\nTenax 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 first quarter of 2021 and provided a business update.\n<\/p>\n
\n\u201cHaving completed the merger with PHPrecisionMed Inc., we now have product development programs in group one and group two pulmonary hypertension patients,\u201d stated Anthony DiTonno, Chief Executive Officer of Tenax, \u201cwhich represent more than 70% of the overall market.\n<\/p>\n
\n\u201cWe have begun the open label transition study using the oral formulation of Levosimendan, which was recently acquired from our agreement with Orion. The purpose of this study is to determine the dose we will take into Phase 3 trials in 2022. Study participants who enrolled in our open label Phase 2 HELP trial are being brought back into their clinics and converted to the oral dosage form. We believe oral delivery will be more convenient for patients and provide more consistent blood levels of Levosimendan compared to weekly IV administration.\n<\/p>\n
\n\u201cWith respect to the imatinib program, we are in the final stages of formulation development. As a reminder, this new formulation is expected to address the previous GI-related side effects associated with its oral administration. We remain highly enthusiastic that imatinib, when formulated correctly, will show substantial clinical benefit in the pulmonary arterial hypertension (PAH) patient population, with the potential to be the first disease-modifying therapy for this indication. The new formulation will be tested in a Phase 1 study, which we anticipate completing in the second half of this year.\u201d\n<\/p>\n
Recent Highlights<\/b><\/p>\n Financial Results<\/b><\/p>\n About Tenax Therapeutics<\/b><\/p>\n \nTenax 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<\/a>.\n<\/p>\n About Levosimendan<\/b><\/p>\n \nLevosimendan 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.\n<\/p>\n About Imatinib<\/b><\/p>\n \nImatinib 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.\n<\/p>\n Caution Regarding Forward-Looking Statements<\/b><\/p>\n \nThis news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company\u2019s 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\u2019s control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company\u2019s control that could impact the Company\u2019s continued compliance with Nasdaq listing requirements; the impact of management changes on the Company\u2019s 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\u2019s 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 May 17, 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\u2019s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.\n<\/p>\n TENAX THERAPEUTICS, INC.<\/b><\/p>\n<\/td>\n<\/tr>\n CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS<\/b><\/p>\n<\/td>\n<\/tr>\n Three months ended March 31,<\/b><\/p>\n<\/td>\n<\/tr>\n 2021<\/b><\/p>\n<\/td>\n 2020<\/b><\/p>\n<\/td>\n<\/tr>\n (Unaudited)<\/b><\/p>\n<\/td>\n (Unaudited)<\/b><\/p>\n<\/td>\n<\/tr>\n \n$\n<\/p>\n<\/td>\n \n1,373,460\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n1,322,959\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n22,376,202\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,342,526\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n23,749,662\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n2,665,485\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n23,749,662\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n2,665,485\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n613\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n(2,135\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(10,841\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n$\n<\/p>\n<\/td>\n \n23,748,140\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n2,654,644\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n332\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,622\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n$\n<\/p>\n<\/td>\n \n23,748,472\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n2,656,266\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n$\n<\/p>\n<\/td>\n \n(1.64\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n(0.38\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n14,515,088\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n6,974,387\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n TENAX THERAPEUTICS, INC.<\/b><\/p>\n<\/td>\n<\/tr>\n CONDENSED CONSOLIDATED BALANCE SHEETS<\/b><\/p>\n<\/td>\n<\/tr>\n March 31, 2021<\/b><\/p>\n<\/td>\n December 31, 2020<\/b><\/p>\n<\/td>\n<\/tr>\n (Unaudited)<\/b><\/p>\n<\/td>\n ASSETS<\/b><\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n3,536,787\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n6,250,241\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n494,877\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n462,687\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n485,935\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n82,578\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n4,517,599\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n6,795,506\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n29,690\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n58,778\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n4,837\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n5,972\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n8,435\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n8,435\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n$\n<\/p>\n<\/td>\n \n4,560,561\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n6,868,691\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n LIABILITIES AND STOCKHOLDERS\u2019 EQUITY<\/b><\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n997,443\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n757,856\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n222,780\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,240,616\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n213,577\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n120,491\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,433,800\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n2,118,963\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n31,080\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n124,166\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n31,080\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n124,166\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,464,880\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n2,243,129\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n1\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,497\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,262\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n272,862,552\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n250,644,197\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n(402\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(70\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n(269,767,967\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n(246,019,827\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n3,095,681\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n4,625,562\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n$\n<\/p>\n<\/td>\n \n4,560,561\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n6,868,691\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210517005819\/en\/<\/a><\/span><\/p>\n \nInvestor Contact: KEYWORDS:<\/b> United States North America North Carolina<\/p>\n INDUSTRY KEYWORDS:<\/b> Pharmaceutical Health Cardiology<\/p>\n\n
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\n<\/li>\n<\/ul>\n\n
\n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Operating expenses<\/td>\n \n \n \n <\/tr>\n \n General and administrative<\/td>\n \n \n \n \n \n \n \n \n \n Research and development<\/td>\n \n \n \n \n \n \n \n \n \n Total operating expenses<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Net operating loss<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Interest expense<\/td>\n \n \n \n \n \n \n \n \n \n Other income, net<\/td>\n \n \n \n \n \n \n \n \n \n Net loss<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Unrealized loss on marketable securities<\/td>\n \n \n \n \n \n \n \n \n \n Total comprehensive loss<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Net loss per share, basic and diluted<\/td>\n \n \n \n \n \n \n \n \n \n Weighted average number of common shares outstanding, basic and diluted<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n<\/table>\n \n
\n <\/tr>\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n <\/tr>\n \n \n \n \n <\/tr>\n \n Current assets<\/td>\n \n \n <\/tr>\n \n Cash and cash equivalents<\/td>\n \n \n \n \n \n \n \n \n Marketable securities<\/td>\n \n \n \n \n \n \n \n \n Prepaid expenses<\/td>\n \n \n \n \n \n \n \n \n Total current assets<\/td>\n \n \n \n \n \n \n \n \n Right of use asset<\/td>\n \n \n \n \n \n \n \n \n Property and equipment, net<\/td>\n \n \n \n \n \n \n \n \n Other assets<\/td>\n \n \n \n \n \n \n \n \n Total assets<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n <\/tr>\n \n Current liabilities<\/td>\n \n \n <\/tr>\n \n Accounts payable<\/td>\n \n \n \n \n \n \n \n \n Accrued liabilities<\/td>\n \n \n \n \n \n \n \n \n Note payable<\/td>\n \n \n \n \n \n \n \n \n Total current liabilities<\/td>\n \n \n \n \n \n \n \n \n Long term liabilities<\/td>\n \n \n <\/tr>\n \n Note payable<\/td>\n \n \n \n \n \n \n \n \n Total long term liabilities<\/td>\n \n \n \n \n \n \n \n \n Total liabilities<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Commitments and contingencies; see Note 8<\/td>\n \n \n <\/tr>\n \n Stockholders’ equity<\/td>\n \n \n <\/tr>\n \n Preferred stock, undesignated, authorized 9,989,558 shares; See Note 9<\/td>\n \n \n <\/tr>\n \n Series A Preferred stock, par value $.0001, issued 5,181,346 shares; outstanding 210, respectively<\/td>\n \n \n \n \n \n \n \n \n Series B Preferred stock, par value $.0001, issued 10,232 shares; outstanding 10,232 and 0, respectively<\/td>\n \n \n \n \n \n \n \n \n Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 14,969,312 and 12,619,369, respectively<\/td>\n \n \n \n \n \n \n \n \n Additional paid-in capital<\/td>\n \n \n \n \n \n \n \n \n Accumulated other comprehensive loss<\/td>\n \n \n \n \n \n \n \n \n Accumulated deficit<\/td>\n \n \n \n \n \n \n \n \n Total stockholders\u2019 equity<\/td>\n \n \n \n \n \n \n \n \n Total liabilities and stockholders’ equity<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n<\/table>\n <\/p>\n
\n
John Mullaly
\n
Managing Director
\n
LifeSci Advisors, LLC
\n
C: 617-429-3548
\n
jmullaly@lifesciadvisors.com<\/a><\/p>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20210517005819\/en\/431885\/3\/TENAX_RGB.jpg\")
<\/td>\n<\/tr>\n