Key Points: – TD Bank has agreed to a $3 billion settlement with the DOJ after pleading guilty to conspiracy to commit money laundering, the largest such plea by a U.S. bank. – The bank allowed $670 million in laundered funds to flow through its accounts over multiple years due to lapses in its anti-money laundering program. – TD is undergoing major reforms, with federal monitoring and restrictions in place, alongside additional penalties from the Federal Reserve Board and CFPB.
TD Bank has agreed to a $3 billion settlement with the U.S. Department of Justice (DOJ) after pleading guilty to conspiracy to commit money laundering, marking the largest such plea from a U.S. bank in history. The charges stem from TD’s failure to adequately address issues in its anti-money laundering program over multiple years, allowing significant illegal financial activity to take place. The Canadian-based bank, the 10th largest in the U.S., has committed to a series of reforms as part of the settlement, including a complete restructuring of its compliance operations.
Major Failures in Anti-Money Laundering Program
According to U.S. officials, TD Bank allowed $670 million in laundered funds to pass through its accounts from three separate networks. One case involved a single individual moving over $470 million in drug-related and other illegal proceeds. Another involved TD employees allegedly collaborating with criminal organizations to launder $39 million to Colombia. These significant failures in TD’s oversight system included transactions exceeding daily limits by over 50 times, without proper scrutiny.
Attorney General Merrick Garland emphasized that TD executives were warned of these issues but did not take corrective action in time. As a result, TD will undergo three years of federal monitoring and five years of probation to ensure the bank’s compliance improvements.
Reforms and Response from TD Bank
TD’s CEO Bharat Masrani expressed regret, stating that the bank accepts full responsibility for the lapses and is committed to fixing its anti-money laundering program. As part of its remediation efforts, TD has appointed new leadership and hired hundreds of specialists to address the compliance shortfalls. The bank has also admitted to failing to monitor $18.3 trillion in customer transactions over six years.
In addition to the settlement, the Federal Reserve Board imposed $124 million in fines earlier this week for violations related to anti-money laundering regulations. The Office of the Comptroller of the Currency (OCC) will restrict TD’s growth until further notice, and the Financial Crimes Enforcement Network (FinCEN) has imposed a four-year independent monitorship to oversee the bank’s efforts to prevent future violations.
Further Legal Consequences
Beyond corporate penalties, two TD employees have been prosecuted, along with two dozen other individuals involved in the laundering schemes. More prosecutions are expected as investigations continue. TD’s legal troubles extend beyond this case, as the Consumer Financial Protection Bureau (CFPB) recently fined the bank $28 million for providing inaccurate customer information to reporting agencies and failing to address these errors.
Brendan Shanahan Appointed Chief Financial Officer of GoHealth, Bringing Decades of Leadership in Healthcare and Financial Strategy
CHICAGO, October 10, 2024 /Globe Newswire/ — GoHealth, Inc. (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, today announced the appointment of Brendan Shanahan as Chief Financial Officer (CFO), effective October 14, following a comprehensive search process. Mr. Shanahan, a seasoned executive with over 30 years of financial leadership experience and over 20 years of expertise in the Medicare Advantage space, will oversee GoHealth’s financial strategy and operations, contributing to the company’s profitable growth and innovation efforts.
“Brendan’s extensive expertise in financial strategy, M&A, operational leadership, and deep knowledge of the Medicare Advantage market makes him the ideal choice to lead GoHealth’s financial organization,” said Vijay Kotte, CEO of GoHealth. “His track record of driving financial performance, operational efficiency, and long-term value aligns perfectly with our mission to deliver outstanding results for shareholders.”
Mr Shanahan, who was also a licensed insurance agent, will manage all financial aspects of GoHealth, including financial planning, analysis, reporting, investor relations, and capital structure optimization. Additionally, he will provide leadership in financial risk management, business analytics, budgeting, audit, and tax compliance, to ensure GoHealth achieves both its short- and long-term financial goals.
Throughout his career, Mr. Shanahan has built high-performing finance teams, implemented systems to streamline financial operations, and played key roles in mergers and acquisitions. His leadership in financial strategy, including P&L oversight, cost containment, and capital management, has consistently delivered tangible results.
Mr. Shanahan holds an MBA in Banking and Finance from Hofstra University and a Bachelor of Science in Business Administration from The Citadel. He is also a Certified Public Accountant (CPA) (inactive) and a Chartered Global Management Accountant.
Mr. Shanahan expressed his excitement to join GoHealth, stating, “I’m thrilled to join GoHealth at such a pivotal time for the Medicare Advantage industry and the brokerage space. Having spent much of my career working to help individuals navigate their healthcare options, I am excited to continue that journey with GoHealth. The combination of GoHealth’s technology, deep expertise in Medicare, and commitment to empowering consumers is unparalleled. I look forward to working with Vijay and the team to capitalize on the significant opportunities ahead as we navigate this dynamic market and drive long-term value for shareholders.”
Katherine O’Halloran will remain as a key leader in the finance organization, continuing to serve as Chief Accounting Officer and reporting to the CFO. “We want to thank Katie for embracing with diligence her interim role as CFO and her commitment to managing GoHealth and the financial team through this transition. Katie is an extraordinary example of living our GoHealth values,” said Kotte.
About GoHealth, Inc.
GoHealth is a leading health insurance marketplace and Medicare-focused digital health company. Enrolling in a health insurance plan can be confusing for customers, and the seemingly small differences between plans can lead to significant out-of-pocket costs or lack of access to critical medicines and even providers. GoHealth combines cutting-edge technology, data science and deep industry expertise to build trusted relationships with consumers and match them with the healthcare policy and carrier that is right for them. Since its inception, GoHealth has enrolled millions of people in Medicare plans and individual and family plans. For more information, visit https://www.gohealth.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements are made in reliance upon the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, future capital expenditures, debt service obligations and adoption and use of artificial intelligence technologies are forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “aims,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “likely,” “future” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions, projections and other statements about future events that are based on current expectations and assumptions. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.
These forward-looking statements speak only as of the date of this press release and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described in the sections titled “Summary Risk Factors,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Annual Report on Form 10-K”) and in our other filings with the Securities and Exchange Commission. The factors described in our 2023 Annual Report on Form 10-K should not be construed as exhaustive and should be read together with the other cautionary statements included in this press release, as well as the cautionary statements and other risk factors set forth in the Quarterly Report on Form 10-Q for the first fiscal quarter ended March 31, 2024, the forthcoming Quarterly Report on Form 10-Q for the second quarter ended June 30, 2024 and in our other filings with the Securities and Exchange Commission.
You should read this press release and the documents that we reference in this press release completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise
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.
Phase 1 Trial Tested Safety, Tolerability, and Pharmacokinetics At Multiple Doses. Unicycive announced completion of the Phase 1 trial testing UNI-494, its product in development for protecting against acute kidney injury. The study was designed to determine tolerability, safety, and pharmacokinetic data for the design of Phase 2. Unicycive plans to present the study at an upcoming scientific meeting.
UNI-494 Is In Development For Preventing Acute Kidney Injury. UNI-494 is a proprietary formulation of nicorandil to protect against the mitochondrial dysfunction and prevent pathways that lead to cell death in acute kidney injury. The proprietary formulation increases the half-life and makes it practical for administration, while maintaining its properties as a nicotinamide ester derivative and selective activator of the ATP-sensitive mitochondrial potassium channel.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
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.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Scores additional funding. This week, the company announced that it secured $11 million in additional funding through the issuance of convertible preferred shares. At $2 per share, the company raised the funds at a premium to the current share price, which has fluctuated around $1 per share in recent months. The shares will pay an 8% annualized dividend (quarterly installments) and are convertible to common shares at $2 per share.
Strategic relationship. Lance Shaner is the leading investor in the preferred share offering, which includes several other company insiders. Notably, Mr. Shaner, who chairs SKYX’s Hotel Advisory Board, is the CEO of Shaner Hotel Group, a leading developer of Marriot hotels. In our view, the vote of confidence given by Mr. Shaner could signal potential hotel partnerships for the company in the future and serves as continued validation of the company’s technology by industry insiders.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
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.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Second quarter financial results. For the fiscal year (FY) 2025, AZZ reported second quarter adjusted net income of $41.3 million or $1.37 per share compared to $37.2 million or $1.27 per share during the prior year period and our estimate of $40.8 million or $1.35 per share. Adjusted EBITDA increased 4.4% to $91.9 million, roughly in line with our estimate, representing 22.5% of sales versus 22.1% of sales during the second quarter of FY 2024. While sales of $409.0 million were modestly below our $410.5 million estimate, AZZ generated a 25.3% gross margin as a percentage of sales compared to 24.4% during the prior year period and our estimate of 24.4%. AZZ maintained its FY 2025 sales guidance range of $1.525 billion to $1.625 billion, lifted the lower end of adjusted EBITDA to a range of $320 million (from $310 million) to $360 million, and increased adjusted diluted EPS expectations to a range of $4.70 to $5.10 from $4.50 to $5.00.
Debt reduction. During the first half of FY25, AZZ generated operating cash flow of $119.4 million and reduced debt by $45 million. Management expects to reduce debt by at least $100 million during the fiscal year compared to prior expectations of $60 million to $90 million. At quarter end, the company’s net leverage was 2.7x trailing twelve months EBITDA and cash and cash equivalents amounted to $2.2 million.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
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.
Key Points: – NexGold and Signal Gold merge to create a leading near-term gold developer, aiming for over 200,000 ounces of annual production. – Combined company holds 4.7 million ounces of measured and indicated gold resources and 1.3 million ounces of inferred resources. – The merger will eliminate single-asset risk for both companies and advance growth, subject to shareholder and regulatory approvals.
NexGold and Signal Gold have announced a merger, aiming to establish a top-tier near-term gold developer. The combined company will focus on advancing NexGold’s Goliath Gold Complex Project and Signal’s Goldboro Gold Project, with both already having Environmental Assessment Approvals in place. The company aims to produce over 200,000 ounces of gold annually from these projects.
The merger brings together significant assets, with a combined 4.7 million ounces of measured and indicated gold resources and 1.3 million ounces of inferred resources between the two companies. Both projects show strong potential for growth. By merging, NexGold and Signal also eliminate the risks associated with being single-asset companies.
The leadership team of the newly merged company will bring together complementary expertise in geology, engineering, finance, and sustainability. Jim Gowans will lead the board as Chairman, with Kevin Bullock serving as CEO, Jeremy Wyeth as COO, and Orin Baranowsky as CFO.
The merger will see NexGold acquire all of Signal Gold’s outstanding shares, with Signal shareholders receiving 0.1244 NexGold shares for each Signal share. Post-merger, NexGold shareholders will own approximately 71% of the company, with Signal shareholders holding the remaining 29%. The merger is still subject to shareholder approval, as well as approvals from the Toronto Venture Exchange and the Toronto Stock Exchange.
Additionally, the companies are planning a non-brokered private placement financing of up to $11.5 million, with NexGold’s board and management expected to subscribe for up to $1.0 million. This financing will provide significant funding to advance both projects toward construction decisions while helping the combined entity deleverage.
Key Points: – CPI rose by 0.2% in September, bringing annual inflation to 2.4%, slightly above expectations. – Weekly jobless claims surged to 258,000, the highest in 14 months, influenced by hurricanes and strikes. – The Federal Reserve is expected to continue lowering interest rates, with an 87.1% chance of a 25-basis-point cut in November.
The Consumer Price Index (CPI) rose by 0.2% in September, slightly higher than expected, bringing the annual inflation rate to 2.4%. This increase was 0.1 percentage point above both August’s reading and market expectations. Over the past 12 months, CPI has increased by 2.4%, outpacing the forecasted 2.3%. Core prices, which exclude food and energy, rose by 0.3% for the month.
Despite this increase, inflation continues to trend down from its peak earlier this year, hitting its lowest level since February 2021. Key price shifts included a 1.9% drop in energy prices, a 0.4% increase in food prices, and a 0.2% rise in shelter costs. These changes, while modest, reflect some external pressures, including the ongoing conflict in the Middle East and the lingering effects of natural disasters.
In labor market news, weekly jobless claims surged to a 14-month high, reaching 258,000 for the week ending October 5, an increase of 33,000 from the previous week. The rise in claims is partly attributed to hurricane and strike activity. Florida and North Carolina, impacted by Hurricane Helene, saw a combined increase of 12,376 jobless claims. Michigan, affected by the Boeing strike, reported an additional 9,490 claims.
Despite the uptick in unemployment claims, nonfarm payrolls rose significantly in September. The Federal Reserve remains focused on reaching its inflation target of 2% and has begun lowering benchmark interest rates, including a half-point reduction in September. Further rate cuts are anticipated, with futures markets pricing in an 87.1% chance of a 25-basis-point cut in November, according to the CME’s FedWatch Tool.
While inflation was slightly higher than expected, external factors like hurricanes, strikes, and global tensions continue to influence economic dynamics. The Fed remains optimistic that inflation will continue its downward trend, though unforeseen events and upcoming political changes could impact future economic stability.
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.
