Executive Summary

Q2 2025 delivered a smaller loss per share than Wall Street expected: EPS of $0.27 loss beat the S&P Global consensus of $0.45 loss; no revenue was reported, consistent with a development-stage profile . The beat was aided by higher interest income on a larger cash balance .
Guidance for LEVEL enrollment was pushed from “around year-end 2025” (Q1) to “first half of 2026,” with topline now expected in 2H 2026; LEVEL-2 initiation in 2025 was reaffirmed .
Operating expenses rose sharply YoY (R&D +$3.8M to $6.1M; G&A +$4.3M to $5.7M) driven by clinical execution and non-cash stock-based compensation; net loss widened to $10.9M vs $3.6M YoY .
Tenax remains well funded (cash $105.5M) and reiterated a runway through 2027—an important risk mitigant while executing two Phase 3 trials .
Stock narrative catalysts: EPS beat, reaffirmed 2025 start of LEVEL-2, and expanded IP protections (Canada allowed claims extending to 2040). Headwind: timeline slip for LEVEL enrollment/topline .

What Went Well and What Went Wrong

What Went Well

“We remain in a strong position to execute and advance our lead program, TNX-103… Our sites in North America continue recruiting toward the expanded target of 230 patients… we remain on track to initiate our global Phase 3 study, LEVEL-2, this year.” — CEO Chris Giordano .
Cash of $105.5M with funding runway through 2027 supports two registrational trials; interest income rose to $0.95M in Q2, cushioning the loss per share vs estimates .
Canadian IP office allowed claims covering TNX-103/102/101 and metabolites with protection to 2040, strengthening the asset’s defensibility .

What Went Wrong

LEVEL enrollment and topline timelines slipped: completion now 1H 2026 (from “around year-end 2025”) and topline 2H 2026 (from “mid-2026”) .
Operating expenses escalated significantly YoY; R&D +$3.8M and G&A +$4.3M, driven by clinical costs and non-cash stock compensation (R&D: $1.0M; G&A: $3.6M) .
Net loss widened to $10.9M vs $3.6M YoY as the company scaled clinical operations and expanded the program footprint .

Financial Results

P&L and Balance Metrics (quarterly)

Metric	Q4 2024	Q1 2025	Q2 2025
Net Loss ($USD Millions)	$6.27	$10.41	$10.85
EPS (Basic & Diluted) ($USD)	$(0.18)	$(0.28)	$(0.27)
R&D Expense ($USD Millions)	$4.59	$5.68	$6.12
G&A Expense ($USD Millions)	$2.70	$5.66	$5.67
Interest Income ($USD Millions)	$1.03	$0.93	$0.95
Cash & Equivalents ($USD Millions)	$94.85	$111.45	$105.46

Notes: Tenax did not report revenue in Q1/Q2; as a development-stage company, the statements focus on operating expenses and other income.

Q2 2025 vs Estimates

Metric	Consensus	Actual	Surprise
EPS ($USD)	$(0.4475)*	$(0.27)	+$0.18 — bold beat
Revenue ($USD Millions)	$0.00*	Not reported (development-stage)	N/A

Values marked with * retrieved from S&P Global.

Year-over-Year and Quarter-over-Quarter Highlights

R&D: $6.1M in Q2 2025 vs $2.3M in Q2 2024 (+$3.8M YoY) ; vs Q1 2025 $5.7M (+$0.4M QoQ) .
G&A: $5.7M vs $1.3M YoY (+$4.3M), reflecting $3.6M non-cash stock comp; QoQ essentially flat .
EPS: $(0.27) vs $(1.83) YoY (improvement driven by share count and interest income) ; vs $(0.28) QoQ (slight improvement) .

Guidance Changes

Metric	Period	Previous Guidance (Q1 2025)	Current Guidance (Q2 2025)	Change
LEVEL Enrollment Completion	230 patients	Around YE 2025	1H 2026	Lowered (timeline pushed)
LEVEL Topline Readout	Efficacy	Mid-2026	2H 2026	Lowered (later half)
LEVEL-2 Initiation	Global Phase 3	2025	2025 (on track)	Maintained
Funding Runway	Operations	Funded through 2027	Funded through 2027	Maintained
IP Protection (Canada)	Patent term	N/A	Claims allowed; protection to 2040	New positive

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was available; we used management’s Q2 press release and the Cantor Global Healthcare Conference fireside chat on September 4, 2025 for current-period commentary.

Topic	Previous Mentions (Q4 2024; Q1 2025)	Current Period (Q2 2025)	Trend
R&D execution (LEVEL)	Phase 3 LEVEL expansion to boost power; YE 2025 enrollment target	Enrollment ongoing; target raised to 230; completion 1H 2026; OLE participation high	Progressing but timeline slipped
Regulatory pathway	FDA reviewed updated Phase 3 plan; LEVEL-2 protocol set	LEVEL-2 protocol finalized; global footprint; >85 sites qualified	Advancing globally
Funding & cash	$94.9M YE cash; +$25M private placement; runway through 2027	$105.5M cash; runway through 2027 reaffirmed	Stable runway
Clinical design (endpoints & power)	6MWD primary endpoint; blinded sample size reassessment planned	6MWD at 12 weeks (LEVEL) and 26 weeks (LEVEL-2); >90% power assumption; blinded SD check at ~150 completes	Confirmed plan
IP & defensibility	USPTO patent issued in 2024 covering levosimendan uses/doses	Canadian IP claims allowed; protection to 2040	Strengthened IP
Market opportunity	Large unmet need in PH-HFpEF; funding to execute	Management frames ~$10B addressable market via prevalence	Reinforced TAM narrative
Safety/Mechanism	Phase 2 HELP demonstrated wedge pressure reduction; transition to oral feasible	No new safety signals reported; mechanistic rationale vs splanchnic approaches; avoids hypotension issues seen in ablation	Consistent safety messaging

Management Commentary

“We remain in a strong position to execute and advance our lead program, TNX-103… we now anticipate completing enrollment in the first half of 2026… we remain on track to initiate our global Phase 3 study, LEVEL-2, this year.” — Chris Giordano, CEO .
“Together, both registrational studies are expected to satisfy the requirements, including safety data expectations, to file for approval in the U.S. and other geographies.” — Chris Giordano .
Clinical operations expansion: new heads of Clinical Operations, Data Management, Pharmacovigilance, and Quality Assurance joined to oversee execution .
Mechanism and differentiated approach: management emphasized wedge pressure reduction and splanchnic blood volume control, positioning levosimendan as a safer pharmaceutical alternative to permanent nerve ablation approaches (e.g., hypotension concerns in Rebalance HF) .

Q&A Highlights

Enrollment and timelines: Management guided to complete LEVEL enrollment in 1H 2026 and reaffirmed comfort with pace and OLE participation .
Blinded sample size reassessment: At ~150 completes, blinded SD assessment could trigger enrollment up to a pre-agreed cap; FDA alignment noted .
Mechanism and safety: HELP showed dramatic wedge pressure and right atrial pressure reductions without hypotension; oral dose selection aligned with IV weekly exposure .
LEVEL vs LEVEL-2 design: LEVEL 12-week 6MWD endpoint; LEVEL-2 26-week 6MWD with broader global population; power based on 25m treatment effect and 55m SD .
Market sizing and standard-of-care context: Large PH-HFpEF prevalence; expected SGLT2 uptake at centers; GLP-1 uptake lower in EU; centers must meet hemodynamic criteria .

Estimates Context

Q2 2025 EPS came in at $(0.27) vs the S&P Global consensus of $(0.4475), a beat of $0.18 per share; estimate count: 4. Revenue consensus was $0.0 with no product revenue reported by the company . Values marked with * are retrieved from S&P Global.

Metric	Q2 2025 Consensus	Q2 2025 Actual
EPS ($USD)	$(0.4475)*	$(0.27)
Revenue ($USD Millions)	$0.00*	Not reported (development-stage)

Drivers for the EPS beat: larger interest income ($0.95M) on substantial cash balances helped offset higher R&D and G&A; non-cash stock-based compensation elevated OpEx but does not impact cash runway .

Key Takeaways for Investors

EPS beat vs consensus despite higher OpEx; interest income is a meaningful non-operational tailwind near term while trials progress .
Timeline slip for LEVEL (enrollment to 1H 2026, topline 2H 2026) is the primary negative surprise; monitor site activation and screen-to-randomization conversion .
LEVEL-2 remains on track for 2025 start with >85 qualified sites globally—execution in Europe/LatAm/Asia may diversify enrollment risk .
Cash runway through 2027 mitigates financing overhang during pivotal execution; non-cash stock comp inflates G&A but does not affect runway .
Clinical risk remains paramount; blinded sample size reassessment provides flexibility to maintain statistical power based on observed SDs .
IP strengthening (Canada allowed claims to 2040) supports long-term defensibility if efficacy is confirmed .
Near-term trading focus: narrative around enrollment pace, OLE participation, and any safety signals; medium-term thesis rests on 6MWD efficacy at 12/26 weeks and regulatory dialogue .

Values marked with * are retrieved from S&P Global.

TENAX THERAPEUTICS, INC. (TENX)·Q2 2025 Earnings Summary