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MAIA Biotechnology, Inc. (MAIA)·Q3 2023 Earnings Summary

Executive Summary

  • Clinical progress drove the narrative: THIO-101 Phase 2 showed an unprecedented 100% disease control rate (DCR) in second-line NSCLC and 88% in third-line, with 49 patients dosed and FDA IND clearance to expand into the U.S., positioning upcoming U.S. site activation as a catalyst .
  • Operating discipline with rising R&D and G&A: Q3 R&D was $2.60M (+11% YoY), G&A $2.36M (+43% YoY), and net loss was $4.88M ($0.36 per share), essentially flat vs Q3 2022 on net loss, better EPS due to absence of 2022 ratchet expense .
  • Liquidity tightened: Cash was $6.10M at September 30, 2023 (down from $9.15M at June 30, 2023), with an at-the-market (ATM) program established and a share repurchase authorization announced (up to $0.8M) .
  • No revenue and going concern language persisted; financing execution remains a key determinant of medium-term runway and equity risk .
  • Street estimates not available through S&P Global for Q3 2023; comparisons anchored on company-reported results and filings. Consensus was unavailable.

What Went Well and What Went Wrong

What Went Well

  • THIO-101 efficacy signals: “Preliminary efficacy data… includes an unprecedented disease control rate (DCR) of 100% in second-line NSCLC treatment” and 88% in third-line, surpassing standard of care DCRs (53–64%) .
  • Enrollment momentum: 49 patients dosed, pace exceeding similar NSCLC trials; early survival data notable (14.6 and 12.5 months in first two 3rd-line subjects, with no new therapy initiated) .
  • U.S. regulatory milestone: FDA cleared the THIO IND for U.S. evaluation within THIO-101, accelerating trial expansion and visibility .

What Went Wrong

  • Higher G&A cost burden: Q3 G&A rose to $2.36M from $1.65M YoY, driven by professional fees (including write-off of deferred offering costs) and investor relations spend .
  • Liquidity compression and going concern: Cash declined to $6.10M; management reiterated substantial doubt about the ability to continue as a going concern without new financing .
  • No revenue and sustained operating losses: The company continues to generate no revenues, with loss from operations of $4.96M in Q3 2023 .

Financial Results

MetricQ3 2022Q2 2023Q3 2023
Revenues ($USD Millions)$0.00 $0.00 $0.00
Research & Development Expense ($USD Millions)$2.34 $2.60 $2.60
General & Administrative Expense ($USD Millions)$1.65 $2.07 $2.36
Other Income, Net ($USD Millions)$0.19 $0.14 $0.08
Loss from Operations ($USD Millions)$(5.10) $(4.66) $(4.96)
Net Loss ($USD Millions)$(4.90) $(4.52) $(4.88)
Diluted EPS ($USD)$(0.48) $(0.35) $(0.36)
Cash and Cash Equivalents ($USD Millions)$14.06 (as of 9/30/22) $9.15 (as of 6/30/23) $6.10 (as of 9/30/23)

Notes:

  • Q3 2022 includes a one-time ratchet share expense under operating expenses .
  • MAIA reports no revenues and remains a clinical-stage entity .

Segment breakdown: Not applicable; no commercial revenues and a single operating segment .

KPIs (clinical/program):

KPIAs of Jul 2023 (Q2 context)As of Nov 2023 (Q3 context)
THIO-101 patients dosed35 49
Post-baseline assessments completedn/a37
DCR (first 11 with scans)82% n/a
DCR second-line NSCLCn/a100%
DCR third-line NSCLCn/a88%
Early survival (first two 3rd-line patients)12.2 and 11.5 months 14.6 and 12.5 months

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY/Q3 2023None providedNone providedMaintained
EPSFY/Q3 2023None providedNone providedMaintained
R&D ExpenseFY/Q3 2023None providedNone providedMaintained
G&A ExpenseFY/Q3 2023None providedNone providedMaintained
Trial milestones (THIO-101)H2 2023Directional updates onlyIND cleared in U.S.; 49 patients dosedPositive milestone progression

Earnings Call Themes & Trends

No Q3 2023 earnings call transcript was located; themes derived from filings and press releases.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3 2023)Trend
R&D execution (THIO-101)Part A safety positive; survival data; 35 dosed; 82% DCR among first 11 scans 49 dosed; 100% DCR second-line; 88% third-line; 37 with post-baseline assessments Strengthening efficacy signal; accelerated enrollment
Regulatory/legalPre-IND with FDA for U.S. expansion FDA IND clearance for U.S. THIO studies Regulatory progress positive
Financing/liquidityFollow-on offering completed in April 2023 ATM established; $6.10M cash; share repurchase authorization; going concern language Liquidity tighter; mixed signals (ATM + buyback)
Partnering/supplyRegeneron supplying cemiplimab; cost savings Ongoing; unchanged Stable
Pipeline expansionPreclinical potency in HCC; glioma/DIPG preclinical updates Additional THIO findings in gliomas, pediatric brain cancer, next-gen conjugates Broader preclinical scope

Management Commentary

  • “Our successful and productive third quarter was punctuated by the outstanding data on our lead asset THIO… includes an unprecedented disease control rate (DCR) of 100% in second-line NSCLC… We achieved the pre-determined statistical requirements to proceed to the next stage of the trial earlier than expected” — Vlad Vitoc, M.D., Chairman & CEO .
  • Q2 preview: “We recently reached an important milestone… first patients dosed… crossing the 1 year mark… without any additional cancer treatment. These positive preliminary results… supported a faster pace of enrollment” — Vlad Vitoc, M.D. .
  • IND cleared for U.S. evaluation of THIO within THIO-101, elevating clinical optionality and visibility .

Q&A Highlights

  • No Q3 2023 earnings call transcript identified; no Q&A disclosures found in filings or press releases .

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2023 EPS and revenue was unavailable; company remains pre-revenue, and comparisons are anchored to reported net loss and opex.
  • Where estimates are unavailable, investors should focus on clinical milestones, liquidity actions (ATM, repurchase authorization), and expense trajectory in modeling .

Key Takeaways for Investors

  • Clinical signals are the near-term stock driver: 100% second-line DCR and 88% third-line, plus U.S. IND clearance, raise visibility into THIO-101 outcomes and next-stage progression; further readouts are potential catalysts .
  • Liquidity is constrained and central to thesis risk: $6.10M cash at Q3-end and persistent going concern language suggest dependence on financing cadence (ATM, potential follow-ons) despite a small buyback authorization .
  • Expense control vs. trial execution: R&D growth reflects scientific progression; G&A inflation from professional fees and investor relations should normalize as one-time items (deferred offering costs) roll off .
  • No revenue/earnings guidance: Pre-revenue status persists; success metrics are clinical KPIs (enrollment, DCR, survival durability) rather than traditional P&L targets .
  • Partner support reduces COGS-like burden: Regeneron drug supply (cemiplimab) continues to be a cost-saving factor during THIO-101 .
  • Watch upcoming U.S. site activation, additional survival follow-ups, and DCR consistency; trial operational momentum is a key medium-term validation stream .
  • Balance sheet actions (ATM utilization vs. repurchases) will signal management’s prioritization between runway extension and capital allocation optics .