Tonix Pharmaceuticals Holding Corp.

Previous wording

This Management’s Discussion and Analysis of Financial Condition and Results of Operations includes a number of forward-looking statements that reflect Management’s current views with respect to future events and financial performance. You can identify these statements by forward-looking words such as “may” “will,” “expect,” “anticipate,” “believe,” “estimate” and “continue,” or similar words. Those statements include statements regarding the intent, belief or current expectations of us and members of our management team as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risk and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements.

Current wording

This Management’s Discussion and Analysis of Financial Condition and Results of Operations includes a number of forward-looking statements that reflect Management’s current views with respect to future events and financial performance. You can identify these statements by forward-looking words such as “may,” “will,” “expect,” “anticipate,” “believe,” “estimate” and “continue,” or similar words. Those statements include statements regarding the intent, belief or current expectations of us and members of our management team as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements.

Previous wording

Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the Securities and Exchange Commission. Important factors known to us could cause actual results to differ materially from those in forward-looking statements. We undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes in the future operating results over time. We believe that our assumptions are based upon reasonable data derived from and known about our business and operations. No assurances are made that actual results of operations or the results of our future activities will not differ materially from our assumptions. Factors that could cause differences include, but are not limited to: our need for additional financing; risks related to the failure to successfully market any of our products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition.

Current wording

Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the Securities and Exchange Commission. Important factors known to us could cause actual results to differ materially from those in forward-looking statements. Except as required by law, we undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes in the future operating results over time. We believe that our assumptions are based upon reasonable data derived from and known about our business and operations. No assurances are made that actual results of operations or the results of our future activities will not differ materially from our assumptions. Factors that could cause differences include, but are not limited to: our need for additional financing; risks related to the failure to successfully market any of our products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition.

Previous wording

We are a fully-integrated biopharmaceutical company commercializing and developing innovative therapies for central nervous system (“CNS”) disorders, infectious diseases, immunology, and rare diseases. Our portfolio consists of both commercial and development-stage programs.

Current wording

We are a fully integrated biopharmaceutical company commercializing and developing innovative therapies for central nervous system (“CNS”) disorders, infectious diseases, and immunology. Our portfolio consists of commercial, development-stage and discovery programs.

Previous wording

We market TONMYA® (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults in the U.S., as well as Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for the treatment of acute migraine in adults in the U.S. Tonix received approval from the U.S. Food and Drug Administration (“FDA”) for TONMYA for the treatment of fibromyalgia in August 2025 and commercially launched TONMYA in November 2025. TONMYA is our first internally developed product to become FDA approved and is the first new medicine for fibromyalgia in more than 15 years. TONMYA is a centrally acting, non-opioid analgesic designed for bedtime administration and long-term use, for which the Company holds worldwide commercialization rights. Tonix’s commercial platform includes sales, marketing, market access, distribution, and patient support capabilities.

Current wording

TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), our flagship internally conceived and developed medicine, is the first new medicine for fibromyalgia in adults approved by the U.S. Food and Drug Administration (“FDA”) in more than 15 years. Our CNS commercial infrastructure supports our marketed products, including our acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). We received approval from the FDA for TONMYA for the treatment of fibromyalgia in adults in August 2025 and commercially launched TONMYA in November 2025. TONMYA is a centrally acting, non-opioid analgesic designed for bedtime administration and long-term use, for which we hold worldwide commercialization rights. Our commercial platform includes sales, marketing, market access, distribution, and patient support capabilities.

Previous wording

We are advancing a diversified development pipeline generated through internal discovery, in-licensing, acquisitions, and collaborations with academic and non-profit institutions. The Company’s pipeline addresses conditions that span CNS, infectious disease, immunology, and rare disease, with multiple programs in clinical and preclinical development. TONMYA’s proprietary cyclobenzaprine HCl sublingual tablet formulation is referred to as “TNX-102 SL” outside of the fibromyalgia indication. We are exploring the utility of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in Phase 2 clinical trials for major depressive disorder (MDD) and acute stress disorder (ASD)/acute stress reaction (ASR). A potentially pivotal Phase 2 study of TNX-102 SL as a first-line monotherapy in adults with MDD, the HORIZON study, commenced in June 2026.

Current wording

TONMYA’s proprietary cyclobenzaprine HCl sublingual tablet formulation is referred to as “TNX-102 SL” outside of the fibromyalgia indication. We are exploring the utility of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in Phase 2 clinical trials for major depressive disorder (“MDD”) and acute stress disorder (“ASD”)/acute stress reaction (“ASR”). A potentially pivotal Phase 2 study of TNX-102 SL as a first-line monotherapy in adults with MDD, the HORIZON study, commenced in June 2026 and is currently enrolling.

Previous wording

TNX-102 SL is being developed to treat ASD/ASR under an Investigator-Initiated investigational new drug application (“IND”) at the University of North Carolina in the ongoing OASIS study funded by a grant they received from the U.S. Department of Defense (“DoD”). Topline data from the OASIS study is expected to be reported mid-2027.

Current wording

TNX-102 SL is being developed to treat ASD/ASR under an investigator-initiated investigational new drug (“IND”) application at the University of North Carolina (“UNC”) in the ongoing OASIS study funded by a grant UNC received from the U.S. Department of Defense (“DoD”). Topline data from the OASIS study is expected to be reported mid-2027.

Previous wording

Our clinical stage infectious disease portfolio includes monoclonal antibody TNX-4800 (antiBorrelia OspA human monoclonal antibody) for the prevention of Lyme disease in the U.S. which has no FDA-approved vaccines or prophylactics. We received positive, final minutes from the FDA following a Type C meeting in early third quarter of 2026. The minutes support the planned initiation of an adaptive Phase 2 field in the first quarter of 2027. TNX-4800 was licensed from UMass Chan Medical School. Our clinical-stage immunology development portfolio includes TNX-1500, which is a Phase 2 ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of kidney transplant rejection, and for the treatment of autoimmune diseases. A Phase 2, open-label, investigator-initiated study in adult kidney transplant patients at Massachusetts General Hospital (MGH) is expected to initiate in the second half of 2026 pending FDA clearance of MGH’s IND application. Another CNS candidate in clinical development is TNX-1300 (double-mutant cocaine esterase), which is in Phase 2 for the treatment of cocaine intoxication. TNX-1300 has been granted Breakthrough Therapy designation by the FDA and a Phase 2a study was completed. We intend to meet with the FDA in 2026 to help inform the clinical design of its next Phase 2 study. Finally, our clinical-stage rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a Phase 2 study in the second half of 2027.

Current wording

Our clinical-stage infectious disease portfolio includes TNX-4800, a human monoclonal antibody targeting Borrelia OspA, for the prevention of Lyme disease in the U.S., where no vaccines or prophylactics for Lyme disease are approved by the FDA. We received positive, final minutes from the FDA following a Type C meeting in the third quarter of 2026. The minutes support the planned initiation of an adaptive Phase 2 field study in the first quarter of 2027. The Phase 2 study is expected to enroll in the 2027 and 2028 seasons, with the majority of participants enrolled in 2028, pending final FDA review and agreement on the study protocol. If the attack rate is lower than expected, the study could continue enrolling in 2029. TNX-4800 was licensed from UMass Chan Medical School.

Previous wording

Our pre-clinical, pre-IND infectious disease portfolio includes TNX-801 (horsepox, live virus vaccine), a potential vaccine for mpox and smallpox, which is expected to enter a Phase 1 study in 2027 pending FDA clearance of an IND. We own a facility in Dartmouth, MA that was purpose-built to manufacture TNX-801 under Good Manufacturing Practices (GMP) to support clinical development and potential commercialization. The GMP suites were decommissioned in 2024 and may be reactivated the earlier of 2028 or in the case of a national or international emergency. Our pre-IND infectious disease portfolio also includes TNX-4200, which is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. The TNX-4200 program is supported by a $34 million contract over five years from the U.S. DoD’s Defense Threat Reduction Agency (DTRA). We own and operate a state-of-the art research facility in Frederick, Maryland that supports this research. Our pre-IND pre-clinical immunology portfolio includes TNX-1700, which is a fusion protein of TFF2 and albumin, is in preclinical development for the treatment of gastric and colorectal cancer in combination with PD-1 blockade in collaboration with Columbia University. Finally, our pre-clinical, pre-IND CNS portfolio also includes TNX-4900, a highly selective small-molecule Sigma-1 receptor (“S1R”) antagonist for neuropathic pain licensed from Rutgers University.

Current wording

We are developing a pre-IND infectious disease program designated TNX-4200, which is a small molecule broad-spectrum antiviral agent targeting CD45 to improve the medical readiness of military personnel in biological threat environments. The TNX-4200 program is supported by a $34.1 million contract over five years from the U.S. DoD’s Defense Threat Reduction Agency (“DTRA”). We own and operate a state-of-the-art research facility in Frederick, Maryland that supports this research.

Previous wording

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are the property of their respective owners. We are led by a management team with significant industry experience in drug development.

Current wording

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are the property of their respective owners. We are led by a management team with significant industry experience in drug development and commercialization.

Previous wording

We anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, such as the sale of our commercialized assets, progress of our research and development efforts and the timing and outcome of regulatory submissions. Due to these uncertainties, accurate predictions of future operations are difficult or impossible to make.

Current wording

We anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, such as the sales of our commercial products, progress of our research and development efforts and the timing and outcome of regulatory submissions. Due to these uncertainties, accurate predictions of future operations are difficult or impossible to make.

Previous wording

The following table sets forth our operating results for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table sets forth our operating results for the three months ended September 30, 2026 and 2025 (in thousands):

Previous wording

Cost of Sales. Cost of sales recognized for the three months ended June 30, 2026 and 2025, was $0.7 million and $3.3 million, respectively. For the three months ended June 30, 2025, cost of sales includes write-downs related to Tosymra and Zembrace finished goods inventory of approximately $2.3 million, based on an assessment of inventory on hand and projected sales. The decrease in cost of sales is driven by a change in product mix and sale of product which had previously been written off.

Current wording

Cost of Sales. Cost of sales recognized for the three months ended September 30, 2026 and 2025, was $1.3 million and $1.4 million, respectively. The decrease in cost of sales is driven by a change in product mix.

Previous wording

Research and Development Expenses. Research and development expenses for the three months ended June 30, 2026 were $19.4 million, an increase of $8.6 million, or 80%, from $10.8 million for the three months ended June 30, 2025. This increase is predominately due to increased clinical expenses of $1.3 million and manufacturing expenses of $4.5 million as a result of advancing our prioritized pipeline period over period, as well as increased employee-related costs of $2.5 million due to increased headcount.

Current wording

Research and Development Expenses. Research and development expenses for the three months ended September 30, 2026 were $25.8 million, an increase of $16.5 million, or 178%, from $9.3 million for the three months ended September 30, 2025. This increase is predominantly due to increased clinical expenses of $3.6 million, non-clinical expenses of $1.1 million and manufacturing expenses of $9.8 million as a result of advancing our prioritized pipeline period over period, as well as increased employee-related costs of $1.5 million due to increased headcount.

Previous wording

Our direct research and development expenses consist principally of external costs for clinical, nonclinical and manufacturing, such as fees paid to contractors, consultants and CROs in connection with our development work. Included in “Internal Staffing, Overhead and Other” is overhead, supplies, research and development employee costs (including stock option expenses), travel, regulatory and legal.

Current wording

Our direct research and development expenses consist principally of external costs for clinical, nonclinical and manufacturing activities, such as fees paid to contractors, consultants and CROs in connection with our development work. Included in “Internal Staffing, Overhead and Other” are overhead, supplies, research and development employee costs (including stock option expenses), travel, and regulatory and legal costs.

Previous wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the three months ended June 30, 2026 were $36.0 million, an increase of $19.8 million, or 122%, from $16.2 million incurred in the three months ended June 30, 2025. The increase is primarily due to an increase in sales and marketing expenses of $13.8 million, employee-related expenses of $3.8 million, and professional expenses of $1.9 million. All increases are a result of the migraine assets program and launch of TONMYA.

Current wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the three months ended September 30, 2026 were $45.6 million, an increase of $19.9 million, or 77% from $25.7 million incurred in the three months ended September 30, 2025. The increase is primarily due to an increase in sales and marketing expenses of $13.5 million, employee-related expenses of $4.1 million, and professional expenses of $1.5 million. These increases primarily reflect commercialization activities following the launch of TONMYA in November 2025.

Previous wording

Net Loss. As a result of the foregoing, the net loss for the three months ended June 30, 2026 was $40.6 million, an increase of $12.3 million, or 43%, compared to a net loss of $28.3 million for the three months ended June 30, 2025.

Current wording

*Net Loss.*As a result of the foregoing, the net loss for the three months ended September 30, 2026 was $53.3 million, an increase of $21.3 million, or 66.6%, compared to a net loss of $32.0 million for the three months ended September 30, 2025.

Previous wording

Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025

Current wording

Nine Months Ended September 30, 2026 Compared to Nine Months Ended September 30, 2025

Previous wording

The following table sets forth our operating results for the quarter ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table sets forth our operating results for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

Revenues. Revenue recognized for the six months ended June 30, 2026 and 2025, was $20.4 million and $4.4 million, respectively. The increase is predominately due to the launch of TONMYA in November 2025. Gross-to-net allowances decreased by approximately $2.8 million due to changes in prior estimates related to a prior year resulting in an additional $2.8 million of revenue being recognized during the six months ended June 30, 2026.

Current wording

Revenues. Revenue recognized for the nine months ended September 30, 2026 and 2025, was $37.7 million and $7.7 million, respectively. The increase is predominantly due to the launch of TONMYA in November 2025. Gross-to-net allowances decreased by approximately $2.8 million due to changes in prior estimates related to a prior year resulting in an additional $2.8 million of revenue being recognized during the nine months ended September 30, 2026.

Previous wording

Cost of Sales. Cost of sales recognized for the six months ended June 30, 2026, was $2.3 million. Cost of sales recognized for the six months ended June 30, 2025, was $4.2 million, including write-downs related to Tosymra and Zembrace finished goods inventory of approximately $2.3 million based on an assessment of inventory on hand and projected sales. The increase in cost of sales, excluding the write-downs, is driven by a change in product mix and sale of product which had previously been written off.

Current wording

Cost of Sales. Cost of sales recognized for the nine months ended September 30, 2026, was $3.5 million. Cost of sales recognized for the nine months ended September 30, 2025, was $5.6 million, including write-downs related to Tosymra and Zembrace finished goods inventory of approximately $2.3 million based on an assessment of inventory on hand and projected sales. The increase in cost of sales, excluding the write-downs, is driven by a change in product mix and sale of products that had previously been written off.

Previous wording

Research and Development Expenses. Research and development expenses for the six months ended June 30, 2026 were $37.6 million, an increase of $19.4 million, or 106%, from $18.3 million for the six months ended June 30, 2025. This increase is predominately due to clinical expenses of $2.1 million and manufacturing expenses of $11.1 million as a result of advancing our prioritized pipeline programs period over period, as well as increased employee-related expenses of $5.0 million as a result increased headcount.

Current wording

Research and Development Expenses. Research and development expenses for the nine months ended September 30, 2026 were $63.5 million, an increase of $36.0 million, or 131% from $27.5 million for the nine months ended September 30, 2025. This increase is predominantly due to increases in clinical expenses of $5.7 million, non-clinical expenses of $1.0 million and manufacturing expenses of $20.9 million as a result of advancing our prioritized pipeline programs period over period, as well as increased employee-related expenses of $6.5 million as a result of increased headcount.

Previous wording

The table below summarizes our direct research and development expenses for our product candidates and development platform for the six months ended June 30, 2026, and 2025.

Current wording

The table below summarizes our direct research and development expenses for our product candidates and development platform for the nine months ended September 30, 2026, and 2025.

Previous wording

Our direct research and development expenses consist principally of external costs for clinical, nonclinical and manufacturing, such as fees paid to contractors, consultants and contract research organizations in connection with our development work. Included in “Internal Staffing, Overhead and Other” is overhead, supplies, research and development employee costs (including stock option expenses), travel, regulatory and legal.

Current wording

Our direct research and development expenses consist principally of external costs for clinical, nonclinical and manufacturing activities, such as fees paid to contractors, consultants and contract research organizations in connection with our development work. Included in “Internal Staffing, Overhead and Other” are overhead, supplies, research and development employee costs (including stock option expenses), travel, and regulatory and legal costs.

Previous wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the six months ended June 30, 2026 were $64.6 million, an increase of $38.3 million, or 146%, from $26.3 million incurred in the six months ended June 30, 2025. The increase is primarily due to increased sales and marketing of $24.7 million, employee-related expenses of $7.8 million and professional expenses of $4.7 million. All increases are a result of the migraine assets program and launch of TONMYA.

Current wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the nine months ended September 30, 2026 were $110.2 million, an increase of $58.2 million, or 112%, from $52.0 million incurred in the nine months ended September 30, 2025. The increase is primarily due to increased sales and marketing of $37.6 million, employee-related expenses of $11.8 million and professional expenses of $6.2 million. These increases primarily reflect commercialization activities following the launch of TONMYA in November 2025.

Previous wording

Net Loss. As a result of the foregoing, the net loss for the six months ended June 30, 2026 was $80.7 million, an increase of $35.6 million, or 79%, compared to a net loss of $45.1 million for the six months ended June 30, 2025.

Current wording

Net Loss. As a result of the foregoing, the net loss for the nine months ended September 30, 2026 was $134.1 million, an increase of $57.0 million, or 74%, compared to a net loss of $77.1 million for the nine months ended September 30, 2025.

Previous wording

We have assumed certain obligations of Upsher Smith, including the payment of quarterly royalty payments on annual net sales from the Business in the U.S. as follows: for Tosymra, 4% for net sales of $0 to $30 million, 7% of net sales of $30 to $75 million; 9% for net sales of $75 to $100 million; 12% for net sales of $100 to $150 million; and 15% for net sales greater than $150 million. Royalty payments with respect to Tosymra are payable until the expiration or termination of the product’s Orange Book listed patent(s) with respect to the United States or, outside the United States, the expiration of the last valid claim covering the product in the relevant country of the territory. For Zembrace, royalty payments on annual net sales in the U.S. are 3% for net sales of $0 to $30 million, 6% of net sales of $30 to $75 million; 12% for net sales of $75 to $100 million; 16% for net sales of greater than $100 million. Such royalty payments were payable until July 19, 2025. Upon the entry of a generic version of the relevant product, the applicable royalty rates will be reduced by 90% for Zembrace, and by 66.7% for Tosymra.

Current wording

We have assumed certain obligations of Upsher Smith, including the payment of quarterly royalties on annual net sales of the acquired products in the U.S. as follows: for Tosymra, 4% for net sales of $0 to $30 million, 7% of net sales of $30 to $75 million; 9% for net sales of $75 to $100 million; 12% for net sales of $100 to $150 million; and 15% for net sales greater than $150 million. Royalty payments with respect to Tosymra are payable until the expiration or termination of the product’s Orange Book listed patent(s) with respect to the United States or, outside the United States, the expiration of the last valid claim covering the product in the relevant country of the territory. For Zembrace, royalty payments on annual net sales in the U.S. are 3% for net sales of $0 to $30 million, 6% of net sales of $30 to $75 million; 12% for net sales of $75 to $100 million; 16% for net sales greater than $100 million. Such royalty payments were payable until July 19, 2025. Upon the entry of a generic version of the relevant product, the applicable royalty rates will be reduced by 90% for Zembrace, and by 66.7% for Tosymra.

Previous wording

As of June 30, 2026, we had working capital of $172.6 million, comprised primarily of cash and cash equivalents of $176.2 million, accounts receivable, net of $11.8 million, inventory of $4.7 million and prepaid expenses and other of $10.7 million, offset by $9.1 million of accounts payable, $21.5 million of accrued expenses, and current lease liabilities of $0.3 million. A significant portion of the accounts payable and accrued expenses are due to work performed in relation to our clinical programs, accruals for gross to net deductions related to our commercial products and launch of TONMYA.

Current wording

As of September 30, 2026, we had working capital of $150.1 million, comprised primarily of cash and cash equivalents of $162.8 million, accounts receivable, net of $14.6 million, inventory of $4.5 million and prepaid expenses and other current assets of $10.3 million, offset by $17.1 million of accounts payable, $24.6 million of accrued expenses, and current lease liabilities of $0.3 million. A significant portion of the accounts payable and accrued expenses is due to work performed in relation to our clinical programs, accruals for gross to net deductions related to our commercial products and launch of TONMYA.

Previous wording

The following table provides a summary of operating, investing and financing cash flows for the six months ended June 30, 2026, and 2025, respectively (in thousands):

Current wording

The following table provides a summary of operating, investing and financing cash flows for the nine months ended September 30, 2026, and 2025, respectively (in thousands):

Previous wording

For the six months ended June, 2026 and 2025, we used approximately $84.6 million and $31.4 million of cash in operating activities, respectively, which represents cash outlays for research and development and general and administrative expenses in such periods. The increase in cash outlays principally resulted from an increase in research and development and general, selling and administrative expenses. For the six months ended June 30, 2026 and 2025, net cash provided from financing activities was $53.7 million and $60.5 million, respectively, predominately from the issuance of common stock. Cash used in investing activities for the six months ended June 30, 2026, was $2.3 million related to the purchase of property and equipment. Cash used in investing activities for the six months ended June 30, 2025, was $2.5 million related to the issuance of a note and purchase of property and equipment.

Current wording

For the nine months ended September 30, 2026 and 2025, we used approximately $125.6 million and $60.2 million of cash in operating activities, respectively, which represents cash outlays for research and development and general and administrative expenses in such periods. The increase in cash outlays principally resulted from an increase in research and development and selling, general and administrative expenses. Cash used in investing activities for the nine months ended September 30, 2026, was $2.9 million related to the purchase of property and equipment. Cash used in investing activities for the nine months ended September 30, 2025, was $3.5 million related to the issuance of a note and purchase of property and equipment. For the nine months ended September 30, 2026 and 2025, net cash provided from financing activities was $82.0 million and $155.4 million, respectively, predominantly from the issuance of common stock.

Previous wording

We believe that our cash resources at June 30, 2026, and the proceeds that we raised from equity offerings during the third quarter of 2026, will meet our operating and capital expenditure requirements into early second quarter of 2027, but will not extend to 12 months from the issuance of these financial statements.

Current wording

We believe that our cash resources at September 30, 2026, and the proceeds that we raised from equity offerings subsequent to September 30, 2026, will meet our operating and capital expenditure requirements into early third quarter of 2027, but will not extend to 12 months from the issuance of these financial statements.

Previous wording

We expect to incur losses from operations for the near future. We expect to incur increasing research and development expenses, including expenses related to additional clinical trials and the build out of our research and development operations and manufacturing. We will not have enough resources to meet our operating requirements for the one-year period from filing date of this report.

Current wording

We expect to continue to incur operating losses and substantial research and development expenses as we advance our prioritized clinical programs. The level and timing of these expenses will depend on program progress, portfolio prioritization and the implementation of planned cost reductions. We do not expect our existing resources to be sufficient to meet our operating requirements for the one-year period from the filing date of this report.

Previous wording

We will need to obtain additional capital in order to fund future research and development activities. Future financing may include the issuance of equity or debt securities, obtaining credit facilities, or other financing mechanisms. Even if we are able to raise the funds required, it is possible that we could incur unexpected costs and expenses, fail to collect significant amounts owed to us, or experience unexpected cash requirements that would force us to seek alternative financing. Furthermore, if we issue additional equity or debt securities, shareholders may experience additional dilution or the new equity securities may have rights, preferences or privileges senior to those of existing holders of our common stock.

Current wording

We will need to obtain additional capital in order to fund future commercialization, research and development activities. Future financing may include the issuance of equity or debt securities, obtaining credit facilities, or other financing mechanisms. Even if we are able to raise the funds required, it is possible that we could incur unexpected costs and expenses, fail to collect significant amounts owed to us, or experience unexpected cash requirements that would force us to seek alternative financing. Furthermore, if we issue additional equity or convertible debt securities, shareholders may experience additional dilution or the new equity securities may have rights, preferences or privileges senior to those of existing holders of our common stock.

Previous wording

Pursuant to the terms of the 2025 Purchase Agreement, at the time we signed the 2025 Purchase Agreement and the 2025 Registration Rights Agreement, we issued 48,708 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the 2025 Purchase Agreement. The commitment shares were valued at $1.8 million and recorded as an addition to equity for the issuance of the common stock and treated as other expense, net on the condensed consolidated statement of operations under the 2025 Purchase Agreement. No shares were sold during 2026 and 2025 under the 2025 Purchase Agreement.

Current wording

Pursuant to the terms of the 2025 Purchase Agreement, at the time we signed the 2025 Purchase Agreement and the 2025 Registration Rights Agreement, we issued 48,708 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the 2025 Purchase Agreement. The commitment shares were valued at $1.8 million and recorded as an addition to equity for the issuance of the common stock and treated as other expense, net on the condensed consolidated statement of operations under the 2025 Purchase Agreement. No shares were sold during the nine months ended September 30, 2026, under the 2025 Purchase Agreement.

Previous wording

On June 11, 2025, we entered into a Sales Agreement (the “2025 Sales Agreement”), with A.G.P./Alliance Global Partners (“AGP”) pursuant to which we may issue and sell, from time to time, shares of common stock having an aggregate offering price of up to $400.0 million in sales. AGP is the sales agent under the ATM and paid a 3% commission on each sale under the 2025 Sales Agreement. Our common stock is sold at prevailing market prices at the time of the sale, and, as a result, prices will vary. During the six months ended June 30, 2026, we sold 4.0 million shares of common stock under the 2025 Sales Agreement, for net proceeds of approximately $53.6 million. Subsequent to June 30, 2026, we sold 0.3 million shares of common stock under the 2025 Sales Agreement, for net proceeds of approximately $3.7 million. No shares were sold during the six months ended June 30, 2025, under the 2025 Sales Agreement.

Current wording

On June 11, 2025, we entered into a Sales Agreement (the “2025 Sales Agreement”), with A.G.P./Alliance Global Partners (“AGP”) pursuant to which we may issue and sell, from time to time, shares of common stock having an aggregate offering price of up to $400.0 million in sales. AGP is the sales agent under the at-the-market (“ATM”) offering program and is paid a 3% commission on each sale under the 2025 Sales Agreement. Our common stock is sold at prevailing market prices at the time of the sale, and, as a result, prices will vary. During the three and nine months ended September 30, 2026, we sold 2.3 million and 6.3 million shares of common stock under the 2025 Sales Agreement, for net proceeds of approximately $28.1 million and $81.7 million, respectively. Subsequent to September 30, 2026, we sold 0.3 million shares of common stock under the 2025 Sales Agreement, for net proceeds of approximately $1.5 million. During each of the three and nine months ended September 30, 2025, we sold approximately 1.7 million shares of common stock under the 2025 Sales Agreement for net proceeds of approximately $55.7 million.

Previous wording

On July 30, 2024, we entered into a Sales Agreement (the “2024 Sales Agreement”), with AGP pursuant to which we may issue and sell, from time to time, shares of common stock having an aggregate offering price of up to $250.0 million in sales. AGP is the sales agent under the ATM and paid a 3% commission on each sale under the 2024 Sales Agreement. Our common stock is sold at prevailing market prices at the time of the sale, and, as a result, prices will vary. During the three and six months ended June 30, 2025, we sold approximately 0.8 million and 3.5 million shares, respectively, of common stock under the 2024 Sales Agreement for net proceeds of approximately $15.5 million and $75.4 million, respectively. Subsequent to June 30, 2025, we sold 0.9 million shares of common stock under the 2024 Sales Agreement, for net proceeds of approximately $37.5 million. We can no longer sell shares under the 2024 Sales Agreement as we have reached the aggregate $250 million in sales.

Current wording

On July 30, 2024, we entered into a Sales Agreement (the “2024 Sales Agreement”), with AGP pursuant to which we may issue and sell, from time to time, shares of common stock having an aggregate offering price of up to $250.0 million in sales. AGP is the sales agent under the ATM and is paid a 3% commission on each sale under the 2024 Sales Agreement. Our common stock is sold at prevailing market prices at the time of the sale, and, as a result, prices will vary. During the three and nine months ended September 30, 2025, we sold approximately 0.9 million and 4.5 million shares, respectively, of common stock under the 2024 Sales Agreement for net proceeds of approximately $37.5 million and $112.9 million, respectively. We can no longer sell shares under the 2024 Sales Agreement as we have reached the aggregate $250 million in sales.

Previous wording

In September 2024, the Board of Directors approved a 2024 share repurchase program pursuant to which we may repurchase up to $10.0 million in value of its outstanding common stock from time to time on the open market and in privately negotiated transactions subject to market conditions, share price and other factors. During the three months ended June 30, 2025, we repurchased 150,000 of shares of common stock outstanding under the 2024 share repurchase program at prices ranging from $18.25 to $20.47 per share for a gross aggregate cost of approximately $2.9 million. The repurchased shares were immediately retired.

Current wording

In September 2024, the Board of Directors approved a 2024 share repurchase program pursuant to which we may repurchase up to $10.0 million in value of our outstanding common stock from time to time on the open market and in privately negotiated transactions subject to market conditions, share price and other factors.

Previous wording

During the six months ended June 30, 2025, we repurchased 400,000 of shares of common stock outstanding under the 2024 share repurchase program at prices ranging from $9.98 to $20.47 per share for a gross aggregate cost of approximately $5.9 million. The repurchased shares were immediately retired.

Current wording

During the nine months ended September 30, 2025, we repurchased 400,000 shares of common stock outstanding under the 2024 share repurchase program at prices ranging from $9.98 to $20.47 per share for a gross aggregate cost of approximately $5.9 million. The repurchased shares were immediately retired. No shares of common stock were repurchased during the nine months ended September 30, 2026.

Previous wording

Under the terms of the 2026 Plan, we may issue (1) stock options (incentive and nonstatutory), (2) restricted stock, (3) stock appreciation rights (“SARs”), (4) RSUs, (5) other stock-based awards, and (6) cash-based awards. The 2026 Plan initially provided for the issuance of up to 1,000,000 shares of common stock, which amount will be increased to the extent that awards granted under the 2026 Plan are forfeited, expire or are settled for cash (except as otherwise provided in the 2026 Plan). In addition, the 2026 Plan contains an “evergreen provision” providing for an annual increase in the number of shares of our common stock available for issuance under the 2026 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2027\ and ending on (and including) January 1, 2036, in an amount equal to the greater of a) difference between (x) twenty percent (20%) of the total number of shares of common stock outstanding on December 31st of the preceding calendar year calculated on a fully diluted basis, and (y) the total number of shares of common stock reserved under the 2026 Plan on December 31 st of such preceding calendar year (including shares subject to outstanding awards, issued pursuant to awards or available for future awards) and (b) five percent (5%) of the total number of shares of stock outstanding as of December 31st of the preceding calendar year, calculated on a fully diluted basis.

Current wording

Under the terms of the 2026 Plan, we may issue (1) stock options (incentive and nonstatutory), (2) restricted stock, (3) stock appreciation rights (“SARs”), (4) restricted stock units (“RSUs”), (5) other stock-based awards, and (6) cash-based awards. The 2026 Plan initially provided for the issuance of up to 1,000,000 shares of common stock, which amount will be increased to the extent that awards granted under the 2026 Plan are forfeited, expire or are settled for cash (except as otherwise provided in the 2026 Plan). In addition, the 2026 Plan contains an “evergreen provision” providing for an annual increase in the number of shares of our common stock available for issuance under the 2026 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2027 and ending on (and including) January 1, 2036, in an amount equal to the greater of (a) the difference between (x) twenty percent (20%) of the total number of shares of common stock outstanding on December 31st of the preceding calendar year calculated on a fully diluted basis, and (y) the total number of shares of common stock reserved under the 2026 Plan on December 31 st of such preceding calendar year (including shares subject to outstanding awards, issued pursuant to awards or available for future awards) and (b) five percent (5%) of the total number of shares of stock outstanding as of December 31st of the preceding calendar year, calculated on a fully diluted basis.

Previous wording

The Board of Directors determines the exercise price, vesting and expiration period of the grants under the 2026 Plan. However, the exercise price of an incentive stock option may not be less than 110% of fair value of the common stock at the date of the grant for a 10% or more shareholder and 100% of fair value for a grantee who is not a 10% shareholder. The fair value of the common stock is determined based on quoted market price or in absence of such quoted market price, by the Board of Directors in good faith. Additionally, the expiration period of grants under the 2026 Plan may not be more than ten years. As of June 30, 2026, there were 808,100 options available for future grants under the 2026 Plan.

Current wording

The Board of Directors determines the exercise price, vesting and expiration period of the grants under the 2026 Plan. However, the exercise price of an incentive stock option may not be less than 110% of fair value of the common stock at the date of the grant for a 10% or more shareholder and 100% of fair value for a grantee who is not a 10% shareholder. The fair value of the common stock is determined based on quoted market price or in the absence of such quoted market price, by the Board of Directors in good faith. Additionally, the expiration period of grants under the 2026 Plan may not be more than ten years. As of September 30, 2026, there were 713,200 shares available for future awards under the 2026 Plan.

Previous wording

The weighted average fair value of options granted during the three and six months ended June 30, 2026 was $11.95 per share and $13.15 per share, respectively. The weighted average fair value of options granted during the three and six months ended June 30, 2025 was $19.63 per share and $12.59 per share, respectively.

Current wording

The weighted average fair value of options granted during the three and nine months ended September 30, 2026 was $9.94 per share and $12.93 per share, respectively. The weighted average fair value of options granted during the three and nine months ended September 30, 2025 was $31.62 per share and $12.72 per share, respectively.