Tonix Pharmaceuticals公布第二季業績 TONMYA銷售季增197%至1100萬美元

EX-99.01
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ex99-01.htm
EX-99.01

 

 

Exhibit
99.01

 

Tonix
Pharmaceuticals Reports Second Quarter 2026 Financial Results and Operational Highlights

 

TONMYA®
net sales totaled approximately $11 million, an increase of 197% quarter-over-quarter 

 

Commercial
and government payer coverage for TONMYA meaningfully expanded, now reaching approximately 136 million covered lives (43% of total U.S.
lives)

 

First
patient enrolled in Phase 2 HORIZON study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of major depressive
disorder (MDD)

 

Phase
2 adaptive field study of TNX-4800 for the prevention of Lyme disease in the U.S. on track to start in the first quarter of 2027 pending
final FDA review and agreement on study protocol

 

Approximately
$176.2 million in cash and cash equivalents as of June 30, 2026

 

Conference
call today at 8:30 a.m. ET

 

BERKELEY
HEIGHTS, N.J., August 10, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or
the “Company”), a fully integrated, commercial-stage biopharmaceutical company, today announced financial results for the
quarter ended June 30, 2026, and provided an overview of recent operational highlights.

 

“We
are pleased with the execution of TONMYA’s launch, including nearly tripling net sales and achieving growth across our key metrics
in the second quarter,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We are
seeing TONMYA’s value resonate among healthcare providers and patients as the first FDA-approved treatment for fibromyalgia in
15 years. It is a first-in-class, non-opioid analgesic designed for daily bedtime administration and long-term use. We are now beginning
to see coverage translate into broader patient access following the execution of agreements with commercial payers, managed Medicare,
and Medicaid. Our newly expanded sales force is expected to deploy in the field by September. We believe we are well positioned to reach
more of our target prescribers and support the treatment of more patients with TONMYA.”

 

Dr.
Lederman continued, “We are also progressing our clinical development pipeline priorities. We enrolled the first patient in HORIZON,
our potentially pivotal Phase 2 study of TNX-102 SL in MDD. For Lyme prevention, we expect to start enrollment in the first quarter of
2027 in a Phase 2 adaptive field study after we reached alignment with FDA on the development path for TNX-4800, an investigational long-acting
borreliacidal human monoclonal antibody targeting OspA on Borrelia burgdorferi.”

 

Commercial
Updates

 

TONMYA
(cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults; commercially
launched on November 17, 2025

 

  

  

 

 

Performance
Across Key Metrics

 

●In
 the second quarter of 2026, key metrics include: 

 

○12,592
 total prescriptions, increasing 100% quarter-over-quarter. This includes bridge prescriptions
 that are facilitated through the Company’s digital pharmacy channel. Bridge prescriptions
 represent initial patient fills provided while coverage determinations are pending and do
 not immediately generate net product revenue. 

○New
 patient prescriptions increased 36% quarter-over-quarter.

○Refills
 increased 207% quarter-over-quarter.

 

Payer
Access and Coverage

 

●The
 Company is prioritizing ongoing engagement with commercial payers, managed Medicare, and
 Medicaid to increase access:

 

○Tonix
 announced commercial payer agreements with two leading GPOs in May and June 2026, providing
 access to a combined approximate 52 million lives (29% of the total commercial lives in the
 U.S.).

○Currently,
 total coverage for TONMYA across commercial, managed Medicare, and Medicaid channels represents
 approximately 136 million covered lives (~43% of the approximately 314 million covered lives
 in the U.S.). 

○When
 the managed Medicare payer coverage agreement goes into effect on January 1, 2027, it will
 add approximately nine million Medicare lives (16% of the approximately 55 million Medicare
 lives in the U.S.). Total coverage will then reach approximately 145 million covered lives
 (~46% of the 314 million covered lives in the U.S.).

○TONMYA
 is covered under Medicaid in most states, representing approximately 75 million lives.

 

Commercial
Execution

 

●Following
 these coverage milestones and encouraging trends across launch key performance indicators,
 Tonix is implementing its strategy to expand the TONMYA sales force. The Company expects
 to deploy 50 new sales representatives in the field by September 2026, bringing the full
 sales force to approximately 150 people. 

●In
 parallel, the Company is advancing marketing activities to enhance understanding of fibromyalgia
 and product awareness among patients and healthcare providers, as well as non-commercial
 medical affairs initiatives.

●In
 the second quarter of 2026, Tonix presented data highlighting TONMYA at the European Alliance
 of Associations for Rheumatology (EULAR) 2026, 2026 American Society of Clinical Psychopharmacology
 (ASCP) Annual Meeting, and Professional Society for Health and Outcomes Research (ISPOR 2026)
 Annual Meeting, as well as published a manuscript in the peer-reviewed journal, Clinical
 Pharmacology in Drug Development.

 

Key
Product Pipeline Candidates: Recent Highlights

 

Central
Nervous System (CNS) Pipeline

 

TNX-102
SL (cyclobenzaprine HCl sublingual tablets): in Phase 2 development for MDD

 

●In
 June 2026, Tonix enrolled the first patient in HORIZON, a potentially pivotal, 6-week, randomized,
 double-blind, placebo-controlled Phase 2 study of TNX-102 SL 5.6 mg as a first-line monotherapy
 in adults with MDD. Approximately 360 patients are expected to enroll at approximately 30
 U.S. sites, with the primary endpoint of change from baseline in MADRS (Montgomery-Asberg
 Depression Rating Scale) total score at Week 6. TNX-102 SL targets disturbed sleep through
 antagonism at four neuronal receptors, an approach mechanistically distinct from currently
 available antidepressants.

 

  

  

 

 

TNX-102
SL: in Phase 2 development for acute stress disorder (ASD) and acute stress reaction (ASR)

 

●The
 U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS)
 study is being conducted by the University of North Carolina under an investigator-initiated
 IND. Topline data is expected to be reported mid-2027.

 

TNX-1300
(double-mutant cocaine esterase) for cocaine intoxication; Phase 2 program has Breakthrough Therapy designation from the FDA, with no
products on the market for this indication

 

●The
 Company plans to meet with the FDA in 2026 to inform the clinical design of the next Phase
 2 study (a Phase 2 study has been completed).

 

Infectious
Disease Pipeline

 

TNX-4800
(anti-OspA mAb): Phase 2-ready long-acting human monoclonal antibody in development for the seasonal prevention of Lyme disease in the
U.S., for which no FDA-approved vaccines or prophylactics are available

 

●The
 Company received final minutes from a Type C meeting held with the FDA in early third quarter
 of 2026. The adaptive Phase 2 field study is expected to start in the first quarter of 2027
 pending final FDA review and agreement on the study protocol.

●The
 study will be a randomized, double-blind, placebo-controlled field study, with the primary
 efficacy endpoint of protection through six months, and a key secondary efficacy endpoint
 of protection through three months. Adults aged 18 and older from U.S. Lyme-endemic areas
 who engage in activities that increase their risk of deer tick bites will be randomized to
 receive placebo or two doses of TNX-4800: 450 mg subcutaneous (SC) dose at Day 1, and a second
 dose of 450 mg SC dose three months later at Day 85. 

●In
 April 2026, Tonix presented Phase 1 data and announced plans for an adaptive Phase 2 field
 study of TNX-4800 at the 4th Annual Ticks and Tickborne Diseases Symposium at
 Johns Hopkins University.

●The
 Company expects to deliver investigational product to the Phase 2 clinical study sites in
 the first quarter of 2027.

 

TNX-801
(recombinant horsepox virus): an attenuated, minimally replicative, live virus vaccine candidate in pre-clinical development for the
prevention of smallpox and mpox

 

●In
 July 2026, Tonix announced a new paper in the Journal of Virology describing new murine
 models for investigating mpox pathogenesis. TNX-801 is expected to enter a Phase 1 study
 in mid-2027 pending FDA clearance of the Investigational New Drug (IND) application. 

 

TNX-4200
(broad-spectrum antiviral targeting CD45) for the prevention or treatment of high-lethality infections to improve the medical readiness
of military personnel in biological threat environments

 

●The
 ongoing TNX-4200 program is supported by an up to $34 million contract over five years from
 the Department of Defense’s Defense Threat Reduction Agency (DTRA). In the second quarter,
 the project began its next project phase.

 

  

  

 

 

Immunology
Pipeline

 

TNX-1500
(dimeric Fc-modified anti-CD40L, humanized mAb): Phase 2-ready third-generation anti-CD40L for prophylaxis of kidney transplant rejection
and treatment of autoimmune diseases

 

●In
 July 2026, the World Health Organization (WHO) included mosdaprubart as the proposed International
 Nonproprietary Name (pINN) for TNX-1500, pending publication as a recommended INN. 

●In
 May 2026, Tonix announced the publication of Phase 1 clinical data for TNX-1500 in the Journal
 of Clinical Immunology that support TNX-1500 as a potentially first-in-class, best-in-class,
 third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection.

●A
 Phase 2, open-label, investigator-initiated study in adult kidney transplant patients at
 Massachusetts General Hospital (MGH) is expected to initiate in the second half of 2026 pending
 FDA clearance of MGH’s IND application. The study is expected to enroll five adult
 kidney transplant recipients.

 

Rare
Disease Pipeline

 

TNX-2900
(intranasal potentiated oxytocin): in development for Prader-Willi syndrome, with Orphan Drug and Rare Pediatric Disease designation
that could potentially make Tonix eligible for a Priority Review Voucher upon approval

 

●Tonix
 plans to initiate a Phase 2, randomized, double-blind, placebo-controlled study in children
 and adolescents with Prader-Willi syndrome in the second half of 2027.

 

Immuno-oncology
Pipeline

 

TNX-1700
(TFF2-albumin fusion protein): in preclinical development for gastric and colorectal cancer

 

●In
 June 2026, Tonix presented preclinical data at the Ninth JCA-AACR Special Joint Conference
 on Novel Therapies and Diagnostics in Upper Digestive and Head and Neck Cancers demonstrating
 TNX-1700 normalizes myelopoiesis and enhances anti-PD-1 therapy in gastric cancer.

 

Financial:
Recent Highlights

 

Tonix
had approximately $176.2 million of cash and cash equivalents as of June 30, 2026, compared to approximately $207.6 million as of December
31, 2025. Net cash used in operating activities was approximately $84.6 million for the six months ended June 30, 2026, compared to $31.4
million for the same period in 2025.

 

Subsequent
to quarter-end, the Company raised $3.7 million in proceeds under its At-the-Market facility.

 

  

  

 

 

The
Company believes that its cash resources as of June 30, 2026, together with the net proceeds that it raised from equity offerings in
the third quarter of 2026 to date, will meet its planned operating and capital expenditure requirements into early second quarter of
2027.

 

As
of August 7, 2026, the Company had 17,151,024 shares of common stock outstanding.

 

Second
Quarter 2026 Financial Results

 

Net
product revenue for the second quarter 2026 was approximately $13.5 million, compared to $2.0 million for the same period in 2025, and
consisted of combined net sales of TONMYA, Zembrace® SymTouch®, and Tosymra®. Net revenue from sales of TONMYA for the second
quarter was approximately $11.0 million. Net revenue from sales of Zembrace SymTouch and Tosymra was approximately $2.5 million, compared
to $2.0 million for the same quarter in 2025. Cost of sales for the second quarter 2026 was approximately $0.7 million, compared to $3.3
million for the same period in 2025. The decrease in the cost of sales is predominantly driven by a change in product mix and a write-off
related to the migraine products in 2025.

 

Research
and development expenses for the second quarter 2026 were approximately $19.4 million, compared to $10.8 million for the same period
in 2025. The increase of $8.6 million was primarily attributable to higher manufacturing and clinical trial costs associated with advancing
the Company’s prioritized pipeline programs, as well as increased employee-related costs reflecting expanded headcount.

 

Selling,
general, and administrative expenses for the second quarter 2026 were approximately $36.0 million, compared to $16.2 million for the
same period in 2025. The increase of $19.8 million was primarily attributable to sales and marketing investment supporting the commercial
launch of TONMYA and the Company’s migraine products, together with increased employee-related and professional expenses.

 

Net
loss available to common stockholders was $40.6 million, or $2.44 per basic and diluted share, for the second quarter 2026, compared
to net loss available to common stockholders of $28.3 million, or $3.86 per basic and diluted share, for the same period in 2025. The
basic and diluted weighted average common shares outstanding for the second quarter 2026 was 16,635,254 compared to 7,327,257 shares
for the same period in 2025.

 

Conference
Call and Webcast Information

 

The
Company will host a conference call and webcast to report second quarter 2026 financial results and operational highlights on Monday,
August 10, 2026, at 8:30 a.m. ET.

 

To
listen to the conference call, register at this link. To view the webcast, register at this link.

 

A
replay will be available under “IR Events” in the Investors section of the Company’s website at https://ir.tonixpharma.com/news-events/ir-events.

 

  

  

 

 

Tonix
Pharmaceuticals Holding Corp.

 

Tonix
Pharmaceuticals* is a fully integrated, commercial-stage biopharmaceutical company focused on central nervous system (CNS) disorders,
infectious diseases, immunology conditions, and rare diseases with high unmet medical needs. TONMYA® (cyclobenzaprine HCl sublingual
tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first treatment for fibromyalgia 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 extending the science
behind TONMYA in Phase 2 clinical studies to evaluate the potential of TNX-102 SL in major depressive disorder and acute stress disorder/acute
stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA
mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention
of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for
the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase
2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

 

*Tonix’s
product development candidates, including TNX-102 SL for new, unapproved indications, 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.

 

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 Company’s expected financial performance, the Company’s anticipated cash runway, the Company’s
expected timelines regarding its clinical and pre-clinical programs, expected enrollment in the Company’s clinical trials, expected
adoption by the medical community and patients of the Company’s products and expected timelines regarding the Company’s manufacturing
processes. 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

 

Deborah
Elson

 

Tonix
Pharmaceuticals

[email protected]

[email protected]

 

Brian
Korb

 

astr
partners

(917)
653-5122

[email protected]

 

Media
Contacts

Andrea
Cohen

Sam
Brown Inc.

(917)
209-7163

[email protected]

 

  

  

 

 

TONIX
PHARMACEUTICALS HOLDING CORP.

CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS

(In
Thousands, Except Share and Per Share Amounts)

(unaudited)

 

 
   
 Three
 Months Ended June 30,  
 Six
 Months Ended June 30, 

 
   
 2026  
 2025  
 2026  
 2025 

 
 REVENUE: 
     
     
     
    

 
 Product revenue, net 
 $13,544  
 $1,998  
 $20,422  
 $4,427 

 
 COSTS AND EXPENSES: 
     
     
     
    

 
 Cost of revenue 
  703  
  3,272  
  2,281  
  4,215 

 
 Research and development 
  19,417  
  10,820  
  37,630  
  18,256 

 
 Selling, general and administrative 
  35,959  
  16,202  
  64,583  
  26,306 

 
   
  56,079  
  30,294  
  104,494  
  48,777 

 
   
     
     
     
    

 
 Operating loss 
  (42,535) 
  (28,296) 
  (84,072) 
  (44,350)

 
   
     
     
     
    

 
 Grant income 
  600  
  1,036  
  600  
  1,959 

 
 Loss on extinguishment of debt 
  —  
  —  
  —  
  (2,092)

 
 Interest income, net 
  1,432  
  943  
  2,778  
  1,571 

 
 Other expense, net 
  (49) 
  (1,955) 
  (52) 
  (2,189)

 
   
     
     
     
    

 
 Net loss available to
 common stockholders 
 $(40,552) 
 $(28,272) 
 $(80,746) 
 $(45,101)

 
   
     
     
     
    

 
 Net loss per common
 share, basic and diluted 
 $(2.44) 
 $(3.86) 
 $(5.32) 
 $(6.80)

 
   
     
     
     
    

 
 Weighted average common
 shares outstanding, basic and diluted 
  16,635,254  
  7,327,257  
  15,179,268  
  6,631,111 

 

 

  

  

 

 

TONIX
PHARMACEUTICALS HOLDING CORP.

CONDENSED
CONSOLIDATED BALANCE SHEETS

(In
Thousands)

(Unaudited)
1

 

 
   
 June
 30, 2026  
 December
 31, 2025 

 
 Assets 
     
    

 
 Cash and cash equivalents 
 $176,232  
 $207,637 

 
 Accounts Receivable, net 
  11,805  
  6,271 

 
 Inventory 
  4,678  
  6,013 

 
 Prepaid expenses and other 
  10,717  
  8,955 

 
 Total current assets 
  203,432  
  228,876 

 
 Other non-current assets 
  50,656  
  48,295 

 
 Total assets 
 $254,088  
 $277,171 

 
   
     
    

 
 Liabilities and stockholders’
 equity 
     
    

 
 Total liabilities 
 $31,807  
 $32,021 

 
 Stockholders’ equity 
  222,281  
  245,150 

 
 Total liabilities and
 stockholders’ equity 
 $254,088  
 $277,171 

 

 

 
  
 1
 The
 condensed consolidated balance sheet for the year ended December 31, 2025, has been derived from the audited financial statements
 but do not include all of the information and footnotes required by accounting principles generally accepted in the United States
 for complete financial statements.