RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL) (“Bowlero” or the “Company”), one of the world’s premier operators of location-based entertainment, will report financial results for the fourth quarter and full year fiscal 2024 on Thursday, September 5, 2024, after the U.S. stock market closes. Management will discuss the results via webcast at 4:30 PM ET on the same day.
The live webcast, replay, and results presentation will be available in the Events & Presentations section of the Bowlero Investor Relations website at https://ir.bowlerocorp.com/ .
About Bowlero Corp.
Bowlero Corporation is one of the world’s premier operators of location-based entertainment. With approximately 350 locations across North America, the Company serves more than 40 million guest visits annually through a family of brands that include Lucky Strike, Bowlero and AMF. In 2019, Bowlero acquired the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Bowlero, please visit BowleroCorp.com.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Reverse split. On August 21, the company announced a one for ten reverse stock split on its ordinary shares. Notably, the reverse split will be effective following the market close on August 28, and will be adjusted for the split when trading opens on August 29. We view the move favorably as the company sheds its SPAC image.
Positive implications. Management highlighted that the reverse split could improve the marketability and attractiveness of its shares, as an investment grade company that it is. We believe the higher share price could improve investor perception, liquidity and marketability of the GDEV shares and open the company to more institutional interest, with the shares trading above single digit price points.
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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.
Key Points: – Options market predicts unprecedented 9.8% stock move post-earnings – Potential $305 billion market value swing, largest in history – Nvidia’s earnings crucial for broader market performance
As Nvidia prepares to release its latest earnings report, the options market is bracing for what could be the largest earnings-related market value swing in history. Traders are anticipating a potential $305 billion fluctuation in Nvidia’s market capitalization, underscoring the chipmaker’s critical role in the artificial intelligence (AI) boom and its impact on the broader market.
Options pricing data from analytics firm ORATS indicates that traders expect Nvidia’s shares to move by approximately 9.8% on the day following its earnings announcement. This projected movement significantly surpasses the company’s average post-earnings move of 8.1% over the past three years and represents the largest expected swing for any Nvidia earnings report during this period.
The magnitude of this potential move is staggering when considering Nvidia’s current market capitalization of about $3.11 trillion. A 9.8% swing would translate to a market value change of around $305 billion – a figure that exceeds the entire market capitalization of 95% of S&P 500 companies, including giants like Netflix and Merck.
Nvidia’s outsized influence on the market is not limited to its own stock performance. The company’s chips, widely regarded as the gold standard in AI, have propelled its shares up by approximately 150% year-to-date. This remarkable growth has contributed to about a quarter of the S&P 500’s 18% gain in 2024, making Nvidia a critical driver of overall market performance.
Steve Sosnick, chief strategist at Interactive Brokers, aptly described Nvidia as “the Atlas holding up the market,” highlighting its substantial contribution to the S&P 500’s profitability. This analogy underscores the weight of expectations resting on Nvidia’s shoulders as it prepares to release its financial results.
Interestingly, the options market reveals a bias towards optimism among traders. Analysis from Susquehanna Financial indicates that traders are assigning a 7% probability to the stock rising more than 20% by Friday, compared to only a 4% chance of a 20% or greater decline. This sentiment suggests that investors are more concerned about missing out on potential gains than hedging against losses.
Christopher Jacobson, a strategist at Susquehanna Financial Group, attributes this phenomenon to the “continued uncertainty/optimism with regards to AI and the ultimate size of the opportunity.” The heightened interest in Nvidia among both institutional and retail investors has contributed to its elevated volatility compared to other trillion-dollar market cap companies.
The anticipation surrounding Nvidia’s earnings report reflects broader market dynamics and the pivotal role of AI in shaping investor sentiment. As the company prepares to unveil its latest financial results, the potential for a record-breaking market value swing serves as a testament to Nvidia’s position at the forefront of the AI revolution and its significance in the current investment landscape.
The outcome of Nvidia’s earnings report will likely have far-reaching implications, not only for the company’s shareholders but also for the broader technology sector and the overall market. As investors and analysts alike await the results, the unprecedented level of options activity surrounding Nvidia underscores the high stakes and intense scrutiny facing this AI chip giant.
Key Points: – Energy Fuels expands capabilities in medical isotope production – Acquisition addresses global shortage of crucial radioisotopes – Potential for repurposing existing process streams for cancer treatments
Energy Fuels Inc., a leader in uranium and rare earth elements production, has made a strategic move to address the growing demand for medical radioisotopes used in cancer treatments. On August 16, 2024, the company announced its acquisition of RadTran LLC, a private firm specializing in the separation of critical radioisotopes.
This acquisition marks a significant step for Energy Fuels in its plans to develop and produce medical isotopes, particularly radium-226 (Ra-226) and radium-228 (Ra-228). These isotopes are crucial components in the production of actinium-225 (Ac-225) and lead-212 (Pb-212), which are used in emerging targeted alpha therapies (TAT) for cancer treatment.
The global shortage of Ra-226 and Ra-228 has been a major hurdle in the advancement and commercialization of these potentially life-saving therapies. Energy Fuels’ move to acquire RadTran is aimed at addressing this shortage and positioning the company as a leader in this developing industry.
Mark Chalmers, President and CEO of Energy Fuels, emphasized the synergy between the two companies. The acquisition combines Energy Fuels’ processing capabilities at the White Mesa Mill – the only permitted and operating uranium mill in the United States – with RadTran’s intellectual property and expertise in radionuclide separation and concentration.
One of the most innovative aspects of this initiative is Energy Fuels’ potential to recover valuable isotopes from its existing process streams. This approach would essentially recycle material that would otherwise be lost to disposal, repurposing it for use in producing cancer treatments. This not only adds value to Energy Fuels’ operations but also contributes to more sustainable practices in the industry.
The acquisition builds upon a Strategic Alliance Agreement between Energy Fuels and RadTran that has been in place since July 2021. Under this agreement, the companies have been evaluating the feasibility of recovering Ra-226 and Ra-228 from existing uranium process streams at Energy Fuels’ White Mesa Mill in Utah.
Energy Fuels has already made significant progress in this area, receiving regulatory approval and licensing in 2023 for the concentration of R&D quantities of Ra-226 at the Mill. The company is currently completing engineering on its research and development pilot facility for Ra-226 production. In 2024, Energy Fuels plans to set up the first stages of the pilot facility and expects to produce R&D quantities of Ra-226 for testing by end-users.
Looking ahead, Energy Fuels aims to develop capabilities for commercial-scale production of Ra-226 and potentially Ra-228 in 2026-2028. This timeline is contingent on completing engineering design, securing sufficient offtake agreements, and receiving all required regulatory approvals.
The acquisition terms include an initial payment of $1.5 million in cash and $1.5 million in Energy Fuels common shares, along with a 2% royalty on future revenues from radium sales. Additional performance-based milestones could lead to up to $14 million more in cash and shares.
As part of the deal, Saleem Drera PhD, President and CEO of RadTran, will join Energy Fuels as Vice President of Radioisotopes, Radiological Systems, and Intellectual Property. Dr. Drera will lead efforts to integrate RadTran’s proprietary technology and drive innovation in medical radioisotope production.
The urgency of this acquisition is underscored by the extensive clinical research currently underway. Over 30 clinical trials are evaluating Ac-225, with several reaching final pre-approval stages for treating neuroendocrine tumors and leukemia. The current shortfall in Ac-225 production is delaying trials and challenging the transition to full commercial and clinical availability of these promising cancer therapies.
Energy Fuels’ strategic acquisition of RadTran represents a significant step towards addressing critical supply chain issues in the medical radioisotope industry. By leveraging existing facilities and expertise, the company is poised to play a crucial role in supporting the development of innovative cancer treatments, potentially improving outcomes for patients worldwide.
MCLEAN, Va., Aug. 27, 2024 /PRNewswire/ — V2X, Inc. (NYSE: VVX) has appointed Jeremy Nance as General Counsel. In this role, Nance will be responsible for managing all legal matters related to V2X’s operations, transactions, and business practices. He will also join the executive team and report directly to President and Chief Executive Officer, Jeremy C. Wensinger.
Nance has served on V2X’s legal team since July 2018, and most recently as Vice President, Deputy General Counsel and Chief Compliance Officer for the company. “Jeremy Nance brings a wealth of experience and a deep understanding of the legal landscape that will benefit V2X as we continue to grow in our industry,” said Jeremy C. Wensinger, President and CEO of V2X.
In a related move, V2X’s Sarita Malakar has been named Corporate Secretary and Sustainability Officer, assuming responsibility for ensuring the efficient and compliant operation of the Board of Directors. Malakar, who has been an essential part of V2X since July 2022, currently serves as Vice President and Deputy General Counsel and Assistant Secretary, bringing a strong legal background and governance expertise to her new role.
These appointments follow Kevin Boyle’s departure, who is departing after six years of valuable service to V2X. The company expresses its gratitude for Boyle’s contributions and wishes him well in this future endeavors.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA IR@GOv2x.com 719-637-5773
Key Points: – Expansion of global reach with 130,000+ new locations – Enhanced offering with advanced gift card and loyalty programs – Strategic alignment for increased customer value and retention
Shift4, the leading integrated payments and commerce technology company, is set to make waves in the global market with its latest acquisition announcement. The company has signed a definitive arrangement agreement to acquire Givex Corp., a renowned provider of gift cards, loyalty programs, and point-of-sale solutions. This strategic move is poised to reshape the landscape of payment processing and customer engagement technologies.
The acquisition, expected to close in the fourth quarter of this year, will significantly expand Shift4’s global footprint. With Givex’s impressive network of over 130,000 active locations across more than 100 countries, Shift4 is positioning itself as a major player in the international payments arena. This expansion not only increases Shift4’s customer base but also opens up new markets and opportunities for growth.
One of the most compelling aspects of this acquisition is the enhancement of Shift4’s service offerings. Givex brings to the table a suite of robust gift card and e-gift solutions, along with customizable loyalty programs that have been adopted by industry giants such as Nike, Marriott, and Wendy’s. These additions will allow Shift4 to offer a more comprehensive package to its existing clients, potentially increasing customer retention and attracting new business.
The synergy between the two companies is evident in their complementary technologies. Shift4’s end-to-end payment solution, combined with Givex’s value-added engagement services, creates a powerful toolkit for businesses looking to streamline their operations and enhance customer relationships. This integration is expected to deliver an unparalleled package to both companies’ customer bases, setting a new standard in the industry.
From a financial perspective, this acquisition aligns perfectly with Shift4’s capital deployment strategy. By acquiring a company with an established customer base, Shift4 is effectively lowering its customer acquisition costs while simultaneously expanding its service portfolio. This approach is likely to contribute positively to Shift4’s bottom line and create long-term value for shareholders.
The merger also presents exciting opportunities for innovation. As the payments industry continues to evolve, the combined expertise of Shift4 and Givex could lead to the development of cutting-edge solutions that address emerging market needs. This potential for innovation could be a key differentiator in a highly competitive market.
As businesses increasingly prioritize customer engagement and loyalty, the timing of this acquisition couldn’t be better. The integration of Givex’s loyalty and gift card solutions into Shift4’s existing infrastructure will enable businesses to create more personalized and rewarding experiences for their customers. This focus on customer retention and engagement is crucial in today’s market, where consumer loyalty is harder than ever to maintain.
In conclusion, Shift4’s acquisition of Givex Corp. marks a significant milestone in the company’s growth strategy. By expanding its global reach, enhancing its product offerings, and strengthening its market position, Shift4 is well-positioned to capitalize on the growing demand for integrated payment and loyalty solutions. As the transaction moves towards completion, industry observers and stakeholders will be watching closely to see how this strategic move unfolds and shapes the future of payment processing and customer engagement technologies.
Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
New Awards. Yesterday, Great Lakes issued a press release revealing receipt of $256.2 million of dredging awards, including the $120 million of awards we highlighted last week. The six awards the Company noted included two capital projects, three coastal protection, and one maintenance award.
Pipeline Over $1 Billion. In addition to the noted awarded projects, Great Lakes has approximately $318 million in low bids and options pending award, according to the release, which includes two jobs on which the Company was low bidder on this month. This brings Great Lakes’ potential total pipeline of work to over $1.2 billion.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Pure play manufacturer. FreightCar America, Inc. is a diversified manufacturer of railroad cars and rail car components. The company designs and manufactures a broad variety of railroad car types for the transportation of bulk commodities and containerized freight products primarily in North America. The company recently reported strong second-quarter financial results and appears poised for greater scale and margin expansion as it increases its market share and expands its product suite.
Updating estimates. While our 2024 and 2025 earnings per share estimates are unchanged at $0.25 and $0.47, respectively, we have increased our EBITDA estimates to $38.8 million and $46.7 million from $38.6 million and $46.0 million. We have assumed modestly higher sales. Importantly, we have increased our forward estimates beginning in 2026 to better reflect the company’s recent order for 1,000 tank car conversions and entry into the new tank car market beginning in 2028 which is expected to have a positive impact on gross margin.
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.
Crude oil prices have spiked nearly 3% as geopolitical tensions in the Middle East escalate and Libya halts its oil production. This sudden surge has caught the attention of investors worldwide, potentially signaling a shift in the energy market landscape.
West Texas Intermediate (WTI) crude jumped to over $77 per barrel, while Brent crude, the international benchmark, surpassed $80 per barrel. This sharp increase comes after a weekend of heightened tensions in the Middle East and a significant disruption in Libyan oil production.
The catalyst for this price surge appears to be twofold. First, Israel’s recent airstrike against Hezbollah’s rocket launching stations in Lebanon has exacerbated fears of a broader conflict involving Iran. The potential for Iranian military response has raised concerns about possible disruptions to global oil movements, a factor that could significantly impact supply chains and pricing.
Adding fuel to the fire, Iran-backed Houthi rebels continue their attacks on vessels in the Red Sea, with a Greek oil tanker being the latest casualty. These ongoing hostilities pose a substantial threat to one of the world’s most crucial shipping routes, potentially disrupting oil transportation and further tightening supply.
The second major factor driving oil prices higher is Libya’s decision to temporarily halt its oil production and exports. This move, prompted by a dispute over the leadership of Libya’s central bank, removes over 1 million barrels of daily crude production from the global market. The sudden supply shock has left traders scrambling to adjust their positions, contributing to the price surge.
For investors, these developments present both opportunities and risks. The energy sector, which has been under pressure due to concerns about global demand, may see a resurgence if oil prices continue their upward trajectory. Oil majors and exploration companies could benefit from higher crude prices, potentially boosting their profit margins and stock valuations.
However, the situation remains fluid. While oil prices have jumped over 5% in the past three sessions, long-term demand concerns still linger in the market. The global economic outlook, particularly in China, continues to cast a shadow over future oil demand projections.
Interestingly, despite the surge in crude prices, U.S. gasoline prices have continued their downward trend. The national average gasoline price currently hovers around $3.35 per gallon, significantly lower than both last month and last year. Industry experts attribute this to seasonal factors and expectations of reduced demand post-Labor Day.
Looking ahead, investors should keep a close eye on several key factors:
Developments in the Middle East, particularly any escalation involving Iran.
Libya’s oil production status and any potential resolution to the current dispute.
OPEC+ decisions on future production levels.
Global economic indicators, especially from major oil consumers like China and the U.S.
Hurricane season’s impact on U.S. Gulf oil production.
While the current price surge may offer short-term opportunities, prudent investors will need to weigh these against longer-term trends in oil demand and the ongoing global transition towards renewable energy sources.
As always, diversification and careful risk management remain key in navigating the volatile energy markets. With geopolitical tensions high and supply disruptions ongoing, the oil market promises to be an area of keen interest for investors in the coming weeks and months.
Key Points: – Fed shifts focus from inflation to job market protection – Powell signals upcoming interest rate cuts – Uncertainty surrounds job market strength and future policy decisions
In a significant shift of monetary policy, the Federal Reserve has turned its attention from battling inflation to safeguarding the U.S. job market. This change in focus, articulated by Fed Chair Jerome Powell at the annual Jackson Hole conference, marks a new chapter in the central bank’s strategy and sets the stage for potential interest rate cuts in the near future.
Powell’s speech at Jackson Hole served as a clear indicator of the Fed’s evolving priorities. After two years of aggressive rate hikes aimed at curbing inflation, the Fed now sees emerging risks to employment as its primary concern. “We do not seek or welcome further cooling in labor market conditions,” Powell stated, effectively drawing a line in the sand at the current 4.3% unemployment rate.
This pivot comes at a critical juncture for the U.S. economy. The Fed’s current interest rate, standing at 5.25%-5.50%, is widely considered to be restricting economic growth and potentially jeopardizing jobs. This rate significantly exceeds the estimated 2.8% “neutral” rate – the theoretical point at which monetary policy neither stimulates nor constrains the economy.
The job market, while still robust by historical standards, has shown signs of cooling. July’s job gains of 114,000 were noticeably lower than the pandemic-era average, though they align with pre-pandemic norms. Another key indicator, the ratio of job openings to unemployed persons, has decreased from a pandemic high of 2-to-1 to a more balanced 1.2-to-1.
These trends have sparked debate among economists and policymakers. Some argue that the economy is simply normalizing after the extremes of the pandemic era. Others, however, worry that the Fed may have delayed its policy shift, potentially risking a more severe economic downturn.
Adding to the complexity is the possibility of data mismeasurement. Fed Governor Adriana Kugler, a labor economist, suggested that both job openings and unemployment might be underreported in current surveys. If true, this could paint a bleaker picture of the job market than official figures indicate.
Looking ahead, the Fed faces a delicate balancing act. Powell expressed hope that the economy can achieve the 2% inflation target while maintaining a strong labor market – a scenario reminiscent of the pre-pandemic economy he oversaw. However, the path to this ideal outcome remains uncertain.
The Fed’s next moves will be closely watched by markets and policymakers alike. In September, officials will update their interest rate projections, providing insight into the expected pace and extent of future rate cuts. These decisions will hinge heavily on upcoming employment reports and other economic indicators.
The central bank’s shift in focus represents more than just a change in policy direction; it reflects a broader reassessment of economic priorities in the post-pandemic era. As the Fed navigates this transition, it must weigh the risks of premature policy easing against the potential consequences of a weakening job market.
For American workers and businesses, the implications of this policy pivot are significant. Lower interest rates could stimulate economic activity and hiring, but they also risk reigniting inflationary pressures. The coming months will be crucial in determining whether the Fed can successfully steer the economy towards a “soft landing” – achieving its inflation target without triggering a recession.
As the economic landscape continues to evolve, one thing is clear: the Federal Reserve’s role in shaping the future of the U.S. job market has never been more critical. With its new focus on employment protection, the Fed is embarking on a challenging journey to maintain economic stability in an increasingly uncertain world.
MALVERN, Pa., Aug. 26, 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 and vaccines, today announced that Health Canada provided a “No Objection Letter” to initiate the OCU400 Phase 3 liMeliGhT (pronounced “limelight”) clinical trial in Canada. OCU400 is a modifier gene therapy product candidate being developed for retinitis pigmentosa (RP).
“Expanding the clinical trial to Canada is significant as it will provide an opportunity to reach a broader patient population encompassing many gene mutations associated with RP,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen. “The Health Canada trial will run in parallel with the U.S. FDA trial, expediting the ability to potentially provide a gene-agnostic treatment option to approximately 110,000 patients in the United States (U.S.) and Canada.”
Currently there are approximately 10,000 patients in Canada with RP and 1.6 million patients globally. The Phase 3 study in Canada will enroll up to 50 subjects across a maximum of 5 sites for the liMeliGhT clinical trial.
Over 200 mutations in more than 100 genes have been linked to RP. The Phase 3 study, spanning one year, will enroll 150 participants divided into two study arms: 75 participants with RHO gene mutations and 75 participants who are gene agnostic. In each arm, participants will be randomized in a 2:1 ratio to receive either treatment (2.5 x 1010 vg/eye of OCU400) or remain in an untreated control group, respectively. The liMeliGhT study is recruiting patients aged eight and older, covering the full spectrum from early to late stages of RP progression.
An enhanced sensitive and specific measurement of functional vision test—Luminance Dependent Navigation Assessment (LDNA)—is the primary endpoint for the study. Specifically, the primary endpoint is a measurement of the change in functional vision from baseline to week 52 as measured by the ability of a study participant to navigate through a maze (the LDNA). Those who demonstrate an improved ability to navigate the maze in dimmer light (i.e., by ≥2 Lux levels) compared to baseline will be classified as “responders” to the therapy. The liMeliGhT study will focus on the proportion of responders in both the treated and untreated eyes.
“Establishing clinical sites in Canada may expedite recruitment and open doors for broader commercialization with the U.S. and Europe,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “With only one currently approved treatment targeting a single mutation associated with RP, there remains a significant unmet medical need, and patients worldwide are eager for new therapeutic options. It is highly rewarding to extend our efforts into a new region and offer hope to Canadian patients with RP.”
Ocugen previously announced that OCU400 has received orphan drug and RMAT designations from the FDA. OCU400 remains on track for the 2026 BLA and MAA approval targets.
About OCU400
OCU400 is the Company’s modifier gene therapy product based on a nuclear hormone receptor gene called NR2E3. This gene regulates diverse physiological functions within the retina, such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation, and cell survival. Retinal cells in RP patients have a dysfunctional gene network, and OCU400 resets this network to reestablish a healthy cellular homeostasis—which has the potential to improve vision in patients with RP.
About RP
RP is a group of rare genetic disorders that cause a breakdown in the cells of the retina, leading to vision loss and blindness. RP is associated with mutations in more than 100 genes.
There are no approved treatment options that slow or stop the progression of multiple forms of RP. Proposed treatments for RP include gene replacement therapy, retinal implant devices, retinal transplantation, stem cells, vitamin therapy, and other pharmacological treatments. Current gene replacement therapies are promising but are limited to treating just a single mutation. In addition, while gene therapies may provide a new functional gene, they do not necessarily eliminate the underlying genetic defect, which may still cause stress and toxic effects leading to retinal degeneration. Therefore, the development of gene-specific replacement therapy will not address all forms of RP, especially when multiple and unknown genes are involved. Thus, novel therapeutic approaches targeting the broader RP disease in a gene-agnostic manner offer greater hope for patients.
About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ 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.
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, 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 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.
LOS ALTOS, Calif., Aug. 26, 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 three poster presentations will be delivered on the Company’s product candidates at the American Society of Nephrology (ASN) Kidney Week 2024 taking place October 24-27, 2024 in San Diego, CA.
“Data from both oxylanthanum carbonate (OLC) and UNI-494 continue to garner strong interest from the medical community, and we look forward to presenting our data at Kidney Week, one of the most prominent meetings in our field,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
Title:
Intravenous UNI-494 Slows the Progression or Halts/Reverses Acute Kidney Injury When Administered After Ischemia/Reperfusion in Rats
Saturday, October 26, 2024 from 10:00 a.m. – 12:00 p.m. PT
Title:
UNI-494 Phase I Safety, Tolerability, and Pharmacokinetics
Lead Author:
Guru Reddy, PH.D., Vice President of Preclinical R&D, Unicycive
Session Title:
AKI: Clinical, Outcomes, and Trials – Management
Poster Board:
#SA-PO036
Date/Time:
Saturday, October 26, 2024 from 10:00 a.m. – 12:00 p.m. PT
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, and expects to report results in the third quarter 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 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 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 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.
World Health Organization declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) for the second time in two years
Worldwide availability and affordability of single-dose mpox vaccine with durable protection will be required to address global health emergency
The newest Clade 1 strain represents a new global threat with mortality up to 10%
Bilthoven Biologicals to develop manufacturing processes in preparation for potential GMP manufacturing
CHATHAM, N.J., Aug. 26, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, and Bilthoven Biologicals (BBio), part of the world’s largest vaccine manufacturer the Cyrus Poonawalla Group, which includes the Serum Institute of India, today announced a collaboration to advance TNX-801, Tonix’s mpox vaccine candidate. TNX-801 (recombinant horsepox virus) is a live replicating, attenuated virus vaccine based on horsepox in preclinical development to prevent mpox and smallpox.
TNX-801 is based on technology that has the potential to be used as a viral vector platform from which recombinant versions can be developed to protect against other infectious diseases. BBio is a global vaccine company, producing prophylactic vaccines as well as vaccines for therapeutic use. BBio has been selected by the European Union for its pandemic preparedness program of ‘ever warm’ vaccine manufacturing companies.
TNX-801 has demonstrated in animal models to provide immune protection with better tolerability than vaccines based on 20th century vaccinia viruses. Preclinical studies have shown positive efficacy data, demonstrating that TNX-801 protected non-human primates against lethal challenge with intratracheal Clade 1 monkeypox virus. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and decreased shedding in the mouth and lungs of non-human primates. These findings are consistent with mucosal immunity and suggest the ability to block forward transmission.
On August 14, 2024, the World Health Organization (WHO) determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern, the second such declaration in the past two years called in response to an mpox outbreak. The current outbreak was caused by Clade 1 monkeypox virus, while the 2022 outbreak was caused by Clade 2 monkeypox virus. The global mpox outbreak from Clade 2, which commenced in 2022, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the U.S. The spread of Clade 2b mpox in 2022 underscores the pandemic potential of the disease. In several Central African countries, including the Democratic Republic of the Congo, mpox is currently endemic, with the Clade 1 showing a mortality rate of up to 10%.
“The recent mpox outbreak exemplifies precisely why we built the pandemic preparedness facility at BBio,” said Jurgen Kwik, Chief Executive Officer of Bilthoven Biologicals. “The establishment of the ‘ever-warm’ facility for pandemic preparedness underscores the critical importance of readiness in the face of global health emergencies, such as mpox. This collaboration encapsulates the essential role of the facility in bolstering pandemic preparedness and response capabilities.”
“We look forward to collaborating with BBio and to accelerating the development of our vaccine candidate to prevent mpox,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-801 is administered with a single dose, which we believe will improve acceptance and eliminate partial vaccination compared to the current two-dose regimens. We believe TNX-801 can be rapidly scaled up for manufacturing and can be distributed and stored without a costly and cumbersome ultra-cold supply chain. TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines.”
Dr. Lederman added, “The worldwide availability of an affordable, safe and effective single dose mpox vaccine is essential given the pandemic potential of the disease. Successful development of TNX-801 will establish the foundation for potentially expanding the viral vector platform, for which recombinant versions can be developed to protect against other infectious diseases and future outbreaks. Our TNX-1800 vaccine (recombinant horsepox virus expressing SARS-CoV-2 spike) in development to protect against COVID-19 was selected by the U.S. National Institutes of Health for Project NextGen.”
About TNX-801 TNX-801 (recombinant horsepox virus) is a live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox.1 Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox.2 Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1 /2 study and the overall clinical development plan. More than 90,000 people contracted mpox globally. during the 2022-23 epidemic.3 The June 2023 cluster of mpox in Chicago revealed breakthrough cases of the disease in individuals who had been vaccinated with the currently authorized non-replicating vaccine, which is administered in two doses.4 In contrast, TNX-801 is delivered percutaneously with only one dose and therefore may achieve higher rates of community protection by eliminating drop-out between doses and limiting forward transmission. Moreover, relying on only one approved mpox vaccine at present is a risk for the global supply chain that has already led to insufficient availability of vaccines to meet global health needs, especially in Africa. TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines.
BBio is a Netherlands-based end-to-end vaccine manufacturer of viral and bacterial vaccines. The company has a long-standing track record in supplying vaccines to European markets and global health partners such as UNICEF, PAHO and WHO/GAVI. With the manufacturing of polio vaccines, BBio is key contributor to the worldwide program to eradicate polio. BBio is also acting as contract manufacturer of vaccines used as cancer treatment, which is registered and supplied to the European market for the treatment of bladder cancer.
BBio is a carve-out of the former Netherlands Vaccine Institute and was acquired by Serum Institute of India in 2012 and employs a little over 500 people. BBio is covering the full vaccine manufacturing value chain with its facilities in Bilthoven on Utrecht Science Park Bilthoven.
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years to develop TNX-4200 small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. 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 TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development, designed to treat cocaine intoxication that has 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, including a vaccine for mpox, TNX-801. 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.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
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