Biopharmaceutical Archives - Page 20 of 26

Release – ZyVersa Therapeutics Announces a Publication in Frontiers in Medicine Showing Direct Inflammasome Activation in Children with Juvenile Idiopathic Arthritis

Posted on May 25, 2023May 25, 2023 by aweinsoff@channelchek.com

May 25, 2023

Juvenile idiopathic arthritis (“JIA”), a complex autoimmune inflammatory disorder, is the most common childhood chronic rheumatic disease
This is the first report documenting inflammasome activation in the two most common types of JIA, oligo-articular (4 or fewer affected joints) and poly-articular (5 or more affected joints), both of which have been considered autoimmune rather than autoinflammatory diseases
ZyVersa is developing Inflammasome ASC Inhibitor IC 100 for treatment of various inflammatory diseases

WESTON, Fla., May 25, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Frontiers in Medicine, demonstrating a role for innate inflammasome activation in two of the most common types of JIA, oligo- and poly-articular, both of which are typically thought to be classical antigen-driven autoimmune conditions.

In the paper titled, “Inflammasome activation and formation of ASC specks in patients with juvenile idiopathic arthritis,” the authors reported the following:

Higher numbers of ASC speck-positive monocytes were detected in peripheral blood of JIA patients compared to controls
ASC speck-positive monocytes were detected significantly more frequently in patients with oligo-articular JIA compared to those with poly-articular JIA
Serum IL-1β was significantly higher in patients with JIA compared to controls
Higher numbers of ASC speck-positive monocytes were observed in JIA patients with an elevated titer of antinuclear antibodies (“ANA”)
Il-1β production from macrophages exposed to extracellular ASC specks was enhanced in serum of JIA patients with a high titer of ANA, suggesting that autoantibodies favor a secondary inflammatory response to ASC specks by macrophages

The authors stated, “We clearly discovered direct inflammasome activity ex vivo in CD14+ CD16− monocytes of oligo- and poly-articular JIA patients.” To read the article, Click Here.

“The research published in Frontiers in Medicine demonstrates the role of inflammasome activation in two of the most common types of JIA, oligo- and poly-articular, which were previously thought to be classical antigen-driven autoimmune conditions. This research provides support for the broad range of conditions that are impacted by activation of the innate immune response,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Additionally, the data demonstrating enhanced IL-1β production from macrophages exposed to extracellular ASC specks in JIA patients with a high titer of ANA supports the potential of ASC speck inhibition in helping to control inflammation in this population.”

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Release – Onconova Therapeutics Announces Dosing Of First Participant In Investigator-Sponsored Phase 2 Trial Of Rigosertib Plus Pembrolizumab In Metastatic Melanoma Patients Refractory To Immune Checkpoint Blockade

Posted on May 25, 2023May 25, 2023 by aweinsoff@channelchek.com

Research News and Market Data ONTX

May 25, 2023

NEWTOWN, Pa., May 25, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the first participant has been dosed in an investigator-sponsored Phase 2 trial of oral rigosertib plus the PD-1 inhibitor pembrolizumab in patients with metastatic melanoma who have progressed on prior PD-1/L1 inhibitor therapy.

“There is an urgent need for new treatment approaches in metastatic melanoma, as 40 to 60% of these patients currently see little to no clinical benefit from PD-1 inhibitors,” said Ann Richmond, Ph.D., Ingram Professor of Pharmacology and Medicine at the Vanderbilt University School of Medicine and Senior Research Career Scientist at TVHS, Department of Veterans Affairs (Nashville). “The limited efficacy of these agents is often due to ‘cold’ tumor microenvironments (TME) that prevent the infiltration of immune effector cells. Peer-reviewed preclinical studies¹ suggest rigosertib can enhance the efficacy of immune checkpoint blockade in metastatic melanoma by reversing cold TMEs, providing a strong scientific rationale for this clinical trial.”

Douglas B. Johnson, M.D., M.S.C.I., Associate Professor of Medicine of Hematology/Oncology at Vanderbilt University Medical Center and Principal Investigator of the trial commented, “Rigosertib combined with anti-PD-1 therapy has shown clinical activity in checkpoint inhibitor refractory lung cancer patients, and we believe this promising finding may translate to melanoma. The newly initiated Phase 2 study has been thoughtfully designed to begin exploring this hypothesis and will afford participants the opportunity to receive a novel therapeutic combination that may lead to improved clinical outcomes. I look forward to conducting the study and to the important scientific insights I expect it will provide.”

The investigator-sponsored Phase 2 trial is an open-label, two-stage, single arm study. Stage 1 of the trial is expected to include ten patients. If a pre-specified response criteria is met, the study will then proceed to Stage 2, during which an additional 19 patients are expected to be enrolled. Patients in the study will receive 560 mg of oral rigosertib twice daily on days 1-21 of 28-day treatment cycles, plus 400 mg of pembrolizumab administered via intravenous infusion every six weeks. The primary endpoint of the trial is overall response rate, while key secondary endpoints include assessments of safety, tolerability, progression-free survival, and overall survival. Correlative biomarker assessments will also be conducted.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “Rigosertib’s investigator-sponsored trials are an important component of our corporate strategy that allows us to diversify the indications studied with our pipeline while remaining internally focused on our lead narazaciclib program. We are thrilled to be collaborating with Vanderbilt’s world-class physician-scientists on this latest trial and look forward to its advancement.”

For additional information on the Phase 2 trial, see Clincialtrials.gov identifier NCT05764395.

References:

Yan, C., Saleh, N., Yang, J. et al. Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade. Mol Cancer 20, 85 (2021). https://doi.org/10.1186/s12943-021-01366-y.

About Onconova Therapeutics, Inc.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

For more information, please visit www.onconova.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Release – Tonix Pharmaceuticals Announces Poster Presentation at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Posted on May 25, 2023May 25, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 25, 2023 7:00am EDT

CHATHAM, N.J., May 25, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, will present a poster at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 30 – June 2, 2023, at the Loews Miami Beach Hotel in Miami Beach, Florida. The poster will provide an update on the status of the Phase 2 UPLIFT study of TNX-601 ER* (tianeptine hemioxalate extended-release tablets) for the treatment of major depressive disorder (MDD). The poster will also highlight advances in the understanding of tianeptine’s mechanism of action and provide new details regarding the preclinical development of the (S)-isomer of tianeptine, TNX-4300* (estianeptine) for MDD, Alzheimer’s disease, and Parkinson’s disease.

A copy of the Company’s poster will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.

Poster Presentation Details

Title:	A Randomized Placebo-Controlled Multicenter Trial of Monotherapy with TNX-601 ER* (Tianeptine Hemioxalate Extended-Release Tablets) for Treatment of Major Depressive Disorder (MDD)
Location:	Loews Miami Beach Hotel, Miami Beach, Florida
Salon No.:	Salon 4
Date:	Thursday, June 1, 2023
Time:	12:30 p.m. – 2:15 p.m. ET

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

^*All of Tonix’s product candidates are investigational new drugs or 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 the 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
madeline.stabinski@russopartnersllc.com
(212) 845-4273

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released May 25, 2023

Release – Tonix Pharmaceuticals to Present at the June 1st Virtual Investor Summit

Posted on May 24, 2023May 24, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 24, 2023 7:00am EDT

CHATHAM, N.J., May 24, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the June 1^st Virtual Investor Summit on Thursday, June 1, 2023, at 10:30 a.m. ET.

Investors interested in arranging a meeting with the Company’s management during the conference should contact the Investor Summit conference coordinator. A webcast of the presentation can be found here and will be available under the IR Events tab of the Tonix website at www.tonixpharma.com.

Tonix Pharmaceuticals Holding Corp.^*

^*All of Tonix’s product candidates are investigational new drugs or 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

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
madeline.stabinski@russopartnersllc.com
(212) 845-4273

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released May 24, 2023

Release – Tonix Pharmaceuticals Announces the Isolation and Characterization of the (S)-Isomer of Tianeptine, TNX-4300 (Estianeptine), Now Under Development for Psychiatric and Neurodegenerative Diseases

Posted on May 23, 2023May 23, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 23, 2023 7:00am EDT

TNX-4300 is a Dual PPAR-β/δ and PPAR-γ Agonist, Free from µ-Opioid Receptor Activity

TNX-4300’s Mechanism of Restoring Neuroplasticity Supports Development as a First-in-Class Oral Therapy for Depression, Bipolar Disorder, Alzheimer’s Disease and Parkinson’s Disease

Restoring Atrophied Neuronal Connections in Psychiatric and Neurological Diseases Seen as Paramount to Achieving Better and More Durable Outcomes

CHATHAM, N.J., May 23, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the isolation and functional characterization of the two mirror image isomers of racemic tianeptine, which is marketed outside the U.S. as a treatment for major depressive disorder (MDD). Tonix scientists discovered that the (S)-isomer of tianeptine activates PPAR-β/δ, restores neuroplasticity in neuronal tissue culture and is free of µ-opioid receptor activity. In contrast, (R)-tianeptine activates the µ-opioid receptor and lacks PPAR-β/δ activity. Based on these discoveries, Tonix has begun preclinical development of the (S)-isomer, TNX-4300 (estianeptine)*, as a treatment for MDD, bipolar disorder, Alzheimer’s disease, and Parkinson’s disease. Tonix is planning to submit data supporting tianeptine’s mechanism of action for presentation at upcoming scientific conferences and for publication in peer reviewed journals.

Tonix recently announced that tianeptine, a drug marketed outside the U.S. for more than 30 years, is a plastogen¹ that acts on nuclear PPAR-β/δ and PPAR-γ in neurons and glia to restore neuronal connectivity in depression and has direct applicability in a number of neurodegenerative diseases in which neuronal connections are atrophying.² The newly reported mechanism also provided clarity on why tianeptine does not cause sexual dysfunction, weight gain or several other treatment-limiting toxicities frequently associated with antidepressants.

“The tianeptine marketed outside the U.S. for treating depression is a 1:1 racemic mixture of two mirror image isomers,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The discovery reported today is that the (S)-isomer is responsible for tianeptine’s activity on PPAR-β/δ and restoring neuroplasticity, and the (R)-isomer for its off-target activity on the µ-opioid receptor. Our team of scientists isolated and characterized the (S)-isomer, that is now TNX-4300 and under development for psychiatric and neurological diseases.”

Dr. Lederman continued, “Our ongoing work on racemic tianeptine in depression is expected to inform and potentially accelerate the development of TNX-4300. Although the dose of tianeptine for treating depression is well-established from racemic studies, the dose range for treating neurological diseases is not yet determined. Because TNX-4300 lacks the µ-opioid receptor activity, we believe such effects will not limit the dosing of the (S)-tianeptine for these other indications.”

Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, said, “(S)-tianeptine mimics naturally occurring polyunsaturated fatty acid ligands in binding PPAR-β/δ and PPAR-γ. (S)-tianeptine’s activation of nuclear PPAR-β/δ and PPAR-γ receptors appears to be a more direct mechanism to achieve the goal of restoring neuronal connectivity than current therapies. Its proposed mechanism as a plastogen is consistent with its clinical effects in promoting cognition in Alzheimer’s disease and bipolar disorder^2,3 in addition to posttraumatic stress disorder (PTSD) and corticosteroid-induced cognitive dysfunction. The PPAR-β/δ target is validated by prior work on agonists treating animal models of neurodegenerative and autoimmune diseases of the central nervous system⁴ and the concept that Alzheimer’s can be considered a form of diabetes that affects the CNS, or type-III diabetes.”⁵

Key experiments were performed by scientists at Tonix’s Research and Development Center (RDC) in Frederick, Maryland.

^* TNX-4300 is an investigational new drug and is not approved for any indication
¹Tonix press release, May 17, 2023 https://ir.tonixpharma.com/news-events/press-releases/detail/1389/tonix-pharmaceuticals-announces-pharmacology-and-medicinal
² García-Alberca JM, et al. J Alzheimer’s Dis 2022, 88 (2), 707-720.
³ Kauer-Sant’Anna M, et al. J Psychopharmacol 2019, 33 (4), 502-510.
⁴ Kahremany S et al. Br J Pharmacol 2015, 172(3):754-70
⁵ Nguyen et al., Int J Mol Sci. 2010, 21(9):3165

About Tianeptine

Racemic tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently no tianeptine-containing product is approved in the U.S. and no extended-release tianeptine product is approved in any jurisdiction. In animal models, tianeptine restores dendritic arborization of pyramidal neurons in the CA3 region of hippocampus and in the dentate gyrus region promotes new neuron formation and integration into hippocampal networks.¹ Tianeptine’s enhancement of neuroplasticity in animal models of stress is believed to be mediated by activation of PPAR isoforms PPAR-β/δ and PPAR-γ, which makes its properties distinct from traditional monoaminergic antidepressants in the U.S. and contributes to its potential for clinical indications beyond MDD and stress disorders. Tianeptine and its MC5 metabolite are also weak mu-opioid receptor (MOR) agonists that present a potential abuse liability if illicitly misused in large quantities (typically abused at 8-80 times the therapeutic dose on a daily basis).² In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated³ suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine does not appear to result in dependence or withdrawal symptoms following 6-weeks^4-8, 3-months⁹, or 12-months¹⁰ of treatment. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder (PTSD), and neurocognitive dysfunction associated with corticosteroid use.

¹ McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249.
² Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–53.
³ Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.
⁴ Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
⁵ Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.
⁶ Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.
⁷ Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.
⁸ Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.
⁹ Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.
¹⁰ Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, 15, 61–65.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

*All of Tonix’s product candidates are investigational new drugs or 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

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
Madeline.Stabinski@russopartnersllc.com
(212) 845-4273

Peter Vozzo (investors)
Westwicke/ICR
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released May 23, 2023

Release – Tonix Pharmaceuticals Announces Clinical Proof-of-Concept Study of TNX-1900 (Intranasal Potentiated Oxytocin)

Posted on May 22, 2023May 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 22, 2023 7:00am EDT

Intranasal Oxytocin Blocks the Release of CGRP in Animal Models

Intranasal Oxytocin is the Core Technology of TNX-1900 for Migraine

Oxytocin Treatment Affects a Pathway that is Distinct from the Recently Available CGRP Migraine Treatment Drug Class

CHATHAM, N.J., May 22, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it has entered into a research collaboration agreement to evaluate the effect of TNX-1900 (intranasal potentiated oxytocin) on capsaicin- or electrical stimulation-induced forehead dermal blood flow in healthy female human volunteers. Dr. Antoinette Maassen van den Brink, Professor of Neurovascular Pharmacology, Erasmus University Medical Center, will serve as principal investigator for the study.

“Collaborating with Professor Maassen van den Brink is an exciting opportunity to learn about the potential for TNX-1900 for treating migraine, facial pain and other related conditions,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In animal studies, intranasal oxytocin blocks the release of calcitonin gene-related peptide (CGRP) release from trigeminal neurons.¹ CGRP is released from trigeminal neurons during a migraine attack and several CGRP inhibitors are approved for the treatment of migraine. Both a CGRP inhibitor and a triptan have been successfully tested in the model and have been found to inhibit the forehead dermal blood flow response to capsaicin in migraineurs and healthy volunteers, respectively.^2,3 We look forward to learning the results of TNX-1900 in this proof-of-concept study. Together with other studies, the results will guide future development of this potential non-addictive treatment for migraine and other painful conditions.”

Dr. Maassen van den Brink, the principal investigator of the study said, “The signaling pathways that mediate migraine and facial pain are becoming understood. Oxytocin represents a potential new therapeutic option, targeting a pathway in migraine that is distinct from the recently available CGRP inhibitor migraine treatment drug class.”

In February 2023, Tonix initiated enrollment in its Phase 2 PREVENTION study of TNX-1900 for chronic migraine. The Company expects topline results in the fourth quarter of this year.

About Migraine

Migraine is a neurovascular condition that typically manifests in a throbbing moderate to severe headache which lasts at least four hours, often on one side of the head and aggravated by routine physical activity. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light and loud noises.⁴ Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually.⁵ In the U.S., approximately 39 million Americans suffer from migraines and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month, at least eight of which are migraines).⁵ The current FDA approved drugs for migraine prevention in chronic migraine include Botox^® (onabotulinumtoxin), and the anti-CGRP/CGRP-receptor monoclonal antibodies Aimovig^® (erenumab), Vyepti^® (eptinezumab), Ajovy^® (fremanezumab) and Emgality^® (galcanezumab).

About TNX-1900

TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for prevention of chronic migraine and other conditions. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. It has been observed that low oxytocin levels in the body are associated with increases in migraine headache frequency, and that increased oxytocin levels are associated with fewer migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels. Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal neurons which, when activated, release calcitonin gene-related peptide (CGRP) which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in migraine. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system⁶ resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release.¹ Blocking CGRP release is a distinct mechanism compared with CGRP receptor antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor, or bind to the peptide CGRP. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding⁷ as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models.⁸ Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children⁹. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP receptor antagonists and anti-CGRP (receptor) antibodies¹⁰. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to chronic migraine, TNX-1900 will be developed for treatment of episodic migraine, craniofacial pain conditions, binge eating disorder, and insulin resistance. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

^*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
¹Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
²de Vries Lentsch S, et al. CGRP-mediated trigeminovascular reactivity in migraine patients treated with
erenumab. J Neurol Neurosurg Psychiatry. 2022 Aug;93(8):911-912.
³Ibrahimi K, et al. A human trigeminovascular biomarker for antimigraine drugs: A randomized double-blind, placebo-controlled, crossover trial with sumatriptan. Cephalalgia. 2017 Jan;37(1):94-98.
⁴The International Classification of Headache Disorders, 3^rd Edition. Cephalalgia. 2018. 38(1):1-211
⁵Burch et al., Migraine: Epidemiology, Burden, and Comorbidity, Neurol Clin 37 (2019):631–649
⁶Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388.
⁷Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4.
⁸Cai Q, et al., Psychiatry Clin Neurosci. 2018. 72(3):140-151.
⁹Yeomans, DC et al. 2017. US patent US2017368095
¹⁰MaassenVanDenBrink A, et al. Trends Pharmacol Sci. 2016. 37(9):779-788

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
madeline.stabinski@russopartnersllc.com
(212) 845-4273

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released May 22, 2023

Release – ZyVersa Therapeutics Announces Changes to ZyVersa’s Board of Directors

Posted on May 22, 2023May 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

May 19, 2023

PDF Version

WESTON, Fla., May 19, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, announces that two members of the Board of Directors have stepped down due to obligations associated with recent executive opportunities: Katrin Rupalla, PhD and Daniel O’Connor. Dr. Rupalla resigned from ZyVersa’s Board of Directors to pursue an opportunity that precludes her ability to serve on any board of directors. Mr. O’Connor, the former CEO of Larkspur which merged with ZyVersa in December of 2022, has recently taken on the CEO role at Ambrx Biopharma and has resigned to focus on growth of his new company.

“On behalf of the Board of Directors and the team at ZyVersa, I would like to thank Dr. Rupalla and Mr. O’Connor for their impactful leadership during their tenure as Board members at ZyVersa,” said Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer, and President of ZyVersa. “As biopharmaceutical leaders with impeccable credentials and a proven track record of success, their knowledge and perspectives have been invaluable as we progress development of our company and our lead renal and anti-inflammatory assets.”

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Release – Tonix Pharmaceuticals to Participate in the A.G.P. Virtual Healthcare Conference

Posted on May 18, 2023May 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 18, 2023 7:00am EDTDownload as PDF

CHATHAM, N.J., May 18, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that management will participate in the A.G.P. Virtual Healthcare Conference and host investor meetings. The conference is being held May 23-24, 2023.

In addition, Seth Lederman, M.D., Chief Executive Officer of Tonix, will participate in a panel discussion titled, “New Approaches to Depression,” scheduled from 12:00 p.m. – 1:00 p.m. ET, Tuesday, May 23, 2023.

Investors interested in arranging a meeting with the Company’s management during the conference should contact the conference coordinator or Ian Frost at ian.frost@westwicke.com.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

^*All of Tonix’s product candidates are investigational new drugs or 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

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
madeline.stabinski@russopartnersllc.com
(212) 845-4273

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released May 18, 2023

Release – Tonix Pharmaceuticals Announces Pharmacology and Medicinal Chemistry Results that Reveal the Molecular Mechanism of Action of Tianeptine, the Active Ingredient of TNX-601 ER, in Treating Depression

Posted on May 17, 2023May 17, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 17, 2023 7:00am EDT

Research Supports Direct Role for Restoring Neuroplasticity and Upsets Previously Held Beliefs About the Significance of Neurotransmitters in Treating Depression

Findings Explain Why Tianeptine Is Not Associated with Sexual Dysfunction and Weight Gain

Mechanism Supports Development of TNX-601 ER for a Broad Range of Neurodegenerative Diseases and Psychiatric Disorders

CHATHAM, N.J., May 17, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the molecular mechanism of action of tianeptine, the active ingredient of TNX-601 ER (tianeptine hemioxalate extended-release tablets), currently in Phase 2 clinical development for the treatment of major depressive disorder (MDD)^*. Based on pharmacology and medicinal chemistry experiments, scientists at Tonix have established that tianeptine is an agonist for the nuclear peroxisome proliferator-activated receptor (PPAR) isoforms PPAR-β/δ and PPAR-γ, and tianeptine’s effects on these PPAR isoforms account for its ability to induce neuroplasticity in cultured neurons.

The findings upset a long-held belief that the only way to restore the connectivity of neurons damaged in the state of depression was to increase the synaptic levels or activity of neurotransmitters such as the monoamines serotonin, norepinephrine, and dopamine. The new findings show that selective activation of nuclear PPAR-β/δ and PPAR-γ in neurons and supporting glia appears to be a more direct mechanism to achieve the goal of restoring neuronal connectivity, which is called neuroplasticity. Drugs that restore neuroplasticity are called plastogens.^1-3 Consequently, tianeptine is a plastogen that acts directly on nuclear receptors that regulate gene expression in neurons and microglia.

“The discovery that tianeptine stimulates neuroplasticity by activating certain PPAR isoforms could lead to a paradigm shift in designing new antidepressants, and change the relative reliance developers place on targeting synaptic neurotransmitter levels and activity,” said Stephen Stahl, M.D., Ph.D., Adjunct Professor of Psychiatry at the University of California San Diego, Chairman of Neuroscience Education Institute, author of the bestselling clinical manual, Essential Psychopharmacology Prescriber’s Guide, and consultant to Tonix. “This may lead to better pharmacological treatments for depression and for a range of neurodegenerative diseases in which neuronal connections are atrophying and the need to restore the connectivity is paramount to achieving more positive and more sustainable outcomes. Tianeptine avoids some of the more intolerable side effects of the traditional antidepressants because it cuts in line and intervenes downstream from the monoamine transporters and receptors.”

The new research provides clarity on why tianeptine does not cause sexual dysfunction, weight gain, or several other treatment-limiting toxicities associated with traditional antidepressants. Tianeptine treats depression by activating select nuclear PPAR isoforms, and has little to do with monoaminergic neurotransmitters, which are known to be implicated in the most frequently cited side effects of most marketed antidepressants. Key experiments were performed by scientists at Tonix’s Research and Development Center (RDC) in Frederick, Maryland.

“Understanding the mechanism of action of a molecule generally speeds its development and often points the way to broader clinical application,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Despite its success in treating depression outside of the U.S. for more than 30 years, tianeptine’s mechanism has remained obscure. Pioneering studies by Prof. Bruce McEwen, Ph.D. at Rockefeller University revealed that tianeptine stimulates stress-atrophied neurons to form new connections.¹ Subsequently, Prof. Ronald Duman, Ph.D. at Yale University discovered that enhancing these connections is a common principle underlying the therapeutic effects of traditional antidepressants, which only act indirectly on neuroplasticity by changing the level and activity of synaptic neurotransmitters.”⁴

“In animal models, tianeptine restores neuroplasticity and reverses stress-induced impairments through activation of select nuclear PPAR isoforms without modulating synaptic monoamine neurotransmitters,”¹ said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Tianeptine mimics naturally occurring polyunsaturated fatty acid in binding to PPARs.⁵ When compared to the traditional classes of antidepressants (SSRIs, tricyclics, etc.), the tianeptine sodium immediate release products available outside of the U.S. demonstrate comparable efficacy⁶ and decreased side effects including sexual dysfunction^7-9, derangement of sleep architecture¹⁰, sedating effects¹¹ despite anxiolysis, weight gain even with long term treatment¹², and cognitive impairment.”^11, ^13-15

Dr. Sullivan continued, “Regarding potential future indications beyond our current program in MDD, the proposed mechanism is consistent with the clinical effects of tianeptine in promoting cognition in Alzheimer’s disease, Parkinson’s disease and bipolar disorder^14,15 and motivates us to develop TNX-601 ER as a treatment for these and other conditions, in addition to our previously stated objectives to study it in posttraumatic stress disorder (PTSD) and corticosteroid-induced cognitive dysfunction. The PPAR-β/δ target is validated by prior work on agonists treating animal models of neurodegenerative and autoimmune disease of the central nervous system.¹⁶ The PPAR-γ target is validated by prior work treating peripheral diabetes in animals and as FDA-approved drugs, and the concept that Alzheimer’s can be considered a form of diabetes that affects the CNS, or type-III diabetes.”¹⁷

Dr. Sullivan noted that the new Tonix findings about tianeptine’s mechanism dispel the notion that tianeptine’s weak µ-opioid receptor activity was central to its mechanism of treating depression.¹⁸ This hypothesis was proposed based on results in the forced swim test (FST) using high-dose tianeptine in mice.¹⁹ “Our work found no connection between tianeptine’s neuroplastic effects on cultured neurons and its weak µ-opioid receptor agonism,” Dr. Sullivan said. “In fact, we have identified a new chemical entity related to tianeptine, TNX-4300, that restores neuroplasticity in cultured neurons and is free from µ-opioid receptor activity.”

Tonix is planning to submit data supporting tianeptine’s mechanism of action for presentation at upcoming scientific conferences and for publication in peer reviewed journals.

^* TNX-601 ER is an investigational new drug and is not approved for any indication
¹ McEwen, BS, et al. Mol. Psychiatry 2010, 15 (3), 237–249.
² Olson DE. J Exp Neurosci. 2018, 19;12:1179069518800508.
³ Cooper T, et al. J Psychopharmacol. 2023, 37(3):242-247.
⁴ Price RB, Duman R. Mol Psychiatry 2020, 25 (3), 530-543.
⁵Helmstädter M et al. Int J Mol Sci. 2022, 23(17):10070.
⁶Wagstaff AJ, et al. CNS Drugs 2001, 15 (3), 231-59.
⁷Bonierbale M, et al. Curr Med Res Opin 2003, 19 (2), 114-124
⁸Ducrocq F. Encephale 1999, 25 (5), 515-6. French.
⁹Atmaca M, et al. Hum Psychopharmacol 2003, 18 (4), 277-80.
¹⁰ Le Bon O. Dialogues Clin Neurosci 2005, 7 (4), 305-13.
¹¹Yoon JS, et al. Clin Psychopharmacol Neurosci 2003, 1, 27-34.
¹²Dalery J, et al. Hum Psychopharmacol 2001, 16 (S1), S39-S47.
¹³Jeon HJ, et al. J Clin Psychopharmacol 2014, 34 (2), 218-25.
¹⁴García-Alberca JM, et al. J Alzheimer’s Dis 2022, 88 (2), 707-720.
¹⁵Kauer-Sant’Anna M, et al. J Psychopharmacol 2019, 33 (4), 502-510.
¹⁶Kahremany S et al. Br J Pharmacol 2015, 172(3):754-70
¹⁷ Nguyen et al., Int J Mol Sci. 2010, 21(9):3165
¹⁸ Samuels BA, et al. Neuropsychopharmacol 2017, 42 (10), 2052-2063.
¹⁹ Reardon S. Nature 2019, 571 (7766), 456-457.

About Depression

According to the National Institute of Mental Health, an estimated 21 million adults in the U.S. in 2020 experienced at least one major depressive episode¹, with highest prevalence among individuals aged 18-25 at a rate of 17.0%. For approximately 2.5 million adults in the U.S., adjunctive therapies are necessary for depression treatment.^2,3 Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behaviors. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.⁴

¹ Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults 2020. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml
² IMS NSP, NPA, NDTI MAT-24-month data through Aug 2017.
³ Kubitz N, et al. PLoS One 2013, 8 (10), e76882.
⁴ Rush AJ, et al. Am J. Psychiatry 2007, 163 (11), 1905-1917.

About TNX-601 ER

TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a novel oral formulation of tianeptine designed for once-daily daytime dosing in development as a candidate for the treatment for MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently no tianeptine-containing is product approved in the U.S. and no extended-release tianeptine product is approved in any jurisdiction. Tonix discovered a novel oxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine. In animal models, tianeptine restores dendritic arborization of pyramidal neurons in the CA3 region of hippocampus and in the dentate gyrus region promotes new neuron formation and integration into hippocampal networks.¹ Tianeptine’s enhancement of neuroplasticity in animal models of stress is believed to be mediated by activation of PPAR isoforms PPAR-β/δ and PPAR-γ, which makes TNX-601 ER’s properties distinct from traditional monoaminergic antidepressants in the U.S. and contributes to its potential for clinical indications beyond MDD and stress disorders. Tianeptine and its MC5 metabolite are also weak mu-opioid receptor (MOR) agonists that present a potential abuse liability if illicitly misused in large quantities (typically abused at 8-80 times the therapeutic dose on a daily basis²). In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated³ suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine does not appear to result in dependence or withdrawal symptoms following 6-weeks^4-8, 3-months⁹, or 12-months¹⁰ of treatment. The ER formulation of TNX-601 includes several potentially abuse deterrent ingredients include gel forming polymers which impede extraction. In addition, the tablet’s hardness makes it difficult to crush, cut or grind to fine particle size, which potentially hinders efforts to misuse by insufflation or intravenous routes. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder (PTSD), and neurocognitive dysfunction associated with corticosteroid use. TNX-601 ER is expected to have patent protection through 2037.

Tonix Pharmaceuticals Holding Corp. ^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

*All of Tonix’s product candidates are investigational new drugs or 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

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
Madeline.Stabinski@russopartnersllc.com
(212) 845-4273

Peter Vozzo (investors)
Westwicke/ICR
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released May 17, 2023

Onconova Therapeutics (ONTX) – 1Q23 Reported With Clinical Progress Review

Posted on May 16, 2023May 16, 2023 by cpereira@noblefcm.com

Tuesday, May 16, 2023

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China. Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Onconova Updates Clinical Progress With 1Q23 Financial Report. Onconova reported a loss of $5.8 million or $(0.28) per share, and gave updates on its clinical programs including Phase 1 testing narazaciclib and several Phase 2 studies testing rigosertib. The company ended 1Q23 with $34.2 million in cash, which it projects to last into 1Q24.

Rigosertib Could Become An Orphan Drug. Results from two patients in an Investigator Initiated Trial testing rigosertib in a rare disease (RDEB-associated SCC, or recessive dystrophic epidermolysis bullosa-associated squamous cell carcinoma) were reported at a meeting of the Society of Investigative Dermatology in Osaka, Japan. Both patients had complete clinical responses of all cancerous lesions following treatment. Since this is a fatal disease with no effective therapy, the company has requested an FDA Type B meeting to review the data and discuss a pivotal study. An announcement is expected in 3Q23.

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Release – ZyVersa Therapeutics Announces Article Published in Metabolism Pointing to Glomerular Cholesterol Accumulation as Key Factor Exacerbating Renal Injury and Dysfunction in Diabetic Kidney Disease

Posted on May 15, 2023May 16, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

May 15, 2023

Published data demonstrate that a deficiency in cholesterol transporter ABCA1 increases deposition of cellular cholesterol, contributing to inflammation, cell death (apoptosis), and damage to the kidney’s filtration barrier in type 2 diabetic mice and in human renal glomerular endothelial cells cultured to simulate type 2 diabetes

ZyVersa’s Cholesterol Transport Mediator™ VAR 200 is in development to reduce renal cholesterol and lipid accumulation that damages the kidneys’ filtration system in patients with glomerular diseases (diabetic kidney disease, focal segmental glomerulosclerosis, and Alport Syndrome)
VAR 200 mediates transport of excess cholesterol out of kidney cells passively and by upregulating cholesterol transporter ABCA1

WESTON, Fla., May 15, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Metabolism, which supports the mechanism of action of Cholesterol Efflux Mediator™ VAR 200 in development to treat kidney diseases.

In the paper titled, “ABCA1 deficiency-mediated glomerular cholesterol accumulation exacerbates glomerular endothelial injury and dysfunction in diabetic kidney disease,” the authors reported that ABCA1 deficiency contributes to injury and dysfunction of the kidney’s filtration system (glomerular endothelium) in early diabetic kidney disease (“DKD”). They proposed that ABCA1 transporter deficiency results in glomerular cholesterol/lipid accumulation leading to inflammation and cell death. This causes structural and functional damage to the kidney’s filtration system and in turn, protein spillage into the urine (proteinuria) and DKD progression.

The authors concluded that therapies which effectively reduce elevated glomerular cholesterol levels have potential to combat early DKD. To read the article, Click Here.

“The research published in Metabolism demonstrating that deposition of glomerular cholesterol contributes to structural damage and dysfunction of the kidney’s filtration system in models of type 2 diabetes is consistent with data from VAR 200’s preclinical program. Our preclinical program showed similar results not only in models of DKD, but also in models of two orphan kidney diseases, focal segmental glomerular sclerosis (FSGS) and Alport Syndrome. More importantly, by mediating cholesterol transport out of the glomeruli through passive transport and upregulation of ABCA1 transporters, VAR 200 protected against glomerular injury and fibrosis, and significantly reduced protein spillage into the urine in all three kidney diseases,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Given the unmet needs for effective treatments for kidney disease, we are hopeful that VAR 200 will demonstrate similar results in patients with kidney disease in studies planned to initiate late this year,” continued Mr. Glover.

About Cholesterol Efflux Mediator™ VAR 200

Cholesterol Efflux Mediator™ VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is a phase 2a-ready drug in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to kidney disease progression. VAR 200 passively and actively removes excess lipids from the kidney.

Preclinical studies with VAR 200 in animal models of FSGS, Alport syndrome, and diabetic kidney disease demonstrate that removal of excess cholesterol and lipids from kidney podocytes protects against structural damage and reduces excretion of protein in the urine (proteinuria).

The lead indication for VAR 200 is orphan kidney disease focal segmental glomerulosclerosis (FSGS). VAR 200 has potential to treat other glomerular diseases, including orphan Alport syndrome and diabetic kidney disease.

About ZyVersa Therapeutics, Inc.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc. (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Release – ZyVersa Therapeutics Reports First Quarter 2023 Corporate and Financial Results

Posted on May 12, 2023May 12, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

May 12, 2023

Key Highlights:

Continued progress has been made in advancing an investigator-initiated clinical trial to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200 in patients with renal disease
Announced publication of several peer-reviewed journal articles supporting ASC inhibition as a promising therapeutic target – data continue to demonstrate that multiple types of inflammasomes are activated in various conditions (Alzheimer’s disease, traumatic brain injury, and injury from intracortical implants), and substantiate that extracellular release of ASC specks to neighboring cells heighten and perpetuate damaging inflammation leading to disease progression in conditions such as Parkinson’s disease and alcoholic hepatitis
Added three internationally recognized experts in the field of glomerular disease to Renal Scientific Advisory Board, and an internationally recognized authority in the field of innate immunity to our Inflammatory Disease Scientific Advisory Board
Enhanced our Board of Directors with addition of three biopharmaceutical leaders with impeccable credentials and a proven track record of success

WESTON, Fla., May 12, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, provides a corporate update and reports financial results for the first quarter of 2023 ending March 31, 2023.

“This is a very exciting time in the growth and evolution of ZyVersa as we seek to build shareholder value through development of first-in-class drugs at the forefront of innovation for renal and inflammatory diseases,” said Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer, and President of ZyVersa. “We are currently advancing a dynamic pipeline of drug candidates with multiple programs built around our two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases and Inflammasome ASC Inhibitor IC 100 for treatment of multiple CNS and other inflammatory diseases. We believe that both technologies have transformative potential, enabling development of drugs for patients who have limited or no therapeutic options.”

Mr. Glover continued: “Highlighting our Inflammasome ASC Inhibitor IC 100, ZyVersa expects to complete IC 100’s preclinical program this year, with an Investigational New Drug (“IND”) submission anticipated in second quarter of 2024. We were pleased to report publication of data in several peer-reviewed journal articles demonstrating the role of ASC specks in heightening and perpetuating damaging inflammation in neurological conditions (Alzheimer’s disease, Parkinson’s disease, and traumatic brain injury), and in alcoholic hepatitis. These data support the therapeutic potential of inhibiting ASC and ASC specks with IC 100 to control inflammation associated with various inflammatory diseases.”

“Regarding Cholesterol Efflux Mediator™ VAR 200, ZyVersa continues to leverage relationships with experts in the field of renal disease,” stated Mr. Glover. “To that end, we welcomed three new members to our Renal Disease Scientific Advisory Board. We look forward to benefitting from their decades of experience as we advance our investigator-initiated trial to evaluate VAR 200 in patients with renal disease, expected to begin in the fourth quarter of 2023.”

FIRST QUARTER AND RECENT PROGRAM UPDATES

Targeting Renal Disease with Phase 2a-Ready Cholesterol Efflux Mediator™ VAR 200

Continued progress is being made to launch an investigator-initiated clinical trial in patients with renal disease to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200, with trial initiation expected in the fourth quarter of 2023
Added to ZyVersa’s Renal Scientific Advisory Board (1) Dr. Daniel C. Cattran, Professor of Medicine, University of Toronto; (2) Dr. Fernando C. Fervenza, Professor of Medicine, Mayo Graduate School of Medicine and Director of the Nephrology Collaborative Group; and (3) Dr. Richard J. Glassock, Professor Emeritus, David Geffen School of Medicine, UCLA

Inflammasome ASC Inhibitor IC 100: Targeting Inflammation Associated with Multiple CNS and Other Inflammatory Diseases

On track to complete IND-enabling preclinical studies by end of year, with the goal of filing an IND application with the U.S. Food and Drug Administration in the second quarter of 2024
Highlighted peer-reviewed journal articles supporting the potential of ASC inhibition to control damaging inflammation associated with numerous diseases, including Alzheimer’s disease, Parkinson’s disease, traumatic brain injury, and alcohol induced hepatitis
Added to ZyVersa’s Inflammatory Disease Scientific Advisory Board Dr. Douglas Golenbock, The Neil and Margery Blacklow Chair in Infectious Diseases and Immunology, and Professor and Chief, Division of Infectious Diseases and Immunology at the UMass Chan Medical School

FIRST QUARTER FINANCIAL RESULTS
Since its inception in 2014 through March 31, 2023, ZyVersa has not generated any revenue and has incurred significant operating losses and negative cash flows from its operations. Based on our current operating plan, we expect our cash of $1.3 million as of March 31, 2023, will only be sufficient to fund our operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations. ZyVersa will seek to fund its operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties.

Research and development expenses were consistent at approximately $1.1 million for the three months ended March 31, 2023 (“Successor Period”), with an immaterial decrease of $11 thousand or 1.0% from the three months ended March 31, 2022 (“Predecessor Period”).

General and administrative expenses were $3.5 million for the three months ended March 31, 2023, an increase of $1.2 million or 53.7% from $2.3 million for the three months ended March 31, 2022. The increase is primarily attributable to an increase of $0.4 million in director and officer insurance, a $0.4 million increase in marketing costs for investor and public relations, and $0.4 million in payments for the Effectiveness Failure related to the PIPE shares.

Net losses were approximately $3.5 million for the three months ended March 31, 2023, with an improvement of $0.2 million or 5.5% compared to a net loss of approximately $3.7M, for the three months ended March 31, 2022. Net losses for the three months ended March 31, 2023 benefited from a $1.0 Million deferred tax benefit compared to none for the year earlier period.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
Dschemelia@tiberend.com
609-468-9325

Release – Onconova Therapeutics To Participate In Ladenburg Thalmann Virtual R&D Showcase On Narazaciclib In Endometrial Cancer

Posted on May 12, 2023May 12, 2023 by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

Showcase to feature presentations by key opinion leaders Drs. Gaël Roué and Bhavana Pothuri

Showcase to take place on May 18, 2023 at 11:00 a.m. ET

NEWTOWN, Pa., May 12, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven M. Fruchtman, M.D., President & CEO of Onconova Therapeutics, will participate in a Ladenburg Thalmann virtual R&D showcase on Thursday, May 18, 2023, at 11:00 a.m. ET.

The R&D showcase will feature presentations by key opinion leaders Gaël Roué, Ph.D. (Josep Carreras Leukaemia Research Institute), and Bhavana Pothuri, M.D. (New York University Langone Health), who will discuss narazaciclib’s differentiated kinase inhibitory profile, the current treatment landscape in endometrial cancer, as well as Onconova’s planned Phase 1/2a trial of narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC). Presentations by the KOLs will be followed by remarks from Dr. Fruchtman as well as a question and answer session moderated by Ahu Demir, Ph.D., Managing Director, Senior Research Analyst, Ladenburg Thalmann & Co.

To register for the showcase, click here.

KOL Bios

Dr. Gaël Roué leads the Lymphoma Translational Group at the Josep Carreras Leukaemia Research Institute, with a special focus on oncogenic signaling, B-cell receptor pathways and the role of intrinsic protein homeostasis in the control of lymphoma-stroma crosstalk. Dr. Roué obtained his Ph.D. in Molecular and Cellular Biology from the University of Caen. Dr Roué is co-author and lead author of a patent, two book chapters, and nearly 90 articles published in international peer-reviewed journals. He has led almost 20 national and international research projects. Dr Roué also serves as an ad-hoc reviewer for several journals in the fields of hematology and oncology, being an editorial board member for three of them, and is an external evaluator for different national and European funding agencies.

Dr. Bhavana Pothuri earned her medical degree from Jefferson Medical College at Thomas Jefferson University. She completed her residency in Obstetrics and Gynecology at the Jefferson Health System and a fellowship in Gynecologic Oncology at Memorial Sloan Kettering Cancer Center. She is a Professor in the Departments of Obstetrics and Gynecology and Medicine at the New York University (NYU) School of Medicine, Medical Director of Clinical Trials Office, Director of Gynecologic Oncology Clinical Trials, Director of Gynecologic Oncology Research, and Site Principal Investigator for the Perlmutter Cancer Center, NYU Langone Health. Dr. Pothuri is also the Principal Investigator for Onconova’s planned Phase 1/2a trial in endometrial cancer. In addition, her research focuses on using the PARP inhibitor, niraparib, as frontline maintenance treatment for ovarian cancer, as well as dostarlimab, a PD-1 inhibitor, in endometrial cancer.

About Onconova Therapeutics, Inc.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC).

For more information, please visit www.onconova.com.

Forward Looking Statements

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com