347 86,981,684 2,903,403 (post-split)

Versus Estimates

MetricQ3 2022 ActualQ3 2022 ConsensusSurprise
Revenue ($USD)$0 N/A (Unavailable via S&P Global)N/A
EPS ($)$(0.82) (post-split) N/A (Unavailable via S&P Global)N/A

Wall Street consensus via S&P Global was unavailable for CWBR at the time of analysis; no estimate comparisons could be made.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CB5138-3 IND Filing2H 2023On track for 2H 2023 (Q2 PR/remarks) On track for 2H 2023, pending suitable formulation; newer formulations in animal testing Maintained (with formulation contingency)
Cash RunwayThrough 2H 2023“Sufficient capital… into the second half of 2023” (Q2 CFO) “Sufficient capital… through Q4 2023” (Q3 CFO) Raised/extended
Nasdaq Listing Status2022Extension to Nov 7, 2022 to regain $1 bid compliance (Q1 PR) Reverse split (1-for-30) completed Sept 23, 2022; compliance regained Improved
Revenue/Margins/OpEx2022No formal guidance providedNo formal guidance providedNo change

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
CB5138-3 Formulation & Injection Site ReactionsNew formulation work initiated; interim formulations identified; clean systemic safety profile but prior injection site reactions noted Interim formulations aggregated in vivo; newer formulations show better in vitro performance under stress; animal tests underway Iterative; risk persists; timeline maintained contingent on formulation
IND Timing for CB5138-3Expect filing in 2H 2023; “on track” reiterated “Assuming… formulating meets in vivo targets… remain on track to file… 2H 2023” Maintained with contingency
Target EngagementApproaches initiated to clarify MOA; biomarker planning for Phase 2 Broad cell surface receptor screen underway; preliminary data expected near-term Advancing discovery; updates pending
Capital Markets / ListingNasdaq granted extension to Nov 7 for bid compliance Reverse split executed; compliance regained; focus on institutional access Improved listing status
CB4211 PartneringActive partnering discussions; NASH interest improving Strategy unchanged; partnership remains preferred path Steady; external market-dependent
Runway & Burn“Into 2H 2023”; burn ~$3.1–$3.5M in Q1/Q2 Runway through Q4 2023; burn ~$1.9M in Q3 Extended runway; lower burn in Q3

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 .