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TENAX THERAPEUTICS, INC. (TENX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered an EPS beat versus Wall Street: Diluted EPS of $(0.28) vs consensus $(0.41); net loss was $10.4M, reflecting higher R&D and G&A as Phase 3 activities ramped and stock-based comp amortized .*
  • Operational guidance maintained: LEVEL enrollment completion still targeted around year-end 2025, topline mid-2026; LEVEL-2 global Phase 3 expected to initiate in 2025 .
  • Cash increased to $111.4M after a $25M private placement in March; management reiterates runway through 2027 .
  • Clinical execution remains strong: blinded OLE continuation rates >95% and >50 sites activated; FDA completed review of expanded Phase 3 plan, increasing LEVEL power >95% .

What Went Well and What Went Wrong

What Went Well

  • CEO emphasized strong start to 2025 with meaningful progress on LEVEL and preparations for LEVEL-2: “2025 is off to a strong start… We expect to share topline data… in the middle of 2026” .
  • Robust clinical engagement and retention: >95% patients remained on therapy; >95% entering and continuing in the OLE, reinforcing tolerability and patient adherence .
  • Strengthened balance sheet and visibility: Cash and equivalents at $111.4M with reiterated funding through 2027, supported by the March private placement .

What Went Wrong

  • Elevated operating expense profile: R&D rose to $5.7M (from $2.7M YoY) and G&A rose to $5.7M (from $1.2M YoY), reflecting Phase 3 costs and $3.3M stock-based compensation from Q4 2024 option grants .
  • Net loss widened to $10.4M vs $6.3M in Q4 2024 and $3.8M in Q1 2024, driven by higher opex despite interest income .
  • No revenue and no transcript/Q&A available this quarter, limiting direct visibility into analyst concerns and detailed guidance clarifications (no earnings call transcript found) .

Financial Results

Income Statement and Cash (development-stage, no revenue reported)

MetricQ3 2024Q4 2024Q1 2025
R&D Expense ($USD Millions)$3.11 $4.59 $5.68
G&A Expense ($USD Millions)$1.51 $2.70 $5.66
Total Operating Expenses ($USD Millions)$4.62 $7.30 $11.34
Interest Income ($USD Millions)$0.665 $1.03 $0.930
Net Loss ($USD Millions)$4.00 $6.27 $10.41
Net Loss per Share ($USD)$(0.19) $(0.18) $(0.28)
Cash & Equivalents ($USD Millions)$98.31 $94.85 $111.45

Notes:

  • No revenue reported; consolidated statements present operating expenses and other income/expense, with no revenue line items .
  • Q1 2025 includes $0.9M R&D SBC and $3.3M G&A SBC from Q4 2024 option grants amortizing over one year .

Year-over-Year (YoY) snapshot – Q1

MetricQ1 2024Q1 2025YoY Delta
R&D Expense ($USD Millions)$2.68 $5.68 +$3.00
G&A Expense ($USD Millions)$1.23 $5.66 +$4.43
Net Loss ($USD Millions)$3.80 $10.41 +$6.61
Net Loss per Share ($USD)$(3.12) $(0.28) +$2.84 (less negative)
Weighted Avg Shares (Basic & Diluted)1,219,139 36,584,920 +35.37M

Estimates vs Actuals

MetricQ4 2024 ConsensusQ4 2024 ActualQ1 2025 ConsensusQ1 2025 Actual
EPS ($USD)$(0.425)*$(0.18) $(0.41)*$(0.28)
# EPS Estimates4*—4*—
Revenue ($USD Millions)$0.00*— (no revenue) $0.00*— (no revenue)
# Revenue Estimates5*—4*—

Values marked with * retrieved from S&P Global.

  • Q1 2025 EPS beat: $(0.28) vs $(0.41) consensus; magnitude $0.13. Potential drivers include higher interest income and substantially higher share count (dilution reduces per-share loss) .*

KPIs (Clinical/Operational)

KPIQ3 2024Q4 2024Q1 2025
LEVEL sites activated52 initiated >50 activated (ongoing) >50 activated; enrollment continues
LEVEL enrollment target—230 patients targeted YE 2025 230 patients targeted YE 2025
LEVEL statistical power——>95% after expansion
OLE continuation rates——>95% remained on therapy; >95% entered OLE; >95% continued
LEVEL topline timing—Mid-2026 Mid-2026
LEVEL-2 initiation—Expected 2025 Expected 2025; global footprint
Cash runwayThrough end of 2027 Through 2027 Through 2027

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
LEVEL enrollment completionYE 2025Around YE 2025 Around YE 2025 Maintained
LEVEL topline dataMid-2026Mid-2026 Mid-2026 Maintained
LEVEL-2 initiation2025Initiate in 2025 Initiate in 2025; global Maintained
Cash runwayThrough 2027Through 2027 Through 2027 Maintained

Earnings Call Themes & Trends

(No earnings call transcript found for Q1 2025; themes inferred from press releases.)

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Clinical execution (LEVEL)52 sites initiated; steady enrollment Enrollment continues; >95% OLE retention; power >95% with 230-patient target Strengthening
Regulatory interactionsFDA alignment disclosed in March 2025 on expanded plan FDA review completed; LEVEL expansion accepted; LEVEL-2 protocol feedback received Positive progress
Financing & runway$100M private placement; runway through 2027 $25M private placement; runway reiterated through 2027 Stable funding
R&D execution and SBCR&D/G&A rising with Phase 3; SBC grants in Q4 2024 R&D +$3.0M YoY; G&A +$4.4M YoY; $0.9M R&D SBC; $3.3M G&A SBC Higher spend as planned
Global footprint (LEVEL-2)Announced intent to commence in 2025 Global LEVEL-2 to start 2025; 26-week primary endpoint Advancing

Management Commentary

  • “2025 is off to a strong start… We expect to share topline data from our first Phase 3 study, LEVEL, in the middle of 2026 and establish TNX-103 as a powerful therapeutic option for this disease currently without any available treatments.” — Chris Giordano, President & CEO .
  • “We are increasing our investment… expanding the ongoing LEVEL study and accelerating our plans to initiate the second registrational study, LEVEL-2… We are funded well beyond our projected date for the release of topline LEVEL data.” — Chris Giordano, President & CEO .
  • “TNX-103 has the potential to meaningfully improve the quality of life of patients with PH-HFpEF… We are continuing to work closely with the FDA… enabling Tenax to accelerate development timelines.” — Stuart Rich, MD, Chief Medical Officer .

Q&A Highlights

  • No Q1 2025 earnings call transcript found; therefore Q&A themes and detailed guidance clarifications are unavailable for this quarter .

Estimates Context

  • Q1 2025 EPS beat: Actual $(0.28) vs $(0.41) consensus; 4 estimates contributed. Revenue consensus at $0.0 reflecting development-stage status.*
  • Q4 2024 EPS beat: Actual $(0.18) vs $(0.425) consensus; 4 estimates. Revenue consensus $0.0.*
  • Implication: Street may need to recalibrate near-term EPS loss trajectory modestly less negative given higher interest income and significantly larger share count post financings, while acknowledging rising opex driven by Phase 3 execution .*

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • EPS beat is notable for a development-stage biotech; dilution and interest income are key drivers of less negative per-share losses near term .*
  • Clinical momentum is strong: >95% OLE continuation and FDA-reviewed expanded plan increase probability of operational success; LEVEL-2 global initiation in 2025 adds a second pivotal catalyst path .
  • Guidance unchanged: Enrollment completion by YE 2025 and topline mid-2026 maintain a clear catalyst timeline; watch for LEVEL-2 first-patient-in .
  • Operating costs are rising as expected with Phase 3 scale-up; SBC from Q4 grants materially lifted G&A in Q1 — monitor opex cadence and cash runway execution .
  • Balance sheet is well-capitalized with $111.4M cash and reiterated runway through 2027; funding risk appears mitigated in the near-to-medium term .
  • Trading setup: Near-term stock moves likely tied to trial operational updates (site activation, enrollment milestones) and LEVEL-2 start; medium-term thesis hinges on LEVEL topline in mid-2026 and regulatory pathway clarity .
  • No revenue; valuation anchored to clinical/regulatory milestones rather than financial metrics — focus diligence on trial design, endpoints (6MWD), and safety/tolerability signals as datasets mature .