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Biden Administration Unveils $7 Billion Investment in Regional Hydrogen Hubs

Posted on by slightbourne@noblecapitalmarkets.com

The Biden administration is making a major push to develop a domestic hydrogen economy by funding 7 regional hydrogen hubs across the United States. The hubs will share up to $7 billion in federal funding aimed at spurring hydrogen production and use.

President Joe Biden and Energy Secretary Jennifer Granholm announced Friday the selection of hubs in Appalachia, California, the Gulf Coast, the Heartland, Mid-Atlantic, Midwest, and Pacific Northwest regions. The funds come from last year’s Bipartisan Infrastructure Law.

Accelerating the Hydrogen Economy

The goal is to accelerate the growth of a clean hydrogen industry in the U.S. Hydrogen is a versatile fuel seen as a critical tool for decarbonizing major sectors like heavy industry, transportation, and power generation.

When produced using low-carbon methods, hydrogen can provide emissions-free energy for hard-to-abate sectors. Expanding hydrogen is a key plank of the Biden administration’s strategy to cut greenhouse gas emissions and combat climate change.

The 16-state regional hubs model fosters clusters of hydrogen supply and demand, minimizing transportation needs. The administration expects the $7 billion federal injection to mobilize over $43 billion in private capital.

Leveraging Regional Strengths

Each hydrogen hub leverages unique geographic strengths ideal for clean hydrogen production. For example:

  • The Appalachia Hub will use the region’s abundant natural gas supply, applying carbon capture to lower emissions.
  • California and the Pacific Northwest have access to seaports critical for shipping hydrogen.
  • The Heartland can utilize wind resources to produce hydrogen via electrolysis.
  • The Midwest Hub will tap into nuclear power to make hydrogen.

In addition to production, the regional hubs focus on cultivating local hydrogen markets. Some will provide hydrogen for industrial uses while others may focus on fertilizer or fuel cell vehicle growth.

Building on Bipartisan Policy

The hydrogen hub funding originated from the bipartisan infrastructure package passed in 2021. The law included $8 billion for at least four regional hubs.

The Biden administration expanded the program to seven hubs to extend geographic impact. The policy builds on bipartisan support for advancing hydrogen in the U.S.

Last year’s Infrastructure Investment and Jobs Act also created a hydrogen production tax credit. The recently passed Inflation Reduction Act further boosted hydrogen incentives with an additional $3 per kg production credit.

The Energy Department will provide guidance on utilizing the tax credits later this year. The credits will aid long-term viability of the regional hubs.

Spurring Private Investment

The federal money is intended to galvanize substantial private capital investment in building out hydrogen infrastructure. Siting hydrogen hubs near key anchor facilities can spur economic growth.

For example, California’s hub grants will likely stimulate billions in private funding around port facilities. Financial incentives like the hydrogen tax credits create ideal conditions for private sector buy-in.

Over time, decreasing costs through scale and technology improvements could make hydrogen competitive with conventional fuels. The regional hubs represent a starting point designed to nurture both supply and demand.

Next Steps for Growth

The hydrogen hubs mark an important early phase of U.S. efforts to scale up the hydrogen economy. Biden administration officials noted work remains to develop connective infrastructure and further applications.

Ongoing policy support via research funding, incentives, and enabling regulation will help drive growth. Continued bipartisan cooperation around hydrogen could lead to additional catalytic investments.

With the right policy environment, hydrogen could become a major pillar of America’s clean energy economy. The regional hubs represent a down payment on the infrastructure needed to realize hydrogen’s vast decarbonization potential across the economy.

OptimizeRx to Acquire Medicx in $95 Million Deal, Expanding Omnichannel Platform

Posted on by slightbourne@noblecapitalmarkets.com

OptimizeRx Corp. announced Thursday it will acquire Scottsdale-based Medicx Health for $95 million, expanding its platform reach to healthcare consumers.

The deal combines OptimizeRx’s solutions focused on healthcare providers (HCPs) with Medicx’s consumer-centric technologies. Together, the companies can engage over 2 million HCPs and a majority of U.S. healthcare consumers.

“Our acquisition of Medicx is expected to be a major business accelerator for us,” said OptimizeRx CEO Will Febbo.

For OptimizeRx, the acquisition enhances its digital health platform that helps life sciences companies educate and engage HCPs and patients. Medicx brings new omnichannel marketing and analytics capabilities aimed at consumers.

Reaching Healthcare’s Key Stakeholders

OptimizeRx’s lead solution is a digital point-of-care network enabling pharma marketing and engagement integrated within EHR and e-prescribing workflows. This allows drug makers to reach HCPs through digital touchpoints at the point of care.

Medicx has developed a Micro-Neighborhood® Targeting Platform using advanced identity resolution to reach healthcare consumers. Combining both solutions offers an end-to-end way for pharma companies to connect with HCPs and patients—healthcare’s two most important stakeholders.

“Coupling consumer and HCP marketing strategies is a natural next step for many of our customers,” said OptimizeRx Chief Commercial Officer Steve Silvestro.

Profitable Addition to Fuel Growth

The acquisition is expected to significantly benefit OptimizeRx’s growth and profitability. Medicx is a highly profitable company that will immediately add to revenue, EBITDA, and earnings per share.

On a combined basis, the deal will bring OptimizeRx’s revenue run-rate close to $100 million. Medicx also opens substantial new opportunities for customer penetration and cross-selling.

“I’m extremely proud of the leading patient-focused omnichannel platform the Medicx team has built,” said Medicx CEO Michael Weintraub. “Integrating with a leading HCP-focused enterprise provides numerous efficiencies.”

Weintraub added the combined platforms can now inform and educate patients and HCPs in a cohesive way no single company has done before.

Funded for Growth

OptimizeRx will pay $95 million in total consideration to acquire Medicx. The deal will be funded through OptimizeRx’s cash on hand, short-term investments, and a new $40 million credit facility from Blue Torch Capital.

Certain members of Medicx’s management will invest approximately $10.5 million of their proceeds into OptimizeRx common stock.

The acquisition is expected to close in Q4 2023. Medicx will operate as a subsidiary under its current management team.

Strong Quarterly Performance

In tandem with the acquisition announcement, OptimizeRx preannounced strong third quarter 2023 results.

The company expects Q3 revenue between $15.2-$15.5 million, ahead of consensus estimates. Non-GAAP net income is projected at $0.6-$1 million.

OptimizeRx saw accelerated organic growth in messaging driven by its recently enhanced Dynamic Audience Activation Platform.

The deal marks OptimizeRx’s largest acquisition to date as it leverages M&A to expand its platform. Medicx’s addition is expected to be immediately accretive while funding future growth.

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

PDS Biotechnology Corp. (PDSB) – Data For PDS0301 Phase 1/2 To Show Immune Response and Safety Data

Posted on by cpereira@noblefcm.com


Thursday, October 12, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

First PDS 0301 Prostate Cancer Data To Be Presented. PDS Biotech announced that data from a Phase 1/2 study testing PDS0301 in combination with docetaxel to treat prostate cancer will be presented by National Cancer Institute (NCI) scientists at the Cytokines 2023 meeting on October 15-18. This combination uses PDS0301 with docetaxel to stimulate an immune response and kill the cancer cells. Preliminary data from the trial shows increases in populations of immune cells, pro-inflammatory cytokines, and decreases in PSA levels.

Preliminary Results Show Immune Stimulation With Tolerability. The presentation includes 18 patients with metastatic castrate resistant prostate cancer (mCRPC, n=11) and sensitive prostate cancer (mCRPC, n=7). Patients received one of three dose levels tested in combination with a standard dose of docetaxel every three weeks. Results showed decreases in PSA ranging from -4% to -100%, with increases in CD4 and CD8 immune cells. Cytokines INF-gamma and IL-10 were increased, with decreases in the Treg (suppressive regulatory) cells. These responses are consistent with our expectations for an effective immune response.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Rising Housing Costs Drive Consumer Inflation Even Higher in September

Posted on by slightbourne@noblecapitalmarkets.com

Consumer inflation accelerated more than expected in September due largely to intensifying shelter costs, putting further pressure on household budgets and keeping the Federal Reserve on high alert.

The consumer price index (CPI) increased 0.4% last month after rising 0.1% in August, the Labor Department reported Thursday. On an annual basis, prices were up 3.7% through September.

Both the monthly and yearly inflation rates exceeded economist forecasts of 0.3% and 3.6% respectively.

The higher than anticipated inflation extends the squeeze on consumers in the form of elevated prices for essentials like food, housing, and transportation. It also keeps the Fed under the microscope as officials debate further interest rate hikes to cool demand and restrain prices.

Source: U.S. Bureau of Labor Statistics

Surging Shelter Costs in Focus

The main driver behind the inflation uptick in September was shelter costs. The shelter index, which includes rent and owners’ equivalent rent, jumped 0.6% for the month. Shelter costs also posted the largest yearly gain at 7.2%.

On a monthly basis, shelter accounted for over half of the total increase in CPI. Surging rents and housing costs reflect pandemic trends like strong demand amid limited supply.

“Just because the rate of inflation is stable for now doesn’t mean its weight isn’t increasing every month on family budgets,” noted Robert Frick, corporate economist at Navy Federal Credit Union. “That shelter and food costs rose particularly is especially painful.”

Energy and Food Costs Also Climb

While shelter led the inflation surge, other categories saw notable increases as well in September. Energy costs rose 1.5% led by gasoline, fuel oil, and natural gas. Food prices gained 0.2% for the third consecutive month, with a 6% jump in food away from home.

On an annual basis, energy costs were down 0.5% but food was up 3.7% year-over-year through September.

Used vehicle prices declined 2.5% in September but new vehicle costs rose 0.3%. Overall, transportation services inflation eased to 0.9% annually in September from 9.5% in August.

Wage Growth Lags Inflation

Rising consumer costs continue to outpace income growth, squeezing household budgets. Average hourly earnings rose just 0.2% in September, not enough to keep pace with the 0.4% inflation rate.

That caused real average hourly earnings to fall 0.2% last month. On a yearly basis, real wages were up only 0.5% through September—a fraction of the 3.7% inflation rate over that period.

American consumers have relied more heavily on savings and credit to maintain spending amid high inflation. But rising borrowing costs could limit their ability to sustain that trend.

Fed Still Focused on Inflation Fight

The hotter-than-expected CPI print keeps the Fed anchored on inflation worries. Though annual inflation has eased from over 9% in June, the 3.7% rate remains well above the Fed’s 2% target.

Officials raised interest rates by 75 basis points in both September and November, pushing the federal funds rate to a range of 3-3.25%. Markets expect another 50-75 basis point hike in December.

Treasury yields surged following the CPI report, reflecting ongoing inflation concerns. Persistently high shelter and food inflation could spur the Fed to stick to its aggressive rate hike path into 2023.

Taming inflation remains the Fed’s number one priority, even at the risk of slowing economic growth. The latest CPI data shows they still have work to do on that front.

All eyes will now turn to the October and November inflation reports heading into the pivotal December policy meeting. Further hotter-than-expected readings could force the Fed’s hand on more supersized rate hikes aimed at cooling demand and prices across the economy.

AZZ Inc. (AZZ) – Sales a bit light, but margins are holding steady.

Posted on by cpereira@noblefcm.com


Thursday, October 12, 2023

Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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

Sales growth stagnated. 2024-2Q sales decreased 1.9% (Metal Coatings up 2.4% and Precoat Metals down 5.0%) due to a soft market for precoated construction and appliances. Management remains optimistic that sales growth will resume pointing to rising new home startups and the AIIJ Act.

EBITDA margins held steady despite the sale decline. Metal Coatings maintained an EBITDA margin above 30% and Precoat Metals held its EBITDA margin near 20%. Importantly, the company has been making a concerted effort to reduce customer inventories. Lower inventories has helped reduce costs and improved cash flow leaving the company well positioned for seasonal sales declines during the winter months.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Harmony Biosciences Bets on Cannabinoid Therapy for Rare Disorders with $200 Million Zynerba Buyout

Posted on by slightbourne@noblecapitalmarkets.com

Harmony Biosciences aims to expand its pipeline into rare neuropsychiatric disorders through the acquisition of Zynerba Pharmaceuticals and its innovative cannabinoid gel technology.

Harmony, known for its narcolepsy drug Wakix, announced Monday that it will acquire Zynerba in a deal worth up to $200 million. The buyout provides Harmony with Zynerba’s lead asset, Zygel, a synthetic cannabidiol gel in mid-stage trials for Fragile X syndrome and 22q11.2 deletion syndrome.

Zygel could become the first FDA-approved drug for managing Fragile X if it succeeds in pivotal trials. Harmony sees the drug as a way to expand beyond sleep disorders while tackling high unmet needs in orphan neuropsychiatric conditions.

Fragile X affects 80,000 in the U.S., causing intellectual disability and behavioral challenges. Zynerba’s focus aligns with Harmony’s mission in rare neurological diseases, said Harmony CEO Jeffrey Dayno, M.D. in Monday’s announcement.

“With Harmony’s scale, resources and proven commercial excellence, they are well positioned to potentially bring to market the first pharmaceutical product indicated for the treatment of behavioral symptoms of Fragile X syndrome and to maximize the value of Zygel,” added Zynerba Chairman and CEO Armando Anido.

No FDA-Approved Options Today

Fragile X syndrome stems from mutations in the FMR1 gene which codes for FMRP, a protein vital for synaptic function and neural connections. The lack of FMRP causes cognitive impairments. Around 60% of Fragile X patients don’t produce any FMRP due to methylation.

While Fragile X affects tens of thousands in the U.S. alone, there are no FDA-approved treatments. Patients rely on behavioral interventions and off-label drug use.

Zynerba’s Zygel aims to modulate the endocannabinoid system impacted by the loss of FMRP. The gel contains synthetic cannabidiol, absorbing through the skin to avoid first-pass metabolism.

Zygel already secured FDA orphan drug status for both Fragile X and 22q deletion syndrome. It also won Fast Track designation for Fragile X.

Now in pivotal Phase 3 trials, Zygel showed positive Phase 2 data in both indications. Harmony believes the drug can help patients manage behavioral symptoms if approved.

Betting Up to $200M on Approval

Under the acquisition terms, Harmony will pay $60 million upfront for Zynerba’s shares, or $1.1059 per share in cash. Zynerba shareholders will also receive one contingent value right (CVR) worth up to $2.5444 per share more.

The CVR payments depend on Zygel hitting clinical, regulatory and sales milestones:

  • $15M for completing Phase 3 Fragile X trial
  • Up to $30M for Phase 3 data (timing-based)
  • $35M for FDA approval in Fragile X
  • $15M for approval in a second indication
  • Up to $45M for reaching sales milestones

Altogether, the deal is valued at up to $200 million if Zygel secures FDA approval and reaches peak sales targets. Harmony expects the buyout to close in Q4 2023.

“Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs,” said Harmony CEO Dayno.

Doubling Down on Rare Diseases

The acquisition aligns with Harmony’s focus on innovative treatments for overlooked neurological diseases. Zynerba’s work in underserved neuropsychiatric disorders complements Harmony’s leading drug in narcolepsy.

Harmony markets Wakix, a first-in-class H3 receptor antagonist that hit $230 million in net sales over the twelve months ending June 30, 2022. But the company sees untapped growth opportunities in adjacent rare diseases.

The Zynerba deal provides pipeline diversification into high-value orphan drug development. Harmony now has new opportunities in gene mutation disorders like Fragile X and 22q deletion syndrome.

With a profitable commercial engine already built, Harmony is betting its expertise and $430 million cash position can maximize Zygel’s impact if approved. The company sees Zynerba’s cannabinoid therapy as both a strategic fit and a long-term growth driver if milestones are met.

For shareholders, the buyout provides Harmony an approved orphan drug asset with potential peak sales upside. And for patients, it brings hope for the first therapy to address Fragile X symptoms.

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