Executive Summary

Q2 2023 reflected continued pipeline execution with THIO-101 Phase 2 milestones; net loss was $4.52M and diluted EPS was -$0.35, vs -$0.40 in Q2 2022 and -$0.38 in Q1 2023 .
Cash was $9.15M at quarter-end; management disclosed substantial doubt about going concern absent additional financing, despite April follow-on net proceeds of ~$4.40M .
Clinical datapoints were a positive surprise: 82% preliminary DCR (9/11 patients) and first two dosed patients progression-free up to 10.2 and 8.5 months without new therapy; enrollment reached 35 patients by July 2023 .
Consensus (S&P Global) estimates were unavailable; a third-party source shows EPS beat (-$0.35 actual vs -$0.43 consensus), implying an $0.08 beat; revenue remains N/A given no product sales .

What Went Well and What Went Wrong

What Went Well

Robust early clinical signals: “first patients dosed…crossing the 1 year mark since starting therapy…without any additional cancer treatment,” aligning with preclinical data and supporting faster enrollment .
Preliminary efficacy stronger than typical real-world comparators: 82% DCR (9/11) at first response in heavily pretreated NSCLC; typical DCRs ~25–35% with chemotherapy .
Platform expansion: filed second provisional composition-of-matter patent for third home-grown telomere-targeting molecule (MAIA-2021-029), broadening pipeline optionality .

What Went Wrong

Operating expense growth drove wider loss: total operating expenses rose 36% YoY to $4.66M; net loss increased to $4.52M from $3.31M YoY .
Going concern risk: management states substantial doubt about ability to continue as a going concern within one year without new capital; cash decreased by ~$1.80M in H1 2023 .
Higher G&A burden of public-company costs: G&A rose 56% YoY to $2.07M in Q2, largely investor relations and insurance, pressuring run-rate absent revenue .

Financial Results

Income Statement and EPS vs prior periods and estimates

Metric	Q2 2022	Q1 2023	Q2 2023
Revenues ($USD Millions)	$0.0	$0.0	$0.0
R&D Expense ($USD Millions)	$2.12	$2.20	$2.60
G&A Expense ($USD Millions)	$1.32	$2.00	$2.07
Total Operating Expenses ($USD Millions)	$3.44	N/A	$4.66
Net Loss ($USD Millions)	$3.31	$4.10	$4.52
Diluted EPS ($USD)	-$0.40	-$0.38	-$0.35
EPS vs Consensus ($USD)	N/A (S&P Global unavailable)	N/A (S&P Global unavailable)	-$0.35 actual vs -$0.43 consensus; Beat +$0.08

Note: S&P Global consensus values were unavailable during retrieval; third-party consensus shown for context.

Balance Sheet and Cash

Metric	Q2 2022	Q1 2023	Q2 2023
Cash And Equivalents ($USD Millions)	$8.20 (as of 6/30/22)	$7.60 (as of 3/31/23)	$9.15 (as of 6/30/23)
Working Capital ($USD Millions)	N/A	N/A	~$6.50

Operating KPIs (Clinical)

KPI	Q1 2023	Q2 2023
Patients Enrolled (THIO-101)	Part B commenced; early Part A safety reported	35 patients dosed as of July 2023
Preliminary DCR (first evaluable pts)	N/A	82% (9/11) met disease control endpoint at first response
Survival/Progression-free datapoints	First two patients alive ~10 and 9 months from initiation	First two patients alive ~12.2 and 11.5 months; progression-free 10.2 and 8.5 months without new therapy

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY/Quarter	No formal financial guidance provided	No formal financial guidance provided	Maintained
Operating Expenses	FY/Quarter	N/A	No formal numeric guidance; cost discipline noted	Maintained
Clinical Milestones (THIO-101)	2H 2023	Part B randomized efficacy/dose selection to progress	Continue evolving Part B; expand sites/enrollment	Maintained/Operational update

No dividend, tax rate, margin, or segment guidance disclosed .

Earnings Call Themes & Trends

No Q2 2023 earnings call transcript found; company IR shows press release and 10‑Q; a third-party site lists a call date, but transcript not available .

Topic	Previous Mentions (Q4 2022, Q1 2023)	Current Period (Q2 2023)	Trend
THIO-101 clinical progress	Europe approvals (Hungary, Poland, Bulgaria); Part A topline safety; first two patients alive 10/9 months	35 patients dosed; 82% preliminary DCR; first two patients alive 12.2/11.5 months, PFS 10.2/8.5 months	Strengthening efficacy signals; accelerated enrollment
Regulatory/partnerships	Pre-IND with FDA; Regeneron drug supply (cemiplimab) at no charge	Ongoing cemiplimab supply; planning Part B and site activations	Steady operational execution
Pipeline expansion	Telomere-targeting molecule program advanced; HCC/SCLC ODD	Second provisional composition-of-matter patent for MAIA-2021-029	Expanding IP/pipeline
Financing/liquidity	IPO; prior equity rounds	April follow-on ~$5.75M gross; cash $9.15M; going concern risk without new capital	Mixed: improved cash from offering, but elevated burn and going concern disclosure

Management Commentary

“We recently reached an important milestone…first patients dosed in the trial crossing the 1 year mark…without any additional cancer treatment…supported a faster pace of enrollment in the last quarter in Europe” — Vlad Vitoc, M.D., Chairman & CEO .
“Topline data from Part A demonstrated that THIO…in sequential combination with Libtayo…were generally well-tolerated” — Vlad Vitoc, M.D. (Q1 2023 PR) .

Q&A Highlights

No Q2 2023 Q&A transcript available; no clarifications beyond press release and 10‑Q disclosures .

Estimates Context

S&P Global consensus EPS and revenue estimates were unavailable at time of retrieval; therefore estimate comparisons to S&P cannot be made.
Third-party aggregator shows Q2 2023 EPS actual -$0.35 vs consensus -$0.43, a beat of +$0.08; revenue estimates not applicable given no product revenue .
Implication: Street likely revisits cash runway and R&D cadence rather than revenue; clinical momentum may support sentiment despite financing overhang .

Key Takeaways for Investors

Clinical signal remains the core near-term catalyst: 82% preliminary DCR and prolonged PFS in first patients underpin efficacy narrative in refractory NSCLC; continued Part B execution is pivotal for value inflection .
Liquidity is the principal risk: with $9.15M cash and going concern disclosure, expect additional financings; monitor dilution/terms and spend pacing .
Operating costs are rising with public-company infrastructure and clinical expansion; watch G&A normalization and R&D allocation to trials with highest probability of registration-enabling data .
Regeneron drug supply agreement reduces trial cost for cemiplimab but does not remove broader funding needs; continuity lowers COGS-like burden in trials .
IP expansion via new composition-of-matter filing adds optionality across tumor types and supports long-term moat if THIO class validates clinically .
Without revenues, trading is event-driven: upcoming survival/ORR updates, enrollment scaling, IND progress, and potential regulatory interactions will likely drive stock moves .
If S&P Global estimates remain sparse, price reactions will hinge on trial updates and financing visibility rather than quarterly P&L metrics .

MAIA Biotechnology, Inc. (MAIA)·Q2 2023 Earnings Summary