Executive Summary

Q1 2025 reflected disciplined cost control amid funding constraints: operating expenses fell 28.5% YoY to $3.39M, narrowing net loss to $3.35M (vs $4.60M YoY) and EPS to -$0.22 (vs -$0.34 YoY) .
EPS modestly missed Wall Street consensus by ~$0.03 per share (actual -$0.22 vs consensus -$0.195); revenue remained $0.00 as the company is pre-revenue.
Management paused new site activations and enrollment in the Phase 3 INVINCIBLE-3 sarcoma study to conserve cash and prioritized the Phase 2 INVINCIBLE-4 TNBC study; EMA authorized initiation in France and eight Swiss sites are active with patients treated .
April public offering raised $2.35M gross (~$1.9M net), but period-end cash fell to $0.93M, elevating liquidity risk; subsequent near-term capital raises in Q2/Q3 were not in-quarter and thus not reflected in Q1 cash .

What Went Well and What Went Wrong

What Went Well

EMA authorization to initiate INVINCIBLE-4 in France alongside eight activated Swiss sites, with several TNBC patients treated, supports continued execution in the Phase 2 program .
Cost discipline: R&D declined to $2.19M (from $2.82M) and G&A to $1.21M (from $1.93M), driven by lower manufacturing, legal/audit, and no new equity grants, reducing total operating expenses to $3.39M .
Management highlighted positive patient imaging signals in sarcoma (“first follow-up scans showed high levels of necrosis in injected tumors”) as qualitative support for INT230-6 activity .

What Went Wrong

Liquidity strain: cash and equivalents dropped to $0.93M at quarter end (from $2.59M at year-end), necessitating the pause of Phase 3 sarcoma enrollment and site activation pending additional funding .
EPS missed consensus by ~1–3 cents (depending on source) as interest income normalized and OpEx remained elevated for clinical operations, limiting near-term earnings support relative to expectations* .
Phase 3 INVINCIBLE-3 momentum slowed with 23 patients enrolled prior to the pause; management must balance trial integrity and pharmacovigilance activities with constrained resources .

Financial Results

Income Statement and Cash

Metric	Q1 2024	Q1 2025
Revenues ($USD Millions)	$0.00	$0.00
R&D Expense ($USD Millions)	$2.82	$2.19
G&A Expense ($USD Millions)	$1.93	$1.21
Total Operating Expenses ($USD Millions)	$4.74	$3.39
Net Loss ($USD Millions)	$4.60	$3.35
Diluted EPS ($USD)	-$0.34	-$0.22
Weighted Avg Shares (Millions)	13.71	15.17
Cash & Equivalents ($USD Millions)	$2.59 (Dec 31, 2024)	$0.93 (Mar 31, 2025)

Notes: Company is pre-revenue; margins not meaningful.

Consensus vs Actual (Q1 2025)

Metric	Consensus	Actual	Surprise
EPS ($USD)	-$0.195*	-$0.22	-$0.025 (miss)*
Revenue ($USD Millions)	$0.00*	$0.00	In line*

Values marked with * retrieved from S&P Global.

Operating Drivers and Balance Sheet Details

Metric	Q1 2025 Detail	YoY Commentary
R&D drivers	+$0.1M clinical trial costs (site initiation/enrollment) offset by -$0.2M manufacturing (no batches) and -$0.4M SBC	Down $0.63M YoY
G&A drivers	Lower legal/audit and -$0.3M SBC	Down $0.72M YoY
Accounts Payable ($USD Millions)	$1.59	Up vs $1.22 at 12/31/24
Accrued Expenses ($USD Millions)	$1.01	Up vs $0.51 at 12/31/24
Stockholders’ Equity ($USD Millions)	$0.33	Down vs $2.92 at 12/31/24

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial guidance (Revenue, EPS, OpEx)	FY 2025	None provided	None provided	Maintained (no guidance)
Clinical program status – INVINCIBLE-3 (STS)	2025	Global enrollment and site activation across 8 countries	Pause new site activations and enrollment due to funding constraints; continue treating enrolled patients (23)	Lowered
Clinical program status – INVINCIBLE-4 (TNBC)	2025	Recruiting in Switzerland	EMA authorized initiation in France; eight Swiss sites activated; several patients treated	Raised (geographic expansion)

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was published; themes are drawn from press releases and the 8-K exhibit.

Topic	Previous Mentions (Q3 2024)	Current Period (Q1 2025)	Trend
Clinical execution – INVINCIBLE-3 (STS)	Regulatory authorizations across U.S., Canada, EU, Australia; first patients dosed; global site activation ramp	23 patients enrolled; pause of new activations/enrollment due to funding constraints	Execution curtailed pending funding
Clinical execution – INVINCIBLE-4 (TNBC)	Swiss authorization and first patient dosed	EMA authorized France; eight Swiss sites activated; several patients treated	Positive momentum; geographic expansion
Funding and liquidity	Cash $2.8M (9/30/24); expected to fund operations into Q1’25	April ’25 offering $2.35M gross (~$1.9M net); period-end cash $0.93M	Tight liquidity; financing necessary
Manufacturing and OpEx management	Elevated OpEx for trial ramp	No Q1 manufacturing batches; OpEx down; G&A efficiencies	Improved cost discipline
Regulatory/legal	Multi-agency authorizations for trials	EMA France authorization confirmed	Steady regulatory progress

Management Commentary

“The first quarter saw continued progress in our important programs despite high volatility in the markets and funding constraints... due to cash needs, we made the necessary decision to pause the Phase 3 sarcoma enrollment and site activation until additional funding becomes available.” — Lewis H. Bender, CEO .
“Meanwhile, our partners SAKK and Unicancer will continue to work with the leading hospitals in Switzerland and France to seek patients for our breast cancer trial, INVINCIBLE-4.” .
April 2025 public offering proceeds: raised $2.35M gross (~$1.9M net) to support operations .

Q&A Highlights

No Q1 2025 earnings call transcript was available; no formal Q&A published for the quarter. Management’s communications centered on press releases and the 8-K exhibit .

Estimates Context

EPS missed consensus by ~$0.025 in Q1 2025 (actual -$0.22 vs consensus -$0.195)* as OpEx remained necessary for trial operations and interest income declined from the prior year quarter .
Revenue remains $0.00 and in line with consensus for a clinical-stage, pre-revenue biotech*.
Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

Liquidity is the central near-term risk: Q1 cash fell to $0.93M despite April offering; management paused Phase 3 sarcoma enrollment to preserve cash, which could weigh on sentiment until funding is secured .
Positive clinical momentum in TNBC: EMA authorization in France and active Swiss sites suggest the INVINCIBLE-4 program can advance even in a constrained funding environment—an important narrative offset .
Cost control is working: OpEx down 28.5% YoY; lower manufacturing and G&A contribute—improves runway efficiency and limits quarterly losses .
Trial pauses can defer catalysts: the INVINCIBLE-3 slowdown likely delays survival readouts and may temper medium-term expectations; resumption hinges on capital access .
Estimate revisions: modest EPS miss may prompt slight near-term estimate downward tweaks; revenue remains at zero, aligning expectations for clinical-stage timelines*.
Trading lens: watch funding updates and any strategic partnership/licensing moves; reacceleration of sarcoma enrollment would be a key positive catalyst, while further delays could pressure shares .
Strategic focus: management’s prioritization of TNBC sites and partnerships indicates an effort to balance capital efficiency with advancing differentiating clinical evidence .

Appendix: Additional Q1 2025 Press Releases and Prior Period Context

Business update (Jan 10, 2025): multi-agency global authorizations for INVINCIBLE-3; ongoing hospital contracting; prior breast cancer data context and TNBC study design .
DMC continuation (Jan 28, 2025): Data Monitoring Committee authorized continuation of INVINCIBLE-3 after periodic review, supporting safety/continuity .
FY 2024 results (Mar 13, 2025): R&D $10.50M; G&A $6.09M; net loss $16.27M; year-end cash $2.59M .
Q3 2024 results (Nov 13, 2024): Q3 OpEx $3.57M; net loss $3.51M; cash $2.78M at 9/30/24; global trial authorizations and first patients dosed .

INTENSITY THERAPEUTICS, INC. (INTS)·Q1 2025 Earnings Summary