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
deborah.elson@tonixpharma.com
investor.relations@tonixpharma.com
Brian
Korb
astr
partners
(917)
653-5122
brian.korb@astrpartners.com
Media
Contacts
Andrea
Cohen
Sam
Brown Inc.
(917)
209-7163
andreacohen@sambrown.com
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. |
