Executive Summary

Ainos reported FY 2024 results (no discrete Q4 release), reflecting the ongoing pivot away from COVID-19 test kits: FY revenue was $0.02M (vs. $0.12M in FY 2023), FY net loss widened to $(14.86)M, and year-end cash was $3.89M .
Implied Q4 2024 (derived as FY less 9M): revenue ≈ $0, operating expenses ≈ $4.63M, and net loss ≈ $(4.65)M as R&D and SG&A stepped up into year-end to advance AI Nose and VELDONA programs .
Management highlighted AI Nose milestones (Ainos Flora accuracy up to 94% in trials; industrial VOC detection ~80% accuracy; mass production targeted H1 2025) and VELDONA progress (IRB approval in Taiwan; Taiwan Tanabe Seiyaku MOU), underscoring a healthcare/industrial roadmap for 2025 commercialization pushes .
No formal quantitative guidance or call transcript was filed for Q4/FY; S&P Global consensus estimates were unavailable, so no beat/miss can be determined; focus turns to execution of clinical and commercialization milestones as key stock catalysts (no transcript found) (Reg FD press-only) (S&P consensus unavailable via tool).

What Went Well and What Went Wrong

What Went Well

AI Nose traction accelerated: Ainos reported Flora’s clinical accuracy “up to 94%,” planned second‑gen clinical studies in H1 2025, and industrial VOC identification at nearly 80% accuracy with mass production targeted H1 2025, expanding use cases into healthcare, elderly telehealth, semiconductor safety, and robotics .
Pipeline/regulatory progress: IRB approval (Shuang Ho Hospital) for Sjögren’s syndrome study maintains the 2025 start timeline, while management targets IND submissions to the U.S. FDA in H2 2025 for key programs .
Strategic partnering: An MOU with Taiwan Tanabe Seiyaku (subsidiary of Mitsubishi Tanabe) to advance manufacturing and Taiwan market promotion of VELDONA for Sjögren’s syndrome supports potential downstream commercialization options .

What Went Wrong

Revenue collapse from the COVID pivot: FY 2024 revenue fell to $20.7K (from $122.1K in 2023) as COVID-19 antigen rapid test sales ended; pet supplement revenue is still nascent .
Operating expenses rose with program acceleration: FY total OpEx increased to $13.81M (vs. $12.95M), driven by higher R&D for collaborative research and staffing; SG&A fell modestly but remained elevated with stock-based comp .
Losses widened amid investment cycle: FY net loss increased to $(14.86)M (from $(13.77)M) and Q3 loss also expanded YoY; management expects near‑term R&D to increase as trials scale .

Financial Results

Quarterly snapshot (Q2–Q4 2024; Q4 derived from FY minus 9M)

Metric	Q2 2024	Q3 2024	Q4 2024 (Implied)
Revenue ($)	$0	$0	$0 (derived from FY=9M)
Total Operating Expenses ($)	$3,023,636	$3,038,002	$4,633,634 (13,809,338 − 9,175,704)
Net Loss ($)	$(3,195,022)	$(3,699,317)	$(4,654,012) (14,863,161 − 10,209,149)
Cash And Equivalents (period-end, $)	$8,014,098	$5,156,606	$3,892,919
R&D Expense ($)	$1,978,756	$2,022,244	$2,328,275 (8,413,923 − 6,085,648)
SG&A Expense ($)	$1,044,880	$1,015,758	$2,305,359 (5,395,415 − 3,090,056)

Notes: Q4 values are derived from FY 2024 minus nine months ended 9/30/2024 and reflect the company’s investment-heavy exit to the year.

Annual comparison (FY 2024 vs FY 2023)

Metric	FY 2023	FY 2024
Revenue ($)	$122,112	$20,729
Gross Profit (Loss, $)	$(253,733)	$(31,866)
Total Operating Expenses ($)	$12,952,663	$13,809,338
R&D Expense ($)	$7,317,388	$8,413,923
SG&A Expense ($)	$5,635,275	$5,395,415
Net Loss ($)	$(13,770,549)	$(14,863,161)
Cash And Equivalents (YE, $)	$1,885,628	$3,892,919

EPS: The company did not present FY 2024 EPS in the FY 8‑K exhibit; quarterly per‑share loss was reported for Q2 ($0.49) and Q3 ($0.33), but no discrete Q4 EPS was disclosed in filings we reviewed .

Segment reporting: Ainos operates a single segment per management’s CODM view .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY/Q4 2024	None	None	n/a (no formal guidance provided)
Gross Margin	FY/Q4 2024	None	None	n/a
Total OpEx / R&D	Near-term 2025	Qualitative: invest prudently	Qualitative: “anticipate a near‑term increase in R&D”	Raised (qualitative)
EPS	FY/Q4 2024	None	None	n/a
Other items (tax, OI&E, dividends)	FY/Q4 2024	None	None	n/a

Management issued no quantitative guidance; commentary indicates higher near‑term R&D as core programs advance .

Earnings Call Themes & Trends

No earnings call transcript was found for Q4/FY 2024; themes below reflect management commentary in the FY press release and prior-quarter filings.

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4/FY 2024)	Trend
AI Nose (Flora)	Targeted design completion in Q3 and clinical kickoff in Q4 for next‑gen Flora with NVIDIA CUDA; 75 cases tested at four Taiwan medical centers .	“Up to 94% accuracy” for Flora; Gen‑2 studies to commence H1 2025; exploring commercialization in global POCT .	Momentum improving with clearer clinical and commercialization timelines .
Industrial VOC platform	Co-developing with Japanese partners; platform for telehealth/industrial use .	~80% accuracy identifying 22 VOCs in semiconductor factories; mass production targeted H1 2025 .	Advancing toward production .
VELDONA human	Q1/Q2 focus on HIV oral warts (ODD) and Sjögren’s; FDA clinical hold response for COVID program submitted; IRB/clinical initiations planned .	IRB approval for Sjögren’s study; aim to submit INDs in H2 2025; MOU with Taiwan Tanabe for Taiwan manufacturing/market promotion .	Regulatory/partnering progress .
Animal health (FCGS)	First subject enrolled July 2024; 30‑subject Taiwan study targeting report by Q1 2025 .	Continued emphasis on animal drug; near‑term R&D increase noted .	Execution ongoing .
Capital & balance sheet	$9M convertible (May 2024) and Lind note prepayment (Aug 2024) → runway >12 months, cash $8.01M at 6/30 .	YE cash $3.89M; convertible notes outstanding; OpEx rising with program scale .	Liquidity adequate but tightening vs mid‑year .
Corporate structure/IP	Patent license from TCNT (Aug 2024) and monthly patent fees; addendum for nitrogen‑oxygen device IP .	Third addendum: exclusive use of patents and $50k/month fee for 12 months from 10/16/24 (plus 5% tax) .	IP base strengthened; added fixed IP cost .
Listing status	Nasdaq minimum bid price deficiency notice (July 2024) disclosed in Q2 10‑Q .	No update in FY 8‑K; separate 2025 filings indicate compliance regained (post‑period) (FY 8‑K silent).	Watch status/volatility risk .

Management Commentary

CEO: “Our AI Nose program has achieved meaningful milestones… Ainos Flora… up to 94% accuracy rates in clinical trials… poised to deliver telehealth-friendly… nearly 80% accuracy in identifying 22 different VOCs in semiconductor factories, positioning us for mass production in H1 2025… we invite global robotics companies to join the Ainos Alliance” .
CEO: “We are prioritizing clinical studies for HIV oral warts and Sjögren’s syndrome… aim for submitting IND applications to the U.S. FDA by H2 2025… partnership with Taiwan Tanabe Seiyaku… recent invention patent in Japan further strengthens our IP portfolio” .
CFO: “Operating expense growth was primarily driven by continued investments in AI Nose and VELDONA development… disciplined financial management enabled us to reduce SG&A… we anticipate a near‑term increase in R&D expenses” .

Q&A Highlights

No Q4/FY 2024 earnings call transcript was filed; therefore, no Q&A themes or clarifications are available from a live call [ListDocuments returned no earnings-call-transcript; none found for the period].

Estimates Context

Wall Street consensus: S&P Global consensus estimates for Q4 2024 were not available via the tool; given the company’s micro-cap profile and lack of discrete quarterly release, formal coverage appears limited or absent (tool returned daily limit error and no estimates) (S&P consensus unavailable via tool).
As a result, no beat/miss versus consensus can be determined for Q4 2024; we anchor analysis on reported financials and qualitative guidance .

Key Takeaways for Investors

Execution is the near-term driver: 2025 milestones include Gen‑2 Flora clinical studies (H1), industrial VOC mass production (H1), and Sjögren’s trial initiation—successful delivery would de‑risk the story and open initial commercial revenue paths .
Operating intensity likely persists: management flagged higher near‑term R&D as programs scale; Q4 implied OpEx of ~$4.63M underscores year-end acceleration—monitor cash burn vs. $3.89M YE cash and access to external financing .
Partner leverage: The Taiwan Tanabe MOU (exclusive right of first negotiation; target Taiwan manufacturing/marketing) provides a potential commercialization conduit for VELDONA but remains non‑binding pending definitive license terms .
IP cost overlay: The October addendum imposes ~$50k/month (+5% tax) for exclusive patent use over 12 months—supportive for IP control, but it adds fixed cost and should be reflected in OpEx run‑rate .
Revenue reset completed: With COVID test sales ended, FY revenue fell to de minimis levels—new product commercialization is essential for moving from R&D-heavy P&L to a revenue-bearing model .
No Q4 call or formal guidance: Absent quant guidance and consensus, shares are likely to trade on milestone newsflow and financing developments; tracking trial progress, industrial deployments, and partners will be critical .

Supporting detail and sources:

FY 2024 8‑K/press release, including financial statements and management commentary .
Q3 2024 10‑Q (financials, MD&A, R&D/SG&A, liquidity) .
Q2 2024 8‑K/press release and 10‑Q (financials, liquidity, program updates, Nasdaq notice) .
Taiwan Tanabe Seiyaku MOU 8‑K/press release .
IP/patent addendum 8‑K (Third Addendum; $50k/month fee) .

Ainos, Inc. (AIMD)·Q4 2024 Earnings Summary