Month: January 2025

Release – Zomedica Announces License & Supply Agreement with Cresilon Inc. to Market and Sell Vetigel(R) Hemostatic Gel in the Animal Health Market

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZOM

License Agreement Expands Zomedica’s Portfolio with Revolutionary Hemostatic Technology

ANN ARBOR, MI / ACCESSWIRE / January 7, 2025 / Zomedica Corp. (NYSE American:ZOM) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, today announced that it had entered into a license and supply agreement with Cresilon, Inc. to market and sell the Vetigel® hemostatic gel product line on an exclusive basis in the United States and on a non-exclusive basis outside the United States.

Under the terms of the agreement, Zomedica will assume responsibility for supplying U.S. customers and will collaborate with Cresilon to support customers outside the U.S. This partnership enables Zomedica to further its mission of delivering innovative solutions that enhance patient care and operational efficiency for veterinary practitioners.

Vetigel is a groundbreaking, plant-based formula designed to stop bleeding rapidly when applied directly to the source. Unlike traditional methods, Vetigel halts bleeding in seconds without becoming incorporated into the clot. The product has been validated in clinical studies reported in white papers, demonstrating its ability to save time during surgical procedures and significantly reduce blood loss in patients. Key applications include:

  • Surgical Procedures: Effective in controlling bleeding during soft organ biopsies and excisions;
  • Dental Applications: Successfully used to manage bleeding in routine and advanced dental procedures;
  • Emergency Care: Proven efficacy in treating venous and arterial bleeds; and
  • Liver Biopsy: Demonstrated to stop bleeding faster than competitive hemostatic agents.

“We are excited to add Vetigel® to Zomedica’s portfolio of innovative veterinary products,” said Kevin Klass, Senior Vice President of Sales at Zomedica. “Vetigel’s ability to rapidly stop bleeding across a variety of procedures makes it an invaluable tool for veterinarians, enabling them to enhance patient outcomes while improving surgical efficiency. This partnership with Cresilon allows us to bring cutting-edge solutions to veterinary professionals in the U.S. and beyond.”

Greg Blair, Zomedica’s Senior Vice President, Business Development & Strategic Planning, added, “This new venture with Cresilon is another way Zomedica stays true to our mission of enhancing the quality of care for pets, increasing pet parent satisfaction, and improving the workflow, cash flow, and profitability of veterinary practices. By bringing innovative solutions like Vetigel to market, we are empowering veterinarians to deliver better outcomes and experiences for their patients and clients.”

“This partnership with Zomedica is ideal for the future of Vetigel,” said Joe Landolina, CEO of Cresilon. “Zomedica’s established reputation, robust field sales team, and commitment to veterinary excellence make them the perfect match for expanding the reach of this revolutionary product. Together, we look forward to making Vetigel an essential tool for veterinary practices worldwide.”

Vetigel’s versatility and proven efficacy make it a game-changer for veterinary practices, addressing critical needs in both routine and emergency settings. Zomedica looks forward to expanding access to this exciting technology to more customers leveraging our existing field sales team, frequent trade show programs, and weekly continuing education programs.

For more information about Vetigel hemostatic gel, please visit https://zomedica.com/vetigel.

About Zomedica
Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW® digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $78 million in liquidity as of September 30, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information about Zomedica and our full range of products visit www.zomedica.com.

About Cresilon
Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping bleeding in seconds. The company’s current and future product lines target trauma care, biosurgery, and animal health. Cresilon’s mission is to save lives. For more information about Cresilon, which was named to Fast Company’s annual list of the World’s Most Innovative Companies of 2024, ranking No. 1 in the medical devices category, visit www.cresilon.com.

Follow Zomedica

Cautionary Note Regarding Forward-Looking Statements
Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.

Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to successfully integrate acquisitions; uncertainty as to Cresilon’s ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products, including acceptance of the Vetigel® hemostatic gel line; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including meeting distribution obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

Investor Relations Contact:
Zomedica Investor Relations
investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.

Release – CVG Announces New Structure to Support Market-Focused Strategy

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on CVGI

NEW ALBANY, Ohio, Jan. 07, 2025 (GLOBE NEWSWIRE) — Commercial Vehicle Group (the “Company” or “CVG”) (NASDAQ: CVGI), a diversified industrial products and services company, today announced that its Board of Directors has authorized the Company to implement a new organizational structure designed to enhance alignment with its customers and end markets, effective January 1, 2025.

Under this new structure, CVG will reorganize its vertical business units into the following three operating divisions and reporting segments.

  • Global Electrical Systems
  • Global Seating
  • Trim Systems and Components

As part of this realignment, the Company’s Aftermarket & Accessories business unit will be absorbed in these three segments. Its seating and electrical portfolio will transition to Global Seating and Global Electrical Systems, respectively. Its wiper systems will become part of the newly formed Trim Systems and Components business unit in addition to the trim and components businesses from the prior Vehicle Solutions segment.

Russell Ketteringham will lead the seating business as President, Global Seating, transitioning from President, Global Vehicle Solutions. Donald Fishel will lead the new trim systems and components business as President, Trim Systems and Components in addition to his Business Development responsibilities. Peter Lugo will continue to lead the Electrical Systems segment.

In 2024, CVG streamlined its operating model and lowered its cost profile as part of its strategic portfolio rationalization. CVG expects this new structure to enhance clarity and focus, with each business unit positioned to deliver on its specific strategic and operational objectives while executing initiatives to advance key priorities. The realignment better positions CVG for future growth, while lowering corporate and administrative costs to align with the company’s current revenue profile.

“This new organizational structure is an important step in our transformation to become a more agile company that puts our customers and our markets first,” said James Ray, President, and CEO of CVG. “We anticipate that our new structure will accelerate our operational momentum and drive higher growth through a product-focused, customer-centric enterprise strategy.”

CVG expects to begin reporting results under the new reportable segment structure beginning with the first quarter 2025 results, and the Company expects to provide historical quarterly segment results under the new structure at that time as well.

About CVG

At CVG, we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about CVG and its products is available at www.cvgrp.com.

Investor Relations Contact:
Ross Collins or Stephen Poe
Alpha IR Group
CVGI@alpha-ir.com

Media Contact:
Patrick Woolford
Director, Communications
Patrick.Woolford@cvgrp.com

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Source: Commercial Vehicle Group, Inc.

Release – FreightCar America, Inc. Announces Agreement to Redeem All Outstanding Preferred Shares with New Term Loan

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on RAIL

New financing arrangement reduces Company’s cost of capital by approximately 40%

Further enhances financial flexibility, cash generation and ability to support growth strategy

CHICAGO, Jan. 06, 2025 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL) (“FreightCar America” or the “Company”), a diversified manufacturer and supplier of railroad freight cars, railcar parts and components, today announced it has completed a new term loan facility. The proceeds from the term loan will be used to redeem all outstanding shares of Series C Preferred Stock, as well as settle all related accrued dividends.

Highlights:

  • The Company closed a $115 million 4-year term loan agreement on December 31st, 2024 (the “Term Loan”).
  • Proceeds from the Term Loan were used to redeem all 85,412 shares of Series C Preferred Stock that were outstanding and all accrued dividends as of December 31st, 2024.
  • The Term Loan is priced at SOFR + 600, which will reduce the Company’s existing cost of capital by approximately 40%, resulting in savings of approximately $9.2 million in the first year, or approximately $0.26 per share on a fully diluted basis.

Mike Riordan, Chief Financial Officer of FreightCar America, commented, “As further testament to the strength and momentum of FreightCar America, I am extremely pleased to announce that we have taken an important step to improve our capital structure and lower borrowing costs. The completion of this financing along with the retirement of our Series C Preferred Stock enhances our financial flexibility, cash flow generation and allows us to continue executing our growth strategy with even greater confidence and agility.”

For additional information about the Company’s update, please refer to the Company’s Form 8-K filed today with the Securities and Exchange Commission.

About FreightCar America

FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com.

Investor Contact   RAILIR@Riveron.com 

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Source: FreightCar America, Inc.

Disney and Fubo Join Forces: A Game-Changing Merger in Streaming TV

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Disney to control 70% of combined streaming entity worth over $6 billion
– Merger creates 6.2 million subscriber base across North America
– Deal settles antitrust litigation and reshapes sports streaming landscape

The streaming TV landscape shifted dramatically today as Disney announced plans to merge its Hulu + Live TV business with sports-focused FuboTV, creating a powerhouse that will reshape how millions of Americans consume live content. The deal, which gives Disney a 70% controlling stake in the combined entity, marks 2025’s first major media consolidation.

The merger creates one of the largest digital pay-TV providers in North America, with over 6.2 million subscribers and projected revenue exceeding $6 billion. Under the agreement, the combined business will operate under the Fubo publicly traded company name, with current Fubo shareholders retaining 30% ownership.

David Gandler, Fubo’s co-founder and CEO, who will lead the new entity, emphasized the strategic benefits of increased scale. The merger provides Fubo with immediate access to $220 million in cash, plus an additional $145 million in committed financing available in January 2026, strengthening its position for future growth and investment.

The deal notably resolves Fubo’s ongoing antitrust litigation with Disney, Fox, and Warner Bros. Discovery regarding the Venu Sports platform. This settlement removes a significant obstacle to the planned sports streaming service and positions the combined company to offer more flexible content packages to consumers.

The merger addresses several key challenges in the streaming landscape. For Fubo, which has struggled with high content costs and subscriber churn, the partnership provides crucial financial stability and enhanced content access, including ESPN+ through new distribution agreements. For Disney, the deal strengthens its position in the increasingly competitive streaming market while expanding its reach in sports content delivery.

Looking ahead, the combined company plans to maintain distinct service offerings. Hulu + Live TV will continue its focus on entertainment-based cable replacement, while Fubo will expand its sports and news offerings. Gandler highlighted the potential for creating “skinnier” bundles tailored to specific consumer preferences, addressing a long-standing market demand for more flexible viewing options.

The market has responded positively to the announcement, with Fubo’s shares surging nearly 250% following the news. The combination is expected to achieve immediate positive cash flow, addressing previous profitability concerns in the streaming sector.

This strategic merger represents a significant evolution in the streaming industry’s maturation, potentially setting the stage for further consolidation as providers seek scale and profitability in an increasingly competitive market. The deal’s success could provide a blueprint for future media partnerships aimed at balancing content costs, subscriber growth, and sustainable business models.

Release – MAIA Biotechnology Announces Clinical Supply Agreement with BeiGene for Upcoming Phase 2 Trials in Three Cancer Indications

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

January 07, 2025 9:12am EST Download as PDF

  • Phase 2 pivotal trials to evaluate efficacy of THIO in combination with BeiGene’s checkpoint inhibitor (CPI) tislelizumab

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 a clinical supply agreement with global oncology company BeiGene to assess the efficacy of THIO, its small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune checkpoint inhibitor (CPI) tislelizumab in three cancer indications. The single arm pivotal Phase 2 trials will study the drug combination in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and colorectal cancer (CRC).

MAIA’s preclinical results in HCC, with THIO in combination with a CPI, showed complete, durable and highly potent anti-tumor immune response. Preclinical results of THIO treatment in SCLC showed profound activation of innate and adaptive anti-tumor responses. In CRC pre-clinical studies, THIO administered in sequence with a CPI resulted in 100% complete response and anticancer immune memory was induced, resulting in no recurrence after rechallenge with 10x more CRC cells and no additional therapy. In all preclinical studies, THIO converted immunologically cold and non-responsive tumors into hot tumors that are responsive to a CPI.

“Based on excellent pre-clinical results, THIO was awarded orphan drug designation (ODD) for the treatment of both HCC and SCLC. Along with a third ODD in glioblastoma, the FDA has clearly recognized THIO’s potential as an effective treatment for multiple cancer indications. Comparatively, most oncology compounds at this stage of development have only one indication,” said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. “BeiGene’s tislelizumab has also demonstrated its potential to deliver clinically meaningful outcomes across a range of tumor types. We are pleased to partner with BeiGene for these important studies, two of which address the top three most lethal cancers worldwide.”

Under the terms of the collaboration, MAIA will sponsor and fund the planned clinical trials and BeiGene will provide tislelizumab. MAIA maintains global development and commercial rights to THIO and is free to develop the programs in combination with other agents and in other indications.

MAIA is targeting accelerated FDA approvals in each of the three indications to be studied along with non-small cell lung cancer (NSCLC), the focus of a current Phase 2 clinical trial of THIO with a CPI.

Market Trends

Hepatocellular carcinoma is the third most common cause of cancer-related deaths globally. The market for HCC was valued at $780 million in 2023 and is expected to increase to grow at a CAGR of 6.3% to $1.5 million by 2034.1

Small cell lung cancer accounts for an estimated 15% of all lung cancer globally. The global SCLC therapeutics market is valued at approximately $6.5 billion in 2024 and is expanding at an estimated CAGR of 12.3% from 2024 to 2034.2

Colorectal cancer is the second leading cause of cancer-related deaths globally.3 Approximately 85% of all CRC cases are classified as microsatellite stable. MSS tumors are “cold tumors” that typically do not trigger the body’s immune system. The global CRC therapeutics market size was $9.26 billion in 2018 and is projected to reach $26.49 billion by 2032.4

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

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.

1 IMARC, Hepatocellular Carcinoma Market: Epidemiology, Industry Trends…, 2023.
2Precedence Research, Small Cell Lung Cancer Therapeutics Market Size… 2024 to 2034, October 2024.
3World Health Organization, Fact Sheet: Colorectal Cancer, July 2023.
4 Fortune Business Insights, Colorectal Cancer Therapeutics Market…, August 2024.

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

Source: MAIA Biotechnology, Inc.

Released January 7, 2025

Release – Unicycive Therapeutics Announces Publication of Positive Oxylanthanum Carbonate (OLC) Dose Escalation Data in Clinical and Translational Science

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

January 07, 2025 7:00am EST Download as PDF

LOS ALTOS, Calif., Jan. 07, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that data from the Company’s oxylanthanum carbonate (OLC) Phase 1 dose escalation study in healthy volunteers was published in the peer-reviewed journal, Clinical and Translational Science.

The publication, entitled “Safety and Phosphate-Binding Capacity of Oxylanthanum Carbonate in Healthy Volunteers,” described a study evaluating the safety of escalating doses of OLC (500 mg, 1,000 mg, 1,500 mg, or 2,000 mg administered three times a day). In the trial, OLC was well tolerated and reduced phosphate absorption, as demonstrated by dose-dependent decreases in urinary phosphorus excretion from baseline during treatment.

“We are pleased with the safety findings across escalating doses of OLC and the publication in the peer-reviewed journal Clinical and Translational Science,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “These positive data are a key component of our OLC New Drug Application (NDA), which is currently under review by the FDA with a Prescription Drug User Fee Action (PDUFA) date of June 28, 2025.”

The objective of the OLC dose-escalation study was to demonstrate the safety of escalating doses of orally administered OLC in healthy participants. A total of 32 participants were treated with OLC swallowable tablets or placebo tablets dosed three times per day (TID) and randomized 3:1 per arm across four OLC treatment arms of 500 mg, 1000 mg, 1500 mg and 2000 mg administered with meals over four days. The primary endpoint was safety, and the secondary endpoints measured phosphate binding capacity using the surrogate markers of phosphorus excreted in urine and feces and pharmacokinetics of OLC. The drug was well tolerated during the treatment period. Overall, there were no serious adverse events (SAE), severe or life-threatening AEs (Grade 3-4), deaths, or AEs leading to discontinuation. Most treatment-emergent adverse events (TEAE) were mild in severity. Across all treatment arms, urinary phosphorus excretion decreased from baseline in a dose-dependent manner during treatment with OLC and fecal phosphorus excretion increased from baseline.

The full publication can be accessed here.

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4

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

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

Forward-looking statements

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

Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.
2 Fortune Business InsightsTM, Hyperphosphatemia Treatment Market, 2023-2030
3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM 
4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com

SOURCE: Unicycive Therapeutics, Inc.

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FreightCar America (RAIL) – FreightCar America Lowers its Cost of Capital

Posted on by cpereira@noblefcm.com


Tuesday, January 07, 2025

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

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

Redemption of preferred stock. FreightCar America closed a $115 million four-year term loan on December 31, 2024. The loan is priced at the secured overnight financing rate (SOFR) plus 600 basis points. Proceeds from the term loan were used to redeem all 85,412 shares of Series C preferred stock for a total redemption price of $113,274,739, including accrued dividends of $27,862,739. Recall that the dividends accrued at a rate of 17.5% per annum on the initial stated value of the preferred stock.

Lower cost of capital. The completion of the term loan financing, along with the retirement of the Series C preferred stock, enhances the company’s financial flexibility, cash flow profile, and lowers borrowing costs. Most recently, the secured overnight financing rate was ~4.40%.


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. 

Kratos Defense & Security (KTOS) – Awarded Largest Contract in Company History

Posted on by cpereira@noblefcm.com


Tuesday, January 07, 2025

Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms, and systems for United States National Security related customers, allies, and commercial enterprises. Kratos is changing the way breakthrough technologies for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research, and streamlined development processes. At Kratos, affordability is a technology, and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training and combat systems and next generation turbo jet and turbo fan engine development. For more information go to www.kratosdefense.com.

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

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

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

Award. Kratos announced yesterday that it was awarded a five-year OTA contract for the Multi-Service Advanced Capability Hypersonic Test Bed (MACH-TB) 2.0 under Task Area 1. The total value of this award, if all options are exercised over the five-year period, is  $1.45 billion, which would be the largest contract in the Company’s history.

Tasks. Kratos was awarded the prime role in Task Area 1 Systems Engineering, Integration, and Testing (SEIT), to include integrated subscale, full-scale, and air launch services to address the need to affordably increase hypersonic flight test cadence. Kratos will lead a team of subcontractors that will provide systems engineering, assembly, integration, and test (AI&T), mission planning and execution, and launch services.


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 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. 

Graham Corp. (GHM) – Raising Price Target

Posted on by cpereira@noblefcm.com


Tuesday, January 07, 2025

Graham Corporation designs, manufactures and sells critical equipment for the energy, defense and chemical/petrochemical industries. The Company designs and manufactures custom-engineered ejectors, vacuum pumping systems, surface condensers and vacuum systems. It is a nuclear code accredited fabrication and specialty machining company. It supplies components used inside reactor vessels and outside containment vessels of nuclear power facilities. Its equipment is found in applications, such as metal refining, pulp and paper processing, water heating, refrigeration, desalination, food processing, pharmaceutical, heating, ventilating and air conditioning. For the defense industry, its equipment is used in nuclear propulsion power systems for the United States Navy. The Company’s products are used in a range of industrial process applications in energy markets, including petroleum refining, defense, chemical and petrochemical processing, power generation/alternative energy and other.

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

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

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

Strong Performance. Since the beginning of November, GHM shares have risen from approximately $30 to over $45, exceeding our $45 price target, which we had raised on November 8th. We believe the positive stock performance reflects investors’ increased awareness of Graham’s current operating performance and future potential.

Defense Opportunity. Graham already has a significant billion dollar plus opportunity with the U.S. Navy. The incoming Trump Administration is likely to drive defense spending at an increased pace, potentially targeting areas in which Graham specializes for even faster growth.


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. 

Biden’s Last-Minute Offshore Drilling Ban

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Ban protects 625 million acres of federal waters from new oil and gas development
– Trump pledges reversal but faces legal hurdles without Congressional support
– Decision impacts East, West coasts and parts of Alaska while preserving current operations

President Joe Biden has announced a sweeping ban on new offshore oil and gas development across vast stretches of U.S. coastlines, creating a potential environmental legacy that his successor may struggle to dismantle. The executive action, protecting 625 million acres of ocean, represents a significant move in Biden’s climate agenda just weeks before the presidential transition.

The ban covers federal waters off the East and West coasts, the eastern Gulf of Mexico, and portions of Alaska’s northern Bering Sea. While largely symbolic, as it doesn’t affect areas with active drilling operations, the decision aligns with Biden’s broader environmental goals, including his commitment to conserve 30% of U.S. lands and waters by 2030.

The timing of this decision carries particular significance, as President-elect Donald Trump has explicitly stated his intention to reverse the ban immediately upon taking office. However, legal precedent suggests this may be more challenging than anticipated. A 2019 court ruling established that while the 70-year-old Outer Continental Shelf Lands Act grants presidents the authority to withdraw areas from drilling, it doesn’t provide the power to reverse such withdrawals without Congressional action.

Industry impact appears limited, as only 15% of U.S. oil production comes from federal offshore acreage, primarily in the Gulf of Mexico. This share has been declining over the past decade as onshore drilling, particularly in Texas and New Mexico, has transformed the United States into the world’s leading oil and gas producer.

The American Petroleum Institute has criticized the decision, arguing it threatens energy security and urging policymakers to reverse what they term a “politically motivated decision.” Conversely, environmental groups like Oceana celebrate the move as a victory for coastal communities and marine ecosystems.

The ban’s geographical scope notably includes areas where Trump himself had previously prohibited drilling during his re-election campaign, including waters off Florida, Georgia, South Carolina, North Carolina, and Virginia. This overlap highlights the bipartisan nature of coastal protection concerns, as many Republican-led coastal states have historically opposed offshore drilling due to its potential impact on tourism.

Biden’s decision invokes the memory of the 2010 Deepwater Horizon disaster, arguing that the minimal drilling potential in the protected areas doesn’t justify the public health and economic risks associated with future leasing. The administration emphasizes that the ban aligns with both environmental protection goals and practical risk assessment.

Looking ahead, the ban’s durability will likely depend on Congressional willingness to intervene, as well as potential legal challenges. The decision adds another layer to the complex relationship between federal energy policy and environmental protection, setting up a significant early test for the incoming Trump administration’s energy agenda.

Release – Bit Digital, Inc. Completes Transition from Foreign Private Issuer Status to Domestic Filer Status

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on BTBT

NEW YORK, January 6, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”), a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York, announced today that as of January 1, 2025, it officially transitioned to domestic issuer status under U.S. securities regulations.

The change reflects the Company’s commitment to transparency, operational growth, U.S. market expectations, and streamlines its regulatory compliance framework.

About Bit Digital

Bit Digital, Inc. is a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York City. Our bitcoin mining operations are located in the US, Canada, and Iceland. 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 (“Annual Report”). Notwithstanding the fact that Bit Digital Inc. has not conducted operations in the PRC since September 30, 2021 we have previously disclosed under Risk Factors in our Annual Report: “We may be subject to fines and penalties for any noncompliance with or any liabilities in our former business in China in a certain period from now on.” Although the statute of limitations for non-compliance by our former business in the PRC is generally two years and the Company has been out of the PRC, for more than two years, the Authority may still find its prior bitcoin mining operations involved a threat to financial security. In such event, the two-year period would be extended to five years. 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.

Release – Kratos Receives $1.45B MACH-TB 2.0 Contract Award

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on KTOS

Contract Represents Single Largest Award in Kratos History

SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in Defense, National Security and Global Markets, announced today that it has been awarded a five-year OTA contract for the Multi-Service Advanced Capability Hypersonic Test Bed (MACH-TB) 2.0 under Task Area 1. The total value of this award, if all options are exercised over the five-year period, is $1.45B. The Office of the Under Secretary of Defense for Research and Engineering (OUSD (R&E)) Test Resource Management Center (TRMC) established MACH-TB to support OUSD’s National Hypersonic Initiative 2.0 by creating an affordable flight test bed to rapidly increase hypersonic flight test capacity. MACH-TB 2.0 will provide an affordable bridge between hypersonic ground tests and system level flight tests. This will reduce overall hypersonic development risks and time and provide rapid transition of innovative hypersonic technologies to the warfighter.

George Rumford, Director of the Test Resource Management Center, said, “We are excited to continue the success of the MACH-TB program with this award. MACH-TB is an essential tool to accelerate science and technology experiments into next generation, leap-ahead hypersonic capabilities for our nation.”

“We are honored to be selected to be part of the MACH-TB 2.0 integrated team. The nation is at a critical point in the need for rapid and affordable hypersonic flight testing to quickly develop and field hypersonic technologies and the MACH-TB program is filling that need,” said Michael Johns, Senior Vice President of Kratos SRE.

Kratos was awarded the prime role in Task Area 1 Systems Engineering, Integration, and Testing (SEIT), to include integrated subscale, full-scale, and air launch services to address the need to affordably increase hypersonic flight test cadence. Kratos will lead a team of subcontractors that will provide systems engineering, assembly, integration, and test (AI&T), mission planning and execution, and launch services. Key teammates on the Kratos team include Leidos, Rocket Lab, Koda Technologies, Corvid Technologies, Northwind, JRC, Stratolaunch, CFD Research, PAR Systems, University of Minnesota, and Purdue University among many others.

Dave Carter, President of Kratos Defense and Rocket Support Services Division, said, “With the recent successes of our low-cost Erinyes Hypersonic Flyer and Zeus Solid Rocket Motors, Kratos is a leader in the testing and fielding of hypersonic systems. We are very excited to bring this unmatched expertise to the MACH-TB 2.0 program.”

Eric DeMarco, President & CEO of Kratos Defense & Security Solutions, Inc., said, “Kratos is honored to receive the largest contract award in our company’s history, a testament of the value Kratos’ employees and team bring both to our Company and United States National Security. This programmatic milestone underscores our unwavering commitment to making upfront investments for rapidly developing, and being first to market with affordable, mission-critical solutions that meet the evolving needs of the warfighter. The MACH-TB 2.0 program award is an important element of Kratos’ future year organic growth forecast and expectation.”

About Kratos Defense & Security Solutions
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:
Claire Burghoff
claire.burghoff@kratosdefense.com

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

Source: Kratos Defense & Security Solutions, Inc.

Release – DLH Awarded OASIS+ GWAC ID/IQ Contract Vehicle

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on DLHC

ATLANTA, Jan. 06, 2025 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading provider of digital transformation and cybersecurity, science research and development, and systems engineering and integration, today announced that it has been awarded a Governmentwide Acquisition Indefinite Delivery/Indefinite Quantity (“GWAC ID/IQ”) contract to deliver complex professional services and advanced capabilities to various federal agencies. The One Acquisition Solution for Integrated Services (“OASIS+”) contract is an expansive suite that may be used by all federal agencies. The Defense Health Agency, Centers for Disease Control and Prevention, and the Department of Defense are among the major users of this contracting vehicle.

This important award has been a long time in the making, with proposals originally submitted during June 2023. Through this contract vehicle, DLH won a position on all five of the domains for which it submitted a bid: Research and Development Services, Technical and Engineering Services, Intelligence Services and Solutions, Logistics Services and Solutions, and Management and Advisory Services. DLH is one of many prime awardees of the OASIS+ contracts, which includes a base period of five years with one option period of five additional years. OASIS+ has no ceiling nor cap on awards.

“Securing positions on high-value, multiple award ID/IQ contracts is vital to our company’s long term organic growth strategy,” said Zach Parker, DLH President and CEO. “This award materially expands our addressable market and access to bids in important competition areas through which we can leverage our differentiating capabilities.”

About DLH

DLH (NASDAQ: DLHC), a Russell 2000 company, enhances technology, public health, and cyber security readiness missions through science, technology, cyber, and engineering solutions and services. Our experts solve some of the most complex and critical missions faced by federal customers, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,800 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 innovative solutions to improve the lives of millions. For more information, visit www.DLHcorp.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or DLH`s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that the Company or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or DLH’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements in this release include, among others, statements regarding estimates of future revenues, operating income, earnings and cash flow. These statements reflect our belief and assumptions as to future events that may not prove to be accurate. Our actual results may differ materially from such forward-looking statements made in this release due to a variety of factors, including: the risk that we will not realize the anticipated benefits of acquisitions (including anticipated future financial performance and results); the diversion of management’s attention from normal daily operations of the business and the challenges of managing larger and more widespread operations; the inability to retain employees and customers; contract awards in connection with re-competes for present business and/or competition for new business; our ability to manage our debt obligations; compliance with bank financial and other covenants; changes in client budgetary priorities; government contract procurement (such as bid and award protests, small business set asides, loss of work due to organizational conflicts of interest, etc.) and termination risks; the impact of inflation and higher interest rates; and other risks described in our SEC filings. For a discussion of such risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s periodic reports filed with the SEC, including our Annual Report on Form 10-K for the fiscal year ended September 30, 2024 as well as subsequent reports filed thereafter. The forward-looking statements contained herein are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about our industry and business.

Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company does not assume any responsibility for updating forward-looking statements, except as may be required by law.

CONTACTS:
INVESTOR RELATIONS
Contact: Chris Witty
Phone: 646-438-9385
Email: cwitty@darrowir.com