TENX Tenax Therapeutics Inc

Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today reported financial results for the third quarter 2020 and provided a business update.

Tenax will share updates related to levosimendan and its recently completed Phase 2 trial for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) on Wednesday, November 18, 2020 at 4:30 p.m. EST. The event will feature presentations from three globally recognized experts in the areas of pulmonary hypertension and heart failure with preserved ejection fraction, as well as a Q&A panel discussion. A live webcast of the Virtual R&D Webinar and accompanying slides will be available under “Events and Presentations” in the Investors section of the Company’s website at www.tenaxthera.com. The Virtual R&D Webinar can also be accessed by dialing (866) 301-1155 from the U.S. and (914) 987-7396 internationally, followed by the conference ID: 5783678. An archived webinar recording of the event will be available on the website for approximately 30 days.

“We are moving forward with our plan to enter Phase 3 of our clinical development program of levosimendan in PH-HFpEF and expect to reach an agreement with the FDA on a path forward before the end of the first quarter next year. The recent announcement related to adding the oral formulation of levosimendan by expanding our license agreement with Orion is an exciting opportunity for us. We believe an oral dosage form will be more convenient to patients in the Phase 3 program, thus potentially making the trial easier to enroll and perhaps shortening the overall time to complete the program. As we finalize our plans, we will provide additional updates,” stated Anthony DiTonno, Chief Executive Officer of Tenax. “We recently convened our Scientific Advisory Board to provide an in-depth review of the results of the HELP trial. The results of the Phase 2 trial received significant interest from the academic community at detailed presentations at the recent AHA and HFSA medical meetings. The R&D webinar on November 18th will be our first opportunity to provide access to a comprehensive review of the data to the investor community.”

Recent Highlights

• On November 13, 2020, data from the 24-hour open-label portion of the HELP Study was presented during the American Heart Association (AHA) Scientific Sessions 2020 by Daniel Burkhoff, MD, PhD, Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation., et al. The Phase 2 HELP Study enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction and was designed to evaluate levosimendan’s hemodynamic and clinical effects during rest and exercise. The initial phase of the trial was open-label and designed to identify patients who elicited a hemodynamic response following a 24-hour infusion of levosimendan. Patients who met the pre-specified response criteria of ≥4 mmHg reduction in pulmonary capillary wedge pressure during supine bicycle exercise were deemed to be responders and were randomized to a 6-week double-blind placebo-controlled phase of the trial.
• On October 9, 2020, Tenax signed an amendment to the existing licensing agreement with Orion Pharmaceuticals to include the rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with preserved ejection fraction (PH-HFpEF), or other pulmonary hypertension or heart failure related indications. The Company recently completed a Phase 2 study in PH-HFpEF using an intravenous formulation of levosimendan, which the Company has exclusive development and commercialization rights to in the US and Canada under the existing license agreement. Tenax expects to use the oral formulation in its upcoming Phase 3 trial in PH-HFpEF.
• On October 3, 2020, detailed results from the Phase 2 HELP Study of levosimendan in PH-HFpEF were presented at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting by Barry Borlaug, MD, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic.

Financial Results

• Research and development expenses for the third quarter of 2020 were $1.0 million, compared to $900,000 for the third quarter of 2019.
• General and administrative expenses for the third quarter of 2020 were $1.2 million, compared to $1.3 million for the third quarter of 2019.
• Net loss for the third quarter of 2020 was $2.2 million, or $0.18 per share, compared to a net loss of $2.2 million, or $0.33 per share, for the third quarter of 2019.
• Cash, cash equivalents and marketable securities totaled $8.7 million as of September 30, 2020, compared with $5.4 million as of December 31, 2019.
• Management expects that current cash, cash equivalents and marketable securities will be sufficient to fund current operations through the third quarter of 2021.

About Phase 2 HELP Trial

The HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Endpoints in the trial evaluated various invasive hemodynamic and clinical measures including a 6-minute walk test. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated a significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.

About Tenax Therapeutics

Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). For more information, visit www.tenaxthera.com.

About Levosimendan

Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company’s control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company’s filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 30, 2020, and its quarterly report on Form 10-Q filed on November 16, 2020, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

 

TENAX THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

 

Three months ended September 30,

 

 

Nine months ended September 30,

2020

 

2019

 

 

2020

 

2019

(Unaudited) (Unaudited) (Unaudited) (Unaudited)   Operating expenses General and administrative

$

1,172,725

 

$

1,343,429

 

$

3,364,890

 

$

3,692,843

 

Research and development

 

1,052,398

 

 

916,984

 

 

3,669,761

 

 

2,049,004

 

Total operating expenses

 

2,225,123

 

 

2,260,413

 

 

7,034,651

 

 

5,741,847

 

  Net operating loss

 

2,225,123

 

 

2,260,413

 

 

7,034,651

 

 

5,741,847

 

  Interest expense

 

610

 

 

-

 

 

1,016

 

 

-

 

Other income, net

 

(5,298

)

 

(36,709

)

 

(14,038

)

 

(139,161

)

Net loss

$

2,220,435

 

$

2,223,704

 

$

7,021,629

 

$

5,602,686

 

  Unrealized loss (gain) on marketable securities

 

1,171

 

 

960

 

 

(445

)

 

(803

)

Total comprehensive loss

$

2,221,606

 

$

2,224,664

 

$

7,021,184

 

$

5,601,883

 

  Net loss per share, basic and diluted

$

(0.18

)

$

(0.33

)

$

(0.73

)

$

(0.93

)

Weighted average number of common shares outstanding, basic and diluted

 

12,427,355

 

 

6,741,084

 

 

9,590,741

 

 

6,011,304

 

 

TENAX THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

  September 30, 2020 December 31, 2019 (Unaudited) ASSETS Current assets Cash and cash equivalents

$

8,235,532

 

$

4,905,993

 

Marketable securities

 

472,648

 

 

493,884

 

Prepaid expenses

 

189,275

 

 

780,952

 

Total current assets

 

8,897,455

 

 

6,180,829

 

Right of use asset

 

87,285

 

 

169,448

 

Property and equipment, net

 

3,461

 

 

6,559

 

Other assets

 

8,435

 

 

8,435

 

Total assets

$

8,996,636

 

$

6,365,271

 

  LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable

$

1,052,824

 

$

1,661,054

 

Accrued liabilities

 

295,451

 

 

871,341

 

Note payable

 

30,900

 

 

-

 

Total current liabilities

 

1,379,175

 

 

2,532,395

 

Long term liabilities Note payable

 

213,757

 

 

-

 

Lease liability

 

-

 

 

60,379

 

Total long term liabilities

 

213,757

 

 

60,379

 

Total liabilities

 

1,592,932

 

 

2,592,774

 

    Commitments and contingencies; see Note 7 Stockholders' equity Preferred stock, undesignated, authorized 9,999,790 shares; See Note 8 Series A Preferred stock, par value $.0001, issued and outstanding 210 and 38,606, respectively

 

-

 

 

4

 

Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 12,619,369 and 6,741,860, respectively

 

1,262

 

 

674

 

Additional paid-in capital

 

250,591,604

 

 

239,939,797

 

Accumulated other comprehensive gain

 

903

 

 

458

 

Accumulated deficit

 

(243,190,065

)

 

(236,168,436

)

Total stockholders’ equity

 

7,403,704

 

 

3,772,497

 

Total liabilities and stockholders' equity

$

8,996,636

 

$

6,365,271

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005957/en/

Investor Contact: Westwicke, an ICR Company Stephanie Carrington, 646-277-1282 stephanie.carrington@westwicke.com