[10-Q] Tonix Pharmaceuticals Holding Corp. Quarterly Earnings Report
Tonix Pharmaceuticals (TNXP) reported cash and cash equivalents of $125.3 million, total assets of $187.4 million and stockholders' equity of $168.0 million at June 30, 2025, with working capital of approximately $124.5 million and an accumulated deficit of about $775.8 million. Product revenue totaled $2.0 million for the quarter (down from $2.2 million a year earlier) and $4.4 million for the six months (down from $4.7 million). The company reported a net loss of $28.3 million for the quarter and $45.1 million for the six months, driven by $16.2 million of selling, general and administrative expense and elevated R&D spending.
The company highlighted regulatory and pipeline progress: a PDUFA goal date of August 15, 2025 for TNX-102 SL with no FDA Advisory Committee meeting required and Fast Track designation; first patient enrolled in an ASD/ASR study in May 2025; positive Phase 1 topline for TNX-1500 supporting a Phase 2 kidney transplant program; and a DTRA contract for up to $34.1 million for TNX-4200 with $2.0 million of grant income recognized year-to-date. Management disclosed substantial doubt about going concern despite noting cash plus subsequent equity proceeds intended to fund operations into the third quarter of 2026.
Tonix Pharmaceuticals (TNXP) ha dichiarato liquidità e mezzi equivalenti per $125,3 milioni, attività totali per $187,4 milioni e patrimonio netto per $168,0 milioni al 30 giugno 2025, con un capitale circolante di circa $124,5 milioni e un deficit accumulato di circa $775,8 milioni. I ricavi da prodotti sono stati pari a $2,0 milioni nel trimestre (in calo rispetto ai $2,2 milioni dell'anno precedente) e a $4,4 milioni nei sei mesi (da $4,7 milioni). La società ha riportato una perdita netta di $28,3 milioni nel trimestre e di $45,1 milioni nei sei mesi, principalmente a causa di $16,2 milioni di spese di vendita, generali e amministrative e di un aumento della spesa in R&S.
La società ha inoltre sottolineato progressi regolatori e di pipeline: data obiettivo PDUFA del 15 agosto 2025 per TNX-102 SL senza convocazione di un comitato consultivo FDA e con designazione Fast Track; primo paziente arruolato in uno studio ASD/ASR a maggio 2025; risultati topline positivi di Fase 1 per TNX-1500 a sostegno di un programma di Fase 2 nel trapianto renale; e un contratto DTRA fino a $34,1 milioni per TNX-4200 con $2,0 milioni di proventi da sovvenzioni riconosciuti da inizio anno. La direzione ha dichiarato significativi dubbi sulla continuità aziendale nonostante abbia indicato che la cassa, insieme ai successivi proventi da aumenti di capitale, dovrebbe finanziare le operazioni fino al terzo trimestre 2026.
Tonix Pharmaceuticals (TNXP) informó efectivo y equivalentes de efectivo por $125,3 millones, activos totales por $187,4 millones y patrimonio neto por $168,0 millones al 30 de junio de 2025, con un capital de trabajo de aproximadamente $124,5 millones y un déficit acumulado de alrededor de $775,8 millones. Los ingresos por productos ascendieron a $2,0 millones en el trimestre (por debajo de $2,2 millones el año anterior) y a $4,4 millones en los seis meses (frente a $4,7 millones). La compañía reportó una pérdida neta de $28,3 millones en el trimestre y de $45,1 millones en los seis meses, impulsada por $16,2 millones en gastos de ventas, generales y administrativos y por un mayor gasto en I+D.
La compañía destacó avances regulatorios y en la cartera: fecha objetivo PDUFA del 15 de agosto de 2025 para TNX-102 SL sin requerir reunión del Comité Asesor de la FDA y con designación Fast Track; primer paciente inscrito en un estudio ASD/ASR en mayo de 2025; resultados topline positivos de Fase 1 para TNX-1500 que respaldan un programa de Fase 2 en trasplante renal; y un contrato DTRA por hasta $34,1 millones para TNX-4200 con $2,0 millones de ingresos por subvenciones reconocidos en lo que va del año. La dirección declaró dudas sustanciales sobre la continuidad operativa a pesar de señalar que la caja, más las posteriores emisiones de capital previstas, deberían financiar las operaciones hasta el tercer trimestre de 2026.
Tonix Pharmaceuticals (TNXP)는 2025년 6월 30일 기준 현금 및 현금성 자산이 $125.3 million, 총자산이 $187.4 million, 자본(주주지분)이 $168.0 million이라고 보고했으며, 운전자본은 약 $124.5 million, 누적적자는 약 $775.8 million입니다. 제품 매출은 분기 기준 $2.0 million(전년 동기 $2.2 million에서 감소), 상반기 기준 $4.4 million(전년 상반기 $4.7 million에서 감소)였습니다. 회사는 분기 순손실 $28.3 million, 상반기 순손실 $45.1 million을 보고했으며, 이는 $16.2 million의 판매·일반관리비와 증가한 연구개발비에 의해 주도되었습니다.
회사 측은 규제 및 파이프라인 진전을 강조했습니다: TNX-102 SL에 대한 PDUFA 목표일이 2025년 8월 15일이며 FDA 자문위원회 소집이 필요 없고 Fast Track 지정이 부여됨; 2025년 5월 ASD/ASR 연구에 첫 환자 등록; TNX-1500의 1상 톱라인 결과가 신장 이식 관련 2상 프로그램을 뒷받침함; TNX-4200에 대해 최대 $34.1 million 규모의 DTRA 계약 체결 및 연초 이후 인식된 보조금 수익 $2.0 million. 경영진은 현금 및 이후의 증자 수익이 2026년 3분기까지 운영 자금을 지원할 것으로 보고하면서도 계속 기업으로서의 존속에 대해 상당한 의문을 제기했습니다.
Tonix Pharmaceuticals (TNXP) a déclaré des liquidités et équivalents de trésorerie de $125,3 millions, un actif total de $187,4 millions et des capitaux propres de $168,0 millions au 30 juin 2025, avec un fonds de roulement d'environ $124,5 millions et un déficit cumulé d'environ $775,8 millions. Les revenus produits se sont élevés à $2,0 millions pour le trimestre (en baisse par rapport à $2,2 millions un an plus tôt) et à $4,4 millions pour les six mois (contre $4,7 millions). La société a enregistré une perte nette de $28,3 millions pour le trimestre et de $45,1 millions pour les six mois, principalement en raison de $16,2 millions de frais de vente, généraux et administratifs et d'une augmentation des dépenses de R&D.
La société a souligné des avancées réglementaires et de pipeline : date cible PDUFA du 15 août 2025 pour TNX-102 SL sans réunion du comité consultatif de la FDA requise et avec la désignation Fast Track ; premier patient enrôlé dans une étude ASD/ASR en mai 2025 ; résultats topline positifs de la phase 1 pour TNX-1500 soutenant un programme de phase 2 en transplantation rénale ; et un contrat DTRA pouvant atteindre $34,1 millions pour TNX-4200, avec $2,0 millions de subventions reconnus depuis le début de l'année. La direction a fait état de doutes substantiels quant à la continuité d'exploitation, tout en précisant que la trésorerie, complétée par des levées de fonds ultérieures, devrait financer les opérations jusqu'au troisième trimestre 2026.
Tonix Pharmaceuticals (TNXP) meldete zum 30. Juni 2025 Zahlungsmittel und Zahlungsmitteläquivalente in Höhe von $125,3 Millionen, Gesamtvermögen von $187,4 Millionen und Eigenkapital von $168,0 Millionen. Das Working Capital betrug rund $124,5 Millionen, das kumulierte Defizit etwa $775,8 Millionen. Die Produktumsätze beliefen sich im Quartal auf $2,0 Millionen (gegenüber $2,2 Millionen im Vorjahr) und in den sechs Monaten auf $4,4 Millionen (gegenüber $4,7 Millionen). Das Unternehmen wies einen Nettoverlust von $28,3 Millionen für das Quartal und $45,1 Millionen für die sechs Monate aus, bedingt durch $16,2 Millionen an Vertriebs-, Verwaltungs- und Gemeinkosten sowie erhöhte F&E-Aufwendungen.
Das Unternehmen hob regulatorische und Pipeline-Fortschritte hervor: PDUFA-Zieldatum 15. August 2025 für TNX-102 SL ohne erforderliche FDA-Beratungsausschusssitzung und mit Fast-Track-Status; erster Patient in einer ASD/ASR-Studie im Mai 2025 eingeschrieben; positive Phase‑1-Topline-Daten für TNX-1500, die ein Phase‑2-Programm für Nierentransplantationen stützen; sowie ein DTRA-Vertrag über bis zu $34,1 Millionen für TNX-4200 mit bislang anerkannten Zuschuss-Erlösen in Höhe von $2,0 Millionen. Das Management äußerte erhebliche Zweifel an der Fortführungsfähigkeit, obwohl es anmerkte, dass Barmittel zuzüglich nachfolgender Eigenkapitalzuflüsse voraussichtlich die Aktivitäten bis ins dritte Quartal 2026 finanzieren sollen.
- None.
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Insights
TL;DR: Cash cushion and recent equity raises help near-term runway, but persistent operating losses and going-concern disclosure create material financial risk.
The balance sheet shows meaningful liquidity with $125.3M in cash and working capital of ~$124.5M, and the company realized net ATM proceeds of $75.4M in the six months ended June 30, 2025. However, recurring operating losses—$28.3M quarterly and $45.1M YTD—plus negative gross margin on product (cost of revenue exceeded product revenue in the quarter) signal ongoing cash burn. Management’s statement of substantial doubt about going concern is material; while planned and subsequent financings are expected to extend runway into Q3 2026, execution and market access risks remain key financial constraints for investors.
TL;DR: Regulatory milestones and clinical progress are positive: PDUFA set for Aug 15, 2025, no Advisory Committee required, and TNX-1500 advanced after Phase 1.
TNX-102 SL has a PDUFA goal date and FDA indicated no advisory committee meeting will be required, which is a favorable regulatory signal explicitly stated in the filing. TNX-1500 reported positive Phase 1 topline results supporting progression to a Phase 2 transplant study. Enrollment of the first patient in the ASD/ASR OASIS study (May 2025) and the DTRA agreement for TNX-4200 funding further validate clinical and government program momentum. These clinical and regulatory developments are material to the company’s development pathway.
Tonix Pharmaceuticals (TNXP) ha dichiarato liquidità e mezzi equivalenti per $125,3 milioni, attività totali per $187,4 milioni e patrimonio netto per $168,0 milioni al 30 giugno 2025, con un capitale circolante di circa $124,5 milioni e un deficit accumulato di circa $775,8 milioni. I ricavi da prodotti sono stati pari a $2,0 milioni nel trimestre (in calo rispetto ai $2,2 milioni dell'anno precedente) e a $4,4 milioni nei sei mesi (da $4,7 milioni). La società ha riportato una perdita netta di $28,3 milioni nel trimestre e di $45,1 milioni nei sei mesi, principalmente a causa di $16,2 milioni di spese di vendita, generali e amministrative e di un aumento della spesa in R&S.
La società ha inoltre sottolineato progressi regolatori e di pipeline: data obiettivo PDUFA del 15 agosto 2025 per TNX-102 SL senza convocazione di un comitato consultivo FDA e con designazione Fast Track; primo paziente arruolato in uno studio ASD/ASR a maggio 2025; risultati topline positivi di Fase 1 per TNX-1500 a sostegno di un programma di Fase 2 nel trapianto renale; e un contratto DTRA fino a $34,1 milioni per TNX-4200 con $2,0 milioni di proventi da sovvenzioni riconosciuti da inizio anno. La direzione ha dichiarato significativi dubbi sulla continuità aziendale nonostante abbia indicato che la cassa, insieme ai successivi proventi da aumenti di capitale, dovrebbe finanziare le operazioni fino al terzo trimestre 2026.
Tonix Pharmaceuticals (TNXP) informó efectivo y equivalentes de efectivo por $125,3 millones, activos totales por $187,4 millones y patrimonio neto por $168,0 millones al 30 de junio de 2025, con un capital de trabajo de aproximadamente $124,5 millones y un déficit acumulado de alrededor de $775,8 millones. Los ingresos por productos ascendieron a $2,0 millones en el trimestre (por debajo de $2,2 millones el año anterior) y a $4,4 millones en los seis meses (frente a $4,7 millones). La compañía reportó una pérdida neta de $28,3 millones en el trimestre y de $45,1 millones en los seis meses, impulsada por $16,2 millones en gastos de ventas, generales y administrativos y por un mayor gasto en I+D.
La compañía destacó avances regulatorios y en la cartera: fecha objetivo PDUFA del 15 de agosto de 2025 para TNX-102 SL sin requerir reunión del Comité Asesor de la FDA y con designación Fast Track; primer paciente inscrito en un estudio ASD/ASR en mayo de 2025; resultados topline positivos de Fase 1 para TNX-1500 que respaldan un programa de Fase 2 en trasplante renal; y un contrato DTRA por hasta $34,1 millones para TNX-4200 con $2,0 millones de ingresos por subvenciones reconocidos en lo que va del año. La dirección declaró dudas sustanciales sobre la continuidad operativa a pesar de señalar que la caja, más las posteriores emisiones de capital previstas, deberían financiar las operaciones hasta el tercer trimestre de 2026.
Tonix Pharmaceuticals (TNXP)는 2025년 6월 30일 기준 현금 및 현금성 자산이 $125.3 million, 총자산이 $187.4 million, 자본(주주지분)이 $168.0 million이라고 보고했으며, 운전자본은 약 $124.5 million, 누적적자는 약 $775.8 million입니다. 제품 매출은 분기 기준 $2.0 million(전년 동기 $2.2 million에서 감소), 상반기 기준 $4.4 million(전년 상반기 $4.7 million에서 감소)였습니다. 회사는 분기 순손실 $28.3 million, 상반기 순손실 $45.1 million을 보고했으며, 이는 $16.2 million의 판매·일반관리비와 증가한 연구개발비에 의해 주도되었습니다.
회사 측은 규제 및 파이프라인 진전을 강조했습니다: TNX-102 SL에 대한 PDUFA 목표일이 2025년 8월 15일이며 FDA 자문위원회 소집이 필요 없고 Fast Track 지정이 부여됨; 2025년 5월 ASD/ASR 연구에 첫 환자 등록; TNX-1500의 1상 톱라인 결과가 신장 이식 관련 2상 프로그램을 뒷받침함; TNX-4200에 대해 최대 $34.1 million 규모의 DTRA 계약 체결 및 연초 이후 인식된 보조금 수익 $2.0 million. 경영진은 현금 및 이후의 증자 수익이 2026년 3분기까지 운영 자금을 지원할 것으로 보고하면서도 계속 기업으로서의 존속에 대해 상당한 의문을 제기했습니다.
Tonix Pharmaceuticals (TNXP) a déclaré des liquidités et équivalents de trésorerie de $125,3 millions, un actif total de $187,4 millions et des capitaux propres de $168,0 millions au 30 juin 2025, avec un fonds de roulement d'environ $124,5 millions et un déficit cumulé d'environ $775,8 millions. Les revenus produits se sont élevés à $2,0 millions pour le trimestre (en baisse par rapport à $2,2 millions un an plus tôt) et à $4,4 millions pour les six mois (contre $4,7 millions). La société a enregistré une perte nette de $28,3 millions pour le trimestre et de $45,1 millions pour les six mois, principalement en raison de $16,2 millions de frais de vente, généraux et administratifs et d'une augmentation des dépenses de R&D.
La société a souligné des avancées réglementaires et de pipeline : date cible PDUFA du 15 août 2025 pour TNX-102 SL sans réunion du comité consultatif de la FDA requise et avec la désignation Fast Track ; premier patient enrôlé dans une étude ASD/ASR en mai 2025 ; résultats topline positifs de la phase 1 pour TNX-1500 soutenant un programme de phase 2 en transplantation rénale ; et un contrat DTRA pouvant atteindre $34,1 millions pour TNX-4200, avec $2,0 millions de subventions reconnus depuis le début de l'année. La direction a fait état de doutes substantiels quant à la continuité d'exploitation, tout en précisant que la trésorerie, complétée par des levées de fonds ultérieures, devrait financer les opérations jusqu'au troisième trimestre 2026.
Tonix Pharmaceuticals (TNXP) meldete zum 30. Juni 2025 Zahlungsmittel und Zahlungsmitteläquivalente in Höhe von $125,3 Millionen, Gesamtvermögen von $187,4 Millionen und Eigenkapital von $168,0 Millionen. Das Working Capital betrug rund $124,5 Millionen, das kumulierte Defizit etwa $775,8 Millionen. Die Produktumsätze beliefen sich im Quartal auf $2,0 Millionen (gegenüber $2,2 Millionen im Vorjahr) und in den sechs Monaten auf $4,4 Millionen (gegenüber $4,7 Millionen). Das Unternehmen wies einen Nettoverlust von $28,3 Millionen für das Quartal und $45,1 Millionen für die sechs Monate aus, bedingt durch $16,2 Millionen an Vertriebs-, Verwaltungs- und Gemeinkosten sowie erhöhte F&E-Aufwendungen.
Das Unternehmen hob regulatorische und Pipeline-Fortschritte hervor: PDUFA-Zieldatum 15. August 2025 für TNX-102 SL ohne erforderliche FDA-Beratungsausschusssitzung und mit Fast-Track-Status; erster Patient in einer ASD/ASR-Studie im Mai 2025 eingeschrieben; positive Phase‑1-Topline-Daten für TNX-1500, die ein Phase‑2-Programm für Nierentransplantationen stützen; sowie ein DTRA-Vertrag über bis zu $34,1 Millionen für TNX-4200 mit bislang anerkannten Zuschuss-Erlösen in Höhe von $2,0 Millionen. Das Management äußerte erhebliche Zweifel an der Fortführungsfähigkeit, obwohl es anmerkte, dass Barmittel zuzüglich nachfolgender Eigenkapitalzuflüsse voraussichtlich die Aktivitäten bis ins dritte Quartal 2026 finanzieren sollen.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended
or
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Transition Period from _________ to _________
Commission file number:
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |||
| (Address of Principal Executive Offices) | (Zip Code) |
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||
Indicate by check mark whether the registrant (1)
has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
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| Large accelerated filer | ☐ | Accelerated filer | ☐ | |
| ☒ | Smaller reporting company | |||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13 (a) of the Exchange Act. ☐
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As of August 11, 2025, there were
TONIX PHARMACEUTICALS HOLDING CORP.
INDEX
| PART I. | FINANCIAL INFORMATION | |||
| ITEM 1. | Financial Statements | |||
| Condensed consolidated balance sheets as of June 30, 2025 (unaudited) and December 31, 2024 | 1 | |||
| Condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024 (unaudited) | 2 | |||
| Condensed consolidated statements of comprehensive loss for the three and six months ended June 30, 2025 and 2024 (unaudited) | 3 | |||
| Condensed consolidated statements of stockholders’ equity for three and the six months ended June 30, 2025 and 2024 (unaudited) | 4-5 | |||
| Condensed consolidated statements of cash flows for the six months ended June 30, 2025 and 2024 (unaudited) | 6 | |||
| Notes to condensed consolidated financial statements (unaudited) | 8-29 | |||
| ITEM 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 30 | ||
| ITEM 3. | Quantitative and Qualitative Disclosures about Market Risk | 42 | ||
| ITEM 4. | Controls and Procedures | 42 | ||
| PART II. | OTHER INFORMATION | |||
| ITEM 1. | Legal Proceedings | 42 | ||
| ITEM 1A. | Risk Factors | 42 | ||
| ITEM 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 42 | ||
| ITEM 3. | Defaults Upon Senior Securities | 43 | ||
| ITEM 4. | Mine Safety Disclosures | 43 | ||
| ITEM 5. | Other Information | 43 | ||
| ITEM 6. | Exhibits | 43 | ||
| 43 | ||||
| SIGNATURES | 46 | |||
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Par Value and Share Amounts) (unaudited)
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable, net | ||||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Intangible assets, net | ||||||||
| Operating lease right-to-use assets | ||||||||
| Other non-current assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses and other current liabilities | ||||||||
| Term loan payable, short term | — | |||||||
| Lease liability, short term | ||||||||
| Total current liabilities | ||||||||
| Term loan payable, long term | — | |||||||
| Lease liability, long term | ||||||||
| Total liabilities | ||||||||
| Commitments (See Note 16) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $ |
— | — | ||||||
| Common stock, $ |
||||||||
| Additional paid in capital | ||||||||
| Accumulated deficit | ( |
) | ( |
) | ||||
| Accumulated other comprehensive loss | ( |
) | ( |
) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See the accompanying notes to the condensed consolidated financial statements
| 1 |
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
| Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| REVENUE: | ||||||||||||||||
| Product revenue, net | $ | $ | $ | $ | ||||||||||||
| COSTS AND EXPENSES: | ||||||||||||||||
| Cost of revenue | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling, general and administrative | ||||||||||||||||
| Asset impairment charges | – | – | ||||||||||||||
| Total operating expenses | ||||||||||||||||
| Operating loss | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Grant income | – | – | ||||||||||||||
| (Loss) gain on change in fair value of warrant liabilities | – | ( |
– | |||||||||||||
| Loss on extinguishment of debt | ( |
|||||||||||||||
| Interest income, net | ||||||||||||||||
| Other expense, net | ( |
( |
( |
( |
||||||||||||
| Net loss available to common stockholders | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| Net loss per common share, basic and diluted | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| Weighted average common shares outstanding, basic and diluted | ||||||||||||||||
See the accompanying notes to the condensed consolidated financial statements
| 2 |
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In Thousands)
(unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net loss | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Foreign currency translation loss | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Comprehensive loss | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
See the accompanying notes to the condensed consolidated financial statements
| 3 |
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
| Accumulated | ||||||||||||||||||||||||
| Additional | Other | |||||||||||||||||||||||
| Common stock | Paid in | Comprehensive | Accumulated | |||||||||||||||||||||
| Shares | Amount | Capital | Gain (loss) | Deficit | Total | |||||||||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
| Repurchase of common stock under share repurchase program including transactional expenses of $ |
( |
— | ( |
) | — | — | ( |
|||||||||||||||||
| Issuance of common stock under At-the-Market, net of transactional expenses of $ |
— | — | ||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | ||||||||||||||||||||
| Foreign currency transaction gain | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||
| Net loss | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||
| Balance, March 31, 2025 | ( |
) | ( |
) | ||||||||||||||||||||
| Repurchase of common stock under share repurchase program including transactional expenses of $ |
( |
— | ( |
) | — | — | ( |
|||||||||||||||||
| Issuance of common stock under At-the-Market, net of transactional expenses of $ |
— | — | ||||||||||||||||||||||
| Issuance of common stock for 2025 Lincoln Park Transaction commitment shares | — | — | — | |||||||||||||||||||||
| Stock-based compensation | — | — | — | — | ||||||||||||||||||||
| Foreign currency transaction gain | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||
| Net loss | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||
| Balance, June 30, 2025 | $ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
See the accompanying notes to the condensed consolidated financial statements
| 4 |
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
| Accumulated | ||||||||||||||||||||||||
| Additional | Other | |||||||||||||||||||||||
| Common stock | Paid in | Comprehensive | Accumulated | |||||||||||||||||||||
| Shares | Amount | Capital | Gain (loss) | Deficit | Total | |||||||||||||||||||
| Balance, December 31, 2023 | $ | — | $ | $ | ( |
) | $ | ( |
) | $ | ||||||||||||||
| Issuance of common stock upon exercise of prefunded common warrants | — | — | — | — | — | |||||||||||||||||||
| Fair value of warrants reclassified from liabilities to equity | — | — | — | — | ||||||||||||||||||||
| Employee stock purchase plan | — | — | — | |||||||||||||||||||||
| Stock-based compensation | — | — | — | — | ||||||||||||||||||||
| Foreign currency transaction gain | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||
| Net loss | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||
| Balance, March 31, 2024 | — | ( |
) | ( |
) | |||||||||||||||||||
| Issuance of common stock, net of transactional expenses of $ |
— | — | — | |||||||||||||||||||||
| Issuance of common stock upon exercise of prefunded common warrants | — | — | — | — | — | |||||||||||||||||||
| Fair value of warrants reclassified from equity to liabilities | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||
| Fair value of warrants reclassified from liabilities to equity | — | — | — | — | ||||||||||||||||||||
| Stock-based compensation | — | — | — | — | ||||||||||||||||||||
| Foreign currency transaction gain | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||
| Net loss | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||
| Balance, June 30, 2024 | $ | — | $ | $ | ( |
) | $ | ( |
) | $ | ||||||||||||||
See the accompanying notes to the condensed consolidated financial statements
| 5 |
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(unaudited)
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | ( |
) | $ | ( |
) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Asset impairment charges | — | |||||||
| Change in fair value of warrant liabilities | — | ( |
||||||
| Inventory write-off | ||||||||
| Amortization of debt discount | ||||||||
| Loss on extinguishment of debt | ||||||||
| Stock-based compensation | ||||||||
| Issuance costs from derivative instruments | — | |||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( |
|||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ( |
|||||||
| Accounts payable | ||||||||
| Lease liabilities and ROU asset, net | ( |
) | ( |
|||||
| Accrued expenses and other current liabilities | ( |
) | ||||||
| Net cash used in operating activities | ( |
) | ( |
) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Issuance of note |
( |
) | — | |||||
| Purchase of property and equipment | ( |
) | ( |
) | ||||
| Net cash used in investing activities | ( |
) | ( |
) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Purchase of a business | — | ( |
) | |||||
| Repurchase of common stock | ( |
— | ||||||
| Proceeds from ESPP | — | |||||||
| Payment of term loan | ( |
) | ( |
|||||
| Proceeds, net of $ |
||||||||
| Net cash provided by financing activities | ||||||||
| Effect of currency rate change on cash | ( |
) | ( |
) | ||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | ( |
) | ||||||
| Cash, cash equivalents and restricted cash beginning of the period | ||||||||
| Cash, cash equivalents and restricted cash end of period | $ | $ | ||||||
| Supplemental disclosures of cash flow information: | ||||||||
| Interest paid | $ | $ | ||||||
| Non-cash financing and investing activities: | ||||||||
| Issuance costs from derivative instruments | $ | — | ||||||
| Net ATM proceeds received after quarter-end | $ | $ | — | |||||
| Purchases of property and equipment included in accounts payable and accrued liabilities | $ | $ | ||||||
See the accompanying notes to the condensed consolidated financial statements
| 6 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 1 – BUSINESS
Tonix Pharmaceuticals Holding Corp. (“Tonix” or the “Company”), through its wholly owned subsidiary Tonix Pharmaceuticals, Inc. (“Tonix Sub”), and its wholly owned commercial subsidiary Tonix Medicines (“Tonix Medicines”), is a fully- integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges.
Tonix’s 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.
Tonix’s 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 from 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.
Tonix’s 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. Tonix has a contract
with the DoD’s Defense Threat Reduction Agency (“DTRA”) for up to $
The consolidated financial statements include the accounts of Tonix Pharmaceuticals Holding Corp. and its wholly owned subsidiaries, Tonix Sub, Krele LLC, Tonix Pharmaceuticals (Canada), Inc., Tonix Medicines, Inc., Jenner Institute LLC, Tonix R&D Center LLC, Tonix Pharma Holdings Limited and Tonix Pharma Limited (collectively, the “Company” or “Tonix”). All intercompany balances and transactions have been eliminated in consolidation.
Going Concern
The accompanying financial statements
have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of
assets and satisfaction of liabilities and commitments in the normal course of business. The Company has suffered recurring losses from
operations and negative cash flows from operating activities. At June 30, 2025, the Company had working capital of approximately $
The Company believes that its
cash resources at June 30, 2025 and the net proceeds of $
These factors raise substantial doubt about the Company’s ability to continue as a going concern. The Company continues 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, the Company may not be able to raise capital on terms acceptable to the Company, or at all. Without additional funds, it may be forced to delay, scale back or eliminate some or all of its 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, the Company’s ability to achieve development and commercialization goals will be adversely affected and the Company may be forced to cease operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
| 7 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES
Interim financial statements
The unaudited condensed consolidated interim financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included.
The condensed consolidated balance sheet as of December 31, 2024, contained herein has been derived from audited financial statements.
Operating results for the three and six months ended June 30, 2025 are not necessarily indicative of results that may be expected for the year ending December 31, 2025. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”) on March 18, 2025.
On February 5, 2025, the Company
effected a
Risks and uncertainties
The Company’s primary efforts are devoted to conducting research and development of innovative pharmaceutical and biological products to address public health challenges. The Company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future. Further, the Company now has commercial products available for sale, and generates revenue from the sale of its Zembrace SymTouch and Tosymra products, with no assurance that the Company will be able to generate sufficient cash flow to fund operations from its commercial products or products in development if and when approved. In addition, there can be no assurance that the Company’s research and development will be successfully completed or that any product will be approved or commercially viable.
Use of estimates
The preparation of financial statements in accordance with Generally Accepted Accounting Principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include, but are not limited to, impairments, provisions for product returns, coupons, rebates, chargebacks, discounts, allowances, inventory realization, the assumptions used in the fair value of stock-based compensation and other equity instruments, and the percent of completion of research and development contracts.
Segment Information and Concentrations
Operating segments are defined
as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker
(“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. The Company considers
its chief executive officer to be the Company’s CODM. The CODM manages its operations and allocates resources based on the Company’s
consolidated results and therefore operates as
| 8 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Segment revenue, profit or loss, significant segment expenses and other segment items - The accounting policies of the Company’s single operating and reportable segment are the same as those described in the summary of significant accounting policies. The Company’s method for measuring segment profitability includes net income (loss), which the CODM uses to assess performance and make decisions for resource allocation, consistent with the measurement principals for net income (loss) as reported on the Company’s consolidated statements of operations. The significant expenses regularly reviewed by the CODM are consistent with those reported on the Company’s consolidated statements of operations, and expenses are not regularly reviewed on a more disaggregated basis for purposes of assessing segment performance and deciding how to allocate resources.
The Company has two products that
each accounted for more than 10% of total revenues during the three and six months ended June 30, 2025, and 2024. These products collectively
accounted for
As of June 30, 2025, accounts
receivable from four customers accounted for
Cash, Cash Equivalents and Restricted Cash
The Company considers cash equivalents
to be those investments which are highly liquid, readily convertible to cash and have an original maturity of three months or less when
purchased. At June 30, 2025, and June 30, 2024, cash equivalents, which consisted of money market funds and other cash equivalents, amounted to approximately $
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows:
| June 30, 2025 |
June 30, 2024 |
|||||||
| (in thousands) | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Restricted cash | ||||||||
| Total | $ | $ | ||||||
| 9 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Accounts Receivable, net
Accounts receivable consists of amounts due from our wholesale and other third-party distributors and pharmacies and have standard payment terms that generally require payment within 30 to 90 days. For certain customers, the accounts receivable for the customer is net of cash discounts, chargebacks and customer rebates. We do not adjust our receivables for the effects of a significant financing component at contract inception if we expect to collect the receivables in one year or less from the time of sale. We provide reserves against accounts receivable for estimated losses that may result from a customer’s inability to pay. Amounts determined to be uncollectible are charged or written-off against the reserve.
As of June 30, 2025 and December 31, 2024, the Company did not have an allowance for credit losses, as the Company’s exposure to credit losses is de minimis. An allowance for credit losses is determined based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established over a longer period.
Concentration of Credit Risk
Financial instruments that potentially subject us to concentrations of credit risk include cash and cash equivalents, and receivables. We attempt to minimize the risks related to cash and cash equivalents by investing in money market accounts, and we have established guidelines related to credit ratings and maturities intended to safeguard principal balances and maintain liquidity. Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due to the variety of customers using our products, as well as their dispersion across different geographic areas.
We monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile. We continue to monitor these conditions and assess their possible impact on our business.
Inventories
Inventories are recorded at the
lower of cost or net realizable value, with cost determined by the weighted average cost method. Acquired inventory was valued at estimated
selling price less a reasonable margin. The Company periodically reviews the composition of inventory in order to identify excess, obsolete,
slow-moving or otherwise non-saleable items taking into account anticipated future sales compared with quantities on hand, and the remaining
shelf life of goods on hand. If non-saleable items are observed and there are no alternate uses for the inventory, the Company records
a write-down to net realizable value in the period that the decline in value is first recognized. During the three months ended June 30,
2025 and 2024, the Company recorded write-downs related to Tosymra and Zembrace finished goods inventory of approximately $
Property and equipment
Property and equipment are stated
at cost, less accumulated depreciation. Depreciation and amortization is calculated using the straight-line method over the asset’s
estimated useful life, which ranges from
Intangible assets, net
Intangible assets deemed to have finite lives are carried at acquisition-date fair value less accumulated amortization and impairment, if any. Finite-lived intangible assets consisted of developed technology intangible assets acquired in connection with the acquisition of certain products from Upsher Smith Laboratories, LLC (“Upsher Smith”) consummated on June 30, 2023 (See Note 5). The acquired intangible assets were amortized using the straight-line method over the estimated useful lives of the respective assets.
| 10 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Amortization expense for the three
and six months ended June 30, 2024, was $
Impairment testing of long-lived assets
The Company evaluates long-lived assets for impairment, including property
and equipment, finite-lived intangibles assets and operating lease right-to-use assets whenever events or changes in circumstances indicate
that their net book value may not be recoverable. When such factors and circumstances exist, the Company compares the projected undiscounted
future cash flows associated with the related asset or group of assets over their estimated useful lives against their respective carrying
amount. Impairment, if any, is based on the excess of the carrying amount over the fair value, based on market value when available, or
discounted expected cash flows, of those assets and is recorded in the period in which the determination is made. For the six months ended
June 30, 2025, the Company concluded that
During the three months ended
June 30, 2024, the Company identified certain triggering events related to its decommissioned Advance Development Center in Dartmouth, Massachusetts (“ADC”). The Company determined
that the carrying value of the ADC was not recoverable and that the carrying value exceeded its fair value. As such, the Company recorded
a non-cash impairment charge of $
Additionally, due to a sustained
decline in revenues and continued delays in building out the sales team for its commercialized products, the Company also tested its commercialized
products asset group for recoverability as of June 30, 2024. The Company determined that the carrying value was not recoverable and therefore
estimated the fair value of the asset group using a discounted cash flow analysis. As the carrying value of the asset group significantly
exceeded its fair value, the Company recorded a full non-cash impairment charge of $
Goodwill
Goodwill represents the excess
of the aggregate purchase price over the fair value of the net tangible and intangible assets acquired in a business combination. Goodwill
is reviewed for impairment on an annual basis, or more frequently if events or changes in circumstances indicate that the carrying amount
of goodwill may be impaired. The Company previously recognized goodwill in connection with the USL Acquisition consummated on June 30,
2023 (See Note 5). The Company completed the required annual impairment test for goodwill as of June 30, 2024, which resulted in full
non-cash impairment of the Company’s $
Leases
The Company determines if an arrangement is, or contains, a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, operating lease liabilities, current and operating lease liabilities, noncurrent in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the transition date and subsequent lease commencement dates in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The operating lease ROU asset excludes lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments made under operating leases is recognized on a straight-line basis over the lease term.
| 11 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Deferred financing costs
Deferred financing costs represent the cost of obtaining financing arrangements and are amortized over the term of the related debt agreement using the effective interest method. Deferred financing costs related to term debt arrangements are reflected as a direct reduction of the related debt liability on the condensed consolidated balance sheet. Amortization of deferred financing costs are included in interest expense on the consolidated statements of operations.
Original issue discount
Certain term debt issued by the Company provides the debt holder with an original issue discount. Original issue discounts are reflected as a direct reduction of the related debt liability on the consolidated balance sheets and are amortized over the term of the related debt agreement using the effective interest method. Amortization of original issue discounts are included in interest expense on the consolidated statements of operations.
Revenue Recognition
The Company records and recognizes
revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration
to which the Company expects to be entitled in exchange for those goods or services. The Company’s revenues primarily result from
contracts with customers, which are generally short-term and have a single performance obligation - the delivery of product. The Company’s
performance obligation to deliver products is satisfied at the point in time that the goods are received by the customer, which is when
the customer obtains title to and has the risks and rewards of ownership of the products, which is generally upon shipment or delivery
to the customer as stipulated by the terms of the sale agreements. The transaction price is the amount of consideration to which the Company
expects to be entitled in exchange for transferring promised goods to a customer. The consideration promised in a contract with a customer
may include fixed amounts, variable amounts, or both. Our contractual payment terms are typically
Revenues from product sales, net of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not probable of occurring and when the uncertainty associated with gross-to-net deductions is subsequently resolved. Taxes assessed by governmental authorities and collected from customers are excluded from product sales. Shipping and handling activities are considered to be fulfillment activities and not a separate performance obligation.
Many of the Company’s products sold are subject to a variety of deductions. Revenues are recognized net of estimated rebates and chargebacks, cash discounts, distributor fees, sales return provisions and other related deductions. Deductions to product sales are referred to as gross-to-net deductions and are estimated and recorded in the period in which the related product sales occur. Accruals for these provisions are presented in the consolidated financial statements as reductions to gross sales in determining net sales, and as a contra asset within accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). Amounts recorded for revenue deductions can result from a complex series of judgements about future events and uncertainties and can rely heavily on estimates and assumptions. The following section briefly describes the nature of the Company’s provisions for variable consideration and how such provisions are estimated:
Chargebacks - The Company sells a portion of its products indirectly through wholesaler distributors, and enters into specific agreements with these indirect customers to establish pricing for the Company’s products, and in-turn, the indirect customers and entities independently purchase these products. Because the price paid by the indirect customers and/or entities is lower than the price paid by the wholesaler, the Company provides a credit, called a chargeback, to the wholesaler for the difference between the contractual price with the indirect customers and the wholesale customer’s purchase price. The Company’s provision for chargebacks is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler inventory levels as well as historical chargeback rates. The Company continually monitors its reserve for chargebacks and adjusts the reserve accordingly when expected chargebacks differ from actual experience.
| 12 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Rebates - The Company participates in certain government and specific sales rebate programs which provides discounted prescription drugs to qualified recipients, and primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, Tri-Care rebates and discounts, specialty pharmacy program fees and other governmental rebates or applicable allowances.
| ● | Managed Care Rebates are processed in the quarter following the quarter in which they are earned. The managed care reporting entity submits utilization data after the end of the quarter and the Company processes the payment in accordance with contract terms. All rebates earned but not paid are estimated by the Company according to historical payments trended for market growth assumptions. |
| ● | Medicaid and State Agency rebates are based upon historical experience of claims submitted by various states. The Company monitors Medicaid legislative changes to determine what impact such legislation may have on the provision for Medicaid rebates. The accrual of State Agency reserves is based on historical payment rates. There is an approximate three-month lag from the time of product sale until the rebate is paid. |
| ● | Tri-Care represents a regionally managed health care program for active duty and retired members, dependents and survivors of the US military. The Tri-Care program supplements health care resources of the US military with civilian health care professionals for greater access and quality healthcare coverage. Through the Tri-Care program, the Company provides pharmaceuticals on a direct customer basis. Prices of pharmaceuticals sold under the Tri-Care program are pre-negotiated and a reserve amount is established to represent the proportionate rebate amount associated with product sales. |
| ● | Coverage Gap refers to the Medicare prescription drug program and represents specifically the period between the initial Medicare Part D prescription drug program coverage limit and the catastrophic coverage threshold. Applicable pharmaceutical products sold during this coverage gap timeframe are discounted by the Company. Since the nature of the program is that coverage limits are reset at the beginning of the calendar year; the payments escalate each quarter as the participants reach the coverage limit before reaching the catastrophic coverage threshold. The Company has determined that the cost of this reserve will be viewed as an annual cost. Therefore, the accrual will be incurred evenly during the year with quarterly review of the liability based on payment trends and any revision to the projected annual cost. |
Prompt-Pay and other Sales Discounts - The Company provides for prompt pay discounts, which early payments are recorded as a reduction of revenue and as a reduction in the accounts receivable at the time of sale based on the customer’s contracted discount rate. Consumer sales discounts represent programs the Company has in place to reduce costs to the patient. This includes copay buy down and eVoucher programs.
Product Returns - Consistent with industry practice, the Company offers customers a right to return any unused product. The customer’s right of return commences typically six months prior to product expiration date and ends one year after product expiration date. Products returned for expiration are reimbursed at current wholesale acquisition cost or indirect contract price. The Company estimates the amount of its product sales that may be returned by the Company’s customers and accrues this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company estimates products returns as a percentage of sales to its customers. The rate is estimated by using historical sales information, including its visibility and estimates into the inventory remaining in the distribution channel. Adjustments are made to the current provision for returns when data suggests product returns may differ from original estimates.
Research and Development Costs
The Company outsources certain of its research and development efforts and expenses these costs as incurred, including the cost of manufacturing products for testing, as well as licensing fees and costs associated with planning and conducting clinical trials. The value ascribed to patents and other intellectual property acquired has been expensed as research and development costs, as such property is related to particular research and development projects and had no alternative future uses.
The Company estimates its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials.
| 13 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company accounts for trial expenses according to the timing of various aspects of the trial. The Company determines accrual estimates taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed.
During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors.
Government Grants
From time to time, the Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities included in the grant application approved by the government authority and, in certain arrangements. U.S. GAAP does not have specific accounting standards covering government grants to business entities. The Company applies International Accounting Standards 20 (“IAS 20”), Accounting for Government Grants and Disclosure of Government Assistance by analogy when accounting for government grants. Under IAS 20, government grants are initially recognized when there is reasonable assurance the conditions of the grant will be met and the grant will be received. After initial recognition, government grants received are recognized in earnings in the same period the underlying costs for which the grant is intended to compensate are incurred. The Company classifies government grants received under these arrangements as either a reduction to the related research and development expense or as grant income in the consolidated statements of operations, depending on the fee structure of the arrangement. The Company also applies the disclosure requirements of ASC 832, Government Assistance.
In August 2022, the Company
received a Cooperative Agreement grant from the National Institute on Drug Abuse (“NIDA”), part of the National Institutes
of Health, to support the development of its TNX-1300 product candidate for the treatment of cocaine intoxication. During the three and six months
ended June 30, 2025, the Company recorded $
In June 2024, the Company
was awarded a prototype Other Transaction Agreement from the Defense Threat Reduction Agency (“DTRA”), an agency within the
U.S. Department of Defense, to fund the Company’s TNX-4200 program for the development of a small molecule broad-spectrum antiviral
for the prevention or treatment of viral infections to improve the medical readiness of military personnel in biological threat environments.
The DTRA grant provides for payments totaling up to $
Stock-based Compensation.
All stock-based payments to employees and to nonemployees for their services, including grants of restricted stock units (“RSUs”), and stock options, are measured at fair value on the grant date and recognized in the consolidated statements of operations as compensation expense over the requisite service period. The Company accounts for share-based awards in accordance with the provisions of the Accounting Standards Codification (“ASC”) 718, Compensation – Stock Compensation.
Foreign Currency Translation
Operations of the Company’s Canadian subsidiary, Tonix Pharmaceuticals (Canada), Inc., are conducted in local currency, which represents its functional currency. The U.S. dollar is the functional currency of the other foreign subsidiaries. Balance sheet accounts of the Canadian subsidiary were translated from foreign currency into U.S. dollars at the exchange rate in effect at the balance sheet date and income statement accounts were translated at the average rate of exchange prevailing during the period. Translation adjustments resulting from this process were included in accumulated other comprehensive loss on the consolidated balance sheets.
Comprehensive Income (Loss)
Comprehensive income (loss) is defined as the change in equity of a business during a period from transactions and other events and circumstances from non-owners sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions to owners. Other comprehensive income (loss) represents foreign currency translation adjustments.
| 14 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Income Taxes
Deferred income tax assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured at the current enacted tax rates. The Company records a valuation allowance on its deferred income tax assets if it is not more likely than not that these deferred income tax assets will be realized.
The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. As of June 30, 2025, the Company has not recorded any unrecognized tax benefits. The Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The Company is currently assessing the impact on its condensed consolidated financial statements.
Derivative Instruments and Warrant Liabilities
The Company evaluates all of its financial instruments, including issued warrants to purchase common stock under ASC 815 – Derivatives and Hedging, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives (See Note 13). For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the consolidated statements of operations. The Company uses the Black-Scholes option pricing model to value the derivative instruments at inception and subsequent valuation dates, which is adjusted for instrument-specific terms as applicable.
From time to time, certain equity-linked instruments may be classified as derivative liabilities due to the variable exercise price of the shares to fully settle the equity-linked financial instruments in shares. In such case, the Company has 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.
In the event that reclassification of contracts between equity and assets or liabilities is necessary, the Company first allocates remaining authorized shares to equity on the basis of 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 to equity beginning with instruments with the latest maturity date first.
The classification of derivative
instruments is reassessed at each reporting date. If the classification changes as a result of events during a reporting period, the instrument
is reclassified as of the date of the event that caused the reclassification. There is no limit on the number of times a contract may
be reclassified. During the three and six months ended June 30, 2025, the Company recorded
$
The Company evaluated the contract that includes the right to require Lincoln Park to purchase shares of Common Stock in the future (“purchased put right”) considering the guidance in ASC 815-40, and concluded that it is an equity-linked contract that does not qualify for equity classification, and therefore requires fair value accounting as a derivative asset (liability). The Company has analyzed the terms of the purchased put right and has concluded that it had insignificant value as of June 30, 2025.
Per Share Data
The computation of basic and diluted loss per share for the quarters ended June 30, 2025 and 2024 excludes potentially dilutive securities when their inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during the period.
All warrants issued participate on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the Board of Directors, on the Company’s common stock. For purposes of computing EPS, these warrants are considered to participate with common stock in earnings of the Company. Therefore, the Company calculates basic and diluted EPS using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders and participating securities according to dividends declared and participation rights in undistributed earnings. Prefunded warrants are assumed exercised on date of issuance and are included in the basic EPS calculation. No income was allocated to the warrants for the three and six months ended June 30, 2025, and 2024, as results of operations were a loss for the periods.
| 15 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Potentially dilutive securities excluded from the computation of basic and diluted net loss per share, as of June 30, 2025 and 2024, are as follows:
| 2025 | 2024 | |||||||
| Warrants to purchase common stock | ||||||||
| Options to purchase common stock | ||||||||
| Totals | ||||||||
Recently Adopted and Issued Accounting Pronouncements
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires entities to disclose disaggregated information about their effective tax rate reconciliations as well as expanded information on income taxes by jurisdiction. The standard is effective for fiscal years beginning after December 15, 2024 on a prospective basis. The Company discloses its income tax rate reconciliation in its annual consolidated financial statements only and does not expect the adoption to have a material impact on its consolidated financial statements.
Recently Issued Accounting Pronouncements
In March 2024, the SEC adopted new rules relating to the disclosure of a range of climate-change-related physical and transition risks, data, and opportunities. The adopted rule contains several new disclosure obligations, including, (i) disclosure on how the board of directors and management oversee climate-related risks and certain climate-related governance items, (ii) disclosure of information related to a registrant’s climate-related targets, goals, and/or transition plans, and (iii) disclosure on whether and how climate-related events and transition activities impact line items above a threshold amount on a registrant’s consolidated financial statements, including the impact of the financial estimates and the assumptions used. This new rule will first be effective in the Company’s disclosures for the year ending December 31, 2027. The Company is in the process of assessing the impact on our consolidated financial statements and disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, to improve transparency in financial reporting by requiring entities to present more detailed information about the nature of expenses included within the Income Statement. The guidance will first be effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is in the process of assessing the impact of ASU 2024-03 on our financial statements.
| 16 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 3 – INVENTORY
The components of inventory consisted of the following (in thousands):
| June 30,
2025 |
December 31,
2024 |
|||||||
| (in thousands) | ||||||||
| Raw Materials | $ | $ | ||||||
| Work-in-process | ||||||||
| Finished Goods | ||||||||
| Total Inventory | $ | $ | ||||||
NOTE 4 – PROPERTY AND EQUIPMENT, NET
Property and equipment, net consisted of the following (in thousands):
| June 30, 2025 |
December 31, 2024 |
|||||||
| (in thousands) | ||||||||
| Property and equipment, net: | ||||||||
| Land | $ | $ | ||||||
| Land improvements | ||||||||
| Buildings | ||||||||
| Office furniture and equipment | ||||||||
| Laboratory equipment | ||||||||
| Leasehold improvements | ||||||||
| Property and equipment gross | ||||||||
| Less: Accumulated depreciation and amortization | ( |
) | ( |
) | ||||
| Property and equipment, net | $ | $ | ||||||
NOTE 5 – GOODWILL AND INTANGIBLE ASSETS
The following table provides the gross carrying amount and accumulated amortization for each major class of intangible asset:
| June 30,
2025 |
December 31,
2024 |
|||||||
| (in thousands) | ||||||||
| Intangible assets subject to amortization | ||||||||
| Developed technology | $ | — | $ | |||||
| Less: Impairment charge | — | |||||||
| Less: Accumulated amortization | — | |||||||
| Total | $ | — | $ | — | ||||
| Intangible assets not subject to amortization Internet domain rights | $ | $ | ||||||
| Total intangible assets, net | $ | $ | ||||||
| 17 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 6 – FAIR VALUE MEASUREMENTS
Fair value measurements affect the Company’s accounting for certain of its financial assets. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date and is measured according to a hierarchy that includes:
| Level 1: | Observable inputs, such as quoted prices in active markets. |
| Level 2: | Inputs, other than quoted prices in active markets, that are observable either directly or indirectly. Level 2 assets and liabilities include debt securities with quoted market prices that are traded less frequently than exchange-traded instruments. This category includes U.S. government agency-backed debt securities and corporate-debt securities. |
| Level 3: | Unobservable inputs in which there is little or no market data. |
As of June 30, 2025, and December
31, 2024, the Company used Level 1 quoted prices in active markets to value cash equivalents of $
The Company used the Black-Scholes
option pricing model to estimate the fair value of the Series D Warrants and the Series C Warrants using significant unobservable inputs,
which represent Level 3 measurements within the fair value hierarchy. For periods prior to the receipt of stockholder approval, the fair
value was then adjusted by applying a discount for lack of marketability (“DLOM”) based on the expected timing of receipt
of stockholder approval to increase the number of authorized shares and to allow the Warrants to become exercisable in accordance with
Nasdaq Listing Rule 5635. Additionally, between April 1, 2024 and May 22, 2024, Level 3 liabilities included a portion of the Company’s
outstanding August 2023 Warrants, Series A Warrants, Series B Warrants, Series C Warrants, and Series D Warrants (collectively, the “Existing
Warrants”), as a result of certain Warrant Amendments entered into upon the closing of an equity financing on April 1, 2024, which
provided for adjustments to the exercise prices of the Existing Warrants, contingent on approval by the Company’s stockholders of
a proposal to allow the Existing Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635. The Company determined that
the exercise price adjustment provision that is contingent on stockholder approval precluded the Existing Warrants from being indexed
to the Company’s own stock, and therefore were reclassified to liabilities at post-modification fair value on April 1, 2024. After
the Company received stockholder approval on May 22, 2024, thereby reducing the exercise prices of each of the Existing Warrants to $
The following table summarizes the range of significant assumptions used in determining the fair value of liability-classified warrants on the respective reclassification dates for the three and six months ended June 30, 2024:
| Three months ended | Six months ended | ||||||
| June 30, 2024 | June 30, 2024 | ||||||
| Common stock price | $ | $ | |||||
| Risk-free rate | |||||||
| Expected term (in years) | |||||||
| Expected volatility | |||||||
| Discount for lack of marketability | N/A | N/A | |||||
| 18 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
A reconciliation of the beginning and ending balances for the liability-classified warrants measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows for the three and six months ended June 30, 2024:
| Warrant liabilities | ||||
| Balance at December 31, 2023 | $ | |||
| Fair value - mark to market adjustment | ( |
) | ||
| Warrants reclassified from liabilities to equity | ( |
) | ||
| Balance at March 31, 2024 | $ | — | ||
| Warrants reclassified from equity to liabilities | ||||
| Fair value - mark to market adjustment | ||||
| Warrants reclassified from liabilities to equity | ( |
) | ||
| Balance at June 30, 2024 | $ | — | ||
For the three and six months ended June 30, 2024, the Company 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.
There were no liability-classified warrants measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the three or six months ended June 30, 2025. Changes in the fair value of the liability-classified warrants are recognized as a separate component in the consolidated statement of operations.
| 19 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 7 – OTHER BALANCE SHEET INFORMATION
Components of selected captions in the consolidated balance sheets consist of:
| June 30, 2025 |
December 31, 2024 |
|||||||
| Prepaid expenses and other current assets: | (in thousands) | |||||||
| Contract-related | $ | $ | ||||||
| Government grants | ||||||||
| At-the-market receivable | ||||||||
| Non-trade receivables | ||||||||
| Debt interest and fees | — | |||||||
| Insurance | ||||||||
| Other | ||||||||
| $ | $ | |||||||
| Accrued expenses and other current liabilities: | ||||||||
| Contract-related | $ | $ | ||||||
| Compensation and compensation-related | ||||||||
| Gross-to-net deductions | ||||||||
| Professional fees and other | ||||||||
| $ | $ | |||||||
NOTE 8 – DEBT FINANCING
Long-term debt consists of the following:
| June 30, 2025 |
December 31, 2024 |
|||||||
| Term Loan | $ | — | $ | |||||
| Less: current portion | — | ( |
) | |||||
| Total long-term debt | — | |||||||
| Less: unamortized debt discount and deferred financing costs | — | ( |
) | |||||
| Total long-term debt, net | $ | — | $ | |||||
On
December 8, 2023, the Company entered into a Loan and Guaranty Agreement (the “Loan Agreement”) by and among the Company,
Krele LLC, Tonix Pharmaceuticals, Inc., Jenner and Tonix R&D Center (collectively, the “Loan Parties”), with JGB Capital,
LP, JGB Partners, LP, JGB (Cayman) Port Ellen Ltd., and any other lender from time to time party hereto (collectively, the “Lenders”),
and JGB Collateral LLC, as administrative agent and collateral agent for the Lenders (in such capacity, “JGB Agent”) for
a
Borrowings under the Term Loan
carried interest at a fluctuating rate equal to the greater of (i) the prime rate as defined in the Loan Agreement plus
| 20 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Commencing on
The Loan Agreement provided for voluntary prepayments of the Term Loan, in whole or in part, subject to a prepayment premium. The Term Loan was secured by first priority security interests in the Company’s R&D Center in Frederick, Maryland, the Advanced Development Center in North Dartmouth, Massachusetts, and substantially all of the relevant deposit accounts.
During the first
quarter of 2025, the Company paid $
NOTE 9 – STOCKHOLDERS’ EQUITY
On February 5, 2025, the Company
effected a
On February 20, 2025,
the Company received a letter from The NASDAQ Stock Market LLC stating that because the Company’s shares had a closing bid price
at or above $
NOTE 10 – REVENUES
Disaggregation of Net Revenues
The Company’s net product revenues are summarized below:
|
Three months ended June 30, |
||||||
| 2025 | 2024 | |||||
| Zembrace Symtouch | $ | $ | ||||
| Tosymra | ||||||
| Total product revenues | $ | $ | ||||
|
Six months ended June 30, | ||||||
| 2025 | 2024 | |||||
| Zembrace Symtouch | $ | $ | ||||
| Tosymra | ||||||
| Total product revenues | $ | $ | ||||
Gross-to-Net Sales Accruals
We record gross-to-net sales accruals for chargebacks, rebates, sales and other discounts, and product returns, which are all customary to the pharmaceutical industry.
| 21 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Our provision for gross-to-net
allowances was $
NOTE 11 – ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH
On June 30, 2023, the Company
completed the acquisition of certain assets from Upsher Smith related to Zembrace SymTouch (sumatriptan injection) 3 mg (“Zembrace”)
and Tosymra (sumatriptan nasal spray) 10 mg (“Tosymra”) products (such businesses collectively, the “Business”)
and certain inventory related to the Business for an aggregate purchase price of approximately $
The Company
has 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,
For Zembrace,
royalty payments on annual net sales in the U.S. are
In addition,
the Company has assumed the obligation to pay an additional
NOTE 12 – SALE AND PURCHASE OF COMMON STOCK
2025 Lincoln Park Transaction
On June 11, 2025, the Company
entered into a purchase agreement (the “2025 Purchase Agreement”) and a registration rights agreement (the “2025 Registration
Rights Agreement”) with Lincoln Park. Pursuant to the terms of the 2025 Purchase
Agreement, Lincoln Park has agreed to purchase from the Company up to $
Pursuant to the terms
of the 2025 Purchase Agreement, at the time the Company signed the 2025 Purchase Agreement and the 2025 Registration Rights
Agreement, the Company issued
The Company evaluated the 2025 Purchase Agreement under ASC 815-40 Derivatives and Hedging-Contracts on an Entity's Own Equity as it represents the right to require Lincoln Park to purchase shares of common stock in the future, similar to a put option. The Company concluded that the 2025 Purchase Agreement represents a freestanding derivative instrument that does not qualify for equity classification and therefore requires fair value accounting. The Company analyzed the terms of the contract and concluded that the derivative instrument had insignificant value as of June 30, 2025.
| 22 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
2025 At-the-Market Offerings
On June 11, 2025, the Company
entered into a Sales Agreement (the “2025 Sales Agreement”), with A.G.P./Alliance Global Partners (“AGP”) pursuant
to which the Company may issue and sell, from time to time, shares of common stock having an aggregate offering price of up to $
2024 At-the-Market Offerings
On July 30, 2024, the Company
entered into a Sales Agreement (the “2024 Sales Agreement”), with AGP pursuant
to which the Company may issue and sell, from time to time, shares of common stock having an aggregate offering price of up to $
June 2024 Financings
On June 12, 2024, the Company
entered into a securities purchase agreement with certain investors, pursuant to which the Company sold
The offering closed on June 13,
2024. The Company incurred offering expenses of approximately $
On June 27, 2024, the Company
entered into a securities purchase agreement with certain institutional and retail investors, pursuant to which the Company sold
The offering closed on June 28,
2024. The Company incurred offering expenses of approximately $
March 2024 Financing
On March 28, 2024, the Company
entered into an agreement to sell
The Company incurred expenses
of approximately $
| 23 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Additionally, with the closing
of the financing on April 1, 2024, the Company entered into warrant amendments (collectively, the “Warrant Amendments”) with
certain holders of its common warrants (referred to herein as the “Existing Warrants”). The Company agreed to amend the exercise
price of each Existing Warrant to $
The Company evaluated the Warrant
Amendments as of April 1, 2024, and determined that the potential adjustment to the exercise price that is contingent on stockholder approval
precluded the Existing Warrants from being indexed to the Company’s own stock, and as a result, did not meet the criteria for equity
classification under ASC 815-40. The Company accounted for the incremental fair value of the Warrant Amendments of $
December 2023 Financing
On December 20, 2023, the Company
entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional investors, pursuant to
which the Company sold and issued (i)
The Pre-Funded Warrants have an
exercise price of $
Upon the closing of the offering,
the Company 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. The Company has 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, the Company determined that the authorized
shares were sufficient to settle all remaining Pre-Funded Warrants and
| 24 |
The $
On January 25, 2024, the date
the Company’s stockholders approved the proposal to file an amendment to the Company’s Articles of Incorporation to increase
the number of authorized shares of common stock from
The liability-classified Series D Warrants and all of the Series C Warrants were presented within non-current liabilities on the consolidated balance sheets as of December 31, 2023, and were adjusted to fair value through January 25, 2024, when the warrants were reclassified to equity. Changes in the fair value of the liability-classified warrants were recognized as a separate component in the consolidated statement of operations.
Stock repurchases
In September 2024,
the Board of Directors approved a 2024 share repurchase program pursuant to which the Company may repurchase up
to $
The Company repurchased the following capital stock:
| Three Months Ended June 30, 2025 |
Three Months Ended June 30, 2024 |
|||||||
| Total cost of repurchased shares (in thousands) | $ | $ | — | |||||
| Shares repurchased | — | |||||||
| Weighted average price per share | $ | — | ||||||
During the six
months ended June 30, 2025, the Company repurchased
The Company repurchased the following capital stock:
| Six Months Ended
June 30, 2025 |
Six Months Ended June 30, 2024 |
|||||||
| Total cost of repurchased shares (in thousands) | $ | $ | — | |||||
| Shares repurchased | — | |||||||
| Weighted average price per share | $ | — | ||||||
The timing and amount of any shares repurchased will be determined based on the Company’s evaluation of market conditions and other factors and the New Share Repurchase Program may be discontinued or suspended at any time. Repurchases will be made in accordance with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements to which the Company may be subject. Repurchases may be made, in part, under a Rule 10b5-1 plan, which allows stock repurchases when the Company might otherwise be precluded from doing so.
| 25 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 13 – STOCK-BASED COMPENSATION
On May 1, 2020, the Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive Plan (“Amended and Restated 2020 Plan”).
Under the terms of the Amended
and Restated 2020 Plan, the Company 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 Amended and Restated 2020 Plan initially
provided for the issuance of up to 50,000 shares of common stock, which amount will be increased to the extent that awards granted
under the Plans are forfeited, expire or are settled for cash (except as otherwise provided in the Amended and Restated 2020 Plan). In
addition, the Amended and Restated 2020 Plan contains an “evergreen provision” providing for an annual increase in the number
of shares of our common stock available for issuance under the Amended and Restated 2020 Plan on January 1 of each year for a period of
ten years, commencing on January 1, 2021 and ending on (and including) January 1, 2030, in an amount equal to the difference between (x)
twenty percent (
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
General
A summary of the stock option activity and related information for the Plans for the six months ended June 30, 2025, is as follows:
| Shares | Weighted-
Average Exercise Price |
Weighted-Average
Remaining Contractual Term |
Aggregate Intrinsic Value |
|||||||||||||
| Outstanding at December 31, 2024 | $ | $ | — | |||||||||||||
| Grants | ||||||||||||||||
| Exercised | — | — | ||||||||||||||
| Forfeitures or expirations | ( |
) | ||||||||||||||
| Outstanding at June 30, 2025 | $ | $ | ||||||||||||||
| Exercisable at June 30, 2025 | $ | $ | ||||||||||||||
The aggregate intrinsic value in the preceding table represents the total pretax intrinsic value, based on options with an exercise price less than the Company’s closing stock price at the respective dates.
The weighted average
fair value of options granted during the three and six months ended June 30, 2025 was $
| 26 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
The Company measures the
fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions discussed
below, and the closing market price of the Company’s common stock on the date of the grant. The fair value of the award is measured
on the grant date. One-third of most stock options granted pursuant to the Plans vest 12 months from the date of grant and 1/36th each
month thereafter for 24 months and expire
The assumptions used in the valuation of stock options granted during the six months ended June 30, 2025, and 2024 were as follows:
| Six Months Ended
June 30, 2025 |
Six Months Ended
June 30, 2024 |
|||||||
| Risk-free interest rate | % | % | ||||||
| Expected term of option | ||||||||
| Expected stock price volatility | % | % | ||||||
| Expected dividend yield | ||||||||
The risk-free interest rate is based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of the options as of the grant date. The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting Bulletin, and the expected stock price volatility is based on the Company’ historical stock price volatility.
Stock-based compensation expense
relating to options granted of $
Stock-based compensation expense
relating to options granted of $
As of June 30, 2025, the Company
had approximately $
Employee Stock Purchase Plans
On May 5, 2023, the Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2023 Employee Stock Purchase Plan. (the “2023 ESPP”), which was replaced by the Tonix Pharmaceuticals Holdings Corp. 2025 Employee Stock Purchase Plan (the “2025 ESPP”, and together with the 2023 ESPP, the “ESPP Plans”), which was approved by the Company’s stockholders on May 8, 2025.
The 2025 ESPP allows eligible
employees to purchase up to an aggregate of
| 27 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED
The 2023 ESPP allows eligible
employees to purchase up to an aggregate of
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, $
NOTE 14 – WARRANTS TO PURCHASE COMMON STOCK
The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at June 30, 2025:
| Exercise | Number | Expiration | ||||
| Price | Outstanding | Date | ||||
| $ | ||||||
| $ | ||||||
| $ | ||||||
| $ | ||||||
| $ | ||||||
| $ | ||||||
| $ | ||||||
During the six months
ended June 30, 2025,
During the six months ended June
30, 2024,
NOTE 15 – LEASES
The Company has various operating lease agreements, which are primarily for office space. These agreements frequently include one or more renewal options and require the Company to pay for utilities, taxes, insurance and maintenance expense. No lease agreement imposes a restriction on the Company’s ability to engage in financing transactions or enter into further lease agreements. At June 30, 2025, the Company has right-of-use assets of $0.5 million and a total lease liability for operating leases of $0.5 million of which $0.3 million is included in long-term lease liabilities and $0.2 million is included in current lease liabilities.
At June 30, 2025, future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands):
| Year Ending December 31, | |||||
| Remainder of 2025 | $ | ||||
| 2026 | |||||
| 2027 | |||||
| 2028 | |||||
| 2029 | |||||
| Included interest | ( |
) | |||
| $ | |||||
| 28 |
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
No new leases or amendments were entered into during the six months ended June 30, 2025 and 2024.
Operating lease expense was $
Operating lease expense was $
Other information related to leases is as follows:
| Cash paid for amounts included in the measurement of lease liabilities: | Six Months Ended June 30, 2025 |
Six Months Ended June 30, 2024 |
||||||
| Operating cash flow from operating leases (in thousands) | $ | $ | ||||||
| Weighted Average Remaining Lease Term | ||||||||
| Operating leases | ||||||||
| Weighted Average Discount Rate | ||||||||
| Operating leases | ||||||||
NOTE 16 – COMMITMENTS
Contractual agreements
The Company has entered into contracts
with various contract research organizations with outstanding commitments aggregating approximately $
Defined contribution plan
The Company established a qualified
defined contribution plan (the “401(k) Plan”) pursuant to Section 401(k) of the Code, whereby all eligible employees may participate.
Participants may elect to defer a percentage of their annual pretax compensation to the 401(k) Plan, subject to defined limitations. The
Company is required to make contributions to the 401(k) Plan equal to
NOTE 17 – SUBSEQUENT EVENTS
Subsequent to June 30, 2025, the
Company sold
Subsequent to June 30, 2025, the
Company sold
| 29 |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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 its 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.
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.
Business Overview
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.
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.
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.
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.
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.
All of our product candidates are investigational new drugs or biologics and have not been approved for any indication.
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.
Zembrace, SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are the property of their respective owners.
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Results of Operations
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.
Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024
The following table sets forth our operating expenses for the quarter ended June 30, 2025 and 2024 (in thousands):
| Three months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| REVENUE | ||||||||
| Product revenue, net | $ | 1,998 | $ | 2,208 | ||||
| COSTS AND EXPENSES: | ||||||||
| Cost of sales | 3,272 | 3,367 | ||||||
| Research and development | 10,820 | 9,698 | ||||||
| Selling, general and administrative | 16,202 | 7,502 | ||||||
| Asset impairment charges | - | 58,957 | ||||||
| Total operating expenses | 30,294 | 79,524 | ||||||
| Operating loss | (28,296 | ) | (77,316 | ) | ||||
| Grant income | 1,036 | - | ||||||
| Loss on change in fair value of warrant liabilities | - | (855) | ||||||
| Interest income, net | 943 | 1 | ||||||
| Other expense, net | (1,955 | ) | (606) | |||||
| Net loss | $ | (28,272 | ) | $ | (78,776 | ) | ||
Revenues. Revenue recognized for the three months ended June 30, 2025 and 2024, was $2.0 million and $2.2 million, respectively.
The Company’s net product revenues are summarized below:
| Three months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Zembrace Symtouch | $ | 1,570 | $ | 1,727 | ||||
| Tosymra | 428 | 481 | ||||||
| Total product revenues | $ | 1,998 | $ | 2,208 | ||||
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.
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.
The table below summarizes our direct research and development expenses for our product candidates and development platform for the three months ended June 30, 2025, and 2024.
| Three Months Ended June 30, | ||||||||||||
| (in thousands) | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| Research and development expenses: | ||||||||||||
| Direct expenses – TNX – 102 SL | $ | 1,463 | $ | 1,273 | $ | 190 | ||||||
| Direct expenses – TNX – 1500 | 1,003 | 432 | 571 | |||||||||
| Direct expenses – Other programs | 3,171 | 155 | 3,016 | |||||||||
| Internal staffing, overhead and other | 5,183 | 7,838 | (2,655) | |||||||||
| Total research & development | $ | 10,820 | $ | 9,698 | $ | 1,122 | ||||||
| 31 |
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.
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.
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.
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.
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.
Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024
The following table sets forth our operating expenses for the six months ended June 30, 2025 and 2024 (in thousands):
| Six months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| REVENUE | ||||||||
| Product revenue, net | $ | 4,427 | $ | 4,690 | ||||
| COSTS AND EXPENSES: | ||||||||
| Cost of sales | 4,215 | 5,027 | ||||||
| Research and development | 18,256 | 22,561 | ||||||
| Selling, general and administrative | 26,306 | 16,812 | ||||||
| Asset impairment charges | - | 58,957 | ||||||
| Total operating expenses | 48,777 | 103,357 | ||||||
| Operating loss | (44,350 | ) | (98,667 | ) | ||||
| Grant income | 1,959 | - | ||||||
| Gain on change in fair value of warrant liabilities | - | 6,150 | ||||||
| Loss on extinguishment of debt | (2,092 | ) | - | |||||
| Interest income, net | 1,571 | 3 | ||||||
| Other expense, net | (2,189 | ) | (1,201 | ) | ||||
| Net loss | $ | (45,101 | ) | $ | (93,715 | ) | ||
Revenues. Revenue recognized for the six months ended June 30, 2025 and 2024, was $4.4 million and $4.7 million, respectively.
| 32 |
The Company’s net product revenues are summarized below:
| Six months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Zembrace Symtouch | $ | 3,596 | $ | 3,574 | ||||
| Tosymra | 831 | 1,116 | ||||||
| Total product revenues | $ | 4,427 | $ | 4,690 | ||||
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.
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.
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.
| Six Months Ended June 30, | ||||||||||||
| (in thousands) | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| Research and development expenses: | ||||||||||||
| Direct expenses – TNX - 102 SL | $ | 2,498 | $ | 2,988 | $ | (490 | ) | |||||
| Direct expenses – TNX - 801 | 413 | 620 | (207 | ) | ||||||||
| Direct expenses – TNX - 1500 | 1,385 | 1,222 | 163 | |||||||||
| Direct expenses – TNX - 1900 | 336 | 659 | (323 | ) | ||||||||
| Direct expenses – Other programs | 3,328 | 1,633 | 1,695 | |||||||||
| Internal staffing, overhead and other | 10,296 | 15,439 | (5,143 | ) | ||||||||
| Total research & development | $ | 18,256 | $ | 22,561 | $ | (4,305 | ) | |||||
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.
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.
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.
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.
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.
| 33 |
Asset Purchase Agreements
On June 23, 2023, we entered into an asset purchase agreement with Upsher Smith for the acquisition of certain assets related to Zembrace and Tosymra (such businesses collectively, the “Business”) and certain inventory related to the Business for an aggregate purchase price of approximately $26.5 million, including certain deferred payments (such transaction, the “USL Acquisition”). The transaction closed on June 30, 2023.
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 are 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% percent for Zembrace, and by 66.7% percent for Tosymra.
In addition, we have assumed the obligation to pay an additional 3% royalty on net sales of Tosymra, plus an additional 3% if a patent containing certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra in the applicable country or for as long as the manufacture, use or sale of Tosymra in such country is covered by a valid claim of a licensed patent, and up to $15 million per Tosymra product on the achievement of sales milestones.
Liquidity and Capital Resources
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.
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):
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Net cash used in operating activities | $ | (31,412 | ) | $ | (27,494 | ) | ||
| Net cash used in investing activities | (2,545 | ) | (108 | ) | ||||
| Net cash provided by financing activities | 60,526 | 6,813 | ||||||
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.
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.
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.
| 34 |
Future Liquidity Requirements
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.
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.
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.
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.
2025 Lincoln Park Transaction
On June 11, 2025, we entered into a purchase agreement (the “2025 Purchase Agreement”) and a registration rights agreement (the “2025 Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant to the terms of the 2025 Purchase Agreement, Lincoln Park has agreed to purchase from us up to $75,000,000 of our common stock (subject to certain limitations) from time to time during the term of the 2025 Purchase Agreement. Pursuant to the terms of the 2025 Registration Rights Agreement, we filed with the SEC a registration statement to register for resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the 2025 Purchase Agreement.
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 2025 under the 2025 Purchase Agreement.
We evaluated the 2025 Purchase Agreement under ASC 815-40 Derivatives and Hedging-Contracts on an Entity's Own Equity as it represents the right to require Lincoln Park to purchase shares of common stock in the future, similar to a put option. We concluded that the 2025 Purchase Agreement represents a freestanding derivative instrument that does not qualify for equity classification and therefore requires fair value accounting. We analyzed the terms of the contract and concluded that the derivative instrument had insignificant value as of June 30, 2025.
2025 At-the-Market Offerings
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.
2024 At-the-Market Offerings
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.
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July 2024 Financings
On July 9, 2024, we entered into a securities purchase agreement with certain institutional and retail investors, pursuant to which we sold 33,936 shares of common stock and pre-funded warrants to purchase up to 37,032 shares of common stock. The offering price per share of common stock was $57.00, and the offering price per share of pre-funded warrant was $56.99.
The offering closed on July 10, 2024. We incurred offering expenses of approximately $0.5 million, including placement agent fees of approximately $0.3 million. We received net proceeds of approximately $3.5 million, after deducting the underwriting discount and other offering expenses.
June 2024 Financings
On June 12, 2024, we entered into a securities purchase agreement with certain investors, pursuant to which we sold 11,995 shares of common stock and pre-funded warrants to purchase up to 25,682 shares of common stock. The offering price per share of common stock was $106.50, and the offering price per share of pre-funded warrant was $106.40.
The offering closed on June 13, 2024. We incurred offering expenses of approximately $0.6 million, including placement agent fees of approximately $0.3 million. We received net proceeds of approximately $3.4 million, after deducting the underwriting discount and other offering expenses.
On June 27, 2024, we entered into a securities purchase agreement with certain institutional and retail investors, pursuant to which we sold 28,339 shares of common stock and pre-funded warrants to purchase up to 42,282 shares of common stock. The offering price per share of common stock was $57.00, and the offering price per share of pre-funded warrant was $56.99.
The offering closed on June 28, 2024. We incurred offering expenses of approximately $0.6 million, including placement agent fees of approximately $0.3 million. We received net proceeds of approximately $3.4 million, after deducting the underwriting discount and other offering expenses.
March 2024 Financing
On March 28, 2024, we entered into an agreement to sell 3,365 shares of common stock, pre-funded warrants to purchase up to 1,219 shares of common stock, and accompanying Series E warrants to purchase up to 4,584 shares of common stock with an exercise price of $1,056.00 per share and expiring five and a half years from date of issuance in a public offering, which closed on April 1, 2024. The offering price per share of common stock was $960.00, and the offering price per share of pre-funded warrants was $959.68.
We incurred expenses of approximately $0.5 million, including placement agent fees of approximately $0.3 million. We received net proceeds of approximately $3.9 million, after deducting the underwriting discount and other offering expenses.
Additionally, with the closing of the financing on April 1, 2024, we entered into warrant amendments (collectively, the “Warrant Amendments”) with certain holders of our common warrants (referred to herein as the “Existing Warrants”). We agreed to amend the exercise price of each Existing Warrant to $1,056.00 upon approval by our stockholders of a proposal to allow the Existing Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635 or, if stockholder approval is not obtained by October 1, 2024, we agreed to automatically amend the exercise price of the Existing Warrants to the Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) of our common stock on October 1, 2024, if and only if the Minimum Price is below the then current exercise price. Upon stockholder approval, the termination date for the warrants issued August 2023 (the “August Warrants”) to purchase up to an aggregate of 2,172 shares was amended to April 1, 2029; the termination date for Series A Warrants to purchase up to an aggregate of approximately 2,782 shares is April 1, 2029; the termination date for Series B Warrants to purchase up to an aggregate of approximately 2,782 shares is April 1, 2025; the termination date for Series C Warrants to purchase up to an aggregate of approximately 10,884 shares is the earlier of (i) April 1, 2026 and (ii) 10 trading days following notice by the Company to the Series C Warrant holders of the Company’s public announcement of the FDA’s acknowledgement and acceptance of the Company’s NDA relating to TNX-102 SL in patients with Fibromyalgia; the termination date for Series D Warrants to purchase up to an aggregate of approximately 10,884 shares is April 1, 2029. The other terms of the Existing Warrants remained unchanged.
We evaluated the Warrant Amendments as of April 1, 2024, and determined that the potential adjustment to the exercise price that is contingent on stockholder approval precluded the Existing Warrants from being indexed to our own stock, and as a result, did not meet the criteria for equity classification under ASC 815-40. We accounted for the incremental fair value of the Warrant Amendments of $3.0 million as a direct and incremental cost of the March 2024 financing as an offset to the proceeds received. As all of the Existing Warrants were equity-classified prior to the Warrant Amendments, the net impact to the consolidated statement of stockholders’ equity was zero. We then reclassified the Existing Warrants from equity to liabilities at post-modification fair value on April 1, 2024. On May 22, 2024, the date our stockholders approved the proposal to fix the exercise prices at $1,056.00 per share, the Existing Warrants were adjusted to fair value and reclassified back to equity.
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December 2023 Financing
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.
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.
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.
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.
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.
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.
Stock repurchases
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.
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We repurchased the following capital stock:
| Three Months Ended June 30, 2025 |
Three Months Ended June 30, 2024 |
|||||||
| Total cost of repurchased shares (in thousands) | $ | 2,902 | $ | — | ||||
| Shares repurchased | 150,000 | — | ||||||
| Weighted average price per share | $ | 19.31 | — | |||||
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.
We repurchased the following capital stock:
| Six Months Ended June 30, 2025 |
Six Months Ended June 30, 2024 |
|||||||
| Total cost of repurchased shares (in thousands) | $ | 5,949 | $ | — | ||||
| Shares repurchased | 400,000 | — | ||||||
| Weighted average price per share | $ | 14.84 | — | |||||
The timing and amount of any shares repurchased will be determined based on our evaluation of market conditions and other factors and the New Share Repurchase Program may be discontinued or suspended at any time. Repurchases will be made in accordance with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements to which the Company may be subject. Repurchases may be made, in part, under a Rule 10b5-1 plan, which allows stock repurchases when the Company might otherwise be precluded from doing so.
Stock Compensation
On May 1, 2020, our stockholders approved the Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive Plan (“Amended and Restated 2020 Plan”).
Under the terms of the Amended and Restated 2020 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 Amended and Restated 2020 Plan initially provided for the issuance of up to 50,000 shares of common stock, which amount will be increased to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise provided in the Amended and Restated 2020 Plan). In addition, the Amended and Restated 2020 Plan contains an “evergreen provision” providing for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated 2020 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on (and including) January 1, 2030, in an amount equal to 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, and (y) the total number of shares of common stock reserved under the Amended and Restated 2020 Plan on December 31st of such preceding calendar year (including shares subject to outstanding awards, issued pursuant to awards or available for future awards). On May 8, 2025, our stockholders approved the addition of 1,000,000 shares to the Company's Amended and Restated 2020 Plan.
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.
The aggregate intrinsic value in the preceding table represents the total pretax intrinsic value, based on options with an exercise price less than our closing stock price at the respective dates.
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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.
We measure the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions discussed below, and the closing market price of our common stock on the date of the grant. The fair value of the award is measured on the grant date. One-third of most stock options granted pursuant to the Plans vest 12 months from the date of grant and 1/36th each month thereafter for 24 months and expire ten years from the date of grant. In addition, we issue options to directors which vest over a one-year period. We also issue premium options to executive officers which have an exercise price greater than the grant date fair value and has issued performance-based options which vest when target parameters are met or probable of being met, subject in each case to a one year minimum service period prior to vesting. Stock-based compensation expense related to awards is amortized over the applicable service period using the straight-line method.
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.
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.
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.
Employee Stock Purchase Plans
On May 5, 2023, our stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2023 Employee Stock Purchase Plan. (the “2023 ESPP”), which was replaced by the Tonix Pharmaceuticals Holdings Corp. 2025 Employee Stock Purchase Plan (the “2025 ESPP”, and together with the 2023 ESPP, the “ESPP Plans”), which was approved by our stockholders on May 8, 2025.
The 2025 ESPP allows eligible employees to purchase up to an aggregate of 2,000,000 shares of our common stock. Under the 2025 ESPP, on the first day of each offering period, each eligible employee for that offering period has the option to enroll for that offering period, which allows the eligible employees to purchase shares of our common stock at the end of the offering period. Each offering period under the 2025 ESPP is for six months, which can be modified from time to time. Subject to limitations, each participant will be permitted to purchase a number of shares determined by dividing the employee's accumulated payroll deductions for the offering period by the applicable purchase price, which is equal to 85 percent of the fair market value of our common stock at the beginning or end of each offering period, whichever is less. A participant must designate in his or her enrollment package the percentage (if any) of compensation to be deducted during that offering period for the purchase of stock under the 2025 ESPP, subject to the statutory limit under the Code.
The 2023 ESPP allows eligible employees to purchase up to an aggregate of 250 shares of our common stock. Under the 2023 ESPP, on the first day of each offering period, each employee eligible for that offering period has the option to enroll for that offering period, which allows the eligible employees to purchase shares of our common stock at the end of the offering period. Each offering period under the 2023 ESPP is for six months, which can be modified from time-to-time. Subject to limitations, each participant will be permitted to purchase a number of shares determined by dividing the employee's accumulated payroll deductions for the offering period by the applicable purchase price, which is equal to 85 percent of the fair market value of our common stock at the beginning or end of each offering period, whichever is less. A participant must designate in his or her enrollment package the percentage (if any) of compensation to be deducted during that offering period for the purchase of stock under the 2023 ESPP, subject to the statutory limit under the Code. As of June 30, 2025, 159 shares were available for future sales under the 2023 ESPP and 2,000,000 shares were available under the 2025 ESPP.
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.
Commitments
Research and Development Contracts
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.
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At June 30, 2025, future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands):
| Year Ending December 31, | |||||
| Remainder of 2025 | $ | 146 | |||
| 2026 | 142 | ||||
| 2027 | 139 | ||||
| 2028 | 100 | ||||
| 2029 | 7 | ||||
| 534 | |||||
| Included interest | (42 | ) | |||
| $ | 492 | ||||
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements.
Revenue Recognition. Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized. Such variable consideration represents chargebacks, rebates, prompt pay and other sales discounts, and product returns. These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these revenue deductions on gross sales for a reporting period. We began recognizing revenue following the completion of the USL Acquisition, beginning July 1, 2023, and required variable consideration estimates are currently primarily based on the acquired products historical results. Adjustments to these estimates to reflect actual results or updated expectations will be assessed each period. If any of our ratios, factors, assessments, experiences, or judgments are not indicative or accurate estimates of our future experience, our results could be materially affected. The potential of our estimates to vary differs by program, product, type of customer and geographic location. In addition, estimates associated with U.S. Medicare and Medicaid governmental rebate programs are at risk for material adjustment because of the extensive time delay.
Research and Development. We outsource certain of our research and development efforts and expense the related costs as incurred, including the cost of manufacturing product for testing, licensing fees and costs associated with planning and conducting clinical trials. The value ascribed to patents and other intellectual property acquired was expensed as research and development costs, as it related to particular research and development projects and had no alternative future uses.
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We estimate our research and development accrued expenses. Our clinical trial accrual process is designed to account for expenses resulting from our obligations under contracts with vendors, consultants and clinical research organizations and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts. We account for trial expenses according to the progress of the trial as measured by participant progression and the timing of various aspects of the trial. We determine accrual estimates that take into account discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. During the course of a clinical trial, we adjust our clinical expense recognition if actual results differ from our estimates. We make estimates of our accrued expenses as of each balance sheet date based on the facts and circumstances known to us at that time. Our clinical trial accruals and prepaid assets are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors.
Stock-Based Compensation. All stock-based payments to employees and to nonemployee directors for their services as directors consisted of grants of restricted stock and stock options, which are measured at fair value on the grant date and recognized in the consolidated statements of operations as compensation expense over the relevant vesting period. In addition, for awards that vest immediately and are nonforfeitable, the measurement date is the date the award is issued.
Derivative Instruments and Warrant Liabilities. The Company evaluates all of its financial instruments, including issued warrants to purchase common stock under ASC 815 – Derivatives and Hedging, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the consolidated statements of operations. The Company uses the Black-Scholes option pricing model to value the derivative instruments at inception and subsequent valuation dates, which is adjusted for instrument-specific terms as applicable.
From time to time, certain equity-linked instruments may be classified as derivative liabilities due to the Company having insufficient authorized shares to fully settle the equity-linked financial instruments in shares. In such a case, the Company has 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. If reclassification of contracts between equity and assets or liabilities is necessary, the Company first allocates remaining authorized shares to equity on the basis of 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 to equity beginning with instruments with the latest maturity date first.
Other than contractual obligations incurred in the normal course of business, we do not have any off-balance sheet financing arrangements or liabilities, guarantee contracts, retain or contingent interests in transferred assets or any obligation arising out of a material variable interest in an unconsolidated entity.
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires entities to disclose disaggregated information about their effective tax rate reconciliations as well as expanded information on income taxes by jurisdiction. The standard is effective for fiscal years beginning after December 15, 2024 on a prospective basis. The Company discloses its income tax rate reconciliation in its annual consolidated financial statements only and does not expect the adoption to have a material impact on its consolidated financial statements.
Recently Issued Accounting Pronouncements
In March 2024, the SEC adopted new rules relating to the disclosure of a range of climate-change-related physical and transition risks, data, and opportunities. The adopted rule contains several new disclosure obligations, including, (i) disclosure on how the board of directors and management oversee climate-related risks and certain climate-related governance items, (ii) disclosure of information related to a registrant’s climate-related targets, goals, and/or transition plans, and (iii) disclosure on whether and how climate-related events and transition activities impact line items above a threshold amount on a registrant’s consolidate financial statements, including the impact of the financial estimates and the assumptions used. This new rule will first be effective in the Company’s disclosures for the year ending December 31, 2027. The Company is in the process of assessing the impact on our consolidated financial statements and disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, to improve transparency in financial reporting by requiring entities to present more detailed information about the nature of expenses included within the Income Statement. The guidance will first be effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is in the process of assessing the impact of ASU 2024-03 on our disclosures.
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ITEM 3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 4 – CONTROLS AND PROCEDURES
Evaluation of disclosure controls and procedures.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act of 1934 as of the end of the period covered by this Quarterly Report on Form 10-Q. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Based on our evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of June 30, 2025, our disclosure controls and procedures are designed at a reasonable assurance level and are effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in internal control over financial reporting.
There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
We are currently not a party to any material legal proceedings or claims.
Item 1A. Risk Factors
Other than as set forth below, there were no material changes from the risk factors set forth under Part I, Item 1A., “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. You should carefully consider the risk factors set forth below and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as well as other reports and statements that we file and have filed with the SEC, in addition to the other information set forth in this report which could materially affect our business, financial condition or future results. The risks and uncertainties described in this report and in our Annual Report on Form 10-K for the year ended December 31, 2024, as well as other reports and statements that we file with the SEC, are not the only risks and uncertainties facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also have a material adverse effect on our financial position, results of operations or cash flows.
Changes in tax laws could adversely affect our business and financial condition.
Tax legislation continues to evolve globally with new laws and regulations that create uncertainty in the global economy. For example, on July 4, 2025, legislation commonly referred to as the One Big Beautiful Bill Act (the "OBBBA") was signed into law, which includes significant provisions, including tax cut extensions and modifications to the international tax framework. We are currently assessing the impact the OBBBA may have on our financial condition, results of operations, cash flows or effective tax rate, and will continue to evaluate the impact of the legislative changes as additional guidance becomes available. Uncertainty remains regarding timing and interpretation by the tax authorities in the affected jurisdictions. Future tax reform and legislative changes could have an adverse impact on our future effective tax rate, tax liabilities, and cash tax.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On June 11, 2025, the Company issued 48,708 shares of common stock to Lincoln Park as a commitment fee in connection with the 2025 Purchase Agreement and subject to the 2025 Registration Rights Agreement. The shares were subsequently registered.
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Item 2(c). Purchases of Equity Securities
The following table shows the activity related to our share repurchase program for the three months ended June 30, 2025:
| Total Number of Shares Purchased |
Average Price Paid Per Share |
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs(1) |
Maximum Number (or Approximate Dollar Value) of Shares that May Yet be Purchased Under the Plans or Programs |
|||||||||||||
| September 2024 Program | ||||||||||||||||
| April 1 through April 30, 2025 | — | $ | — | — | $ | — | ||||||||||
| May 1 through May 31, 2025 | 150,000 | 19.31 | 150,000 | 4,051,125 | ||||||||||||
| June 1 through June 30, 2025 | — | — | — | $ | — | |||||||||||
| Second Quarter Total | 150,000 | $ | 19.31 | 150,000 | $ | 4,051,125 | ||||||||||
| (1) | On September 6, 2024, the Board of Directors approved a share repurchase program pursuant to which the Company may purchase 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. |
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
None.
Item 5. Other Information
Rule 10b5-1 Trading Arrangements and Non-Rule 10b5-1 Trading Arrangements
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Item 6. Exhibits
EXHIBIT INDEX
| Exhibit No. |
Description |
| 3.01 | Articles of Incorporation, filed as an exhibit to the Registration Statement on Form S-1, filed with the Securities and Exchange Commission (the “Commission”) on April 9, 2008 and incorporated herein by reference. |
| 3.02 | Articles of Merger between Tamandare Explorations Inc. and Tonix Pharmaceuticals Holding Corp., effective October 11, 2011, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on October 17, 2011 and incorporated herein by reference. |
| 3.03 | Third Amended and Restated Bylaws, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 3, 2016 and incorporated herein by reference. |
| 3.04 | Certificate of Change of Tonix Pharmaceuticals Holding Corp., dated March 13, 2017 and effective March 17, 2017, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on March 16, 2017 and incorporated herein by reference. |
| 3.05 | Certificate of Amendment to Articles of Incorporation, effective June 16, 2017, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 16, 2017 and incorporated herein by reference. |
| 3.06 | Certificate of Amendment to Tonix Pharmaceuticals Holding Corp.’s Articles of Incorporation, as amended, filed with the Secretary of State of the State of Nevada on May 3, 2019. |
| 3.07 | Form of Certificate of Designation of Series A Convertible Preferred Stock, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on October 25, 2022 and incorporated herein by reference. |
| 3.08 | Form of Certificate of Designation of Series B Convertible Preferred Stock, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on October 25, 2022 and incorporated herein by reference. |
| 3.09 | Certificate of Amendment to Tonix Pharmaceuticals Holding Corp.’s Articles of Incorporation, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on May 16, 2022 and incorporated herein by reference. |
| 3.10 | Certificate of Amendment to Tonix Pharmaceuticals Holding Corp.’s Articles of Incorporation, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on January 25, 2024 and incorporated herein by reference |
| 4.01 | Specimen Common Stock Certificate of the Registrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on May 24, 2018 and incorporated herein by reference. |
| 4.07 | Form of Pre-Funded Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on July 18, 2023 and incorporated herein by reference. |
| 4.08 | Form of Common Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on July 28, 2023 and incorporated herein by reference. |
| 4.09 | Form of Pre-Funded Warrant. filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on December 21, 2023 and incorporated herein by reference. |
| 4.10 | Form of Series C Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on December 21, 2023 and incorporated herein by reference. |
| 4.11 | Form of Series D Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on December 21, 2023 and incorporated herein by reference. |
| 44 |
| 4.12 | Form of Pre-Funded Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on March 29, 2024, and incorporated herein by reference. |
| 4.13 | Form of Series E Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on March 29, 2024, and incorporated herein by reference. |
| 4.14 | Form of Pre-Funded Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 13, 2024, and incorporated herein by reference. |
| 4.15 | Form of Pre-Funded Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 28, 2024 and incorporated herein by reference. |
| 4.16 | Form of Pre-Funded Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on July 10, 2024 and incorporated herein by reference. |
| 10.1 | Pay-Off Letter, dated February 3, 2025, by and among the Loan Parties, the Lenders and the JGB Agent, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on February 3, 2025 and incorporated herein by reference. |
| 10.02 | Purchase Agreement, dated June 11, 2025, by and between Tonix Pharmaceuticals Holding Corp. and Lincoln Park Capital Fund, LLC , filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 11, 2025, and incorporated herein by reference.† |
| 10.03 | Registration Rights Agreement, dated June 11, 2025, by and between Tonix Pharmaceuticals Holding Corp. and Lincoln Park Capital Fund, LLC, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 11, 2025, and incorporated herein by reference.† |
| 31.01 | Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, filed herewith. |
| 31.02 | Certification of Chief Financial Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, filed herewith. |
| 32.01 | Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, filed herewith. |
† Certain portions of this exhibit, that are not material and would likely cause competitive harm to the registrant if publicly disclosed, have been redacted pursuant to Item 601(b)(10) of Regulation S-K.
| 45 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| TONIX PHARMACEUTICALS HOLDING CORP. | ||
| (Registrant) | ||
| Date: August 11, 2025 | By: | /s/ SETH LEDERMAN |
| Seth Lederman | ||
| Chief Executive Officer (Principal Executive Officer) | ||
| Date: August 11, 2025 | By: | /s/ BRADLEY SAENGER |
| Bradley Saenger | ||
|
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) | ||
| 46 |
