Central Nervous System Pipeline Progressing with Two Phase 2 Studies (TNX-1300 and TNX-1900) and One Phase 3 Study (TNX-102 SL) Expected to Start This Year
COVID-19 Pipeline Progressing with First-in-Human Trial of TNX-2100, a Novel in vivo Skin Test for COVID-19 T cell Immunity, Expected to Start This Year
New Advanced Development Center, Currently Under Construction, and Planned Acquisition of Infectious Disease R&D Facility Will Expand Internal R&D and Manufacturing Capabilities for Vaccines and Antiviral Therapeutics, With Initial Focus on COVID-19
At June 30, 2021, Cash and Cash Equivalents Totaled Approximately $166 Million
CHATHAM, N.J., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the second quarter ended June 30, 2021 and provided an overview of recent operational highlights.
“Our clinical, manufacturing, and regulatory teams are advancing four programs into clinical trials by the end of 2021,” said Seth Lederman, M.D., President and Chief Executive Officer. “We look forward to initiating Phase 2 studies of TNX-1300 for cocaine intoxication and TNX-1900 for chronic migraine in the third and fourth quarters of 2021, respectively. We also expect to initiate a Phase 3 study of TNX-102 SL for PTSD outside of the U.S. and a first-in-human study of TNX-2100, a skin test diagnostic for COVID-19 T cell immunity, in the fourth quarter of 2021.”
Dr. Lederman continued, “We are expanding our R&D and manufacturing facilities. In July we announced an agreement to acquire an infectious disease research facility in Frederick, MD, and earlier this month we began construction on our Advanced Development Center (ADC) in New Bedford MA. We expect these facilities, coupled with our planned commercial scale manufacturing facility for vaccines in Hamilton, MT, will enable us to avoid future outsourcing bottlenecks and to work with greater efficiency in developing our programs for COVID-19, its variants, and other infectious diseases.”
Dr. Lederman added, “Recent reports of COVID-19 outbreaks in the U.S. and elsewhere, due primarily to the Delta variant, point to the urgent needs for more robust vaccines and more potent antiviral therapeutics. We believe the recent steps we have taken to strengthen our internal capabilities with company-controlled R&D and manufacturing facilities will accelerate our full pipeline of COVID-19 product candidates, which currently includes the TNX-1800 vaccine, TNX-3500 antiviral, TNX-2100 diagnostic, and TNX-102 SL for treating Long COVID.”
Recent Highlights—Key Product Candidates*
Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual tablets): small molecule for the management of fibromyalgia
TNX-102 SL for the treatment of Posttraumatic Stress Disorder (PTSD)
TNX-102 SL for the treatment of Long COVID Syndrome or Post-Acute Sequelae of COVID-19 (PASC)
TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication
TNX-1900 (intranasal potentiated oxytocin): small peptide for migraine, craniofacial pain, insulin resistance and related disorders
TNX-601 CR (tianeptine oxalate and naloxone controlled-release tablets): small molecule for the treatment of major depressive disorder, PTSD and neurocognitive dysfunction associated with corticosteroid use.
TNX-1800 (live virus vaccine based on Tonix’s horsepox virus vector, TNX-801): COVID-19 vaccine designed as a single-administration vaccine to elicit T cell immunity
TNX-2100 (diagnostic skin test): SARS-CoV-2 epitope peptide mixtures for intradermal administration to measure the delayed-type hypersensitivity (DTH) reaction to SARS-CoV-2
TNX-3500 (sangivamycin): antiviral inhibitor of SARS-CoV-2 for the treatment of COVID-19 and potential other viral disorders
TNX-1500 (anti-CD154 monoclonal antibody): third generation monoclonal antibody as first line monotherapy for preventing or treating organ transplant rejection and treating autoimmune disorders.
Recent Highlights—Facilities and Corporate
As of June 30, 2021, Tonix had $165.7 million of cash and cash equivalents, compared to $77.1 million as of December 31, 2020.
Cash used in operations was approximately $19.1 million for the three months ended June 30, 2021, compared to $10.1 million for the three months ended June 30, 2020. The increase in cash used in operations resulted primarily from an increase in research and development programs and general and administrative activities as defined below.
Second Quarter 2021 Financial Results
Research and development expenses for the second quarter of 2021 were $18.1 million, compared to $10.6 million for the same period in 2020. This increase is predominately due to increased non-clinical expenses of $7.1 million, manufacturing expenses of $2.7 million, employee-related expenses of $1.2 million and regulatory/legal expenses of $0.4 million offset by a decrease in clinical expenses of $4.1 million. We expect research and development expenses to increase during 2021 as we move our clinical development programs forward and continue to invest in our development pipeline.
General and administrative expenses for the second quarter of 2021 were $5.4 million, compared to $3.6 million for the same period in 2020. The increase is primarily due to an increase in employee-related expenses of $1.1 million, an increase in investor relations/public relations expenses of $0.2 million, an increase in financial reporting expenses of $0.2 million and an increase in insurance premiums of $0.2 million.
Net loss available to common stockholders was $23.6 million, or $0.07 per share, basic and diluted, for the second quarter of 2021, compared to net loss of $14.2 million, or $0.23 per share, basic and diluted, for the second quarter of 2020. The basic and diluted weighted average common shares outstanding for the second quarter of 2021 was 331,281,242, compared to 62,391,006 shares for the second quarter of 2020.
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia. Tonix’s immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix’s lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is a small molecule antiviral drug in the pre-IND stage of development.
1TNX-102 SL is an investigational new drug and has not been approved for any indication.
2TNX-1800 and TNX-801 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication.
3TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
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, the development of R&D facilities, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All 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)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|COSTS AND EXPENSES:|
|Research and development||$||18,133||$||10,571||$||33,460||$||15,247|
|General and administrative||5,429||3,621||10,838||6,242|
|Interest and other income, net||9||13||92||37|
|Warrant deemed dividend||—||—||—||451|
|Preferred stock deemed dividend||—||—||—||1,260|
|Net loss available to common stockholders||$||(23,553||)||$||(14,179||)||$||(44,206||)||$||(23,163||)|
|Net loss per common share, basic and diluted||$||(0.07||)||$||(0.23||)||$||(0.14||)||$||(0.54||)|
|Weighted average common shares outstanding, basic and diluted||331,281,242||62,391,006||310,807,619||43,209,988|
|TONIX PHARMACEUTICALS HOLDING CORP.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
June 30, 2021
||December 31, 20201|
|Cash and cash equivalents||$165,719||$77,068|
|Prepaid expenses and other||11,550||10,921|
|Total current assets||177,269||87,989|
|Other non-current assets||11,896||10,194|
|Liabilities and stockholders' equity|
|Total liabilities and stockholders' equity||$189,165||$98,183|
1The condensed consolidated balance sheets for the year ended December 31, 2020 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.
Jessica Morris (corporate)
Olipriya Das, Ph.D. (media)
Peter Vozzo (investors)