Key Points: – Combined company to focus on ML/AI-powered drug development platform – Decoy shareholders to own 86% of merged entity – Pipeline includes treatments for respiratory viruses and GI cancers
In a strategic move to accelerate the development of next-generation therapeutics, Salarius Pharmaceuticals (NASDAQ: SLRX) announced today its merger with privately-held Decoy Therapeutics in an all-stock transaction. The combined company, which will operate under the Decoy Therapeutics name, aims to leverage artificial intelligence and machine learning to revolutionize peptide conjugate drug development.
The merger brings together Decoy’s proprietary IMP3ACT™ platform, which has already attracted approximately $7 million in non-dilutive funding from prestigious organizations including The Bill & Melinda Gates Foundation, with Salarius’ clinical-stage pipeline and public market presence. Under the terms of the agreement, Decoy shareholders will own approximately 86% of the combined company, with Salarius stockholders retaining the remaining 14%.
“Peptide conjugates have become one of the most important drug classes as measured by prescription rates and revenue growth,” said Rick Pierce, Decoy’s Co-founder and CEO, who will lead the combined company. “Our highly experienced team is excited to be able to unlock significant shareholder value from our IMP3ACT platform, which can rapidly design new peptide conjugate drugs by applying ML and AI tools.”
The merged entity’s immediate focus includes advancing a pan-coronavirus antiviral toward an FDA Investigational New Drug (IND) application within the next 12 months. Additionally, the company plans to develop a broad-acting antiviral targeting flu, COVID-19, and respiratory syncytial virus (RSV), as well as a peptide drug conjugate for gastrointestinal cancers.
David Arthur, Salarius’ CEO, emphasized the strategic rationale: “The compelling science supporting Decoy’s peptide conjugate technology and the company’s management team are truly impressive. Based on our diligence, we believe Decoy is poised to advance multiple drug candidates that address significant unmet needs in numerous therapeutic areas.”
The combined company will maintain Salarius’ ongoing Phase 1/2 clinical trial at MD Anderson Cancer Center while exploring strategic alternatives for its seclidemstat program. The merger has received unanimous approval from both companies’ boards of directors and is expected to close following customary closing conditions.
Advancements Position GEO-CM04S1 as a Leading Vaccine Candidate Addressing Unmet Medical Needs, Especially Among Immunocompromised Patients
ATLANTA, GA, January 13, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in immunotherapies and vaccines against infectious diseases and cancers, is pleased to announce substantial progress in the clinical development of its COVID-19 vaccine portfolio during 2024. These achievements underscore the potential of GEO-CM04S1 to address critical public health needs, particularly among immunocompromised populations.
Project NextGen (PNG) Award
In June 2024, GeoVax received a significant award through the Rapid Response Partnership Vehicle (RRPV), funded by the Biomedical Advanced Research and Development Authority (BARDA) as part of PNG. This award supports a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 compared to an approved COVID-19 vaccine. The study is set to commence in the second half of 2025, with Allucent, a global clinical research organization, selected to conduct and manage the trial.
Chronic Lymphocytic Leukemia (CLL) Interim Study Results
In November 2024, the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1 as a booster vaccine for patients with CLL conducted an interim data review of the study. Following its review, the DSMB recommended that the study should continue enrollment of the experimental arm utilizing GEO-CM04S1, but that the mRNA control arm of the study should be halted as it failed to meet the predetermined primary immune endpoint. This suggests a potentially superior immune response in this vulnerable population. Further enrollment of the remaining patient participants is expected to be completed during 2025.
Completion of Enrollment in Booster Vaccine Study for Healthy Adult Volunteers
GeoVax has successfully completed enrollment in its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster vaccine in healthy adults who previously received COVID-19 vaccines. This study aims to assess the vaccine’s safety and immunogenicity at two different dose levels, with data readouts anticipated in the first half of 2025.
Ongoing Stem Cell Transplant Study
The Company continues to advance its Phase 2 clinical trial of GEO-CM04S1 as a primary vaccine for immunocompromised patients undergoing stem cell transplantation. This study addresses a critical need for effective vaccination strategies in populations that may not respond adequately to existing vaccines.
Potential Benefits of GEO-CM04S1 Over Existing Authorized COVID-19 Vaccines
GEO-CM04S1 offers several potential benefits compared to currently authorized COVID-19 vaccines:
Public Health Impact: By providing robust protection for immunocompromised individuals, GEO-CM04S1 could significantly reduce COVID-19-related risks of morbidity and mortality among such high-risk patient populations.
Durability: Preliminary data suggest that GEO-CM04S1 may offer longer-lasting immunity, potentially reducing the frequency of booster doses required.
Breadth of Protection: The inclusion of both Spike (S) and Nucleocapsid (N) antigens in GEO-CM04S1 may confer broader immunity, making it more effective against a range of variants without the need for frequent reformulation.
Primary Vaccine for Immunocompromised Patients: With approximately 40 million immunocompromised individuals in the U.S. and an estimated 400+ million worldwide, many of whom may not respond adequately to current vaccines, GEO-CM04S1 has the potential to become the preferred vaccine for this population.
Safety. The safety profile of MVA as the platform for GEO-CM04S1 is well-established, with decades of data supporting its use as a smallpox vaccine, as well as its use as a platform with diverse vaccine candidates. This robust safety record is particularly important as the new HHS administration prioritizes transparency and rigorous oversight in vaccine safety evaluation. GEO-CM04S1 aligns with these priorities, offering a scientifically validated platform backed by comprehensive safety data.
Market Potential and Partnering Opportunities
GEO-CM04S1 offers an alternative approach to boosting existing COVID-19 vaccines, providing enhanced and more durable immunity. Its applicability for immunocompromised patients further broadens its public health and commercial value. GeoVax estimates the annual market potential for GEO-CM04S1 to be approximately $30 billion, reflecting the critical medical need to better address high-risk immunocompromised patients. The global need for a next-generation COVID-19 vaccine with the advantages offered by GEO-CM04S1 creates multiple partnering opportunities for GeoVax.
Looking Ahead to 2025
The continued development of GEO-CM04S1 is a key component of GeoVax’s catalyst-rich agenda for 2025. The Company anticipates multiple data readouts and regulatory milestones that will further define the vaccine’s role in combating COVID-19.
“Our progress in 2024 has been remarkable, particularly in advancing GEO-CM04S1 as a next-generation COVID-19 vaccine,” said David Dodd, Chairman & CEO of GeoVax. “The MVA platform underlying our vaccine offers unique advantages, including the potential for broader and more durable protection, which is especially critical for immunocompromised individuals. We are committed to delivering solutions that address unmet medical needs and improve public health outcomes.”
Upcoming Presentations
GeoVax’s CEO, David Dodd, will present the Company’s 2024 progress and future outlook at the following conferences:
Biotech Showcase: January 14, 2025, at 10:30 AM PST
Emerging Growth Conference: January 16, 2025, at 2:35 PM ET
For more information on GeoVax’s portfolio and developments, please visit www.geovax.com
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate during the first half of 2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Completed enrollment in Phase 2 BESTOW trial assessing tegoprubart in kidney transplantation four months ahead of schedule; on track to report topline results in fourth quarter of 2025
Presented updated data on 13 participants from ongoing Phase 1b trial that continue to support safety and tolerability of tegoprubart for prevention of organ rejection in kidney transplantation
Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine
Completed two financings totaling $135 million in combined gross proceeds, with funds expected to support operations through end of 2026
IRVINE, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced a summary of 2024 accomplishments and provided guidance for anticipated 2025 business milestones.
“2024 was a transformative year for Eledon as we achieved multiple key clinical milestones for tegoprubart across kidney, islet cell, and xenograft transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Moreover, the data we reported reinforced the potential of tegoprubart to be a best-in-class immunosuppression therapy to prevent transplant rejection and disrupt the current standard of care. We now look forward to another pivotal year ahead.”
2024 Key Highlights
Completed enrollment of 120 patients in the Phase 2 BESTOW clinical trial approximately four months earlier than originally planned. The Phase 2 trial is designed to assess the safety and efficacy of tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation.
Presented updated data at the American Transplant Congress (ATC) from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Updated data from 13 participants demonstrated that tegoprubart was generally safe and well tolerated, with an overall mean estimated glomerular filtration rate (eGFR) of 70.5 mL/min/1.73m2 at all reported time points after day 30 post-transplant. Two participants completed more than 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m2 at one-year post-transplant.
Announced positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in subjects with type 1 diabetes in an investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute. The data demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody immunosuppression therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.
Announced the use of tegoprubart as part of the immunosuppression treatment regimen used following the first-ever kidney xenotransplant procedure of a genetically modified pig kidney to a human.
Completed two financings for combined total gross proceeds of $135.0 million, before deducting any offering related expenses, which is anticipated to support company operations to the end of 2026.
Anticipated 2025 Milestones
Summer 2025: Report updated interim clinical data from the ongoing Phase 1b and long-term efficacy extension studies of tegoprubart in kidney transplantation.
4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
2025: Report longer-term follow up results from the investigator-led clinical trial at UChicago Medicine Transplant Institute for pancreatic islet transplantation in subjects with type 1 diabetes involving use of tegoprubart as part of immunosuppression regimen.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
100% (9/9) of treated evaluable subjects demonstrated improvement or preservation in visual function compared to untreated eyes at both one and two years
100% (9/9) of treated evaluable subjects demonstrated improvement or stabilization in mobility testing, which was only performed up to one year
Improvement in visual function was statistically significant (p=0.01, treated vs untreated eyes), regardless of mutation at two years
Favorable long-term safety and tolerability profile with no serious adverse events related to OCU400
MALVERN, Pa., Jan. 13, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced a positive 2-year safety and efficacy update for the Phase 1/2 OCU400 clinical trial. OCU400 is intended for the treatment of early to advanced retinitis pigmentosa (RP) in pediatric and adult populations. Currently, about 2 million patients globally (~300,000 in U.S./EU) desperately need rescue, otherwise they can potentially become legally blind at some point in their life. OCU400 is intended to treat all these patients with a one-time therapy.
OCU400 demonstrated meaningful improvement of 2-line gain (10 letters on ETDRS chart) in low-luminance visual acuity (LLVA) in treated eyes when compared to untreated fellow eyes. This treatment effect was statistically significant (p=0.01) in all subjects, regardless of mutation at two years, validating the gene-agnostic mechanism of action for OCU400.
This data highlights the unique therapeutic potential of OCU400. To date, Ocugen’s groundbreaking modifier gene therapy platform provides long-term safety and meaningful improvements in visual function for patients suffering from RP—a condition that leads to progressive vision loss.
“We are thrilled to share these compelling results from the Phase 1/2 OCU400 trial,” said Shankar Musunuri, PhD, MBA, Chairman, CEO, and Co-Founder of Ocugen. “These findings represent a significant step forward in our mission to bring life-changing therapies to patients with inherited retinal disorders and confirm the transformative potential of our modifier gene therapy platform.”
“It is truly remarkable to see the significant improvements in visual acuity in patients treated with OCU400 sustained at two years,” said Syed M. Shah, MD, FACS, Vice Chair for Research and Digital Medicine, Director of Retina Service at Gundersen Health System, La Crosse, Wisconsin. “The broad spectrum of genes and mutations causing RP presents a unique challenge in developing treatments for this unmet need. This is where the promise of mutation-agnostic therapies becomes particularly compelling. OCU400’s demonstrated effectiveness across multiple mutations not only offers hope to RP patients but also opens new possibilities for treating other retinal diseases.”
“Establishing the long-term safety and efficacy of OCU400 demonstrates the durability of this novel gene therapy,” said Huma Qamar, MD, MPH, Chief Medical Officer at Ocugen. “These 2 year low light visual acuity (LLVA) findings, which are the most sensitive measure of visual function, are consistent with the results observed at one year.”
The Phase 3 OCU400 liMeliGhT clinical trial is currently ongoing and on target for BLA submission in the first half of 2026.
About OCU400 OCU400 is the Company’s modifier gene therapy product based on a nuclear hormone receptor (NHR) gene called NR2E3. This gene regulates diverse physiological functions within the retina, such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation, and cell survival. Retinal cells in RP patients have a dysfunctional gene network, and OCU400 resets this network to reestablish a healthy cellular homeostasis—which has the potential to improve vision in patients with RP.
AboutModifierGeneTherapy Modifier gene therapy is designed to fulfill unmet medical needs related to retinal diseases, including IRDs, such as RP and Stargardt disease, as well as multifactorial diseases like dry age-related macular degeneration (dAMD). Our modifier gene therapy platform is based on the use of NHRs, master gene regulators, which have the potential to restore homeostasis—the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, we believe that our modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and to address complex diseases that are potentially caused by imbalances in multiple gene networks. Currently, Ocugen has three modifier gene therapy programs in the clinic: OCU400, OCU410, and OCU410ST. In addition to the OCU400 Phase 3 liMeliGhT clinical trial, the OCU410 Phase 1/2 ArMaDa clinical trial for geographic atrophy (GA) secondary to dAMD and the OCU410ST Phase 1/2 GARDian clinical trial for Stargardt disease are currently underway. GA affects approximately two to three million people in the U.S. and EU combined, and Stargardt disease affects nearly 100,000 people in the U.S. and EU combined.
AboutOcugen,Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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.
CautionaryNoteonForward-LookingStatements Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including,butnotlimitedto,therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU400 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.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.
Twin Hospitality Transaction. On Friday after the market closed, Twin Hospitality Group filed an amended Form 10 providing additional detail regarding the distribution of Twin Hospitality shares to existing FAT Brands shareholders. We believe the distribution and subsequent potential actions will highlight the value of Twin Hospitality and, by extension, FAT Brands shares.
Details. Initially, FAT Brands will own 100% of the equity of Twin Hospitality, consisting of 47,298,271 Class A shares and 2,870,000 Class B shares. Just like at FAT Brands, the B shares are super-voting with 50 votes per share. Class A shares have one vote.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
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.
Private placement financing. In December, Aurania closed the second and final tranche of its private placement financing. A total of 3,747,243 units were sold at C$0.45 per unit for gross proceeds of C$1,686,259.35. Each unit is comprised of one common share and one common share purchase warrant, which entitles the holder to purchase one common share at an exercise price of C$0.75 for a period of 24 months following the closing date of the applicable tranche of the offering. Aurania expects to allocate most of the net proceeds to fund exploration activities in France.
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.
CHANDLER, Ariz. – Jan. 10, 2025– Comtech Telecommunications Corp. (NASDAQ: CMTL) (“Comtech” or the “Company”) today announced that it plans to release its first quarter fiscal 2025 results before the market opens on Monday, January 13, 2025.
At 8:30 a.m. ET that day, Comtech’s leadership team will hold a conference call to discuss the Company’s first quarter fiscal 2025 results, operations, and business trends. A real-time webcast of the call will be available to the public at the investor relations section of the Comtech web site at www.comtech.com. Alternatively, investors can access the conference call by dialing (800) 579-2543 (primary) or (785) 424-1789 (alternate) and using the conference I.D. of “Comtech.” A replay of the call will also be available by dialing (800) 839-9557 or (402) 220-6089 through Monday, January 27, 2025.
About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 911 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
Key Points: – Mercury General stock falls 20% as California represents one-fifth of its US premiums – JPMorgan doubles damage estimate to $20B as fires continue to rage – Over 246,000 Californians left without power amid safety shutoffs
The devastating Los Angeles wildfires are sending shockwaves through financial markets, with major insurance stocks tumbling Friday as the disaster shapes up to be one of California’s costliest natural catastrophes. Mercury General Corporation led the decline with a dramatic 20% drop, reflecting its heavy exposure to the California market, where it derives approximately one-fifth of its U.S. homeowners’ insurance premiums.
The fires, which have already claimed at least 10 lives and destroyed thousands of structures, are prompting major reassessments of potential losses by financial analysts. JPMorgan has doubled its estimate of insured losses to $20 billion, with warnings that this figure could climb higher as fires continue to burn across the region.
Other major insurers are also feeling the impact, with industry giants including Allstate, Travelers Companies, Chubb, and American International Group seeing their shares decline between 2% and 4% in early trading. The widespread market reaction underscores the growing concerns about the insurance industry’s exposure to climate-related disasters in high-value property markets.
“It will take weeks or months to determine the magnitude of the insured damages, but the Los Angeles wildfires are likely among the most costly wildfires in the state’s history,” Moody’s insurance analysts noted in their Thursday report. The catastrophe’s timing is particularly problematic as it comes just as California attempts to attract insurers back to the state amid increasing climate-related risks.
The impact extends beyond insurance companies, with utility stocks also facing significant pressure. Edison International, parent company of Southern California Edison, is heading toward a 13% weekly loss, while Pacific Gas & Electric shares dropped more than 10%. Although Southern California Edison maintains its equipment did not spark the fires, JPMorgan analysts note that if found responsible, the company’s liability would be capped at $4 billion.
The crisis has forced Southern California Edison to implement widespread safety-related power shutoffs, affecting approximately 173,000 residents, while total power outages across California have reached 246,000 customers. These measures, while necessary for safety, underscore the growing challenges faced by both insurers and utilities in managing climate-related risks in one of America’s most populous states.
The situation draws parallels to PG&E’s historic 2019 bankruptcy filing, which Harvard researchers dubbed “the first climate change bankruptcy.” That case, resulting from over $30 billion in legal claims related to previous California wildfires, serves as a stark reminder of the financial vulnerabilities faced by companies operating in regions increasingly affected by climate change.
As firefighters continue their efforts to contain the blazes, the financial impact of this disaster is likely to reverberate through the insurance and utility sectors for months to come. The event may also accelerate discussions about the sustainability of current insurance models in areas prone to climate-related disasters, potentially leading to significant changes in how risk is assessed and priced in vulnerable regions.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Adding 50 kiosks. On December 8, the company announced the deployment of 50 additional kiosks through a new partnership with a convenience store operator. The newly deployed kiosks are in the Texas Panhandle and surrounding region, including multiple states.
Executing its kiosk expansion strategy. In our view, the recent development illustrates the company’s favorable execution of its kiosk expansion strategy. Importantly, the company owns over 10,000 kiosks, of which roughly 8,300 were deployed as of September 30, 2024. As such, we believe the company is well positioned to aggressively deploy additional kiosks and seed future revenue growth.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
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 Momentum. Hot on the heels of announcing the largest award in Company history, Kratos Defense & Security received two more awards totaling over $107 million. The two new awards continue the award momentum for Kratos, in our view, and suggest a solid growth opportunity for the Company in 2025.
Geolocation Services. Kratos was awarded a Geolocation Global Support Services (GGSS) contract in the amount of $48 million. The Company will provide support services to Space Forces Space electromagnetic interference managers and supporting elements with EMI resolution services. Notably, this award takes advantage of Kratos’ internally funded and constructed, one-of-a-kind, worldwide Space Domain Awareness network.
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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.
DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.
Joe Gomes, 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.
New Contract. On Monday, DLH was awarded a new Governmentwide Acquisition Indefinite Delivery/Indefinite Quantity contract through the One Acquisition Solution for Integrated Services (OASIS+). OASIS+ is a multi-billion dollar expansive suite program used by various federal agencies such as the Defense Health Agency, CDC, and the DoD, and is expected to grow in usage over the next few years.
Details. Through the contract, DLH will deliver complex professional services and advanced capabilities to various federal agencies. DLH won all five domains for which the Company submitted a bid, including Research and Development Services, Technical and Engineering Services, Intelligence Services and Solutions, Logistics Services and Solutions, and Management and Advisory Services. As a prime awardee of the contract, the base period is five years, with one option for an additional five.
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.
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.
HPC/AI Side. At year-end,Bit Digital had 266 servers actively generating revenue from its Bit Digital AI contracts and earned approximately USD $4.5 million of total unaudited GPU Cloud revenue during the month of December. In addition, $177k in revenue from the Boosteroid contract was recognized. The Company’s HPC data center colocation revenue was approximately CAD $757.8k (approximately USD $528.1k) and had 14 customers generating revenue at the Enovum Data Center facility as of December 31, 2024.
Mining. The Company produced 32.4 BTC in December, a 27.8% decrease from 44.9 BTC last month due to changes in the Company’s hosting portfolio, ongoing redeployment of mining assets to new sites, and the retirement of older generation miners. The active hash rate was roughly 1.8 EH/s, a decline from 2.51 EH/s last month due to the reasons mentioned earlier. During the month, 941 S21 miners were purchased for $3.2 million, with the Company selling 4,506 S19 mining units for approximately $836.6k. We expect the hash rate to climb back up as the Company redeploys its new and current miners to new sites.
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.
Updating estimates. We have increased our 2025 EBITDA and EPS estimates to $351.6 million and $5.23, respectively, from $346.8 million and $5.05. Our 2026 EBITDA and EPS estimates have been raised to $372.6 million and $5.77, respectively, from $371.5 million and $5.70. Our revised estimates are largely due to changes in sales growth and gross margin assumptions. The company is expected to provide guidance for FY 2026 in early February.
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.
