Tonix Pharmaceuticals Holding Corp.
For the period ended Sep 30, 2025. Filed Nov 10, 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.
Sep 30, 2025 · Filed Nov 10, 2025
TNXP$4.74+3.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-11.
0001999371-25-011050
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001999371-25-017370
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 118 previous paragraphs and 108 current paragraphs.
63 unchanged; 36 reworded; 9 added; 16 removed; 3 previous and 0 current paragraphs rearranged.
Tables are not compared: 10 previous and 9 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 (9)
Current report
We are a fully-integrated, commercial-stage biotechnology company with marketed products and a pipeline of development candidates.
Current report
Our marketed products include Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, for which we received approval in August 2025 by the U.S. Food and Drug Administration (FDA). Fibromyalgia is a chronic pain condition that affects millions of adults, the majority of whom are women. Tonmya is the first new prescription medicine for fibromyalgia approved by the FDA in more than 15 years. We expect to launch Tonmya in the U.S. before the end of November 2025. We also market two treatments for acute migraine in adults, Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray).
Current report
*Revenues.*Revenue recognized for the quarter ended September 30, 2025 and 2024, was $3.3 million and $2.8 million, respectively. The increase is predominantly due to increased demand for our marketed migraine products and additional sales representatives.
Current report
Cost of Sales. Cost of sales recognized for the quarter ended September 30, 2025 and 2024, was $1.4 million and $1.6 million, respectively. The decrease is predominantly due to decreased inventory write-offs quarter over quarter.
Current report
Revenues. Revenue recognized for the nine months ended September 30, 2025 and 2024, was $7.7 million and $7.5 million, respectively. The increase is predominantly due to increased demand for our marketed migraine products and additional sales representatives.
Current report
Cost of Sales. Cost of sales recognized for the nine months ended September 30, 2025 and 2024, was $5.6 million and $6.6 million, respectively. The decrease is predominantly due to decreased write-offs period over period.
Current report
License Agreement
Current report
On June 26, 2025, we obtained an exclusive worldwide license from UMass Chan Medical School for the development of TNX-4800 (formerly known as mAb 2217LS). As of September 30, 2025, other than an upfront fee of $1.3 million, no payments have been accrued or paid in relation to this agreement.
Current report
We have entered into various exclusive license agreements with various institutions with the right to sublicense, certain patents, technical information and material, and to develop and commercialize products thereunder. In addition to any upfront payments already paid, we may be obligated to pay milestone fees ranging from $0.4 million to $5.0 million based on the potential achievement of certain development milestones, as well as milestone fees ranging from $1.0 million to $20.0 million based on certain potential commercial achievements, as specified in the respective license agreement. Additionally, for licensed products sold during the applicable royalty term, we must pay royalties in the low-to-mid single digits, beginning in the year after we complete our first commercial sale of a licensed product. Finally, we have the right under each license agreement to grant sublicenses to third parties and are required to pay a sublicense income share based on the stage of development of the licensed product at the time the sublicense is granted.
Removed paragraphs (16)
Previous report
We are a fully-integrated biotechnology company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Our development portfolio is focused on central nervous system (“CNS”) disorders, immunology, immuno-oncology and infectious diseases.
Previous report
Our priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which a Prescription Drug User Fee Act (“PDUFA”) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. A New Drug Application (“NDA”) for TNX-102 SL was submitted to the U.S. Food and Drug Administration (“FDA”) based on two statistically significant Phase 3 studies for the management of fibromyalgia. In March 2025 the FDA guided that no Advisory Committee Meeting will be required for this NDA. The FDA had also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia which indicates that the FDA views fibromyalgia as a serious condition that remains an unmet medical need. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder (ASR/ASD) under a Physician-Initiated Investigational New Drug application (“IND”) at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (“DoD”). The first patient was enrolled in the ASD/ASR study in May 2025 and topline results are expected in the second half of 2026.
Previous report
Our immunology and immune-oncology pipeline consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. In February 2025, Tonix announced positive topline results form a Phase 1 trial of TNX-1500 which supported proceeding to develop a Phase 2 trial for the prevention of kidney transplant rejection. TNX-1700 is a stabilized recombinant version of Trefoil Factor 2 (TFF2) and is in the preclinical stages of development to treat gastric and colorectal cancers.
Previous report
Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
Previous report
Tonmya has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
Previous report
Revenues. Revenue recognized for the three months ended June 30, 2025 and 2024, was $2.0 million and $2.2 million, respectively.
Previous report
Cost of Sales. Cost of sales recognized for the three months ended June 30, 2025 and 2024, was $3.3 million and $3.4 million, respectively. For the three months ended June 30, 2025 and 2024, cost of sales includes write-downs related to Tosymra and Zembrace finished goods inventory of approximately $2.3 million and $1.7 million, respectively, based on an assessment of inventory on hand and projected sales.
Previous report
Revenues. Revenue recognized for the six months ended June 30, 2025 and 2024, was $4.4 million and $4.7 million, respectively.
Previous report
Cost of Sales. 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. Cost of sales recognized for the six months ended June 30, 2024, was $5.0 million, including write-downs related to Tosymra and Zembrace finished goods inventory of approximately $1.7 million based on an assessment of inventory on hand and projected sales.
Previous report
December 2023 Financing
Previous report
On December 20, 2023, we entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional investors, pursuant to which we sold and issued (i) 7,920 shares of our common stock, (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 8,973 shares of common stock and (iii) Series C warrants to purchase up to 25,338 shares of common stock (the “Series C Warrants”), and (iv) Series D warrants to purchase up to 25,338 shares of common stock (the “Series D Warrants” and, together with the Series C Warrants, the “Common Warrants”). The securities sold in the offering were sold in fixed combinations as units. The offering price per share of common stock and accompanying Common Warrants was $1,776.00, and the offering price per Pre-Funded Warrant and accompanying Common Warrants was $1,775.68. The offering closed on December 22, 2023, generating gross proceeds of approximately $30.0 million, before deducting offering expenses of $2.3 million payable by us. At the closing of the offering, 2,034 Pre-Funded Warrants were immediately exercised into shares of common stock for nominal proceeds.
Previous report
The Pre-Funded Warrants have an exercise price of $0.32 per share, were immediately exercisable subject to certain ownership limitations, and can be exercised at any time until exercised in full. The Series C Warrants have an exercise price of $1,776.00 per share, and were exercisable on the later of approval by our stockholders of (i) a proposal to approve the filing of an amendment to our Articles of Incorporation, increasing the number of authorized shares of common stock from 160,000,000 to 1,000,000,000 and (ii) a proposal to allow the Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635 (the later of such events, the “Approval Date”) and initially expired on the later of (a) 10 trading days following the Approval Date and (b) the earlier of (x) the two year anniversary of the Approval Date and (y) 10 trading days following the public announcement of the U.S. Food and Drug Administration’s (“FDA”) acknowledgement and acceptance of the New Drug Application (“NDA”) relating to the Company’s TNX-102 SL product candidate in patients with fibromyalgia. The Series D Warrants have an exercise price of $2,720.00 per share and were exercisable beginning on the Approval Date through the five-year anniversary of the Approval Date.
Previous report
Upon the closing of the offering, we determined that certain of the Common Warrants did not meet the criteria for equity classification due to the lack of sufficient authorized and unissued shares to settle the instruments. We have adopted a sequencing approach under ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity to determine the classification of its contracts at issuance and at each subsequent reporting date, whereby shares are allocated based on the earliest issuance date of potentially dilutive instruments, with the earliest issuance date receiving the first allocation of shares. In the event of identical issuance dates, shares are then allocated beginning with instruments with the latest maturity date first. Pursuant to this sequencing approach, we determined that the authorized shares were sufficient to settle all remaining Pre-Funded Warrants and 15,917 Series D Warrants and were therefore classified in equity. The remaining 9,422 Series D Warrants and the Series C Warrants associated with the deficit shares were initially classified as liabilities at fair value and presented within non-current liabilities on the consolidated balance sheet as of December 31, 2023.
Previous report
The $30.0 million in gross proceeds received by us were first allocated to the Series C Warrants and the liability-classified Series D Warrants at their respective fair values, and the residual proceeds were allocated between the shares of common stock, the Pre-Funded Warrants, and the equity-classified Series D Warrants on a relative fair value basis. The issuance costs were allocated between the equity and liability-classified instruments on a relative fair value basis, resulting in issuance costs of $1.4 million recognized as a discount to the equity-classified instruments, and $0.9 million allocated to the liability-classified instruments and immediately expensed within Selling, general and administrative expense on the consolidated statements of operations.
Previous report
For the three and six months ended June 30, 2024, we recognized a change in fair value resulting in a loss of $0.9 million and gain of $6.2 million, respectively, related to the liability-classified warrants prior to meeting the criteria for equity classification.
Previous report
On January 25, 2024, the date our stockholders approved the proposal to file an amendment to our Articles of Incorporation to increase the number of authorized shares of common stock from 160,000,000 to 1,000,000,000, the liability-classified Series D Warrants and the Series C Warrants were adjusted to fair value and reclassified to equity.
Reworded paragraphs (36)
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 its 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 its assumptions. Factors that could cause differences include, but are not limited to: our need for additional financing; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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. 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 its 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 its assumptions. Factors that could cause differences include, but are not limited to: the ability to commercialize our approved products; substantial competition; our need for additional financing; 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 risks related to failure to obtain clearances or approvals from the United States Food and Drug Administration, or FDA, and noncompliance with FDA regulations.
Previous wording
Our infectious disease portfolio includes TNX-801, a vaccine in development to prevent mpox and smallpox, as well as TNX-4200 , a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. We have a contract with the DoD’s Defense Threat Reduction Agency (“DTRA”) for up to $34 million over five years to develop TNX-4200. We own and operate a state-of-the art infectious disease research facility in Frederick, Md.
Current wording
Our development pipeline is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. Within CNS, TNX-102 SL is being studied to treat acute stress reaction and acute stress disorder under an Investigator-Initiated Investigational New Drug Application (“IND”) at the University of North Carolina in the OASIS Phase 2 study funded by the U.S. Department of Defense (“DoD”). TNX-102 SL is also in development for major depressive disorder, with us expecting to initiate a potential pivotal Phase 2 study by mid-year 2026, contingent on IND clearance by the FDA. Our immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a dimeric Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of kidney transplant rejection and the treatment of autoimmune diseases. In collaboration with Massachusetts General Hospital (“MGH”), an open-label Phase 2 study of TNX-1500 is planned to initiate in the first half of 2026 to evaluate safety and activity in five kidney transplant recipients, contingent on FDA clearance of an investigator-initiated IND and approval by the institutional review board (“IRB”). Our rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and for which we plan to initiate a Phase 2 study in the second half of 2026. Our infectious disease portfolio includes TNX-801 (recombinant horsepox, live vaccine), a vaccine in development for prevention of mpox and smallpox. We are also developing TNX-4800 (anti-OspA mAb), a long-acting monoclonal antibody for the seasonal prevention of Lyme Disease, and expects to initiate an adaptive Phase2/3 study in 2027. TNX-4800 was licensed from the University of Massachusetts Chan Medical School in 2025. Finally, TNX-4200 for which we have a contract with the U.S. DoD’s Defense Threat Reduction Agency (“DTRA”) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. We own and operate a state-of-the art research and development facility in Frederick, Maryland.
Previous wording
All of our product candidates are investigational new drugs or biologics and have not been approved for any indication.
Current wording
Our product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Previous wording
Zembrace, SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are the property of their respective owners.
Current wording
Tonmya™, Zembrace® SymTouch® and Tosymra® are registered trademarks of Tonix Medicines, Inc. All other marks are the property of their respective owners.
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 Zembrace and Tosymra and ultimately Tonmya, following launch in November 2025, the 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
Research and Development Expenses. Research and development expenses for the three months ended June 30, 2025 were $10.8 million, an increase of $1.1 million, or 11%, from $9.7 million for the three months ended June 30, 2024. This increase is predominately due to increased clinical expenses of $1.3 million, non-clinal expenses of $1.6 million, manufacturing expenses of $0.8 million as a result of pipeline prioritization period over period, offset by a reduction in employee-related expenses of $0.6 million, regulatory expenses of $1.2 million and office-related expenses of $0.9 million due to a reduction in expenditures.
Current wording
Research and Development Expenses. Research and development expenses for the three months ended September 30, 2025 were $9.3 million, an increase of $0.2 million, or 2%, from $9.1 million for the three months ended September 30, 2024. This increase is predominately due to increased manufacturing expenses of $2.3 million, non-clinical expenses of $0.4 million and employee-related expenses of $0.6 million, as a result of pipeline prioritization period over period, offset by a reduction in clinical expenses of $2.1 million, regulatory expenses of $0.3 million and professional fees of $0.6 million due to a reduction in expenditures.
Previous wording
Selling, general and Administrative Expenses. General and administrative expenses for the three months ended June 30, 2025 were $16.2 million, an increase of $8.7 million, or 116%, from $7.5 million incurred in the three months ended June 30, 2024. The increase is primarily due to an increase in sales and marketing expenses of $5.3 million, employee-related expenses of $1.3 million, professional medical expenses of $0.9 million, and legal expenses of $0.4 million. All increases are a result of the migraine assets program and potential launch of TNX-102 SL.
Current wording
Selling, general and Administrative Expenses. General and administrative expenses for the three months ended September 30, 2025, were $25.7 million, an increase of $18.0 million, or 234%, from $7.7 million incurred in the three months ended September 30, 2024. The increase is primarily due to an increase in sales and marketing of $13.3 million, employee-related expenses of $2.5 million, professional expenses of $1.6 million, and legal expenses of $0.4 million. All increases are related to our marketed migraine products as well as preparation for 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, 2025 was $28.3 million, a decrease of $50.5 million, or 64%, compared to a net loss of $78.8 million for the three months ended June 30, 2024.
Current wording
Net Loss. As a result of the foregoing, the net loss for the three months ended September 30, 2025 was $32.0 million, an increase of $17.8 million, or 125%, compared to a net loss of $14.2 million for the three months ended September 30, 2024.
Previous wording
Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024
Current wording
Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024
Previous wording
The following table sets forth our operating expenses for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table sets forth our operating expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
Research and Development Expenses. Research and development expenses for the six months ended June 30, 2025 were $18.3 million, a decrease of $4.3 million, or 19%, from $22.6 million for the six months ended June 30, 2024. This decrease is predominately due to decreased clinical expenses of $0.9 million as a result of fewer trials in the clinic, employee-related expenses of $2.1, office-related expenses of $1.9 million and regulatory of $1.3 million due to a reduction in expenditures offset by an increase in non-clinal expenses of $1.1 million and manufacturing expenses of $0.6 million as a result of pipeline prioritization period over period.
Current wording
Research and Development Expenses. Research and development expenses for the nine months ended September 30, 2025 were $27.5 million, a decrease of $4.2 million, or 13%, from $31.7 million for the nine months ended September 30, 2024. This decrease is predominately due to decreased clinical expenses of $2.9 million, as a result of fewer trials in the clinic and pipeline prioritization period over period, employee-related expenses of $1.5 million, regulatory expenses of $1.6 million and office-related expenses of $2.6 million due to a reduction in expenditures offset by an increase in non-clinical expenses of $1.5 million and manufacturing expenses of $2.9 million due to pipeline prioritization.
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, 2025, and 2024.
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, 2025, and 2024.
Previous wording
Selling, general and Administrative Expenses. General and administrative expenses for the six months ended June 30, 2025 were $26.3 million, an increase of $9.5 million, or 57%, from $16.8 million incurred in the six months ended June 30, 2024. The increase is primarily due to an increase in in sales and marketing of $6.7 million, employee-related expenses of $1.0 million, professional expenses of $0.9 million, and legal expenses of $0.7 million. All increases are a result of the migraine assets program and potential launch of TNX-102 SL.
Current wording
General and Administrative Expenses. General and administrative expenses for the nine months ended September 30, 2025 were $52.0 million, an increase of $27.5 million, or 112%, from $24.5 million incurred in the nine months ended September 30, 2024. The increase is primarily due to an increase in sales and marketing of $19.9 million, employee-related expenses of $3.6 million, professional expenses of $2.6 million, and legal expenses of $1.1 million. All increases are related to our marketed migraine products as well as preparation for the launch of Tonmya in November 2025.
Previous wording
Asset impairment charges. We recognized a non-cash impairment charge of $48.8 million related to property and equipment, a non-cash impairment of $1.0 million related to goodwill, and a non-cash impairment charge of $9.2 million related to intangible assets, which is reflected in asset impairment charges in the consolidated statements of operations for the three months ended June 30, 2024.
Current wording
Asset impairment charges. Reflected in asset impairment charges in the consolidated statements of operations for the nine months ended September 30, 2024, is a non-cash impairment charge of $48.8 million related to property and equipment, a non-cash impairment of $1.0 million related to goodwill, and a non-cash impairment charge of $9.2 million related to intangible assets.
Previous wording
The impairment of the Tosymra and Zembrace inventory, intangibles and goodwill was driven by our delayed investment in the sales personnel required to drive growth in the business as we were focusing our cash resources to further our efforts to bring TNX-102 SL through the approval process and to market. However, we believe that the benefits and long-term value proposition of the 2023 acquisition of Tosymra and Zembrace remain, in that we now have the infrastructure to be ready to manufacture and sell TNX-102 SL under an expedited timeline pending FDA approval for which we expect an FDA decision in August 2025.
Current wording
The impairment of the Tosymra and Zembrace inventory, intangibles and goodwill was driven by our delayed investment in the sales personnel required to drive growth in the business as we are focusing our cash resources to further our efforts to bring TNX-102 SL through the approval process and to market. However, we believe that the benefits and long-term value proposition of the 2023 acquisition of Tosymra and Zembrace remain, in that we now have the infrastructure to be ready to manufacture and sell TNX-102 SL under an expedited timeline following FDA approval in August 2025.
Previous wording
Net Loss. As a result of the foregoing, the net loss for the six months ended June 30, 2025 was $45.1 million, a decrease of $48.6 million, or 52%, compared to a net loss of $93.7 million for the six months ended June 30, 2024.
Current wording
Net Loss. As a result of the foregoing, the net loss for the nine months ended September 30, 2025 was $77.1 million, a decrease of $30.8 million, or 29%, compared to a net loss of $107.9 million for the nine months ended September 30, 2024.
Previous wording
As of June 30, 2025, we had working capital of $124.5 million, comprised primarily of cash and cash equivalents of $125.3 million, accounts receivable, net of $2.3 million, inventory of $6.0 million and prepaid expenses and other of $9.9 million, offset by $7.8 million of accounts payable, $11.1 million of accrued expenses, and current lease liabilities of $0.2 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 potential product launch of TNX-102 SL.
Current wording
As of September 30, 2025, we had working capital of $187.0 million, comprised primarily of cash and cash equivalents of $190.1 million, accounts receivable, net of $3.5 million, inventory of $5.7 million and prepaid expenses and other of $8.8 million, offset by $8.5 million of accounts payable, $12.3 million of accrued expenses, and current lease liabilities of $0.2 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 product launch of TNX-102 SL.
Previous wording
The following table provides a summary of operating, investing and financing cash flows for the six months ended June 30, 2025, and 2024, 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, 2025, and 2024, respectively (in thousands):
Previous wording
For the six months ended June, 2025 and 2024, we used approximately $31.4 million and $27.5 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 general and administrative expenses. For the six months ended June 30, 2025, net cash provided from financing activities was $60.5 million and $6.8 million, respectively predominately from the issuance of common stock. 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. Cash used in investing activities for the six months ended June 30, 2024, was $0.1 million related to the purchase of property and equipment.
Current wording
For the nine months ended September, 2025 and 2024, we used approximately $60.2 million and $46.3 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 general and administrative expenses as a result of the potential product launch of TNX-102 SL. For the nine months ended September 30, 2025, net cash provided from financing activities was $155.4 million and $49.7 million, respectively predominately from the issuance of common stock. 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. Cash used in investing activities for the nine months ended September 30, 2024, was $0.1 million related to the purchase of property and equipment.
Previous wording
We believe that our cash resources at June 30, 2025, and the proceeds that we raised from equity offerings during the third quarter of 2025, will meet our operating and capital expenditure requirements into the third quarter of 2026.
Current wording
We believe that our cash resources at September 30, 2025, and the proceeds that we received from the sales of equity during the fourth quarter of 2025, will meet our operating and capital expenditure requirements into the first quarter of 2027.
Previous wording
These factors raise substantial doubt about our ability to continue as a going concern. We continue to face significant challenges and uncertainties and must obtain additional funding through public and private financing and collaborative arrangements with strategic partners to increase the funds available to fund operations. However, we may not be able to raise capital on terms acceptable to us, or at all. Without additional funds, we may be forced to delay, scale back or eliminate some or all of our research and development activities or other operations, and potentially delay product development in an effort to maintain sufficient funds to continue operations. If any of these events occurs, our ability to achieve development and commercialization goals will be adversely affected and we may be forced to cease operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Current wording
We continue to face significant challenges and uncertainties and must successfully launch Tonmya and obtain additional funding through public and private financing and collaborative arrangements with strategic partners to increase the funds available to fund operations. However, we may not be able to raise capital on terms acceptable to us, or at all. Without the successful product launch of Tonmya and obtaining additional funds, we may be forced to delay, scale back or eliminate some or all of our research and development activities or other operations, and potentially delay product development in an effort to maintain sufficient funds to continue operations. If any of these events occurs, our ability to achieve development and commercialization goals will be adversely affected and we may be forced to cease operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Previous wording
We expect to incur losses from operations for the near future. We expect to increase our operating costs to align the Company’s capital and human resources with its previously announced strategic prioritization of TNX-102 SL product candidate for the management of fibromyalgia. 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 incur losses from operations for the near future. We expect to increase our operating costs to align the Company’s capital and human resources with its previously announced strategic prioritization of the commercial launch of Tonmya for the treatment of fibromyalgia.
Previous wording
Our future capital requirements will depend on a number of factors, including the progress of our research and development of product candidates, the timing and outcome of regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights, the status of competitive products, the availability of financing and our success in developing markets for our product candidates.
Current wording
Our future capital requirements will depend on a number of factors, including the successful product launch of Tonmya, the progress of our research and development of product candidates, the timing and outcome of regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights, the status of competitive products, the availability of financing and our success in developing markets for our product candidates.
Previous wording
We will need to obtain additional capital in order to fund future research and development activities and future capital expenditures. 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 successfully launch Tonmya and obtain additional capital in order to fund future research and development activities and future capital expenditures. 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.
Previous wording
If additional financing is not available or is not available on acceptable terms, we may be required to delay, reduce the scope of or eliminate our research and development programs, reduce our commercialization efforts or obtain funds through arrangements with collaborative partners or others that may require us to relinquish rights to certain product candidates that we might otherwise seek to develop or commercialize independently.
Current wording
If the product launch of Tonmya is unsuccessful and additional financing is not available or is not available on acceptable terms, we may be required to delay, reduce the scope of or eliminate our research and development programs, reduce our commercialization efforts or obtain funds through arrangements with collaborative partners or others that may require us to relinquish rights to certain product candidates that we might otherwise seek to develop or commercialize independently.
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 $150.0 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. No shares were sold during 2025 under the 2025 Sales Agreement. Subsequent to June 30, 2025, we sold 0.3 million shares of common stock under the Sales Agreement, for net proceeds of approximately $12.3 million.
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 $150.0 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 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. Subsequent to September 30, 2025, we sold 1.6 million shares of common stock under the Sales Agreement, for net proceeds of approximately $34.7 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 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 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 June 30, 2025, we repurchased 150,000 of shares of common stock outstanding under the 2024 share repurchase 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 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.
Previous wording
During the six months June 30, 2025, we repurchased 400,000 of shares of common stock outstanding under the 2024 share repurchase 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 of shares of common stock outstanding under the 2024 share repurchase 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.
Previous wording
The Board of Directors determines the exercise price, vesting and expiration period of the grants under the Amended and Restated 2020 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 Amended and Restated 2020 Plan may not be more than ten years. As of June 30, 2025, there were 723,113 options available for future grants under the Amended and Restated 2020 Plan.
Current wording
The Board of Directors determines the exercise price, vesting and expiration period of the grants under the Amended and Restated 2020 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 Amended and Restated 2020 Plan may not be more than ten years. As of September 30, 2025, there were 737,782 options available for future grants under the Amended and Restated 2020 Plan.
Previous wording
The weighted average fair value of options granted during the three and six months ended June 2025 was $19.63 per share and $12.59 per share, respectively. The weighted average fair value of options granted during the three and six months ended June 2024 was $506.04 per share and $1,015.52 per share, respectively.
Current wording
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. The weighted average fair value of options granted during the three and nine months ended September 30, 2024 was $15.24 per share and $867.96 per share, respectively.
Previous wording
Stock-based compensation expense relating to options granted of $1.4 million, of which $1.0 million and $0.4 million, related to General and Administration and Research and Development, respectively was recognized for the quarter ended June 30, 2025. Stock-based compensation expense relating to options granted of $1.1 million, of which $0.8 million and $0.3 million, related to General and Administration and Research and Development, respectively was recognized for the quarter ended June 30, 2024.
Current wording
Stock-based compensation expense relating to options granted of $1.8 million, of which $1.2 million and $0.6 million, related to General and Administration and Research and Development, respectively was recognized for the quarter ended September 30, 2025. Stock-based compensation expense relating to options granted of $1.0 million, of which $0.7 million and $0.3 million, related to General and Administration and Research and Development, respectively was recognized for the quarter ended September 30, 2024.
Previous wording
Stock-based compensation expense relating to options granted of $2.3 million, of which $1.6 million and $0.7 million, related to General and Administration and Research and Development, respectively was recognized for the six-month period ended June 30, 2025. Stock-based compensation expense relating to options granted of $2.8 million, of which $2.0 million and $0.8 million, related to General and Administration and Research and Development, respectively was recognized for the six-month period ended June 30, 2024.
Current wording
Stock-based compensation expense relating to options granted of $4.1 million, of which $2.8 million and $1.3 million, related to General and Administration and Research and Development, respectively was recognized for the nine-month period ended September 30, 2025. Stock-based compensation expense relating to options granted of $3.9 million, of which $2.8 million and $1.1 million, related to General and Administration and Research and Development, respectively was recognized for the nine-month period ended September 30, 2024.
Previous wording
As of June 30, 2025, we had approximately $15.5 million of total unrecognized compensation cost related to non-vested awards granted under the Plans, which we expect to recognize over a weighted average period of 3.08 years.
Current wording
As of September 30, 2025, we had approximately $13.6 million of total unrecognized compensation cost related to non-vested awards granted under the Plans, which we expect to recognize over a weighted average period of 2.89 years.
Previous wording
The ESPP Plans are considered compensatory plans with the related compensation cost expensed over the six-month offering period. For the six months ended June 30, 2025, and 2024, $0 and $27,000, respectively, was expensed. In January 2024, 21 shares that were purchased as of December 31, 2023, under the 2022 ESPP, were issued. As of June 30, 2024, approximately $33,000 of employee payroll deductions had accumulated and had been recorded in accrued expenses. In July 2024, 70 shares that were purchased as of June 30, 2024, under the 2022 ESPP, were issued.
Current wording
The ESPP Plans are considered compensatory plans with the related compensation cost expensed over the six-month offering period. For the nine months ended September 30, 2025, and 2024, $84,000 and $27,000, respectively, was expensed. In January 2024, 21 shares that were purchased as of December 31, 2023, under the 2022 ESPP, were issued. As of June 30, 2024, approximately $33,000 of employee payroll deductions had accumulated and had been recorded in accrued expenses. In July 2024, 70 shares that were purchased as of June 30, 2024, under the 2022 ESPP, were issued. As of September 30, 2025, approximately $57,000 of employee payroll deductions had accumulated and had been recorded in accrued expenses.
Previous wording
We have entered into contracts with various contract research organizations with outstanding commitments aggregating approximately $21.7 million at June 30, 2025 for future work to be performed.
Current wording
We have entered into contracts with various contract research organizations with outstanding commitments aggregating approximately $22.7 million at September 30, 2025 for future work to be performed.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Asset impairment charges. We recognized a non-cash impairment charge of $48.8 million related to property and equipment, a non-cash impairment of $1.0 million related to goodwill, and a non-cash impairment charge of $9.2 million related to intangible assets, which is reflected in asset impairment charges in the consolidated statements of operations for the three months ended June 30, 2024.
Previous report — wording carried elsewhere
The impairment of the Tosymra and Zembrace inventory, intangibles and goodwill was driven by our delayed investment in the sales personnel required to drive growth in the business as we were focusing our cash resources to further our efforts to bring TNX-102 SL through the approval process and to market. However, we believe that the benefits and long-term value proposition of the 2023 acquisition of Tosymra and Zembrace remain, in that we now have the infrastructure to be ready to manufacture and sell TNX-102 SL under an expedited timeline pending FDA approval for which we expect an FDA decision in August 2025.
Previous report — wording carried elsewhere
We repurchased the following capital stock: