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.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Initiating Research Coverage. We are initiating research coverage of Steelcase Inc. with an Outperform rating and a $16 price target. Already the global leader in the office furniture marketplace, we believe there is a substantial opportunity to capture additional wallet share. The Company’s research driven approach is a competitive differentiator, in our view.
Largest, But Room to Grow. Despite being the market leader, we believe Steelcase can benefit from a rising market share in a growing market. Steelcase’s overall market share is relatively modest, providing opportunity for Steelcase to capture additional market share, while secular trends are driving overall growth in the market, with the worldwide Office Furniture space projected to grow at a 7.1% CAGR through 2032.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Positive Results Announced From Tivoxavir Marboxil Study. Positive data was announced from the Phase 1 clinical trial testing safety and pharmacokinetics of Tivoxavir Marboxil, Traw’s drug in development for seasonal and pandemic influenza. The study showed tolerability and bloodstream levels within the expected range, supporting use as a one-time treatment for flu. The dose for Phase 2 has been selected with the trial planned to begin in 1H2025.
Tivoxavir Inhibitor A Protease Needed For Viral Replication. Tivoxavir acts through inhibition of CAP-dependent endonucleases (CEN), a highly conserved influenza protein needed for the synthesis of its viral mRNA. Tivoxavir was designed for use across a broad range of flu viruses including the H5N1 bird flu virus. Preclinical studies have shown potent inhibition of drug-resistant influenza viruses.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Comtech Telecommunications Corp. engages in the design, development, production, and marketing of products, systems, and services for advanced communications solutions in the United States and internationally. It operates in three segments: Telecommunications Transmission, Mobile Data Communications, and RF Microwave Amplifiers. The Telecommunications Transmission segment provides satellite earth station equipment and systems, over-the-horizon microwave systems, and forward error correction technology, which are used in various commercial and government applications, including backhaul of wireless and cellular traffic, broadcasting (including HDTV), IP-based communications traffic, long distance telephony, and secure defense applications. The Mobile Data Communications segment provides mobile satellite transceivers, and computers and satellite earth station network gateways and associated installation, training, and maintenance services; supplies and operates satellite packet data networks, including arranging and providing satellite capacity; and offers microsatellites and related components. The RF Microwave Amplifiers segment designs, develops, manufactures, and markets satellite earth station traveling wave tube amplifiers (TWTA) and broadband amplifiers. Its amplifiers are used in broadcast and broadband satellite communication; defense applications, such as telecommunications systems and electronic warfare systems; and commercial applications comprising oncology treatment systems, as well as to amplify signals carrying voice, video, or data for air-to-satellite-to-ground communications. The company serves satellite systems integrators, wireless and other communication service providers, broadcasters, defense contractors, military, governments, and oil companies. Comtech markets its products through independent representatives and value-added resellers. The company was founded in 1967 and is headquartered in Melville, New York.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Peterman Endorsement. Former CEO Ken Peterman, who was terminated for “conduct unrelated to Comtech’s business strategy, financial results or previously filed financial statements” this past March, has publicly declared his personal endorsement for the full slate of director nominees proposed by Michael Porcelain for the Company’s upcoming 2024 Annual Meeting of Stockholders, adding another layer of intrigue to the dissident efforts.
Reasons. Mr. Peterman notes serious concerns about many decisions made by the current Board, including the June 2024 refinancing, and what he terms the Board’s lack of critical domain expertise in Comtech’s core satellite and NG 911 markets.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Key Points: – Rio Tinto is acquiring Arcadium Lithium in an all-cash deal worth $5.85 per share, a 90% premium over Arcadium’s recent stock price. – Arcadium’s lithium production capacity is set to more than double by 2028, positioning it for growth in the rising lithium market. – The acquisition strengthens Rio Tinto’s role in energy transition commodities, with long-term lithium demand expected to grow 10% annually through 2040.
Arcadium Lithium (NYSE: ALTM) announced that it has entered into a definitive agreement to be acquired by global mining giant Rio Tinto in an all-cash transaction valued at $5.85 per share. The deal represents a 90% premium over Arcadium’s October 4 closing price of $3.08, highlighting the significant value Rio Tinto sees in Arcadium’s assets and growth potential.
Arcadium, a rapidly growing, vertically integrated lithium chemicals producer, currently boasts a production capacity of 75,000 tonnes of lithium carbonate equivalent, with plans to more than double that by 2028. Rio Tinto’s acquisition of Arcadium strengthens its portfolio in energy transition commodities, establishing it as a leader in the fast-growing lithium market.
The transaction is expected to unlock additional growth for Arcadium by leveraging Rio Tinto’s global expertise, scale, and resources. Arcadium’s Tier 1 assets, which include high-margin operations and an attractive suite of growth projects, will benefit from Rio Tinto’s capacity to accelerate their development. The long-term outlook for lithium demand is robust, with annual growth projected at 10% through 2040, providing a solid foundation for future expansion.
Despite falling lithium carbonate prices, driven by oversupply from China, the acquisition reflects Rio Tinto’s confidence in the long-term value of Arcadium’s business. The deal is subject to customary regulatory approvals and shareholder consent.
Key Points: – DOJ Remedies: The DOJ may force Google to sell off parts of its business or provide competitors with access to critical search and AI data to break its online search monopoly. – Legal Precedents: Similar to historic antitrust cases involving AT&T and Microsoft, the case could result in significant structural changes for Google, though a full breakup remains uncertain. – Impact on Big Tech: This case is part of a broader effort by the U.S. government to limit the dominance of tech giants, including Google, Apple, Amazon, and Microsoft, which could reshape the industry.
The U.S. Department of Justice (DOJ) has ramped up its antitrust case against Google, with a landmark lawsuit that could potentially force the tech giant to divest parts of its business. The DOJ argues that Google has maintained an illegal monopoly in the online search market for over a decade, leveraging its dominance across key platforms and products like Chrome, Android, Google Play, and its AI offerings to suppress competition. The case, which has already led to an August 2024 ruling from U.S. District Judge Amit Mehta, found that Google exploited its dominance to eliminate rivals and stifle innovation. Now, the DOJ is pushing for remedies that go beyond fines, aiming for structural changes that could reshape Google’s business.
Key Allegations and DOJ’s Proposed Remedies:
The DOJ’s filing highlights the numerous ways Google allegedly unfairly reinforces its search monopoly. For instance, Google has long maintained exclusive agreements to make its search engine the default option on devices running its Android operating system and on the Chrome browser, which holds a dominant market share. These arrangements leave competitors little room to gain traction in the search space.
In its filing, the DOJ proposed several aggressive remedies:
Divestiture: The most significant remedy the DOJ is considering is a forced divestiture, which could see parts of Google’s business—such as the Chrome browser or the Android operating system—spun off to eliminate Google’s ability to cross-leverage its products and maintain its search dominance.
Data Access for Competitors: Another potential remedy would require Google to allow competitors access to the underlying data that powers its search and artificial intelligence (AI) systems. This data is critical for the development of competitive search engines and AI tools, and the DOJ argues that Google’s control of this information has been a major barrier to competition.
Limiting Default Agreements: The DOJ has also suggested prohibiting Google from entering into exclusive or default agreements with device manufacturers or other digital platforms, which has been a cornerstone of Google’s search dominance strategy. This would open the door for rival search engines to be pre-installed on more devices, increasing competition in the market.
Data Privacy Restrictions: The DOJ is considering prohibiting Google from using or retaining certain data for its own purposes if it cannot be shared with others due to privacy concerns. This would limit Google’s advantage in data-driven areas like AI and personalized advertising.
In response, Google has labeled the DOJ’s proposals as extreme government overreach, with its vice president of regulatory affairs, Lee-Anne Mulholland, warning that such actions could have “significant unintended consequences” for consumers, businesses, and U.S. global competitiveness. Google maintains that its products and services provide immense value to consumers and that the company’s dominance in search is due to the quality of its products, not anti-competitive behavior.
Judge Mehta’s August 2024 Ruling and Google’s Appeal:
In August 2024, Judge Mehta ruled that Google has been using its market position to unfairly eliminate competition in the search engine market. While the ruling was a major victory for the DOJ, it did not immediately impose remedies. Instead, the next phase of the case focuses on what steps should be taken to remedy the situation. Google has already indicated plans to appeal the ruling, which could delay any concrete outcomes for years.
Should Google succeed in its appeal, the remedies proposed by the DOJ may never materialize. However, if the DOJ’s arguments hold up in the courts, it could lead to some of the most sweeping changes to a tech company’s structure since the breakup of AT&T in the 1980s.
Broader Antitrust Efforts:
Google’s legal troubles are part of a broader push by the Biden administration to rein in the perceived dominance of Big Tech companies. Google, which holds a 90% market share in search, is just one of several tech giants facing antitrust scrutiny. The DOJ has also filed a separate lawsuit against Google, accusing it of monopolizing the online advertising technology market. Other companies like Apple, Amazon, and Microsoft have also been caught up in the government’s efforts to curb anti-competitive practices in the tech sector.
Historical Context and Similar Antitrust Cases:
The potential break-up of Google recalls some of the most significant antitrust actions in U.S. history:
Microsoft (1990s): In a case with striking similarities to Google’s, Microsoft was accused of using its Windows operating system to promote its Internet Explorer browser, stifling competition. While the courts initially ruled to break up Microsoft, a settlement allowed the company to remain intact while agreeing to share APIs and alter its business practices.
AT&T (1980s): One of the most famous U.S. antitrust cases, AT&T was forced to divest its regional Bell operating companies, ending its monopoly over U.S. phone service. This breakup opened up the telecommunications market, increasing competition and innovation.
IBM (1960s-80s): The DOJ filed an antitrust case against IBM for monopolizing the computer hardware market. The case dragged on for over a decade before it was dropped, allowing IBM to avoid a breakup, though the company’s market dominance eroded over time due to rising competition.
The Long-Term Outlook:
The DOJ’s case against Google is significant not only because of its implications for the company but also for the broader tech industry. With a long-term growth outlook of 10% annually for digital markets like search and online advertising, Google remains an essential player in the global economy. Any structural changes to its business could reshape the tech landscape, affecting consumers, competitors, and even national competitiveness in the rapidly growing fields of AI and data-driven innovation.
However, many legal experts believe that a forced breakup of Google is unlikely. Instead, the case could result in more incremental remedies designed to increase competition in search and related markets, such as making it easier for users to switch search engines or banning certain exclusive agreements. Regardless of the outcome, this case will likely set the tone for how the U.S. government handles Big Tech monopolies in the coming years.
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.
