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
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
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.
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.
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:
Enhancing transparency in digital ad auction rules and practices
Standardizing reporting of auction variables and outcomes
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.
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.
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.
PURCHASE, N.Y., Oct. 08, 2024 (GLOBE NEWSWIRE) — Townsquare Media, Inc. (NYSE: TSQ) (“Townsquare” or the “Company”) announced today that it will release third quarter 2024 financial results before the market opens on Thursday, November 7, 2024. The Company will host a conference call to discuss certain third quarter 2024 financial results on Thursday, November 7, 2024 at 10:00 a.m. Eastern Time.
The conference call dial-in number is 1-800-717-1738 (U.S. & Canada) or 1-646-307-1865 (International) and the conference ID is “Townsquare”. A live webcast of the conference call as well as the press release disclosing the Company’s results will be available on the investor relations page of the Company’s website at www.townsquaremedia.com.
A telephone replay of the conference call will be available through November 14, 2024. To access the replay, please dial 1-844-512-2921 (U.S. & Canada) or 1-412-317-6671 (International) and enter confirmation code 1142541. A web-based archive of the conference call will also be available on the investor relations page of the Company’s website.
About Townsquare Media, Inc. Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for approximately 23,575 SMBs; a robust digital advertising division, Townsquare Ignite, a powerful combination of a) an owned and operated portfolio of more than 400 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data, and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 349 local terrestrial radio stations in 74 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com and NJ101.5.com, and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com, and Loudwire.com. For more information, please visit www.townsquaremedia.com, www.townsquareinteractive.com, and www.townsquareignite.com.
Partnership Reduces Malicious Ads and Enhances Security, Improving Ad Quality for Publishers and Advertisers Across the Digital Ecosystem
HOUSTON, Oct. 8, 2024 /PRNewswire/ — Colossus Media LLC (“Colossus SSP”), a subsidiary of the only Black-owned publicly traded advertising technology company, Direct Digital Holdings (DDH), announced today it has partnered with Confiant, a leader in cybersecurity for digital advertising, to combat criminal activity online and malicious advertising. This collaboration aims to safeguard publishers, advertisers and consumers by integrating Confiant’s advanced cybersecurity technology with the Colossus SSP platform.
The digital advertising landscape faces ongoing challenges from “malvertising,” a serious threat that encompasses various malicious activities from forced redirects to ransomware. Recent industry data highlights the severity of this issue, with 1 in every 79 ad impressions revealing significant security or quality issues, and U.S. consumers losing more than $12.5 billion to malicious ads in the past year. Recognizing these growing risks, Colossus SSP has taken a proactive approach to protect its network of over 21,000 publishers and the billions of impressions it serves monthly.
“Protecting users from online threats and malvertising is a critical priority. Thanks to our partnership with Confiant, we can offer publishers a safer platform for monetizing their inventory, while ensuring that advertisers reach real people in brand-safe environments,” said Lashawnda Goffin, Chief Executive Officer of Colossus SSP.
Colossus SSP’s new partnership addresses the industry’s security challenges by leveraging Confiant’s cutting-edge platform to monitor and block potentially malicious ads, complementing the company’s already rigorous quality control measures. This technique targets both security violations involving malicious code and quality violations such as misleading ads that lure users into scams. By enhancing overall security measures, the partnership delivers a safer, more trustworthy experience for users while ensuring advertisers’ campaigns are displayed in brand-safe environments.
The partnership between Colossus SSP and Confiant has already demonstrated impressive results. Security violations have been reduced from the industry average of 0.19% to less than 0.002%, while ad quality violations have dropped from 1.57% to 0.08%. This represents a nearly 95% reduction across both issues. As a result, ads served through Colossus SSP are now 20x safer compared to industry norms. These outcomes underscore Colossus SSP’s commitment to protecting the digital advertising ecosystem.
By providing a more secure environment for both consumers and advertisers, Colossus SSP and Confiant are working to improve user safety, enhance ad quality and implement robust security measures across the digital advertising landscape. This partnership reinforces Colossus SSP’s ongoing efforts to create a safer and more trustworthy digital advertising experience for all stakeholders. Advertisers can access Colossus SSP’s inventory directly or through leading DSPs, including Yahoo DSP, Microsoft Invest, and Zeta Global.
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.
About Confiant
Confiant is the cybersecurity leader in detecting and stopping Malvertising attacks. Having built hundreds of integrations directly into the web’s ad tech infrastructure, Confiant has unparalleled visibility to the malware, scams, and fraud serving through ads today. Leveraging our security expertise, we deliver complete control over ads to publishers and ad platforms, also remediating quality issues, privacy violations, and mis-categorized ads. In publishing the industry’s leading ad quality benchmark report and mapping the threat actors that use ads-as-an-attack-vector at Matrix.Confiant.com, Confiant is leading the charge in protecting users from criminals hijacking the ad tech supply chain. Trusted by customers like Microsoft, Paramount, and Magnite, we celebrate our 10th anniversary this year.
AI (Artificial Intelligence) and ML (Machine Learning) drug discovery collaboration will accelerate the development of small molecules as orally available host-targeted broad-spectrum medical countermeasures
Host-directed antiviral drugs have the potential to enhance the immune response to viruses from a range of viral families
Tonix was awarded a contract with the U.S. Department of Defense for up to $34 million for the accelerated development of its host-directed broad-spectrum antiviral program TNX-4200
CHATHAM, N.J., Oct. 08, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it has entered into an AI and ML research collaboration with X-Chem, Inc. (X-Chem), a leader in small molecule drug discovery, to accelerate development of Tonix’s oral broad-spectrum antivirals.
Tonix’s TNX-4200 antiviral program focuses on the development of oral CD45 phosphatase inhibitors, with broad-spectrum activity against a range of viral families. As previously disclosed, Tonix entered into a contract with the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA) for up to $34 million to advance the development of Tonix’s TNX-4200 broad-spectrum oral antiviral program for medical countermeasures, including an Investigational New Drug (IND) submission and a first-in-human Phase 1 clinical study.
“We are excited to enter into this research collaboration with X-Chem, which we believe will expand our capabilities, and deepen our understanding of host-targeted small molecule therapeutics for a variety of targets,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “With the support of X-Chem’s drug discovery AI/ML technology, we expect to optimize the physicochemical properties, pharmacokinetics, and safety attributes of our drug candidates.”
“We are excited to partner with Tonix in their pursuit of such important programs in human health, at the intersection of laboratory and in silico technology. This collaboration highlights how integrative work continues to leverage the creation of target-specific high-quality data to drive AI drug discovery,” said Erin Davis, Ph.D., Chief Technology Officer of X-Chem.”
The DTRA contract awarded to Tonix is expected to help fund and accelerate the development of the Company’s lead oral host-directed TNX-4200 broad-spectrum antiviral program. The TNX-4200 program aims to reduce viral load and to allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors to optimize lead compounds for therapeutic intervention of biothreat agents.
For the oral broad-spectrum antiviral programs, including TNX-4200, Tonix is utilizing its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center (RDC) located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland’s ‘I-270 biotech corridor’ and is close to the center of the U.S. biodefense research community.
About X-Chem, Inc.
X-Chem, Inc. is a leader in small molecule drug discovery services for pharmaceutical and biotech companies. As pioneers of DNA-encoded chemical library (DEL) technology and its integration with proprietary AI technology and computational sciences, X-Chem can accelerate all steps in the discovery process. The company leverages its unique AI/ML approach, market-leading DEL platform, and computationally-driven medicinal chemistry expertise to discover novel small molecule leads against challenging, high-value therapeutic targets. Integrated with X-Chem’s extensive chemistry and computational technologies, project teams can deliver clinical candidates with unmatched speed. X-Chem also provides libraries, reagents, and informatic tools to allow DEL operators to get the most of their DEL platform. X-Chem empowers its partners to effectively build drug pipelines from target to clinical candidate, enhanced with AI and extensive data packages.
Further information about X-Chem can be found at www.x-chemrx.com.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in October of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL was generally well tolerated in the Phase 3 program. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract 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. The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates are investigational new drugs or biologics; 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.
Investigational agent in development as a one dose treatment or prevention of seasonal and pandemic influenza
A dose ranging, Phase 1 study in healthy volunteers demonstrated positive tolerability results and plasma levels in the predicted therapeutic window, enabling selection of Phase 2 dose
Preclinical data showed potent inhibition of drug-resistant and bird influenza viruses
Phase 2 study expected to begin in H1 2025
Improved therapy is an important need for both seasonal and pandemic flu
NEWTOWN, Pa., Oct. 08, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced positive topline Phase 1 safety and pharmacokinetic results for its investigational one-dose influenza (flu) therapy, tivoxavir marboxil (tivoxavir). Tivoxavir was designed as a potential best-in-class inhibitor of the highly-conserved influenza protein, CAP-dependent endonuclease (CEN), intended for use across a broad range of flu viruses.
“Topline data from the Phase 1 healthy volunteer study showed good overall tolerability and a pharmacokinetic profile that appears to support tivoxavir’s potential use as a one-time treatment for flu, including pandemic flu. We are especially pleased with data showing that a single dose of tivoxavir maintained plasma drug levels above the EC90 for greater than 5 days1,” said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. “In addition, preclinical data show that tivoxavir is a potent inhibitor of drug-resistant influenza and bird flu viruses1. Together, these initial results suggest that tivoxavir has the potential to be developed as a best-in-class agent for influenza. With these data, we plan to advance the program to a Phase 2 study in H1 2025.”
“Influenza is a substantial public health burden in the US2, with a disproportionate impact on older adults and vulnerable populations. Data from the last influenza season showed that flu-related hospitalizations3 and mortality4 were highest, by approximately three times, among people 65 years of age or older5. Recent bird flu outbreaks, and the risk that this highly pathogenic virus (H5N1) poses for evolving into a pandemic outbreak6, also signal the need for new antiviral treatments,” said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). “Our enthusiasm for tivoxavir is based on the data announced today and the need for novel therapeutics, especially as valuable resources in case of an avian flu outbreak or a pandemic, and for potential use to prevent virus spread in households and congregant settings.”
“We selected CEN as the target for our flu program because it is conserved among human and avian influenza viruses, including the highly pathogenic H5N1. As a result, we believe tivoxavir has the potential to suppress a wide range of viruses. We are very pleased that tivoxavir demonstrated broad activity in laboratory studies against drug-resistant viruses and highly pathogenic strains such as avian flu1. In addition, we believe that preferential uptake in the lung is another important feature of a candidate agent. Preclinical data indicate that a single dose of tivoxavir has more than 15X higher accumulation in the lung compared to plasma1,” said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. “Positive Phase 1 data showing that tivoxavir achieved plasma blood levels in healthy subjects that are consistently above the EC90 and within the predicted therapeutic window for more than five days lead to the identification of our Phase 2 dose, supporting further development of the program.”
Topline Phase 1 Results The Phase 1 trial was a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending doses of one-time tivoxavir marboxil treatment in healthy, influenza-negative, adult volunteers.
At the identified Phase 2 dose, no treatment related adverse events were reported during the Phase 1 study. Topline data from this study showed that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 for more than five days and within the predicted therapeutic window. Preclinical studies showed that tivoxavir marboxil demonstrated potent inhibition of drug-resistant influenza viruses, as well as potent inhibition of highly pathogenic bird flu viruses1.
About Tivoxavir Marboxil Seasonal influenza is estimated to represent a multi-billion antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1, with upside potential from pandemic flu outbreaks. Tivoxavir marboxil (also known as 27-5116 or TRX-100) was designed as an inhibitor of the highly conserved influenza protein, CAP-dependent endonuclease (CEN). It has demonstrated potent in vitro activity against a range of influenza strains, including the highly pathogenic avian flu, in preclinical studies. The drug candidate’s Phase 1 pharmacokinetic (PK) profile in healthy subjects, including the ability to achieve plasma levels that are consistently above the EC90 (as determined in laboratory studies), for more than five days and within the predicted therapeutic window, may enable a single dose treatment regimen. These data, combined with good overall tolerability results in healthy subjects, support further development of tivoxavir marboxil as a one-time treatment for influenza.
About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes two oral, novel, Phase 1, potentially best-in-class, small molecule drug candidates: tivoxavir marboxil, in development for flu and pandemic flu, targeting the influenza cap-dependent endonuclease (CEN); and ratutrelvir, in development as a COVID treatment, targeting the Mpro (3CL protease), without the need for co-administration of ritonavir.
In the cancer program, Traws is utilizing a partnering strategy, supported by investigator sponsored studies, to advance two novel proprietary multi-kinase inhibitors, narazaciclib, targeting CDK4+, and rigosertib, targeting cell cycle proteins including PLK-1.
Traws is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we aim to build solutions for important medical challenges and alleviate the burden of viral infections.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and the regulatory plans for tivoxavir marboxil. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Management Emphasizes That It Has Sufficient Cash to Achieve Its Goals Including Recently Announced Collaborations and Being Cash Flow Positive During 2025
The $11 Million Investment includes Leading Builders and Hotel Developers
MIAMI, Oct. 07, 2024 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive smart platform technology company with more than 97 issued and pending patents globally and over 60 lighting and home décor websites, today announced the completion of a strategic investment of $11 million of a new class of preferred stock in SKYX, with a conversion price of $2.00 per common share, with an 8% annual dividend, led by Lance Shaner, Chairman & CEO of Shaner Hotel Group, joined by other strategic and key SKYX investors.
Mr. Shaner said, “I clearly recognize SKYX’s extreme value proposition for hotels, buildings, and homes, and its significant global growth opportunity. I am now aligned to participate as a significant long term minded SKYX investor. I strongly believe that SKYX’s game-changing advanced and smart platform technologies will make hotels, buildings, and homes, advanced, smart, and safe instantly, while saving cost, time, and lives.”
Steve Schmidt, President of SKYX, said, “We are truly excited about this strategic investment, led by a Marriott global hotel chain developer such as Lance Shaner. This represents another significant confirmation of our value proposition for hotels, buildings, and homes, while enhancing our cash position to support our continuing growth including our recent collaborations with U.S. and world leading companies.”
Rani Kohen, Founder and Executive Chairman of SKYX, said, “We are thrilled to have Mr. Shaner as a strategic lead investor, as he contributes vast multi-faceted business experience including in community and hospitality developments. His experience and reputation not only represent success, but his involvement also provides continued validation and a major stamp of approval that SKYX’s advanced and smart technologies are game-changing for buildings, hotels, and homes.”
About Shaner Hotels
Headquartered in State College, Pa., Shaner Hotels is one of the foremost owner-operator companies in the hospitality industry with more than $1 billion invested in 60 hotel properties owned and managed across the U.S., Italy, Greece and the Bahamas. Over the past 40 years, the company has also been engaged in both new development and redevelopment of more than 80 hotel projects with leading brand affiliations such as Marriott International, InterContinental Hotels, Choice Hotels and Hilton. New properties are constantly evaluated as Shaner Hotels continues a conservative yet opportunistic approach to growth. For more information about the company and its divisions visit shanercorp.com.
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.
Forward-Looking Statements
Certain statements made in this press release are not based on historical facts but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
New Scientific Advisory Board (SAB) comprised of five leading experts in the areas of obesity and metabolic diseases, and four leading inflammasome experts and inventors of IC 100 from University of Miami Miller School of Medicine who have provided ongoing scientific advisory support for IC 100 since its license.
WESTON, Fla., Oct. 07, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces a new SAB to support advancement of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications. Based on its mechanism of action, IC 100, in combination with incretin therapy, is anticipated to augment weight loss, but more importantly, to attenuate the chronic systemic inflammation leading to metabolic complications and other inflammatory comorbidities of obesity.
“We are honored to work with such an accomplished and esteemed group of experts,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Our advisors’ combined expertise and insights in the areas of obesity, metabolic diseases, and inflammasomes will be invaluable as we design IC 100’s clinical development program for obesity and metabolic complications.”
Members of ZyVersa’s Obesity, Metabolic and Inflammatory Diseases SAB are listed below. Full biographies are available on ZyVersa’s Website.
Caroline M. Apovian, MD, FACP, FTOS, DABOM
Co-Director, Center for Weight Management and Wellness, Division of Endocrinology, Diabetes, and Hypertension at Brigham and Women’s Hospital
Professor of Medicine, Harvard Medical School
Harold Bays, MD, MFOMA, FTOS, FACC, FACE, FNLA, FASPC
Medical Director and President, Louisville Metabolic and Atherosclerosis Research Center
Clinical Associate Professor, Endocrinology, University of Louisville School of Medicine
Chief Science Officer of the Obesity Medicine Association
Helen Bramlett, PhD
Professor, Department of Neurological Surgery, University of Miami Miller School of Medicine
The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
Marc-Andre Cornier, MD
Professor of Medicine, Medical University of South Carolina
Director, Division of Endocrinology, Diabetes and Metabolic Diseases, Medical University of South Carolina
Juan Pablo de Rivero Vaccari, PhD
Associate Professor, Department of Neurological Surgery, University of Miami Miller School of Medicine
The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
Distinguished Faculty Member, the Center for Cognitive Neuroscience and Aging, University of Miami Miller School of Medicine
W. Dalton Dietrich, III, PhD
Kinetic Concepts Distinguished Chair in Neurosurgery, and Scientific Director,
The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
Senior Associate Dean for Discovery Science and Co-Director, the Institute for Neural Engineering, University of Miami Miller School of Medicine
Professor, Neurological Surgery, Neurology, Biomedical Engineering, and Cell Biology, University of Miami Miller School of Medicine
Robert W. Keane, PhD
Professor, Physiology and Biophysics, Neurological Surgery and Microbiology, and Immunology, University of Miami Miller School of Medicine
The Miami Project to Cure Paralysis. University of Miami Miller School of Medicine
Samuel Klein, MD
William H. Danforth Professor of Medicine, Washington University School of Medicine
Director, Center for Human Nutrition, Washington University School of Medicine
Chief, Division of Nutritional Science and Obesity Medicine, Washington University School of Medicine
Suneil Koliwad, MD, PhD
Chief, Division of Endocrinology and Metabolism, UCSF Health
Gerold Grodsky Professor of Diabetes Research, UCSF
Mount Zion Health Fund Distinguished Professor of Endocrinology, UCSF
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 spread of inflammation 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 with metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator™ VAR 200. The lead indication for IC 100 is obesity with 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.
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
Expansion adds new countries to Grovet’s existing PulseVet distribution coverage and enables launch of the TRUFORMA® equine platform in Europe
ANN ARBOR, MI / ACCESSWIRE / October 3, 2024 / Zomedica Corp. (NYSE American:ZOM) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, today announced the expansion of its distribution partnership in Europe with Grovet, a leading equine-focused veterinary distributor.
The terms of the updated agreement offer Grovet equine distribution rights for Zomedica’s equine PulseVet® and TRUFORMA product platforms throughout most of Europe. Grovet will exclusively distribute these equine products in 27 countries, including Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and Switzerland, and will distribute these products on anon-exclusive basis in Italy and the UK.
In addition to expanding the distribution of PulseVet products to equine veterinarians into additional European countries, this agreement also expands their product offerings to include the TRUFORMA platform as well as the Company’s current equine assays for eACTH and Cortisol, and equine Insulin when it launches later this year.
“We are very pleased to expand our relationship with Grovet for all of Zomedica’ s equine products in Europe,” stated Kevin Klass, Zomedica’s Senior Vice President of Sales. “Grovet has been a terrific partner since inception. Having them lead the way for us in equine by introducing the TRUFORMA equine product line to the market in 29 countries is a natural recipe for success,” continued Klass.
“Working with Zomedica and selling the PulseVet device has been a great experience for us,” stated Koen Schmitz-Managing Director of Grovet. “We only partner with companies whose products are rooted in scientific studies, and all of Zomedica’s products we are carrying are exactly just that, rooted in science and steeped in research,” continued Schmitz.
“Grovet has been a great partner to Zomedica for the equine PulseVet product line over the last several years, and they were the perfect partner to help expand the reach of our TRUFORMA equine platform within Europe,” stated Brandon Marino, Senior Director of Global Channels for Zomedica.
“PPID, or Cushing’s disease, is one of the most common endocrine disorders in horses and ponies. Left undiagnosed and untreated, quality of life for these animals will rapidly decline and their life expectancy will shorten. The TRUFORMA eACTH assay for equine plasma offers equine veterinarians the ability to diagnose and screen for PPID as well as monitor patients during treatment, in minutes in their own labs or stall-side. The equine Cortisol assay provides critical data to veterinarians treating foals, and the upcoming equine insulin assay will be of benefit for assessing insulin issues commonly faced by horses. The compact, easy to use, and durable TRUFORMA device offers reference lab accuracy with point of care convenience, making it a great fit for the unique challenges that face equine practitioners,” concluded Marino.
For more information on these products or any of Zomedica’s other products please visit, wwww.zomedica.com.
About Grovet – Equine health company Grovet has been supporting equine veterinarians with high-quality products for over 25 years. Our team consists of people who are passionate about horses, which is why horse health is at the heart of everything we do.
With our extensive experience and knowledge, we offer a wide range of innovative products, including instruments, medicines, MedTech and supplements to support equine veterinarians. We are committed to continuously improving and expanding our product line to meet the evolving needs of equine practitioners. By working closely with veterinarians and industry experts, we stay up to date on the latest trends and challenges, allowing us to provide effective solutions that help vets deliver the best care possible.
A key example of our ongoing commitment to innovation is our successful collaboration with Zomedica. This partnership has allowed us to expand our product offerings with the PulseVet and now the TRUFORMA equine line of products. PulseVet products are highly regarded by our clients and fit seamlessly into Grovet’s existing range and customer base. Our clients are pleased to have access to these products through a European distributor, making it easier than ever to incorporate them into their veterinary practices.
For more information about our products or to explore partnership opportunities, please visit www.grovet.com or contact us directly.
Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW™ digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $83 million in liquidity as of June 30, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.
Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.
Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.
Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to successfully integrate acquisitions; uncertainty as to our ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products, including acceptance of the TRUFORMA platform by veterinarians in Europe; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including meeting distribution obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.
The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.
