Preclinical data indicate that narazaciclib shows monotherapy and combination anti-tumor activity in ibrutinib-sensitive and resistant cells and xenograft models
NEWTOWN, Pa., Nov. 02, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Onconova and collaborators will present a preclinical poster related to its lead program, narazaciclib, at the 65th American Society for Hematology Annual Meeting & Exposition (ASH), taking place in San Diego, California from December 9 to 12, 2023.
“The poster that we and researchers from the Josep Carreras Leukaemia Research Institute in Barcelona, Spain are presenting at ASH 2023 shows that the study of narazaciclib, either as a single agent or in combination with ibrutinib, effectively controls tumor growth in preclinical models of mantle cell lymphoma (MCL), including those that are resistant to Bruton’s tyrosine kinase inhibitors (BTKis), a mainstay of care for this aggressive and difficult to treat cancer. The experiments included a broad comparison of narazaciclib with three other approved cyclin-D-kinase inhibitors (CDKis), used in combination with several BTKis,” said Steven Fruchtman, M.D., President and CEO of Onconova.
Dr. Fruchtman continued, “We were especially pleased by the broad translational data set that provided an understanding of narazaciclib’s role in cell cycle blockade. These studies show that narazaciclib appears to act in the G1 phase of the cell cycle. Furthermore, the studies also indicate that the combination of narazaciclib and ibrutinib act in a synergistic way to achieve in vitro and in vivo anti-tumor activity in ibrutinib sensitive- and resistant -cells and xenograft models. Together, these data support the potential use of narazaciclib in MCL and other cyclin-dependent indications, and further inform our understanding of narazaciclib’s mechanism of action as we advance the clinical program, led by the Phase 1/2a study in patients with low grade endometrioid endometrial cancer, an indication with a great unmet medical need.”
Poster Presentation Information:
Title: Narazaciclib, a Differentiated CDK4/6 Antagonist, Prolongs Cell Cycle Arrest and Metabolomic Reprogramming, Enabling Restoration of Ibrutinib Sensitivity in Btki-Resistant Mantle Cell Lymphoma Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster III Session Date: Monday, December 11, 2023 Presentation Time: 6:00 PM – 8:00 PM PT Location: San Diego Convention Center, Halls G-H Poster Number: 4181 Presenters: Dr. Nuria Profitos-Peleja, Lymphoma Translational Group, Josep Carreras Leukaemia Research Institute, Barcelona, Spain
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer.
Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
In a bold move to combat surging fuel prices and rampant inflation, President Biden is unleashing a flood of black gold onto the markets. The White House is planning to tap a massive 180 million barrels of crude oil from the nation’s Strategic Petroleum Reserve (SPR) – the biggest withdrawal in the reserve’s history.
The news sent oil prices tumbling 5% in early trading as speculators reacted to the supply boost. But will the SPR floodgates really succeed in taming the oil price beast that has economists worried about recession?
The sheer size of the release, equivalent to two full days of global oil consumption, grabbed headlines. Set to be gradually emptied over several months, Biden’s SPR unleashing is meant to act like a shot of bear tranquilizer for the raging oil market.
Ever since Russia’s invasion of Ukraine, reduced supply from the world’s No. 2 exporter combined with surging demand has driven prices to their highest levels since 2008. Brent crude already flirted with a mind-boggling $140 per barrel in March. Even after the SPR news-driven dip, benchmark oil remains stubbornly high at around $105.
For Biden, doling out the emergency crude is a midterm elections Hail Mary pass. Painfully high gas prices have contributed to the president’s dismal approval ratings. Tapping the SPR to lower fuel costs may be his best bet to avoid Democrats enduring a disastrous drubbing by the Republicans in November.
Beyond politics, uncorking America’s oil reserves also sends an important message to the market. It signals the Administration’s determination to fight an inflation rate that keeps printing four-decade highs. Few things impact inflation expectations like changes in oil prices. A meaningful drop could help tamp down the runaway price increases eroding consumer confidence.
But will the effort succeed or will it flounder like past attempts? With global crude inventories at historic lows, many analysts see the SPR release as a mere band-aid solution. It provides some short-term relief but doesn’t fix the supply and demand imbalance.
Goldman Sachs estimates the 180 million barrel slug will help rebalance markets this year. But it warned the move doesn’t resolve the structural deficit caused by excluding Russian exports.
Previous SPR releases also failed to produce lasting effects. Oil prices quickly rebounded after 60 million barrels were tapped in November 2021 and another 30 million in March 2022.
This time, the White House is also counting on allies for help. The International Energy Agency meets soon to potentially coordinate a collective release from its members’ reserves.
But Biden’s SPR gambit already seems at odds with other moves meant to restrict oil supply and fight climate change. Canceling the Keystone XL pipeline permit and banning new federal drilling auctions counterproductively worsened the supply crunch. A of couple million extra daily barrels from those sources would have eased pressure on prices.
The Administration now finds itself trying to fix with one hand problems partly created by the other. That internal tension undermines the large SPR release’s credibility.
Traders also scoffed when OPEC refused to boost production more than a token amount after the U.S. lobbied for extra output. With the cartel and allies like Russia benefitting handsomely from $100+ oil, they have little incentive to pump much more.
Meanwhile, risks of a demand-killing recession loom if the Fed’s inflation fight requires jumbo interest rate hikes. And Covid lockdowns in China already hurt oil demand in the world’s largest importer.
So while Biden’s SPR flow should offer some near-term relief at the pump, it may not move the needle much for long. Markets fear what happens if 180 million barrels merely postpones the supply day of reckoning rather than preventing it.
With inventories low, spare capacity shrinking, geopolitical unrest continuing, and ESG considerations constraining investment, oil looks poised to remain highly volatile. While the SPR release was historic in size, it likely won’t fully tranquilize the energy markets.
Data from 11 participants demonstrates tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated
Aggregate mean eGFR was above 70 mL/min/1.73m2at all reported time points after day 90 supporting tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation
Eledon will host a conference call today at 5:00 p.m. ET
IRVINE, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported results from the Company’s ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing de novo kidney transplantation. Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting taking place in Philadelphia, PA from November 2-5, 2023.
“We are excited to present updated safety and efficacy results from our ongoing Phase 1b trial which continue to support the potential of tegoprubart as a novel kidney transplant immunosuppressive therapy to prevent rejection and better preserve organ function without many of the side effects associated with tacrolimus, the current standard of care,” said David-Alexandre C. Gros, M.D., Chief Executive Officer. “We remain committed to the transplant community who are in urgent need of better treatment options, and we look forward to continuing this study in parallel with our Phase 2 BESTOW study initiated earlier this year.”
At the time of data submission, results from the 11 participants in the Phase 1b trial demonstrated that tegoprubart is generally safe and well-tolerated in patients undergoing kidney transplantation. There have been no cases of hyperglycemia, new onset diabetes, tremor, or cytomegalovirus infection commonly seen with tacrolimus. One participant experienced a mild T cell mediated rejection (Banff score 1a) on day 99. This patient was treated for the rejection and remains in the study. There were no cases of graft loss or death.
Aggregate mean estimated glomerular filtration rate (eGFR) – a measure of kidney function – was above 70 mL/min/1.73m2 at all reported time points after day 90. Historical studies have reported average eGFRs generally in the low 50 mL/min/1.73m2 range during the first year after kidney transplant using standard of care. One participant has completed the study with an eGFR of 91 at one year (day 374) and is now enrolled in a Phase 2 open-label extension (OLE) study, which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in either the ongoing Phase 1b or Phase 2 BESTOW study.
“In this Phase 1b trial, patients treated with tegoprubart demonstrated robust improvements in eGFR with a strong safety profile,” said Dr. John S. Gill, MD, Professor of Medicine at the University of British Columbia, St. Paul’s Hospital, Vancouver, Canada, and Principal Investigator of the study. “These results further support the promise of CD40L costimulatory blockade in organ transplantation. I look forward to additional readouts from this study in 2024.”
The Phase 1b open-label study has enrolled 11 participants who underwent kidney transplantation in Canada, Australia, and the United Kingdom. Each participant received rabbit antithymocyte globulin (ATG) induction and a maintenance regimen consisting of tegoprubart, mycophenolate mofetil, and corticosteroids. The primary endpoint of the study is safety. Other endpoints include characterizing the pharmacokinetic profile of tegoprubart, the incidence of biopsy proven rejection, and eGFR.
In September, Eledon announced that the first participant had been dosed in the Company’s Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. The multicenter, two-arm, active comparator clinical study is enrolling approximately 120 participants undergoing kidney transplantation in the United States and other countries to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart compared to the calcineurin inhibitor tacrolimus. The BESTOW trial’s primary endpoint is designed to test the potential superiority of tegoprubart vs. tacrolimus in post kidney transplant kidney function at 12 months as measured by eGFR. The Company expects to complete enrollment at the end of 2024.
Full details on the poster presentations are below:
Title: Tegoprubart for the prevention of rejection in kidney transplant: update of emerging data from an ongoing trial Presenter: Steve Perrin, Ph.D., President and Chief Scientific Officer, Eledon Pharmaceuticals Poster Number: TH-PO835 Session Title: Transplantation: Clinical – I [PO2102-1] Session Date and Time: November 2, 2023 from 10:00 AM to 12:00 PM EDT
Eledon will hold a conference call today, November 2, 2023 at 5:00 p.m. Eastern Time to discuss the updated trial results. The dial-in numbers are 1-888-886-7786 for domestic callers and 1-416-764-8658 for international callers. The conference ID is 66816567. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.
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 CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. 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.
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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.
NIAID is conducting early phase clinical trials on select next generation COVID-19 vaccine candidates with the intent to identify promising vaccine candidates
TNX-1800, a live virus percutaneous vaccine candidate, is based on Tonix’s recombinant pox virus (RPV) platform
Phase 1 clinical trial of TNX-1800 expected to start in the second half of 2024
NIAIDwill cover the full cost of the clinical trial; Tonix will supply the vaccine candidate
CHATHAM, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial with TNX-1800 (recombinant horsepox virus, live vaccine),1 Tonix Pharmaceuticals’ vaccine candidate to protect against COVID-19.
Tonix is developing a novel vaccine platform initially targeting COVID-19, smallpox and mpox (monkeypox). The intent is to provide durable protection against severe disease and prevent forward transmission, primarily by eliciting a T-cell immune response. TNX-1800 expresses the spike protein of SARS-CoV-2, was immunogenic, well tolerated2 and showed promise in protecting animals from challenge with SARS-CoV-2 delivered directly into the lungs.3 A related horsepox-based vaccine, TNX-8011, protected animals against challenge with monkeypox virus delivered directly into the lungs.4 TNX-801 is also the vector on which TNX-1800 is based and has been shown to be >1,000-fold more attenuated than modern vaccinia virus vaccine (VACV) strains in immunocompromised mice.5 The Phase 1 trial of TNX-1800 is expected to start in the second half of 2024. NIAID will study TNX-1800 by percutaneous administration.
“We believe our novel vaccine platform technology has the potential to provide durable protection from respiratory pathogens and slow their spread,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1800 will be the first vaccine candidate using our live virus recombinant pox virus (RPV) platform technology to enter clinical trials. We hope to expand the portfolio of RPV-based vaccines to address several other known respiratory threats including smallpox, mpox and tuberculosis. We are committed to supporting NIAID in assembling a variety of vaccine platform options to ensure the availability of effective vaccines in the face of known and emerging threats. We look forward to participating in the Project NextGen initiative.”
“Project NextGen,” is an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19. NIAID will be conducting clinical trials to evaluate several early-stage vaccine candidates. The Phase 1 study involving TNX-1800 is designed to assess safety and immunogenicity in approximately 60 healthy adult volunteers. Upon completion of the trial, NIAID and Tonix Pharmaceuticals will assess the results and determine the next steps for the development of TNX-1800.
NIAID will cover the full cost of the clinical trial, including operations and related analysis. Tonix will be responsible for providing clinical trial materials, and upon completion will have the right to rely on the findings in regulatory filings with the U.S. Food and Drug Administration (FDA) to support the approval of its COVID-19 vaccine and other vaccines based on the RPV platform.
Project NextGen is a $5 billion initiative to develop the next generation of vaccines and therapeutics to combat COVID-19. Based at the HHS and led by the Administration for Strategic Preparedness and Response’s Biomedical Advanced Research and Development Authority and the NIH’s NIAID, Project NextGen will coordinate across the federal government and the private sector to advance the pipeline of new, innovative vaccines and therapeutics into clinical trials and potential review by the U.S. Food and Drug Administration (FDA) for authorization or approval, and commercial availability for the American people. The program will focus on several areas, including mucosal vaccines, vaccines that provide broader protection against variants of concern and a longer duration of protection, pan-coronavirus vaccines, and new and more durable monoclonal antibodies.
About TNX-1800* TNX-1800 (recombinant horsepox virus) is a live virus vaccine for percutaneous administration that is designed to express the spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response. The RPV platform is based on a horsepox vector, which is a live replicating, attenuated virus that has been shown to be >1,000-fold more attenuated than modern VACV strains in immunocompromised mice.5 Horsepox and the vaccinia vaccine viruses are closely related orthopoxviruses that are believed to share a common ancestor. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner. 6-9 Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice.4,6 The current formulation is a frozen liquid, but we believe that future lyophilized versions can be stored and shipped at standard refrigeration. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines that can be administered without sterile injection, manufactured using conventional cell culture systems with the potential for mass scale production, and packaged in multi-dose vials. Moreover, we believe the low dose of TNX-1800 makes this technology amenable for future implementation in microneedle delivery systems.
About TNX-801* TNX-801 (recombinant horsepox virus) is a live virus vaccine based on horsepox4-7 in pre-clinical development to prevent smallpox and mpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox.4 Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox.10 Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1 /2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND. More than 30,000 people have contracted mpox in the U.S. so far during the 2022-23 epidemic,11 The recent cluster of mpox in Chicago revealed breakthrough cases of mpox in individuals who had been vaccinated with the currently authorized non-replicating vaccine, which is administered in two doses.12 In contrast, TNX-801 is delivered percutaneously with only one dose and therefore may achieve higher rates of community protection by eliminating drop-out between doses and limiting forward transmission. Moreover, relying on only one approved mpox vaccine at present is a risk for the global supply chain that has already led to insufficient availability of vaccines to meet global health needs, especially in Africa. TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines.
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment for chronic migraine, and enrollment has been completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.
1 TNX-1800 and TNX-801 are experimental new vaccines and have not been approved for any indication. 2 Awasthi, M. et al. Viruses. 2023. 15(10):2131. 3 Awasthi, M. et al. BioRxiv. 2023. 4 Trefry S, et al. BioRxiv. 2023. 5 Noyce RS, et al. Viruses. 2023. 15(2):356. 6 Jenner E. “An Inquiry Into the Causes and Effects of the Variole Vaccinae, a Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire and Known by the Name of the cow‐pox.” London: Sampson Low, 1798. 7 Noyce RS, et al. PloSOne. 2018. 13(1):e0188453. 8 Schrick L et al. N Engl J Med. 2017. 377:1491-1492. 9 Tulman ER, et al. J Virol. 2006. 80(18):9244-58. 10 TNX-801 PR pre-IND meeting August 20, 2023: https://ir.tonixpharma.com/news-events/press-releases/detail/1417/tonix-pharmaceuticals-announces-results-of-pre-ind-meeting 11 McQuiston JH, et al. MMWR Morb Mortal Wkly Rep. 2023. 72:547–552. 12 Centers for Disease Control. MMWR Morb Mortal Wkly Rep. 2023. 72(25);696-698.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
MALVERN, Pa., Nov. 02, 2023 (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 that it will host a conference call and live webcast to discuss the Company’s third quarter 2023 financial results and provide a business update at 8:30 a.m. ET on Thursday, November 9, 2023.
Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 1787631 Webcast: Available on the events section of the Ocugen investor site
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s 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.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Enables greater focus on higher margin, higher growth global managed service provider (MSP) solutions, global recruitment process outsourcing (RPO) solutions, and specialty outcome-based and staffing services in North America
Transaction expected to close in the first quarter of 2024; cash consideration of €100 million with additional earnout potential of up to €30 million
Unlocks significant capital to invest in organic and inorganic growth
TROY, Mich., Nov. 2, 2023 /PRNewswire/ — Kelly (Nasdaq: KELYA, KELYB), a leading global specialty talent solutions provider, today announced that it has entered into a definitive agreement to sell its European staffing business to Gi Group Holdings S.P.A. (“Gi”), one of the largest staffing companies in Europe, for cash consideration of up to €130 million. The transaction is expected to close in the first quarter of 2024, subject to receipt of required regulatory approvals and other customary closing conditions.
Under the terms of the agreement, Kelly will transfer its European staffing business within its International operating segment to Gi. Kelly provides staffing services to customers in 14 countries across Europe. The company will retain its managed service provider, recruitment process outsourcing, and functional service provider (FSP) business with customers in the Europe, Middle East, and Africa (EMEA) region.
Following the close of the transaction, Kelly will maintain its global footprint and continue to provide MSP, RPO, and FSP solutions to customers in the EMEA region through KellyOCG, Kelly’s outsourcing and consulting group. As a leading global vendor-neutral provider of talent supply chain strategies and workforce solutions, KellyOCG leverages a network of 3,000 suppliers spanning 140 countries – including Gi – to connect customers across North America, Asia Pacific, and EMEA with top talent to grow their businesses. In Everest Group’s 2023 PEAK Matrix®, KellyOCG was recognized as a leader and major contender for its MSP and RPO solutions, respectively, with the latter earning KellyOCG star performer status. Everest Group also recognized KellyOCG as a leader and star performer in statement-of-work (SOW) management.
“The sale of Kelly’s European staffing business demonstrates our commitment to taking bold, transformative action to optimize our portfolio and maximize value creation,” said Peter Quigley, president and chief executive officer. “This transaction unlocks significant capital to pursue organic and inorganic investments in our chosen specialties. Furthermore, it sharpens our focus on our higher margin, higher growth global MSP solutions, global RPO solutions, and specialty outcome-based and staffing services in North America. Together, we expect these outcomes will accelerate Kelly’s progress toward achieving a normalized, adjusted EBITDA margin in the range of 3.3% to 3.5% as we shared in August and drive profitable growth over the long term.”
The transaction is the latest in a series of strategic actions Kelly has executed to unlock capital in pursuit of its specialty strategy and further optimize its operating model, which includes monetizing non-core real estate holdings and businesses; unwinding Kelly’s cross-shareholding arrangement with Persol and reducing the company’s ownership interest in PersolKelly, its Asia-Pacific staffing joint venture; selling its operations in Brazil and Russia; and most recently, implementing strategic restructuring actions which enhance organizational efficiency and effectiveness.
Quigley and Olivier Thirot, executive vice president and chief financial officer, will provide additional details about this transaction as it relates to the company’s specialty strategy during its upcoming third-quarter earnings conference call on November 9, 2023.
DLA Piper is serving as legal counsel to Kelly.
About Kelly®
Kelly Services, Inc. (Nasdaq: KELYA, KELYB) helps companies recruit and manage skilled workers and helps job seekers find great work. Since inventing the staffing industry in 1946, we have become experts in the many industries and local and global markets we serve. With a network of suppliers and partners around the world, we connect more than 450,000 people with work every year. Our suite of outsourcing and consulting services ensures companies have the people they need, when and where they are needed most. Headquartered in Troy, Michigan, we empower businesses and individuals to access limitless opportunities in industries such as science, engineering, technology, education, manufacturing, retail, finance, and energy. Revenue in 2022 was $5.0 billion. Learn more at kellyservices.com.
Forward-Looking Statements
This release contains statements that are forward looking in nature and, accordingly, are subject to risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about Kelly’s financial expectations, are forward-looking statements. Factors that could cause actual results to differ materially from those contained in this release include, but are not limited to, (i) changing market and economic conditions, (ii) disruption in the labor market and weakened demand for human capital resulting from technological advances, loss of large corporate customers and government contractor requirements, (iii) the impact of laws and regulations (including federal, state and international tax laws), (iv) unexpected changes in claim trends on workers’ compensation, unemployment, disability and medical benefit plans, (v) litigation and other legal liabilities (including tax liabilities) in excess of our estimates, (vi) our ability to achieve our business’s anticipated growth strategies, (vi) our future business development, results of operations and financial condition, (vii) damage to our brands, (viii) dependency on third parties for the execution of critical functions, (ix) conducting business in foreign countries, including foreign currency fluctuations, (x) availability of temporary workers with appropriate skills required by customers, (xi) cyberattacks or other breaches of network or information technology security, and (xii) other risks, uncertainties and factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. All information provided in this press release is as of the date of this press release and we undertake no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company’s expectations.
Drill intercepts of 6.28 gpt AuEq over 15.00m, 2.96 gpt AuEq over 22.52m, 2.00 gpt AuEq over 61.23m and 1.39 gpt AuEq over 45.67m encountered at Cumberland
Rock chip samples of 37.23, 23.34, 20.34 and 20.23 gpt AuEq from Scarlet Knob
TORONTO, ON / ACCESSWIRE / November 2, 2023 / Eskay Mining Corp. (“Eskay” or the “Company”) (TSXV:ESK)(OTCQX:ESKYF)(Frankfurt:KN7)(WKN:A0YDPM) is pleased to announce it has received very encouraging assay results from its 2023 diamond drill and exploration campaign at its 100% controlled Consolidated Eskay Gold Project in the Golden Triangle of British Columbia. Precious metal-rich volcanogenic massive sulfide (“VMS”) deposits are the focus of Eskay’s exploration.
Cumberland VMS Discovery
Nine short diamond core holes were completed at the Cumberland Showing in 2023 (Figure 2), several of which encountered very promising precious and base metal-rich stockwork and massive mineralization. Notable results include:
3.02 gpt Au, 68.66 gpt Ag, 0.24% Cu, 0.73% Pb and 4.86% Zn (6.28 gpt AuEq) over 15.00m including 8.48 gpt Au, 103.27 gpt Ag, 0.23% Cu, 1.08% Pb and 4.16% Zn (12.02 gpt AuEq) over 3.41m in hole CBL23-28.
1.21 gpt Au, 29.22 gpt Ag, 0.12% Cu, 0.32% Pb and 2.94% Zn (2.96 gpt AuEq) over 22.52m including 3.45 gpt Au, 108.21 gpt Ag, 0.65% Cu, 0.54% Pb and 19.40% Zn (13.24 gpt AuEq) over 1.75m in hole CBL23-29.
0.68 gpt Au, 15.72 gpt Ag, 0.07% Cu, 0.27% Pb and 0.90% Zn (1.39 gpt AuEq) over 45.67m in hole CBL23-30.
0.95 gpt Au, 29.04 gpt Ag, 0.07% Cu, 0.29% Pb and 1.31% Zn (2.00 gpt AuEq) over 61.23m including 1.57 gpt Au, 58.80 gpt Ag, 0.16% Cu, 0.60% Pb and 3.13% Zn (3.91 gpt AuEq) over 20.08m in hole CBL23-31.
Cumberland lies approximately 6km due south of the TV deposit and is similarly situated along the east side of the Eskay anticline. Eskay’s geologic team thinks this discovery opens up considerable exploration potential in areas between Cumberland and the TV-Jeff VMS complex (Figures 3 and 4). It is notable that mineralization at Cumberland displays very high base metals, an indicator of high formational fluid temperatures, a potential sign that this area lies in proximity to a major feeder vent or vents.
Based upon data from this limited first phase drill program, the Cumberland VMS deposit is interpreted to be tabular with a N-S orientation and a near vertical dip, perhaps slightly overturned. It remains open along strike and at depth. A review of historic soil data (Figures 3 and 4) from areas up to 1.5 km south of Cumberland indicates a broad area of strongly anomalous geochemistry, especially elevated silver values, confirming a likely extension of mineralization in this direction. Eskay’s geologic team observed significant outcropping sulfide mineralization while conducting traverses in this region south of Cumberland.
While prospecting late in the season, a notable area of outcropping sulfide mineralization was observed approximately 2.5 km to the northeast of Cumberland and is potentially part of the same VMS system. This area has been named Mahogany Ridge. Historic rock chip sample data from the broader Cumberland trend includes samples grading 25.0, and 27.9 gpt Au.
Given the strong drill and rock chip sample results from the Cumberland-Mahogany Ridge area, Eskay Mining views this discovery as a high priority exploration target. Compelling evidence is emerging that the corridor starting at TV-Jeff in the north through Mahogany Ridge and Cumberland and continuing a further 1.5km south of Cumberland is highly prospective for further precious metal-rich VMS discoveries. Eskay Mining thinks this corridor requires urgent follow up work including drilling in 2024.
“Cumberland is shaping up to be a very compelling and unique target”, commented John DeDecker, Eskay’s VP of Exploration. “Intense polymetallic sulfide mineralization ranges from stockwork-style, to massive seafloor-hosted mineralization. The seafloor-hosted mineralization is associated with barite breccia, and is capped by a non-mineralized and highly magnetic pillow basalt. Drilling and field investigations have defined the orientation of the mineralized seafloor horizon, and have shown that Ag anomalies in historic soil samples, and a pronounced magnetic anomaly evident in the 2021 EM survey lie along the trend of mineralization extending at least 300 m south of Cumberland. Our team looks forward to investigating this area further in 2024. The confirmation of another mineralized seafloor horizon at Scarlet Knob, and extensive disseminated Au mineralization at Tarn Lake opens these areas up to targeted exploration in 2024.”
Summary of significant results from nine core holes completed at the Cumberland Showing in 2023:
Hole
From (m)
To (m)
Length (m)
Au (gpt)
Ag (gpt)
Cu (%)
Pb (%)
Zn (%)
Au Eq (gpt)
CBL23-26
NSV
CBL23-27
1.26
8.15
6.89
0.58
16.93
–
–
–
0.79
22.57
25.76
3.19
0.33
12.50
–
0.25
0.34
0.70
30.50
35.39
4.89
0.43
11.80
–
0.10
0.61
0.85
71.83
92.65
20.82
0.28
1.11
0.06
0.08
2.00
1.16
includes
73.63
76.71
3.08
0.17
6.62
0.08
0.04
2.80
1.44
includes
84.90
85.90
1.00
1.78
23.00
0.35
0.25
11.85
7.13
103.98
121.03
17.05
0.34
10.12
–
–
–
0.47
CBL23-28
1.29
16.29
15.00
3.02
68.66
0.24
0.73
4.86
6.28
includes
5.68
16.29
10.61
4.11
92.84
0.30
0.92
6.33
8.39
includes
9.86
13.27
3.41
8.48
103.27
0.23
1.08
4.16
12.02
CBL23-29
1.69
24.21
22.52
1.21
29.22
0.12
0.32
2.94
2.96
includes
1.69
4.79
3.10
2.90
14.18
0.06
0.29
0.49
3.44
and
14.94
24.21
9.27
1.70
53.89
0.23
0.51
0.62
3.07
includes
22.46
24.21
1.75
3.45
108.21
0.65
0.54
19.40
13.24
CBL23-30
0.89
46.56
45.67
0.68
15.72
0.07
0.27
0.90
1.39
includes
0.89
2.79
1.90
2.72
5.03
0.02
1.46
0.19
3.37
and
17.12
46.56
29.44
0.84
21.40
0.11
0.38
1.56
1.97
CBL23-31
1.22
62.45
61.23
0.95
29.04
0.07
0.29
1.31
2.00
includes
1.22
2.22
1.00
9.84
6.78
0.02
0.15
0.06
10.02
and
30.20
50.28
20.08
1.57
58.80
0.16
0.60
3.13
3.91
includes
30.20
35.20
5.00
1.36
57.82
0.48
0.43
8.75
6.18
and
36.20
38.25
2.05
4.64
155.07
0.07
1.16
1.34
7.57
85.00
95.00
10.00
0.48
13.07
–
0.08
0.17
0.74
CBL23-32
NSV
CBL23-33
NSV
CBL23-34
114.28
117.28
3.00
0.20
7.42
–
0.09
1.38
0.85
127.61
136.65
9.04
0.14
3.42
–
0.02
1.01
0.58
NSV = No Significant Values; AuEq values have been calculated using a Ag-to-Au ratio of 80:1, Cu-to-Au ratio of 8,100:1, Pb-to-Au ratio of 29,800:1 and Zn-to-Au ratio of 26,050:1 for this news release.
Scarlet Knob-Bruce Glacier Discovery
Near the end of the exploration season at a time of maximum snowmelt, Eskay Mining’s exploration team found outcrops of metal-rich VMS mineralization immediately adjacent to the eastern margin of Bruce Glacier. This area is called Scarlet Knob and is located in the northeastern part of the Consolidated Eskay Gold Project approximately 7km southeast of the Eskay Creek mine. Four rock chip samples collected from a 100 m long, 5 m wide sulfide replacement body (Figures 6 and 7) returned very strong precious and base metal values as presented below:
Sample
Au (gpt)
Ag (gpt)
Cu (%)
Pb (%)
Zn (%)
Au Eq (gpt)
1001A
11.71
199.03
0.33
7.77
8.16
20.34
1001B
22.26
461.97
0.22
14.57
10.50
37.23
1001C
10.04
169.50
0.16
12.00
10.02
20.23
1001D
14.80
160.82
0.16
9.53
8.18
23.34
Although this outcropping sulfide body is small, it appears to occur at or near the paleo-sea floor interface, a stratigraphic position conducive for hosting a deposit like that at the nearby Eskay Creek mine. Given the very strong precious metal values from these samples, Eskay mining’s geologic team takes a strong view that this occurrence suggests a bigger system may be present in this area.
Early in the drill season, four core holes were drilled in an area approximately 200 m south of this high-grade discovery. These holes were drilled based upon a conceptual view formed by Eskay Mining’s geologic team that the paleo-seafloor position, possibly mineralized, should be hiding under Bruce Glacier. All four of these drill holes indeed pierced the contact between volcanic rocks and sea floor mudstone, and two of these holes encountered highly elevated precious and base metal values as seen in the table below:
Hole
From (m)
To (m)
Length (m)
Au (gpt)
Ag (gpt)
Cu (%)
Pb (%)
Zn (%)
Au Eq (gpt)
SKN23-01
172.92
174.10
1.18
0.24
46.90
–
1.93
1.19
1.93
255.32
257.51
2.19
0.40
49.66
–
0.45
0.47
1.35
SKN23-02
188.81
191.43
2.62
0.52
33.75
–
0.62
1.63
1.78
SKN23-03
NSV
SKN23-04
NSV
Although these intercepts are not long, the strong precious and base metal contents encountered in these holes are considered the sort of values that might occur proximal to a much stronger VMS system. Combined with the latter surface discovery of high-grade precious and base metal mineralization discussed above, this lends further strong evidence for a larger VMS system in this area. Eskay Mining’s geologic team takes the view that more exploration including core drilling is warranted at Scarlet Knob in 2024.
Tarn Lake
Four diamond drill holes were completed at Tarn Lake during the 2023 drill campaign (Figure 5) to follow up on encouraging drill results from this area in 2022. While all four holes encountered short to moderate length intervals of mineralization, two holes, TN23-14 and TN23-16 encountered short high-grade intervals, 4.84 gpt Au and 8.14 gpt Ag (4.94 gpt AuEq) over 2.00m in TN23-14 and 7.83 gpt Au and 6.96 gpt Ag (7.92 gpt AuEq) over 2.45m in TN23-16. These can be seen in the table below:
Hole
From (m)
To (m)
Length (m)
Au (gpt)
Ag (gpt)
Cu (%)
Pb (%)
Zn (%)
Au Eq (gpt)
TN23-13
34.00
37.69
3.69
0.48
2.69
–
–
–
0.51
43.50
48.50
5.00
0.37
4.44
–
–
–
0.43
TN23-14
66.39
67.80
1.41
3.33
0.84
–
–
–
3.34
78.40
84.40
6.00
2.07
4.82
–
–
–
2.13
includes
80.40
82.40
2.00
4.84
8.14
–
–
–
4.94
114.81
117.90
3.09
0.59
4.70
–
–
–
0.65
TN23-15
51.00
54.02
3.02
0.43
3.08
–
–
–
0.47
63.15
65.28
2.13
0.83
1.95
–
–
–
0.85
136.80
153.70
16.90
0.31
6.40
–
–
–
0.39
175.90
187.50
11.60
0.82
5.88
–
–
–
0.89
208.30
215.82
7.52
0.75
8.00
–
–
–
0.85
244.93
250.30
5.37
0.46
2.04
–
–
–
0.49
TN23-16
130.44
132.89
2.45
7.83
6.96
–
–
–
7.92
includes
130.44
131.39
0.95
12.40
10.00
–
–
–
12.53
Given the most promising results from Tarn Lake to date come from feeder zone type mineralization perhaps occurring deep in a VMS system, Eskay Mining’s geologic team is considering where the upper part of this system, including the favorable paleo-sea floor position, might lie. Rock chip sampling conducted in 2023 shows that disseminated Au mineralization extends approximately 100 m to the west of and over 200 m to the north of the drill holes at Tarn Lake (Figure 6). More field work and follow up drilling will be needed to ascertain if the better part of this system is present in the Tarn Lake area.
Other Targets
Targeting at Hexagon-Mercury (Figure 1), situated on the western flank of the Eskay Anticline approximately 9 km south of Eskay Creek mine, was driven by geophysical anomalies interpreted by Riaz Mirza of Simcoe Geoscience. One of two drill holes completed at the target yielded an intercept of over 100 m of appreciable stockwork sulfide mineralization hosted by volcanic rock thought to be part of the lower Hazelton Group. While no appreciable precious metals were encountered, moderately elevated pathfinder elements are present. Further work is needed in this location to refine future targets.
Two holes tested the Maroon Cliffs target (Figure 1) situated in the far northeast corner of the Consolidated Eskay Gold Project. Similar to Hexagon-Mercury, targeting at Maroon Cliffs was driven by geophysics. Neither hole encountered appreciable precious metal mineralization, and only weak pathfinder geochemistry. The magnetic expression that defined this target is believed to be driven by a package of conglomerate rock with magnetite-bearing clasts observed in core.
One hole was completed at Storie Creek, a target situated just 3.5 km SSE of the Eskay Creek mine. Prior to drilling, Eskay Mining’s geologic team formed the view that favorable Hazelton Group host rocks dip westward under the drill site thus making an intriguing blind target. Drilling determined that an east dipping reverse fault underlies Storie Creek. Therefore, any prospective Hazelton Group rocks will only lie to the east of Storie Creek. Consideration is being given to what further exploration might be done in the area.
Drill hole data from 2023 program:
Hole ID
Easting (m)
Northing (m)
Elevation (m)
Azimuth
Dip
Total Depth (m)
CBL23-26
408644
6261448
367
65
45
210
CBL23-27
408679
6261475
375
40
65
258
CBL23-28
408679
6261475
375
330
80
78
CBL23-29
408679
6261475
375
354
70
81
CBL23-30
408679
6261475
375
10
70
62
CBL23-31
408679
6261475
375
25
65
122
CBL23-32
408679
6261475
375
85
65
95
CBL23-33
408679
6261475
375
30
50
16.5
CBL23-34
408644
6261448
367
45
45
142
TV23-124
409628
6265299
963
283
55
299
TN23-13
415192
6273601
1461
270
44
141.2
TN23-14
415198
6273503
1465
305
55
190.4
TN23-15
415001
6273619
1518
100
50
463.2
TN23-16
415001
6273619
1518
100
75
284
SKN23-01
416097
6273570
1465
270
45
339
SKN23-02
416097
6273570
1465
295
45
289
SKN23-03
416097
6273570
1465
255
45
296
SKN23-04
416097
6273570
1465
275
65
307
MC23-02
421550
6280156
917
180
45
248
MC23-01
423441
6279855
917
180
45
260
HM23-02
408901
6270942
541
245
45
255
HM23-01
408473
6272255
831
245
45
276
SC23-01
411834
6273639
399
130
50
810
SC23-02
413145
6275147
559
130
50
151
QA/QC, Methodology Statement:
Halved HQ drill core samples are submitted to ALS Geochemistry in Terrace, British Columbia for preparation and analysis. ALS is accredited to the ISO/IEC 17025 standard for gold assays. All analytical methods include quality control standards inserted at set frequencies. The entire sample interval is crushed and homogenized, 250 g of the homogenized sample is pulped. All samples were analyzed for gold, silver, mercury, and a suite of 48 major and trace elements. Analysis for gold is by fire assay fusion followed by Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) on 30 g of pulp. Analysis for silver is by fire assay and gravimetric analysis on 30 g of pulp. Mercury is analyzed using the trace Hg Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) method. All other major and trace elements are analyzed by four-acid digestion followed by ICP-MS.
The assay results for rock chip samples reported for Scarlet Knob were obtained from Skeena Resources field assay laboratory. The entire sample is crushed and homogenized, and 100g of the homogenized sample is pulped. All samples were analyzed for gold, silver, arsenic, copper, lead, and zinc. Duplicates of these samples were sent to ALS Geochemistry in Terrace, British Columbia for certified analyses. Certified assay results for the Scarlet Knob rock chip samples are pending.
Historical rock chip and soil sample data is sourced from Assessment Reports AR17205 and AR22231. Eskay Mining is unable to fully verify this data, and it should be treated as such by the reader.
Mineralization at the TV and Jeff deposits displays similar characteristics and mineralogy to the Eskay Creek deposit and therefore for Au eq, and Au:Ag, a ratio of 78:1 is used and Au eq and Ag eq values are deemed to be reasonable based on assumed gold recovery (84.2%) and silver recovery (87.3%) as reported in the Eskay Creek Project NI 43-101 Technical Report and Prefeasibility Study, British Columbia, Canada, Effective Date: 22 July, 2021, Prepared for: Skeena Resources Ltd., Prepared by: Absence Engineering Canada Inc.
True widths of reported intercepts are not fully understood at this time. More drilling is required to ascertain true widths at these newly identified mineralized areas.
Dr. Quinton Hennigh, P. Geo., a Director of the Company and its technical adviser, a qualified person as defined by National Instrument 43-101, has reviewed and approved the technical contents of this news release.
About Eskay Mining Corp:
Eskay Mining Corp (TSX-V:ESK) is a TSX Venture Exchange listed company, headquartered in Toronto, Ontario. Eskay is an exploration company focused on the exploration and development of precious and base metals along the Eskay rift in a highly prolific region of northwest British Columbia known as the “Golden Triangle,” 70km northwest of Stewart, BC. The Company currently holds mineral tenures in this area comprised of 177 claims (52,600 hectares).
All material information on the Company may be found on its website at www.eskaymining.com and on SEDAR at www.sedar.com.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements: This Press Release contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. When used in this document, the words “may”, “would”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions are intended to identify forward-looking statements. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties. Many factors could cause our actual results to differ materially from the statements made, including those factors discussed in filings made by us with the Canadian securities regulatory authorities. Should one or more of these risks and uncertainties, such as actual results of current exploration programs, the general risks associated with the mining industry, the price of gold and other metals, currency and interest rate fluctuations, increased competition and general economic and market factors, occur or should assumptions underlying the forward looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, or expected. We do not intend and do not assume any obligation to update these forward-looking statements, except as required by law. Shareholders are cautioned not to put undue reliance on such forward-looking statements.
(Figure 1. Plan view of Eskay Mining’s land holdings at Consolidate Eskay Gold Project.)
(Figure 2. Plan view (top) and section looking southeast (bottom) showing assay results in Au equivalent for 2023 drill holes at Cumberland.)
(Figure 3. Map of the Cumberland prospect showing Ag values in soil samples and Au in rock chip samples reported in assessment reports 17205 and 22231. The Ag anomaly immediately south of Cumberland lies along the trend of mineralization as determined by drilling and field work in 2023.)
(Figure 4. Magnetic map of the Cumberland-Excelsior-Mahogany Ridge-TV area showing soil sample results from the 2021-2022 exploration programs and historic sampling programs reported in assessment reports 17205, and 22231. There are pronounced magnetic and Ag soil anomalies along trend from mineralization at the Cumberland prospect. This area will be a focus of exploration activities in 2024.)
(Figure 5. Plan view (top) and section looking southeast (bottom) showing assay results in Au equivalent for 2023 drill holes at Tarn Lake.)
(Figure 6. Map of the Bruce Glacier area showing the drill traces at Tarn Lake and Scarlet Knob, and Au assay results for rock chip samples collected during the 2021-2023 exploration programs. An approximately 100 m long and 5 m wide trend of semi-massive replacement-style polymetallic sulfide mineralization at Scarlet Knob yielded several Au- and Ag-bearing samples. Sampling at Tarn Lake shows that disseminated Au mineralization extends at least 100 m west of and 200 m north of 2022-2023 drilling. Both of these areas remain high-priority targets for exploration in 2024.)
(Figure 7. Top: The trend of semi-massive sulfide mineralization that was sampled at Scarlet Knob, with geologist for scale. Bottom: Photograph of sample 1001B showing massive polymetallic sulfide mineralization. This zone is associated with an andesite dike, with the most intense mineralization associated with sulfide replacement of volcaniclastic debris flow breccia surrounding the dike. The presence of replacement-style mineralization indicates a stratigraphic position within 200 m of the paleoseafloor. The confirmation of a paleoseafloor horizon in the 2023 drill holes at Scarlet Knob, raises the possibility that the VMS system that produced the replacement-style mineralization shown above may have fed seafloor vents. Investigation of this possibility will be an objective of the 2024 exploration program.)
EPS of $0.22, up 100% year-over-year Adjusted EBITDA of $16.6 million, up 16.1% year-over-year Our strategy continues to favorably impact our results as Electrical Systems revenues were up 16.8% year-over-year
NEW ALBANY, Ohio, Nov. 01, 2023 (GLOBE NEWSWIRE) — CVG (NASDAQ: CVGI), a diversified industrial products and services company, today announced financial results for its third quarter ended September 30, 2023.
Third Quarter 2023Highlights(Compared with prior year, where comparisons are noted)
Revenues of $246.7 million, down 1.9% due primarily to higher revenue in the prior year as a result of a COVID backlog in Asia-Pacific which offset an increase in revenue in Electrical Systems in 2023.
Operating income of $12.4 million, up 30.5%; adjusted operating income of $12.5 million, up 17.9%. Improved operating income was driven primarily by improved pricing and cost management, partially offset by volume decreases.
Net income and adjusted net income were both $7.3 million, or $0.22 per diluted share, compared to net income of $3.6 million, or $0.11 per diluted share and adjusted net income of $5.1 million, or $0.15 per diluted share.
Adjusted EBITDA of $16.6 million, up 16.1% with an adjusted EBITDA margin of 6.7%, up from 5.7%.
New business wins year-to-date are expected to be approximately $140 million when fully ramped. The majority of the new business awards continue to be in the Electrical Systems segment.
Strong free cash flow and debt pay down reduced our leverage ratio down to 1.5x from 2.7x.
Robert Griffin, Chairman of the Board and Interim President and Chief Executive Officer, said, “CVG continues to execute on its strategic long-term plan, which again delivered year-over-year bottom line improvements in the quarter. Electrical Systems remains a key growth area for the Company, as evidenced by the strong revenue growth compared to last year and the successful start-up at our new Electrical Systems facilities in Aldama, Mexico, and Tangier, Morocco, which has gone very well. As always, I would like to thank our global CVG teams for their hard work, dedication, and commitment as we continue to execute our strategic goals.”
Andy Cheung, Chief Financial Officer, added, “CVG continued executing on our strategy, delivering strong year-over-year improvements in profitability during the quarter. Despite the strong performance, revenues declined slightly year-over-year against a tough comparable base year in 2022, when our Asia-Pacific business benefited from a post-COVID increase in backlogged sales orders. We also had improved earnings and generated strong free cash flow of $12.5 million during the quarter, further strengthening our financial foundation, and reduced our leverage to 1.5x from 2.7x in the third quarter last year.”
“Going forward, we remain committed to driving strong free cash flow, paying down debt, and investing to support our growing, diverse portfolio of businesses.”
Third Quarter Financial Results (amounts in millions except per share data and percentages)
ThirdQuarter
2023
2022
$ Change
% Change
Revenues
$
246.7
$
251.4
$
(4.7
)
(1.9)%
Gross profit
$
33.9
$
26.8
$
7.1
26.5%
Gross margin
13.7
%
10.7
%
Adjusted gross profit 1
$
34.0
$
27.4
$
6.6
24.1%
Adjusted gross margin 1
13.8
%
10.9
%
Operating income
$
12.4
$
9.5
$
2.9
30.5%
Operating margin
5.0
%
3.8
%
Adjusted operating income 1
$
12.5
$
10.6
$
1.9
17.9%
Adjusted operating margin 1
5.1
%
4.2
%
Net income
$
7.3
$
3.6
$
3.7
102.8%
Adjusted net income 1
$
7.3
$
5.1
$
2.2
43.1%
Earnings per share, diluted
$
0.22
$
0.11
$
0.11
100.0%
Adjusted earnings per share, diluted 1
$
0.22
$
0.15
$
0.07
46.7%
Adjusted EBITDA 1
$
16.6
$
14.3
$
2.3
16.1%
Adjusted EBITDA margin 1
6.7
%
5.7
%
1 See Appendix A for GAAP to Non-GAAP reconciliation
Consolidated Results
Third Quarter 2023 Results
Third quarter 2023 revenues were $246.7 million, compared to $251.4 million in the prior year period, a decrease of 1.9%. The overall decrease in revenues was due to higher revenue in the prior year as a result of a COVID backlog in Asia-Pacific. Foreign currency translation also favorably impacted third quarter 2023 revenues by $2.0 million, or 0.8%.
Operating income in the third quarter 2023 was $12.4 million compared to $9.5 million in the prior year period. The increase in operating income was attributable to improved pricing and cost management, partially offset by volume decreases. Third quarter 2023 adjusted operating income was $12.5 million, excluding special charges.
Interest associated with debt and other expenses was $2.6 million and $2.8 million for the third quarter 2023 and 2022, respectively.
Net income was $7.3 million, or $0.22 per diluted share, for the third quarter 2023 compared to net income of $3.6 million, or $0.11 per diluted share, in the prior year period.
On September 30, 2023, the Company had $5.0 million of outstanding borrowings on its U.S. revolving credit facility and $4.1 million outstanding on its China credit facility, $46.3 million of cash and $152.0 million of availability from the credit facilities, resulting in total liquidity of $198.3 million.
Third Quarter 2023 Segment Results
Vehicle Solutions Segment
Revenues were $145.4 million compared to $154.0 million for the prior year period, a decrease of 5.6%, due to higher revenue in the prior year as a result of a COVID backlog in Asia-Pacific.
Operating income was $10.9 million, compared to $9.6 million in the prior year period, an increase of 14.0%, primarily attributable to price increases, material and freight cost reduction improvements, partially offset by volume decreases.
Electrical Systems Segment
Revenues were $53.9 million compared to $46.1 million in the prior year period, an increase of 16.8%, primarily resulting from increased sales volume, pricing and favorable foreign exchange.
Operating income was $5.9 million compared to $5.2 million in the prior year period, an increase of 13.7%. The increase in operating income was primarily attributable to increased sales volume and pricing, partially offset by startup costs related to new facilities.
Aftermarket & Accessories Segment
Revenues were $34.4 million compared to $37.1 million in the prior year period, a decrease of 7.4%, primarily resulting from decreased sales volume.
Operating income was $4.5 million compared to $5.0 million in the prior year period, a decrease of 9.1%. The decrease in operating income was primarily attributable to cost inflation, partially offset by increased pricing.
Industrial Automation Segment
Revenues were $13.0 million compared to $14.1 million in the prior year period, a decrease of 7.8%, primarily due to lower sales volume due to decreased customer demand.
Operating income was $0.7 million compared to an operating loss of $1.0 million in the prior year period. The increase in operating income was primarily attributable to profit reported from the liquidation of certain excess inventories. Adjusted operating income was $0.8 million.
2023 Demand Outlook
According to ACT Research, the 2023 North American Class 8 truck production levels are expected to be at 336,000 units, compared to approximately 315,000 units in 2022. Class 8 estimates from FTR for 2023 are 327,000 units, slightly lower than ACT Research for Class 8 truck builds. Class 5-7 production levels are expected to be at 266,000 units in 2023. The 2024 forecast Class 8 truck builds according to ACT Research is approximately 274,000 units.
According to Transparency Market Research Inc, the global commercial and automotive vehicle wire harness market is growing at approximately 5% per year.
According to Interact Analysis, the Global Off-Highway vehicle market is expected to increase approximately 5% in 2023. Beyond 2023, the Off-Highway vehicle market is expected to grow in the 4-5% range.
According to MacKay and Company, North American aftermarket truck parts are expected to see at least 4% growth in 2023. Compounded annual growth of at least 4% is forecasted for 2023-2027.
GAAP to Non-GAAP Reconciliation
A reconciliation of GAAP to non-GAAP financial measures referenced in this release is included as Appendix A to this release.
Conference Call
A conference call to discuss this press release is scheduled for Thursday, November 2, 2023, at 10:00 a.m. ET. Management intends to reference the Q3 2023 Earnings Call Presentation during the conference call. To participate, dial (888) 259-6580 using conference code 93330617. International participants dial (416) 764-8624 using conference code 93330617.
This call is being webcast and can be accessed through the “Investors” section of CVG’s website at ir.cvgrp.com, where it will be archived for one year.
A telephonic replay of the conference call will be available for a period of two weeks following the call. To access the replay, dial (877) 674-7070 using access code 051647 and international callers can dial (416) 764-8692 using access code 051647.
Company Contact Andy Cheung Chief Financial Officer CVG IR@cvgrp.com
Investor Relations Contact Ross Collins or Stephen Poe Alpha IR Group CVGI@alpha-ir.com
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 the Company and its products is available on the internet at www.cvgrp.com.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to risks and uncertainties. These statements often include words such as “believe”, “anticipate”, “plan”, “expect”, “intend”, “will”, “should”, “could”, “would”, “project”, “continue”, “likely”, and similar expressions. In particular, this press release may contain forward-looking statements about the Company’s expectations for future periods with respect to its plans to improve financial results, the future of the Company’s end markets, changes in the Class 8 and Class 5-7 North America truck build rates, performance of the global construction equipment business, the Company’s prospects in the wire harness, warehouse automation and electric vehicle markets, the Company’s initiatives to address customer needs, organic growth, the Company’s strategic plans and plans to focus on certain segments, competition faced by the Company, volatility in and disruption to the global economic environment and the Company’s financial position or other financial information. These statements are based on certain assumptions that the Company has made in light of its experience as well as its perspective on historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from the anticipated results because of certain risks and uncertainties, including those included in the Company’s filings with the SEC. There can be no assurance that statements made in this press release relating to future events will be achieved. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time. All subsequent written and oral forward-looking statements attributable to the Company or persons acting on behalf of the Company are expressly qualified in their entirety by such cautionary statements.
COMMERCIAL VEHICLE GROUP, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months and Nine Months Ended September 30, 2023 and 2022 (Unaudited) (Amounts in thousands, except per share amounts)
Three Months Ended
Nine Months Ended
September 30, 2023
September 30, 2022
September 30, 2023
September 30, 2022
Revenues
$
246,687
$
251,412
$
771,590
$
746,635
Cost of revenues
212,763
224,570
664,056
672,531
Gross profit
33,924
26,842
107,534
74,104
Selling, general and administrative expenses
21,476
17,304
64,498
49,955
Operating income
12,448
9,538
43,036
24,149
Other expense
383
1,924
488
2,798
Interest expense
2,614
2,813
8,308
6,892
Loss on extinguishment of debt
—
—
—
921
Income before provision for income taxes
9,451
4,801
34,240
13,538
Provision for income taxes
2,161
1,250
8,110
3,520
Net income
$
7,290
$
3,551
$
26,130
$
10,018
Earnings per Common Share:
Basic
$
0.22
$
0.11
$
0.79
$
0.30
Diluted
$
0.22
$
0.11
$
0.78
$
0.30
Weighted average shares outstanding:
Basic
33,100
32,460
33,010
32,950
Diluted
33,350
32,922
33,408
33,645
COMMERCIAL VEHICLE GROUP, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Amounts in thousands, except per share amounts)
ASSETS
September 30, 2023
December 31, 2022
Current assets:
Cash
$
46,293
$
31,825
Accounts receivable, net
159,863
152,626
Inventories
128,192
142,542
Other current assets
29,892
12,582
Total current assets
364,240
339,575
Property, plant and equipment, net
71,554
67,805
Intangible assets, net
12,041
14,620
Deferred income taxes
11,181
12,275
Other assets, net
37,026
35,993
Total assets
$
496,042
$
470,268
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
105,110
$
122,091
Accrued liabilities and other
52,999
42,809
Current portion of long-term debt and short-term debt
18,331
10,938
Total current liabilities
176,440
175,838
Long-term debt
135,573
141,499
Pension and other post-retirement benefits
9,325
8,428
Other long-term liabilities
28,150
24,463
Total liabilities
$
349,488
$
350,228
Stockholders’ equity:
Preferred stock
$
—
$
—
Common stock
330
328
Treasury stock
(15,322
)
(14,514
)
Additional paid-in capital
263,641
261,371
Retained deficit
(69,465
)
(95,595
)
Accumulated other comprehensive loss
(32,630
)
(31,550
)
Total stockholders’ equity
146,554
120,040
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
496,042
$
470,268
COMMERCIAL VEHICLE GROUP, INC. AND SUBSIDIARIES BUSINESS SEGMENT FINANCIAL INFORMATION (Unaudited) (Amounts in thousands)
Three Months Ended September 30,
Vehicle Solutions
Electrical Systems
Aftermarket and Accessories
Industrial Automation
Corporate/Other
Total
2023
2022
2023
2022
2023
2022
2023
2022
2023
2022
2023
2022
Revenues
$
145,393
$
154,024
$
53,862
$
46,129
$
34,412
$
37,143
$
13,020
$
14,116
$
—
$
—
$
246,687
$
251,412
Gross profit
17,661
13,839
7,881
6,210
6,605
6,389
1,777
404
—
—
33,924
26,842
Selling, general & administrative expenses
6,761
4,279
2,018
1,055
2,104
1,436
1,087
1,371
9,506
9,163
21,476
17,304
Operating income (loss)
$
10,900
$
9,560
$
5,863
$
5,155
$
4,501
$
4,953
$
690
$
(967
)
$
(9,506
)
$
(9,163
)
$
12,448
$
9,538
Nine Months Ended September 30,
Vehicle Solutions
Electrical Systems
Aftermarket and Accessories
Industrial Automation
Corporate/Other
Total
2023
2022
2023
2022
2023
2022
2023
2022
2023
2022
2023
2022
Revenues
$
458,707
$
436,966
$
172,236
$
133,350
$
108,870
$
99,530
$
31,777
$
76,789
$
—
$
—
$
771,590
$
746,635
Gross profit
58,035
35,657
26,524
16,857
21,620
13,341
1,355
8,249
—
—
107,534
74,104
Selling, general & administrative expenses
19,609
18,269
6,932
3,998
6,017
4,636
3,588
4,242
28,352
18,810
64,498
49,955
Operating income (loss)
$
38,426
$
17,388
$
19,592
$
12,859
$
15,603
$
8,705
$
(2,233
)
$
4,007
$
(28,352
)
$
(18,810
)
$
43,036
$
24,149
COMMERCIAL VEHICLE GROUP, INC. AND SUBSIDIARIES Appendix A: Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (Amounts in thousands, except per share amounts and percentages)
Three Months Ended
Nine Months Ended
September 30, 2023
September 30, 2022
September 30, 2023
September 30, 2022
Gross profit
$
33,924
$
26,842
$
107,534
$
74,104
Restructuring
70
607
1,443
2,958
Adjusted gross profit
$
33,994
$
27,449
$
108,977
$
77,062
% of revenues
13.8
%
10.9
%
14.1
%
10.3
%
Three Months Ended
Nine Months Ended
September 30, 2023
September 30, 2022
September 30, 2023
September 30, 2022
Operating income (loss)
$
12,448
$
9,538
$
43,036
$
24,149
Restructuring
70
647
1,501
3,387
Deferred consideration purchase accounting
—
103
—
341
Executive transition
—
329
—
329
Total operating income adjustments
70
1,079
1,501
4,057
Adjusted operating income
$
12,518
$
10,617
$
44,537
$
28,206
% of revenues
5.1
%
4.2
%
5.8
%
3.8
%
Three Months Ended
Nine Months Ended
September 30, 2023
September 30, 2022
September 30, 2023
September 30, 2022
Net income
$
7,290
$
3,551
$
26,130
$
10,018
Operating income adjustments
70
1,079
1,501
4,057
Pension settlement
—
1,116
—
1,116
Loss on extinguishment of debt
—
—
—
921
Hryvnia fair value adjustments on forward exchange contracts
—
(153
)
—
98
Adjusted provision for income taxes1
(18
)
(511
)
(375
)
(1,548
)
Adjusted net income
$
7,342
$
5,082
$
27,256
$
14,662
Diluted EPS
$
0.22
$
0.11
$
0.78
$
0.30
Adjustments to diluted EPS
$
—
$
0.04
$
0.04
$
0.14
Adjusted diluted EPS
$
0.22
$
0.15
$
0.82
$
0.44
Reported Tax Provision adjusted for tax effect of special charges at 25%
Three Months Ended
Nine Months Ended
September 30, 2023
September 30, 2022
September 30, 2023
September 30, 2022
Net income
$
7,290
$
3,551
$
26,130
$
10,018
Interest expense
2,614
2,813
8,308
6,892
Provision for income taxes
2,161
1,250
8,110
3,520
Depreciation expense
3,639
3,749
10,615
11,043
Amortization expense
847
851
2,544
2,563
EBITDA
$
16,551
$
12,214
$
55,707
$
34,036
% of revenues
6.7
%
4.9
%
7.2
%
4.6
%
EBITDA adjustments
Restructuring
$
70
$
647
$
1,501
$
3,387
Deferred consideration purchase accounting
—
103
—
341
Loss on extinguishment of debt
—
—
—
921
Hryvnia fair value adjustments on forward exchange contracts
—
(153
)
—
98
Executive transition
—
329
—
329
Pension settlement
—
1,116
—
1,116
Adjusted EBITDA
$
16,621
$
14,256
$
57,208
$
40,228
% of revenues
6.7
%
5.7
%
7.4
%
5.4
%
Three Months Ended September 30, 2023
Vehicle Solutions
Electrical Systems
Aftermarket and Accessories
Industrial Automation
Corporate/Other
Total
Operating income (loss)
$
10,900
$
5,863
$
4,501
$
690
$
(9,506
)
$
12,448
Restructuring
—
—
—
70
—
70
Adjusted operating income (loss)
$
10,900
$
5,863
$
4,501
$
760
$
(9,506
)
$
12,518
% of revenues
7.5
%
10.9
%
13.1
%
5.8
%
5.1
%
Nine Months Ended September 30, 2023
Vehicle Solutions
Electrical Systems
Aftermarket and Accessories
Industrial Automation
Corporate/Other
Total
Operating income (loss)
$
38,426
$
19,592
$
15,603
$
(2,233
)
$
(28,352
)
$
43,036
Restructuring
423
8
—
1,070
—
1,501
Adjusted operating income (loss)
$
38,849
$
19,600
$
15,603
$
(1,163
)
$
(28,352
)
$
44,537
% of revenues
8.5
%
11.4
%
14.3
%
(3.7
)%
5.8
%
Three Months Ended September 30, 2022
Vehicle Solutions
Electrical Systems
Aftermarket and Accessories
Industrial Automation
Corporate/Other
Total
Operating income (loss)
$
9,560
$
5,155
$
4,953
$
(967
)
$
(9,163
)
$
9,538
Restructuring
66
445
136
$
647
Deferred consideration purchase accounting
—
—
—
103
—
103
Executive transition
—
—
—
—
329
329
Adjusted operating income (loss)
$
9,626
$
5,155
$
5,398
$
(728
)
$
(8,834
)
$
10,617
% of revenues
6.2
%
11.2
%
14.5
%
(5.2
)%
4.2
%
Nine Months Ended September 30, 2022
Vehicle Solutions
Electrical Systems
Aftermarket and Accessories
Industrial Automation
Corporate/Other
Total
Operating income (loss)
$
17,388
$
12,859
$
8,705
$
4,007
$
(18,810
)
$
24,149
Restructuring
270
571
1,440
800
306
3,387
Deferred consideration purchase accounting
—
—
—
341
—
341
Executive transition
—
—
—
—
329
329
Adjusted operating income (loss)
$
17,658
$
13,430
$
10,145
$
5,148
$
(18,175
)
$
28,206
% of revenues
4.0
%
10.1
%
10.2
%
6.7
%
3.8
%
Three Months Ended
Nine Months Ended
September 30, 2023
September 30, 2022
September 30, 2023
September 30, 2022
Cash flows from operating activities
$
18,468
$
38,301
$
29,990
$
33,794
Purchases of property, plant and equipment
(6,017
)
(3,925
)
(15,196
)
(12,541
)
Free cash flow
$
12,451
$
34,376
$
14,794
$
21,253
Use of Non-GAAP Measures
This earnings release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). In general, the non-GAAP measures exclude items that (i) management believes reflect the Company’s multi-year corporate activities; or (ii) relate to activities or actions that may have occurred over multiple or in prior periods without predictable trends. Management uses these non-GAAP financial measures internally to evaluate the Company’s performance, engage in financial and operational planning and to determine incentive compensation.
Management provides these non-GAAP financial measures to investors as supplemental metrics to assist readers in assessing the effects of items and events on the Company’s financial and operating results and in comparing the Company’s performance to that of its competitors and to comparable reporting periods. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.
The non-GAAP financial measures disclosed by the Company should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP. The financial results calculated in accordance with GAAP and reconciliations to those financial statements set forth above should be carefully evaluated.
Program recognizes innovative approaches to leveraging technology and new operating models for business success
STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced the finalists for the 2023 ISG Paragon Awards™ South America, which celebrate the ongoing transformation of sourcing industry partnerships through new approaches and technologies.
Winners in each category will be selected by a panel of independent industry experts and announced at the ISG Sourcing Industry Awards Gala Dinner on Thursday, November 9, at the Grand Hyatt Hotel in São Paulo, Brazil.
Here are the South America finalists for the 2023 awards:
Excellence: Recognizing outstanding delivery by a technology or service provider
Kyndryl with a renowned motor vehicle manufacturer
Megawork Consultoria with a major retailer in Brazil
MIGNOW with a top financial firm offering banking services and solutions
T-Systems do Brasil with a renowned motor vehicle manufacturer
senhasegura with a leading pharmaceutical company
Innovation: Recognizing the importance of imagination and entrepreneurial spirit in helping organizations future-proof their businesses and better serve clients
Monitora Soluções Tecnológicas with a major hotel and apartment chain
Prime Control with a fashion and technology-focused company
Teleperformance with a prominent retail group
Vericode with Brazil’s financial market infrastructure firm
Teltec Solutions with a dynamic food solutions provider
Transformation: Recognizing the successful transformation of an organization or key business function
Enkel with a major player in the food industry
Fcamara with a distributor and wholesaler of food products
Spassu Tecnologia with Brazil’s state-owned oil and gas company
Logicalis with a data intelligence company
Dedalus with a healthcare technology and services provider
Environmental Sustainability: Recognizing outstanding positive impacts in one or more environmental sustainability fields for clients, consumers, communities and/or employees
ST IT Cloud with a global pharmaceutical and life sciences company
TIVIT with a leading agribusiness and food company
Yaman with a comprehensive benefits and rewards provider
Darede Serviços de TI with an energy solutions company
The ISG Paragon Awards™ South America, produced by ISG Events, recognize the innovative ways enterprises and providers are driving business success by leveraging digital technology and new operating models.
“Enterprises in South America seek partners to help them create hybrid, connected, autonomous, intelligent and effective organizations,” said Todd Lavieri, partner and president, ISG Americas and Asia Pacific. “ISG research finds regional providers in South America are outpacing many larger global firms in helping clients adopt the technologies that can deliver transformative business outcomes. It is an honor to recognize the partnerships that are driving agility and productivity in the region.”
Winners of the ISG Provider Lens™ Awards, recognizing outstanding performances by providers featured in ISG Provider Lens™ studies, will also be honored at the November 9 ISG Sourcing Industry Awards gala.
Full details of the ISG Paragon Awards program are available on the award website.
About ISG
ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.
IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today a new partnership between the Salem Podcast Network and Just The News to place the podcasts of John Solomon, Victor Davis Hanson, and Bauer and Rose on the SPN Platform. The agreement will allow Salem to market and sell the podcasts to its array of advertisers and provide additional promotional support.
The Salem Podcast Network has grown to become the 11th largest network on the Triton Digital national rankings, featuring such programs as Charlie Kirk, Dinesh D’Souza, and Trish Regan. “John Solomon and his team are a perfect fit for Salem and will provide an additional layer of news credibility to the stories he covers,” said Salem Senior VP Phil Boyce. “When you add Victor Davis Hanson’s podcasts, and those of Bauer and Rose, it makes the partnership complete.”
Solomon currently hosts seven podcasts a week dealing with many of the breaking news stories he covers on his website. In addition, Hanson hosts four podcasts a week, dealing with many of the culture war issues facing the country. Bauer and Rose host one podcast a week, so this adds an additional 12 weekly podcasts to the SPN platform.
“Salem Podcast Network has amassed one of the most formidable audiences and lineups in the industry,” said Solomon. “We are excited to be joining the team and introducing our news and analysis to a whole new audience.”
The Salem Podcast Network is one of Salem’s fastest growing business entities, providing podcasters with advertising, promotional support, and social media infrastructure. Podcasting in general is one of the fastest growing outlets for spoken word content, now reaching 14 million listeners a day, and Salem is a leader in the breaking news categories.
ABOUT SALEM MEDIA GROUP:
Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.com.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
3Q23 Results. Revenue of $246.7 million was down 1.9% y-o-y, and slightly below our $255 million estimate, mostly due to a COVID related backlog in Asia-Pacific last year that was not repeated this year. Adjusted EBITDA came in at $16.6 million, up 16.1% y-o-y, and in-line with our $17 million estimate. GAAP and adjusted net income was $7.3 million, or $0.22/sh, compared to GAAP $3.6 million, or $0.11/sh, and adjusted $5.1 million, or $0.15/sh, last year. We had forecast net income of $7.2 million, or $0.21/sh.
Segments. Vehicle Solutions revenue was $145.4 million compared to $154 million last year, while operating income was $10.9 million versus $9.6 million. Electrical Systems revenue was $53.9 million versus $46.1 million and operating income grew to $5.9 million from $5.2 million. Aftermarket revenue was $34.4 million, down from $37.1 million and operating income was $4.5 million compared to $5.0 million. Industrial Automation revenue was $13.0 million compared to $14.1 million and segment operating income was $0.7 million compared to an operating loss of $1.0 million last year.
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.
Beasley Broadcast Group, Inc. owns and operates 61 stations (47 FM and 14 AM) in 15 large- and mid-size markets in the United States. Approximately 20 million consumers listen to the Company’s radio stations weekly over-the-air, online and on smartphones and tablets, and millions regularly engage with the Company’s brands and personalities through digital platforms such as Facebook, Twitter, text messaging, digital and web applications and email. The Overwatch League’s Houston Outlaws esports team is a wholly owned subsidiary. The Company also owns BeasleyXP, a national esports content hub, and AXLR-R8, a Rocket League Championship Series team, in its esports portfolio. For more information, please visit www.bbgi.com.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
A noisy quarter. Q3 total revenues were $60.1 million, slightly less than our $61.3 million estimate. Adj. EBITDA was $5.5 million, 13% below our $6.3 million estimate. The company had non cash charges in the quarter which created a lot of noise in its earnings.
Some green shoots. The company indicated that September revenue increased 2.1% excluding Political revenues. In addition, national advertising appears to be moderating, down 8%, ex Political, versus down 20% in the first half 2023. Furthermore, the company generated a significant $8 million in new direct business in the quarter.
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).
A buoyant optimism filled Wall Street on Thursday as investors interpreted the Fed’s latest decision to stand pat on rates as a sign the end of the hiking cycle may be near. The Nasdaq leapt 1.5% while the S&P 500 and Dow climbed nearly 1.25% each as traders priced in dwindling odds of additional tightening.
While Fed Chair Jerome Powell stressed future moves would depend on the data, markets increasingly see one more increase at most, not the restrictive 5-5.25% peak projected earlier. The CME FedWatch tool shows only a 20% chance of a December hike, down from 46% before the Fed meeting.
The prospect of peak rates arriving sparked a “risk-on” mindset. Tech stocks which suffered during 2023’s relentless bumps upward powered Thursday’s rally. Apple rose over 3% ahead of its highly anticipated earnings report. The iPhone maker’s results will offer clues into consumer spending and China demand trends.
Treasury yields fell in tandem with rate hike expectations. The 10-year yield dipped under 4.6%, nearing its early October lows. As monetary policy tightening fears ease, bonds become more attractive.
Meanwhile, Thursday’s batch of earnings updates proved a mixed bag. Starbucks and Shopify impressed with better than forecast reports showcasing resilient demand and progress on cost discipline. Shopify even managed to eke out a quarterly profit thanks to AI-driven optimization.
Both stocks gained over 10%, extending gains for October’s worst sectors – consumer discretionary and tech. But biotech Moderna plunged nearly 20% on underwhelming COVID vaccine sales guidance. With demand waning amid relaxed restrictions, Moderna expects revenue weakness to persist.
Still, markets found enough earnings bright spots to sustain optimism around what many now view as the Fed’s endgame. Bets on peak rates mark a momentous shift from earlier gloom over soaring inflation and relentless hiking.
Savoring the End of Hiking Anxiety
Just six weeks ago, recession alarm bells were clanging loudly. The S&P 500 seemed destined to retest its June lows after a brief summer rally crumbled. The Nasdaq lagged badly as the Fed’s hawkish resolve dashed hopes of a policy pivot.
But September’s surprisingly low inflation reading marked a turning point in sentiment. Rate hike fears moderated and stocks found firmer footing. Even with some residual CPI and jobs gains worrying hawkish Fed members, investors are increasingly looking past isolated data points.
Thursday’s rally revealed a market eager to rotate toward the next major focus: peak rates. With the terminal level now potentially in view, attention turns to the timing and magnitude of rate cuts once inflation falls further.
Markets are ready to move on from monetary policy uncertainty and regain the upside mentality that supported stocks for so long. The Nasdaq’s outperformance shows traders positioning for a soft landing rather than bracing for recession impact.
Challenges Remain, but a Peak Brings Relief
Reaching peak rates won’t instantly cure all market ills, however. Geopolitical turmoil, supply chain snarls, and the strong dollar all linger as headwinds. Corporate earnings face pressure from margins strained by high costs and waning demand.
And valuations may reset lower in sectors like tech that got ahead of themselves when easy money flowed freely. But putting an endpoint on the rate rollercoaster will remove the largest overhang on sentiment and allow fundamentals to reassert influence.
With peak rates cementing a dovish pivot ahead, optimism can return. The bear may not yet retreat fully into hibernation, but its claws will dull. As long as the economic foundation holds, stocks have room to rebuild confidence now that the end is in sight.
Of course, the Fed could always surprise hawkishly if inflation persists. But Thursday showed a market ready to look ahead with hopes the firehose of rate hikes shutting off will allow a modest new bull run to take shape in 2024.
