Executive Summary

Q4 2024 operating spend scaled with Phase 3 execution: R&D $4.6M (+170% YoY) and G&A $2.7M (+65% YoY), driving net loss of $6.3M and EPS of -$0.18; cash and equivalents were $94.9M at year-end 2024 .
EPS beat Wall Street: Q4 EPS -$0.18 vs consensus -$0.43*, with revenue at $0 as expected for a development-stage biotech*; beats also occurred in Q3 and Q2 as expenses ran below consensus EPS loss expectations* (see Estimates Context).
Guidance and program trajectory strengthened: FDA completed review of the updated Phase 3 plan; LEVEL enrollment increased to 230 by YE 2025, topline targeted mid-2026, and LEVEL-2 initiation expected in 2025 .
Funding extends runway: ~$125M aggregate private placements (Aug-2024 $100M and Mar-2025 $25M) provide runway through 2027, supporting two registrational studies and operations .
Stock reaction catalysts: Phase 3 enrollment pace, FDA interactions, mid-2026 topline timing, and durable tolerability signals from OLE; additional catalysts include LEVEL-2 start and continued KOL engagement .

What Went Well and What Went Wrong

What Went Well

Funding secured and runway extended: “Successfully Completed Private Placements with Aggregate Gross Proceeds of Approximately $125 Million… Fund Operations through 2027” .
Regulatory clarity and trial scaling: “FDA… completed its review… plan includes an amendment to expand enrollment and enhance the statistical power… anticipates completing enrollment of 230 patients… LEVEL-2… expected to commence in 2025” .
Positive patient/tolerability signals in OLE: “Almost every patient has gone into the OLE… almost everyone has stayed on… very, very little dropout… we’ve had no concerns in [AE] category” .

What Went Wrong

Operating expenses and losses widened with Phase 3 ramp: Q4 R&D $4.6M vs $1.7M YoY; G&A $2.7M vs $1.6M YoY; net loss $6.3M vs $3.2M YoY .
Continued absence of product revenue as a development-stage biotech: “We currently have no approved drug products for sale” (implying no product revenue) .
Dilution from financings increased share count (e.g., WANS rose materially), press release shows Q4 WANS 35.3M vs 0.3M YoY as capital structure reset to fund trials .

Financial Results

Quarterly financials vs prior periods (USD Millions unless noted)

Metric	Q2 2024	Q3 2024	Q4 2024
R&D Expense ($M)	$2.33	$3.11	$4.59
G&A Expense ($M)	$1.34	$1.51	$2.70
Total Operating Expenses ($M)	$3.67	$4.62	$7.30
Net Loss ($M)	$3.58	$3.96	$6.27
EPS (basic & diluted) ($)	-$1.83	-$0.19*	-$0.18
Cash & Equivalents ($M)	$9.38	$98.31	$94.85

Values marked with * retrieved from S&P Global.

Consensus vs Actual (EPS and Revenue)

Metric	Q2 2024	Q3 2024	Q4 2024
EPS Consensus ($)	-$2.25*	-$1.39*	-$0.43*
EPS Actual ($)	-$1.83	-$0.19*	-$0.18
Revenue Consensus ($M)	$0.00*	$0.00*	$0.00*
Revenue Actual ($M)	0.00*	0.00*	0.00*

Values marked with * retrieved from S&P Global.

Notes: The Q3 press release’s tabular EPS shows 0.19 without parentheses, while the period was a net loss; we reference S&P Global actual (-$0.19*) for consistency with net loss reporting .

Segment breakdown

Not applicable; Tenax reports as a single development-stage entity with no commercial segments .

KPIs

KPI	Q2 2024	Q3 2024	Q4 2024
LEVEL Sites Initiated (#)	39 sites	52 sites	N/A
Enrollment Target (LEVEL)	152 prior target	152 prior target	Raised to 230 by YE 2025
Cash Runway	Not stated	Through end of 2027	Funded through 2027 (post Mar-2025 raise)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
LEVEL Enrollment Target	LEVEL trial	152 subjects	230 subjects by YE 2025	Raised
LEVEL Topline Timing	LEVEL trial	Not previously explicit	Mid-2026 topline	Initiated/Specified
LEVEL-2 Initiation	LEVEL-2 trial	Not previously explicit	Initiation in 2025; global sites expected	Initiated/Specified
Cash Runway	Corporate	Through end of 2027	Funded through 2027 (after Mar-2025 $25M)	Maintained

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q4 2024)	Trend
Funding & Runway	Q2: planning private placement; Q3: cash $98.3M, runway through 2027	Added $25M private placement; runway reiterated through 2027	Strengthened
FDA/Regulatory Plan	Q2: IP patent granted; KOL event; IND cleared later (context from 10-K)	FDA completed review of updated Phase 3 plan; protocol expansion	Increased clarity
Enrollment & Powering	Q2/Q3: site activation progress (39→52)	LEVEL up-sized to 230; powering >90% for 25m 6MWD effect	Up-sized/powered
OLE Tolerability	Not highlighted	“Very little dropout… almost everyone has stayed on”	Positive patient signal
Market Opportunity	Limited mention	Addressable market $6–$10B and 2.2–3.7M U.S. patients projected	Narrative building

Management Commentary

CEO perspective: “The past year has been transformational… expand our investment in TNX-103 and accelerate development timelines… paving the way for an earlier potential regulatory filing… current funding sustains Tenax well beyond topline LEVEL data readout.” — Chris Giordano, President & CEO .
Program status: “We… proposed… increase [LEVEL] to 230 subjects… anticipate enrolling 230… start [LEVEL-2] now.” — Chris Giordano .
Powering and endpoint: “We’re now powered above 90% to show a treatment effect of 25 meters… conservative estimate relative to HELP’s 29 meters at trough.” — Chris Giordano .
Clinical relevance: “30 meters clinically meaningful in PAH; in Group 2… 15 or even 10 meters could be meaningful… patients feel better and walk farther.” — Stuart Rich, MD, CMO .
OLE experience: “Very, very little dropout… almost every patient has gone into the OLE… we’ve had no concerns [on AEs].” — Chris Giordano .

Q&A Highlights

Trial expansion and powering: Management detailed >90% powering for a 25m 6MWD effect and rationale vs Phase 2 HELP trough data .
Timing roadmap: Final patient targeted end-2025; topline mid-2026 with broader analyses; LEVEL-2 U.S. enrollment expected in 2025 with global expansion later in 2025 .
Funding composition: August 2024 $100M led by BVF and top healthcare funds; March 2025 added RTW; runway through 2027 encompassing the second trial .
Patient tolerability/adherence: Low dropout, strong OLE continuation supports tolerability and perceived benefit signals .
FDA engagement: Consistent feedback; safety database targets maintained (300 at 6 months; 100 at 12 months) .

Estimates Context

Q4 2024: EPS -$0.18 vs consensus -$0.43 (beat); revenue $0 vs $0 (in-line)*.
Q3 2024: EPS -$0.19 vs consensus -$1.39 (beat); revenue $0 vs $0 (in-line)*.
Q2 2024: EPS -$1.83 vs consensus -$2.25 (beat); revenue $0 vs $0 (in-line)*.
Values retrieved from S&P Global.

Implications: Consensus EPS loss was too pessimistic relative to actual spend pace; as Phase 3 scales, analysts should track R&D cadence and interest income offsets given cash balances .

Key Takeaways for Investors

Tenax is fully funded through 2027, enabling completion of LEVEL and initiation of LEVEL-2 without near-term financing overhang .
The FDA’s review of the updated program and the upsize to 230 patients increases statistical power and de-risks the topline readout path .
Trial execution KPIs (sites, enrollment pace, OLE retention) are trending positively; watch for enrollment milestones through 2025 .
EPS beats reflect disciplined OpEx and interest income on larger cash balances; expect spend to rise as LEVEL-2 ramps .
Mid-2026 topline is the primary stock catalyst; pre-readout narratives on clinical relevance (≥25m 6MWD) will influence sentiment .
IP footing extends protections (levosimendan patents into ~2040), supporting potential commercialization post-approval .
Near-term trading: sensitivity to enrollment updates and regulatory interactions; medium-term thesis: first-to-market potential in PH-HFpEF with large addressable market and unserved need .

Citations:

Q4 2024 press release and 8-K 2.02:
Q3 2024 press release:
Q2 2024 press release:
10-K FY 2024 for context:
Investor transcript (Needham, Mar-10-2025):
Values marked with * retrieved from S&P Global.

TENAX THERAPEUTICS, INC. (TENX)·Q4 2024 Earnings Summary