Author: aweinsoff@channelchek.com

Release – SKYX Reports Record Second Quarter Sales of $21.4 Million Compared to $15.0 Million for Second Quarter 2023 as it Continues to Grow its Market Penetration in the U.S and Canada of its Advanced and Smart Platform Products

Posted on by aweinsoff@channelchek.com

News Research and Market Data on SKYX

August 12, 2024

MIAMI, Aug. 12, 2024 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive platform technology company with over 97 pending and issued patents globally and over 60 lighting and home décor websites, with a mission to make homes and buildings become safe and smart as the new standard, today reported its financial and operational results for the second quarter ended June 30, 2024.

Second Quarter 2024 and Recent Achievements

  • Generated record second quarter revenues of $21.4 million compared to $15.0 million for the second quarter of 2023, including sales of its advanced and smart platform plug and play products.
  • Reported $15.6 million in cash, cash equivalents, and restricted cash, as of June 30, 2024, as compared to $19.8 million as of March 31, 2024. As common with companies such as ours when sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, the Company leverages its trades payable to finance its operations, to enhance its cash position and to lower its cost of capital.
  • SKYX’s collaboration with Home Depot, a world leading home improvement retailer, was announced for its advanced and smart plug & play products. SKYX will offer a variety of its Advanced and Smart Plug & Play Products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, and Recessed Lights among others. A large assortment of these advanced and smart products is expected to be offered on Home Depot’s website in the next coming months, while some advanced and smart plug & play retrofit products are expected to arrive in a variety of stores and online to be offered as a fixture upgrade. Management believes that the collaboration with Home Depot can be significant for SKYX’s growth to both retail and professional markets.
  • The Company continues to grow its market penetration of its advanced and smart plug & play products as its products are in nearly 10,000 U.S. and Canadian homes and are expected to be in tens of thousands of homes in 2025.
  • SKYX continues to utilize its e-commerce platform of over 60 websites for lighting and home décor to educate and enhance its market penetration to both retail and professional segments.
  • SKYX and General Electric / GE Licensing are making progress with initiatives related to the recently signed 5-year licensing partnership agreement for the U.S. and global markets. SKYX and GE’s goal is to make SKYX’s game-changing ceiling outlet/receptacle the standard for homes and buildings by licensing it and its related products including SKYX’s advanced and smart home platform technologies to various industries including tech, smart home, AI, lighting, ceiling fans and electrical.
  • Company started production of its new global patented advanced, smart, plug & play recessed light. The global recessed light market is a multi-billion-unit market. SKYX’s new Plug & Play recessed light global patents include the U.S., China, Canada, Hong-Kong and Mexico. As billions of recessed lights are installed globally with hazardous electrical wires, SKYX’s recessed light solution enables an advanced, simple Plug & Play installation that saves time, cost and lives. SKYX’s Plug & Play recessed lights can be controlled through SKYX’s App, Voice Control and Phone and works with Apple’s Siri, Amazon Alexa, Google Home and Samsung.
  • Collaboration with a world-leading Chinese Lighting supplier and manufacturer Ruee Appliances. The collaboration with Ruee includes SKYX’s advanced and smart products to both professional and retail markets and provides SKYX substantial backing in several areas including financial, mass production manufacturing capabilities, and distribution to global markets, including China and Europe. The collaboration is expected to substantially enhance gross margins on SKYX’s product sales and favorably impact its cash conversion cycle.
  • New Global Smart Home and AI Related Patents. SKYX’s new and existing patents, including the new global patented advanced, smart, plug & play recessed light, enable and enhance performance of smart home and AI sensors in addition to home safety sensors bringing the Company’s intellectual property portfolio to a total of over 97 issued and pending patents, 36 of which are issued patents covering SKYX’s advanced plug and play and smart home platform technologies for the smart home, AI, electrical, and lighting industries in the U.S. and internationally including China, Europe, Mexico and 2 patents in India. This also includes the recent issuance of 6 additional patents in the U.S. and internationally, in China, India, Europe, Canada, and Mexico for its advanced smart Plug & Play Ceiling Fan & Heater. The 6 additional patent issuances cover SKYX’s advanced plug-and-play smart ceiling fan and heater, enabling an all-in-one all-season product providing cool air for summertime and hot air for wintertime.
  • Announced a collaboration with world-leading lighting company Kichler, to include SKYX’s advanced smart and standard products online, for retail, and professional channels.
  • Announced a collaboration with Quoizel, a premier U.S. lighting manufacturer for nearly 100 years, to integrate SKYX’s advanced smart and standard products for online, retail, and professional channels.
  • The Company entered into an agreement to supply approximately 1,000 homes with its advanced smart home platform technologies and is expected to deliver approximately 30,000 units representing a variety of its advanced and smart platform technology products to the developer’s upcoming projects.
  • SKYX won 7 CES (Consumer Electronics Show) Awards including most recently two awards for its All-In-One Smart Home Platform.
  • Announced a collaboration with Golden Lighting, a leading provider of elegant lighting solutions in the U.S., which will feature SKYX advanced smart and standard products for online, retail, and professional channels.

Safety Standardization Highlights

The Company filed for a mandatory safety standardization with the National Electrical Code (NEC) for its ceiling outlet receptacle for ceilings in homes and buildings in 2023.

Management believes that after over 12 years of its standardization process, including its product specification approval voting for by ANSI / NEMA (American National Standardization Institute / National Electrical Manufacturing Association), it has met the necessary safety conditions for becoming a ceiling safety standardization requirement for homes and buildings. In the past 12 years, the Company’s product was voted into 10 segments in the NEC Code Book. Voting decisions are at the discretion of the NEC voting members.

The Company’s code team is led by Mark Earley – former head of the National Electrical Code (NEC) and former Chief Electrical Engineer of the National Fire Protection Association (NFPA) – as well as Eric Jacobson, former President and CEO of The American Lighting Association (ALA). Mr. Earley and Mr. Jacobson were instrumental in numerous code and safety changes in both the electrical and lighting industries.

Second Quarter 2024 Financial Results

Revenue in the second quarter of 2024 increased to a record $21.4 million, including E-commerce sales as well as smart and standard plug and play products, as compared to $15.0 million in the second quarter of 2023.

Reported $15.6 million in cash, cash equivalents, and restricted cash, as of June 30, 2024, as compared to $19.8 million as of March 31, 2024. As common with companies such as ours when their sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, we leverage our trades payable to finance our operations to enhance our cash position and lower our cost of capital.

We had a $2.5 million reduction in net cash loss before interest, taxes, depreciation, and amortization, as adjusted for share-based payments (“adjusted EBITDA”), a non-GAAP measure, to $2.1 million, in the second quarter of 2024, as compared to $4.6 million, in the first quarter of 2024.

Adjusted EBITDA loss, a non-GAAP measure, amounted to $2.1 million, in addition to a non-cash basis loss of $5.4 million, amounted to a net loss of $7.5 million, or $(0.08) per share, in the second quarter of 2024, as compared to a net cash loss of $2.7 million, in addition to a non-cash basis loss of $9.6 million, amounted to a net loss of $12.3 million, or $(0.14) per share, in the second quarter of 2023.

The Company’s financial statements for the quarter ended June 30, 2024, will be filed with the SEC and are available on the Company’s investor relations website. https://ir.skyplug.com/sec-filings/.

Management Commentary

The second quarter of 2024 was highlighted by our continued market penetration and positioning that includes our announced collaboration with Home Depot which we believe can be significant for our growth to both retail and professional markets. Additionally, the Ruee Appliances collaboration will assist us with product variety, gross margins, future distribution channels, and sales and marketing programs with key stakeholders in such channels. We believe we have accelerated our cadence of sales, notably managing our cash burn, while our e-commerce platform with over 60 websites is providing additional cash flow to the Company, which, when combined with our existing cash, enhances our cash position to continue executing our business plan. We believe we will be cash flow positive during 2025.

We are encouraged by our path to the builder/commercial segments, large online and brick-and-mortar retail partners as well as our future potential to realize incremental licensing, subscription, and AI/data aggregation revenues.

Furthermore, our e-commerce website platform with 60 websites enhances the acceleration of marketing, distribution channels, collaborations, and sales to both professional and retail segments. Our websites include banners, videos, and educational materials regarding the simplicity, cost savings, timesaving, and lifesaving aspects of the Company’s patented technologies. 

About SKYX Platforms Corp.

As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com or follow us on LinkedIn.

Forward-Looking Statements

Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

Non-GAAP Financial Measures

Management considers earnings (loss) before interest, taxes, depreciation and amortization, or EBITDA, as adjusted, an important indicator in evaluating the Company’s business on a consistent basis across various periods. Due to the significance of non-recurring items, EBITDA, as adjusted, enables management to monitor and evaluate the business on a consistent basis. The Company uses EBITDA, as adjusted, as a primary measure, among others, to analyze and evaluate financial and strategic planning decisions regarding future operating investments and potential acquisitions. The Company believes that EBITDA, as adjusted, eliminates items that are not part of the Company’s core operations, such as interest expense and amortization expense associated with intangible assets, or items that do not involve a cash outlay, such as share-based payments and non-recurring items, such as transaction costs. EBITDA, as adjusted, should be considered in addition to, rather than as a substitute for, pre-tax income (loss), net income (loss) and cash flows used in operating activities. This non-GAAP financial measure excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements and is subject to inherent limitations. Investors should review the reconciliation of this non-GAAP financial measure to the comparable GAAP financial measure. Investors should not rely on any single financial measure to evaluate the Company’s business.

Investor Relations Contact:

Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com

Release – Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia, the Prototypic Nociplastic Pain Syndrome, at the IASP 2024 World Congress on Pain

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 12, 2024 8:00am EDT

Bedtime TNX-102 SL (sublingual cyclobenzaprine HCl) treatment in the Phase 3 RESILIENT study resulted in statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality

Post hoc analyses highlight the strong correlations between improvements in nociplastic pain and sleep quality

Nociplastic pain originates from altered pain perception in the brain and is the type of pain that manifests in fibromyalgia and other chronic overlapping pain conditions (COPCs)

FDA granted TNX-102 SL Fast Track designation for the management of fibromyalgia; NDA submission on track for second half 2024

CHATHAM, N.J., Aug. 12, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data in a poster presentation at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain, held August 5-9, 2024 in Amsterdam, the Netherlands. A copy of the Company’s poster presentation titled, “Targeting Fibromyalgia Non-Restorative Sleep with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl): Results of the Positive Phase 3 RESILIENT Trial Consistent with Syndromal Improvement”, is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

TNX-102 SL met the pre-specified primary endpoint in the Phase 3 RESILIENT study, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. TNX-102 SL also demonstrated broad syndromal benefits with statistically significant improvement in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. A new post hoc analysis showed correlations between improvements in pain and sleep quality at Week 14, supporting the concept that targeting sleep quality has the potential to achieve syndromal improvement in fibromyalgia. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed.

“Approximately 50 years ago, the central role of nonrestorative sleep in the pathogenesis and persistence of fibromyalgia was recognized by Dr. Harvey Moldofsky1,2”, said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-102 SL was designed as a bedtime treatment to target non-restorative sleep and improve sleep quality. The statistically significant results of TNX-102 SL in two positive Phase 3 studies provide evidence of the activity and tolerability of TNX-102 SL in fibromyalgia and also support the critical role of sleep quality in the pathogenesis, persistence and exacerbations of fibromyalgia originally proposed by Dr. Moldofsky.”

Greg Sullivan, M.D., Chief Medical Officer, added, “Today, fibromyalgia is recognized as the prototypic ‘nociplastic syndrome’. Understanding nociplastic syndromes is crucial for developing effective treatment strategies for chronic overlapping pain conditions (COPCs)3,4,5. Traditional analgesics like NSAIDs or opioids often prove ineffective if not deleterious in these conditions. In contrast, TNX-102 SL provided broad-spectrum symptom relief in the RESILIENT study. We believe TNX-102 SL has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”

TNX-102 SL was recently granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Tonix remains on track to submit an NDA to the FDA in the second half of 2024 for TNX-102 SL for the management of fibromyalgia.

1Moldofsky H, et al. Psychosom Med. 1975;37:341-51

2Moldofsky H, Scarisbrick P. Psychosom Med. 1976;38:35-44

3Fitzcharles MA, et al. Lancet. 2021;397:2098-110

4Clauw DJ. Ann Rheum Dis. Published Online First: 2024

5Kaplan CM, et al. Nat Rev Neurol. 2024;20, 347–363

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. According to the recent report from the U.S. National Academies of Sciences, fibromyalgia is a diagnosable condition that may also occur in the context of Long COVID

About TNX-102 SL

TNX-102 SL is a centrally acting, non-opioid, non-addictive, bedtime investigational drug. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of TNX-102 SL for the management of fibromyalgia. In the study, TNX-102 SL met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first statistically significant Phase 3 trial of TNX-102 SL in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). TNX-102 SL was recently granted Fast Track Designation by the FDA for the management of fibromyalgia and remains on track to submit an NDA to the U.S. Food and Drug Administration in the second half of 2024.

About Nociplastic Pain

Nociplastic pain is the third category of pain distinct from nociceptive pain and neuropathic pain. Nociplastic pain is characterized by pain arising from altered nociception despite no evidence of actual or threatened tissue damage causing activation of peripheral nociceptors or somatosensory system disease or lesion. Its underlying pathophysiology involves altered pain processing by the central nervous system (CNS). Nociplastic syndromes, officially recognized by the International Association for the Study of Pain (IASP) in 2017, also include several other chronic overlapping pain conditions: myalgic encephalomyelitis/chronic fatigue syndrome, irritable bowel syndrome, temporomandibular disorders, forms of chronic back pain and chronic headache. The pathophysiology of nociplastic pain involves central sensitization (CS), where neurons of the CNS become hyperexcitable, amplifying pain signals. CS can be triggered by peripheral pain stimuli, emotional stress, or other factors, leading to persistent pain despite no peripheral nociceptive input.

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 TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. 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. 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

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released August 12, 2024

Release – ZyVersa Therapeutics Reports Second Quarter, 2024 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Aug 9, 2024

PDF Version

KEY HIGHLIGHTS

  • Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease on track to begin H2-2024.
  • Obesity with related metabolic complications selected as lead indication for Inflammasome ASC Inhibitor IC 100.
    • Supportive data from preclinical study in atherosclerosis, a common obesity-related metabolic complication, is expected to be available H2-2024.
  • IC 100 Investigational New Drug (IND) submission planned for Q4-2024, to be followed by initiation of a Phase 1 clinical trial in obesity with metabolic complications expected to begin Q1-2025.
  • Raised approximately $0.8 million from exercise of investor warrants.

WESTON, Fla., Aug. 09, 2024 (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, reports financial results for the quarter ended June 30, 2024, and provides business update.

“We are pleased to announce that ZyVersa remains on track to achieve key development milestones over the next 3 quarters,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Our Phase 2a clinical trial with Cholesterol Efflux Mediator™ VAR 200 in diabetic kidney disease is expected to enroll the first patient(s) within the next few months, with an initial data read-out around the end of the year. In preparation for the planned Q4-2024 IND submission and subsequent phase 1 trial for Inflammasome ASC Inhibitor, a lead indication has been selected, obesity with related metabolic complications. This selection was based on unmet needs and IC 100’s mechanism of action substantiated in its robust preclinical program. By inhibiting ASC, IC 100 targets all four inflammasome pathways associated with obesity and related metabolic complications. Importantly, IC 100 disrupts the structure and function of extracellular ASC specks which perpetuate and spread damaging inflammation leading to obesity-related metabolic complications. We believe our milestone achievement will be a key inflection point for ZyVersa that will drive shareholder value.” 

BUSINESS UPDATE

CHOLESTEROL EFFLUX MEDIATOR™ VAR 200 FOR RENAL DISEASE

  • Phase 2a clinical trial in diabetic kidney disease is on target to begin H2-2024.
    • Clinical trial agreements have been successfully negotiated with both sites
    • Clinical trial Site IRB submissions have been approved for both sites
    • Clinical product and lab kits are ready to ship
    • Site initiation visits are scheduled
    • Enrollment of first patient(s) is expected in the next few months

INFLAMMASOME ASC INHIBITOR IC 100 FOR INFLAMMATORY DISEASES

  • IND submission planned for Q4-2024, to be followed by initiation of a Phase 1 clinical trial in obese patients with metabolic complications expected to begin Q1-2025.
    • IC 100 preclinical study in obesity with associated metabolic complications planned to conclude by year’s end, with a second study evaluating concomitant treatment of IC 100 and a GLP-1 agonist to begin shortly thereafter
    • Supportive data read-out from preclinical study in atherosclerosis expected H2-2024
    • GLP toxicology studies scheduled to begin H2-2024
  • ZyVersa has recruited six top-tiered experts in obesity and related metabolic complications for a scientific advisory board, which will be announced in the next few weeks, to guide clinical development plans for IC 100.
  • Recently published preclinical study demonstrated that IC 100 attenuates retinal inflammation, abnormal retinal vascularization, and retinal thinning, leading to restored retinal function in an animal model of retinopathy of prematurity (ROP).
    • 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
    • The other indications are early Alzheimer’s disease, multiple sclerosis, acute respiratory distress syndrome, spinal cord injury, and traumatic brain injury
  • Recently published preclinical study supports the potential of plasma ASC levels as a biomarker for early stages of cognitive decline, reinforcing the role of inflammasome-induced inflammation in the development of neurodegenerative conditions such as Alzheimer’s and Parkinson’s diseases, and the potential of inhibiting ASC with IC 100 as a treatment option.

SECOND QUARTER FINANCIAL RESULTS

Net losses were approximately $2.8 million for the three months ended June 30, 2024, with an improvement of $75.7 million or 96.5% compared to a net loss of approximately $78.5 million, for the three months ended June 30, 2023. This large improvement is due primarily to no further impact from our one-time impairment in 2023 of in-process research and development and goodwill.

Based on its current operating plan, ZyVersa expects its cash of $0.1 million as of June 30, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations and to meet its stated milestones. ZyVersa will seek to fund its operations and clinical activity through public or private equity or debt financings or other sources, which may include government grants, collaborations with third parties or outstanding warrant exercises.

Research and development expenses were $0.7 million for the three months ended June 30, 2024, a decrease of $0.5 million or 41.9% from $1.2 million for the three months ended June 30, 2023. The decrease is primarily attributable to a decrease of $0.4 million in the costs of manufacturing of IC 100 and a decrease in payroll expenses due to employee attrition of $0.1 million.

General and administrative expenses were $2.0 million for the three months ended June 30, 2024, a decrease of $1.9 million or 48.0% from the three months ended June 30, 2023. The decrease is primarily attributable to a one-time 2023 charge of $1.2 million for common stock granted to certain members of the SPAC merger sponsor in exchange for certain concessions to extend the duration of their holding period. Other reductions include professional fees, marketing costs, director and officer insurance totaling $0.6 million, and a $0.1 million decrease in stock-based compensation as a result of options becoming fully amortized in February 2024.

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

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, IR Contact

Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641        

View full release HERE.

Release – PDS Biotech Announces Abstract Accepted for Oral Presentation at 2024 ASTRO Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., Aug. 08, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV (formerly PDS0101) with chemoradiation to treat locally advanced cervical cancer will be presented during an oral presentation at the 2024 ASTRO Annual Meeting being held in Washington, DC, and virtually September 29 through October 2, 2024.

Details of the presentation are as follows:

Date: Tuesday, October 1, 2024, 2:50-3:00 p.m. ET
Session title: SS 34 – GYN 2: Strategies and Innovations of Clinical Trials in Gynecologic Cancers
Presentation title: 298 – IMMUNOCERV Phase II Trial Combining the HPV-Specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer
Presenting author: Adam Grippin, M.D., Ph.D., The University of Texas MD Anderson Cancer Center

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

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

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

Release – Ocugen Provides Business Update with Second Quarter 2024 Financial Results

Posted on by aweinsoff@channelchek.com

News Research and Market Data on OCGN

August 8, 2024

PDF Version

Conference Call and Webcast Today at 8:30 a.m. ET

  • Actively dosing patients in OCU400 Phase 3 liMeliGhT clinical trial
  • OCU410 preliminary safety and efficacy data expected later this year
  • Expanded access program approved for OCU400
  • $32.6 million net cash from underwritten public offering of common stock

MALVERN, Pa., Aug. 08, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today reported second quarter 2024 financial results along with a business update.

“The first half of 2024 has been marked with significant accomplishments for our modifier gene therapy platform—including dosing patients in the OCU400 Phase 3 clinical trial for retinitis pigmentosa (RP) and progressing into Phase 2 of the OCU410 ArMaDa clinical trial for the treatment of geographic atrophy (GA),” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “These meaningful milestones bring us closer to providing a potential one-time therapy for life for patients living with RP (300,000 in the U.S. and Europe) and GA (2-3 million in the U.S. and Europe) who desperately need effective treatment options. Thanks to our Ocugen team for their tireless efforts to keep these and all our clinical trials on track.”

The OCU400 Phase 3 trial has a sample size of 150 participants: one arm has 75 participants with RHO gene mutations, and the other arm has 75 participants with mutations in any of several other genes associated with RP. The Luminance Dependent Navigation Assessment (LDNA) is the primary endpoint for the study. In this assessment, a participant navigates an obstacle course that constitutes a more sensitive and specific measurement of visual function than the mobility measurement used in previous Phase 3 clinical trials. The Phase 3 liMeliGhT trial will focus on the proportion of responders, in treated and untreated groups, who achieve an improvement of at least 2 Lux (light) levels from baseline in the study eyes. More than 60% of the intent-to-treat patients from the Phase 1/2 clinical trial, including patients with the RHO mutation, meet the responder criteria established for Phase 3. The Phase 3 mobility test responder rate for the only FDA-approved product to treat one mutation in RP was 52%. The Phase 3 trial is powered greater than 95% assuming a 50% responder rate.  

Recently, the FDA approved the OCU400 expanded access program (EAP) for the treatment of adult patients, aged 18 and older, with RP. This is the first ever gene therapy candidate to treat patients with RP, regardless of mutation, approved for an EAP and the EAP further supports the gene-agnostic mechanism of action for this novel modifier gene therapy.

Novel modifier gene therapy has the potential to address multiple inherited retinal diseases as well as multifactorial causes of blindness that affect millions of patients, like dry age-related macular degeneration (dAMD). OCU410 and OCU410ST aim to treat geographic atrophy secondary to dAMD and Stargardt disease, respectively. These modifier gene therapies leverage a nuclear hormone receptor gene called RORA (RAR-related orphan receptor A) as a potential one-time therapy for life with a single sub-retinal injection.

OCU410 is specifically designed to address multiple pathways implicated in the pathogenesis of dAMD and offers a distinct advantage over current treatment options that target only one pathway—the complement system—and require frequent intravitreal injections (about 6-12 doses per year), accompanied by various safety concerns, such as roughly 12% of patients progressing to wet AMD. OCU410 has the potential to regulate all four pathways related to disease progression—lipid metabolism, inflammation, oxidative stress, and the complement system—with a one-time sub-retinal injection.

OCU410ST has received an Orphan Drug Designation from the FDA for the treatment of Stargardt disease, which has no approved treatment and affects approximately 100,000 people in the U.S. and Europe combined. The third cohort of the clinical trial is currently receiving the high dose. OCU410ST has the potential to be the first one-time gene therapy for Stargardt disease.

Ocugen continues to pursue strategic partnerships that will drive long-term strategy, and most importantly, will help patients access these novel modifier gene therapies globally. During the 2024 BIO International Convention, Ocugen engaged with potential partners and pharmaceutical executives to explore opportunities for the Company’s dynamic pipeline.

“Ocugen’s inclusion in the Russell Index in June further bolsters the value of our pipeline and recognizes the Company’s robust growth strategy,” said Dr. Musunuri. “This ranking supports our efforts to enable long-term shareholder value, garner significant visibility for Ocugen within the investment community, and broaden our shareholder base. I look forward to the second half of 2024 as we continue to solidify Ocugen’s position as a biotechnology leader.”

Subsequent to June 30, 2024, the Company closed a public offering of common stock with net proceeds of $32.6 million—extending its expected cash runway into the third quarter of 2025. The offering was led by a large premier mutual fund, along with participation from leading life sciences investors.

Ophthalmic Gene Therapies—First-in-Class

OCU400 – Ocugen is actively dosing subjects in the OCU400 Phase 3 liMeliGhT trial for the treatment of RP. With dosing of the Phase 3 trial underway, OCU400 remains on track for the 2026 BLA and MAA approval targets.

OCU410 – In July 2024, Ocugen announced the completion of dosing in the third cohort of the OCU410 Phase 1/2 ArMaDa clinical trial for the treatment of GA. To date, nine patients with GA have been dosed in the Phase 1/2 clinical trial (with low, medium, and high doses). Phase 2 of the clinical trial has been initiated and will assess the safety and efficacy of OCU410 in a larger group of patients who will be randomized into either of two treatment groups (medium or high dose) or a control group.

OCU410ST – Currently dosing the high dose of OCU410ST in the dose-escalation phase of the study.

Regenerative Cell Therapies—First-in-class

NeoCart® – Ocugen intends to initiate the Phase 3 trial contingent on the availability of adequate funding.
Vaccines Portfolio—First-in-class

Inhaled Mucosal Vaccine Platform – NIAID plans to submit an IND to initiate the OCU500 (COVID-19) Phase 1 clinical trial this year. Ocugen is continuing discussions with relevant government agencies as well as strategic partners regarding funding for the development of the OCU510 and OCU520 platforms.

Ophthalmic Biologic Product

OCU200 – Ocugen continues to work with the FDA to lift the clinical hold.

Second Quarter 2024 Financial Results

  • Received $32.6 million net cash from underwritten public offering of common stock that closed on August 2, 2024.
  • The Company’s cash, cash equivalents, and restricted cash totaled $16.0 million as of June 30, 2024, compared to $39.5 million as of December 31, 2023. The Company had 257.4 million shares of common stock outstanding as of June 30, 2024.
  • Total operating expenses for the three months ended June 30, 2024 were $16.6 million and included research and development expenses of $8.9 million and general and administrative expenses of $7.7 million. This compares to total operating expenses for the three months ended June 30, 2023 of $24.0 million that included research and development expenses of $14.5 million and general and administrative expenses of $9.5 million.
  • Ocugen reported a $0.04 net loss per common share for the three months ended June 30, 2024 compared to a $0.10 net loss per common share for the three months ended June 30, 2023.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There also will be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 7453742
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; Ocugen’s financial condition and expected cash runway into the third quarter of 2025, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com 

View full release HERE.

Release – GoHealth Reports Second Quarter 2024 Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Aug 08, 2024 at 6:00 AM EDT

CHICAGO, Aug. 08, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (NASDAQ: GOCO) (“GoHealth” or the “Company”), a leading health insurance marketplace and Medicare-focused digital health company, today announced financial results for the three and six months ended June 30, 2024.

Second Quarter Highlights

  • Second quarter 2024 net revenues of $105.9 million, a $36.9 million decrease compared to $142.8 million in the prior year period.
  • Second quarter 2024 Submissions of 152,394, a 6% decrease compared to 162,837 Submissions in the prior year period, driven by an increase in Submissions generated by GoHealth’s internal captive agents offset by a decrease in Submissions generated by our external GoPartner Solutions agents.
  • Second quarter 2024 net loss of $59.3 million, an improvement of $10.9 million compared to a net loss of $70.2 million in the prior year period.
  • Second quarter 2024 Adjusted EBITDA(1) of negative $12.3 million, a decrease of $13.1 million compared to positive $0.8 million in the prior year period.
  • Second quarter 2024 trailing twelve months (“TTM”) positive cash flow from operations was $53.8 million, a decrease of $32.1 million compared to TTM positive cash flow from operations of $85.9 million in the prior year period.

“We experienced a decline in net revenues to $105.9 million due to a 6% decrease in total Submissions. Submissions generated by our internal captive agents increased year-over-year, offset by a decline in Submissions generated by our external GoPartner Solutions, or GPS, agents,” said Vijay Kotte, CEO of GoHealth. “We are particularly pleased with the performance of our internal captive agents despite unchanged shopping and switching dynamics since last year’s annual enrollment period (“AEP”). We anticipated year-over-year declines from Q1 through Q3, but our team has managed these expected dynamics by driving efficiencies. These results highlight the benefits of our proprietary Encompass workflow and PlanFit CheckUp process. GoHealth plays a critical role in helping Medicare eligible consumers navigate plan options every year. As we gear up for AEP in just 67 days, GoHealth is intensifying targeted marketing efforts to better identify and reach consumers in need of PlanFit CheckUp’s.”

“We also remain committed to leveraging our strengths and strategic initiatives to drive future growth,” continued Kotte. “GoHealth continues to advance our technology to ensure a seamless experience for agents and consumers. We believe that our advancements in artificial intelligence (“AI”) and automation are setting a new industry standard. Our proprietary technology leverages machine and deep learning models atop our sophisticated data platforms, enabling us to deliver more precise, data-driven insights and significantly enhance agent efficiency. We expect these innovations to streamline processes, provide dynamic personalization in our workflows, and improve our overall operational efficiency. By integrating AI and automation into our operations, we intend to not only enhance the consumer experience but also solidify our position as an industry leader in customer acquisition costs, represented by our Direct Cost of Submission.(2) With our consumer orientation and technology enablement, we are looking forward to continuing to support consumers during what we currently believe will be a dynamic AEP,” continued Kotte.

“We expect various factors to influence the second half of the year and we remain confident in our performance expectations for 2024. We anticipate growth in Submission volume, revenue, and Adjusted EBITDA,” said Katie O’Halloran, Interim CFO of GoHealth. “We believe our mix of agency versus non-agency agreements will be a key driver of our cash flow from operations performance. With our continued strategic focus and disciplined execution, we are committed to achieving our goals and delivering long-term value.”

(1)   Adjusted EBITDA is a non-GAAP measure. For a definition of Adjusted EBITDA and a reconciliation to the most comparable GAAP measure, please see below.

(2)   Direct Cost of Submission is a key operating metric. For a definition of Direct Cost of Submission and a description of how it is calculated, please see below.

Conference Call Details

The Company will host a conference call today, Thursday, August 8, 2024 at 8:00 a.m. (ET) to discuss its financial results. A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.

Investor Relations:
John Shave
JShave@gohealth.com
 
Media Relations:
Pressinquiries@gohealth.com
 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements are made in reliance upon the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, future capital expenditures, debt service obligations and adoption and use of artificial intelligence technologies are forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “aims,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “likely,” “future” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions, projections and other statements about future events that are based on current expectations and assumptions. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.

These forward-looking statements speak only as of the date of this press release and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described in the sections titled “Summary Risk Factors,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Annual Report on Form 10-K”) and in our other filings with the Securities and Exchange Commission. The factors described in our 2023 Annual Report on Form 10-K should not be construed as exhaustive and should be read together with the other cautionary statements included in this press release, as well as the cautionary statements and other risk factors set forth in the Quarterly Report on Form 10-Q for the first fiscal quarter ended March 31, 2024, the forthcoming Quarterly Report on Form 10-Q for the second quarter ended June 30, 2024 and in our other filings with the Securities and Exchange Commission.

You should read this press release and the documents that we reference in this press release completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

View fill release HERE.

Release – Cadrenal Therapeutics Provides Second Quarter 2024 Corporate Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Aug. 7, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, next-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions, today provided a corporate update coinciding with the filing of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation. (PRNewsfoto/Cadrenal Therapeutics, Inc.)


Recent Highlights

  • Cadrenal and Abbott initiated a collaborative effort to advance tecarfarin for patients with left ventricular assist devices (LVADs). The only LVAD available in the U.S. is the HeartMate 3™, manufactured by Abbott, which has been shown to be superior to all prior LVADs.
  • In April 2024, tecarfarin received FDA Orphan Drug Designation (ODD) to prevent blood clots and strokes in patients with LVADs and other implanted mechanical circulatory support devices.
  • At the International Society for Heart & Lung Transplantation 44th Annual Meeting & Scientific Sessions in April 2024, Dr. Mandeep Mehra made a groundbreaking presentation of a secondary data analysis from the ARIES-HM3 study sponsored by Abbott that underscored the deficiencies of warfarin and the need for a new VKA therapy for patients with rare cardiovascular conditions. Dr. Mehra commented, “Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anticoagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves further study.”
  • Engaged pharmaceutical contract development and manufacturing organizations to supply active pharmaceutical ingredients and clinical trial materials.
  • Q2 2024 operating expenses (excluding non-cash items) totaled $2.3 million.
  • Cash used in operating activities totaled $1.5 million during Q2 2024.
  • As of June 30, 2024, cash balances were $5.0 million.

“We have made significant progress with advancing our planned pivotal trial to evaluate tecarfarin’s effectiveness for LVAD patients, including collaborative efforts with Abbott,” commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Following the receipt of tecarfarin’s orphan drug designation to prevent blood clots and strokes in patients with LVADs and other implanted mechanical circulatory support devices in April 2024, we expanded conversations with Abbott, the leading global manufacturer of LVADs, to determine the next steps in accelerating tecarfarin development. Our team is developing an LVAD study protocol and is eager to move ahead with Phase 3 trials to evaluate tecarfarin’s superiority to warfarin in LVAD patients and potentially bring our better anticoagulation solution to those in need.”

Tecarfarin, the only oral anticoagulant in development worldwide for patients with implanted cardiac devices and other rare cardiovascular conditions, has been uniquely designed to overcome many of the challenges patients experience with warfarin. If approved, tecarfarin has the potential to be the only on-label drug for LVAD patients in the U.S.

In addition, tecarfarin may prove valuable for other patients where warfarin is not providing recommended anticoagulation because of genetic warfarin resistance or renal impairment making warfarin metabolism difficult. These include individuals with end-stage renal disease and atrial fibrillation or those with mechanical heart valves and hard-to-control International Normalized Ratio, which measures how long it takes the blood to clot.

Upcoming Conference Presentations

The Company will be presenting at the following investment conferences:

  • Sidoti Micro Cap Conference – August 14-15, 2024
  • Summer 2024 Investor Summit – August 20, 2024
  • Emerging Growth Conference – August 21, 2024
  • H.C. Wainwright 26th Annual Global Investment Conference – September 9-11, 2024

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions. Tecarfarin has orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding our planned pivotal trial to evaluate tecarfarin’s effectiveness for LVAD patients, including collaborative efforts with Abbott, tecarfarin potentially being an important therapy for patients with LVADs who all require chronic anticoagulation, trials to evaluate tecarfarin’s superiority to warfarin in LVAD patients and potentially bring the Company’s better anticoagulation solution to those in need, tecarfarin proving valuable for other patients where warfarin is not providing recommended anticoagulation because of genetic warfarin resistance or renal impairment making warfarin metabolism difficult and tecarfarin having the potential to be the only on-label drug for LVAD patients in the U.S. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve anticoagulation treatment in patients, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs),the collaborative efforts with Abbott being successful and those with AFib and ESKD, the collaboration with Abbott being successful and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-provides-second-quarter-2024-corporate-update-302217094.html

SOURCE Cadrenal Therapeutics, Inc.

Release – Conduent Reports Second Quarter 2024 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CNDT

August 07, 2024

Key Q2 2024 Highlights

  • Revenue: $828M
  • Adj. Revenue(1): $811M
  • Pre-tax Income: $300M
  • Adj. EBITDA Margin(1): 3.6%
  • New Business Signings ACV(2): $142M
  • Net ARR Activity Metric(2) (TTM): $(49)M

FLORHAM PARK, N.J., Aug. 07, 2024 — Conduent (NASDAQ: CNDT), a global technology-led business process solutions and services company, today announced its second quarter 2024 financial results.

Cliff Skelton, Conduent President and Chief Executive Officer stated, “We are pleased to report that our Adjusted Revenue and Adjusted EBITDA exceeded expectations, with upside from here. Meanwhile, as anticipated, Q2 represented the low point in our previously communicated growth trajectory. Commercial sales were stronger on both a year-over-year and sequential basis and although Government sales is off to a slower than anticipated start to the year, our overall sales pipeline remains strong as does our balance sheet.”

“Our strategy also remains on track. Targeted divestitures and a balanced use of capital have allowed us to reduce debt and share count, and will allow us to reduce capital intensity and improve cash conversion over time. Our streamlined portfolio and the infusion of new and proven leadership position us well for the future as we advance our solution sets and leverage our strong culture.”      

Key Financial Q2 2024 Results

($ in millions, except margin and per share data)Q2 2024Q2 2023Current
Quarter
Y/Y B/(W)
Revenue$828$915(9.5)%
Adjusted Revenue(1)$811$851(4.7)%
GAAP Net Income (Loss)$216$(7)n/m
Adjusted EBITDA(1)$29$64(54.7)%
Adjusted EBITDA Margin (1)3.6%7.5%(390) bps
GAAP Income (Loss) Before Income Tax$300$(7)n/m
GAAP Diluted EPS$1.07$(0.04)n/m
Adjusted Diluted EPS(1)$(0.14)$0.01n/m
Cash Flow from Operating Activities$(41)$(10)(310.0)%
Adjusted Free Cash Flow(1)$(55)$(26)(111.5)%

Performance Commentary
During the second quarter of 2024, the company completed the transfer of the BenefitWallet portfolio, receiving the remaining $261 million of the aggregate purchase price of $425 million.

The divestiture of the Curbside Management and Public Safety businesses was announced on December 28, 2023 and closed on April 30, 2024 with a purchase price of $230 million, $61 million of which is deferred over the next nine months.

The company entered into a definitive agreement to sell its Casualty Claims Solutions business on May 3, 2024 for $240 million in cash, subject to certain purchase price adjustments, which is expected to close during the third quarter of 2024.

Also, during the second quarter of 2024, the company used the proceeds from the completed divestitures to prepay $300 million of principal of the Term Loan B.

On June 8, 2024 Conduent entered into a share purchase agreement to repurchase all of the shares of the company’s common stock beneficially owned by Carl Icahn and affiliates. The aggregate purchase price for the repurchase from Carl Icahn and affiliates was approximately $132 million.

Pre-tax income (loss) for the second quarter of 2024 was $300 million versus $(7) million in the prior year period. This increase is primarily driven by the gain on the transfer of the BenefitWallet portfolio and the sale of the Curbside Management and Public Safety businesses.

Second quarter’s Adjusted EBITDA of $29 million and Adjusted EBITDA Margin of 3.6% exceeded the company’s expectations.

Revenue and Adjusted Revenue for the second quarter of 2024 also exceeded the company’s expectations.

Conduent’s liquidity position remains strong with long-dated debt maturities and a modest net leverage ratio.

In the second quarter of 2024, the company repurchased approximately 43.3 million shares of its common stock in connection with its ongoing share repurchase program, including approximately 38 million shares of its common stock repurchased from Carl Icahn and affiliates, as mentioned above.

Additional Q2 2024 Performance Highlights

Conduent achieved several milestones in technology-led solutions, operational excellence and culture, including:

  • Recognized as a Leader in Multi-Process HR Transformation Services for Large Enterprises by NelsonHall;
  • Named to Newsweek’s Top 100 Global Most Loved Workplaces® for 2024 for second consecutive year;
  • Selected to provide Business Intelligence and Data Management technology services to Colorado Department of Health Care Policy and Financing;
  • Implemented technologies for South Carolina Department of Social Services to combat fraud and enhance security for its EBT program;
  • Significantly expanded relationship with one of the largest health insurance companies in the U.S. including both CXM and multichannel communications solutions; and
  • Implemented Express Lanes tolling system for Virginia Department of Transportation.

FY 2024 Outlook(2,3)

 FY 2023
Actuals		FY 2024
Outlook(2,3)
   
Adj. Revenue(1)$3,466M$3,325M – $3,375M
   
Adj. EBITDA(1) / Adj. EBITDA Margin(1)$264M / 7.6%4% – 5%
   


(1) Refer to Appendix for definition and complete non-GAAP reconciliations of Adjusted Revenue, Adjusted EBITDA, Adjusted EBITDA Margin, Adjusted Diluted EPS and Adjusted Free Cash Flow.

(2) Refer to Appendix for definition.

(3) Refer to Appendix for additional information regarding non-GAAP outlook.


Conference Call
Management will present the results during a conference call and webcast on August 7, 2024 at 9:00 a.m. ET.

The call will be available by live audio webcast along with the news release and online presentation slides at https://investor.conduent.com/.

The conference call will also be available by calling 877-407-4019 toll-free. If requested, the conference ID for this call is 13747159.

The international dial-in is 1-201-689-8337. The international conference ID is also 13747159.
A recording of the conference call will be available by calling 1-877-660-6853 three hours after the conference call concludes. The replay ID is 13747159.

The telephone recording will be available until August 21, 2024.

About Conduent  
Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 55,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.

Non-GAAP Financial Measures
We have reported our financial results in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP). In addition, we have discussed our financial results using non-GAAP measures. We believe these non-GAAP measures allow investors to better understand the trends in our business and to better understand and compare our results. Accordingly, we believe it is necessary to adjust several reported amounts, determined in accordance with U.S. GAAP, to exclude the effects of certain items as well as their related tax effects. Management believes that these non-GAAP financial measures provide an additional means of analyzing the results of the current period against the corresponding prior period. However, these non-GAAP financial measures should be viewed in addition to, and not as a substitute for, our reported results prepared in accordance with U.S. GAAP. Our non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable U.S. GAAP measures and should be read only in conjunction with our Condensed Consolidated Financial Statements prepared in accordance with U.S. GAAP. Our management regularly uses our non-GAAP financial measures internally to understand, manage and evaluate our business and make operating decisions. Providing such non-GAAP financial measures to investors allows for a further level of transparency as to how management reviews and evaluates our business results and trends. These non-GAAP measures are among the primary factors management uses in planning for and forecasting future periods. Compensation of our executives is based in part on the performance of our business based on certain of these non-GAAP measures. Refer to the “Non-GAAP Financial Measures” section attached to this release for a discussion of these non-GAAP measures and their reconciliation to the reported U.S. GAAP measures.

Forward-Looking Statements

This press release, any exhibits or attachments to this release, and other public statements we make may contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “estimate,” “expect,” “expectations,” “in front of us,” “plan,” “intend,” “will,” “aim,” “should,” “could,” “forecast,” “target,” “may,” “continue to,” “looking to continue,” “endeavor,” “if,” “growing,” “projected,” “potential,” “likely,” “see,” “ahead,” “further,” “going forward,” “on the horizon,” “as we progress,” “going to,” “path from here forward,” “think,” “path to deliver,” “from here,” and similar expressions (including the negative and plural forms of such words and phrases), as they relate to us, are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. All statements other than statements of historical fact included in this press release or any attachment to this press release are forward-looking statements, including, but not limited to, statements regarding our financial results, condition and outlook; changes in our operating results; general market and economic conditions; our portfolio rationalization plans; our share repurchases; strength of our sales pipeline and balance sheet; our growth strategy; expectations regarding our trajectory toward top line growth, sequential margin improvement, less capital intensity and improved cash flow conversion; statements regarding portfolio divestitures, such as the sale of our Casualty Claims Solutions business, including all statements regarding anticipated timing of closing of and receipt of proceeds related to such divestitures; Conduent’s liquidity position remaining strong; progress that we’re making towards our billion dollars of deployable capital; and our projected financial performance for the full year 2024 and 2025, including all statements made under the section captioned “FY 2024 Outlook” within this release. These statements reflect our current views with respect to future events and are subject to certain risks, uncertainties and assumptions, many of which are outside of our control, that could cause actual results to differ materially from those expected or implied by such forward-looking statements contained in this press release, any exhibits to this press release and other public statements we make.

Important factors and uncertainties that could cause our actual results to differ materially from those in our forward-looking statements include, but are not limited to: risks related to pending dispositions, including the company’s ability to realize the benefits anticipated from the sale of our Casualty Claims Solutions business to MedRisk, including as a result of a delay or failure to obtain certain required regulatory approvals or the failure of any other condition to the closing of the transaction such that the closing of the transaction is delayed or does not occur; unexpected costs, liabilities or delays in connection with the proposed transaction, the significant transaction costs associated with the proposed transaction, negative effects of the announcement, pendency or consummation of the transaction on the market price of our common stock or operating results, including as a result of changes in key customer, supplier, employee or other business relationships, the risk of litigation or regulatory actions, our inability to retain and hire key personnel, the risk that certain contractual restrictions contained in the definitive transaction agreement during the pendency of the proposed transaction could adversely affect our ability to pursue business opportunities or strategic transactions; risks related to recently completed dispositions including the transfer of our BenefitWallet HSA, MSA and flexible spending account portfolio and the sale of our Curbside Management and Public Safety Solutions businesses, including but not limited to our ability to realize the benefits anticipated from such transactions, unexpected costs, liabilities or delays in connection with such transactions, and the significant transaction costs associated with such transactions; our ability to renew commercial and government contracts, including contracts awarded through competitive bidding processes; our ability to recover capital and other investments in connection with our contracts; our reliance on third-party providers; risk and impact of geopolitical events and increasing geopolitical tensions (such as the wars in the Ukraine and Middle East), macroeconomic conditions, natural disasters and other factors in a particular country or region on our workforce, customers and vendors; our ability to deliver on our contractual obligations properly and on time; changes in interest in outsourced business process services; claims of infringement of third-party intellectual property rights; our ability to estimate the scope of work or the costs of performance in our contracts; the loss of key senior management and our ability to attract and retain necessary technical personnel and qualified subcontractors; our failure to develop new service offerings and protect our intellectual property rights; our ability to modernize our information technology infrastructure and consolidate data centers; expectations relating to environmental, social and governance considerations; utilization of our stock repurchase program; the failure to comply with laws relating to individually identifiable information and personal health information; the failure to comply with laws relating to processing certain financial transactions, including payment card transactions and debit or credit card transactions; breaches of our information systems or security systems or any service interruptions; our ability to comply with data security standards; developments in various contingent liabilities that are not reflected on our balance sheet, including those arising as a result of being involved in a variety of claims, lawsuits, investigations and proceedings; risks related to divestitures and acquisitions; risk and impact of potential goodwill and other asset impairments; our significant indebtedness and the terms of such indebtedness; our failure to obtain or maintain a satisfactory credit rating and financial performance; our ability to obtain adequate pricing for our services and to improve our cost structure; our ability to collect our receivables, including those for unbilled services; a decline in revenues from, or a loss of, or a reduction in business from or failure of significant clients; fluctuations in our non-recurring revenue; increases in the cost of voice and data services or significant interruptions in such services; our ability to receive dividends or other payments from our subsidiaries; and other factors that are set forth in the “Risk Factors” section, the “Legal Proceedings” section, the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section and other sections in our 2023 Annual Report on Form 10-K, as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with or furnished to the Securities and Exchange Commission. Any forward-looking statements made by us in this release speak only as of the date on which they are made. We are under no obligation to, and expressly disclaim any obligation to, update or alter our forward-looking statements, whether because of new information, subsequent events or otherwise, except as required by law.

View full release HERE.

Media Contacts

Sean Collins

Conduent

Sean.Collins2@conduent.com

+1-310-497-9205

Giles Goodburn

Conduent

ir@conduent.com

+1-203-216-3546

Release – SKYX Announces Corporate Update Call

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SKYX

Company to Provide Corporate Updates Including Second Quarter 2024 Financial Results; Conference Call to be Held on Monday, August 12, 2024 at 4:30 PM Eastern Time

August 07, 2024 08:30 ET

MIAMI, Aug. 07, 2024 (GLOBE NEWSWIRE) — SKYX (NASDAQ: SKYX) (d/b/a “SKYX Technologies”), a highly disruptive smart platform technology company with over 97 issued and pending patents in the U.S. and globally, and which owns over 60 lighting and home décor websites with a mission to make homes and buildings become smart, safe, and advanced as the new standard, announced today that it will host a Corporate Update call and present second quarter 2024 financial results. The conference call will be held on Monday, August 12, 2024 at 4:30 p.m. Eastern time.

SKYX Participating Members Will Include:

  • Rani Kohen, Founder and Executive Chairman
  • Steve Schmidt, SKYX President (Former President of Office Depot International and former CEO of Nielsen Data Corporation)
  • Lenny Sokolow, Co-CEO
  • Marc Boisseau, CFO

SKYX Platforms – Q2 2024 Corporate Update Call

Date: Monday, August 12, 2024
Time: 4:30 p.m. Eastern time
U.S./Canada Dial-in: 1-877-269-7751
International Dial-in: 1-201-389-0908
Conference ID: 13748347
Webcast: SKYX Q2 2024 Webcast

Please dial in at least 10 minutes before the start of the call to ensure timely participation.

A playback of the call will be available through Thursday, September 12, 2024. To listen, call 1-844-512-2921 within the United States and Canada or 1-412-317-6671 when calling internationally. Please use the replay pin number 13748347. A webcast is also available at the following link: SKYX Q2 2024 Webcast.

About SKYX Platforms Corp.

As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.

Forward-Looking Statements
Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

Investor Relations Contact:

Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com 

Release – PDS Biotech to Announce Second Quarter Financial Results on August 13, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that the Company will report financial results for the second quarter of 2024 and provide a business update on Tuesday, August 13, 2024, before the market opens. The press release will be available in the Investor Relations section of the Company’s website at www.pdsbiotech.com.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

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

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

Release – ZyVersa Therapeutics Announces Published Data Supporting the Rationale for Inhibiting Inflammasome ASC with IC 100 to Control Chronic Inflammation

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Aug 7, 2024

PDF Version

  • Data demonstrate that extracellular ASC specks, independent of IL-1β, govern the pathogenesis and extent of amyloid A (AA) amyloidosis, which is characterized by deposition of insoluble amyloid fibrils in tissues and organs disrupting their structure and function.
  • Extracellular ASC interacts with serum amyloid A (SAA) released by the liver during inflammation, forming a scaffold that accelerates SAA aggregation into amyloid fibrils, which are deposited in tissues and organs.
  • Amyloid A amyloidosis occurs in a heterogeneous spectrum of chronic inflammatory conditions such as rheumatoid arthritis, Crohn’s disease, and inflammatory bowel disease.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits intra- and extracellular ASC and specks associated with multiple types of inflammasomes to attenuate damaging inflammation and its perpetuation and spread to surrounding tissues.

WESTON, Fla., Aug. 07, 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 data published in the peer-reviewed journal, EMBO Molecular Medicine, demonstrating that extracellular ASC has a crucial role in aggregation and deposition of amyloid A fibrils leading to associated chronic inflammatory conditions.

“This research highlighting the role of extracellular ASC specks, independent of IL-1β, in the pathogenesis of chronic conditions associated with amyloid A amyloidosis reinforces our selection of ASC as a target for our inflammasome inhibitor IC 100,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “This paper provides one more piece of evidence that inhibiting extracellular ASC specks associated with multiple types of inflammasomes has potential to control damaging inflammation associated with a broad range of inflammatory diseases.”

The paper titled, The ASC inflammasome adapter governs SAA-derived protein aggregation in inflammatory amyloidosis, summarizes data from in vitro and in vivo research investigating the role of ASC in inflammation-associated amyloidosis. Following is a summary of key findings:

  • ASC colocalized tightly with SAA in human AA amyloidosis.
  • ASC specks accelerated SAA fibril formation.
  • Splenic amyloid load was decreased in a Pycard knock-out mouse model of AA Amyloidosis which lacks ASC.
  • Treatment with anti-ASCPYD antibodies decreased amyloid loads in wild-type mice suffering from AA amyloidosis.

“Our findings might have therapeutic implications that advance the fields of protein misfolding disorders (PMDs) and chronic inflammatory diseases in general as ASC could be a target of disease-modifying therapies that aim to reduce amyloid deposition and pathology in various proteinopathies,” concluded the authors.

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 MediatorTM 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

Release – Cadrenal Therapeutics and Abbott Initiate Collaborative Effort to Advance Novel Anticoagulant Tecarfarin for Patients with LVADs

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Aug. 6, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, new-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions, announced today that it has been in discussions with Abbott (NYSE: ABT) about Cadrenal’s planned pivotal study of tecarfarin in patients with recently implanted LVADs. All patients with LVADs require lifelong anticoagulation (AC) to protect against thromboembolic events.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation. (PRNewsfoto/Cadrenal Therapeutics, Inc.)


In April 2024, tecarfarin received FDA Orphan Drug Designation (ODD) to prevent blood clots and strokes in patients with implanted mechanical circulatory support devices such as LVADs.

Currently, the only LVAD available in the United States is the HeartMate 3™, manufactured by Abbott, which has been shown to be superior to all prior LVADs.

A recent secondary analysis of the ARIES-HM3 study conducted by Abbott on the necessity of aspirin therapy demonstrated that maintaining high-quality AC can result in further improvement of outcomes with the HeartMate 3 LVAD.

“We are pleased that Abbott has initiated a collaborative effort with us for this trial, which we believe is very important to LVAD patients,” said Quang Pham, Chairman and Chief Executive of Cadrenal Therapeutics. “We believe that tecarfarin has the potential to further improve AC treatment for HeartMate 3 patients.”

Prior clinical studies provide evidence that tecarfarin yields improved AC quality, particularly in patients on multiple medications and those with impaired renal function, both of which are common in LVAD patients.

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a new-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions. Tecarfarin has orphan drug designation from the FDA for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes the left ventricular assist device (LVAD). Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Tecarfarin is specifically designed to use a different metabolism pathway than the oldest and most commonly prescribed VKA warfarin. Tecarfarin has been evaluated in eleven (11) human clinical trials in more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit www.cadrenal.com.

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding Cadrenal’s planned pivotal study of tecarfarin in patients with recently implanted LVADs, maintaining high-quality AC resulting in further improvement of outcomes with the HeartMate 3 LVAD, the collaborative effort with Abbott for the trial being very important to LVAD patients and tecarfarin having the potential to further improve AC treatment for HeartMate 3 patients. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve outcomes in patients with a HeartMate 3, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs), and those with AFib and ESKD, the collaboration with Abbott being successful and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-and-abbott-initiate-collaborative-effort-to-advance-novel-anticoagulant-tecarfarin-for-patients-with-lvads-302214878.html

SOURCE Cadrenal Therapeutics, Inc.

Release – 1-800-FLOWERS.COM, Inc. to Release its Fiscal 2024 Fourth Quarter and Year-End Results on Thursday, August 29, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FLWS

Aug 06, 2024

JERICHO, N.Y.–(BUSINESS WIRE)– 1-800-FLOWERS.COM, Inc. (NASDAQ: FLWS) (the “Company”),a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships, today announced that the Company will release financial results for its fiscal 2024 fourth quarter and year-end on Thursday, August 29, 2024. The press release will be issued prior to market opening and will be followed by a conference call with members of senior management at 8:00 a.m. (ET).

The conference call will be available via live webcast from the Investors section of the Company’s website at www.1800flowersinc.com/investors. A recording of the call will be posted on the website within two hours of the call’s completion. A telephonic replay of the call can be accessed beginning at 2:00 p.m. (ET) on August 29, 2024, through September 5, 2024, at: (US) 1-877-344-7529; (Canada) 855-669-9658; (International) 1-412-317-0088; enter conference ID: #5141252.

Special Note Regarding Forward-Looking Statements:

Some of the statements contained in the Company’s scheduled Thursday, August 29, 2024, press release and conference call regarding its results for its fiscal 2024 fourth quarter and year-end, other than statements of historical fact, may be forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the applicable statements. For a more detailed description of these and other risk factors, please refer to the Company’s SEC filings including its Annual Reports and Forms 10K and 10Q available at the Investor Relations section of the Company’s website at 1800flowersinc.com. The Company expressly disclaims any intent or obligation to update any of the forward-looking statements made in the scheduled conference call and any recordings thereof, or in any of its SEC filings, except as may be otherwise stated by the Company.

About 1-800-FLOWERS.COM, Inc.

1-800-FLOWERS.COM, Inc. is a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships. The Company’s e-commerce business platform features an all-star family of brands, including: 1-800-Flowers.com®, 1-800-Baskets.com®, Cheryl’s Cookies®, Harry & David®, PersonalizationMall.com®, Shari’s Berries®, FruitBouquets.com®, Things Remembered®, Moose Munch®, The Popcorn Factory®, Wolferman’s Bakery®, Vital Choice®, and Simply Chocolate®. Through the Celebrations Passport® loyalty program, which provides members with free standard shipping and no service charge on eligible products across our portfolio of brands, 1-800-FLOWERS.COM, Inc. strives to deepen relationships with customers. The Company also operates BloomNet®, an international floral and gift industry service provider offering a broad-range of products and services designed to help members grow their businesses profitably; Napco℠, a resource for floral gifts and seasonal décor; DesignPac Gifts, LLC, a manufacturer of gift baskets and towers; and Alice’s Table®, a lifestyle business offering fully digital livestreaming and on demand floral, culinary and other experiences to guests across the country. 1-800-FLOWERS.COM, Inc. was recognized among America’s Most Trustworthy Companies by Newsweek. 1-800-FLOWERS.COM, Inc. was also recognized among the top 5 on the National Retail Federation’s 2021 Hot 25 Retailers list, which ranks the nation’s fastest-growing retail companies, and was named to the Fortune 1000 list in 2022. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS. For more information, visit 1800flowersinc.com.

FLWS-COMP
FLWS-FN

Investor Contact:

Andy Milevoj

(516) 237-4617

amilevoj@1800flowers.com

Media Contact:

Cherie Gallarello

cgallarello@1800flowers.com

Source: 1-800-FLOWERS.COM, Inc.