false
0001430306
0001430306
2024-11-12
2024-11-12
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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):
November 12, 2024
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.) |
26
Main Street, Chatham, New
Jersey 07928
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area
code: (862) 904-8182
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 Capital 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 2.02 |
Results of Operations and Financial Condition |
On November 12,
2024, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced its operating results for the quarter ended September
30, 2024. A copy of the press release that discusses these matters is filed as Exhibit 99.01 to, and incorporated by reference in, this
report.
Item 9.01 |
Financial Statements and Exhibits. |
(d) |
|
Exhibit
No. |
|
Description. |
|
|
99.01
104 |
|
Press Release of the Company, dated November 12, 2024
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirement of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
TONIX PHARMACEUTICALS HOLDING CORP. |
|
|
Date: November 12, 2024 |
By: |
/s/ Bradley Saenger |
|
|
Bradley Saenger |
|
Chief Financial Officer |
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
EXHIBIT 99.01
Tonix Pharmaceuticals
Reports Third Quarter 2024 Financial Results and Operational Highlights
Submitted New Drug Application (NDA) to FDA for
TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studies
Granted Fast Track Designation by FDA in July 2024
for TNX-102 SL, a centrally-acting, non-opioid analgesic; Fibromyalgia is a common chronic pain condition that affects mostly women
Expect FDA decision in December 2024 on TNX-102
SL NDA acceptance for review and 2025 PDUFA date; If FDA-approved in 2025, TNX-102 SL would be the first new drug for fibromyalgia in
more than 15 years
Presented new data on potential mpox vaccine, TNX-801,
in September and October 2024, demonstrating tolerability in immunocompromised animals; Previously reported studies showed a single-dose
provided immune protection against a monkeypox challenge
Awarded U.S. Department of Defense (DoD) contract
for up to $34 million over five years in July 2024 to develop a broad-spectrum antiviral drug; Received first payment from DTRA
CHATHAM, N.J., November 12, 2024 (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 third quarter ended September 30, 2024, and
provided an overview of recent operational highlights.
“With our recent NDA submission to the U.S.
Food and Drug Administration (FDA), Tonix is excited about the potential of TNX-102 SL to become the first new drug treatment option in
more than 15 years for the roughly 10 million adults in the U.S. suffering from fibromyalgia,” said Seth Lederman, M.D., Chief Executive
Officer of Tonix. “FDA awarded TNX-102 SL Fast Track designation in the third quarter of 2024, which is intended to expedite FDA
review of important new drugs to fill unmet needs for serious conditions. We look forward to next steps with FDA. If the NDA filing is
accepted in December, we expect a decision on the marketing approval of TNX-102 SL for fibromyalgia in 2025.”
Dr. Lederman continued, “As we continue to
advance key pipeline products through a capital efficient strategy, we are excited to have announced collaborations with world-class institutions
to advance the development of TNX-801, a potential mpox vaccine whose single-dose administration and other characteristics align closely
with The World Health Organization’s preferred target product profile (TPP) criteria for mpox vaccines. The World Health Organization
(WHO) previously announced the growing number of mpox cases constitutes a public health emergency of international concern (PHEIC), with
clade 1b mpox strains now detected in 16 countries in Africa as well as in Sweden, Thailand, Singapore, India, England and Germany.”
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.
| · | In October 2024, Tonix announced submission of the TNX-102 SL New Drug Application (NDA) for fibromyalgia
to the FDA. The submission was based upon two Phase 3 studies of TNX-102 SL in fibromyalgia that showed statically significant reduction
in the chronic, widespread pain associated with fibromyalgia. If approved by the FDA, TNX-102 SL would be the first member of a new class
of analgesic drugs for fibromyalgia and the first new drug available for treating fibromyalgia in more than 15 years. Fibromyalgia affects
more than 10 million adults in the U.S., most of whom are women. |
| · | In September 2024, at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS
2024), the Company announced data highlighting the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL, including
composition and methods patents based on the proprietary eutectic1 formulation of TNX-102 SL that are expected to provide market
exclusivity until at least 2034 in the U.S., EU, Japan, China and other jurisdictions. The eutectic protects cyclobenzaprine HCl from
interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. The formulation
of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed
sleep, improve pain and other fibromyalgia symptoms, while reducing the risk of daytime somnolence. |
| · | In August 2024, at both the DoD’s 2024 Military Health System Research Symposium (MHSRS), and at
the International Association for the Study of Pain’s (IASP’s) 2024 World Congress on Pain, Tonix announced additional data
and analyses of TNX-102 SL for the management of fibromyalgia. TNX-102 SL had met the pre-specified primary endpoint in the Phase 3 RESILIENT
study, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia while demonstrating broad
syndromal benefits with statistically significant improvement in all six pre-specified key secondary endpoints, including those related
to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. TNX-102
SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals were observed. |
| · | In July 2024, Tonix noted that, based on the new definition of Long COVID by the U.S. National Academies
of Sciences, Engineering and Medicine (NASEM), fibromyalgia is a ‘diagnosable condition’ in people suffering from Long COVID.
The Company believes that diagnosing fibromyalgia in Long COVID patients will increase the potential market for TNX-102 SL following approval
as compared to market estimates from before the COVID-19 pandemic. |
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)
| · | In August 2024 at the DoD’s MHSRS conference, the Company presented clinical data and rationale
supporting the potential for TNX-102 SL to be studied for the treatment of ASR and prevention of PTSD. Prior studies showed that treatment
with TNX-102 SL showed effects on sleep and PTSD symptoms in PTSD patients at two and four weeks1. This supportive data on
the effects of TNX-102 SL on reducing PTSD symptoms suggest early intervention immediately after trauma using TNX-102 SL has the potential
to reduce ASR/ASD symptoms which are similar to those of PTSD2,3. Data from these trials support testing of TNX-102 SL within
24 hours of index trauma for effects on ASR symptoms and the subsequent incidence of PTSD. |
| · | The DoD-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial will be conducted by the University
of North Carolina under an investigator-initiated investigational new drug (IND) application. The OASIS trial will examine the safety
and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department (ED) after
a motor vehicle collision. Fourteen days of bedtime TNX-102 SL will be dosed and tested in the immediate aftermath of motor vehicle collision.
The study will test the potential for TNX-102 SL to target trauma-related sleep disturbance and its ability to facilitate recovery from
ASR and to prevent PTSD. The results may ultimately provide military personnel with a new treatment option that, when administered in
the early aftermath of a traumatic event to individuals with ASR symptoms, improves warfighter function. |
TNX-1300 (recombinant double mutant cocaine
esterase): biologic for life-threatening cocaine intoxication
| · | Tonix announced the first patient in the Phase 2 CATALYST study of TNX-1300 for the treatment of cocaine intoxication was enrolled
in August 2024. CATALYST is a Phase 2 single-blind, placebo-controlled, proof-of-concept study in patients presenting to the emergency
department. Topline results are expected in the first half of 2025. |
| · | The National Institutes of Health (NIH)’s National Institute of Drug Abuse (NIDA) previously awarded
Tonix a Cooperative Agreement grant for approximately $5 million from to support development of TNX-1300. |
| · | TNX-1300 has been granted Breakthrough Therapy designation by the FDA. |
Infectious Disease Pipeline
TNX-801 (recombinant horsepox virus, live
vaccine): potential vaccine to protect against mpox disease and smallpox.
| · | In September 2024, at the DoD’s MHSRS conference and in October 2024 at the World Vaccine
Congress in Barcelona, Spain, Tonix presented new data on potential mpox vaccine, TNX-801, demonstrating tolerability and no
evidence of spreading to blood or tissues, even at high doses, in immunocompromised animals. TNX-801 is an attenuated live-virus
vaccine based on synthesized horsepox that has been shown to provide
single-dose immune protection against a monkeypox challenge. After a single-dose vaccination, TNX-801 prevented clinical disease and lesions,
and also decreased shedding in the mouth and lungs of non-human primates after a lethal challenge with Clade Ia monkeypox. These findings
are consistent with TNX-801 inducing mucosal immunity and suggest TNX-801 has the ability to block forward transmission. |
| · | In August 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa
constitutes a public health emergency of international concern (PHEIC), the second such declaration in the past two years in response
to transmission of the virus. Mpox cases of the new clade 1b mpox have since also been detected in Sweden, Thailand, Singapore, India,
Germany and England. |
| · | In September 2024, the Company announced that the WHO’s preferred TPP aligns with the characteristics
of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability
at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact
vaccination strategies and suitability for use in immunocompromised individuals. |
Footnotes:
| 1. | The TNX-102 SL eutectic is a composition of matter based on co-penetration of cyclobenzaprine HCl and
mannitol crystals and protected by 5 issued U.S patents: Nos. 9,636,408; 9,956,188; 10,117,936; 10,864,175; 11,839,594; 9,918,948; 11,826,321. |
| 2. | Sullivan GM, et al. Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in
military-related PTSD and the role of sleep quality in treatment response. Psychiatry Res. 2021 Jul;301:113974. |
| 3. | Parmenter ME, et al. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and
safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder. Psychiatry Res. 2024 (In
Press). https://doi.org/10.1016/j.psychres.2024.115764 |
Corporate and Partnerships – Recent
Highlights
| · | In November 2024, the Company announced that it has entered into a sponsored research agreement with the Kenya Medical Research Institute
(KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study in Kenya to test the safety, tolerability, and immunogenicity
of TNX-801 (horsepox, live virus) as a vaccine to prevent mpox and smallpox. Tonix is expected be the sponsor and KEMRI is expected to
lead the execution of the proposed clinical trial. |
| · | In October 2024, the Company announced it entered into an artificial intelligence and machine learning drug discovery collaboration
with X-Chem, Inc., a leader in small molecule drug discovery, to accelerate the development of small molecules as orally available host-targeted
broad-spectrum medical countermeasures. Tonix’s TNX-4200 antiviral program focuses on the development of oral CD45 phosphatase inhibitors, with broad-spectrum
activity against a range of viral families. |
| · | In September 2024, Tonix announced the appointment of Thomas Englese as its new Executive Vice President, Commercial Operations. Mr.
Englese brings significant leadership to Tonix across several functions, including commercial operations, sales and marketing, and launching
and managing major brands through all stages of commercialization. |
| · | In August 2024, the Company announced a collaboration with Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for TNX-801
as a potential mpox vaccine. Bbio is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which also includes
the Serum Institute of India. |
| · | In July 2024, Tonix announced it had been awarded a DoD contract with a potential for up to $34 million over five years by DoD’s
Defense Threat Reduction Agency (DTRA). The objective of the contract is to develop small molecule broad-spectrum antiviral agents for
the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix’s
program will focus on optimization and development of its TNX-4200 program, to develop an orally available CD45 antagonist, with broad-spectrum
efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties,
pharmacokinetics, and safety attributes to support an IIND submission and to fund a first-in-human Phase 1 clinical study. |
Marketed Products – Recent Highlights
| · | In September 2024, Tonix announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,097,183 to
the Company, claiming use of a pre-filled autoinjector comprising a composition of Zembrace® SymTouch® for treating migraines
via subcutaneous administration. This patent, excluding possible patent term extensions, is expected to fortify protection and market
exclusivity into 2036. |
| · | Tonix announced that the USPTO issued U.S. Patent No. 12,090,139 to the Company, claiming a pharmaceutical composition, a method of
treating migraine via intranasal administration, and an intranasal delivery system for Tosymra®. This patent is expected to fortify
protection and market exclusivity into 2030. |
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 aura
in adults.
Financial - Recent Highlight
As of September 30, 2024, Tonix had
approximately $28.2 million of cash and cash equivalents, compared to approximately $24.9 million as of December 31, 2023.
Additionally, Tonix had inventory totaling approximately $7.9 million as of September 30, 2024. Net cash used in operations was
approximately $46.3 million for the nine months ended September 30, 2024, compared to approximately $79.7 million for the same
period in 2023. Cash used in investing activities for the nine months ended September 30, 2024 was approximately $117,000 compared
to $28.6 million for the same period in 2023.
In July 2024, Tonix received net proceeds
of approximately $3.5 million in a securities offering with certain institutional and retail investors. Additionally, during the three
months ended September 30, 2024, Tonix sold approximately 134.5 million shares of common stock under the 2024 ATM Sales Agreement for
net proceeds of approximately $41.8 million.
Third Quarter 2024 Financial Results
Net product revenue for the third quarter
2024 was approximately $2.8 million. Net product revenue consisted of combined net sales of Zembrace® SymTouch® and Tosymra®,
which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of sales for the third quarter 2024 was approximately $1.6
million.
During the three months ended September 30,
2024, Tonix received its first payment from DTRA as part of its previously announced award from DTRA for up to $34 million over five years.
Research and development expenses for the
third quarter 2024 were approximately $9.1 million, compared to $21.0 million for the same period in 2023. This decrease is predominantly
due to lower clinical, non-clinical and manufacturing expenses aligned with the Company’s capital efficient strategy.
Selling, general and administrative expenses
for the third quarter 2024 were approximately $7.7 million, compared to $8.7 million for the same period in 2023. The decrease was primarily
due to lower employee-related expenses, transactional services and sales and marketing expenses partially offset by an increase in professional
fees.
Net loss available to common stockholders
was approximately $14.2 million, or $0.23 per share, basic and diluted, for the third quarter 2024, compared to net loss available to
common stockholders of $28.0 million, or $38.63 per share, basic and diluted, for the same period in 2023. The basic and diluted weighted
average common shares outstanding for the third quarter 2024 was 62,122,283 compared to 724,190 shares for the same period in 2023.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical
company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development
portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate
for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the
management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. We expect
an FDA decision on the acceptance of the NDA for review and a PDUFA date in December and if accepted, a decision on NDA approval in
2025. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at
the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio
includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA
Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institute of Drug Abuse and
Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity
and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being
developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates
in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a
vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for
up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the
prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments.
Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, our commercial
subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for
the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates 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. All other marks are property of their respective owners.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the
use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,”
“expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations
and actual results could differ materially. 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 obtain FDA
clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products;
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 forth in the Annual Report on Form 10-K for the year
ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports
filed with the SEC on or after the date thereof. 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.
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, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
2,822 |
|
|
$ |
3,989 |
|
|
$ |
7,512 |
|
|
$ |
3,989 |
|
COSTS AND EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
1,555 |
|
|
|
2,374 |
|
|
|
6,582 |
|
|
|
2,374 |
|
Research and development |
|
|
9,114 |
|
|
|
21,050 |
|
|
|
31,675 |
|
|
|
69,535 |
|
Selling, general and administrative |
|
|
7,707 |
|
|
|
8,712 |
|
|
|
24,519 |
|
|
|
23,131 |
|
Asset impairment charges |
|
|
— |
|
|
|
— |
|
|
|
58,957 |
|
|
|
— |
|
|
|
|
18,376 |
|
|
|
32,136 |
|
|
|
121,733 |
|
|
|
95,040 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(15,554 |
) |
|
|
(28,147 |
) |
|
|
(114,221 |
) |
|
|
(91,051 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
|
1,668 |
|
|
|
— |
|
|
|
1,668 |
|
|
|
— |
|
Gain on change in fair value of warrant liabilities |
|
|
— |
|
|
|
— |
|
|
|
6,150 |
|
|
|
— |
|
Other (expense) income, net |
|
|
(327 |
) |
|
|
172 |
|
|
|
(1,525 |
) |
|
|
1,715 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common stockholders |
|
$ |
(14,213 |
) |
|
$ |
(27,975 |
) |
|
$ |
(107,928 |
) |
|
$ |
(89,336 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(38.63 |
) |
|
$ |
(4.66 |
) |
|
$ |
(143.47 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding, basic and diluted |
|
|
62,122,283 |
|
|
|
724,190 |
|
|
|
23,136,172 |
|
|
|
622,684 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands)
(Unaudited)
| |
September 30, 2024 | |
December 31, 20231 |
Assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 28,233 | | |
$ | 24,948 | |
Accounts Receivable, net | |
| 4,013 | | |
| — | |
Inventory | |
| 7,931 | | |
| 13,639 | |
Prepaid expenses and other | |
| 10,366 | | |
| 9,181 | |
Total current assets | |
| 50,543 | | |
| 47,768 | |
Other non-current assets | |
| 44,446 | | |
| 106,689 | |
Total assets | |
$ | 94,989 | | |
$ | 154,457 | |
| |
| | | |
| | |
Liabilities and stockholders' equity | |
| | | |
| | |
Total liabilities | |
$ | 20,778 | | |
$ | 48,932 | |
Stockholders' equity | |
| 74,211 | | |
| 105,525 | |
Total liabilities and stockholders' equity | |
$ | 94,989 | | |
$ | 154,457 | |
1The condensed consolidated balance sheet for the
year ended December 31, 2023 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.
Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
Peter Vozzo
ICR Healthcare
peter.vozzo@westwicke.com
(443) 213-0505
Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432
v3.24.3
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14a -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From Oct 2024 to Nov 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From Nov 2023 to Nov 2024