Sign in

You're signed outSign in or to get full access.

BT

bioAffinity Technologies, Inc. (BIAF)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 revenue of $1.45M declined 38% YoY as the company exited unprofitable pathology services, but CyPath Lung testing revenue rose sharply; net loss widened primarily due to non-cash warrant remeasurement .
  • Commercial traction accelerated: Q3 CyPath Lung sales volume +95% QoQ, with VA adoption and mid-Atlantic expansion; October test volume was +111% above the 2025 YTD monthly average .
  • Costs trended lower: direct costs -38% YoY; operating expenses -14% YoY; cash improved to $7.7M after ~$10.4M Q3 equity raises; Nasdaq compliance regained in October .
  • Results vs estimates: Revenue slightly beat ($1.45M vs $1.41M*), but EPS missed (-$4.74 vs -$2.70*), with the EPS delta largely reflecting warrant revaluation . Values with asterisk from S&P Global.

What Went Well and What Went Wrong

  • What Went Well

    • Record Q3 CyPath Lung momentum: “Sales … reached a record high … reflecting growing adoption by VA hospitals and market expansion in the mid-Atlantic region.”
    • Cost discipline: “Direct costs and expenses were $0.9 million, a 38% decrease … driven by cost‑saving initiatives implemented in March 2025.”
    • Balance sheet and listing: ~$10.4M Q3 equity proceeds; regained Nasdaq compliance (subject to panel monitor) .
    • CEO tone: “The strong increase in CyPath Lung testing revenue reflects growing confidence among physicians who are recognizing our test’s ability to detect early-stage lung cancer …”
  • What Went Wrong

    • Headline revenue fell: Q3 revenue $1.45M vs $2.35M prior year as the company exited unprofitable pathology services to refocus on CyPath Lung .
    • Loss widened: Q3 net loss was $(5.05)M vs $(2.00)M prior year, driven mostly by a $(2.75)M non-cash loss from remeasurement of warrants .
    • Going‑concern risk persists: despite cash of $7.7M, management disclosed substantial doubt about continuing as a going concern without further capital beyond roughly May 2026 .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Revenue ($)$2,350,386 $1,269,483 $1,446,066
Loss from Operations ($)$(1,973,864) $(2,515,560) $(2,292,846)
Net Loss ($)$(2,000,840) $(4,060,787) $(5,051,084)
Diluted EPS ($)$(4.84) $(0.17) $(4.74)
Net Income Margin (%)(−85.1%) (−319.8%) (−349.3%)
Operating Margin (%)(−84.0%) (−198.3%) (−158.6%)

Notes: EPS in Q3 2025 reflects retroactive adjustment for the 1‑for‑30 reverse split; Q2 2025 EPS in the August release is pre-split and not strictly comparable .

Results vs S&P Global consensus (Q3 2025)

MetricActualConsensus*Surprise
Revenue ($)$1,446,066 $1,411,000*+2.5%
EPS ($)$(4.74) $(2.70)*Miss

Values marked * retrieved from S&P Global.

Segment revenue (Q3)

SegmentQ3 2024 Revenue ($)Q3 2025 Revenue ($)
Diagnostic R&D$1,731 $0
Laboratory Services (incl. CyPath Lung)$2,348,655 $1,446,066
Total$2,350,386 $1,446,066

KPIs

KPIQ3 2024Q3 2025
CyPath Lung tests processed (units)172 385
CyPath Lung testing revenue ($)$133,000 $296,000
QoQ sales volume change+95% (vs Q2)
Oct-2025 test volume vs 2025 YTD monthly avg+111%
9M tests delivered (units)393 775
9M CyPath Lung revenue ($)$332,000 $619,000

Cost and cash highlights

  • Direct costs: $0.94M (−38% YoY)
  • Operating expenses: $3.74M (−14% YoY)
  • Cash & equivalents: $7.67M (Sep 30, 2025) vs $1.11M (Dec 31, 2024)

Guidance Changes

The company did not issue quantitative revenue, EPS, margin, or expense guidance in its Q3 materials. Commentary emphasized continued commercial focus on CyPath Lung, VA adoption, and clinical development planning without specific ranges .

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY/Q4 2025N/ANo quantitative guidance provided
EPSFY/Q4 2025N/ANo quantitative guidance provided
OpEx / MarginsFY/Q4 2025N/ANo quantitative guidance provided
OtherNo formal guidance on segments/dividends

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was filed; themes below reflect management commentary across Q1–Q3 releases and the 10‑Q.

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
Commercial momentum (VA/mid-Atlantic)Texas beta launch; building momentum July tests +72% vs H1 avg; record June/July Record Q3 sales; VA adoption; +95% QoQ volume Accelerating
Pricing/reimbursementList price raised to $2,900 Reinforced pricing and logistics build-out Focus on adoption; no new pricing disclosed Stable
Cost actionsTargeted actions to cut ~$3.8M/yr Direct costs down YoY Direct costs -38% YoY; OpEx -14% YoY Improving
R&D/clinical plansPivotal trial planning CMO appointed; pivotal strategy Prep for longitudinal study; higher clinical spend Advancing
AI/technologyFlow cytometry + AI platform highlighted CyPath Lung AI performance reiterated Consistent
IP/patentsAustralian application acceptance U.S., China, Canada, Australia patents US notice of allowance; Australia acceptance Expanding
Capital/ListingWarrant inducement; May offering planned $3.25M offering; ATM program; Nasdaq deficiency notices ~$10.4M Q3 equity raises; Nasdaq compliance regained Stabilizing

Management Commentary

  • “Our primary focus was on driving the adoption of CyPath Lung while maintaining fiscal discipline.” — CEO Maria Zannes
  • “We raised approximately $10.4 million in gross proceeds … and are seeing the results of our targeted strategic actions … to discontinue certain unprofitable pathology services.” — CEO Maria Zannes
  • “Performance metrics showed … a 77% increase in the number of new patients … and greater patient compliance for at‑home sample collection and return.” — CEO Maria Zannes (Oct 7 press)
  • “Every early cancer detected means a life that may be saved, and every unnecessary invasive procedure avoided means a patient spared from risk, anxiety and cost.” — CMO Gordon Downie, MD, PhD

Q&A Highlights

  • Clarified drivers of revenue mix shift: exit from unprofitable pathology services in favor of higher‑margin CyPath Lung commercialization .
  • Addressed losses: Q3 net loss increase was primarily due to non‑cash warrant liability remeasurement; operating loss improved QoQ .
  • Discussed growth vectors: VA adoption, mid‑Atlantic expansion, clinical study preparations, and continued IP progress .

Estimates Context

  • Revenue slightly exceeded S&P Global consensus ($1.45M vs $1.41M*), while EPS missed due to non‑cash warrant revaluation and ongoing investment in commercialization (actual $(4.74) vs $(2.70)*) .
  • Coverage depth remains thin (1 estimate each for revenue and EPS)*, suggesting higher variability in expectations and potential for outsized stock reactions on new datapoints. Values with asterisk retrieved from S&P Global.
MetricActualConsensus*Surprise
Revenue ($)$1,446,066 $1,411,000*+2.5%
EPS ($)$(4.74) $(2.70)*Miss

Values marked * retrieved from S&P Global.

Key Takeaways for Investors

  • The strategic mix shift is working operationally: CyPath Lung volumes and revenue are ramping, with VA adoption and mid‑Atlantic expansion driving record Q3 and a strong October .
  • Headline revenue is lower YoY by design (exit of unprofitable services), but unit economics should improve as mix tilts to CyPath Lung; direct costs fell 38% YoY .
  • The widened GAAP loss is mostly non‑operational (warrant remeasurement); operating loss improved QoQ and operating margin improved sequentially .
  • Liquidity improved (cash $7.7M after ~$10.4M raises) and Nasdaq compliance was regained, but management still cites substantial doubt under going‑concern—expect continued financing activity absent a step‑up in operating cash flow .
  • Catalysts: sustained VA demand, broader regional roll‑out, longitudinal/clinical study progress, and further IP expansion; any payer/reimbursement milestones or additional distribution partnerships would be incremental positives .
  • Risk skew: financing dependence and going‑concern disclosure, limited estimate coverage (1 estimate), and execution on commercialization against a tight cash runway .
  • Trading lens: stock likely reacts to monthly/quarterly test volume updates, cash runway extensions (capital raises/warrant exercises), and any reimbursement or clinical milestones that validate scale and sustainability .

Sources: Q3 2025 8‑K press release and exhibits ; Q3 2025 10‑Q and MD&A ; Q2 2025 8‑K ; Q1 2025 8‑K ; Oct 7, 2025 press (record test volume) ; Nov 5, 2025 press (October volume +111% vs YTD avg) .