Tonix Pharmaceuticals Reports Third Quarter 2026 Financial Results and Operational Highlights

Higher research and commercialization expenses accompanied TONMYA sales growth, while nine-month operating cash use reached approximately $125.6 million.

Rhea-AI Summary

Tonix Pharmaceuticals (TNXP) reported third-quarter 2026 net product revenue of approximately $17.2 million, led by continued growth in TONMYA sales. Revenue compared with $3.3 million a year earlier. TONMYA sales were approximately $15 million, up 37% from the second quarter. Net loss widened to $53.3 million from $32.0 million, while loss per share narrowed to $2.89 from $3.59.

Cash totaled approximately $163 million at September 30, down from approximately $207.6 million at year-end. Tonix expects cash plus subsequent equity proceeds to fund operations and capital expenditures into early third-quarter 2027. TONMYA coverage reached approximately 166 million lives. Enrollment continues in the TNX-102 SL depression study. TNX-4800's Phase 2 study is expected to begin in first-quarter 2027, pending final FDA protocol agreement; a TNX-1500 kidney-transplant study is also expected to start that quarter.

17 points · 0 major

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1 major · 15 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointThird-quarter net product revenue rose to approximately $17.2 million from $3.3 million a year earlier.
• Moderate pointTONMYA third-quarter net sales reached approximately $15 million, up 37% from the second quarter.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Funding runway is expected by Tonix to extend into early third-quarter 2027, including subsequent equity proceeds.
• Minor pointTONMYA total prescriptions increased 28% quarter-over-quarter to 16,375, including bridge prescriptions.
• Minor pointTONMYA new prescriptions increased 17% quarter-over-quarter.

12 minor points

• Minor pointTONMYA refills increased 56% quarter-over-quarter.
• Minor pointTONMYA coverage reached approximately 166 million lives, approximately 53% of U.S. covered lives.
• Minor pointManaged Medicare agreements added approximately nine million lives in July and approximately 21 million in September 2026.
• Minor pointSales-force expansion added 50 representatives September 1, completing the planned increase to approximately 150.
• Minor pointTNX-102 SL enrollment continues in HORIZON, a potentially pivotal Phase 2 study in major depressive disorder.
• Minor point. Forward-looking: it has not happened yet and may not happen.TNX-4800 Phase 2 TRAIL is expected to begin in first-quarter 2027 for seasonal Lyme disease prevention.
• Minor point. Forward-looking: it has not happened yet and may not happen.TNX-4800 investigational product remains on track for delivery to Phase 2 sites in first-quarter 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.TNX-1500 Phase 2 study at Massachusetts General Hospital is expected to start first-quarter 2027, enrolling five adult kidney-transplant recipients.
• Minor pointThird-quarter cost of sales decreased to approximately $1.3 million from $1.4 million a year earlier.
• Minor pointNine-month net product revenue rose to $37.656 million from $7.717 million in the same 2025 period.
• Minor pointNine-month cost of sales fell to $3.533 million from $5.582 million in the same 2025 period.
• Minor pointSubsequent equity offerings raised approximately $1.5 million in net proceeds after September 30, 2026.

Negative

• Major pointThird-quarter net loss widened to $53.3 million from $32.0 million; per-share loss narrowed to $2.89 from $3.59.
• Moderate pointThird-quarter research and development expenses increased to approximately $25.8 million from $9.3 million a year earlier.
• Moderate pointThird-quarter selling, general and administrative expenses increased to approximately $45.6 million from $25.7 million a year earlier.
• Moderate pointNine-month operating cash use increased to approximately $125.6 million from $60.2 million in the same 2025 period.
• Moderate pointCash and cash equivalents declined to approximately $163 million at September 30 from $207.6 million at year-end.
• Moderate pointThird-quarter weighted average shares increased to 18,440,773 from 8,922,792 a year earlier.

9 minor points

• Minor pointZembrace SymTouch and Tosymra third-quarter sales declined to approximately $2.2 million from $3.3 million a year earlier.
• Minor pointTNX-4800 study initiation remains dependent on final FDA agreement on the study protocol.
• Minor pointBridge prescriptions await coverage determinations and do not immediately generate net product revenue.
• Minor pointEquity offerings after September 30 issued shares, diluting existing holders.
• Minor pointNine-month net loss widened to $134.075 million from $77.111 million; per-share loss narrowed to $8.24 from $10.42.
• Minor pointNine-month research and development expenses increased to $63.454 million from $27.545 million in the same 2025 period.
• Minor pointNine-month selling, general and administrative expenses increased to $110.173 million from $52.007 million in the same 2025 period.
• Minor pointTotal liabilities increased to $42.941 million at September 30, 2026, from $32.021 million at year-end.
• Minor pointStockholders’ equity decreased to $199.485 million at September 30, 2026, from $245.150 million at year-end.

News Explained

Tonix reports that Dr. Reddy’s filed an FDA application for generic TONMYA with a Paragraph IV patent certification; Tonix says it intends to enforce its intellectual-property rights but cannot predict the outcome, leaving the patent-related matter unresolved.

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Key Figures

TONMYA net sales: Approximately $15 million, up 37% Net product revenue: Approximately $17.2 million vs. $3.3 million Cash and cash equivalents: Approximately $163 million +5 more

TONMYA net sales

Approximately $15 million, up 37%

Third quarter 2026; increase versus second quarter

Net product revenue

Approximately $17.2 million vs. $3.3 million

Third quarter 2026 vs. third quarter 2025

Cash and cash equivalents

Approximately $163 million

As of September 30, 2026

Net cash used in operating activities

Approximately $125.6 million

Nine months ended September 30, 2026

Cash runway

Into early third quarter 2027

Company estimate including approximately $1.5 million raised in subsequent equity offerings

TONMYA covered lives

Approximately 166 million (~53%)

Coverage among approximately 314 million U.S. covered lives

Net loss available to common stockholders

$53.3 million

Third quarter 2026

Net loss per share

$2.89

Basic and diluted, third quarter 2026

Previous Earnings Reports

1 past event · Latest: Aug 10

Same Type 1 event

1. Aug 10

   2Q26 earnings

   24h Move

   +4.7%

   Q2 report disclosed approximately $11.0 million in TONMYA sales, establishing a comparable product-sales baseline.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

abbreviated new drug application, paragraph iv patent certification, placebo-controlled, monoclonal antibody

4 terms

abbreviated new drug application regulatory

"filed an Abbreviated New Drug Application (ANDA)"

An abbreviated new drug application is a regulatory submission used to gain approval to market a generic version of an already approved prescription medicine by showing it is equivalent in effect and safety to the original product, without repeating full clinical trials. For investors, an approval signals a lower-cost competitor entering the market that can quickly capture sales from the branded drug, similar to a generic knock‑off replacing a name‑brand item on store shelves.

paragraph iv patent certification regulatory

"containing a Paragraph IV patent certification"

A paragraph IV patent certification is a formal statement an applicant files with the U.S. Food and Drug Administration when seeking approval of a generic drug that says a patent listed for the branded drug is either invalid, unenforceable, or will not be infringed by the generic product. Filing that certification requires the applicant to notify the patent holder and the original drug sponsor; the patent owner can sue within a set period, and such a lawsuit triggers an automatic stay that can delay FDA approval of the generic for up to 30 months while the patent dispute is resolved. The certification is part of the Hatch‑Waxman regulatory pathway for abbreviated new drug applications and is distinct from other certification types that accept the patent's validity or defer challenge until after expiration.

placebo-controlled medical

"randomized, double-blind, placebo-controlled Phase 2 study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

monoclonal antibody medical

"anti-OspA monoclonal antibody (mAb)"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Third quarter TONMYA^® net sales of approximately $15 million, up 37% from the second quarter

Approximately $163 million in cash and cash equivalents as of September 30, 2026

Strategic focus on supporting TONMYA growth and advancing core clinical programs

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

BERKELEY HEIGHTS, N.J., Nov. 09, 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 September 30, 2026, and provided an overview of recent operational highlights.

“We delivered another strong quarter for TONMYA, with net sales up 37% over the second quarter,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Total prescriptions, new prescriptions, and refills also increased. Payer access expanded to include two commercial group purchasing organization (GPO) agreements, two managed Medicare agreements, and Medicaid access in almost every state. This expanded access contributed to third quarter sales growth. We have seen promising growth in our key performance indicators since adding 50 sales representatives on September 1, bringing our total sales force to approximately 150.”

“In addition to TONMYA’s growth, we are focused on our core clinical priorities,” Dr. Lederman continued. “Our priorities include advancing TNX-102 SL in major depressive disorder (MDD), TNX-4800 for Lyme disease prevention, and the investigator-initiated study of TNX-1500 (mosdaprubart)¹ to prevent kidney transplant rejection.”

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

Performance

• Third quarter 2026 key performance metrics included:
  • Total prescriptions increased 28% quarter-over-quarter to 16,375, including bridge prescriptions 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 prescriptions increased 17% quarter-over-quarter.
  • Refills increased 56% quarter-over-quarter.

Payer Access and Coverage

• TONMYA coverage now totals approximately 166 million covered lives (~53% of the approximately 314 million covered lives in the U.S.). The Company remains engaged with commercial payers, managed Medicare, and Medicaid to increase patient access.
  • In July 2026, Tonix announced a major managed Medicare agreement, adding approximately nine million Medicare lives.
  • In September 2026, Tonix announced a second major managed Medicare agreement, adding approximately 21 million Medicare lives.
    

Execution

• On September 1, 2026, the Company added 50 representatives to the TONMYA sales force, completing its planned expansion to approximately 150 sales representatives.
• On September 8, 2026, Tonix announced the promotion of Thomas Englese, MBA, to Chief Commercial Officer. Mr. Englese served as Executive Vice President, Commercial Operations, since September 2024.
• On October 2, 2026, the Company disclosed it had received notice from Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, DRL) that DRL had filed an Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification with the U.S. Food and Drug Administration (FDA) for a generic version of TONMYA. The Company intends to vigorously enforce its intellectual property rights relating to TONMYA against infringement but cannot predict the outcome of this matter or guarantee the outcome of any litigation.
  

Prioritized R&D Pipeline Updates

Central Nervous System (CNS) 
TNX-102 SL (cyclobenzaprine HCl sublingual tablets): MDD

• Enrollment is ongoing for HORIZON, a potentially pivotal, six-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.
  

Infectious Disease 
TNX-4800 (anti-OspA monoclonal antibody (mAb): long-acting human mAb in development for the seasonal prevention of Lyme disease in the U.S.

• On August 3, 2026, Tonix announced receipt of positive official minutes from its Type C meeting with the FDA. The FDA is reviewing the final study protocol.
• The adaptive Phase 2 TRAIL field study is expected to begin in the first quarter of 2027 pending final FDA agreement on the study protocol.
• The Company is on track to deliver investigational product to the Phase 2 clinical study sites in the first quarter of 2027.
  

Immunology
TNX-1500 (mosdaprubart) (dimeric Fc-modified humanized anti-CD40L mAb): Phase 2-ready third-generation anti-CD40L mAb in development to prevent kidney transplant rejection and treat autoimmune diseases

• A Phase 2, open-label, investigator-initiated study at Massachusetts General Hospital (MGH) is expected to initiate in the first quarter of 2027 and enroll five adult kidney transplant recipients.
  

Recent Financial Highlights
Tonix had approximately $163 million of cash and cash equivalents as of September 30, 2026, compared to approximately $207.6 million as of December 31, 2025. Net cash used in operating activities was approximately $125.6 million for the nine months ended September 30, 2026, compared to approximately $60.2 million for the same period in 2025.

The Company believes that its cash resources as of September 30, 2026, together with the net proceeds of approximately $1.5 million raised from equity offerings subsequent to September 30, 2026, will meet its operating and capital expenditure requirements into the early third quarter of 2027.

As of November 6, 2026, the Company had 19,431,516 shares of common stock outstanding.

Third Quarter 2026 Financial Results
Net product revenue for the third quarter 2026 was approximately $17.2 million, compared to $3.3 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 third quarter was approximately $15.0 million. Net revenue from sales of Zembrace SymTouch and Tosymra was approximately $2.2 million, compared to $3.3 million for the same quarter in 2025. Cost of sales for the third quarter 2026 was approximately $1.3 million, compared to $1.4 million for the same period in 2025. The decrease in cost of sales is driven by a change in product mix.

Research and development expenses for the third quarter 2026 were approximately $25.8 million, compared to $9.3 million for the same period in 2025. The increase of $16.5 million was primarily attributable to higher manufacturing expenses of $9.8 million, clinical expenses of $3.6 million and non-clinical expenses of $1.1 million as the Company advanced its prioritized pipeline, as well as higher employee-related costs of $1.5 million due to increased headcount.

Selling, general, and administrative expenses for the third quarter 2026 were approximately $45.6 million, compared to $25.7 million for the same period in 2025. The increase of $19.9 million was primarily attributable to higher sales and marketing expenses of $13.5 million, employee-related expenses of $4.1 million, and professional expenses of $1.5 million. These increases primarily reflect commercialization activities following the launch of TONMYA in November 2025.

Net loss available to common stockholders was $53.3 million, or $2.89 per basic and diluted share, for the third quarter 2026, compared to net loss available to common stockholders of $32.0 million, or $3.59 per basic and diluted share, for the same period in 2025. The basic and diluted weighted average common shares outstanding for the third quarter 2026 was 18,440,773 compared to 8,922,792 shares for the same period in 2025.

Conference Call and Webcast Information
The Company will host a conference call and webcast to report third quarter 2026 financial results and operational highlights on Monday, November 9, 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.

Citations
¹Mosdaprubart is the proposed International Nonproprietary Name (INN); final designation pending confirmation from the World Health Organization (WHO).

Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully integrated, commercial-stage biopharmaceutical company focused on central nervous system (CNS) disorders, infectious diseases, and immunology conditions with high unmet medical needs. TONMYA^® (cyclobenzaprine HCl sublingual tablets 2.8 mg), the Company’s flagship internally conceived and developed medicine, is the first FDA-approved 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 (Tonix-led study) and acute stress disorder/acute stress reaction (investigator-initiated study). Tonix is also advancing monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection (investigator-initiated study). 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 for the indications being investigated have not been established, and they have not been approved for those indications.

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 preclinical programs, expected enrollment in the Company’s clinical trials, expected adoption by the medical community and patients of the Company’s products, and the expected outcome of litigation. 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; uncertainties of patent protection and litigation; 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 government or third-party payer 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. Investors should read the risk factors set forth 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 hereof.

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 September 30,										Nine Months Ended September 30,
		2026					2025					2026					2025
REVENUE:
Product revenue, net		$	17,234				$	3,290				$	37,656				$	7,717
COSTS AND EXPENSES:
Cost of sales			1,252					1,367					3,533					5,582
Research and development			25,824					9,289					63,454					27,545
Selling, general and administrative			45,590					25,701					110,173					52,007
			72,666					36,357					177,160					85,134
Operating loss			(55,432	)				(33,067		)			(139,504	)				(77,417	)
Contract income			666					982					1,266					2,941
Loss on extinguishment of debt			—					—					—					(2,092	)
Interest income, net			1,362					1,231					4,140					2,713
Other income (expense), net			75					(1,156	)				23					(3,256	)
Net loss available to common stockholders		$	(53,329	)			$	(32,010		)		$	(134,075	)			$	(77,111	)
Net loss per common share, basic and diluted		$	(2.89	)			$	(3.59		)		$	(8.24	)			$	(10.42	)
Weighted average common shares outstanding, basic and diluted			18,440,773					8,922,792					16,278,383					7,403,400

TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED BALANCE SHEETS (In Thousands) (Unaudited)1
	September 30, 2026			December 31, 2025
Assets
Cash and cash equivalents	$	162,793		$	207,637
Accounts receivable, net		14,599			6,271
Inventory		4,478			6,013
Prepaid expenses and other		10,265			8,955
Total current assets		192,135			228,876
Other non-current assets		50,291			48,295
Total assets	$	242,426		$	277,171
Liabilities and stockholders’ equity
Total liabilities	$	42,941		$	32,021
Stockholders’ equity		199,485			245,150
Total liabilities and stockholders’ equity	$	242,426		$	277,171

1

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much did Tonix's TONMYA sales grow in the third quarter of 2026?

TONMYA net sales reached approximately $15 million in third-quarter 2026, up 37% from the second quarter. Total company net product revenue, including Zembrace SymTouch and Tosymra, was approximately $17.2 million, compared with $3.3 million in third-quarter 2025.

What was Tonix Pharmaceuticals' third-quarter 2026 net loss?

Tonix reported a net loss available to common stockholders of $53.3 million, or $2.89 per basic and diluted share. A year earlier, the loss was $32.0 million, or $3.59 per share. Weighted average shares increased to 18,440,773 from 8,922,792.

Do all TONMYA prescriptions reported by Tonix immediately generate revenue?

No. The 16,375 total prescriptions reported for third-quarter 2026 include bridge prescriptions through Tonix's digital pharmacy channel. These are initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue.

What is the design of Tonix's HORIZON depression study?

HORIZON is a six-week, randomized, double-blind, placebo-controlled Phase 2 study evaluating TNX-102 SL 5.6 mg as first-line monotherapy in adults with major depressive disorder. Enrollment is ongoing, and Tonix describes the study as potentially pivotal.

Why did Tonix's research and commercialization expenses rise in third-quarter 2026?

Higher manufacturing and clinical expenses primarily drove the research spending increase, while sales and marketing primarily drove the administrative spending increase. Research and development included increases of $9.8 million in manufacturing and $3.6 million in clinical expenses. Selling, general and administrative expenses included a $13.5 million increase in sales and marketing, primarily reflecting commercialization following TONMYA's November 2025 launch.