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EX-99

2 ex99-01.htm

PRESS RELEASE OF THE COMPANY, DATED MAY 11, 2026

Tonix Pharmaceuticals Holding Corp. Form 8-K

Exhibit 99.01

Tonix Pharmaceuticals Reports First Quarter 2026 Financial Results and

Operational Highlights

In the first full quarter since launch, 2,145 healthcare providers prescribed TONMYA®, 3,588 patients initiated treatment, and ~5,400 prescriptions were filled

Agreement signed in May with leading group purchasing organization (GPO) that provides access to TONMYA for approximately 35 million U.S. commercial lives

Expect to initiate adaptive Phase 2 field study for the prevention of Lyme disease in the U.S. in the first half of 2027 for TNX-4800, pending FDA agreement

Approximately $185.5 million in cash and cash equivalents as of March 31, 2026

BERKELEY HEIGHTS, N.J., May 11, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today announced financial results for the quarter ended March 31, 2026, and provided an overview of recent operational highlights.

“TONMYA is the first new fibromyalgia medicine in 15 years," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TONMYA is a non-opioid analgesic designed for bedtime administration and long-term use by adults. Since launch in November 2025, TONMYA has shown growth in prescriptions, new writers, refills, and patient access. Our first managed care partnership was announced in May, providing access to approximately 35 million U.S. commercial lives. We will continue engagement with commercial and government payers to expand patient access. Our focus remains on operational excellence across sales, marketing, medical affairs, and market access to educate and deliver on TONMYA’s differentiated potential.”

Dr. Lederman continued, “We also continue to meaningfully advance our mid-stage clinical programs and our earlier-stage pipeline. For TNX-4800, our investigational long-acting borreliacidal, human monoclonal antibody targeting OspA on Borrelia burgdorferi, which causes the majority of Lyme disease in the U.S., we announced positive Phase 1 data and plans for an adaptive Phase 2 field study in 2027, pending FDA agreement. We look forward to our scheduled Type C meeting with the FDA early in the third quarter of 2026 to discuss the study. We believe TNX-4800 offers several advantages over vaccines in development, including onset of protection within two days and a simpler two-dose regimen with a second booster dose two months after the first. We also expect to begin our Phase 2 study of TONMYA for the treatment of Major Depressive Disorder (MDD) mid-year. Our other programs across CNS, infectious disease, immunology, and rare disease remain well positioned for near-term milestones.”

Commercial Updates

TONMYA (cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults

•On November 17, 2025, TONMYA became commercially available, following U.S. FDA approval in August 2025 for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. The approval was based on two double-blind, randomized, placebo-controlled Phase 3 clinical studies of nearly 1,000 patients that demonstrated durable and statistically significant reduction in daily pain scores compared to placebo. There are now approximately 100 TONMYA sales reps in the field.

•In the first quarter of 2026, the first full quarter since launch, key metrics include:

o2,145 unique healthcare providers prescribed TONMYA to patients.

o3,588 unique patients initiated treatment with TONMYA.

oApproximately 5,400 prescriptions were filled. This includes bridge prescriptions that are facilitated through the Company's specialty pharmacy channel. Bridge prescriptions represent initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue.

•For the period beginning November 17, 2025, through April 24, 2026, cumulative key metrics include:

oMore than 2,700 unique healthcare providers have prescribed TONMYA to patients.

oApproximately 5,618 unique patients have initiated treatment with TONMYA.

•For the period beginning November 17, 2025, through May 1, 2026, cumulative key metrics include:

oApproximately 11,016 prescriptions were filled. This includes bridge prescriptions that are facilitated through the Company's specialty pharmacy channel.

•Repeat prescriber and patient refill trends are encouraging.

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

oIn May 2026, Tonix secured commercial payer coverage with its first managed care partnership agreement with a leading GPO, which will provide access for approximately 35 million U.S. patients (20% of ~177 million commercial lives in the U.S.)

oTo date,

Current Report

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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 1, 2026

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.)

200 Connell Drive, Berkeley Heights, New Jersey, 07922

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (862) 799-8599

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 Global Select 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 2.02Results of Operations and Financial Condition.

Tonix Pharmaceuticals Holding Corp. (the “Company”) is disclosing selected preliminary operating results for the quarter ended March 31, 2026, and certain preliminary financial condition information as of April 30, 2026, as set forth below:

·The Company ended the quarter with approximately $185.5 million in cash and cash equivalents. As of April 30, 2026, the Company had 15,540,801 shares of common stock outstanding.

·The Company’s net cash used in operating activities for the quarter ended March 31, 2026, was approximately $40.2 million compared to $16.6 million for the quarter ended March 31, 2025.

·The Company’s capital expenditures for the quarter ended March 31, 2026, was approximately $1.7 million compared to $6,000 for the quarter ended March 31, 2025.

·The Company’s net loss for the quarter ended March 31, 2026, was approximately $40.8 million compared to $16.8 million for the quarter ended March 31, 2025.

·The Company’s net revenue from sales of its marketed products for the quarter ended March 31, 2026, was approximately $6.9 million compared to $2.4 million for the quarter ended March 31, 2025.

o Net revenue from sales of Zembrace® SymTouch® and Tosymra® for the quarter ended March 31, 2026, was approximately $3.2 million compared to $2.4 million for the quarter ended March 31, 2025.

o Net revenue from sales of TONMYA® for the quarter ended March 31, 2026, was approximately $3.7 million. TONMYA® was launched in November 2025. Net revenue from sales of TONMYA® for the period from November 17, 2025, to December 31, 2025, was approximately $1.4 million.

The Company believes that its cash resources at March 31, 2026, together with the net proceeds of $17.4 million that it raised from equity offerings in the second quarter of 2026, will fund its planned operating and capital expenditure requirements into the second quarter of 2027.

The above information is preliminary financial information for the quarter ended March 31, 2026, and subject to completion. The unaudited, estimated results for the quarter ended March 31, 2026, are preliminary and were prepared by the Company’s management, based upon its estimates, a number of assumptions and currently available information, and are subject to revision based upon, among other things, quarter-end closing procedures and/or adjustments, the completion of the Company’s consolidated financial statements and other operational procedures. This preliminary financial information is the responsibility of management and has been prepared in good faith on a consistent basis with prior periods. However, the Company has not completed its financial closing procedures for the quarter ended March 31, 2026, and its actual results could be materially different from this preliminary financial information, which preliminary information should not be regarded as a re