TENAX THERAPEUTICS INC
For the period ended Mar 31, 2025. Filed May 14, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 14, 2025
TENX$1.69+3.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0001654954-24-014262
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-14.
0000950170-25-071395
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 84 previous paragraphs and 57 current paragraphs.
19 unchanged; 19 reworded; 19 added; 40 removed; 6 previous and 0 current paragraphs rearranged.
Tables are not compared: 8 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (19)
Current report
Tenax Therapeutics is a clinical-stage pharmaceutical company leveraging clinical insights to develop novel cardiopulmonary therapies. We employ a clinician-driven drug development approach, led by key opinion leaders and advised by thought leaders who are pulmonary hypertension and heart failure experts and informed by their clinical insights to precisely target disease pathophysiology. We are currently actively conducting the LEVEL clinical trial to evaluate levosimendan as our prioritized product candidate, and have deprioritized a Phase 3 clinical trial of imatinib, two drugs supported by promising evidence that they may significantly improve the lives of patients with pulmonary hypertension. Importantly, both levosimendan and imatinib have already been approved in other indications and prescribed around the world for more than 20 years, and we believe their mechanisms of action are uniquely suitable to target and treat pulmonary hypertension. We believe this derisked approach of using already-approved drugs that provide well-established safety profiles from millions of patients, combined with a development path led by preeminent cardiology and pulmonary hypertension experts, puts us in a strong position to deliver breakthrough cardiopulmonary therapies designed to improve patients’ function and quality of life.
Current report
Recent Events
Current report
In March 2025, we closed a private placement financing (the “March 2025 Offering”) raising gross proceeds of approximately $25.0 million. We intend to use the net proceeds from the March 2025 Offering to advance our Phase 3 oral levosimendan program, by completing our ongoing Phase 3 LEVEL study and initiating a second, planned global Phase 3 study, LEVEL-2. We intend to submit marketing authorization applications following completion of the two Phase 3 trials of levosimendan and, when appropriate, a single Phase 3 trial of imatinib. Given our resources on March 31, 2025, we believe we can continue our operations through 2027.
Current report
Operating Expenses (in thousands)
Current report
Salary and benefits increased $19 thousand for the three months ended March 31, 2025, compared to the same period in 2024. The change was primarily attributable to higher salaries and related compensation. Stock-based compensation expense increased $3.3 million for the three months ended March 31, 2025 due to stock options granted in December 2024, for which the expense amortizes over a one year term.
Current report
On March 5, 2025, we sold in the March 2025 Offering an aggregate of 378,346 shares of our common stock and pre-funded warrants to purchase an aggregate of 3,760,726 shares of our common stock at an offering price of $6.04 per share of common stock and $6.03 per pre-funded warrant, resulting in gross proceeds of $25.0 million. The pre-funded warrants do not expire and have an exercise price of $0.01. Net proceeds from the offering were $23.2 million, after deducting the placement agent fees and offering expenses payable by the Company.
Current report
Operating Activities
Current report
Investing Activities
Current report
Financing Activities
Current report
the initiation, design, progress, timing and completion of clinical trials for our product candidates and potential product candidates;
Current report
the outcome, timing and cost of regulatory approvals and the regulatory approval process;
Current report
delays that may be caused by changing regulatory requirements and resource levels at regulators;
Current report
the number of product candidates we pursue;
Current report
the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
Current report
the timing and terms of future collaboration, licensing, consulting or other arrangements that we may enter into;
Current report
the cost and timing of establishing sales, marketing, manufacturing and distribution capabilities;
Current report
the cost of procuring clinical and commercial supplies of our product candidates;
Current report
the extent to which we acquire or invest in businesses, products or technologies; and
Current report
the possible costs of litigation.
Removed paragraphs (40)
Previous report
The Company was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc. Effective June 30, 2008, we changed the domiciliary state of the corporation to Delaware and changed the Company name to Oxygen Biotherapeutics, Inc. On September 19, 2014, the Company changed its name to Tenax Therapeutics, Inc.
Previous report
In November 2013, we acquired a license with Orion Corporation (“Orion”) granting our wholly-owned subsidiary an exclusive, sublicensable right to develop and commercialize pharmaceutical products containing levosimendan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial in the United States and Canada. In October 2020 and January 2022, we entered into an amendment to the license agreement between the Company and Orion to include in the scope of the license two new oral product formulations containing levosimendan, in capsule and solid dosage form (TNX-103) and a subcutaneously administered dosage form (TNX-102), subject to specified limitations. In February 2024, we entered into an additional amendment to the license, providing global rights to oral and subcutaneous formulations of levosimendan used in the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (“PH-HFpEF”), revising the royalty structure, lowering the royalty rates, modifying milestones associated with certain regulatory and commercial achievements, and excluding from our right of first refusal the right to commercialize new applications of levosimendan for neurological diseases and disorders developed by Orion.
Previous report
In January 2021, we acquired 100% of the equity of PHPrecisionMed Inc., a Delaware corporation (“PHPM”), with PHPM surviving as our wholly-owned subsidiary. As a result of the merger, we have rights to commercialize pharmaceutical products containing imatinib for the treatment of pulmonary arterial hypertension (“PAH”).
Previous report
In August 2024, we closed a private placement financing (the “August 2024 Offering”) in which we sold to multiple accredited investors, including certain members of the Company’s Board of Directors, an aggregate of 1,450,661 shares of the Company’s common stock, and pre-funded warrants (“Pre-Funded Warrants”) to purchase an aggregate of 31,882,671 shares of the Company’s common stock, along with accompanying warrants (“Warrants”) to purchase an aggregate of 16,666,666 shares of the Company’s common stock (or, in lieu thereof, additional Pre-Funded Warrants) for gross process of approximately $99.7 million, before deducting placement agent fees and estimated offering expenses payable by the Company. We intend to use the net proceeds from the August 2024 Offering to complete our ongoing Phase 3 LEVEL trial, to initiate all sites and advance enrollment in a second planned Phase 3 trial of oral levosimendan, and for working capital, capital expenditures, and other general corporate purposes. The approximately $99.7 million in gross proceeds from the August 2024 Offering, combined with the Company’s current cash and cash equivalents, are expected to fund the Company’s operations through the end of 2027.
Previous report
Business Strategy
Previous report
Having raised capital expected to fund the Company through the end of 2027, the Company plans to accelerate its Phase 3 program. Site selection and initiation processes, and enrollment of participants, are ongoing in the Phase 3 LEVEL study, the Company having received U.S. Food and Drug Administration (“FDA”) input into this oral levosimendan protocol and clinical development program in the third quarter of 2023. The Company began initiating LEVEL sites in the fourth quarter of 2023 and continues to enroll patients. The Company also plans an open label extension phase following the completion of the randomized phase. The Company will complete efficacy and safety analyses of levosimendan versus placebo at the end of the randomized treatment phase, but many patients will continue, beyond the completion of these statistical analyses, to be treated under the protocol on open label levosimendan, allowing for additional weeks of safety observation that will contribute to the overall body of safety data on oral levosimendan. With the net proceeds of the August 2024 Offering, the Company also expects to fund the initiation of a second Phase 3 study planned for 2025.
Previous report
The Company has two U.S. Patents, issued in March and July 2023, covering the use of IV and oral levosimendan in patients with PH-HFpEF. An additional new patent was issued in early 2024 which provides protection covering all therapeutic doses of all three formulations of the product in patients with PH-HFpEF. Given our prioritization of the Phase 3 testing of levosimendan, we have suspended plans to launch an imatinib Phase 3 trial.
Previous report
The key elements of our business strategy are outlined below.
Previous report
Efficiently conduct clinical development to establish clinical proof of principle in new indications, refine dosage levels and dosing strategies, conduct other required clinical and nonclinical testing as FDA and other regulators may require, and continue Phase 3 testing of oral levosimendan, as our prioritized product candidate.
Previous report
Levosimendan and imatinib have been approved and prescribed in countries around the world for more than 20 years, but we believe their mechanisms of action have not been fully exploited, despite promising evidence they may significantly improve the lives of patients with pulmonary hypertension. We are conducting clinical development with the intent to establish proof of beneficial activity in cardiopulmonary diseases in which these therapeutics would be expected to have benefit for patients with diseases for which either no pharmaceutical therapies are approved at all, or in the case of pulmonary arterial hypertension (“PAH”), where numerous, expensive therapies generally offer a modest reduction of symptoms. Our focus is primarily on designing and executing formulation improvements, protecting these innovations with patents and other forms of exclusivity, and employing innovative clinical trial science to establish a robust foundation for subsequent development, product approval, and commercialization. We intend to submit marketing authorization applications following two Phase 3 trials of levosimendan and, when appropriate, a single Phase 3 trial of imatinib. Our trials are designed to incorporate and reflect advanced clinical trial design science and the regulatory and advisory experience of our team. We intend to continue partnering with innovative companies, renowned biostatisticians and trialists, medical leaders, formulation and regulatory experts, and premier clinical testing organizations to help expedite development, and continue expanding into complementary areas when opportunities arise through our development, research, and discoveries. We also intend to continue outsourcing to CROs, and seeking and acting upon the advice of preeminent scientists focused on cardiovascular and pulmonary drug development, when designing and executing our research.
Previous report
Efficiently explore new high-potential therapeutic applications, in particular where expedited regulatory pathways are available, leveraging third-party research collaborations and our results from related areas.
Previous report
Levosimendan has shown promise in multiple disease areas in the more than two decades following its approval. Our own Phase 2 study and open-label extension has demonstrated that levosimendan’s property of relaxing the venous circulation, a formerly under-appreciated mechanism of action of levosimendan, brings durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. The FDA has not approved a therapy for this disease. We are committed to exploring potential clinical indications where our therapies may achieve best-in-class profile, and where we can address significant unmet medical needs.
Previous report
We believe these factors will support approval by the FDA of this product candidate based on positive Phase 3 data. Through our agreement with our licensor, Orion, the originator of levosimendan for acute decompensated heart failure, we have access to a library of ongoing and completed trials and research projects, including certain documentation, which we believe, in combination with positive Phase 3 data we hope to generate in at least one indication, will support FDA approval of levosimendan. Likewise, the regulatory pathway for approval of imatinib for the treatment of PAH, as formulated by us at the dose shown to be effective in a prior Phase 3 trial conducted by Novartis, allows us to build on the dossier of research results already reviewed by the FDA. In order to achieve our objective of developing these medicines for new groups of patients, we have established collaborative research relationships with investigators from leading research and clinical institutions, and our strategic partners. These collaborative relationships have enabled us to explore where our product candidates may have therapeutic relevance, gain the advice and support of key opinion leaders in medicine and clinical trial science, and invest in development efforts to exploit opportunities to advance beyond current clinical care.
Previous report
Continue to expand our intellectual property portfolio.
Previous report
Our intellectual property and the confidentiality of all our Company information is important to our business and we are taking significant steps to help protect its value. Our research and development efforts, both through internal activities and through collaborative research activities with others, aim to develop new intellectual property and enable us to file patent applications that cover new uses of our existing technologies, alone or in combination with existing therapies, as well as other product candidates.
Previous report
Notice of Allowance and Patents
Previous report
On February 1, 2023, the Company announced it was granted a Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for its patent application with claims covering the use of IV levosimendan (TNX-101) in the treatment of PH-HFpEF. This patent (U.S. Patent No. 11,607,412) was issued on March 21, 2023. On July 19, 2023, the Company announced USPTO issuance of another patent, this one including claims covering the use of oral levosimendan (TNX-103) in patients with PH-HFpEF. This issued patent (U.S. Patent No. 11,701,355) provides exclusivity through December 2040. On February 6, 2024, the Company announced it was granted a Notice of Allowance from the USPTO for its patent application broadening IP protection for oral, I.V., and subcutaneous use of levosimendan and its active metabolites in PH-HFpEF, at all therapeutic doses and in combination with various cardiovascular drugs. At present, the Company has other patent applications pending, with additional decisions expected in the future. Patents pending in Europe may lead to intellectual property protections on the use of levosimendan in patients with PH-HFpEF in 2024.
Previous report
Enter into licensing or product co-development arrangements.
Previous report
In addition to our internal development efforts, an important part of our product development strategy is to work with collaborators and partners to accelerate product development, maintain our low development and business operations costs, and broaden our commercialization capabilities globally. We believe this strategy will help us develop a portfolio of high-quality product development opportunities, enhance our clinical development and commercialization capabilities, and increase our ability to generate value from our proprietary technologies.
Previous report
We also continue to position ourselves to execute upon licensing and other partnering opportunities. To do so, we need to continue to maintain our strategic direction, manage and deploy our available cash efficiently, and strengthen our collaborative research development and partner relationships.
Previous report
Historically, we have financed our operations principally through equity and debt offerings, including private placements such as the August 2024 Offering and loans from our stockholders. Based on its current operating plan, the Company has determined that there is no longer substantial doubt about its ability to continue as a going concern. Given its resources on September 30, 2024, the Company believes it can continue its operations over at least the next 12 months.
Previous report
Operating Expenses
Previous report
Personnel costs increased approximately $203,000 for the three months ended September 30, 2024, compared to the same period in 2023. The change was primarily attributable to higher salaries and performance-based compensation expense.
Previous report
Legal fees increased approximately $36,000 for the three months ended September 30, 2024, compared to the same period in the prior year. The change was primarily due to increased legal fees associated with general corporate matters, fundraising activities and IP costs compared to the same period in the prior year.
Previous report
Facilities costs include costs paid for rent and utilities at our corporate headquarters in North Carolina. Facilities costs decreased by a de minimis amount of approximately $400 for the three months ended September 30, 2024 compared to the same period in 2023.
Previous report
Financial Overview – Nine Months Ended September 30, 2024
Previous report
Operating Expenses
Previous report
General and Administrative Expenses
Previous report
Personnel costs increased approximately $285,000 for the nine months ended September 30, 2024, compared to the same period in 2023. The change was primarily attributable to higher salaries and performance-based compensation plan expense.
Previous report
Legal fees increased approximately $77,000 for the nine months ended September 30, 2024, compared to the same period in the prior year. The change was primarily due to increased legal fees associated with general corporate matters, fundraising activities and IP costs compared to the same period in the prior year.
Previous report
Professional fees increased approximately $356,000 for the nine months ended September 30, 2024, compared to the same period in the prior year. The change was primarily attributable to increased capital market expenses, consulting expenses, and accounting expenses.
Previous report
Facilities costs include costs paid for rent and utilities at our corporate headquarters in North Carolina. Facilities costs decreased approximately $16,000 for the nine months ended September 30, 2024, compared to the same period in 2023. The decrease is the result of the Company’s relocation to new shared office space resulting in lower rent and utility costs.
Previous report
Research and Development Expenses
Previous report
Clinical and preclinical development costs increased approximately $6.1 million for the nine months ended September 30, 2024, compared to the same period in the prior year. Clinical and preclinical development costs for the nine months ended September 30, 2024, consists of expenses associated with our Phase 2 HELP Open Label Extension Study and Phase 3 LEVEL trial for oral levosimendan, compared with costs for the nine months ended September 30, 2023, associated with our Phase 2 HELP Open Label Extension Study for levosimendan.
Previous report
Personnel costs increased approximately $392,000 for the nine months ended September 30, 2024, compared to the same period in the prior year, primarily attributable to vesting of options associated with the commencement of the Phase 3 LEVEL trial for oral levosimendan and additional performance-based compensation plan expense.
Previous report
Other costs increased approximately $106,000 for the nine months ended September 30, 2024, compared to the same period in the prior year, primarily due to increased regulatory consulting costs.
Previous report
Other Income and Expense
Previous report
Clinical and Preclinical Product Development
Previous report
As retrospectively adjusted for the Reverse Stock Split effected in January 2024, on February 3, 2023, we sold in a registered public offering (i) an aggregate of 86,994 shares of our common stock and pre-funded warrants to purchase an aggregate of 21,341 shares of our common stock and (ii) accompanying warrants to purchase up to an aggregate of 216,667 shares of our common stock at a combined offering price of $144.00 per share of common stock and accompanying warrant, or $143.92 per pre-funded warrant and accompanying warrant, resulting in gross proceeds to the Company of approximately $15.6 million. Net proceeds of the offering were approximately $14.1 million, after deducting the placement agent fees and offering expenses payable by the Company.
Previous report
As retrospectively adjusted for the Reverse Stock Splits, on May 17, 2022, we sold 6,623 units in a private placement at a purchase price of $1,240.00 per unit for net proceeds of approximately $7.9 million. Each unit consisted of one unregistered pre-funded warrant to purchase one share of our common stock and one unregistered warrant to purchase one share of common stock.
Reworded paragraphs (19)
Previous wording
Research and development expenses were approximately $3.1 million for the three months ended September 30, 2024, compared to $1.1 million for the same period in the prior year. Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with contract research organizations and investigative sites, which conduct our clinical trials and a substantial portion of our pre-clinical studies; (ii) the cost of supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the three months ended September 30, 2024, and 2023, respectively, are as follows:
Current wording
Research and development expenses were approximately $5.7 million for the three months ended March 31, 2025, compared to $2.7 million for the same period in the prior year. Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct a substantial portion of our pre-clinical and clinical studies; (ii) the cost of supplying clinical trial materials; (iii) payments to CROs and consultants; (iv) employee-related expenses, including salaries and benefits; and (v) facilities, depreciation and other allocated expenses, including direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the three months ended March 31, 2025 and 2024 are as follows (in thousands):
Previous wording
Clinical and preclinical development costs increased approximately $1.7 million for the three months ended September 30, 2024, compared to the same period in the prior year. Clinical and preclinical development costs for the three months ended September 30, 2024 consist of expenses associated with our Phase 2 HELP Open Label Extension Study and Phase 3 LEVEL trial for oral levosimendan, compared with costs for the three months ended September 30, 2023, associated with our Phase 2 HELP Open Label Extension Study for levosimendan.
Current wording
Clinical and preclinical development costs increased $1.8 million for the three months ended March 31, 2025 as compared to the same period in the prior year. Clinical and preclinical development costs for the three months ended March 31, 2025 consists primarily of expenses associated with our ongoing Phase 3 LEVEL trial for oral levosimendan, compared with costs for the three months ended March 31, 2024, associated with the planning of LEVEL and the initiation of the first LEVEL sites and enrolment of the first LEVEL patients.
Previous wording
Personnel costs increased approximately $202,000 for the three months ended September 30, 2024, compared to the same period in the prior year, primarily attributable to higher salaries and additional performance-based compensation expense.
Current wording
Salary and benefit costs increased $200 thousand for the three months ended March 31, 2025, compared to the same period in the prior year, which is primarily attributable to higher salaries and additional performance-based compensation expense. Stock-based compensation expense increased by $767 thousand for the three months ended March 31, 2025 compared to the same period in the prior year due to stock options granted in December 2024 and January 2025.
Previous wording
Other costs increased approximately $132,000 for the three months ended September 30, 2024, compared to the same period in the prior year, primarily due to increased regulatory consulting costs.
Current wording
Other costs increased $169 thousand for the three months ended March 31, 2025, compared to the same period in the prior year, primarily due to increased regulatory consulting costs.
Previous wording
General and administrative expenses were $1.5 million for the three months ended September 30, 2024, compared to $1.1 million for the same period in 2023. General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, and other professional and consulting services. General and administrative expenses and percentage changes for the three months ended September 30, 2024 and 2023, respectively, are as follows:
Current wording
General and administrative expenses were $5.7 million for the three months ended March 31, 2025, compared to $1.2 million for the same period in 2024. General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, and other professional and consulting services. General and administrative expenses and percentage changes for the three months ended March 31, 2025 and 2024 are as follows (in thousands):
Previous wording
Legal and professional fees increased approximately $269,000 for the three months ended September 30, 2024, compared to the same period in the prior year. Professional fees consist of the costs incurred for accounting fees, capital market expenses, consulting fees and investor relations services, as well as fees paid to the members of our Board of Directors.
Current wording
Legal fees consist of the cost of our legal counsel as well as legal costs related to our intellectual property. Professional fees consist of the costs incurred for accounting fees, capital market expenses, consulting fees and investor relations services, as well as fees paid to the members of our Board of Directors. Legal and professional fees increased $0.8 million for the three months ended March 31, 2025 compared to the same period in the prior year primarily related to increased capital market expenses, consulting expenses, and accounting expenses.
Previous wording
Other costs decreased approximately $16,000 for the three months ended September 30, 2024, compared to the same period in 2023. Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation, and other miscellaneous charges. The change was primarily attributable to decreases in insurance costs.
Current wording
Other costs increased $324 thousand for the three months ended March 31, 2025, compared to the same period in 2024. Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation, and other miscellaneous charges. The change was primarily attributable to decreases in insurance costs.
Previous wording
Other income and expenses include non-operating income and expense items not otherwise recorded in our consolidated statement of comprehensive loss. These items include but are not limited to interest income earned and fixed asset disposals. Interest expenses were approximately $6,000 and $5,000 for three months ended September 30, 2024 and 2023. Other income increased approximately $514,000 primarily related to higher interest income on increased cash deposits as a result of the August 2024 Offering.
Current wording
Other income and expenses include non-operating income and expense items not otherwise recorded in our consolidated statement of comprehensive loss. These items include but are not limited to interest income earned and fixed asset disposals. Interest income increased $813 thousand primarily related to higher interest income on increased cash deposits as a result of the August 2024 Offering and the March 2025 Offering. The company had no interest expense for three months ended March 31, 2025 and $8 thousand for three months ended March 31,2024.
Previous wording
We have incurred losses since our inception and, as of September 30, 2024, we had an accumulated deficit of approximately $308.6 million. We will continue to incur losses until we generate sufficient revenue to offset our expenses, and we anticipate that we will continue to incur net losses for at least the next several years. We expect to incur additional expenses related to our development and potential commercialization of levosimendan and, over the long term, imatinib for PAH, and other potential indications, as well as identifying and developing other potential product candidates, and as a result, we will need to generate significant net product sales, royalty and other revenues to achieve profitability.
Current wording
We have incurred losses since our inception and, as of March 31, 2025, we had an accumulated deficit of $325.3 million. We will continue to incur losses until we generate sufficient revenue to offset our expenses, and we anticipate that we will continue to incur net losses for at least the next several years. We expect to incur additional expenses related to our development and potential commercialization of levosimendan and, over the long term, imatinib for PAH, and other potential indications, as well as identifying and developing other potential product candidates, and as a result, we will need to generate significant net product sales, royalty and other revenues to achieve profitability.
Previous wording
The process of conducting preclinical studies and clinical trials necessary to obtain approval from the FDA is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among other things, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of the uncertainties discussed above, uncertainty associated with clinical trial enrollment and risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely. We are currently focused on developing our two product candidates, levosimendan and imatinib, and have prioritized levosimendan; however, we will need substantial additional capital in the future in order to finalize the development of levosimendan, commence its commercialization, potentially develop imatinib, and to continue with the development of other potential product candidates.
Current wording
The process of conducting preclinical studies and clinical trials necessary to obtain approval from the United States Food and Drug Administration is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among other things, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of the uncertainties discussed above, uncertainty associated with clinical trial enrollment and risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely. We are currently focused on developing our two product candidates, levosimendan and imatinib, and have prioritized levosimendan; however, we will need substantial additional capital in the future in order to finalize the development of levosimendan, commence its commercialization, potentially develop imatinib, and to continue with the development of other potential product candidates.
Previous wording
We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. We had total current assets of approximately $99.8 million and $11.7 million and working capital of approximately $97.2 million and $8.1 million as of September 30, 2024, and December 31, 2023, respectively. Our practice is to invest excess cash, where available, in short-term money market investment instruments and high-quality government bonds.
Current wording
We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. We had total current assets of $112.1 million and $96.7 million and working capital of $109.3 million and $92.0 million as of March 31, 2025 and December 31, 2024, respectively. Our practice is to invest excess cash, where available, in short-term money market investment instruments and high quality corporate and government bonds.
Previous wording
We are currently conducting the LEVEL trial and intend to recruit patients through 2024 and into at least the first half of 2025. Our ability to continue to pursue development of our products, including completion of a second Phase 3 oral levosimendan trial, beyond 2027, will depend on obtaining license income or outside financial resources. There is no assurance that we will obtain any license agreement or outside financing or that we will otherwise succeed in obtaining any necessary resources.
Current wording
We are currently conducting the LEVEL trial and intend to recruit patients through approximately the end of 2025. Our ability to continue to pursue development of our products, including completion of a second Phase 3 oral levosimendan trial, beyond 2027, will depend on obtaining license income, income from warrants exercised by investors should they elect to do so, or outside financial resources. There is no assurance that we will obtain any license agreement or outside financing or that we will otherwise succeed in obtaining any necessary resources.
Previous wording
On August 8, 2024, we sold in the August 2024 Offering an aggregate of 1,450,661 shares of our common stock, and Pre-Funded Warrants to purchase an aggregate of up to 31,882,671 shares of our common stock, along with accompanying Warrants to purchase an aggregate of up to 16,666,666 shares of our common stock (or, in lieu thereof, additional Pre-Funded Warrants). The purchase price for each share and accompanying Warrant was $3.00, with the accompanying Warrant having an exercise price of $4.50 (provided, the purchase price for each Pre-Funded Warrant and accompanying Warrant was $2.99, with the Pre-Funded Warrants having an exercise price of $0.01). Gross proceeds from the August 2024 Offering were approximately $99.7 million, before deducting the placement agent fees and estimated offering expenses payable by the Company. Net proceeds from the offering were approximately $92.3 million, after deducting the placement agent fees and offering expenses payable by the Company.
Current wording
On August 8, 2024, we sold in the August 2024 Offering an aggregate of 1,450,661 shares of our common stock, and pre-funded warrants to purchase 31,882,671 shares of our common stock, along with accompanying warrants to purchase up to 16,666,666 shares of our common stock. The purchase price for each share and accompanying warrant was $3.00, with the accompanying warrant having an exercise price of $4.50 (provided, the purchase price for each pre-funded warrant and accompanying warrant was $2.99, with the pre-funded warrants having an exercise price of $0.01). Net proceeds from the offering were $92.3 million, after deducting the placement agent fees and offering expenses payable by the Company.
Previous wording
On February 8, 2024, we sold in a registered public offering (the “February 2024 Offering”) (i) an aggregate of 421,260 shares of our common stock and pre-funded warrants to purchase an aggregate of 1,178,740 shares of our common stock and (ii) accompanying warrants to purchase up to an aggregate of 3,200,000 shares of our common stock at a combined offering price of $5.65 per share of common stock and accompanying warrant, or $5.649 per pre-funded warrant and accompanying warrant, resulting in gross proceeds to the Company of approximately $9.0 million. Net proceeds of the offering were approximately $8.0 million, after deducting the placement agent fees and offering expenses payable by the Company.
Current wording
On February 8, 2024, we sold in a registered public offering (the “February 2024 Offering”) (i) an aggregate of 421,260 shares of our common stock and pre-funded warrants to purchase an aggregate of 1,178,740 shares of our common stock and (ii) accompanying warrants to purchase up to an aggregate of 3,200,000 shares of our common stock at a combined offering price of $5.65 per share of common stock and accompanying warrant, or $5.649 per pre-funded warrant and accompanying warrant. Net proceeds of the offering were $8.0 million, after deducting the placement agent fees and offering expenses payable by the Company.
Previous wording
The following table shows a summary of our cash flows for the periods indicated:
Current wording
The following table shows a summary of our cash flows for the periods indicated (in thousands):
Previous wording
Net cash used in operating activities. Net cash used in operating activities was approximately $11.3 million for the nine months ended September 30, 2024, compared to approximately $4.7 million for the nine months ended September 30, 2023. The increase in cash used for operating activities was primarily due to higher study expense activity in the current period as compared to the prior year.
Current wording
Net cash used in operating activities was $7.0 million for the three months ended March 31, 2025, compared to $5.2 million for the three months ended March 31, 2024. The increase in cash used in operating activities was primarily due to higher study expense activity as we expanded our clinical trials during the three months ended March 31, 2025 as compared to the prior year.
Previous wording
Net cash provided by investing activities. There was no net cash provided or consumed by investing activities for the nine months ended September 30, 2024, compared to net cash provided by investing activities of approximately $2,800 in the nine months ended September 30, 2023. The decrease in cash provided by investing activities was primarily due to the sale of all remaining office furniture related to the Company’s headquarters in the prior year.
Current wording
There was no net cash provided or consumed by investing activities for the three months ended March 31, 2025 or the three months ended March 31, 2024.
Previous wording
Net cash provided by financing activities. Net cash provided by financing activities was approximately $99.8 million for the nine months ended September 30, 2024, compared to approximately $14.0 million in the nine months ended September 30, 2023. The increase in cash provided by financing activities was due to higher net proceeds received from the August 8, 2024 and February 8, 2024 sales of common stock, pre-funded warrants, and warrants, compared to the February 3, 2023 sale of common stock and warrants and the exercise of warrants.
Current wording
Net cash provided by financing activities was $23.6 million for the three months ended March 31, 2025, compared to $7.9 million for the three months ended March 31, 2024. The increase during the three months ended March 31, 2025 was due to the $23.2 million net cash provided from the sale of common stock and pre-funded warrants in the March 2025 Offering and $0.3 million from the exercise of warrants and pre-funded warrants as compared to $8.0 million net cash provided from the sale of common stock, pre-funded warrants and warrants in the February 2024 Offering, offset by the principal payment of $0.1 million related to a short-term note, during the three months ended March 31, 2024.
Previous wording
Based on our working capital on September 30, 2024, including the approximately $92.3 million in net proceeds from the August 2024 Offering, we believe we have sufficient capital on hand to continue to fund operations through the end of 2027.
Current wording
Based on our working capital on March 31, 2025, we believe we have sufficient capital on hand to fund operations through 2027.
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
Professional fees increased approximately $233,000 for the three months ended September 30, 2024, compared to the same period in the prior year. The change was primarily attributable to increased capital market expenses, consulting expenses and accounting expenses.
Previous report — wording carried elsewhere
General and administrative expenses were $4.1 million for the nine months ended September 30, 2024, compared to $3.4 million for the same period in 2023. General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, and other professional and consulting services. General and administrative expenses and percentage changes for the nine months ended September 30, 2024, and 2023, are as follows:
Previous report — wording carried elsewhere
Legal and professional fees increased approximately $433,000 for the nine months ended September 30, 2024, compared to the same period in the prior year. Professional fees consist of the costs incurred for accounting fees, capital market expenses, consulting fees and investor relations services, as well as fees paid to the members of our Board of Directors.
Previous report — wording carried elsewhere
Other costs increased approximately $18,000 for the nine months ended September 30, 2024, compared to the same period in 2023. Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation, and other miscellaneous charges. The change was primarily attributable to increases in franchise tax fees offset by lower costs for insurance and general office supplies.
Previous report — wording carried elsewhere
Research and development expenses were approximately $8.1 million for the nine months ended September 30, 2024, compared to $1.5 million for the same period in the prior year. Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with contract research organizations and investigative sites, which conduct our clinical trials and a substantial portion of our pre-clinical studies; (ii) the cost of supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the nine months ended September 30, 2024, and 2023, respectively, are as follows:
Previous report — wording carried elsewhere
Other income and expenses include non-operating income and expense items not otherwise recorded in our consolidated statement of comprehensive loss. These items include but are not limited to interest income earned and fixed asset disposals. Interest expenses were approximately $23,000 and $21,000 for the nine months ended September 30, 2024, and 2023, respectively. The change is due primarily to an increase in the interest rate associated with the premium finance note agreement with Premium Funding Associates, Inc. Other income increased approximately $458,000 primarily related to higher interest income on cash deposits as a result of the February 2024 Offering (as defined below) and August 2024 Offering.