From Crypto to Computing: Bit Digital’s AI Pivot Pays Off Big

In a move that’s turning heads on Wall Street, Bit Digital (Nasdaq: BTBT) is doubling down on its artificial intelligence infrastructure play. The New York-based company, once primarily known for its cryptocurrency mining operations, has just inked a deal that could redefine its future – and potentially reshape the landscape of AI computing services.

On June 25, 2024, Bit Digital announced the expansion of a contract with a major high-performance computing customer. The numbers are eye-popping: an additional 2,048 GPUs, bringing the total to 4,096, with a contract value of approximately $275 million over three years. That’s $92 million annually, for those keeping score at home.

But what’s really intriguing here isn’t just the scale of the deal – it’s what it represents. Bit Digital is making a calculated pivot, leveraging its expertise in managing complex computing operations to carve out a niche in the booming AI infrastructure market. And they’re doing it with gusto.

The company isn’t just talking a big game; they’re putting their money where their mouth is. They’ve placed an order for 256 servers from Dell Technologies, packed with Nvidia’s coveted HGX H100 GPUs. These aren’t your run-of-the-mill graphics cards; they’re the cream of the crop for AI computations, and Bit Digital is betting big on their potential.

What’s particularly savvy about this move is how Bit Digital is financing it. They’re using a mix of cash, digital assets, and a sale-leaseback agreement for half of the new GPUs. This financial juggling act demonstrates a level of fiscal acumen that should pique the interest of potential investors. It’s a strategy that minimizes upfront capital requirements while maximizing potential returns – music to any investor’s ears.

But here’s where it gets really interesting: this deal puts Bit Digital tantalizingly close to its goal of a $100 million annualized revenue run-rate by the end of 2024. They’re now sitting at over 90% of that target. For a company that was once primarily focused on bitcoin mining, this represents a remarkable transformation.

CEO Sam Tabar’s comments suggest this is just the beginning. He’s talking about “robust growth trajectory” and “scaling even further as the year progresses.” It’s the kind of optimistic language that makes investors’ ears perk up, especially when it’s backed by concrete deals like this one.

Of course, it’s not all smooth sailing. The AI infrastructure market is heating up, with tech giants and startups alike vying for a piece of the pie. Bit Digital will need to leverage its first-mover advantage and continue to execute flawlessly to maintain its edge.

Investors keen on getting more details won’t have to wait long. Bit Digital is slated to present at the Noble Capital Markets Consumer/TMT Virtual Conference this week. It’s an opportunity to hear directly from the company’s leadership about their strategy and future prospects.

As the lines between cryptocurrency, blockchain, and AI continue to blur, companies like Bit Digital are positioning themselves at the intersection of these transformative technologies. Their ability to pivot from crypto mining to AI infrastructure demonstrates an agility that could serve them well in the fast-paced tech sector.

For investors, Bit Digital represents an intriguing proposition. It’s a company with roots in the volatile world of cryptocurrency that’s now making significant inroads into the AI boom. As the demand for AI computing resources continues to skyrocket, Bit Digital’s bold moves could position them as a key player in this burgeoning field.

While the risks inherent in such a rapidly evolving sector shouldn’t be overlooked, Bit Digital’s recent contract win and ambitious revenue targets suggest a company that’s not just adapting to change, but actively shaping it. As always, potential investors should do their due diligence, but for those looking to ride the AI wave, Bit Digital is certainly a company worth watching.

Economic Headwinds: Labor Market Softens and Housing Sector Cools

Recent economic reports suggest that the U.S. economy may be facing increasing headwinds, with signs of softening in both the labor market and housing sector. These indicators point to a moderation in economic activity for the second quarter of 2024, potentially setting the stage for a shift in Federal Reserve policy later this year.

The Labor Department reported that initial jobless claims for the week ended June 15 fell by 5,000 to a seasonally adjusted 238,000. While this represents a slight improvement from the previous week’s 10-month high, it only partially reverses the recent upward trend. More tellingly, the four-week moving average of claims, which smooths out weekly volatility, rose to 232,750 – the highest level since mid-September 2023.

Adding to concerns about the labor market, continuing unemployment claims edged up to 1.828 million for the week ending June 8, marking the highest level since January. This uptick in ongoing claims could indicate that laid-off workers are facing increased difficulties in finding new employment, a potential red flag for overall job market health.

The unemployment rate, which rose to 4.0% in May for the first time since January 2022, further underscores the gradual cooling of the labor market. While job growth did accelerate in May, some economists caution that this may overstate the true robustness of employment conditions.

Turning to the housing sector, the news is equally sobering. The Commerce Department reported that housing starts plummeted 5.5% in May to a seasonally adjusted annual rate of 1.277 million units – the lowest level since June 2020. This decline was even more pronounced in the critical single-family housing segment, which saw starts fall 5.2% to a rate of 982,000 units, the lowest since October 2023.

The slowdown in housing construction is mirrored by a drop in building permits, often seen as a leading indicator for future construction activity. Permits for new housing projects tumbled 3.8% in May, again reaching levels not seen since June 2020. This decline in both current and future building activity paints a concerning picture for the housing market’s near-term prospects.

Several factors appear to be contributing to the housing sector’s struggles. Mortgage rates have seen significant volatility, with the average 30-year fixed rate reaching a six-month high of 7.22% in early May before retreating slightly. These elevated borrowing costs are keeping many potential buyers on the sidelines, as noted by the National Association of Home Builders, which reported that homebuilder confidence hit a six-month low in June.

The combination of a softening labor market and a cooling housing sector has led some economists to revise their growth projections downward. Goldman Sachs, for instance, has pared back its GDP growth estimate for the second quarter to a 1.9% annualized rate, down from an earlier projection of 2.0%.

These economic indicators are likely to factor heavily into the Federal Reserve’s decision-making process in the coming months. Despite the Fed’s more hawkish stance at its recent meeting, where officials projected just one quarter-point rate cut for this year, financial markets are anticipating the possibility of multiple rate cuts. The latest data may bolster the case for monetary easing, with some economists now seeing the potential for an initial rate cut as early as September.

Many economists believe that the soft activity and labor market data reinforce expectations for the Fed to begin cutting interest rates in the coming months, with potential cuts in September and December being discussed.

While the U.S. economy continues to show resilience in many areas, the emerging signs of moderation in both the labor and housing markets suggest that the impact of higher interest rates is beginning to be felt more broadly. As we move into the second half of 2024, all eyes will be on incoming economic data and the Federal Reserve’s response to these evolving conditions. The delicate balance between managing inflation and supporting economic growth remains a key challenge for policymakers in the months ahead.

The confluence of a cooling job market and a struggling housing sector paints a picture of an economy at a crossroads. As these trends continue to develop, they will likely play a crucial role in shaping both economic policy and market expectations for the remainder of the year and beyond.

Trump Media’s Truth Social Faces Market Turmoil as Shares Plummet

The digital media landscape is witnessing a dramatic shakeup as Trump Media & Technology Group, the company behind the conservative social network Truth Social, experiences a sharp decline in its stock value. The Nasdaq-listed company, trading under the ticker DJT, has seen its shares plummet by over 40% since early June, opening at a mere $27 per share on Thursday. This downturn has sent shockwaves through the social media stock market, raising questions about the future of alternative platforms in an increasingly competitive digital ecosystem.

The sell-off intensified Thursday, with shares sinking as much as 15% shortly after the opening bell, continuing a trend that has wiped billions from the company’s market capitalization. This steep decline has had a profound impact on the paper wealth of former President Donald Trump, the majority stakeholder in the company. Trump’s 114,750,000 shares, once valued at over $5.6 billion in early June, have now plummeted to around $3.2 billion – a staggering loss of approximately $2.4 billion in less than a month.

The catalyst for this market turbulence appears to be rooted in recent legal developments. The company’s stock began its downward spiral on May 30, coinciding with a New York jury’s decision to convict the former president on 34 felony counts of falsifying business records. This legal setback has evidently shaken investor confidence, highlighting the potential risks associated with companies closely tied to controversial public figures.

Adding to the tumult, Trump Media recently reached a crucial milestone in its regulatory journey. The Securities and Exchange Commission (SEC) declared the company’s registration statement effective, a development that triggered significant market reaction. The stock fell nearly 10% during Tuesday’s trading session on more than double the average volume, followed by a further 17% plunge in after-hours trading following the announcement.

This SEC approval marks a pivotal moment for Trump Media, authorizing early investors to exercise warrants and allowing stockholders to publicly resell securities covered by the registration statement. While this development provides greater liquidity for existing shareholders, it also introduces the potential for increased selling pressure, which could further impact the stock’s performance.

The volatility surrounding Trump Media serves as a case study in the challenges faced by emerging social media platforms as they navigate the complex interplay of market forces, regulatory requirements, and public perception. As the digital advertising landscape continues to evolve, investors and industry observers are closely watching how alternative social networks like Truth Social can carve out their niche and sustain growth in a highly competitive market.

The unfolding situation at Trump Media also underscores the importance of diversification in investment portfolios, particularly when dealing with stocks tied to high-profile individuals or emerging technologies. As the company strives to weather this storm, its ability to adapt to changing market conditions and demonstrate sustainable user growth will be crucial in regaining investor confidence.

In the broader context of social media innovation and digital marketing trends, the Trump Media saga highlights the ongoing shifts in online engagement and content monetization strategies. As users increasingly seek out niche platforms that align with their values and interests, the success of companies like Trump Media may hinge on their ability to foster engaged communities while navigating the complex regulatory and financial landscapes of the modern digital economy.

As this story continues to develop, it will undoubtedly remain a focal point for those interested in the intersection of technology, politics, and finance, offering valuable insights into the future of social media entrepreneurship and the challenges of building sustainable digital platforms in today’s rapidly changing online environment.

Release – Tonix Pharmaceuticals Presented Poster of Tonmya™ for the Management of Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2024

Research News and Market Data on TNXP

June 17, 2024 8:00am EDT

Treatment with Tonmya™ (TNX-102 SL, sublingual cyclobenzaprine HCl) in Phase 3 RESILIENT study significantly reduced daily pain and demonstrated broad fibromyalgia symptom improvement, as demonstrated by significant improvement on the primary pain endpoint and on all six key secondary endpoints

RESILIENT was the second Phase 3 study to reach statistical significance on the primary endpoint

New Drug Application (NDA) submission to the FDA on track for the second half of 2024

CHATHAM, N.J., June 17, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data from a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2024, held June 12-15, 2024 at the Messe Wien Congress Center in Vienna, Austria. A copy of the Company’s poster presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

In the poster presentation titled, “Targeting Non-Restorative Sleep in Fibromyalgia with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) Significantly Improves Pain in RESILIENT, a Confirmatory Phase 3 Randomized Clinical Trial”, Tonyma met the pre-specified primary endpoint in the Phase 3 RESILIENT trial, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia while also demonstrating broad syndromal improvement. Tonmya demonstrated statistically significant improvement in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. Tonmya was well tolerated with an adverse event (AE) profile comparable to prior studies and no new safety signals observed.

In pre-specified exploratory analyses, Tonmya treatment also improved depressive symptoms measured by the Beck Depression Inventory and improved female sexual function by the Changes in Sexual Function Questionnaire in the RESILIENT trial.

“People suffering with fibromyalgia tend to struggle with daily activities, have impaired quality of life and are frequently disabled, said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe the activity of Tonmya on pain, sleep quality, fatigue cognitive dysfunction, and depression are indicative of the broad-spectrum activity of Tonmya, suggesting Tonmya treats fibromyalgia at a syndromal level. We are excited by the prospect of offering this patient population its potential first new therapy option in more than a decade.”

Tonix remains on track to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and is in Phase 2 development supported by a grant from the National institute of Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 17, 2024

Homebuyers Face Ongoing Affordability Challenges Despite Slight Mortgage Rate Dip

The mortgage market has seen a slight reprieve this week, with average rates on a 30-year fixed mortgage dipping just below 7%. According to Freddie Mac, the average rate has decreased to 6.95% from 6.99% the previous week. However, for many prospective homebuyers, this minor drop may not be enough to make a significant difference in affordability.

Freddie Mac’s report on Thursday highlights a small but noteworthy dip in mortgage rates. A separate measure tracking daily averages by Mortgage News Daily shows fluctuations between 6.97% and 7.17% over the past week. Despite this slight decline, the rates remain relatively high compared to historical lows, creating challenges for budget-conscious homebuyers.

The Federal Reserve’s policies continue to play a crucial role in shaping mortgage rates. Recently, the Fed decided to hold the benchmark rates steady at 5.25% to 5.50%, signaling only one rate cut for the rest of the year. This decision suggests that any substantial decline in mortgage rates is unlikely in the near future. The Fed’s cautious approach indicates that significant rate drops might not occur until well into 2025.

A recent study indicates that a majority of homebuyers, particularly first-time buyers, need significantly lower rates before they feel confident returning to the market. Ralph McLaughlin, Realtor.com’s senior economist, emphasizes that for inventory-constrained buyers, current mortgage trends will likely maintain the “mortgage rate lock-in effect.” This effect, where homeowners are reluctant to sell and buy new homes at higher rates, is expected to persist until at least the end of the year.

The latest inflation data has shown signs of moderation, with the core Consumer Price Index (CPI) excluding food and energy costs, climbing just 0.2% monthly in May—the lowest since last June. Overall inflation has decelerated year-over-year compared to April. While this news initially caused a dip in mortgage rates, the Fed’s subsequent announcement to hold rates steady tempered this effect. The Fed now projects one rate cut for the rest of the year, a reduction from previous expectations.

Fannie Mae’s homebuyer sentiment survey from May reveals that only one in four Americans expect mortgage rates to decrease over the next 12 months. In contrast, more than 30% of respondents anticipate that rates will rise. This sentiment has led to a new low in consumer confidence, driven by the overall lack of purchase affordability.

Despite current challenges, there is a glimmer of hope on the horizon for homebuyers. Economists at Bank of America Global Research predict multiple rate cuts over the next 24 months—four in 2025 and two in 2026. These cuts, in increments of 25 basis points, could bring rates down to between 3.50% and 3.75% by 2026. This long-term outlook provides a potential path to more affordable mortgage rates, but significant declines in the short term remain unlikely.

Last week saw a brief surge in mortgage application volume, increasing by 16% according to the Mortgage Bankers Association. This surge was primarily driven by a short-lived drop in daily rates, which hovered near 7%. New mortgage applications increased by 9%, though they remain 12% lower than the same week last year. Refinancing activity also saw a notable increase of 28% week-over-week, particularly among VA borrowers who took advantage of the lower rates.

At the current average rate of 6.95%, a homebuyer would pay approximately $1,600 monthly on a $300,000 home with a 20% down payment, according to the Yahoo Finance mortgage calculator. This cost highlights the ongoing challenge of affordability for many potential buyers.

While the slight dip in mortgage rates below 7% offers a small reprieve for homebuyers, significant declines are still months away. The Federal Reserve’s cautious approach, coupled with persistent inflation concerns, suggests that substantial rate reductions are unlikely until 2025. Homebuyers must navigate these challenges with careful planning and realistic expectations, while keeping an eye on long-term trends that may eventually bring relief.

Noble Corporation Acquiring Diamond Offshore in $3.6 Billion Deal

In a blockbuster transaction in the offshore drilling sector, Noble Corporation plc (NYSE:NE) announced today that it has agreed to acquire Diamond Offshore Drilling, Inc. (NYSE:DO) in an all-stock and cash deal valued at $3.6 billion. The combination will create one of the largest offshore drilling contractors, with a massive fleet and diverse global footprint.

Deal Terms
Under the agreement, Diamond Offshore shareholders will receive 0.2316 shares of Noble stock plus $5.65 in cash for each Diamond share they own. This represents an 11.4% premium over Diamond’s closing share price on June 7th. Upon closing, Diamond shareholders will own approximately 14.5% of the combined company.

Noble has secured $600 million in committed bridge financing to fund the cash portion of the deal. One member of Diamond’s board will join Noble’s expanded board once the transaction is completed.

Strategic Rationale
This transaction brings together two leading offshore drillers with complementary capabilities and customer bases. The combined company will boast an impressive fleet of 41 rigs, including 28 floaters and 13 jackups, with a $6.5 billion backlog providing strong revenue visibility.

Of particular note, Noble will acquire four of Diamond’s 7th generation ultra-deepwater drillships along with the harsh environment semi-submersible Ocean GreatWhite. These high-spec assets augment Noble’s already formidable ultra-deepwater fleet, cementing its pole position as the leader in this critical offshore segment.

On the other side, Noble brings additional scale in jackup rigs and geographic diversity. The companies cited synergy opportunities around operational excellence, safety culture, and customer relationships as key strategic benefits.

Noble management forecast at least $100 million in annual cost synergies, with 75% achieved within a year of closing. The deal is expected to be immediately accretive to Noble’s free cash flow per share.

Return of Capital Emphasis
Illustrating the combined company’s commitment to shareholder returns, Noble’s board approved a 25% increase to its quarterly dividend to $0.50 per share starting in Q3 2024. This represents an annualized dividend of $2.00 per share.

Noble has prioritized generous capital returns in recent years as offshore drilling activity and dayrates have recovered. With enhanced scale, efficiencies and cash flow from this acquisition, Noble is well-positioned to continue growing its dividend over time.

Management Comments
“This acquisition enables Noble to continue our journey of delivering superior innovation and value to a broad range of the leading offshore operators across the world,” stated Noble CEO Robert Eifler. He highlighted the drillship additions and accretion to free cash flow as key drivers.

Diamond CEO Bernie Wolford noted “This combination is an ideal outcome that provides Diamond shareholders both immediate and long-term upside potential as part of a more fully scaled platform that can deliver customer and shareholder value on a through-cycle basis.”

Neal Goldman, Chairman of Diamond, added “We have created tremendous value for our shareholders and customers that has culminated in a strategic merger that will continue to add value for all.”

Path to Completion
The deal is subject to customary closing conditions including regulatory approvals and a vote of Diamond’s shareholders. It is expected to close by Q1 2025 after securing the necessary approvals.

With the financial incentive of an 11.4% premium, supportive comments from leadership, and strategic benefits like increased scale and cost synergies, this transaction has a high likelihood of being consummated as proposed in the coming months.

V2X (VVX) – Capital Structure Enhancement


Tuesday, June 04, 2024

For more than 70 years, Vectrus has provided critical mission support for our customers’ toughest operational challenges. As a high-performing organization with exceptional talent, deep domain knowledge, a history of long-term customer relationships, and groundbreaking technical expertise, we deliver innovative, mission-matched solutions for our military and government customers worldwide. Whether it’s base operations support, supply chain and logistics, IT mission support, engineering and digital integration, security, or maintenance, repair and overhaul, our customers count on us for on-target solutions that increase efficiency, reduce costs, improve readiness, and strengthen national security. Vectrus is headquartered in Colorado Springs, Colo., and includes about 8,100 employees spanning 205 locations in 28 countries. In 2021, Vectrus generated sales of $1.8 billion. For more information, visit the company’s website at www.vectrus.com or connect with Vectrus on Facebook, Twitter, and LinkedIn.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Repricing and Extension. Yesterday, V2X announced a repricing and extension of its $907 million First Lien term loan. The actions are another step by management to enhance the capital structure, in our view, and should lead to lower interest costs and additional financial flexibility.

Details. Under the repricing, the annual interest margin was reduced by 50 basis points to 2.75%. Additionally, the 10-basis point credit spread adjustment was eliminated from the Company’s Secured Overnight Financing Rate, further improving the anticipated savings from the repricing. The company also extended the maturity of the loan by two years to December 2030.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*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 – Unicycive Therapeutics Presents Bioequivalence Data On Oxylanthanum Carbonate (OLC) At The National Kidney Foundation Spring Clinical Meeting

Research News and Market Data on UNCY

Unicycive Therapeutics Presents Bioequivalence Data On Oxylanthanum Carbonate (OLC) At The National Kidney Foundation Spring Clinical Meeting

May 15, 2024 7:03am EDT Download as PDF

– OLC Demonstrates Bioequivalence to Lanthanum Carbonate –

– Additional Poster Highlights Key Features of OLC as Perceived by Renal Dieticians –

LOS ALTOS, Calif., May 15, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that two posters related to the Company’s lead product candidate, oxylanthanum carbonate (OLC), were presented at the National Kidney Foundation (NKF) Spring Clinical Meeting. OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD).

“The NKF Spring Clinical Meeting was an important meeting for Unicycive as we were able to present data from the OLC bioequivalence study and our second poster was featured as a top-rated submission,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Phosphate binders are integral to the management of hyperphosphatemia in patients with CKD and their effectiveness is adversely affected by non-adherence and limitations of phosphate binding capacity relative to dietary intake. Our data confirms that OLC is bioequivalent to lanthanum carbonate (LC) by showing similar outcomes in both groups with respect to mean change in urinary phosphate excretion. Importantly, OLC demonstrated a well-tolerated safety profile with no serious adverse events. This data is important as it serves as one of the key components for our New Drug Application filing with the FDA under the 505(b)(2) regulatory pathway.”

Dr. Gupta, concluded, “We are grateful to Dr. Hill Gallant who delivered a poster presentation on a survey of renal dieticians who play a critical role in helping patients manage serum phosphate and are close witnesses to patients’ experiences and challenges with phosphate management. The findings of the survey concluded that strategies that reduce pill burden and increase ease of use for patients are needed, reinforcing our belief that, if approved, the characteristics of OLC including the reduction of pill volume may increase compliance and improve the quality of life for patients living with this condition.”

Presentation Details:

Title: Two-Way Crossover Study to Establish Pharmacodynamic Bioequivalence Between Oxylanthanum Carbonate and Lanthanum Carbonate
Lead Author: Vandana Mathur, MD
Results: The poster presentation described the results of the randomized, crossover bioequivalence study comparing OLC with lanthanum carbonate (LC). The study was a Phase 1, single-center, randomized 1:1, open-label, controlled, 2-way crossover study designed to demonstrate the pharmacodynamic (PD) equivalence between two phosphate binders: orally administered OLC as compared to LC. Both treatments were administered at doses of one 1000 mcg tablet three-times-a-day (TID) in healthy volunteers who received the same standardized meals to control for daily phosphate intake. OLC tablets are swallowed whole as opposed to the LC tablets that must be chewed completely. The study consisted of a screening period, two dosing periods separated by a 14-day washout period, and a follow-up period 7 days after last study drug dose. The primary PD variable was Least Squares (LS) mean change in urinary phosphate excretion from baseline (48hrs prior to dosing) to Evaluation Period (Days 1-3). The baseline characteristics were balanced between OLC/LC and LC/OLC sequences. LS mean change from baseline for OLC (-320.4mg/day) was similar to the LS mean change from BL for LC (-324.0mg/day). The 90% confidence interval for the LS mean change in urinary phosphate excretion from baseline (test-reference) was (-37.83, 45.12), which was entirely contained within the predefined ±20% acceptance range of (-64.80, 64,80). There were no serious adverse events (SAEs) and no treatment discontinuations. The incidence of treatment-emergent adverse events (TEAEs) and related AEs were also the same in both groups at 35% and 25%, respectively.

Title: Renal Dietitians Perceive Phosphate Binder and Low-Phosphate Diet Non-Compliance as Top Reasons for Above Target Serum Phosphorous Concentrations
Lead Author: Kathleen Hill Gallant, PhD, RD
Results: The poster presentation delivers results of a recent dietitian survey evaluating perceived reasons for noncompliance to phosphate binder (PB) therapy and identifies the most appealing potential aspects of OLC. The poster concluded that strategies that reduce pill burden and increase ease of use for patients may promote PB treatment compliance, which may improve patient outcomes. OLC, which is a smaller tablet that can be swallowed whole without chewing, may address compliance issues seen with current PBs. In fact, 47% of dieticians noted the high perceived potency of OLC and 34% noted its perceived lower number of pills required as the most appealing aspects of OLC.

Recent studies reported PB non-adherence rates of up to 78% in patients with end-stage kidney disease on dialysis. For the analysis, 100 renal dietitians were surveyed and there were several key findings. The most common reasons for phosphate levels above the target range were non-compliance to PB prescription (36%) or low phosphate diet (34%). The two leading reasons for PB discontinuation were too many pills and formulation issues. One-third of dietitians attributed non-compliance with patients forgetting to take their PBs with meals or snacks and 16% attributed it to high pill burden.

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established.

Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Released May 15, 2024

Release – Graham Corporation Announces Filing of Universal Shelf Registration Statement

Research News and Market Data on GHM

BATAVIA, N.Y.–(BUSINESS WIRE)– Graham Corporation (NYSE: GHM) (“GHM” or “the Company”), a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy, and process industries, announced today that it has filed a universal shelf registration statement on Form S-3 with the Securities and Exchange Commission (SEC). If and when the shelf registration is declared effective, it will permit the Company to offer and sell, from time to time in one or more offerings, up to $150 million of common stock, preferred stock, warrants, purchase contracts, units, or any combination of these securities.

Christopher J. Thome, Chief Financial Officer, commented, “We believe a shelf registration is a demonstration of good corporate governance as it provides GHM with enhanced financial flexibility to meet our long-term strategic goals. It enables us to access the capital markets quickly and efficiently, if and when favorable conditions align for the Company and our shareholders.”

Should the Company decide to raise capital in a future offering using the shelf registration statement, GHM will describe the specific details of that future offering in a prospectus supplement that is filed with the SEC.

The registration statement on Form S-3 has been filed with the SEC but is not yet effective. These securities may not be sold nor may offers to buy be accepted under the Form S-3 registration statement prior to the time the Form S-3 registration statement becomes effective. This News release shall not constitute an offer to sell nor the solicitation of an offer to buy the securities that are proposed to be registered on the Form S-3, nor shall there be any sale of such securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of any such state.

About Graham Corporation

GHM is a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy, and process industries. The Graham Manufacturing and Barber-Nichols’ global brands are built upon world-renowned engineering expertise in vacuum and heat transfer, cryogenic pumps, and turbomachinery technologies, as well as its responsive and flexible service and the unsurpassed quality customers have come to expect from the Company’s products and systems. Graham Corporation routinely posts news and other important information on its website, grahamcorp.com, where additional information on Graham Corporation and its businesses can be found.

Safe Harbor Regarding Forward Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.

Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “believe,” “if,” “when,” “intended,” “should,” ”may”, “will,” and other similar words and include all statements with respect to the Company’s plans and expectations regarding its registration statement on Form S-3 and any potential future offering or capital raises and the use of proceeds therefrom. Because they are forward-looking, they should be evaluated in light of important risk factors and uncertainties. These risk factors and uncertainties are more fully described in Graham Corporation’s most recent Annual Report filed with the Securities and Exchange Commission (the “SEC”), included under the heading entitled “Risk Factors”, and in other reports filed with the SEC.

Should one or more of these risks or uncertainties materialize or should any of Graham Corporation’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on Graham Corporation’s forward-looking statements. Except as required by law, Graham Corporation disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this news release.

For more information, contact:
Christopher J. Thome
Vice President – Finance and CFO
Phone: (585) 343-2216

Deborah K. Pawlowski
Kei Advisors LLC
Phone: (716) 843-3908
dpawlowski@keiadvisors.com

Source: Graham Corporation

Released May 13, 2024

Release – Orion Group Holdings Announces Significant Contract Award for Port Everglades Bulkhead Replacement Project

Research News and Market Data on ORN

HOUSTON, May 09, 2024 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (the “Company”), a leading specialty construction company, today announced a significant contract award valued at nearly $80 million for its Marine construction business. The contract was awarded by Port Everglades Seaport Engineering & Construction Division through Moss Construction as Managing General Contractor for the Port Everglades Bulkhead Replacement Project – Group 1, a pivotal infrastructure upgrade at one of the nation’s busiest ports. Orion has supported Port Everglades and worked with Moss successfully on previous projects.

Orion Group Holdings won the Port Everglades Bulkhead Replacement Project award through a competitive bid process. The scope of work includes the replacement of approximately 2,240 linear feet of aging steel sheet pile bulkheads, including large diameter combi-wall systems, soil anchors and encapsulated concrete caps. In addition, the project will address the aging North Bulkhead at the Entrance Channel (NBEC), which spans 1,200 feet and is vital for the safe and smooth flow of maritime traffic. The project is set to commence June 1 and will conclude in late 2026.

“We are excited to continue our relationship with Moss and the Port Everglades Seaport Engineering & Construction Division by delivering this critical marine project that will modernize and strengthen the Port’s capabilities. With our deep marine construction expertise, we look forward to supporting port business into the future,” said Travis Boone, Chief Executive Officer of Orion Group Holdings, Inc. “This project not only reinforces our commitment to maintaining the highest standards of maritime infrastructure but also ensures Port Everglades continues to serve as a critical hub for the world-class cruise industry and the growing international cargo and petroleum business.”

Orion Group Holdings, Inc. is a renowned name in specialty construction, known for its dedication to safety, quality, innovation, and timely project execution. With these new contract awards, Orion continues to strengthen its position as an industry leader capable of tackling complex projects with unmatched expertise.

About Orion Group Holdings

Orion Group Holdings, Inc., a leading specialty construction company serving the infrastructure, industrial and building sectors, provides services both on and off the water in the continental United States, Alaska, Hawaii, Canada and the Caribbean Basin through its marine segment and its concrete segment. The Company’s marine segment provides construction and dredging services relating to marine transportation facility construction, marine pipeline construction, marine environmental structures, dredging of waterways, channels and ports, environmental dredging, design and specialty services. Its concrete segment provides turnkey concrete construction services including place and finish, site prep, layout, forming, and rebar placement for large commercial, structural and other associated business areas. The Company is headquartered in Houston, Texas with regional offices throughout its operating areas. The Company’s website is located at: https://www.oriongroupholdingsinc.com.

Forward-Looking Statements

The matters discussed in this press release may constitute or include projections or other forward-looking statements within the meaning of the “safe harbor” provisions of Section 27A of the Securities Exchange Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, of which provisions the Company is availing itself. Certain forward-looking statements can be identified by the use of forward-looking terminology, such as ‘believes’, ‘expects’, ‘may’, ‘will’, ‘could’, ‘should’, ‘seeks’, ‘approximately’, ‘intends’, ‘plans’, ‘estimates’, or ‘anticipates’, or the negative thereof or other comparable terminology, or by discussions of strategy, plans, objectives, intentions, estimates, forecasts, outlook, assumptions, or goals. In particular, statements regarding future operations or results, including those set forth in this press release, and any other statement, express or implied, concerning future operating results or the future generation of or ability to generate revenues, income, net income, gross profit, EBITDA, Adjusted EBITDA, Adjusted EBITDA margin, or cash flow, including to service debt or maintain compliance with debt covenants, and including any estimates, forecasts or assumptions regarding future revenues or revenue growth, are forward-looking statements. Forward-looking statements also include project award announcements, estimated project start dates, anticipated revenues, and contract options which may or may not be awarded in the future. Forward-looking statements involve risks, including those associated with the Company’s fixed price contracts that impacts profits, unforeseen productivity delays that may alter the final profitability of the contract, cancellation of the contract by the customer for unforeseen reasons, delays or decreases in funding by the customer, levels and predictability of government funding or other governmental budgetary constraints, and any potential contract options which may or may not be awarded in the future, and are at the sole discretion of award by the customer. Past performance is not necessarily an indicator of future results. Considering these and other uncertainties, the inclusion of forward-looking statements in this press release should not be regarded as a representation by the Company that the Company’s plans, estimates, forecasts, goals, intentions, or objectives will be achieved or realized. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update information contained in this press release whether as a result of new developments or otherwise, except as required by law.

Please refer to the Company’s 2023 Annual Report on Form 10-K, filed on March 1, 2024 which is available on its website at www.oriongroupholdingsinc.com or at the SEC’s website at www.sec.gov, for additional and more detailed discussion of risk factors that could cause actual results to differ materially from our current expectations, estimates or forecasts.

Contacts:

Financial Profiles, Inc.
Margaret Boyce 310-622-8247
orn@finprofiles.com 

The Rise of PIPEs in the Biotech World

For biotech companies operating in the small and micro-cap arena, access to capital can often be the difference between make or break. Developing cutting-edge therapies is an expensive endeavor, with clinical trials alone costing millions. When equity markets turn volatile, these small players can find themselves in a funding crunch that stalls or derails their most promising innovations.

This dilemma has led to a surge in an alternative financing technique known as the PIPE – a private investment in public equity. PIPEs allow select investors to directly purchase shares or convertible securities from a public biotech company at a discounted price in a private placement. In exchange, these investors gain access to highly coveted non-public information like interim clinical trial data or study results before they hit the mainstream.

The allure is obvious – getting an early peek under the hood allows “PIPE investors” to make educated bets on a company’s prospects ahead of any market-moving news releases. If the confidential data looks promising, they can stock up on discounted shares before the positive study results send the share price shooting upwards.

For the issuing biotech, a PIPE deal solves a dire cash crunch while attracting buy-in from reputable healthcare funds who often have existing holdings. It’s a win-win that has fueled a PIPE boom, with U.S. biotechs raising a record $5.7 billion through these private placements in Q1 2024 alone according to Jefferies data.

However, this lucrative trend is also igniting a raging controversy. The investing community is deeply divided between those with a rarefied seat at the PIPE table, and those feeling deprived of a chance at the same insight and opportunities.

On one side are specialist healthcare funds like Adage Capital, Logos Capital, and EcoR1 which have made PIPEs their bread-and-butter. They argue the confidential data access merely levels the playing field, as professional biotech investors already do rigorous public-sourced analyses that give them an edge over casual investors.

“You have companies spending years running clinical trials, taking huge risks to develop these drugs for patients. PIPEs give them a fighting chance to meet funding needs when equity markets turn hostile,” says Oleg Nodelman of EcoR1. “It’s better than watching all that work disintegrate.”

Opposing them are generalist investors and even some biotech CEOs who decry PIPEs as sanctioned insider trading that unfairly favors an elite group. Sounding the loudest alarms are those burned by buying into hyped PIPEs only to see outsized stock gains instantly materialize for PIPE investors.

“There are instances where stocks rallied over 40% the day positive PIPE data was announced,” notes Daphne Zohar, CEO of Seaport Therapeutics, who avoids PIPEs. “These lopsided deals make generalist investors feel the deck is stacked against them.”

The controversy deepened when an investor sued Taysha Gene Therapies in April, alleging company leaders strategically timed disclosures alongside a $150 million PIPE to maximize profits for an inner circle before share prices spiked.

As PIPEs proliferate from niche deals into a $5 billion-plus financing pipeline, stakes are rising for all sides. Furious retail investors have even conjectured PIPEs could enable “shadow trading” – using confidential data about one company’s study to invest in an unrelated competitor ahead of public releases.

While merely allegations now, any concrete evidence of foul play could precipitate a harsh regulatory crackdown to ensure fair markets. Already some PIPEs have seen muted stock bounces as news travels faster about these non-public data disclosures.

For now, cash-strapped biotechs seem willing to accept the criticism as a worthwhile price to pay for crucial growth capital. PIPE defenders argue if disclosure rules are followed, there’s no meaningful distinction between benefiting from non-public information as an investor versus as a biotech executive or regulator with early trial data access.

Only time will tell if the alluring but contentious PIPE well runs dry from overuse and regulatory scrutiny. But in today’s turbulent climate, it offers a vital lifeline to biotech innovators facing turbulent public capital currents. Just be prepared to defend your stake in this high-stakes game of data-driven musical chairs.

Take a moment to take a look at some emerging growth biotech companies, by looking at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage list.

Blockbuster Music Rights Deal: Blackstone Outbids Concord for Hipgnosis Songs

In a major shakeup in the booming music rights acquisition space, private equity giant Blackstone has emerged victorious in a heated bidding war to acquire Hipgnosis Songs Fund, trumping an earlier offer from music company Concord.

The deal, valued at around $1.57 billion, sees Blackstone acquiring the prized music rights portfolio of Hipgnosis, which holds over 65,000 songs from iconic artists like Shakira, Red Hot Chili Peppers, Blondie, and Neil Young. Blackstone’s superior cash offer of $1.30 per share outmaneuvered Concord’s bid of $1.25 per share, which had previously received the backing of Hipgnosis’ board. However, the board has now withdrawn its recommendation in favor of Blackstone’s higher bid.

The transaction represents a significant expansion of Blackstone’s already formidable music rights holdings. The private equity titan has been aggressively building its intellectual property portfolio, with existing assets including hit songs from superstars like Justin Bieber, Justin Timberlake, and performance rights organization SESAC, which boasts affiliates like Bob Dylan and Adele.

The Hipgnosis acquisition also sets the stage for an insightful discussion at Noble Capital Markets’ upcoming Consumer, Communications, Media and Technology Virtual Conference in June. Hosted by leading industry analysts, the conference will provide a comprehensive look at the latest trends, challenges, and opportunities shaping the dynamic technology, media, and telecom landscape. With disruptive forces like streaming, 5G, and AI reshaping multiple industries, analysts are eager to examine the strategic implications and growth avenues for major players across this critical sector. The music rights boom will undoubtedly be a key topic of discussion, but the conference aims to deliver a holistic perspective on the evolving TMT ecosystem.

As the dust settles on this blockbuster deal, all eyes will be on Blackstone’s next strategic moves in the world of music IP. With its substantial resources and existing portfolio, the private equity titan is well-positioned to further consolidate its dominance in this lucrative arena. The company’s aggressive pursuit of Hipgnosis signals its belief in the long-term value and growth potential of iconic musical works as the industry continues its shift towards streaming platforms and new content consumption models emerge.

Direct Digital Holdings (DRCT) – Marcum Gives A Bad Impression


Wednesday, April 24, 2024

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.

Non-compliance notice. On April 17 the company was not able to file its 10-K on time, and, subsequently, received a notification of non-compliance from NASDAQ. Notably, the company has 30 days to submit an actionable plan to regain compliance. Importantly, the failure to file its 10-K on time was attributed to the inability of  its auditor, Marcum, to verify impressions data. 

New auditor expected soon. Marcum is terminating its relationship with the company, citing its inability to verify the company’s impressions data. Importantly, we expect the company to sign a top 10 US accounting firm within the 30-day window. The audit should be able to ramp quickly, given that the company will be able to provide timely access to all the data the was requested by the previous auditor. Additionally, we expect Nasdaq will accept its plan and grant the company up to 6 months to complete the10-K filing, as well as its first quarter 10-Q filing. 


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