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.
Pre-Clinical Study Shows Synergy With Tenapanor. Unicycive Therapeutics announced the results of an animal model study that tested its phosphate binder, OLC, or oxylanthanum carbonate, and tenapanor, a phosphate-control drug that works through a different mechanism than the phosphate binding drugs. The results showed OLC had a greater reduction than tenapanor, and the combination of both drugs given together had synergistic effects that were better than either drug given alone.
Study Design. Tenapanor (Xphozah, from Ardelyx) is a sodium/hydrogen exchanger 3 (NHE3) inhibitor that works through paracellular absorption. It is used in patients that do not respond to phosphate binders or do not tolerate them. The study, “Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rats,” was published in the American Nephrology Society’s journal Kidney360. It compared the two drugs against a control (delivery vehicle alone) in rats receiving a high phosphorus diet.
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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.
InPlay Oil is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Transaction highlights. The acquisition appears to offer significant synergies and benefits to InPlay’s operations. InPlay’s production is expected to more than double to 18,750 boe/d from previous guidance of 8,650-9,150. Additionally, on a per share basis, 2025 adjusted funds flow (AFF) is expected to increase to C$204 million from previous guidance of C$69-75 million. Furthermore, the nature of the assets acquired is expected to enhance operational efficiencies to InPlay’s existing Pembina asset base by increasing the scale and contributing to lower decline, higher oil-weighting, and less capital-intensive production.
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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.
Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile application. Codere currently operates in its core markets of Spain, Italy, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence in the region.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Currency exchange impact. Q4 revenue of €52.6 million was roughly in line with our estimate of €55.0 million in spite of currency headwinds. Adj. EBITDA of €1.9 million was better than our estimate of €1.5 million, as illustrated in Figure #1 Q4 Results. Revenues would have been stronger if not for the depreciation of the Mexican Peso, down roughly 13.5% against the Euro. On a constant currency basis, revenue was up a strong 15% compared to reported growth of 5%.
NASDAQ extends deadline. The company’s auditor, Marcum, resigned unexpectedly in December, quickly replaced by MaloneBailey. Importantly, the company was able to present a plan to NASDAQ in its hearing on January 16 and was granted an extension until May 12 to file its 2023 annual report, the maximum extension allowed. The company intends to file within the extension deadline.
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.
Hans Baldau, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Kuri-Yawi epithermal gold target. In late 2024, Aurania commenced an induced polarization (IP) geophysical survey over its Kuri-Yawi epithermal gold target at the company’s Lost Cities-Cutucu project in Ecuador. Kuri-Yawi is a geochemical anomaly with enrichments in epithermal pathfinder elements. The IP survey was designed to identify deep conductors that could correspond to gold mineralization and to target drill holes for a future drilling program.
Survey results. Data collected from the survey was used to generate a three-dimensional model of the ground’s resistivity and chargeability. Conductive and chargeability anomalies are geophysical signatures that can indicate the presence of gold mineralization. The survey returned two main chargeability vertical structures. Resistivity results highlighted different bodies of rock, or lithologic units, with a conductive sedimentary unit to the east and a resistive volcanic unit overlaying another conductive unit at depth.
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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.
ACCO Brands Corporation is one of the world’s largest designers, marketers and manufacturers of branded academic, consumer and business products. Our widely recognized brands include AT-A-GLANCE®, Esselte®, Five Star®, GBC®, Kensington®, Leitz®, Mead®, PowerA®, Quartet®, Rapid®, Rexel®, Swingline®, Tilibra®, and many others. Our products are sold in more than 100 countries around the world. More information about ACCO Brands, the Home of Great Brands Built by Great People, can be found at www.accobrands.com.
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.
4Q24. Fourth quarter sales and EPS were in line with expectations, excluding greater than anticipated foreign currency headwinds. ACCO experienced ongoing softer demand for certain office-related products and lower demand for back-to-school products in Brazil, partially offset by growth in the technology accessories categories. ACCO further increased its multi-year cost reduction program to $100 million of cumulative savings.
Details. Revenue of $448.1 million was down 8.3% y-o-y, with comp sales down 5.9% and adverse foreign exchange reducing sales by 2.4%. Adjusted operating income was $64.2 million versus $68.3 million last year. Adjusted net income was $37.5 million, and adjusted EPS was $0.39 for both 4Q24 and 4Q23.
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: – Treasury yields declined slightly as investors analyzed economic data and Trump’s proposed tariffs. – Jobless claims came in higher than expected, signaling a potential softening in the labor market. – Fed officials emphasized the need for further inflation progress before considering rate cuts.
U.S. Treasury yields edged lower on Thursday as investors assessed fresh economic data and the potential impact of U.S. President Donald Trump’s proposed tariffs. The 10-year Treasury yield declined more than 2 basis points to 4.507%, while the 2-year Treasury yield dropped 2.3 basis points to 4.253%. Yields move inversely to bond prices, meaning demand for Treasuries increased slightly as investors sought stability amid economic uncertainty.
One of the key economic reports influencing the bond market was the latest weekly initial jobless claims data, which showed 219,000 new claims for unemployment benefits in the week ending Feb. 15. This was slightly above the 215,000 claims economists had expected, signaling a modest cooling in the labor market. Investors also awaited the release of the Philadelphia Fed Manufacturing Index, an important measure of regional economic activity that could provide further insight into the strength of the U.S. economy.
At the same time, Federal Reserve officials were scheduled to speak throughout the day, offering additional perspectives on monetary policy. Among them, Fed Bank of Chicago President Austan Goolsbee and Fed Governor Adriana Kugler were expected to discuss economic conditions and the outlook for inflation. The market remained focused on any indications of future interest rate changes, particularly given the Federal Reserve’s cautious stance on inflation.
Another factor weighing on investor sentiment was Trump’s latest tariff proposal, which called for a 25% duty on key imports, including automobiles, pharmaceuticals, and semiconductors. The former president stated that these tariffs could increase significantly over time and potentially take effect as early as April 2. Investors closely monitored these developments, as trade policies can have broad economic implications, affecting corporate profitability, inflationary pressures, and overall market stability.
Meanwhile, the Federal Reserve’s recently released meeting minutes suggested that policymakers remain concerned about inflation risks. Officials emphasized that they would need to see sustained progress on inflation before considering additional interest rate cuts. They also noted that potential shifts in trade and immigration policies could create further economic uncertainty.
Bond markets reacted cautiously to these developments, with Treasury yields experiencing a slight decline as investors weighed the implications for future monetary policy. Lower yields often indicate increased investor demand for safe-haven assets, particularly when concerns about economic growth or inflation emerge.
As the economic landscape continues to evolve, market participants will closely watch upcoming data releases and Federal Reserve commentary for further indications of policy direction. The trajectory of interest rates remains a key focus, with investors balancing optimism about economic resilience against concerns over inflation and potential trade disruptions.
Key Points: – Acquiring FibroGen’s China operations for $160M secures rights to anemia drug roxadustat. – The sale extends cash runway to 2027 and funds key drug development. – Roxadustat leads in China, but faces generic competition and regulatory scrutiny.
AstraZeneca (AZN) has announced a $160 million acquisition of FibroGen’s (FGEN) China business, securing regional rights to the oral anemia drug roxadustat. This deal strengthens AstraZeneca’s footprint in the Chinese pharmaceutical market while providing FibroGen with a much-needed financial boost.
The relationship between AstraZeneca and FibroGen surrounding roxadustat dates back over a decade. Initially, AstraZeneca held broader rights to the HIF-PH inhibitor but returned control in the U.S. and select other markets last year. However, the company maintained an interest in China and South Korea, where the drug is marketed under the brand name Evrenzo.
With this acquisition, AstraZeneca will pay an enterprise value of $85 million, in addition to $75 million of net cash currently held by FibroGen’s Chinese operations. The transaction is expected to close in mid-2025, at which point FibroGen plans to use the proceeds to repay a term loan facility managed by Morgan Stanley Tactical Value, simplifying its capital structure.
For FibroGen, this sale represents a crucial financial lifeline. Entering 2024, the company held $121.1 million in cash and equivalents. The proceeds from this transaction, coupled with loan repayment, should extend FibroGen’s cash runway into 2027. The move allows the company to refocus on developing FG-3246, a CD46-targeting antibody-drug conjugate, and FG-3180, a companion PET imaging agent for metastatic castration-resistant prostate cancer (mCRPC).
“This deal bolsters our company on several fronts,” said FibroGen CEO Thane Wettig. “It strengthens our financial position, meaningfully extending our cash runway, and enables us to continue progressing key clinical development programs.”
Roxadustat is a leading treatment for anemia in chronic kidney disease in China, and regulatory bodies are considering its approval for chemotherapy-induced anemia. Despite its dominance, the drug faces increasing competition, as Chinese regulators approved a generic version from CSPC Pharmaceutical last summer. Several other companies are also seeking approval for their own generic versions.
China remains a crucial market for AstraZeneca, though the company has recently encountered challenges, including a slowdown in sales and an ongoing investigation into its former China head, Leon Wang, over potential tax violations. Nevertheless, AstraZeneca CEO Pascal Soriot remains optimistic, stating in a recent earnings call that “longer term, we see continuous opportunity for growth in China.”
While today’s deal secures AstraZeneca’s position in China, FibroGen retains the rights to roxadustat in other markets, including the U.S., where it has faced regulatory setbacks. The drug was rejected by the FDA in 2021 for chronic kidney disease and later failed a Phase 3 anemia trial in 2023. However, FibroGen is still evaluating development plans for anemia associated with lower-risk myelodysplastic syndrome, with hopes of meeting with the FDA in the second quarter to discuss potential next steps.
As the transaction moves forward, both AstraZeneca and FibroGen are positioning themselves for long-term growth, with AstraZeneca reinforcing its presence in China’s expanding pharmaceutical sector and FibroGen securing the resources to pursue future drug development.
New guide helps organizations create clear, responsible AI usage policies to unlock the value of artificial intelligence while mitigating risks
HOUSTON, Feb. 20, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), today announced the release of its framework for establishing an employee generative AI usage policy, a practical guide from the company’s AI Council designed to help organizations set clear expectations and guardrails for AI use in the workplace.
As generative AI tools become more common in daily workflows, employees use them to streamline tasks, increase efficiency, and drive productivity. However, organizations risk data leaks, misinformation, compliance challenges, and reputational damage without well-defined policies. Despite widespread AI adoption, only 44% of companies have formal policies to govern its use.
Providing a Framework for AI Adoption and Governance
“AI adoption in the workplace is happening faster than many businesses are prepared for,” said Anu Pillai, Chief Technology Officer at Direct Digital Holdings. “Employees are already using these tools, but companies are leaving themselves open to significant risks without clear guidelines. Our framework offers business leaders a starting point to create transparent, structured AI policies that allow teams to safely and securely take advantage of the technology’s benefits.”
The “Framework for Employee Generative AI Usage Policy” guide is designed to help organizations craft policies tailored to their needs, addressing:
Ethical AI use and transparency
When AI can be used to add value and when its use poses an unnecessary risk
Data privacy guidelines to protect sensitive information
Human review and decision-making as a last line of defense
Creating cyclic structures for evaluating and auditing AI tools to maintain security
“Businesses can’t afford to take a wait-and-see approach on AI governance,” said Christy Nolan, VP of Delivery Solutions at Direct Digital Holdings. “By setting clear guidelines now, companies can foster a culture of informed AI adoption, positioning themselves to stay competitive while maintaining trust with customers, partners, and stakeholders.”
The framework is a foundational resource for business leaders, IT teams, and compliance officers looking to implement AI usage policies aligning with their industry, regulatory requirements, and company goals. It is designed to help organizations stay agile as AI evolves, providing a roadmap for responsible and sustainable AI integration in the workplace.
To download the “Framework for Employee Generative AI Usage Policy,” visit our AI Council resource center.
About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT) combines cutting-edge sell-side and buy-side advertising solutions, providing data-driven digital media strategies that enhance reach and performance for brands, agencies, and publishers of all sizes. Our sell-side platform, Colossus SSP, offers curated access to premium, growth-oriented media properties throughout the digital ecosystem. On the buy-side, Orange 142 delivers customized, audience-focused digital marketing and advertising solutions that enable mid-market and enterprise companies to achieve measurable results across a range of platforms, including programmatic, search, social, CTV, and influencer marketing. With extensive expertise in high-growth sectors such as Energy, Healthcare, Travel & Tourism, and Financial Services, our teams deliver performance strategies that connect brands with their ideal audiences. At Direct Digital Holdings we prioritize personal relationships by humanizing technology, ensuring each client receives dedicated support and tailored digital marketing solutions regardless of company size. This empowers everyone to thrive by generating billions of monthly impressions across display, CTV, in-app, and emerging media channels through advanced targeting, comprehensive data insights, and cross-platform activation. DDH is “Digital advertising built for everyone.”
The Three Projects Will Include an 80 Story High-Rise Building in the Miami Brickell District at 1040 South Miami Ave, Two Buildings in Clearwater Beach, and a Project in Jupiter Florida, Totaling Over 400 High-End Luxury Units
SKYX is Expected to Supply Forte Development with Over 12,000 Smart and Plug & Play Products Across Three Luxury Projects, Including Ceiling Outlet Receptacles, Lighting, Ceiling Fans, Recessed Lights, EXIT Signs, Emergency Lights, Downlights, and Indoor/Outdoor Wall Lights
SKYX’s Technologies Provide Opportunities for Recurring Revenues Through Upgrades, Interchangeability, Monitoring and Subscriptions and More
MIAMI, Feb. 20, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive smart platform technology company with more than 97 issued and pending patents globally and over 60 lighting and home décor websites, announces that it will start supplying its technologies to Forte Developments’ upcoming high-end luxury projects, including an 80-story building in Miami located at the Brickell district, two buildings in Clearwater Beach and a project in Jupiter, Florida.
Forte Developments is a leading high-end luxury condo and home development company. Forte’s developments include well-known luxury buildings in Palm Beach and Miami, Florida, as well as in The Hamptons, New York, among others.
During the course of the three projects, SKYX is expected to deliver over 12,000 of its products, representing a variety of its advanced and smart platform technology plug & play platform products. SKYX is expected to start supplying its products during the second half of 2025.
Marius Fortelni CEO and Founder of Forte Developments said: “We are excited to develop our ultra-high-end luxury upcoming projects utilizing SKYX’s game-changing advanced, smart, and safe plug and play technologies. I strongly believe that SKYX’s disruptive ceiling platform technologies will become the standard for new construction as they provide smart capabilities, safety and time savings, while adding significant value to our homes and buildings.” Link to Forte’s website here: https://fortedevelopmentus.com/
Rani Kohen, Founder/Inventor and Executive Chairman, of SKYX Platforms, said: “We are excited to work with a high-end condo developer such as Forte Developers. This is another step toward our goal of making homes and buildings become advanced, safe, and smart as the new standard. We look forward to continuing to demonstrate our advanced smart platform technology’s ability to make homes and buildings become smart and safe instantly, while significantly advancing buildings and saving time and cost to developers.”
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.
Forward-Looking Statements Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
RESTON, Va., Feb. 20, 2025 /PRNewswire/ — V2X Inc., (NYSE: VVX) has been awarded a $21 million firm-fixed-price contract to continue sustaining critical avionics and electronic warfare systems for the U.S. Air Force. The contract supports the repair and maintenance of AN/ALQ-172 and AN/ALQ-161 components, ensuring the continued operational effectiveness of the B-52 Stratofortress, the B-1B, and C-130 fleet.
As global forces continue to refine their electronic warfare capabilities, V2X’s work ensures that U.S. aircraft remain protected in contested environments. The AN/ALQ-172 self-protection integrated RF subsystem provides multi-threat countermeasures, defending against pulse, continuous wave, pulse Doppler, and monopulse radar threats. Similarly, the AN/ALQ-161system, has been continuously upgraded to detect and counter evolving electronic threats, extending its life and improving its capability from its initial fielding in the 1980s.
V2X’s expertise in sustaining and enhancing these complex avionics plays a crucial role in extending the lifespan and effectiveness of legacy aircraft and their mission systems.
“Our mission is twofold: enhancing the capabilities of legacy systems with cost effective and technology driven solutions, and more importantly, ensuring the safety of B-52, B-1, and C-130 aircrews in an ever-evolving threat environment,” said Jeremy C. Wensinger, President and Chief Executive Officer of V2X. “This contract reinforces our commitment to delivering and sustaining cutting-edge battlefield solutions that protect warfighters and maintain combat readiness.”
Work under this contract will be performed at Robins Air Force Base, Georgia and Indianapolis, Indiana, with an expected completion date in 2029. The contract underscores V2X’s trusted expertise in electronic warfare sustainment.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
Media Contact Angelica Spanos Deoudes Senior Director, Marketing and Communications Angelica.Deoudes@goV2X.com 571-338-5195
Total revenue was €50.0 mm in Q4 2024, while net gaming revenue1 was €52.6 mm in the period, 5% above Q4 2023.
Net income excluding the non-cash variation in fair value of public warrants2 was €6.8 mm in 2024 versus a net loss of €4.0 mm in 2023.
Total cash position of €40.5 mm as of December 31, 2024.
Providing full year 2025 net gaming revenue outlook of €220-230 mm and Adj. EBITDA3 outlook of €10-15 mm.
The Company’s Board of Directors has authorized a share buyback plan of up to $5.0 mm, subject to shareholder approval.
Madrid, Spain and Tel Aviv, Israel, February 20, 2025 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), a leading online gaming operator in Spain and Latin America, has released its preliminary unaudited4 financial results for the quarter and year ended December 31, 2024.
Below are the main financial and operating metrics of the period.
Aviv Sher, CEO of Codere Online, stated, “We delivered another solid quarter, with net gaming revenue reaching €52.6 million, a 5% increase compared to the fourth quarter of 2023. In Mexico, net gaming revenue was flat at €25.1 million, driven by the significant devaluation of the Mexican peso. On a constant currency basis, our growth in Mexico would have been 14%. Meanwhile, Spain continued to perform well, with net gaming revenue rising 10% to €22.8 million.”
Oscar Iglesias, CFO of Codere Online, commented, “Our strong fourth-quarter performance brought our full-year net gaming revenue to nearly €212 million, 10% above the midpoint of our initial €185-200 million outlook from early 2024. More importantly, we delivered a fourth consecutive quarter of positive Adjusted EBITDA, allowing us to reach €6.4 million for the full year, at the higher end of our outlook of €2.5-7.5 million.”
Mr. Iglesias added, “We are very encouraged by our 2024 results and our ability to meet our commitment to investors despite the headwinds faced, mostly on the currency front. For 2025, we anticipate net gaming revenue of €220-230 million and Adj. EBITDA of €10-15 million. Also, we are pleased to announce an up to $5.0 million share buyback plan, subject to shareholder approval, which reflects our confidence in the business and future cash flow generation.”
Recent Events
Listing Extension from Nasdaq
Following a hearing on January 16, 2025, at which the Company presented its plan to regain compliance, the Nasdaq Hearings Panel granted the Company’s request to continue its listing on Nasdaq on February 12, 2025;
The extension is subject to the Company filing its 2023 annual report on or before May 12, 2025;
The Company continues to work diligently to complete and file its 2023 annual report as soon as possible and expects to do so within the extension period it has been granted.
Implementation of a Share Buyback Plan
The Board of Directors of the Company has authorized (subject to obtaining shareholder approval) the repurchase of up to $5.0 million of the Company’s ordinary shares over a one-year period;
A general meeting of shareholders will be convened today and held on March 3, 2025 to approve the plan and the conditions under which it may be executed;
The share buyback plan does not require the Company to acquire any specific number of shares and may be terminated at any time. Repurchases of shares pursuant to the share buyback plan will be conducted in accordance with applicable law, including U.S. securities laws.
New Tax in Colombia
On February 14, 2025, Colombia’s Ministry of Finance introduced, through executive decree, a value added (i.e. indirect) tax of 19% on all online deposits;
The tax will be effective on February 21, 2025, and will remain in effect through December 31, 2025, though we expect legal challenges from the industry with respect to its constitutionality;
The Company is currently assessing how it will respond from a legal and operating perspective to this tax and potential impacts on its business in Colombia.
Conference Call Information
Codere Online’s management will host a conference call to discuss the results and provide a business update at 8:30 am US Eastern Time today, February 20, 2025. Dial-in details as well as the audio webcast and presentation will be accessible on Codere Online’s website at www.codereonline.com. A recording of the webcast will also be available following the conference call.
About Codere Online
Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online, launched in 2014 as part of the renowned casino operator Codere Group, offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere Online currently operates in its core markets of Spain, Mexico, Colombia, Panama and Argentina; this online business is complemented by Codere Group’s physical presence in Spain and throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.
About Codere Group Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).
Note on Rounding. Due to decimal rounding, numbers presented throughout this report may not add up precisely to the totals and subtotals provided, and percentages may not precisely reflect the absolute figures.
Forward-Looking Statements Certain statements in this document may constitute “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding Codere Online Luxembourg, S.A. and its subsidiaries (collectively, “Codere Online”) or Codere Online’s or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this document may include, for example, statements about Codere Online’s financial performance and, in particular, the potential evolution and distribution of its net gaming revenue; any prospective and illustrative financial information; and changes in Codere Online’s strategy, future operations and target addressable market, financial position, estimated revenues and losses, projected costs, prospects and plans as well as he Company’s expectations about the timing of completion and filing of the Form 20-F for the year ended December 31, 2023 (the “2023 Annual Report”), and statements related to the Company’s plan, timing and actions taken to regain compliance with the Listing Rule 5250(c)(1).
These forward-looking statements are based on information available as of the date of this document and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing Codere Online’s or its management team’s views as of any subsequent date, and Codere Online does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
As a result of a number of known and unknown risks and uncertainties, Codere Online’s actual results or performance may be materially different from those expressed or implied by these forward-looking statements. There may be additional risks that Codere Online does not presently know or that Codere Online currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Some factors that could cause actual results to differ include (i) changes in applicable laws or regulations, including online gaming, privacy, data use and data protection rules and regulations as well as consumers’ heightened expectations regarding proper safeguarding of their personal information, (ii) the impacts and ongoing uncertainties created by regulatory restrictions, changes in perceptions of the gaming industry, changes in policies and increased competition, and geopolitical events such as war, (iii) the ability to implement business plans, forecasts, and other expectations and identify and realize additional opportunities, (iv) the risk of downturns and the possibility of rapid change in the highly competitive industry in which Codere Online operates, (v) the risk that Codere Online and its current and future collaborators are unable to successfully develop and commercialize Codere Online’s services, or experience significant delays in doing so, (vi) the risk that Codere Online may never achieve or sustain profitability, (vii) the risk that Codere Online will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all, (viii) the risk that Codere Online experiences difficulties in managing its growth and expanding operations, (ix) the risk that third-party providers, including the Codere Group, are not able to fully and timely meet their obligations, (x) the risk that the online gaming operations will not provide the expected benefits due to, among other things, the inability to obtain or maintain online gaming licenses in the anticipated time frame or at all, (xi) the risk that Codere Online is unable to secure or protect its intellectual property, (xii) the risk that Codere Online’s securities may be delisted from Nasdaq and (xiii) the possibility that Codere Online may be adversely affected by other political, economic, business, and/or competitive factors. Additional information concerning certain of these and other risk factors is contained in Codere Online’s filings with the U.S. Securities and Exchange Commission (the “SEC”). All subsequent written and oral forward-looking statements concerning Codere Online or other matters and attributable to Codere Online or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above.
Financial Information and Non-GAAP Financial Measures Codere Online’s financial statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”), which can differ in certain significant respects from generally accepted accounting principles in the United States of America (“U.S. GAAP”).
This document includes certain financial measures not presented in accordance with U.S. GAAP or IFRS (“non-GAAP”), such as, without limitation, net gaming revenue, Adjusted EBITDA and constant currency information. These non-GAAP financial measures are not measures of financial performance in accordance with U.S. GAAP or IFRS and may exclude items that are significant in understanding and assessing Codere Online’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to revenue, net income, cash flows from operations or other measures of profitability, liquidity or performance under U.S. GAAP or IFRS. You should be aware that Codere Online’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. In addition, the audit of Codere Online’s financial statements in accordance with PCAOB standards, may impact how Codere Online currently calculates its non-GAAP financial measures, and we cannot assure you that there would not be differences, and such differences could be material.
Codere Online believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing Codere Online’s financial measures with other similar companies, many of which present similar non-GAAP financial measures to investors. These non-GAAP financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-GAAP financial measures. Reconciliations of non-GAAP financial measures to their most directly comparable measure under IFRS are included herein.
This document may include certain projections of non-GAAP financial measures. Codere Online is unable to quantify certain amounts that would be required to be included in the most directly comparable U.S. GAAP or IFRS financial measures without unreasonable effort, due to the inherent difficulty and variability of accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such comparable measures or such reconciliation that have not yet occurred, are out of our control, or cannot be reasonably predicted, ascertained or assessed, which could have a material impact on its future IFRS financial results. Consequently, no disclosure of estimated comparable U.S. GAAP or IFRS measures is included and no reconciliation of the forward-looking non-GAAP financial measures is included.
Use of Projections This document contains financial forecasts with respect to Codere Online’s business and projected financial results, including net gaming revenue and adjusted EBITDA. Codere Online’s independent auditors have not audited, reviewed, compiled or performed any procedures with respect to the projections for the purpose of their inclusion in this document, and accordingly, they did not express an opinion or provide any other form of assurance with respect thereto for the purpose of this document. These projections should not be relied upon as being necessarily indicative of future results. The assumptions and estimates underlying the prospective financial information are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the prospective financial information. See “Forward-Looking Statements” above. Accordingly, there can be no assurance that the prospective results are indicative of the future performance of Codere Online or that actual results will not differ materially from those presented in the prospective financial information. Inclusion of the prospective financial information in this document should not be regarded as a representation by any person that the results contained in the prospective financial information will be achieved.
For further information on the limitations and assumptions underlying these projections, please refer to Codere Online’s filings with the SEC.
Preliminary Information This document contains figures, financial metrics, statistics and other information that is preliminary and subject to change (the “Preliminary Information”). The Preliminary Information has not been audited, reviewed, or compiled by any independent registered public accounting firm. This Preliminary Information is subject to ongoing review including, where applicable, by Codere Online’s independent auditors. Accordingly, no independent registered public accounting firm has expressed an opinion or any other form of assurance with respect to the Preliminary Information. During the course of finalizing such Preliminary Information, adjustments to such Preliminary Information presented herein may be identified, which may be material. Codere Online undertakes no obligation to update or revise the Preliminary Information set forth in this document as a result of new information, future events or otherwise, except as otherwise required by law. The Preliminary Information may differ from actual results. Therefore, you should not place undue reliance upon this Preliminary Information. The Preliminary Information is not a comprehensive statement of financial results, and should not be viewed as a substitute for full financial statements prepared in accordance with IFRS. In addition, the Preliminary Information is not necessarily indicative of the results to be achieved in any future period.
No Offer or Solicitation This document does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.
Industry and Market Data In this document, Codere Online relies on and refers to certain information and statistics obtained from publicly available information and third-party sources, which it believes to be reliable. Codere Online has not independently verified the accuracy or completeness of any such publicly-available and third-party information, does not make any representation as to the accuracy or completeness of such data and does not undertake any obligation to update such data after the date of this document. You are cautioned not to give undue weight to such industry and market data.
Contacts:
Investors and Media Guillermo Lancha Director, Investor Relations and Communications Guillermo.Lancha@codere.com (+34) 628.928.152
1 Net Gaming Revenue is a non-IFRS measure; please see reconciliation of Net Gaming Revenue to Revenue at the end of the report.
2 Net income excluding the non-cash variation in fair value of public warrants is a non-IFRS measure and reflects a net income of €3.7 mm (€3.1 mm net loss in 2023) excluding a €3.1 mm loss (€0.9 mm gain in 2023) from the variation in fair value of public warrants. Figures presented for illustrative purposes and do not include any potential impacts on the provision for corporate income taxes.
3 Adjusted EBITDA is a non-IFRS measure; please see reconciliation of Adjusted EBITDA to Net Income at the end of the report. Net gaming revenue and Adjusted EBITDA outlooks are forward-looking non-IFRS measures; please see important disclaimers at the end of the report.
4 See “Preliminary Information” below.
5 Average Monthly Active Players include real money (i.e. exclude free bets) sports betting and casino actives.
6 Figures primarily reflect differences in recognition of revenue related to certain partner and affiliate agreements in place in Colombia, VAT impact from entry fees in Mexico and the impact from the application of inflation accounting (IAS 29) in Argentina.
7 Please refer to page 26 of our Q4 2024 Earnings Presentation for further details regarding this reconciliation.
Toronto, Ontario–(Newsfile Corp. – February 20, 2025) – Aurania Resources Ltd. (TSXV: ARU) (OTCQB: AUIAF) (FSE: 20Q) (“Aurania” or the “Company”) reports that the induced polarization (IP) geophysical survey has provided invaluable information that will assist in defining the location of future drill holes at the Kuri-Yawi gold target in Ecuador. Kuri-Yawi is a geochemical anomaly with enrichments in epithermal pathfinder elements. In addition, large pieces of siliceous sinter in float were recovered from the grid signifying the presence of an extinct geothermal system. The Fruta del Norte gold deposit some 100 km to the south lies beneath a siliceous sinter unit.
The IP survey detected conductive and chargeability anomalies at the Kuri-Yawi epithermal gold target. Chargeability (or induced polarization) is a measure of the ability of the rock to temporarily retain an induced electrical charge, usually due to disseminated sulphides
Our geologists are now working to interpret the IP survey results in relation to and compared to existing field data and data from the previous Mobile MagnetoTellurics (MobileMT) airborne survey to define optimal drill hole positions. A start date for a proposed drill program at Kuri-Yawi has not yet been determined.
The IP survey at Kuri-Yawi was conducted by GexplOre in late 2024 using the Fullwaver system (from Iris Instruments). The Fullwaver is a distributed acquisition system with each system being fully independent of the other. This drastically reduces the need for cables making it optimal for challenging terrain.
Two different methods were deployed during the geophysical survey:
Pseudo-3D profiling using 2D DC electrical methods in Pole-dipole configuration with simultaneous measurement of apparent resistivity (ρa) and induced polarization (IP) along eleven profiles, each of 2700 m length; and
3D DC electrical methods over a selected area with simultaneous measurement of apparent resistivity (ρa) and induced polarization (IP) along two grids (0.6 km²).
The collected data was processed and inverted to generate a 3D model of the ground’s resistivity and chargeability.
Resistivity and Conductivity
The resistivity results highlight the different lithologic units with a conductive sedimentary unit to the east and a resistive volcanic unit overlying another conductive unit at depth that could correspond to an alternation of black shale, limestone and volcanic tuff. These facies are known further to the north and are suspected to be a good trap for gold mineralisation. The conductive unit at surface may correspond to the tropically weathered clay level.
In the southeastern area, conductive vertical structures are locally present and remain relatively consistently sub-perpendicular along the lines, forming a large vertical conductive corridor. The direction of this corridor is similar to the direction of the chalcedony veins with high grade thallium that was discovered while walking the cut lines on the survey grid.
Fig 1: Resistivity and conductivity image of the Kuri-Yawi target to the south (red is conductive and blue is resistive).
The survey returned two main chargeability vertical structures:
One to the Northwest of the grid extending to a deeper more chargeable model (Fig 2).
The others to the south of the grid are associated with the corridor of vertical conductive anomalies (see above). They extend to the depth of the inverted model as one (western area) or two vertical structures (eastern area), forming a single large vertical structure. In the eastern area, the unit is separated into two main vertical structures of high chargeability (Fig 3). In contrast to western anomalies (Fig 2), the maximum chargeability of these structures is observed along the edges of the vertical conductive corridor.
Fig 2: Chargeability in the west area of the grid at Kuri-Yawi (red is high chargeability and blue is low chargeability).
Aurania will be attending the Prospector’s and Developers International Convention (PDAC) being held March 2nd – 5th, 2025 at the Metro Toronto Convention Centre (MTCC) in Toronto, Canada. Visit us at booth 2948 in the Investors Exchange located in the MTCC South Building, Level 800. For more information about PDAC and registration, please visit the PDAC website.
Aurania is hosting a meet-and-greet for its shareholders on Sunday, March 2nd from 5:00pm-8:00pm in Salon 1, 19th Floor, at The Fairmont Royal York Hotel, 100 Front Street West, Toronto, Ontario.
Due to capacity limitations, we kindly ask that youconfirm your attendance no later than 10am ET on February 24th by RSVP to Carolyn: Carolyn.muir@aurania.com
Qualified Persons:
The geological information contained in this news release has been verified and approved by Aurania’s VP Exploration, Mr. Jean-Paul Pallier, MSc. Mr. Pallier is a designated EurGeol by the European Federation of Geologists and a Qualified Person as defined by National Instrument 43-101, Standards of Disclosure for Mineral Projects of the Canadian Securities Administrators.
About Aurania
Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucu Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.
Neither the TSX-V nor its Regulation Services Provider (as that term is defined in the policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains forward-looking information as such term is defined in applicable securities laws, which relate to future events or future performance and reflect management’s current expectations and assumptions. The forward-looking information includes Aurania’s objectives, goals or future plans, statements, exploration results, potential mineralization, the corporation’s portfolio, treasury, management team and enhanced capital markets profile, the estimation of mineral resources, exploration, timing of the commencement of operations, the Company’s teams being on track ahead of any drill program, the commencement of any drill program and estimates of market conditions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to Aurania, including the assumption that, there will be no material adverse change in metal prices, all necessary consents, licenses, permits and approvals will be obtained, including various local government licenses and the market. Investors are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected. Risk factors that could cause actual results to differ materially from the results expressed or implied by the forward-looking information include, among other things: commodity prices, supply chain disruptions, restrictions on labour and workplace attendance and local and international travel; a failure to obtain or delays in obtaining the required regulatory licenses, permits, approvals and consents; an inability to access financing as needed; a general economic downturn, a volatile stock price, labour strikes, political unrest, changes in the mining regulatory regime governing Aurania; a failure to comply with environmental regulations; a weakening of market and industry reliance on precious metals and base metals; and those risks set out in the Company’s public documents filed on SEDAR+. Aurania cautions the reader that the above list of risk factors is not exhaustive. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law.
Combination therapy with oxylanthanum carbonate plus tenapanor led to greater reductions in urinary phosphate excretion than either drug alone
LOS ALTOS, Calif., Feb. 20, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the publication of preclinical data describing the benefits of combination treatment of oxylanthanum carbonate (OLC) and tenapanor on phosphate management in the American Society of Nephrology (ASN) journal, Kidney360.
The publication, entitled “Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rats,” examines the potential synergistic benefits of a combination of OLC, a phosphate binder, with tenapanor, a sodium/hydrogen exchanger 3 (NHE3) inhibitor, on urinary phosphate excretion. Data demonstrated sizeable reductions in urinary phosphate excretion (a proxy for intestinal phosphate absorption) in response to both OLC monotherapy and the combination of OLC with tenapanor.
“With approximately 75% of patients receiving maintenance dialysis failing to meet serum phosphate targets set by international Kidney Disease Improving Global Outcomes (KDIGO) guidelines, we must explore new approaches to improve control of hyperphosphatemia” said Glenn M. Chertow, M.D., M.P.H., Professor of Medicine, Stanford University School of Medicine. “Based on the results of this pre-clinical study, we believe that OLC, an investigational phosphate binder, when used alone or in combination with tenapanor, could improve control of hyperphosphatemia in patients receiving maintenance dialysis who are either unresponsive to currently available phosphate binders or intolerant to their associated adverse effects, high pill burden, and poor palatability.”
“We’re excited by these preclinical data showing a synergistic treatment effect from the combination of OLC and tenapanor. OLC, with its low pill burden and more palatable formulation, could complement tenapanor, significantly enhancing patient adherence and clinical outcomes,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Further studies in patients with end-stage kidney disease and hyperphosphatemia will be required to understand the most effective and best tolerated OLC-containing regimens, as we aim to improve long-term control of hyperphosphatemia and prevent its myriad complications.”
Key Findings:
Treatment with tenapanor alone (0.15 mg/kg) led to 12.5% lower mean urinary phosphate excretion compared to the vehicle in rats fed a high phosphorus diet.
A pooled analysis of monotherapy with OLC (0.75%, 1.5%, and 3%) demonstrated a 17.7% reduction in urinary phosphate excretion compared to vehicle.
Treatment with tenapanor in combination with OLC demonstrated a more pronounced 41.3% reduction in urinary phosphate excretion compared to vehicle.
The combination of OLC and tenapanor was synergistic and statistically significant (p=0.009 for 0.75% OLC + tenapanor and p=0.010 for 1.5% OLC + tenapanor).
About Oxylanthanum Carbonate (OLC)
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
About 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. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. 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.
1Reason Research, LLC 2022 survey. Results here. 2 Fortune Business InsightsTM, Hyperphosphatemia Treatment Market, 2023-2030 3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM 4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.
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