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Release – PDS Biotech Announces Data from IMMUNOCERV Phase 2 Trial Investigating PDS0101 and Chemoradiotherapy in Cervical Cancer to be Featured in Oral Presentation at the ASTRO 2023 Annual Meeting

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PDS Biotech Announces Data from IMMUNOCERV Phase 2 Trial Investigating PDS0101 and Chemoradiotherapy in Cervical Cancer to be Featured in Oral Presentation at the ASTRO 2023 Annual Meeting

Study evaluates the effect of combining PDS0101 with standard of care on levels of circulating HPV viral DNA in cervical cancer patients and impact on disease status and clearance

PRINCETON, N.J., Aug. 16, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that data from the IMMUNOCERV Phase 2 clinical trial investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the treatment of locally advanced cervical cancer will be featured in an oral presentation at the American Society for Radiation Oncology (ASTRO 2023) Annual Meeting. ASTRO 2023 is being held October 1-4, 2023, in San Diego, CA.

The abstract, titled “HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation,” will report on the levels of circulating HPV-positive cell-free DNA (HPV-cfDNA) in the blood of 47 cervical cancer patients during and after CRT treatment, including subjects in the IMMUNOCERV study who received PDS0101 in addition to CRT. The research is designed to evaluate the relationship between the levels of circulating HPV viral DNA and the extent of disease, clinical staging, and treatment response in patients with HPV-positive cervical cancer. The findings will be presented by Dr. Aaron Seo, MD, Ph.D., The University of Texas MD Anderson Cancer Center.

“We are pleased that PDS0101 is being evaluated in this cutting-edge approach to better understand the patients’ prognosis and the mechanism by which PDS0101 may impact clinical outcomes in cervical cancer, and we look forward to Dr. Seo’s presentation at ASTRO 2023,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “Examination of HPV-cfDNA in this larger cohort of patients will also provide additional insights to the IMMUNOCERV data presented at SITC 2022, which suggested that PDS0101 promotes the induction of multifunctional CD8 killer T cells that were associated with declines in circulating tumor DNA and 100% (9/9) clinical response with greater than 60% tumor shrinkage at mid-point evaluation in high-risk cervical cancer patients.”

The IMMUNOCERV Phase 2 study is investigating PDS0101 in combination with standard-of-care CRT in the treatment of patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes.
Presentation Details:
Abstract #: 55593 
Abstract Title: HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation 
Presenter: Aaron Seo 
Author Block: Aaron Seo, Weihong Xiao, Olsi Gjyshi, Kyoko Court, Tatiana Cisneros Napravnik, Aradhana Venkatesan, Erica Lynn, Julie Sammouri, Lauren Colbert, Anuja Jhingran, Melissa Joyner, Lilie Lin, Maura Gillison, Ann Klopp 
Scientific Session Number: SS 02  
Scientific Session Title: GYN 1: Integrating the Next Wave of Biomarkers for Future Gynecologic Clinical Trials 
Session Date/Time: October 1, 8:00AM-9:00AM

About PDS Biotechnology 

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech. 

About Versamune®

Versamune® is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune® based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune® based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune® based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.

About PDS0101 

PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

Forward Looking Statements 

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.    

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts: 
Deanne Randolph 
PDS Biotech 
Phone: +1 (908) 517-3613 
Email: drandolph@pdsbiotech.com 

Rich Cockrell 
CG Capital 
Phone: +1 (404) 736-3838 
Email: pdsb@cg.capital 

Media Contacts: 
Dave Schemelia 
Tiberend Strategic Advisors 
Phone: +1 (609) 468-9325 
Email: dschemelia@tiberend.com 

Eric Reiss 
Tiberend Strategic Advisors 
Phone: +1 (802) 249-1136 
Email: ereiss@tiberend.com 

Release – Defense Metals Advances Pre-feasibility Study

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VANCOUVER, BC, Aug. 16, 2023 /CNW/ – Defense Metals Corp. (“Defense Metals” or the “Company“) (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to provide a progress update with respect to its 2023 site infrastructure geotechnical investigations. The work, with support of the Defense Metals’ technical team and APEX Geoscience Ltd., is being completed by SRK Consulting (Canada) Inc. (“SRK“) one of the principal consultants for the preliminary feasibility study (“PFS“) regarding the Company’s Wicheeda Rare Earth Element (REE) Project located near Prince George, Canada.

Image 1: SRK engineering personnel logging WSF sonic overburden material (CNW Group/Defense Metals Corp.)

Image 2: Excavated test pit sampling underway (CNW Group/Defense Metals Corp.)

Craig Taylor, CEO of Defense Metals, commented:

“It is great to see our technical consulting teams making significant headway with the Wicheeda site investigations. Defence Metals has assembled a world class team of experts who have both the experience and technical skills to bring this project through pre-feasibility.” 

The SRK geotechnical investigation includes the following scopes:

  • Geotechnical engineering (waste rock, tailings, contact water pond, and site infrastructure geotechnical investigation),
  • Tailings alternative assessment prior to advancing into PFS-level design of a preferred alternative,
  • Geochemical characterization (to support mine planning/waste management and to develop preliminary water chemistry predictions for the main mine facilities).

The work completed to date included field site inspections from SRK personnel: Principial Consultant – Mining Rock Mechanics, Ed Saunders, P.Eng. (waste storage facility geotechnical); Principal Consultant – Geochemistry, Kirsty Ketchum, Ph.D., P.Geo. (metal leaching and acid/alkaline rock drainage geochemical characterization); and Senior Consultant- Mining Rock Mechanics, Aton Bloem (open pit geotechnical).

Site infrastructure geotechnical investigations planned include a series of excavated test pits, and sonic overburden drill holes designed to support the preliminary characterization of the shallow soil subsurface and bedrock foundations of potential future waste rock storage (WSF), mineralization stockpile, contact water pond (CWP), crusher, processing plant (INF), and tailings storage facility (TSF) locations.

To date a total of 13 excavated tests pits and 4 sonic overburden geotechnical holes for a total of 93 metres have been completed to characterize surficial material conditions within the proposed WSF, CWP, and TSF areas (Images 1 and 2). Site geotechnical investigations encountered shallow overburden conditions (nil or <1 metre overburden depth), excavated test pit depths ranging from 1 to 5 metres; and sonic overburden drill holes in areas of thicker surficial material ranging from 7 metre to >36.6 metre depth to bedrock.

SRK on site engineering consultants supervised the investigations and carried out soil geotechnical logging, direct testing, sampling, photography of recovered materials, standpipe installation, and coordination of laboratory testing. SRK will process the data collected from the sonic drilling and test pit investigations, and laboratory testing results will be incorporated into the QA/QC dataset.

In addition to infrastructure geotechnical investigations, SRK has commenced a tailings alternatives assessment prior to advancing into PFS-level design of a preferred alternative. This will include tailings characterization and development of design criteria, a siting evaluation, and an alternatives trade-off.

As part of the geochemical characterization scopes SRK has completed a review and compilation of site geological and geochemical data and drill core logs that have been acquired since the 2021 preliminary economic assessment (PEA). These data will be used to develop a sampling plan of the existing drill core for geochemical characterization of the proposed mine facilities, and future set-up of on-site kinetic leach tests (barrel tests). Data will be interpreted to support mine planning/waste management and to develop preliminary water chemistry predictions for the main mine facilities (source terms). Source terms are an input to the site water and load balance model.

Excavated test pit and sonic overburden drilling is currently paused and is expected to resume as part of the WSF, CWP, INF, and TSF (and TSF alternative) geotechnical investigations during September in conjunction with the planned drilling of an additional four (4) pit geotechnical core holes totalling 820 metres.

Qualified Person

The scientific and technical information contained in this news release as it relates to the Wicheeda REE Project has been reviewed and approved by Kristopher J. Raffle, P.Geo. (B.C.), Principal and Consultant of APEX Geoscience Ltd. of Edmonton, Alberta, who is a director of Defense Metals and a “Qualified Person” as defined in NI 43-101. 

About the Wicheeda REE Property

Defense Metals 100% owned, 6,759-hectare (~16,702-acre) Wicheeda Project is located approximately 80 km northeast of the city of Prince George, British Columbia; population 77,000. The Wicheeda REE Project is readily accessible by all-weather gravel roads and is near infrastructure, including hydro power transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the port facilities at Prince Rupert, the closest major North American port to Asia.

The 2021 Wicheeda REE Project Preliminary Economic Assessment technical report outlined a robust after-tax net present value (NPV@8%) of $517 million and an 18% IRR1. This PEA contemplated an open pit mining operation with a 1.75:1 (waste:mill feed) strip ratio providing a 1.8 Mtpa (“million tonnes per year”) mill throughput producing an average of 25,423 tonnes REO annually over a 16 year mine life. A Phase 1 initial pit strip ratio of 0.63:1 (waste:mill feed) would yield rapid access to higher grade surface mineralization in year 1 and payback of $440 million initial capital within 5 years.

_____________________________
1 Independent Preliminary Economic Assessment for the Wicheeda Rare Earth Element Project, British Columbia, Canada, dated January 6, 2022, with an effective date of November 7, 2021, and prepared by SRK Consulting (Canada) Inc. is filed under Defense Metals Corp.’s Issuer Profile on SEDAR (www.sedarplus.ca).

About Defense Metals Corp.

Defense Metals Corp. is a mineral exploration and development company focused on the development of its 100% owned Wicheeda Rare Earth Element Deposit located near Prince George, British Columbia, Canada. Defense Metals Corp. trades on the TSX Venture Exchange under the symbol “DEFN”, in the United States, trading symbol “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.

Defense Metals is a proud member of Discovery Group. For more information please visit: http://www.discoverygroup.ca/

For further information, please contact:

Todd Hanas, Bluesky Corporate Communications Ltd.
Vice President, Investor Relations
Tel: (778) 994 8072
Email: todd@blueskycorp.ca

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.

Cautionary Statement Regarding “Forward-Looking” Information

This news release contains “forward‐looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to advancing the Wicheeda REE Project, completion of additional geotechnical work including pit geotechnical core holes and the expected timelines, the expected completion of the PFS, the technical, financial and business prospects of the Company, its project and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of rare earth elements, the anticipated costs and expenditures, accuracy of assay results, performance of available laboratory and other related services, future operating costs, interpretation of geological, engineering and metallurgical data, the ability to achieve its goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties relating to the interpretation of exploration, engineering and metallurgical results, risks related to the inherent uncertainty of exploration, metallurgy and development and cost estimates, the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR at www.sedarplus.ca. While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, adverse weather and climate conditions, failure to maintain or obtain all necessary government permits, approvals and authorizations, failure to maintain community acceptance (including First Nations), risks relating to unanticipated operational difficulties (including failure of equipment or processes to operate in accordance with specifications or expectations, cost escalation, unavailability of personnel, materials and equipment, government action or delays in the receipt of government approvals, industrial disturbances or other job action, and unanticipated events related to health, safety and environmental matters), risks relating to inaccurate geological, metallurgical and engineering assumptions, decrease in the price of rare earth elements, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, an inability to predict and counteract the effects of COVID-19 and other viruses and diseases on the business of the Company, the price of commodities, capital market conditions, restriction on labour and international travel and supply chains, loss of key employees, consultants, or directors, increase in costs, delayed results, litigation, and failure of counterparties to perform their contractual obligations. The Company does not undertake to update forward‐looking statements or forward‐looking information, except as required by law.

SOURCE Defense Metals Corp.

Release – Labrador Gold Reports High Grade Gold Assays Up to 30.58g/t Au Between Big Vein and Golden Glove

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TORONTO, Aug. 16, 2023 (GLOBE NEWSWIRE) — Labrador Gold Corp. (TSX.V:LAB | OTCQX:NKOSF | FNR: 2N6) (“LabGold” or the “Company”) is pleased to announce results from recent prospecting along the highly prospective Appleton Fault Zone at its 100% owned Kingsway Project.

Recent prospecting between Big Vein and Golden Glove near the southern property boundary has located a new gold showing, the Knobby occurrence. Grab samples from quartz vein outcrops returned gold values from below detection (<5ppb) to 30.58 g/t including samples grading 0.4g/t, 2.7g/t and 29.19 g/t Au. Three parallel veins were observed and have been traced along an east-west strike for approximately 200 metres. Stibnite mineralization was observed associated with the quartz veining. This is the first indication of gold mineralization along the Appleton Fault Zone between Big Vein and Golden Glove, an area that has seen little work to date.

“Today’s results of high-grade, surface gold mineralization in quartz vein outcrops between Big Vein and Golden Glove is very encouraging for the prospectivity of this 3-kilometre section of the Appleton Fault Zone,” said Roger Moss, President and CEO of Labrador Gold Corp. “This is an area that we have prioritized for drilling in the latter part of this year once we complete an ongoing ground magnetic/VLF survey and receive the necessary permits. We are excited by the discovery of the Knobby occurrence which is reminiscent of our initial discovery of Big Vein by prospecting almost three years ago.”

Figure 1. Location of Knobby occurrence between Big Vein and Golden Glove.

Figure 2. Geochemical anomalies between Big Vein and Golden Glove.

Figure 3. Photos of Knobby Vein outcrop.

Prospecting is ongoing in the area of the Knobby occurrence and Groundtruth Exploration is currently completing a ground Mag/VLF survey extending from the southern property boundary to Big Vein. LabGold has submitted an application to drill up to 95 drill holes along this portion of the Appleton Fault Zone.

Upcoming Webinar

The Company is also pleased to announce that LabGold CEO, Roger Moss, will be presenting an exploration update on the Kingsway Project in a live webinar taking place on Wednesday, August 23rd at 12:00pm PT / 3:00pm ET. To register for the event please click the link below.

Registration Link: https://event.webinarjam.com/register/229/p512nhoy

QA/QC

All rock samples are grab samples, which are selective samples and not necessarily representative of mineralization found on the property. Samples 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.

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.

The Company gratefully acknowledges the Newfoundland and Labrador Ministry of Natural Resources’ Junior Exploration Assistance (JEA) Program for its financial support for exploration of the Kingsway property.

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 $12 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. 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

Twitter: @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/c137ff09-83ff-4af6-bd78-6016e5ada881

https://www.globenewswire.com/NewsRoom/AttachmentNg/8295dae2-bf35-4a45-a5cb-4b55b1ade38d

https://www.globenewswire.com/NewsRoom/AttachmentNg/8a69be67-4ea5-4115-876e-ff296fde420a

https://www.globenewswire.com/NewsRoom/AttachmentNg/5f746398-66df-47df-a945-5a19184f9aa9

Release – Snail, Inc. Announces Early Access Launch of Survivor Mercs, Developed by Wolpertinger Games

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August 16, 2023 at 7:53 AM EDT

CULVER CITY, Calif., Aug. 16, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail”), a leading, global independent developer and publisher of interactive digital entertainment, today announced Wolpertinger Games, a newly contracted independent studio, aims to launch the early access of Survivor Mercs on Thursday September 14th, 2023, on Steam and Steam Deck. This launch marks a major progression in the collaborative journey between Snail and Wolpertinger Games since the recent partnership announcement.

Survivor Mercs is a rogue-lite action game that blends the bullet-heaven and extraction shooter genre for a challenging single-player experience where no two gameplay runs are alike. Players assume the role of the Commander of an elite Mercs squad, battling against a formidable mega-corporation’s private robot army on procedurally generated battlefields. The game offers an engaging combination of strategy, tactics, action and adventure, coupled with the opportunity to build your squad from a diverse roster of Mercs, each with individual skill trees and weapon configurations. Furthermore, the procedurally generated maps of Survivor Mercs present different mission parameters and unique bosses, ensuring unpredictability and excitement in every operation.

Jim Tsai, Chief Executive Officer of Snail, commented, “Following our recent strategic partnership announcement with Wolpertinger Games, we are delighted to present the early access launch of Survivor Mercs. We aim to leverage our resources and expertise to assist Wolpertinger Games in publishing and promoting this high – quality indie game, ensuring players enjoy a seamless early access launch experience. As we move forward, we will continue fostering such partnerships, supporting indie studios, and delivering captivating gaming experiences to our global audience.”

Survivor Mercs can be wish-listed now and purchased later upon launch on Steam store at https://store.steampowered.com/app/2141520/Survivor_Mercs/.

About Snail, Inc.

Snail 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.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful, including the launch of ARK: Survival Ascended, ARK: The Animated Series and ARK 2; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, the Apple App Store, the Google Play Store, My Nintendo Store and the Amazon Appstore; expectations for future growth and performance; and assumptions underlying any of the foregoing.

Contacts:

Investors:

investors@snail.com

Release – Tonix Pharmaceuticals Initiates Phase 1 Trial of TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers

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August 16, 2023 7:00am EDT

Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500

Study Designed to Support Planned Phase 2 Trial in Prevention of Kidney Transplant Rejection

Multiple Possible Indications, Including Bone Marrow Transplantation and Autoimmune Diseases: Potential Pipeline in a Product

TNX-1500 is the First of Tonix’s Internally-Developed Biologic Candidates to Reach the Clinic

CHATHAM, N.J., Aug. 16, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the initiation of a Phase 1 single ascending dose escalation study of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody or mAb) in healthy volunteers. The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous (IV) TNX-1500.

TNX-1500 is in development for the prevention of kidney transplant rejection and other potential transplant and autoimmune disorder indications. Recent animal studies indicate that TNX-1500 prevents organ rejection and preserves graft function either as a single agent or in combination with other drugs.1,2 Eligible participants enrolled in the Phase 1 study will be evaluated regularly over a 120-day period after dosing. Target enrollment is 36 participants. Initiation of this first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients.

“Despite advancements in the field of solid organ transplantation, there remains a significant need for new treatments with improved activity and tolerability,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1500 has demonstrated single agent activity for long-term organ acceptance and induction of tolerance in animals.1,2 Potentially related to its activity, in preclinical studies, TNX-1500 preserves T regulatory cells, or Tregs, which are key to maintaining tolerance to grafts as well as to self-antigens. We believe TNX-1500 has the potential to prevent organ transplant rejection and improve long-term graft survival with reduced long-term toxicity burden compared to current immunosuppressive regimens. In addition, TNX-1500 has the potential to address multiple indications, including a number of autoimmune diseases. The range of potential indications suggests ‘pipeline in a product’ potential.”

“We are excited to advance TNX-1500 into the clinic by initiating this Phase 1 trial,” said Dr. Greg Sullivan, Chief Medical Officer of Tonix. “TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRIIA binding. Preclinical studies in non-human primates demonstrated that TNX-1500 is active in preventing allograft organ rejection and is well tolerated. Specifically, thrombotic complications associated with first generation anti-CD40L mAbs, were not observed, suggesting that the protein engineering underlying TNX-1500 has achieved its design goals.”

Dr. Lederman continued, “Recently, positive clinical data with other CD40L blockers have been reported by Sanofi, with its Fc-modified humanized anti-CD40L mAb frexalimab in treating relapsing multiple sclerosis,3 and from Horizon Therapeutics plc with its tn03 fusion protein dazodalibep in treating Sjögren’s syndrome.4,5   UCB is in Phase 3 development with its anti-CD40L pegylated Fab, dapirolizumab pegol, for the treatment of systemic lupus erythematosus.6 Based on results from animals, we consider Fc-modified humanized TNX-1500 to be a potential best-in-class therapeutic in the CD40L blocker space.”  

CD40L is a member of the TNF-α superfamily, which includes TNF-α and RANKL. TNF-α is the target for several established drugs, including Humira® (adalimumab), Remicade® (infliximab), Enbrel® (etanercept), and Cimzia® (certolizumab). RANKL is targeted by Prolia® and Xgeva® (denosumab). Emerging TNF-α superfamily targets for therapeutics include TL1A, CD30L, Ox40L, and 41BBL. Merck acquired Prometheus Biosciences for its anti-TL1A and anti-CD30L programs.

Dr. Lederman concluded, “TNX-1500 is the first of Tonix’s internally-developed biologic candidates to reach the clinic. Tonix owns worldwide rights to TNX-1500, which are unencumbered by royalties. Our ability to develop and advance protein therapeutics is facilitated by our Research and Development Center (RDC) in Frederick, Md. and our Advanced Development Center (ADC) in Dartmouth, Mass.”

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), which is also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the treatment of autoimmune diseases and for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT). A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Two articles have recently published in the American Journal of Transplantation that demonstrate TNX-1500 prolongs non-human primate renal and heart allograft survival1,2.

  1. Lassiter, G., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate renal allograft survival. American Journal of Transplantation. April 3, 2023. https://doi.org/10.1016/j.ajt.2023.03.022
  2. Miura, S., et al. (2023) TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate cardiac allograft survival. American Journal of Transplantation. April 6, 2023. https://doi.org/10.1016/j.ajt.2023.03.025
  3. Sanofi press release May 31, 2023 “Press Release: Positive Phase 2 data of novel investigational anti-CD40L antibody frexalimab show significantly reduced disease activity in relapsing multiple sclerosis”: https://www.sanofi.com/en/media-room/press-releases/2023/2023-05-31-05-00-00-2678991 (accessed August 11 2023)
  4. Horizon press release September 12, 2022 “Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sjögren’s Syndrome Meets Primary Endpoint” https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-announces-phase-2-trial-evaluating (accessed August 11 2023)
  5. Horizon Press Release January 18, 2023 “Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sjögren’s Syndrome Meets Primary Endpoint in the Second Study Population; Only Phase 2 Trial to Meet Primary Endpoint in Both Patient Populations ”https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-announces-phase-2-trial-evaluating-0 (accessed August 11 2023)
  6. https://www.ucb.com/our-science/pipeline (accessed August 11 2023)

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 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 the fourth quarter of 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 are expected 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 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, 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 µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 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 third 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.

Tonix Medicines has contracted to acquire the Zembrace SymTouch and Tosymra registered trademarks. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc.

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
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released August 16, 2023

SPACtrac Report – FG Merger Corp. (FGMC) -Asymmetric Return Profile Acquisition To Unlock iCoreConnect SaaS Potential

Posted on by cpereira@noblefcm.com


Wednesday, August 16, 2023

iCoreConnect Inc. (ICCT)

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

An Asymmetric Return Profile SPAC. iCoreConnect Inc. (OTC; ICCT) will merge with FG Merger Sub Inc., a wholly owned subsidiary of FG Merger Corp. (Nasdaq; FGMC). In connection with this merger, FGMC will change its name to iCoreConnect Inc. Management believes this is a unique convertible preferred stock asymmetric return structure transaction for FGMC holders, as the preferred will pay a 12% dividend and offer downside protection. The merger is targeting unlocking value in ICCT, and seeking uplisting ICCT to Nasdaq to gain better access to capital. The merger is expected to close mid-to-late August 2023.

Secular Drivers of Growth. iCoreConnect’s target customers are healthcare providers, dental support organizations, hospitals, and payors. Customers are seeking to reduce costs, improve profitability, and achieve better compliance with regulatory mandates through cloud-based multi-solution SaaS (Software as a Service) applications. The SaaS market is estimated to grow nearly 18% annually through 2028, but iCoreConnect expects to grow substantially faster, with an increasing sales reach as the Company expands its commercial sales force. 


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QuoteMedia Inc. (QMCI) – A Decent Performance, But We Were Hoping For A Little More

Posted on by cpereira@noblefcm.com


Wednesday, August 16, 2023

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Broadridge Financial Systems, JPMorgan Chase, CI Financial, Canaccord Genuity Corp., Hilltop Securities, HD Vest, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, FolioFN, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Qtrade Financial, CNW Group, IA Private Wealth, Ally Invest, Inc., Suncor, Virtual Brokers, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Cirano, Equisolve, Stock-Trak, Mergent, Cision, Day Trade Dash and others. Quotestream®, QModTM and Quotestream ConnectTM are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Mixed Q2 results. The second quarter results were mixed, with revenues lighter than expected and adj. EBITDA largely in line. Revenues were adversely affected by exchange rates but, after that adjustment, were still a little light. Total company revenues increased 9.6% to $4.7 million versus our $4.95 million estimate. Adj. EBITDA was $808,000 versus our $850,000 estimate.

Tempered revenue outlook. Management anticipates that revenue growth in the back half of the year will look similar to the growth rate in Q2. In addition to the exchange rate, revenues are expected to be adversely impacted by customers switching to cheaper exchange feed alternatives. This portion of its business carries a very low margin and, as such, adj. EBITDA is not significantly impacted. 


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

Lifeway Foods (LWAY) – Continuing to Grow

Posted on by cpereira@noblefcm.com


Wednesday, August 16, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Increased Demand for Kefir. Lifeway experienced continued momentum in its kefir products, as the Company had its 15th consecutive quarter of topline growth. Higher volumes of the drinkable kefir along with higher prices continued to benefit Lifeway’s sales, while more favorable milk pricing allowed the Company to generate better gross margin, which improved 1,170 basis points over the previous year.

Great 2Q Results. Lifeway reported sales of $39.2 million, above last year’s $33.5 million and our projection of $37.5 million. Gross margin was 28.7% versus 17.0% in the prior year. Net income for Lifeway was $3.16 million, or diluted EPS of $0.21, compared to $0.12 million, or $0.01, last year. We projected net income of $0.97 million, or EPS of $0.06.


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InPlay Oil (IPOOF) – Gas processing constraints, wildfire shut ins, and road closings combine to lower production

Posted on by cpereira@noblefcm.com


Wednesday, August 16, 2023

InPlay Oil is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.

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.

A combination of negative events led to a 7.6% year over year and 6.1% quarter over quarter decline in production. Management estimates that the events reduced production by 1,350 boe/day. The decline was larger than expected and led to management taking down 2023 production guidance to 9,100-9,500 boe/day from 9,500-10,000 boe/day. The production decline is unfortunate but should be viewed as temporary. 


New wells coming on should boost production. Six wells have recently, or are about to, come on line. Initial well production is impressive. In addition, six new wells are planned for the rest of 2023. Management believes processing constraints should ease in the third quarter. Higher production, combined with easing processing constraints should help boost cash flow and earnings.


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The FOMC Minutes Suggest They are Not Done Yet

Posted on by phoffman@channelchek.com
U.S. Federal Reserve Board of Governors

The Majority of Fed Policymakers are Still Concerned About Inflation

The minutes of the July 25-26 FOMC meeting were released and showed ongoing concerns about U.S. inflation are still front and center on the minds of most policymakers. During the July meeting, Federal Reserve officials were still focused on rising prices expressing that more rate hikes could be necessary unless conditions change. The July meeting had resulted in a quarter percentage point rate hike; the minutes are being looked at by market participants to get a sense of the Fed’s next steps.

While the Fed says it is data dependent, so a surprisingly weak economic report or lower-than-expected inflation statistics could change the Fed’s hawkish stance at the next meeting, if economic conditions remain unchanged or get stronger, the Fed is likely to keep applying the economic brakes by raising rates.

“With inflation still well above the Committee’s longer-run goal and the labor market remaining tight, most participants continued to see significant upside risks to inflation, which could require further tightening of monetary policy,” the meeting summary stated.

The increase in the Fed Funds rate after the last meeting brought the key interest rate to its highest level in 22 years, 5.25%-5%.

The Fed has held for more than 18 months that they are targeting a 2% inflation rate. During that time, key inflation indicators have been as high as 9%. Depending on the measure used, inflation at the last read was between 3% and 4%.

“In discussing the policy outlook, participants continued to judge that it was critical that the stance of monetary policy be sufficiently restrictive to return inflation to the Committee’s 2% objective over time,” according to the Fed’s recent release.

The Fed always risks overdoing it during a tightening policy period. So, while members agreed inflation is “unacceptably high,” there were indications “that a number of tentative signs that inflation pressures could be abating.”

As written in the release, “Almost all” the meeting participants, which includes nonvoting members, were in favor of the July rate increase. However, a couple of members opposed and suggested the Committee could skip a hike to monitor how previous hikes play out in inflation indicators. Navigating economic activity and price levels is not a precise science, and there is a lag between actions and impact.

“Participants generally noted a high degree of uncertainty regarding the cumulative effects on the economy of past monetary policy tightening,” the minutes said.

The minutes did indicate that the economy was expected to slow and unemployment likely will rise somewhat. Of note is a retraction in an earlier forecast that troubles in the banking industry could lead to a mild recession this year. A number of smaller banks found themselves challenged and even requiring government assistance in March.

The minutes indicated that the policymakers are also watching the health of the commercial real estate (CRE) market as they raise rates. Specifically cited were “risks associated with a potential sharp decline in CRE valuations that could adversely affect some banks and other financial institutions, such as insurance companies, that are heavily exposed to CRE. Several participants noted the susceptibility of some nonbank financial institutions” such as money market funds and the like.

Looking Forward

Federal Open Market Committee members emphasized the two-sided risks of easing too quickly and risking higher inflation against tightening too much and sending the economy into contraction. The most current data shows that while inflation is still 50% or more from the central bank’s 2% target, it has made marked progress since peaking above 9% in June 2022. Examples are the Consumer Price Index (CPI), ran at a 3.2% annual rate through July. The Personal Consumption Expenditures (PCE) price index core was at 4.6%.  

In their consideration of appropriate monetary policy actions at this meeting, participants concurred that economic activity had been expanding at a moderate pace. The labor market remained very tight, with robust job gains in recent months and the unemployment rate still low, but there were continuing signs that supply and demand in the labor market were coming into better balance. Participants also noted that tighter credit conditions facing households and businesses were a source of headwinds for the economy and would likely weigh on economic activity, hiring, and inflation. However, the extent of these effects remained uncertain. Although inflation had moderated since the middle of last year, it remained well above the Committee’s longer-run goal of 2%, and participants remained resolute in their commitment to bring inflation down to the Committee’s 2% objective.

Take Away

While the Fed will react to incoming data when they decide at the September 19-20 FOMC meeting, the minutes from the July meeting suggest that if there is little change in economic activity, the majority of members are apt to vote to hike rates once more.

Paul Hoffman

Managing Editor, Channelchek

Source

https://www.federalreserve.gov/monetarypolicy/fomcminutes20230726.htm

Yellen Feels Cautiously Optimistic About U.S. Prospects

Posted on by phoffman@channelchek.com
Image: US Treasury Secretary Janet Yellen in Las Vegas, Nevada, US, on Monday, Aug. 14, 2023.

China’s Economic slowdown is a “Risk Factor” for US, Says Treasury Secretary Yellen

A month after returning from her visit to China, U.S. Secretary of the Treasury Janet Yellen opened up about the interplay between the two countries’ economies, the risks the Chinese slowdown has on the U.S., and a side trip she took courtesy of ingesting magic mushrooms. Addressing growing concerns over the economic downturn in the world’s second-largest economy, and possible spillover effects to the U.S., the Treasurer was optimistic about her country’s path.  

China and U.S.

Amidst the growing concerns surrounding China’s economic prospects, including a 5% devaluation of the yuan, and across-the-board weakening economic indicators, China now has the worst-performing currency in Asia after the yen.

Treasury Secretary Yellen, speaking in Las Vegas, seemed to be undoing some of the recent strong talk from U.S. President Biden at a fundraiser on August 11. Biden referred to China’s economic issues as a “ticking time bomb” and referred to Communist Party leaders as “bad folks.” The U.S. President expressed concerns about China’s slowed growth and elevated unemployment rate. She was speaking at  a press conference following a speech in Las Vegas. Yellen referred to China’s economic woes as a “risk factor” for the US, a risk that she believes won’t significantly undermine the overall prospects of the American economy.

As Yellen touted the economic policy achievements of the Biden administration, she highlighted the resilient state of the US economy.

Risks to U.S.

In classic economist style, Yellen hedged her “low risk” comments by suggesting there is a possibility that while China’s slowdown will primarily impact its neighboring Asian nations, there will inevitably be some repercussions for the United States.

Yellen strongly emphasized uncertainty, “That said, I feel very good about US prospects overall. Let’s call that a risk, she said, signalling her measured optimism amidst the uncertainties linked to China’s economic trajectory. Yellen underscored the unexpectedly robust state of the U.S. labor market despite the Federal Reserve’s aggressive rate-hiking campaign – one of the most vigorous tightening efforts in decades.

Janet Yellen spoke on CNN about her meal in China

Psychedelic Side Trip?

While in Beijing, Yellen made a bit of a stir both in China and in her home country for having been seen easting a psychedelic mushroom-based dish called Jian shou qing, or “see hand blue”, a fungi dish known for being hallucinogenic.

Yellen spoke about her experiences on CNN. She recognized the humor of the episode but said that the cooked food had no side effects.

Take Away

The U.S. economy is likely to be impacted by trade with the world’s second-largest economy. According to the U.S. Treasury Secretary, weakness in China will be somewhat contagious. She remains cautious but optimistic that the robust state of growth and employment in the U.S will serve to minimize negative effects.

Paul Hoffman

Managing Editor, Channelchek

Snail Inc. (SNAL) – Expecting A Rise With The Tide With Ark

Posted on by cpereira@noblefcm.com


Tuesday, August 15, 2023

Snail 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.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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

Q2 results. The company reported Q2 revenue of $9.9 million and adj. EBITDA of a loss of $4.7 million, both of which were below our forecast. We anticipated $22.5 million in revenue and positive adj. EBITDA of $4.0 million. In our view, the miss was largely a result of the timing of the company’s releases.

Looking ahead to Q4. Despite the negative adj. EBITDA in the quarter, the company remains on track to release ARK: Survival Ascended in October of this year. Survival Ascended is a re-release of the company’s flagship game with several updates, powered by Unreal Engine 5. The company is also slated to re-release all 5 ARK DLCs using Unreal Engine 5, subsequent to the release of ARK: Survival Ascended.


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

PDS Biotechnology Corp. (PDSB) – 2Q23 Achieves Important Milestones With More To Follow

Posted on by cpereira@noblefcm.com


Tuesday, August 15, 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.

PDS Reports 2Q23. PDS reported a 2Q23 loss of $11.5 million or $(0.37) per share and ended the quarter with $60.6 million in cash. Importantly, PDS completed the filing of its final clinical trial design required for the Phase 3 VERSATILE-003 trial testing PDS0101 in head and neck cancer, a milestone that should allow the start of the trial before YE2023.

The Phase 3 VERSATILE-003 Trial On Track To Start In 2023. PDS completed the FDA filing for the final protocols for the Phase 3 VERSATILE-003 trial, meeting the expected milestone. This filing includes the study design and manufacturing data (CMC section) that should allow the trial to begin before year-end. The trial will test the combination of PDS0101 with Keytruda (pembrolizumab, from Merck) against Keytruda alone in patients with HPV16+ head and neck cancer.


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