Tonix (Nasdaq: TNXP) advances TNX-4800 Lyme prevention antibody on Phase 1 data
Rhea-AI Filing Summary
Tonix Pharmaceuticals Holding Corp. reported Phase 1 results and next-step plans for TNX-4800, a long-acting monoclonal antibody being developed to prevent Lyme disease. The single-dose subcutaneous treatment is designed to offer about four months of protection for people in Lyme-endemic U.S. regions.
The Phase 1 trial enrolled 44 healthy adults, with 41 completing, and showed TNX-4800 was generally safe and well tolerated across doses from 0.5 to 10 mg/kg, with most side effects mild or moderate. Pharmacokinetic data showed rapid absorption, long half-life of roughly two to three months, and serum levels remaining measurable for up to 12 months.
Based on these data, Tonix plans a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study using a fixed 350 mg dose. The primary goal is to test whether TNX-4800 prevents the first occurrence of confirmed Lyme disease over the four months after dosing, with a key secondary endpoint at six months. The company expects GMP clinical material in early 2027 and aims to start Phase 2 in the first half of 2027, pending FDA clearance, with a potential controlled human infection model study in 2028.
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Insights
Tonix advances TNX-4800 from supportive Phase 1 data into a planned Phase 2 Lyme disease prevention study.
Tonix Pharmaceuticals is progressing TNX-4800, a long-acting anti‑OspA monoclonal antibody, on the back of a 44‑subject Phase 1 trial showing acceptable safety and extended exposure. Mean half‑life of about 62–69 days supports a single seasonal dose concept.
The company selected a fixed 350 mg subcutaneous dose for Phase 2, targeting blood levels comparable to the 5 mg/kg Phase 1 cohort, which achieved around 10 μg/mL at four months, near the nonclinical Minimum Effective Concentration estimates. The planned randomized, double‑blind, placebo‑controlled adaptive design focuses on preventing first confirmed Lyme disease cases between Day 3 and Month 4.
Nonclinical work showed up to 95% protection in non‑human primates and durable exposure, but human efficacy is unproven. Execution now depends on timely FDA clearance, manufacturing GMP material expected in early 2027, and enrolling at‑risk individuals aged 16–65 in endemic U.S. regions. Subsequent disclosures on Phase 2 initiation and design details will shape how central TNX‑4800 becomes to the company’s broader CNS and immunology portfolio.
8-K Event Classification
Key Figures
Key Terms
adaptive Phase 2 field study medical
controlled human infection model (CHIM) medical
Minimum Effective Concentration (MEC) medical
borreliacidal medical
post-treatment Lyme disease syndrome (PTLDS) medical
OspA medical
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| Item 7.01 | Regulation FD Disclosure. |
On March 31, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced program updates on its TNX-4800 (formerly known as mAb 2217LS) product candidate for protection against Lyme disease. A copy of the press release that discusses these matters is furnished hereto as Exhibit 99.01, and is incorporated herein by reference. Copies of presentations that discuss these matters are furnished hereto as Exhibits 99.02 and 99.03, and are incorporated herein by reference.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.01, 99.02 and 99.03 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United States Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
On March 31, 2026, the Company announced program updates on its TNX-4800 product candidate for protection against Lyme disease, including the announcement that Phase 1 data of TNX-4800 was presented by Mark S. Klempner, MD, professor of medicine at UMass Chan Medical School, an inventor of TNX-4800 and principal investigator of the study, on March 30, 2026, at the World Vaccine Congress Washington 2026.
The Company also announced its strategy for a Phase 2 field study of TNX-4800, expected to initiate in the first half of 2027, pending U.S. Food and Drug Administration (“FDA”) clearance. The Company intends to study TNX-4800 in a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a single subcutaneous dose of TNX-4800, 350 mg, in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 4 following administration). A fixed dose of 350 mg was selected for the Phase 2 field study based on Phase 1 pharmacokinetic data, which dose (i) is expected to provide exposures comparable to the 5 mg/kg dose evaluated in the Phase 1 study and (ii) resulted in mean blood levels of 10 μg/ml at four months. Participants will include adolescents and adults 16 to 65 years of age in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease at four months (comparison of TNX-4800 group and placebo group). The key secondary endpoint will be the prevention of Lyme disease at six months (comparison of TNX-4800 vs. placebo).
The Company expects to have GMP investigational product available for clinical testing in early 2027. Additionally, if necessary and pending FDA clearance, the Company plans to initiate a controlled human infection model study in 2028.
The charts below set forth certain data from the Phase 1 trial for TNX-4800.
Observed Phase 1 Pharmacokinetics
TNX-4800 Phase 1: Variability of Serum Concentrations at Sampling Time Points Among Subjects in Each Dosing Cohort
Forward-Looking Statements
This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical trials, clinical and regulatory timelines and approvals and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibit No. |
Description. | ||
| 99.01 | Press Release of the Company, March 31, 2026 | |||
99.02 |
Corporate Presentation, March 31, 2026 | |||
| 99.03 | Presentation, March 30, 2026 | |||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirement 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. | |||
| Date: March 31, 2026 | By: | /s/ Bradley Saenger | |
| Bradley Saenger | |||
| Chief Financial Officer | |||
TONIX PHARMACEUTICALS HOLDING CORP 8-K
Exhibit 99.01
Tonix Pharmaceuticals Announces Presentation of Phase 1 Data and Outlines Planned Adaptive Phase 2 Field Study of TNX-4800 for the Prevention of Lyme Disease, at the World Vaccine Congress Washington 2026
TNX-4800 is a long-acting anti-Borrelia burgdorferi OspA human monoclonal antibody in development as a single-dose Lyme prophylactic
Phase 1 study of TNX-4800 demonstrated safety, tolerability, and pharmacokinetics supportive of approximately four months protection
Company expects to initiate a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA clearance
BERKELEY HEIGHTS, N.J., March 31, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced Phase 1 data of TNX-4800 (formerly known as mAb 2217LS)1,2 was presented by Mark S. Klempner, MD, professor of medicine at UMass Chan Medical School, an inventor of TNX-4800 and principal investigator of the study, on March 30, 2026, at the World Vaccine Congress Washington 2026. Tonix also announced its planned strategy for an adaptive Phase 2 field study expected to initiate in the first half of 2027, pending FDA clearance.
TNX-4800 is a long-acting borreliacidal (or bactericidal), human monoclonal antibody (mAb) with an engineered crystallizable fragment (Fc) domain for an extended half-life that targets the outer surface protein A (OspA) of Borrelia burgdorferi, which causes 99.9% of Lyme disease cases in the U.S.3,4 Tonix is developing TNX-4800, which the Company in-licensed from UMass Chan Medical School in 2025, as a prophylactic that is administered in a single subcutaneous (SC) dose expected to provide approximately four months protection to people in endemic areas during the U.S. tick season. There are currently no marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease.
“TNX-4800 is expected to provide a preventative option to the 87 million5 people in the United States who are at high risk of contracting the disease because they live, work, or vacation in a tick-endemic area,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “As a monoclonal antibody, we believe TNX-4800 offers significant advantages over vaccines in development. Lyme disease vaccines that elicit antibodies to OspA currently in development take more than six months to offer protection and require complex immunization schedules. A previously approved anti-OspA vaccine was withdrawn due to poor uptake,6 potentially relating to its complex immunization schedule.”
Dr. Lederman continued, “TNX-4800, targeting Borrelia burgdorferi, the serotype that causes 99.9% of Lyme disease in the U.S., is a single dose subcutaneous administration that potentially offers immunity within two days for a duration of approximately four months. We believe TNX-4800’s differentiating characteristics could offer meaningful improvements for people seeking protection from Lyme disease. We believe the Phase 1 pharmacokinetic (PK) data support our plan to conduct an adaptive field study in the first half of 2027, pending FDA clearance, in which protection at four months is the primary endpoint, and protection at six months is a key secondary endpoint.”
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Phase 1 Results
“Our study demonstrated potentially protective blood levels of TNX-4800 at two days, with protective blood levels sustained for at least four months due to its extended half-life design,” said Dr. Klempner. “Additionally, with its differentiated mechanism of action, TNX-4800 has the potential to provide passive immunity by directly supplying neutralizing antibodies, bypassing the need for a vaccine to induce a patient’s immune system to generate its own antibodies, which can be associated with other issues. We look forward to further clinical investigation of TNX-4800 as we strive to overcome this major public health challenge.”
The primary objective of the Phase 1 study was to evaluate the safety and tolerability of a SC injection of TNX-4800 when administered to healthy male and female subjects ages 19-65 years old. The secondary objective was to evaluate the PK of a SC dose of TNX-4800 when administered to healthy subjects. 44 subjects were enrolled, with 41 subjects completing the study. Subjects received a single SC administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg.
Results showed no significant clinical or laboratory safety signals, with most adverse events mild or moderate. Peak serum concentration (Cmax) increased by ~25-fold for a 20-times increase in dose. Serum TNX-4800 was measurable at earliest sampling time of two days, indicating rapid systemic absorption. TNX-4800 levels remained quantifiable for >200 days in 80% of subjects at the lowest dose, and for up to 350 days in the majority of subjects at higher doses (i.e., ≥ 1.5 mg/kg). The mean half-life ranged from 62-69 days across TNX-4800 cohorts. Serum concentrations were quantifiable for up to 12 months in most subjects.
| · | Mean exposure for the 10 mg/kg cohort had <17% of the highest exposures in a nonclinical toxicology study. |
| · | The maximum half-life ranged from 81-104 days, with the 10mg/kg cohort at 97 days and 5mg/kg cohort at 87 days. |
| · | In the 5mg/kg dose cohort, mean serum TNX-4800 concentration was approximately 10 μg/ml at four months, which was approximately twice the minimum effective concentration, or MEC, calculated from in vitro bactericidal activity, and approximately the MEC from in vitro tick-feeding experiments. These data support Tonix’s planned evaluation of protection at four months as the proposed primary endpoint. |
Adaptive Phase 2 Field Study Plans
Pending FDA clearance, the Company plans to initiate an adaptive field study in the first half of 2027. TNX-4800 will be studied in a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a single SC dose of TNX-4800, 350 mg, in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 4 following administration). Based on the Phase 1 PK data, a fixed dose of 350 mg was selected for the Phase 2 field study, which is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. Participants will include adolescents and adults 16 to 65 years of age in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease at four months (comparison of TNX-4800 group and placebo group). A key secondary endpoint will be the prevention of Lyme disease at six months (comparison of TNX-4800 and placebo).
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The Company expects to have GMP investigational product available for clinical testing in early 2027. Additionally, if necessary and pending FDA clearance, the Company plans to initiate a controlled human infection model (CHIM) study in 2028.
A copy of Dr. Klempner’s World Vaccine Congress Washington 2026 presentation is available under the Scientific Presentations tab on the Tonix website at https://www.tonixpharma.com/scientific-presentations. The Company’s TNX-4800 specific presentation can be found under the Presentations tab on the Investors section of the Tonix website at https://ir.tonixpharma.com/presentations.
About TNX-4800
TNX-4800 (formerly known as mAb 2217LS) is a long-acting borreliacidal (or bactericidal), human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on Lyme-causing Borrelia bacteria. When TNX-4800-containing blood is ingested by the tick, TNX-4800 kills and blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. The Company in-licensed TNX-4800 from UMass Chan Medical School in 2025. Published work in animals showed that TNX-4800 was 95% effective at preventing infection of non-human primates after six days of exposure to ticks infected with Borrelia burgdorferi.1 TNX-4800 was derived from mAb 2217 by amino acid substitutions in its Fc domain, which serve to prolong the serum half-life. A single administration is designed to potentially provide immunity against Lyme disease within two days and maintain protective antibody levels for approximately four months, without relying on the recipient’s immune system to generate antibodies. TNX-4800 also avoids the multidose priming schedules required for OspA vaccines in development7 and the FDA-approved vaccine that was withdrawn from the market.8
About the TNX-4800 Phase 1 Study
TNX-4800 was studied in a randomized, double-blind, sequential dose-escalation study (NCT04863287) that evaluated safety, tolerability, PK, and immunogenicity of TNX-4800 in healthy adults. 44 subjects were randomized, and 41 completed the study. Subjects received a single SC administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Safety was assessed via clinical and lab evaluations. Drug exposure increased by approximately 25 times for a 20-times increase in dose. Serum TNX-4800 was measurable at the earliest sampling time of two days, indicating rapid systemic absorption. TNX-4800 concentrations remained quantifiable for >200 days in 80% of volunteers at the lowest dose and for up to 350 days in the majority of volunteers at higher doses (i.e., ≥ 1.5 mg/kg). Mean half-life ranged from 62-69 days across groups. Serum concentrations remained quantifiable for up to 12 months in most subjects. Mean exposure for the 10 mg/kg cohort was less than 17% of the highest exposures in a rat toxicology study. Anti-drug antibodies were detected in <10% of treated subjects, with no impact on PK. Most adverse events were mild or moderate. TNX-4800 was determined to be generally safe and well tolerated.
About Lyme Disease
In the United States, Lyme disease is caused by the bacterium Borrelia burgdorferi. Lyme disease remains the most common vector-borne
infection in the United States, and its incidence is climbing each year, due in part to global changes in climate expanding the habitat
range for ticks.9 It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria
are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue,
and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, heart, and nervous system.
Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully
with antibiotics, diagnosis and treatment are often delayed or missed. Chronic Lyme is considered an Infection Associated Chronic Illness
(IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue, and other symptoms.10
Citations
1Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843.
2Wang Y, et al. J Infect Dis. 2016. 214(2):205-11.
3Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017-2024.
4Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556-564.
5Kugeler KJ, et al. Emerg Infect Dis. 2021. 27(2):616-619.
6 Nigrovic LE, et al. Epidemiol Infect. 2006. Aug 8;135(1):1-8.
7Comstedt P, et al. Vaccine. 2015 33(44):5982-8.
8Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8.
9Gomes-Solecki M, et. al. Clin Infect Dis. 2020 70(8):1768-1773.
10National Academies of Sciences, Engineering, and Medicine. 2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses. Washington, DC: The National Academies Press. https://doi.org/10.17226/28578.
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Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. In addition, the Company’s CNS portfolio includes TNX-2900 (intranasal oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.
*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. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
About UMass Chan Medical School
UMass Chan Medical School, one of five campuses of the University of Massachusetts system, comprises the T.H. Chan School of Medicine, the Morningside Graduate School of Biomedical Sciences, the Tan Chingfen Graduate School of Nursing, ForHealth Consulting at UMass Chan Medical School, MassBiologics, and a thriving Nobel-Prize-winning biomedical research enterprise. UMass Chan is advancing together to improve the health and wellness of our diverse communities throughout Massachusetts and across the world by leading and innovating in education, research, health care delivery and public service. It is ranked among the best medical schools in the nation for primary care education and biomedical research by U.S. News & World Report. Learn more at www.umassmed.edu.
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Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. 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 successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; 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 in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. 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 Contacts
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599
Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com
Media Contacts
Deborah Elson
Tonix Pharmaceuticals
deborah.elson@tonixpharmaceuticals.com
Ray Jordan
Putnam Insights
ray@putnaminsights.com
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
EXHIBIT 99.02
© 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800: A Long - Acting , Borreliacidal (Bactericidal), Human Monoclonal Antibody to Prevent Lyme Disease in the U.S. NASDAQ: TNXP March 31, 2026 PO6131 March 31, 2026 1648
2 © 2026 Tonix Pharmaceuticals Holding Corp. Cautionary Note on Forward - Looking Statements Certain statements in this presentation 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 successfully launch and commercialize TONMYA ® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; 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, 2025, as filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2026, 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.
3 © 2026 Tonix Pharmaceuticals Holding Corp. Addressing the Significant Public Health Challenge of Lyme Disease in the U.S. Manufacturing GMP Material for Human Studies Currently on Track for Early 2027 Plan to Initiate Adaptive Phase 2 Field Study, Pending FDA Clearance Plan to Initiate CHIM (Controlled Human Infection Model) Study, If Necessary 2026 1H 2027 2028 x Phase 1 study complete, showing favorable safety, tolerability, immunogenicity, and pharmacokinetics
4 © 2026 Tonix Pharmaceuticals Holding Corp. 1. U.S. Centers for Disease Control and Prevention. National Notifiable Diseases Surveillance System; maps. February 11, 2025 . A ccessed July 18, 2025. https://www.cdc.gov/lyme/data - research/facts - stats/surveillance - data - 1.html. 2. U.S. Centers for Disease Control and Prevention. National Notifiable Diseases Surveillance System; graphs: annual cases. F ebr uary 11, 2025. Accessed July 18, 2025. https://www.cdc.gov/lyme/data - research/facts - stats/surveillance - data - 1.html 3. Rodino KG, et al. J Clin Microbiol . 2025:e0080723. Lyme Disease: Epidemiology in the U.S. Images from CDC NNDSS Lyme disease is reported most often in the Northeast and Midwest, with 95% of cases coming from “high - incidence” areas 1 1995 2023 The range of Lyme disease is expanding 1 0 50000 100000 1996 Criteria: erythema migrans or clinical presentation of late Lyme with laboratory confirmation 2008 Criteria: added reporting of “probable” cases and refined criteria for laboratory confirmation 2022 Criteria: removed requirement for clinical information in “high - incidence” areas Lyme disease is an increasing problem 2 The actual prevalence of Lyme disease is estimated to be 8 to 12 times higher than reported. 3 In 2022, more sensitive surveillance criteria resulted in a 67% increase in reported cases 2 CDC=Centers for Disease Control and Prevention; NNDSS=National Notifiable Diseases Surveillance System.
5 © 2026 Tonix Pharmaceuticals Holding Corp. Clinical Presentation: Acute Lyme Disease Headache Fever/Chills Fatigue Swollen Lymph Nodes Joint and Muscle Ache Erythema Migrans Rash There are 3 stages of Lyme disease: early, early disseminated, and late 1 Early, or acute, Lyme disease has many signs or symptoms 1,2 Erythema migrans rash is a hallmark symptom of early Lyme disease, occurring in 70% to 80% of people 1,2 • Begins at site of tick bite and expands up to 12 inches in diameter • Development is delayed, with an average of 7 days after bite • Sometimes has a “bull’s - eye” appearance 1. Cleveland Clinic. Updated August 16, 2022. Accessed July 18, 2025. https://my.clevelandclinic.org/health/diseases/11586 - lyme - disease. 2. U.S. Centers for Disease Control and Prevention. May 15, 2024. Accessed July 18, 2025. https://www.cdc.gov/lyme/signs - symptoms/index.html.
6 © 2026 Tonix Pharmaceuticals Holding Corp. c c c c Current Landscape f or Lyme Disease Prophylaxis a nd Treatment U.S. population where Lyme disease is endemic is estimated to be 87 million 1 Recommendations for pre - exposure prevention focus on tick bite avoidance. No vaccine is currently on the market 2 - 5 Presently available post - exposure prophylaxis is limited to antibiotic regimens, typically doxycycline. 6 Extended use of antibiotics has recognized side effects 5 Approximately 10 - 20% of Lyme disease patients experience long - term sequelae including Post - Treatment Lyme Disease Syndrome (PTLDS) 6,7 87 m 1. Kugeler KJ, et al. Emerg Infect Dis. 2021;27(2):616 - 619. 2. U.S. Centers for Disease Control and Prevention. May 15, 2024. Accessed July 18, 2025. https://www.cdc.gov/lyme/signs - symptom s/index.html. 3. https://www.idsociety.org/practice - guideline/lyme - disease/o. 4. Chan PA, et al.. Sex Transm Dis . 2023 50(11):701 - 712. 5. Lantos PM et al, Clinical Infectious Diseases , 72,(1) 2021, Pages e1 – e48. 6. Zafar K, et al. Front Microbiol . 2024;15:1459202. 7. Melia M.T. N Engl J Med. 2016;374:1277 – 1278.
7 © 2026 Tonix Pharmaceuticals Holding Corp. c c Lyme Disease in the U.S. and Europe are Caused by Different Borrelia • >99.9% caused by B. burgdorferi sensu stricto ( s.s. ) 1,2 • U.S. B. burgdorferi minimal genetic variability 3 • Incidence is seasonal in summer months 3 1. Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017 - 2024. 2. Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556 - 564. 3. Lemieux JE, et al. PLoS Pathog . 2023.19(8):e1011243. 4. Nigrovic LE, et al. Epidemiol Infect. 2006. Aug 8;135(1):1 - 8. • Caused by a diverse group of serotyptes 1 • Serotypes are ( B. afzelii , B. garinii , B. bavariensis , etc.) • Lyme disease “Season” varies, based on country and climate • The only approved U.S. vaccine was directed to B. burgdorferi OspA • SmithKline Beecham’s LYMErix vaccine had ~70 - 80% protection, but was withdr awn from the market 4 U.S. E.U.
8 © 2026 Tonix Pharmaceuticals Holding Corp. B. b urgdorferi Bacteria Are Transmitted t o Humans v ia Tick Salivary Glands 1 • The outer membrane protein OspA supports B. burgdorferi survival in the tick midgut via adherence 1 - 3 • Once the tick bites a host, the iron in a blood meal downregulates Osp A, and bacteria migrate from the midgut to the salivary glands for transmission 1 - 3 • While OspA is essential for transmission, it is only expressed within infected ticks, and levels seen in the human host are insufficient for seroconversion (antibody production) 4 B. burgdorferi Outer lipid membrane OspA/ OspC Outer membrane protein Lipoprotein BamA Bam=β - barrel assembly machinery; Osp =outer surface lipoprotein. Blood meal Host Midgut Salivary glands 1. de Silva AM, et al. J Exp Med . 1996;183(1):271 - 275. 2. Radolf JD, et al. Nat Rev Microbiol . 2012;10(2):87 - 99. 3. Anderson C, et al. Pathogens. 2021;10(3):281. 4. Woodman ME, et al. FEMS Immunol Med Microbiol . 2008;54(2):277 - 282. B. burgdorferi transmission via tick saliva
9 © 2026 Tonix Pharmaceuticals Holding Corp. OspA Facilitates Bacterial Adherence to the Tick Midgut, and Downregulation Promotes Migration to Salivary Glands for Transmission 1 - 3 Midgut Salivary glands Migration Adherence Osp =outer surface lipoprotein. 1. de Silva AM, et al. J Exp Med . 1996;183(1):271 - 275. 2. Radolf JD, et al. Nat Rev Microbiol . 2012;10(2):87 - 99. 3. Anderson C, et al. Pathogens. 2021;10(3):281. Migration Blood meal Iron - dependent OspA downregulation Midgut OspA Transmission Mouthpiece Salivary glands Mouthpiece
10 © 2026 Tonix Pharmaceuticals Holding Corp. Circulating Anti - O spA Monoclonal Antibody (TNX - 4800) Ingested by Tick Blocks B. b urgdorferi Transmission From Tick to Human 1 B. burgdorferi Outer lipid membrane OspA/ OspC Outer membrane protein Lipoprotein BamA Bam=β - barrel assembly machinery; Fc=fragment crystallizable; Osp =outer surface lipoprotein. • TNX - 4800 is a human monoclonal antibody against OspA 1 • An Fc region mutation in TNX - 4800 extends its half - life : a single administration provide s protection during the months of high infection risk • If a tick bites a human immunized with TNX - 4800, anti - OspA antibodies enter the tick midgut and bind to OspA on B. burgdorferi spirochetes 2,3 • After TNX - 4800:OspA binding, bacteria are killed or fail to migrate from the midgut to salivary glands, preventing transmission t o the human host 2 1 Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. 2. de Silva AM, et al. J Exp Med . 1996;183(1):271 - 275. 3. Radolf JD, et al. Nat Rev Microbiol . 2012;10(2):87 - 99. Host Midgut Salivary glands B. b urgdorferi can’t migrate to salivary glands, transmission fails Blood meal
11 © 2026 Tonix Pharmaceuticals Holding Corp. Antibodies Can Be Created Endogenously o r Received From Exogenous Sources Active c c Natural Engineered Passive c c Natural Engineered Pathogen Exposure Vaccines Maternal Antibodies Monoclonal Antibodies Infection with a pathogen stimulates the immune system to create antibodies Injection of weakened pathogens or pathogen components stimulates the immune system to create antibodies Breast milk contains maternal antibodies that support underdeveloped infant immune systems Monoclonal antibodies may be infused or delivered subcutaneously including in patients who require additional immune support Active immunity necessitates the creation of endogenous antibodies, while passive immunity entails the transfer of external antibodies U.S. Centers for Disease Control and Prevention. July 30, 2024. Accessed July 15, 2025. https://www.cdc.gov/vaccines/basics/i mmu nity - types.html
12 © 2026 Tonix Pharmaceuticals Holding Corp. Introducing TNX - 4800 TNX - 4800 1 is a human anti - OspA monoclonal antibody with engineered Fc domain for extended half - life, licensed from UMass Chan Medical School in 2025 c Single Injection Patient receives one subcutaneous dose expected to provide ≥ 4 months protection c Tick Attaches Infected tick feeds on protected individual c Antibody Ingested TNX - 4800 enters tick midgut via blood meal c OspA Binding Antibody binds OspA on Borrelia Expected Mechanism of Action c Transmission Blocked Bacteria killed or trapped in midgut — cannot reach human tissue TNX - 4800 provides passive immunity by directly supplying neutralizing antibodies, bypassing the need for a patient’s immune system to generate its own antibodies 1. TNX - 4800 is an investigational biologic and is not approved for any indication.
13 © 2026 Tonix Pharmaceuticals Holding Corp. Clinical and Market Acceptance o f Monoclonal Antibody Preventive Treatments Monoclonal antibody prophylaxis has been approved for respiratory syncytial virus (RSV) and COVID - 19, including ENFLONSIA , 1 BEYFORTUS ® , 2 and PEMGARDA 3 1. Enflonsia . Prescribing information. Merck Sharp & Dohme LLC; 2025. 2. Beyfortus . Prescribing information. Sanofi; 2024. 3. Pemgarda . Prescribing information. Invivyd , Inc.; 2025.
14 © 2026 Tonix Pharmaceuticals Holding Corp. Not All anti - OspA mAbs are Bactericidal 1. Embers ME, et al. Vaccine . 2026 75:128231. doi : 10.1016/j.vaccine.2026.128231. 2. Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. 3. LYMErix was full length OspA aa 20 - 273 from B. burgdorferi strain B31produced in E. Coli 4. VLA15 modifies the B31 OspA sequence to remove the putative arthritogenic/LFA - 1 – mimicking epitope (~aa 165 – 173) Bactericidal OspA Epitope 1,2 Name C - terminus Central Domain N - terminus Vaccine Antibody ~aa 165 – 173 - + 184.1 + + TNX - 4800 + + LA - 2 + + + + + LYMErix + + - + + VLA15 • Monoclonal anti - OspA antibodies can be bactericidal • In a series of mAbs , only those directed towards the C - terminal and central domains manifested bactericidal activity in vitro , and prevention of transmission in vivo 1 • For example, mAbs TNX - 4800 (2217) (central domain) 2 and LA - 2 ( C - terminal) are bactericidal • N - terminal anti - OspA antibodies can be inactive • 184.1 is an example of a non - bactericidal mAb that binds the N - terminal region
15 © 2026 Tonix Pharmaceuticals Holding Corp. Comparison of TNX - 4800 with VAL15, mRNA - 1975, and mRNA1982 1. Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017 - 2024. doi : 10.3201/eid2708.204763. 2. Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556 - 564. doi : 10.1016/S1473 - 3099(15)00464 - 8. 3. Lemieux JE, et al. PLoS Pathog . 2023.19(8):e1011243. doi : 10.1371/journal.ppat.1011243. 4. Comstedt P, et al. PLoS One . 2014 9(11):e113294. doi : 10.1371/journal.pone.0113294. *VLA15 contains 3 OspA’s from different garinii genospecies. mRNA - 1982 mRNA - 1975 VLA15 TNX - 4800 Moderna Moderna Pfizer/Valneva Tonix Sponsor Phase 1/2 Phase 1/2 Phase 3 Phase 2 - ready Status mRNA mRNA Vaccine – alum adjuvant Monoclonal Antibody Type Active Active Active Passive Immunity EU + Asia U.S. EU + U.S. U.S. Target Market B. burgdorferi (U.S.) B. afzelii (Europe) B. garinii (Europe) B. bavariensis ( OspA type 4) (Europe) B. garinii ( OspA type 5 and 6 variants)(Asia) B. spielmanii B. burgdorferi (U .S.) B. burgdorferi (U.S.) B. afzelii (Europe) B. garinii * (Europe) B. Bavariensis (Europe) B. burgdorferi (U .S.) Borrelia targeted 1 - 4
16 © 2026 Tonix Pharmaceuticals Holding Corp. Comparison of TNX - 4800 with Alum - Adjuvanted Subunit Vaccines LYMErix (Withdrawn) and VLA15 (in Development) in Terms of OspA Targeting 1. Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017 - 2024. doi : 10.3201/eid2708.204763. 2. Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556 - 564. doi : 10.1016/S1473 - 3099(15)00464 - 8. 3. Lemieux JE, et al. PLoS Pathog . 2023.19(8):e1011243. doi : 10.1371/journal.ppat.1011243. 4. Comstedt P, et al. PLoS One. 2014 9(11):e113294. doi : 10.1371/journal.pone.0113294. *VLA15 contains 3 OspA’s from different garinii genospecies. VLA15 1 - 4 LYMErix 1 - 4 TNX - 4800 Pfizer/Valneva SmithKline (GSK) Tonix Sponsor In Development Withdrawn In Development Status Vaccine Vaccine Monoclonal Antibody Type Active Active Passive Immunity EU + U.S. U.S. U.S. Target Market EU + U.S. U.S. U.S. Clinical Trials B. burgdorferi (U.S.) B. afzelii (Europe) B. garinii * (Europe) B. Bavariensis (Europe) B. burgdorferi (U.S.) B. burgdorferi (U .S.) Borrelia targeted
17 © 2026 Tonix Pharmaceuticals Holding Corp. Comparison of TNX - 4800 with Alum - Adjuvanted LYMErix and VAL15 Administration Protocol and Intended Timing (Onset and Duration) of Protection 1. Comstedt P, et al. PLoS One. 2014 9(11):e113294. doi : 10.1371/journal.pone.0113294 2. VALOR study missed primary endpoint – Pfizer press release March 23, 2026. VLA15 1 LYMErix (Withdrawn) TNX - 4800 Pfizer/Valneva SmithKline (now GSK) Tonix Sponsor Day 1 Day 1 Day 1 1 st dose 2 months 1 month - 2 nd dose 5 - 9 months 12 months - 3 rd dose 12 months - - 4th dose Seasonal Seasonal At least ~four months Protection duration After 4 th shot 2 After 3 rd shot Within 2 days Protection onset • TNX - 4800 is expected to be protective within 2 days • Based on human pharmacokinetics and animal models • Lyme vaccines typically take >6 months to be protective • Depend on high - titer antibodies • Require annual boosters • Complex immunization schedule may have contributed to poor LYMErix uptake
18 © 2026 Tonix Pharmaceuticals Holding Corp. Comparison of TNX - 4800 (Monoclonal Antibody) and VLA15 ( Vaccine) : Administration Protocol and Intended Timing (Onset and Duration) of Protection VLA15 4,5 TNX - 4800 ( mAb ) 1,2 Criteria Pre - exposure 4 - dose vaccination regimen Pre - exposure single - dose mAb Treatment mode > 1 year post 4 th intramuscular (IM) dose 3 Within 2 days following subcutaneous (SC) dose Onset of maximal protection General populations who do not need immediate protection General population Populations with short - term trips/summer vacations/deployments to endemic areas Target patient population The VLA15 vaccine reportedly covers 6 serotypes prevalent in North America and Europe Designed to cover B. burgdorferi Activity Multiple doses needed to obtain initial protection with seasonal durability Single dose expected to provide approximately four months protection Dosing regimen IM SC Dosing route OspA - targeted vaccines induce immune responses (associated with side effects), and include polyclonal antibody responses (that may have off - target effects) Anticipated low safety risk like other fully human mAbs for which there is considerable experience Does not recognize the putative arthritogenic T - cell epitope Risks 1. Wang Y, et al. J Infect Dis. 2016. 214(2):205 - 11. 2. Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. 3. VALOR study missed primary endpoint – Pfizer press release March 23, 2026. 4. Proposed attributes – not yet finalized or validated 5. https://valneva.com/research - development/lyme - disease. Data on file. Proposed attributes – not yet finalized or validated IM=intramuscular; mAb =monoclonal antibody; Osp =outer surface protein
19 © 2026 Tonix Pharmaceuticals Holding Corp. Comparison of TNX - 4800 and VLA15 Lyme Preventatives in Development • TNX - 4800 is a long - acting humanA mAb (in development) against B. burgdorferi OspA • Bactericidal monoclonal antibody • TNX - 4800 showed EC 50 ≈ 0.56 μ g/mL in vitro 1 • Planned testing exclusively targets U.S. serotype ( Borrelia burgdorferi ) • Safety studies, field testing, and marketing approval, if any, planned for U.S. only • Pfizer/Valneva’s VLA15 (in development) is a vaccine that elicits antibodies against 6 different Borrelia OspAs 2 • Vaccine that elicits polyclonal antibodies to six OspA - derived peptide antigens • Field tests in EU and the U.S. • 5 of 6 OspA antigens in VLA15 are European serotypes: • B. afzelii (one serotype), B. garinii (3 serotypes), B. bavariensis (one serotype) • 1 of 6 OspA antigens in VLA15 is US: Borrelia burgdorferi sensu stricto ( s.s. ) 1. Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843.(TNX - 4800 has EC 50 = 3.71 ± 2.81 nM ) 2. Comstedt P, et al. PLoS One. 2014 9(11):e113294. doi : 10.1371/journal.pone.0113294.
20 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Binds t o a Specific Epitope o n OspA to Avoid Off - Target Effects 178 - 273 71 - 141 TNX - 4800 e pitope 165 - 173 Putative arthritogenic T - cell epitope (YVLEGTLTA), mimicking LFA - 1 178 - 273 OspA Protein 1. S teere AC, et al. Arthritis Rheum . 2003;48(2):534 - 540. 2. Nigrovic LE, Thompson KM. Epidemiol Infect. 2007 135(1):1 - 8. 3. Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. • An epitope in the OspA protein mimics human leukocyte function – associated antigen 1 (hLFA - 1 or LFA - 1) 1 • Antibodies to the LFA - 1 - like epitope can trigger an arthritogenic autoimmune condition 1,2 • LYMErix was withdrawn from the market in part over unsubstantiated claims of this concern 2 • TNX - 4800 does not bind to this epitope and instead binds to the 71 - 141 region, which has no human homologue and does not carry the same risk 3 • This advantage of TNX - 4800 may extend to individuals who have experienced previous infections and/or carry allelic genotype predispositions ( HLA - DRB1*0401 ) to autoimmune arthritis 1 OspA TNX - 4800 LFA - 1 LFA - 1 OspA TNX - 4800 TNX - 4800 Osp =outer surface lipoprotein.
21 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Target Product Profile (TPP)* Target Variable Pre - exposure prophylactic against Lyme disease Primary Indication Blood levels sufficient to provide protection within 2 - 3 days and maintained efficacy for ≥ four months Consistent with bacterial - targeted, fully human mAbs Clinical Pharmacology Consistent with bacterial - targeted, fully human mAbs Nonclinical Toxicology Adolescents and adults 16 - 65 initially, then ≥6 months old Persons at risk living in or traveling to endemic areas Patient Population None Limitations of Use in Specific Populations Single dose Expected to provide approximately four months protection Duration of protection SC injection Delivery Mode Protection against the transmission of Lyme disease from an infected tick ≥80% efficacy* Efficacy 2 o C to 8 o C Storage Requirements None Drug Interactions United States Target Jurisdictions Consistent with fully human mAbs directed against bacterial antigen with no human homologue Safety Profile Risks/Side Effects Warnings and Precautions Adverse Reactions None currently Contraindications *Subject to change and to FDA approval mAb =monoclonal antibody; mg=milligrams; SC=subcutaneous.
22 © 2026 Tonix Pharmaceuticals Holding Corp. Engineered Fc Mutations Extend Half - Life of TNX - 4800 (2217LS) in Nonhuman Primates Relative to mAb 2217 1 1 Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. N=4 for each group and each dot represents one monkey. Half - lives are reported in days and hours as mean ± SD (line) Fc=fragment crystallizable.
23 © 2026 Tonix Pharmaceuticals Holding Corp. Analysis of Minimum Effective Concentration (MEC) #1 – in vitro Bactericidal Activity 1. Wang Y, et al. J Infect Dis. 2016. 214(2):205 - 11. 2. Rogers RR et al , Antimicrobial Agents and Chemotherapy , Oct. 2004, p. 3670 – 3676 • TNX - 4800 showed EC 50 ≈ 0.56 μ g/mL in vitro 1 • MEC ~ 10X EC 50 2 • Conclusion: MEC ~ 5 μ g/mL – based on in vitro bactericidal activity
24 © 2026 Tonix Pharmaceuticals Holding Corp. Analysis of Minimum Effective Concentration (MEC) #2 Tick Feeding Method The monoclonal anti - OspA antibody TNX - 4800 (2217LS) inhibits tick - to - blood transmission of B. burgdorferi B31 - 5A4 in a dose - dependent manner in an artificial membrane feeding system I r r e l e v a n t A b O s p A S e r a 0 . 6 2 5 2 . 5 5 1 0 2 0 4 0 10 0 10 2 10 4 10 6 B a c t e r i a l b u r d e n ( c o p i e s / 1 0 0 n g D N A ) * * * * ug 2217LS/mL blood Blood 5dpf Data on file. N=5 Asterisk * = statistically significant Methods described in: Kröber T, Guerin PM. Trends Parasitol . 2007 23(9):445 - 9.
25 © 2026 Tonix Pharmaceuticals Holding Corp. Analysis of Minimum Effective Concentration (MEC) #3 – in vivo Primate Challenge Model
26 © 2026 Tonix Pharmaceuticals Holding Corp. Nonhuman Primate Challenge Model: Protocol and Protection by Dosage Level Day - 7 0 6 14 21 28 45 63 Serum Collection 1 Jacket Acclimation Tick Challenge Tissue Biopsy Culture Observations HuMAb Injection Study Design 1 : Results: • 4 dosing cohorts, 1 irrelevant IgG control • 4 to 6 animals per cohort • Seroconversion for IgG antibodies against B. burgdorferi was measured as an indicator of efficacy Irrelevant IgG Cohort 4 Cohort 3 Cohort 2 Cohort 1 Cohort 10 90 30 10 3 Dose (mg/kg) 0 100 100 83 100 Protection (%) N/A <0.001 <0.001 <0.001 <0.001 P value 1. Schiller ZA, et al. J Clin Invest . 2021;131(11):e1144843. HuMAb =human monoclonal antibody; IgG=immunoglobulin G.
27 © 2026 Tonix Pharmaceuticals Holding Corp. Primate Challenge Model 1. Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. • Infected ticks were placed on each non - human primate administered TNX - 4800 (N=20) for 6 days 1 • Only 1 in 20 became infected (95% protection)
28 © 2026 Tonix Pharmaceuticals Holding Corp. Analysis of Minimum Effective Concentration (MEC) 1 Wang Y, et al. J Infect Dis. 2016. 214(2):205 - 11. 2 Rogers RR et al , Antimicrobial Agents and Chemotherapy, Oct. 2004, p. 3670 – 3676 3 Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. Three methods: • Serum ~ 5 μ g/mL – in vitro bactericidal activity • TNX - 4800 showed EC 50 ≈ 0.56 μ g/mL in vitro 1 • MEC ~ 10X EC 50 2 • Serum <10 μ g/mL – in vitro tick feeding experiment • TNX - 4800 showed killing ≥ 10 μ g/ml 3 • Serum <21 μ g/mL – in vivo primate challenge model • TNX - 4800 serum levels >21 μ g/ml were 95% protective 1,3
29 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800: Nonclinical Safety Data • cGLP Tissue Cross Reactivity study in rat and human tissues • No significant cross - reactivity • Non - GLP pharmacokinetic and tick challenge studies in monkeys • Did not reveal a safety signal • cGLP 5 - week multiple dose study with 4 - week recovery in rats and a cGLP single dose local tolerance study in rats • Observed abnormalities were mild to moderate and all findings were judged non aversive (hematologic and ALT, AST ALP and APTT increases (notably without bilirubin changes), injection site inflammation, liver and spleen organ weight increases, liver histopathology, primarily in males. All findings were reversible) • Exposure in Phase 1 study was multiples relative to NOAEL in rats • Starting dose: 63 - to 242 - fold lower • Highest dose: 3 - to 12 - fold lower cGLP = clinical good laboratory practice, ALT = alanine transaminase, AST = aspartate aminotransferase, AP = alkaline phosphatase, A PTT = activated partial thromboplastin time, NOAEL = No - observed - adverse - effect level Once weekly administration of TNX - 4800 (intravenous or subcutaneous) for 4 weeks followed by a 35 - day recovery period in male an d female Sprague Dawley rats was tolerated at doses of up to 500 mg/kg/week intravenous or 300 mg/kg/week SC with no adverse findings. Therefore, under the co ndi tions of this study, 500 mg/kg/week intravenous or 300 mg/kg/week SC was considered to be the NOAEL.
30 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Phase 1 Study Overview Primary Objective : • Evaluate safety and tolerability of a SC injection of TNX - 4800 (2217LS) when administered to healthy subjects Secondary Objective : • Evaluate pharmacokinetics of a SC dose of TNX - 4800 (2217LS) when administered to healthy subjects Study Population : • Healthy male and female subjects, age 19 to 65 years, inclusive
31 © 2026 Tonix Pharmaceuticals Holding Corp. Human Phase 1 Study: Safety, Tolerability and Immunogenicity: Design Sullivan - Bólyai JZ, et al. Manuscript in progress. 2025. • First - in - human, randomized, double - blind, sequential dose - escalation study (N=44) • Healthy male and female subjects aged 19 to 65 years, serum negative for anti – B. burgdorferi antibodies, by an FDA - approved modified 2 - tier ELISA test, were recruited • Safety was assessed via clinical and lab evaluations • Serum TNX - 4800 concentrations were measured by ELISA, with pharmacokinetic analysis • Antidrug antibodies were detected using an electrochemiluminescence immunoassay 1.5 mg/kg 2217LS (N=8) Completed (N=41) Enrolled (N=44) 0.5 mg/kg 2217LS (N=10) 5.0 mg/kg 2217LS (N=8) Cohort 1 Cohort 2 Cohort 3 10 mg/kg 2217LS (N=8) Placebo (N=10) Cohort 4
32 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Phase 1 Study Results • No significant clinical or laboratory safety signals • The mean exposure, based on AUC - inf and C max for Cohort 4 (10mg/kg), was less than 17% of the highest exposures in the rat toxicology study • Serum TNX - 4800 (2217LS) was measurable at the earliest sampling time of 2 days indicating rapid absorption • For all cohorts C max was observed at 10 - 13 days followed by a prolonged elimination phase • Apparent terminal T ½ after 10 mg/kg dose was 64 days • Max T ½ ranged from 81 - 104 days: • 10mg/kg - 97 days, 5mg/kg - 87 days, 1.5mg/kg - 104 days, 0.5mg/kg - 81 days • Cohort 3 (5mg/kg) serum concentrations: • 10 μ g/ml at 4 months (~ in vitro tick - feeding MEC and > ~ in vitro MEC)
33 © 2026 Tonix Pharmaceuticals Holding Corp. Observed Phase 1 Pharmacokinetics 5 μ g/ml – in vitro ~10x EC 50 10 μ g/ml – in vitro MEC tick feeding 120 days 180 days Each point represents a mean for the cohort at the specified timepoint and dose
34 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Phase 1: Variability of Serum Concentrations at Sampling Time Points Among Subjects in Each Dosing Cohort Each point represents a mean for the cohort at the specified timepoint and dose The profiles for 1.5 mg/kg, 5 mg/kg and 10 mg/kg TNX - 4800 (2217LS) are shifted to the right for ease of reaching
35 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Phase 1 Pharmacokinetics Parameters Each point represents a mean for the cohort at the specified timepoint and dose 10 mg/kg 2217LS 5 mg/kg 2217LS 1.5 mg/kg 2217LS 0.5 mg/kg 2217LS Pharmacokinetic Parameters 165500000 (26.0) [n=8] 79760000 (36.5) [n=8] 20610000 (23.7) [n=8] 6271000 (26.0) [n=10] AUC0 - t (ng* hr /mL) 168100000 (25.9) [n=8] 82070000 (37.2) [n=8] 21490000 (23.5) [n=8] 6812000 (25.3) [n=10] AUC0 - inf (ng* hr /mL) 1.494 ± 0.49258 [n=8] 2.805 ± 1.3920 [n=8] 4.103 ± 1.6271 [n=8] 7.832 ± 4.8735 [n=10] AUC%ext (%) 84560 (37.5) [n=8] 45650 (22.0) [n=8] 10880 (41.3) [n=8] 3397 (31.4) [n=10] Cmax (ng/mL) 108.050 (48.00, 167.78) [n=8] 108.319 (71.98, 216.06) [n=8] 144.019 (95.95, 215.95) [n=8] 96.075 (72.00, 335.91) [n=10] Tmax ( hr ) 0.0004751 ± 0.000072023 [n=8] 0.0005851 ± 0.00037231 [n=8] 0.0004258 ± 0.000060386 [n=8] 0.0004984 ± 0.00025308 [n=10] Kel (1/hr) 1491 ± 244.47 [n=8] 1516 ± 655.84 [n=8] 1658 ± 243.26 [n=8] 1614 ± 533.84 [n=10] t½ ( hr ) 0.06121 ± 0.015541 [n=8] 0.06474 ± 0.025934 [n=8] 0.07151 ± 0.017398 [n=8] 0.07557 ± 0.020144 [n=10] CL/F (mL/ hr /kg) 133.0 ± 44.405 [n=8] 123.7 ± 29.838 [n=8] 170.1 ± 47.286 [n=8] 171.2 ± 61.264 [n=10] Vd /F (mL/kg) 0.5 mg/kg 2217LS: A single subcutaneous injection of 0.5 mg/kg 2217LS, Cohort 1 1.5 mg/kg 2217LS: A single subcutaneous injection of 1.5 mg/kg 2217LS, Cohort 2 5 mg/kg 2217LS: A single subcutaneous injection of 5 mg/kg 2217LS, Cohort 3 10 mg/kg 2217LS: A single subcutaneous injection of 10 mg/kg 2217LS, Cohort 4 AUCs and Cmax are presented as geometric mean (geometric CV%). Tmax values are presented as median (min, max). Other parameters are presented as arithmetic mean ± SD. Source: Tables 14.2.1.5 through 14.2.1.8 Program: /CA29655/ sas_prg / pksas / adam_intext_pkparam.sas 13FEB2023 9:20
36 © 2026 Tonix Pharmaceuticals Holding Corp. Phase 1 Clinical Trial Summary Results • TNX - 4800 studied in randomized, double - blind, sequential dose - escalation study (NCT04863287) to evaluate its safety, tolerability, pharmacokinetics and immunogenicity • 44 healthy adult subjects randomized and 41 completed study; subjects received a single subcutaneous (SC) administration of placebo or TNX - 4800 at 0.5, 1.5, 5, or 10 mg/kg • Peak serum concentration ( C max ) increased by ~25 - fold for a 20 - times increase in dose • Serum TNX - 4800 measurable at earliest sampling time of 2 days, indicating rapid systemic absorption • TNX - 4800 levels remained quantifiable for >200 days in 80% of subjects at lowest dose and for up to 350 days in majority of participants at higher doses (i.e., ≥ 1.5 mg/kg) • Mean half - life ranged from 62 – 69 days across TNX - 4800 groups; serum concentrations quantifiable for up to 12 months in most subjects; mean exposure for 10 mg/kg group <17% of the highest exposures in a nonclinical toxicology study • Anti - drug antibodies (ADA) detected in <10% of treated subjects, with no impact on pharmacokinetics • Most adverse events were mild or moderate 1 • TNX - 4800 determined to be generally safe and well tolerated 1. One serious adverse event deemed unrelated to study drug .
37 © 2026 Tonix Pharmaceuticals Holding Corp. Planned Phase 2 Field Trial • TNX - 4800 intended to be studied in an adaptive randomized, double - blind, placebo - controlled study, pending FDA clearance • Goal: To evaluate the efficacy and safety of TNX - 4800 in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 4 following administration) • Inclusion: Adolescents and adults 16 to 65 years of age from Lyme - endemic areas in the U.S. • Primary endpoint: Prevention of Lyme disease at four months (comparison of TNX - 4800 group and placebo group) • Key secondary endpoint: Prevention of Lyme disease at six months (comparison of TNX - 4800 vs. placebo) • Dose: A single SC dose of placebo or TNX - 4800 350 mg • Rationale: TNX - 4800 5 mg/kg dose resulted in mean blood levels of 10 μ g/ml at four months 1 1. Average patient is assumed to be approximately 70kg.
38 © 2026 Tonix Pharmaceuticals Holding Corp. Phase 2 Ready: Clinical Development Plans for TNX - 4800 Pending FDA Clearance Manufacturing GMP Material for Human Studies Currently on Track for Early 2027 Plan to Initiate Adaptive Phase 2 Field Study, Pending FDA Clearance Plan to Initiate CHIM Study, If Necessary 2026 1H 2027 2028
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TONIX PHARMACEUTICALS HOLDING CORP. 8-K
EXHIBIT 99.03
UMass Chan Medical School A Long - Acting Monoclonal Antibody for Seasonal Prevention of Lyme Disease Mark S. Klempner, MD Professor of Medicine March 30, 2026 World Vaccine Congress
UMass Chan Medical School Disclosures Co - Inventor US Patent 10,457,721 Consultant Tonix Pharmaceuticals, Inc Support from N ational C enter for A dvancing T ranslational S ciences (NCATS) NIH, DARPA, DOD Tick Borne Disease Research Program, and NIAID
UMass Chan Medical School Growing Unmet Need: Prevention of Lyme Disease • Lyme disease is the most common tick - borne illness (80% of all tick - borne diseases) in the Northern hemisphere. The CDC estimates over 450,000 cases annually. • Global changes in climate is a factor in the expanding habitat range for ticks and other vectors, indicating the problem is likely to worsen in the coming years. • LYMErix (GSK Vaccine) was FDA approved in 1998 but withdrawn due to low sales amid overhyped fears of vaccine - induced side effects including arthritis. LYMErix elicited active immunity (antibody responses) against outer surface protein A ( OspA ) and demonstrated an efficacy of 78%. • Vaccine hesitancy, now driven mostly by online misinformation, continues to be a headwind for the uptake of new vaccines. We are developing a monoclonal antibody treatment (not a vaccine) for Lyme Disease prevention. A single shot potentially provides protection 2 days after dosing and lasts approximately 4 months 3
UMass Chan Medical School 4 Pre - exposure prophylaxis human antibody Person receives 1 injection of a single protective antibody ( red ) at beginning of tick season. Tick carrying the Lyme disease bacteria bites the person and takes in blood containing the protective antibody preventing transmission. Vaccination Person receives 3 injections over 6 months of Lyme bacteria proteins and develops many different antibodies. Tick carrying the Lyme disease bacteria bites the vaccinated person, takes in blood containing multiple antibodies including one (red) that prevents transmission. Lyme bacteria foreign proteins Preventing Lyme Disease Vaccine Compared to Antibody Pre - Exposure Prophylaxis
UMass Chan Medical School 5 Discovery of mAB 221 - 7 with Potent Bactericidal Activity and Coverage of Three OspA Serotypes • Essential for survival while in tick midgut • Anti - OspA immunity is effective in both animals and humans The Target Approach Outer surface protein A ( OspA ) of the Spirochete
UMass Chan Medical School 6 Discovery of mAb 221 - 7 with Strong Potency and Coverage In vivo Potency In vitro Potency and Coverage Mouse in vivo tick challenge model In vitro Borreliacidal assay against three Borrelia strains Antibody Borreliacidal assay Burgdorferi, afzelii , and garinii 4 leads were selected for animal study 319 - 44, 221 - 7, 857 - 2 and 221 - 55
UMass Chan Medical School 7 Identified Four Lead anti - OspA Borrelia Antibodies
UMass Chan Medical School 8 mAb 221 - 7 Epitope Resolved by Crystallization
UMass Chan Medical School 9 mAb 221 - 7 Does not Recognize the Putative Arthritogenic T - cell Epitope OspA Protein 178 - 273 71 - 141 221 - 7 Epitope 165 - 173 Putative arthritogenic T - cell epitope (YVLEGTLTA), mimicking human leukocyte function - associated antigen - 1 (hLFA - 1) 178 - 273
UMass Chan Medical School 10 Fold Change to WT 2217LS 2217WT Average Human Ab half - life Species 2.0 16.0 ± 1.1 days 8.0 ± 0.4 days 6 - 8 days FcRN Mice 2.1 31.8 ± 2.5 days 15.41 ± 7.5 days 10.2 ± 3.3 days Nonhuman Primates Half - Life Extension in FcRn Mice and NHP: TNX - 4800 (2217LS) NHP= non - human primate
UMass Chan Medical School 11 Blocking Borrelia burgdorferi Transmission from Infected Ticks to Non - Human Primates with TNX - 4800 (2217 - LS) 4 - 6 animals each dose group P value Protection (%) Dose (mg/kg) Monoclonal Antibody <0.001 100% 90 2217LS <0.001 100% 30 2217LS <0.001 83% 10 2217LS <0.001 100% 3 2217LS N/A 0% 10 Irrelevant IgG Day - 7 0 1 6 14 21 28 63 45 Tick Challenge HuMAb Injection Jacket Acclimation Tissue Biopsy Culture Observations Serum Collection
UMass Chan Medical School 12 Serum levels above 21 µg/mL were ~95% protective . Estimating Minimum Effective Concentration of TNX - 4800 (2217 - LS) in Non - Human Primates
UMass Chan Medical School 13 Minimum Effective Concentration (MEC) TNX - 4800 (2217 - LS) • ~ 5 μ g/mL – in vitro bactericidal activity • TNX - 4800 showed EC 50 ≈ 0.56 μ g/mL in vitro 1 • MEC ~ 10X EC 50 • <10 μ g/mL – in vitro tick feeding experiment • TNX - 4800 showed bactericidal activity ≥10 μ g/ml • <21 μ g/mL – in vivo primate challenge models 1,2 • TNX - 4800 serum levels >21 μ g/ml were 95% protective 1 Wang Y, et al. J Infect Dis. 2016 Jul 15;214(2):205 - 11. 2 Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843.
UMass Chan Medical School 14 Nonclinical Safety Data TNX - 4800 ▪ cGLP Tissue Cross Reactivity study in rat and human tissues • No significant cross - reactivity ▪ Non - GLP pharmacokinetic and tick challenge studies in monkeys • Did not reveal a safety signal ▪ cGLP 5 week multiple dose study with 4 week recovery in rats and a cGLP single dose local tolerance study in rats • Observed abnormalities were mild to moderate and all findings were judged non aversive (hematologic and ALT, AST ALP and APTT increases (notably without bilirubin changes), injection site inflammation, liver and spleen organ weight increases, liver histopathology, primarily in males. All findings were reversible). ▪ Exposure in Phase 1 was multiples relative to NOAEL in rats • Starting dose: 63 to 242 – fold lower • Highest dose: 3 to 12 – fold lower NOAEL = No - observed - adverse - effect level
UMass Chan Medical School 15
UMass Chan Medical School Primary Objective : • Evaluate safety and tolerability of a SC injection of TNX - 4800 (2217LS) when administered to healthy subjects Secondary Objective : ▪ Evaluate pharmacokinetics (PK) of a SC dose of TNX - 4800 (2217LS) when administered to healthy subjects Study Population : ▪ Healthy male and female subjects, age 19 to 65 years, inclusive. 44 volunteers enrolled, 41 completed. TNX - 4800 Phase 1 Study Overview Route 2217LS Dose (mg/kg) Treatment N 1 Cohort SC 0.5 2 subjects: placebo 10 subjects: 2217LS 12 1 SC 1.5 2 subjects: placebo 8 subjects: 2217LS 10 2 SC 5 2 subjects: placebo 8 subjects: 2217LS 10 3 SC 10 2 subjects: placebo 8 subjects: 2217LS 10 4 16
UMass Chan Medical School • No significant clinical or laboratory safety signals • The mean exposure, based on AUC - inf and C max for Cohort 4 (10mg/kg), was less than 17% of the highest exposures in the rat toxicology study • Serum TNX - 4800 (2217LS) was measurable at the earliest sampling time of 24 hours indicating rapid absorption. • For all cohorts C max was observed at 10 - 13 days followed by a prolonged elimination phase. • Apparent terminal T ½ after 10 mg/kg dose was 64 days • Max T ½ ranged from 81 - 104 days: ( 10mg/kg - 97 days, 5mg/kg - 87 days, 1.5mg/kg - 104 days, 0.5mg/kg - 81 days) • Cohort 3 (5mg/kg) serum concentrations: • 10 μ g/ml at 4 months (~ in vitro tick - feeding MEC and > in vitro MEC or ~10x EC 50 ) TNX - 4800 Phase 1 Study Results 17
UMass Chan Medical School 18 Observed Phase 1 Pharmacokinetics 5 μ g/ml – in vitro ~10x EC 50 10 μ g/ml – in vitro MEC tick feeding 120 days 180 days Each point represents a mean for the cohort at that timepoint and dose
UMass Chan Medical School • Licensed to Tonix Pharmaceuticals - 2025 now TNX - 4800 • Proposed Phase 2 field study – 2027 pending FDA clearance Next Steps: Phase 2 Field Study 19
UMass Chan Medical School A Long - Acting Monoclonal Antibody for Seasonal Prevention of Lyme Disease Mark S. Klempner, MD Professor of Medicine
UMass Chan Medical School 21 Supplemental Slides
UMass Chan Medical School 22 The monoclonal OspA antibody TNX - 4800 ( 2217 LS) inhibits tick - to - blood transmission of B . burgdorferi B 31 - 5 A 4 in a dose - dependent manner in an artificial membrane feeding system . Minimum Effective Concentration of TNX - 4800 is < 10 μ g/ml in the Infected Tick I r r e l e v a n t A b O s p A S e r a 0 . 6 2 5 2 . 5 5 1 0 2 0 4 0 10 0 10 2 10 4 10 6 B a c t e r i a l b u r d e n ( c o p i e s / 1 0 0 n g D N A ) * * * * ug 2217LS/mL blood Blood 5dpf
UMass Chan Medical School 23 Variability of serum concentrations at sampling time points among subjects in each dosing cohort
UMass Chan Medical School 24 Pharmacokinetic Parameters 10 mg/kg 2217LS 5 mg/kg 2217LS 1.5 mg/kg 2217LS 0.5 mg/kg 2217LS Pharmacokinetic Parameters 165500000 (26.0) [n=8] 79760000 (36.5) [n=8] 20610000 (23.7) [n=8] 6271000 (26.0) [n=10] AUC0 - t (ng* hr /mL) 168100000 (25.9) [n=8] 82070000 (37.2) [n=8] 21490000 (23.5) [n=8] 6812000 (25.3) [n=10] AUC0 - inf (ng* hr /mL) 1.494 ± 0.49258 [n=8] 2.805 ± 1.3920 [n=8] 4.103 ± 1.6271 [n=8] 7.832 ± 4.8735 [n=10] AUC%ext (%) 84560 (37.5) [n=8] 45650 (22.0) [n=8] 10880 (41.3) [n=8] 3397 (31.4) [n=10] Cmax (ng/mL) 108.050 (48.00, 167.78) [n=8] 108.319 (71.98, 216.06) [n=8] 144.019 (95.95, 215.95) [n=8] 96.075 (72.00, 335.91) [n=10] Tmax ( hr ) 0.0004751 ± 0.000072023 [n=8] 0.0005851 ± 0.00037231 [n=8] 0.0004258 ± 0.000060386 [n=8] 0.0004984 ± 0.00025308 [n=10] Kel (1/hr) 1491 ± 244.47 [n=8] 1516 ± 655.84 [n=8] 1658 ± 243.26 [n=8] 1614 ± 533.84 [n=10] t½ ( hr ) 0.06121 ± 0.015541 [n=8] 0.06474 ± 0.025934 [n=8] 0.07151 ± 0.017398 [n=8] 0.07557 ± 0.020144 [n=10] CL/F (mL/ hr /kg) 133.0 ± 44.405 [n=8] 123.7 ± 29.838 [n=8] 170.1 ± 47.286 [n=8] 171.2 ± 61.264 [n=10] Vd /F (mL/kg) 0.5 mg/kg 2217LS: A single subcutaneous injection of 0.5 mg/kg 2217LS, Cohort 1 1.5 mg/kg 2217LS: A single subcutaneous injection of 1.5 mg/kg 2217LS, Cohort 2 5 mg/kg 2217LS: A single subcutaneous injection of 5 mg/kg 2217LS, Cohort 3 10 mg/kg 2217LS: A single subcutaneous injection of 10 mg/kg 2217LS, Cohort 4 AUCs and Cmax are presented as geometric mean (geometric CV%). Tmax values are presented as median (min, max). Other parameters are presented as arithmetic mean ± SD. Source: Tables 14.2.1.5 through 14.2.1.8 Program: /CA29655/ sas_prg / pksas / adam_intext_pkparam.sas 13FEB2023 9:20
UMass Chan Medical School 25 Outcome • Two - thirds of parents were willing to vaccinate their child against LD (68.0% definitely/probably would, 18.4% unsure, 13.7% definitely/probably would not) • Parental willingness to be vaccinated against LD was highly correlated with willingness for their child in. • Vaccine safety concerns were among the top reasons for LD vaccine hesitancy • More parents preferred pre - formed antibody (42.4%) over 3 - dose vaccine series (36.2%) • Significant predictors of preference for monoclonal antibody included prior awareness of LD, living in a rural area, and positive attitude towards vaccines CDC Study Makes a Strong case for Antibody vs Vaccine Methods • Conducted online survey (N=1,351) of parents of children aged 5 – 18 years in states with high or emerging Lyme Disease (LD) incidence. • Primary outcome was willingness (definitely / probably would vs unsure or definitely / probably would not) for their child to receive an LD vaccine. • Secondary outcome was preference for annual monoclonal antibody injections vs. a 3 - dose vaccine series with boosters every few years. Lyme Disease Vaccine Intentions Among Parents of 5 – 18 Year Olds in U.S. States with High or Emerging Incidence (CDC - sponsored study presented at 2023 Pediatric Academic Societies (PAS) Conference) CDC = U.S. Centers for Disease Control
FAQ
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