Biopharmaceutical Archives - Page 3 of 24

Release – ZyVersa Therapeutics Announces Published Data Demonstrating That Plasma Levels of Inflammasome ASC Show Promise as Biomarker of Early Cognitive Changes in Older Adults

Posted on July 29, 2024July 29, 2024 by aweinsoff@channelchek.com

Jul 29, 2024

This data supports the potential of plasma ASC levels as a biomarker for early stages of cognitive decline, based on elevated ASC levels in older adults (>60 years) who were cognitively normal at baseline but demonstrated cognitive decline one year later (N_I) compared to ASC levels in those who:
1. Were cognitively normal at both baseline and 1 year later (N_N), and
2. Were cognitively impaired at both baseline and one year later (I_I)
Inflammasome-induced neuroinflammation has been associated with early stages of cognitive decline in dementia associated with Alzheimer’s and Parkinson’s diseases.
Excessive inflammasome activation leads to cell death (pyroptosis) and systemic release of cell contents, including ASC that can be measured in the plasma.

WESTON, Fla., July 29, 2024 (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 that leading inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed International Journal of Molecular Sciences demonstrating that plasma levels of inflammasome ASC show promise as a biomarker of early cognitive decline in older adults.

“Elevations in plasma ASC in early cognitive decline reinforce the role of inflammasome-induced inflammation in the development of neurodegenerative conditions such as Alzheimer’s and Parkinson’s diseases,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation pathogenic in neurological and other inflammatory diseases, such as obesity and its metabolic complications, our lead indication.”

The paper titled, The Inflammasome Adaptor Protein ASC in Plasma as a Biomarker of Early Cognitive Changes, summarizes biomarker assessments in older adults at baseline and at one-year follow-up. Following is a summary of key findings:

Plasma ASC levels were elevated in older adults (>60 years) who were cognitively normal at baseline but demonstrated cognitive decline one year later (N_I) compared to ASC levels in those who remained cognitively normal one-year post-baseline assessment (N_N). The increase in ASC levels was even higher in people who were 70 years or older.
Likewise, plasma ASC levels in the N_I group were elevated compared to ASC levels in older adults who demonstrated cognitive impairment at both baseline and one year later (I_I), indicating that plasma ASC levels are increased in the early stages of cognitive decline. Again, the increase in ASC levels was even higher in people who were 70 years or older.
In the group over 70 years old, area under the curve (AUC) for plasma levels of ASC in group N_Iversus group N_N was 0.81, indicating excellent ability to differentiate between people with cognitive decline at one year versus those who were cognitively normal both at baseline and at one year. AUC is used to determine the diagnostic power of a biomarker.

“Dementia affects 57 million people worldwide, and the incidence is expected to double by 2040. There is an unmet need to develop minimally invasive, reliable biomarkers to diagnose early brain impairments so that emerging interventions can be applied before brain degeneration,” said Dr. Juan Pablo de Rivero Vaccari, Associate Professor of Neurological Surgery and The Miami Project to Cure Paralysis and Distinguished Faculty of the Center for Cognitive Neuroscience and Aging at the University of Miami Miller School of Medicine. “Our data indicate that plasma levels of ASC are a strong early indicator of the eventual development of cognitive impairment, especially in persons older than 70 years.”

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, and 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. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

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 inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator^TM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. 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, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Dexcom’s Stock Plummets: A Wake-Up Call for the Diabetes Management Giant

Posted on July 26, 2024July 26, 2024 by slightbourne@noblecapitalmarkets.com

Key Points:
– Dexcom shares dropped over 40% in a single day, the worst in company history.
– Disappointing Q2 revenue and lowered full-year guidance shocked investors.
– Internal issues, not market changes, appear to be the primary cause of the downturn.

Dexcom, a leader in diabetes management technology, experienced a seismic shock on Friday, July 26, 2024, as its stock plunged more than 40% following a disappointing second-quarter earnings report. This dramatic fall, erasing approximately $18 billion in market capitalization, marks the company’s worst single-day performance since its 2005 IPO.

The catalyst for this financial tremor was Dexcom’s Q2 revenue report, which fell short of analyst expectations. Despite a 15% year-over-year increase to $1 billion, it missed the projected $1.04 billion target. More alarmingly, the company significantly lowered its full-year revenue guidance from $4.20-$4.35 billion to $4.00-$4.05 billion, a reduction that caught many investors off guard.

During the earnings call, CEO Kevin Sayer attributed the shortfall to several internal factors. A major restructuring of the sales team led to disruptions in customer relationships, particularly affecting the crucial durable medical equipment (DME) channel. The company also faced challenges with lower-than-expected new customer acquisition and reduced revenue per user, partly due to rebates offered for their new G7 continuous glucose monitor.

The magnitude of the guidance cut raised eyebrows among analysts. JPMorgan downgraded Dexcom’s stock, expressing shock at the level of disruption caused by internal reorganization. However, they and other analysts, including those from William Blair and Leerink, maintained that these issues are likely transient and should not significantly impact Dexcom’s long-term trajectory.

Interestingly, Dexcom’s woes do not appear to be linked to broader market trends, such as the rising popularity of GLP-1 weight loss treatments. Instead, the company’s stumbles seem largely self-inflicted, a fact that has both frustrated and perplexed market watchers.

Looking ahead, Dexcom is pinning hopes on its new over-the-counter continuous glucose monitor, Stelo, cleared by the FDA in March 2024 and set for an August launch. Designed for Type 2 diabetes patients who don’t use insulin, Stelo represents a significant expansion of Dexcom’s addressable market.

Despite the current turmoil, some analysts believe the market’s reaction may be overblown. Leerink analysts, in particular, argue that the magnitude of the sell-off is excessive given the likely temporary nature of Dexcom’s challenges.

Nevertheless, the incident serves as a stark reminder of the volatility inherent in the healthcare technology sector. It underscores the importance of effective execution, particularly in sales and customer relationship management, even for established market leaders.

As Dexcom works to right the ship, investors and industry observers will be watching closely. The company’s ability to overcome these short-term hurdles and leverage opportunities like the Stelo launch will be crucial in regaining market confidence.

While the road ahead may be bumpy, Dexcom’s strong market position and innovative product pipeline suggest that this may be a temporary setback rather than a long-term decline. However, the company will need to demonstrate improved execution and a clear path to recovery in the coming quarters to fully reassure investors and regain its market momentum.

Release – ZyVersa Therapeutics Selects Obesity and Related Metabolic Complications as Lead Indication for Inflammasome ASC Inhibitor IC 100

Posted on July 25, 2024July 25, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jul 25, 2024

PDF Version

WESTON, Fla., July 25, 2024 (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 that obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100.

“Obesity, a well-established risk factor for an array of different metabolic disorders, including insulin resistance, type 2 Diabetes, hypertension, cardiovascular disease, and cancer, has reached pandemic proportions, affecting up to two-thirds of the adult population in developed countries,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Published research demonstrating that inflammasome activation in fat tissue triggers cell death and systemic release of proinflammatory IL-1β, and ASC specks, which can perpetuate and spread inflammation leading to metabolic disturbances associated with obesity provides support for Inflammasome ASC Inhibitor IC 100 as a potential therapeutic option. We are excited about progressing our development program in this area of high unmet needs.”

Following is the rationale behind selection of obesity and related metabolic complications, and an overview of the development program.

Why Obesity and Related Metabolic Complications as an Indication?

Large Growing Market: The global obesity drug market reached nearly $24 billion in 2023, more than a sevenfold growth in just three years, and it is forecasted by IQVIA t to reach up to $131 Billion by 2028 (24 – 27% CAGR).
Significant Health and Economic Impact: Obesity, which now affects over 40% of Americans (CDC), is associated with multiple chronic medical conditions, including type 2 diabetes, heart disease, and some forms of cancer, at an annual cost and economic impact exceeding 1.4 trillion in the United States including healthcare expenditures, loss of productivity (Milken Institute).
Need for Alternative Mechanisms of Action to Complement GLP-1 agonists: While GLIP-1 drugs deliver meaningful weight loss, improve glucose control, and help to mitigate cardiovascular disease, they do not address the chronic tissue inflammation observed in adipose tissue, liver, muscle, and pancreatic islet cells that has emerged as a key feature of obesity. This chronic tissue inflammation, termed, “immunometabolism,” leads to insulin resistance, beta cell dysfunction, and development of type 2 diabetes and long-term inflammatory complications including microvascular disease (retinopathy, nephropathy, and neuropathy), macrovascular disease (stroke, myocardial infarction, and peripheral arterial disease), heart failure, and nonalcoholic fatty liver disease. As such, anti-inflammatory drugs have potential to provide additional benefits in obesity management (Immunity. 2022 Jan 11;55(1):31-55).

Rationale for Inflammasome Inhibitors as a Treatment for Obesity and Related Metabolic Complications

Inflammasomes, which are activated by nutrients, such as glucose and free fatty acids, trigger activation and stimulation of downstream inflammatory pathways, leading to chronic inflammation in obesity (Front Endocrinol (Lausanne). 2023 Aug 31;14:1232171).

Nutrient overload triggers inflammasome-induced inflammation in the brain’s hypothalamus, causing increased appetite and food intake, increasing the number and size of fat cells associated with weight gain and obesity.
The fat cells become hypoxic, resulting in cell death and macrophage recruitment. This leads to inflammasome activation, death of inflamed cells, and systemic release of proinflammatory cytokines, such as IL-1β, and ASC specks, spreading inflammation throughout the body. If unresolved, sustained inflammation leads to the metabolic complications of obesity.

Why Inflammasome ASC Inhibitor IC 100?

Multiple types of inflammasomes, not just NLRP3, are activated in obesity and related metabolic complications (NLRP1, NLRP3, NLRC4, and AIM2). Because IC 100 targets the inflammasome ASC component, it inhibits each of these inflammasomes, including NLRP3, with potential to better attenuate the damaging inflammation associated with obesity and its complications (Immunology. 2021 Aug;163(4):348-362).
Inflammation is spread and perpetuated by systemic release of proinflammatory IL-1β and ASC specks during death of inflamed cells, leading to obesity-related complications. IC 100 disrupts the structure and function of ASC specks, thereby attenuating spread and perpetuation of inflammation (Transl Res. 2022 Jul 3:S1931-5244(22)00150-5).

ZyVersa believes that inflammasome ASC Inhibitor IC 100 administered concurrently with GLIP-1 agonists will lead to incremental weight loss, and more importantly, attenuate the chronic tissue inflammation not addressed by GLIP-1 agonists to reduce the long-term micro- and macrovascular inflammatory complications.

Inflammasome ASC Inhibitor IC 100 Development Plans for Obesity and Related Complications

IC 100’s preclinical program is nearing completion, with a planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation shortly thereafter.
Preclinical scientific collaboration to assess IC 100 as a potential treatment for atherosclerosis, a common obesity-related metabolic complication, is expected to conclude H2-2024.
Preclinical scientific collaboration with University of Miami Miller School of Medicine to assess IC 100 as a potential treatment for obesity and metabolic syndrome is expected to begin H2-2024, with a second study looking at concomitant treatment with IC 100 and a GLIP-1 agonist to begin shortly thereafter.
ZyVersa has recruited six top-tiered experts in obesity and related metabolic complications for a scientific advisory board to guide clinical development plans for IC 100, which will be announced in the next few weeks.

About Inflammasome ASC Inhibitor IC 100

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 inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator^TMVAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. 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, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Release – Beyond “One Bug, One Drug” – Tonix Pharmaceuticals Secures Up To $34 Million In Funding From The U.S. Department Of Defense To Develop a Broad-Spectrum Antiviral

Posted on July 24, 2024July 24, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 24, 2024 7:45am EDT

CHATHAM, NJ / ACCESSWIRE / July 24, 2024 / From anthrax to the plague, biological warfare is a real threat to U.S. forces and civilians, so much so the Pentagon budgeted about $2 billion for the country’s biological defense for the coming fiscal year. It’s also why the U.S. Department of Defense is seeking broad-spectrum antiviral drugs and teaming up with the biotech companies developing them.

That’s the case with Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully integrated biopharmaceutical company. The DoD’s Defense Threat Reduction Agency (DTRA) recently inked a five-year deal with Tonix Pharmaceuticals to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Through the Other Transaction Agreement (OTA) contracting vehicle, Tonix could get as much as $34 million in funding over five years.

“Through our agreement with DTRA, our broad-spectrum antiviral research program will address the DoD’s goal of protecting U.S. forces in the event biological weapons are introduced onto the battlefield,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “This funding provides important validation for our ongoing research and current in-house capabilities and will enable Tonix to advance its antiviral discovery program.”

Stop Viruses In Their Tracks

Antiviral drugs are designed to stop a virus in its tracks by either attacking it or preventing it from spreading. In the case of Tonix’s program, the goal is to fortify the immune system so that it can protect against a range of viruses. Demand for antiviral drugs is rising along with the concerns about viruses on the battlefield. Viruses are changing, jumping back and forth between humans and animals and there’s the new risk that synthetic biology can be used maliciously, to make new viruses or to make existing viruses more virulent in what’s called “gain of function”. On the battlefield, the DoD is looking for antiviral drugs that can protect soldiers regardless of the agent. It is pouring money into different initiatives designed to react in the event of a biological attack.

Take DTRA’s Chemical and Biological Technologies Department which is sponsoring Tonix’s research. The department, which is funded out of DTRA’s approximately $1.9 billion budget for fiscal 2024, invests in medical countermeasure projects to fulfill its mission to anticipate future threats and equip the warfighter to survive, fight and win in chemical and biological contested environments.

Across the U.S. government, chemical and biological countermeasures programs have approximately $1.26 billion budgeted for fiscal 2024 and includes programs to reduce the risks to both U.S. troops and the global community from bacteria or viruses. The need to slow the spread of viruses and protect troops from biowarfare is just part of an over-all antiviral market estimated to reach $74.75 billion by 2028, growing at a CAGR of 6.19%.

Attacking The CD45 Protein

Tonix Pharmaceuticals’ program will focus on optimizing and developing TNX-4200, the company’s oral CD45 antagonist program, which is designed to have broad-spectrum efficacy against a range of viral pathogens. This broad-spectrum capability is a move beyond the previous “one bug, one drug” approach and seeks to target a broad range of deadly agents through just a single drug. Reduction of CD45 activity, a protein tyrosine phosphatase, protects animals against many viruses, including the Ebola virus. Through this funding, Tonix expects to establish the treatment’s biological activity and safety in animals and then submit an Investigational New Drug application (IND) to conduct a first-in-human phase 1 clinical study.

Tonix said it plans to leverage previous research on phosphatase inhibitors – specifically compounds that target CD45 – to optimize compounds for therapeutic intervention of biothreat agents and provide the government with a broad-spectrum medical countermeasure. The idea behind Tonix’s compound is that partial inhibition of CD45 will provide optimal antiviral protection with an acceptable safety profile. The $34 million, five-year contract will help bankroll and accelerate the development of Tonix’s host-directed antivirals which have the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response, reports the company.

Leveraging R&D Capabilities

To develop its program, Tonix plans to rely on what it says are state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center in Frederick, Maryland. The research center is located in Maryland’s I-270 biotech corridor and is close to the center of the U.S. biodefense research community. The research facilities will help to accelerate the development of vaccines and antiviral drugs against infectious diseases.

The threat of viruses, pandemics and biochemical attacks is increasing, driving demand for antivirals that can stop pathogens in their tracks. Tonix is betting it can deliver a single remedy to cover several viruses – and has up to $34 million to prove it.

Featured photo by api.army.mil.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-24072/

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

Important notice, please read: Certain statements in this document 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; risks related to the failure to successfully market any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

SOURCE: Tonix Pharmaceuticals Holding Corp.

View the original press release on accesswire.com

Released July 24, 2024

Release – ZyVersa Therapeutics Announces Publication Demonstrating that Inflammasome ASC Inhibitor IC 100 Restored Retinal Structure and Function in a Retinopathy of Prematurity Animal Model

Posted on July 18, 2024July 18, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jul 18, 2024

PDF Version

Publication showed that IC 100 suppressed retinal microglia activation by interfering with ASC speck formation, attenuating retinal inflammation, abnormal retinal vascularization, and retinal thinning, and it led to restored retinal function.
Retinopathy of Prematurity (ROP), affecting very low birth weight premature infants is a leading cause of childhood blindness worldwide.
ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation and its perpetuation and spread to surrounding tissues.

WESTON, Fla., July 18, 2024 (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 that acclaimed inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed journal, Angiogenesis. The paper demonstrates the crucial role of inflammasome ASC and ASC specks in the development of oxygen-induced retinopathy and provides data showing that Inflammasome ASC Inhibitor IC 100 attenuates impairment of retinal structure and function.

The paper titled, “IC 100, a humanized therapeutic monoclonal anti-ASC antibody alleviates oxygen-induced retinopathy in mice,” summarizes research evaluating mouse models representative of ROP. Following is a summary of key findings:

ASC specks, which lead to inflammasome activation, were significantly increased in animal model retinas and colocalized with the abnormal vasculature, along with increased microglial activation indicative of retinal inflammation that leads to retinal damage and disease progression.
IC 100 decreased expression of inflammasome-related molecules (ASC, gasdermin D), inflammatory cytokines (IL-1β, IL-6, and TNF), and VEGF in animal model retinas.
Importantly, IC 100 reduced ASC speck formation and microglial activation, attenuating inflammation, abnormal vascularization, retinal thinning, and retinal dysfunction.
The structural and functional improvements demonstrated with IC 100 treatment correlated with corrections of hyperoxia-modulated gene pathways associated with eye development, leukocyte migration, angiogenesis, inflammation, neurogenesis, and VEGF signaling.

“We have demonstrated that IC 100 effectively treated both phases of oxygen-induced retinopathy in a mouse model that resembles ROP in preterm infants, as it decreased retinal vaso-obliteration and intravitreal vascularization,” said Dr. Shu Wu, Professor of Pediatrics at the University of Miami. “Our data suggest that IC 100 may have potential therapeutic use in the treatment of preterm infants with ROP.”

“This research highlighting that Inflammasome ASC Inhibitor IC 100 attenuated retinal inflammation, abnormal retinal vascularization, and retinal thinning leading to restored retinal function in an animal model of ROP supports the broad range of indications that IC 100 has potential to treat. ROP is the sixth indication with preclinical data demonstrating that IC 100 attenuates pathogenic inflammasome signaling pathways resulting in reduced inflammation and improved histopathological and/or functional outcomes,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “The other promising indications are early Alzheimer’s disease, multiple sclerosis, acute respiratory distress syndrome, spinal cord injury, and traumatic brain injury.”

About Inflammasome ASC Inhibitor IC 100

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 inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator™ VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. 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, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Release – Tonix Pharmaceuticals, Set to File an NDA for Tonmya for the Management of Fibromyalgia, is Planning Expected Launch in 2H 2025

Posted on July 17, 2024July 17, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 17, 2024 8:00am EDTDownload as PDF

CHATHAM, NJ / ACCESSWIRE / July 17, 2024 / With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025.

The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now with two drugs making their way through the FDA – Tonix’s Tonmya and one from another U.S. company – there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created $10 billion in peak sales.

Fibromyalgia Landscape

According to an opportunity analysis commissioned by Tonix and carried out by Eversana for Tonix’s drug, Tonmya™, fibromyalgia affects around 2.7 million diagnosed and treated patients in the United States. Despite the high prevalence of this condition, the treatment landscape has remained largely stagnant for over 15 years. The last approved medication was approved in 2009, and two earlier ones were approved in 2008 and 2007.

Despite widely reported side effects and tolerability issues, the two biggest selling fibromyalgia drugs generated combined peak sales of approximately $5 billion each. Both are now generic. A big difference about the fibromyalgia market today is that the condition is widely accepted. Before the heydays of the two blockbusters, many doctors doubted the existence of fibromyalgia due to the lack of visible physical signs and specific diagnostic tests. Many believe that fibromyalgia was overlooked because it affects mostly women.

Tonix will be competing for a slice of a global market that was valued at over $3 billion in 2023 and is expected to grow at a compound annual growth rate of 3.8% from 2024 to 2030.

Tonix Enters the Ring with Tonmya

Tonmya is a new therapeutic class and unlike the three currently approved fibromyalgia drugs, which are involved in the uptake of both serotonin and norepinephrine or are more specific for norepinephrine than serotonin. The other new drug candidate heading for FDA approval is very specific for norepinephrine and does not affect serotonin.

Tonmya (also known as TNX-102 SL) is a non-opioid, non-addictive sublingual tablet designed for bedtime use. Tonmya is a sublingual formulation of cyclobenzaprine hydrochloride, which has improved sleep quality in clinical studies. Sleep quality is different than sleep quantity – or the amount of time spent asleep. By focusing on sleep quality, Tonmya is different from conventional sleep drugs. Traditional sleep aids like Ambien^® fail to manage the type of sleep disturbances that exacerbate fibromyalgia symptoms.

In the latest Phase 3 trial, Tonmya showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that statistically significant results were also seen in improving sleep quality, reducing depression and fatigue and improving overall fibromyalgia symptoms and function. Tonmya was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablets under the tongue.

Tonmya has been conditionally accepted by FDA as a trade name for the management of fibromyalgia. Tonix says it will file a new drug application (NDA) with the FDA in the second half of this year and has completed both manufacturing and multi-disciplinary-focused pre-NDA meetings with FDA.

As the anticipated NDA filing and FDA approval dates for Tonmya and a second new drug draw near, a battle in the fibromyalgia market heats up. Tonix Pharmaceuticals, with its innovative approach and promising clinical trial results, could be well positioned to disrupt a market long dominated by a few large players.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-2407/

*Tonmya is an investigational new drug and is not approved for any indication

Investor Contact

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

Important notice, please read: Certain statements in this document 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; risks related to the failure to successfully market any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

SOURCE: Tonix Pharmaceuticals Holding Corp.

View the original press release on accesswire.com

Released July 17, 2024

GeoVax Labs (GOVX) – Looking Forward To Continued Progress In 2H24

Posted on July 10, 2024July 10, 2024 by slightbourne@noblecapitalmarkets.com

Wednesday, July 10, 2024

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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.

GeoVax Reached Important Milestones For Both Platforms During 1H2024. The first half of 2024 has been a transformational period for GeoVax. A Phase 2 trial testing CM04S1 as a booster vaccine for COVID-19 reported initial data in February, then received a BARDA grant to conduct a large Phase 2b in June. The Gedeptin gene therapy program in head and neck cancer reported interim Phase 1/2 data showing successful proof-of-concept. Both programs are moving forward with additional milestones in 2H24.

BARDA Grant Allocates $367 Million For A Phase 2b Trial. In June, GeoVax announced that it has received a grant from BARDA to conduct a Phase 2b trial testing CM04S1 as a booster vaccine to protect healthy patients from COVID-19. As discussed in our Research Note on June 28, the grant terms include payments to GeoVax for clinical supplies and regulatory costs of $24.3 million (which could be increased to $45 million). The balance will be payable to Allucent, the CRO that will conduct the trial.

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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.

Release – Tonix Pharmaceuticals Announces Pricing of Approximately $4.0 Million Public Offering

Posted on July 9, 2024July 9, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 09, 2024 9:15am EDT

CHATHAM, N.J., July 09, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of 7,096,740 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.57 per share (or $0.569 per pre-funded warrant in lieu thereof). The closing of the public offering is expected to take place on or about July 10, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya¹, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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 including those relating to the completion of the public offering, the satisfaction of customary closing conditions, the intended use of proceeds from the public offering and other statements that are predictive in nature. 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; risks related to the failure to successfully market any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

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

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

Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Source: Tonix Pharmaceuticals Holding Corp.

Released July 9, 2024

Release – Tonix Pharmaceuticals Announces Proposed Public Offering

Posted on July 8, 2024July 9, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 08, 2024 5:00pm EDT

CHATHAM, N.J., July 08, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

Tonix Pharmaceuticals Holding Corp.^*

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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; risks related to the failure to successfully market any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

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

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

Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Source: Tonix Pharmaceuticals Holding Corp.

Released July 8, 2024

Lilly Expands Immunology Footprint with $3.2 Billion Morphic Acquisition

Posted on July 8, 2024July 8, 2024 by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Eli Lilly and Company (NYSE: LLY) announced on July 8, 2024, its plans to acquire Morphic Holding, Inc. (NASDAQ: MORF) for $3.2 billion, marking a significant expansion of its presence in the immunology space. This strategic move aims to enhance Lilly’s pipeline in inflammatory bowel disease (IBD) treatments and broaden its portfolio of oral integrin therapies.

Under the agreement, Lilly will pay $57 per share in cash for all outstanding Morphic shares, representing a substantial 79% premium over Morphic’s closing stock price on July 5, 2024. The transaction, approved by both companies’ boards of directors, is expected to close in the third quarter of 2024, pending customary closing conditions and regulatory approvals.

At the heart of this acquisition is Morphic’s lead program, MORF-057, a selective oral small molecule inhibitor of α4β7 integrin. This promising compound is currently undergoing multiple Phase 2 studies for the treatment of ulcerative colitis and Crohn’s disease, two prevalent forms of IBD. The oral nature of MORF-057 could offer significant advantages over existing injectable therapies, potentially improving patient compliance and quality of life.

Dr. Daniel Skovronsky, Chief Scientific Officer of Lilly and President of Lilly Research Laboratories, highlighted the potential impact of oral therapies in IBD treatment. “Oral therapies could open up new possibilities for earlier intervention in diseases like ulcerative colitis, and also provide the potential for combination therapy to help patients with more severe disease,” he stated. This acquisition underscores Lilly’s commitment to developing first-in-class molecules in gastroenterology, an area where the company has been making substantial investments.

The deal also brings Morphic’s preclinical pipeline into Lilly’s fold, including molecules targeting autoimmune diseases, pulmonary hypertensive diseases, fibrotic diseases, and cancer. This addition further diversifies Lilly’s research and development efforts, potentially opening new avenues for therapeutic breakthroughs.

For Morphic, this deal represents a validation of its Integrin Technology platform and years of research. Dr. Praveen Tipirneni, CEO of Morphic Therapeutic, expressed confidence in Lilly’s ability to maximize MORF-057’s potential. “Lilly brings unparalleled resources and commitment to the inflammation and immunology field,” he noted, adding that the acquisition could “unlock new possibilities in IBD treatment.”

The transaction comes amid rapid growth in the global IBD therapeutics market. With the increasing prevalence of IBD worldwide and the limitations of current treatments, there is a significant unmet need for novel, more effective therapies. Lilly’s acquisition of Morphic positions the company to potentially capture a larger share of this expanding market and address critical patient needs.

From a financial perspective, the $3.2 billion deal represents a significant investment for Lilly. The company will determine the accounting treatment of the transaction as either a business combination or an asset acquisition upon closing, which will impact how it’s reflected in Lilly’s financial results and guidance.

The acquisition has ignited interest across the pharmaceutical industry, with analysts speculating that it could trigger a wave of similar deals in the integrin therapy space. As large pharmaceutical companies seek to bolster their pipelines and secure promising assets in high-growth therapeutic areas, smaller biotechnology firms with innovative platforms may become increasingly attractive targets.

However, Lilly faces the challenge of successfully integrating Morphic’s team and technologies into its existing operations. The company’s ability to manage this integration smoothly will be crucial in realizing the full potential of this deal and translating it into tangible benefits for patients and shareholders alike.

Lilly’s acquisition of Morphic represents a strategic move to strengthen its position in the immunology market, particularly in IBD treatments. With the potential to bring novel oral therapies to patients and expand its research capabilities, this deal could have far-reaching implications for both Lilly and the broader landscape of IBD treatment. As the transaction progresses towards closing, industry observers and patients alike will be watching closely to see how Lilly leverages this significant investment to drive innovation and improve patient outcomes in the years to come.

Ligand Pharmaceuticals Expands Oncology Portfolio with $100 Million APEIRON Biologics Acquisition

Posted on July 8, 2024July 8, 2024 by slightbourne@noblecapitalmarkets.com

In a strategic move to bolster its commercial-stage portfolio, Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced on July 8, 2024, its agreement to acquire APEIRON Biologics AG for $100 million in cash. This acquisition marks a significant expansion of Ligand’s oncology footprint, particularly in the realm of rare pediatric cancers.

The crown jewel of this acquisition is QARZIBA® (dinutuximab beta), a highly differentiated oncology drug used in the treatment of high-risk neuroblastoma in patients aged 12 months and above. QARZIBA, which received European Medicines Agency approval in 2017, is currently marketed in over 35 countries by global pharmaceutical company Recordati S.p.A.

Todd Davis, CEO of Ligand, emphasized the strategic importance of this acquisition, stating, “The addition of QARZIBA to our commercial royalty portfolio further supports our growth strategy to invest in high-value medicines that deliver significant clinical value and generate predictable and long-term revenue streams for our investors.”

The deal structure includes the initial $100 million cash payment, with the potential for up to an additional $28 million based on future commercial and regulatory milestones. Specifically, these additional payments are tied to QARZIBA royalties exceeding certain predetermined thresholds by either 2030 or 2034.

From a financial perspective, this acquisition is expected to make an immediate positive impact on Ligand’s bottom line. The company projects that the deal will be accretive to its earnings per share (EPS) by approximately $1.00 on an annualized basis, with a $0.50 impact expected for 2024 alone. In light of this, Ligand has increased its 2024 adjusted EPS guidance by 17% to a range of $5.00-$5.50.

The acquisition of APEIRON represents the sixth key asset added to Ligand’s commercial stage portfolio since the beginning of 2023, underscoring the company’s aggressive growth strategy. This diversification is expected to provide Ligand with a more stable and predictable revenue stream, a key consideration for investors in the volatile biotech sector.

QARZIBA’s unique position as the only immunotherapy for high-risk neuroblastoma marketed across Europe and other parts of the world makes it a particularly valuable addition to Ligand’s portfolio. Neuroblastoma, a rare cancer that primarily affects children, has limited treatment options, highlighting the potential impact of QARZIBA on patient outcomes.

In a parallel move, Ligand has also committed to investing up to $4 million in invIOs Holding AG, a privately held spin-off of APEIRON. This investment is aimed at financing the research and development of three innovative early-stage immuno-oncology assets, further expanding Ligand’s development stage portfolio.

Peter Llewellyn-Davies, CEO of APEIRON, expressed satisfaction with the deal, noting, “This transaction is an important milestone for our company and shareholders. We have spent more than 20 years translating academic research into therapeutic products for diseases with high unmet needs.”

The acquisition is expected to close in July 2024, subject to a 30-day shareholder objection period and other customary closing conditions. Upon completion, it will significantly reshape Ligand’s commercial portfolio and financial outlook.

As the biopharmaceutical industry continues to consolidate and seek ways to mitigate risk while maximizing potential returns, Ligand’s acquisition of APEIRON represents a strategic move to strengthen its position in the oncology market. By focusing on high-value, commercially available assets like QARZIBA, Ligand is positioning itself for sustained growth in the competitive and rapidly evolving pharmaceutical landscape.

Take a moment to take a look at emerging biotech companies by taking a look at Noble Capital Markets Research Analyst Robert LeBoyer’s coverage list.

Release – LakeShore Biopharma to Hold an Extraordinary General Meeting on July 25, 2024, Pursuant to Shareholders’ Requisition

Posted on July 5, 2024July 5, 2024 by aweinsoff@channelchek.com

Research News and Market Data on LSB

Download this Press Release

GAITHERSBURG, Md., July 5, 2024 /PRNewswire/ — LakeShore Biopharma Co., Ltd (Nasdaq: LSB) (“LakeShore Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that the Company received a shareholders’ requisition dated June 14, 2024, issued by certain shareholders of the Company holding shares which carry in aggregate not less than 10% of all votes attaching to all issued and outstanding shares of the Company, including Yi Zhang, All Brilliance Investments Limited, Apex Pride Global Limited, Hopeful World Company Limited, and Acton Town International Limited (together, the “Requisitioning Shareholders”), requesting the directors of the Company to convene an extraordinary general meeting (the “EGM”) of the Company (the “Requisition”) to provide explanations to the shareholders of the Company on matters as described below:

The circumstances leading to the filing of the United States Securities and Exchange Commission Form 6-K Report, filed on June 10, 2024 (the “SEC Report”), including the reasons for the resignation of each of the former directors specified in the SEC Report.
The justification for establishing new subsidiaries of the Company, including Lakeshore Tech Hong Kong Limited and Huan Yuanhang Technology (Beijing) Co., Ltd. The purpose of establishing these new subsidiaries, the related costs, the intended operations of each entity, and if any assets or personnel are intended to be transferred from the Company to any of the subsidiaries.
The reasons leading to the conclusion that “[t]aking into account the financial resources available to the Company and Liaoning Yisheng, the Company does not expect the arbitration proceedings and related asset preservation order to have a material adverse impact on its business, financial condition and results of operations. The Company is in the course of evaluating its options to protect the legitimate interests of the Company and its shareholders through legal means” in the SEC Report.

The Board has reviewed the Requisition and decided to convene an EGM (the “Proposed EGM”) at 10:00 a.m. Hong Kong Time on July 25, 2024, virtually via a Zoom video conference call. The Proposed EGM will be held for the sole purpose of providing information as requested by the Requisitioning Shareholders. A copy of the notice of the Proposed EGM posted to the Company’s website will be attached as an exhibit to the Current Report on Form 6-K to be furnished by the Company with the United States Securities and Exchange Commission today.

The close of business on July 15, 2024 (Eastern Time) has been fixed as the record date of ordinary shares of the Company, par value $0.00002 per share for the EGM. Holders of record of the Company’s ordinary shares as of the record date shall be entitled to vote and have their votes counted at the EGM and any adjourned meeting thereof.

Instructions for accessing the video conference call are as follows:

Zoom dial-in details:

Meeting URL: https://us06web.zoom.us/j/6195900008?pwd=OTEvOGtnNFVpaUdBUkdRRlp4Y0txUT09

Meeting ID: 619 590 0008

Passcode: 666666

About LakeShore Biopharma (formerly known as YS Biopharma)

LakeShore Biopharma, previously known as YS Biopharma, is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. The Company operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit https://investor.lakeshorebio.com/.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “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. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of LakeShore Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, LakeShore Biopharma’s ability to source and retain talent, and the cash position of LakeShore Biopharma. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of LakeShore Biopharma’s management and are not predictions of actual performance.

LakeShore Biopharma cannot assure you the forward-looking statements in this press release will be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading “Risk Factors” in the Post-effective Amendment No. 2 to the Company’s Registration Statement on Form F-1 filed with the SEC on January 23, 2024, and other filings with the SEC. There may be additional risks that LakeShore Biopharma does not presently know or that LakeShore Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of LakeShore Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while LakeShore Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of LakeShore Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, LakeShore Biopharma does not undertake any duty to update these forward-looking statements.

Investor Relations Contact

Alyssa Li
Director of Investor Relations
Email: ir@lakeshorebio.com

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: LakeShoreBiopharma.IR@icrinc.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/lakeshore-biopharma-to-hold-an-extraordinary-general-meeting-on-july-25-2024-pursuant-to-shareholders-requisition-302189967.html

SOURCE LakeShore Biopharma Co., Ltd

Release – Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering

Posted on June 28, 2024July 1, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 28, 2024 4:05pm EDTDownload as PDF

CHATHAM, N.J., June 28, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 2,833,900 shares of its common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569 per pre-funded warrant. The warrants have an exercise price of $0.001 per share and became exercisable upon issuance.

The gross proceeds of the offering are $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. acted as the sole placement agent for the offering.

Lowenstein Sandler, New York, NY, represented the Company in connection with the offering, and ArentFox Schiff LLP, Washington, DC, represented the placement agent.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering was made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering were filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com.

Tonix Pharmaceuticals Holding Corp.^*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya¹, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

¹Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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 including those relating to the intended use of proceeds from the public offering and other statements that are predictive in nature. 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; risks related to the failure to successfully market any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

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

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

Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Source: Tonix Pharmaceuticals Holding Corp.

Released June 28, 2024