Tonix Pharmaceuticals Recently Announced Preliminary Full Year 2024 Operating Results and Year-End Cash
Tonix Pharmaceuticals (TNXP) reported preliminary 2024 financial results with $98.8 million in cash as of December 31, 2024. The company generated $10.1 million in net sales from migraine products, up from $7.8 million in 2023. Net operating loss was $126.6 million, including $59.0 million in non-cash impairment charges.
Key highlights include becoming debt-free after repaying a mortgage to JGB Capital, and raising $30.4 million through ATM facility in Q1 2025. The company expects current cash to fund operations into Q1 2026, beyond the FDA PDUFA date of August 15, 2025 for TNX-102 SL fibromyalgia treatment. Operating cash burn decreased to $60.9 million from $102.0 million in the previous year.
Tonix Pharmaceuticals (TNXP) ha riportato i risultati finanziari preliminari per il 2024 con $ 98,8 milioni in cassa al 31 dicembre 2024. L'azienda ha generato $ 10,1 milioni in vendite nette da prodotti per l'emicrania, in aumento rispetto ai $ 7,8 milioni del 2023. La perdita operativa netta è stata di $ 126,6 milioni, inclusi $ 59,0 milioni in oneri di impairment non monetari.
I principali punti salienti includono il diventare senza debiti dopo aver ripagato un mutuo a JGB Capital e aver raccolto $ 30,4 milioni tramite una struttura ATM nel primo trimestre del 2025. L'azienda si aspetta che la liquidità attuale possa finanziare le operazioni fino al primo trimestre del 2026, oltre alla data PDUFA della FDA del 15 agosto 2025 per il trattamento della fibromialgia TNX-102 SL. Il burn di cassa operativo è diminuito a $ 60,9 milioni rispetto ai $ 102,0 milioni dell'anno precedente.
Tonix Pharmaceuticals (TNXP) informó resultados financieros preliminares para 2024 con $ 98.8 millones en efectivo al 31 de diciembre de 2024. La compañía generó $ 10.1 millones en ventas netas de productos para migrañas, un aumento respecto a los $ 7.8 millones en 2023. La pérdida operativa neta fue de $ 126.6 millones, incluyendo $ 59.0 millones en cargos no monetarios de deterioro.
Los aspectos destacados incluyen el logro de estar libre de deudas después de pagar una hipoteca a JGB Capital y haber recaudado $ 30.4 millones a través de una instalación de ATM en el primer trimestre de 2025. La compañía espera que el efectivo actual financie las operaciones hasta el primer trimestre de 2026, más allá de la fecha PDUFA de la FDA del 15 de agosto de 2025 para el tratamiento de fibromialgia TNX-102 SL. La quema de efectivo operativo disminuyó a $ 60.9 millones desde $ 102.0 millones del año anterior.
톤익스 제약 (TNXP)는 2024년의 예비 재무 결과를 발표하며 2024년 12월 31일 기준으로 9880만 달러의 현금을 보유하고 있다고 밝혔습니다. 이 회사는 편두통 제품에서 1010만 달러의 순매출을 올렸으며, 이는 2023년의 780만 달러에서 증가한 수치입니다. 한국어 운영 손실은 1억 2660만 달러였으며, 이에는 5900만 달러의 비현금 손상 비용이 포함되어 있습니다.
주요 하이라이트에는 JGB Capital에 대한 담보 대출을 상환함으로써 부채가 없는 상태가 되었으며, 2025년 1분기 동안 ATM 시설을 통해 3040만 달러를 모금한 것이 포함됩니다. 이 회사는 현재 현금이 2026년 1분기까지 운영 자금을 지원할 것으로 예상하고 있으며, 이는 TNX-102 SL 섬유형 통증 치료의 FDA PDUFA 날짜인 2025년 8월 15일을 넘습니다. 운영 현금 소진액은 작년의 1억 0200만 달러에서 6090만 달러로 감소했습니다.
Tonix Pharmaceuticals (TNXP) a rapporté des résultats financiers préliminaires pour 2024 avec 98,8 millions de dollars de liquidités au 31 décembre 2024. L'entreprise a généré 10,1 millions de dollars de ventes nettes provenant de produits contre les migraines, en hausse par rapport aux 7,8 millions de dollars en 2023. La perte opérationnelle nette était de 126,6 millions de dollars, y compris 59,0 millions de dollars en charges de dépréciation non monétaires.
Les points clés incluent le fait de devenir sans dette après avoir remboursé une hypothèque à JGB Capital et d'avoir levé 30,4 millions de dollars par le biais d'une facilité ATM au premier trimestre de 2025. L'entreprise s'attend à ce que les liquidités actuelles financent ses opérations jusqu'au premier trimestre de 2026, au-delà de la date PDUFA de la FDA du 15 août 2025 pour le traitement de la fibromyalgie TNX-102 SL. La consommation de liquidités opérationnelles a diminué à 60,9 millions de dollars contre 102,0 millions de dollars l'année précédente.
Tonix Pharmaceuticals (TNXP) berichtete über die vorläufigen Finanzzahlen für 2024 mit 98,8 Millionen Dollar in Barbeständen zum 31. Dezember 2024. Das Unternehmen erzielte 10,1 Millionen Dollar an Nettoumsatz aus Migräneprodukten, ein Anstieg von 7,8 Millionen Dollar im Jahr 2023. Der operative Nettoverlust belief sich auf 126,6 Millionen Dollar, einschließlich 59,0 Millionen Dollar an nicht zahlungswirksamen Wertminderungsaufwendungen.
Zu den wichtigsten Höhepunkten zählt der Status schuldentilgt zu sein, nachdem eine Hypothek an JGB Capital zurückgezahlt wurde, sowie die Beschaffung von 30,4 Millionen Dollar über eine ATM-Anlage im ersten Quartal 2025. Das Unternehmen erwartet, dass das aktuelle Bargeld die Betriebe bis ins erste Quartal 2026 finanzieren kann, über den FDA PDUFA-Termin am 15. August 2025 für die TNX-102 SL Fibromyalgie-Behandlung hinaus. Der operative Cash-Burn verringerte sich auf 60,9 Millionen Dollar, nachdem er im Vorjahr 102,0 Millionen Dollar betrug.
- Net sales increased 29.5% to $10.1 million in 2024
- Operating cash burn reduced by 40.3% to $60.9 million
- Became debt-free after mortgage repayment
- Secured $30.4 million in additional funding through ATM facility
- Cash runway extended into Q1 2026
- Net operating loss increased to $126.6 million from $116.7 million
- Recorded $59.0 million in non-cash impairment charges
- Dilution of shareholders through $30.4 million ATM facility
Insights
The 2024 financial results reveal significant operational improvements and strategic positioning ahead of a important regulatory milestone. The
The
Most critically, the combined
The August 15, 2025 PDUFA date for TNX-102 SL represents a transformative opportunity in fibromyalgia, a condition affecting approximately 6-12 million Americans. The FDA's Fast Track designation acknowledges both the unmet medical need and the drug's potential impact. Having two statistically significant Phase 3 studies strengthens the likelihood of approval.
The pipeline diversification strategy is noteworthy, with TNX-1300's Breakthrough Therapy designation for cocaine intoxication providing another potential near-term catalyst. The
The company's integrated approach, combining commercial products (migraine portfolio), late-stage development (TNX-102 SL) and early-stage programs (TNX-1500, TNX-801), creates multiple value-driving opportunities while mitigating risk through portfolio diversification.
Company had
Company is debt-free after repaying mortgage on facilities
TNX-102 SL fibromyalgia FDA PDUFA goal date is August 15, 2025
CHATHAM, N.J., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, recently announced selected preliminary operating results for the year ended December 31, 2024, and certain preliminary financial condition information as of December 31, 2024.
Preliminary Full Year 2024 Financial Results1
- The Company had approximately
$98.8 million in cash and cash equivalents as of December 31, 2024. - Net cash used in operating activities was approximately
$60.9 million , compared to$102.0 million for the prior year. - Capital expenditures was approximately
$0.1 million , compared to$29.1 million for the prior year. - Net operating loss was approximately
$126.6 million , which includes non-cash impairment charges of approximately$59.0 million , compared to net operating loss of$116.7 million for the prior year. - The Company announced that net revenue from the sale of its marketed products was approximately
$10.1 million , compared to$7.8 million for the prior year. - On February 3, 2025, the Company repaid a mortgage (Loan and Guaranty Agreement) with JGB Capital and related parties that was secured by two facilities and the Company is now debt-free.
The Company expects that its cash resources at December 31, 2024, and the gross proceeds of approximately
The cash runway is expected to fund the company beyond the August 15, 2025 Prescription Drug User Fee Act (PDUFA) goal date assigned by the U.S. Food and Drug Administration (FDA) for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia.
1 The above information is preliminary financial information for the year ended December 31, 2024 and subject to completion. The unaudited, estimated results for the year ended December 31, 2024 are preliminary and were prepared by the Company’s management, based upon its estimates, a number of assumptions and currently available information, and are subject to revision based upon, among other things, quarter and year-end closing procedures and/or adjustments, the completion of the Company’s consolidated financial statements and other operational procedures. This preliminary financial information is the responsibility of management and has been prepared in good faith on a consistent basis with prior periods. However, the Company has not completed its financial closing procedures for the year ended December 31, 2024, and its actual results could be materially different from this preliminary financial information, which preliminary information should not be regarded as a representation by the Company or its management as to its actual results for the year ended December 31, 2024. In addition, EisnerAmper LLP, the Company’s independent registered public accounting firm, has not audited, reviewed, compiled, or performed any procedures with respect to this preliminary financial information and does not express an opinion or any other form of assurance with respect to this preliminary financial information. During the course of the preparation of the Company’s financial statements and related notes as of and for the year ended December 31, 2024, the Company may identify items that would require it to make material adjustments to this preliminary financial information. As a result, prospective investors should exercise caution in relying on this information and should not draw any inferences from this information. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles and reviewed by the Company’s auditors.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio 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. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, 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; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599
Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505
Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432
Indication and Usage
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
- discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
- history of heart problems
- narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
- uncontrolled high blood pressure
- hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
- had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
- severe liver problems
- taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
- are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
- an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
- changes in color or sensation in your fingers and toes
- sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
- cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
- increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
- medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
- serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
- hives (itchy bumps); swelling of your tongue, mouth, or throat
- seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
FAQ
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