Bit Digital (BTBT) – Potential Expansion of AI Contract


Wednesday, March 27, 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.

More GPUs. Yesterday, Bit Digital received a proposal from the Company’s existing customer in Bit Digital AI to expand the scope of its agreement. The proposal calls for an additional 2,048 GPUs, amounting to a total of 4,096 GPUs under the amended agreement. Management intends to accept the proposal, subject to agreement on certain terms and conditions.

Revenue Potential. The current contract before the potential upsize has an annualized revenue run-rate of $50 million. If the proposal is fully realized, the Company would be close to, or meet, its goal of $100 million of annualized revenue by the end of 2024, in our view. Recall, management noted an additional $60 million of capital would be needed to get to the $100 million target through acquiring the necessary GPUs, based on current market conditions.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Alamos Gold’s Acquisition of Argonaut Gold Points to Renewed Anticipation Mining Sector

The gold mining industry saw an intriguing deal announced this week, with mid-tier producer Alamos Gold Inc. unveiling plans to acquire smaller rival Argonaut Gold Inc. for US$325 million. The transaction highlights an ongoing trend of consolidation in the metals mining space, as bigger players look to grow through acquisitions of promising assets and companies.

For Alamos, the main prize in this deal is the Magino development project in Ontario, Canada owned by Argonaut. Located right next door to Alamos’ Island Gold mine, Magino provides the company an opportunity to combine the two operations into one large, low-cost complex. Alamos expects to realize over US$500 million in synergies by integrating the two adjacent mines.

The acquisition of Magino significantly increases Alamos’ production profile. The combined company is expected to produce over 600,000 ounces of gold annually in the near-term, with longer-term potential exceeding 900,000 ounces per year at declining costs. This expanded scale bolsters Alamos’ position as one of Canada’s largest and lowest cost gold producers.

While Alamos gains Magino through this transaction, Argonaut’s other assets in the U.S. and Mexico will be spun out into a newly created company called SpinCo that will be owned by Argonaut’s current shareholders. This includes the operating Florida Canyon mine in Nevada as well as several development and exploration projects in Mexico.

The Alamos-Argonaut deal follows a number of similar acquisitions of smaller gold companies by more established miners over the past year. In 2023, Agnico Eagle Mines acquired Teck Resources’ minority stake in the Minas de San Nicolas mine in Mexico, while Kinross Gold acquired Great Bear Resources and its promising Dixie project in Ontario. Going back to 2022, there were several billion-dollar M&A transactions, including Newmont’s acquisition of Newcrest’s stake in the Cadia mine and Yamana Gold’s takeover by the Pan American Silver and Agnico Eagle joint venture.

According to analysts, this renewed appetite for M&A activity reflects a growing consensus that a new bull cycle may be emerging for precious metals like gold and silver. Record high inflation rates, continued economic uncertainty, and a lack of major new production sources coming online have contributed to this increasingly bullish outlook.

The major gold producers are acquiring to restock their project pipelines and take advantage of prevailing low valuations for many junior developers and explorers. With higher metals prices anticipated, the big miners want to get positioned now ahead of the curve.

In addition to building out their growth profiles through M&A, the large miners are also investing heavily in exploration and advancing their existing development projects. This dual strategy of acquisitions and organic growth initiatives should help drive a new phase of production growth across the sector in the coming years as a potential bull market unfolds.

For smaller mining companies like Argonaut, deals like this provide an attractive exit opportunity and way to unlock value for shareholders. But they also highlight the continual restructuring happening in the mining space, as promising assets and companies get consolidated into the hands of more well-capitalized mid-tier and senior producers.

With metals prices expected to keep rising on the back of supply/demand imbalances, this wave of consolidation could be just the beginning. Analysts anticipate an acceleration of M&A activity as the big miners look to position themselves for the next bullish upswing in the commodity cycle.

Take a moment to take a look at Noble Capital Markets’ Senior Research Analyst Mark Reichman’s coverage list in the metals & mining sector.

Trump’s Truth Social Debut: A High-Stakes Gamble for Bullish Investors

Donald Trump’s social media platform Truth Social hit the public markets with a bang, surging over 30% on its first day of trading and ballooning the former president’s stake in the company to over $5 billion. However, the staggering valuation and volatility highlight both the risks and potential rewards for investors looking to capitalize on Truth Social’s polarizing popularity.

Trading under the appropriate ticker DJT, Truth Social’s parent company managed to achieve a peak market capitalization around $9 billion despite the fledgling business having under $5 million in sales over the prior year. The massive $6.8 billion opening valuation put Truth Social on par with well-established companies like U.S. Steel and Skechers.

This eye-popping disconnect from financial fundamentals echoes the frenzied trading in meme stocks like GameStop that has gripped markets in recent years. In Truth Social’s case, the dramatic stock rise seems fueled largely by Trump’s devoted base of supporters, who have banded together to push up the shares.

For investors who bought in early, those efforts have paid off handsomely – at least on paper. However, cashing in those gains won’t be easy for Trump himself or others with a major stake. Stocks that go public through deals like Truth Social’s typically prohibit insider sales for 6 months.

Trump and the seven-member Truth Social board, stacked with allies like his son Don Jr., certainly have incentive to allow some profits to be taken off the table soon. Any signal of insider selling could severely dent the company’s lofty stock price if shareholders perceive waning confidence.

Therein lies one of the biggest risks surrounding an investment in Truth Social – the potential for exceedingly high volatility driven by speculation rather than business performance. If Trump’s devoted base sours on the company’s prospects, a spiral could ensue.

On the other hand, the frenzied first day demonstrated how Trump’s mere involvement and ability to marshal his base can supercharge an investment thesis, at least in the short term.

Additionally, Trump may receive tens of millions of extra shares if the sky-high valuation holds up in the coming weeks. This would further concentrate his influence over the company’s future.

For risk-tolerant investors, there’s also the potential that Truth Social could eventually disrupt incumbent social media platforms and transform into a financially viable business at scale. Though it has struggled against larger rivals thus far, Trump’s massive following of over 90 million combined on X and Facebook could provide a springboard.

From a trading perspective, Truth Social’s arrival has already juiced options volumes to potentially record levels. Traders loaded up on bullish call options betting on shares surging to $80 or $90 in a sign of the speculative frenzy around the stock.

Ultimately, while Truth Social’s jaw-dropping debut minted a new billionaire out of Trump, it has set the stage for a gladiator battle between bullish and bearish investors. With both immense risks and rewards, Truth Social is shaping up as the ultimate “investor Rorschach test” based on one’s convictions around Trump and his ability to create a viable media business.

Major Bridge Collapse in Baltimore Disrupts Shipping, Highlights Infrastructure Risks

In a shocking incident early Tuesday morning, the Francis Scott Key Bridge in Baltimore collapsed after being struck by a large container ship. The bridge carried Interstate 695 over the Patapsco River, a critical transportation artery southeast of the Baltimore metropolitan area. Up to seven people may have fallen into the water after vehicles on the bridge were impacted, with two rescued so far.

This catastrophic event has wide-ranging implications, not just for the tragic loss of life and regional transportation, but also for the shipping and logistics industry. The container ship involved has been identified as the Singapore-flagged DALI, a 948-foot vessel chartered by shipping giant Maersk and operated by Synergy Marine Group.

While the cause is still under investigation, the incident starkly highlights the risks and vulnerabilities faced by the shipping industry and supply chains. A single accident can bring a vital port and transportation hub to a standstill. The U.S. Coast Guard has already suspended all vessel traffic in and out of the Port of Baltimore until further notice.

This is likely to cause significant disruptions and delays, not just for Baltimore but rippling across global shipping routes and supply chains that rely on the port. The Port of Baltimore handled over 15 million tons of foreign cargo in 2021 and is a critical gateway for international trade on the U.S. East Coast.

Investors in the shipping and logistics sectors will be watching developments closely. Major players like Maersk could face legal liabilities, higher insurance costs, reputational damage, and loss of business from prolonged port closures. Smaller shipping companies that rely on the Baltimore port may be even more heavily impacted operationally and financially.

The incident also casts a harsh spotlight on the state of U.S. infrastructure. Despite the Biden administration’s efforts through the Bipartisan Infrastructure Law, incidents like this underscore the costs and risks of deficient transportation infrastructure. According to the American Road & Transportation Builders Association, over 43,000 bridges across the U.S. are classified as structurally deficient.

This could spur renewed focus on infrastructure spending and improvements, creating potential opportunities for companies involved in construction, engineering, and building materials. However, it also highlights risks for industries like trucking and logistics that depend heavily on safe and reliable transportation networks.

In the small cap space, companies with localized operations around the Baltimore area could face disruptions to business activity and supply chains. This may create trading opportunities for investors watching the impacts closely. Conversely, small caps that provide solutions for infrastructure monitoring, maintenance and security may see increased interest.

Overall, while the human toll is the primary tragedy, this incident is likely to have significant ripple effects across the economy, policy landscape and investment markets in the weeks and months ahead. Investors would be wise to closely monitor developments and reassess potential risks and opportunities across sectors like shipping, infrastructure, and industrial small caps.

Release – MAIA Biotechnology Announces $1.33 Million Private Placement

Research News and Market Data on MAIA

March 26, 2024 8:01am EDT

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 578,643 shares of common stock at a purchase price of $2.295 per share, in a private placement to accredited investors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.55 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The private placement is expected to close on or about March 28, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.33 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund research and development activities, such as to fund the first third of the pivotal accelerated approval Part C of the THIO-101 trial in non-small cell lung cancer (NSCLC).

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240326325996/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released March 26, 2024

Release – Bitcoin Depot Expands into Puerto Rico with Nearly 100 BTM Locations Signed

Research News and Market Data on BTM

March 26, 2024 8:00 AM EDT

Bitcoin Depot Kiosks to be Installed in 87 Retail Locations

ATLANTA, March 26, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, plans to install its BTM machines in 87 retail locations in Puerto Rico that have been signed on the Company’s location agreements to receive BTMs. Bitcoin Depot currently has 40 kiosks that have arrived in Puerto Rico and are already being prepared for installation.

“This geographical expansion will introduce our Bitcoin ATMs to a totally new market with low competition,” said Bitcoin Depot CEO Brandon Mintz. “According to Coinatmradar.com, there are only roughly 45 existing Bitcoin ATMs in Puerto Rico. We believe Puerto Rico can support a much larger supply of Bitcoin ATMs compared to what it has today, and we look forward to working closely with our new location partners in Puerto Rico to provide Bitcoin to new customers across the island.”

Bitcoin Depot’s products and services provide an intuitive, quick, and convenient process for converting cash into Bitcoin. This allows users to access the broader digital financial system, including using Bitcoin to make payments, transfers, remittances, online purchases, and investments.

About Bitcoin Depot 
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with approximately 6,400 kiosk locations as of September 30, 2023. Learn more at www.bitcoindepot.com 

Cautionary Note Regarding Forward-Looking Statements
This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, the anticipated effects of the Amendment, and the closing of the Preferred Sale. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,” “plan,” “potential,” “priorities,” “project,” “pursue,” “seek,” “should,” “target,” “when,” “will,” “would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.

These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.

We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.

Contacts: 

Investors  
Cody Slach, Alex Kovtun  
Gateway Group, Inc.  
949-574-3860  
BTM@gateway-grp.com 

Media  
Christina Lockwood, Brenlyn Motlagh, Ryan Deloney  
Gateway Group, Inc. 
949-574-3860  
BTM@gateway-grp.com  

Source: Bitcoin Depot Inc.

Released March 26, 2024

ZyVersa Therapeutics, Inc. (ZVSA) – FY23 Reported With Reiteration of Milestones For Kidney and Inflammasome Trials


Tuesday, March 26, 2024

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

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

ZyVersa Reported FY2023. ZyVersa Reported a FY2023 loss of $106.2 million or $(108.97) per share, including write-downs of In-process Research and Development of $81.4 million and Goodwill of $11.9 million that were recorded with the reverse merger in December 2022. Excluding these items, the operating loss would have been $14.4 million. Cash on hand was $3.1 million on December 31, and does not include $2.7 million from warrant exercise reported during February 2024.

ZyVersa Has Made Progress Toward Starting VAR 200 Clinical Trials. ZyVersa announced the selection of a CRO and approval by an Institutional Review Board (IRB). These are steps required to start the Phase 2a clinical trial for VAR 200, its lead molecule for modulating cholesterol and lipid accumulation in the kidney that starts damage and declining function pathways. VAR 200 is expected to begin treating patients with diabetic kidney disease in 1H24.


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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. 

Bitcoin Depot (BTM) – A Set Up Year For Future Growth


Tuesday, March 26, 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.

Q4 results. For Q4 the company reported $148.4 million in revenue, below our forecast of $157.0 million and roughly flat compared to the prior year period. Adj. EBITDA  for the quarter was $9.0 million, which was in line with our estimate. The softer than expected revenue was largely driven by the company’s redeployment of kiosks. Notably, we believe the company’s favorable redeployment efforts could improve operating results in the long-run.

Expansion strategy. Management highlighted franchising as a favorable option for expansion. Notably, franchising offers the company a less capital intensive method for expansion, which captures approximately 30%-50% of profits from licensed kiosks. Additionally, management views New York as a significant opportunity for growth, and is currently in the application process to obtain a license to operate in the state.


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. 

DLH Holdings (DLHC) – Another CMOP Update


Tuesday, March 26, 2024

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

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

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

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

More Changes? The Veterans Administration appears to be making more changes to the Consolidated Mail Outpatient Pharmacy contract process. The procurements were set-aside for a service-disabled veteran owned small business as the prime contractor with each of the eight procurements being evaluated separately for 5-year contracts. On March 14th, the VA issued a notice for services for durations of up to three months.

Background. In an extended process, the VA is again seeking to complete a re-bid and award of the CMOP contracts. In January 2023 DLH and other parties submitted bids for the eight separately competed procurements pertaining to the program. Recall, DLH has operated under a series of “bridge” contracts since 2016. Most recently, the VA extended these contracts through April 30, 2024.


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. 

Nuvation Bio Acquires AnHeart Therapeutics, Gains Promising Oncology Assets

In a strategic move to strengthen its oncology pipeline, Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company focused on developing novel cancer therapies, has announced its acquisition of AnHeart Therapeutics Ltd. in an all-stock transaction. This acquisition promises to transform Nuvation Bio into a late-stage global oncology company, positioning it as a potential commercial organization by the end of 2025.

The deal, which is subject to approval by AnHeart’s shareholders and other customary closing conditions, is expected to close in the second quarter of 2024. Upon completion, the former shareholders of AnHeart will own approximately 33% of Nuvation Bio on a fully diluted basis, while the current stockholders of Nuvation Bio will retain a 67% stake.

The primary asset driving this acquisition is taletrectinib, AnHeart’s lead investigational therapy and a next-generation ROS1 inhibitor for the treatment of ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib has already received Breakthrough Therapy Designations from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA).

Notably, taletrectinib is currently completing two pivotal Phase 2 studies, TRUST-I in China and TRUST-II, a global pivotal study, potentially positioning it as a best-in-class treatment option for patients with ROS1-positive NSCLC. The NMPA has also granted Priority Review Designation to New Drug Applications for taletrectinib, further underscoring its potential.

In addition to taletrectinib, the acquisition also brings safusidenib, a potentially best-in-class mutant IDH1 inhibitor, into Nuvation Bio’s pipeline. Safusidenib is currently being evaluated in a global Phase 2 study for the treatment of patients with grades 2 and 3 IDH1-mutant glioma.

“This transaction represents a significant milestone for our company and reflects Nuvation Bio’s continued commitment to developing therapies for patients with the most difficult-to-treat cancers,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “AnHeart’s lead asset, taletrectinib, which will become our lead asset as it completes two pivotal studies, is a differentiated, next-generation ROS1 inhibitor with a potentially best-in-class profile that may overcome the significant limitations of existing therapies.”

For Nuvation Bio, this all-stock acquisition preserves the company’s robust cash balance, enabling the development of both the newly acquired assets and its existing pipeline without the immediate need to raise additional capital. This financial strength positions Nuvation Bio to execute its development strategy effectively and advance its combined portfolio of differentiated oncology therapeutic candidates.

The acquisition also brings together the talented teams from both companies, with Nuvation Bio’s current management team, including Dr. Hung, remaining at the helm. Additionally, Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, an investor in AnHeart, and Junyuan Jerry Wang, Ph.D., Co-Founder and Chief Executive Officer of AnHeart, will join Nuvation Bio’s board of directors.

As the demand for innovative cancer therapies continues to grow, Nuvation Bio’s acquisition of AnHeart Therapeutics represents a strategic move to bolster its oncology pipeline and position itself as a potential commercial organization in the near future. With taletrectinib and safusidenib as promising additions to its portfolio, Nuvation Bio is poised to make significant strides in addressing the unmet needs of patients with challenging forms of cancer.

Release – Orion Group Holdings, Inc. Announces Retirement of Board Member

Research News and Market Data on ORN

Mar 25, 2024

HOUSTON, March 25, 2024 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (“Orion” or the “Company”), a leading specialty construction company, announced today that Richard L. Daerr, Jr., who has served as an independent member of the Company’s Board of Directors (the “Board”) since 2007 and was Chairman of the Board from 2007 to 2020 as well as Lead Independent Director from 2022 to 2023, informed the Company that he has chosen not to stand for re-election and instead retire from the Board effective at the Company’s upcoming Annual General Meeting of Stockholders on May 16, 2024. Effective upon Mr. Daerr’s retirement, the Board has determined to reduce its size from eight directors to seven directors, six of whom are independent.

Austin Shanfelter, Orion’s Chairman of the Board, commented, “We want to thank Richard for his years of service to the Company and his many valuable contributions, including his board leadership in the transition of Orion to a public company, establishing the standards for governance, the growth of the Company, and agreeing to serve as our Lead Independent Director through our recent executive transition. We wish him all the best in his future endeavors.”

Mr. Daerr stated, “It has been my distinct honor to serve on this Board for almost seventeen years and lead the Board for almost all of that time. I am proud of the tremendous transformation the Company has achieved over this time, and I leave with great confidence in Orion’s future and the strength of its Board.”

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

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

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

Contact:

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

Release – Eledon Pharmaceuticals Announces 12th Participant Enrolled in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Organ Rejection

Research News and Market Data on ELDN

March 25, 2024

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IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.

“We are pleased with the strong pace of enrollment in our Phase 2 BESTOW trial and believe it speaks to the underlying demand for a new immunosuppressive regimen for the tens of thousands of patients each year who undergo kidney transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer.

The Risk of Organ Failure in Transplantation

In transplantation procedures, organ rejection is a major cause of graft failure, which can be a life-threatening condition. Rejection occurs due to allorecognition, wherein the recipient’s immune system identifies the transplanted organ as foreign tissue, triggering an immune response against the transplanted organ. To reduce the risk of rejection, patients are treated with immunosuppressive therapies for life. Calcineurin inhibitors (“CNIs”) are a critical component of most immunosuppressive regimens to prevent acute and long-term organ transplant rejection. However, chronic exposure to CNIs (tacrolimus is the drug most commonly used) is associated with nephrotoxicity, hypertension, new onset diabetes due to pancreatic beta cell toxicity, as well as central nervous system side effects like tremor. Regarding kidney transplantation, the toxicity associated with CNIs causes 30-50% of kidney transplants to fail with 10-15 years of transplantation. Strategies to better and more safely protect transplanted organs and thus increase how long they function represent a significant area of unmet need in organ transplantation.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedInTwitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the demand for a new and better immunosuppressive regimen for patients who undergo kidney transplantation, or statements about the Company’s other future expectations, plans and prospects, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Qs, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise. 

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

AbbVie’s Acquisition of Landos Biopharma Highlights Potential in Small-Cap Biotech

In a strategic move that could have significant implications for the small-cap biotech sector, pharmaceutical giant AbbVie Inc. (NYSE: ABBV) announced its acquisition of Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company focused on developing novel oral therapeutics for autoimmune diseases. The deal, valued at approximately $212.5 million including contingent value rights, underscores the growing interest and potential in the small-cap biotech space, particularly in the field of inflammatory and autoimmune diseases.

Under the terms of the agreement, AbbVie will acquire Landos at $20.42 per share in cash upon closing, plus a contingent value right of up to $11.14 per share, subject to the achievement of a clinical development milestone. The acquisition is expected to close in the second quarter of 2024, subject to customary closing conditions, including approval by Landos’ stockholders.

The primary asset driving this deal is NX-13, Landos’ lead investigational asset and a first-in-class, oral NLRX1 agonist with a bimodal mechanism of action. NX-13 is currently in Phase 2 clinical trials for the treatment of ulcerative colitis (UC), a chronic inflammatory bowel disease affecting millions worldwide.

“With this acquisition, we aim to advance the clinical development of NX-13, a differentiated, first-in-class, oral asset with the potential to make a difference in the lives of people living with ulcerative colitis and Crohn’s disease,” said Roopal Thakkar, M.D., AbbVie’s senior vice president and chief medical officer, global therapeutics.

NX-13’s unique bimodal mechanism of action, which is both anti-inflammatory and facilitates epithelial repair, could provide a novel approach to treating UC and other inflammatory bowel diseases. If successful, it could address a significant unmet need in this therapeutic area.

The acquisition underscores AbbVie’s commitment to strengthening its portfolio in inflammatory and autoimmune diseases, which represent a substantial market opportunity. According to estimates, the global inflammatory bowel disease treatment market is projected to reach $8.6 billion by 2027, driven by factors such as increasing prevalence, rising healthcare expenditure, and a growing focus on developing targeted therapies.

For small-cap investors, this deal highlights the potential value and attractiveness of emerging biotech companies with promising pipeline candidates. As larger pharmaceutical companies seek to bolster their portfolios and drive innovation, strategic acquisitions of small-cap biotechs with compelling assets can provide attractive exit opportunities and significant returns for investors.

This acquisition also comes at an opportune time, as Noble Capital Markets’ upcoming virtual healthcare event on April 17-18 will showcase emerging growth companies in the healthcare, biotech, and medical device industries. Investors interested in exploring opportunities in the small-cap biotech space should mark their calendars for this event, which promises to provide valuable insights and potential investment prospects in this dynamic sector.

With the rising interest in novel therapies for inflammatory and autoimmune diseases, the AbbVie-Landos deal serves as a reminder of the potential value that can be unlocked in the small-cap biotech realm. As larger players seek to fortify their pipelines, the spotlight on promising small-cap innovators is likely to intensify, presenting exciting opportunities for investors in this space.