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AstraZeneca Makes $2.4 Billion Bet on Next-Gen Cancer Radioconjugates

Posted on by slightbourne@noblecapitalmarkets.com

In a bold move to fortify its oncology pipeline, pharmaceutical giant AstraZeneca (NASDAQ: AZN) has agreed to acquire clinical-stage biotech Fusion Pharmaceuticals (NASDAQ: FUSN) for up to $2.4 billion. The deal gives AstraZeneca full access to Fusion’s pioneering radioconjugate (RC) therapies and expertise as it aims to transform cancer treatment and unseat traditional chemotherapy and radiation regimens.

Fusion specializes in developing a promising new class of precision oncology drugs called RCs, which dispense powerful, targeted radiation directly to cancer cells via targeting molecules like antibodies. By delivering potent radioisotope payloads to tumors in this manner, RCs may improve upon external beam radiation’s limitations and indiscriminately toxic effects.

Under the agreed terms, AstraZeneca will pay $21 per share in cash upfront to acquire all outstanding Fusion shares, valuing the biotech at approximately $2 billion. This headline price represents a staggering 97% premium over Fusion’s closing price prior to deal announcement. AstraZeneca has also committed up to $3 per share in additional contingent value rights tied to a future regulatory milestone, which could push the total deal value to $2.4 billion if achieved.

For AstraZeneca, the acquisition paves the way for a major expansion into promising RC therapeutics, which could revolutionize how cancers are treated in the future. The crown jewel of the deal is FPI-2265, Fusion’s lead RC candidate that uses the alpha particle-emitting isotope actinium-225 to target PSMA proteins in metastatic castration-resistant prostate cancer. FPI-2265 is already in Phase 2 clinical trials with early data expected in 2024.

Beyond this advanced asset, AstraZeneca gains control of Fusion’s broader pipeline of RC programs and candidates across multiple solid tumor types. Just as importantly, the transaction provides AstraZeneca with Fusion’s specialized R&D capabilities, manufacturing infrastructure, and actinium-225 supply chain specifically tailored for developing these next-wave radiotherapeutics.

This strategic acquisition doubles down on AstraZeneca’s burgeoning radio-isotope therapy initiatives. The pharma giant already has a collaboration with Fusion exploring lung cancer applications using one of its RC molecules. By bringing Fusion’s RC therapy capabilities fully in-house, AstraZeneca can now swiftly integrate and scale up this cutting-edge treatment modality across its industry-leading oncology portfolio.

For Fusion investors, the buyout represents a lucrative exit at a substantial premium, especially compared to the company’s $300 million market cap prior to deal reports. While always bittersweet to see a promising biotech get absorbed, Fusion’s technology and team are now set to be fueled by abundant AstraZeneca resources in pursuing RC breakthroughs.

The transaction, expected to close in Q2 2024 pending customary approvals, foreshadows a future where RCs could potentially supplant chemotherapy and radiotherapy as more precise, less toxic foundational cancer regimens. While still an emerging field, AstraZeneca’s bold multi-billion dollar investment signals its confidence in harnessing RCs’ unique advantages over traditional oncology treatments.

As AstraZeneca executes an ambitious pivot toward next-generation RC therapies, biotech and pharma investors would be wise to monitor this rapidly evolving space. The acquisition of Fusion continues to position the pharma titan at the vanguard of replacing archaic cancer protocols with targeted radioconjugate precision medicines.

WaveDancer’s Acquisition of AI Neuroscience Firm Firefly Poised to Shake Up Healthcare Tech

Posted on by slightbourne@noblecapitalmarkets.com

The financial markets are abuzz over WaveDancer, Inc.’s approved merger deal to acquire Firefly Neuroscience, an artificial intelligence company pioneering brain health diagnostics and analytics software. With stockholders from both companies green-lighting the transaction, the stage is set for a new player to emerge in the rapidly evolving neurological healthcare technology space.

WaveDancer (NASDAQ: WAVD), currently an IT services provider to government and commercial clients, is essentially acquiring the capabilities and pipeline of private AI neuroscience firm Firefly through a merger of one of its subsidiaries into the latter. Once the deal closes in Q2 2024, the combined entity will rebrand as Firefly Neuroscience, Inc. and trade under the new ticker AIFF on the Nasdaq Capital Market.

The new Firefly Neuroscience will be laser-focused on commercializing and advancing the development of Firefly’s innovative Brain Network Analytics (BNA) software platform, cleared by the U.S. Food and Drug Administration. Leveraging AI, machine learning, and a massive database of over 17,000 EEG brain scans, the BNA Platform aims to revolutionize the diagnosis and treatment of mental health conditions like depression and anxiety, as well as neurological disorders such as dementia, concussions, and ADHD.

“The WaveDancer favorable shareholder vote is an important step in consummating the merger and reinventing WaveDancer as an AI-enabled neurological health platform,” stated Jamie Benoit, Chairman and CEO of WaveDancer. The company plans to divest its legacy IT services operations to fully concentrate on scaling up Firefly’s neuroscience technology business post-merger.

Firefly’s unique AI platform has already garnered significant attention and investment from the medical community, with the company raising approximately $60 million to date to build out its EEG database, develop the software, secure patents, and attain FDA clearance. Now poised to transition into a publicly-traded commercial entity, Firefly Neuroscience could rapidly accelerate adoption of its solutions among pharmaceutical companies, clinical trials, and medical practitioners globally.

The combined firm will hit the ground running, with Firefly management slated to present at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference on April 17-18, 2024. This high-profile investor forum will provide an ideal platform to lay out Firefly Neuroscience’s growth strategy and market opportunity to Wall Street.

The Emerging Growth Virtual Healthcare Conference will feature 2 days of corporate presentations from up to 50 innovative public healthcare, biotech, and medical device companies, showcasing their latest advancements and investment opportunities. Each presentation will be followed by a fireside-style…Read More

While the technology is highly specialized, analysts forecast significant potential upside for Firefly’s brain mapping and analytics capabilities across a range of healthcare markets struggling with neurological and mental health challenges. The company’s AI edge in these areas could position it to drive improved patient outcomes, lower costs through earlier interventions, and open new avenues for drug development and therapies.

For WaveDancer shareholders, the transaction marks a bold pivot into a cutting-edge industry riding powerful tailwinds of AI adoption in healthcare settings. Assuming a seamless merger and transition, the company could quickly morph into a promising pure-play on validated, scalable neurotechnology solutions backed by substantial technical assets and IP.

As the deal approaches the finish line, all eyes will be on Firefly Neuroscience’s market debut and ability to execute on the immense growth prospects its AI brain analytics platform presents. Healthcare investors would be wise to keep a close watch as this under-the-radar neuroscience firm prepares to seize a starring role on Wall Street.

Release – Bit Digital, Inc. Announces Fiscal Year 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BTBT

NEW YORK, March 18, 2024 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (the “Company”), a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure headquartered in New York City, announced that it filed its annual report on Form 20-F for the fiscal year ended December 31, 2023 with the U.S. Securities and Exchange Commission (“SEC”) on March 18, 2024.

Financial Highlights for Fiscal Year 2023

  • Total revenue for fiscal year 2023 was $44.9 million, a 39% increase compared to the prior year. The majority of revenue was earned from our bitcoin mining business.
  • The Company had cash, cash equivalents and restricted cash of $18.2 million, and total liquidity (defined as cash equivalents and restricted cash, USDC, and the fair market value of digital assets) of approximately $81.2 million1, as of December 31, 2023.
  • Total assets were $189.3 million and Shareholders’ Equity amounted to $152.7 million as of December 31, 2023.
  • Adjusted EBITDA2 was $12.4 million for the fiscal year 2023.
  • Adjusted earnings per share3 was $0.12 for fiscal year 2023.

Operational Highlights for Fiscal Year 2023

  • The Company earned 1,507.3 bitcoins during 2023, a 21% increase from the prior year. Growth was primarily driven by a higher active hash rate and partially offset by an increase in network difficulty.
  • The Company paid approximately $0.05 per kilowatt hour to its hosting partners for electricity consumed during fiscal year 2023.
  • The average fleet efficiency for the active fleet was approximately 28.8 J/TH as of December 31, 2023.
  • The Company earned 287.0 ETH in native staking and 81.9 ETH in liquid staking, respectively, during fiscal year 2023.
  • Treasury holdings of BTC and ETH were 642.6 and 15,108.0, with a fair market value of approximately $27.2 million and $34.5 million on December 31, 2023, respectively.
  • The BTC equivalent4 of our digital asset holdings as of December 31, 2023 (defined as if all ETH, LsETH, and USDC holdings were converted into BTC as of that date) was approximately 1,489.9 BTC, or approximately $63.0 million. This figure excludes approximately 2,701 ETH that transferred to an internally managed fund.
  • As of December 31, 2023, we had 46,548 miners owned or operating (in Iceland) for bitcoin mining with a total maximum hash rate of 3.9 EH/S.
  • The Company’s active hash rate of its bitcoin mining fleet was approximately 2.50 EH/s as of December 31, 2023.
  • The Company purchased approximately 10,900 bitcoin mining units during 2023.
  • For the year ended December 31, 2023, the Company wrote off 5,328 bitcoin miners and 730 ETH miners.
  • Approximately 93% of our fleet’s run-rate electricity consumption was generated from carbon-free energy sources as of December 31, 2023. These figures are based on data provided by our hosts, publicly available sources, and internal estimates, demonstrating our commitment to sustainable practices in the digital asset mining industry.
  • The Company had approximately 12,752 ETH actively staked in native and liquid staking protocols as of December 31, 2023. Approximately 12,352 were natively staked and 400 ETH were deployed in liquid staking protocols as of that date.
  • In October 2023, Bit Digital finalized an agreement with Soluna Computing, Inc (“Soluna”) for 4.4 megawatts of incremental hosting capacity in Kentucky to power its miners for an initial contract term of twelve months.
  • In October 2023, the Company announced the launch of Bit Digital AI, a new business line that provides specialized infrastructure to support generative artificial intelligence (“AI”) workstreams. The Company subsequently finalized a service agreement with a customer to provide the customer with computational power from 2,048 GPUs over a three-year period. To fulfil the contract, the Company purchased 256 servers manufactured by Super Micro Computer, Inc., an authorized Nvidia OEM, that were equipped with 2,048 Nvidia HGX H100 GPUs along with related equipment. To help finance this operation, the Company subsequently entered into a sale-leaseback agreement with a third party, selling 96 AI servers (equivalent to 768 GPUs) and leasing them back for three years. The GPUs are deployed at a third-party datacenter located in Iceland.
  • In November 2023, Bit Digital finalized an agreement with Dory Creek, a subsidiary of Bitdeer Technologies Group, for 17.5 MW of incremental hosting capacity to power its miners at a location in Texas. Additionally, Bit Digital will have the first right for up to an additional 17.5 MW of capacity that may be brought online by the operator.

Subsequent Events

  • On January 22, 2024, approximately 192 servers (1,536 GPUs) began generating revenue from the Company’s AI customer contact. Subsequently, approximately 64 additional servers (512 GPUs) commenced revenue generation on February 2, 2024.
  • On January 26, 2024, the Company finalized an agreement Coinmint for up to 6 MW of additional mining capacity at Coinmint’s hosting facility in Massena, New York. This new agreement brings the Company’s total contracted hosting capacity with Coinmint to approximately 46 MW. Bit Digital purchased approximately 2,340 S19k Pro mining units that have since been deployed at the facility as of the date of this report.

Strategic Priorities for Fiscal Year 2024

  • Expand the active bitcoin mining fleet to approximately 6.0 EH/s.
  • Diversify and grow Bit Digital AI with the goal of increasing annualized revenue to $100 million by year-end 2024.
  • Maintain a strong and flexible balance sheet
  • Increase our treasury holdings of staked ETH with retained earnings
  • Continued focus on sustainability

Management Commentary

“2023 was a foundational year for Bit Digital. The year began with the price of bitcoin near cyclical lows and ended on a trajectory that would propel the asset to new all-time highs in 2024. Despite the improvement in the price of bitcoin, our core mission remains unchanged; to build a company that can successfully endure all phases of the bitcoin price cycle.

We enacted numerous changes to our bitcoin mining hosting portfolio during 2023, ending the year with six hosting partners and seven operating sites across three countries. Notably, we expanded our operations into Iceland during 2023, providing Bit Digital with geographic diversification outside of North America and into a region with an abundance of clean energy and supportive government policies. We will continue to focus our expansion areas in areas that provide cost-effective, carbon-free energy sources. As we consider our growth targets for 2024, our focus is on improving our overall fleet efficiency and lowering our production cost.

Bit Digital enacted a growth strategy in 2023 which prioritized maintaining a formidable balance sheet ahead of the ‘halving’ which is expected to occur during April 2024. We ended 2023 with a strong liquidity position and zero debt, and our liquidity position has improved materially since year-end in sympathy with rising digital asset prices. We also managed to more than double our active hash rate compared to the end of 2022, leading to a 21% increase in total bitcoin production.

We announced the launch of a new business line, Bit Digital AI, during the fall of 2023. This business aims to provide AI-focused clients with digital infrastructure services, including GPU rental services. It was important to us that we didn’t merely announce an ambition, but a real business, and this business line has already begun to contribute meaningful revenue to Bit Digital (approximately $4 million during February 2024). This enterprise draws on our core competencies as a bitcoin miner, and we believe we are on a credible path to materially expanding the scope of this business line. We look forward to demonstrating the earnings power from this business as the year progresses.”

About Bit Digital

Bit Digital, Inc. is a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure headquartered in New York City. Our bitcoin mining operations are located in the US, Canada, and Iceland. The Company has also established a business line, Bit Digital AI, that offers infrastructure services for artificial intelligence applications. For additional information, please contact ir@bit-digital.com or visit our website at www.bit-digital.com.

Investor Notice

Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 3.D of our Annual Report on Form 20-F for the fiscal year ended December 31, 2023. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. Future changes in the network-wide mining difficulty rate or bitcoin hash rate may also materially affect the future performance of Bit Digital’s production of bitcoin. Actual operating results will vary depending on many factors including network difficulty rate, total hash rate of the network, the operations of our facilities, the status of our miners, and other factors. See “Safe Harbor Statement” below.

Safe Harbor Statement

This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Footnotes:
1 This figure excludes approximately 2,701 ETH that were transferred to an internally managed fund.
2 Adjusted EBITDA refers to earnings before interest expense, income tax expense and depreciation and amortization expense (“EBITDA”) adjusted to eliminate the effects of certain non-cash and / or non-recurring items.
3 Adjusted EPS is a financial measure defined as our EBITDA divided by our diluted weighted-average shares outstanding, adjusted with the EPS impact related to the adjustments made to EBITDA to derive Adjusted EBITDA.
4 “BTC equivalent” is a hypothetical illustration of the value of our digital asset portfolio in bitcoin terms. BTC equivalent is defined as if all non-BTC digital assets, comprised of ETH, LsETH, and USDC, were converted into BTC as of December 31, 2023, and added to our existing BTC balance. Conversion values are found using the closing price on coinmarketcap.com.

Apple’s AI Ambitions Could Involve Major Partnerships

Posted on by slightbourne@noblecapitalmarkets.com

Apple is actively exploring partnerships with tech giants like Google and OpenAI as it accelerates its artificial intelligence efforts, according to a recent report from Bloomberg. The iPhone maker is said to be in “active negotiations” with Google to integrate the search giant’s Gemini generative AI into future Apple products and services.

The potential deal would give Apple access to Google’s advanced AI capabilities, allowing it to rapidly implement features like AI-powered text and image generation into offerings like iOS, Siri, and its productivity apps. Bloomberg reports that Apple has also considered integrating OpenAI’s viral ChatGPT model, highlighting the company’s willingness to leverage external AI expertise.

This openness to AI partnerships represents a strategic shift for the traditionally vertically integrated Apple. CEO Tim Cook confirmed earlier this year that the company is devoting “tremendous time and effort” to generative AI, with plans to release AI-powered features to consumers “later this year” with iOS 18. However, Apple’s in-house AI development efforts are reportedly lagging rivals.

While Apple employees have been testing an internal AI assistant called “Apple GPT,” the company’s generative AI tech is described as less capable than that of Microsoft, Google, and others. A partnership would allow Apple to utilize cutting-edge cloud AI while its own large language model, codenamed “Ajax,” continues development.

For Google, scoring an AI integration deal with its chief mobile rival would be a coup – expanding its AI’s reach to over 2 billion active iPhones globally. It could also strengthen Google’s position amid intensifying regulatory scrutiny over its lucrative deals making Google Search the default on Apple devices.

The two tech titans already have an $18 billion annual agreement in place for Google to be the preloaded search engine on iPhones and iPads. Adding AI services could make this partnership even more lucrative and harder for regulators to disentangle.

However, the deal risks being perceived as an admission from Apple that its AI capabilities lag behind Google’s, at least for now. Apple prides itself on cutting-edge silicon and integrated hardware/software experiences. Relying on Google’s AI could undermine its position as an innovation leader.

Apple may aim to provide on-device AI through its own models, while tapping Google’s cloud AI for more intensive generative tasks like text prompts or image creation. It’s already taken this hybrid approach with other services like Maps and web search.

Another complicating factor is Apple’s historical stance on privacy and protecting user data. Integrating Google’s AI could raise concerns about data sharing and usage policies that differ from Apple’s privacy-centric approach.

While the negotiations underscore Apple’s AI ambitions, many details remain unclear – including potential branding, business terms, technical implementation, or whether a deal will even be reached. Bloomberg reports any announcement is unlikely before Apple’s Worldwide Developers Conference in June.

As the AI Arms race intensifies, Apple is evidently willing to consider previously unorthodox partnerships and concessions to avoid falling behind rivals in this revolutionary technological domain. How it balances AI capabilities with its core principles and ultimately delivers its AI-powered user experiences will be crucial to maintaining its industry-leading device ecosystem.

Release – Kratos Receives $57.6 Million Contract for 70 BQM-177A Aerial Targets

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KTOS

March 18, 2024 at 8:00 AM EDT

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SAN DIEGO, March 18, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets and industry-leading provider of high-performance, jet-powered unmanned aerial systems, announced today that its Unmanned Systems Division has received a $57,673,542 modification to a previously awarded firm-fixed-price contract. This modification exercises options to procure full rate production Lot Five of the BQM-177A Surface Launched Aerial Targets to provide for the production and delivery of 70 BQM-177A Surface Launched Aerial Targets and 70 Rocket-Assisted Takeoff attachment kits, as well as associated technical and administrative data in support of weapons system test, and evaluation and fleet training for the Navy.

Kratos BQM-177A Shipboard Launch

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d9916314-cd45-49cf-b0e0-d22296646070

Steve Fendley, President of Kratos Unmanned Systems Division, said, “It’s exciting to be a major part of this critically important capability for the U.S. Navy with our BQM-177A Sub-Sonic Aerial Target (SSAT) aircraft system (target). The 177A continues to push the envelope delivering leading edge realistic threat-representative capabilities to support today’s peer-level threat environment. We look forward to the increased production rate and continuing to evolve the system with our customer as the threats evolve.”

Greg Crewse, Program Manager for the Navy’s Aerial Targets program office (PMA-208), said, “In partnership with the Navy Aerial Targets program office, Kratos Defense and the BQM-177A Air Vehicle are true assets to the Navy and, together, we have the opportunity to engage in critical training exercises that will prepare our personnel to face a multitude of scenarios in a challenging, cost-effective test environment prior to engaging real-world threats, should the need arise. As recent real-world events have proven, these target presentations are growing ever more critical to prepare our warfighters to go into harm’s way – and prevail.”

About Kratos Defense & Security Solutions, Inc.
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value-add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high, and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 31, 2023, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Release – ZyVersa Therapeutics Announces IRB Approval of Phase 2a Clinical Trial Protocol to Evaluate Cholesterol Efflux Mediator™ VAR 200 in Patients with Diabetic Kidney Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Mar 18, 2024

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  • Phase 2a trial is on track to begin in the first half of 2024.
  • Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.

WESTON, Fla., March 18, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, announces Institutional Review Board (IRB) approval of the Phase 2a clinical trial protocol to evaluate the efficacy and safety of Cholesterol Efflux Mediator VAR 200 in patients with diabetic kidney disease. The clinical trial is on track to begin in the first half of 2024.

Initiation of this clinical trial is a key milestone for ZyVersa. It is the first in human trial for VAR 200 intended to substantiate that the promising preclinical results demonstrated in three different animal models of kidney disease (diabetic kidney disease, focal segmental glomerulosclerosis, and Alport syndrome) translate to patients with kidney disease. The preclinical data demonstrated across all three kidney disease models that VAR 200:

  • Reduced cholesterol and lipid levels in the kidneys’ filtration system.
  • Protected against kidney injury and fibrosis.
  • Significantly reduced protein in the urine (proteinuria).

For more information about VAR 200, Click Here.

“A large body of evidence reinforces the importance of addressing kidney accumulation of cholesterol and lipids to help attenuate progression of chronic kidney disease, which affects over 35 million adults in the United States,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Currently, over 130,000 patients with kidney disease progress to renal failure each year, and more than 800,000 patients are living with renal failure requiring dialysis or transplant to sustain life. We are excited about the potential of Cholesterol Efflux MediatorTM VAR 200 to protect against kidney injury and reduce kidney disease progression.”

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641        

Release – Ocugen, Inc. Appoints Huma Qamar, MD, MPH As Chief Medical Officer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

March 18, 2024

MALVERN, Pa., March 18, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the appointment of Dr. Huma Qamar as Chief Medical Officer (CMO).

“I’m very pleased to name Dr. Qamar as the CMO at Ocugen,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “This appointment recognizes her invaluable contributions to building a strong clinical team, overseeing a well-conducted Phase 1/2 gene therapy trial, and establishing relationships with leading medical and academic institutions and key opinion leaders.”

Dr. Qamar is a distinguished healthcare professional with a rich background in clinical research, having contributed her expertise to esteemed Ivy League institutions including Yale University, Harvard University, and University of Pennsylvania. Her expertise encompasses the development of Phase I-IV clinical protocols and execution of clinical studies, FDA inspections, and effective leadership of medical affairs teams.

“Having been a part of Ocugen’s mission and vision for more than three years now, it’s a pleasure to lead Ocugen’s clinical development at this pivotal time,” said Dr. Qamar. “I am committed to addressing patients’ unmet medical needs and bringing novel modifier gene therapy products to the market globally.”

Dr. Qamar has expertise in multiple therapeutic areas, including gene and cell therapy, vaccines, oncology (Heme-Onc, CAR-T, rare tumors, sarcoma, melanoma, women’s health, GU & GI, fetal oncology), rheumatology, dermatology, neurology, cardiology, hepatology, and infectious diseases.

“Dr. Qamar has a deep understanding of Ocugen’s ongoing clinical trials and a close working relationship with the clinical and regulatory teams, both of which are fundamentally important to the success of Ocugen’s programs,” said Dr. Prabhavathi Fernandes, Independent Lead Director, Ocugen board. “I’m confident that her determination and dedication will bring the Company’s first-in-class candidates through the upcoming clinical milestones to deliver on Ocugen’s long-term strategy.”

Prior to joining Ocugen, Dr. Qamar was Senior Vice President, Head of R&D at FSD Pharma—demonstrating her commitment to advancing scientific innovation and pharmaceutical development.

About Ocugen, Inc. 

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

Forward-Looking Statements 

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release. 

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

Townsquare Media (TSQ) – Improving Fundamental Outlook; Boosts Dividend

Posted on by cpereira@noblefcm.com


Monday, March 18, 2024

Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for approximately 26,800 SMBs; a robust digital advertising division, Townsquare IGNITE, a powerful combination of a) an owned and operated portfolio of more than 330 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data, and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 321 local terrestrial radio stations in 67 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com, and NJ101.5.com and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com and Loudwire.com.

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

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Solid Q4 Results. The company reported Q4 revenue of $114.8 million and adj. EBITDA of $24.8 million, in line with expectations. Revenue for full year 2023 declined a modest 0.9%, excluding political revenue, and adj. EBITDA decreased 9.1% when political is excluded. Digital Advertising was a bright spot for the company in 2023, increasing a solid 7.1% from the prior year. Notably, revenue and adj. EBITDA met the company’s previously issued full year guidance. 

Digital at its trough. Digital revenue in Q4 was down 6.4% from the prior year period. The decrease was attributed to softness in Digital Marketing Solutions, which declined $3.2 million or 14.5% in the quarter. Management provided a sanguine view that this business may have troughed and is positioned for growth by year end. 


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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. 

Seanergy Maritime (SHIP) – Strong results allow us to raise our estimates and price target

Posted on by cpereira@noblefcm.com


Monday, March 18, 2024

Seanergy Maritime Holdings Corp. is the only pure-play Capesize ship-owner publicly listed in the US. Seanergy provides marine dry bulk transportation services through a modern fleet of Capesize vessels. The Company’s operating fleet consists of 17 Capesize vessels with an average age of approximately 12 years and aggregate cargo carrying capacity of approximately 3,011,083 dwt. The Company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP” and its Class B warrants under “SHIPZ”.

Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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

Shipping rates were even higher than our recently-raised rates. Shipping rates spiked in December. We raised our estimates in February to reflect favorable conditions, but rates surpassed our raised projections. Seanergy was able to extend/reprice six vessels at favorable terms due to higher rates.

Seanergy has fixed 93% of 2024-1Q and 58% of 2024-2Q operating days at attractive prices. We believe cash flow and earnings will be fairly stable due to fixed prices. Seanergy’s exposure to shipping rates increases as the year progresses as charters expire and the company adds vessels to its fleet.


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. 

Titan Medical Announces Transformative Merger with Conavi Medical

Posted on by slightbourne@noblecapitalmarkets.com

Toronto-based medical device company Titan Medical Inc. (TSX: TMD) unveiled a definitive agreement to merge with Conavi Medical Inc. in an all-stock transaction that will create a new publicly-traded leader in hybrid intravascular imaging.

The deal, announced on March 18, 2024, will see Titan acquire all of the outstanding shares of Conavi, a commercial-stage firm that has developed the Novasight Hybrid System for guiding minimally invasive coronary procedures. In exchange, Conavi shareholders will receive newly issued shares of Titan.

The merger will constitute a reverse takeover of Titan by Conavi. Upon completion, the combined entity plans to change its name to Conavi Medical Inc. and apply to list its shares on the TSX Venture Exchange after delisting from the Toronto Stock Exchange.

“This planned merger comes at a pivotal moment as we advance the Novasight Hybrid System, unlocking its full potential in the U.S. and globally,” said Thomas Looby, CEO of Conavi. “Gaining public company status will enhance our financial strength and growth strategy.”

Conavi’s Novasight Hybrid system is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging modalities, enabling simultaneous and co-registered imaging of coronary arteries. It has regulatory approvals in the U.S., Canada, China and Japan.

Paul Cataford, Interim CEO and Board Chair of Titan, said “Conavi is an exciting commercial-stage company with groundbreaking technology. We are confident in their ability to drive adoption of the Novasight Hybrid System.”

As part of the transaction, Conavi will complete a concurrent equity financing raising between $15-20 million before the deal closes around July 15th. The financing is expected to attract support from institutional investors.

Take a moment to take a look at Noble Capital Markets’ Senior Research Analyst Robert Leboyer’s coverage universe.

Key benefits anticipated for the combined company include a strong balance sheet following the financing, established product capabilities, a proven coronary imaging product being commercialized, a large market opportunity, and increasing user traction.

Under the agreement terms, Titan will consolidate its shares on an agreed ratio prior to the merger. A Titan subsidiary will then amalgamate with Conavi, with Titan issuing new consolidated shares to Conavi shareholders based on an exchange ratio valuing Conavi at $69.84 million pre-money. This ratio will ensure existing Titan shareholders own at least 10% of the combined company.

All officers and certain Titan directors will resign upon closing and be replaced by Conavi nominees. The merger requires approval from shareholders of both companies as well as regulatory approvals. Titan’s board unanimously recommends shareholders vote in favor based on a fairness opinion from its financial advisor.

The transaction marks the culmination of a strategic review process for Titan over the past 15 months. The company previously halted work on its surgical robotics program to conserve cash before pursuing asset sales and IP licensing deals.

With Conavi’s commercial hybrid imaging technology and anticipated financial resources from the merger and financing, the combined company aims to drive market penetration in the fast-growing field of intravascular imaging for coronary procedures. The deal transforms Titan from an R&D-stage firm into a revenue-generating medtech leader.

Geron Stock Skyrockets on Pivotal FDA Panel Backing for Blood Disorder Drug

Posted on by slightbourne@noblecapitalmarkets.com

In a major vindication for Geron Corporation’s therapeutic pipeline, the biotech company’s shares skyrocketed nearly 90% in after-hours trading Thursday after receiving a critical green light from U.S. drug regulators.

In a 12-2 vote, the Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) ruled that the clinical benefits of Geron’s investigational drug imetelstat outweigh its risks for treating a serious blood disorder. Specifically, the independent panel of experts endorsed imetelstat as a potential new therapy for transfusion-dependent anemia in certain adult patients with low to intermediate-risk myelodysplastic syndromes.

Myelodysplastic syndromes (MDS) are a group of malignant bone marrow disorders that disrupt the production of healthy blood cells. In the lower-risk forms of MDS being targeted by imetelstat, anemia caused by a lack of red blood cells is one of the most problematic complications, often requiring regular blood transfusions.

Imetelstat, an innovative first-in-class drug candidate, works by inhibiting the enzyme telomerase. This mechanism of action allows imetelstat to potentially restore normal red blood cell production and alleviate the need for transfusions in these MDS patients.

In Geron’s pivotal phase 3 IMerge study involving over 200 patients, those treated with imetelstat showed significantly higher rates of achieving red blood cell transfusion independence for at least 8 weeks compared to placebo. The study also found 28% of imetelstat patients achieved transfusion independence for 24 weeks or longer – with a median duration of 80 weeks. Only 3% of those on placebo matched that level of durable response.

“There are few treatment options and significant unmet medical need remains for these patients, particularly among those with difficult-to-treat subtypes of this blood cancer,” said Faye Feller, Geron’s chief medical officer. “We believe that imetelstat has the potential to be an important new medicine.”

Wall Street clearly agrees with that assessment. Geron shares, which had already surged over 60% year-to-date in anticipation of Thursday’s advisory meeting, ripped nearly 90% higher in extended trading after the result was announced.

While not binding, the FDA typically follows the recommendations of its advisory panels when making final approval decisions. The agency has set a target action date of June 16 to decide on whether to greenlight imetelstat for MDS patients based on the totality of evidence – including the IMerge trial data and ODAC’s favorable risk-benefit evaluation.

Approval appears likely after the decisive ODAC vote, providing a tremendous boost for Geron as it pushes ahead with commercialization plans for imetelstat. In addition to seeking FDA approval, the company is pursuing European regulatory clearance after submitting its marketing application to health authorities there last year.

Analysts see imetelstat generating hundreds of millions in peak sales if approved for this initial MDS population with unmet needs. But Geron is also evaluating the drug’s potential utility in other blood and bone marrow disorders like myelofibrosis, significantly expanding imetelstat’s commercial opportunity.

Even after Thursday’s enormous stock spike, Geron remains modestly valued at around $1.5 billion in market capitalization. While certainties remain around pricing, reimbursement and ultimate market penetration, the positive ODAC outcome drastically improves the outlook for this longtime drugmaker to finally bring its first product to market after years of development setbacks.

For a company that has relied primarily on partnerships, licensing deals and equity raises to sustain its operations, having a wholly-owned product with multi-billion dollar sales potential could completely transform Geron’s outlook – validating the bold decision to double down on imetelstat’s high-risk, high-reward proposition in recent years.

While challenges still lie ahead, investors are clearly salivating over imetelstat’s bright future after the pivotal FDA panel vote removed a major roadblock on the path to potential commercialization. The overwhelmingly positive outcome sent an unmistakable signal that Geron may finally be nearing the lucrative promised land after getting mired in drug development purgatory for decades.

Apple Ramps Up AI Capabilities With Acquisition of Startup DarwinAI

Posted on by slightbourne@noblecapitalmarkets.com

Apple is making a concerted push to bring generative artificial intelligence capabilities to its core products and services, as evidenced by its recent acquisition of Canadian startup DarwinAI.

The iPhone maker purchased the AI company earlier this year, according to a report from Bloomberg. While Apple remained characteristically tight-lipped about the deal’s financial terms or strategic rationale, the move signals Apple is accelerating its efforts to match rivals like Microsoft and Google in deploying advanced AI across its offerings.

DarwinAI specialized in using artificial intelligence for visual inspection and analysis during the manufacturing process. Its technology served customers across multiple industries to automatically detect defects and anomalies in components through AI-powered computer vision models.

As part of the acquisition, dozens of DarwinAI employees have been absorbed into Apple’s artificial intelligence division, the report states. This influx of AI talent and technical expertise could prove critical as Apple looks to develop its own large language models and generative AI applications.

Alexander Wong, an AI researcher from the University of Waterloo who co-founded DarwinAI, has assumed a director role overseeing portions of Apple’s AI group. His background aligns with DarwinAI’s focus on building compact, efficient AI systems that can run on-device without constant cloud connectivity.

This thrust toward making AI work smoothly and privately on iPhones, iPads and Macs represents a key priority for Apple as it races to integrate generative AI across its mobile operating systems and productivity software over the next year.

At the company’s annual shareholder meeting in early March, CEO Tim Cook confirmed Apple’s intentions to “break new ground in generative AI in 2024,” citing the “breakthrough potential” and “transformative opportunities” it creates for enhancing user experiences around productivity, problem-solving and more.

Specific areas where Apple may deploy generative AI span Siri’s voice assistant capabilities, automated summarization in apps like Mail and Messages, and content creation tools within Pages, Keynote and other office productivity programs. The technology could even extend to areas like automated music playlist curation.

For the AppleCare product support team, generative AI may be leveraged to better assist customers troubleshoot technical issues by suggesting solutions based on conversational prompts. This could represent a major upgrade over today’s more manually intensive processes.

Ultimately, Apple’s biggest advantages revolve around its ability to build tighter hardware/software integration and maintain strict privacy guardrails unavailable to cloud-based rivals. The company aims to run its generative AI models directly on user devices rather than routing data to remote servers – a key differentiator from competitors like Microsoft and Google.

“We see incredible breakthrough potential for generative AI, which is why we’re currently investing significantly in this area,” Cook told shareholders.

Still, Apple faces an uphill battle catching up to the generative AI leaders. While the iPhone maker’s cautious approach focuses on curating secure AI experiences, companies like OpenAI, Anthropic and Google have rapidly advanced their public-facing products and pushed the boundaries of what’s possible with large language models.

Microsoft has already integrated AI co-pilots across its entire suite of Office apps and cloud services through partnerships with OpenAI, Anthropic and others. Google has made generative AI like Bard a centerpiece of its efforts to modernize search and productivity tools.

With developers and companies increasingly exploring AI customization and co-pilots that can streamline workflows, Apple may feel pressure to open up its ecosystem to third-party generative AI tools in the near future.

The DarwinAI acquisition represents an early step for Apple to transform itself into a formidable AI player. But just like the company’s iconic “Get a Mac” ads from years past, it may take some additional star power and rebranding to recast Apple as the face of consumer-friendly, privacy-focused artificial intelligence going forward.

Release – Harte Hanks Reports Fourth Quarter and Fiscal 2023 Full-Year Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on HHS

  • Project “Elevate” Sales and Marketing Transformation Revamped for Strategic Growth;
  • Anticipate approximately $6 Million in 2024 Cost Reductions, $16 Million over Two Years;
  • Ends Year with $18 Million of Cash and No Debt

CHELMSFORD, MA / ACCESSWIRE / March 14, 2024 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for over 100 years, today announced financial results for the fourth quarter and year ended December 31, 2023.

Kirk Davis, Chief Executive Officer, said: “ Project Elevate , the outcome of a comprehensive review of our business in collaboration with newly hired executive sales leadership and respected consultants, is designed to modernize our go-to-market strategy, invest in lead generation, and enable organic growth. We have added two experienced sales leaders in Kelly Waller, our new SVP of sales and marketing, and Ron Lee, our new SVP of sales services. These two accomplished sales executives are the ideal people to drive the key components of our organic growth initiatives forward. More recently, we added additional experienced personnel to lead international sales expansion, grow our newly created partner network, and form our company’s first inside sales division. These talented people are in place, and we are rapidly improving our marketing programs, value proposition, and pipeline formulation to effectively capitalize on our core competencies and key differentiators.”

“Over the next few quarters, we will be expanding our enterprise-wide revenue pipeline, participating in numerous high-profile events that facilitate one-to-one meetings with decision makers, and growing a robust partnership network,” continued Davis. “These initiatives are bolstered by a revised incentive structure for our sales team, better alignment between business units, and a clear focus on the SMB and mid-market segments. We expect these changes will drive consistent pipeline growth and enhance our sales performance over the course of the year. We’ve accomplished an end-to-end transformation of our sales and marketing strategy and structure, and the team is now in place to drive organic growth.”

“Simultaneously, we are taking steps, in collaboration with the Kearney Organization, to optimize our cost structure to enable us to invest in sales and marketing without depleting our cash reserves,” continued Davis. “We have identified costs we can eliminate totaling approximately $16 million over next two years with $6 million of savings expected in 2024. David Fisher, our new Chief Transformation Officer, is working closely with David Garrison, our new Chief Financial Officer, to execute these important changes.”

“I believe the opportunity for Harte Hanks is significant,” concluded Davis. “Our solutions meet the current and expected needs of customers, and we drive tangible value for clients and their customers. We can deliver organic growth, expanding the number of logos we work with and deepening our relationship with these customers over time. We are confident that we can streamline our organization to expand profitability and cash generation as we grow. The benefits of Project Elevate are expected to become evident in the second half of 2024 and into 2025.”

Fourth Quarter Highlights

  • The Company ended the year with a cash balance of $18.4 million compared to $10.4 million at December 31, 2022, and $13.3 million at September 30, 2023, with zero debt.
  • Extended the current $25 million line of credit until June 30, 2025.
  • Executing, as planned, the termination of Pension Plan 1.
  • Total revenues for Q4 2023 were $49.5 million, down 9.7% compared to $54.8 million in Q4 2022; included in 2023 was $2.5 million of revenue from InsideOut compared to $1.0 million in the fourth quarter of 2022.
  • Operating loss was $2.3 million compared to operating income of $3.4 million in the prior-year quarter.
  • Harte Hanks recorded $5.7 million in non-recurring restructuring charges, related primarily to consulting expenses tied to the development and execution of Project Elevate and other cost-reduction initiatives, as well as severance and lease impairment charges. There were no restructuring charges in the fourth quarter of last year.
  • Net loss, inclusive of the $5.7 million in restructuring charges, was $2.0 million, or $0.27 per basic and diluted share, compared to net income of $21.8 million, or $2.81 per basic and $2.70 per diluted share, in the prior year quarter. The fourth quarter of 2022 included a $19.8 million tax benefit.
  • The fourth quarter of 2023 had negative EBITDA of $1.1 million compared to positive EBITDA of $4.4 million in the same period in the prior year. Adjusted EBITDA, which excludes stock-based compensation, severance and restructuring charges, was $5.2 million in both Q4 2023 and 2022.

Segment Highlights

  • Customer Care, $17.7 million in revenue, 36% of total – Segment revenue increased $1.0 million or 6.0% versus the prior year and EBITDA totaled $3.7 million for the quarter, up 14.6% year-over-year. InsideOut contributed an increase of $1.4 million to revenue in the fouth quarter compared to same quarter in 2022. The increase in revenue from the sales services group offset the $0.4 million decrease in our traditional CX business.
  • Fulfillment & Logistics Services, $21.3 million in revenue, 43% of total – Segment revenue decreased $3.2 million or 12.9% versus the prior year quarter and EBITDA totaled $1.9 million, down 17.2%. Revenue mix and a 12.2% decrease in operating expenses drove the improved EBITDA margins. The margin percentage continues to be impacted by variation in the revenue mix between lower margin logistics and the higher margin fulfillment services.
  • Marketing Services, $10.5 million in revenue, 21% of total – Segment revenue decreased $3.1 million or 23.1% compared to the prior year quarter and EBITDA for the fourth quarter totaled $1.4 million vs. $2.1 million. The decrease in revenue was attributable to reduced project work in the financial services sector.

Consolidated Fourth Quarter 2023 Results

Fourth quarter revenues were $49.5 million, down 9.7% from $54.8 million in the fourth quarter of 2022 due to decreased revenue in two of the Company’s operating segments.

Fourth quarter operating loss was $2.3 million, compared to income of $3.4 million in the fourth quarter of 2022. The decrease resulted from a restructuring expense during the quarter.

Net loss for the quarter was $2.0 million, or $0.27 per basic and diluted share, compared to net income of $21.8 million, or $2.81 per basic and $2.70 per diluted share, in the fourth quarter last year. The net loss included $5.7 million of restructuring expense, without which the Net Income is estimated to be $3.7 million for the quarter. The net income for the fourth quarter of 2022 included a one time tax asset valuation reversal benefiting more than $19.8 million, without this the net income would have only been $2.0 million. Discounting for the two events in the respective fourth quarters, the estimated net income improvement was $1.7 million.

Consolidated Full Year 2023 Results

Full-year revenues were $191.5 million, down 7.2% from $206.3 million in 2022. Operating income was $3.4 million, compared to operating income of $15.1 million. Net loss for the year was $1.6 million, or $0.21 per basic and $0.21 per diluted share, compared to net income of $36.8 million, or $4.98 per basic and $4.75 per diluted share, last year.

Balance Sheet and Liquidity

Harte Hanks ended the year with $18.4 million in cash and cash equivalents and $24.2 million of capacity on its credit line. The Company has no outstanding debt as of December 31, 2023. The Company’s financial position continues to be strong, and it is well-positioned to execute on its long-term growth strategies in 2024 and beyond.

Conference Call Information

The Company will host a conference call and live webcast to discuss these results at 4:30 p.m. EST today, March 14, 2024. Interested parties may access the webcast at https://www.webcaster4.com/Webcast/Page/2810/49883 or may access the conference call by dialing 888-506-0062 in the United States or 973-528-0011 from outside the U.S. and using access code 692780.

A replay of the call can also be accessed via phone through March 28, 2024 by dialing (877) 481-4010 from the U.S., or (919) 882-2331 from outside the U.S. The conference call replay passcode is 49883.

About Harte Hanks:

Harte Hanks (NASDAQ: HHS ) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.

Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea, Sony and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.

For more information, visit hartehanks.com

As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks, Inc.

Cautionary Note Regarding Forward-Looking Statements:

Our press release and related earnings conference call contain “forward-looking statements” within the meaning of U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements other than historical facts are forward-looking and may be identified by words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “seeks,” “could,” “intends,” or words of similar meaning. These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements. In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments. These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) market conditions that may adversely impact marketing expenditures, and (ii) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (iii) the demand for our products and services by clients and prospective clients, including (iv) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (vi) our ability to predict changes in client needs and preferences; (b) economic and other business factors that impact the industry verticals we serve, including competition, inflation and consolidation of current and prospective clients, vendors and partners in these verticals; (c) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (d) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (e) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (f) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (g) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (h) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (i) the number of shares, if any, that we may repurchase in connection with our repurchase program; (j) unanticipated developments regarding litigation or other contingent liabilities; (k) our ability to complete reorganizations, including cost-saving initiatives; and (l) other factors discussed from time to time in our filings with the Securities and Exchange Commission, including under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 which was filed on March 31, 2023. The forward-looking statements in this press release and our related earnings conference call are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.

Supplemental Non-GAAP Financial Measures:

The Company reports its financial results in accordance with generally accepted accounting principles (“GAAP”). However, the Company may use certain non-GAAP measures of financial performance in order to provide investors with a better understanding of operating results and underlying trends to assess the Company’s performance and liquidity in this press release and our related earnings conference call. We have presented herein a reconciliation of these measures to the most directly comparable GAAP financial measure.

The Company presents the non-GAAP financial measure “Adjusted Operating Income” as a useful measure to both management and investors in their analysis of the Company’s financial results because it facilitates a period-to-period comparison of Operating Income excluding stock-based compensation and severance. The most directly comparable measure for this non-GAAP financial measure is Operating Income.

The Company presents the non-GAAP financial measure “EBITDA” as a supplemental measure of operating performance in order to provide an improved understanding of underlying performance trends. The Company defines “EBITDA” as Net Income adjusted to exclude income tax expense, other expense (income), net, and depreciation and amortization expense. The Company defines “Adjusted EBITDA” as EBITDA adjusted to exclude stock-based compensation and severance. The most directly comparable measure for EBITDA and Adjusted EBITDA is Net Income. We believe EBITDA and Adjusted EBITDA are an important performance metric because it facilitates the analysis of our results, exclusive of certain non-cash items, including items which do not directly correlate to our business operations; however, we urge investors to review the reconciliation of non-GAAP EBITDA to the comparable GAAP Net Income, which is included in this press release, and not to rely on any single financial measure to evaluate the Company’s financial performance.

The use of non-GAAP measures do not serve as a substitute and should not be construed as a substitute for GAAP performance but should provide supplemental information concerning our performance that our investors and we find useful. The Company evaluates its operating performance based on several measures, including these non-GAAP financial measures. The Company believes that the presentation of these non-GAAP financial measures in this press release and earnings conference call presentations are useful supplemental financial measures of operating performance for investors because they facilitate investors’ ability to evaluate the operational strength of the Company’s business. However, there are limitations to the use of these non-GAAP measures, including that they may not be calculated the same by other companies in our industry limiting their use as a tool to compare results. Any supplemental non-GAAP financial measures referred to herein are not calculated in accordance with GAAP and they should not be considered in isolation or as substitutes for the most comparable GAAP financial measures.

Investor Relations Contact:

Rob Fink or Tom Baumann
646.809.4048 / 646.349.6641
FNK IR
HHS@fnkir.com

View full release here.

SOURCE: Harte Hanks, Inc.