Tenax Therapeutics(US:TENX)2020-11-16 21:16Financial Performance - Cash and cash equivalents were $8.7 million as of September 30, 2020[104]. - Net loss from operations for Q3 2020 was $2.2 million, compared to $2.3 million for Q3 2019[104]. - Net cash used in operating activities was $2.4 million for Q3 2020, up from $1.8 million in Q3 2019[104]. - Other income decreased approximately $125,000 for the nine months ended September 30, 2020, primarily due to a decrease in interest earned on marketable securities[131]. - As of September 30, 2020, the company had an accumulated deficit of approximately $243 million and anticipates continued net losses for at least the next several years[133]. - Net cash used in operating activities for the nine months ended September 30, 2020, was approximately $7.3 million, an increase from $5.8 million in the same period of 2019[145]. Expenses - Personnel costs increased by approximately $72,000 (12%) for Q3 2020 compared to Q3 2019, primarily due to higher bonuses and stock option expenses[106][107]. - Legal and professional fees decreased by $253,982 (46%) for Q3 2020 compared to Q3 2019[106]. - Research and development expenses for clinical and preclinical development increased by approximately $1.6 million for the nine months ended September 30, 2020, primarily due to increased expenditures for CRO costs[127]. - Clinical and preclinical development costs for the three months ended September 30, 2020 were $989,159, representing a 17% increase compared to the same period in the prior year[113]. - Personnel costs increased approximately $164,000 for the nine months ended September 30, 2020, driven by increases in stock options, bonuses, and salaries[121]. - Other costs increased approximately $81,000 for the nine months ended September 30, 2020, mainly due to higher insurance premiums[124]. - Facilities costs remained consistent for the nine months ended September 30, 2020, compared to the same period in the prior year[125]. - Investor relations costs decreased approximately $94,000 for the nine months ended September 30, 2020, due to reduced fees for outreach and conferences[123]. - Other costs decreased approximately $16,000 for the nine months ended September 30, 2020, primarily due to reductions in travel and consulting fees[129]. - Interest income from marketable securities for the nine months ended September 30, 2020 was approximately $15,000, down from approximately $118,000 in the prior year[132]. Funding and Capital Requirements - The company raised approximately $2.75 million from a March 2020 offering and approximately $6.5 million from a July 2020 offering, contributing to a total of approximately $10.6 million in financing activities for the nine months ended September 30, 2020[147]. - The net proceeds from the March 2020 offering, after fees, were approximately $2.125 million, while the July 2020 offering netted approximately $6.5 million for clinical trials and general corporate purposes[137][140]. - The company received a Paycheck Protection Program loan of $244,657, with monthly payments of approximately $31,100 starting September 30, 2021[141][142]. - The company plans to use proceeds from the PPP Loan to fund payroll costs, although there is no assurance of loan forgiveness[143]. - Future capital requirements will depend on various factors, including clinical trial progress and regulatory approvals, with substantial additional capital needed for product development[148][149]. - The company may seek additional funding through public or private equity offerings, debt financing, or collaboration arrangements, which could lead to dilution for existing shareholders[150]. - As of September 30, 2020, the current and long-term portions of the PPP Loan were $30,900 and $213,757, respectively[144]. Clinical Development - The company is conducting a Phase 2 clinical trial of levosimendan for PH-HFpEF, with an estimated U.S. prevalence of over 1.5 million patients[91][92]. - Levosimendan demonstrated a statistically significant improvement in 6-minute walk distance of 29 meters (p=0.0329) in the HELP Study[99]. - The FDA agreed to a Phase 3 study design for levosimendan in PH-HFpEF patients, with a primary endpoint of change in 6-minute walk distance over 12 weeks[94]. - The HELP Study utilized a unique home-based IV infusion regimen, with no reported serious adverse events[96]. - Legal and professional fees decreased approximately $575,000 for the nine months ended September 30, 2020, primarily due to reimbursement of direct costs and legal fees related to arbitration proceedings for levosimendan[122]. - An amendment to the license with Orion includes two new oral products and extends the license term to 10 years post-launch, contingent on regulatory approval by September 20, 2028[102].