Executive Summary

Q3 2025 was execution-focused: Tenax reiterated Phase 3 timelines (LEVEL enrollment completion in 1H 2026; topline in 2H 2026) and highlighted strengthened IP positioning in Europe, while operating spend stepped up as LEVEL and LEVEL-2 advanced .
EPS beat: GAAP diluted EPS of ($0.40) vs S&P Global consensus of ($1.124), a $0.724 beat; revenue expectations remain $0 as the company is development-stage (consensus revenue $0) *.
Operating expenses rose sharply on higher R&D for LEVEL/LEVEL-2 and non-cash stock-based comp in G&A (R&D: $10.3m; G&A: $6.5m), widening net loss to $15.8m from $4.0m YoY .
Liquidity remains solid: Cash and equivalents were $99.4m; management continues to expect funding through 2027, underpinning completion of the two registrational studies .
Call note: No Q3 earnings call transcript was published; management hosted a KOL event (Nov 13) that provided deep color on mechanism, trial design, competitive read-throughs, and regulatory path considerations—useful for near-term narrative/catalysts (e.g., LEVEL-2 initiation; EPO intention to grant) .

What Went Well and What Went Wrong

What Went Well
- IP strengthening: EPO issued an Intention to Grant a broad PH-HFpEF levosimendan patent (TNX-101/102/103, transdermal, active metabolites; combinations and dose ranges) with protection to Dec 2040, with potential SPC extension .
- Program advancement and global expansion: LEVEL enrollment “progressing well” with high continuation into OLE; >160 new sites across 15 countries qualified for LEVEL-2 global study .
- Strategic clarity and enthusiasm from KOLs: Management and external experts articulated a differentiated, venodilatory mechanism and patient-reported benefits; “the pill … improving upon [IV]” with life-altering effects described in OLE experiences .
What Went Wrong
- Higher OpEx and widening losses: R&D rose to $10.3m (vs $3.1m YoY) and G&A to $6.5m (vs $1.5m YoY) on clinical costs and non-cash SBC; net loss widened to $15.8m (vs $4.0m) .
- Timeline slippage occurred earlier in 2025: Q1 guided LEVEL enrollment “around year-end 2025,” then extended to 1H 2026 in Q2—maintained in Q3 (neutral this quarter but a 1H slip vs Q1) .
- No traditional earnings call: While the KOL call provided rich content, the absence of a standard Q3 earnings call may leave some investors seeking explicit financial/guidance Q&A; however, KOL Q&A covered regulatory and IP topics materially .

Financial Results

Metric ($USD Millions, except per-share)	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Revenue	— (development-stage; no product revenue line reported)	—	—	—
R&D Expense	$3.11	$5.68	$6.12	$10.33
G&A Expense	$1.51	$5.66	$5.67	$6.48
Total OpEx	$4.62	$11.34	$11.79	$16.81
Net Loss	$3.96	$10.41	$10.85	$15.80
Diluted EPS	$0.19 (net loss per share per filing)	($0.28)	($0.27)	($0.40)
Cash & Equivalents (period-end)	$98.31	$111.45	$105.46	$99.37

Notes: Management reiterated cash runway through 2027 . Non-cash SBC: Q3 R&D included $1.1m; Q3 G&A included $4.5m .

EPS vs S&P Global Consensus (Actual vs Estimate)

Metric	Q1 2025	Q2 2025	Q3 2025
EPS Actual ($)	($0.28)	($0.27)	($0.40)
Primary EPS Consensus Mean ($)	($0.41)*	($0.4475)*	($1.124)*
Primary EPS – # of Estimates	4*	4*	5*

Revenue Consensus Mean ($mm): Q1 2025: 0.0*, Q2 2025: 0.0*, Q3 2025: 0.0*.

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

Non-GAAP/Adjustments

Q3 2025 included significant non-cash SBC: R&D $1.1m; G&A $4.5m, materially impacting OpEx and EPS .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
LEVEL (TNX-103) enrollment completion	Q1 2025 vs Q3 2025	Around year-end 2025 (Q1)	1H 2026 (Q3)	Lowered/timed later (slipped in Q2; maintained in Q3)
LEVEL topline data	Q1 2025 vs Q3 2025	Mid-2026 (Q1)	2H 2026 (Q3)	Timed later (shifted in Q2; maintained in Q3)
LEVEL-2 initiation	Q1 2025 vs Q3 2025	Expected in 2025 (Q1)	On track to initiate in 2025 (Q3)	Maintained
Cash runway	Q1 2025 vs Q3 2025	Through 2027 (Q1)	Through 2027 (Q3)	Maintained

Earnings Call Themes & Trends

Note: No Q3 2025 earnings-call transcript; management hosted a KOL event (Nov 13, 2025), which is used here for “Current Period” .

Topic	Previous Mentions (Q2 2025; Q1 2025)	Current Period (Q3 2025 KOL/PR)	Trend
Enrollment & timelines	Q2: LEVEL to 230 pts; completion 1H 2026; protocol paper published; ops team expanded . Q1: LEVEL 230 pts “around YE25” .	LEVEL progressing with high continuation; completion 1H 2026; Level-2 on track 2025; >160 sites in 15 countries qualified .	Stable since Q2; earlier slip vs Q1 now maintained
Mechanism & differentiation	Q2/Q1 PRs emphasize advancing TNX-103 in PH-HFpEF .	Deep KOL discussion on venous capacitance, splenic reservoir, venodilatory MoA, preserving CO during exercise; why PVR can mislead in PH-HFpEF .	Elevated detail and scientific conviction
Competitive landscape	Limited prior detail (PRs) .	Read-through vs PAH vasodilators/Relaxin analogs; RCTs in HFpEF have failed/raised concerns; Tenax approach aims to reduce left atrial pressure load .	More explicit contrasts; thoughtful critique
Regulatory path	Not discussed in Q1/Q2 PRs .	Q&A explored accelerated approval possibilities and safety database needs; plan remains two trials before filing .	New color; prudent baseline
IP	Q2: Canada CIPO allowed claims to 2040 .	EPO Intention to Grant with broad PH-HFpEF coverage; patents extend to 2040, SPC possible .	Strengthened geographically
Funding/runway	Q1–Q3: Runway through 2027 reiterated .	Unchanged; cash $99.4m at Q3-end .	Stable

Management Commentary

“We continued to advance our lead program, TNX-103… and remain on track to enroll 230 patients in the ongoing Phase 3 LEVEL study in the first half of 2026, and initiate the global LEVEL-2 study this year.” — Chris Giordano, President & CEO .
“LEVEL enrollment … progressing well, with high rates of study and therapy continuation” .
On potential regulatory path: “Accelerated approval… would depend on the effect size… we anticipate going through both trials and then submitting at that time.” — Stuart Rich, CMO .
On patient experience: “Even above and beyond the IV, the pill… actually improving… In the LEVEL study… it has really been life-altering for many people.” — Dr. Barry Borlaug (KOL) .
On program de-risking: exercise hemodynamics, patient enrichment, and oral PK/PD legacy data support Phase 3 approach — Stuart Rich .

Q&A Highlights

Accelerated approval and safety database: Management is open to discussions post-LEVEL readout but currently planning to complete both registrational trials; robust safety database likely required given chronic oral use .
Patent estate: Multiple method-of-use patents covering PH-HFpEF across routes/doses/combinations into 2040, with potential extensions; viewed as “very solid” by management .
Placebo effects and clinically meaningful benefit: KOLs view ~15–20 meters improvement in 6MWD as meaningful in PH-HFpEF; anecdotes suggest symptomatic improvement in OLE, aligning with mechanistic rationale .
Competitive trials: Concerns articulated around pulmonary vasodilators/Relaxin analogs worsening congestion or missing the key HFpEF physiology; Tenax’s approach targets venous capacitance and left-sided pressure .
Translation IV→oral: Dosing/PK of metabolite (OR1896) and titration strategy aim to match/extend therapeutic exposure; transition data bolster confidence .

Estimates Context

EPS beats across 2025 to-date:
- Q3 2025: Actual ($0.40) vs consensus ($1.124) → beat of $0.724 *.
- Q2 2025: Actual ($0.27) vs consensus ($0.4475) → beat of $0.1775 *.
- Q1 2025: Actual ($0.28) vs consensus ($0.41) → beat of $0.13 *.
Revenue estimates remain $0 (development-stage; no product revenue reported) *.
Implication: Street likely lifts near-term EPS trajectory modestly given sustained OpEx ramp but recurring beats vs conservative loss expectations; attention remains on OpEx cadence vs cash runway into 2027 to fund both registrational trials .

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

Key Takeaways for Investors

Thesis rests on PH-HFpEF differentiation: Venodilatory mechanism aimed at lowering left atrial pressure under exertion addresses pathophysiology that has stymied prior pulmonary vasodilator approaches .
Program momentum intact: LEVEL progressing; LEVEL-2 readying globally; clear line-of-sight to 2H 2026 topline with funding runway through 2027 .
IP de-risking: EPO Intention to Grant broad PH-HFpEF coverage to 2040 (SPC potential) supports long-duration exclusivity in a first-approvals scenario .
Financial watchpoints: Elevated non-cash SBC materially impacted G&A in 2025; monitor normalization in 2026 and R&D run-rate as LEVEL-2 initiates .
Stock catalysts (near term): LEVEL-2 initiation; EPO grant finalization; additional site activations/enrollment updates; further KOL/medical meeting visibility .
Risk balance: Clinical execution and event timing remain paramount; narrative strengthened by mechanistic/clinical rationale and KOL validation, but binary Phase 3 outcomes and potential regulatory safety database requirements persist .
Trading implications: Continued estimate beats on EPS loss magnitude provide limited downside support; material stock inflections likely tied to program milestones (LEVEL-2 start, patent grant) and interim operational updates rather than quarterly P&L .

Appendices

Additional KPIs and Operating Detail

KPI	Q3 2025	Q2 2025	Q1 2025
Cash Runway (management view)	Through 2027	Through 2027	Through 2027
LEVEL Enrollment Target	230 patients	230 patients	230 patients
LEVEL Enrollment Completion Timing	1H 2026	1H 2026	Around YE 2025
LEVEL-2 Status	On track to initiate in 2025; >160 qualified sites in 15 countries	Protocol finalized; >85 sites/15 countries qualified	Expected 2025 initiation
Non-cash SBC (R&D; G&A)	$1.1m; $4.5m	$1.0m; $3.6m	$0.9m; $3.3m

References:

Q3 2025 8-K and press release (financials, guidance, IP):
Q2 2025 press release/8-K (trend):
Q1 2025 press release/8-K (trend):
Q3 2024 press release/8-K (YoY):
KOL event transcript (themes, MoA, competitive, reg): -

TENAX THERAPEUTICS, INC. (TENX)·Q3 2025 Earnings Summary