Author: aweinsoff@channelchek.com

Release – Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 16, 2024 8:00am EDTDownload as PDF

NDA based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant results on the primary endpoint of reducing widespread pain; generally well tolerated

TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA

Fibromyalgia affects more than 10 million adults in the U.S. who are mostly women

If approved by FDA, TNX-102 SL would be the first member of a new class of analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years

CHATHAM, N.J., Oct. 16, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, centrally-acting analgesic that showed statistically significant reduction in the chronic, widespread pain associated with fibromyalgia in two Phase 3 studies and was generally well tolerated. TNX-102 SL was granted Fast Track designation for fibromyalgia by the FDA in July of 2024. Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.

“With the submission of this NDA, Tonix has achieved a critical milestone in potentially bringing a new first-line treatment option to the large and dissatisfied fibromyalgia population that has not had a new pharmacotherapy in over 15 years,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-102 SL would be the first member of a new class of medicines for treating fibromyalgia. TNX-102 SL was designed and developed as a bedtime treatment to be taken daily on a chronic basis. Tonix believes bedtime TNX-102 SL relieves fibromyalgia pain by targeting the non-restorative sleep that is characteristic of fibromyalgia.”

The NDA submission is supported by data from two 14-week double-blind, randomized, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of TNX-102 SL 5.6 mg as a bedtime treatment for fibromyalgia. The prior Phase 3 RELIEF trial of TNX-102 SL in fibromyalgia, completed in December 2020, met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p=0.010). In the confirmatory Phase 3 RESILIENT study in fibromyalgia, completed in December 2023, TNX-102 SL met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p =0.00005). In both trials, TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and with no new safety signals observed. 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). Therefore, Tonix believes the submitted dossier contains the requisite safety and efficacy data from two adequate and well-controlled studies to support NDA submission.

“Despite three FDA-approved medications, representing two different classes of medicines, there remains a need for new treatment options for fibromyalgia patients,” commented Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “If approved by FDA, TNX-102 SL would be the first of a new tricyclic class of medicines for treating fibromyalgia. The existing FDA-approved drugs for fibromyalgia include the gabapentinoid class, represented by Pfizer’s Lyrica® (pregabalin) approved in 2008, and the SNRI class, represented by Lilly’s Cymbalta® (duloxetine) and AbbVie’s Savella® (milnacipran) approved in 2007 and 2009, respectively. The TNX-102 SL tablet is based on a proprietary eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and efficiently delivers cyclobenzaprine by the transmucosal route into the bloodstream. I would like to thank all the participants in our clinical trials, as well as the trial investigators and staff, who worked together over many years to help make this important milestone possible.”

The FDA typically has a 60-day filing review period to determine whether the submitted NDA is complete and accepted for review. If FDA accepts the NDA for review, the Company expects a 2025 date for an FDA decision on approval, based on the Prescription Drug User Fee Act (PDUFA).

About Fibromyalgia

Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insular and anterior cingulate cortex. 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 depression, anxiety, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are a spectrum of mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that occurs after recovery from COVID-19 in the context of Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, due to shared symptoms with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), irritable bowel syndrome, endometriosis, low back pain, post-concussive syndrome (also known as mild traumatic brain injury), chronic Lyme Disease, chronic diabetic neuropathy and chronic post-herpetic neuralgia.

About TNX-102 SL

TNX-102 SL is a centrally acting, non-opioid bedtime investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine interacts as an antagonist at four different receptors in the brain: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia that was identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that the addition of a basifying agent was necessary for efficient transmucosal absorption which results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies 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 and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institude of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. 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; their efficacy and safety have not been established 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

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released October 16, 2024

Release – Direct Digital Holdings Reports Filings for Full-Year 2023, Q1 2024 and Q2 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

October 15, 2024 5:03 pm EDT Download as PDF

HOUSTON, Oct. 15, 2024 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Orange142, LLC (“Orange 142”) and Huddled Masses LLC (“Huddled Masses”), today announced the Company has filed its Form 10-K for the full-year ended December 31, 2023 (the “2023 Annual Report”), as well as its Form 10-Q for the first quarter ended March 31, 2024 (the “March 2024 Quarterly Report”) and its Form 10-Q for the second quarter ended June 30, 2024 (the “June 2024 Quarterly Report”).

Upon the filing of the 2023 Annual Report, the March 2024 Quarterly Report and the June 2024 Quarterly Report with the SEC, Direct Digital Holdings believes it has evidenced compliance with Nasdaq Listing Rule 5250(c)(1). However, the Company is awaiting a formal compliance determination from the Nasdaq Stock Market staff. The Company will provide an update upon receipt of such determination.

Mark D. Walker, CEO and Co-Founder of Direct Digital Holdings, commented, “We are pleased to complete these filings, which we believe will allow us to regain compliance with Nasdaq and put us on the path back to our regular reporting cadence. At Direct Digital Holdings, we remain excited to return to the normal execution of our industry-leading business model and company mission.”

Keith Smith, President and Co-Founder of Direct Digital Holdings, commented, “Since we last reported earnings, Direct Digital Holdings has encountered challenges due to two factors: first, the unexpected resignation of our previous auditor; and second, a series of coordinated and malicious misinformation attacks against the company, including the publication of false and defamatory articles and blog posts by a third party, which, we believe, have been comprehensively refuted. The proximity of these two events was then used to create a disparaging narrative which disrupted our business and existing capital-raising efforts, as well as creating additional audit, legal and other expenses. We have been fully engaged in addressing the issues, and I am proud of our team’s resilience during this time.”

The Company has taken several actions to address these challenges including (i) the execution on July 1, 2024 of a plan to reduce expenses through a staff reduction, a pause on hiring and cost savings measures, (ii) working with lenders to provide temporary relief from debt covenants while rebuilding sell-side volumes via debt amendments executed on October 15, 2024, (iii) engaging BDO, USA, P.C. as the Company’s independent registered public accounting firm for the audit of the Company’s consolidated financial statements for the fiscal year ended December 31, 2023 and (iv) filing its 2023 Annual Report, March 2024 Quarterly Report and June 2024 Quarterly Report.

Going forward, Direct Digital Holdings expects to (i) receive notification from Nasdaq that by filing the Annual and Quarterly Reports, the Company has regained compliance with respect to the delinquent SEC filings, which will allow the Company to access the capital markets as well as other financing sources, (ii) raise capital through arrangements with various providers, and (iii) continue to work with the Company’s partners to rebuild sell-side volumes.

Financial Outlook Update

Due to the aforementioned challenges, Direct Digital Holdings is unable to provide guidance for the full-year 2024 at this time.

Diana Diaz, Chief Financial Officer, stated, “As we move forward, we are committed to reestablishing a normal cadence of reporting our financial results which will provide our investors with the timely and accurate information they deserve. We remain dedicated to creating long-term value for our shareholders and will continue to provide best-in-class advertising solutions to our partners.”

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws that are subject to certain risks, trends and uncertainties. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Accordingly, any such statements are qualified in their entirety by reference to the information described under the caption “Risk Factors” and elsewhere in our most recent Annual Report on Form 10 K (the “Form 10-K”) and subsequent periodic and or current reports filed with the Securities and Exchange Commission (the “SEC”).

The forward-looking statements contained in this press release are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this press release, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (many of which are beyond our control) and assumptions.

Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements. We believe these factors include, but are not limited to, the following: the restrictions and covenants imposed upon us by our credit facilities; the substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing; our ability to secure additional financing to meet our capital needs, including the establishment of any equity line of credit facility; our ineligibility to file short-form registration statements on Form S-3, which may impair our ability to raise capital; our failure to satisfy applicable listing standards of the Nasdaq Capital Market resulting in a potential delisting of our common stock; any significant fluctuations caused by our high customer concentration; risks related to non-payment by our clients; reputational and other harms caused by our failure to detect advertising fraud; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; our failure to manage our growth effectively; the difficulty in identifying and integrating any future acquisitions or strategic investments; any changes or developments in legislative, judicial, regulatory or cultural environments related to information collection, use and processing; challenges related to our buy-side clients that are destination marketing organizations and that operate as public/private partnerships; any strain on our resources or diversion of our management’s attention as a result of being a public company; the intense competition of the digital advertising industry and our ability to effectively compete against current and future competitors; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any failure by us to maintain or implement effective internal controls or to detect fraud; and other factors and assumptions discussed in our Form 10-K and subsequent periodic and current reports we may file with the SEC.

Should one or more of these risks or uncertainties materialize, or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. New factors that could cause our business not to develop as we expect emerge from time to time, and it is not possible for us to predict all of them. Further, we cannot assess the impact of each currently known or new factor on our results of operations 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. 

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions generate billions of impressions per month across display, CTV, in-app and other media channels. 

Contacts:
Investors:
Brett Milotte, ICR
Brett.Milotte@icrinc.com

Direct Digital Holdings Logo (PRNewsfoto/Direct Digital Holdings)

View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-reports-filings-for-full-year-2023-q1-2024-and-q2-2024-302277043.html

SOURCE Direct Digital Holdings

Released October 15, 2024

Release – ZyVersa Therapeutics CEO, Stephen C. Glover, Was a Featured Guest on The Big Biz Show to Discuss Current Trends in the Obesity Drug Market and the Potential Role of Inflammasome Inhibitors

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Oct 15, 2024

PDF Version

Lead indication for ZyVersa’s Inflammasome ASC Inhibitor IC 100 is obesity with metabolic complications.

WESTON, Fla., Oct. 15, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, was interviewed on the Big Biz Show to address current trends in the obesity drug market and the potential role of inflammasome inhibitors.

Key Points

  • Obesity is an international health crisis, with over 50% of the world’s population predicted to be overweight or obese within the next ten years.
  • Launch of incretin therapy (GLP-1 agonists) for obesity has resulted in substantial and unsurpassed weight loss, stimulating a drug revolution that has led to a 10-fold increase in venture dollars flowing into the category.
  • High levels of investment in the obesity category are expected to continue due to the trend toward development of add-on therapies to GLP-1 agonists to preserve muscle during weight loss and to attenuate obesity-related inflammation that leads to chronic complications such as cardiovascular disease, type 2 diabetes, and even neurodegenerative diseases like Parkinson’s and Alzheimer’s disease. This is reflected in the billion-dollar acquisitions recently made by Novo and Lilly, and Sanofi’s $27 Million strategic investment in Ventyx’s NLRP3 inhibitor to address the complications of obesity.
  • ZyVersa’s Inflammasome ASC Inhibitor IC 100 is being developed for use in combination with GLP-1 agonists to control obesity-associated inflammation, attenuate the associated complications, and enhance weight loss. The company is working with renowned experts in the field who are providing guidance to the development program.

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 – MAIA Biotechnology Announces Poster Presentation of Novel THIO Prodrugs at ENA 2024 Symposium on Molecular Targets and Cancer Therapeutics

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

October 15, 2024 8:15am EDT

  • MAIA seeks to advance two new THIO-derived telomere-targeting molecules to clinical trials

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that an abstract related to the company’s second generation of proprietary telomere-targeting THIO prodrugs has been accepted for poster presentation during the upcoming 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place October 23-25, 2024, in Barcelona, Spain. The Symposium is hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR).

MAIA will present the results of preclinical studies for its new THIO-based prodrugs, designated as MAIA-2021-20 and MAIA-2022-12, which are lipid-conjugated compounds derived from THIO. These second-generation compounds belong to a new chemical class of molecules called telomere targeting divalent dinucleotides. These preclinical studies were designed to evaluate the efficacy of the new molecules alone and in combination with or without immune checkpoint-blocking antibodies (anti-PD-L1).

MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. commented, “Our presentation will demonstrate that treatment with each of the prodrugs studied was highly efficacious and was shown to overcome immunotherapy resistance. Our results have shown marked activity in advanced tumors and resulted in tumor growth inhibition in preclinical models of lung cancer, colorectal carcinoma, melanoma and hepatocellular carcinoma. We are actively working to advance these candidates toward clinical development.”

Presentation details:

Title:New Dual-Pharmacophore Dinucleotide Prodrugs as Potent Telomere Targeting Anticancer Molecules
Abstract number:ENA24-0044
Session title:New Drugs
Date and time:Wednesday, October 23, 2024, at noon CEST
Presenting author:Ilgen Mender, Ph.D., Director of Biology Research, MAIA Biotechnology
Poster access:MAIA’s poster will be available at maiabiotech.com/publications on October 23, 2024

MAIA has designed and evaluated more than 80 THIO-like compounds to date and has submitted three U.S. patent applications for its second-generation telomere targeting agents.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released October 15, 2024

Release – Unicycive Therapeutics Announces Late-Breaker Poster Presentation on Oxylanthanum Carbonate (OLC) at the American Society of Nephrology (ASN) Kidney Week 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

October 14, 2024 7:03am EDT Download as PDF

LOS ALTOS, Calif., Oct. 14, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that a poster presentation on oxylanthanum carbonate (OLC) was selected for a Late-Breaker session at the American Society of Nephrology (ASN) Kidney Week 2024. Unicycive will also deliver three additional poster presentations on OLC and UNI-494. The conference will take place October 24-27, 2024 in San Diego, CA.

Late Breaking Science Poster:

Title:Effects of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia
Lead Author:Geoffrey A. Block, MD, FASN, Associate Chief Medical Officer & Senior Vice President, Clinical Research & Medical Affairs, U.S. Renal Care
Session Title:Late-Breaking Science Posters [LB-PO]
Poster Board:#TH-PO1188
Date/Time:Thursday, October 24, 2024 from 10:00 a.m. – 12:00 p.m. PT
  

Three additional poster presentations:

Title:Intravenous UNI-494 Slows the Progression or Halts/Reverses Acute Kidney Injury When Administered After Ischemia/Reperfusion in Rats
Lead Author:Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Session Title:AKI: Mechanisms
Poster Board:#FR-PO155
Date/Time:Friday, October 25, 2024 from 10:00 a.m. – 12:00 p.m. PT
Title:Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rat
Lead Author:Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Session Title:CKD-MBD: Basic and Translational
Poster Board:#SA-PO243
Date/Time:Saturday, October 26, 2024 from 10:00 a.m. – 12:00 p.m. PT
Title:UNI-494 Phase I Safety, Tolerability, and Pharmacokinetics
Lead Author:Guru Reddy, PH.D., Vice President of Preclinical R&D, Unicycive
Session Title:AKI: Clinical, Outcomes, and Trials – Management
Poster Board:#SA-PO036
Date/Time:Saturday, October 26, 2024 from 10:00 a.m. – 12:00 p.m. PT
  

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established. A pivotal clinical trial was also conducted in CKD patients on hemodialysis that achieved the study objective and established favorable tolerability of OLC at clinically effective doses.

Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive has completed enrollment in the UNI-494 Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom, and expects to report results in the third quarter of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

About Acute Kidney Injury

Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital, and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Primary Logo

Source: Unicycive Therapeutics, Inc.

Released October 14, 2024

Release – Alliance Resource Partners, L.P. Announces Third Quarter 2024 Earnings Conference Call

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ARLP

October 14, 2024

Download(opens in new window)

TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) will report its third quarter 2024 financial results before the market opens on Monday, October 28, 2024. Alliance management will discuss these results during a conference call beginning at 10:00 a.m. Eastern that same day.

To participate in the conference call, dial U.S. Toll Free (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com.

An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13749425.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.

Investor Relations Contact
Cary P. Marshall
Senior Vice President and Chief Financial Officer
(918) 295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

Release – Brendan Shanahan Appointed Chief Financial Officer of GoHealth, Bringing Decades of Leadership in Healthcare and Financial Strategy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Oct 10, 2024 at 10:45 AM EDT

Brendan Shanahan Appointed Chief Financial Officer of GoHealth, Bringing Decades of Leadership in Healthcare and Financial Strategy

CHICAGO, October 10, 2024 /Globe Newswire/ — GoHealth, Inc. (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, today announced the appointment of Brendan Shanahan as Chief Financial Officer (CFO), effective October 14, following a comprehensive search process. Mr. Shanahan, a seasoned executive with over 30 years of financial leadership experience and over 20 years of expertise in the Medicare Advantage space, will oversee GoHealth’s financial strategy and operations, contributing to the company’s profitable growth and innovation efforts.

“Brendan’s extensive expertise in financial strategy, M&A, operational leadership, and deep knowledge of the Medicare Advantage market makes him the ideal choice to lead GoHealth’s financial organization,” said Vijay Kotte, CEO of GoHealth. “His track record of driving financial performance, operational efficiency, and long-term value aligns perfectly with our mission to deliver outstanding results for shareholders.”

Mr Shanahan, who was also a licensed insurance agent, will manage all financial aspects of GoHealth, including financial planning, analysis, reporting, investor relations, and capital structure optimization. Additionally, he will provide leadership in financial risk management, business analytics, budgeting, audit, and tax compliance, to ensure GoHealth achieves both its short- and long-term financial goals.

Throughout his career, Mr. Shanahan has built high-performing finance teams, implemented systems to streamline financial operations, and played key roles in mergers and acquisitions. His leadership in financial strategy, including P&L oversight, cost containment, and capital management, has consistently delivered tangible results.

Mr. Shanahan holds an MBA in Banking and Finance from Hofstra University and a Bachelor of Science in Business Administration from The Citadel. He is also a Certified Public Accountant (CPA) (inactive) and a Chartered Global Management Accountant.

Mr. Shanahan expressed his excitement to join GoHealth, stating, “I’m thrilled to join GoHealth at such a pivotal time for the Medicare Advantage industry and the brokerage space. Having spent much of my career working to help individuals navigate their healthcare options, I am excited to continue that journey with GoHealth. The combination of GoHealth’s technology, deep expertise in Medicare, and commitment to empowering consumers is unparalleled. I look forward to working with Vijay and the team to capitalize on the significant opportunities ahead as we navigate this dynamic market and drive long-term value for shareholders.”

Katherine O’Halloran will remain as a key leader in the finance organization, continuing to serve as Chief Accounting Officer and reporting to the CFO. “We want to thank Katie for embracing with diligence her interim role as CFO and her commitment to managing GoHealth and the financial team through this transition. Katie is an extraordinary example of living our GoHealth values,” said Kotte.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company. Enrolling in a health insurance plan can be confusing for customers, and the seemingly small differences between plans can lead to significant out-of-pocket costs or lack of access to critical medicines and even providers. GoHealth combines cutting-edge technology, data science and deep industry expertise to build trusted relationships with consumers and match them with the healthcare policy and carrier that is right for them. Since its inception, GoHealth has enrolled millions of people in Medicare plans and individual and family plans. For more information, visit https://www.gohealth.com.

Media Inquiries 
pressinquiries@gohealth.com 
Investor Relations 
jshave@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

Release – Gray Sets Date for Third Quarter Earnings Release and Earnings Conference Call

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GTN

October 09, 2024

ATLANTA, Oct. 09, 2024 (GLOBE NEWSWIRE) —  Gray Media (NYSE: GTN) today announced that it will release its earnings results for the quarter ended September 30, 2024 on Friday, November 8, 2024.

Earnings Conference Call Information

Gray Media will host a conference call to discuss its operating results for the quarter ended September 30, 2024 on Friday, November 8, 2024. The call will begin at 11:00 a.m. Eastern Time. The live dial-in number is 1-800-285-6670. The call will be webcast live and available for replay at www.graymedia.com. The taped replay of the conference call will be available at 1-888-556-3470 Passcode: 898476# until December 8, 2024.

About Gray Media:

Gray Media, or Gray, is a multimedia company headquartered in Atlanta, Georgia, formally known as Gray Television, Inc.  The company is the nation’s largest owner of top-rated local television stations and digital assets serving 113 television markets that collectively reach approximately 36 percent of US television households. The portfolio includes 77 markets with the top-rated television station and 100 markets with the first and/or second highest rated television station, as well as the largest Telemundo Affiliate group with 43 markets totaling nearly 1.5 million Hispanic TV Households.  The company also owns Gray Digital Media, a full-service digital agency offering national and local clients digital marketing strategies with the most advanced digital products and services.  Gray’s additional media properties include video production companies Raycom Sports, Tupelo Media Group, and PowerNation Studios, and studio production facilities Assembly Atlanta and Third Rail Studios. Gray owns a majority interest in Swirl Films. For more information, please visit www.graymedia.com.


Gray Contacts:

Jeff Gignac, Executive Vice President, Chief Financial Officer, 404-504-9828
Kevin P. Latek, Executive Vice President, Chief Legal and Development Officer, 404-266-8333

Release – SKYX Provides Corporate Update, including Significant Insider Buying

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SKYX

MIAMI, Oct. 09, 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, provides today a corporate update including significant insider buying.

  • SKYX Secures $11 million equity preferred stock investment representing $2.00 per share of common stock with NO warrants, led by global Marriott Hotel chain developer/owner of over 60 hotels.
  • Significant insider investing in this equity preferred round at $2.00 includes SKYX’s President Steve Schmidt, who invested $500,000, Co-CEO Lenny Sokolow, who invested $250,000, and Co-CEO John Campi, who also invested $250,000
  • Management emphasizes that it has sufficient cash to achieve its goals including being cash flow positive in 2025
  • 2023 Sales of $58 million / 2024 Q-2 Record Sales of $21.4 million
  • Company’s total addressable market (TAM) in the U.S. of $500 billion with over 4.2 billion ceiling applications in the U.S. alone
  • Expected revenue streams from retail and professional segments include product sales, royalties/licensing/subscription/monitoring/sale of global country rights

Recent Collaborations:

  • Announced a Collaboration with Home Depot for the retail and professional markets. Company started shipping and products are already in 100 stores. Company has also started to sell product on Home Depot website and expects to have hundreds of advanced smart plug & play products on Home Depot’s website.
  • Signed with General Electric / GE Licensing a 5-year global licensing agreement to license its advanced and smart technologies with a goal to create an advanced smart global ceiling standard
  • Collaboration with world leading Chinese lighting distributor and manufacturer Ruee Appliances for the U.S., China and European markets, including financial backing
  • Collaboration with world leading lighting company Kichler for online and builder segments
  • Collaboration with U.S. leading lighting company Quoizel including for online and builder segments
  • Collaboration European leading lighting company EGLO for online and builder segments
  • Future Collaborations: Management is in the process of working on additional collaborations with leading strategic companies
  • Companies collaborating with SKYX are expected to leverage the fast and easy interchangeability capabilities of the technology to enhance sales of smart fixtures and fixture replacements for seasonality, energy savings, holidays, smart capabilities and renovations for both retail and professional segments
  • SKYX smart home technology wins 7 CES Awards (Consumer Electronics Show)
  • Safety Standardization Code: Based on the safety applications of the technology it was voted into 10 segments the National Electrical Code (NEC) Book and has filed for a mandatory safety standardization for its ceiling outlet receptacle for ceilings in homes and buildings
  • Leadership: Management, Board members, and Senior Advisors include former CEO’s and executives from Fortune 100 companies including Nielsen, Microsoft, Disney, GE, Home Depot, Office Depot, Chrysler, among others
  • Link to an updated company summary Click Here
  • Link to an updated video Click Here

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 94 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 – 1-800-FLOWERS.COM, Inc. Reports Fiscal 2024 Fourth Quarter and Year-End Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FLWS

Aug 29, 2024

Reports Fiscal Year 2024 Revenue of $1.83 Billion and a Net Loss of $6.1 Million, which Includes a Non-Cash Impairment Charge of $19.8 million Recorded in the Second Quarter

Fiscal Year 2024 Gross Profit Margin Increased 260 Basis Points to 40.1%

Fiscal Year 2024 Adjusted EBITDA1 Increased to $93.1 million

Issues Fiscal Year 2025 Outlook

(1) Refer to “Definitions of Non-GAAP Financial Measures” and the tables attached at the end of this press release for reconciliation of non-GAAP results to applicable GAAP results.)

JERICHO, N.Y.–(BUSINESS WIRE)– 1-800-FLOWERS.COM, Inc. (NASDAQ: FLWS), a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships, today reported results for its Fiscal 2024 fourth quarter and year ended June 30, 2024.

“In a dynamic consumer environment that impacted discretionary consumer spending, especially amongst lower income households, our organization was able to grow year-over-year adjusted EBITDA, which benefitted from our significant gross margin recovery and our expense optimization efforts that more than offset the top line decline,” said Jim McCann, Chairman and Chief Executive Officer of 1-800-FLOWERS.COM, Inc. “During Fiscal 2024, through our Relationship Innovation initiatives, we significantly enhanced our gifting platform, including category expansion, broadening our price points, increasing our assortment of gifts available for same-day delivery, and enhancing the user experience. We also experienced a significant recovery in our gross profit margin, which benefitted from a reversion to the mean on a number of commodity costs combined with our Work Smarter initiatives to operate more efficiently.”

“As we turn to Fiscal 2025, with our gross margin recovery well underway, our organization continues to be keenly focused on improving our sales trends by leveraging our Relationship Innovation initiatives. Acknowledging the uncertain consumer environment, we anticipate revenue trends improving as the fiscal year progresses as consumers respond to our newer offerings and services. We are confident in our strategic direction to be the gifting destination of choice for thoughtful and expressive gift-giving occasions and remain focused on delivering long-term value to our shareholders,” Mr. McCann continued.

Fiscal 2024 Fourth Quarter Highlights

  • Total consolidated revenues decreased 9.5% to $360.9 million, compared with total consolidated revenues of $398.8 million in the prior year period.
  • Gross profit margin increased 130 basis points to 38.4%, compared with 37.1% in the prior year period. The gross profit margin improved on lower freight costs, a decline in certain commodity costs, and the Company’s logistics optimization efforts.
  • Operating expenses declined $5.8 million to $166.2 million, as compared with the prior year period.
  • Net loss for the quarter was $20.9 million, or ($0.32) per share, as compared to a net loss of $22.5 million, or ($0.35) per share in the prior year period.
  • Adjusted Net Loss1 was $21.8 million, or ($0.34) per share, compared with an Adjusted Net Loss1 of $17.8 million, or ($0.28) per share, in the prior year period.
  • Adjusted EBITDA1 loss for the quarter was $8.8 million, as compared with an Adjusted EBITDA1 loss of $6.6 million in the prior year period.
  • Acquired Scharffen Berger Chocolate Maker, a high-end producer of extraordinary craft chocolates, that enhances and expands the Company’s chocolate offerings within its gourmet food and gift basket business. The acquisition closed after the fourth quarter ended.

Fiscal Year 2024 Highlights

  • Total consolidated revenues decreased 9.2% to $1.83 billion, compared with total consolidated revenues of $2.02 billion in the prior year period.
  • Gross profit margin increased 260 basis points to 40.1%, compared with 37.5% in the prior year period. The gross profit margin improved on lower freight costs, improved commodity costs, and the Company’s logistics optimization efforts.
  • Operating expenses declined $55.7 million to $736.8 million, as compared with the prior year period. Excluding impairment and other non-recurring charges in both periods, as well as the impact of the Company’s non-qualified deferred compensation plan in both periods, operating expenses declined by $22.2 million to $706.1 million, as compared with the prior year.
  • Net loss for the fiscal year was $6.1 million, or ($0.09) per share, compared with $44.7 million, or ($0.69) per share, in the prior year period. Both periods include impairment charges as outlined in the financial tables.
  • Adjusted Net Income1 was $11.6 million, or $0.18 per share, compared with Adjusted Net Income1 of $13.4 million, or $0.21 per share, in the prior year period.
  • Adjusted EBITDA1 for the fiscal year was $93.1 million, as compared with $91.2 million in the prior year period.
  • Net cash provided by operating activities was $95.0 million.
  • Generated Free Cash Flow1 of $56.4 million.

Segment Results

The Company provides Fiscal 2024 fourth quarter and full year selected financial results for its Gourmet Foods and Gift Baskets, Consumer Floral and Gifts, and BloomNet segments in the tables attached to this release and as follows:

  • Gourmet Foods and Gift Baskets: Revenues for the quarter declined 12.8% to $105.2 million, as compared with the prior year period. Gross profit margin increased 190 basis points from the prior year period to 30.0%, benefiting from lower freight costs, the Company’s inventory and labor optimization efforts, as well as a decline in certain commodity costs. Segment contribution margin1 loss was $14.4 million, compared with a loss of $13.4 million in the prior year period.

    For the full fiscal year, revenue decreased 9.4% to $874.3 million. Gross profit margin increased 340 basis points to 38.3%, benefiting from lower freight costs, the Company’s inventory and labor optimization efforts, as well as a decline in certain commodity costs. Excluding the impact of the severance charge in the current year and the impairment charge a year ago, segment contribution margin1 for the year was $85.0 million, compared with $77.5 million in the prior year.
  • Consumer Floral & Gifts: Revenues for the quarter declined 6.7% to $231.6 million, as compared with the prior year period. Gross profit margin increased 20 basis points from the prior year period to 40.8%. Segment contribution margin1 was $25.7 million, compared with $30.7 million in the prior year period.

    For the full fiscal year, revenues decreased 7.7% to $849.8 million, as compared with the prior year period. Gross profit margin increased 130 basis points from the prior year period to 40.8%, improving on lower fulfillment costs and the Company’s logistics optimization efforts. Excluding the impact of the severance and impairment charges in the current year, segment contribution margin1 was $87.7 million, compared with $95.5 million in the prior year.
  • BloomNet: Revenues for the quarter declined 18.7% to $24.4 million, as compared with the prior year period. Revenue and gross margin were impacted by the lower volume of lower margin orders processed by BloomNet. Gross profit margin increased 710 basis points from the prior year period to 49.7%, also benefitting from lower ocean freight costs as well as product mix. Segment contribution margin1 was $7.8 million, compared with $7.4 million in the prior year period.

    For the year, revenues decreased 19.1% to $107.8 million, as compared with the prior year period. Gross profit margin increased 550 basis points from the prior year period to 48.2% due to lower volume of lower margin orders, lower ocean freight costs, as well as product mix. Excluding the impact of the severance charge in the current year, segment contribution margin1 for the year was $33.8 million, compared with $37.2 million in the prior year.

Company Guidance

For Fiscal 2025, with a sustained challenging consumer environment, the Company expects revenue trends to improve as the fiscal year progresses benefitting from the company’s Relationship Innovation initiatives that have expanded the Company’s product offerings, broadened price points, and enhanced the user experience, combined with increased marketing spend. Additionally, the guidance assumes increased incentive compensation expense.

As a result, for Fiscal Year 2025 the Company expects:

  • total revenues on a percentage basis to be in a range of flat to a decrease in the low-single digits, as compared with the prior year;
  • Adjusted EBITDA1 to be in a range of $85 million to $95 million; and
  • Free Cash Flow1 to be in a range of $45 million to $55 million.

Conference Call

The Company will conduct a conference call to discuss the above details and attached financial results today, August 29, 2024, at 8:00 a.m. (ET). The conference call will be webcast from the Investors section of the Company’s website at www.1800flowersinc.com. A recording of the call will be posted on the Investors section of the Company’s 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) today through September 5, 2024, at: (US) 1-877-344-7529; (Canada) 855-669-9658; (International) 1-412-317-0088; enter conference ID #: 5141252.

Definitions of non-GAAP Financial Measures:

We sometimes use financial measures derived from consolidated financial information, but not presented in our financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). Certain of these are considered “non-GAAP financial measures” under the U.S. Securities and Exchange Commission rules. Non-GAAP financial measures referred to in this document are either labeled as “non-GAAP” or designated as such with a “1”. See below for definitions and the reasons why we use these non-GAAP financial measures. Where applicable, see the Selected Financial Information below for reconciliations of these non-GAAP measures to their most directly comparable GAAP financial measures. Reconciliations for forward-looking figures would require unreasonable efforts at this time because of the uncertainty and variability of the nature and amount of certain components of various necessary GAAP components, including, for example, those related to compensation, tax items, amortization or others that may arise during the year, and the Company’s management believes such reconciliations would imply a degree of precision that would be confusing or misleading to investors. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The lack of such reconciling information should be considered when assessing the impact of such disclosures.

EBITDA and Adjusted EBITDA:

We define EBITDA as net income (loss) before interest, taxes, depreciation, and amortization. Adjusted EBITDA is defined as EBITDA adjusted for the impact of stock-based compensation, Non-Qualified Plan Investment appreciation/depreciation, and for certain items affecting period-to-period comparability. See Selected Financial Information for details on how EBITDA and Adjusted EBITDA were calculated for each period presented. The Company presents EBITDA and Adjusted EBITDA because it considers such information meaningful supplemental measures of its performance and believes such information is frequently used by the investment community in the evaluation of similarly situated companies. The Company uses EBITDA and Adjusted EBITDA as factors to determine the total amount of incentive compensation available to be awarded to executive officers and other employees. The Company’s credit agreement uses EBITDA and Adjusted EBITDA to determine its interest rate and to measure compliance with certain covenants. EBITDA and Adjusted EBITDA are also used by the Company to evaluate and price potential acquisition candidates. EBITDA and Adjusted EBITDA have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of the Company’s results as reported under GAAP. Some of the limitations are: (a) EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, the Company’s working capital needs; (b) EBITDA and Adjusted EBITDA do not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on the Company’s debts; and (c) although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future and EBITDA does not reflect any cash requirements for such capital expenditures. EBITDA and Adjusted EBITDA should only be used on a supplemental basis combined with GAAP results when evaluating the Company’s performance.

Segment Contribution Margin and Adjusted Segment Contribution Margin

We define Segment Contribution Margin as earnings before interest, taxes, depreciation, and amortization, before the allocation of corporate overhead expenses. Adjusted Segment Contribution Margin is defined as Segment Contribution Margin adjusted for certain items affecting period-to-period comparability. See Selected Financial Information for details on how Segment Contribution Margin and Adjusted Segment Contribution Margin were calculated for each period presented. When viewed together with our GAAP results, we believe Segment Contribution Margin and Adjusted Segment Contribution Margin provide management and users of the financial statements meaningful information about the performance of our business segments. Segment Contribution Margin and Adjusted Segment Contribution Margin are used in addition to and in conjunction with results presented in accordance with GAAP and should not be relied upon to the exclusion of GAAP financial measures. The material limitation associated with the use of Segment Contribution Margin and Adjusted Segment Contribution Margin is that they are an incomplete measure of profitability as they do not include all operating expenses or non-operating income and expenses. Management compensates for this limitation when using these measures by looking at other GAAP measures, such as Operating Income and Net Income.

Adjusted Net Income (Loss) and Adjusted or Comparable Net Income (Loss) Per Common Share:

We define Adjusted Net Income (Loss) and Adjusted or Comparable Net Income (Loss) Per Common Share as Net Income (Loss) and Net Income (Loss) Per Common Share adjusted for certain items affecting period-to-period comparability. See Selected Financial Information below for details on how Adjusted Net Income (Loss) Per Common Share and Adjusted or Comparable Net Income (Loss) Per Common Share were calculated for each period presented. We believe that Adjusted Net Income (Loss) and Adjusted or Comparable Net Income (Loss) Per Common Share are meaningful measures because they increase the comparability of period-to-period results. Since these are not measures of performance calculated in accordance with GAAP, they should not be considered in isolation of, or as a substitute for, GAAP Net Income (Loss) and Net Income (Loss) Per Common share, as indicators of operating performance and they may not be comparable to similarly titled measures employed by other companies.

Free Cash Flow:

We define Free Cash Flow as net cash provided by operating activities less capital expenditures. The Company considers Free Cash Flow to be a liquidity measure that provides useful information to management and investors about the amount of cash generated by the business after the purchases of fixed assets, which can then be used to, among other things, invest in the Company’s business, make strategic acquisitions, strengthen the balance sheet, and repurchase stock or retire debt. Free Cash Flow is a liquidity measure that is frequently used by the investment community in the evaluation of similarly situated companies. Since Free Cash Flow is not a measure of performance calculated in accordance with GAAP, it should not be considered in isolation or as a substitute for analysis of the Company’s results as reported under GAAP. A limitation of the utility of Free Cash Flow as a measure of financial performance is that it does not represent the total increase or decrease in the Company’s cash balance for the period.

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 or follow @1800FLOWERSInc on Twitter.

FLWS–COMP
FLWS-FN

Special Note Regarding Forward Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s current expectations or beliefs concerning future events and can generally be identified using statements that include words such as “estimate,” “expects,” “project,” “believe,” “anticipate,” “intend,” “plan,” “foresee,” “forecast,” “likely,” “should,” “will,” “target” or similar words or phrases. These forward-looking statements are subject to risks, uncertainties, and other factors, many of which are outside of the Company’s control, which could cause actual results to differ materially from the results expressed or implied in the forward-looking statements, including, but not limited to, statements regarding the Company’s ability to achieve its guidance for the full Fiscal year; the Company’s ability to leverage its operating platform and reduce its operating expense ratio; its ability to successfully integrate acquired businesses and assets; its ability to successfully execute its strategic initiatives; its ability to cost effectively acquire and retain customers; the outcome of contingencies, including legal proceedings in the normal course of business; its ability to compete against existing and new competitors; its ability to manage expenses associated with sales and marketing and necessary general and administrative and technology investments; its ability to reduce promotional activities and achieve more efficient marketing programs; and general consumer sentiment and industry and economic conditions that may affect levels of discretionary customer purchases of the Company’s products. The Company undertakes no obligation to publicly update any of the forward-looking statements, whether because of new information, future events or otherwise, made in this release or in any of its SEC filings. Consequently, you should not consider any such list to be a complete set of all potential risks and uncertainties. For a more detailed description of these and other risk factors, refer to the Company’s SEC filings, including the Company’s Annual Reports on Form 10-K and its Quarterly Reports on Form 10-Q.

Note: The following tables are an integral part of this press release without which the information presented in this press release should be considered incomplete.

Investor Contact:

Andy Milevoj

(516) 237-4617

amilevoj@1800flowers.com

Media Contact:

Cherie Gallarello

cgallarello@1800flowers.com

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

Release – Colossus SSP Joins Industry Initiative to Bring Transparency to Digital Ad Auctions

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

October 09, 2024 9:00 am EDT

The participation aims to enhance industry standards while creating new opportunities for diverse digital publishers.

HOUSTON, Oct. 9, 2024 /PRNewswire/ — Colossus Media LLC (“Colossus SSP”), the inclusive supply-side advertising platform, today announced its participation in the Media Rating Council’s (MRC) newly formed Digital Ad Auction Standards Working Group. This initiative aims to bring greater transparency, standardization, and predictability to auction dynamics in the digital advertising marketplace.

The digital advertising ecosystem has long grappled with challenges surrounding auction transparency and consistency. The Auction Standards Working Group, spearheaded by MRC in coordination with member organizations, including 4A’s and others to establish insights, metrics, and standards to enable auction users to transact with complete knowledge and confidence. By fostering an environment of open dialogue and shared expertise, the working group seeks to develop comprehensive standards that will empower advertisers, publishers, and technology providers alike.

“At Colossus SSP, we’ve always believed that a transparent and efficient marketplace is the cornerstone of effective digital advertising,” said Anu Pillai, CTO of Direct Digital Holdings. “Our participation in the Digital Ad Auction Standards Working Group aligns perfectly with our mission to drive innovation and foster trust in the programmatic ecosystem. We’re committed to leveraging our expertise to contribute to industry standards that will benefit all stakeholders.”

The Auction Standards Working Group’s objective is crucial to the industry’s evolution, focusing on key areas such as:

  1. Enhancing transparency in digital ad auction rules and practices
  2. Standardizing reporting of auction variables and outcomes
  3. Developing a framework for independent audit and verification

Mark D. Walker, CEO, Co-Founder, & Chairman of Direct Digital Holdings, added: “As we push the boundaries of programmatic advertising, it’s crucial that we establish a common set of standards for auction transparency. This working group provides an opportunity to align innovation with industry-wide transparency goals. We’re excited to contribute our resources to making digital advertising more effective and trustworthy for all parties involved.”

“MRC greatly appreciates Colossus SSP’s participation in the Auction Standards Working Group,” stated Ron Pinelli Jr., SVP Digital Research and Standards at Media Rating Council. “We look forward to them participating in our effort to develop standards that will shape the future of transparency and reporting related to digital advertising auctions.”

As the working group begins its initial research phase, it will delve into the intricacies of various digital ad auction models, current disclosure practices, and reporting standards. This foundational work will pave the way for future phases aimed at developing and implementing industry-wide standards.

Participating in this initiative with the MRC will enhance Colossus SSP’s Momentum initiative, which supports underrepresented, diverse digital publishers with best practices, knowledge, resources, and tools. This participation positions Colossus as a conduit for these publishers to provide input into the MRC’s initiative more directly. In turn, Colossus will provide deeper insight into MRC’s accreditation framework in the area of auction transparency, allowing publishers to potentially unlock more ad dollars and opportunities.

About MRC
The Media Rating Council is a non-profit industry association established in 1963 comprised of leading television, radio, print and digital media companies, as well as advertisers, advertising agencies and trade associations, whose goal is to ensure measurement services that are valid, reliable and effective.

About Colossus SSP
Colossus SSP (Nasdaq: DRCT) owns and operates Colossus SSP, Huddled Masses, and Orange142. The company offers a unified platform that serves various clients across various sectors, managing over 326 billion monthly impressions. Colossus SSP is committed to providing innovative, data-driven advertising solutions prioritizing ROI, DEI, and sustainability.

About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange 142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions generate billions of impressions per month across display, CTV, in-app and other media channels.

Direct Digital Holdings Logo (PRNewsfoto/Direct Digital Holdings)

View original content to download multimedia:https://www.prnewswire.com/news-releases/colossus-ssp-joins-industry-initiative-to-bring-transparency-to-digital-ad-auctions-302270961.html

SOURCE Direct Digital Holdings

Released October 9, 2024

Release – Unicycive Therapeutics Successfully Completes UNI-494 Phase 1 Study in Healthy Volunteers

Posted on by aweinsoff@channelchek.com

Research News and Market Data

October 09, 2024 7:03am EDT

UNI-494 was Well-Tolerated as a Single Dose up to 160 mg and in Multiple Doses at 40 mg Twice-a-Day

LOS ALTOS, Calif., Oct. 09, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the successful completion of the UNI-494 Phase 1 study in healthy volunteers.

“We are pleased to announce the successful completion of the UNI-494 Phase 1 study that informs our next steps for advancement to a potential Phase 2 clinical trial in patients with acute kidney injury,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This is an important milestone for the clinical development of UNI-494 as it provides the necessary dosing and tolerability data to progress the program. We plan to request a meeting with the U.S. Food and Drug Administration (FDA) before the end of the year to review these Phase 1 results and a potential Phase 2 study design. We would like to extend our gratitude to the trial investigator and participants who committed their time and effort to the study.”

Trial Design: The Phase 1 study was a single center, double-blind, placebo-controlled, randomized single ascending dose (Part 1) and multiple ascending dose (Part 2) study in healthy volunteers conducted in the United Kingdom. Dosing in both arms was completed in a stepwise fashion. The objective of the study was to assess the safety, tolerability and pharmacokinetics of UNI-494.

Single Ascending Dose: Part 1 of the study enrolled 40 participants in 5 cohorts with 30 participants dosed with UNI-494 and 10 participants dosed with placebo. UNI-494 was well-tolerated in healthy participants as a single dose ranging from 10 mg to 160 mg. There were no serious adverse events (SAEs) or adverse events (AEs) leading to withdrawal. Headache was the most common adverse event reported. Most of the adverse events were mild, and all participants dosed with UNI-494 completed the study.

Multiple Ascending Dose: Part 2 of the study enrolled 19 participants in two cohorts with 15 participants dosed with UNI-494 and 4 dosed with placebo. In Cohort One (n=9), participants were dosed with 40 mg two times a day (BID) for 5 days with UNI-494 or matching placebo. In Cohort Two (n=10), participants were dosed with 80 mg BID for 5 days. There were no serious adverse events (SAEs) in Part 2 of the study, and UNI-494 was safe and well-tolerated at the 40 mg BID dose for 5 days. Most common adverse events reported included headache, nausea, and vomiting. In Cohort One, the majority of the adverse events reported were mild and all but one participant completed the study. In Cohort Two, UNI-494 was not well-tolerated with 4 participants withdrawing from the study due to adverse events.

Pharmacokinetics of UNI-494 were also evaluated in the study. The absorption of UNI-494 was fast, and UNI-494 was rapidly metabolized to release nicorandil and the linker as expected. Plasma concentration of nicorandil increased in a slightly greater than proportional manner as the dose increased.

Collectively, these results will help determine the dose and schedule of UNI-494 for a potential Phase 2 clinical trial in patients with acute kidney injury.

Unicycive intends to present additional details of the study at an upcoming scientific conference.

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.

About Acute Kidney Injury

Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease, end stage renal disease.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Primary Logo

Source: Unicycive Therapeutics, Inc.

Released October 9, 2024

Release – Ocugen, Inc. Announces Removal of Clinical Hold on Investigational New Drug Application for OCU200 Phase 1 Clinical Trial

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

October 9, 2024

PDF Version

MALVERN, Pa., Oct. 09, 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 announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the investigational new drug application for the Phase 1 clinical trial evaluating OCU200, a recombinant fusion protein consisting of tumstatin and transferrin, for treating diabetic macular edema (DME).

“We are excited to launch the Phase 1 clinical trial for OCU200, which is designed to treat patients with DME,” said Dr. Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen. “Approximately 30 to 40% of DME patients are refractive to current anti-VEGF therapies. OCU200 targets the underlying disease mechanisms through the integrin pathway and holds promise to provide benefits to all DME patients, including non-responders to currently approved therapy.”

OCU200 possesses unique features that potentially enable it to treat vascular complications of DME. Tumstatin is the active component of OCU200 and binds to integrin receptors, which play a crucial role in disease pathogenesis. Transferrin is expected to facilitate the targeted delivery of tumstatin into the retina and choroid and potentially help increase the interaction between tumstatin and integrin receptors.

“I look forward to bringing OCU200 into the clinic and advancing this important candidate in Ocugen’s portfolio for treating blindness diseases,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “DME is becoming more prevalent as the number of people with diabetes in the U.S. rises, making the condition even more imperative to address.”

This is a multicenter, open-label, dose-ranging study with 3 cohorts in the dose-escalation portion assessing safety of OCU200 and in the fourth cohort a combination of OCU200 (MTD) with anti-VEGF following sequential intravitreal administration.

DME is one of the most common vision-threatening diseases occurring in people with diabetes and includes blurriness in vision and progressive vision loss as the disease progresses. Approximately 746,000 people in the United States are affected with DME.

The Company intends to pursue additional indications for OCU200 to potentially treat diabetic retinopathy and wet age-related macular degeneration, which combined affect nearly nine million Americans.

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; 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
Head of Communications
Tiffany.Hamilton@ocugen.com