Author: aweinsoff@channelchek.com

Release – Alliance Resource Partners, L.P. Reports Third Quarter Financial and Operating Results; Declares Quarterly Cash Distribution of $0.70 Per Unit and Updates Committed & Priced Sales Tons

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ARLP

October 28, 2024

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2024 Quarter Highlights

  • 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.

View the full release HERE.

Investor Relations Contact
Cary P. Marshall
Senior Vice President and Chief Financial Officer
918-295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

Release – Ocugen Clinical Showcase Highlighting Progress in Retinal Gene Therapy Clinical Trials in New York City on Tuesday, November 12, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

October 28, 2024

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  • 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.

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com 

Release – Century Lithium Reports Progress on Angel Island

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CYDVF

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

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
scacos@centurylithium.com
centurylithium.com

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

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.

Release – GoHealth to Announce Third Quarter 2024 Results on November 7, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Oct 24, 2024 at 8:00 AM EDT

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.

Investor Relations
John Shave
jshave@gohealth.com

Media Relations
Pressinquiries@gohealth.com

Release – Tonix Pharmaceuticals Announces Oral Presentation at the World Vaccine Congress Europe 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 24, 2024 8:00am EDT

CHATHAM, N.J., Oct. 24, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical, Tonix Pharmaceuticals, will deliver an oral presentation at the World Vaccine Congress Europe, which will be held in Barcelona, Spain, October 28-31, 2024. A copy of the Company’s presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the World Vaccine Congress Europe website here.

Presentation Details
  
Presenter:Zeil Rosenberg, M.D., M.P.H.
Title:A Novel, Single-dose, Live, Attenuated, Minimally Replicating Mpox Vaccine
Location:Fira de Barcelona – Montjuïc – Hall 2
Date:Wednesday, October 30, 2024
Time:2:10 p.m. GMT
 

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institute of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Healthcare
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released October 24, 2024

Release – Beasley Broadcast Group, Inc. Appoints Lauren Burrows Coleman as Chief Financial Officer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BBGI

Marie Tedesco to Retire as CFO Following Three Decades of Service

October 24, 2024 07:00 ET

    NAPLES, Fla., Oct. 24, 2024 (GLOBE NEWSWIRE) — Beasley Broadcast Group, Inc. (Nasdaq: BBGI), a multi-platform media company, today announced the appointment of Lauren Burrows Coleman as Chief Financial Officer, effective Friday, November 1, 2024. Longtime CFO Marie Tedesco will retire from Beasley after 33 years of dedicated service to the company.

    Before joining Beasley, Ms. Burrows Coleman served as Global Head of Strategic Corporate and Commercial Finance at Wayfair (NYSE: W), where she led a global team of 50 across Financial Planning & Analysis, Commercial Finance, Capital Markets, Corporate Development, and Global Tax functions.

    Ms. Burrows Coleman’s impressive career also includes leadership positions at WindSail Capital Group and Wind Point Partners, both private equity firms, as well as GE Capital, where she managed equity and debt investments across various industries. She began her career as an investment banker in the Communications & Media group at Lehman Brothers.

    “We are absolutely thrilled to welcome Lauren into the Beasley family,” said Caroline Beasley, Chief Executive Officer of Beasley Broadcast Group, Inc. “Her extensive and diverse experience, combined with her leadership skills, are exactly what we need to drive the company forward as we evolve into the future.”

    Ms. Burrows Coleman holds an MBA from Harvard Business School and an A.B. cum laude from Dartmouth College.

    She will succeed Marie Tedesco, who is retiring on November 1st after more than three decades with the organization.

    “Marie has been an integral part of our success and her contributions have shaped the organization into what it is today,” said Caroline Beasley. “It has been a privilege to work alongside her, and we are deeply grateful for her unwavering commitment, hard work, and leadership. We will greatly miss Marie’s wisdom and guidance, and we wish her nothing but the very best!”

    About Beasley Broadcast Group:
    Beasley Broadcast Group, Inc. (NASDAQ: BBGI) is a multi-platform media company whose primary business is operating radio stations throughout the United States. The Company offers local and national advertisers integrated marketing solutions across audio, digital and event platforms. The Company owns and operates stations in the following markets: Atlanta, GA, Augusta, GA, Boston, MA, Charlotte, NC, Detroit, MI, Fayetteville, NC, Fort Myers-Naples, FL, Las Vegas, NV, Middlesex, NJ, Monmouth, NJ, Morristown, NJ, Philadelphia, PA, and Tampa-Saint Petersburg, FL. Approximately 20 million consumers listen to the Company’s radio stations weekly over-the-air, online and on smartphones and tablets, and millions regularly engage with the Company’s brands and personalities through digital platforms such as Facebook, Twitter, text, apps and email. For more information, please visit www.bbgi.com.

    Contact

    Joseph Jaffoni, Jennifer Neuman JCIR
    (212) 835-8500
    bbgi@jcir.com

    Heidi Raphael, BBGI
    (239) 263-5000

    Release – Cadrenal Therapeutics Joins Corporate Council Of Anticoagulation Forum

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on CVKD

    Participation Reinforces Cadrenal’s Commitment to Innovation, Education and Improved Patient Outcomes with Anticoagulation Therapy

    PONTE VEDRA, Fla., Oct. 23, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to improve anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions, today announced its membership in the Corporate Council of the Anticoagulation Forum (AC Forum).

    Cadrenal Therapeutics, Inc. is a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation. (PRNewsfoto/Cadrenal Therapeutics, Inc.)


    The AC Forum is the largest professional organization of anticoagulation specialists, committed to advancing the quality and safety of chronic anticoagulation care globally. Through participation in the Corporate Council, Cadrenal Therapeutics will collaborate with the AC Forum as it works to identify and address unmet clinical needs, share cutting-edge research, and promote advocacy and educational initiatives for the organization’s 15,000 healthcare professional members aimed at improving outcomes for patients on anticoagulants.

    “Our membership in the AC Forum’s Corporate Council reflects our shared commitment to transforming anticoagulation care,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “We look forward to partnering with the AC Forum and contributing to programs that advance safer, more effective care and inform about ongoing research and anticoagulation best practice guidelines.”

    Darren Triller, PharmD, Director of Strategic Initiatives at the Anticoagulation Forum, welcomed Cadrenal Therapeutics to the Corporate Council, saying: “We are excited to have Cadrenal Therapeutics join us in our mission to improve the quality of care for patients receiving antithrombotic therapies. We look forward to a productive partnership that will help us address the challenges in the anticoagulation landscape together.”

    About Cadrenal Therapeutics, Inc.

    Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds and deaths than warfarin, the most commonly used anticoagulant for these patients despite its prevalent side effects, drug-to-drug interactions and frequent dosing changes. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted left ventricular assist devices (LVADs) as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is planning pivotal clinical trials and pursuing clinical and commercial partnerships. The company’s plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit www.cadrenal.com to learn more.

    About the Anticoagulation Forum

    The Anticoagulation Forum has led advancements in thrombosis-related care for over three decades. With more than 15,000 members across 3,000 healthcare institutions, the AC Forum is dedicated to enhancing the safety and quality of care for over 1 million patients annually. Through education, thought leadership, and partnerships with industry leaders, the AC Forum shapes the future of anticoagulation management to ensure the best outcomes for patients.

    For more information, please contact:
    Cadrenal Therapeutics:
    Matthew Szot, CFO
    858-337-0766
    press@cadrenal.com

    Investors:
    Lytham Partners, LLC
    Robert Blum, Managing Partner
    602-889-9700
    CVKD@lythampartners.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-joins-corporate-council-of-anticoagulation-forum-302283944.html

    SOURCE Cadrenal Therapeutics, Inc.

    Release – Conduent to Report Third-Quarter 2024 Financial Results on Nov. 6, 2024

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on CNDT

    October 23, 2024

    Earnings/Financial

    FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, plans to report its third-quarter 2024 financial results on Wednesday, November 6 before market open. Management will present the results during a conference call and webcast at 9:00 a.m. ET.

    The call will be available by live audio cast along with the news release and online presentation slides at https://investor.conduent.com.

    The conference call will also be available by calling 877-407-4019 toll free. If requested, the conference ID 13748951.

    The international dial-in is +1 201-689-8337. The international conference ID is also 13748951.

    A recording of the conference call will be available by calling 877-660-6853 three hours after the conference call concludes. The access ID for the recording is 13748951.

    The call recording will be available until November 20, 2024.

    We look forward to your participation.

    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.

    Note: To receive RSS news feeds, visit www.news.conduent.com. For open commentary, industry perspectives and views, visit http://twitter.com/Conduent, http://www.linkedin.com/company/conduent or http://www.facebook.com/Conduent.

    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.

    Media Contacts

    Sean Collins

    Conduent

    Sean.Collins2@conduent.com

    +1-310-497-9205

    Giles Goodburn

    Conduent

    ir@conduent.com

    +1-203-216-3546

    Release – Travelzoo Announces Share Repurchase Program

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on TZOO

    Oct 23, 2024, 08:35 ET

    NEW YORK, Oct. 23, 2024 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO), the club for travel enthusiasts, today announced that its board of directors has authorized a new program to repurchase up to 1,000,000 shares of the Company’s outstanding common stock.

    Purchases may be made, from time to time, in the open market and will be funded from available cash. The number of shares to be purchased and the timing of purchases will be based on the level of Travelzoo’s cash balances, general business and market conditions, and other factors, including alternative investment opportunities.

    About Travelzoo
    We, Travelzoo®, are the club for travel enthusiasts. Our 30 million members receive exclusive offers and one-of-a-kind experiences personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with more than 5,000 top travel suppliers—our long-standing relationships give Travelzoo members access to irresistible deals.

    Investor Relations: 
    ir@travelzoo.com   

    SOURCE Travelzoo

    Release – Bowlero to Report First Quarter 2025 Financial Results on November 4, 2024

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on BOWL

    10/22/2024

    RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL) (“Bowlero” or the “Company”), one of the world’s premier operators of location-based entertainment, will report financial results for the first quarter of fiscal 2025 on Monday, November 4, 2024, after the U.S. stock market closes. Management will discuss the results via webcast at 4:30 PM ET on the same day.

    The live webcast, replay, and results presentation will be available in the Events & Presentations section of the Bowlero Investor Relations website at https://ir.bowlerocorp.com/.

    About Bowlero Corp.
    Bowlero Corporation is one of the world’s premier operators of location-based entertainment. With approximately 350 locations across North America, the Company serves more than 40 million guest visits annually through a family of brands that include Lucky Strike, Bowlero and AMF. In 2019, Bowlero acquired the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Bowlero, please visit BowleroCorp.com.

    IRSupport@BowleroCorp.com

    Source: Bowlero Corp

    Release – SelectQuote to Release Fiscal First Quarter 2025 Earnings on November 4

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on SLQT

    10/22/2024

    OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT), a leading distributor of Medicare insurance policies and owner of a rapidly growing Healthcare Services platform, today announced it will release its first quarter 2025 financial results before market open on Monday, November 4, 2024. Chief Executive Officer, Tim Danker, and Chief Financial Officer, Ryan Clement, will host a conference call on the day of the release (November 4, 2024) at 8:30 am ET to discuss the results.

    To register for this conference call, please use this link: https://registrations.events/direct/Q4I1559258472

    After registering, a confirmation will be sent via email, including dial in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx or via this link.

    About SelectQuote:

    Founded in 1985, SelectQuote (NYSE: SLQT) provides solutions that help consumers protect their most valuable assets: their families, health, and property. The company pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads.

    With an ecosystem offering high touchpoints for consumers across insurance, medicare, pharmacy, and value-based care, the company now has four core business lines: SelectQuote Senior, SelectQuote Healthcare Services, SelectQuote Life, and SelectQuote Auto and Home. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, and Healthcare Select which proactively connects consumers with a wide breadth of healthcare services supporting their needs.

    Investor Relations:
    Sloan Bohlen
    877-678-4083
    investorrelations@selectquote.com

    Media:
    Matt Gunter
    913-286-4931
    matt.gunter@selectquote.com

    Source: SelectQuote, Inc.

    Release – Data and Safety Monitoring Board Approves Initiation of Phase 2 of OCU410ST GARDian Clinical Trial for Stargardt Disease

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data On OCGN

    October 22, 2024

    PDF Version

    • Determined the high dose of OCU410ST to be the maximum tolerated dose
    • No serious adverse events have been reported
    • Approved proceeding to Phase 2 using high and medium doses of OCU410ST

    MALVERN, Pa., Oct. 22, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian clinical trial recently convened and approved enrollment for the second phase of the Phase 1/2 clinical trial. OCU410ST (AAV5-hRORA) is a novel modifier gene therapy candidate being developed for Stargardt disease.

    “The DSMB has recommended moving forward with Phase 2 enrollment, as safety data indicates that OCU410ST appears to be safe and well-tolerated to date,” said Charles Wykoff, MD, PhD, Director of Research, Retina Consultants of Texas & Retina Consultants of America, and a lead study investigator. “The safety and tolerability profile of OCU410ST remains encouraging as the clinical trial has progressed and continues to bring hope to patients with Stargardt disease, which still has no FDA-approved treatments.”

    The first phase of the Phase 1/2 clinical trial was an open-label, dose-ranging study that enrolled nine patients to receive either a low (3.75 x 1010 vg/mL), medium (7.5 x 1010 vg/mL), or high (2.25 x 1011 vg/mL) dose of OCU410ST administered via subretinal injection. No serious adverse events (SAEs) have been reported, and the DSMB determined the high dose to be the maximum tolerated dose (MTD).

    Stargardt disease is the most common form of inherited macular dystrophy. Symptoms of bilateral central vision loss typically begin in childhood and gradually worsen over time.

    “We are enthusiastic about the potential of OCU410ST to be the first one-time novel modifier gene therapy for Stargardt disease,” said Huma Qamar, MD, MPH, Chief Medical Officer of Ocugen. “We are encouraged by the prospect of addressing a substantial unmet medical need for the estimated 100,000 Stargardt patients in the U.S. and Europe.”

    The GARDian clinical trial is currently being performed at 6 leading retinal surgery centers across the U.S.

    About Stargardt Disease
    Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

    Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

    About OCU410ST
    OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathway links to Stargardt disease such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.

    About Ocugen, Inc.
    Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on 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.

    Contact:
    Tiffany Hamilton
    Head of Communications
    Tiffany.Hamilton@ocugen.com

    Release – PDS Biotech Announces Presentation of Rationale and Design of First Recurrent Prostate Cancer Trial to Combine an Androgen Receptor Pathway Inhibitor with an Immunocytokine

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on PDSB

    Study to evaluate PDS01ADC + Xtandi® (Enzalutamide) versus Xtandi® alone to be presented by Dr. Ravi Madan, National Cancer Institute at Cytokines 2024

    PRINCETON, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that the rationale and trial design for a study evaluating PDS01ADC for the treatment of recurrent prostate cancer will be discussed during an oral presentation at the 12th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2024) in Seoul, South Korea. Details of the presentation are as follows:

    Date: Wednesday, October 23, 2024
    Session time: 08:30-10:10 Korean Standard Time (KST)
    Session title: Symposium 20 – Cytokine-mediated Translational Approaches of Human Diseases
    Presentation time: 09:20-09:32 KST
    Presentation title: A Clinical Trial Combining a Tumor Targeting Immunocytokine (PDS01ADC) and Enzalutamide without Testosterone Lowering Therapy in Biochemically Recurrent Prostate Cancer
    Presenter: Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National Institutes of Health

    About PDS Biotechnology
    PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

    For more information, please visit www.pdsbiotech.com.

    Forward Looking Statements
    This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, Versamune® HPV (formerly PDS0101), PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, Versamune® HPV, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

    Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

    Xtandi® is a registered trademark of Astellas Pharma, Inc.

    Investor Contact:
    Mike Moyer
    LifeSci Advisors
    Phone +1 (617) 308-4306
    Email: mmoyer@lifesciadvisors.com

    Media Contact:
    Janine McCargo
    6 Degrees
    Phone +1 (646) 528-4034
    Email: jmccargo@6degreespr.com