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Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Positive results from confirmatory Phase 3 RESILIENT study reported in December 2023 position Tonmya™ for fibromyalgia for NDA submission second half of 2024; pre-NDA meeting with FDA scheduled for second quarter 2024

Commercial planning underway, including go-to-market, supply chain and manufacturing strategies, for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia

CHATHAM, N.J., April 01, 2024 (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, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an overview of recent operational highlights.

“Our near-term focus is seeking U.S. marketing approval for Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia from the U.S. Food and Drug Administration (FDA),” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Our pre-NDA meeting with the FDA is scheduled to take place this quarter and we plan to submit our New Drug Application (NDA) for Tonmya™ in the second half of 2024. We believe the positive Phase 3 RESILIENT results reported in December of 2023 together with the positive results from the first Phase 3 RELIEF study should satisfy the requirements for approval and, if so, would provide the opportunity for Tonix to launch the first FDA-approved drug for fibromyalgia in more than a decade. We believe the activity of Tonmya on improving pain, sleep quality, fatigue and brain fog in the RESILIENT study are indicative of the broad-spectrum of activity in fibromyalgia.”

Dr. Lederman added, “While Tonix is focusing its resources on progressing Tonmya toward NDA submission and potential FDA approval, we are seeking partnerships and collaborations on our pipeline programs from government agencies, non-profit organizations and other biotechnology or pharmaceuticals companies. Tonix has already shifted portions of our research and development (R&D) expenses to U.S. government agencies and other institutions through partnerships involving grants and in-kind contributions. These outside collaborations leverage our internal resources, and we believe they provide a capital efficient strategy for progress.”

Selected Product Candidates* — Recent Highlights

Central Nervous System (CNS) Pipeline

Tonmya (also known as TNX-102 SL; cyclobenzaprine HCl sublingual tablets): a centrally-acting, non-opioid, small molecule analgesic taken once-daily at bedtime for the management of fibromyalgia (FM).

TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

TNX-102 SL for the treatment of Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)

TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication

TNX-1900 (intranasal potentiated oxytocin): small peptide in development through investigator-initiated studies for bone health in autism, social anxiety disorder (SAD), adolescent obesity and binge eating disorder

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)

Immunology Pipeline

TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.

Infectious Disease Pipeline

TNX-1800 (modified recombinant horsepox virus, live vaccine): potential vaccine to protect against COVID-19 designed to express the SARS-CoV-2 spike protein

TNX-801 (recombinant horsepox virus, live vaccine): potential vaccine to protect against mpox disease and smallpox.

Broad-spectrum anti-viral programs

Tonix is developing potential broad-spectrum antiviral drugs in three programs: CD45-targeted therapeutics (TNX-4200), cathepsin inhibitors (TNX-3900) and viral glycan-targeted engineered biologics (TNX-4000). In 2020, the DoD announced that they are seeking broad spectrum antiviral drugs since it would be hard to predict which or how many viruses may be deployed on the battlefield.16 Tonix hopes that one or more of our programs may help the DoD address that goal.

Marketed Products — Recent Highlights

Facilities — Recent Highlights

*All of Tonix’s product candidates are investigational new drugs or biologics and none have been approved for any indication.

1 Bergmans RS, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003110.
2 Fitzcharles M-A, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003129.
3 Lassiter G., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.022
4 Miura S., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025
5 Anand, R.P., et al Nature. 622, 393–401 (2023). https://doi.org/10.1038/s41586-023-06594-4
6 Massachusetts General Hospital press release. March 21, 2024. “World’s First Genetically Edited Pig Kidney Transplant into Living Recipient Performed at Massachusetts General Hospital.” www.massgeneral.org/news/press-release/worlds-first-genetically-edited-pig-kidney-transplant-into-living-recipient (accessed March 29, 2024)
7 Awasthi M, et al. 2023. Vaccines (Basel) 11(11):1682. https://doi:10.3390/vaccines11111682
8 Office of Science and Technology Policy (OSTP). American Pandemic Preparedness: Transforming Our Capabilities. September 2021
9 National Biodefense Science Board (NBSB). Prioritization of Product Attribute Categories to Maximize Access for Next Generation COVID-19 Vaccines and Therapeutics. August 2023
10 BARDA Strategic Plan 2022-2026.
11 Noyce RS, et al. Viruses. 2023 26;15(2):356. doi: 10.3390/v15020356
12 U.S. National Academy of Sciences. March 28, 2024. “Consensus Study Report: Future State of Smallpox Medical Countermeasures.” https://nap.nationalacademies.org/catalog/27652/future-state-of-smallpox-medical-countermeasures
13 Bipartisan Commission on Biodefense. (2024). Box the Pox: Reducing the
Risk of Smallpox and Other Orthopoxviruses. Bipartisan Commission on
Biodefense: Washington, DC. https://biodefensecommission.org/reports/box-the-pox-reducing-the-risk-of-smallpox-and-other-orthopoxviruses/
14 Emanuel, G. NPR. March 27, 2024. “Why the mpox outbreak in the Democratic Republic of Congo is worrying disease docs.” URL: www.npr.org/sections/goatsandsoda/2024/03/27/1239276957/mpox-outbreak-democratic-republic-of-congo-deadlier-strain
15 Trefry, SV et al., BioRxiv 2023.10.25.564033; doi: https://doi.org/10.1101/2023.10.25.564033
16 U.S. Department of Defense. Chemical and Biological Defense Program. 2022. “Approach for Research, Development, and Acquisition of Medical Countermeasure and Test Products.” U.S. Department of Defense. https://media.defense.gov/2023/Jan/10/2003142624/-1/-1/0/APPROACH-RDA-MCM-TEST-PRODUCTS.PDF (accessed March 5, 2024)

Recent Highlights — Financial

As of December 31, 2023, Tonix had approximately $24.9 million of cash and cash equivalents, compared to $120.2 million as of December 31, 2022. Additionally, Tonix had inventory totaling approximately $13.6 million as of December 31, 2023. Net cash used in operations was approximately $102.0 million for the full year ended December 31, 2023, compared to $98.1 million for the same period in 2022. Net cash used by investing activities for the full year ended December 31, 2023 was approximately $29.1 million compared to $48.1 million for the same period in 2022.

In August 2022, the Company announced that it 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 year ended December 31, 2023, Tonix received $2.7 million in funding as a reduction of related research and development expenses. Included in prepaid expense and other is an additional $0.2 million that was not received until January 2024.

On December 8, 2023, the Company executed a Loan and Guaranty Agreement (the “Loan Agreement”) to issue a 36-month term loan (the “Term Loan”) in the principal amount of $11.0 million with a maturity date of December 8, 2026 (the “Maturity Date”). The Term Loan was funded with an original issue discount of 9% of the principal amount of the Term Loan, or $1.0 million, which is being amortized over the term of the debt as an adjustment to the effective interest rate on the outstanding borrowings.

On December 20, 2023, the Company announced it had signed securities purchase agreements with existing healthcare-focused institutional investors for upfront gross proceeds of approximately $30 million through a registered direct offering.

On March 28, 2024, the Company announced it had signed securities purchase agreements with existing healthcare-focused institutional investors for upfront gross proceeds of approximately $4.4 million through a registered direct offering.

As of April 1, 2024, there were 84,490,862 shares of Tonix Pharmaceuticals common stock outstanding.

Fourth Quarter 2023 Financial Results

Net product revenue for the fourth quarter 2023 was approximately $3.8 million. Cost of Sales for the fourth quarter 2023 was approximately $2.4 million. Tonix completed the acquisition of two currently marketed products from Upsher-Smith Laboratories, LLC on June 30, 2023.

R&D expenses for the fourth quarter 2023 were approximately $17.1 million, compared to $24.7 million for the same period in 2022. This decrease is predominantly due to decreased non-clinical and manufacturing expenses.

SG&A expenses for the fourth quarter 2023 were $11.6 million, compared to $8.1 million for the same period in 2022. The increase was primarily due to sales and marketing and the transition services expenses associated with the Company’s recently acquired marketed products offset by a decrease in compensation-related expenses.

Net loss available to common stockholders was $27.3 million, or $0.86 per share, basic and diluted, for the fourth quarter 2023, compared to net loss available to common stockholders of $34.1 million, or $3.42 per share, basic and diluted, for the same period in 2022. The basic and diluted weighted average common shares outstanding for the fourth quarter 2023 was 31,756,759 compared to 9,952,780 shares for the same period in 2022.

Full Year 2023 Financial Results

Net product revenue for the full year 2023 was approximately $7.8 million. Cost of sales for the full year 2023 was approximately $4.7 million.

R&D expenses for the full year 2023 were approximately $86.7 million, compared to $81.9 million for the same period in 2022. This increase is predominantly due to decreased non-clinical and regulatory expenses, offset by an increase in clinical, manufacturing, employee-related and professional expenses.

SG&A expenses for the full year 2023 were $34.8 million, compared to $30.2 million for the same period in 2022. The increase was primarily due to sales and marketing associated with the Company’s recently acquired marketed products.

Net loss available to common stockholders was $116.7 million, or $6.85 per share, basic and diluted, for the full year 2023, compared to net loss available to common stockholders of $116.9 million, or $20.01 per share, basic and diluted, for the same period in 2022. The basic and diluted weighted average common shares outstanding for the full year 2023 was 17,039,309 compared to 5,841,447 shares for the same period in 2022.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 the areas of rare disease and infectious disease. 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.

*Tonix’s product development candidates are investigational new drugs or biologics 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 as filed with the Securities and Exchange Commission (the “SEC”) 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.

 
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
 
    Year Ended
December 31,
    Three Months Ended
December 31,
 
    2023     2022     2023     2022  
REVENUE:                                
Product revenue, net   $ 7,768     $     $ 3,779     $  
                                 
COSTS AND EXPENSES:                                
Cost of revenue   $ 4,741     $     $ 2,367     $  
Research and development     86,655       81,876       17,120       24,674  
Selling, general and administrative     34,752       30,215       11,621       8,054  
      126,148       112,091       31,108       32,728  
                                 
Operating loss     (118,380 )     (112,091 )     (27,329 )     (32,728 )
                                 
Other income, net     1,722       1,873       7       1,048  
                                 
Net loss     (116,658 )     (110,218 )     (27,322 )     (31,680 )
                                 
Preferred stock deemed dividend           6,659             2,404  
                                 
Net loss available to common stockholders   $ (116,658 )   $ (116,877 )   $ (27,322 )   $ (34,084 )
                                 
Net loss per common share, basic and diluted   $ (6.85 )   $ (20.01 )   $ (0.86 )   $ (3.42 )
                                 
Weighted average common shares outstanding, basic and diluted     17,039,309       5,841,447       31,756,759       9,952,780  
 
See the accompanying notes to the condensed consolidated financial statements
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands)
(Unaudited)
 
    December 31, 2023
    December 31, 20221
 
Assets              
Cash and cash equivalents   $ 24,948     $ 120,229  
Inventory     13,639        
Prepaid expenses and other     9,181       10,548  
Total current assets     47,768       130,777  
Other non-current assets     106,689       94,913  
Total assets   $ 154,457     $ 225,690  
               
Liabilities and stockholders’ equity              
Total liabilities   $ 48,932     $ 18,508  
Stockholders’ equity     105,525       207,182  
Total liabilities and stockholders’ equity   $ 154,457     $ 225,690  
 
1The condensed consolidated balance sheet for the year ended December 31, 2022 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
 

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Zembrace® SymTouch® (sumatriptan Injection): IMPORTANT SAFETY INFORMATION

Zembrace SymTouch (Zembrace) 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:

Zembrace is 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 if you have:

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace 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 may cause serious side effects including:

The most common side effects of Zembrace include: pain and redness at injection site; 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.

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. For more information, ask your provider.

This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE

Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.

Tosymra® (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:

Tosymra is 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 is done and shows no problem.

Do not use Tosymra if you have:

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

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.

Tosymra may cause serious side effects including:

The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

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 Tosymra. For more information, ask your provider.

This is the most important information to know about 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 www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE
Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.

Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age.


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