TENAX THERAPEUTICS INC

Previous wording

In August 2024, we closed a private placement financing (the “2024 Private Placement”) 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 $100 million, before deducting placement agent fees and estimated offering expenses payable by the Company. We intend to use the net proceeds from the 2024 Private Placement 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 $100 million in gross proceeds from the 2024 Private Placement, combined with the Company’s current cash and cash equivalents, are expected to fund the Company’s operations through the end of calendar year 2027.

Current wording

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 wording

Having raised capital expected to fund the Company through the end of calendar year 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 2024 Private Placement, the Company also expects to fund the initiation of a second Phase 3 study planned for 2025.

Current wording

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 wording

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 protections 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.

Current wording

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 wording

Our intellectual property and the confidentiality of all our Company information is important to our business and we take 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.

Current wording

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 wording

Historically, we have financed our operations principally through equity and debt offerings, including private placements such as the 2024 Private Placement 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 June 30, 2024 in addition to the approximately $100 million in gross proceeds from the 2024 Private Placement, which the Company believes is sufficient for it to continue its operations over at least the next 12 months.

Current wording

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 wording

General and administrative expenses were $1.3 million for the three months ended June 30, 2024, compared to $1.0 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 June 30, 2024 and 2023, respectively, are as follows:

Current 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:

Previous wording

Personnel costs increased approximately $131,000 for the three months ended June 30, 2024, compared to the same period in 2023. The change was primarily attributable to higher performance-based compensation expense.

Current wording

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 wording

Legal and professional fees increased approximately $158,000 for the three months ended June 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 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.

Previous wording

Legal fees increased approximately $8,000 for the three months ended June 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.

Current wording

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 wording

Professional fees increased approximately $150,000 for the three months ended June 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.

Current wording

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 wording

Other costs increased approximately $34,000 for the six months ended June 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.

Current 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.

Previous wording

Facilities costs include costs paid for rent and utilities at our corporate headquarters in North Carolina. Facilities costs decreased approximately $15,000 for the six months ended June 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.

Current wording

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 wording

Research and development expenses were approximately $2.3 million for the three months ended June 30, 2024, compared to $0.2 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 June 30, 2024, and 2023, respectively, are as follows:

Current 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:

Previous wording

Clinical and preclinical development costs increased approximately $2.1 million for the three months ended June 30, 2024, compared to the same period in the prior year. Clinical and preclinical development costs for the three months ended June 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 June 30, 2023 associated with our Phase 2 HELP Open Label Extension Study for levosimendan.

Current 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.

Previous wording

Personnel costs increased approximately $97,000 for the three months ended June 30, 2024, compared to the same period in the prior year, primarily attributable to higher salaries and additional performance-based compensation expense.

Current 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.

Previous wording

Other costs decreased approximately $24,000 for the three months ended June 30, 2024, compared to the same period in the prior year, primarily due to decreased regulatory consulting costs.

Current 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.

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 was approximately $9,000 for each of the three months ended June 30, 2024, and 2023. Other income decreased approximately $34,000 primarily related to lower interest income on cash deposits.

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 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.

Previous wording

General and administrative expenses were $2.6 million for the six months ended June 30, 2024, compared to $2.3 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 six months ended June 30, 2024 and 2023, are as follows:

Current wording

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 wording

Personnel costs increased approximately $83,000 for the six months ended June 30, 2024, compared to the same period in 2023. The change was primarily attributable to higher performance-based compensation plan expense.

Current wording

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 wording

Legal and professional fees increased approximately $163,000 for the six months ended June 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 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 wording

Legal fees increased approximately $14,000 for the six months ended June 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.

Current wording

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 wording

Professional fees increased approximately $149,000 for the six months ended June 30, 2024, compared to the same period in the prior year. The change was primarily attributable to increased consulting and accounting expenses, offset by decreased capital market expenses.

Current wording

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 wording

Other costs increased approximately $17,000 for the three months ended June 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.

Current wording

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 wording

Facilities costs include costs paid for rent and utilities at our corporate headquarters in North Carolina. Facilities costs decreased approximately $1,000 for the three months ended June 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.

Current wording

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 wording

Research and development expenses were approximately $5.0 million for the six months ended June 30, 2024, compared to $0.5 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 six months ended June 30, 2024, and 2023, respectively, are as follows:

Current wording

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 wording

Clinical and preclinical development costs increased approximately $4.4 million for the six months ended June 30, 2024, compared to the same period in the prior year. Clinical and preclinical development costs for the three months ended June 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 three months ended June 30, 2023, associated with our Phase 2 HELP Open Label Extension Study for levosimendan.

Current wording

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 wording

Personnel costs increased approximately $190,000 for the six months ended June 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.

Current wording

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 wording

Other costs decreased approximately $26,000 for the six months ended June 30, 2024, compared to the same period in the prior year, primarily due to decreased regulatory consulting costs.

Current wording

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 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 $17,000 and $16,500 for the six months ended June 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 decreased approximately $56,000 primarily related to higher licensing fees earned in the prior year offset by the interest income on cash deposits as a result of the February 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 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.

Previous wording

We have incurred losses since our inception and, as of June 30, 2024, we had an accumulated deficit of approximately $304.6 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 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.

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 $10.6 million and $11.7 million and working capital of approximately $8.9 million and $8.1 million as of June 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 corporate and 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 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.

Previous wording

We are currently conducting the LEVEL trial and intend to recruit patients throughout 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 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.

Previous wording

On August 8, 2024, we sold in the 2024 Private Placement 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 is $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 is $2.99, with the Pre-Funded Warrants having an exercise price of $0.01). Gross proceeds of the 2024 Private Placement are approximately $100 million, before deducting the placement agent fees and estimated 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 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.

Previous wording

On February 8, 2024, we sold in a registered public 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 associated warrant, or $5.649 per pre-funded warrant and associated 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, 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.

Previous wording

As retrospectively adjusted for the Reverse Stock Split, 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 associated warrant, or $143.92 per pre-funded warrant and associated 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.

Current wording

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 wording

Net cash used in operating activities. Net cash used in operating activities was approximately $8.2 million for the six months ended June 30, 2024, compared to approximately $2.6 million for the six months ended June 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. 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.

Previous wording

Net cash provided by investing activities. There was no net cash provided or consumed by investing activities for the three months ended June 30, 2024, compared to net cash provided by investing activities of approximately $2,800 in the six months ended June 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

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.

Previous wording

Net cash provided by financing activities. Net cash provided by financing activities was approximately $7.8 million for the six months ended June 30, 2024, compared to approximately $14.0 million in the six months ended June 30, 2023. The decrease in cash provided by financing activities was due to lower net proceeds received from the February 8, 2024, sale of common stock 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. 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.

Previous wording

Based on our working capital on June 30, 2024 and the approximately $100 million in gross proceeds from the 2024 Private Placement, we believe we have sufficient capital on hand to continue to fund operations through the end of the 2027 calendar year.

Current 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.