DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
More Changes? The Veterans Administration appears to be making more changes to the Consolidated Mail Outpatient Pharmacy contract process. The procurements were set-aside for a service-disabled veteran owned small business as the prime contractor with each of the eight procurements being evaluated separately for 5-year contracts. On March 14th, the VA issued a notice for services for durations of up to three months.
Background. In an extended process, the VA is again seeking to complete a re-bid and award of the CMOP contracts. In January 2023 DLH and other parties submitted bids for the eight separately competed procurements pertaining to the program. Recall, DLH has operated under a series of “bridge” contracts since 2016. Most recently, the VA extended these contracts through April 30, 2024.
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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.
In a strategic move to strengthen its oncology pipeline, Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company focused on developing novel cancer therapies, has announced its acquisition of AnHeart Therapeutics Ltd. in an all-stock transaction. This acquisition promises to transform Nuvation Bio into a late-stage global oncology company, positioning it as a potential commercial organization by the end of 2025.
The deal, which is subject to approval by AnHeart’s shareholders and other customary closing conditions, is expected to close in the second quarter of 2024. Upon completion, the former shareholders of AnHeart will own approximately 33% of Nuvation Bio on a fully diluted basis, while the current stockholders of Nuvation Bio will retain a 67% stake.
The primary asset driving this acquisition is taletrectinib, AnHeart’s lead investigational therapy and a next-generation ROS1 inhibitor for the treatment of ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib has already received Breakthrough Therapy Designations from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA).
Notably, taletrectinib is currently completing two pivotal Phase 2 studies, TRUST-I in China and TRUST-II, a global pivotal study, potentially positioning it as a best-in-class treatment option for patients with ROS1-positive NSCLC. The NMPA has also granted Priority Review Designation to New Drug Applications for taletrectinib, further underscoring its potential.
In addition to taletrectinib, the acquisition also brings safusidenib, a potentially best-in-class mutant IDH1 inhibitor, into Nuvation Bio’s pipeline. Safusidenib is currently being evaluated in a global Phase 2 study for the treatment of patients with grades 2 and 3 IDH1-mutant glioma.
“This transaction represents a significant milestone for our company and reflects Nuvation Bio’s continued commitment to developing therapies for patients with the most difficult-to-treat cancers,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “AnHeart’s lead asset, taletrectinib, which will become our lead asset as it completes two pivotal studies, is a differentiated, next-generation ROS1 inhibitor with a potentially best-in-class profile that may overcome the significant limitations of existing therapies.”
For Nuvation Bio, this all-stock acquisition preserves the company’s robust cash balance, enabling the development of both the newly acquired assets and its existing pipeline without the immediate need to raise additional capital. This financial strength positions Nuvation Bio to execute its development strategy effectively and advance its combined portfolio of differentiated oncology therapeutic candidates.
The acquisition also brings together the talented teams from both companies, with Nuvation Bio’s current management team, including Dr. Hung, remaining at the helm. Additionally, Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, an investor in AnHeart, and Junyuan Jerry Wang, Ph.D., Co-Founder and Chief Executive Officer of AnHeart, will join Nuvation Bio’s board of directors.
As the demand for innovative cancer therapies continues to grow, Nuvation Bio’s acquisition of AnHeart Therapeutics represents a strategic move to bolster its oncology pipeline and position itself as a potential commercial organization in the near future. With taletrectinib and safusidenib as promising additions to its portfolio, Nuvation Bio is poised to make significant strides in addressing the unmet needs of patients with challenging forms of cancer.
HOUSTON, March 25, 2024 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (“Orion” or the “Company”), a leading specialty construction company, announced today that Richard L. Daerr, Jr., who has served as an independent member of the Company’s Board of Directors (the “Board”) since 2007 and was Chairman of the Board from 2007 to 2020 as well as Lead Independent Director from 2022 to 2023, informed the Company that he has chosen not to stand for re-election and instead retire from the Board effective at the Company’s upcoming Annual General Meeting of Stockholders on May 16, 2024. Effective upon Mr. Daerr’s retirement, the Board has determined to reduce its size from eight directors to seven directors, six of whom are independent.
Austin Shanfelter, Orion’s Chairman of the Board, commented, “We want to thank Richard for his years of service to the Company and his many valuable contributions, including his board leadership in the transition of Orion to a public company, establishing the standards for governance, the growth of the Company, and agreeing to serve as our Lead Independent Director through our recent executive transition. We wish him all the best in his future endeavors.”
Mr. Daerr stated, “It has been my distinct honor to serve on this Board for almost seventeen years and lead the Board for almost all of that time. I am proud of the tremendous transformation the Company has achieved over this time, and I leave with great confidence in Orion’s future and the strength of its Board.”
About Orion Group Holdings Orion Group Holdings, Inc., a leading specialty construction company serving the infrastructure, industrial and building sectors, provides services both on and off the water in the continental United States, Alaska, Hawaii, Canada and the Caribbean Basin through its marine segment and its concrete segment. The Company’s marine segment provides construction and dredging services relating to marine transportation facility construction, marine pipeline construction, marine environmental structures, dredging of waterways, channels and ports, environmental dredging, design and specialty services. Its concrete segment provides turnkey concrete construction services including place and finish, site prep, layout, forming, and rebar placement for large commercial, structural and other associated business areas. The Company is headquartered in Houston, Texas with regional offices throughout its operating areas. The Company’s website is located at: https://www.oriongroupholdingsinc.com.
Forward-Looking Statements The matters discussed in this press release may constitute or include projections or other forward-looking statements within the meaning of the “safe harbor” provisions of Section 27A of the Securities Exchange Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, of which provisions the Company is availing itself. Certain forward-looking statements can be identified by the use of forward-looking terminology, such as ‘believes’, ‘expects’, ‘may’, ‘will’, ‘could’, ‘should’, ‘seeks’, ‘approximately’, ‘intends’, ‘plans’, ‘estimates’, or ‘anticipates’, or the negative thereof or other comparable terminology, or by discussions of strategy, plans, objectives, intentions, estimates, forecasts, outlook, assumptions, or goals. In particular, statements regarding future operations or results, including those set forth in this press release, and any other statement, express or implied, concerning future operating results or the future generation of or ability to generate revenues, income, net income, gross profit, EBITDA, Adjusted EBITDA, Adjusted EBITDA margin, or cash flow, including to service debt, and including any estimates, forecasts or assumptions regarding future revenues or revenue growth, are forward-looking statements. Forward-looking statements also include project award announcements, estimated project start dates, anticipated revenues, and contract options which may or may not be awarded in the future. Forward-looking statements involve risks, including those associated with the Company’s fixed price contracts that impacts profits, unforeseen productivity delays that may alter the final profitability of the contract, cancellation of the contract by the customer for unforeseen reasons, delays or decreases in funding by the customer, levels and predictability of government funding or other governmental budgetary constraints, and any potential contract options which may or may not be awarded in the future, and are at the sole discretion of award by the customer. Past performance is not necessarily an indicator of future results. In light of these and other uncertainties, the inclusion of forward-looking statements in this press release should not be regarded as a representation by the Company that the Company’s plans, estimates, forecasts, goals, intentions, or objectives will be achieved or realized. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update information contained in this press release whether as a result of new developments or otherwise, except as required by law.
Please refer to the Company’s 2023 Annual Report on Form 10-K, filed on March 1, 2024, which is available on its website at www.oriongroupholdingsinc.com or at the SEC’s website at www.sec.gov, for additional and more detailed discussion of risk factors that could cause actual results to differ materially from our current expectations, estimates or forecasts.
IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
“We are pleased with the strong pace of enrollment in our Phase 2 BESTOW trial and believe it speaks to the underlying demand for a new immunosuppressive regimen for the tens of thousands of patients each year who undergo kidney transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer.
The Risk of Organ Failure in Transplantation
In transplantation procedures, organ rejection is a major cause of graft failure, which can be a life-threatening condition. Rejection occurs due to allorecognition, wherein the recipient’s immune system identifies the transplanted organ as foreign tissue, triggering an immune response against the transplanted organ. To reduce the risk of rejection, patients are treated with immunosuppressive therapies for life. Calcineurin inhibitors (“CNIs”) are a critical component of most immunosuppressive regimens to prevent acute and long-term organ transplant rejection. However, chronic exposure to CNIs (tacrolimus is the drug most commonly used) is associated with nephrotoxicity, hypertension, new onset diabetes due to pancreatic beta cell toxicity, as well as central nervous system side effects like tremor. Regarding kidney transplantation, the toxicity associated with CNIs causes 30-50% of kidney transplants to fail with 10-15 years of transplantation. Strategies to better and more safely protect transplanted organs and thus increase how long they function represent a significant area of unmet need in organ transplantation.
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 demand for a new and better immunosuppressive regimen for patients who undergo kidney transplantation, or statements about the Company’s other future expectations, plans and prospects, 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 sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. 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-Qs, 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.
In a strategic move that could have significant implications for the small-cap biotech sector, pharmaceutical giant AbbVie Inc. (NYSE: ABBV) announced its acquisition of Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company focused on developing novel oral therapeutics for autoimmune diseases. The deal, valued at approximately $212.5 million including contingent value rights, underscores the growing interest and potential in the small-cap biotech space, particularly in the field of inflammatory and autoimmune diseases.
Under the terms of the agreement, AbbVie will acquire Landos at $20.42 per share in cash upon closing, plus a contingent value right of up to $11.14 per share, subject to the achievement of a clinical development milestone. The acquisition is expected to close in the second quarter of 2024, subject to customary closing conditions, including approval by Landos’ stockholders.
The primary asset driving this deal is NX-13, Landos’ lead investigational asset and a first-in-class, oral NLRX1 agonist with a bimodal mechanism of action. NX-13 is currently in Phase 2 clinical trials for the treatment of ulcerative colitis (UC), a chronic inflammatory bowel disease affecting millions worldwide.
“With this acquisition, we aim to advance the clinical development of NX-13, a differentiated, first-in-class, oral asset with the potential to make a difference in the lives of people living with ulcerative colitis and Crohn’s disease,” said Roopal Thakkar, M.D., AbbVie’s senior vice president and chief medical officer, global therapeutics.
NX-13’s unique bimodal mechanism of action, which is both anti-inflammatory and facilitates epithelial repair, could provide a novel approach to treating UC and other inflammatory bowel diseases. If successful, it could address a significant unmet need in this therapeutic area.
The acquisition underscores AbbVie’s commitment to strengthening its portfolio in inflammatory and autoimmune diseases, which represent a substantial market opportunity. According to estimates, the global inflammatory bowel disease treatment market is projected to reach $8.6 billion by 2027, driven by factors such as increasing prevalence, rising healthcare expenditure, and a growing focus on developing targeted therapies.
For small-cap investors, this deal highlights the potential value and attractiveness of emerging biotech companies with promising pipeline candidates. As larger pharmaceutical companies seek to bolster their portfolios and drive innovation, strategic acquisitions of small-cap biotechs with compelling assets can provide attractive exit opportunities and significant returns for investors.
With the rising interest in novel therapies for inflammatory and autoimmune diseases, the AbbVie-Landos deal serves as a reminder of the potential value that can be unlocked in the small-cap biotech realm. As larger players seek to fortify their pipelines, the spotlight on promising small-cap innovators is likely to intensify, presenting exciting opportunities for investors in this space.
Cholesterol Efflux MediatorTM VAR 200 on target to begin Phase 2a clinical trial in patients with diabetic kidney disease H1-2024.
Inflammasome ASC Inhibitor IC 100 preclinical program nearing completion, with planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation shortly thereafter.
Inflammasome ASC Inhibitor IC 100 preclinical research funded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) nearing completion, with potential for a second MJFF grant for further research.
Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for atherosclerosis expected to conclude H1-2024.
Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for obesity and metabolic syndrome expected to begin Q2-2024.
WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.
“Throughout 2023 and early 2024, ZyVersa achieved considerable progress in advancing development of our two lead candidates. A Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR 200 is on target to be initiated in the first half of this year in patients with diabetic kidney disease; preclinical studies for indication expansion are underway for Parkinson’s disease, atherosclerosis, and obesity with Inflammasome ASC Inhibitor IC 100; and IND submission for IC 100 is expected by end of the year,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “We view 2024 as a potentially transformative year for the company based on the value-building milestones that we expect to achieve over the next 12 to 15 months. I look forward to working with my leadership team and fellow Board members to execute a business and clinical strategy that has potential to position ZyVersa as a leading, innovative company developing transformative drugs for underserved patients with renal and inflammasome-mediated inflammatory diseases.”
BUSINESS Update
CHOLESTEROL EFFLUX MEDIATORTM VAR 200 FOR RENAL DISEASE
Phase 2a clinical trial in patients with diabetic kidney disease is on target to begin in the first half of 2024.
CRO, George Clinical was engaged in December 2023 to initiate and manage the trial.
An IND amendment to study diabetic kidney disease was filed on February 16, 2024.
A central Institutional Review Board (IRB) approved the clinical trial protocol for trial initiation.
INFLAMMASOME ASC INHIBITOR IC 100 FOR INFLAMMATORY DISEASES
Inflammasome ASC Inhibitor IC 100’s preclinical program is nearing completion, with a planned IND submission in Q4-2024, followed by initiation of a Phase 1 clinical trial shortly thereafter.
Preclinical research funded by MJFF and conducted by researchers at University of Miami Miller School of Medicine to determine the potential of Inflammasome ASC Inhibitor IC 100 to block the damaging neuroinflammation that induces neural degeneration in Parkinson’s disease is nearing completion.
Research update and key findings were provided to MJFF project team on March 8, 2024.
Based on the findings, the MJFF project team suggested that the team apply for a second grant to further the research in an established animal model.
A scientific collaboration was initiated with an undisclosed partner to assess the potential of Inflammasome ASC Inhibitor IC 100 as a treatment for atherosclerosis in a well-established animal model.
Study is expected to conclude in H1-2024.
A scientific collaboration with inflammasome and neurology experts at University of Miami Miller School of Medicine to assess the potential of Inflammasome ASC Inhibitor IC 100 as a treatment for obesity and metabolic syndrome is expected to begin in Q2-2024.
YEAR END 2023 FINANCIAL RESULTS
Net losses were $98.3 million for the year ended December 31, 2023 (the “2023 Period”), an increase of $84.2 million compared to a net loss of $14.1 million for the “2022 Period,” which is comprised of the financial results of the company containing our operations prior to our business combination from January 1, 2022 through December 12, 2022, and our financial results after the business combination, from December 13, 2022 through December 31, 2022. A deferred tax benefit of $9.5 million for the 2023 Period, compared to $0.7 million tax benefit during the 2022 Period, resulted from the impairment of the in-process research and development.
Pre-tax losses were $107.8 million for the 2023 Period, an increase of $92.9 million compared to a pre-tax loss of $14.9 million for the 2022 Period. The higher net loss reported for the 2023 Period is primarily due to the impairment of in-process research and development and impairment of goodwill of $81.4 million and $11.9 million, respectively, compared to none for the 2022 Period. The impairment is a result of the decline in stock value and the resulting market capitalization of ZyVersa during the 2023 Period.
Based on its current operating plan, ZyVersa expects its cash of $3.1 million as of December 31, 2023 will be sufficient to fund its operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations. ZyVersa will seek to fund its operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties.
Research and development expenses for the 2023 Period were $3.2 million, a decrease of $2.6 million or 44.8% from $5.8 million for the 2022 Period. The decrease in research and development expenses was primarily due to spending for materials supplies for manufacturing in 2022 that were not required in 2023 as manufacturing was completed in 2022.
General and administrative expenses for the 2023 Period were $11.2 million, an increase of $3.2 million or 39.7% from $8.0 million for the 2022 Period. The increase is primarily attributed to increased costs for legal and professional fees of $2.7 million, investor and public relations fees of $1.2 million, and increased director and officer insurance of $1.3 million, all due to increased costs associated with being a public company. These were offset by reduced business combination transaction costs of $2.2 million.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc. (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
FY 2023 Record Revenue of $689 Million, Up 7% Year-over-Year
FY 2023 Net Income of $1.6 Million, Down 54% Year-over-Year
FY 2023 Record Adjusted EBITDA (non-GAAP) of $56 Million, Up 37% Year-over-Year
Strengthens Footprint and Continues Business Momentum in the First Quarter of 2024
Provides First Quarter 2024 Guidance for Revenue and Adjusted EBITDA
ATLANTA, March 25, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, today reported financial results for the fourth quarter and full year ended December 31, 2023. Bitcoin Depot will host a conference call and webcast at 11:00 a.m. ET today. An earnings presentation and link to the webcast will be made available at ir.bitcoindepot.com.
“Bitcoin Depot had its strongest year ever in 2023 as we delivered $689 million in revenue, $56 million in Adjusted EBITDA, and had sustained strength in customer traffic and transaction volume,” said Brandon Mintz, CEO and Founder of Bitcoin Depot. “We continued to advance our growth strategy by expanding the number of Bitcoin access points across North America while optimizing our footprint to drive an improvement in profitability. Looking ahead, Bitcoin Depot is well positioned to deliver profitable growth going forward while supporting our mission to safely, securely and efficiently bring Bitcoin to the masses. We see opportunities for accelerated market share growth and aim to have over 8,000 kiosks installed by the end of 2024, the largest installed fleet of Bitcoin ATMs in our history.”
Fourth Quarter and Full-Year 2023 Financial Results
Revenue in the fourth quarter of 2023 was $148.4 million, down 1% from $149.7 million for the fourth quarter of 2022. For the full year, revenue increased 7% to $689.0 million compared to $646.8 million in the prior year.
Gross Profit in the fourth quarter of 2023 was $17.9 million, up 23% from $14.6 million for the fourth quarter of 2022. Gross Profit margin in the fourth quarter of 2023 was 12.1% compared to 9.8% in the fourth quarter of 2022. For the full year, Gross Profit increased 64% to $87.8 million compared to $53.5 million in the prior year and Gross Profit margin was 12.8% compared to 8.3% in the prior year.
Total operating expenses were $17.0 million for the fourth quarter of 2023, compared to $14.8 million for the fourth quarter of 2022. For the full year, operating expenses were $69.8 million compared to $55.8 million in the prior year.
Net loss for the fourth quarter of 2023 was $1.5 million, compared to a net loss of $0.5 million for the fourth quarter of 2022. For the full year, net income was $1.6 million compared to net income of $3.5 million in the prior year.
Adjusted EBITDA, a non-GAAP measure, in the fourth quarter of 2023 was $9.0 million, compared to Adjusted EBITDA of $11.4 million for the fourth quarter of 2022. For the full year, Adjusted EBITDA was $56.4 million compared to $41.2 million in the prior year. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.
Cash and cash equivalents were $26.4 million as of the end of the fourth quarter of 2023.
2023 Highlights
Completed software conversion to BitAccess across the Company’s full BTM fleet. The completion of the conversion vertically integrates Bitcoin Depot’s hardware and software, eliminating previous annual software licensing fees.
Closed its previously announced business combination with GSR II Meteora Acquisition Corp. on June 30th and subsequently began trading on the Nasdaq on July 3rd.
Announced multiple partnerships with convenience store brands with locations spanning across several states to increase Bitcoin Depot’s fleet of deployed kiosks, including FastLane, Gas Express, High’s, Majors Management, Stinker Stores, GetGo® Café + Market, and Jacksons Food Store.
Expanded BDCheckout program into three additional states and over 725 additional locations across a variety of convenience store partners through an ongoing partnership with a leading global payments technology company.
Announced distribution partnership with CORD Financial Services to distribute Bitcoin Depot kiosks across the U.S.
Secured preferred BTM vendor status with National Retail Association, AATAC, a national trade association of retailers, distributors, vendor suppliers and partners for the convenience store and retail industries.
Hired a new Chief Technology Officer to lead software development efforts.
Q1 2024 and Recent Highlights
Announced the sale of 50 new BTM kiosks to Sopris Capital as part of the Company’s franchise program.
Purchased 900 additional Bitcoin ATMs for Q1 2024 Expansion.
Announced expansion deal with a leading operator of convenience stores across 63 stores.
Announced deployment of 940 Bitcoin Depot kiosks in convenience store locations across 24 states beginning in Q1 of 2024.
Announced the expansion of the Company’s sales team with the hiring of 13 new sales representatives.
Guidance
Based on current market conditions, Bitcoin Depot expects consolidated revenue in the first quarter of 2024 to range between $137 million and $138 million compared to $163.6 million in the first quarter of 2023. Bitcoin Depot expects Adjusted EBITDA (non-GAAP) in the first quarter of 2024 to range between $5 million – $6 million compared to net income of $6.1 million and Adjusted EBITDA of $13.6 million in the first quarter of 2023.
For important disclosures about Adjusted EBITDA, see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.
Conference Call
Bitcoin Depot will hold a conference call at 11:00 a.m., Eastern time (8:00 a.m. Pacific time), today to discuss its financial results for the fourth quarter and full year ended December 31, 2023.
Call Date: Monday, March 25, 2024 Time: 11:00 a.m. Eastern time (8:00 a.m. Pacific time) U.S. dial-in: 646-307-1963 International dial-in: 800-715-9871 Conference ID: 2505953
The conference call will broadcast live and be available for replay here following the call.
Please call the conference telephone number approximately 10 minutes before the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 1-949-574-3860.
A replay of the call will be available beginning after 3:00 p.m. Eastern time on March 25, 2024 through April 1, 2024.
U.S. replay number: 609-800-9909 International replay number: 800-770-2030 Conference ID: 2505953
About Bitcoin Depot
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to Bitcoin at Bitcoin Depot’s kiosks and at thousands of name-brand retail locations through its BDCheckout product. The Company has the largest market share in North America with approximately 6,339 kiosk locations as of December 31, 2023. Learn more at www.bitcoindepot.com.
This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, our ability to strengthen our financial profile, worldwide growth in the adoption and use of cryptocurrencies, and our guidance regarding our generation of revenue and Adjusted EBITDA for Q1 2024. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,“ ”plan,“ ”potential,“ ”priorities,“ ”project,“ ”pursue,“ ”seek,“ ”should,“ ”target,“ ”when,“ ”will,“ ”would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.
These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; risks relating to the uncertainty of our projected financial information; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.
We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.
BITCOIN DEPOT INC. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts)
As of December 31,
2023
2022
(unaudited)
Assets
Current:
Cash and cash equivalents
$
26,388
$
37,540
Cryptocurrencies
712
540
Accounts receivable, net
245
263
Prepaid expenses and other current assets
6,538
2,015
Total current assets
33,883
40,358
Property and equipment:
Furniture and fixtures
635
618
Leasehold improvements
172
172
Kiosk machines – owned
24,222
15,234
Kiosk machines – leased
20,524
36,591
Vehicles
—
17
Total property and equipment
45,553
52,632
Less: accumulated depreciation
(20,699
)
(13,976
)
Total property and equipment, net
24,854
38,656
Intangible assets, net
3,836
5,351
Goodwill
8,717
8,717
Operating lease right-of-use assets, net
484
302
Deposits
412
17
Deferred tax assets
4,027
—
Total assets
$
76,213
$
93,401
BITCOIN DEPOT INC. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts)
As of December 31,
2023
2022
(unaudited)
Liabilities and Stockholders’ Equity and Member’s Equity
Current:
Accounts payable
$
8,320
$
8,119
Accrued expenses and other current liabilities
19,745
11,309
Note payable
3,985
8,050
Income taxes payable
2,272
647
Deferred revenue
297
19
Operating lease liabilities, current portion
319
228
Current installments of obligations under finance leases
6,801
18,437
Other tax payable
700
—
Total current liabilities
$
42,439
$
46,809
Long-term liabilities
Note payable, non-current
17,101
29,522
Operating lease liabilities, non-current
279
247
Obligations under finance leases, non-current
2,848
6,140
Deferred income tax, net
805
1,239
Tax receivable agreement liability
2,582
—
Total Liabilities
$
66,054
$
83,957
Commitments and Contingencies (Note 22)
Stockholders’ Equity and Member’s Equity
Series A Preferred Stock, $0.0001 par value; 50,000,000 authorized, 3,125,000 shares issued and outstanding, at December 31, 2023
—
—
Class A common stock, $0.0001 par value; 800,000,000 authorized, 13,671,691 shares issued, and 13,551,047 shares outstanding at December 31, 2023
1
—
Class B common stock, $0.0001 par value; 20,000,000 authorized, no shares issued and outstanding at December 31, 2023
—
—
Class E common stock, $0.0001 par value; 2,250,000 authorized, 1,075,761 shares issued and outstanding at December 31, 2023
—
—
Class M common stock, $0.0001 par value; 300,000,000 authorized, no shares issued and outstanding at December 31, 2023
—
—
Class O common stock, $0.0001 par value; 800,000,000 authorized, no shares issued and outstanding at December 31, 2023
—
—
Class V common stock, $0.0001 par value; 300,000,000 authorized, 44,100,000 shares issued and outstanding at December 31, 2023
4
—
Treasury stock
(279
)
—
Additional paid-in capital
17,933
—
Retained earnings (accumulated deficit)
(30,991
)
—
Equity attributed to Legacy Bitcoin Depot
—
7,396
Accumulated other comprehensive loss
(203
)
(182
)
Total Stockholders’ Equity (Deficit) and Equity Attributable to Legacy Bitcoin Depot
$
(13,535
)
$
7,214
Equity attributable to non-controlling interests
23,694
2,230
Total Stockholders’ Equity and Member’s Equity
$
10,159
$
9,444
Total Liabilities and Stockholders’ Equity and Member’s Equity
$
76,213
$
93,401
BITCOIN DEPOT INC. CONSOLIDATED STATEMENTS OF INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) (UNAUDITED) (in thousands, except share and per share amounts)
Year ended December 31,
2023
2022
(unaudited)
Revenue
$
688,967
$
646,830
Cost of revenue (excluding depreciation and amortization)
588,637
574,535
Operating expenses:
Selling, general, and administrative
57,046
36,991
Depreciation and amortization
12,788
18,783
Total operating expenses
$
69,834
$
55,774
Income from operations
$
30,496
$
16,521
Other (expense) income:
Interest (expense)
(11,926
)
(12,318
)
Other (expense) income
(16,626
)
118
(Loss) gain on foreign currency transactions
(289
)
(380
)
Total other (expense)
$
(28,841
)
$
(12,580
)
Income before provision for income taxes and non-controlling interest
1,655
3,941
Income tax benefit (expense)
(8
)
(395
)
Net income
$
1,647
$
3,546
Net income attributable to Legacy Bitcoin Depot unit holders
12,906
3,980
Net income (loss) attributable to non-controlling interest
13,172
(434
)
Net (loss) attributable to Bitcoin Depot Inc.
$
(24,431
)
$
–
Other comprehensive income (loss), net of tax
Net income
$
1,647
$
3,546
Foreign currency translation adjustments
66
(110
)
Total comprehensive income
$
1,713
$
3,436
Comprehensive income attributable to Legacy Bitcoin Depot unit holders
12,885
3,870
Comprehensive income (loss) attributable to non-controlling interest
13,259
(434
)
Comprehensive loss attributable to Bitcoin Depot Inc.
$
(24,431
)
$
–
Explanation and Reconciliation of Non-GAAP Financial Measures
Bitcoin Depot reports its financial results in accordance with accounting principles generally accepted in the United States of America (“GAAP”). This press release includes both historical and projected Adjusted EBITDA, Adjusted Gross Profit, and certain ratios and other metrics derived therefrom such as Adjusted EBITDA margin and Adjusted Gross Profit margin, which are not prepared in accordance with GAAP.
Bitcoin Depot defines Adjusted EBITDA as net income before interest expense, income tax expense, depreciation and amortization, non-recurring expenses, stock-based compensation, expenses related to the PIPE financing and miscellaneous cost adjustments. Such items are excluded from Adjusted EBITDA because these items are non-cash in nature, or because the amount and timing of these items is unpredictable, not driven by core results of operations and renders comparisons with prior periods and competitors less meaningful. In addition, Bitcoin Depot defines Adjusted Gross Profit (a non-GAAP financial measure) as revenue less cost of revenue (excluding depreciation and amortization) and depreciation and amortization adjusted to add back depreciation and amortization. Bitcoin Depot believes Adjusted EBITDA and Adjusted Gross Profit each provide useful information to investors and others in understanding and evaluating Bitcoin Depot’s results of operations, as well as provide a useful measure for period-to-period comparisons of Bitcoin Depot’s business performance. Adjusted EBITDA and Adjusted Gross Profit are each key measurements used internally by management to make operating decisions, including those related to operating expenses, evaluate performance and perform strategic and financial planning. However, you should be aware that Adjusted EBITDA and Adjusted Gross Profit are not measures of financial performance calculated in accordance with GAAP and may exclude items that are significant in understanding and assessing Bitcoin Depot’s financial results, and further, that Bitcoin Depot may incur future expenses similar to those excluded when calculating these measures. Bitcoin Depot primarily relies on GAAP results and uses both Adjusted EBITDA and Adjusted Gross Profit on a supplemental basis. Neither Adjusted EBITDA or Adjusted Gross Profit should be considered in isolation from, or as an alternative to, net income, cash flows from operations or other measures of profitability, liquidity or performance under GAAP and may not be indicative of Bitcoin Depot’s historical or future operating results. Bitcoin Depot’s computation of both Adjusted EBITDA and Adjusted Gross Profit may not be comparable to other similarly titled measures computed by other companies because not all companies calculate such measures in the same fashion. As such, undue reliance should not be placed on such measures.
Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from the projections of Adjusted EBITDA, together with some of the excluded information not being ascertainable or accessible, Bitcoin Depot is unable to quantify certain amounts that would be required to be included in the most directly comparable GAAP financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable GAAP measures is included and no reconciliation of the forward-looking non-GAAP financial measures is included.
The following table presents a reconciliation of revenue to Adjusted EBITDA for the periods indicated:
BITCOIN DEPOT INC. RECONCILIATION OF NET (LOSS) INCOME TO ADJUSTED EBITDA
Year Ended December 31,
(in thousands)
2023
2022
(unaudited)
Net income
$
1,647
$
3,546
Adjustments:
Interest expense
11,926
12,318
Income tax (benefit) expense
8
395
Depreciation and amortization
12,788
18,783
Expense related to the PIPE transaction (1)
14,785
—
Non-recurring expenses (2)
9,298
4,879
Stock based compensation
2,523
1,230
Special bonus (3)
3,040
—
Expenses associated with the termination of the phantom equity participation plan
350
—
Adjusted EBITDA
$
56,365
$
41,151
Adjusted EBITDA margin (4)
8.2
%
6.4
%
(1)
Amounts include the recognition of a non-cash expense of $14.8 million and $2.5 million related to the PIPE transaction, entered into as of close of the Merger on June 30, 2023, for the twelve and three months ended December 31, 2023, respectively.
(2)
Comprised of non-recurring professional service fees.
(3)
Amount includes (A) Transaction bonus and related taxes to employees of approximately $1.4 million and (B) Founder Transaction bonus as a result of close of the Merger, of approximately $1.6 million, recognized as stock-based compensation, for the year ended December 31, 2023.
(4)
Adjusted EBITDA margin is defined as Adjusted EBITDA divided by revenue. The Company uses this measure to evaluate its overall profitability.
The following table presents a reconciliation of revenue to Adjusted Gross Profit for the periods indicated:
BITCOIN DEPOT INC. RECONCILIATION OF REVENUE TO ADJUSTED GROSS PROFIT
Year Ended December 31,
(in thousands)
2023
2022
(unaudited)
Revenue
$
688,967
$
646,830
Cost of revenue (excluding depreciation and amortization)
(588,637
)
(574,535
)
Depreciation and amortization excluded from cost of revenue
(12,455
)
(18,783
)
Gross Profit
$
87,875
$
53,512
Adjustments:
Depreciation and amortization excluded from cost of revenue
$
12,455
$
18,783
Adjusted Gross Profit
$
100,330
$
72,295
Gross Profit Margin (1)
12.8
%
8.3
%
Adjusted Gross Profit Margin (1)
14.6
%
11.2
%
(1) Calculated as a percentage of revenue.
Contacts:
Investors Cody Slach, Alex Kovtun Gateway Group, Inc. 949-574-3860 BTM@gateway-grp.com
Media Zach Kadletz, Brenlyn Motlagh, Ryan Deloney Gateway Group, Inc. 949-574-3860 BTM@gateway-grp.com
TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating
Prader Willi syndrome is the most common genetic cause of life-threatening childhood obesity
CHATHAM, N.J., March 25, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to TNX-2900* (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-potentiated formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023. The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing. Recently, vouchers have sold for approximately $100 million.
“The Rare Pediatric Disease Designation is an important regulatory milestone in the development of TNX-2900. With PWS being the most common genetic cause of life-threatening childhood obesity, we are excited that the FDA has recognized this significant unmet need in children and adolescents, particularly for PWS hyperphagia, which currently has no approved treatments1,2,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “As PWS is a genetic disorder associated with abnormalities of the oxytocin system, Tonix believes TNX-2900’s unique formulation has the potential to improve intranasal oxytocin’s therapeutic action by addressing limitations in efficacy observed at high-dose intranasal oxytocin that is not Mg2+-potentiated3,4.”
The FDA defines a rare pediatric disease as a serious or life-threating disease that primarily affects individuals aged from birth to 18 years and affects under 200,000 people in the United States.
About FDA’s Rare Pediatric Disease Priority Voucher Program
The FDA’s Rare Pediatric Disease Priority Voucher Program is intended to encourage the development of new drugs to treat certain rare pediatric diseases. Under the FDA’s Rare Pediatric Disease Designation and Voucher Program, if TNX-2900 is approved for marketing, Tonix may qualify for a priority review voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product. Priority review vouchers may also be sold or transferred to another sponsor. The new sponsor can redeem the voucher to receive priority review for a different product, which reduces the review time of NDAs from 10 months to six months. There is no limit on the number of times a priority review voucher can be transferred. A 2020 U.S. Government Accounting Office analysis5 of the voucher program found that in the ten years since launch of the program in 2009, the price of buying priority review vouchers ranged from $67 million to $350 million. More recently, priority review vouchers were acquired by Novo Nordisk for $110 million in June of 2022, and by Novartis for $100 million from Marinus in July of 2022.6 Bluebird Bio sold vouchers for $102 million, $95 million and $103 million in November 2022, January 2023, and October 2023, respectively.7-9 In June of 2023, Novartis bought a priority review voucher from Pharming for $21 million, a price that had been negotiated as part of a purchase agreement when Pharming acquired the asset from Novartis.5
About Prader-Willi Syndrome (PWS)
PWS is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races and ethnicities. PWS results from the absence of expression of a group of genes on the paternally acquired chromosome 15. The hallmarks of PWS are lack of suckling in newborns and, in children and adolescents, severe hyperphagia – an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. A systematic review of the morbidity and mortality as a consequence of hyperphagia in PWS found that the average age of death in PWS was 22.1 years.10 There is no approved medication to treat poor feeding in newborns or hyperphagia in children and adolescents with PWS. Given the serious or life-threatening manifestations of these conditions, there is a critical need for effective treatments to decrease morbidity and mortality, improve quality of life, and increase life expectancy in people with PWS. Oxytocin has potent effects in correcting behavioral characteristics of the Magel2 knock-out mouse model for PWS and autism.11-13 Six clinical trials have investigated intranasal oxytocin as a treatment in pediatric patients with PWS. Four studies showed evidence for improvement in PWS-related behaviors/symptoms14-17; three clinical studies reported evidence for improvement in hyperphagia14,15,17; and one clinical study showed an improvement in sucking in infants16.
About TNX-2900 and Tonix’s Potentiated Oxytocin Platform
TNX-2900 is based on Tonix’s patented intranasal Mg2+-potentiated oxytocin formulation intended for use by children and adolescents. This formulation is believed to enhance the potency of oxytocin as well as increase specificity for oxytocin receptors relative to vasopressin receptors, potentially reducing unwanted side effects from activating vasopressin receptors. Tonix is also developing a different intranasal formulation, designated TNX-1900 for adolescent obesity, binge eating disorder, bone health in autism, and social anxiety disorder. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians, and fish.18 It was initially approved by the U.S. Food and Drug Administration as Pitocin®**, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor and control postpartum bleeding or hemorrhage. An intranasal formulation of oxytocin is marketed in some European countries to assist in breast milk production as Syntocinon®*** (oxytocin nasal 40 units/ml).
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 and infectious disease. 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 and have not been approved for any indication. Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia.
**Pitocin® is a trademark of Par Pharmaceutical, Inc.
***Syntocinon® is a trademark of BGP Products Operations GmbH
Citations
Meyerowitz JG, et al. Nat Struct Mol Biol. 2022. 29(3):274-281.
Meziane H, et al. Biol Psychiatry. 2015. 78(2):85-94.
Correa-da-Silva F, et al. J Neuroendocrinol. 2021. 33(7):e12994.
Bharadwaj VN, et al. Pharmaceutics. 2022. 14(5):1105.
U.S. Government Accounting Office, Jan 31, 2020. “Drug Development: FDA’s Priority Review Voucher Programs”. GAO-20-251. https://www.gao.gov/products/gao-20-251.
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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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.
RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corporation (NYSE: BOWL), the global leader in bowling entertainment, announced today the opening of Lucky Strike Miami, the second new build using the Lucky Strike brand since it was acquired in September. Lucky Strike Miami is located in the heart of Downtown Miami within Miami Worldcenter, a 27-acre, $6 billion mixed-use destination transforming Miami’s urban core with world-class shopping, dining, hospitality, and residential options, just steps away from the Kaseya Center, home to the Miami Heat.
“Lucky Strike Miami epitomizes our commitment to innovation and excellence,” stated Thomas Shannon, Founder, Chairman, and CEO of Bowlero Corp. “As we continue to strategically expand the Lucky Strike brand nationwide, this new location represents not only a new chapter in our growth but also a testament to our commitment to providing unparalleled experiences for guests across the country.”
Lucky Strike Miami is a 30,000 sq. ft. premier entertainment destination featuring 28 state-of-the-art bowling lanes and a contemporary aesthetic. Beyond bowling, this destination elevates leisure with its expansive arcade, a craft cocktail bar, and an intimate VIP room with six private bowling lanes. Lucky Strike Miami’s menu will consist of dynamic culinary concepts that feature luxe fair with quality ingredients while elevating traditional classics.
“Not only are we thrilled to be welcoming Lucky Strike to Miami Worldcenter, but we are excited to be bringing the beloved bowling brand back to Miami once again following its nearly decade-long run on Miami Beach,” said Nitin Motwani, Managing Partner of Miami Worldcenter Associates. “Lucky Strike will not only enhance Downtown Miami’s status as a family-friendly destination, but it will also be a wonderful complement to Miami Worldcenter’s various food, beverage, and entertainment options.”
Lev Ekster, President of Bowlero Corp., said in closing “Lucky Strike Miami embodies the vibrant ambiance of Miami, redefining the bowling experience for guests of all ages. Our mission extends beyond entertainment; it’s about creating memorable moments and fostering positive guest experiences. We look forward to this next chapter in Miami as we open our doors to the community.”
Lucky Strike Miami will open to the public on March 25th.
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.
About Miami Worldcenter:
Miami Worldcenter is a new $6 billion mixed-use destination in the heart of Downtown Miami. As one of the largest private urban real estate developments underway in the United States, the project occupies 27 acres spanning ten city blocks and offers world-class retail, hospitality, commercial and residential uses. Several phases of the project have already been completed and occupied, including three residential towers, a significant portion of the retail component, and a newly opened citizenM hotel.
Miami Worldcenter Associates serves as the master developer for the overall mixed-use development, led by Managing Partners Art Falcone and Nitin Motwani, in partnership with CIM Group, a community-focused real estate and infrastructure owner, operator, lender and developer. Together they have assembled a best-in-class development team that is currently transforming the urban core of Miami into one of the country’s largest mixed-use destinations. Learn more at www.miamiworldcenter.com.
LOS ALTOS, Calif., March 25, 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 will be delivered on the Company’s product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the 61st European Renal Association (ERA) Congress taking place May 23-26, 2024, in Stockholm, Sweden.
Shalabh Gupta, MD, Chief Executive Officer of Unicycive, commented, “The ERA Congress is one of the most prominent nephrology meetings of the year, and we are excited to deliver presentations on both OLC and UNI-494. In addition to presenting preclinical data supporting both of our programs, we will also be reporting on our two clinical trials in progress. We look forward to participating in this important event.”
Oxylanthanum Carbonate (OLC)
Title:
Enhanced Urinary Phosphorous Reduction: Comparative Study of Oxylanthanum Carbonate and Tenapanor in Rats
UNI-494 Phase I Tolerability and Pharmacokinetics: Trial in Progress
Lead Author:
Guru Reddy, Ph.D., Vice President of Preclinical R&D, Unicycive
Type:
Focused Oral Presentation
Dates/Times:
May 25, 2024 from 12:45 p.m. – 12:50 p.m. CEST
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 topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established.
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 is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in 2H of 2024. 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 Delayed Graft Function
Delayed Graft Function (DGF) refers to the acute kidney injury (AKI) that occurs in the first week after kidney transplantation, which necessitates dialysis intervention. As the name indicates, DGF can result in sub-optimal or impaired graft function and is one of the most common and serious complications of kidney transplantation. Poor kidney function in the first week of graft life is detrimental to the longevity of the allograft. DGF is also associated with higher rates of tissue rejection and decreased patient survival. Currently, there are no FDA approved drugs for the treatment of DGF.
Ischemia/reperfusion injury (IRI) is known to be a major causative factor for the AKI that results in DGF during kidney transplantation. Ischemic preconditioning, that works by activating KATP channels in mitochondria, is a natural endogenous mechanism which protects cells from IRI in the heart, kidney, liver, and other organs. UNI-494 is a pharmacological approach that emulates and enhances this natural phenomenon of ischemic preconditioning.
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 late preclinical development for the treatment of acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn 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, 2022, 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.
One Stop Systems, Inc. (OSS) designs and manufactures innovative AI Transportable edge computing modules and systems, including ruggedized servers, compute accelerators, expansion systems, flash storage arrays, and Ion Accelerator™ SAN, NAS, and data recording software for AI workflows. These products are used for AI data set capture, training, and large-scale inference in the defense, oil and gas, mining, autonomous vehicles, and rugged entertainment applications. OSS utilizes the power of PCI Express, the latest GPU accelerators and NVMe storage to build award-winning systems, including many industry firsts, for industrial OEMs and government customers. The company enables AI on the Fly® by bringing AI datacenter performance to ‘the edge,’ especially on mobile platforms, and by addressing the entire AI workflow, from high-speed data acquisition to deep learning, training, and inference. OSS products are available directly or through global distributors. For more information, go to www.onestopsystems.com.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
A Transformational Year. 2023 was a transformational year for OSS. The low margin digital business went away, a new management team and Board members were installed, and the Company is now firmly focused on large and rapidly growing global markets driven by AI and ML.
4Q23 Results. Revenue totaled $13.2 million, slightly above our $13 million estimate, but down 28% y-o-y, reflecting the continued runoff of the Disguise business, which contributed $3.1 million of revenue in the year ago quarter. Gross margin, however, rose 640 basis points to 33.7%. OSS net loss was $277,560, or a loss of $0.01/sh in the quarter, compared to a net loss of $3.3 million, or a loss of $0.16/sh last year. Adjusted EPS was $0.01/sh compared to a net loss of $0.14/sh last year. We had forecasted a loss of $0.07/sh.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
Haynes International, Inc. is a leading developer, manufacturer and marketer of technologically advanced, nickel and cobalt-based high-performance alloys, primarily for use in the aerospace, industrial gas turbine and chemical processing industries.
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.
Special meeting of stockholders. Haynes International recently filed definitive proxy materials in anticipation of a special meeting of stockholders to vote on the company’s proposed merger with North American Stainless, Inc., a wholly owned subsidiary of Acerinox S.A. Acerinox is a leader in the manufacturing and distribution of stainless steel and high-performance alloys and will acquire all the outstanding shares of Haynes for $61.00 per share in an all-cash transaction. The special meeting of stockholders of Haynes International will be held virtually on Tuesday, April 16, 2024, at 9:30 am ET. Haynes stockholders of record as of the close on March 11 are entitled to vote the shares of Haynes International common stock held on the record date.
Closing is expected in the third calendar quarter. The waiting period under the Hart-Scott-Rodino Antitrust Improvements Act expired on March 18. Remaining closing conditions include approval of the merger under other applicable foreign investment laws and the adoption of the merger agreement by Haynes’ stockholders. The transaction is expected to close in the third calendar quarter of 2024.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Comtech Telecommunications Corp. engages in the design, development, production, and marketing of products, systems, and services for advanced communications solutions in the United States and internationally. It operates in three segments: Telecommunications Transmission, Mobile Data Communications, and RF Microwave Amplifiers. The Telecommunications Transmission segment provides satellite earth station equipment and systems, over-the-horizon microwave systems, and forward error correction technology, which are used in various commercial and government applications, including backhaul of wireless and cellular traffic, broadcasting (including HDTV), IP-based communications traffic, long distance telephony, and secure defense applications. The Mobile Data Communications segment provides mobile satellite transceivers, and computers and satellite earth station network gateways and associated installation, training, and maintenance services; supplies and operates satellite packet data networks, including arranging and providing satellite capacity; and offers microsatellites and related components. The RF Microwave Amplifiers segment designs, develops, manufactures, and markets satellite earth station traveling wave tube amplifiers (TWTA) and broadband amplifiers. Its amplifiers are used in broadcast and broadband satellite communication; defense applications, such as telecommunications systems and electronic warfare systems; and commercial applications comprising oncology treatment systems, as well as to amplify signals carrying voice, video, or data for air-to-satellite-to-ground communications. The company serves satellite systems integrators, wireless and other communication service providers, broadcasters, defense contractors, military, governments, and oil companies. Comtech markets its products through independent representatives and value-added resellers. The company was founded in 1967 and is headquartered in Melville, New York.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
New T&W President. Thursday after the market close, Comtech announced the hiring of Jeff Robertson as the Company’s new President of the Terrestrial and Wireless Networks business segment. Prior to joining Comtech, Mr. Robertson served as President and CEO of Intrado Life Safety, a firm specializing in first responder technology in North America.
Significant News. We view the hiring of Mr. Robertson positively on a couple of fronts. First, Intrado is a direct competitor to Comtech and we expect Mr. Robertson to be familiar with Comtech’s T&W capabilities. Mr. Robertson’s choice of joining Comtech speaks positively about Comtech’s T&W business, in our view. Secondly, his hire indicates that top level executives still view Comtech as an attractive option to work, even given the recent challenges.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
