Announced Positive Phase 3 RELIEF Study Results for TNX-102 SL 5.6 mg in Fibromyalgia
Interim Analysis Results from Second Confirmatory Phase 3 Study, RALLY, Expected in Third Quarter 2021: Interim Cohort Enrolled
Efficacy Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800, Expected in First Quarter 2021
Phase 1 Safety Study in Humans of TNX-1800 Expected to Start in Second Half 2021
At December 31, 2020, Cash and Cash Equivalents Totaled $77.1 Million; Approximately $110 Million in Gross Proceeds Raised Subsequent to Year-End
CHATHAM, N.J., March 15, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2020, and provided an overview of recent operational highlights.
“We continue to make progress across our development programs and are steadily advancing our diverse pipeline of CNS and immunology product candidates,” said Seth Lederman, M.D., President and Chief Executive Officer. “In 2021, we expect to deliver on several important milestones. Following on the success of our first pivotal Phase 3 fibromyalgia study, RELIEF, we look forward to reporting interim and topline data from a second potentially pivotal Phase 3 fibromyalgia study, RALLY, this year. We recently reported that we achieved enrollment of the first 50 percent of participants in RALLY, which we expect will be the interim analysis cohort. We also expect to report preclinical efficacy data from our COVID-19 vaccine candidate this quarter and start a Phase 1 study in humans in the second half of this year. Finally, we expect to initiate new clinical trials this year for several other programs including a Phase 2 cocaine intoxication trial, Phase 2 migraine trial, and a proof-of-concept study for the skin test for COVID-19 exposure to measure T cell immunity.”
Research and Development*
TNX-102 SL (cyclobenzaprine HCl sublingual tablets): small molecule product candidate for management of fibromyalgia
TNX-1800 (live attenuated vaccine based on Tonix’s horsepox virus vector, TNX-801): COVID-19 vaccine candidate 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-1900 (intranasal potentiated oxytocin): small peptide product candidate for migraine, craniofacial pain, insulin resistance and related disorders
TNX-2900 (novel formulation of intranasal potentiated oxytocin): small peptide product candidate for the treatment of Prader-Willi syndrome
TNX-1300 (recombinant double mutant cocaine esterase): biologic product candidate for life-threatening cocaine intoxication
TNX-1500 (monoclonal antibody anti-CD154): third generation monoclonal antibody as a potential first line monotherapy for preventing or treating organ transplant rejection and treating autoimmune disorders
*All Tonix product candidates are investigational new drugs or biologics and have not been approved for any indication.
As of December 31, 2020, Tonix had $77.1 million of cash and cash equivalents, compared to $11.2 million as of December 31, 2019. Cash used in operations was approximately $48.6 million for the full year ended December 31, 2020, compared to $26.7 million for full year ended December 31, 2019. The increase in cash used in operations resulted principally from an increase in research and development and general and administrative activities as defined below.
For the year ended December 31, 2020, net proceeds from financing activities were $123.1 million, predominantly from the sale of common stock and exercise of warrants. In January 2021, the Company sold 50,000,000 shares of common stock at $0.80 per share, priced at-the-market, for gross proceeds of approximately $40 million, and net proceeds of approximately $36.9 million, after deducting the underwriting discount and other offering expenses. In February 2021, the Company sold 58,333,334 shares of common stock at $1.20 per share in a registered direct public offering, priced at-the-market, for gross proceeds of approximately $70 million, and net proceeds of approximately $65.0 million, after deducting the underwriting discount and other offering expenses.
Fourth Quarter 2020 Financial Results
Research and development expenses for the fourth quarter of 2020 were $12.1 million, compared to $5.7 million for the same period in 2019. This increase is predominantly due to two Phase 3 studies ongoing during this time for TNX-102 SL for fibromyalgia as well as the development of potential COVID-19 vaccine candidate, TNX-1800, which was not in development in 2019.
General and administrative expenses for the fourth quarter of 2020 were $4.9 million, compared to $3.0 million for the same period in 2019. The increase is primarily due to an increase in financial reporting expenses, patent prosecution and maintenance costs and an increase in headcount.
Net loss available to common stockholders was $17.0 million, or $0.10 per share, basic and diluted, for the fourth quarter of 2020, compared to net loss of $11.2 million, or $2.86 per share, basic and diluted, for the fourth quarter of 2019. The basic and diluted weighted average common shares outstanding for the fourth quarter of 2020 was 163,873,489, compared to 3,912,800 shares for the fourth of 2019.
Full Year 2020 Financial Results
Research and development expenses for full year 2020 were $36.2 million, compared to $18.2 million for the same period in 2019. This increase is predominantly due to the timing of development milestones related to the Phase 3 RELIEF and RALLY studies in fibromyalgia in 2020, increased activities for the development of potential vaccine candidates, TNX-1800 and TNX-801 as well as the Trigemina asset acquisition.
General and administrative expenses for full year 2020 were $14.4 million, compared to $10.6 million for the same period in 2019. The increase is primarily due to an increase in legal fees, patent prosecution and maintenance costs, financial reporting expenses and increased employee headcount.
Net loss available to common stockholders was $52.2 million, or $0.55 per share, basic and diluted, for full year 2020, compared to net loss available to common stockholders of $31.1 million, or $19.33 per share, basic and diluted, for full year 2019. The basic and diluted weighted average common shares outstanding for full year 2020 was 94,591,715, compared to 1,608,568 shares for full year 2019.
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 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, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix’s lead vaccine candidate, TNX-1800, 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 expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.
1TNX-102 SL is an investigational new drug and has not been approved for any indication.
2Pending submission and agreement from FDA on statistical analysis plan.
3TNX-1800 and TNX-801 are investigational new biologics and have 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, 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 Reports Fourth Quarter 2020 Financial Results
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
Full Year Ended
Three Months Ended
|Costs and expenses|
|Research and development||$||36,157||$||18,192||$||12,097||$||5,690|
|General and administrative||14,354||10,636||4,926||3,044|
|Total costs and expenses||50,511||28,828||17,023||8,734|
|Interest income, net||48||210||2||27|
|Warrant deemed dividend||(451||)||-||-||-|
|Preferred stock deemed dividend||(1,260||)||(2,474||)||-||(2,474||)|
|Net loss available to common stockholders||$||(52,174||)||$||(31,092||)||$||(17,021||)||$||(11,181||)|
|Net loss per common share, basic and diluted||$||(0.55||)||$||(19.33||)||$||(0.10||)||$||(2.86||)|
|Weighted average common shares outstanding, basic and diluted||94,591,715||1,608,568||163,873,489||3,912,800|
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, 20201
December 31, 20191
|Cash and cash equivalents||$||77,068||$||11,249|
|Prepaid expenses and other||10,921||2,699|
|Total current assets||87,989||13,948|
|Other non-current assets||10,194||610|
|Liabilities and stockholders' equity|
|Total liabilities and stockholders' equity||$||98,183||$||14,558|
1The condensed consolidated balance sheets for the years ended December 31, 2020 and December 31, 2019 have 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)