Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Q3 preview. We estimate the company’s upcoming Q3 revenue and adj. EBITDA to be $103.0 million and $4.9 million, respectively. There is the prospect for an upside surprise, however, particularly for adj. EBITDA. We believe that the company’s ongoing strategy for improving operational efficiency could be reflected in this quarter. The company is expected to report Q3 results in the second week in November.
Enhancing efficiency. During the company’s Q2 earnings call, management highlighted its focus on efficiency in its user acquisition strategy. We believe the company’s efficient use of marketing spend, particularly in areas that provide sufficient returns, could indicate upside surprise potential for adj. EBITDA, not only from our estimate, but also the Street consensus which is $8.5 million.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Eledon Announces Islet Cell Transplant Patients Achieve Insulin Independence. A clinical study using tegoprubart as an immunosuppressant in islet cell transplantation was presented at a medical meeting on Tuesday, October 29, 2024. The first two subjects treated with tegoprubart as an immunosuppressant were able to control blood glucose within the normal range and achieve insulin independence. We see this as a significant advance that could allow islet cell transplantation to allow diabetics to become insulin independent.
Tegoprubart Prevented The Toxicities That Have Led To Failure. Previous attempts to transplant healthy islet cells to restore insulin production have been unsuccessful. This is partly due to the side effects of tacrolimus, the standard of care for immunosuppression that is effective but toxic to the kidney and islet cells. In this trial, tegoprubart was used instead of tacrolimus, with results showing the islet cells were able to survive, engraft, and produce insulin and without the toxicities associated with tacrolimus.
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Key Points: – Bitcoin surged to $73,544, marking a 13% rise in October as inflation concerns grow. – Spot Bitcoin ETFs have accumulated $66 billion, adding stability and appeal to institutional investors. – Increased odds of a pro-Bitcoin presidency add speculative interest as the election nears.
Bitcoin reached a significant seven-month high of $73,544 on Tuesday, driven by a range of economic and political factors. With the U.S. presidential election just a week away, both major candidates have introduced policies that could impact fiscal stability and inflation rates. These potential economic shifts are increasing demand for Bitcoin as a hedge against inflation and a safe investment during times of uncertainty.
The cryptocurrency’s price increase of roughly 6% has led to an impressive 13% gain in October alone, far outperforming the 1% gain seen in the S&P 500. This recent surge extends beyond Bitcoin, as other major cryptocurrencies like Ethereum and Binance coin have also posted notable gains.
Bitcoin’s surge stems from a mix of inflation concerns, Fed policy changes, and favorable political sentiment. Economists anticipate that proposed government policies, especially those from presidential candidates Kamala Harris and Donald Trump, may lead to a rise in the national debt, which often heightens inflation concerns. As inflation worries grow, traditional and digital safe-haven assets have become increasingly appealing. Since the Federal Reserve cut interest rates last month, Bitcoin has risen as investors seek alternatives, especially since monetary policy may not fully address the inflation outlook.
Another factor is the approval of spot Bitcoin exchange-traded funds (ETFs) by U.S. regulators earlier this year, which has driven billions in inflows from institutional investors. Asset management giants like BlackRock, Fidelity, and Grayscale have collectively accumulated about $66 billion worth of Bitcoin in these ETFs, representing around 5% of the global Bitcoin market. This growing institutional support has added momentum to Bitcoin’s recent rally, increasing investor confidence.
Bitcoin’s status as a potential hedge against inflation has also been supported by recent moves in the gold market. Gold prices have risen 6% since the Fed’s rate cut, indicating a shift by investors toward assets that retain value during inflationary periods.
Bitcoin is currently the world’s largest digital currency, with a market cap that dwarfs other cryptocurrencies. Despite a turbulent history marked by the 2022 “crypto winter” and notable bankruptcies, such as the collapse of FTX, Bitcoin has recovered strongly, gaining over 300% from its 2022 lows. Today, it remains more than four times the size of the second-largest cryptocurrency, Ethereum.
The political landscape may also play a role in Bitcoin’s performance. Betting markets have shown an increase in the odds of a Trump victory, as the former president advocates for a national Bitcoin reserve. This pro-Bitcoin stance has drawn attention to the digital asset, especially among investors who view it as a more favorable environment for cryptocurrency adoption.
As the U.S. election approaches, Bitcoin may see continued interest from both institutional and individual investors. With the possibility of new fiscal policies that could further fuel inflation, Bitcoin’s role as a digital hedge remains a central narrative in its current price momentum.
Key Points: – Goods trade deficit rose by 14.9% to $108.2 billion, the highest in over two years. – Goods imports increased by 3.8%, reflecting a rise in consumer and capital goods. – Inventory growth in retail, especially for motor vehicles, is likely to cushion GDP impact.
The U.S. goods trade deficit soared in September to its highest level since March 2022, reaching $108.2 billion. This rise, primarily driven by a 3.8% jump in imports, underscores strong consumer demand but has led some economists to scale back their growth projections for the third quarter. Released by the Commerce Department, the deficit reflects the challenges of balancing robust domestic consumption with slowing exports, which declined by 2%.
Economists noted that while a larger trade deficit traditionally weighs down gross domestic product (GDP), this impact may be mitigated by increased retail inventories, particularly in motor vehicles. Consumer spending remains strong, anticipated to be a major driver of growth for the third quarter. Yet, the trade data has led analysts to revise their economic forecasts downward, with some now expecting annualized GDP growth to hit 2.7% rather than the initially forecasted 3.2%.
Imports of consumer goods led the surge, climbing by 5.8%, while food imports saw a 4.6% boost. The demand for capital goods also rose, with businesses stocking up on equipment and industrial supplies, including petroleum and automotive parts. Analysts suggest that businesses were also building up inventories in anticipation of potential supply disruptions, such as the recently resolved dockworkers strike.
Although the high import figures signal economic strength, the dip in exports of consumer goods, industrial supplies, and capital goods points to potential headwinds for U.S. trade competitiveness. The export decline in consumer goods, down by 6.3%, indicates that external demand may be softening, potentially challenging U.S. exporters.
Meanwhile, both wholesale and retail inventories saw shifts in September. Wholesale inventories slipped slightly by 0.1%, while retail inventories rose 0.8%, reflecting sustained consumer demand. Motor vehicle and parts inventories surged by 2.1%, while non-automotive retail inventories grew modestly. Rising inventories support GDP growth, though they also suggest that retailers may have overestimated sales for the period.
Economists are closely watching inventory levels as they provide insight into whether consumer demand can match the increased supply. According to Carl Weinberg, chief economist at High Frequency Economics, an unexpected rise in retail inventories could signal a slowdown in consumer demand but could still provide short-term GDP support.
The recent trade data arrives ahead of Wednesday’s anticipated GDP report, which is expected to provide a clearer picture of the U.S. economy’s trajectory. While strong consumer demand is evident, analysts remain cautious, noting that the elevated goods trade deficit may continue to be a drag on economic growth in the near term.
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.
ARLP is a diversified natural resource company that generates operating and royalty income from coal produced by its mining complexes and royalty income from mineral interests it owns in strategic oil & gas producing regions in the United States, primarily the Permian, Anadarko and Williston basins. ARLP currently produces coal from seven mining complexes its subsidiaries operate in Illinois, Indiana, Kentucky, Maryland and West Virginia. ARLP also operates a coal loading terminal on the Ohio River at Mount Vernon, Indiana. ARLP markets its coal production to major domestic and international utilities and industrial users and is currently the second largest coal producer in the eastern United States. In addition, ARLP is positioning itself as an energy provider for the future by leveraging its core technology and operating competencies to make strategic investments in the fast growing energy and infrastructure transition.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Third quarter financial results. Alliance reported third quarter EBITDA and earnings per unit (EPU) of $170.7 million and $0.66, respectively, compared to $227.6 million and $1.18 during the prior year period. We had forecast adjusted EBITDA of $220.5 million and $0.82, respectively. Revenue declined 3.6% to $613.6 million because of lower coal sales prices which declined 2.1% due in part to lower export pricing in Appalachia. Operating expenses increased 13.5% due to a longwall move and challenging mining conditions at all three Appalachia operations that reduced recoveries and increased costs. The partnership also experienced a $2.3 million loss related to its equity investment in Francis Energy.
Adjusting estimates. We have lowered our 2024 EBITDA and EPU estimates to $760.1 million and $3.25, respectively, from $813.6 million and $3.60. Our estimates reflect lower coal sales and higher segment adjusted EBITDA expense per ton. Additionally, we have modestly lowered our 2025 EBITDA and EPU estimates to $831.7 million and $3.40, respectively, from $835.2 million and $3.43.
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Key Points: – Alphabet gained ahead of its quarterly report, seen as a key influencer for the tech-driven “Magnificent Seven” group. – Companies like VF Corp and D.R. Horton had earnings-driven movements that affected sectors such as retail and housing. – U.S. job openings fell, while consumer confidence exceeded expectations, suggesting mixed signals on economic resilience.
Ahead of Alphabet’s highly anticipated earnings report, Wall Street’s main indexes remained mixed on Tuesday. Alphabet, a top tech leader and a key part of the so-called “Magnificent Seven” group of mega-cap stocks, traded up by 1.8% in anticipation of the report, set to be released after the market close. As one of the top-performing tech stocks, Alphabet’s performance will influence the broader market’s direction and its ongoing focus on artificial intelligence investments, which have driven much of the tech sector’s gains this year.
Alphabet’s performance comes amid a heavy week for S&P 500 earnings reports. This week, five of the “Magnificent Seven” companies, which have been instrumental in boosting the market, are scheduled to report quarterly results. Investors and analysts alike view these results as key indicators for whether Wall Street’s tech-driven momentum can continue through year-end.
Beyond Alphabet, other large tech players displayed a mixed performance, with Nvidia gaining 0.6% and Apple adding 0.2%, while Tesla fell 1.4%. The performance of these stocks is closely monitored, as they collectively represent a substantial portion of the S&P 500’s market capitalization. The potential for a leveling-off in growth between these “high fliers” and the rest of the market is increasingly under scrutiny by investors.
Adding to the mix, several other corporations released quarterly earnings reports. VF Corp, the parent company of Vans, saw a notable 22.2% jump in its stock price following the announcement of its first profit in two quarters. Conversely, D.R. Horton, the major U.S. homebuilder, dropped 8.5% after delivering revenue forecasts below market expectations. Other homebuilders also declined, with the PHLX Housing index on track for its largest single-day drop since April. Meanwhile, Ford reported that it expects to achieve the lower end of its annual profit target, sending its shares down by over 8%. Chipotle also saw a decrease ahead of its report later in the day.
In economic news, recent data from the Labor Department’s Job Openings and Labor Turnover Survey (JOLTS) revealed that job openings in September came in at 7.44 million, lower than the expected 8 million, suggesting a possible cooling in labor market demand. Additionally, a report on consumer confidence exceeded expectations, reaching 108.7 in October compared to the estimated 99.5, indicating continued consumer resilience.
The benchmark U.S. 10-year Treasury yield also reached a high of 4.3%, marking the first time since early July it hit this level. The rise in bond yields led to a decline in bond-linked sectors, with utilities dropping 1.8% as they tend to respond inversely to yield changes. Bond market dynamics have placed added pressure on stocks with bond-like characteristics, such as utilities.
With the Federal Reserve’s upcoming policy meeting, rising Middle East tensions, and the Nov. 5 U.S. elections looming, investors are bracing for volatility in the weeks ahead. The potential for shifts in monetary policy and new geopolitical developments could further influence market performance and investor sentiment.
– 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.
CHICAGO, Oct. 28, 2024 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL or the “Company”), a diversified manufacturer and supplier of railroad freight cars, railcar parts and components, today announced that it will release its third quarter 2024 financial results on Tuesday, November 12, 2024 before the market opens.
The conference call and live webcast will be held on Tuesday, November 12 at 11:00 a.m. (ET), and will be available on the Investor Relations page of the Company’s website at https://viavid.webcasts.com/starthere.jsp?ei=1693396&tp_key=feca4932b6 or by dialing (877) 407-0789 or (201) 689-8562. It is recommended that listeners log on or dial in approximately 10 to 15 minutes prior to the start of the call.
An audio replay of the conference call will be available shortly after the call has ended on the Company’s Investor Relations website until November 26, 2024.
About FreightCar America
FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com.
