Executive Summary

Q3 2025 burn moderated: net loss was $2.67M vs. $3.51M YoY (-24%), driven by lower R&D and G&A; cash rose to $7.1M at 9/30 on sequential financings, and management now guides cash runway into end of Q1 2027 .
Clinical program updates: INVINCIBLE-4 enrollment paused in September due to localized skin irritation; company plans a protocol amendment and expects to reinitiate enrollment in Q1 2026; INVINCIBLE-3 remains paused pending funding .
Peer‑reviewed validation: eBioMedicine (Lancet Discovery Science) published IT‑01 results showing 75% disease control rate and 11.9‑month mOS (21.3 months in sarcoma subset), with ~20% abscopal effects at higher tumor coverage and favorable safety .
Estimates context: Q3 EPS of ($0.06) slightly beat S&P Global consensus of ($0.063); revenue consensus was $0 (pre‑revenue) (S&P Global) .*
Financing de‑risked near‑term liquidity: $13.6M gross raised since Q3 start (ATM and an Oct. 31 registered direct at $0.80/sh), extending runway and adding a new institutional investor; key near‑term stock catalysts are INVINCIBLE‑4 restart and any INVINCIBLE‑3 funding updates .

What Went Well and What Went Wrong

What Went Well

Cash runway extended to end of Q1 2027 via $13.6M of gross proceeds since Q3 start (ATM plus $4.0M registered direct), improving balance sheet resilience for clinical execution .
Peer‑reviewed IT‑01 data strengthen scientific narrative: 75% disease control, 11.9‑month mOS overall, 21.3‑month mOS in sarcoma subset, ~20% abscopal rate at higher tumor coverage, and >95% intratumoral drug retention .
Management tone: “new long‑term fundamental, healthcare‑savvy investor” and a plan to restart INVINCIBLE‑4 with pCR as FDA‑accepted accelerated approval endpoint; “execute on our business strategy until the end of the first quarter of 2027 without any additional funds” .

What Went Wrong

INVINCIBLE‑4 pause due to localized skin irritation (cosmesis concerns in TNBC); enrollment on hold until dosing modification via protocol amendment, delaying timelines to Q1 2026 restart .
INVINCIBLE‑3 (Phase 3 sarcoma) remains paused for new site activations and enrollment due to funding; only 21–23 patients were enrolled before the pause, prolonging OS‑driven timelines .
Still pre‑revenue; statements show only operating expenses and net loss, underscoring reliance on external capital and clinical milestones for valuation inflection .

Financial Results

Quarterly P&L and liquidity (oldest → newest):

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Revenues ($USD)	N/A – no revenue line in statements	N/A – no revenue line in statements	N/A – no revenue line in statements	N/A – no revenue line in statements
Total Operating Expenses ($USD)	$3.570M	$3.394M	$2.705M	$2.733M
Net Loss ($USD)	($3.513M)	($3.347M)	($2.537M)	($2.671M)
Diluted EPS ($)	($0.25)	($0.22)	($0.13)	($0.06)
Cash & Cash Equivalents ($USD)	$— (not provided in Q3 2024 table)	$0.929M	$2.216M	$7.067M

Expense detail (oldest → newest):

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
R&D ($USD)	$2.151M	$2.189M	$1.541M	$1.553M
G&A ($USD)	$1.419M	$1.205M	$1.164M	$1.180M

Estimates vs. actuals:

Metric	Q3 2025 Consensus	Q3 2025 Actual
EPS (Primary/Diluted)	($0.0633)*	($0.06)
Revenue ($USD)	$0.0*	N/A – no revenue line in statements

*Values retrieved from S&P Global.

KPIs and clinical datapoints referenced in quarter:

KPI (IT‑01 and Program)	Value
Disease Control Rate (IT‑01)	75% (48/64)
Median OS – overall (IT‑01)	11.9 months
Median OS – sarcoma subset (INT230‑6 monotherapy)	21.3 months
>40% Tumor Burden Coverage: DCR	83.3% (40/48) vs. 50% (8/16)
>40% Tumor Burden Coverage: mOS	18.7 months vs. 3.1 months; HR 0.17 (P<0.0001)
Abscopal responses (~uninjected tumors shrink)	~20% in >40% group
Grade 3 TRAEs (monotherapy)	10.9%; no grade 4/5

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	“Into 2H 2026” (Q2 PR)	“To end of Q1 2027” (Q3 PR/8‑K)	Raised runway
INVINCIBLE‑4 (TNBC) – Enrollment Status/Timing	Study operations	Recruiting in CH/FR; scans showed necrosis post‑INT230‑6	Paused in Sept due to skin irritation; protocol amendment; reinitiation targeted Q1 2026	Modified plan; restart timing set
INVINCIBLE‑3 (Sarcoma) – Enrollment	Study operations	Paused in Mar 2025 for funding; treat/monitor existing patients	Still paused; will restart upon sufficient funding	Maintained pause
Regulatory endpoints	Clinical	pCR acceptable for accelerated approval (context)	pCR remains endpoint for INVINCIBLE‑4	Maintained

Earnings Call Themes & Trends

Note: We found no Q3 2025 earnings call transcript on filings or IR; company instead issued a press release and hosted a clinical results webinar (Oct. 31).

Topic	Previous Mentions (Q‑2 and Q‑1)	Current Period (Q3 2025)	Trend
Funding & Liquidity	Raised ~$11.3M since Q2 start; runway into 2H 2026	Total $13.6M gross since Q3 start; runway to end Q1 2027	Improving runway
INVINCIBLE‑4 (TNBC)	EMA authorization; active recruiting in CH/FR; early necrosis on scans	Enrollment paused; protocol amendment; restart Q1 2026; pCR remains endpoint	Temporary setback; path to restart
INVINCIBLE‑3 (Sarcoma)	Paused for funding; treating enrolled patients	Still paused; restart contingent on funding	Unchanged
Clinical Evidence	Prior company data; ongoing trials	IT‑01 peer‑reviewed in eBioMedicine with DCR 75%, mOS 11.9 months, abscopal ~20%	Strengthened validation
Nasdaq Compliance	–	Company regained Nasdaq equity compliance Aug. 12, 2025	Improving governance posture

Management Commentary

“The new capital raised in 2025 enables us to execute on our business strategy until the end of the first quarter of 2027… [and] provides another level of validation of the potential of our lead drug INT230‑6…” — Lewis H. Bender, Founder, President & CEO .
“A pathological complete response (‘pCR’) has been observed in the first patient evaluated in Cohort A… we expect to reinitiate the enrollment with a modified INT230‑6 dosing regimen as soon as possible.” — Ursina Zürrer, M.D., Coordinating Investigator, INVINCIBLE‑4 .
“Abscopal effect was observed in at least 20% of patients who received drug volumes above 40% of their tumor burden… notable increase in activated CD4+ and CD8+ T cells…” — Anthony El‑Khoueiry, M.D., USC Norris (IT‑01 senior author) .

Q&A Highlights

No Q3 2025 earnings call transcript was located on filings or IR; company hosted an Oct. 31 webinar with IT‑01 authors to discuss clinical results, indicating investor focus on mechanistic and translational aspects rather than quarterly financials .
Management clarified that INVINCIBLE‑4’s enrollment pause was due to localized skin irritation with a plan to amend dosing and maintain pCR as the endpoint; timeline set to Q1 2026 for restart .
Funding remains the gating item for resuming INVINCIBLE‑3 enrollment; ongoing patient treatment/monitoring continues at existing sites .

Estimates Context

EPS: Q3 2025 actual ($0.06) vs. S&P Global consensus ($0.0633), a slight beat; revenue consensus $0 for a pre‑revenue biotech (S&P Global). Actual revenue was not reported as a line item in the statements (i.e., no revenue line) .*
With operating expenses trending lower and elevated share count, near‑term estimate revisions are likely modest; larger changes hinge on INVINCIBLE‑4 restart timing and any INVINCIBLE‑3 funding catalysts .