Indaptus Therapeutics, Inc. (INDP)·Q1 2025 Earnings Summary

Executive Summary

• Indaptus reported Q1 2025 net loss per share of $0.32 and reiterated its shift from weekly Decoy20 monotherapy to a Phase 1b/2 combination focus with PD‑1 inhibitor tislelizumab after enrolling 32 patients in weekly dosing and observing tolerability with instances of stable disease .
• Operating expenses rose year over year on higher clinical spend (R&D $2.81M vs $1.59M), while G&A declined (to $1.76M vs $2.35M), reflecting trial execution offset by cost control; net loss increased to $4.53M from $3.81M YoY .
• Liquidity tightened: cash fell to $3.89M (from $5.79M at year‑end), operating cash burn was $5.05M in Q1, and management said it will need additional capital to fund activities beyond Q2 2025 .
• Near‑term catalysts center on clinical execution: initiation of the Phase 1b/2 combination arm, expanded trial footprint (Health Canada CTA), and ongoing pharmacodynamic readouts; management guided to further clinical updates through 2025 .

What Went Well and What Went Wrong

• What Went Well

  • Clinical progress and transition to combination strategy: “we… announced the initiation of the expansion arm of our Phase 1b/2 clinical trial of Decoy20… in combination with… Tislelizumab,” with early safety and signals of benefit from weekly dosing and a decision to focus resources on the combo arm .
  • Mechanistic validation: new weekly dosing data showed broad immune activation and immune cell trafficking consistent with Decoy20’s MOA, reinforcing biologic plausibility for anti‑tumor activity .
  • Platform strengthening: additional international patents in China, Japan, and Israel broadened IP coverage across infectious disease and cancer indications .

• What Went Wrong

  • Cash runway pressure: cash declined to $3.89M with Q1 operating cash outflows of $5.05M; management stated it will need to obtain capital beyond Q2 2025, elevating financing risk .
  • Higher clinical spend: R&D rose to $2.81M (from $1.59M YoY) as the Phase 1 program advanced; total operating expenses increased to $4.57M (from $3.94M YoY) with net loss widening to $4.53M .
  • Limited revenue visibility and no quant guidance: as a clinical‑stage company with no product revenue, there is no revenue or margin guidance; operating metrics hinge on trial progress and funding availability .

Financial Results

Quarterly P&L summary (USD millions, except per-share). Columns are oldest to newest.

Q1 2025 vs Consensus (S&P Global)

Values with an asterisk (*) are retrieved from S&P Global.

KPIs and Liquidity

Notes: Revenue and gross/operating margins are not applicable for Q1 given no revenues; non‑GAAP metrics were not provided .

Guidance Changes

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available in our document set.

Management Commentary

• Strategy and execution: “We made meaningful progress in the first quarter… initiated the expansion arm… evaluating Decoy20 in combination with… Tislelizumab… Early data from the weekly dosing suggests that Decoy20 is generally well‑tolerated… with encouraging signs of clinical benefit, including instances of stable disease.” — Jeffrey Meckler, CEO .
• Focus and resource allocation: Management concluded enrollment in the weekly dosing arm “and [will] shift… focus to the combination treatment” to prioritize clinical value creation .
• Mechanism validation: “Weekly Decoy20 treatment… leads to broad, blood‑based immune cell trafficking… consistent with the chemokine induction we previously reported,” supporting Decoy20’s ability to modulate the immune system — Michael Newman, Founder & CSO .
• Geographic expansion: “Health Canada’s approval… will allow the Company to expand its ongoing U.S. clinical trial… to Canadian sites… accelerating the collection of valuable clinical data” — Management .

Q&A Highlights

• No Q1 2025 earnings call transcript was available; therefore, no Q&A highlights could be extracted.

Estimates Context

• EPS: Q1 2025 EPS of $(0.32) materially outperformed the S&P Global consensus of $(5.04) on one estimate, implying a positive surprise; limited coverage (one estimate) reduces reliability of the comparison . Primary EPS Consensus Mean: $(5.04); Primary EPS – # of Estimates: 1.
• Revenue: Consensus expected $0.0 with one estimate and the company recorded no revenue in Q1 2025, as reflected by operating statements lacking a revenue line . Revenue Consensus Mean: $0.0*; Revenue – # of Estimates: 1*.

Values with an asterisk (*) are retrieved from S&P Global.

Key Takeaways for Investors

• The clinical narrative is shifting from weekly Decoy20 monotherapy to a combination strategy with tislelizumab following enrollment of 32 patients and supportive safety/PD signals—this is the core near‑term catalyst path in 2025 .
• Mechanistic biomarkers (cytokine/chemokine induction and immune cell trafficking) continue to align with Decoy20’s intended immune activation, increasing confidence ahead of combo readouts .
• Liquidity is the principal risk: cash of $3.89M against Q1 operating cash burn of $5.05M and an explicit need for capital beyond Q2 2025—expect financing overhang and potential dilution .
• Operating discipline helped moderate G&A, but R&D will remain the key driver of spend as the program advances; monitoring OpEx trajectory and clinical milestones remains critical .
• Patent and geographic expansions (new IP in China/Japan/Israel; Health Canada authorization) broaden platform durability and execution capacity, supporting medium‑term optionality .
• With no revenue and no quantitative guidance, stock moves will hinge on clinical datapoints and financing developments; milestone cadence (site expansion, combo dosing progress, PD/early activity updates) should drive trading opportunities .
• Q1 EPS “beat” versus a single S&P Global estimate underscores low coverage and model variance; investors should anchor on cash runway, financing path, and clinical validation rather than short‑term EPS prints .