SAN DIEGO, Oct. 26, 2023 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets, announced today that it will publish financial results for the third quarter 2023 after the close of market on Thursday, November 2nd. Management will discuss the Company’s operations and financial results in a conference call beginning at 2:00 p.m. Pacific (5:00 p.m. Eastern).
The call will be available at www.kratosdefense.com. Participants may register for the call using this Online Form. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN that can be used to access the call. For those who cannot access the live broadcast, a replay will be available on Kratos’ website.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a Technology Company that develops and fields transformative, affordable systems, products and solutions for United States National Security, our allies and global commercial enterprises. At Kratos, Affordability is a Technology, and Kratos is changing the way breakthrough technology is rapidly brought to market – at a low cost – with actual products, systems, and technologies rather than slide decks or renderings. Through proven commercial and venture capital backed approaches, including proactive, internally funded research and streamlined development processes, Kratos is focused on being First to Market with our solutions, well in advance of competition. Kratos is the recognized Technology Disruptor in our core market areas, including Space and Satellite Communications, Cyber Security and Warfare, Unmanned Systems, Rocket and Hypersonic Systems, Next-Generation Jet Engines and Propulsion Systems, Microwave Electronics, C5ISR and Virtual and Augmented Reality Training Systems. For more information, visit www.KratosDefense.com.
TROY, Mich., Oct. 26, 2023 /PRNewswire/ — Kelly, a leading global specialty talent solutions provider, will release its third-quarter earnings before the market opens on Thursday, November 9, 2023. In conjunction with its third-quarter earnings release, Kelly will publish a financial presentation on the Investor Relations page of its public website and will host a conference call at 9 a.m. ET.
The call may be accessed in one of the following ways:
Via the Telephone (877) 692-8955 (toll free) or (234) 720-6979 (caller paid) Enter access code 5728672 After the prompt, please enter ”#”
A recording of the conference call will be available after 2:30 p.m. ET on November 9, 2023, at (866) 207-1041 (toll-free) and (402) 970-0847 (caller-paid). The access code is 7027637#. The recording will also be available at kellyservices.com during this period.
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.
Novel formulation of intranasal oxytocin contains magnesium (Mg2+), shown to potentiate the analgesic effects of oxytocin on the oxytocin receptor in animal models
TNX-1900 blocks release of CGRP, a key peptide in the pathogenesis of migraine, from trigeminal ganglia neurons while limiting systemic exposure
CHATHAM, N.J., Oct. 26, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical phase of the Phase 2 proof-of-concept, double-blind, randomized, placebo-controlled PREVENTION1 study of TNX-19002 (intranasal potentiated oxytocin) as a potential treatment for the prevention of migraine headaches in chronic migraineurs. A total of 88 patients were enrolled in this multi-site study in the U.S. Topline results are expected in early December 2023.
TNX-1900 is a proprietary formulation of oxytocin that contains magnesium, which Tonix has shown in animal models potentiates the action of oxytocin at oxytocin receptors and potentially improves the consistency of treatment by reducing paradoxical high-dose inhibition. Its unique, multimodal mechanism of action includes an ability to inhibit the release of the trigeminal neuropeptide calcitonin gene-related peptide (CGRP) in blood vessels within the brain, its lining and the brainstem, and to suppress signaling in pain neurons. Tonix believes that by engaging and activating oxytocin receptors in the trigeminal ganglia, TNX-1900 has the potential to help those suffering from chronic migraine.
“TNX-1900 is being developed as a novel, non-CGRP antagonist approach to treatment for chronic migraineurs,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are an estimated four million individuals in the U.S. suffering from this debilitating condition, and despite several classes of migraine preventives available, there remains an unmet need for novel approaches.”
“With the last patient now treated, we look forward to analysis of the results of this proof-of-concept study, which will help to inform our plans as we discuss next steps with the U.S. Food and Drug Administration (FDA),” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “We would like to thank the participants, their families, and all the investigators and researchers who have been an important part of this journey so far.”
1Clinical Trials.gov I.D. NCT05679908 2TNX-1900 is an investigational new drug and is not approved for any indication.
About the Phase 2 PREVENTION Study The Phase 2 PREVENTION study is a double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-1900 taken prophylactically on a daily basis to prevent chronic migraine. There are three arms: two treatment regimens of TNX-1900 and one placebo in a 1:1:1 ratio in a total of 88 participants across approximately 26 U.S. sites. After a four-week Run-In phase to confirm chronic migraine criteria are met, there are 12-weeks of a double-blind Treatment phase with study drug, followed by a 2-week safety Follow-Up phase. The primary efficacy endpoint is mean change in the number of migraine headache days between the 28-day Run-In phase and the last 28-days of the Treatment phase. Key secondary efficacy endpoints include proportion of patients experiencing a ≥ 50% reduction in the number of migraine headache days, mean change in the number of days using migraine abortive medications, and mean change in a migraine-specific quality of life measure.
For more information, see ClinicalTrials.gov Identifier: NCT05679908.
About Migraine Migraine is a neurological condition that typically manifests in a throbbing moderate to severe headache which lasts at least four hours, often on one side of the head and aggravated by routine physical activity. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light and loud noises1. Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually2. In the U.S., approximately 39 million Americans suffer from migraines and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month, at least eight of which are migraines)2. The current FDA approved drugs for migraine prevention in chronic migraine include Botox® (onabotulinumtoxinA), and the anti-CGRP/CGRP-R monoclonal antibodies Aimovig® (erenumab), Vyepti® (eptinezumab), Ajovy® (fremanezumab) and Emgality® (galcanezumab).
1The International Classification of Headache Disorders, 3rd Edition. Cephalalgia. 2018. 38(1):1-211.
2Burch et al., Migraine: Epidemiology, Burden, and Comorbidity. Neurol Clin. 2019. 631–649.
About TNX-1900 TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for prevention in chronic migraine and other conditions. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. It has been observed that low oxytocin levels in the body are associated with increases in migraine headache frequency, and that increased oxytocin levels are associated with fewer migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels. Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal neurons which, when activated, release of calcitonin gene-related peptide (CGRP) which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in headache. Oxytocin, when delivered via the nasal route, concentrates in the trigeminal system1 resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release2. Blocking CGRP release is a distinct mechanism compared with CGRP antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding3 as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models4. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children5. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP antagonists such as anti-CGRP antibodies6. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to chronic migraine, TNX-1900 will be developed for treatment of episodic migraine, binge eating disorder, craniofacial pain conditions, and insulin resistance. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.
1Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388.
2Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
3Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4.
4Cai Q, et al., Psychiatry Clin Neurosci. 2018. 72(3):140-151.
5Yeomans, DC et al. 2017. US patent US2017368095.
6MaassenVanDenBrink A, et al. Trends Pharmacol Sci. 2016. 37(9):779-788.
Tonix Pharmaceuticals Holding Corp.* 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-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 study in the third quarter of 2023, with topline results expected in early November of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the mu-opioid receptor while maintaining activity and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and the clinical phase of a Phase 2 proof-of-concept study is now completed 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.
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.
BOCA RATON, Fla.–(BUSINESS WIRE)–Oct. 25, 2023– The ODP Corporation (NASDAQ:ODP) (“ODP,” or the “Company”), a leading provider of business services, products and digital workplace technology solutions to businesses and consumers, will announce third quarter 2023 financial results before the market open on Wednesday, November 8th, 2023. The ODP Corporation will webcast a call with financial analysts and investors that day at 9:00 am Eastern Time which will be accessible to the media and the general public.
To listen to the conference call via webcast, please visit The ODP Corporation’s Investor Relations website at investor.theodpcorp.com. A replay of the webcast will be available approximately two hours following the event. A copy of the earnings press release, supplemental financial disclosures and presentation will also be available on the website.
About The ODP Corporation
The ODP Corporation (NASDAQ:ODP) is a leading provider of products and services through an integrated business-to-business (B2B) distribution platform and omnichannel presence, which includes world-class supply chain and distribution operations, dedicated sales professionals, a B2B digital procurement solution, online presence and a network of Office Depot and OfficeMax retail stores. Through its operating companies Office Depot, LLC; ODP Business Solutions, LLC; Veyer, LLC; and Varis, Inc., The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.
ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc. Veyer is a trademark of Veyer, LLC. Varis is a trademark of Varis Inc. Grand&Toy is a trademark of Grand & Toy, LLC in Canada. Any other product or company names mentioned herein are the trademarks of their respective owners.
HOUSTON, Oct. 25, 2023 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (the “Company”), a leading specialty construction company, today reported its financial results for the third quarter ended September 30, 2023.
Highlights for the quarter ended September 30, 2023:
Contract revenues of $168.5 million
GAAP net loss was $0.7 million or $0.02 per diluted share
Adjusted net income was $0.8 million or $0.02 per diluted share
Adjusted EBITDA was $9.4 million
Signed contract valued over $100 million with Grand Bahama Shipyard Limited (GBSL) for the turnkey design-build of the Grand Bahama Shipyard Dry Dock Replacement Project
Other recently awarded new contracts in both the Concrete and Marine segments for a combined total of approximately $121 million
Backlog and contracts awarded subsequent to quarter end totaled $920 million
See definitions and reconciliation of non-GAAP measures elsewhere in this release.
Management Commentary
“As CFO Scott Thanisch and I marked our first anniversary with Orion, we are incredibly proud of how our people have worked collaboratively to embrace change and deliver positive results,” said Travis Boone, Chief Executive Officer of Orion Group Holdings. “Backlog is a key metric and indicator of the health of the business. As of September 30, backlog stood at $878 million compared with backlog of $549 million in the prior year period. We have won several prestigious projects including the $435 million contract to build a dry dock at Pearl Harbor for the US Navy and a contract valued over $100 million with the Grand Bahama Shipyard Limited (GBSL) for the turnkey design-build of the Grand Bahama Shipyard Dry Dock Replacement Project.”
“Last quarter we told you that we expected continued improvement in profitability through the back half of the year, and we are delivering on that promise. Third-quarter Adjusted EBITDA was $9.4 million versus $3.7 million in the second quarter of 2023. While our third quarter revenue of $169 million is down year-over-year due to our exit from the Central Texas concrete business, the higher quality of our revenue is delivering improved profitability.”
“Since March, our Concrete business has been profitable and improving on an Adjusted EBITDA basis. Adjusted EBITDA margin increased from negative 1.7% to positive 2.4% year-over-year. In addition, the Concrete business was operating income positive on an unconsolidated basis in the third quarter. In Marine, we have a lot of momentum with projects won and potential future projects. There’s a tremendous amount of pent-up demand that we think will be a significant tailwind for us well into 2024 and 2025.”
“As we look ahead to the fourth quarter and beyond, we are optimistic. Our investments in business development are paying off, and we have sufficient capacity and a more disciplined approach to optimize our people and assets. We will see continued improvement in our margins and benefit from operating leverage as we grow the top line. We are excited to build on our success this year and continue growing profitably in 2024,” concluded Boone.
Third Quarter 2023 Results
Contract revenues of $168.5 million decreased 7.7% from $182.6 million in the third quarter last year, primarily due to our decision to exit the unprofitable concrete business in central Texas, partially offset by an increase in marine segment revenue related to the Pearl Harbor, Hawaii drydock project (the “Pearl Harbor Project”).
Gross profit was $19.1 million or 11.3% of revenue up from $13.4 million or 7.4% of revenue in the third quarter of 2022. The increase in gross profit dollars and margin was primarily driven by margin improvements in both segments stemming from higher quality projects and improved execution, partially offset by lower equipment and labor utilization in our dredging business.
Selling, general and administrative (“SG&A”) expenses were $17.1 million, up 11.4% from $15.4 million in the third quarter of 2022. As a percentage of total contract revenues, SG&A expenses increased to 10.2% from 8.5%, primarily due to lower revenues and an increase in SG&A in the third quarter. The increase in SG&A dollars reflected an increase in IT and business development spending and higher legal costs related to customer claims.
Net loss for the third quarter was $0.7 million or $0.02 per diluted share compared to net income of $0.2 million or $0.01 per diluted share in the third quarter of 2022.
The third quarter 2023 net loss included $1.5 million ($0.04 diluted income per share) of non-recurring items. Third quarter 2023 adjusted net income was $0.8 million ($0.02 diluted income per share).
EBITDA for the third quarter of 2023 was $8.7 million, representing a 5.2% EBITDA margin, as compared to EBITDA of $7.2 million, or a 4.0% EBITDA margin in the third quarter last year. Adjusted for non-recurring items, EBITDA for the third quarter of 2023 was $9.4 million, representing a 5.6% adjusted EBITDA margin, as compared to adjusted EBITDA for the third quarter of 2022 of $8.8 million, representing a 4.8% adjusted EBITDA margin.
Backlog
Total backlog at September 30, 2023 was $877.5 million, compared to $818.7 million at June 30, 2023 and $548.6 million at September 30, 2022. Backlog for the Marine segment was $699.9 million, compared to $614.9 million at June 30, 2023 and $280.2 million at September 30, 2022. Backlog for the Concrete segment was $177.6 million, compared to $203.8 million at June 30, 2023 and $268.4 million at September 30, 2022. In addition, the Company has been awarded $43 million in new project work subsequent to the end of the quarter ended September 30, 2022 that is not included in backlog at the end of the quarter.
Recent Wins
On September 22, the Company entered into a design-build contract valued over $100 million for its Marine and Engineering business. The contract was awarded by Grand Bahama Shipyard Limited (GBSL) for the turnkey design-build of the Grand Bahama Shipyard Dry Dock Replacement Project, situated in Grand Bahama, Bahamas. In addition, the Company was recently awarded other new contracts in both its concrete and marine segments for a combined total of approximately $121 million.
Safety Award
Orion Group Holdings, Inc. was presented with the Company Award for Leadership in Safety from the Council of Dredging and Marine Construction Safety (CDMCS). The award, presented at the 2023 CDMCS Annual Awards Dinner in Washington, D.C. on September 28, recognizes outstanding safety leadership in the dredging and marine construction industry.
Orion Group Holdings was recognized for advancing a safety-first culture through safety-conscious policies and procedures in the workplace, mentoring others in safety, training on identifying and properly controlling hazards, and placing high personal value on collaborative and proactive work toward improving safety.
Balance Sheet Update
As of September 30, 2023, current assets were $228.5 million, including unrestricted cash and cash equivalents of $3.9 million. Total debt outstanding as of September 30, 2023 was $50.3 million. At the end of the quarter, the Company had $13.5 million in outstanding borrowings under its revolving credit facility.
Conference Call Details
Orion Group Holdings will host a conference call to discuss results for the third quarter 2023 at 9:00 a.m. Eastern Time/8:00 a.m. Central Time on Thursday, October 26, 2023. To participate, please dial (800) 715-9871 and ask for the Orion Group Holdings Conference Call. A live audio webcast of the call will also be available on the Investor Relations section of Orion’s website at https://www.oriongroupholdingsinc.com/investor/ and will be archived for replay.
About Orion Group Holdings
Orion Group Holdings, Inc., a leading specialty construction company serving the infrastructure, industrial and building sectors, provides services both on and off the water in the continental United States, Alaska, Hawaii, Canada and the Caribbean Basin through its marine segment and its concrete segment. The Company’s marine segment provides construction and dredging services relating to marine transportation facility construction, marine pipeline construction, marine environmental structures, dredging of waterways, channels and ports, environmental dredging, design and specialty services. Its concrete segment provides turnkey concrete construction services including place and finish, site prep, layout, forming, and rebar placement for large commercial, structural and other associated business areas. The Company is headquartered in Houston, Texas with regional offices throughout its operating areas. The Company’s website is located at: https://www.oriongroupholdingsinc.com.
Backlog Definition
Backlog consists of projects under contract that have either (a) not been started, or (b) are in progress but are not yet complete. The Company cannot guarantee that the revenue implied by its backlog will be realized, or, if realized, will result in earnings. Backlog can fluctuate from period to period due to the timing and execution of contracts. The typical duration of the Company’s projects ranges from three to nine months on shorter projects to multiple years on larger projects. The Company’s backlog at any point in time includes both revenue it expects to realize during the next twelve-month period as well as revenue it expects to realize in future years.
Non-GAAP Financial Measures
This press release includes the financial measures “adjusted net income/loss,” “adjusted earnings/loss per share,” “EBITDA,” “Adjusted EBITDA” and “Adjusted EBITDA margin.” These measurements are “non-GAAP financial measures” under rules of the Securities and Exchange Commission, including Regulation G. The non-GAAP financial information may be determined or calculated differently by other companies. By reporting such non-GAAP financial information, the Company does not intend to give such information greater prominence than comparable GAAP financial information. Investors are urged to consider these non-GAAP measures in addition to and not in substitute for measures prepared in accordance with GAAP.
Adjusted net income/loss and adjusted earnings/loss per share should not be viewed as an equivalent financial measure to net income/loss or earnings/loss per share. Adjusted net income/loss and adjusted earnings/loss per share exclude certain items that management believes impairs a meaningful evaluation of the Company’s financial performance. The Company believes these adjusted financial measures are a useful supplement to earnings/loss calculated in accordance with GAAP because they better inform our common stockholders as to the Company’s operational trends and performance relative to other companies. Generally, items excluded are one-time items or items whose timing or amount cannot be reasonably estimated. Accordingly, any guidance provided by the Company generally excludes information regarding these types of items.
Orion Group Holdings defines EBITDA as net income/loss before net interest expense, income taxes, depreciation and amortization. Adjusted EBITDA is calculated by adjusting EBITDA for certain items that management believes impairs a meaningful comparison of operating results. Adjusted EBITDA margin is calculated by dividing Adjusted EBITDA for the period by contract revenues for the period. The GAAP financial measure that is most directly comparable to EBITDA and Adjusted EBITDA is net income, while the GAAP financial measure that is most directly comparable to Adjusted EBITDA margin is operating margin, which represents operating income divided by contract revenues. EBITDA, Adjusted EBITDA and Adjusted EBITDA margin are used internally to evaluate current operating expense, operating efficiency, and operating profitability on a variable cost basis, by excluding the depreciation and amortization expenses, primarily related to capital expenditures and acquisitions, and net interest and tax expenses. Additionally, EBITDA, Adjusted EBITDA and Adjusted EBITDA margin provide useful information regarding the Company’s ability to meet future debt service and working capital requirements while providing an overall evaluation of the Company’s financial condition. In addition, EBITDA is used internally for incentive compensation purposes. The Company includes EBITDA, Adjusted EBITDA and Adjusted EBITDA margin to provide transparency to investors as they are commonly used by investors and others in assessing performance. EBITDA, Adjusted EBITDA and Adjusted EBITDA margin have certain limitations as analytical tools and should not be used as a substitute for operating margin, net income, cash flows, or other data prepared in accordance with GAAP, or as a measure of the Company’s profitability or liquidity.
Forward-Looking Statements
The matters discussed in this press release may constitute or include projections or other forward-looking statements within the meaning of the “safe harbor” provisions of Section 27A of the Securities Exchange Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, of which provisions the Company is availing itself. Certain forward-looking statements can be identified by the use of forward-looking terminology, such as ‘believes’, ‘expects’, ‘may’, ‘will’, ‘could’, ‘should’, ‘seeks’, ‘approximately’, ‘intends’, ‘plans’, ‘estimates’, or ‘anticipates’, or the negative thereof or other comparable terminology, or by discussions of strategy, plans, objectives, intentions, estimates, forecasts, outlook, assumptions, or goals. In particular, statements regarding future operations or results, including those set forth in this press release, and any other statement, express or implied, concerning future operating results or the future generation of or ability to generate revenues, income, net income, gross profit, EBITDA, Adjusted EBITDA, Adjusted EBITDA margin, or cash flow, including to service debt, and including any estimates, forecasts or assumptions regarding future revenues or revenue growth, are forward-looking statements. Forward-looking statements also include project award announcements, estimated project start dates, anticipated revenues, and contract options which may or may not be awarded in the future. Forward-looking statements involve risks, including those associated with the Company’s fixed price contracts that impacts profits, unforeseen productivity delays that may alter the final profitability of the contract, cancellation of the contract by the customer for unforeseen reasons, delays or decreases in funding by the customer, levels and predictability of government funding or other governmental budgetary constraints, and any potential contract options which may or may not be awarded in the future, and are at the sole discretion of award by the customer. Past performance is not necessarily an indicator of future results. In light of these and other uncertainties, the inclusion of forward-looking statements in this press release should not be regarded as a representation by the Company that the Company’s plans, estimates, forecasts, goals, intentions, or objectives will be achieved or realized. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update information contained in this press release whether as a result of new developments or otherwise, except as required by law.
Please refer to the Company’s 2022 Annual Report on Form 10-K, filed on March 16, 2023, which is available on its website at www.oriongroupholdingsinc.com or at the SEC’s website at www.sec.gov, for additional and more detailed discussion of risk factors that could cause actual results to differ materially from our current expectations, estimates or forecasts.
Legendary Chains Merge for the First Time to Serve Up Burgers and Pizzas Under One Roof in Lantana, Texas
LOS ANGELES, Oct. 25, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Fatburger, Round Table Pizza, and 16 other restaurant concepts, announces that it has officially opened its first-ever co-branded Fatburger and Round Table Pizza location in Dallas. Situated in the vibrant Lantana neighborhood, the 3,500 sq. foot restaurant offers a full-service, full-bar casual dining experience great for game day. It is the first of four co-branded Fatburger and Round Table Pizza locations planned for the greater Dallas area operated by SNM Management Group.
“We are beyond thrilled to introduce our first co-branded Fatburger and Round Table Pizza concept to Dallas,” says Taylor Wiederhorn, Chief Development Officer of FAT Brands. “This new restaurant will allow guests to enjoy the best of both brands in one space, creating a seamless experience that caters to a range of tastes. With the success Fatburger has seen co-branding with Buffalo’s Cafe and Express, we’re eager to see this new venture with Round Table Pizza flourish.”
Ever since the first Fatburger opened in Los Angeles 70 years ago, the chain has been known for its delicious, grilled-to-perfection and cooked-to-order burgers. Founder Lovie Yancey believed that a big burger with everything on it is a meal in itself; at Fatburger “everything” is not just the usual roster of toppings. Burgers can be customized with everything from bacon and eggs to chili and onion rings. In addition to its famous burgers, the Fatburger menu also includes Fat and Skinny Fries, sweet potato fries, scratch-made onion rings, Impossible™ Burgers, turkeyburgers, hand-breaded crispy chicken sandwiches, and hand-scooped milkshakes made from 100 percent real ice cream.
Since its founding, Round Table Pizza has been recognized as “Pizza Royalty™” for its homemade dough, signature three-cheese blend, and gold-standard ingredients topped to the edge. Customers can enjoy the chain’s proprietary handmade pizzas, salads, baked-to-perfection Garlic Parmesan Twists, classic and boneless wings, and more.
The new co-branded Fatburger and Round Table Pizza location is located at 3701 FM 407 Suite 600, Bartonville, Texas 76226. It is open Sunday to Thursday, 11 a.m. to 10 p.m., and Fridays and Saturdays 11 a.m. to 12 a.m. – perfect for late-night cravings.
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.
About Fatburger
An all-American, Hollywood favorite, Fatburger is a fast-casual restaurant serving big, juicy, tasty burgers, crafted specifically to each customer’s liking. With a legacy spanning 70 years, Fatburger’s extraordinary quality and taste inspire fierce loyalty amongst its fan base, which includes a number of A-list celebrities and athletes. Featuring a contemporary design and ambiance, Fatburger offers an unparalleled dining experience, demonstrating the same dedication to serving gourmet, homemade, custom-built burgers as it has since 1952 – The Last Great Hamburger Stand™. For more information, visit www.fatburger.com.
About Round Table Pizza
Inspired by the honor, valor, and revelry of the Knights of the Round Table, Round Table Pizza’s® superior pizza and commitment to quality and authenticity have earned the reputation of “Pizza Royalty™” for over 60 years. With more than 410 restaurants across the United States, Round Table celebrates community, family, and making merry. For more information, visit www.roundtablepizza.com.
SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision (NYSE: EVC), a leading global advertising solutions, media and technology company, today announced the following updates to its Board of Directors (“the Board”), effective immediately, as part of the Company’s ongoing commitment to corporate governance practices and enhancing stockholder value:
Michael Christenson, Entravision’s Chief Executive Officer, was appointed as a director of the Company.
Lara Sweet, currently a director of MediaAlpha, Inc. and previously the Chief People Officer, Interim Chief Financial Officer, and Chief Accounting Officer and Controller of Snap Inc., was appointed as an independent director of the Company. Ms. Sweet will serve on the Audit Committee as a financial expert and on the Compensation Committee.
Juan Saldivar von Wuthenau, Entravision’s Chief Digital, Strategy and Accountability Officer, has resigned as a director of the Company. Mr. Saldivar will remain in his current executive role at Entravision which he has held since November 2020.
“We are pleased to welcome both Mr. Christenson and Ms. Sweet as directors, consistent with our commitment to corporate governance and periodically refreshing the Board with new perspectives, skill sets and experiences,” commented Paul Zevnik, Chair of Entravision’s Board of Directors. “We look forward to benefiting from Mr. Christenson’s extensive experience with high-growth public and private technology companies and, in conjunction with his role as CEO of the Company, building on our strategy to drive growth and stockholder value. In addition, Ms. Sweet has valuable leadership experience in finance and human resources at major technology companies. These updates align with our ongoing Board refreshment and succession planning, which includes the appointment earlier this year of Brad Bender, who brings significant digital advertising industry experience, and Tom Strickler, who added deep knowledge of the media and entertainment industry as well as significant business leadership expertise. I’d also like to thank Mr. Saldivar for his contributions to the Board over the past nine years and for remaining in his executive role as the Company continues to build value with our digital media, advertising and technology platforms.”
Mr. Saldivar added, “It has been an honor to serve as a director since 2014, while helping develop and implement the Company’s digital strategy as an external consultant since 2011 and a member of the executive team for the past three years. I believe Entravision’s future is bright and I look forward to continuing to collaborate with the Board and executive team as we advance our strategy of being a premiere global media, advertising solutions and technology company.”
Ms. Sweet has been a director of MediaAlpha, Inc., a marketing technology company that uses technology and data science to help businesses optimize their customer acquisition efforts, since the completion of its initial public offering in October 2020 and serves as the chair of its Audit Committee. In addition, Ms. Sweet serves as an advisor to private technology companies. From May 2019 to June 2021, Ms. Sweet served as the Chief People Officer at Snap Inc., a social media company and owner of the Snapchat application. Prior to that, Ms. Sweet served as Snap’s Interim Chief Financial Officer from January 2019 to May 2019, and as Chief Accounting Officer and Controller from June 2016 to September 2019. During her tenure in these roles, Ms. Sweet was integrally involved in developing and implementing best practices across Snap’s accounting and financial reporting functions, among other key initiatives. Prior to Snap, Ms. Sweet served as Controller and Chief Accounting Officer at AOL. She has also held the positions of Senior Director, External Reporting at Freddie Mac and Senior Manager, Internal Audit at Marriott International. Ms. Sweet received a B.S. in Accounting from George Mason University.
About Entravision Communications Corporation
Entravision is a global advertising solutions, media and technology company. Over the past three decades, we have strategically evolved into a digital powerhouse, expertly connecting brands to consumers in the U.S., Latin America, Europe, Asia and Africa. Our digital segment, the company’s largest by revenue, offers a full suite of end-to-end advertising services in 40 countries. We have commercial partnerships with Meta, X Corp. (formerly known as Twitter), TikTok, and Spotify, and marketers can use our Smadex and other platforms to deliver targeted advertising to audiences around the globe. In the U.S., we maintain a diversified portfolio of television and radio stations that target Hispanic audiences and complement our global digital services. Entravision remains the largest affiliate group of the Univision and UniMás television networks. Shares of Entravision Class A Common Stock trade on the NYSE under ticker: EVC. Learn more about our offerings at entravision.com or connect with us on LinkedIn and Facebook.
Christopher Young Chief Financial Officer Entravision 310-447-3870
Paper reports that obesity exacerbates scarring of the heart’s muscular tissue (myocardial fibrosis) through recruitment of inflammasome ASC to the heart’s mitochondria, facilitating NLRP3 inflammasome assembly and activation leading to damaging inflammation
Obesity, which affects over 650 million adults, is a known risk factor for myocardial fibrosis which is associated with almost all heart diseases
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit formation of multiple types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation
WESTON, Fla., Oct. 25, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces a publication in the peer-reviewed journal, Diabetes, demonstrating the role of ASC in myocardial fibrosis induced by obesity. ASC is an inflammasome adaptor protein that has a critical role in inflammasome activation.
In the paper titled, “Obesity enables NLRP3 activation and induces myocardial fibrosis via hyperacetylation of HADHa,” the authors performed MRIs on obese and lean people and evaluated their plasma. They also studied an animal model of obesity, with and without induced myocardial injury. Data indicate that:
Activated NLRP3 inflammasomes leading to increased levels of proinflammatory IL-1β and IL-18 contribute to obesity-related myocardial fibrosis in obese humans and mice.
Inflammasome ASC localized in the heart’s mitochondria participates in NLRP3 inflammasome formation and activation based on mouse data.
Inhibition of NLRP3 activation or removal of IL-1β and IL-18 abated the adverse effects on cardiac fibrosis and function in mice.
The authors concluded that these results provide new evidence for the involvement of mitochondria-localized ASC in obesity-induced cardiac fibrosis. To read the article, Click Here.
“Obesity, a well-established risk factor for cardiovascular disease, has reached pandemic proportions, and may affect up to two-thirds of the adult population in developed countries,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “The research published in Diabetes demonstrates that ASC in the heart’s mitochondria facilitates NLRP3 inflammasome assembly and activation leading to damaging inflammation and myocardial fibrosis associated with obesity. This provides support for Inflammasome ASC Inhibitor IC 100 as a potential therapeutic option. By inhibiting ASC, IC 100 blocks formation of NLRP3 and other types of inflammasomes to block initiation of the inflammatory cascade. Likewise, IC 100 uniquely inhibits ASC specks to attenuate perpetuation of damaging inflammation.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
About Inflammasome ASC Inhibitor IC 100
IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
Corporate and IR Contact: Karen Cashmere Chief Commercial Officer kcashmere@zyversa.com 786-251-9641
ATLANTA, Oct. 24, 2023 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading provider of digital transformation, science, research and development, and systems engineering and integration, today announced selected key metrics for the fiscal year ended September 30, 2023.
Debt Reduction Total debt at fiscal year end was $179.4 million compared to $207.6 million following the acquisition of Grove Resource Solutions, Inc. (“GRSi”) in December 2022, outperforming management expectations of $186.4 million. The Company reduced its debt by $28.2 million in total for the post-acquisition period, composed of $14.3 million in mandatory payments and $13.9 million in prepayments.
“DLH has a history of effectively deploying free cashflow to aggressively pay down debt,” said DLH President & CEO Zach Parker. “This track record provides the capacity to make transformative acquisitions, invest in our people, and grow the Company’s footprint within key markets. I am proud that we are once again making tremendous progress towards de-levering the balance sheet and providing additional value to our shareholders.”
Fourth Quarter Revenue The preliminary estimate of revenue for the fiscal 2023 fourth quarter is approximately $100 million versus $67.2 million in the prior-year period. The increase was primarily driven by contributions from GRSi. The Company’s legacy contract portfolio grew moderately to offset the completion of short-term contracts associated with the COVID-19 pandemic response in fiscal 2022.
Facility Rationalization During the fourth quarter of fiscal 2023, DLH reduced its leased office space requirement by consolidating underutilized premises as part of an ongoing facility rationalization effort, to accurately reflect the operational needs of the business. As a result, the Company has determined that its Right of Use Assets experienced a reduction in fair value below its associated carrying value. While DLH continues to quantify this reduction, the Company anticipates that its year end audited financial statements will include an impairment in the amount of approximately $8 million. This non-cash charge will decrease operating income for the fourth quarter, but the Company expects to benefit from lower lease expenses by approximately $1 million annually going forward. DLH expects to primarily utilize such savings in strategic initiatives related to organic growth.
As the Company has not completed its year end annual close procedures and the audit of its 2023 financial statements is not complete, the financial information presented in this press release is preliminary, subject to final year end closing adjustments and may change materially. The information presented above has not been audited by the Company’s independent accountants, should not be considered a substitute for audited financial statements, and should not be regarded as a representation by DLH as to the actual financial results for the fiscal year ended September 30, 2023. DLH expects to release full audited financial results for its fiscal fourth quarter and year ended September 30, 2023, on December 6, 2023.
About DLH DLH (NASDAQ: DLHC) delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 3,200 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit http://www.DLHcorp.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or DLH’s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that the Company or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or DLH’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements in this release include, among others, statements regarding estimates of future revenues, operating income, earnings and cash flow. Forward-looking statements are based only on our current beliefs, expectations and assumptions that may not prove to be accurate and are subject to numerous risks and uncertainties, including the completion of the audit of the Company’s consolidated financial statements for the fiscal year ended September 30, 2023, as well as other risks relating to our business or general economic and market factors. Our actual results may differ materially from such forward-looking statements made in this release due to a variety of factors, including: the risk that we will not realize the anticipated benefits of our acquisition of GRSi or any other acquisitions (including anticipated future financial performance and results); the diversion of management’s attention from normal daily operations of the business and the challenges of managing larger and more widespread operations resulting from our recent acquisition; the inability to retain employees and customers; contract awards in connection with re-competes for present business and/or competition for new business; our ability to manage our increased debt obligations; compliance with bank financial and other covenants; changes in client budgetary priorities; government contract procurement (such as bid and award protests, small business set asides, loss of work due to organizational conflicts of interest, etc.) and termination risks; the ability to successfully integrate the operations of GRSi or any future acquisitions; the impact of inflation and higher interest rates; and other risks described in our SEC filings. For a discussion of such risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s periodic reports filed with the SEC, including our Annual Report on Form 10-K for the fiscal year ended September 30, 2022, as well as subsequent reports filed thereafter. The forward-looking statements contained herein are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about our industry and business.
Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company does not assume any responsibility for updating forward-looking statements, except as may be required by law.
INVESTOR RELATIONS Contact: Chris Witty Phone: 646-438-9385 Email: cwitty@darrowir.com
ATLANTA, GA, October 24, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced an update on key strategic initiatives.
“The third quarter marked advancements in our next-generation COVID-19 vaccine clinical programs and our cancer therapy program, along with advanced manufacturing developments, and new patents issued for our Ebola, Marburg, Malaria, and HIV vaccines. I look forward to sharing more details about these developments during our upcoming investor/analyst earnings call on November 8,” said David Dodd, GeoVax’s Chairman and CEO.
“We believe this is a defining moment for the Company, as we expand the full potential of a next-generation COVID-19 vaccine (GEO-CM04S1) currently in three Phase 2 clinical trials and the broad application of Gedeptin® against solid tumors. We are gearing up to announce initial data readouts from two of these trials, along with updates from our Gedeptin clinical trial against advanced head and neck cancer as well as other important corporate developments. We believe that these upcoming catalysts will have a profound impact on patients in need and all our stakeholders.”
Recent Company Highlights
GEO-CM04S1
Investigator-Initiated Clinical Trial Begins, “Randomized Observer-Blinded Phase 2 Trial of COVID-19 Booster with GEO-CM04S1 or Pfizer-BioNtech Bivalent Vaccine in Patients with Chronic Lymphocytic Leukemia.”
Trial is rapidly enrolling patients, progressing towards an interim data review.
Enrollment Target Completed for Phase 2 Clinical Trial Evaluating GEO-CM04S1 as a Booster for Healthy Patients Who Have Previously Received the Pfizer or Moderna mRNA Vaccine.
Initial data readout is expected soon.
GeoVax Next-Generation COVID-19 Vaccine (GEO-CM04S1) Demonstrated Potent Antibody and Cellular Immunity in Immunocompromised Patients.
The journal, Vaccines, publishes data (GEO-CM04S1 Publication) from GeoVax’s Phase 2 clinical trial evaluating the safety and immunogenicity of GEO-CM04S1 next-generation COVID-19 vaccine, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine in patients who have previously received an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or CAR-T cell therapy.
GeoVax Universal COVID-19 Vaccine Data Presented at Keystone Symposia Conference.
Abstract Title: MVA-vector multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal modes.
Data revealed: GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.
Gedeptin®
Gedeptin® Clinical Data presented at the AACR-AHNS Head and Neck Cancer Conference
Abstract Title: Phase 1/2 study of Ad/PNB with Fludarabine for the Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC).
Data revealed: FDA-funded study reveals that administration of Gedeptin® is safe and feasible.
Advanced Vaccine Manufacturing Process
GeoVax and ProBioGen announced the signing of a landmark commercial license agreement for ProBioGen’s groundbreaking AGE1.CR.pIX® suspension cell line. The agreement empowers GeoVax to enhance the manufacturing capabilities of its entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio.
Intellectual Property Developments
GeoVax announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/584,231 titled patent titled “Replication Deficient Modified Vaccina Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).”
GeoVax announced that the U.S Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.”
GeoVax announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria.”
GeoVax announced that the U.S. Patent and Trademark Office has issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company’s patent application No. 15/543,139 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40).”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Pixar | Vera Bradley Toy Story Collection Now Available Nationwide
FORT WAYNE, Ind., Oct. 24, 2023 (GLOBE NEWSWIRE) — Vera Bradley, Inc. (Nasdaq: VRA) today announced that Vera Bradley, its iconic American bag and luggage lifestyle brand, has collaborated with Disney and Pixar to launch its first-ever collection inspired by the beloved Toy Story franchise.
Celebrating the magic of childhood, friendship and adventure with more than 60 lighthearted styles made especially for new adventures with special friends, the Pixar | Vera Bradley Toy Story Collection includes four new patterns—Andy’s Room, Festive Toy Story, Toy Chest, and Toy Story Sketch—featuring Pixar’s Woody, Buzz Lightyear and the entire Pixar Toy Story gang.
“The Vera Bradley brand came to life more than 40 years ago thanks to the friendship of co-founders Barbara Bradley Baekgaard and Patricia R. Miller, so we are especially excited to celebrate the power of friendship with our new Pixar | Vera Bradley Toy Story Collection,” noted Alison Hiatt, CMO of Vera Bradley, Inc. “Fans of the Disney and Pixar Toy Story franchise are sure to love the colorful, fun and festive patterns and embroidered motifs featuring their favorite Toy Story characters.”
Pixar | Vera Bradley Toy Story Collection styles range in price from $15 to $160 and are perfect for holiday gift-giving. Shop the collection now in Vera Bradley Full Line Stores, participating Vera Bradley retailers and online at www.verabradley.com/disney. Follow @verabradley for updates and to learn more.
ABOUT VERA BRADLEY
Vera Bradley, based in Fort Wayne, Indiana, is a leading designer of women’s handbags, luggage and other travel items, fashion and home accessories, and unique gifts. Founded in 1982 by friends Barbara Bradley Baekgaard and Patricia R. Miller, the brand is known for its innovative designs, iconic patterns, and brilliant colors that inspire and connect women unlike any other brand in the global marketplace. Visit www.verabradley.com and follow @verabradley to learn more.
CHELMSFORD, MA / ACCESSWIRE / October 24, 2023 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for 100 years, today announced that Kelly Waller, a proven executive with a diverse and successful career in global marketing/demand generation, field/inside sales, client retention and sales enablement, has agreed to join Harte Hanks as Senior Vice President of Sales and Marketing. Ms. Waller is relocating to Boston, working in close proximity to Kirk Davis, Chief Executive Officer, as part of the Harte Hanks senior leadership team.
For the past seven years, Ms. Waller has served as Global Vice President, Mid-Market (Marketing Demand Generation, GTM & Sales) for Finastra, a global provider of financial software applications and marketplaces with $1.85 billion in revenue. In this role, she managed the revenue generating function for Mid-Market for Finastra, consisting of over 120 global employees. Previously, she served as Inside Sales Director for Extreme Networks managing inside sales account managers, new logo sales, and services sales team across EMEA and APAC. Previous sales leadership roles include tenures at SunGard, Kantar Media and Durrants.
Kirk Davis, Chief Executive Officer, commented: “Kelly brings robust experience and a significant track record of success in lead generation, sales organization leadership and client retention, with particular expertise in selling marketing solutions, making her the ideal executive to lead our sales organization going forward. Her experience is especially well-aligned with Harte Hanks’ future, leveraging data assets and technology to drive modern solutions for our customers. I welcome her to the Harte Hanks leadership team.”
“Harte Hanks is a company with decades of history, but a modern approach to delivering innovative solutions, and I am excited to pursue new logo growth, customer retention, and process excellence to drive long-term growth,” commented Ms. Waller. “Global organizations are seeking new ways to identify and target customers, harnessing technology to deliver customized solutions, and Harte Hanks is well-positioned to meet this growing need.”
About Harte Hanks:
Harte Hanks (NASDAQ:HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.
Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea, Sony and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.
As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks.
Our press release and related earnings conference call contain “forward-looking statements” within the meaning of U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements other than historical facts are forward-looking and may be identified by words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “seeks,” “could,” “intends,” or words of similar meaning. These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements. In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments. These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) the outbreak of diseases, such as the COVID-19 coronavirus, which has curtailed travel to and from certain countries and geographic regions, created supply chain disruption and shortages, disrupted business operations and reduced consumer spending, (ii) market conditions that may adversely impact marketing expenditures, (iii) the impact of the Russia/Ukraine conflict on the global economy and our business, including impacts from related sanctions and export controls and (iv) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (b) the demand for our products and services by clients and prospective clients, including (i) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (ii) our ability to predict changes in client needs and preferences; (c) economic and other business factors that impact the industry verticals we serve, including competition and consolidation of current and prospective clients, vendors and partners in these verticals; (d) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (e) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (f) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (g) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (h) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (i) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (j) the number of shares, if any, that we may repurchase in connection with our repurchase program; (k) unanticipated developments regarding litigation or other contingent liabilities; (l) our ability to complete anticipated divestitures and reorganizations, including cost-saving initiatives; (m) our ability to realize the expected tax refunds; and (n) other factors discussed from time to time in our filings with the Securities and Exchange Commission, including under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 which was filed on March 31, 2023. The forward-looking statements in this press release and our related earnings conference call are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.
Investor Relations Contact:
Rob Fink or Tom Baumann 646.809.4048 / 646.349.6641 FNK IR HHS@fnkir.com
Dr. Victor Moyo named Chief Medical Officer Meena Arora joins as Vice President Global Medical Affairs and R&D
NEWTOWN, Pa., Oct. 24, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company expanded its leadership team with the naming of Dr. Victor Moyo as Chief Medical Officer (CMO), and the addition of Meena Arora as Vice President, Global Medical Affairs and Research and Development (R&D).
“We are delighted to have Dr. Moyo and Ms. Arora as integral members of our team at Onconova as we prepare to enter the next phase of development for narazaciclib and rigosertib, our novel and proprietary cell pathway inhibitors for oncology,” said Dr. Steven Fruchtman, President and Chief Executive Officer (CEO). Both are accomplished experts in their fields and bring significant and wide expertise in drug development. I believe Victor’s extensive track record as a clinical researcher and drug developer in oncology and Meena’s unique medical affairs expertise in rare diseases and oncology will be instrumental to the Company’s success as we advance the clinical plan and regulatory strategy for each program.”
Victor Moyo commented, “I am very pleased to be named as Onconova’s Chief Medical Officer. Working with the team over the last quarter has given me the opportunity to appreciate the potential for Onconova’s product pipeline, especially the excellent work that the Company has done differentiating narazaciclib from other CDK4/6 inhibitors. I believe narazaciclib holds the promise of prolonging progression in patients with endometrial and other gynecological cancers as well as hematologic malignancies in indications where there is still an unmet medical need. I look forward to working with my colleagues at Onconova and our clinical collaborators to contribute to our mission of bringing narazaciclib and rigosertib to patients with cancer.
Meena Arora shared, “I am excited to join Onconova’s talented and experienced group of professionals and look forward to beginning my tenure as Vice President Global Medical Affairs and Research and Development to execute on Onconova’s vision. I joined the Company because I believe that our oncology programs are based on impressive science and preliminary clinical results and are focused on important indications where there is a need for improved clinical outcomes. I am excited to couple my expertise in rare disease and oncology with my dedicated experience in medical and regulatory affairs and research and development strategy to help advance Onconova’s potential priority therapies for people with cancer.”
Dr. Moyo is a highly experienced physician researcher and drug developer, with extensive clinical research pharmaceutical industry experience. He has held a variety of senior leadership positions with responsibility for a number of clinical development plans, IND filings, NDA filings, post-market development plans, notably including his work on such programs as Onivyde® for metastatic pancreatic cancer, epoetin alpha trial in myelodysplastic syndrome, and the Doxil® trial in advanced ovarian cancer. He is also a named inventor on numerous granted patents and patent applications.
Dr. Moyo joined Onconova as Consulting Chief Medical Officer in August, 2023. He has also held various leadership roles as Vice President of Clinical Investigations at Merrimack Pharmaceuticals and the Centocor Ortho Biotech Services, LLC division of Johnson & Johnson.
Dr. Moyo earned his M.D. from the University of Zimbabwe. Following his move to the U.S., he went on to complete his internship and residency in Internal Medicine at the George Washington School of Medicine and Health Sciences and his fellowship in Hematology and Oncology at the Johns Hopkins University School of Medicine
Meena Arora is a highly credentialed executive with experience in both pharmaceutical and emerging biotechnology companies, working in roles of increasing responsibility in medical affairs, regulatory strategy and scientific leadership in oncology, rare disease immunology, and inflammation. Over the course of her career, she has worked on development programs for notable products including Filsuvez®, Revlimid®, Imnovid®, Abraxane®, Vidaza® and CAR-T cell therapy (Breyanzi® and Abecma®).
Most recently, Ms. Arora served as Vice President/Head of Global Medical Affairs – Epidermolysis Bullosa (EB) for Amryt Pharma. Prior to that, she held various leadership roles as Medical Director or Associate Medical Director, as well as roles in Investigator Research and Medical Affairs at Celgene International. Ms. Arora has also held multiple advancing roles in medical and commercial development at GlaxoSmithKline and SmithKline Beecham.
Ms Arora earned degrees in Pharmaceutical Science, Pharmaceutical Medicine and Biomedical Science with a Master of Science in Drug Development Science with studies in Biotechnology and Advanced Therapeutics from Kings College London and a Post Graduate Diploma in Pharmaceutical Medicine/Clinical Research from the University of Surrey. Ms. Arora received a Chartered Institute of Marketing Advanced Diploma from Cambridge Marketing College and earned a Post Graduate Diploma in Pharmaceutical Science and Bachelor of Science (Hons) in Biomedical Science from the Nottingham Trent University. Ms Arora is the recipient of multiple industry awards and publication co-author.
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.
