FLORHAM PARK, N.J. & DEERFIELD BEACH, Fla. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, and AshBritt, the nation’s leading rapid-response emergency management, logistics and disaster-response contractor, today announced a collaboration to offer emergency services and instant payments to those in need.
The new offering combines Conduent’s expertise in managing a range of payment services for public sector clients with AshBritt’s experience with various disaster recovery efforts. The companies stand ready to quickly support government agencies or other organizations that help people and communities affected by natural disasters or other crises.
As a U.S. industry leader delivering electronic payments for government services in 37 states, Conduent offers instant or digital payment capabilities to agencies and other entities. Its Rapid Assistance solution can dramatically accelerate agencies’ and non-profits’ ability to securely deliver funds to individuals in minutes, rather than in days or weeks. Conduent can also provide chip-enabled, pre-paid debit cards – helping to ensure that those affected by disasters and crises receive aid quickly regardless of their banking status.
AshBritt is an industry leader in rapid-response logistics, such as base camps and comfort stations set up in communities. These types of facilities usually become points of distribution for those affected by a disaster, and this collaboration further expands the services that can be offered. AshBritt’s senior management and technical consultants have more than 200 years of combined experience and are intimately acquainted with all facets of disaster recovery efforts, including debris removal, management, reduction, processing, recycling and disposal, as well as emergency planning, damage mitigation and risk abatement.
“This innovative new collaboration with AshBritt is a great example of how two companies can combine their unique capabilities and expertise to meet a critical need among communities nationwide,” said Wade Fairey, General Manager, Payments and Child Support Solutions at Conduent. “Many natural disasters require mass distribution of funds as quickly as possible, and Conduent has deep experience in providing secure payment solutions that offer recipients near-immediate assistance. We’re proud to play a role in helping those who need support.”
“AshBritt is a government solutions provider always looking for new and innovative methods for delivering resources and services to communities we serve after an emergency event,” said Gerardo Castillo, President, Management and Logistics at AshBritt. “This novel collaboration with Conduent, a leader in their respective industry, allows us to continue offering the clients we serve with the most effective post-emergency solutions.”
About Conduent Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 55,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.
About AshBritt AshBritt is a national rapid-response emergency management, turn-key logistics, and disaster debris removal contractor. Since its inception in 1992, AshBritt has conducted over 500 disaster response missions and 52 special environmental projects, successfully serving more than 600 clients across the United States. The AshBritt team has been directly involved in the recovery efforts of more than 108 federally declared disasters in over 30 states, responding to major weather events, like Hurricanes Ian, Harvey, Irma, and Michael, wildfires in northern California, historic flooding in Kentucky, and mobilizing during the COVID-19 pandemic to administer more than 1 million vaccines across 20 states. Through the AshBritt Foundation, AshBritt supports communities where our team lives and works, investing more than $15 million across the U.S. Learn more at www.ashbritt.com .
Trademarks Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.
CHELMSFORD, MA / ACCESSWIRE / October 31, 2024 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for over 100 years, announced today that the company will release financial results for the third quarter of 2024, the period ended September 30, 2024, on Thursday, November 14, 2024, after the close of the market.
The Company will host a conference call and live webcast to discuss these results at 4:30 p.m. EDT on the same day. Interested parties may access the webcast at https://www.webcaster4.com/Webcast/Page/2810/51436 or access the conference call by dialing 888-506-0062 in the United States or 973-528-0011 from outside the U.S. and using access code 687861.
A replay of the call can also be accessed via phone through November 28, 2024 by dialing (877) 481-4010 from the U.S., or (919) 882-2331 from outside the U.S. The conference call replay passcode is 51436.
About Harte Hanks:
Harte Hanks (NASDAQ:HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.
Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including GlaxoSmithKline, Unilever, Pfizer, Warner Bros Discovery, Volvo, Ford, FedEx, Midea, and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,000 employees in offices across the Americas, Europe, and Asia Pacific.
As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks, Inc.
Investor Relations Contact:
Rob Fink or Tom Baumann 646.809.4048 / 646.349.6641 FNK IR HHS@fnkir.com
The Company’s antiviral candidate for seasonal and pandemic influenza shows in vitro activity against the avian influenza A PB2 protein, whereas current influenza vaccines offer no protection against pandemic avian influenza
BOTHELL, Wash., Oct. 31, 2024 (GLOBE NEWSWIRE) — As the fall seasonal influenza and COVID season gets underway in the Northern Hemisphere, Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) highlights the ability of the Company’s innovative structure-based drug discovery platform technology to discover and develop novel broad-spectrum antivirals therapeutics to treat a wide range of viral diseases, including newly emerging pandemic strains such as recent H5N1 avian influenza identified in the US.
“As our nation enters the fall flu and COVID season and learns of the emerging highly pathogenic avian H5N1 influenza A strain in dairy cattle and humans, the need for more effective antivirals is clear. Current flu vaccines are developed for seasonal influenza strains, not for pandemic avian influenza strains. Also, treatment-emergent resistance to approved antivirals and transmission of resistant viruses has been a challenging issue,” said Sam Lee, PhD, President and co-CEO of Cocrystal. “For example, the widespread oseltamivir (Tamiflu®) resistance of the pandemic avian influenza strains could create a serous public health situation. Clearly, there continues to be an unmet need for therapeutics with a high barrier to resistance.
“We believe our approach makes it possible to develop highly effective therapeutics for noroviruses, coronaviruses and influenza A because we target the highly conserved, essential function of viral enzymes, regardless of whether the strain is seasonal or pandemic,” he added. “We recently revealed the high-resolution cocrystal structure of the avian influenza PB2 protein complexed with CC-42344, further confirming that our PB2 inhibitor CC-42344 binds to its highly conserved PB2 region, indicating activity against this strain.”
Cocrystal’s platform utilizes Nobel Prize-winning technology to develop a new class of direct-acting antivirals that work against enzymes that are essential for viral replication. The Company is evaluating its oral CC-42344 in a Phase 2a study in healthy subjects infected with a seasonal influenza A strain. Topline safety and tolerability results from this trial are expected by the end of 2024, and preparations are underway for an Investigational New Drug (IND) application to conduct a late-stage clinical study with CC-42344 in the U.S.
The Company is also conducting a Phase 1 study with its oral protease inhibitor CDI-988, the first pan-viral drug candidate in clinical evaluation for both noroviruses and coronaviruses. Topline safety and tolerability results of the multiple-ascending cohorts are expected late this year or early next year. There is no approved vaccine or antiviral for norovirus. Norovirus is highly contagious and is the most common cause of acute gastroenteritis, which has gained notoriety for outbreaks in closed quarters such as on cruise ships and in nursing homes. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 200,000 deaths are attributed to norovirus each year worldwide, with an estimated societal cost of approximately $60 billion.
“We view the next viral pandemic as a question of timing as seasonal viruses like flu and COVID continue to evolve,” said James Martin, CFO and co-CEO of Cocrystal. “Our proprietary technology platform allows us to efficiently discover and develop potent, broad-spectrum, effective antiviral drug candidates for pandemic and seasonal outbreaks relatively quickly and far less costly than traditional approaches to drug development. As a small company, Cocrystal is highly efficient in utilizing our groundbreaking technology to develop differentiated antivirals for high-value indications with the goal of improving people’s lives.”
Avian Influenza A multistate outbreak of highly pathogenic avian influenza in dairy cows was initially reported in March 2024. This is the first time that avian flu viruses were found in cows, with outbreaks now confirmed in herds in 14 states. In April 2024 the CDC confirmed an avian flu infection in a person exposed to dairy cows that were presumed to be infected with the virus. This is believed to be the first instance of likely mammal to human spread of this virus. In September 2024 the CDC reported the first human case of avian influenza without a known occupational exposure to sick or infected animals. As of October 30, 2024, the CDC has reported 36 human cases of this highly pathogenic avian influenza A in the U.S. during 2024.
The CDC analyzed blood collected from people of all ages in all 10 Health & Human Services regions during the 2022-2023 and 2021-2022 flu seasons. These samples were challenged with the avian flu subtype H5N1 virus to determine whether there was an antibody reaction. Data from this study suggest that there is extremely low to no population immunity to clade 2.3.4.4b A (H5N1) viruses in the U.S. Antibody levels remained low regardless of whether or not participants received a seasonal flu vaccination, meaning that seasonal flu vaccination did not produce antibodies to avian flu H5N1 viruses.
Antiviral Influenza Candidate CC-42344 CC-42344 is Cocrystal’s novel, broad-spectrum investigational antiviral candidate for the treatment of pandemic and seasonal influenza A. CC-42344 inhibits the first step in influenza A’s viral replication by binding to a highly conserved PB2 site of the influenza polymerase complex that is essential to replication and was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology.
Cocrystal is evaluating safety, viral and clinical measures of oral CC-42344 in healthy volunteers who are challenged with influenza A in a Phase 2a human challenge study underway in the United Kingdom. CC-42344 was advanced into this study following favorable safety and tolerability results reported in a Phase 1 study in healthy volunteers conducted in Australia. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable pharmacokinetic and safety profiles.
Cocrystal used its structure-based platform to determine the high resolution X-ray crystal structure of the recent avian influenza A (H5N1) PB2 protein, and confirmed activity of CC-42344 in vitro (NIH GeneBank ID:influenza A/Texas/37/2024(H5N1). The crystal structure of the avian influenza A (H5N1) PB2 protein showed new mutations located outside the PB2 active site. Subsequent studies showed that CC-42344 binds to the active site of the avian influenza A (H5N1) PB2 protein as previously demonstrated with the pandemic and seasonal influenza A PB2.
Structure-Based Platform Technology Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of best-in-class antiviral therapies that have fast onset of action and/or shortened treatment time, are safe, well tolerated and easy to administer, are effective against all viral subtypes that cause disease and have a high barrier to viral resistance.
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses, and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy of Cocrystal’s product candidates against certain viruses, ongoing research and development efforts including the expected timing of clinical studies and topline results for such product candidates, and the potential market for such product candidates. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers for such studies by our clinical research organizations and vendors, the results of such studies, our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, and potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Generates Revenues of $242.1 million and a Net Loss of $34.2 million
Gross Profit Margin Increases 20 basis points to 38.1%
Reports Adjusted EBITDA(1) Loss of $27.9 million
(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 2025 first quarter ended September 29, 2024.
“Our first quarter performance generally came in-line with our expectations, as we began to see a slight improvement in our e-commerce revenue trends during the quarter, our gross profit margin continued to grow, and we reduced expenses as a result of our Work Smarter initiatives to operate more efficiently,” said Jim McCann, Chairman and Chief Executive Officer of 1-800-FLOWERS.COM, Inc. “We expect the improvement in our e-commerce revenue trends to accelerate as we move closer to the holiday selling season, and our revenues will further benefit from the growth of wholesale orders this year. Through the Relationship Innovation initiatives that we implemented over the last two years, we have expanded our offerings and broadened our price points, providing gift givers with more choices at prices that span from budget-friendly to premium. We look forward to helping our customers connect and express their sentiments with the important people in their lives.”
Fiscal 2025 First Quarter Highlights
Total consolidated revenues decreased 10.0% to $242.1 million, as compared with the prior year period.
E-commerce revenues decreased 8.0% over the prior year period, comprised of a 6.5% decline in orders and a 1.5% decline in Average Order Value (AOV).
Gross profit margin increased 20 basis points to 38.1%, as compared with the prior year period.
Operating expenses declined $0.2 million to $139.3 million, as compared with the prior year period. Excluding the impact of non-recurring charges in the current period associated with new systems implementation costs, as well as the impact of the Company’s non-qualified deferred compensation plan in both periods, operating expenses declined by $4.2 million to $135.8 million, as compared with the prior year period.
Net loss for the quarter was $34.2 million, or ($0.53) per share, as compared to a net loss of $31.2 million, or ($0.48) per share in the prior year period.
Adjusted Net Loss1 was $32.9 million, or ($0.51) per share, compared with an Adjusted Net Loss1 of $31.2 million, or ($0.48) per share, in the prior year period.
Adjusted EBITDA1 loss for the quarter was $27.9 million, as compared with an Adjusted EBITDA1 loss of $22.5 million in the prior year period.
1-800-FLOWERS.COM, Inc. was named one of Newsweek’s Most Admired Workplaces for 2025.
Segment Results
The Company provides Fiscal 2025 first quarter 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 14.4% to $84.0 million as compared with the prior year period. This decline reflects the timing of approximately $3.0 million of wholesale orders that shifted from the first quarter into the second quarter. Gross profit margin increased 50 basis points to 32.0%, benefiting from the Company’s inventory optimization efforts and a decline in certain commodity costs. Excluding the impact of the systems implementation costs, adjusted segment contribution margin1 loss was $11.3 million, compared with a loss of $11.0 million in the prior year period.
Consumer Floral & Gifts: Revenues for the quarter declined 4.9% to $135.2 million as compared with the prior year period. Gross profit margin increased 30 basis points to 39.9%. Segment contribution margin1 was $4.9 million, compared with $8.8 million in the prior year period.
BloomNet: Revenues for the quarter declined 20.1% to $23.1 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 decreased 20 basis points to 50.0% due to deleveraging on the lower sales volume. Segment contribution margin1 was $6.8 million, compared with $9.4 million in the prior year period.
Company Guidance
For Fiscal 2025, the Company continues to expect its revenue trend to improve as the fiscal year progresses benefiting 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. The Adjusted EBITDA range reflects the acknowledgement that the consumer environment remains uncertain.
As a result, for Fiscal 2025 the Company continues to expect:
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, October 31, 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 November 7, 2024, at: (US) 1-877-344-7529; (Canada) 855-669-9658; (International) 1-412-317-0088; enter conference ID #: 1727189.
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®, Simply Chocolate® and Scharffen Berger®. 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; Alice’s Table®, a lifestyle business offering fully digital livestreaming and on demand floral, culinary and other experiences to guests across the country; and Card Isle®, an e-commerce greeting card service. 1-800-FLOWERS.COM, Inc. was recognized among America’s Most Trustworthy Companies by Newsweek. 1-800-FLOWERS.COM, Inc. was also recognized as one of America’s Most Admired Workplaces for 2025 by Newsweek 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.
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.
October 30, 2024 – Limassol, Cyprus – GDEV Inc. (NASDAQ: GDEV), an international gaming and entertainment company (“GDEV” or the “Company”), announces changes to its Board of Directors and executive leadership team as part of its ongoing strategy to enhance operational efficiency and support its global growth ambitions.
Olga Loskutova, who has served as an Independent Director on GDEV’s Board since 2022, will be stepping down from her position on the Board of Directors to assume the role of Chief Operating Officer (COO) of GDEV. Olga brings with her a wealth of experience in global business and general management, positioning her to provide management, leadership, and vision to guide GDEV Inc. towards meeting both its short-term and long-term strategic goals.
Following Olga’s transition, GDEV’s Board will consist of six members, with four remaining independent directors. In addition, Olga’s seat on the Nomination and Compensation Committee, on which she previously served, has been assumed by current independent director Tal Shoham.
Anton Reinhold, the former COO of GDEV, will now fully focus on his current role as CEO of Nexters Global Ltd., GDEV’s flagship game studio. This decision will enable him to dedicate his efforts to further expanding the Hero Wars franchise and driving the development of new products within the studio.
“During 2 years as an independent board member, I’ve had the opportunity to gain invaluable insight into the company and the gaming industry as a whole,” said Olga Loskutova. “In my time on the board, I’ve come to admire what makes GDEV truly special – its values, exceptional people, and bold ambitions. I am excited to step into this role and partner with the CEO and the team to help GDEV achieve its strategic goals.”
ABOUT GDEV
GDEV is a gaming and entertainment holding company, focused on development and growth of its franchise portfolio across various genres and platforms. With a diverse range of subsidiaries including Nexters and Cubic Games, among others, GDEV strives to create games that will inspire and engage millions of players for years to come. Its franchises, such as Hero Wars, Island Hoppers, Pixel Gun 3D and others have accumulated over 550 million installs and $2.5 bln of bookings worldwide. For more information, please visit www.gdev.inc
CONTACTS:
Investor Relations
Roman Safiyulin | Chief Corporate Development Officer
Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws. Such statements are based on current expectations that are subject to risks and uncertainties. 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 forward-looking statements contained in this press release are based on the Company’s current expectations and beliefs concerning future developments and their potential effects on the Company. There can be no assurance that future developments affecting the Company will be those that the Company has anticipated. Forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’s control) or other assumptions. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of the Company’s 2023 Annual Report on Form 20-F, filed by the Company on April 29, 2024, and other documents filed by the Company from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, 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 may be required under applicable securities laws.
IRVINE, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), today announced the pricing of its underwritten offering of (i) 18,356,173 shares of its common stock at a price of $3.65 per share and (ii) pre-funded warrants to purchase up to an aggregate of 4,931,507 shares of common stock at a price of $3.649 per pre-funded warrant. The pre-funded warrants will be immediately exercisable and will have an exercise price of $0.001 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $85 million. All of the shares of common stock and pre-funded warrants in the offering are to be sold by Eledon. The offering is expected to close on or about October 30, 2024, subject to the satisfaction of customary closing conditions.
The financing includes participation from new and existing investors, including BVF Partners LP, RA Capital Management, Frazier Life Sciences, Blue Owl Healthcare Opportunities, First Light Asset Management, Sphera Healthcare, Woodline Partners LP, Nantahala Capital and T1D Fund: A Breakthrough T1D Venture.
Leerink Partners is acting as sole book-running manager for the offering. Noble Capital Markets Inc. is acting as financial advisor.
Eledon currently intends to use the net proceeds from this offering to advance its pipeline and for working capital and general corporate purposes.
The offering is being made pursuant to a registration statement on Form S-3 (File No. 333-282260), previously filed with the Securities and Exchange Commission (the “SEC”) on September 20, 2024 and declared effective on October 2, 2024. The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and final prospectus supplement relating to the offering will be filed with the SEC and available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and final prospectus supplement and the accompanying prospectus, once available, may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. Eledon’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. Eledon is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding Eledon’s expectations on the timing and completion of the offering and the anticipated use of proceeds therefrom. No assurance can be given that the offering will be completed on the terms described. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including market conditions, failure of customary closing conditions and the risk factors and other matters set forth in the final prospectus supplement and accompanying prospectus that will be included in the registration statement. Additional risks and uncertainties that could cause Eledon’s actual results to differ materially from the forward-looking statements contained herein are discussed in the company’s quarterly 10-Qs, annual 10-K, and other filings with the SEC, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
– First two out of three subjects treated with tegoprubart as part of immunosuppression regimen to prevent transplant rejection achieved insulin independence and remain insulin free, with glucose control in the normal range; Third subject was recently transplanted and is on trajectory for insulin independence
– Islet engraftment in the first two subjects with tegoprubart estimated three to five times higher than engraftment in three comparable subjects receiving standard of care tacrolimus-based immunosuppression
– Treatment with tegoprubart was generally well tolerated
– Study data to be presented by UChicago Medicine’s team in oral presentation at the 5th IPITA/HSCI/Breakthrough T1D Stem Cells Summit
IRVINE, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today annoutechpients treated with an immunosuppression regimen that includes tegoprubart, the Company’s investigational anti-CD40L antibody, for prevention of islet transplant rejection in subjects with type 1 diabetes (T1D). The investigator-initiated trial, conducted by the research team at the University of Chicago Medicine’s Transplantation Institute, demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection. The first two subjects achieved insulin independence and normal hemoglobin A1C (HbA1c) levels, a measure of average blood glucose, post-transplant. The third subject, who recently received an islet transplant, decreased insulin use by more than 60% three days following the procedure and continues on an insulin independence trajectory.
Subjects on study received islet transplants combined with induction therapy, mycophenolate mofetil (MMF), and tegoprubart, given every third week by intravenous (IV) infusion. The first two subjects achieved insulin independence and presented stable islet graft function at approximately three months and six months post-transplant, respectively. Islet engraftment, measured by graft function standardized to the number of islets infused, was three to five times higher than three comparable subjects outside this study who received tacrolimus-based immunosuppression, suggesting treatment with tegoprubart is less toxic to transplanted islets resulting in improved graft survival and function. Treatment was generally well tolerated in all subjects with no unexpected adverse events or hypoglycemic episodes. After initial islet transplant, the first participant reduced insulin requirements by over 60% and normalized blood glucose control. The first patient then achieved insulin independence approximately two weeks after the second islet transplantation procedure.
The data are being featured in an oral presentation at the International Pancreas and Islet Transplantation Association (IPITA), Harvard Stem Cell Institute (HSCI), and Breakthrough T1D (formerly JDRF) 5th Annual Summit on Stem Cell Derived Islets on Tuesday, October 29, 2024.
“We are very pleased that tegoprubart played a pivotal role in yet another landmark advance in transplantation research through the work of Dr. Witkowski, Dr. Fung and their team at UChicago Medicine,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Following promising results in kidney allotransplant procedures as well as heart and kidney xenograft procedures, these data from subjects following islet transplantation further demonstrate tegoprubart’s potential to protect transplanted organs and cells. Dr. Witkowski’s study also further reinforces prior study results showing that tegoprubart may offer a favorable safety and efficacy profile compared to tacrolimus-based immunosuppression regimens.”
“These data are another step in our quest to achieve a path for functional cures in type 1 diabetes,” said Piotr Witkowski, M.D., Ph.D., Director, Pancreas and Islet Transplant Program, UChicago Medicine and one of the study’s lead investigators. “For more than 30 years, we have been looking for options that can deliver target levels of immunosuppression without the side effects associated with standard of care, including toxicity to the kidneys, central nervous system and islet cells, and increased risk of diabetes and hypertension. These data further support tegoprubart as a novel immunosuppression option that can play a central role in advancing islets transplantation as a potentially transformational alternative for subjects with type 1 diabetes.”
“Breakthrough T1D is proud to fund and support this research and is encouraged by the tegoprubart study showing that subjects who received islet transplants with a tacrolimus-free immunosuppressive regimen are making insulin again,” said Breakthrough T1D Chief Scientific Officer Sanjoy Dutta, Ph.D. “Islet replacement therapies are a key priority for Breakthrough T1D, and we’re committed to driving research that moves us toward a world where these therapies are available to the broader T1D community. Achieving this goal requires novel approaches to keep transplanted cells functional with a tolerable immunosuppression regimen. These results are an important step toward that goal, and we look forward to seeing additional data.”
Efficacy and Safety Results
The first participant was a 42-year-old female with a baseline weight of 88 kg/194 lbs (BMI of 30). At 90 days post-transplant, the participant’s HbA1c level improved to 6.0% (from 8.4% at baseline) and daily insulin dose decreased to 16 units per day (from 80 units per day at baseline). After 16 weeks, the participant received a second islet transplant, and approximately two weeks later achieved insulin independence, maintaining improved HbA1c levels of 5.4% afterwards.
The second participant was a 30-year-old female with a baseline weight of 50 kg/110 lbs (BMI of 21). This patient stopped insulin support (from 60 units per day at baseline) four weeks after the islet transplant. Her HbA1c levels improved to 5.8% and below (from 8.5% at baseline) starting at seven weeks after the transplant.
The third participant was a 37-year-old male with a baseline weight of 92 kg/203 lbs (BMI of 30) with a baseline HbA1C of 9.3%. This patient was discharged home on day three post-transplant, requiring 29 units of insulin (from 90 units per day at baseline).
The treatment was generally well tolerated in all subjects with no unexpected adverse events, severe hypoglycemic episodes, or graft rejection.
In January 2024, Eledon announced that it would be supplying tegoprubart for this investigator-led clinical trial with the UChicago Medicine Transplantation Institute for pancreatic islet transplantation in subjects with type 1 diabetes (NCT06305286). Tegoprubart is the cornerstone component of the chronic immunosuppressive regimen for trial participants and is being evaluated for the prevention of transplant rejection in the trial. Funding for the study includes grants from Breakthrough T1D (formerly known as JDRF) and The Cure Alliance.
About Islet Transplantation for Type 1 Diabetes
Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. Post-procedure, subjects remain on immunosuppression therapy to prevent transplant rejection.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation or kidney transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,079,784 shares of common stock at a purchase price of $2.259 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.51 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about October 30, 2024, subject to the satisfaction of customary closing conditions.
The gross proceeds from the offering are expected to be approximately $2.44 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund manufacturing of THIO to be used in the Phase 2 THIO-101 trial in non-small cell lung cancer (NSCLC) and as working capital.
The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; (viii) the completion of the offering and (ix) the satisfaction of customary closing conditions related to the offering, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
– Two Publications Recently Issued Featuring OLC and UNI-494 –
LOS ALTOS, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that multiple presentations were delivered at the American Society of Nephrology (ASN) Kidney Week 2024 that highlighted the extensive development progress for both oxylanthanum carbonate (OLC) and UNI-494.
“Kidney Week was extremely productive for us featuring a late-breaking presentation on our OLC pivotal trial, and our numerous data presentations were well received by the medical community,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We were excited to present our positive pivotal clinical trial data demonstrating that OLC enabled adequate control of serum phosphate in more than 90% of patients with chronic kidney disease (CKD) on dialysis who entered the maintenance phase of the trial. OLC preclinical data was also presented at the conference and recently published. This data supports our recently submitted New Drug Application as we seek U.S. Food and Drug Administration (FDA) approval to bring OLC to the millions of CKD patients with hyperphosphatemia on dialysis.”
Dr. Gupta continued, “Earlier this month, we announced the successful competition of our UNI-494 Phase 1 study and were pleased to present the safety and tolerability data at ASN. We plan to request a meeting with the FDA before the end of the year to review these Phase 1 results and a potential Phase 2 study design.”
“For patients with CKD on dialysis, achieving adequate serum phosphate control is critically important because it can lead to other major complications including cardiovascular disease. I am encouraged by the results from the OLC pivotal trial presented at Kidney Week, and I believe that a product like OLC could have a meaningful impact on the overall care of CKD patients on dialysis,” added Dr. Pablo Pergola, MD, PhD, Research Director of the Clinical Advancement Center, PLLC, and a member of Renal Associates PA, San Antonio, Texas.
PUBLICATIONS
In addition to the presentations at ASN, preclinical studies for both OLC and UNI-494 were recently featured in two publications.
“Systemic Absorption of Oxylanthanum Carbonate is Minimal in Preclinical Models” was published in the Pharmaceutical Chemistry Journal.
“Evaluation of UNI-494 in Acute Kidney Injury Treatment Efficacy When Administered After Ischemia-Reperfusion in a Rat Model” was published in EC Pharmacology and Toxicology.
ASN KIDNEY WEEK PRESENTATIONS
Title:
Effects of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia
Lead Author:
Geoffrey A. Block, MD, FASN, Associate Chief Medical Officer & Senior Vice President, Clinical Research & Medical Affairs, U.S. Renal Care
Summary:
This late-breaking poster describes the pivotal Phase 2 open-label, single-arm, multicenter, multidose study in adult patients with CKD with hyperphosphatemia receiving maintenance hemodialysis. The aim of the study was to assess the tolerability and safety of OLC at doses that achieve satisfactory serum phosphate control of ≤5.5 mg/dl. Most patients (69%) who achieved the target serum phosphate did so with ≤1500 mg/day and the percent of patients with serum phosphate ≤5.5 mg/dl increased from 59% at Screening to 91% at the end of titration. OLC was safe and well-tolerated with adverse events commonly seen in this patient population and with other phosphate binders. The use of OLC enabled adequate control of serum phosphate in >90% of patients who entered maintenance.
Title:
Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rat
This study evaluated the effects of OLC plus tenapanor on urinary phosphate excretion in rats on a high phosphorus diet. The study showed that the combination of OLC and tenapanor may support a pronounced inhibition of intestinal phosphate absorption by leveraging two distinct mechanisms of action: OLC, an intestinal phosphate binder, and tenapanor, a sodium/hydrogen exchanger (NHE3) blocker that diminishes transcellular phosphate absorption. The results demonstrated that the OLC plus tenapanor combination achieved a much more pronounced reduction in urinary phosphate excretion as compared to OLC alone and 3.3 times greater than tenapanor alone. In addition, the OLC plus tenapanor combination exhibited four- to seven-fold more synergistic effects compared to the sevelamer plus tenapanor combination. The study demonstrated potent effects of the novel lanthanum-based phosphate binder OLC and found that OLC plus tenapanor has synergistic, rather than additive, effects in rats.
Title:
UNI-494 Phase I Safety, Tolerability, and Pharmacokinetics
Lead Author:
Guru Reddy, PH.D., Vice President of Preclinical R&D, Unicycive
Summary:
The poster described the results from the single ascending dose (SAD) cohorts from the Phase 1 study evaluating safety, tolerability, and pharmacokinetics (PK) of UNI-494 capsules administered to healthy volunteers. The study was a single-center, double-blind, placebo-controlled, randomized study that enrolled up to 40 subjects in 5 cohorts of 8 subjects each (6 active/2 placebo per cohort). Safety assessments and pharmacokinetics and systemic exposure of UNI-494 and its metabolites (nicorandil and CHEA) were evaluated. The data demonstrated that a single dose of 10-160 mg of UNI-494 capsules were safe and well-tolerated, and that UNI-494 was rapidly converted to nicorandil and the exposure to nicorandil increased in a dose-proportional manner. Therapeutic levels (AUC >200 hour*ng/mL) of nicorandil were achieved at 160 mg of UNI-494. This rapid conversion of UNI-494 to nicorandil and 1-cyclohexylethylamine indicates a potential for a fast-acting therapy for the prevention of Delayed Graft Function (DGF) and other acute kidney injury (AKI) clinical conditions.
Title:
Intravenous UNI-494 Slows the Progression or Halts/Reverses Acute Kidney Injury When Administered After Ischemia/Reperfusion in Rats
The poster presented the results from a study evaluating the in vivo efficacy of intravenous (IV) UNI-494 when administered therapeutically after unilateral renal ischemia-reperfusion (I/R) in a rat model of AKI, which is a well-established model of DGF. The study showed that single IV doses of 10 mg/kg of UNI-494 administered after I/R significantly reduced serum and urinary AKI markers and improved proximal tubular injury scores. Specifically, a single IV dose of 10 mg/kg of UNI-494 improved key kidney functional markers (serum creatinine, blood urea nitrogen, urinary samples collected for albumin-creatinine ratio), the tubular injury marker neutrophil gelatinase-associated lipocalin, and proximal tubular injury scores. These data indicate therapeutic administration of UNI-494 slows down and may even halt or reverse AKI progression.
The posters and publications can be found on the Unicycive Therapeutics website here.
About Oxylanthanum Carbonate (OLC)
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established. A pivotal clinical trial was also conducted in CKD patients on hemodialysis that achieved the study objective and established favorable tolerability of OLC at clinically effective doses.
Fosrenol® is a registered trademark of Shire International Licensing BV. 1Reason Research, LLC 2022 survey. Results here.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
About UNI-494
UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive has completed enrollment in the UNI-494 Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.
About Acute Kidney Injury
Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital, and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Third quarter 2024 total revenue of $613.6 million, net income of $86.3 million, and EBITDA of $170.7 million
Increased oil & gas royalty volumes to 864 MBOE, up 11.9% year-over-year
Completed $10.5 million in oil & gas mineral interest acquisitions
Declares quarterly cash distribution of $0.70 per unit, or $2.80 per unit annualized
Increased committed & priced sales tons for the 2025 full year by 5.9 million tons to 22.5 million tons
TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) (“ARLP” or the “Partnership”) today reported financial and operating results for the three and nine months ended September 30, 2024 (the “2024 Quarter” and “2024 Period,” respectively). This release includes comparisons of results to the three and nine months ended September 30, 2023 (the “2023 Quarter” and “2023 Period,” respectively) and to the quarter ended June 30, 2024 (the “Sequential Quarter”). All references in the text of this release to “net income” refer to “net income attributable to ARLP.” For a definition of EBITDA and related reconciliation to its comparable GAAP financial measure, please see the end of this release.
Total revenues in the 2024 Quarter decreased 3.6% to $613.6 million compared to $636.5 million for the 2023 Quarter primarily as a result of reduced coal sales prices, which declined 2.1% due in part to lower export pricing in Appalachia, and lower transportation revenues. Net income for the 2024 Quarter was $86.3 million, or $0.66 per basic and diluted limited partner unit, compared to $153.7 million, or $1.18 per basic and diluted limited partner unit, for the 2023 Quarter as a result of lower revenues and increased total operating expenses. EBITDA for the 2024 Quarter was $170.7 million compared to $227.6 million in the 2023 Quarter.
Total revenues in the 2024 Quarter increased 3.4% compared to $593.4 million in the Sequential Quarter primarily as a result of increased coal sales volumes, which rose 6.7% to 8.4 million tons sold compared to 7.9 million tons sold. Net income and EBITDA for the 2024 Quarter decreased by 13.9% and 3.9%, respectively, compared to the Sequential Quarter as a result of higher total operating expenses, partially offset by increased revenues.
Total revenues decreased 4.3% to $1.86 billion for the 2024 Period compared to $1.94 billion for the 2023 Period primarily due to lower coal sales and transportation revenues, partially offset by higher oil & gas royalties and other revenues. Net income for the 2024 Period was $344.5 million, or $2.64 per basic and diluted limited partner unit, compared to $514.7 million, or $3.93 per basic and diluted limited partner unit, for the 2023 Period as a result of lower revenues and increased total operating expenses, partially offset by an increase in the fair value of our digital assets. EBITDA for the 2024 Period was $583.4 million compared to $747.7 million in the 2023 Period.
CEO Commentary
“We delivered sequential improvement in revenue, coal sales, and minerals volumes during the third quarter, however revenues were lower than our expectations primarily due to lower coal sales volumes and pricing related to export sales from our MC Mining, Mettiki and Hamilton operations, as well as shipping deferrals on some of our higher priced domestic contracted commitments,” commented Joseph W. Craft III, Chairman, President, and CEO. “Segment Adjusted EBITDA Expense per ton sold was $46.11 during the 2024 Quarter, slightly higher than the Sequential Quarter and increasing 11.9% year-over-year due to a longwall move at our Tunnel Ridge operations and challenging mining conditions at all three Appalachia operations that lowered recoveries and increased costs related to roof control and maintenance. We took proactive steps during the 2024 Quarter to more closely align production with shipments at our MC Mining, Mettiki and Hamilton operations by reducing production due to high stockpile levels at each operation which also impacted our costs. As a result, coal inventory levels declined by over 0.5 million tons in the 2024 Quarter.”
Mr. Craft added, “We are pleased to report that all of the major capital and mine infrastructure projects we have been investing in over the last several years are wrapping up and are projected to be on schedule to deliver lower mining expenses beginning next year.”
Mr. Craft concluded, “We realized another solid quarter of year-over-year volumetric growth in our Oil & Gas Royalties business. We continue to reap the benefits of a minerals portfolio that is heavily weighted towards the Permian Basin, where top-tier upstream operators are actively drilling and completing new wells on our mineral acreage. Additionally, we continued to add to our position in the Permian, successfully closing $10.5 million of ground game acquisitions during the 2024 Quarter. As we have mentioned previously, we believe the value and prospects for our oil and gas royalty segment was a major contributor to the success of our Senior Notes offering earlier this year. We remain committed to growing this segment as a complement to our core coal operations, and as we scale the business, we believe investors will continue to recognize the intrinsic value the segment possesses as a growth vehicle.”
Coal Operations
Total coal sales volumes for the 2024 Quarter increased 6.7% compared to the Sequential Quarter while remaining relatively consistent compared to the 2023 Quarter. Sequentially, tons sold increased by 3.1% in the Illinois Basin due to higher sales volumes from our River View and Hamilton mines. In Appalachia, tons sold increased by 16.9% in the 2024 Quarter compared to the Sequential Quarter primarily due to improved conditions on the Ohio River allowing for higher shipments from our Tunnel Ridge operation. Coal sales price per ton decreased by 5.8% in Appalachia compared to the 2023 Quarter as a result of reduced export price realizations from our Mettiki and MC Mining operations. Compared to the Sequential Quarter, coal sales prices decreased by 7.7% in Appalachia primarily due to reduced domestic price realizations across the region. ARLP ended the 2024 Quarter with total coal inventory of 2.0 million tons, representing an increase of 0.2 million tons and a decrease of 0.5 million tons compared to the end of the 2023 Quarter and Sequential Quarter, respectively.
Segment Adjusted EBITDA Expense per ton for the 2024 Quarter increased by 7.2% in the Illinois Basin compared to the 2023 Quarter due primarily to reduced production and higher beginning inventory cost per ton at our Hamilton and River View mines. Increased expenses and lower production at our Hamilton mine during the 2024 Quarter was partially attributable to increased longwall move days compared to the 2023 Quarter. In Appalachia, Segment Adjusted EBITDA Expense per ton for the 2024 Quarter increased by 19.3% compared to the 2023 Quarter due to a longwall move at our Tunnel Ridge operation, increased subsidence related expenses and challenging mining conditions at all three operations that lowered recoveries, and increased costs related to roof control and maintenance.
Royalties
Oil & gas volumes increased to 864 MBOE in the 2024 Quarter, representing an 11.9% and a 5.8% increase compared to the 2023 Quarter and Sequential Quarter, respectively, due to increased drilling and completion activities on our interests and acquisitions of additional oil & gas mineral interests. Segment Adjusted EBITDA for the Oil & Gas Royalties segment decreased 8.5% and 8.2% in the 2024 Quarter compared to the 2023 Quarter and Sequential Quarter, respectively, primarily due to reduced average realized sales prices per BOE.
Segment Adjusted EBITDA for the Coal Royalties segment in the 2024 Quarter increased by $1.2 million and $1.1 million compared to the 2023 Quarter and Sequential Quarter, respectively, as a result of increased royalty tons sold and reduced expenses, partially offset by reduced prices.
Balance Sheet and Liquidity
As of September 30, 2024, total debt and finance leases outstanding were $497.4 million, including $400 million in recently issued Senior Notes due 2029. The Partnership’s total and net leverage ratios were 0.64 times and 0.39 times debt to trailing twelve months Adjusted EBITDA, respectively, as of September 30, 2024. ARLP ended the 2024 Quarter with total liquidity of $657.7 million, which included $195.4 million of cash and cash equivalents and $462.3 million of borrowings available under its revolving credit and accounts receivable securitization facilities.
Distributions
ARLP is also announcing today that the Board of Directors of ARLP’s general partner (the “Board”) approved a cash distribution to unitholders for the 2024 Quarter of $0.70 per unit (an annualized rate of $2.80 per unit), payable on November 14, 2024, to all unitholders of record as of the close of trading on November 7, 2024. The announced distribution is consistent with the cash distributions for the 2023 Quarter and Sequential Quarter.
Outlook
“We have repeatedly warned about the impact of federal regulations on grid reliability, influencing what we believe to be the premature retirement of essential baseload power sources even as significant demand growth from AI, data centers, and manufacturing onshoring is being projected,” commented Mr. Craft. “This summer’s PJM capacity auction results highlight these concerns. Recognizing a potential crisis due to unexpectedly high demand growth, the delayed construction of new generation, and planned capacity retirements, particularly in our served markets, PJM prioritized baseload capacity over interruptible sources. This further supports recent third-party sources which indicate that greater than 40% of previously announced baseload power plant retirement dates have been deferred nationwide.”
Mr. Craft concluded, “Many of our largest domestic customers have been active on the contracting side of late. Since our last update, we are in the process of finalizing commitments for 21.7 million tons over the 2025 to 2030 time period. We are also in active discussions with other customers to add to future commitments, that if secured, will lift our 2025 domestic sales order book to a level near our historical contracted position heading into the new calendar year. Looking longer-term, the underlying coal demand fundamentals of non-traditional demand growth is accelerating, particularly in the markets we serve in the Midwest, Mid-Atlantic, and Southeast.”
ARLP is maintaining the following guidance for the full year ended December 31, 2024 (the “2024 Full Year”) and updating our committed and priced sales tons:
Conference Call
A conference call regarding ARLP’s 2024 Quarter financial results is scheduled for today at 10:00 a.m. Eastern. To participate in the conference call, dial (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com.
An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13749425.
Concurrent with this announcement we are providing qualified notice to brokers and nominees that hold ARLP units on behalf of non-U.S. investors under Treasury Regulation Section 1.1446-4(b) and (d) and Treasury Regulation Section 1.1446(f)-4(c)(2)(iii). Brokers and nominees should treat one hundred percent (100%) of ARLP’s distributions to non-U.S. investors as being attributable to income that is effectively connected with a United States trade or business. In addition, brokers and nominees should treat one hundred percent (100%) of the distribution as being in excess of cumulative net income for purposes of determining the amount to withhold. Accordingly, ARLP’s distributions to non-U.S. investors are subject to federal income tax withholding at a rate equal to the highest applicable effective tax rate plus ten percent (10%). Nominees, and not ARLP, are treated as the withholding agents responsible for withholding on the distributions received by them on behalf of non-U.S. investors.
About Alliance Resource Partners, L.P.
ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.
News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.
The statements and projections used throughout this release are based on current expectations. These statements and projections are forward-looking, and actual results may differ materially. These projections do not include the potential impact of any mergers, acquisitions or other business combinations that may occur after the date of this release. We have included more information below regarding business risks that could affect our results.
FORWARD-LOOKING STATEMENTS: With the exception of historical matters, any matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from projected results. Those forward-looking statements include expectations with respect to our future financial performance, coal and oil & gas consumption and expected future prices, our ability to increase unitholder distributions in future quarters, business plans and potential growth with respect to our energy and infrastructure transition investments, optimizing cash flows, reducing operating and capital expenditures, infrastructure projects at our existing properties, growth in domestic electricity demand, preserving liquidity and maintaining financial flexibility, and our future repurchases of units and senior notes, among others. These risks to our ability to achieve these outcomes include, but are not limited to, the following: decline in the coal industry’s share of electricity generation, including as a result of environmental concerns related to coal mining and combustion, the cost and perceived benefits of other sources of electricity and fuels, such as oil & gas, nuclear energy, and renewable fuels and the planned retirement of coal-fired power plants in the U.S.; our ability to provide fuel for growth in domestic energy demand, should it materialize; changes in macroeconomic and market conditions and market volatility, and the impact of such changes and volatility on our financial position; changes in global economic and geo-political conditions or changes in industries in which our customers operate; changes in commodity prices, demand and availability which could affect our operating results and cash flows; the outcome or escalation of current hostilities in Ukraine and the Israel-Gaza conflict; the severity, magnitude and duration of any future pandemics and impacts of such pandemics and of businesses’ and governments’ responses to such pandemics on our operations and personnel, and on demand for coal, oil, and natural gas, the financial condition of our customers and suppliers and operators, available liquidity and capital sources and broader economic disruptions; actions of the major oil-producing countries with respect to oil production volumes and prices could have direct and indirect impacts over the near and long term on oil & gas exploration and production operations at the properties in which we hold mineral interests; changes in competition in domestic and international coal markets and our ability to respond to such changes; potential shut-ins of production by the operators of the properties in which we hold oil & gas mineral interests due to low commodity prices or the lack of downstream demand or storage capacity; risks associated with the expansion of and investments into the infrastructure of our operations and properties, including the timing of such investments coming online; our ability to identify and complete acquisitions and to successfully integrate such acquisitions into our business and achieve the anticipated benefits therefrom; our ability to identify and invest in new energy and infrastructure transition ventures; the success of our development plans for our wholly owned subsidiary, Matrix Design Group, LLC, and our investments in emerging infrastructure and technology companies; dependence on significant customer contracts, including renewing existing contracts upon expiration; adjustments made in price, volume, or terms to existing coal supply agreements; the effects of and changes in trade, monetary and fiscal policies and laws, and the results of central bank policy actions, including interest rates, bank failures, and associated liquidity risks; the effects of and changes in taxes or tariffs and other trade measures adopted by the United States and foreign governments; legislation, regulations, and court decisions and interpretations thereof, both domestic and foreign, including those relating to the environment and the release of greenhouse gases, such as the Environmental Protection Agency’s recently promulgated emissions regulations for coal-fired power plants, mining, miner health and safety, hydraulic fracturing, and health care; deregulation of the electric utility industry or the effects of any adverse change in the coal industry, electric utility industry, or general economic conditions; investors’ and other stakeholders’ increasing attention to environmental, social, and governance matters; liquidity constraints, including those resulting from any future unavailability of financing; customer bankruptcies, cancellations or breaches to existing contracts, or other failures to perform; customer delays, failure to take coal under contracts or defaults in making payments; our productivity levels and margins earned on our coal sales; disruptions to oil & gas exploration and production operations at the properties in which we hold mineral interests; changes in equipment, raw material, service or labor costs or availability, including due to inflationary pressures; changes in our ability to recruit, hire and maintain labor; our ability to maintain satisfactory relations with our employees; increases in labor costs, adverse changes in work rules, or cash payments or projections associated with workers’ compensation claims; increases in transportation costs and risk of transportation delays or interruptions; operational interruptions due to geologic, permitting, labor, weather, supply chain shortage of equipment or mine supplies, or other factors; risks associated with major mine-related accidents, mine fires, mine floods or other interruptions; results of litigation, including claims not yet asserted; foreign currency fluctuations that could adversely affect the competitiveness of our coal abroad; difficulty maintaining our surety bonds for mine reclamation as well as workers’ compensation and black lung benefits; difficulty in making accurate assumptions and projections regarding post-mine reclamation as well as pension, black lung benefits, and other post-retirement benefit liabilities; uncertainties in estimating and replacing our coal mineral reserves and resources; uncertainties in estimating and replacing our oil & gas reserves; uncertainties in the amount of oil & gas production due to the level of drilling and completion activity by the operators of our oil & gas properties; uncertainties in the future of the electric vehicle industry and the market for EV charging stations; the impact of current and potential changes to federal or state tax rules and regulations, including a loss or reduction of benefits from certain tax deductions and credits; difficulty obtaining commercial property insurance, and risks associated with our participation in the commercial insurance property program; evolving cybersecurity risks, such as those involving unauthorized access, denial-of-service attacks, malicious software, data privacy breaches by employees, insiders or others with authorized access, cyber or phishing attacks, ransomware, malware, social engineering, physical breaches, or other actions; and difficulty in making accurate assumptions and projections regarding future revenues and costs associated with equity investments in companies we do not control.
Additional information concerning these, and other factors can be found in ARLP’s public periodic filings with the SEC, including ARLP’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on February 23, 2024,and ARLP’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024 and June 30, 2024, filed on May 9, 2024 and August 7, 2024, respectively. Except as required by applicable securities laws, ARLP does not intend to update its forward-looking statements.
Progress on OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) and new data from Phase 1/2
Preliminary safety and efficacy update on OCU410 Phase 1/2 ArMaDa clinical trial for geographic atrophy (GA)
Clinical update on OCU410ST Phase 1/2 GARDian clinical trial for Stargardt disease
Featuring patients, investigators and thought leaders
MALVERN, Pa., Oct. 28, 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 it will host an in-person Clinical Showcase on Tuesday, November 12, 2024. The event will take place from 10 a.m.-noon ET at the Nasdaq MarketSite in Times Square, New York City.
The event will focus on encouraging updates from Ocugen’s ongoing gene therapy trials, including:
Clinical update on Phase 3 liMeliGhT clinical trial for retinitis pigmentosa along with data updates from Phase 1/2 RP and Leber congenital amaurosis (LCA)
Preliminary safety and efficacy data from Phase 1/2 OCU410 ArMaDa clinical trial for GA
Clinical trial progress from Phase 1/2 OCU410ST GARDian study for Stargardt disease
In addition, background on Ocugen’s biologic candidate, OCU200 for diabetic macular edema, will be presented. The Company is planning to initiate the OCU200 Phase I clinical trial this quarter.
Ocugen presenters will include:
Dr. Shankar Musunuri, Chairman, CEO & Co-founder
Dr. Huma Qamar, Chief Medical Officer
Dr. Arun Upadhyay, Chief Scientific Officer & Head of R&D
Mike Shine, Senior Vice President, Commercial
Joining the Ocugen team will be study investigators:
Dr. Benjamin Bakall, Director of Clinical Research at Associated Retina Consultants (ARC) and Clinical Assistant Professor at University of Arizona, College of Medicine – Phoenix
Dr. Lejla Vajzovic, Professor of Ophthalmology, Pediatrics, and Biomedical Engineering with Tenure at Duke Eye Center and Duke University School of Medicine
Dr. Syed M. Shah, Vice Chair for Research and Digital Health, Director of Retina Service at Gundersen Health – La Crosse, Wisconsin
The program will conclude with a patient panel representing participants in Ocugen’s ongoing clinical trials.
Advance registration is required and can be done by contacting Tiffany Hamilton at Tiffany.Hamilton@ocugen.com.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s 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.
October 24, 2024 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or the “Company”) is pleased to report on progress at its wholly owned Angel Island lithium project (“Project”) located in Esmeralda County, Nevada, USA. Since the completion of a Feasibility Study on Angel Island in April 2024, the Company continues to focus on critical steps for the Project’s development. Primary attention is on process optimization to drive reductions in the Project’s estimated capital and operating costs, environmental studies and permitting, and Project funding. Among these actions, testing has continued at the Company’s Lithium Extraction Facility (“Pilot Plant”) in Amargosa Valley, Nevada, with emphasis on producing lithium carbonate samples for evaluation by domestic end-users and interested parties.
“Century Lithium is focused on delivering results that will position the Company as one of the most advanced opportunities for a new domestic supply of this important and strategic commodity for the EV and battery storage industry” said Bill Willoughby, President, and CEO of Century Lithium. “The State of Nevada has expressed the desire to play a critical role in the clean energy transition, specifically through Nevada’s Lithium Loop initiative focusing on local resources to products to recycling. We are working with Century’s resources and technology to position us at the forefront of this effort.”
Pilot Plant Testing and Engineering
Review of the Feasibility Study with emphasis on pursuing several avenues to reduce the estimated capital and operating costs and achieve significant improvement of the Project’s economics
Achieved onsite production of battery quality lithium carbonate samples for evaluation and to demonstrate Angel Island’s capability as an end-to-end process for taking lithium claystone to a battery-quality product
Conducted initial tests with third parties on alternate reagents and media for the Pilot Plant
Currently installing equipment at the Pilot Plant based on results from the above
Initiated materials testing program to optimize and potentially reduce the estimated costs of the tailings storage facility
Environmental Studies and Permitting
Completed draft hydrologic model and addressing comments from federal regulators
Completed a draft plan of operations
Modeled alternate locations for water supply to potentially source process water closer to the Project within the scope of the Company’s water rights permit
Engaged consultants to prepare key state permits with emphasis on water pollution control and air quality
Angel Island Funding
Communicating with potential strategic partners and end-users of lithium carbonate for testing of our product samples
Pursuing parties interested in marketing or obtaining a future supply of sodium hydroxide; Century Lithium’s process will produce a surplus of sodium hydroxide, the sales of which are estimated to result in a low net production cost for lithium carbonate
Compiling Project information to support applications for government funding opportunities available through the U.S. Department of Energy and U.S. Department of Defense
ABOUT CENTURY LITHIUM CORP.
Century Lithium Corp. is an advanced stage lithium company, focused on developing its wholly owned Angel Island project in Esmeralda County, Nevada, which hosts one of the largest sedimentary lithium deposits in the United States. The Company has utilized its patent-pending process for chloride leaching combined with Direct Lithium Extraction to make battery quality lithium carbonate samples from Angel Island lithium-bearing claystone on-site at its Lithium Extraction Facility in Amargosa Valley, Nevada.
Angel Island is one of the few advanced lithium projects in development in the United States to provide an end-to-end process to produce battery grade lithium carbonate for the growing electric vehicle and battery storage market. Angel Island is currently in the permitting stage for a three-phase feasibility-level production plan expected to yield an average of 34,000 tonnes per year of battery grade lithium carbonate over a 40-year mine-life.
Century Lithium trades on both the TSX Venture Exchange under the symbol “LCE” and the OTCQX under the symbol “CYDVF”; and on the Frankfurt Stock Exchange under the symbol “C1Z”. To learn more, please visit centurylithium.com.
ON BEHALF OF CENTURY LITHIUM CORP. WILLIAM WILLOUGHBY, PhD., PE President & Chief Executive Officer
NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.
This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.
Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.
These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.com. The Company expressly disclaims any obligation to update-forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.
CHICAGO, Oct. 24, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (GoHealth) (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, announced that the company will release its third quarter 2024 financial results on the morning of November 7, 2024.
Chief Executive Officer, Vijay Kotte, and Chief Financial Officer, Brendan Shanahan, will host a conference call and live audio webcast on the day of the release at 8:00 a.m. (ET) to discuss the results.
A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.
About GoHealth, Inc.
GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.
