Month: December 2023

The SEC’s Clearing Mandate: A Major Shift for the US Treasury Market

Posted on by slightbourne@noblecapitalmarkets.com

The US Securities and Exchange Commission (SEC) has implemented a major shift in the $26 trillion US Treasury market, adopting new regulations aimed at reducing systemic risk by forcing more trades through clearing houses. This overhaul, approved on December 13th, 2023, marks the most significant change to this global benchmark for assets in decades.

The Need for Reform:

In recent years, the Treasury market has experienced periods of volatility and liquidity concerns. The COVID-19 pandemic in 2020 highlighted these vulnerabilities, as liquidity all but evaporated during the initial market panic. This prompted calls for reform, with the SEC identifying the need to increase transparency and reduce counterparty risk.

Central Clearing: The Centerpiece of Reform:

The core of the SEC’s new rules revolves around central clearing. A central clearinghouse acts as the intermediary for every transaction, assuming the role of both buyer and seller. This ensures that trades are completed even if one party defaults, significantly minimizing risk.

The new regulations mandate that a broader range of Treasury transactions now be centrally cleared. This includes cash Treasury transactions as well as repurchase agreements (“repos”), which are short-term loans backed by Treasuries. Additionally, clearing houses must implement stricter risk management practices and maintain separate collateral for their members and their customers.

Phased Implementation:

Recognizing the complexity of implementing such a significant change, the SEC has provided a phased approach. Clearing houses have until March 2025 to comply with the new risk management and asset protection requirements. They will have until December 2025 to begin clearing cash market Treasury transactions and June 2026 for repo transactions. Similarly, members of clearing houses have until December 2025 and June 2026, respectively, to begin clearing these transactions.

Industry Concerns and Potential Impact:

While the SEC’s initiative aims to enhance the safety and stability of the Treasury market, some industry participants have voiced concerns. The primary concern revolves around the potential increase in costs associated with central clearing. Clearing houses charge fees for their services, which could be passed on to market participants. Additionally, the requirement for additional margin, which serves to limit risk, could also lead to higher costs.

Another concern is the potential impact on liquidity. Some critics argue that mandatory clearing could lead to a decrease in liquidity, particularly during times of market stress. This is because central clearing adds another layer of bureaucracy to the transaction process, which could discourage some market participants from trading.

Furthermore, there are concerns about the potential concentration of risk in clearing houses. If a major clearing house were to fail, it could have a devastating impact on the entire financial system. To mitigate this risk, the SEC has implemented stricter capital and risk management requirements for clearing houses.

The Road Ahead:

The implementation of these new regulations will undoubtedly impact the US Treasury market. While the long-term effects remain to be seen, the SEC’s goal is to create a safer and more resilient market for all participants. The phased approach allows for a smoother transition, giving market participants time to adjust to the new requirements.

The success of these reforms will depend on several factors, including the effectiveness of implementation by clearing houses and market participants, the ongoing monitoring and oversight by the SEC, and the overall economic environment. Only time will tell whether these changes will achieve their intended goal of enhancing the stability and efficiency of the US Treasury market.

Additional Considerations:

The SEC’s decision to exempt certain transactions, such as those between broker-dealers and hedge funds, has garnered mixed reactions. Some argue that this creates loopholes and undermines the effectiveness of the reforms. Others contend that it is a necessary concession to address industry concerns and avoid stifling market activity.

The implementation of these new rules will also require close collaboration between the SEC, clearing houses, and market participants. Clear communication and education will be essential to ensuring a smooth transition and maximizing the benefits of these reforms.

Ultimately, the success of these changes will hinge on their ability to strike a delicate balance between enhancing safety and maintaining market efficiency. Only time will tell if this major overhaul of the US Treasury market will ultimately achieve its intended objectives.

Has The Fed Hit a Turning Point?

Posted on by slightbourne@noblecapitalmarkets.com

After two years of aggressive rate hikes to combat inflation, the Federal Reserve is on the cusp of a significant policy shift. This Wednesday’s meeting marks a turning point, with a pause on rate increases and a focus on what lies ahead. While the immediate decision is anticipated, the subtle nuances of the Fed’s statement, economic projections, and Chair Powell’s press conference hold the key to understanding the future trajectory of monetary policy.

A Pause in the Rate Hike Cycle:

The Federal Open Market Committee (FOMC) is virtually certain to hold the benchmark overnight borrowing rate steady at a range of 5.25% to 5.5%. This decision reflects the Fed’s recognition of the recent slowdown in inflation, as evidenced by Tuesday’s Consumer Price Index report showing core inflation at a 4% annual rate. The aggressive rate hikes have had their intended effect, and the Fed is now in a position to assess the impact and determine the next course of action.

Shifting Narrative: From Hiking to Cutting?

While the pause is a significant development, the Fed’s communication will provide further insights into their future plans. Economists anticipate subtle changes in the post-meeting statement, such as dropping the reference to “additional policy firming” and focusing on achieving the 2% inflation target. These changes would signal a shift in the narrative from focusing on rate hikes to considering potential cuts in the future.

The closely watched dot plot, which reflects individual members’ expectations for future interest rates, will also be scrutinized. The removal of the previously indicated rate increase for this year is expected, but the market’s anticipation of rate cuts starting in May 2024 might be perceived as overly aggressive. Most economists believe the Fed will take a more cautious approach, with cuts likely to materialize in the second half of 2024 or later.

Economic Outlook and the Real Rate:

Alongside the policy decision, the Fed will update its projections for economic growth, inflation, and unemployment. While significant changes are not anticipated, these projections will provide valuable information about the current state of the economy and the Fed’s expectations for the future.

The real rate, or the difference between the fed funds rate and inflation, is also a key factor in the Fed’s deliberations. Currently, the real rate stands at 1.8%, significantly above the neutral rate of 0.5%. This high real rate is considered restrictive, meaning it is slowing down economic activity. Chair Powell’s comments will be closely watched for any hints about how the Fed might balance the need to control inflation with the potential for slowing economic growth.

Powell’s Press Conference: Clues for the Future:

The press conference following the meeting will be the most anticipated event of the week. Chair Powell’s remarks will be analyzed for any clues about the Fed’s future plans. While Powell is likely to remain cautious, his comments could provide valuable insights into the Fed’s thinking and their views on the economic outlook.

Markets are eagerly anticipating any indication of a dovish pivot, which could lead to a further surge in equity prices. However, Powell may also address concerns about the recent loosening of financial conditions, emphasizing the Fed’s commitment to achieving their inflation target. Striking a balance between these competing concerns will be a major challenge for Powell and the FOMC.

Looking Ahead: A Cautious Path Forward

The Federal Reserve’s Wednesday meeting marks a significant turning point in their fight against inflation. While the immediate pause in rate hikes is expected, the future trajectory of monetary policy remains uncertain. The Fed will closely monitor the economic data and adjust their policy as needed. The coming months are likely to be characterized by careful consideration and cautious action as the Fed navigates the complex task of balancing inflation control with economic growth.

This article has highlighted the key details of the upcoming Fed meeting and its potential impact on the economy and financial markets. By understanding the nuances of the Fed’s communication and the challenges they face, we can gain a deeper understanding of the future of monetary policy and its implications for businesses, consumers, and investors alike.

Release – Ocugen, Inc. Announces First Patient Dosed In Phase 1/2 Clinical Trial Evaluating The Safety And Efficacy Of OCU410—Modifier Gene Therapy—For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

December 13, 2023

MALVERN, Pa., Dec. 13, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in the ArMaDa Phase 1/2 clinical trial of OCU410 (AAV-RORA), a modifier gene therapy product candidate being developed for dry AMD (dAMD).

“OCU410, our first-in-class modifier gene therapy for dAMD, addresses gaps among other therapies available and in development for dAMD as a potential one-time treatment for life,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “We are very pleased to continue advancing our ophthalmic gene therapy pipeline, which remains the Company’s primary focus.”

This Phase 1/2 trial will assess the safety and efficacy of OCU410 for geographic atrophy (GA) secondary to dAMD and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study. Phase 2 is a randomized expansion phase in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 dose groups or to an untreated control group.

OCU410 is a potential curative therapy with a single sub-retinal injection that targets multiple pathways causing dAMD, including lipid metabolism, inflammation, oxidative stress, and complement activation. Currently, the other therapeutic options available target only complement activation and require approximately 6-12 intravitreal injections annually.

“Breaking new ground in the pursuit of vision restoration, our pioneering modifier gene therapy candidate, OCU410, achieves another major milestone by dosing a GA patient in a Phase 1/2 clinical trial,” said Arun Upadhyay, PhD, Chief Scientific Officer, Head of R&D at Ocugen. “OCU410 offers hope for those battling GA that are faced with limited treatment options and the real prospect of ultimately losing their vision.”

“There remains a great unmet need for novel durable and effective treatments for GA, which remains one of the most common causes of vision loss globally,” said Benjamin Bakall, MD, PhD, director of clinical research at Associated Retina Consultants (ARC) and clinical assistant professor at University of Arizona, College of Medicine – Phoenix. “I am excited that we performed the first surgery with this novel therapeutic approach—designed to restore homeostasis and slow disease progression following a single treatment—at ARC in Phoenix, AZ, with the surgical team led by Dr. Mark Kwong, medical director of ARC.”

The first surgery was successful in delivering the new gene underneath the retina; the light sensitive nerve tissue lining the inside of the eye.

About dAMD and GA
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight.

dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.

GA, an advanced form of dry age-related macular degeneration, affects approximately 1 million people in the United States alone.
About OCU410
OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role in-vitro and in-vivo (animal model) studies. These results demonstrate the ability for OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA. Currently, the other therapeutic options available target only complement activation and require approximately 6-12 intravitreal injections annually.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

About Associated Retina Consultants
Associated Retina Consultants is the largest independent retina practice in the state of Arizona, taking part in groundbreaking clinical trials to bring new treatments for the benefit of patients with diseases affecting the retina. In addition to collaborating with Ocugen on the OCU410 clinical trial, in October 2023, Associated Retina Consultants—with a surgical team led by Dr. Mark Kwong—performed gene therapy with OCU400 on a pediatric CEP290 patient. This was the first retinal gene therapy of its kind performed on a child in Arizona.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, 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. 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.

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

Snail (SNAL) – Highlights From Noblecon19

Posted on by cpereira@noblefcm.com


Wednesday, December 13, 2023

Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Noblecon19. On December 4th, management presented at Noblecon19 at Florida Atlantic University (FAU) in Boca Raton, Florida, to the investment community. The presentation conducted by Jim Tsai, CEO, and Heidy Chow, CFO, highlighted the success of the recently released Ark: Survival Ascended title and provided notable updates on the product release roadmap heading into 2024.  

Strong release. Ark: Survival Ascended is a remastered version of the Ark game with all previously released DLC packages. In the first 30 days following the release of Ark: Survival Ascended, 700 thousand units were sold on Steam and it was the best seller the weekend of the launch.


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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. 

Orion Group Holdings (ORN) – NobleCon19 Presentation Notes

Posted on by cpereira@noblefcm.com


Wednesday, December 13, 2023

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.

NobleCon19. Orion Group Holdings CEO Travis Boone and CFO Scott Thanisch presented at NobleCon19. Management highlighted recent improvements at the Marine and Concrete segments and the strategy for growth. A rebroadcast is available at https://www.channelchek.com/videos/orion-group-holdings-noblecon19-replay.

Marine Segment. Orion’s Marine segment is being provided with some tailwinds for growth, including U.S. Navy expansion in the Pacific with Orion’s contract award earlier in the year, and port expansion and maintenance, among other events. The segment also carries a diversified revenue base, with 46% being in private customers and the remaining 54% being the government (34% state and local, 20% federal).


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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. 

Onconova Therapeutics (ONTX) – Poster Presentations Show Activity Of Narazaciclib In Breast Cancer and Lymphoma

Posted on by cpereira@noblefcm.com


Wednesday, December 13, 2023

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Additional Presentations At Medical Meetings Show Broad Activity and Targeting. In the past week, Onconova has presented additional narazaciclib data at the American Society of Hematology (ASH) conference and the San Antonio Breast Cancer Symposium (SABCS). These presentations show broad multi-kinase activity, improved inhibition of tumor growth, and synergy with other drugs used in mantle cell lymphoma.

The Data Are Consistent With Earlier Presentations. The additional data details broad multi-kinase effects of narazaciclib. Comparisons with the three approved CDK4/6 inhibitors have shown narazaciclib stops cancer cell proliferation by inhibiting more targets and leads to potent, irreversible G1cell cycle blockade. Its side effect profile allows for daily dosing, rather than the 3-week dosing followed by a week of rest to allow recovery.


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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. 

Information Services Group (III) – NobleCon19 Presentation Notes

Posted on by cpereira@noblefcm.com


Wednesday, December 13, 2023

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 700 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For additional information, visit www.ISG-One.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.

NobleCon19. Information Services Group CEO Michael Connors and CFO Michael Sherrick presented at NobleCon19. Management highlighted how ISG’s service can enable clients to be more efficient and effective in the deployment of their technology, a focus on recurring revenue and growth, and returning value to shareholders. A rebroadcast is available at https://www.channelchek.com/videos/information-services-group-noblecon19-replay.

Recurring Revenue. Recurring revenue for the Company has been about $125 million over the trailing twelve months, and has accounted for 42% of firm-wide total revenue year-to-date. ISG has set a new Company goal of $150 million in annual recurring revenues by 2025 and we believe that the Company can achieve this goal.


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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. 

Great Lakes Dredge & Dock (GLDD) – NobleCon19 Presentation Notes

Posted on by cpereira@noblefcm.com


Wednesday, December 13, 2023

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, 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.

NobleCon19. Great Lakes CEO Lasse Petterson and CFO Scott Kornblau presented at NobleCon19. Highlights included record backlog, the improving quality of the Company’s backlog, and the opportunity the wind market is providing for Great Lakes. A rebroadcast is available at https://www.channelchek.com/videos/great-lakes-dredge-dock-noblecon19-replay.

Size of Backlog. Great Lakes’ backlog is at a record $1.03 billion and consists of roughly 71% in capital projects. The bid market has continued to remain strong, as year-to-date, the market has totaled $1.8 billion compared to $1.3 billion for all of last year and a $1.4 billion five year average. The Company expects the market to grow to $2 billion by the end of the year. 


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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. 

Beasley Broadcast Group (BBGI) – Highlights From Noblecon19

Posted on by cpereira@noblefcm.com


Wednesday, December 13, 2023

Beasley Broadcast Group, Inc. owns and operates 61 stations (47 FM and 14 AM) in 15 large- and mid-size markets in the United States. Approximately 20 million consumers listen to the Company’s radio stations weekly over-the-air, online and on smartphones and tablets, and millions regularly engage with the Company’s brands and personalities through digital platforms such as Facebook, Twitter, text messaging, digital and web applications and email. The Overwatch League’s Houston Outlaws esports team is a wholly owned subsidiary. The Company also owns BeasleyXP, a national esports content hub, and AXLR-R8, a Rocket League Championship Series team, in its esports portfolio. For more information, please visit www.bbgi.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.

Noblecon19. On December 4th, management presented at Noblecon19 at Florida Atlantic University (FAU) in Boca Raton, Florida, to the investment community. The presentation conducted by Caroline Beasley, CEO, Tina Murley, CRO, and Marie Tedesco, CFO, focused on growing digital revenues, improving digital margins and reducing debt. 

Digital growth. From Q3 2019 to Q3 2023, the company’s digital revenues have grown at a 23% CAGR, and comprised nearly 19% of total revenues in Q3 2023. Notably, the company has a monthly average digital audience of 13.6 million and its owned and operated assets are viewed as a catalyst for improving digital margins.


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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. 

AstraZeneca’s $1.1B Investment in Next-Gen Vaccine Innovation via Icosavax

Posted on by slightbourne@noblecapitalmarkets.com

Pharma giant AstraZeneca (AZN) announced Monday that it will purchase clinical-stage biotech Icosavax (ICVX) for up to $1.1 billion to augment its pipeline of vaccines targeting respiratory illnesses. Specifically, AstraZeneca aims to leverage Icosavax’s innovative virus-like particle (VLP) platform to develop a first-in-class combination vaccine against respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

Icosavax’s novel VLP technology promises stronger efficacy, fewer side effects, and more durable protection than traditional vaccines – a potential game changer. And the biotech’s lead asset IVX-A12 delivered stellar phase 2 results earlier this year, prompting AstraZeneca to make this big bet on the future of infectious disease prevention.

Transformational Vaccine Approach

At the heart of this deal lies Icosavax’s VLP platform that engineers tiny proteins to mimic the structure of viruses and trigger a robust immune response. Think of VLPs as a sneaky way to train the body to fight off viruses without exposing it to any actual viral particles.

And the data so far indicates VLPs induce broader, more durable protection against infection than conventional vaccines. For example, the VLP approach is behind the extremely efficacious human papillomavirus and hepatitis B virus vaccines on the market today.

Icosavax builds on this proven concept with computationally designed VLPs targeting the unique antigens of RSV and hMPV. So AstraZeneca clearly coveted access to this next-generation technology that could change the way we immunize populations against common illness.

Expedited Path for Lead Asset

Central to the deal is Icosavax’s IVX-A12, a combo VLP vaccine to prevent RSV and hMPV, which both cause severe respiratory infection in the elderly and immunocompromised. IVX-A12 demonstrated outstanding immunogenicity – triggering enduring antibody responses – along with a clean safety profile in trials so far.

In fact, the vaccine’s phase 2 results were strong enough for the FDA to award IVX-A12 Fast Track designation. This promises an expedited path to approval given the high unmet need: there are no approved vaccines for older adults against these widespread, often dangerous pathogens.

So AstraZeneca leapfrogs development by 3-4 years via this acquisition rather than advancing an early-stage candidate itself. As part of a big pharma, IVX-A12 now has the resources for rapid phase 3 trials and submission for emergency use authorization potentially next year.

Aligns with Growth Strategy

Importantly, this deal fits squarely with AstraZeneca’s strategy of strengthening its portfolio in areas of high unmet need. As Executive VP Iskra Reic highlighted, adding IVX-A12 distinguishes AstraZeneca’s late-stage pipeline in preventative infectious disease treatments.

While the company already markets FluMist for influenza, a next-gen offering like IVX-A12 that could supplant outdated RSV vaccines or ineffective hMPV options would be a true differentiator. It also complements AstraZeneca’s leading COVID-19 antibody cocktail for immunocompromised patients unable to mount their own response.

Beyond the tech and pipeline boost, Icosavax also brings its experienced team and manufacturing capabilities to scale up production in anticipation of launch.

Investor Implications

Turning to the transaction itself, AstraZeneca’s upfront $15 per share offer in cash reflects a 43% premium to Icosavax’s December 9 close before rumors leaked. Including the $5 per share milestone payment, the total value exceeds $1 billion for a 91% premium.

Of course the back half requires IVX-A12 to gain approval and hit $750 million in sales, so some risk is baked in. But given peak revenue estimates exceeding $2 billion, this seems doable over 5-10 years post-launch.

Investors should watch for completion of the tender offer expected in Q1 2024. Passing majority shareholder approval should be straightforward with such a compelling premium. Then it becomes about execution – advancing IVX-A12 rapidly through late-stage trials.

Ultimately though, AstraZeneca makes a well-timed bet on revolutionary vaccine science that could elevate its infectious disease segment to new heights. And Icosavax investors get to participate in this next chapter via an up to 91% buyout windfall. Once again, merger mania in biopharma looks set to pay off handsomely.

Eagle Bulk Shipping to Merge with Rival to Create Dry Bulk Behemoth

Posted on by slightbourne@noblecapitalmarkets.com

Dry bulk shipping company Eagle Bulk Shipping (EGLE) announced Sunday night that it has agreed to an all-stock merger with sector peer Star Bulk Carriers Corp. (SBLK). The deal will create one of the world’s premiere owners of dry bulk vessels with a combined fleet of 169 ships worth over $2 billion.

Under the terms of the agreement, Eagle shareholders will receive 2.6211 shares of Star Bulk for each Eagle share they currently hold. With Star Bulk shares closing at $19.95 on Monday, December 11, this values Eagle stock at $52.29 per share. Compared to Eagle’s actual close of $46.19 on Monday, this deal premium comes out to 13%.

Powerhouse in Making

The merger brings together two already sizable dry bulk fleets under one umbrella to better compete on costs and provide customers integrated solutions. For example, the combined entity can offer both Capesize vessels ideal for long haul bulk transport as well as Supramax ships designed for flexibility.

With over 150 million deadweight tonnage (DWT), the new entity will rank among the top five largest publicly-traded dry bulk owners globally. Management estimates at least $50 million per year in cost savings through operational synergies, consolidated corporate overhead, and improved purchasing leverage with suppliers.

And the company will maintain an industry-leading balance sheet with net debt of $1.4 billion equaling a reasonable 37% of its $2.1 billion capitalization. The merger therefore sets up the new Star Bulk as a dominant player in dry bulk shipping both in scale and efficiency. Noble Capital Markets Senior Research Analyst Michael Heim states in his latest research report that “the combined market capitalization of $2.1 billion and fleet of 159 ships makes it one of the largest in the world.”

Modern, Eco-Friendly Fleet

Critically, Star Bulk inherits an even more modern and environmentally-friendly fleet from Eagle. The average vessel age will drop to 11 years versus 14 years currently. Eagle’s ships were built at top-tier Asian shipyards known for quality and efficiency.

Just as important, Eagle has been an early and enthusiastic adopter of exhaust gas scrubbers which reduce harmful emissions. In fact, 97% of the combined fleet will now have these scrubbers installed well positioning the company for impending environmental regulations.

Maintaining a modern, eco-friendly fleet is increasingly important to winning business from customers like commodities giants Glencore and Trafigura who value corporate responsibility. So the transaction gives Star Bulk key competitive advantages on this front.

Market Perform on Limited Remaining Upside

With significant strategic rationale behind the merger, the analyst still downgraded Eagle stock to a Market Perform with limited additional upside. Specifically, they dropped their price target to $52 simply reflecting the implicit deal price.

So while the merger appears to make industrial sense and places fair long-term value on Eagle, investors shouldn’t expect much added price appreciation from current levels. Of course, there is a small chance the merger fails to close as anticipated allowing shares to diverge back downward.

But assuming smooth sailing through the expected close in 1H 2024, Eagle shareholders can take comfort in the 13% premium and exciting combined company outlook. This sets up Eagle owners to become owners in the industry’s next dry bulk titan.

Take a moment to take a look at more research on Eagle Bulk Shipping by Noble Capital Markets Analyst Michael Heim.

Release – Onconova Therapeutics’ Narazaciclib Ash Poster Highlights Activity In Treatment Resistant Mantle Cell Lymphoma

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX


Dec 12, 2023

Preclinical data show that narazaciclib treatment led to significant tumor growth inhibition, demonstrating synergy with standard-of-care ibrutinib, in ibrutinib-sensitive and -resistant settings

Early Phase 1/2 studies suggest potential for an improved profile and daily dosing

Dose escalation is underway in lead indication of Low Grade Endometrioid Endometrial Carcinoma (LGEEC), with plans to define the Recommended Phase 2 Dose (RP2D) and prepare for registrational studies, with a planned update in H1 2024

NEWTOWN, Pa., Dec. 12, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced preclinical data, highlighting narazaciclib’s preclinical activity in Bruton’s kinase inhibitor (BTKi)-resistant mantle cell lymphoma (MCL), in a poster presented on December 11, 2023 at the 65th Annual Meeting of the American Society for Hematology (ASH 2023) in San Diego.

“We are pleased to have shared data at ASH 2023 from preclinical studies with narazaciclib in MCL models. These results, which are consistent with data presented this year at the international MCL conferences, demonstrate that treatment with narazaciclib led to significant tumor growth inhibition when used as a single agent and that combination with ibrutinib demonstrated synergy, in both ibrutinib-sensitive and -resistant in vitro and in vivo settings,” said Steve Fruchtman, M.D., President and Chief Executive Officer. “These data are important because they provide further evidence for the potential use of narazaciclib in cancers with cyclin over-expression and elaborate our understanding of narazaciclib’s mechanism of action, including its ability to promote G1 cell cycle blockade.”

Dr. Fruchtman continued, “We believe that these data, along with the preclinical data presented on Friday, December 8th at the San Antonio Breast Cancer Symposium (SABCS), further underscore the impressive and differentiated profile of narazaciclib. The data presented at SABCS highlight narazaciclib’s multi-kinase activity, its ability to target resistance pathways missed by other CDK4/6 inhibitors, and its differentiated anti-tumor and immunomodulatory activity. The data presented at ASH 2023 show that narazaciclib, in combination with BTKi’s such as ibrutinib, also trigger metabolic reprogramming alongside DNA damage.”

“The totality of these data is helping us to shape the clinical program for narazaciclib, including the lead indication of LGEEC, with further potential to expand into additional investigator-sponsored studies in breast, ovarian, and other cancers. We are pleased with the early Phase 1/2 data for narazaciclib monotherapy and in combination with letrozole, showing lower levels of neutropenia and diarrhea, and the potential for once daily dosing. Both of these attributes could position narazaciclib as a differentiated and improved CDK4/6i. Looking ahead, we are enthusiastic to advance the clinical program for narazaciclib in 2024 and to update our stakeholders regarding our progress, including the planned completion of dose escalation studies, definition of an RP2D, and development of our registrational trial plans for LGEEC. The data presented at ASH suggest narazaciclib is a drug with the potential to target a variety of cancer indications with an unmet medical need, including MCL,” concluded Dr. Fruchtman.

Poster Highlights

Title: Narazaciclib, a differentiated CDK4/6 antagonist, prolongs cell cycle arrest and metabolomic reprogramming, enabling restoration of ibrutinib sensitivity in BTKi-resistant mantle cell lymphoma

Objectives: To evaluate the activity and mechanism of action of narazaciclib as a single agent and in combination with ibrutinib, in comparison to the standard-of-care ibrutinib, in preclinical models of MCL that are sensitive and resistant to ibrutinib treatment.

Snapshot of the Results and Conclusions:

  • Tumor Growth Inhibition: Narazaciclib showed safety and efficacy as a single agent in preclinical MCL models, including ibrutinib-resistant settings, with significant reductions in cell viability.
  • Combination Synergy: The narazaciclib plus ibrutinib combination showed synergy in vitro and in vivo, especially in ibrutinib-resistant models, with overall greater synergy, measured by lower “Combination Index” values, versus ibrutinib-sensitive cells.
  • Cell Cycle Blockade: The combination of narazaciclib plus ibrutinib induces a superior G1 cell cycle blockade in both ibrutinib-sensitive and ibrutinib-resistant MCL cells.
  • Metabolic programming: In ibrutinib-resistant cases, the synergy between narazaciclib and ibrutinib triggers metabolic reprogramming alongside DNA damage, mediated by the USP24 and P53 axis, as evidenced by several assays to assess mitochondrial metabolism.

Together, these preclinical data suggest that narazaciclib has important single agent activity and the potential to restore ibrutinib sensitivity in BTKi-resistant models, successfully meeting the primary objective of the study.

A copy of the poster is available on the “Scientific Presentations” section of the Onconova website.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer, ovarian cancer, multiple myeloma, and mantle cell lymphoma.

Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).

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

Forward Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Bit Digital (BTBT) – NobleCon19 Presentation Notes

Posted on by cpatches


Tuesday, December 12, 2023

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.

NobleCon19. Bit Digital CEO Sam Tabar presented at NobleCon19. Highlights included the discussion of diversification efforts and additional detail on the Bit Digital AI business. A rebroadcast is available at https://www.channelchek.com/videos/bit-digital-noblecon19-replay.

Diversification. The new Bit Digital AI business provides a non-correlated revenue source for the Company, significantly diversifying Bit Digital’s business. as we have mentioned in prior reports, Bit Digital AI provides specialized infrastructure to support generative artificial intelligence (“AI”) workstreams.


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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.