Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals Reports

Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights

August 15, 2025, is the FDA PDUFA goal date for

TNX-102 SL for the management of fibromyalgia;

If approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years

Company expects to have sufficient cash to fund planned operations beyond

FDA PDUFA goal date and anticipated fourth quarter 2025 launch of TNX-102 SL

for fibromyalgia; $98.8 million in cash as of December

Announced positive topline results from Phase 1

study of TNX-1500, a next generation anti-CD40L mAb candidate

for prevention of kidney transplant rejection and treatment of autoimmune diseases

Received government grant for potential mpox vaccine,

TNX-801, which has demonstrated single-dose immune protection

against a monkeypox challenge in non-human primates

Received first payments from U.S. Department of

Defense (DoD) contract for up to $34 million over five years

to develop a broad-spectrum antiviral drug program

CHATHAM, N.J., March 18, 2025 (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, today announced financial results for the fourth quarter and full year ended December

31, 2024, and provided an overview of recent operational highlights.

"With commercial preparations underway, we believe

we are well positioned to launch TNX-102 SL for the management of fibromyalgia in the fourth quarter of this year if approved by the U.S.

Food and Drug Administration," said Seth Lederman, M.D., Chief Executive Officer of Tonix. "We believe that TNX-102 SL has

the potential to be the first in a new class of non-opioid analgesic medicines for the management of fibromyalgia, and the first new drug

for treating fibromyalgia in more than 15 years."

Fibromyalgia is a debilitating chronic pain condition

affecting over 10 million adults in the United States, most of whom are women. Data from our pivotal Phase 3 trials indicate that TNX-102

SL can provide fibromyalgia patients with significant reduction in pain. TNX-102 SL was generally well tolerated and has no known addictive

Dr. Lederman continued, "Tonix is debt free

and expects to have sufficient cash to fund operations through the PDUFA target date of August 15, 2025, and the anticipated commercial

launch of TNX-102 SL in the fourth quarter of this year. We continue to meaningfully add to our commercial team and are engaged in pre-launch

activities. We look forward to continuing discussions with the FDA throughout the review period in advance of the PDUFA goal date to bring

patients a potential new treatment option."

"Beyond TNX-102 SL for fibromyalgia, we are

encouraged by the continued development of our pipeline in a capital efficient manner. Positive results from a Phase 1 study evaluating

the tolerability and pharmacokinetics of TNX-1500, a next generation anti-CD40L mAb for prevention of kidney transplant rejection, support

advancing to a planned Phase 2 trial in kidney transplant recipients with monthly dosing. In addition, we continue to advance TNX-801

vaccine for preventing mpox and smallpox towards the clinic. With the ongoing global mpox epidemic continuing to spread, TNX-801's

ability to protect animals from lethal challenge with Clade Ia monkeypox virus and its tolerability in immune-compromised animals is encouraging

and further supports testing in humans. We look forward to providing additional updates to each of these promising programs in 2025."

Key Product Candidates* - Recent Highlights

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual tablets):

5.6 mg, once-daily at bedtime small molecule for the management of fibromyalgia (FM) - a centrally-acting, non-opioid analgesic.

TNX-102 SL for the treatment of acute stress reaction

(ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

TNX-1300 (recombinant double mutant cocaine esterase):

biologic for cocaine intoxication

The Phase 2 CATALYST study of TNX-1300 for the treatment

of cocaine intoxication began enrolling in August 2024. CATALYST is a Phase 2 single-blind, placebo-controlled, proof-of-concept study

in patients presenting to the emergency department. Because of the challenges of recruiting eligible patients into this study, we are

not guiding to a timeline for completion of enrollment or topline data.

TNX-1500 (anti-CD40L Fc-modified humanized monoclonal

antibody): third generation anti-CD40L monoclonal antibody for prophylaxis for organ transplant rejection and treatment of autoimmune

Infectious Disease Pipeline

TNX-801 (recombinant horsepox virus, minimally

replicative live vaccine): potential vaccine to protect against mpox and smallpox.

Corporate and Partnerships - Recent Highlights

Marketed Products - Recent Highlights

In September 2024, Tonix Medicines launched a national

educational campaign focusing on the link between migraine, gastroparesis, and the need for non-oral acute migraine therapies. Tonix Medicines

is the only manufacturer with both a branded injectable and nasal spray indicated for the acute treatment of migraine with or without

Financial - Recent Highlight

Tonix had approximately $98.8 million of cash and

cash equivalents as of December 31, 2024, compared to approximately $24.9 million as of December 31, 2023. Net cash used in operations

was approximately $60.9 million for the full year ended December 31, 2024, compared to $102.0 million for the same period in 2023. Net

cash used in investing activities for the full year ended December 31, 2024, was approximately $0.1 million compared to $29.1 million

for the same period in 2023.

Following the repayment of a mortgage (Loan and Guaranty

Agreement) with JGB Capital and related parties in February 2025, the Company is now debt-free.

Tonix continues to expect that its cash resources

at December 31, 2024, and the net proceeds of approximately $46.3 million raised from the sale of common stock under an at-the-market

(ATM) facility in the first quarter of 2025, will be sufficient to fund its planned operations into the first quarter of 2026, beyond

the August 15, 2025 PDUFA goal date assigned by the FDA for a decision on marketing authorization for TNX-102 SL for management of fibromyalgia.

Subsequent to December 31, 2024, the Company repurchased

250,000 of its shares of common stock outstanding under the 2024 share repurchase program.

Fourth Quarter 2024 Financial Results

Net product revenue for the fourth quarter 2024 was

approximately $2.6 million, compared to $3.8 million for the same period in 2023, and consisted of combined net sales of Zembrace

SymTouch and Tosymra . Cost of Sales for the fourth quarter 2024 was approximately $1.2 million, compared to $2.4 million for

the same period in 2023.

R&D expenses for the fourth quarter 2024 were

approximately $8.3 million, compared to $17.1 million for the same period in 2023. This decrease is predominantly due to decreased clinical

expenses resulting from fewer clinical trials and pipeline prioritization efforts.

SG&A expenses for the fourth quarter 2024 were

$15.6 million, compared to $11.6 million for the same period in 2023. The increase was primarily due to an increase in financial reporting

expenses, sales and marketing, and professional fees associated with TNX-102 SL's NDA submission.

Net loss available to common stockholders was $22.1

million, or $9.77 per basic and diluted share, for the fourth quarter 2024, compared to net loss available to common stockholders of $27.3

million, or $2,179.83 per basic and diluted share, for the same period in 2023. The basic and diluted weighted average common shares outstanding

for the fourth quarter 2024 was 2,263,535 compared to 12,534 shares for the same period in 2023.

Full Year 2024 Financial Results

Net product revenue for the full year 2024 was approximately

$10.1 million. Cost of sales for the full year 2024 was approximately $7.8 million.

R&D expenses for the full year 2024 were approximately

$40.0 million, compared to $86.7 million in 2023. This decrease is predominantly due to fewer clinical trials and from pipeline prioritization

efforts, which further decreased non-clinical, manufacturing, employee-related and professional expenses as well.

SG&A expenses for the full year 2024 were $40.1