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MAIA Biotechnology, Inc. (MAIA)·Q4 2022 Earnings Summary

Executive Summary

  • MAIA reported no revenue for FY 2022 and a net loss of $15.77M; diluted EPS was $(1.75). Operating expenses rose sharply as clinical and public company costs increased .
  • Q4 was operationally focused: patient dosing and enrollment began in Europe for THIO-101, a pre‑IND meeting with FDA was completed for planned U.S. expansion, and the company outlined a second Phase 2 go‑to‑market trial (THIO‑102) .
  • Cash was $10.95M at 12/31/2022; management disclosed substantial doubt about continuing as a going concern without further financing, a negative change from Q2/Q3 runway commentary (24 months in Q2; 12 months in Q3) .
  • No Q4 earnings call transcript or Wall Street consensus estimates were available; the press release provided full-year results and a corporate update rather than a quarter-specific breakout .

What Went Well and What Went Wrong

What Went Well

  • Europe activation of THIO‑101: “Dosed first two patients in Europe in ongoing Phase 2 trial (THIO-101)”—evidence of clinical execution in NSCLC .
  • Regulatory engagement: “Held pre-IND meeting with FDA… received positive initial feedback… U.S. IND application” groundwork for U.S. sites in THIO‑101 .
  • Pipeline breadth: “Outlined plan to initiate… THIO‑102” and advanced new telomere‑targeting molecules, expanding optionality beyond THIO‑101 .
  • CEO tone: “We are very pleased with the progress… remain excited to share the safety data from Part A of the THIO‑101 trial” signaling confidence heading into 2023 .

What Went Wrong

  • OpEx escalation: FY R&D rose to $8.93M (+155% YoY) and G&A to $6.14M (+43% YoY) as clinical start-up and public company costs ramped, deepening losses .
  • Cash runway reset: After Q2 stating ~24 months and Q3 ~12 months, year-end disclosure noted “substantial doubt” about ability to continue as a going concern without additional capital .
  • Lack of quarter granularity: Q4 press materials did not provide quarter-specific EPS or net loss, limiting precision in QoQ comparisons and estimate variance analysis .

Financial Results

MetricQ2 2022Q3 2022Q4 2022FY 2022
Revenue ($USD Millions)$0 $0 $0 $0
Net Loss ($USD Millions)$3.3 $3.9 n/a (not disclosed) $15.77
Diluted EPS ($USD)n/a (not disclosed) n/a (not disclosed) n/a (not disclosed) $(1.75)
R&D Expense ($USD Millions)$2.1 $2.3 n/a (not disclosed) $8.93
G&A Expense ($USD Millions)$1.3 $1.7 n/a (not disclosed) $6.14
Other Income (Expense) ($USD Millions)$0.1 $0.1 n/a (not disclosed) $0.41
Cash And Equivalents ($USD Millions)$8.2 $14.1 $10.95 $10.95

Notes:

  • Revenue remains zero as a clinical-stage, pre-revenue company .
  • FY net loss increased vs 2021 ($12.58M) due to higher R&D and G&A outlays .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
THIO‑101 safety data disclosure2022→2023“Plan to share safety data from THIO‑101” (Q3) “Excited to share safety data from Part A in 2023” (Q4) Timeline clarified (into 2023)
THIO‑101 EU expansion2022EU approvals in HU/PL/BG (Dec 2022) Enrollment underway; first two EU patients dosed Progressing (operational)
THIO‑101 U.S. IND1H23 targetPre‑IND submitted; feedback received (Nov 2022) Pre‑IND meeting held; plan to file U.S. IND 1H23 Maintained/firmed timeline
THIO‑102 (2nd Phase 2)2023 planNot previously outlined (Q2/Q3) Plan to initiate THIO‑102 go‑to‑market trial New program outlined
Cash runway2022Q2: “sufficient… next 24 months”; Q3: “next 12 months” Year-end going concern caution without new capital Lowered/negative

No financial guidance on revenue, margins, tax, or dividends was provided in Q4 materials .

Earnings Call Themes & Trends

No Q4 earnings call transcript available; themes derived from press releases and 10‑K.

TopicPrevious Mentions (Q2 & Q3)Current Period (Q4)Trend
R&D execution (THIO‑101)First patient dosed; trial design presented at ESMO EU sites active; first two EU patients dosed; enrollment underway Positive execution
Regulatory/legalFDA ODD in SCLC/HCC; pre‑IND request submitted Pre‑IND meeting held; US IND targeted 1H23 Advancing toward U.S. sites
Regional expansionSubsidiaries in Romania/Australia EU approvals (HU/PL/BG) and patient dosing Broadened footprint
Pipeline breadthTHIO focus plus collaboration with Nationwide Children’s THIO‑102 plan; second‑generation molecules advanced Diversifying
Financing/runwayIPO completed; cash “24 months” then “12 months” Going concern caution at YE Deteriorated runway
Scientific visibilityXIV Round Table; ESMO; EORTC‑NCI‑AACR SITC HCC data presentation Ongoing visibility

Management Commentary

  • “We are very pleased with the progress MAIA has made… expanding the THIO‑101 trial to Europe and outlining… THIO‑102… remain excited to share the safety data from Part A of the THIO‑101 trial…” — Vlad Vitoc, M.D., CEO .
  • “We continue to make significant progress with advancing the clinical development of THIO… first patient… dosed in our Phase 2… We have received orphan drug designation… SCLC and HCC.” — Vlad Vitoc, M.D., CEO (Q2) .
  • “The clinical development of THIO continues to be our primary focus… we plan to share our safety data from the THIO‑101 trial.” — Vlad Vitoc, M.D., CEO (Q3) .
  • “We are thrilled to have recently strengthened our balance sheet with the completion of our July IPO and continue to maintain no long-term debt.” — Joseph McGuire, CFO (Q2) .

Q&A Highlights

No Q4 earnings call or Q&A transcript was available; no guidance clarifications were provided beyond the press release/10‑K narrative .

Estimates Context

We attempted to retrieve S&P Global consensus for Q4 2022 and FY 2022 EPS and revenue; the data was unavailable due to system limits and there was no coverage evident for quarter-specific estimates for MAIA in the materials reviewed. As a result, estimate comparisons could not be performed .

Key Takeaways for Investors

  • Clinical progress is the primary 2023 catalyst: EU dosing and planned U.S. IND for THIO‑101, plus initiation of THIO‑102, should drive data flow and partnership optionality .
  • Funding needs are pressing: year-end going concern language indicates a near-term capital raise is likely; expect financing overhang and potential dilution until runway is extended .
  • Expense trajectory will remain elevated with multiple Phase 2 efforts; monitor R&D/G&A growth versus trial milestones to assess spend productivity .
  • Second-generation telomere-targeting molecules offer medium-term upside if preclinical potency translates clinically, broadening the platform beyond NSCLC .
  • Regulatory engagement de-risks U.S. expansion; successful IND acceptance and site activation would be a tangible milestone for value inflection .
  • Near-term trading implications: stock likely sensitive to clinical enrollment updates, safety readouts (Part A THIO‑101), and financing announcements; limited quarter-level financials reduce earnings event volatility .

Appendix: Prior Quarters’ Financials (for trend analysis)

KPI ($USD Millions)Q2 2022Q3 2022
Cash$8.2 $14.1
R&D Expense$2.1 $2.3
G&A Expense$1.3 $1.7
Other Income (Expense)$0.1 $0.1
Net Loss$3.3 $3.9

YoY full-year comparison:

  • R&D: $8.93M (2022) vs $3.50M (2021) .
  • G&A: $6.14M (2022) vs $4.29M (2021) .
  • Net Loss: $15.77M (2022) vs $12.58M (2021) .

Corporate highlights across Q2/Q3/Q4 reflect sustained execution in THIO‑101, regulatory steps toward U.S. expansion, and platform broadening via THIO‑102 and second-generation compounds .