Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Pharmaceuticals Reports First Quarter 2020 Financial Results and Operational Highlights
Potential Vaccines in Development to Protect Against New Coronavirus Disease 2019 (COVID-19) Based on the Company's Horsepox
Virus Vaccine Platform
Vaccine, TNX-801, in Development to Protect Against Smallpox and Monkeypox Based on Horsepox Virus
50 Percent Enrollment in Phase 3 RELIEF Study of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for the Management of Fibromyalgia;
Topline Results Expected First Quarter 2021
YORK, May 12, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage
biopharmaceutical company, today announced financial results for the quarter ended March 31, 2020, and provided an overview of
recent operational highlights.
have continued to expand our portfolio, recently adding three new potential vaccines to protect against COVID-19, bringing the
total COVID-19 vaccines candidates to four," said Seth Lederman, M.D., President and Chief Executive Officer. "TNX-1800
is designed to elicit a predominant T cell response and TNX-1810, -1820 and -1830 are designed to elicit almost pure T cell responses.
We believe that T cell responses are important in protecting against COVID-19, in contrast to many other vaccine programs that
are designed to elicit predominantly antibody responses. The horsepox vector is related to vaccines that prevented and eradicated
smallpox, therefore we expect horsepox-based vaccines can be manufactured at a scale consistent with a global pandemic. We also
remain focused on advancing TNX-801 as a potential vaccine against smallpox and monkeypox, and TNX-102 SL for the management of
fibromyalgia. We expect topline results from the Phase 3 RELIEF study for TNX-102 SL for the management of fibromyalgia in the
first quarter of 2021, barring any interruptions due to the COVID-19 pandemic. In addition to these programs, we maintain a strong
and growing pipeline of product candidates including TNX-102 SL as a treatment for agitation in Alzheimer's disease and
alcohol use disorder, TNX-601 CR as a treatment for major depressive disorder, treatment for PTSD and treatment for corticosteroid-induced
cognitive dysfunction, TNX-1300 for the treatment of cocaine intoxication, TNX-1500 for the prevention and treatment of organ
transplant rejection, and TNX-1200 as a vaccine against smallpox and monkeypox disease."
TNX-1810, TNX-1820 and TNX-1830 (live recombinant modified horsepox virus vaccines from cell culture)
(live synthesized horsepox virus (sHPXV) vaccine from cell culture)
SL (cyclobenzaprine HCl sublingual tablets)
Quarter 2020 Financial Results
and development expenses for the first quarter of 2020 totaled $4.7 million, compared to $3.9 million for the same period in 2019.
This increase is primarily due to increased clinical expenses related to the ongoing Phase 3 trials of TNX-102 SL in both fibromyalgia
and PTSD and the beginning of the COVID-19 vaccine work.
and administrative expenses for the first quarter of 2020 totaled $2.6 million, compared to $2.4 million for the same period in
2019. The increase is primarily due to an increase in legal fees, patent prosecution and maintenance costs.
loss available to common stockholders was $9.0 million, or $0.37 per share, for the first quarter of 2020, compared to net loss
of $6.2 million, or $12.76 per share, for the first quarter of 2019. The weighted average common shares outstanding, basic and
diluted, for the first quarter of 2020 was 24,028,970, compared to 488,315 shares for the first quarter of 2019.
March 31, 2020, Tonix had $30.7 million of cash and cash equivalents, compared to $11.2 million as of December 31, 2019. In the
first quarter of 2020, the Company raised net proceeds of approximately $28.8 million through equity financings and warrant exercises.
Cash used in operations was $9.3 million for the three months ended March 31, 2020, compared to $8.6 million for the three months
ended March 31, 2019.
April 8, 2020, Tonix entered into a sales agreement with AGP, pursuant to which Tonix may issue and sell, from time to time, shares
of its common stock having an aggregate offering price of up to $50.0 million in at-the-market offerings ("ATM") sales.
of May 11, 2020, the Company has an aggregate of 52,302,475 shares of common stock outstanding.
TNX-1800, TNX-1810, TNX-1820, TNX-1830 and TNX-801*
is a modified horsepox virus that is designed to express the Spike protein of the SARS-CoV-2 virus that causes COVID-19 and
to elicit a predominant T cell response. TNX-1810, TNX-1820 and TNX-1830 are modified horsepox viruses that are designed to
express different SARS-CoV-2 proteins than Spike and to elicit almost pure T cell responses. TNX-801 is a live virus vaccine
based on synthesized horsepox1. Horsepox and vaccinia are closely related orthopoxviruses that are believed
to share a common ancestor. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign
genes and have been explored as platforms for vaccine development because they possess: (1) large packaging capacity for
exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or
genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert
constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to
vaccinia, horsepox has substantially decreased virulence in mice1. TNX-801 vaccinated macaques showed no overt
clinical signs after monkeypox challenge2.
RS, et al. (2018) PLoS One. 13(1):e0188453
RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the
American Society of Microbiology BioThreats Conference - January 29, 2020, Arlington, VA. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf
TNX-1800, TNX-1810, TNX-1820 and TNX-1830 are in the pre-IND stage and have not been approved for any indication
the Phase 3 RELIEF Study
RELIEF study is a double-blind, randomized, placebo-controlled adaptive design trial designed to evaluate the efficacy and safety
of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in fibromyalgia. The trial is expected to enroll approximately 470 patients
across approximately 40 U.S. sites. For the first two weeks of treatment, there will be a run-in period in which patients will
start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first two weeks, all patients will have the dose increased to TNX-102
SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks. The primary endpoint is daily diary pain severity score change
from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated
measures with multiple imputation.
RELIEF study is expected to have one unblinded interim analysis when the study has results from approximately the first 50% of
efficacy-evaluable patients, pending agreement with the FDA. Additional details about the RELIEF study are available at www.theRELIEFstudy.com
or clinicaltrials.gov (NCT04172831).
Tonix Pharmaceuticals Holding Corp.
is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing drugs and biologics
to treat and prevent human disease and alleviate suffering. Tonix's current portfolio includes biologics to prevent
infectious diseases, and small molecules and biologics to treat pain, psychiatric and addiction conditions. Tonix is
developing four potential vaccines, based on the horsepox viral vector platform to protect against the novel coronavirus
disease emerging in 2019, or COVID-19: TNX-1800, TNX-1810, TNX-1820 and TNX-1830*. TNX-1800 is designed to express the Spike
protein of the SARS-CoV-2 and to a predominant T cell response. TNX-1810, TNX-1820 and TNX-1830 are designed to express
different proteins from SARS-CoV-2 and to elicit almost pure T cell responses. TNX-801* (live horsepox virus vaccine for
percutaneous administration) is in development to protect against smallpox and monkeypox. Tonix's most advanced drug
development programs are focused on delivering safe and effective long-term treatments for fibromyalgia, or FM, and
posttraumatic stress disorder, or PTSD. Tonix's most advanced product candidate, TNX-102 SL**, is in Phase 3
development as a bedtime treatment for fibromyalgia and PTSD. The Company is enrolling participants in the Phase 3 RELIEF
trial in fibromyalgia and expects results from an unblinded interim analysis in September of 2020 and topline data in the
first quarter of 2021. The Phase 3 RECOVERY trial (P302) for TNX-102 SL (trade name Tonmya***) in PTSD has stopped
enrollment based on the Independent Data Monitoring Committee's recommendation to stop the study for futility following
an interim analysis of the first 50% of enrolled participants. Topline data for RECOVERY are expected in the second quarter
of 2020. TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). The
agitation in Alzheimer's disease program is Phase 2 ready with FDA Fast Track designation, and the development program
for AUD is in the pre-Investigational New Drug (IND) application stage. Tonix s programs for treating addiction
conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in
Phase 2 development for the treatment of cocaine intoxication and has FDA Breakthrough Therapy Designation. TNX-601 CR
(tianeptine oxalate controlled-release tablets) is in development as a daytime treatment for depression as well as PTSD and
corticosteroid-induced cognitive dysfunction. The first efficacy study will be in the treatment of major depressive disorder.
TNX-1600 (a triple reuptake inhibitor) is a pre-clinical new molecular entity (NCE) being developed as a treatment for PTSD.
Tonix's preclinical pipeline includes TNX-1500 (anti-CD154), a monoclonal antibody being developed to prevent and treat
organ transplant rejection and autoimmune conditions, and TNX-1700 (rTFF2), a biologic being developed to treat gastric and
pancreatic cancers. TNX-1200* (live vaccinia virus vaccine for percutaneous administration) is in development to protect
against smallpox and monkeypox. Finally, TNX-701 (undisclosed small molecule) to prevent radiation effects is being advanced
as a medical countermeasure to improve biodefense.
TNX-1810, TNX-1820, TNX-1830, TNX-801, TNX-1200 and TNX-1300 are investigational new biologics and have not been approved for
SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.