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CI

CohBar, Inc. (CWBR)·Q2 2022 Earnings Summary

Executive Summary

  • Q2 2022 delivered lowered operating expenses and a narrower net loss, with cash and investments at $20.1M and quarterly cash burn of approximately $3.5M, leaving capital sufficient into the second half of 2023 .
  • IND for lead IPF candidate CB5138-3 remains on track for the second half of 2023; formulation work showed promising interim results and a clean systemic safety profile in IND-enabling studies, though prior injection site reactions remain a focus .
  • Shareholders approved a reverse stock split (up to 1-for-30) to support maintaining Nasdaq listing, following an earlier extension to November 7, 2022 to regain minimum bid compliance—an important capital markets catalyst for future fundraising and partnership visibility .
  • R&D ($1.2M) fell ~54% YoY on timing of preclinical/clinical costs, and G&A ($1.6M) declined ~38% YoY primarily due to lower compensation and stock-based comp following the former CEO’s departure—improving loss per share to $(0.03) from $(0.08) YoY .
  • Wall Street consensus estimates from S&P Global for Q2 2022 were unavailable; framing and narrative shifts suggest focus for investors on execution milestones (IND filing, formulation advances, and Nasdaq compliance) rather than near-term financial beats/misses .

What Went Well and What Went Wrong

What Went Well

  • “IND for CB5138-3 on track for second half of 2023,” with formulation progress and expanding discovery pipeline (Mito+) supporting future catalysts .
  • Systemic safety profile of CB5138-3 looked clean in IND-enabling studies, bolstering confidence for first-in-human after IND clearance .
  • Cost discipline: R&D and G&A declined sharply YoY, driving a narrower net loss and improved EPS; management reiterated capital sufficiency into H2 2023 .

What Went Wrong

  • No revenues; company remains pre-revenue and reliant on external capital/partnerships, with focus on pipeline execution rather than near-term P&L .
  • Injection site reactions previously reported for peptide programs still require mitigation in formulation work to support clinical success .
  • S&P Global consensus estimates were unavailable, limiting near-term beat/miss framing; investors must lean on execution milestones and narrative momentum rather than consensus comparison (S&P Global consensus unavailable).

Financial Results

Quarterly Comparison

MetricQ4 2021Q1 2022Q2 2022
Cash & Investments ($USD Millions)$26.2 $23.5 $20.1
R&D Expense ($USD Millions)$0.8 $1.5 $1.2
G&A Expense ($USD Millions)$2.0 $1.7 $1.6
Total Operating Expenses ($USD Millions)$2.8 $3.25 $2.74
Net Loss ($USD Millions)$2.79 $3.26 $2.72
Diluted EPS ($USD)$(0.04) $(0.04) $(0.03)
Cash Burn ($USD Millions)~$3.0 ~$3.1 ~$3.5

Notes: Revenue was $0 in all periods; margin metrics (e.g., Net Income Margin %) are not meaningful without revenue .

Year-over-Year (Q2 2022 vs Q2 2021)

MetricQ2 2021Q2 2022
R&D Expense ($USD Millions)$2.62 $1.19
G&A Expense ($USD Millions)$2.58 $1.56
Net Loss ($USD Millions)$5.22 $2.72
Diluted EPS ($USD)$(0.08) $(0.03)

Estimates vs Actuals (Q2 2022)

MetricConsensus EstimateActualBeat/Miss
Revenue ($USD Millions)N/A (S&P Global consensus unavailable)$0.00 N/A
Primary EPS ($USD)N/A (S&P Global consensus unavailable)$(0.03) N/A

S&P Global consensus was unavailable for CWBR Q2 2022; results comparison to estimates cannot be determined.

Segment Breakdown

No reportable segments disclosed; company is a clinical-stage biotech with no revenue .

KPIs

KPIQ4 2021Q1 2022Q2 2022
Cash Burn ($USD Millions)~$3.0 ~$3.1 ~$3.5
Cash & Investments ($USD Millions)$26.2 $23.5 $20.1
Capital Sufficiency (Mgmt)N/A“Into H2 2023” “Into H2 2023”

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CB5138-3 IND Filing TimelineH2 2023On track for H2 2023 On track for H2 2023 Maintained
Capital SufficiencyThrough H2 2023Sufficient capital into H2 2023 Sufficient capital into H2 2023 Maintained
Nasdaq Listing Compliance Plan2022180-day extension to Nov 7, 2022 Shareholders approved reverse split (up to 1-for-30) to support compliance Execution Progress

No formal revenue, margin, OpEx, OI&E, or tax rate guidance was issued.

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2021 and Q1 2022)Current Period (Q2 2022)Trend
IPF Program (CB5138-3)Focused pipeline; IND targeted H2 2023 ; IND-enabling on track; initial clinical plan outlined (SAD/MAD then Phase II) IND on track; clean systemic safety; advancing improved formulations; rapid start post-IND Improving execution confidence
Formulation & Injection Site ReactionsIterative formulation to improve delivery and mitigate injection site reactions; daily SC dosing expected but subject to PK Promising interim formulations; prior injection site reactions acknowledged; next in-vivo tests planned Addressing technical risks
Nasdaq ComplianceFinancing completed Q4 2021 ; NASDAQ extension to Nov 7, 2022; reverse split proposal in proxy Shareholder approval of reverse split to maintain listing De-risked listing status
CB4211 Partnering/NASHSeeking partner; IP portfolio expanded Active BD discussions; optimism given recent NASH investor/big pharma interest Ongoing momentum
Mito+ Discovery PlatformDiscovery focus highlighted Expanded peptide library; broader screening; target engagement work Expanding discovery scope

Management Commentary

  • “We remain excited about the opportunity for CB5138-3… moving forward with promising interim formulations… planned IND filing in the second half of 2023.” – CEO, Dr. Joseph Sarret .
  • “Our IND-enabling studies… systemic safety profile looks clean… gives us additional confidence as we move forward with testing new CB5138-3 formulations.” – SVP Research, Dr. Kent Grindstaff .
  • “We… expect to kick off the clinical program quickly after IND approval.” – Acting CMO, Dr. Nick Vlahakis .
  • “We continue to be in a solid financial position… $20.1 million in cash and investments… quarterly burn approximately $3.5 million… we have no debt… sufficient capital to finance operations into the second half of 2023.” – CFO, Jeff Biunno .
  • “Shareholders approved… reverse stock split… maintain our listing on the NASDAQ exchange… greater access to capital… attracting high-quality institutional investors and commercial partners.” – CFO, Jeff Biunno .

Q&A Highlights

  • Target engagement: Management is pursuing new approaches to validate targets and biomarkers but could not disclose specifics; timing updates will follow validation .
  • Formulation selection and manufacturing: Iterative development with in-vivo confirmation to mitigate injection site reactions and improve exposure; manufacturing expected to be standard with no unusual complexities .
  • Delivery modality and dosing frequency: Non-oral (subcutaneous) delivery favored; daily dosing plausible but contingent on PK from reformulated product and clinical data; inhaled approach not currently planned for IPF .
  • CB4211 partnering: Active discussions; sector momentum in NASH expected to benefit partnering prospects .
  • OpEx cadence: R&D spend likely to “hockey stick” later in the year as programs advance; historical allocation ranges cited, but no precise guidance .

Estimates Context

  • S&P Global Wall Street consensus for CWBR Q2 2022 was unavailable at the time of analysis; as a pre-revenue micro-cap biotech focused on pipeline execution, near-term estimates are limited. Management framing emphasizes execution milestones (IND, formulation, Nasdaq compliance) over near-term P&L benchmarks (S&P Global consensus unavailable) .
  • With estimates unavailable, analysts may need to adjust coverage frameworks toward milestone-driven valuation and liquidity/partnership catalysts rather than quarterly EPS/revenue comparisons (S&P Global consensus unavailable).

Key Takeaways for Investors

  • Balance sheet supports execution: $20.1M cash/investments and ~($3.5M) quarterly burn provide runway into H2 2023, aligning with CB5138-3 IND timing .
  • Clinical pathway clarity: Clean systemic safety and formulation advances increase confidence in rapid initiation post-IND; watch for in-vivo formulation data and IND submission timing .
  • Listing de-risked: Reverse split approval and prior Nasdaq extension mitigate delisting risk, improving access to capital and BD optics .
  • Cost discipline improving P&L optics: Significant YoY declines in R&D and G&A reduce net loss and EPS, though revenue remains $0 in preclinical stage .
  • Partnership optionality: Expanded CB4211 IP and favorable NASH sentiment may catalyze partnering; monitor BD updates .
  • Near-term trading implications: Headlines around IND progress, formulation data, and Nasdaq compliance actions are key stock drivers; absence of consensus estimates shifts attention to milestone news flow .
  • Medium-term thesis: If CB5138-3 advances on schedule with supportive early human safety/PK, CohBar’s Mito+ platform differentiation and antifibrotic potential could justify re-rating contingent on clinical readouts and capital access .