Author: aweinsoff@channelchek.com

Release – Technical Directions, Inc. and Boeing Sign Memorandum of Understanding for Kratos TDI Engines

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KTOS

October 16, 2023 at 8:00 AM EDT

PDF Version

SAN DIEGO, Oct. 16, 2023 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. [Nasdaq: KTOS], a Technology Company in the Defense, National Security and Global Markets, today announced a Memorandum of Understanding between Technical Directions, Inc. (TDI), a business unit within Kratos Unmanned Systems Division, and Boeing [NYSE: BA] for the TDI-J85 turbine engine to provide propulsion for the Powered Joint Direct Attack Munition (JDAM).

Boeing’s Powered JDAM combines a 500-pound ordnance, the conventional JDAM guidance kit, with a wing kit and a Kratos TDI-J85 engine to deliver high-end range at an affordable price. The cost savings is in part due to the low-cost turbine engine technology developed and enhanced by TDI over four decades. Powered JDAM will provide low-cost stand-off capability against land and maritime threats. Leveraging the JDAM family of weapons, it is designed to be produced at scale, exportable to any of the 35 JDAM partner nations, at a cost-point that enables affordable mass.

“We are proud that Boeing has selected our TDI-J85 engine for the Powered JDAM system. Incredible potential exists for this long-range, precision strike capability,” said Joseph Kovasity, Senior Vice President for TDI. “At Kratos TDI, we have been singularly focused on producing small, low-cost, military-grade turbine engines at quantity in the United States with U.S. suppliers and partners. With the Kratos acquisition of TDI, we have substantially invested in manufacturability for production scale resulting in an incredibly high engine performance-to-cost ratio, while ensuring we can meet the large quantity deliveries predicted for the Powered JDAM system and program.”

“Powered JDAM is the next step in the modular evolution of the JDAM and JDAM Extended Range family of weapons systems. Its ability to complement exquisite weapons system with low-cost stand-off capability will add new weapons capacity to the U.S. defense industrial base to support the current fight and deter future fights,” said Bob Ciesla, Vice President of Boeing Precision Engagement Systems.

The TDI-J85 straightforward architecture is capable of producing 200-lbf of net thrust at Sea-Level Static conditions. Specific Powered JDAM requirements are met with design adjustments achieving the desired thrust output at design point. The TDI-J85 is compatible with commercial and/or military kerosene-grade turbine fuels. The TDI-J85’s shaft-integral permanent magnet generator will produce up to 1.5 kW of AC power, from idle through maximum engine speeds, for P-JDAM’s onboard power requirements.

About Technical Directions Inc.
TDI has developed and refined turbine engine technologies for military applications in Michigan since 1983—providing unique features in support of low-cost, expendable turbojet engine applications, such as miniature cruise missiles and other Unmanned Aerial Vehicles (UAVs). With the engineering, manufacturing, and system integration employees in the Oxford, Michigan facility, TDI’s subject matter experts have experience that encompasses all aspects of this turbine engine class, from clean-sheet design, through performance testing, vehicle integration, flight testing, and production manufacturing. TDI is a wholly owned subsidiary of Kratos Defense & Security Solutions. For more information, visit www.TDI-Engines.com.

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 the 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 http://www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events, or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 25, 2022, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Kratos Press Contact:
Yolanda White
858-812-7302 Direct

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

Source: Kratos Defense & Security Solutions, Inc.

Release – Tonix Pharmaceuticals Completes Clinical Stage of Phase 2 UPLIFT Study of TNX-601 ER for the Treatment of Major Depressive Disorder

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 16, 2023 7:00am EDTDownload as PDF

Topline Results Expected Early November 2023

Tianeptine, the Active Ingredient in TNX-601 ER, is Not Associated with Sexual Dysfunction or Weight Gain Which are Treatment-Limiting Side Effects of Many Traditional Antidepressants

Tianeptine Acts by Directly Restoring Neuroplasticity and Neurogenesis and Limiting the Effects of Oxidative Stress in the Brain

CHATHAM, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the completion of the clinical phase of the Phase 2 potential registration-quality, double-blind, randomized, multicenter, placebo-controlled UPLIFT1 study of TNX-601 ER2 (tianeptine hemioxalate extended-release tablets) as a potential treatment for major depressive disorder (MDD). Topline results from the intention-to-treat (ITT) sample (N=132) are expected in early November 2023.

TNX-601 ER is being developed as a monotherapy and first-line treatment for MDD and works by a distinct mechanism of action as compared to traditional monoaminergic antidepressants. Tonix recently reported that tianeptine activates peroxisome proliferator-activated receptors PPAR-β/δ and PPAR-γ. These activities on intracellular molecular targets in neurons and glia in the brain are believed to relate to tianeptine’s ability to restore connectivity between neurons that atrophy under conditions of stress, in animal models.3,4 Tianeptine is the active ingredient of an antidepressant that has been marketed as a three-times-a-day medicine outside the U.S. for more than 30 years. Tonix has developed a novel, patented once-daily oral formulation.

“Because of its unique mechanism, tianeptine avoids some of the treatment-limiting side effects of traditional antidepressants, including sexual dysfunction and weight gain,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Tianeptine restores connectivity between neurons, or neuroplasticity, and limits the effects of oxidative stress in the brain in animal models of depression. In contrast to traditional antidepressants which alter the levels of neurotransmitters in the synapse, tianeptine directly induces mature neurons to sprout new connections and also induces formation of new neurons.”

“With the last patient now treated, we look forward to analysis of the results of this registration-quality 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.”

  1. Clinical Trials.gov I.D. NCT05686408
  2. TNX-601 ER is an investigational new drug and is not approved for any indication.
  3. McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249
  4. Sullivan, GM et al. June 1, 2023. Poster presentation at the American Society of Clinical Psychopharmacology, Miami, FL. https://www.tonixpharma.com/wp-content/uploads/2023/06/ASCP-Poster-2023-A-Randomized-Placebo-Controlled-Multicenter-Trial-of-Monotherapy-with-TNX-601-ER.pdf

About the Phase 2 UPLIFT Study

The Phase 2 UPLIFT study, TNX-TI-M201, is a potential registration-quality, double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-601 ER taken by mouth once-daily for 6 weeks for the treatment of moderate-to-severe MDD. It is a parallel design study with two arms, a TNX-601 ER 39.4 mg arm and a placebo arm. A total of 132 participants were randomized in a 1:1 ratio into the two arms across approximately 27 U.S. sites, enrolling adult patients 18-65 years old with a DSM-5 diagnosis of depression and a duration for the current major depressive episode of at least 12 weeks. The primary efficacy endpoint is mean change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. Key secondary efficacy endpoints include the Clinical Global Impression of Severity Scale (CGI-S) and the Sheehan Disability Scale (SDS).

For more information, see ClinicalTrials.gov Identifier: NCT05686408.

About Major Depressive Disorder (Depression)

According to the National Institute of Mental Health, an estimated 21 million adults in the U.S. in 2020 experienced at least one major depressive episode1, with highest prevalence among individuals aged 18-25 at a rate of 17.0%. For approximately 2.5 million adults in the U.S., adjunctive therapies are necessary for depression treatment.2,3 Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behaviors. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.4

1 Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults 2020. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml

2 IMS NSP, NPA, NDTI MAT-24-month data through Aug 2017.

3 Kubitz N, et al. PLoS One 2013, 8 (10), e76882.

4 Rush AJ, et al. Am J. Psychiatry 2007, 163 (11), 1905-1917.

About TNX-601 ER

TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a novel oral formulation of tianeptine designed for once-daily daytime dosing in development as a candidate for the treatment of MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently no tianeptine-containing product is approved in the U.S. and no extended-release tianeptine product is approved in any jurisdiction. Tonix discovered a novel oxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine. In animal models, tianeptine restores dendritic arborization of pyramidal neurons in the CA3 region of hippocampus and in the dentate gyrus region promotes new neuron formation and integration into hippocampal networks.1 Tianeptine’s enhancement of neuroplasticity in animal models of stress is believed to be mediated by activation of PPAR isoforms PPAR-β/δ and PPAR-γ, which makes TNX-601 ER’s properties distinct from traditional monoaminergic antidepressants in the U.S. and contributes to its potential for clinical indications beyond MDD and stress disorders. Tianeptine and its MC5 metabolite are also weak mu-opioid receptor (MOR) agonists that present a potential abuse liability if illicitly misused in large quantities (typically abused at 8-80 times the therapeutic dose on a daily basis2). In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated3 suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine does not appear to result in dependence or withdrawal symptoms following 6-weeks4-8, 3-months9, or 12-months10 of treatment. The ER formulation of TNX-601 includes several potentially abuse deterrent ingredients, such as gel forming polymers which impede extraction. In addition, the tablet’s hardness makes it difficult to crush, cut or grind to fine particle size, which potentially hinders efforts to misuse by insufflation or intravenous routes. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder (PTSD), and neurocognitive dysfunction associated with corticosteroid use. TNX-601 ER is expected to have patent protection through 2037.

1 McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249.

2 Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–53.

3 Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.

4 Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)

5 Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.

6 Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.

7 Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.

8 Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.

9 Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.

10 Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, 15, 61–65. 

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 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 enrollment has 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. 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released October 16, 2023

Release – Orion Group Holdings Announces Significant Design-Build Contract Award for Grand Bahama Shipyard Dry Dock and $121 Million in Additional Awards

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ORN

Oct 13, 2023

HOUSTON, Oct. 13, 2023 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (“Orion” and “Company”), a leading specialty construction and engineering company today announced a significant contract award valued at 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 new contracts in both its Concrete and Marine segments for a combined total of $121 million.

Orion Group Holdings won the Grand Bahama Shipyard Dry Dock award through a competitive bid/negotiation process based on demonstrating its multiple core skill competencies. The scope of work includes marine works and infrastructure construction, dredging, creating new mooring facilities, and providing enhancements to shore stability. In addition, Orion will modify and extend service piers for the installation of two cutting-edge floating dry docks, which are among the largest in the western hemisphere. The project is set to commence immediately and will conclude in late 2025. Orion will be working with Bahamian subcontractors on the project.

Travis Boone, President and Chief Executive Officer of Orion Group Holdings, said, “The scope of the Bahama project demonstrates the extensive capabilities and commitment to predictable excellence that our integrated Marine & Engineering teams can deliver to large-scale and complex projects. We are excited to embark on this project and look forward to contributing to the growth and success of the Grand Bahama Shipyard.”

“When completed, the Grand Bahama dry docks will be a milestone in the maritime industry. With this enormous undertaking, Grand Bahama Shipyard will have the first floating dry docks for the Atlantic region capable of lifting the largest cruise ships in the world. The installation of two state-of-the-art floating dry docks, categorized as XL and Mega XL, promises substantial efficiency and cost savings for GBSL’s customers.”

Boone added, “As part of our strategic plan, we have been focused on strengthening our business development efforts and I am very proud of the energy and impact our expanded team is having on our business. In addition to this project award in the Bahamas for Marine, we also recently received new awards totaling $121 million, comprised of $50.8 million in the Concrete segment and $68.5 million in our Marine segment.” For additional information, see our 8-k filed on September 28, 2023.

Orion Group Holdings, Inc. is a renowned name in specialty construction, known for its dedication to quality, innovation, and timely project execution. With these new contract awards, Orion continues to strengthen its position as an industry leader capable of tackling complex projects with unmatched expertise.

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. https://www.oriongroupholdingsinc.com.

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.

Contact:

Financial Profiles, Inc.
Margaret Boyce 310-622-8247
mboyce@finprofiles.com

Release – Eledon Pharmaceuticals to Present Data from Ongoing Phase 1b Trial of Tegoprubart in Patients Undergoing Kidney Transplantation at the American Society of Nephrology Kidney Week 2023 Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

IRVINE, Calif., Oct. 13, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the Company will present a poster at the American Society of Nephrology’s upcoming Kidney Week 2023 Annual Meeting taking place in Philadelphia, PA from November 2-5, 2023. The poster will highlight new data from Eledon’s ongoing open-label Phase 1b trial evaluating tegoprubart for the prevention of rejection in kidney transplantation.

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

Following the presentation, a copy of the poster can be found on the Investor section of the Company’s website at https://ir.eledon.com/events-and-presentations/presentations.

About Eledon Pharmaceuticals and Tegoprubart (formerly AT-1501)

Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand (also called “CD154”), a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Release – Alliance Resource Partners, L.P. Announces Third Quarter 2023 Earnings Conference Call

Posted on by aweinsoff@channelchek.com

October 13, 2023

Download(opens in new window)

TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) will report its third quarter 2023 financial results before the market opens on Friday, October 27, 2023. Alliance management will discuss these results during a conference call beginning at 10:00 a.m. Eastern that same day.

To participate in the conference call, dial (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at https://www.arlp.com/.

An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13741573.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at https://www.arlp.com/. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.

Investor Relations Contact
Cary P. Marshall
Senior Vice President and Chief Financial Officer
(918) 295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

Release – 1-800-FLOWERS.COM, Inc. to Release its Fiscal 2024 First Quarter Results on Thursday, November 2, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FLWS

Oct 12, 2023

JERICHO, N.Y.–(BUSINESS WIRE)– 1-800-FLOWERS.COM, Inc. (NASDAQ: FLWS) (the “Company”),a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships, today announced that the Company will release financial results for its fiscal 2024 first quarter on Thursday, November 2, 2023. The press release will be issued prior to market opening and will be followed by a conference call with members of senior management at 8:00 a.m. (ET).

The conference call will be available via live webcast from the Investors section of the Company’s website at 1800flowersinc.com. A recording of the call will be posted on the website within two hours of the call’s completion. A telephonic replay of the call can be accessed beginning at 2:00 p.m. (ET) on November 2, 2023, through November 9, 2023, at: (US) 1-877-344-7529; (Canada) 855-669-9658; (International) 1-412-317-0088; enter conference ID: #3621353.

Special Note Regarding Forward-Looking Statements:

Some of the statements contained in the Company’s scheduled Thursday, November 2, 2023, press release and conference call regarding its results for its fiscal 2024 first quarter, other than statements of historical fact, may be forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the applicable statements. For a more detailed description of these and other risk factors, please refer to the Company’s SEC filings including its Annual Reports and Forms 10K and 10Q available at the Investor Relations section of the Company’s website at 1800flowersinc.com. The Company expressly disclaims any intent or obligation to update any of the forward-looking statements made in the scheduled conference call and any recordings thereof, or in any of its SEC filings, except as may be otherwise stated by the Company.

About 1-800-FLOWERS.COM, Inc.

1-800-FLOWERS.COM, Inc. is a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships. The Company’s e-commerce business platform features an all-star family of brands, including: 1-800-Flowers.com®, 1-800-Baskets.com®, Cheryl’s Cookies®, Harry & David®, PersonalizationMall.com®, Shari’s Berries®, FruitBouquets.com®, Things Remembered®, Moose Munch®, The Popcorn Factory®, Wolferman’s Bakery®, Vital Choice®, and Simply Chocolate®. Through the Celebrations Passport® loyalty program, which provides members with free standard shipping and no service charge across our portfolio of brands, 1-800-FLOWERS.COM, Inc. strives to deepen relationships with customers. The Company also operates BloomNet®, an international floral and gift industry service provider offering a broad-range of products and services designed to help members grow their businesses profitably; Napco℠, a resource for floral gifts and seasonal décor; DesignPac Gifts, LLC, a manufacturer of gift baskets and towers; and Alice’s Table®, a lifestyle business offering fully digital livestreaming and on demand floral, culinary and other experiences to guests across the country. 1-800-FLOWERS.COM, Inc. was recognized among the top 5 on the National Retail Federation’s 2021 Hot 25 Retailers list, which ranks the nation’s fastest-growing retail companies, and was named to the Fortune 1000 list in 2022. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS. For more information, visit 1800flowersinc.com or follow @1800FLOWERSInc on Twitter.

FLWS-COMP
FLWS-FN

Investor Contact:

Andy Milevoj

(516) 237-4617

amilevoj@1800flowers.com

Media Contact:

Cherie Gallarello

cgallarello@1800flowers.com

Source: 1-800-FLOWERS.COM, Inc.

Release – Direct Digital Holdings Selects HPE GreenLake To Deliver Edge-To-Cloud Solution In Multiyear Platform Deal

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

October 12, 2023 9:00am EDT Download as PDF

Green Tea Technology Instrumental in Forging Relationship with Hewlett Packard Enterprise and Ad-Tech Holding Group, Direct Digital Holdings

HOUSTON, Oct. 12, 2023 /PRNewswire/ — Direct Digital Holdings (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced it has selected the HPE GreenLake edge-to-cloud platform to build a highly reliable, scalable and secure production environment. Green Tea Technology, an authorized HPE partner, will provide installation and support services.

Colossus SSP will now incorporate the HPE GreenLake platform with its on-premises infrastructure and cloud services across its entire marketplace to support Direct Digital Holdings’ sell-side platform. The marketplace manages approximately 136,000 clients monthly, generating over 250 billion impressions per month across display, CTV, in-app video and other media channels.

“HPE GreenLake has enabled Direct Digital Holdings to deliver a modern cloud experience to customers with flexibility to meet their demands in real time,” said Alexia Clements, VP of worldwide go-to-market for HPE GreenLake Cloud Services, HPE. “We’re focused on delivering differentiated cloud solutions that allow our partners to serve as trusted advisors and help customers modernize their IT environments to improve their business outcomes.”

“Our relationship with HPE is strategic for our company, as we partner with HPE GreenLake for our digital infrastructure for our supply-side technology platform,” said Mark Walker, co-founder and CEO of Direct Digital Holdings. “Thanks to the flexibility provided by HPE GreenLake, we have the ability to continue our accelerated growth as we bring new technology products to our media partners. Green Tea Technology has been an excellent resource and partner in helping us leverage HPE for this strategic platform solution.”

Brad Davis, the owner and CTO of Green Tea Technology, stated that the HPE GreenLake platform is more than a year ahead of its competitors in terms of innovation and edge-to-cloud capabilities. Davis believes that the platform is an excellent solution for Direct Digital Holdings, considering their rapid growth and expansion underway.

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage approximately 136,000 clients monthly, generating over 250 billion impressions per month across display, CTV, in-app and other media channels.

About Green Tea Technology

Green Tea Technology is a leading IT solutions provider headquartered in Austin, Texas. As an accredited HPE Certified GreenLake integration partner , the company is at the forefront of delivering cutting-edge Hybrid cloud solutions tailored to meet the unique needs of businesses, both large and small. With a commitment to innovation and sustainability, Green Tea Technology is dedicated to architecting robust, scalable, and environmentally-friendly IT infrastructures.

Forward Looking Statements

This press release may contain forward-looking statements within the meaning of federal securities laws and which are subject to certain risks, trends and uncertainties.

As used below, “we,” “us,” and “our” refer to the Company. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; our limited operating history, which could result in our past results not being indicative of future operating performance; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, on receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; the satisfaction of the conditions to the Offer, including the minimum tender condition; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the Securities and Exchange Commission that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Contacts:

Investors:
Brett Milotte, ICR
Brett.Milotte@icrinc.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-selects-hpe-greenlake-to-deliver-edge-to-cloud-solution-in-multiyear-platform-deal-301954588.html

SOURCE Direct Digital Holdings

Released October 12, 2023

Release – Labrador Gold Intersects 1.81g/t Au Over 20.15 Metres at Dropkick, Extends Zone to 360 Metres

Posted on by aweinsoff@channelchek.com

Research News and Market Data on NKOSF

OCTOBER 12, 2023

TORONTO, Oct. 12, 2023 (GLOBE NEWSWIRE) — Labrador Gold Corp. (TSX.V:LAB | OTCQX:NKOSF | FNR: 2N6) (“LabGold” or the “Company”) is pleased to announce results from recent drilling targeting the highly prospective Appleton Fault Zone. The drilling is part of the Company’s ongoing 100,000 metre diamond drilling program at its 100% owned Kingsway Project.

Final results from first stage drilling at DropKick include significant near surface gold mineralization of 20.15 metres grading 1.81g/t Au from 50 metres, including 4.14g/t Au over 4.5 metres in Hole K-23-248. Several near surface intervals were also intersected in Hole K-23-245 including 1.77g/t Au over 5.15 metres from 31.85 metres downhole. Holes K-23-245 and -248 represent a 67 metre step out to the northeast. Hole K-23-254, a 136 metre step out to the southwest, intersected 2.45g/t Au over 4.1 metres from 108.9 metres, including an interval of 16.68g/t Au over 0.3 metres that contained visible gold. These latest intersections extend the known mineralization at Dropkick to over 360 metres strike length and it remains open in both directions. Twelve of the 15 holes drilled at Dropkick intersected gold mineralization with four holes containing visible gold.

“During the first phase of drilling at DropKick we demonstrated the presence of near surface gold over significant widths while increasing the strike length of known mineralization which remains open along strike in both directions. Further drilling is required to demonstrate the true potential of this discovery,” said Roger Moss, President and CEO of LabGold. ”Planning is currently underway for drilling in The Gap, between Big Vein and Pristine, and to the south of Big Vein towards the recent Knobby discovery. Drilling of targets in these areas is expected to begin before the end of the month. We are excited to start filling in the gaps between the four discoveries made along a 7 kilometre section of the Appleton Fault Zone at Kingsway.”

Follow up drilling at Pristine included an intersection of 1.05g/t Au over 11 metres from 90 metres in Hole K-23-276 and 1.28g/t Au over 6.18 metres from 66.47 metres in Hole K-23-272. Mineralization drilled to date at Pristine mostly occurs above 86 metres vertical depth and extends over a strike length of approximately 160 metres.

Ongoing drilling at Big Vein intersected 2.76g/t Au over 8.97 metres from 233.56 metres, including 7.04g/t over 3.09 metres in Hole K-23-278.

Hole IDFrom (m)To (m)Interval (m)Au (g/t)Zone
K-23-278233.56242.538.972.76Big Vein
including236.00239.093.097.04
K-23-27690.00101.0011.001.05Pristine
including92.9597.804.851.82
K-23-27266.4772.656.181.28Pristine
including68.0070.802.802.33
K-23-260156.57160.003.431.06Pristine
K-23-25967.5068.350.851.22Pristine
K-23-254108.90113.004.102.45DropKick
including108.90110.801.904.56
including109.40109.700.3016.68
K-23-253nsvBig Vein
K-23-25253.0091.0038.000.55Big Vein
including60.0064.004.001.28
and73.0074.001.001.11
K-23-249nsvBig Vein
K-23-24850.0070.1520.151.81DropKick
including55.0070.1515.152.32
including58.0070.1512.152.72
including59.9064.404.504.14
K-23-247126.70128.001.301.32Big Vein
198.00198.950.951.20
K-23-24510.0012.652.651.16Dropkick
31.8537.005.151.77
including35.0036.351.353.17
44.8045.600.801.34
53.0054.501.501.04
89.00103.0014.000.60
including91.9594.002.051.42
192.00193.151.151.90
250.25251.150.901.32
K-23-24429.0033.004.001.10Big Vein
K-23-243nsvDropKick
K-23-242224.43225.160.731.88Big Vein
K-23-241nsvBig Vein

Table 1. Summary of assay results. All intersections are downhole length
as there is insufficient Information to calculate true width.

Almost 85,000 metres have been drilled to date out of the planned 100,000 metre program. Assays are pending for samples from approximately 6,100 metres of core.

The Company has approximately $10 million in cash and is well funded to carry out the remaining 15,000 metres of the planned drill program as well as further exploration to add to the current pipeline of drill targets on the property.

Figure 1. Plan map of Dropkick drill holes showing highlights of latest results.

Figure 2. Plan map of occurrences with selected drill intersections along the Appleton Fault Zone.

Hole IDEastingNorthingElevationAzimuthInclinationTotal Depth
K-23-27866173654353923713065420
K-23-27666192754360725627565200
K-23-27266193354360695931565278
K-23-260661750543587258090209
K-23-25966184554360015330045191
K-23-25466315954381265514045160.55
K-23-2536615545435459452045160
K-23-25266145054353125412570349
K-23-24966127254350936214565379
K-23-24866340854383815214065173
K-23-24766155354354585012550233
K-23-24566340954383805314045259
K-23-24366335354382735814065131
K-23-24466158954354304914045228
K-23-24266132154351115214555307
K-23-24166145054353125312550250

Table 2. Drill hole collar details

QA/QC

True widths of the reported intersections have yet to be calculated. Assays are uncut. Samples of HQ split core are securely stored prior to shipping to Eastern Analytical Laboratory in Springdale, Newfoundland for assay. Eastern Analytical is an ISO/IEC17025 accredited laboratory. Samples are routinely analyzed for gold by standard 30g fire assay with atomic absorption finish as well as by ICP-OES for an additional 34 elements. Samples containing visible gold are assayed by metallic screen/fire assay, as are any samples with fire assay results greater than 1g/t Au. The company submits blanks and certified reference standards at a rate of approximately 5% of the total samples in each batch. Approximately 5% of sample pulps are submitted to Bureau Veritas, an ISO 17025 accredited Laboratory in Vancouver, BC for check assays.

Qualified Person

Roger Moss, PhD., P.Geo., President and CEO of LabGold, a Qualified Person in accordance with Canadian regulatory requirements as set out in NI 43-101, has read and approved the scientific and technical information that forms the basis for the disclosure contained in this release.

About Labrador Gold
Labrador Gold is a Canadian based mineral exploration company focused on the acquisition and exploration of prospective gold projects in Eastern Canada.

Labrador Gold’s flagship property is the 100% owned Kingsway project in the Gander area of Newfoundland. The three licenses comprising the Kingsway project cover approximately 12km of the Appleton Fault Zone which is associated with numerous gold occurrences in the region. Infrastructure in the area is excellent located just 18km from the town of Gander with road access to the project, nearby electricity and abundant local water. LabGold is drilling a projected 100,000 metres targeting high-grade epizonal gold mineralization along the Appleton Fault Zone with encouraging results. The Company has approximately $10 million in working capital and is well funded to carry out the planned program.

The Hopedale property covers much of the Florence Lake greenstone belt that stretches over 60 km. The belt is typical of greenstone belts around the world but has been underexplored by comparison. Work to date by Labrador Gold show gold anomalies in rocks, soils and lake sediments over a 3 kilometre section of the northern portion of the Florence Lake greenstone belt in the vicinity of the known Thurber Dog gold showing where grab samples assayed up to 7.8g/t gold. In addition, anomalous gold in soil and lake sediment samples occur over approximately 40 km along the southern section of the greenstone belt (see news release dated January 25 th 2018 for more details). Labrador Gold now controls approximately 40km strike length of the Florence Lake Greenstone Belt.

The Company has 170,009,979 common shares issued and outstanding and trades on the TSX Venture Exchange under the symbol LAB.

For more information please contact:

Roger Moss, President and CEO Tel: 416-704-8291

Or visit our website at: www.labradorgold.com

X : @LabGoldCorp

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release .

Forward-Looking Statements: This news 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.

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/8ada2b49-2cf3-4482-ba32-69dcfdfdee84

https://www.globenewswire.com/NewsRoom/AttachmentNg/37ca58a1-438d-41be-9aa5-01115a320d9a

Release – Encouraging Rigosertib Data Presented at EADV As Late Breaker

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX

Oct 12, 2023

PDF Version

Reporting responses in patients with RDEB-associated SCC, a devastating disease with a significant unmet need

NEWTOWN, Pa., Oct. 12, 2023 (GLOBE NEWSWIRE) — (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 a late-breaking abstract studying rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB), associated with advanced/metastatic squamous cell carcinoma (SCC), will be presented today in the Late Breaking News session at the European Academy of Dermatology and Venereology (EADV) in Berlin, Germany, by Professor Dr. Johann Bauer, from the University Hospital Salzburg, Dermatology and Allergology of the PMU, Salzburg, Austria, an Investigator on the investigator-led study (IST).

“RDEB-associated SCC is a devastating disease with few if any treatment options for advanced patients. We are very pleased for additional data on the potential use of rigosertib in patients with RDEB-associated SCC to be presented as a ‘late breaker’ at EADV 2023,” said Steven Fruchtman, M.D., President and CEO of Onconova. “We believe that rigosertib’s profile and impact on key cell signaling pathway targets, including PLK-1 kinase, could make rigosertib a very attractive approach for this indication and other cancers. We are employing an “investigator-sponsored trial” strategy to evaluate rigosertib and believe the data that are being presented at EADV 2023 highlight the potential clinical utility of the compound.”

Professor Bauer commented, “I have been working with patients and their families affected by RDEB and the devastating sequalae of squamous cell carcinoma. I am pleased to share the initial encouraging patient experience with rigosertib at this conference. We are keen to further enroll other potential patients on this study.”

Presentation Details

Date:Thursday, October 12, 2023
Time:4:00 to 4:15 p.m. in Germany/10:00 to 10:15 a.m. ET
Abstract Title:Efficacy and Safety of Rigosertib in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) Associated Advanced/Metastatic Squamous Cell Carcinoma (SCC)
Presenter:Prof. Dr. Johann Bauer, M.D., MBA
Session:D2T01.3: Late breaking news
  

Abstract Details

The abstract outlines promising results from an open-label, single arm safety and efficacy study of four patients with recessive dystrophic epidermolysis bullosa (RDEB) associated advanced/metastatic squamous cell carcinoma (SCC) treated with intravenous/IV or oral rigosertib. Two patients achieved complete cutaneous responses of 12 months or more, one patient experienced metastatic disease progression, and one patient remains on study. Responding patients included one patient who achieved both cutaneous and histological remission of 16 months. The patient’s rigosertib dose was reduced following the report of a grade 2 adverse event (irritative cystitis), which led to symptomatic relief. The other responding patient achieved a complete cutaneous remission and completed the protocol-specified 12-months of therapy. The authors suggest that the preliminary study results indicate rigosertib as a potential treatment for RDEB-associated SCC. Additional patients are being sought for the trial.

A copy of the Abstract will be available on the Scientific Presentations section of the Onconova website following the Presentation.

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).

For more information, please visit www.onconova.com.

Forward Looking Statements

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.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Release – CoreCivic Enters Into Amendment and Extension of Bank Credit Facility

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CXW

October 12, 2023

PDF Version

Increases Size to $400 Million

BRENTWOOD, Tenn., Oct. 12, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic”) announced today it entered into a Fourth Amended and Restated Credit Agreement dated October 11, 2023, by and among CoreCivic, as Borrower, certain lenders party thereto from time to time, and the administrative agent for the lenders, or the New Bank Credit Facility. The New Bank Credit Facility effectively replaces CoreCivic’s Third Amended and Restated Credit Agreement dated May 12, 2022. The New Bank Credit Facility is in the aggregate principal amount of $400 million, consisting of a $125 million term loan and a $275 million revolving credit facility.

The New Bank Credit Facility, among other things, increases the available borrowings under the revolving credit facility from $250 million to $275 million and increases the size of the term loan from an initial balance of $100 million to $125 million, extends the maturity date to October 11, 2028 from May 12, 2026, and makes conforming changes to replace the Bloomberg Short-Term Bank Yield Index, or BSBY, to the secured overnight financing rate, or SOFR. Further, financial covenants were modified to remove the $100 million limit of netting unrestricted cash and cash equivalents when calculating the consolidated total leverage ratio, the consolidated secured leverage ratio, and to increase the consolidated total leverage ratio resulting in a “springing lien” event from 4:00 to 1.00 to 4.25 to 1.00. At the closing of the New Bank Credit Facility, CoreCivic received approximately $33.8 million of net borrowings before transaction costs as a result of the increased size of the term loan, and the revolving credit facility remains undrawn except for approximately $17.4 million in outstanding letters of credit.

David M. Garfinkle, Executive Vice President and Chief Financial Officer, stated, “We are very pleased with the support from our new and existing financial partners enabling us to further extend our overall debt maturity profile, maintain a similar pricing structure, while providing us with greater financial flexibility.”

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest prison operators in the United States. We have been a flexible and dependable partner for government for 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Forward-Looking Statements

This press release contains statements as to our beliefs and expectations of the outcome of future events that 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, as amended. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Examples of these statements include, but are not limited to, statements regarding CoreCivic’s financial flexibility. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made including, but not limited to, risks and uncertainties associated with economic conditions affecting the corrections and detention industry. Other factors that could cause operating and financial results to differ are described in the filings we make from time to time with the Securities and Exchange Commission.

Except as required by applicable law, CoreCivic does not undertake any responsibility for updating the information contained in this press release following the date hereof to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events or for any changes or modifications made to this press release or the information contained herein by any third-parties, including, but not limited to, any wire or internet services.

ContactInvestors: David Garfinkle – Chief Financial Officer – (615) 263-3008
 Financial Media: David Gutierrez, Dresner Corporate Services – (312) 780-7204

Release – Salem Media Group’s La Nueva Poderosa 670 AM Partners with The Weather Channel en Español

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SALM

 Download as PDFOctober 12, 2023 6:00am EDT

The Partnership Will Provide Daily Expert Weather Forecasts & Extreme Weather Warnings to South Florida Hispanics

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today that La Nueva Poderosa 670 AM in Miami and The Weather Channel en Español have entered into a strategic partnership that will enhance weather coverage and climate reporting in Spanish, specifically curated for South Florida.

La Nueva Poderosa, South Florida’s leading Spanish-language, news/talk radio station in Miami, will broadcast the Weather Channel forecasts twice a day with additional reporting and expert interviews during critical weather. The Weather Channel en Español reports will feature its diverse team of award-winning meteorologists and its exceptional behind-the-scenes production/news gathering team. The Weather Channel en Español’s forecasts will also air on Salem Media Group’s Radio Oasis 990 AM in Miami.

The content will also be distributed on La Nueva Poderosa’s website www.lapoderosa.com, Radio Oasis’ website www.oasisradiomiami.com and the stations’ apps and social media platforms.

ABOUT LA NEUVA PODEROSA 670 AM:

La Nueva Poderosa 670 AM, a Salem Media Group station, has been a trusted stalwart of the South Florida community for 25 years, transmitting 50,000 kilowatts over South Florida and the Caribbean. Streaming online 24 hours a day, it also boasts a worldwide audience. For decades, La Nueva Poderosa has been the station that South Florida Hispanics turn to as the hub of information and the latest local, national, and international news and opinions. Its emphasis on listener participation, expert interviews and around-the-clock news updates makes La Neva Poderosa 670 the go-to source for South Florida’s very diverse Hispanic community. La Nueva Poderosa simulcasts on WWFE 670 AM, WRHC 1550 AM, and 103.1 FM.

ABOUT THE WEATHER CHANNEL en ESPANOL:

The Weather Channel en Español network is the first 24/7 Spanish-language free-streaming weather news network in the United States, providing weather coverage and news across the U.S., the Caribbean and Latin America. The network is 100% free and available across over-the-top streaming platforms. Outside of live broadcasts, the new network features original content that adds value to the viewer’s experience with programming that provides interesting and unexpected views into the world of weather, climate change and more.

The Weather Channel en Español is available on The Weather Channel streaming app and Allen Media Group’s Local Now, Sports.TV and theGrio. TWCE is also available on Roku Channel, YouTube TV, Hulu+LIVE TV, Redbox, Verizon Fios, FuboTV, Xumo Play, Plex, FreeCast, Canela.TV, and the Audacy app.

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, Facebook and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230919243663/en/

Evan D. Masyr
Executive Vice President and Chief Financial Officer
(805) 384-4512
evan@salemmedia.com

Source: Salem Media Group, Inc.

Released October 12, 2023

Release – Snail Games USA and Angela Game Settle Myth of Empires Trade Secret and Copyright Allegations

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SNAL

October 11, 2023 at 4:00 AM EDT

PDF Version

Under the Agreement Snail Games Will Partner With Angela Game to Distribute Myth of Empires on Digital and Retail Platforms

CULVER CITY, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail”), a leading, global independent developer and publisher of interactive digital entertainment and video game software, along with its subsidiary Studio Wildcard, has officially disclosed a settlement agreement with Suzhou Angela Online Game Technology Co., Ltd (“Angela”) and Imperium Interactive Entertainment Limited (“Imperium”). The settlement marks the resolution of copyright and trade secret litigation concerning Myth of Empires (MoE) and includes ongoing royalty payments of Myth of Empires from Angela to Snail, while Snail assists the distribution of Myth of Empires. While details of the Settlement and Release Agreement remain confidential, the parties jointly announced the resolution of their disputes and Snail Games’s cooperation with Angela in the distribution of Myth of Empires going forward.

The original legal complaint can be found HERE:
https://casetext.com/case/suzhou-angela-online-game-tech-co-v-snail-games-us-inc-3/
Full title: Suzhou Angela Online Game Technology Co., Ltd. et al. v. Snail Games USA…
Court: United States District Court, Central District of California

“Following nearly two years of litigation, we are pleased to announce this settlement agreement for Snail, Angela, and Studio Wildcard. Angela acknowledges that it caused difficulties for Snail’s business. By working together, Angela and Snail will put those difficulties behind them. Angela regrets any difficulties it caused Snail and looks forward to moving into this business partnership. At the same time we hope that, with Snail’s extensive user resources and excellent platform relationships built on ARK, they can assist us in our future publishing efforts, injecting greater market vitality into Myth of Empires,” said Yi Ling Zheng, President, Angela Game.

“We are pleased to announce this settlement agreement and facilitate the re-release of Myth of Empires which benefits both parties and opens up additional revenue streams for us through the partnership with Angela,” said Doug Kennedy, Co-founder of Studio Wildcard.

This is pursuant to the terms of the settlement, Snail Games will withdraw its DMCA Notice against Myth of Empires and work collaboratively with PC distribution platforms for a re-release of the game in early 2024. Additionally, Snail Games will partner on the global launch of MoE on both PlayStation and Microsoft platforms in early 2024 and will assist in public relations, marketing, and first party support for the game. Myth of Empires will be released by Angela and Snail Games both physically and digitally on console and PC. Angela Games will also develop a steady cadence of DLC and expansion packs for Myth of Empires, in partnership with Snail Games USA.

About Snail Games USA, Inc.

Snail Games is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

About Angela Game

Founded in 2019, Angela Game is a developer devoted to creating next-generation multiplayer titles that feature profound realism and authenticity, immersive large-scale battles, and innovative gameplay.

Contacts:
Investors:
investors@snail.com

Release – Alvopetro Announces 183-A3 Well Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ALVOF

Oct 11, 2023

CALGARY, AB, Oct. 11, 2023 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) is pleased to announce that we have now completed drilling the 183-A3 well on our 100% owned Murucututu natural gas field. Based on open-hole logs, the well encountered potential net natural gas pay across two separate formations totaling 127.7 metres, with an average porosity of 10.3%.

President and CEO, Corey C. Ruttan commented:

“The results from our uphole 183-A3 Caruaçu exploration target has significantly exceeded our pre-drill expectations and has the potential to open up a large stacked multi-zone development opportunity in further support of our longer-term natural gas growth objectives.”

The 183-A3 well was drilled to a total measured depth (“MD”) of 3,540 metres. Based on open-hole logs, the well encountered potential net natural gas pay in both the Caruaçu Member of the Maracangalha Formation and the Gomo Member of the Candeias Formation, with an aggregate 127.7 metres total vertical depth (“TVD”) of potential natural gas pay, using a 6% porosity cut-off, 50% Vshale cut-off and 50% water saturation cutoff.

Caruaçu Exploration Target

In the Caruaçu Member, a total of 116.1 metres TVD of potential net natural gas pay was encountered between 2,542 metres and 3,062 metres, at an average 38.5% water saturation and an average porosity of 10.4%. Alvopetro currently has no reserves or resources assigned to this Target.

Candeias Formation

In the Gomo Member of the Candeias Formation, a total of 11.6 metres TVD of potential net natural gas pay was encountered between 3,085 metres and 3,270 metres, at an average water saturation of 30.6% and an average porosity of 9.1%. Our Proved reserves for this development well had estimated 12.5 meters of net natural gas pay with porosity of 11.0% and 17% water saturation.

Based on these drilling results, subject to regulatory approvals and equipment availability, we plan to complete the well and put it on production directly to the adjacent field production facility.

Corporate Presentation

Alvopetro’s updated corporate presentation is available on our website at:http://www.alvopetro.com/corporate-presentation.

Social Media

Follow Alvopetro on our social media channels at the following links:

Twitter – https://twitter.com/AlvopetroEnergyInstagram – https://www.instagram.com/alvopetro/LinkedIn – https://www.linkedin.com/company/alvopetro-energy-ltdYouTube –https://www.youtube.com/channel/UCgDn_igrQgdlj-maR6fWB0w

Alvopetro Energy Ltd.’s vision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé and Murucututu natural gas fields and our strategic midstream infrastructure.

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 news release.

All amounts contained in this new release are in United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.

Testing and Well Results. Data obtained from the 183-A3 well identified in this press release, including hydrocarbon shows, open-hole logging, net pay and porosities should be considered to be preliminary until testing, detailed analysis and interpretation has been completed. Hydrocarbon shows can be seen during the drilling of a well in numerous circumstances and do not necessarily indicate a commercial discovery or the presence of commercial hydrocarbons in a well. There is no representation by Alvopetro that the data relating to the 183-A3 well contained in this press release is necessarily indicative of long-term performance or ultimate recovery. The reader is cautioned not to unduly rely on such data as such data may not be indicative of future performance of the well or of expected production or operational results for Alvopetro in the future.

Cautionary statements regarding the filing of a Notice of Discovery. We have submitted a Notice of Discovery of Hydrocarbons to the Agência Nacional do Petróleo, Gás Natural e Biocombustíveis (the “ANP”) with respect to the 183-A3 well. All operators in Brazil are required to inform the ANP, through the filing of a Notice of Discovery, of potential hydrocarbon discoveries. A Notice of Discovery is required to be filed with the ANP based on hydrocarbon indications in cuttings, mud logging or by gas detector, in combination with wire-line logging. Based on the results of open-hole logs, we have filed a Notice of Discovery relating to our 183-A3 well. These routine notifications to the ANP are not necessarily indicative of commercial hydrocarbons, potential production, recovery or reserves.

Oil and natural gas reserves. This news release includes certain information contained in the independent reserves and resources assessment and evaluation prepared by GLJ Ltd. (“GLJ”) dated February 27, 2023 with an effective date of December 31, 2022 (the “GLJ Reserves and Resource Report”). Specifically, this news release contains information concerning proved reserves in the GLJ Reserves and Resource Report applicable to the 183-A3 well. The information included herein represents only a portion of the disclosure required under NI 51-101. Full disclosure with respect to the Company’s reserves as at December 31, 2022 is included in the Company’s annual information form for the year ended December 31, 2022 which has been filed on SEDAR+ (www.sedarplus.ca) The reserves definitions used in this evaluation are the standards defined by COGEH reserve definitions and are consistent with NI 51-101 and used by GLJ. The recovery and reserve estimates of the Company’s reserves provided herein are estimates only and there is no guarantee that the estimated reserves will be recovered. Actual reserves may be greater than or less than the estimates provided herein

Forward-Looking Statements and Cautionary Language. This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward‐looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning potential net natural gas pay in the 183-A3 well and expectations regarding future development plans for the well and the Murucututu natural gas field. The forward‐looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning results from completing the 183-A3 well, equipment availability, the timing of regulatory licenses and approvals, the success of future drilling, completion, testing, recompletion and development activities, the outlook for commodity markets and ability to access capital markets, the impact of global pandemics and other significant worldwide events, the performance of producing wells and reservoirs, well development and operating performance, foreign exchange rates, general economic and business conditions, weather and access to drilling locations, the availability and cost of labour and services, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors.  Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR+ profile at www.sedarplus.ca. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

SOURCE Alvopetro Energy Ltd.