MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today reported financial results for the second quarter of 2021 and provided a business update.
“We are entering an exciting period for Tenax Therapeutics, with continued progress being made for our two lead clinical programs – imatinib for the treatment of pulmonary arterial hypertension and levosimendan for the treatment of pulmonary hypertension associated with left heart failure,” said Christopher T. Giordano, Chief Executive Officer of Tenax Therapeutics.
“Our imatinib program for PAH remains on track, and we are presently completing the final stages of the formulation work. We believe our new, delayed release, oral formulation of imatinib will confer significant therapeutic advantages over the prior oral formulation, including improved GI tolerability and the potential for disease-modifying clinical activity.”
“With respect to levosimendan, our open label transition study using the oral formulation also remains on track. As a reminder, the purpose of this study is to determine the optimal dosage for levosimendan for our planned Phase 3 trial, which is expected to start in 2022. We believe oral delivery of levosimendan will provide more consistent blood levels compared to weekly IV administration, with the added benefit of administrative convenience to the patient. More than 50% of the subjects in this open label extension study have already transitioned from weekly IV infusion to the daily oral formulation.”
Recent Highlights
- On August 16, 2021, Tenax held a KOL webinar on Levosimendan for pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The webinar featured a presentation by Key Opinion Leader (KOL) Daniel Burkhoff, M.D., Ph.D. (Cardiovascular Research Foundation) who discussed the current treatment landscape and unmet medical need in treating patients with pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) and how levosimendan could become an important new treatment option for this patient population.
- On August 12, 2021, Tenax announced the publication of a new article that identifies a novel mechanism of action behind the improved cardiovascular hemodynamics and exercise tolerance that was reported in the recent Phase 2 HELP Study (Burkhoff et al., JACC Heart Failure 2021; 9:360-70). The new publication, “Changes in Stressed Blood Volume with Levosimendan in Pulmonary Hypertension from Heart Failure with Preserved Ejection Fraction: Insights Regarding Mechanism of Action” appears in the Journal of Cardiac Failure. The article is available online as an “Article In Press.” https://www.onlinejcf.com/article/S1071-9164(21)00215-3/fulltext
- Effective July 14, 2021, the Tenax Board of Directors appointed Mr. Christopher T. Giordano to serve as Chief Executive Officer and a Director of the Company. On July 7, 2021, Tenax announced a transition in connection with the retirement of its former CEO Mr. Anthony A. DiTonno following a successful decade of service with the Company.
- On July 7, 2021, Tenax announced that it entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of 4,773,269 Units at a purchase price of $2.095 per Unit. Each Unit consists of one unregistered pre-funded warrant to purchase one share of common stock, par value $0.0001 and one unregistered warrant to purchase one share of common stock. In the aggregate, 9,546,538 shares of the Company’s common stock are underlying the warrants. The unregistered pre-funded warrants have an exercise price of $0.0001 per share of common stock, are immediately exercisable, and may be exercised at any time until exercised in full. The unregistered warrants have an exercise price of $1.97 per share of common stock, are immediately exercisable, and will expire five and one-half years from the date of issuance. The aggregate gross proceeds to the Company of the offering was approximately $10 million
Financial Results
- Research and development expenses for the second quarter of 2021 were $0.7 million, compared to $1.3 million for the second quarter of 2020.
- General and administrative expenses for the second quarter of 2021 were $1.3 million, compared to $0.9 million for the second quarter of 2020.
- Net loss for the second quarter of 2021 was $1.7 million, or $0.10 per share, compared to a net loss of $2.1 million, or $0.23 per share, for the second quarter of 2020.
- Cash, cash equivalents and marketable securities totaled $2.2 million as of June 30, 2021, compared with $6.7 million as of December 31, 2020. Following the close of the second quarter, Tenax raised $10 million in gross proceeds from an equity offering with a single institutional investor. Including the proceeds from this offering, management expects that current cash, cash equivalents and marketable securities, including the net proceeds from the July 2021 offering, will be sufficient to fund current operations through the second quarter of 2022.
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 detailed results from the Phase 2 HELP Study of levosimendan in Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting. Tenax is also developing a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. 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.
About Imatinib
Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.
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 31, 2021 and its quarterly report on Form 10-Q filed on August 16, 2021, 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 June 30, |
|
Six months ended June 30, |
||||||||||||
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | $ |
1,271,278 |
|
$ |
869,206 |
|
$ |
2,644,738 |
|
$ |
2,192,165 |
|
||||
| Research and development |
|
693,222 |
|
|
1,274,837 |
|
|
23,069,424 |
|
|
2,617,363 |
|
||||
| Total operating expenses |
|
1,964,500 |
|
|
2,144,043 |
|
|
25,714,162 |
|
|
4,809,528 |
|
||||
| Net operating loss |
|
1,964,500 |
|
|
2,144,043 |
|
|
25,714,162 |
|
|
4,809,528 |
|
||||
| Interest expense |
|
336 |
|
|
406 |
|
|
949 |
|
|
406 |
|
||||
| Other (income) expense, net |
|
(247,820 |
) |
|
2,101 |
|
|
(249,955 |
) |
|
(8,740 |
) |
||||
| Net loss | $ |
1,717,016 |
|
$ |
2,146,550 |
|
$ |
25,465,156 |
|
$ |
4,801,194 |
|
||||
| Unrealized (gain) loss on marketable securities |
|
(128 |
) |
|
(3,238 |
) |
|
204 |
|
|
(1,616 |
) |
||||
| Total comprehensive loss | $ |
1,716,888 |
|
$ |
2,143,312 |
|
$ |
25,465,360 |
|
$ |
4,799,578 |
|
||||
| Net loss per share, basic and diluted | $ |
(0.10 |
) |
$ |
(0.23 |
) |
$ |
(1.60 |
) |
$ |
(0.59 |
) |
||||
| Weighted average number of common shares outstanding, basic and diluted |
|
17,218,103 |
|
|
9,339,309 |
|
|
15,874,062 |
|
|
8,156,848 |
|
||||
TENAX THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
| June 30, 2021 | December 31, 2020 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ |
1,671,422 |
|
$ |
6,250,241 |
|
||
| Marketable securities |
|
510,943 |
|
|
462,687 |
|
||
| Prepaid expenses |
|
349,862 |
|
|
82,578 |
|
||
| Total current assets |
|
2,532,227 |
|
|
6,795,506 |
|
||
| Right of use asset |
|
338,698 |
|
|
58,778 |
|
||
| Property and equipment, net |
|
5,821 |
|
|
5,972 |
|
||
| Other assets |
|
8,435 |
|
|
8,435 |
|
||
| Total assets | $ |
2,885,181 |
|
$ |
6,868,691 |
|
||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ |
791,947 |
|
$ |
757,856 |
|
||
| Accrued liabilities |
|
383,063 |
|
|
1,240,616 |
|
||
| Note payable |
|
- |
|
|
120,491 |
|
||
| Total current liabilities |
|
1,175,010 |
|
|
2,118,963 |
|
||
| Long term liabilities | ||||||||
| Lease liability |
|
239,039 |
|
|
- |
|
||
| Note payable |
|
- |
|
|
124,166 |
|
||
| Total long term liabilities |
|
239,039 |
|
|
124,166 |
|
||
| Total liabilities |
|
1,414,049 |
|
|
2,243,129 |
|
||
| Commitments and contingencies; see Note 8 | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, undesignated, authorized 9,999,790 shares; See Note 9 | ||||||||
| Series A Preferred stock, par value $.0001, issued 5,181,346 shares; outstanding 210, respectively |
|
- |
|
|
- |
|
||
| Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 25,201,312 and 12,619,369 respectively |
|
2,520 |
|
|
1,262 |
|
||
| Additional paid-in capital |
|
272,953,869 |
|
|
250,644,197 |
|
||
| Accumulated other comprehensive loss |
|
(274 |
) |
|
(70 |
) |
||
| Accumulated deficit |
|
(271,484,983 |
) |
|
(246,019,827 |
) |
||
| Total stockholders’ equity |
|
1,471,132 |
|
|
4,625,562 |
|
||
| Total liabilities and stockholders' equity | $ |
2,885,181 |
|
$ |
6,868,691 |
|
||
