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Release – Ocugen Announces Dosing Completion Of Subjects With Geographic Atrophy In Cohort 2 Of Phase 1/2 ArMaDa Clinical Trial Of OCU410—A Modifier Gene Therapy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

April 19, 2024

MALVERN, Pa., April 19, 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 dosing is complete in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 1 million people in the United States alone.

“We are very enthusiastic about the potential of OCU410 as a one-time, gene-agnostic option for the treatment of GA,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “OCU410 regulates multiple pathways involved with the disease, including lipid metabolism, inflammation, oxidative stress, and membrane attack complex (complement) with a single sub-retinal injection.”

Dosing in the second cohort is complete and 3 subjects received 200 mL single subretinal administration of the medium dose (5×1010 vg/mL) of OCU410. Up to 13 leading retinal surgery centers across the United States are participating in the ArMaDa clinical trial.

“Currently we have two FDA approved, anti-complement therapies for GA targeting a single pathway of the disease, which has multifactorial and complex etiology,” said Syed M. Shah, MD, Vice Chair of Research and Digital Medicine and Director of Retina Service at Gundersen Health System, La Crosse, WI, and the lead investigator for the OCU410 Phase 1/2 trial. “The limited benefit comes with the burden of continued multiple intravitreal injections spanning over several years. This novel modifier gene therapy has the potential to transform the therapeutic landscape in GA treatment.”

A Data and Safety Monitoring Board meeting will convene next month to review the 4-week safety data of the medium dose cohort before proceeding with high dose, which is the final dose in the Phase 1 dose-escalation study.

The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL). Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

The Company will continue to provide clinical updates on an ongoing basis.

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.

About OCU410
OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (ROR 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 as well as inhibiting the complement system in 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.

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.

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

Tesla Slashes Workforce by Over 10% as Demand Softens

Posted on by slightbourne@noblecapitalmarkets.com

In a move that has sent shockwaves through the electric vehicle industry, Tesla Inc. announced plans to lay off more than 10% of its global workforce. The decision, confirmed by CEO Elon Musk in an internal memo, comes on the heels of a disappointing first-quarter delivery report that missed analyst estimates and left the company with an excess inventory of over 46,000 vehicles.

The layoffs, which are expected to impact at least 14,000 employees out of Tesla’s 140,000-strong workforce, are part of a broader effort to cut costs and increase productivity as the company prepares for its “next phase of growth,” according to Musk’s memo. The move underscores the challenges facing Tesla amid a slowdown in EV demand, both in the United States and globally.

“As we prepare the company for our next phase of growth, it is extremely important to look at every aspect of the company for cost reductions and increasing productivity,” Musk wrote in the memo. “As part of this effort, we have done a thorough review of the organization and made the difficult decision to reduce our headcount by more than 10% globally. There is nothing I hate more, but it must be done.”

The announcement has sent shockwaves through the industry, with analysts offering mixed reactions to the news. Dan Ives, a noted Tesla bull at Wedbush Securities, described the layoffs as an “ominous signal” that speaks to tough times ahead for the company. “Demand has been soft globally, and this is an unfortunately necessary move for Tesla to cut costs with a softer growth outlook,” Ives said, adding that the move signals that Musk is navigating a “Category 5 storm.”

However, not all analysts view the layoffs as a negative development. Garrett Nelson, an analyst at CFRA, sees the move as consistent with actions undertaken by other automakers – and particularly EV pure-plays such as Rivian and Lucid – amid slowing EV growth rates. “We view the announcement as a sign of the times, but the fact Tesla is taking action to reduce costs amid the slowdown should be positive for the bottom line,” Nelson said.

The layoffs come at a critical juncture for Tesla, which has long been hailed as a pioneer in the electric vehicle space. After years of breakneck growth and ambitious expansion plans, the company now finds itself grappling with a rapidly changing market landscape. Rising interest rates and higher overall prices have dampened consumer demand for electric vehicles, while increased competition from legacy automakers and upstart EV manufacturers has intensified pressure on Tesla to maintain its competitive edge.

Musk has repeatedly emphasized the importance of affordability in driving EV adoption, fueling speculation that Tesla was working on a next-generation vehicle that would start at around $25,000. However, recent reports suggesting that the company had canceled the project were met with a swift denial from Musk, who instead teased the debut of a Tesla robotaxi on August 8.

As Tesla prepares to report its first-quarter earnings on April 23, all eyes will be on the company’s ability to weather the current storm and chart a course for long-term growth. The layoffs, while painful, may be a necessary step in ensuring Tesla’s long-term competitiveness in an increasingly crowded and challenging market.

Biotechs Onconova and Trawsfynydd Merge to Create Traws Pharma

Posted on by slightbourne@noblecapitalmarkets.com

In a deal uniting two biotech companies from opposite coasts, Onconova Therapeutics and Trawsfynydd Therapeutics announced they are combining forces through an all-stock merger. The newly created entity, dubbed Traws Pharma, will have a deep pipeline spanning virology and oncology when it begins trading on the Nasdaq as “TRAW” this Wednesday.

Traws is being launched with an approximately $28 million cash balance after a $14 million private placement investment led by elite life sciences funds OrbiMed and Torrey Pines. The cash provides ample runway as Traws prepares for multiple clinical catalysts in 2024 across its three lead programs.

The combined company will be led by an executive team blending leadership from the previous organizations. Incoming CEO Werner Cautreels, Ph.D., previously headed Trawsfynydd, while Onconova’s Steven Fruchtman, M.D., will serve as President and Chief Scientific Officer of Oncology for Traws.

On the virology side, Traws inherits Trawsfynydd’s advancing pipeline of antiviral candidates for influenza and COVID-19. Viroksavir, a novel cap-dependent endonuclease inhibitor, has completed Phase 1 testing for influenza and is slated to begin Phase 2 trials in the second half of this year. Early data could read out by the first half of 2025.

Travaltrelvir is Trawsfynydd’s oral protease inhibitor targeting COVID-19. A first-in-human Phase 1 study initiated screening in the first quarter, with topline data expected in the second half of 2024. If positive, Traws plans to rapidly advance travaltrelvir into a Phase 2 trial in the second half of 2024 enrolling moderate to severe COVID-19 patients.

From Onconova, Traws gains narazaciclib, a next-generation CDK4/6 inhibitor being evaluated in a Phase 1/2 trial for low-grade endometrioid endometrial cancer (LGEEC). Preclinical data suggests narazaciclib could offer an improved therapeutic window over approved CDK4/6 drugs like palbociclib with potentially fewer bone marrow and GI toxicities.

The merger deal terms entail Trawsfynydd shareholders receiving 75.7% ownership in the combined Traws entity, with Onconova shareholders getting 13.7% and the OrbiMed/Torrey Pines investors getting 10.6%. A key piece allows current Onconova investors to retain a contingent value right (CVR) entitling them to potential future proceeds from narazaciclib.

Traws’ board will blend representation as well, co-led by Executive Chairman Iain Dukes, DPhil from OrbiMed and Nikolay Savchuk, Ph.D. of Torrey Pines, along with continuing Onconova directors.

While delivering upside potential from a fresh pipeline spanning anti-infectives and cancer, the Traws merger does come with a degree of complexity and deal risk. The share issuances require a shareholder vote, which could potentially disrupt the closing if there are any hiccups.

But if the transaction goes through as anticipated, Traws Pharma will emerge as a unique hybrid biotech play. Bolstered by crossover financing, it will seek to advance multiple clinical candidates toward key data inflections that could help unlock their full therapeutic and commercial potential across areas of significant unmet medical need.

Take a moment to take a look at more biotech companies by taking a look at Noble Capital Market’s Senior Research Analyst Robert Leboyer’s coverage list.

Job Market Stays Resilient as Openings Hold Steady

Posted on by slightbourne@noblecapitalmarkets.com

The latest employment data shows the resilience of the US labor market, even as the Federal Reserve remains locked in an inflation battle. The number of job openings across the country was essentially unchanged in February at 8.76 million, according to the Job Openings and Labor Turnover Survey (JOLTS) released by the Labor Department.

While just a slight 0.1% uptick from January’s revised 8.75 million openings, the figure highlights how robust hiring demand remains from employers over a year into the Fed’s interest rate hiking campaign. Job vacancies have been sticky at extremely elevated levels, leaving Fed officials frustrated in their efforts to ease wage growth and inflationary pressures.

“The labor market continues to defy expectations of a meaningful cooling,” said Samantha Gunther, economist at Credence Economics. “With openings still so high, wage growth is likely to remain too strong for the Fed’s liking in the months ahead.”

The JOLTS data precedes this week’s highly anticipated March jobs report, which is forecast to show nonfarm payrolls increased by 230,000 positions. That would mark a fourth straight month of job gains over 200,000, underscoring the employment market’s enduring tightness.

There were some modest signs of a gradual loosening in labor conditions buried within February’s openings figures. Job vacancies fell in sectors like information, healthcare and retail trade. More notably, the overall level of layoffs jumped to 1.8 million, the highest since last April, led by a spike in the leisure and hospitality industry.

“While the bar remains high for calling a turn in the labor cycle, we’re seeing some initial hints of cracks starting to form,” said Ryan Bingham, lead labor economist at ADP. “Higher borrowing costs are clearly starting to bite for certain service-sector businesses.”

The report also showed rates of workers quitting their jobs to pursue other opportunities held steady at 2.2% in February, the lowest since the summer of 2020. The diminished quits rate could indicate employees are feeling less confident about switching roles in a more uncertain economic climate.

Another indicator pointing to some easing was the ratio of available workers to job openings, which slipped to 1.36 from 1.43 in January. While still a very tight ratio favoring employers over job seekers, it marked progress toward better balance after peaking above 2-to-1 last year.

For the Fed, the upshot is likely more patience in leaving interest rates elevated. Chair Jerome Powell reiterated last week that stronger labor market “gives” would be needed to bring down unacceptably high inflation back toward the 2% goal.

With payroll growth expected to remain solid and job openings still extremely elevated, it will take more time before productivity-enhancing labor slack emerges. The latest JOLTS figures suggest that process is underway, however gradual it may prove to be.

Big Pharma Goes Bio-Prospecting: Why Major Drug Makers Are Buying Innovative Biotech Startups

Posted on by slightbourne@noblecapitalmarkets.com

The biotech sector has seen a flurry of acquisition activity in recent months, with large pharmaceutical companies opening their checkbooks to snap up promising small and micro-cap players. This deal-making frenzy underscores the value that nimble startups can bring to big pharma through their cutting-edge research and drug development pipelines.

For the pharmaceutical giants, acquiring innovative biotechs provides a vital influx of new drug candidates and therapies to revitalize stagnant pipelines and drive future revenue growth. Many large drug makers have struggled to internally develop enough new blockbuster treatments to replace aging cash cows going off-patent. Rather than go it alone in risky early-stage R&D, they are turning to biotech upstarts working at the frontiers of medicine.

These small biotech firms are proving to be fertile ground for novel drug discoveries. Despite their tiny team and budget, biotech startups can move nimbly to translate university research into therapeutic candidates. Their laser focus on narrow areas like orphan diseases, gene therapies, or targeted oncology treatments allows them to rapidly innovate in ways that large pharma bureaucracies cannot.

By acquiring these startups, big pharma gains a fast-track to promising new drugs and therapies that would take years and billions to develop internally. They can get first-mover advantage on groundbreaking new treatment modalities. Just as importantly, they acquire the entrepreneurial scientific talent behind the discoveries.

This acquisition appetite from pharma giants shows no signs of slowing. Just this month, AbbieVie acquired small biotech Landos Biopharma for $212 million to gain its promising autoimmune pipeline. AstraZeneca paid $2.4 billion for Fusion Pharmaceuticals and its next-gen oncology radioconjugates. The list goes on.

The drivers behind this deal surge were presciently spotted by Channelchek back in December 2023. Channelchek’s biotech research analysis predicted that the beaten-down biotech sector was poised for a major rebound, writing:

“The fresh upswing in biotech M&A follows a wave of dip buying from some the world’s largest asset managers in shares of industry leaders like Vertex Pharmaceuticals and Regeneron Pharmaceuticals. Warren Buffett’s Berkshire Hathaway has been particularly aggressive stepping in to purchase stakes in key biopharma bluechips.”

Channelchek’s forecast proved accurate, as biotech stocks have rallied and M&A activity has heated up in recent months. Big pharma’s shopping spree for innovative biotechs continues to gain momentum.

As Nico Pronk, Chief Executive Officer at Noble Capital Markets, stated: “Our platform aims to help amplify the stories of these cutting-edge biotech innovators to the investors and strategic partners seeking out emerging growth opportunities.” There is a funding gulf that still exists for startups looking to take their discoveries to the next level.

For investors and emerging biotechs seeking to capitalize on this next wave of consolidation, Noble Capital Markets is hosting its Emerging Growth Virtual Healthcare Equity Conference on April 17-18, 2024. This online investor forum will allow public healthcare, biotech and medical devices firms to present their company stories directly to institutional funds, family offices, and retail investor audiences. To register for this event showcasing the future disruptors of healthcare, visit the conference registration page here.

The big pharma acquisition binge shines a light on the value that small, innovative biotech players can bring to the healthcare ecosystem through their scientific discoveries. With deep-pocketed buyers on the prowl, the stage is set for the next generation of medical breakthroughs to be commercialized at scale.

Release – PDS Biotechnology Announces Conference Call and Webcast for Business Update and Full Year 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., March 20, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell-activating platforms, today announced that the Company will provide a business update and release financial results for the year ended December 31, 2023, on Wednesday, March 27, 2024. Following the release, management will host a conference call to review the financial results and provide a business update.

Wednesday, March 27, 2024, 8:00 AM ET
Domestic: 877-704-4390
International: 201-389-0920
Conference ID: 13745320
Webcast: PDS Biotech Earnings Webcast

After the live webcast, the event will be archived on PDS Biotech’s website for six months.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS01ADC and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches. Our Versamune® platform activates the right type, quantity and potency of tumor attacking T cells. Our IL-12 fused antibody drug conjugate (PDS01ADC) is designed to target the tumor to promote suppression of the tumor’s defenses while promoting T-cell activity in the tumor. To date, Versamune® HPV (PDS0101), PDS01ADC and PDS0101 co-administered with PDS01ADC, our lead clinical candidates, have demonstrated the ability to shrink tumors and/or stabilize disease when used as single agents or in combination with approved therapies in patients with a broad range of solid tumors in multiple Phase 2 clinical trials. We plan to advance our lead program into a pivotal trial for the treatment of recurrent/metastatic HPV16-positive head and neck cancer. Our Infectimune® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on X at @PDSBiotech.

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

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

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

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

Drivers Brace for Higher Gas Prices as Oil Costs Spike

Posted on by slightbourne@noblecapitalmarkets.com

Motorists across the nation are once again feeling the pinch at the gas pump as oil prices have climbed sharply in recent months. After a brief reprieve earlier this year, the national average price for a gallon of regular gasoline has risen over 18 cents in just the last month to around $3.40 according to AAA data. Experts warn that prices could jump another 10-15 cents over the next couple of weeks alone.

The primary culprit behind the surge is the rising cost of crude oil. Both the U.S. benchmark West Texas Intermediate and the global Brent crude have seen prices spike, with WTI crude now hovering around $79 per barrel and Brent north of $83 per barrel. Just a few months ago, WTI started 2024 just over $70 a barrel.

As crude gets more expensive for refiners to purchase, the costs get passed along to consumers in the form of higher gasoline prices. Tighter supplies and seasonal factors are also contributing to price increases at the pump.

“This week, Gulf Coast refiners began transitioning to more expensive summer blend gasoline, which accounts for nearly 50% of the nation’s refining capacity,” said Andy Lipow of Lipow Oil Associates. “That switch means higher prices are ahead.”

California drivers are being hit particularly hard, with the statewide average price per gallon already at a lofty $4.88 as of Wednesday. Refinery maintenance, lower inventory levels, and the changeover to summer blends have caused California gas prices to jump around 25 cents in recent weeks according to Lipow.

The overall lower supply situation is being exacerbated by disruptions at some key refineries. For example, BP’s massive Whiting refinery in Indiana, the largest in the Midwest, is still recovering from a recent power outage caused by cold weather that impacted production.

Historically, spring represents the start of the annual rise in gas prices as refiners transition to summer blends and demand picks up with more drivers hitting the road after the winter months. Consumer demand typically peaks during summer’s peak driving season.

While higher energy costs were one of the main factors driving an unexpected increase in inflation in February, rising gas prices take an oversized toll on household budgets. The latest Consumer Price Index data showed the gasoline index spiked 3.8% last month alone after declining in January.

Analysts caution there is likely more pain at the pump on the horizon with the summer driving season still ahead. Unless crude oil prices reverse course or refining capacity increases, American drivers can expect gasoline to remain unusually expensive compared to this time last year.

“With the industry having less refining capacity and the economy remaining relatively strong, I expect retail gasoline prices to set new records across the nation in the coming months,” Lipow stated.

Whether taking a road trip for spring break or commuting to and from work and activities, consumers have little choice but to absorb the impact of elevated gas prices cutting into other spending. Budgets will be further squeezed if crude oil costs remain stubbornly high and gasoline supply remains tight.

Information Services Group (III) – Waiting Out the Delays

Posted on by cpereira@noblefcm.com


Monday, March 11, 2024

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.

Continued Challenging Environment. Client decision making drove a decrease in performance for ISG in the fourth quarter. However, it was not just the Company experiencing this, the IT and business services industry felt the squeeze as well. We believe the Company’s recurring revenues (now 43% of total sales) and the expansion of its AI services will allow ISG to push through an expected challenging first half in 2024.

Full Year Results. Revenue increased 2% to $291.1 million for the year, with the Americas segment showing growth while Europe and Asia Pacific decreased from last year. Net income was $9.8 million, or $0.20 per share excluding a bad debt reserve. Adjusted EBITDA was $37.7 million or a margin of 12.9%.


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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. 

Orion Group Holdings (ORN) – 4Q Post Call Commentary – Progress Against the Plan

Posted on by slightbourne@noblecapitalmarkets.com


Monday, March 04, 2024

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.

Progress. In 2023 Orion transformed into a more focused, more competitive and more driven company. Management implemented a disciplined project bidding and delivery strategy, attracted high-caliber business development executives, invested in systems, training and tools, secured a three-year, $103 million credit facility, and closed over $25 million in equipment and real estate sale-leaseback transactions.

Marine Segment. Segment revenue was up 40.3% to $135.2 million, while operating income was $4.3 million, compared to  $234,000 in 4Q22. The revenue growth was primarily related to the Pearl Harbor project.


Get the Full Report

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. 

Release – ACCO Brands Reports Fourth Quarter and Full Year 2023 Results and Provides Outlook for 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ACCO

02/22/2024

DOWNLOAD(OPENS IN NEW WINDOW)

Company Exceeds Full Year 2023 Outlook

Full Year

  • Reported net sales of $1.833 billion, with gross margin expanding 420 basis points
  • Operating income of $45 million; adjusted operating income grew 17% to $205 million
  • Loss per share of $(0.23); adjusted EPS of $1.09, above the Company’s outlook
  • Net operating cash flow improved $51 million, generated adjusted free cash flow of $118 million
  • Reduced total debt by $88 million with a consolidated net leverage ratio of 3.4x at year-end

LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today reported financial results for the fourth quarter and fiscal year ended December 31, 2023.

“I am pleased to report that our fourth quarter financial performance, including our reported net sales and adjusted EPS and free cash flow, was better than expected. During the year, we successfully executed against our 2023 priorities and implemented our previously announced restructuring plans, which enabled us to significantly expand our gross margin, deliver strong free cash flow, and reduce our consolidated net leverage ratio to 3.4x at the end of 2023. We believe our achievement of these results against a challenging demand environment is a testament to the solid execution of our team and our geographically diverse portfolio of leading brands. The restoration of our gross margins and improved cash flows enables us to make investments that position the Company for long-term growth,” stated ACCO Brands’ President and Chief Executive Officer, Tom Tedford.

Fourth Quarter Results

Net sales declined 2.2 percent to $488.6 million from $499.4 million in 2022. Comparable sales fell 4.6 percent, as favorable foreign exchange increased sales by $12.2 million, or 2.4 percent. Both reported and comparable sales declines reflect softer demand due to a weaker macroeconomic environment, which has also led to lower global demand for our technology accessories. These factors more than offset growth in our International segment, driven by the recovery of back-to-school sales in Latin America.

Operating loss was $52.8 million versus operating income of $35.6 million in 2022, primarily due to a non-cash goodwill impairment charge of $89.5 million related to the North America segment. In 2023, we recognized restructuring charges of $20.9 million, compared to $7.3 million in the prior-year period, with the increase related to our continuing footprint rationalization and cost reduction programs. Adjusted operating income increased 30.6 percent to $68.3 million from $52.3 million in the prior-year period. This increase reflects recovery of gross margin from the effect of cumulative global price increases and cost reduction actions, as well as moderating input costs. This was partially offset by higher SG&A expense, primarily due to an increase in incentive compensation compared to the prior year.

The Company reported a net loss of $59.4 million, or $(0.62) per share, compared with prior-year net income of $18.8 million, or $0.20 per share. The net loss is primarily due to the non-cash goodwill impairment charge of $89.5 million, with no associated tax benefit, as well as the higher restructuring charges noted above. In addition, there was a favorable change in discrete tax items of $21.8 million, largely related to recent tax legislation in both Brazil and the United States. Adjusted net income was $37.5 million, or $0.39 per share, compared with $30.5 million, or $0.32 per share in 2022. The increase in adjusted net income was due to the items noted above in adjusted operating income, partially offset by higher interest and non-operating pension expenses.

Full Year Results

Net sales decreased 5.9 percent to $1.83 billion from $1.95 billion in 2022. Favorable foreign exchange increased sales by $11.3 million, or 0.6 percent. Comparable sales decreased 6.5 percent. Both reported and comparable sales declines reflect the challenging macroeconomic environment, especially in North America and EMEA, and lower than anticipated return to office trends, as well as tight inventory management by our customers in North America. Sales of technology accessories were most negatively impacted. This more than offset the benefit of cumulative price increases across all segments, and volume growth in Latin America.

Operating income was $44.7 million compared to $34.8 million in 2022. The increase in operating income is primarily due to a lower non-cash goodwill impairment charge of $89.5 million versus the $98.7 million recorded in 2022. In 2023, we recorded restructuring charges of $27.2 million compared to $9.6 million in 2022, with the increase related to our continuing footprint rationalization and cost reduction programs. 2022 includes a benefit related to the change in value of the PowerA contingent earnout of $9.0 million, which did not repeat in 2023. Adjusted operating income increased to $204.8 million from $175.8 million in 2022. Both reported and adjusted operating income increases reflect the benefit of cumulative global price increases and cost reduction initiatives, partially offset by negative fixed cost leverage and higher SG&A expense, primarily due to increased incentive compensation.

Net loss was $21.8 million, or $(0.23) per share, compared with a net loss of $13.2 million, or $(0.14) per share, in 2022. The net losses were primarily related to the items noted above in operating income. In 2023, there was a significant increase in discrete tax benefits largely related to recent tax legislation in both Brazil and the United States, partially offset by reduced operating tax gains. Adjusted net income was $105.6 million compared with $101.0 million in 2022, and adjusted earnings per share were $1.09 per share compared with $1.04 per share in 2022. The increase in adjusted net income was due to the items noted above in adjusted operating income, partially offset by higher interest and non-operating pension expenses.

Capital Allocation and Dividend

For the full year, the Company significantly improved its operating cash flow to $128.7 million versus $77.6 million in the prior year, driven primarily by improved profits and working capital. Adjusted free cash flow in 2023 improved by $40.0 million to $117.5 million versus $77.5 million in 2022. Adjusted free cash flow in 2022 excludes the contingent earnout payment. The Company’s consolidated leverage ratio as of December 31, 2023 was 3.4x.

On February 16, 2024, ACCO Brands announced that its board of directors declared a regular quarterly cash dividend of $0.075 per share. The dividend will be paid on March 27, 2024 to stockholders of record at the close of business on March 15, 2024.

Restructuring and Cost Savings Program

On January 30, 2024, the Company announced a multi-year restructuring and cost savings program, with anticipated annualized pre-tax cost savings of at least $60 million. The program incorporates initiatives to simplify and delayer the Company’s operating structure and reduce costs through headcount reductions, supply chain optimization, global footprint rationalization, and better leveraging the Company’s sourcing capabilities. As a result of these actions, the Company will improve its speed of execution and bring key leaders closer to customers.

In connection with the program, the Company recognized pre-tax restructuring charges of $20.9 million in the fourth quarter of 2023, related to costs associated with the headcount reductions, as well as the closing of its Sidney, NY manufacturing facility. This was the fourth facility closure announced in 2023.

New Operating Segments

As previously announced, the Company will be implementing a new operating model, consolidating its three reportable segments into two reportable segments. The Americas reporting segment will include the U.S., Canada, Brazil, Mexico and Chile and the International reporting segment will include EMEA, Australia, New Zealand, and Asia. The Company will report on this basis for the fiscal year commencing January 1, 2024.

Business Segment Results

ACCO Brands North America – For the full year, North America net sales of $887.2 million decreased 11.1 percent from $998.0 million in 2022, and comparable sales declined 10.7 percent. Fourth quarter segment net sales of $199.0 million and comparable sales of $199.1 million both decreased 11.8 percent versus the prior year. Both full-year and fourth quarter reported and comparable sales decreases reflect softer demand due to a weaker macroeconomic environment, lower than anticipated return to office trends and retailers maintaining lower inventory levels, which resulted in lower demand for technology accessories and office products. This more than offset the benefit of cumulative pricing actions.

In North America, full year operating loss was $5.9 million versus an operating loss of $4.9 million in 2022. In 2023, we recorded a $89.5 million non-cash goodwill impairment charge compared to the $98.7 million recorded in the prior year. In 2023, restructuring charges were $16.7 million, an increase from the $5.3 million in 2022, largely related to our cost reduction and productivity programs. Adjusted operating income was $122.4 million, up from $121.5 million in the prior year, as benefits of the cumulative effect of pricing and cost actions, were largely offset by lower volume and negative fixed cost leverage.

ACCO Brands EMEA – Full year net sales in the EMEA segment of $547.2 million decreased 5.7 percent from $580.3 million in 2022. Favorable foreign exchange increased sales by 1.0 percent. Comparable sales declined 6.7 percent. Fourth quarter segment net sales of $159.1 million increased 2.0 percent versus the prior year’s net sales of $156.0 million. Favorable foreign exchange increased sales by 4.6 percent for the quarter. Comparable sales of $152.0 million decreased 2.6 percent versus the prior-year period as volume declines moderated sequentially in the quarter. Both full year and fourth quarter comparable sales declines reflect reduced demand, especially for technology accessories, due to a weaker macroeconomic environment. This more than offset the benefit of cumulative pricing actions.

The EMEA segment posted full-year operating income of $38.7 million compared with operating income of $21.7 million in 2022. In 2023, we recorded restructuring charges of $8.9 million versus $3.4 million in 2022, with the increase related to our ongoing footprint rationalization and cost reduction programs. Adjusted operating income was $62.5 million, up from $37.0 million in 2022. The increases in both reported operating income and adjusted operating income reflect recovery of gross margins from price increases and cost savings actions, more than offsetting negative fixed cost leverage and higher incentive compensation.

ACCO Brands International – International segment net sales of $398.4 million for the full year increased 7.9 percent from $369.3 million in 2022. Favorable foreign exchange increased sales by 2.6 percent. Comparable sales were $388.7 million, up 5.3 percent versus the prior year. Fourth quarter segment net sales of $130.5 million increased 10.9 percent versus the prior year’s net sales of $117.7 million. Favorable foreign exchange increased sales by 4.4 percent for the quarter. Comparable sales were $125.3 million an increase of 6.5 percent versus the year-ago period. Both full year and fourth quarter reported and comparable sales increases reflect stronger pricing and volume growth in Latin America, more than offsetting the impact of weaker economic conditions in Australia and Asia and overall lower demand for technology accessories.

Operating income for the full year was $60.7 million, an increase from $50.5 million in 2022. Adjusted operating income of $68.1 million increased from $58.3 million in the prior year. The increase in both operating and adjusted operating income were primarily due to the cumulative benefit of pricing and cost actions, somewhat offset by higher go-to-market spending, people costs and incentive compensation.

2024 Outlook

“We are taking actions to reposition the company for long-term, sustainable, profitable growth. In January, we announced a multi-year restructuring and cost savings program, to reset our cost structure. The program is expected to deliver at least $60 million in annual cost savings once fully implemented and will better leverage our global platform and leading brands. We continue to focus on our margin profile by exiting low margin business and better leveraging our sourcing and supply chain infrastructure. These actions will enable us to accelerate investments in new product development, innovation, and other growth initiatives, while increasing our profitability and cash flow, leading to improved shareholder value,” concluded Mr. Tedford.

For the full year, we expect reported sales to be down in the range of 2.0% to 5.0%. The Company’s sales outlook reflects the uncertain demand environment for its categories. Full year adjusted EPS is expected to be within a range of $1.07 to $1.11. The Company expects 2024 free cash flow to grow to at least $120 million and to end the year with a consolidated leverage ratio of approximately 3.0x to 3.2x.

In the first quarter, we expect reported sales to be down in the range of 6.5% to 8.0% and adjusted EPS within a range of $0.01 to $0.04. Seasonally, sales can shift between first and second quarter due to the timing of back-to-school shipments in North America.

Webcast

At 8:30 a.m. ET on February 23, 2024, ACCO Brands Corporation will host a conference call to discuss the Company’s fourth quarter and full year 2023 results. The call will be broadcast live via webcast. The webcast can be accessed through the Investor Relations section of www.accobrands.com . The webcast will be in listen-only mode and will be available for replay following the event.

About ACCO Brands Corporation

ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn, and play. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com .

Non-GAAP Financial Measures

In addition to financial results reported in accordance with generally accepted accounting principles (GAAP), we have provided certain non-GAAP financial information in this earnings release to aid investors in understanding the Company’s performance. Each non-GAAP financial measure is defined and reconciled to its most directly comparable GAAP financial measure in the “About Non-GAAP Financial Measures” section of this earnings release.

Forward-Looking Statements

Statements contained herein, other than statements of historical fact, particularly those anticipating future financial performance, business prospects, growth, strategies, business operations and similar matters, results of operations, liquidity and financial condition, and those relating to cost reductions and anticipated pre-tax savings and restructuring costs are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on the beliefs and assumptions of management based on information available to us at the time such statements are made. These statements, which are generally identifiable by the use of the words “will,” “believe,” “expect,” “intend,” “anticipate,” “estimate,” “forecast,” “project,” “plan,” and similar expressions, are subject to certain risks and uncertainties, are made as of the date hereof, and we undertake no duty or obligation to update them. Forward-looking statements are subject to the occurrence of events outside the Company’s control and actual results and the timing of events may differ materially from those suggested or implied by such forward-looking statements due to numerous factors that involve substantial known and unknown risks and uncertainties. Investors and others are cautioned not to place undue reliance on forward-looking statements when deciding whether to buy, sell or hold the Company’s securities.

Our outlook is based on certain assumptions, which we believe to be reasonable under the circumstances. These include, without limitation, assumptions regarding the impact of inflation and global geopolitical and economic uncertainties and fluctuations in foreign currency exchange rates; and the other factors described below.

Among the factors that could cause our actual results to differ materially from our forward-looking statements are: our ability to successfully execute our restructuring and cost savings plans and realize the anticipated benefits of these plans and our other ongoing productivity initiatives; our ability to obtain additional price increases and realize longer-term cost reductions; the ongoing impact of the COVID-19 pandemic; a relatively limited number of large customers account for a significant percentage of our sales; issues that influence customer and consumer discretionary spending during periods of economic uncertainty or weakness; risks associated with foreign currency exchange rate fluctuations; challenges related to the highly competitive business environment in which we operate; our ability to develop and market innovative products that meet consumer demands and to expand into new and adjacent product categories that are experiencing higher growth rates; our ability to successfully expand our business in emerging markets and the exposure to greater financial, operational, regulatory, compliance and other risks in such markets; the continued decline in the use of certain of our products; risks associated with seasonality; the sufficiency of investment returns on pension assets, risks related to actuarial assumptions, changes in government regulations and changes in the unfunded liabilities of a multi-employer pension plan; any impairment of our intangible assets; our ability to secure, protect and maintain our intellectual property rights, and our ability to license rights from major gaming console makers and video game publishers to support our gaming accessories business; continued disruptions in the global supply chain; risks associated with inflation and other changes in the cost or availability of raw materials, transportation, labor, and other necessary supplies and services and the cost of finished goods; risks associated with outsourcing production of certain of our products, information technology systems and other administrative functions; the failure, inadequacy or interruption of our information technology systems or its supporting infrastructure; risks associated with a cybersecurity incident or information security breach, including that related to a disclosure of personally identifiable information; our ability to grow profitably through acquisitions; our ability to successfully integrate acquisitions and achieve the financial and other results anticipated at the time of acquisition, including planned synergies; risks associated with our indebtedness, including limitations imposed by restrictive covenants, our debt service obligations, and our ability to comply with financial ratios and tests; a change in or discontinuance of our stock repurchase program or the payment of dividends; product liability claims, recalls or regulatory actions; the impact of litigation or other legal proceedings; our failure to comply with applicable laws, rules and regulations and self-regulatory requirements, the costs of compliance and the impact of changes in such laws; our ability to attract and retain qualified personnel; the volatility of our stock price; risks associated with circumstances outside our control, including those caused by public health crises, such as the occurrence of contagious diseases, severe weather events, war, terrorism and other geopolitical incidents; and other risks and uncertainties described in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, and in other reports we file with the Securities and Exchange Commission.

Click to read the the full release: ACCO Brands Reports Fourth Quarter and Full Year 2023 Results and Provides Outlook for 2024

Christopher McGinnis

Investor Relations

(847) 796-4320

Kori Reed

Media Relations

(224) 501-0406

Source: ACCO Brands Corporation

AstraZeneca Completes $1.1 Billion Buyout of Seattle Biotech Icosavax

Posted on by slightbourne@noblecapitalmarkets.com

UK pharmaceutical giant AstraZeneca has finalized its $1.1 billion acquisition of Icosavax, a Seattle-based biotechnology company specializing in virus-like particle (VLP) vaccines. This buyout provides key insights into AstraZeneca’s pipeline strategy and the ongoing consolidation in the biopharma sector.

Icosavax was founded in 2017 as a spinout from the University of Washington’s Institute for Protein Design. The company leverages computationally designed VLPs to induce robust and durable immune responses against respiratory viruses, including COVID-19, respiratory syncytial virus (RSV), and human metapneumovirus (hMPV).

Since its founding, Icosavax has raised over $150 million in private funding and completed a successful IPO in 2021. However, the company caught the eye of pharma giant AstraZeneca, who sees Icosavax’s VLP platform and talented research team as a strategic fit.

For AstraZeneca, this acquisition provides access to a versatile new vaccine modality with broad applicability beyond Icosavax’s current clinical programs. It also bolsters AstraZeneca’s pipeline with a Phase 1/2 COVID-19 vaccine candidate, IVX-411, which produced robust neutralizing antibody titers in early clinical testing.

Broader Implications for Investors and the Biopharma Industry

The buyout has several key implications for biotech investors and industry dynamics. Firstly, it highlights that platform technologies with versatile applications across disease areas remain highly valued, even in the ongoing biotech market downturn. Vaccines also continue to see strong corporate interest after the pandemic spotlight.

Secondly, it reflects Big Pharma’s pursuit of emerging biotech innovation to replenish pipelines and access cutting-edge modalities like VLPs. With the Icosavax deal, AstraZeneca gains talented scientists and potential new products without costly in-house R&D.

Thirdly, from a structure standpoint, the deal provides an upfront cash payout to Icosavax investors but leaves upside through future contingent payments on pipeline advancement. This highlights a flexible model to balance the high valuations sought by biotechs with the risk management needs of acquirers.

Finally, the buyout continues the wave of consolidation between large and small biopharma players. With the market downturn squeezing biotech funding, more mergers and acquisitions are likely on the horizon. Investors should watch for other innovative biotechs with promising science that become acquisition targets.

What Drove AstraZeneca’s Interest in Icosavax

AstraZeneca has been one of the more active Big Pharmas on the M&A front, and the Icosavax deal provides strategic rationale. The VLP technology adds a promising new platform to AstraZeneca’s vaccine capabilities, already bolstered by its previous acquisitions of drug delivery player MedImmune and biotech Sobi.

Icosavax’s potential COVID-19 and RSV vaccine candidates can be added to AstraZeneca’s pipeline as it looks to expand beyond its core oncology portfolio. Additionally, Icosavax’s team and VLP engineering expertise will be valuable assets for the company.

By acquiring Icosavax while still early-stage compared to more established biopharmas, AstraZeneca secures access to the technology at a reasonable price. The $1.1 billion price tag is well below the multi-billion deals that some commercial-stage biotechs have commanded.

Overall, Icosavax represented an opportunity for AstraZeneca to obtain cutting-edge vaccine technology and talent to boost its R&D capabilities in new directions. It highlights that Big Pharmas are willing to buy innovation at early stages rather than develop it internally.

Take a moment to take a look at emerging growth healthcare and biotech companies by taking a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyers’s coverage universe

The Future for Icosavax’s Programs

While the buyout places Icosavax’s pipeline under AstraZeneca’s control, active development of the VLP programs is expected to continue. Lead COVID-19 vaccine candidate IVX-411 recently began Phase 1/2 trials, and its RSV and hMPV programs are progressing towards clinical stages as well.

AstraZeneca has expressed interest in advancing Icosavax’s full portfolio of vaccines leveraging the versatility of the VLP platform. Its resources and late-stage development expertise can help progress these experimental vaccines through clinical trials and regulatory approval pathways.

Meanwhile, Icosavax will continue operations as an AstraZeneca subsidiary based in Seattle. Keeping its operations separate allows Icosavax to retain its innovative biotech culture while benefiting from AstraZeneca’s financial backing and synergies.

In summary, AstraZeneca’s acquisition of Icosavax underscores its strategy of looking to smaller biotechs to supplement its pipeline with cutting-edge science. The deal rewards Icosavax investors for their early backing while retaining upside potential through milestone payments. For the biopharma industry, it exemplifies the ongoing consolidation between pharmas and biotechs amidst market pressures. Investors should watch for other emerging biotechs that may become tomorrow’s M&A targets.

Haynes International (HAYN) – Haynes International Shares Rise on Acquisition Announcement; Rating Lowered to Market Perform

Posted on by cpereira@noblefcm.com


Tuesday, February 06, 2024

Haynes International, Inc. is a leading developer, manufacturer and marketer of technologically advanced, nickel and cobalt-based high-performance alloys, primarily for use in the aerospace, industrial gas turbine and chemical processing industries.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Haynes to be acquired by Acerinox, S.A. Haynes International entered into a definitive agreement to be acquired in an all-cash transaction by Acerinox’s wholly owned U.S. subsidiary, North American Stainless, Inc. Acerinox is a leader in the manufacturing and distribution of stainless steel and high-performance alloys and will acquire all the outstanding shares of Haynes for $61.00 per share valuing Haynes at an enterprise value of approximately $970 million and a fully diluted equity value of $798 million. The shares are trading close to the proposed transaction price per share.

Closing is expected in the third calendar quarter. The transaction has been unanimously approved by the board of directors of both companies and is expected to close in the third calendar quarter of 2024, subject to the satisfaction of closing conditions, including receipt of regulatory approvals and approval by Haynes stockholders. Because the Haynes shareholder meeting is tentatively planned for April 2024, we think the transaction could close sooner than later.


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NAYA Biosciences Strengthens Pipeline Through Acquisition of Gene Therapy Asset

Posted on by slightbourne@noblecapitalmarkets.com

NAYA Biosciences is expanding its clinical portfolio through the acquisition of an innovative gene therapy program from Florida Biotechnologies focused on treating rare mitochondrial diseases. This binding deal demonstrates NAYA’s strategy to rapidly build pipeline assets in high-potential areas like gene therapy.

NAYA has entered into a binding letter of intent to acquire Florida Biotechnologies for $20 million in NAYA shares, with potential milestone payments up to $5 million more. The deal specifically targets Florida Biotech’s clinical-stage gene therapy for Leber’s Hereditary Optic Neuropathy (LHON).

LHON is a rare mitochondrial genetic disease leading to progressive vision loss and blindness. There are currently no approved treatments. Florida Biotech’s AAV gene therapy aims to deliver functional copies of the mutated gene to restore cellular function.

Encouraging Safety Data

This therapeutic has already demonstrated encouraging safety data in a 28-patient Phase 1 trial conducted by Florida Biotech and the University of Miami’s Bascom Palmer Eye Institute. Building on this initial study, NAYA aims to accelerate Phase 2 development and provide early access to patients.

The therapy delivers the gene of interest inside an adeno-associated virus (AAV) vector containing a mitochondrial targeting sequence. This sequence enables delivery specifically to mitochondria, the key site of pathology in LHON and many other mitochondrial diseases.

Broad Applicability

While the lead indication is LHON, NAYA highlights this approach has potential for various mitochondrial orphan diseases. The platform’s strong intellectual property covers use of different AAV capsids and routes of administration.

This flexibility and the high unmet need enables a streamlined regulatory path, including Regenerative Medicine Advanced Therapy and priority review voucher opportunities. The technology has already received over $6 million in grant funding to date.

The asset aligns with NAYA’s focus on innovative regenerative medicine approaches with near-term clinical potential. Gene therapy represents a key component of NAYA’s strategy to build a pipeline addressing major unmet needs.

Expertise in Developing Gene Therapies

NAYA has extensive in-house expertise to advance the acquired AAV gene therapy through late-stage trials toward commercialization. For example, NAYA Chief Medical Officer Dr. Fred Grossman previously led development of the first approved gene therapy, Glybera, during his time at uniQure.

Florida Biotech co-founder Dr. Peter Kash also joins NAYA’s board, bringing over 36 years of biotech leadership experience, including developing and financing gene therapy pioneer Kite Pharma. This expertise will prove valuable for unlocking the platform’s full potential.

Execution of Broader Growth Strategy

NAYA Biosciences was formed earlier in 2023 through the merger of Clinigence Holdings and 4Front Biotech. This deal created a holding company structure to facilitate pipeline expansion through additional strategic acquisitions.

The Florida Biotechnologies program represents the next step in this growth strategy. NAYA plans to continue acquiring high-potential clinical assets to build a robust portfolio spanning gene therapy, oncology, fertility and other areas.

These efforts support NAYA’s overall mission of providing patients earlier access to transformative therapies. The company aims to take an entrepreneurial approach to aggressively advance new technologies through development.

Pending Merger to Unlock Public Markets

NAYA’s deal to acquire Florida Biotechnologies is contingent upon the completion of NAYA’s previously announced merger with fertility company INVO Bioscience, expected in Q1 2024.

The merger will create a publicly traded life sciences company under the INVO name, providing access to capital to support NAYA’s development programs and commercialization. The combined company is valued at over $100 million.

Conclusion

In summary, NAYA Bioscience’s move to acquire Florida Biotechnologies’ AAV gene therapy strengthens its pipeline and aligns with its strategy to focus on high-potential clinical assets. Leveraging its development expertise, NAYA is positioned to accelerate this innovative therapy toward commercialization and fill an important unmet need for patients with mitochondrial diseases.