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BT

BIORA THERAPEUTICS, INC. (BIOR)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 delivered Phase 1 BT-600 success (precise colon delivery, 3–4x lower systemic exposure), advancing to a Phase 1B UC patient study toward year-end and setting up October ACG data presentation .
  • Financials: Net income of $6.5M driven by non-cash gains on warrants/derivatives; operating expenses were flat at $16.1M QoQ; revenue was $0.318M; diluted EPS was $(0.04) despite positive net income due to dilutive effects .
  • Strategic momentum: Active BioJet partnership talks with multiple large pharma; management anticipates concluding at least one near-term agreement; platform bioavailability >40% vs IV across molecule types .
  • Liquidity bridge: Up to $16M incremental funding from existing investors via tranches supports operations through partnership process .
  • Stock-reaction catalysts: Near-term partnership announcement, October ACG BT-600 data, Phase 1B UC start by year-end, and manufacturing scale readiness for NaviCap devices .

What Went Well and What Went Wrong

What Went Well

  • Phase 1 BT-600 met all objectives: >95% colon-release accuracy; delayed systemic detection at ~6 hours with Tmax at 8–10 hours; tissue concentrations above IC50 across distal colon sites; modeling indicates tissue ≥IC90 for at least 16 hours .
  • Management confidence and KOL validation: “We are thrilled to have met all our study objectives… our approach should lead to improved response and reduced toxicity for UC patients” — Adi Mohanty .
  • BioJet platform performance exceeded targets, showing >40% bioavailability vs IV across peptides, antibodies, and ASOs; partner interest confirmed with active negotiations .

What Went Wrong

  • Operating expenses remain elevated at $16.1M vs $14.9M prior year as SG&A and R&D investment continue; core G&A still burdened by legacy matters (targeted for elimination by year-end) .
  • Liquidity declined: cash, cash equivalents and restricted cash fell to $5.3M from $10.8M in Q1 and $15.2M in Q4 despite new funding commitments; dependence on external capital persists .
  • EPS optics: diluted EPS of $(0.04) alongside net income reflects complex capital structure and non-cash fair value changes, complicating Street comparability and fundamental signal .

Financial Results

MetricQ2 2023Q1 2024Q2 2024
Revenue ($USD Thousands)$2 $542 $318
Research & Development ($USD Thousands)$5,983 $7,005 $7,704
Selling, General & Administrative ($USD Thousands)$8,953 $9,053 $8,400
Total Operating Expenses ($USD Thousands)$14,936 $16,058 $16,104
Loss from Operations ($USD Thousands)$(14,934) $(15,516) $(15,786)
Net Income (Loss) ($USD Thousands)$(17,807) $(4,189) $6,465
EPS – Basic ($USD)$(1.47) $(0.14) $0.18
EPS – Diluted ($USD)$(1.47) $(0.14) $(0.04)

Liquidity and Capitalization

MetricQ4 2023Q1 2024Q2 2024
Cash, Cash Equivalents & Restricted Cash ($USD Thousands)$15,211 $10,820 $5,325
Total Liabilities ($USD Thousands)$132,636 $123,175 $107,585
Stockholders’ Deficit ($USD Thousands)$(101,421) $(100,185) $(89,322)

Operational KPIs

KPIQ2 2024
Colon-release accuracy (NaviCap, BT-600)>95% devices detected colon entry
Systemic exposure vs conventional oral tofacitinib3–4x lower systemic levels with NaviCap
PK timing (BT-600)First systemic detection ~6 hours; Tmax ~8–10 hours
Colon tissue exposureDistal colon biopsy sites above IC50; modeled ≥IC90 ≥16 hours post-dose
BioJet bioavailability (vs IV)>40% across multiple molecule types
Core OpEx spend (non-GAAP indicator)$11.7M in Q2; Q1 was $11.5M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BT-600 Phase 1B UC patient study initiation2H 2024“Initiation… anticipated during the second half of 2024” “Initiation… anticipated toward the end of 2024” Maintained; timing narrowed
BT-600 data disclosure pathwayQ2/Q3 2024“Topline SAD/MAD data toward end of Q2” “Present Phase 1 data at ACG in October 2024” Added conference milestone
BioJet partnership2024“Goal to confirm partner interest by mid-2024; on track toward a pharma partnership in 2024” “Active discussions with >1 large pharma; anticipate concluding at least one near-term agreement; remain on track for 2024” Confidence raised/clarified timing
Capital access2024~$31M raised over four months; notes reduced to ~$52M by end Q1 Up to $16M incremental funding in $4M tranches from existing investors Incremental facility added

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2023 and Q1 2024)Current Period (Q2 2024)Trend
NaviCap BT-600 clinical readoutsSAD met targets; 3–4x lower systemic PK vs oral; MAD completion expected Q2 Full Phase 1 met objectives; >95% colon-release accuracy; tissue above IC50; modeled ≥IC90; plan Phase 1B by year-end Execution progressing; expanded validation
BioJet performance and partnering15%+ target; 20–30%+ bioavailability in animals; active partner process by mid-2024 >40% bioavailability; active talks with >1 large pharma; anticipate ≥1 near-term partnership Performance improved; deal timing clarified
Capital structure and liquidityNotes reduced >$80M in 2023; ~$31M capital raised; further optimization planned Up to $16M funding from existing investors; bridge to partnership Liquidity bridged; still reliant on external capital
Manufacturing/supply readinessNot highlightedNaviCap capacity: several hundred now via CMOs, plan for several thousand in 12–18 months; automation ongoing Scaling plans in motion
KOL/external validationPlanned DDW presentation in May KOL event with leading gastroenterologists; ACG presentation scheduled Strengthened external engagement

Management Commentary

  • “Our Phase 1 clinical trial demonstrated the NaviCap platform’s ability to achieve higher tissue drug exposure by direct, topical delivery to the colon, and we are thrilled to have met all our study objectives.” — Adi Mohanty .
  • “We’re currently in active partnership discussions with more than one large pharma company… anticipate bringing at least one of these through to completion in the near term.” — Adi Mohanty .
  • “Operating expenses… were $14.5 million [ex-SBC], … core OpEx spend was $11.7 million in Q2… we are posting a $6.5 million net income position for the second quarter.” — Eric d’Esparbes .
  • “The platform continues to exceed its performance targets, with over 40% bioavailability compared to IV administration demonstrated across multiple molecule types.” — Company press release .
  • “We anticipate initiating a clinical study with BT-600 in UC patients towards the end of the year.” — Adi Mohanty .

Q&A Highlights

  • Partnership scope and negotiations: Talks have narrowed; BIOR aims to maximize value while maintaining optionality, potentially working with more than one partner; specifics pending near-term conclusion .
  • BT-600 tissue vs systemic delivery: NaviCap achieves high tissue exposure with minimal systemic levels, addressing JAK inhibitor toxicity concerns and enabling potential efficacy improvements vs dose-limited systemic delivery .
  • Drug absorption efficiency: Majority of colon-deposited drug is absorbed; residual amounts assessed, with more data expected at upcoming conferences .
  • Manufacturing capacity: NaviCap units can be produced in the hundreds now via CMOs, thousands planned in 12–18 months; automation underway for eventual larger-scale needs .
  • BioJet bioavailability context: ~40% vs IV approaches subcutaneous ranges (50–60%), achieved with minimal formulation change; viewed favorably by collaborators .

Estimates Context

  • Wall Street consensus from S&P Global was unavailable for BIOR for Q2 2024 due to missing CIQ mapping; as a result, we cannot provide standardized revenue/EPS estimate comparisons for this quarter. Guidance was qualitative (clinical/partnering milestones) rather than financial, and reported net income was primarily driven by non-cash fair value changes in warrant/derivative liabilities, which can complicate Street comparability .
  • If consensus becomes available, we would expect sell-side models to emphasize operating cash burn (core OpEx ~$11.7M) and milestone timing (Phase 1B start and partnership signing) rather than revenue/EPS near-term given de minimis revenue and non-cash EPS volatility .

Key Takeaways for Investors

  • Clinical validation: BT-600 Phase 1 success with precise colon delivery and favorable PK/safety profile sets up Phase 1B UC patient study by year-end and an October ACG data presentation — key clinical catalysts in Q4 2024 .
  • Platform leverage: NaviCap’s targeted delivery could optimize multiple UC drug classes (JAKs, TNFs, integrins) and enable combination therapy; BioJet’s >40% bioavailability offers needle-free potential with minimal reformulation — both expand strategic optionality .
  • Partnership timeline: Management anticipates at least one near-term BioJet agreement with a large pharma, a potential stock-moving event and funding/validation inflection point .
  • Liquidity bridge: Up to $16M tranche funding supports operations while concluding partnerships; however, cash fell to $5.3M at quarter-end, keeping focus on external capital and deal timing .
  • Financial optics: Net income and EPS are heavily impacted by non-cash fair value changes; focus on operating metrics (R&D progress, core OpEx/burn) for fundamental trajectory .
  • Execution readiness: Manufacturing partners and internal capabilities support scaling NaviCap to several thousand units within 12–18 months, aligning with clinical ramp .
  • Near-term trading implications: Headlines on partnership signing, ACG data quality, and Phase 1B initiation are likely to be primary stock catalysts; watch for any capital structure updates and additional funding arrangements .

Notes

  • Consensus estimates for BIOR were unavailable via S&P Global for Q2 2024; therefore, “vs estimates” comparisons are not presented. Values retrieved from S&P Global would be presented with an asterisk and disclaimer if available.