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CI

CohBar, Inc. (CWBR)·Q1 2022 Earnings Summary

Executive Summary

  • Q1 2022 delivered disciplined OpEx control with net loss of $3.3M (-$0.04 EPS), improving YoY from $4.0M (-$0.07 EPS); cash and investments were $23.5M with ~$3.1M quarterly burn, aligning with CFO commentary .
  • Strategic focus tightened on CB5138-3 (IPF) IND-enabling work and reformulation; IND timing maintained at H2 2023 after prior quarter’s delay, with systemic tolerability reinforced on the call .
  • IP portfolio strengthened: second U.S. patent for CB4211 (methods for obesity) and Japanese patent (CB4211/NASH), positioning for future Orange Book listing; management continues to seek a partner for CB4211 .
  • Nasdaq granted a 180-day extension to Nov 7, 2022 to regain $1 bid compliance; Board proposed reverse split to preserve listing, a governance catalyst that could affect liquidity and access to capital .
  • Near-term stock narrative likely shaped by patent expansion, Nasdaq compliance actions, and progress updates on CB5138-3 preclinical/IND work; no revenue and limited near-term commercial catalysts temper upside until clinical milestones emerge .

What Went Well and What Went Wrong

What Went Well

  • Strengthened IP position: issuance of second U.S. patent for CB4211’s use in obesity and a Japanese patent for CB4211 compositions and NASH, enhancing partnering attractiveness; CEO: “This most recent patent is expected to be eligible for listing in the FDA Orange Book upon approval…” .
  • Program execution: CB5138-3 IND-enabling studies on track, reformulation progressing, systemic safety profile “continues to look quite clear”; Acting CMO described compelling antifibrotic preclinical data in IPF .
  • Cost discipline and liquidity: R&D down YoY ($1.5M vs $2.7M), net loss improved YoY; cash and investments $23.5M, burn ~$3.1M, with CFO estimating runway into H2 2023 .

What Went Wrong

  • IND timing pushout sustained: CB5138-3 IND target remained H2 2023 (shifted from a 2022 goal articulated last year), delaying human PoC timelines .
  • Nasdaq non-compliance risk: required extension and potential reverse split underscore listing pressure; can add overhang until resolved .
  • No revenue and limited near-term catalysts: continued operating losses with zero revenue; partnering for CB4211 still pending, constraining external validation/commercial visibility .

Financial Results

MetricQ3 2021Q4 2021Q1 2022
Revenue ($USD Millions)$0.0 $0.0 $0.0
EPS (GAAP, $)-$0.05 -$0.04 -$0.04
Net Loss ($USD Millions)$3.4 $2.8 $3.3
R&D Expense ($USD Millions)$1.6 $0.8 $1.5
G&A Expense ($USD Millions)$1.8 $2.0 $1.7
Total OpEx ($USD Millions)$3.41 $2.78 $3.25
Cash & Investments ($USD Millions)$15.0 $26.2 $23.5
Cash Burn ($USD Millions)$3.3 $3.0 $3.1

Notes:

  • Operating loss was $3.25M in Q1 (consistent with OpEx and zero revenue) .
  • Weighted average shares rose to 86.7M in Q1 (from 79.1M in Q4), diluting EPS but still at -$0.04 .

Segment breakdown: N/A (no revenue) .

KPIs (selected):

  • Cash runway: “sufficient capital to finance operations into the second half of 2023” (management commentary) .
  • Program status: CB5138-3 IND enabling ongoing; reformulation progressing .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CB5138-3 IND filing timelineRegulatoryGoal to file IND and initiate First-in-Human in 2022 IND expected H2 2023 (set in Q4), maintained in Q1 2022 Lowered/Delayed in Q4; Maintained in Q1
Cash runwayLiquidityN/ASufficient capital into H2 2023 (CFO commentary) New disclosure
Nasdaq listing complianceCorporateN/A180-day extension to Nov 7, 2022; reverse split proposal to regain $1 bid New disclosure

No financial guidance on revenue, margins, OpEx percentages, or tax provided; R&D allocation noted qualitatively may “hockey stick” later in year .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2021 and Q4 2021)Current Period (Q1 2022)Trend
CB5138-3 (IPF) timingTargeted 2022 IND initiation IND-enabling on track; IND filed H2 2023; reformulation underway; systemic safety positive Delayed then maintained; execution progressing
CB4211 partnering & IPPositive Phase 1a/1b topline; foundational U.S. patent for NASH; seeking partner Second U.S. patent (obesity methods); Japanese patent (NASH/compositions); Orange Book eligibility upon approval Strengthening IP; partnering effort ongoing
Mito+ platform investmentBroad platform and discovery engine highlighted Increased investment to discover peptide families; >100 peptides identified; 400+ MDP publications cited Elevated focus within resource constraints
Delivery modality & dosingNot detailed previouslyPreference for subcutaneous; inhaled not pursued for IPF; likely daily dosing, to be refined post PK/human data Clarified modality; dosing evolving
R&D spend cadenceN/AExpect “hockey stick” later in year (45–60% OpEx historically); timing-dependent Increasing later-year spend
Nasdaq compliance & capital accessFinancing in Nov 2021; no compliance issue noted Extension to Nov 7, 2022; reverse split proposal to preserve listing and capital market access New governance priority

Management Commentary

  • CEO: “I am optimistic about the year ahead… we remain focused on execution… aligned our resources to focus on three main areas – the advancement of our IPF program toward the clinic, the discovery and development of additional novel peptide families with our Mito+ platform, and securing a potential partner for CB4211.”
  • Acting CMO: “In our ongoing toxicology work, the systemic safety profile of CB5138-3 continues to look quite clear… we expect our initial clinical study will be a Phase I SAD/MAD in healthy volunteers, followed quickly by a multicenter Phase II in IPF patients.”
  • CEO on IP expansion: “The new U.S. patent… is expected to be eligible for listing in the FDA Orange Book upon approval of CB4211… Japanese patent covering CB4211 and related compositions, as well as medicines… for treating NASH.”
  • CFO on runway and listing: “We continue to be in a solid financial position… $23.5 million in cash and investments… we continue to estimate that we have sufficient capital to finance our operations into the second half of 2023… NASDAQ has granted us an extension until November 7… reverse stock split… designed to enable us to regain NASDAQ compliance.”

Q&A Highlights

  • Delivery approach: Team favors non-oral peptide delivery; subcutaneous accepted by IPF patients; inhaled delivery not pursued currently .
  • Dosing frequency: Likely daily SC injection; final frequency depends on reformulation PK and human data; iterative formulation process described .
  • Patent life: CB4211 U.S. patents expected to expire in 2037; Japanese counterpart similarly positioned; broad jurisdictional filings pending .
  • R&D cadence: Spend expected to “hockey stick” later in the year; historical R&D allocation 45–60% of OpEx depending on timing .
  • Resource allocation: Majority of spend on CB5138-3; incremental discovery work continues under Mito+ with near-term clinical expansion contingent on funding .

Estimates Context

  • S&P Global consensus for CWBR’s Q1 2022 EPS and revenue was unavailable via our estimates tool due to missing CIQ mapping; as a pre-revenue biotech, reported revenue was $0 and GAAP EPS was -$0.04, so we cannot assess beats/misses versus Street consensus for this quarter . Values retrieved from S&P Global were unavailable.

Key Takeaways for Investors

  • Liquidity supports operations into H2 2023; monitor burn trajectory and potential financing needs as IND work intensifies in late 2022/2023 .
  • CB5138-3 remains the central value driver; IND-enabling progress and reformulation updates are the critical milestones before Phase I initiation in 2023 .
  • IP is expanding meaningfully for CB4211 (obesity/NASH), improving partnership prospects; however, partnering remains the gating item for further development and non-dilutive validation .
  • Nasdaq listing overhang persists until compliance regained; reverse split vote is a near-term governance catalyst affecting liquidity and investor base composition .
  • Expect R&D spend to ramp (“hockey stick”) later in the year; OpEx mix may shift toward program acceleration as IND approaches—plan for higher cash usage .
  • No revenue and limited near-term commercial catalysts suggest trading will key off patent news, governance actions, and preclinical/IND updates; clinical entry in 2023 becomes the next major inflection point .
  • For positioning: maintain event-driven exposure around IND progress and Nasdaq actions; reassess size near reverse split decision and as CB5138-3 safety/PK data emerge post-IND .