Executive Summary

Pre-revenue biotech quarter with continued clinical execution: Q1 2023 operating expenses rose 22% YoY to $4.18M, driving a net loss of $4.12M (vs. $3.41M YoY); diluted EPS improved YoY to $(0.38) from $(0.50) on a higher share count .
Liquidity: Cash was $7.59M at March 31; the company subsequently raised gross proceeds of $5.75M (net ≈$5.1M) on April 27, extending runway for THIO-101 and pipeline work .
Clinical highlights are the principal stock catalysts: Part A of THIO-101 (NSCLC) met safety objectives with no DLTs at the highest dose; preliminary survival observations for first two patients (~10 and ~9 months from treatment initiation) support continued enrollment in Part B dose-selection; HCC preclinical data showed complete and durable responses, potentiated by CPI combo .
No financial guidance or revenue outlook; cost trajectory reflects public company costs and R&D hiring. No S&P Global consensus figures were available in our tools at run-time; as a pre-revenue micro-cap, Street estimate coverage may be limited .

What Went Well and What Went Wrong

What Went Well

THIO-101 safety lead-in (Part A) positive: THIO (up to 360 mg/cycle) sequential with Libtayo was well tolerated with no dose-limiting toxicities, enabling progression to randomized Part B dose selection .
Early clinical durability signals: First two Part A patients (3rd/4th line, post-ICI failure) remained alive ~10 and ~9 months from treatment start; both progression-free for 7 and 6 months respectively after last THIO dose with no new treatment, notable vs real‑world survival of 3–4 months in this setting .
Liquidity bolstered post-quarter: April follow-on raised ~~$5.75M gross (~~$5.1M net), funding THIO-101 and second‑gen telomere-targeting compounds .

Management quote: “We are thrilled with the advancement of the THIO-101 trial… The clinical activity seen with THIO thus far, in addition to its favorable safety and efficacy profiles, puts us one step closer to our goal of treating NSCLC and liver cancer.” — Vlad Vitoc, CEO .

What Went Wrong

Continued operating loss and cash burn: Q1 net loss was $4.12M with cash used in operations of $3.36M; cash fell to $7.59M before the April raise .
OpEx inflation: G&A rose 46% YoY on public company costs (+$0.58M) and payroll (+$0.28M); R&D rose on headcount (+$0.46M) despite lower THIO‑101 start-up fees .
Going-concern disclosure: Management noted substantial doubt about the company’s ability to continue as a going concern absent additional capital; post‑quarter financing partially mitigates but does not eliminate funding needs .

Financial Results

Income Statement and EPS (YoY comparison)

Metric	Q1 2022	Q1 2023
Revenues ($USD)	$0 (pre‑revenue)	$0 (pre‑revenue)
Research & Development Expense ($)	$2,077,329	$2,195,991
General & Administrative Expense ($)	$1,366,229	$1,988,259
Total Operating Expenses ($)	$3,443,558	$4,184,250
Net Loss ($)	$(3,413,845)	$(4,116,876)
Diluted EPS ($)	$(0.50)	$(0.38)
Weighted Avg. Shares (Diluted)	7,752,042	10,977,054

Notes: YoY OpEx up 22%; EPS improved due to higher share count while absolute loss increased .

Prior-quarter trend (most recent available prior quarter)

Metric	Q3 2022	Q1 2023
R&D Expense ($)	~$2.3M	$2,195,991
G&A Expense ($)	~$1.7M	$1,988,259
Net Loss ($)	~$3.9M	$(4,116,876)

Note: A discrete Q4 2022 quarterly release was not furnished; MAIA provided full‑year 2022 results on March 24, 2023 .

Liquidity and Cash Flow KPIs

KPI	Q1 2022	Q1 2023
Cash and Equivalents (period end) ($)	$10,293,460	$7,586,312
Cash Used in Operations ($)	$(2,807,811)	$(3,360,649)
Working Capital ($)	—	~$4,567,000 (as of 3/31/23)
Subsequent Equity Raise	—	$5.75M gross on 4/27; ≈$5.1M net

Segment reporting: MAIA operates as a single segment (oncology R&D) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
THIO‑101 Part A safety readout	2023	Planned to share safety data in 2023 (FY22 update)	Positive topline safety completed; proceeding to Part B randomized dose selection	Achieved milestone
THIO‑101 U.S. IND (expansion)	2023	Seek U.S. IND clearance in 2023 (FY22 update)	Reiterated intent to receive U.S. IND clearance in 2023	Maintained
Revenue/Margin/OpEx financial guidance	2023	None provided	None provided	Maintained

MAIA did not issue quantitative financial guidance; updates focus on clinical milestones .

Earnings Call Themes & Trends

Note: An earnings call transcript was not available in our document set; themes below derive from Q3 2022 and FY22 press releases and Q1 2023 8‑K/10‑Q.

Topic	Previous Mentions (Q3 2022, FY22)	Current Period (Q1 2023)	Trend
THIO‑101 clinical progress (NSCLC)	Trial design presented at ESMO; dosing initiation; EU expansion	Part A safety positive; Part B enrollment initiated	Accelerating
U.S. regulatory path (IND)	Pre‑IND meeting held; positive initial FDA feedback	Plan to receive U.S. IND clearance in 2023 reiterated	Maintained/advancing
Preclinical expansion (HCC, other tumors)	HCC efficacy data presented; new telomere‑targeting molecules advanced	Additional HCC in vivo data: complete and durable responses; immune memory; CPI potentiation	Strengthening
Financing/liquidity	IPO proceeds sufficient for Phase 2 lead‑in; cash $10.9M at YE22	$5.75M gross follow‑on post‑Q1; going-concern disclosure despite raise	Focus on extending runway
Internal controls	—	Material weaknesses in ICFR; remediation plan underway	Addressing

Management Commentary

“We are thrilled with the advancement of the THIO-101 trial, inclusive of reporting the positive topline data and preliminary survival data from the completed Part A safety lead-in… The clinical activity seen with THIO thus far… puts us one step closer to our goal of treating NSCLC and liver cancer.” — Vlad Vitoc, CEO .
“We remain excited to share the safety data from Part A of the THIO-101 trial, advance patient enrollment at sites in Europe, and seek to receive IND clearance in the U.S.” — Vlad Vitoc, CEO (FY22 release, framing 2023 priorities) .

Q&A Highlights

No Q&A section was available in the documents reviewed; an earnings call transcript for Q1 2023 was not found in our source set (press release and 10‑Q furnished instead).

Estimates Context

Wall Street consensus for revenue/EPS was not available via our S&P Global tool at run‑time; MAIA is pre‑revenue and micro‑cap, and the company furnished results without referencing Street comparisons .
Given the absence of revenue and the clinical-stage profile, estimate revisions (if any) would likely center on R&D cadence and cash runway; we could not retrieve S&P Global consensus figures to quantify changes at this time.

Key Takeaways for Investors

Clinical de‑risking: Positive Part A safety and preliminary durability signals in heavily pretreated NSCLC support proceeding to randomized Part B dose selection — the main near‑term clinical catalyst .
Liquidity extended, but runway still finite: March‑end cash of $7.59M plus ~$5.1M net raised in April supports continued THIO‑101 execution; ongoing capital access remains critical given going‑concern disclosure .
Operating discipline vs progress: OpEx rose 22% YoY driven by public company costs and R&D hiring; watch for OpEx trajectory vs enrollment pace as Part B ramps .
HCC optionality: Strong preclinical data in HCC and immune memory observations may expand THIO’s opportunity or partnership potential beyond NSCLC over time .
Regulatory path: Pre‑IND groundwork in 2022 and reiterated plan for U.S. IND clearance in 2023 provide a clearer expansion route for THIO‑101; U.S. site activation would broaden enrollment funnel .
Execution milestones, not financial beats, drive the story: With no revenue and no Street estimate anchors furnished, the stock is likely to trade on clinical readouts (Part B safety/early efficacy), IND progress, and financing cadence .

Supporting citations:

Q1 2023 press release and financial detail: .
Q1 2023 10‑Q financials, liquidity, cash flow, going concern, ICFR: .
Prior quarter (Q3 2022) baseline: .
FY22 context and 2023 clinical priorities: .

MAIA Biotechnology, Inc. (MAIA)·Q1 2023 Earnings Summary