50% of Enrollment Complete for Phase 3 RECOVERY Trial of Tonmya® for the Treatment of PTSD
Results from RECOVERY Interim Analysis Expected First Quarter 2020
Topline Data Expected Second Quarter 2020 Based on Currently-Planned Sample Size
NEW YORK, Nov. 08, 2019 (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 September 30, 2019, and provided an overview of recent operational highlights. Tonix’s lead product candidate, TNX-102 SL*, is in Phase 3 development for the treatment of both posttraumatic stress disorder (PTSD) and fibromyalgia.
“We recently reported that we have enrolled over 50 percent of the current target number of participants for our Phase 3 RECOVERY study of TNX-102-SL or Tonmya®** for the treatment of PTSD,” said Seth Lederman, M.D., President and Chief Executive Officer. “The first 50% of participants (n = 125) are the cohort for the interim analysis of the RECOVERY study for which we expect results in the first quarter of 2020. We also expect to report topline data from RECOVERY in the second quarter of 2020 unless the Independent Data Monitoring Committee (IDMC) recommends increasing the number of participants. In addition, we are planning to start a new Phase 3 study of TNX-102 SL in fibromyalgia, the F304 or RELIEF study.”
Research and Development
TNX-102 SL (cyclobenzaprine HCl sublingual tablets)
TNX-601 CR (tianeptine oxalate)
TNX-1700 (recombinant trefoil factor 2, or rTFF2)
TNX-1500 (monoclonal antibody anti-CD154)
TNX-1300*** (double-mutant cocaine esterase)
TNX-1600 (triple reuptake inhibitor)
TNX-801 (live virus vaccine for percutaneous [scarification] administration)
Raised $5.4 million in gross proceeds in an underwritten public offering in July 2019.
Third Quarter 2019 Financial Results
Research and development expenses for the third quarter of 2019 totaled $5.1 million, compared to $3.3 million for the same period in 2018. This increase is primarily due to timing of activities related to the PTSD RECOVERY study, ramp-up of work related to TNX-601, and an increase in non-clinical expenses related to development of the pipeline.
General and administrative expenses for the third quarter of 2019 totaled $2.8 million, compared to $2.3 million for the same period in 2018. The modest increase is primarily due to an increase in patent prosecution costs and higher insurance premiums.
Net loss was $7.8 million, or $5.69 per share, for the third quarter of 2019, compared to net loss of $5.5 million, or $54.99 per share, for the third quarter of 2018. The weighted average common shares outstanding were 1,377,857 for the third quarter of 2019 and 99,640 for the third quarter of 2018, which amounts have been retroactively restated to reflect a 1-for-10 reverse stock split of our issued and outstanding shares that was effectuated on November 1, 2019.
At September 30, 2019, Tonix had $10.0 million of cash and cash equivalents, compared to $25.0 million as of December 31, 2018. Cash used in operations was $6.6 million for the third quarter of 2019, compared to $4.9 million for the same period last year.
About the Phase 3 RECOVERY Study
The RECOVERY Phase 3 study is a double-blind, randomized, placebo-controlled study of Tonmya 5.6 mg (2 x 2.8 mg sublingual tablets) over 12 weeks of treatment for civilian and military-related PTSD. The RECOVERY Phase 3 study restricts enrollment of study participants to individuals with PTSD who experienced an index trauma within nine years of screening. Two previous PTSD studies of Tonmya by the Company (P201 and P301) restricted enrollment to participants who experienced traumas during military service since 2001. The primary efficacy endpoint is the Week 12 mean change from baseline in the severity of PTSD symptoms as measured by CAPS-5 between those treated with Tonmya and those receiving placebo. The CAPS-5 is a standardized structured clinical interview and serves as the standard in research for measuring the symptom severity of PTSD. A formal unblinded interim analysis will be completed when approximately 50 percent (n=125) of participants have been randomized and have completed or discontinued the 12-week course of treatment with bedtime Tonmya 5.6 mg or placebo sublingual tablets. The Company expects to report the results of the interim analysis and the recommendation of the IDMC in the first quarter of 2020. If the current projected population of 250 study participants remains unchanged, the Company expects to report topline data in the second quarter of 2020.
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on discovering and developing small molecules and biologics to treat psychiatric, pain and addiction conditions. Tonix’s lead product candidate, TNX-102 SL, is in development for posttraumatic stress disorder (PTSD), fibromyalgia, agitation in Alzheimer’s disease and alcohol use disorder (AUD). TNX-102 SL is in Phase 3 development as a bedtime treatment for PTSD (trade name Tonmya) and fibromyalgia. The Phase 3 RECOVERY trial (P302) in PTSD is currently enrolling and results from an interim analysis are expected in the first quarter of 2020 and topline data are expected in the second quarter of 2020 if the sample size remains the same. The Company is planning the Phase 3 RELIEF trial (F304) in fibromyalgia. The agitation in Alzheimer’s disease program is Phase 2 ready and the development for AUD is in the pre-Investigational New Drug (IND) application stage. Tonix is advancing two other PTSD therapeutic programs in the pre-IND stage, with different mechanisms than TNX-102 SL and designed for daytime dosing: TNX-601 (tianeptine oxalate-CR tablets) and TNX-1600 (a triple reuptake inhibitor). TNX-601 is in clinical formulation testing outside of the U.S and is expected to be IND-ready in 2020. Tonix‘s programs for treating addiction conditions also include TNX-1300 (double-mutant cocaine esterase), which is in Phase 2 development for the treatment of cocaine intoxication. 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. Finally, TNX-801 (live virus vaccine for percutaneous [scarification] administration) to potentially prevent smallpox and TNX-701 (undisclosed small molecule) to prevent radiation effects are being advanced as medical countermeasures to improve biodefense.
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.
**Tonmya has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the proposed trade name for TNX-102 SL for the treatment of PTSD.
***TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is an investigational new biologic 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, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; 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, 2018, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2019, 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 Reports Third Quarter 2019 Financial Results
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
Three Months Ended
|Nine Months Ended
|Costs and expenses|
|Research and development||$||5,052||$||3,264||$||12,502||$||12,501|
|General and administrative||2,839||2,277||7,592||6,171|
|Total costs and expenses||7,891||5,541||20,094||18,672|
|Interest income, net||53||62||183||171|
|Net loss per common share, basic and diluted||$||(5.69||)||$||(54.99||)||$||(23.93||)||$||(195.51||)|
|Weighted average common shares outstanding, basic and diluted*||1,377,857||99,640||832,050||94,628|
* All per share amounts and number of shares in the condensed consolidated financial statements have been retroactively restated to reflect the reverse stock split.
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
|September 30, 2019||December 31, 2018(1)|
|Cash and cash equivalents||$||10,024||$||25,034|
|Prepaid expenses and other||1,529||1,022|
|Total current assets||11,553||26,056|
|Other non-current assets||719||263|
|Liabilities and stockholders' equity|
|Total liabilities and stockholders' equity||$||12,272||$||26,319|
(1) The condensed consolidated balance sheet for the year ended December 31, 2018 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)
Scott Stachowiak (media)
Peter Vozzo (investors)