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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of report (date of earliest event reported):
May 21, 2024
TONIX PHARMACEUTICALS HOLDING CORP.
(Exact name of registrant as specified in its
charter)
| Nevada |
001-36019 |
26-1434750 |
|
(State or Other Jurisdiction of Incorporation)
|
(Commission File Number)
|
(IRS Employer Identification No.)
|
26 Main Street, Chatham, New Jersey 07928
(Address of principal executive offices) (Zip
Code)
Registrant’s telephone number, including
area code: (862) 904-8182
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered
pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
| Common Stock |
TNXP |
The NASDAQ Capital Market |
Indicate by check mark
whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter)
or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth
company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 |
Regulation FD Disclosure. |
On May 21, 2024, Tonix Pharmaceuticals
Holding Corp. (the “Company”) announced that EVERSANA® Life Science Services, LLC (“Eversana”) completed the
initial phase of an assessment of the U.S. market opportunity for the Company’s TonmyaTM product candidate (also known
as TNX-102 SL, cyclobenzaprine HCl sublingual tablets). A copy of the press release that discusses this matter is filed as Exhibit 99.01
and hereto and incorporated herein by reference.
The Company updated its investor
presentation, which is used to conduct meetings with investors, stockholders and analysts and at investor conferences, and which the Company
intends to place on its website, which may contain nonpublic information. A copy of the presentation is filed as Exhibit 99.02 hereto
and incorporated herein by reference.
The information in this Item
7.01 of this Current Report on Form 8-K, including Exhibits 99.01 and 99.02 attached hereto, shall not be deemed “filed”
for purposes of Section 18 of the United States Securities Exchange Act of 1934 (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 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
On May 21, 2024, the Company
announced Eversana completed the initial phase of an assessment of the U.S. market opportunity for Tonmya. Key findings from Eversana’s
assessment include the following:
| · | Approximately 2.7 million adults in the U.S.
are currently diagnosed and treated for fibromyalgia, 90% of which are female. |
| · | Percentage of fibromyalgia patients who were
prescribed certain drugs: |
| ‒ | FDA-approved fibromyalgia drug prescriptions: |
| i. | duloxetine (generic Cymbalta®:) 23%), pregabalin (generic Lyrica®): 13%), and Savella® (milnacipran):
1% |
| ‒ | Off-label drug prescriptions: |
| i. | Gabapentin: (26%), hydroxycodone: 20%, cyclobenzaprine: 18%, oxycodone: 19%, tramadol: 13%, meloxicam:
12%, and amitriptyline: 6% |
| ‒ | Off-label opioids prescriptions: |
| i. | Hydroxycodone: 20%, oxycodone: 19%, and tramadol: 13% |
| · | Most
physicians who prescribe drugs for patients suffering from fibromyalgia are rheumatologists, pain medicine specialists, primary care
physicians, neurologists, and psychiatrists. |
| · | 85%
of fibromyalgia patients fail first-line therapy due to efficacy and tolerability issues; 79% are on multiple therapies. |
| · | Median interest in Tonmya as a new treatment option among physicians interviewed
of 4.0 on a 5-point scale; physicians interviewed indicated intended use in 40% of their fibromyalgia patients, assuming no market access
barriers. |
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 of 1933 and Section 21E of the
Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s
product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed
future results of operations, business strategies, potential growth opportunities and other statement 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
we operate 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 or our financial performance 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 SEC. Prospective investors are cautioned not to place undue reliance on such
forward-looking statements, which speak only as of the date of this press release. 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. |
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: May 21, 2024 |
By: |
/s/ Bradley Saenger |
|
| |
Bradley Saenger |
| |
Chief Financial Officer |
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Exhibit 99.01
Tonix Pharmaceuticals Announces Key Findings from
Initial Phase of EVERSANA Market Opportunity Analysis for Tonmya™ for the Management of Fibromyalgia
Tonmya is a potential new first-line, centrally
acting non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials
Primary physician research found high level of interest
in Tonmya as a potential new treatment option for fibromyalgia
Significant dissatisfaction reported with drugs
currently approved by FDA for the treatment of fibromyalgia
Analysis of claims data revealed that addictive
opioids are prescribed more frequently than currently approved drugs following fibromyalgia diagnosis
New Drug Application (NDA) submission to the FDA
on track for the second half of 2024
CHATHAM, N.J., May 21, 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, announced today that EVERSANA® Life Science Services, LLC, a leading provider
of commercialization services to the global life sciences industry, completed the initial phase of an assessment of the U.S market opportunity
for TonmyaTM (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets), a potential new first line therapy for the
management of fibromyalgia. Tonix previously announced that EVERSANA was selected to support the launch strategy and commercial planning
of Tonmya. Specifically, EVERSANA is working with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market
(GTM) strategy.
“The primary research and analysis conducted
by EVERSANA provides valuable insights and informs the vision for the commercialization of Tonmya,” said Seth Lederman, M.D., Chief
Executive Officer of Tonix Pharmaceuticals. “We are excited to refine our business strategy for the anticipated launch of Tonmya
in 2025. It has been approximately fifteen years since patients suffering with fibromyalgia have been provided a new therapeutic option.
The market research conducted by EVERSANA with physicians indicates a continued high unmet need, with the need ranked > 4.0 on a 5-point
scale.”
Dr. Lederman continued, “We were surprised to
learn that opioids dominate the fibromyalgia prescription market, despite the well-known risks of dependency. Opioids are prescribed to
more patients following fibromyalgia diagnosis than all the FDA-approved fibromyalgia drugs combined. If approved, we believe that Tonmya
can provide a non-opioid, centrally-acting solution for fibromyalgia patients. This is corroborated by EVERSANA’s primary market
research in which physicians indicated median interest of 4.0 on a 5-point scale and intended use of Tomya in 40% of their fibromyalgia
patients, upon approval.1 We look forward to submitting the NDA for Tonmya in the second half of this year and expect an FDA
decision on approval in 2025.”
EVERSANA’s analysis of the market size was based
on medical claims databases and epidemiological studies on prevalence and diagnosis2. Primary research with physicians was
conducted to test the potential adoption of Tonmya based on its activity and tolerability.
Key findings from claims data analyses2:
| ■ | ~2.7 million adults in the U.S. currently diagnosed and treated for fibromyalgia. |
| ‒ | ~90 percent of patients diagnosed with fibromyalgia are female. |
| ■ | Percentage of fibromyalgia patients who were prescribed certain drugs3: |
| ‒ | FDA-approved fibromyalgia drug prescriptions: |
| i. | Duloxetine (generic Cymbalta®): 23%, pregabalin (generic
Lyrica®): 13%, and Savella® (milnacipran): 1% |
| ‒ | Off-label drug prescriptions: |
| i. | Gabapentin: 26%, hydroxycodone: 20%, cyclobenzaprine: 18%, oxycodone: 19%, tramadol: 13%, meloxicam: 12%, and amitriptyline: 6% |
| ‒ | Off-label opioids prescriptions: |
| i. | Hydroxycodone: 20%, oxycodone: 19%, and tramadol: 13% |
| ■ | Targeted prescriber strategy for launch. |
| ‒ | High prescribers are rheumatologists, pain medicine specialists, primary care physicians, neurologists,
and psychiatrists. |
| ■ | ~50 percent of diagnosed fibromyalgia patients are covered by Medicare. |
| ‒ | Medicare population stands to benefit from a decrease in out-of-pocket prescription drug liability to
$2,000 per year when the changes from the Inflation Reduction Act are enacted in 2025. |
Key findings from primary physician research4:
| ■ | High level of dissatisfaction with currently prescribed drugs. |
| ‒ | Physicians interviewed estimate that 85% of their patients fail first-line therapy due to efficacy and
tolerability issues and 79% of their patients are on multiple therapies. |
| ‒ | Prescribers indicate high unmet need in fibromyalgia, ranked >4.0 on a 5-point scale. |
| ■ | High level of interest in Tonmya from physicians interviewed as a potential new treatment option based
on favorable activity and tolerability profile observed in Tonmya fibromyalgia clinical studies. |
| ‒ | Median interest in Tonmya of 4 on a 5-point scale. |
| ‒ | Physicians indicated intended use of Tonmya in 40% of their fibromyalgia patients.1 |
Tonmya is a centrally acting, non-opioid medication.
As previously announced, Tonix’s second statistically significant Phase 3 study, RESILIENT, met its pre-specified primary endpoint,
significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically
meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue,
and improving overall fibromyalgia symptoms and function.
Tonix plans to submit an NDA to the U.S. Food and
Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia and has scheduled a Type B pre-NDA
meeting with FDA for the second quarter of 2024.
1 40% was the median preference share
among physicians interviewed, assuming no market access barriers.
2 EVERSANA analysis of claims database,
May 2024; commissioned by Tonix
3Note: the total number of patients
is greater than 100% because of switching between medications and polypharmacy.
4 EVERSANA primary physician research,
May 2024; commissioned by Tonix
About Tonmya* (also known as TNX-102 SL)
Tonmya is a centrally acting, non-opioid, non-addictive,
bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia.
In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second
positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint,
significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically
meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall
fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020.
It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.
*Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for
any indication.
About EVERSANA®
EVERSANA® is a leading independent provider of
global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span
all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The
company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences
solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated 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 with 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 commercialize any of our products; risks related to the timing and
progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and
litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon
third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development,
regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking
statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as
filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on
or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary
statements. The information set forth herein speaks only as of the date thereof.
Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505
Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151
Matt Braun
EVERSANA
Matt.braun@eversana.com
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Exhibit 99.02
© 2024 Tonix Pharmaceuticals Holding Corp. Corporate Presentation Abbreviated Focus on: Tonmya * (TNX - 102 SL) in Development for the Management of Fibromyalgia May 2024 NASDAQ: TNXP * Tonmya is conditionally accepted by FDA as the tradename for TNX - 102 SL for the management of fibromyalgia Version P0567 May 21 , 2024 (Doc 1434 )
2 © 2024 Tonix Pharmaceuticals Holding Corp. Cautionary Note on Forward - Looking Statements Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are “forward - looking statements” as defined by 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” 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, the risks related to 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. The forward - looking statements in this presentation are made as of the date of this presentation, even if subsequently made available by Tonix on its website or otherwise. Tonix does not undertake an obligation to update or revise any forward - looking statement, except as required by law. Investors should read the risk factors set forth in the Annual Report on Form 10 - K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1 , 202 4 , and periodic reports and current 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.
3 © 2024 Tonix Pharmaceuticals Holding Corp. Tonix is committed to developing and marketing therapeutics to treat pain, neurologic, psychiatric and addiction conditions through our central nervous system portfolio and within other areas of high unmet need , including immunology, infectious disease, and rare disease With a Focus on: Filing a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Tonmya (TNX - 102 SL) for the management of Fibromyalgia (FM) Who We Are
4 © 2024 Tonix Pharmaceuticals Holding Corp. NDA Submission Phase 3 Phase 2 Phase 1 Indication Molecule * Fibromyalgia Tonmya TNX - 102 SL Cyclobenzaprine HCl Protectic ® Sublingual Tablets Long COVID Acute Stress Disorder Cocaine Intoxication TNX - 1300 Cocaine Esterase NIDA Funded Prader - Willi Syndrome TNX - 2900 Intranasal Potentiated Oxytocin FDA Orphan Drug and Rare Pediatric Disease Designation Organ Transplant Rejection/ Autoimmune Conditions TNX - 1500 Anti - CD40L mAb Key Clinical Programs *All of Tonix’s product candidates are investigational new drugs or biologics and none has been approved for any indication. **Investigator - initiated study Statistically Significant Phase 3 Topline Results Reported 4Q’23 Phase 2 Study Start Expected 2Q’24 Phase 1 Study Ongoing Submission expected 2H’24 Phase 2 Ready Phase 2 Topline Results Reported 3Q’23 Phase 2 Study** Start Expected 2Q’24 Clinical Stage complete
5 © 2024 Tonix Pharmaceuticals Holding Corp. Tonmya (TNX - 102 SL, Cyclobenzaprine HCl Sublingual Tablets) A unique, sublingual formulation of cyclobenzaprine designed to optimize delivery and absorption Tonmya is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX - 102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
6 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO About Fibromyalgia Fibromyalgia is considered a chronic overlapping pain condition (COPC) - the only COPC with any FDA - approved drugs 3 Fibromyalgia is the prototypic nociplastic syndrome Multisite pain Fatigue Non - Restorative Sleep Fibromyalgia is a chronic pain disorder resulting from amplified sensory and pain signaling within the CNS 1 Fibromyalgia is a syndrome comprised of the symptoms : chronic widespread pain, nonrestorative sleep , and fatigue 1 American Chronic Pain Association (www.theacpa.org, 2019) 3 CFS/ME = chronic fatigue syndrome/ myalgic encephalomyelitis 3 The three drugs with FDA approval for the treatment of fibromyalgia: Pregabalin (Lyrica®); Duloxetine (Cymbalta®); Milnacipra n ( Savella ®)
7 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia is a Large, Underserved and Dissatisfied Population* • ~10 million U.S. adults are affected – predominantly women 1,2 ‒ Debilitating and life altering condition ‒ Significant economic impact • Patients are dissatisfied, despite three FDA approved drugs 3,4 ‒ 85% of patients fail first - line therapy 5 : efficacy variability, tolerability issues especially when used long - term and lack of broad - spectrum activity ‒ Typical for patients to rotate between drugs and be on multiple drugs at the same time; 79% of FM patients are on multiple therapies 5 • ~2.7 million diagnosed FM patients see their physician each year 6 ‒ >22 million prescriptions are issued for the treatment of fibromyalgia (on - and off - label usage) each year 7,8 *This slide and others contain market information and analyses regarding fibromyalgia prepared for Tonix by EVERSANA 1 American College of Rheumatology ( www.ACRPatientInfo.org accessed May 7, 2019) – prevalence rate of 2 - 4% for U.S. adult population (~250 million) 2 Vincent A, et al. Arthritis Care Res (Hoboken) . 2013 65(5):786 - 92. doi : 10.1002 ; diagnosed prevalence rate was 1.1% of adult population or 50% of the prevalent population 3 Robinson RL, et al. Pain Med . 2012 13(10):1366 - 76. doi : 10.1111; 85% received drug treatment 4 The three drugs with FDA approval for the treatment of fibromyalgia: Pregabalin (Lyrica); Duloxetine (Cymbalta); Milnacipran ( Savella ) 5 EVERSANA primary physician research, May 2024; commissioned by Tonix 6 EVERSANA analysis of claims database, May 2024; commissioned by Tonix 7 Product sales derived from IMS MIDAS; IMS NDTI used to factor usage for fibromyalgia; data accessed April 2015. 8 Market research by Frost & Sullivan, commissioned by Tonix , 2011
8 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Poor Sleep and Pain have Bi - directional Reinforcing Effects 1 1 Moldofsky H, et al. J Rheumatol . 1996;23:529 – 533. 2 Grönbald M, et al. Clin Rheumatol . 1993;12(2):186 – 191 • Poor sleep and pain form a vicious cycle in driving fibromyalgia decompensation • Can’t sleep → worse pain / In pain → can’t sleep • Poor sleep and pain contribute to persistence, chronicity and severity • Syndrome includes symptoms of fatigue and brain fog • Treating sleep disturbance in fibromyalgia has the potential to break the vicious cycle • Potential to remove an obstacle to recovery • Using the right medicine is important – some sedative/hypnotics don’t work 1,2 PAIN BAD SLEEP Fatigue Brain Fog
9 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonmya (TNX - 102 SL, Cyclobenzaprine HCl Sublingual Tablets) 1 • Non - opioid analgesic designed for long - term daily bedtime use in fibromyalgia patients ‒ Targets non - restorative sleep ‒ Potent binding and antagonist activities at four post - synaptic receptors ‒ serotonin - 5 - HT2A ‒ α1 - adrenergic ‒ histaminergic - H1 ‒ muscarinic - M1 ‒ No recognized risk for abuse • Improves sleep quality , does not increase sleep quantity : ‒ Not a traditional hypnotic or sedative • Proprietary, sublingual transmucosal formulation of cyclobenzaprine designed to optimize delivery and absorption ‒ P rotectic ® formulation based on eutectic composition of matter • Rapid a bsorption • Decrease in major metabolite by bypassing first - pass hepatic metabolism
10 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Sublingual Administration and Transmucosal Delivery • Advantages of the sublingual route • Faster absorption provides PK that is ideal for bedtime dosing • Bypasses “first - pass” hepatic metabolism • Reduced metabolism of parent CBP to active metabolite norcyclobenzaprine ( nCBP )
11 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia Program Status Fibromyalgia Tonmya * (TNX - 102 SL) Cyclobenzaprine Protectic ® Sublingual Tablets Statistically Significant 2 nd Phase 3 Topline Results Reported 4Q’23 First pivotal Phase 3 study ( RELIEF ) reported – December 2020 1 Second Phase 3 study ( RALLY ) missed primary endpoint – July 2021 Confirmatory pivotal Phase 3 study ( RESILIENT ) reported – December 2023 1 Lederman S, et al. Arthritis Care Res (Hoboken) . 2023 Nov;75(11):2359 - 2368. doi : 10.1002. * Tonmya is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX - 102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication. Next Steps: • Type B Pre - NDA meeting scheduled with FDA in 2Q’24 • NDA filing expected 2H’24 • FDA decision on NDA approval expected 2H’25
12 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Weekly Average of Daily Diary NRS Ratings of Average Pain Over Prior 24 Hours RESILIENT Primary Outcome Measure Reduction in Widespread Pain -2.2 -2 -1.8 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 LS Mean (SE) Change in NRS Pain Score Week of Study Placebo (N=225) TNX-102 SL (N=231) * *** *** ** ** ** *** *** *** *** *** *** *** ** *p<0.01; **p<0.001; ***p<0.0001 Week 14 LS mean (SE) change from baseline for TNX - 102 SL - 1.82 (0.12) and for placebo - 1.16 (0.12); LSMD from placebo - 0.65 (0.1 6); p=0.00005 # # Based on Mixed Model Repeated Measures with Multiple Imputation, with fixed categorical effects of treatment, center, study w eek , and treatment by study week interaction, as well as baseline value and baseline value - by - study week interaction. Abbreviations: LS, least squares; LSMD, least squares mean differe nce; NRS, numerical rating scale; SE, standard error
13 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Summary of Endpoints *In order of statistical serial gate - keeping hierarchy (or, “waterfall”) to control overall Type 1 error **Statistical significance met Effect Size (ES) P - value Endpoint Primary Endpoint ES = 0.38 p = 0.00005** Daily Diary Pain ratings Key Secondary Endpoints* -- p = 0.00013** Patient Global Impression of Change (PGIC), responders ES = 0.44 p = 0.000002** Fibromyalgia Impact Questionnaire – Symptoms domain ES = 0.30 p = 0.001** Fibromyalgia Impact Questionnaire – Function domain ES = 0.50 p = 0.0000001** PROMIS Sleep Disturbance instrument ES = 0.37 p = 0.00009** PROMIS Fatigue instrument ES = 0.32 p = 0.0007** Diary Sleep Quality ratings
14 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT – Cognitive Dysfunction or “Brain Fog” Brain Fog assessed by the FIQ - R 1 item on memory • P atients rated their level of memory problems • 11 - pt scale going from “Good Memory” to “Very Poor Memory” • Prespecified endpoint, but not in the “waterfall” with the key secondary endpoints • TNX - 102 SL patients vs PBO change from baseline LS mean (SE) difference of −0.8 (0.23) • p = 0.001 (not corrected for multiple comparisons) • Cohen’s d effect size = 0.31 Multisite pain Brain Fog Fatigue Non - Restorative Sleep 1 FIQ - R = Fibromyalgia Impact Questionnaire - Revised
15 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonmya Showed Broad - Spectrum Activity and was Well Tolerated Tonmya Cymbalta® Savella ® Lyrica® YES YES YES Pain Activity YES - YES Sleep YES YES - Fatigue - + - Insomnia Systemic Tolerability Issues - - + Fatigue - - + Weight - + - Blood Pressure - + - Sexual function - + - GI issues • Tonmya showed activity in all three measures of pain, sleep, and fatigue • Tonmya is not associated with any of the commonly reported side effects of the FDA - approved medications for fibromyalgia
16 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Safety and Tolerability • Completion Rate (safety population): TNX - 102 SL: 81.0% and Placebo: 79.2% • No new safety signals observed • Only systemic adverse events (AEs) at rate ≥ 3.0% (TNX - 102 SL v. Placebo) ‒ COVID - 19 (4.3% v. 3.1%), somnolence (3.0% v. 1.3%), and headache (3.0% v. 1.8%) • As previously observed TNX - 102 SL associated with administration site reactions ‒ Hypoaesthesia oral (23.8% v. 0.4%), product taste abnormal (11.7% v. 0.9%), paraesthesia oral (6.9% v. 0.9%), and tongue discomfort (6.9% v. 0%) • No effect on weight or blood pressure (BP) ‒ Weight: Week 14 change from baseline for TNX - 102 SL of +0.04 lbs.; and for Placebo of +0.44 lbs. ‒ Systolic BP: Week 14 change from baseline for TNX - 102 SL of +0.7 mmHg; and for Placebo of +0.5 mmHg ‒ Diastolic BP: Week 14 change from baseline for TNX - 102 SL of +1.1 mmHg; and for Placebo of +0.2 mmHg • No sexual dysfunction AEs and improved female sexual functioning ‒ No reported AEs of any type of sexual dysfunction ‒ Improvement in female sexual function using Changes in Sexual Functioning Questionnaire (p=0.010)
17 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Safety Summary *Safety Population Treatment - Emergent Adverse Events (TEAEs) at Rate of ≥ 3% in Either Treatment Group Total* N=457 Placebo N=226 TNX - 102 SL N=231 System Organ Class Preferred Term Systemic Adverse Events 17 (3.7%) 7 (3.1%) 10 (4.3%) COVID - 19 10 (2.2%) 3 (1.3%) 7 (3.0%) Somnolence 11 (2.4%) 4 (1.8%) 7 (3.0%) Headache Oral Cavity Adverse Events 56 (12.3%) 1 (0.4%) 55 (23.8%) Hypoaesthesia oral 29 (6.3%) 2 (0.9%) 27 (11.7%) Product taste abnormal 18 (3.9%) 2 (0.9%) 16 (6.9%) Paraesthesia oral 16 (3.5%) 0 (0.0%) 16 (6.9%) Tongue discomfort
18 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ~50% of U.S. Fibromyalgia Patients are on Medicare: Prescription Coverage in Medicare Stands to Benefit from Changes in IRA Approximately 50% of fibromyalgia patients are on Medicare ‒ EVERSANA analysis of claims database consisting of 2.2M patients, for which 1.2M claims were submitted throughout March 2002 - March 2023 1 Beneficial Changes in 2025 to Medicare Part D through Inflation Reduction Act (IRA) 2 ‒ Medicare prescription payment plan to offer enrollees the option to pay out - of - pocket prescription drug costs in the form of capped monthly installment payments instead of all at once at the pharmacy ‒ Annual out - of - pocket costs will be capped at $2,000 in year 2025 ‒ Will replace the existing Coverage Gap Discount Program, which sunsets as of January 1, 2025 Fibromyalgia Patients by Coverage 1 1 EVERSANA analysi s of claims database , May 2024; commissioned by Tonix 2 Source: Final CY 2025 Part D Redesign Program Instructions Fact Sheet | CMS
19 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Prescribers Interviewed are Broadly Dissatisfied with Available Fibromyalgia Medications: Results of Primary Research 1 Perspectives on FM Therapies from Prescribers Interviewed Negatives Positives Drug • Tolerability issues: worsening depression, insomnia • Seldom used as a monotherapy; often requires adjunct • Relatively high efficacy (compared to alternatives) • Can be titrated slowly from 20mg to 120mg Duloxetine (Cymbalta, generic) • Suboptimal for long - term use (e.g., weight gain) • Schedule V status makes some HCPs more cautious to Rx • Relatively high efficacy (compared to alternatives) • Can often be safely combined with other medications Pregabalin (Lyrica, generic) • Subpar efficacy does not counterbalance tolerability issues • High cost and access constraints (~$50/month) • Offers another option if patient fails Cymbalta or Lyrica Savella (milnacipran) • Mixed perspectives on pain benefit independent of sleep • Suboptimal long - term results as efficacy wanes • Active for initiating and sustaining sleep; can be titrated up • Active for pain driven by stiffness and muscle spasms Cyclobenzaprine (Flexeril, generic; oral formulation, off - label) 85% of patients (avg) fail first line therapy 79% of FM patients (avg) are on multiple therapies 1 EVERSANA primary physician research, May 2024; commissioned by Tonix
20 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Opportunity for a New, Unique Fibromyalgia Treatment Option: Results of Primary Research from EVERSANA 1,2 • Prescribers indicate a very high unmet need in FM (ranked ≥4.0 on a 5 - point scale) • Prescribers report there is no standard of care in FM , employ an individualized approach based on symptomology • No new treatments approved since 2009 • Prescribers report minimal promotional activities by any pharmaceutical company • Highly concentrated prescriber base with 50% of patients treated by ~16k physicians FM Landscape • Physicians reacted positively to Tonmya’s efficacy and safety profile (based on Phase 3 Study results) • Median interest = 4.0 on a 5 - point scale • Driving attributes included strong efficacy, safety and tolerability • Unique & differentiating efficacy features included improvements in sleep and fatigue Physician Primary Market Research • Physicians indicated intended use in 40% of their FM patients • Majority of respondents indicated Tonmya would be their first choice, if accessible • Physicians surveyed indicated they are well - equipped to deal with access restrictions including prior authorizations and step - edits Anticipated Use 1 EVERSANA primary physician research, May 2024; commissioned by Tonix 2 EVERSANA analysis of claims database, May 2024; commissioned by Tonix
21 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Many Fibromyalgia Patients are Prescribed Off - Label Drugs; ~53% FM Patients Prescribed Opioids Off - Label 1,2 1.04% 6.03% 11.74% 12.96% 13.23% 17.58% 19.45% 20.47% 22.62% 25.50% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Milnacipran Amitriptyline Meloxicam Pregabalin Tramadol Cyclobenzaprine Oxycodone Hydrocodone Duloxetine HCl Gabapentin % FM Patients (after index 3 date) 1 2022 - 2023 2 EVERSANA analysis of claims database, May 2024; commissioned by Tonix 3 I ndex date refers to date when ICD10 code was entered into database Anti - convulsant SNRI Opiate Tricyclic antidepressant NSAID Muscle relaxant FDA Approved Off - Label Off - Label FDA Approved Off - Label Opioid Off - Label Off - Label Opioid Off - Label Opioid FDA Approved Off - Label
22 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Planning for Tonmya Launch and Marketing Several companies that successfully developed CNS drugs have launched them • Big Pharma wants the commercial launch de - risked before acquisition ( e.g. , Nurtec ®) To prepare for the launch of Tonmya , Tonix acquired two marketed Rx drugs: Zembrace ® and Tosymra ® • Both are indicated for the acute treatment of migraine Exit FDA Approval Indication Product Company 8/2022 Depression Auvelity ® AXSM Axsome Sold to PFE for $12 B in Oct 2022 2/2020 Migraine Nurtec ® BHVN Biohaven 12/2019 Schizophrenia Caplyta ® ITCI IntraCellular 1/2019 Seizures Oxtella - XR® SUPN Supernus 4/2017 Tardive Dyskinesia Ingrezza ® NBIX Neurocrine 4/2016 Parkinson’s psychosis Nuplazid ® ACAD Acadia
23 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Two Marketed Proprietary Migraine Drugs Non - oral Formulations of Sumatriptan • Each indicated for the tr eatment of acute migraine with or without aura in adults • Sumatriptan remains the acute migraine ‘gold standard’ treatment for many patients and continues to represent the largest segment of the market in terms of unit sales 3 • Each may provide migraine pain relief in as few as 10 minutes for some patients 1,2,4,5 • Patents to 2036 ( Zembrace ) and 2031 ( Tosymra ) 1 Zembrace SymTouch [package insert] . Maple Grove, MN : Upsher - Smith Laboratories, LLC : February 2021 - For more information, talk to your provider and read the Patient Information and Instructions for Use . – Important Safety Information is provided in the appendix 2 Tosymra [package insert]. Maple Grove, MN: Upsher - Smith Laboratories, LLC: Feb 2021. For more information, talk to your provider and read the Patient Information and Instructions for Use. – Important Safety Information is provided in the appendix 3 Tonix Medicines, Inc.; Data On File, 2023 Zembrace® SymTouch ® (sumatriptan injection) 3 mg 1 Tosymra® (sumatriptan nasal spray) 10 mg 2 Acquired from Upsher - Smith Laboratories which has managed care contracts covering ~200 M lives • Contract includes a transition period during which Tonix expects to secure its own contracts Tonix Medicines Commercial Subsidiary • Complete commercialization capability • Manage supply chain and contract manufacturer • Distribution • Trade, Managed Care & Government contracting • Team of professionals including Sales & Marketing personnel 4 Mathew NT, et al. Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine. US Sumatri pta n Research Group. Arch Neurol. 1992;49(12):1271 - 1276. 5 Wendt J, et al. A randomized, double - blind, placebo - controlled trial of the efficacy and tolerability of a 4 - mg dose of subcutan eous sumatriptan for the treatment of acute migraine attacks in adults. Clinical Therapeutics. 2006;28(4):517 - 526. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines, Inc. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis , Inc.
24 © 2024 Tonix Pharmaceuticals Holding Corp. Marketed Products • Zembrace ® and Tosymra ® indicated for the treatment of acute migraine Tonmya fo r Fibromyalgia: Preparing New Drug Application (NDA) • Two Phase 3 trials completed with statistical significance on primary endpoint • NDA filing expected 2H’24 • FDA decision on NDA approval expected 2H’25 Internal Capabilities • Commercial prescription drug sales • R&D and clinical - trial scale manufacturing Strategic Partnerships • With government institutions, world - class academic & research organizations Pipeline • Phase 2 biologic cocaine antidote, FDA “Breakthrough Therapy Designation” • Phase 1 anti - CD40L monoclonal antibody to prevent organ transplant rejection * Tonmya is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX - 102 SL for the management of fibromyalgia CNS - Focused Biopharma with Preclinical, Clinical and Commercial Stage Products
25 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Additional Potential Indications for Tonmya (TNX - 102 SL) Fibromyalgia - Type Long COVID • Status: Phase 2 • Phase 2 study ( PREVAIL ) completed • Topline results reported 3Q 2023 Next Steps: Meet with FDA Acute Stress Reaction/ Acute Stress Disorder • Phase 2 ready investigator - initiated study • Department of Defense funded • UNC will perform study • Received IND clearance from FDA Next Steps: Expect to start Phase 2 in 2Q 2024
26 © 2024 Tonix Pharmaceuticals Holding Corp. Additional Programs and Pipeline Strategy Focusing on government and academic collaborations • Validates Tonix’s scientific expertise and technology • Reduces internal spend • Increases number of trials • Potentially speeds tim e to market • Grants, contracts, cost - sharing or “in - kind” arrangements
TNX - 1500: Next Generation anti - CD40L mAb 27 Re - engineered to better modulate the binding of Fc R and mitigate risk of thrombosis Clinical Stage of Phase 1 study completed Key Differentiators © 2024 Tonix Pharmaceuticals Holding Corp. Selectively Modified anti - CD40L AB Ruplizumab full Fab Contains the full ruplizumab Fab and the engineered Fc region that modulates Fc γ R - binding, while preserving FcRn function Mutated Fc γ R - binding region FcRn - binding region Fc γ R - modulated Fc region First Generation: Development halted due to thromboembolic (TE) complications — blood clots — traced to Fc gamma receptor (Fc R) Second Generation: Eliminated the Fc R TE complication but potency and half life was reduced, limiting utility Third Generation (TNX - 1500): Re - engineered to better modulate the binding of Fc R. Expected to deliver efficacy without compromising safety *TNX - 1500 has not been approved for any indication.
28 © 2024 Tonix Pharmaceuticals Holding Corp. External Partnerships Government partners providing direct funding, cost sharing or in - kind support include: • National Institutes of Health (NIH) • National Institute of Allergy and Infectious Disease (NIAID) ▪ TNX - 1800 selected for Project NextGen • National Institute on Drug Abuse (NIDA) ▪ TNX - 1300 for cocaine intoxication; Phase 2 study funding • Department of Defense (DoD) ▪ TNX - 102 SL for ASD; Phase 2 study funding Academic partners sponsoring clinical trials of Tonix’s investigational drug products include: • Massachusetts General Hospital (MGH) • University of Washington • University of North Carolina
29 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 801 Live Virus Vaccine Live virus vaccine platform with multitude of potential applications
TNX - 801: Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology 30 C loned version of horsepox 1 purified from cell culture Key Differentiators © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 801* (Horsepox) *TNX - 801 is in the pre - IND stage of development and has not been approved for any indication. 1 Noyce et al., 2018. PLoS One . 13(1):e0188453. Live virus vaccines are the most established vaccine technology o Prevents forward transmission o Effective in eliciting durable or long - term immunity Economical to manufacture at scale o Low dose because replication amplifies dose in vivo o Single administration Standard refrigeration for shipping and storage Mpox and Smallpox Future Pandemics & New Infectious Diseases COVID - 19 Biodefense Vaccinia Horsepox Oncology ANTIGEN CODING
31 © 2024 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO TNX - 1800: Designed to Express the SARs - CoV - 2 Spike Protein TNX - 1800 (recombinant horsepox virus) is a live virus vaccine based on Tonix’s TNX - 801 that is designed to express the spike protein of the SARS - CoV - 2 virus and to elicit a predominant T cell response • I mmunogenic and well tolerated 1 • S howed promise in protecting animals from challenge with SARS - CoV - 2 delivered directly into the lungs 1 Status: National Institute of Allergy and Infectious Diseases (NIAID) will conduct a Phase 1 clinical trial with TNX - 1800 • First vaccine candidate using Tonix’s live virus recombinant pox virus (RPV) platform technology to enter clinical trials • “Project NextGen” is an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics for COVID - 19. NIAID will be conducting clinical trials to evaluate several early - stage vaccine candidates, including TNX - 1800 • Phase 1 study is designed to assess safety and immunogenicity in approximately 60 healthy adult volunteers • Upon completion of the trial, NIAID and Tonix will assess the results and determine the next steps for the development of TNX - 1800 1 Awasthi, M. et al. Viruses . 2023. 15(10):2131. 2 Awasthi, M. et al. Vaccines (Basel) . 2023. 11(11):1682.
32 © 2024 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Broad - Spectrum Antiviral Discovery Programs Host - directed antiviral discovery programs CD45 targeted therapeutics • Small molecule therapeutics that reduce endogenous levels of CD45, a protein tyrosine phosphatase • Reduction in CD45 protects against many viruses including the Ebola virus Cathepsin inhibitors • Small molecule therapeutics that inhibit essential cathepsins which are required by viruses such as coronaviruses and filoviruses to infect cells • Activity as monotherapy and in combination with other antivirals Virus - directed antivirals discovery program Viral glycan - targeted engineered biologics • B ind to viral densely branched high - mannose (DBH) glycans • Neutralize circulating virus and stop the entry of the progeny virus into cells • Antiviral activity against a broad range of RNA viruses • Activity as monotherapy and in combination with other antivirals
33 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION Key Partnerships TNX - 1500: ALLOGRAFT REJECTION TNX - 1800 : COVID - 19 VACCINE TNX - 2900: PRADER - WILLI SYNDROME TNX - 102 SL: ACUTE STRESS DISORDER
© 2024 Tonix Pharmaceuticals Holding Corp. TEAM, NETWORK, & UPCOMING MILESTONES
35 © 2024 Tonix Pharmaceuticals Holding Corp. Management Team Seth Lederman, MD Co - Founder, CEO & Chairman Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer
36 © 2024 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming x Tonmya Milestones Initiate Phase 2 study of TNX - 102 SL for acute stress disorder □ 2 nd Quarter 2024 Initiate Phase 2 study of TNX - 1300 for the treatment of cocaine intoxication □ 2 nd Quarter 2024 Other Key Program Milestones Type B Pre - NDA meeting with FDA for Tonmya for fibromyalgia scheduled □ 2 nd Quarter 2024 Submit NDA to FDA for Tonmya for fibromyalgia □ 2 nd Half 2024 Statistically significant topline results of Phase 3 RESILIENT study for Tonmya for the management of fibromyalgia □ 4 th Quarter 2023
© 2024 Tonix Pharmaceuticals Holding Corp. THANK YOU
38 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® Important Safety Information (1 of 2) 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: D iscomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back; severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw; pain or discomfort in your arms, back, neck, jaw or stomach ; shortness of breath with or without chest discomfort ; breaking out in a cold sweat ; nausea or vomiting ; feeling lightheaded Zembrace 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: H istory of heart problems ; narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) ; uncontrolled high blood pressure ; hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider. H ad a stroke, transient ischemic attacks (TIAs), or problems with blood circulation ; severe liver problems ; taken any of the following medicines in the last 24 hours: almotriptan , eletriptan , frovatriptan , naratriptan, rizatriptan, ergotamines , dihydroergotamine ; are taking certain antidepressants, known as monoamine oxidase (MAO) - A inhibitors or it has been 2 weeks or less since you stopped taking a MAO - A inhibitor. Ask your provider for a list of these medicines if you are not sure. A n allergy to sumatriptan or any of the components of Zembrace 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.
39 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® Important Safety Information (2 of 2) Zembrace may cause serious side effects including: • Changes in color or sensation in your fingers and toes; sudden or severe stomach pain, stomach pain after meals, weight loss, na usea or vomiting, constipation or diarrhea, bloody diarrhea, fever; cramping and pain in your legs or hips; feeling of heaviness or t igh tness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold fe eli ng or color changes in one or both legs or feet; increased blood pressure including a sudden severe increase even if you have no history of high blood pressure; medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches g et worse, call your provider. • Serotonin syndrome, a rare but serious problem that can happen in people using Zembrace , especially when used with anti - depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not th ere (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or tro ubl e walking. • Hives (itchy bumps); swelling of your tongue, mouth, or throat • Seizures even in people who have never had seizures before The most common side effects of Zembrace 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 ti red. Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effe cts 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. For full Prescribing Information, visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e5b104f - 2b9e - 416e - 92fb - ef1bdaea867d You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1 - 800 - FDA - 1088. 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.
40 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra® Important Safety Information (1 of 2) 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: • D iscomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back ; severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw ; pain or discomfort in your arms, back, neck, jaw, or stomach ; shortness of breath with or without chest discomfort; breaking out in a cold sweat ; nausea or vomiting ; feeling lightheaded 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: • H istory of heart problems ; narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) ; uncontrolled high blood pressure ; severe liver problems ; hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider. • H ad a stroke, transient ischemic attacks (TIAs), or problems with blood circulation ; taken any of the following medicines in the last 24 hours: almotriptan , eletriptan , frovatriptan , naratriptan, rizatriptan, ergotamines , or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above • are taking certain antidepressants, known as monoamine oxidase (MAO) - A inhibitors or it has been 2 weeks or less since you stopped taking a MAO - A inhibitor . A sk your provider for a list of these medicines if you are not sure • A n allergy to sumatriptan or any ingredient in Tosymra 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.
41 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra may cause serious side effects including: • Changes in color or sensation in your fingers and toes; sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever; cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet; increased blood pressure including a sudden severe increase even if you have no history of high blood pressure; medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider . • Serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti - depressant medicines called SSRIs or SNRIs. Call your provider right away if you have : mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. • Seizures even in people who have never had seizures before 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. For full Prescribing Information, visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=015a5cf9 - f246 - 48bc - b91e - cd730a53d8aa 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. 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. Tosymra ® Important Safety Information (2 of 2)
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