Form 8-K

8-K — TENAX THERAPEUTICS, INC.

Accession: 0001193125-26-341236

Filed: 2026-08-10

Period: 2026-08-10

CIK: 0000034956

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — d115761d8k.htm (Primary)

EX-99.1 (d115761dex991.htm)

EX-99.2 (d115761dex992.htm)

GRAPHIC (g115761ex99_2s10g1.jpg)

GRAPHIC (g115761ex99_2s11g1.jpg)

GRAPHIC (g115761ex99_2s12g1.jpg)

GRAPHIC (g115761ex99_2s13g1.jpg)

GRAPHIC (g115761ex99_2s14g1.jpg)

GRAPHIC (g115761ex99_2s15g1.jpg)

GRAPHIC (g115761ex99_2s16g1.jpg)

GRAPHIC (g115761ex99_2s17g1.jpg)

GRAPHIC (g115761ex99_2s18g1.jpg)

GRAPHIC (g115761ex99_2s19g1.jpg)

GRAPHIC (g115761ex99_2s1g1.jpg)

GRAPHIC (g115761ex99_2s2g1.jpg)

GRAPHIC (g115761ex99_2s3g1.jpg)

GRAPHIC (g115761ex99_2s4g1.jpg)

GRAPHIC (g115761ex99_2s5g1.jpg)

GRAPHIC (g115761ex99_2s6g1.jpg)

GRAPHIC (g115761ex99_2s7g1.jpg)

GRAPHIC (g115761ex99_2s8g1.jpg)

GRAPHIC (g115761ex99_2s9g1.jpg)

GRAPHIC (g115761g0810074128422.jpg)

GRAPHIC (g115761g0810074457736.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: d115761d8k.htm · Sequence: 1

8-K

false 0000034956 0000034956 2026-08-10 2026-08-10

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 10, 2026

Tenax Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-34600

26-2593535

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

101 Glen Lennox Drive, Suite 300

Chapel Hill, North Carolina 27517

(Address of principal executive offices) (Zip Code)

919-855-2100

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share

TENX

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01

Other Events.

On August 10, 2026, Tenax Therapeutics, Inc. (the “Company”) issued a press release announcing topline results from its Phase 3 LEVEL clinical trial of TNX-103 in patients with PH-HFpEF. As announced, the Company intends to host a conference call and live webcast at 8:00 a.m., ET on August 10, 2026 related to those results. A copy of the press release and the presentation the Company intends to display during the live webcast are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit 99.1

Press release, dated August 10, 2026.

Exhibit 99.2

Investor presentation, dated August 10, 2026.

Exhibit 104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: August 10, 2026

TENAX THERAPEUTICS, INC.

By:

/s/ Christopher T. Giordano

Name:

Christopher T. Giordano

Title:

President and Chief Executive Officer

EX-99.1

Filename: d115761dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Tenax Therapeutics Announces Topline Results from Phase 3 LEVEL Clinical Trial of TNX-103 in Patients with PH-HFpEF

TNX-103 did not meet statistical significance on the primary endpoint of improvement in 6-minute walk

distance versus placebo

In prespecified exploratory analyses in the overall trial population, treatment with TNX-103 resulted

in a

49% greater reduction in NT-proBNP compared to placebo (nominal p<0.0001) and a

reduction of

3.5 mmHg in right ventricular systolic pressure compared to placebo (nominal p=0.0045)

In a prespecified analysis, patients with a baseline 6-minute walk distance below the trial median of

333 meters

showed a 26.3-meter improvement compared to placebo (95% CI 6.0, 46.7; nominal

p=0.0112)

Company to hold conference call and webcast today at 8:00 a.m. ET

CHAPEL HILL, N.C., August 10, 2026 (GLOBE NEWSWIRE) — Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax

Therapeutics” or the “Company”) today announced topline results from the Phase 3 LEVEL clinical trial evaluating TNX-103 (oral levosimendan) in patients with

PH-HFpEF. LEVEL did not meet its primary endpoint of improvement in the 6-minute walk distance versus placebo, or the key secondary endpoint of improvement in Kansas

City Cardiomyopathy Questionnaire total symptom score. Prespecified subgroup analyses identified a substantial beneficial treatment effect in patients with greater disease burden, supported by clinically meaningful changes in predefined cardiac

biomarker and pulmonary hemodynamic measures across the overall trial population. TNX-103 was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced

across treatment arms. Based on the results of the LEVEL trial, Tenax intends to request a Type C Meeting with the U.S. Food and Drug Administration (FDA) to discuss revisions to the ongoing registrational development of TNX-103 for the treatment of PH-HFpEF.

“Having reviewed the available

trial results, I am encouraged we have a clear path forward. The prespecified subgroup analyses demonstrate that there is a meaningful beneficial treatment effect of TNX-103 in patients with more disease

burden, which is the patient population with the greatest unmet need. Our entry criteria enrolled a broad population, including too many patients with less severe disease. In a prespecified subgroup analysis of patients who walked less than the

trial median of 333 meters at baseline, the improvement in the levosimendan group compared to placebo was 26.3 meters (95% confidence interval 6.0, 46.7 meters), demonstrating a strong result in a more characteristic HFpEF population that needs this

therapy. This association is corroborated by a 49% decrease in NT-proBNP compared to placebo (p=0.0001, nominal) and a clinically meaningful reduction in right ventricular systolic pressure of 3.5 mmHg,

compared to placebo (p=0.0045, nominal). Taken together, these data support TNX-103’s substantial cardiovascular and pulmonary biologic effects on reducing the severity of disease in patients with

pulmonary hypertension due to HFpEF,” said Stuart Rich, MD, Chief Medical Officer of Tenax Therapeutics.

“Although the result in the overall population was not statistically significant, the LEVEL trial is an

important advancement for patients with pulmonary hypertension due to HFpEF, a disease that still has no approved therapy. What stands out to me is the marked reduction in NT-proBNP, the most established

marker of cardiac wall stress and prognosis in heart failure, which was reduced by an extraordinary 49% relative to placebo. The treatment effect on NT-proBNP is larger than any prior HFpEF trial, and it was

accompanied by improvements in multiple echocardiographic measures of cardiac structure and function, spanning right ventricular systolic function, left atrial function, left ventricular mass and diastolic filling, and pulmonary pressure. In my

opinion, a drug that lowers wall stress and modifies cardiac structure and function this robustly is likely to be disease-modifying. The improvement in exercise capacity was concentrated in patients with lower baseline walk distance and more

advanced disease, which is consistent with a therapy that may improve long-term outcomes in those patients who need it most,” said Sanjiv Shah, MD, Director of the HFpEF Program at Northwestern University Feinberg School of Medicine and

LEVEL’s Principal Investigator.

Key Results from LEVEL

LEVEL (NCT05983250) was a registrational Phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating

TNX-103 in patients with PH-HFpEF across 41 sites in the United States and Canada. 241 patients were randomized to TNX-103 1 mg

twice daily, titrated to 1 mg three times daily starting at Week 5 as tolerated, versus placebo. The primary endpoint was change in 6-minute walk distance (6MWD) at Week 12, and a key secondary endpoint was

change in Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS). N-terminal pro-B natriuretic peptide (NT-proBNP), a measure of cardiac wall stress, and right ventricular systolic pressure (RVSP) by echocardiography, were exploratory endpoints. Patients completing the double-blind period were eligible to enter an

open-label extension of up to two years, which is ongoing.

•

6MWD at Week 12: least-squares means +14.0 meters (SE 7.7) on TNX-103

(n=116) versus +10.4 meters (SE 7.6) on placebo (n=120); least-squares mean difference 3.5 meters (SE 7.3), p=0.63. The primary endpoint was not met. Estimates are from a mixed model for repeated measures in all 241 randomized patients (120 TNX-103, 121 placebo), adjusted for baseline 6MWD and randomization strata with missing Week 12 values handled by the prespecified estimand strategies.

•

Among patients with an observed Week 12 walk test, the mean change from baseline was +17.7 meters (SD 40.2) on TNX-103 (n=116) versus +9.8 meters (SD 54.7) on placebo (n=120), an unadjusted difference of +8.0 meters.

•

KCCQ-TSS at Week 12: least-squares mean +6.6 (SE 2.4) on TNX-103 (n=114) versus +6.5 (SE 2.3) on placebo (n=120); least-squares mean difference 0.1 points (SE 2.2).

Prespecified Analyses of Primary Endpoint

•

Baseline 6MWD below the trial median of 333 meters (n=119): least-squares mean treatment difference +26.3 meters

(95% confidence interval 6.0, 46.7), nominal p=0.0112. On average, patients on TNX-103 in this sub-group improved 26.7 meters while patients on placebo declined 2.6

meters.

•

Patients aged 71 years and older: least squares mean treatment difference +27.1 meters (95% confidence interval

9.9, 44.4), nominal p=0.0021. In the oldest tertile (>74 years): +37.6 meters (95% confidence interval 14.7, 60.5), nominal p=0.0013. Mean age was 71.8 years among patients walking less than 333 meters at baseline, versus 66.5 years among those

at or above that threshold.

Prespecified Exploratory Biomarker and Hemodynamic Analyses

•

NT-proBNP (overall population): geometric least-squares mean ratio of

0.51 versus placebo (95% confidence interval 0.43, 0.60), nominal p<0.0001, corresponding to a 49% reduction compared to placebo. On average, the change from baseline was -39.1 pmol/L (SD 78.6) on TNX-103 (n=116) versus +13.7 pmol/L (SD 81.0) on placebo (n=120).

•

RVSP by echocardiography (overall population): placebo-controlled reduction of 3.5 mmHg on TNX-103 (95% confidence interval -6.01, -1.10), nominal p=0.0045. In patients with a baseline 6MWD below 333 meters the reduction was

4.9 mmHg (nominal p=0.009).

Post hoc Analysis of Primary Endpoint

•

By baseline 6MWD quartile, the treatment difference diminished consistently as baseline exercise capacity

increased: +32.4 meter improvement in the first quartile (≤264 meters), +21.4 meters in the second (>264–333 meters), -10.7 meters in the third (>333–384 meters) and -27.3 meters in the fourth (>384 meters).

Safety

TNX-103 was generally safe and well-tolerated in the LEVEL trial, and no new safety signals were observed.

•

Adverse events were reported in 86.7% of patients on TNX-103 versus 71.9%

on placebo. Treatment-related adverse events were reported in 38.3% of patients in the treatment group versus 17.4% on placebo.

•

Serious adverse events were balanced across arms, at 10.8% on TNX-103 and

10.7% on placebo. Adverse events of special interest occurred in 9.2% versus 5.8%.

The biomarker and hemodynamic analyses described

above were prespecified in the statistical analysis plan; the quartile analysis was post hoc. Nominal p-values are not adjusted for multiplicity and these analyses do not establish efficacy. Multivariable

analyses are ongoing.

“We believe the data from LEVEL provide new information that will guide us toward approval. Our mission is to bring the first

approved therapy to patients with PH-HFpEF. The data from LEVEL provide us with a key insight into the population that exhibits the treatment effect of TNX-103. These

trial results also confirm we had the appropriate dosing in HFpEF patients, illustrate a very favorable overall pharmacokinetic profile of oral levosimendan, and demonstrate the safety of oral levosimendan. Based on the results from LEVEL, we are

moving quickly to strengthen the development plan for TNX-103 to generate data we believe will support regulatory submissions,” said Chris Giordano, President and Chief Executive Officer of Tenax

Therapeutics.

Tenax intends to request a Type C meeting with the FDA to present the complete LEVEL dataset together with

the Company’s recommendations, and in parallel to seek scientific consultation from the European Medicines Agency. The Company intends to enrich the study population to ensure a robust treatment effect, as demonstrated in the subgroup findings

observed in LEVEL. We will discuss an enrichment strategy in the Type C meeting, along with the FDA’s previous agreement that a single Phase 3 trial with a p-value of 0.01 would be sufficient for an NDA

submission for TNX-103 for the treatment of PH-HFpEF.

Full results from

LEVEL will be presented in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026, being held August 28-31 in Munich, Germany.

Conference Call and Webcast

Tenax will host a conference

call and live webcast today, Monday, August 10, 2026 at 8:00 a.m. ET to discuss the topline LEVEL results. Members of the management team will be joined by Sanjiv Shah, MD, Director of the HFpEF Program at Northwestern University Feinberg

School of Medicine and LEVEL’s Principal Investigator.

To participate in the conference call, please dial one of the following numbers and ask to

join the Tenax Therapeutics call:

•

+1-888-349-0106 for

callers in the United States

•

+1-412-902-0131 for

international callers

The live and archived webcast of the call will be accessible from the Company’s investor relations webpage.

About Levosimendan (TNX-101, TNX-102,

TNX-103)

Levosimendan is a novel,

first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH)

associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has

received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL-2, a Phase 3, double-blind, randomized, placebo-controlled

clinical trial in patients with PH-HFpEF.

About Tenax Therapeutics

Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company

owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been

approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.

Caution Regarding Forward-Looking Statements

Except for

historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning our clinical data, our regulatory plans,

our future trial designs, and our possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ

materially include: risks of our clinical trials, including, but not limited to, the results of such trials, and the design, timing, delays, costs, location, initiation, and enrollment of any future trials; any delays in regulatory review and

approval of product candidates in development; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; risks related to our business strategy, including the prioritization and

development of product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; our estimates regarding the potential market opportunity for our product candidates; cash usage and runway may not be within

management’s expected ranges; the potential advantages of our product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including our executives and

members of our Board of Directors; risks associated with our cash needs; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics,

global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate, and the

impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these

forward-looking statements except as required by law.

Contact:

Investor and Media:

Argot Partners

tenax@argotpartners.com

EX-99.2

Filename: d115761dex992.htm · Sequence: 3

EX-99.2

LEVEL Clinical Trial Topline Results

August 10, 2026 Exhibit 99.2

Today’s Agenda Opening

RemarksChris Giordano President and CEO LEVEL Topline ResultsStuart Rich, MD CMO KOL ThoughtsSanjiv Shah, MD Northwestern University Path ForwardChris Giordano CEO Q&AChris Giordano President and CEO Stuart Rich, MD CMO Doug Randall CBO Tom

Staab CFO Sanjiv Shah, MD Northwestern University

Forward-Looking Statements Disclaimers

Except for historical information, all of the statements, expectations and assumptions contained in this presentation are forward-looking statements. These forward-looking statements may include information concerning our clinical data, our

regulatory plans, our future trial designs, and our possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual

results to differ materially include: risks of our clinical trials, including, but not limited to, the results of such trials, and the design, timing, delays, costs, location, initiation, and enrollment of any future trials; any delays in regulatory

review and approval of product candidates in development; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; risks related to our business strategy, including the

prioritization and development of product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; our estimates regarding the potential market opportunity for our product candidates; cash usage and runway may

not be within management’s expected ranges; the potential advantages of our product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including our

executives and members of our Board of Directors; risks associated with our cash needs; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility

of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we

operate and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to

update these forward-looking statements except as required by law.

Introduction Chris Giordano President

and CEO, Tenax Therapeutics

What LEVEL Told Us WHERE THE TRIAL

LANDED *Prespecified analysis; nominal p-values are not adjusted for multiplicity. NT-proBNP: N-terminal pro B-type natriuretic peptide; RVSP: right ventricular systolic pressure; HELP: Hemodynamic Evaluation of Levosimendan in Patients with

PH-HFpEF; 6MWD: 6-minute walk distance; CI: confidence interval. LEVEL did not meet its primary endpoint, but a strong treatment effect was seen across patients with higher disease burden What we confirmed Oral levosimendan is safe and

well-tolerated Biologically active, as measured by NT-proBNP and RVSP Treatment effect seen in HELP study validated Successful trial execution by sites and clinical development team What we learned Drug effect is evident in patients with higher

disease burden Study entry criteria allowed patients with moderate disease In patients with baseline 6MWD* < 333 m, treatment effect was +26.3 m vs placebo (95% CI: 6.0, 46.7; nominal p = 0.0112) In the overall population, NT-proBNP was reduced

by 49% vs placebo (nominal p < 0.0001)

Phase 3 LEVEL Clinical Trial Topline

Results Stuart Rich, MD CMO, Tenax Therapeutics

LEVEL Study PHASE 3 REGISTRATIONAL

TRIAL IN US AND CANADA BID: twice a day; TID: three times a day; 6MWD: 6-minute walk distance; RHC: right heart catheterization; PCWP: pulmonary capillary wedge pressure; mPAP: mean pulmonary artery pressure; RAP: right arterial pressure. 1mg oral

capsule BID, titrated to 1mg TID Open-Label Extension to 2 Years TNX-103 2mg (Weeks 0-4) TNX-103 3mg (Weeks 5-12) Placebo (Weeks 0-4) Placebo (Weeks 5-12) Primary Endpoint: Δ6MWD Hemodynamic Inclusion Criteria Randomize 1:1 (n=241) RHC with

qualifying hemodynamics at rest: PCWP > 18 mmHg, and mPAP > 30 mmHg, and RAP > 8 mmHg Hemodynamics with passive leg raise PCWP > 20 mmHg, and mPAP > 32 mmHg, and RAP > 8 mmHg Hemodynamics with bicycle exercise PCWP > 25 mmHg,

and mPAP > 35 mmHg, and RAP > 10 mmHg OR OR

Patient Demographics BASELINE

CHARACTERISTICS WERE BROADLY BALANCED ACROSS TREATMENT ARMS BMI: body mass index; 6MWD: 6-minute walk distance; eGFR: estimated glomerular filtration rate; NYHA: New York Heart Association. Characteristic TNX-103 (N=120) Placebo (N=121) Overall

(N=241) Age, years, mean (SD) 69.8 (9.7) 68.5 (10.1) 69.1 (9.9) Female, n (%) 86 (71.7) 86 (71.1) 172 (71.4) BMI, kg/m², mean (SD) 33.2 (5.8) 32.9 (6.6) 33.1 (6.2) eGFR <60 mL/min/1.73 m², n (%) 33 (27.5) 44 (36.4) 77 (32.0) SGLT2

inhibitor use, n (%) 80 (66.7) 93 (76.9) 173 (71.8) GLP-1 receptor agonist use, n (%) 36 (30.0) 32 (26.4) 68 (28.2) MRA use, n (%) 68 (56.7) 76 (62.8) 144 (59.8) Diuretic use, n (%) 103 (85.8) 106 (87.6) 209 (86.7) Baseline 6MWD, m, mean (SD) 316.5

(87.3) 322.5 (83.5) 319.5 (85.3) Characteristic TNX-103 (N=120) Placebo (N=121) Overall (N=241) NYHA Functional Class II, n (%) 53 (44.2) 55 (45.5) 108 (44.8) NYHA Functional Class III, n (%) 67 (55.8) 64 (52.9) 131 (54.4) NYHA Functional Class IV,

n (%) 0 2 (1.7) 2 (0.8) Qualified at rest, n (%) 46 (38.3) 51 (42.1) 97 (40.2) Qualified on provocation, n (%) 74 (61.7) 70 (57.9) 144 (59.8) Slow acetylator, n (%) 66 (55.0) 54 (44.6) 120 (49.8) Intermediate acetylator, n (%) 33 (27.5) 48 (39.7) 81

(33.6) Rapid acetylator, n (%) 14 (11.7) 7 (5.8) 21 (8.7) Acetylator status unknown, n (%) 7 (5.8) 12 (9.9) 19 (7.9)

Primary and Key Secondary Endpoints

*N=120 and N=121 for TNX-103 and placebo arms, respectively. 6MWD: 6-minute walk distance; LS: least squares; SE: standard error; SD: standard deviation; KCCQ-TSS: Kansas City Cardiomyopathy Questionnaire-Total Symptom Score; NYHA: New York Heart

Association; NS: not significant p-value. Primary Endpoint (Week 12) TNX-103 (N=116) Placebo (N=120) Treatment difference 6MWD LS mean 14.0 m (SE: 7.7 m) 10.4 m (SE: 7.6 m) 3.5 m (SE: 7.3; p = 0.63) Mean 17.7 m (SD: 40.2 m) 9.8 m (SD: 54.7 m) 8.0 m

Secondary Endpoints (Week 12) TNX-103 (N=116) Placebo (N=120) Treatment difference KCCQ-TSS, LS mean change 6.6 (SE: 2.4) 6.5 (SE: 2.3) 0.1 (SE: 2.2); NS NYHA functional class improvement, n (%) 28 (24.1) 27 (22.5) NS Adjudicated clinical worsening,

n (%) 3 (2.5)* 3 (2.5)* NS

Safety TOLERABILITY DIFFERENCE

BETWEEN ARMS; SERIOUS EVENTS AND CLINICAL WORSENING BALANCED CWE: clinical worsening event; AE: adverse event; CV: cardiovascular; IV: intravenous. Adverse event summary TNX-103 (N=120) Placebo (N=121) Any adverse event, n (%) 104 (86.7) 87 (71.9)

Treatment-related adverse event, n (%) 46 (38.3) 21 (17.4) Leading to treatment discontinuation, n (%) 10 (8.3) 2 (1.7) Leading to dose reduction, n (%) 18 (15.0) 5 (4.1) Serious adverse event, n (%) 13 (10.8) 13 (10.7) Adverse event of special

interest, n (%) 11 (9.2) 7 (5.8) Associated with adjudicated CWE, n (%) Unplanned 24-hr CV hospitalization Outpatient visit for IV diuretics Death 3 (2.5) 0 (0) 1 (0.8) 2 (1.7) 3 (2.5) 3 (2.5) 0 (0) 0 (0) Higher rates of treatment-related AEs, dose

reductions and discontinuations on drug, driven by headache, palpitations and hypotension Serious AEs and adjudicated clinical worsening events were balanced across arms No new-onset atrial fibrillation or ventricular tachycardia in patients without

pre-existing evidence

Confirming Biological Activity

Using NT-proBNP NT-proBNP FELL IN OVERALL POPULATION *nominal p-value. NT-proBNP: N-terminal pro B-type natriuretic peptide; LS: least squares; CI: confidence interval.. NT-proBNP vs. placebo at Week 12 Geometrics LS mean ratio 0.51 (95% CI: 0.43,

0.60; p < 0.0001*) − 49% All Patients (N=120) (N=116)

Impressive Reductions in

Exploratory Endpoints BIOMARKER AND HEMODYNAMIC REDUCTIONS EVEN MORE PRONOUNCED IN PATIENTS WITH HIGHER DISEASE BURDEN *nominal p-value; #95% confidence interval is -6.010, -1.100; HHodges-Lehmann shift estimate. NT-proBNP: N-terminal pro B-type

natriuretic peptide; RVSP: right ventricular systolic pressure; PASP: pulmonary artery systolic pressure; 6MWD: 6-minute walk distance.. Exploratory endpoint TNX-103 Placebo Treatment Difference NT-proBNP, mean change − 39.1 pmol/L + 13.7

pmol/L 49% (p < 0.0001*) RVSP (PASP), median − 3.6 mmHg + 0.5 mmHg − 3.5 mmHg#H (p = 0.0045*) RVSP Δ vs. placebo at Week 12 Echocardiography (p = 0.009*) − 4.9 mmHg All Patients Enrolled in LEVEL Patients in LEVEL with High

Disease Burden Below Median (Baseline < 333 m)

Treatment Effect Correlates with

Disease Severity *Post-hoc analysis 6MWD: 6-minute walk distance; LS: least squares; CI: confidence interval. Δ vs. placebo, LS mean 95% CI: 6.0, 46.7; nominal p = 0.0112 + 26.3 meters Δ vs. placebo, LS mean 95% CI: -36.7, 1.7; nominal p =

0.0744 − 17.6 meters Below Median (Baseline < 333 m) Above Median (Baseline > 333 m) Q1 <264 m Q2 >264-333 m Q3 >333-384 m Q4 >384 m (N=61) (N=61) (N=59) (N=60)

Three Disease Burden Markers

Correlate with Treatment Effect KEY BASELINE CHARACTERISTICS PREDICT RESPONSE By age Δ 6MWD vs placebo 95% CI Nominal p-value Top tertile (> 74 years), N=77 + 37.6 m 14.7, 60.5 0.0013 Above median (> 71 years), N=124 + 27.1 m 9.9, 44.4

0.0021 Below median (< 71 years), N=117 - 19.2 m - 42.0, 3.5 0.0972 *Least squares mean difference; #post-hoc analysis. 6MWD: 6-minute walk distance; NT-proBNP: N-terminal pro B-type natriuretic peptide; CI: confidence interval. By baseline

NT-proBNP# Δ 6MWD vs placebo* 95% CI Nominal p-value Above median (> 225 pg/mL), N=122 + 16.7 m - 2.3, 35.8 0.0850 Below median (< 225 pg/mL), N=119 - 9.0 m - 30.2, 12.3 0.4074 By baseline 6MWD Δ 6MWD vs placebo* 95% CI Nominal

p-value Below median (< 333 m), N=119 + 26.3 m 6.0, 46.7 0.0112 Above median (> 333 m), N=122 - 17.6 m - 36.9, 1.7 0.0744

What We Learned 6MWD IS BOTH OUR

PRIMARY ENDPOINT AND OUR BEST ENRICHMENT CRITERION 6MWD: 6-minute walk distance; HELP: Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF. HELP Phase 2 ~90% of patients enrolled below 400 m Protocol cap 550 m LEVEL Phase 3 50% of

patients enrolled below 333 m (Responded: + 26.3 m) 50% of patients enrolled above 333 m (Responded: - 17.6 m) Protocol cap 450 m Median 333 m 100 200 300 400 500 meters TNX-103 is safe and well-tolerated TNX-103 is effective in patients with a

higher disease burden In patients with lower baseline walks, NT-proBNP decreased dramatically Clear benefit seen in LEVEL will inform regulatory strategy moving forward ~10% of patients enrolled above 400 m

Additional Thoughts On LEVEL

Results Sanjiv Shah, MD Director of HFpEF Program Northwestern University Feinberg School of Medicine Principal Investigator on LEVEL Clinical Trial

Next Steps for Tenax Chris Giordano

President and CEO, Tenax Therapeutics

Where We Go From Here WHAT WE KNOW,

WHAT WE WILL DO, AND WHAT IS STILL OPEN PK: pharmacokinetics; NT-proBNP: N-terminal pro B-type natriuretic peptide; RVSP: right ventricular systolic pressure; FDA: Food and Drug Administration; EMA: European Medicines Agency; NDA: New Drug

Application; ESC: European Society of Cardiology; 6MWD: 6-minute walk distance. TNX-103 lowers NT-proBNP and RVSP, reflecting its biologic activity Therapeutic dose is confirmed Drug is safe and well-tolerated More effective in patients with higher

disease burden WHAT LEVEL ESTABLISHED Request a Type C meeting with the FDA Seek parallel EMA scientific consultation Present additional data at ESC and publish Baseline 6MWD in LEVEL-2 will be capped moving forward WHAT WE WILL DO NEXT Modify

overall Phase 3 development plan, following regulatory interactions WHAT REMAINS OPEN

Q&A Chris Giordano President

and CEO, Tenax Therapeutics Stuart Rich, MD CMO, Tenax Therapeutics Sanjiv Shah, MD Northwestern University Doug Randall CBO, Tenax Therapeutics Tom Staab CFO, Tenax Therapeutics

GRAPHIC

Filename: g115761ex99_2s10g1.jpg · Sequence: 7

Binary file (81423 bytes)

Download g115761ex99_2s10g1.jpg

GRAPHIC

Filename: g115761ex99_2s11g1.jpg · Sequence: 8

Binary file (51506 bytes)

Download g115761ex99_2s11g1.jpg

GRAPHIC

Filename: g115761ex99_2s12g1.jpg · Sequence: 9

Binary file (70314 bytes)

Download g115761ex99_2s12g1.jpg

GRAPHIC

Filename: g115761ex99_2s13g1.jpg · Sequence: 10

Binary file (60776 bytes)

Download g115761ex99_2s13g1.jpg

GRAPHIC

Filename: g115761ex99_2s14g1.jpg · Sequence: 11

Binary file (88741 bytes)

Download g115761ex99_2s14g1.jpg

GRAPHIC

Filename: g115761ex99_2s15g1.jpg · Sequence: 12

Binary file (68605 bytes)

Download g115761ex99_2s15g1.jpg

GRAPHIC

Filename: g115761ex99_2s16g1.jpg · Sequence: 13

Binary file (42886 bytes)

Download g115761ex99_2s16g1.jpg

GRAPHIC

Filename: g115761ex99_2s17g1.jpg · Sequence: 14

Binary file (30590 bytes)

Download g115761ex99_2s17g1.jpg

GRAPHIC

Filename: g115761ex99_2s18g1.jpg · Sequence: 15

Binary file (69040 bytes)

Download g115761ex99_2s18g1.jpg

GRAPHIC

Filename: g115761ex99_2s19g1.jpg · Sequence: 16

Binary file (38699 bytes)

Download g115761ex99_2s19g1.jpg

GRAPHIC

Filename: g115761ex99_2s1g1.jpg · Sequence: 17

Binary file (40552 bytes)

Download g115761ex99_2s1g1.jpg

GRAPHIC

Filename: g115761ex99_2s2g1.jpg · Sequence: 18

Binary file (51803 bytes)

Download g115761ex99_2s2g1.jpg

GRAPHIC

Filename: g115761ex99_2s3g1.jpg · Sequence: 19

Binary file (181262 bytes)

Download g115761ex99_2s3g1.jpg

GRAPHIC

Filename: g115761ex99_2s4g1.jpg · Sequence: 20

Binary file (27393 bytes)

Download g115761ex99_2s4g1.jpg

GRAPHIC

Filename: g115761ex99_2s5g1.jpg · Sequence: 21

Binary file (81494 bytes)

Download g115761ex99_2s5g1.jpg

GRAPHIC

Filename: g115761ex99_2s6g1.jpg · Sequence: 22

Binary file (35494 bytes)

Download g115761ex99_2s6g1.jpg

GRAPHIC

Filename: g115761ex99_2s7g1.jpg · Sequence: 23

Binary file (76175 bytes)

Download g115761ex99_2s7g1.jpg

GRAPHIC

Filename: g115761ex99_2s8g1.jpg · Sequence: 24

Binary file (102399 bytes)

Download g115761ex99_2s8g1.jpg

GRAPHIC

Filename: g115761ex99_2s9g1.jpg · Sequence: 25

Binary file (77048 bytes)

Download g115761ex99_2s9g1.jpg

GRAPHIC

Filename: g115761g0810074128422.jpg · Sequence: 26

Binary file (3909 bytes)

Download g115761g0810074128422.jpg

GRAPHIC

Filename: g115761g0810074457736.jpg · Sequence: 27

Binary file (3909 bytes)

Download g115761g0810074457736.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 29

v3.26.1

Document and Entity Information

Aug. 10, 2026

Cover [Abstract]

Amendment Flag

false

Entity Central Index Key

0000034956

Document Type

8-K

Document Period End Date

Aug. 10, 2026

Entity Registrant Name

Tenax Therapeutics, Inc.

Entity Incorporation State Country Code

Entity File Number

001-34600

Entity Tax Identification Number

26-2593535

Entity Address, Address Line One

101 Glen Lennox Drive

Entity Address, Address Line Two

Suite 300

Entity Address, City or Town

Chapel Hill

Entity Address, State or Province

Entity Address, Postal Zip Code

27517

City Area Code

919

Local Phone Number

855-2100

Written Communications

false

Soliciting Material

false

Pre Commencement Tender Offer

false

Pre Commencement Issuer Tender Offer

false

Security 12b Title

Common Stock, $0.0001 par value per share

Trading Symbol

TENX

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration