Page 307 – Channelchek

Release – Aurania Provides Update And Directors Receive Options In Lieu Of Fees

Posted on October 2, 2023October 2, 2023 by aweinsoff@channelchek.com

Aurania Resources Ltd. (TSXV: ARU; OTCQB: AUIAF; Frankfurt: 20Q) (“Aurania” or the “Company”) provides a brief update and announces that its directors received their quarterly director fees in the form of stock options in lieu of cash for the period ended September 30th (see press release dated April 12, 2023).

On September 29, 2023, each director was granted 26,800 stock options at an exercise price of $0.235 in lieu of their director fees for Q3 2023. An aggregate of 107,200 stock options were granted. The stock options will be exercisable for three years and will vest on September 29, 2023. The Company will grant stock options equivalent in fair value to the director fees forfeited each quarter during 2023, at an exercise price of one cent above the closing price of Aurania’s shares the day prior to the grant and exercisable at any time for a period of three years following the date of issuance.

Update on Ecuador and France

The next President of Ecuador will be determined in a run-off election on October 15. The two candidates, Luisa Gonzalez (UNES – Correa’s party) and Daniel Noboa (ADN – centrist, business-aligned) are expected to be supportive of responsible mining. Gonzalez was in first place with 34% of the votes on August 20th, and Daniel Noboa held 24% of the votes at that time. The winning candidate will be in power until the next president is elected in Ecuador’s regularly scheduled election in the first half of 2025. After the first-round results, Noboa emerges as the candidate with the most promising prospects for the presidency in the upcoming second round. This is because González’s room for growth on her 34 percent showing remains limited to those supportive of Correa’s former Socialist government (2007-2017). Noboa, by contrast, is positioned to secure substantial backing from voters who had initially supported a variety of “anti-Correísmo” candidates. At time of writing, Noboa is ahead in the polls, from 5-8%. He has already met with the Ecuador Chamber of Mines, of which Aurania is a member, and recognizes the importance of mining to the Ecuador economy. Whomever wins the election will take office in December.

In the meantime, Aurania’s CSR team continues to work with local communities in Ecuador to advance various social programs and initiatives within the areas of the Company’s key targets, strengthening the bonds with the communities and improving the social license the Company has. The management team’s focus is to work on those initiatives with the higher potential to create value for our shareholders in Ecuador and France, where the applications for mineral exploration permits, announced in July 2023, are being processed. The Company will report on those activities as new developments occur.

About Aurania

Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucú Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.

Click here to view the full press release dated October 2, 2023 on Aurania’s website including contact details and forward-looking statements.

Release – Great American Cookies And Marble Slab Creamery Open At Cook Children’s Medical Center In Fort Worth

Posted on October 2, 2023October 2, 2023 by aweinsoff@channelchek.com

Research News and Market Data on FAT

10/02/2023

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Dessert Duo’s New Co-Branded Location Marks FAT Brands ’ Continued Expansion into Non-Traditional Venues

LOS ANGELES, Oct. 02, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Great American Cookies, Marble Slab Creamery and 16 other restaurant concepts, announces the opening of a co-branded Great American Cookies and Marble Slab Creamery location at Cook Children’s Medical Center in Fort Worth, Texas. Situated in the first floor of the newly expanded Dodson Specialty Clinics, the new store underscores FAT Brands’ strategic approach to broadening its footprint in non-traditional spaces.

“The opening of our co-branded Great American Cookies and Marble Slab Creamery location at Cook Children’s reinforces FAT Brands’ commitment to executing a diverse growth strategy that brings our 18 restaurant brands to a wider audience,” said Taylor Wiederhorn, Chief Development Officer at FAT Brands. “With this new opening, FAT Brands continues to demonstrate adaptability and a forward-thinking approach in the ever-evolving franchise landscape.”

For nearly 40 years, Marble Slab Creamery has been an innovator in the ice cream space, dreaming up the frozen slab technique and offering homemade, small-batch ice cream with free unlimited mix-ins, shakes in a variety of flavors, and ice cream cakes.

Since 1977, Great American Cookies has baked up a reputation for not only being the creator of the Original Cookie Cake, but also for its famous chocolate chip cookie recipe. Other craveable menu items include decadent Double Doozies^™, made with delectable icing sandwiched between two cookies.

Great American Cookies and Marble Slab Creamery at Cook Children’s Medical Center is located in the Dodson Specialty Clinics, which is found at 1500 Cooper St., Fort Worth, TX 76104. The store will be open from 8 a.m. to 5 p.m. Monday through Friday to hospital guests, staff and patients. For more information on Great American Cookies, visit www.greatamericancookies.com. For more information on Marble Slab Creamery, visit www.marbleslab.com.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Smokey Bones, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

About Great American Cookie s

Founded on a family chocolate chip cookie recipe in 1977, Great American Cookies believes that pure, simple delight is part of living a full life. Serving the Original Cookie Cake, fresh baked cookies in a variety of flavors, brownies, and Double Doozies^™, we promise to treat you to bites of bliss that prove how sweet life can be. With more than 400 bakeries across the country and internationally in Bahrain, Guam, Saudi Arabia, and treats available to ship right to your door, the sweet spot is always close to home. For more information, visit www.greatamericancookies.com.

About Marble Slab Creamery

Since dreaming up the frozen slab technique and serving fresh homemade, small-batch Ice Cream in-store since 1983, Marble Slab Creamery has always known how to dream big. We sprinkle our customers with imagination and promise to inspire with infinite Ice Cream possibilities to feed your curiosity and capture cravings. With our always free mix-in philosophy, delicious Ice Cream and Shakes in a variety of flavors, hand-rolled waffle cones, and Ice Cream Cakes, imagination has no limits. Today, Marble Slab Creamery is enjoyed by consumers across the globe with locations in Bahrain, Canada, Kuwait, Saudi Arabia, Guam, Puerto Rico, and the United States. For more information, visit www.marbleslab.com.

About Cook Children’s Medical Center

Cook Children’s is more than a health care system: we strive to be an extension of your family, growing with your child from their first steps to adulthood. By collaborating to deliver on our Promise—to improve the well-being of every child in our care and our communities, we connect the dots for our patients. Between primary and specialty. Between home and medical home. Between short-term care and long-term health.

Based in Fort Worth, Texas, we’re 8,000+ dedicated team members strong, passionately caring for over 1.5 million patient encounters each year. Our integrated, not-for-profit organization spans two medical centers (including our new, state-of-the-art location in Prosper), two surgery centers, a physician network, home health services and a health plan. It also includes Child Study Center at Cook Children’s, Cook Children’s Health Services Inc., and Cook Children’s Health Foundation.

And our impact extends beyond the borders of Texas. We proudly treat children from virtually every state in the nation and 32 countries. By seeing the world through the eyes of children and their families from all backgrounds, we’re able to shape health care suited to them: connected by kindness, imagination and respect—with an extra dose of magical wonder.

Discover more at cookchildrens.org.

MEDIA CONTACT:
Ali Lloyd, FAT Brands
alloyd@fatbrands.com
435-760-6168

Kim Brown, APR, Cook Children’s
Kim.brown3@cookchildrens.org
817-266-3728

Source: FAT Brands Inc.

Release – CVG Announces Election of Melanie K. Cook to Board of Directors

Posted on October 2, 2023October 2, 2023 by aweinsoff@channelchek.com

Research News and Market Data on CVGI

October 2, 2023

NEW ALBANY, Ohio, Oct. 02, 2023 (GLOBE NEWSWIRE) — Commercial Vehicle Group (the “Company” or “CVG”) (NASDAQ: CVGI) announced today that its Board of Directors (the “Board”) has elected Melanie K. Cook as an independent director to the Board, effective September 26, 2023. Ms. Cook will serve on the Audit and Compensation committees of the Board. Ms. Cook will stand for re-election at the Company’s 2024 Annual Meeting of Stockholders.

Ms. Cook, 51, brings tremendous operating experience and expertise in a multitude of business areas. Ms. Cook retired as Chief Operating Officer of GE Appliances (a global appliance manufacturer and a Haier Company). Her professional experience includes: Chief Operating Officer of GE Appliances from 2017 until retirement in 2021; previously Vice President Sourcing from 2014 to 2017. Prior to GE Appliances, she held multiple roles within General Electric including within the Corporate Audit Staff. Ms. Cook’s nearly 30 years of global experience includes business unit leadership roles with full profit and loss responsibility, product lifecycle management, digitization, end-to-end supply chain, global sourcing and finance/audit across multiple industries globally. Ms. Cook’s public company board experience includes serving as an independent Director of Badger Meter, Inc. (BMI: NYSE) since February 2022, where she serves on the Audit and Compliance Committee of the Board. Ms. Cook holds a Bachelor of Science in Business Administration, with a specialty in Decision and Information Sciences, from the University of Florida.

Ms. Cook stated, “It is an honor to join CVG’s Board and I look forward to adding my perspective to the Board room.”

Robert Griffin, Chairman of the Board, welcomed Director Cook to the Board. Mr. Griffin added, “We are very pleased to have Ms. Cook join the CVG Board, bringing tremendous skills and significant experience in areas of critical importance to the Company and enhancing our Board’s capabilities as we guide the Company through the execution of its strategy.”

About CVG

At CVG, we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.

Investor Relations Contact:
Ross Collins or Stephen Poe
Alpha IR Group
CVGI@alpha-ir.com

Media Contact:
Patrick Woolford
Patrick.woolford@cvgrp.com

Source: Commercial Vehicle Group, Inc.

Release – PDS Biotech Announces PDS0101 Combined with Chemoradiotherapy Associated with Rapid Decline in Circulating Tumor DNA (ctDNA/cfDNA)

Posted on October 2, 2023October 2, 2023 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Study evaluated levels of circulating cell-free HPV DNA (cfDNA) in patients with locally advanced cervical cancer in the IMMUNOCERV Phase 2 clinical trial and patients receiving standard of care (SOC) treatment
Patients treated with PDS0101 had greater clearance of cfDNA as compared to those treated with SOC (at week 5, 91.7% vs. 53.1%, P=0.0179)
Data presented during oral presentation at ASTRO 2023 Annual Meeting

PRINCETON, N.J., Oct. 02, 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 data demonstrating lead candidate PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy (CRT) was associated with a rapid decline in human papillomavirus (HPV) circulating cell-free DNA (cfHPV-DNA), a potential predictive biomarker of treatment response. The data from the IMMUNOCERV Phase 2 clinical trial were featured in an oral presentation by Aaron Seo, MD, PhD, of The University of Texas MD Anderson Cancer Center, at the American Society for Radiation Oncology (ASTRO 2023) Annual Meeting in San Diego, CA.

The IMMUNOCERV Phase 2 trial is investigating PDS0101 in combination with SOC CRT in the treatment of cervical cancer patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes. HPV is the primary cause of cervical cancer with over 99% caused by HPV infection, and cfHPV-DNA can be detected in the blood of patients with cervical cancer. HPV type 16 (HPV16) is the most prominent subtype associated with cervical cancer. The study presented at ASTRO 2023 evaluated the relationship between the levels of circulating cfHPV-DNA and the extent of disease, clinical staging, and treatment response in patients with HPV-positive cervical cancer.

“We are encouraged by this data from the IMMUNOCERV trial, which highlight the potential of PDS0101 to positively impact cfDNA, an emerging biomarker of clinical response in cervical and other HPV-related cancers,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “The findings complement previously presented IMMUNOCERV data which suggested PDS0101 promotes the induction of multifunctional CD8 killer T cells that were associated with declines in circulating tumor DNA and a clinical response with greater than 60% tumor shrinkage at mid-point evaluation in 100% of high-risk cervical cancer patients on the trial. We look forward to continuing to address the unmet needs of patients suffering from HPV-positive cancers such as cervical cancer.”

Sixty-one patients with cervical cancer were included in the analysis either as part of a SOC treatment banking protocol (n=44) or as part of the IMMUNOCERV Phase 2 clinical trial combining PDS0101 with SOC (n=17). Longitudinal plasma samples were collected from each patient at baseline, during weeks 1, 3, and 5, and at 3-4 months after CRT.

In the study, HPV16 was detected in 59% of tumors and 70% of cfDNA. The median cfDNA at baseline was 28.15 copies/mL, with a range of 0 to 206,030 copies/mL.

The presentation at ASTRO 2023 highlighted the following data:

Earlier and greater proportion of cfDNA clearance with PDS0101 plus chemoradiation (CRT) vs. SOC CRT alone (81.3% clearance after 3 weeks vs. 30.3% with SOC (p=0.0018), and 91.7% of clearance at 5 weeks vs. 53.1% with SOC (p=0.0179)
Baseline cfDNA levels correlated with the International Federation of Gynecology and Obstetrics (FIGO) stage and lymph node involvement; 100% of patients treated with PDS0101 had cancer that had spread to the lymph nodes

“HPV16 cfDNA represents a novel biomarker with the potential to help oncologists make more informed treatment decisions for their patients with HPV16-positive cancers. This early data are encouraging, and we will continue to evaluate patients to determine any potential correlations between cfDNA clearance and clinical outcomes. Further analysis of cfDNA kinetics could provide valuable information on the relationship between cfDNA levels, treatment response, and ongoing clinical outcomes,” said study principal investigator Ann Klopp, MD, PhD, Professor of Radiation Oncology at MD Anderson. “I look forward to the continued evaluation of PDS0101 in combination with standard-of-care chemoradiotherapy.”

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 active 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.

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.

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 Corporation. KEYTRUDA^® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

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

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: gcestari@6degreespr.com

Release – Shawn Mural Named Senior Vice President and Chief Financial Officer at V2X

Posted on October 2, 2023October 2, 2023 by aweinsoff@channelchek.com

Research News and Market Data on VVX

10/02/2023

DOWNLOAD(OPENS IN NEW WINDOW)

MCLEAN, Va., Oct. 2, 2023 /PRNewswire/ — V2X, Inc. (NYSE: VVX), today announced Shawn Mural has been appointed as its Senior Vice President and Chief Financial Officer (CFO). In this role, Mural will oversee all finance and accounting functions, including controllership, finance operations, planning, tax, treasury, investor relations, and corporate development.

Mr. Mural joins V2X from RTX Corporation and its subsidiaries (“RTX”), where he served in various capacities of increasing responsibility and most recently as Vice President of Finance and CFO of Raytheon. Over his 24 years at RTX, Shawn’s experience in various leadership roles, as well as managing large integration and operational excellence-related activities, will help support the future growth of V2X.

“As we continue to the next phase of the company’s growth, Shawn brings strong financial leadership and deep knowledge and understanding of the aerospace and defense industry,” said Chuck Prow, President and Chief Executive Officer of V2X. “I look forward to working alongside him as we continue to execute the V2X strategy.”

This appointment follows Susan Lynch’s retirement from the company. The V2X team thanks Susan for her dedicated service and wishes her every success in future endeavors.

About V2X
V2X builds smart solutions designed to integrate physical and digital infrastructure – from base to battlefield – by aligning people, actions, and outputs. Formed by the merger of Vectrus and Vertex, we bring a combined 120 years of successful mission support. Our lifecycle solutions improve security, streamline logistics, and enhance readiness.

The Company delivers a comprehensive suite of integrated solutions across the operations and logistics, aerospace, training, and technology markets to national security, defense, civilian and international clients. Our global team of approximately 15,000 employees brings innovation to every point in the mission lifecycle, from preparation to operations to sustainment, as it tackles the most complex challenges with agility, grit, and dedication.

Media Contact
Angelica Spanos Deoudes
Senior Media Strategist
Communications@goV2X.com
571-338-5195

Investor Contact
Michael Smith
Vice President, Treasury, Corporate Development and Investor Relations
IR@goV2X.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/shawn-mural-named-senior-vice-president-and-chief-financial-officer-at-v2x-301943910.html

SOURCE V2X, Inc.

Release – Eledon Pharmaceuticals Appoints Kidney Transplant Specialist Dr. Allan Douglas Kirk to Board of Directors

Posted on October 2, 2023October 2, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

IRVINE, Calif., Oct. 02, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the appointment of Allan Douglas Kirk, M.D., Ph.D., to its Board of Directors. Dr. Kirk is internationally recognized for his work in organ transplantation, with a specialized focus on kidney transplants and transplant immunology. He is currently Chairman of the Department of Surgery and Surgeon-in-Chief at Duke University School of Medicine. He is also the David C. Sabiston, Jr. Professor of Surgery, a Professor of Integrative Immunobiology, and a Professor of Pediatrics at Duke.

“We are pleased to have Dr. Kirk join our Board of Directors at a pivotal time at the company following initiation of our Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Dr. Kirk’s renowned expertise in the field of organ transplantation, including kidney transplantation, will be incredibly valuable as we advance tegoprubart in clinical development on our mission to fulfill an urgent unmet need for the thousands of patients in need of an organ transplant. I look forward to working closely together.”

“Organ transplantation remains an area of significant unmet need – a need that is often overlooked or underrecognized – and my decades of research have been driven by my desire to improve immunosuppression regimens for transplant patients. Transplant recipients deserve new treatment options with better efficacy and fewer side-effects to help protect their transplanted organs,” said Dr. Kirk. “I am proud to join the Eledon team on their mission to bring patients a novel treatment option that has the potential to transform immunosuppression and improve the lives of patients.”

Dr. Kirk served as the inaugural Chief of the Transplantation Branch for the National Institute of Diabetes and Digestive and Kidney Diseases and has been a principal investigator for multiple clinical trials, including the first-in-human experience with novel immunosuppressive agents. Dr. Kirk has helped pioneer the use of co-stimulation pathway blockade to prevent organ rejection in transplant patients. He has a special interest in immune management of transplant recipients, including therapies that influence T cell co-stimulation pathways and adjuvant therapies that facilitate co-stimulation blockade to prevent the rejection of transplanted organs without undue suppression of protective immunity. His research is directed toward understanding transplant rejection and translating this understanding into improved therapies for transplant recipients. He has co-authored hundreds of peer-reviewed journal publications.

Dr. Kirk is a member of the Duke Transplant Center and is a core faculty member of the Duke Innovation & Entrepreneurship program. He also previously served as Editor-in-Chief for the American Journal of Transplantation. Dr. Kirk earned an M.D. from Duke University School of Medicine, a Ph.D. from Duke University and a B.S. from Old Dominion University.

About Eledon Pharmaceuticals and tegoprubart (formerly AT-1501)

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

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about planned clinical trials and the Company’s other future expectations, plans and prospects, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

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

Media Contact:

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

Source: Eledon Pharmaceuticals

Metals & Mining Third Quarter 2023 Review and Outlook

Posted on October 2, 2023October 2, 2023 by cpatches

Monday, October 2, 2023

Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the bottom of the report for important disclosures

Mining companies outperform the broader market. During the third quarter, mining companies (as measured by the XME) rose 3.3% compared to a decline of 3.6% for the S&P 500 index. The VanEck Vectors Gold Miners (GDX) and Junior Gold Miners (GDXJ) ETFs were down 10.6% and 9.6%, respectively. Gold, silver, and copper futures prices fell 3.3%, 1.6%, and 0.6%, respectively, while zinc and lead were up 8.7% and 6.2%. Gold was likely negatively impacted by the Federal Reserve’s higher rates for longer messaging coupled with a 3.2% increase in the U.S. Dollar Index. Year-to-date through September 30th, the XME, GDX, and GDXJ have all lagged the S&P 500 index return of 11.7%.

Looking ahead to 2024. While we expected weakness in the second half of 2023, prices have remained relatively resilient, and we are increasingly bullish going into 2024. Factors supporting our view include: 1) the Federal Reserve appears to be nearing the end of its tightening cycle, 2) a new norm of heightened geopolitical uncertainty, 3) unsustainable growth in U.S. deficit spending and national debt, and 4) increasing investments in gold by central banks. Given the level of uncertainty reinforced by a dysfunctional U.S. political environment, we think portfolio allocations to precious metals could increase. While much will depend on monetary policy which appears to be working, we think the higher for longer mantra makes for nice messaging but actual policy will be data driven.

Outlook for industrial metals. While a potential economic downturn in the U.S. coupled with sluggish growth abroad could weigh on industrial metals demand and prices, longer-term secular trends such as electrification remain supportive of supply and demand fundamentals for metals such as copper. In the intermediate term, government support for infrastructure spending and strong demand from certain sectors such as aerospace, defense, and electronics are supportive of industrial metals.

Putting it all together. We think precious metals equities may be poised for outperformance in 2024. While well-diversified portfolios should have exposure to precious metals, mining equities may offer a stronger current alternative to bullion. In our opinion, junior companies remain attractive based on valuation and we expect industry consolidation to increase as senior producers seek to replenish reserves and resources. For industrial metals stocks, investors may need to be more selective by focusing on suppliers to end use markets with favorable demand growth fundamentals.

GENERAL DISCLAIMERS

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ANALYST CREDENTIALS, PROFESSIONAL DESIGNATIONS, AND EXPERIENCE

Senior Equity Analyst focusing on Basic Materials & Mining. 20 years of experience in equity research. BA in Business Administration from Westminster College. MBA with a Finance concentration from the University of Missouri. MA in International Affairs from Washington University in St. Louis.
Named WSJ ‘Best on the Street’ Analyst and Forbes/StarMine’s “Best Brokerage Analyst.”
FINRA licenses 7, 24, 63, 87

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RESEARCH ANALYST CERTIFICATION

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Orion Group Holdings (ORN) – More Awards

Posted on October 2, 2023October 2, 2023 by cpereira@noblefcm.com

Monday, October 02, 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.

More Awards. In an 8-K release late last week, Orion Group Holdings reported that on September 22nd its Marine segment business entered into a design-build contract with an undisclosed customer valued at approximately $120 million. In addition, the Company noted that it was recently awarded new contracts in both its Concrete and Marine segments for a combined total of approximately $121 million. Unfortunately, the 8-K does not provide a date range for the $121 million of additional contracts so we do not know if the figure includes the $58 million of new awards announced in early August or if the $121 million is in addition to the $58 million.

Awaiting Additional Detail. While the Company has yet to issue a press release on the new business, we believe the Company likely will, at the same time providing additional detail regarding the nature of the work, timing, and customer details. In any case, the new awards continue a recent trend for Orion of adding substantial new business which should result in improved operating results in the future.

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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.

Great Lakes Dredge & Dock (GLDD) – More Business

Posted on October 2, 2023October 2, 2023 by cpereira@noblefcm.com

Monday, October 02, 2023

Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

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.

New Awards. Great Lakes was awarded some additional work, according to the DOD daily new awards announcements. The work totals some $48 million and continues the recent trend of building backlog.

Award 1. On September 27th, Great Lakes was awarded a $14.4 million modification to contract W912HY-21-C-0015 for removal and disposal of pipelines. Work will be performed in Corpus Christie, Texas, with an estimated completion date of March 20, 2024. Fiscal 2021 and 2023 civil construction funds and fiscal 2023 non-federal, Port of Corpus Christie funds in the amount of $14.4 million were obligated at the time of the award.

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

Commercial Vehicle Group, Inc. (CVGI) – Updating Third Quarter Estimates

Posted on October 2, 2023October 2, 2023 by cpereira@noblefcm.com

Monday, October 02, 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.

Management Call. We recently had an opportunity to chat with Commercial Vehicle Group management. While major trends continue, there has been some reduced overall industry expectations in truck builds. While management did not comment on any impact on Commercial Vehicle, to be on the conservative side we are modestly lowering our expectations for the quarter. This does not change our longer term outlook for the Company.

Heavy Duty Trucks. Between mid-August and mid-September, industry specialist ACT Research slightly lowered their forecast for Class 8 trucks for the quarter, lowering the forecast by nearly 5,000 to 84,779 units. We would note, however, the full year 2023 and 2024 forecasts remain very positive.

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

Cocrystal Pharma (COCP) – CDI-988 Begins Phase 1a/b Clinical Trial

Posted on October 2, 2023October 2, 2023 by cpereira@noblefcm.com

Monday, October 02, 2023

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

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.

CDI-988 Begins Clinical Studies. Cocrystal announced that CDI-988 has begun Phase 1a/b studies, meeting our expected timeframe. CDI-988 is a 3CL protease inhibitor that interferes with an enzyme early in the viral lifecycle, stopping a virus from reproducing. This early action contrasts with other approaches that seek to kill the virus after it reaches the bloodstream. The study objective is to establish safety, dosing, and pharmacokinetics for design of a Phase 2 study.

Phase 1a/b Study Will Test Ascending Dose Cohorts. The study will have a Phase 1a single ascending-dose stage (SAD) in which patients receive a single administration of CDI-988. As safety is established for each dose, subsequent groups receive higher doses. The Phase 1b stage will have multiple administrations of CDI-988 at ascending doses (MAD). Since CDI-988 is an orally administered vaccine, pharmacokinetic data will include the effect of food drug adsorption. The results of the study will be used to design Phase 2 studies in both norovirus, a frequent cause of acute gastroenteritis, and COVID-19.

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

Bassett Furniture (BSET) – Reports Fiscal Third Quarter

Posted on October 2, 2023October 2, 2023 by cpereira@noblefcm.com

Monday, October 02, 2023

Bassett Furniture Industries, Incorporated manufactures, markets, and retails home furnishings in the United States. The company operates in three segments: Wholesale, Retail, and Logistical Services. It is involved in the design, manufacture, sourcing, sale, and distribution of furniture products to a network of company-owned and licensee-owned Bassett Home Furnishings (BHF) retail stores, as well as independent furniture retailers; and wood and upholstery operations. As of September 16, 2017, the company operated a network of 91 company-and licensee-owned stores. It also provides shipping, delivery, and warehousing services to customers in the furniture industry. In addition, the company owns and leases retail store properties. It also distributes its products through other multi-line furniture stores, Bassett galleries or design centers, specialty stores, and mass merchants. Bassett Furniture Industries was founded in 1902 and is based in Bassett, Virginia.

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

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

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

3Q23 Results. Bassett reported 3Q23 results in-line with the September 6th lowered expectations. Revenue was $87.2 million, down 26.1% year-over-year. Wholesale revenue declined 28.2% while Retail revenue declined 26.2%. Operating loss was $3.8 million compared to adjusted operating income of $6.1 million last year. Basset reported a net loss of $2.6 million, or $0.30 per share better than we had anticipated as SG&A expenses were reduced.

Uncertain Environment. The operating environment remains uncertain. While traffic and business increases around holiday events, day-to-day store traffic and wholesale order writing between the big events remain very challenging. We do not expect this situation to change until the consumer feels more confident about future prospects for the economy.

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Energy Industry Report – Oil prices on a tear – the case for why prices will stay high

Posted on October 2, 2023October 2, 2023 by cpatches

Monday, October 2, 2023

Michael Heim, CFA, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the bottom of the report for important disclosures

Oil price rose 30% in the third quarter helping propel the XLE Energy Index up 11.4%. Natural gas prices also rose after twelve months of decline. Higher oil prices reflect declining inventories due to rising demand that is not being met by rising supply.

Domestic oil demand is rising. Oil demand largely tracks the economy. And, while monetary tightening has slowed growth, demand is still growing. Recently, domestic demand has increased due to warm summer weather and increased propane exports to Europe.

Oil supply is not keeping pace. OPEC+ extended its production cuts. In previous decades, domestic producers would respond to production cuts by accelerating drilling. In recent years, producers have not increased drilling as noted by a sharp decline in domestic oil rig activity. Oil drilling rigs even declined this quarter despite the rise in oil prices. Limited drilling, combined with sharper well decline curves, has meant supply is not keeping up with demand.

Small cap producers are uniquely positioned to take advantage of higher prices. The production gains that came from horizontal drilling and fracking in the Permian Basin appear to be waning. That means well profitability has declined as producers move on to secondary and tertiary targets. This is especially an issue for larger production companies that need a large number of wells drilled to provide growth. In addition, large companies face regulatory and investor pressures regarding fossil fuel production that the smaller companies may avoid.

Energy Stocks

Energy stocks, as measured by the XLE Energy Index, rose 11.4% in the 2023 third quarter as compared to a 3.6% decline in the S&P 500 Index. The outperformance was largely due to rising oil prices. The November 2023 futures contract rose 30% during the quarter. Natural gas prices rose 4.9% during the quarter largely reflecting normal seasonal trends.

Oil Prices

The rise in oil prices corresponds to a drop in inventories. After a covid-induced spike in early 2020, domestic inventories have fallen steadily. During this period of monetary tightening, demand growth has slowed but remained positive. Supply, on the other hand, has stagnated. OPEC+ has extended cutbacks and domestic drilling activity has declined.

Figure #1

Source: EIA

The decline in drilling activity can best be seen by looking at domestic oil rig activity. Where once there were more than 1600 active wells, now there are one-third that number. What’s more, oil drilling activity has continued to decline in the third quarter even as oil prices have risen.

Figure #2

Source: Baker Hughes

Weather has also played a part as warm temperatures have meant increased use of oil for electric generations. Although oil represents a small portion of the generation load, it is an important component in the summer months when generation demand is greatest. Temperatures in the United States have been warmer than average each month this summer and 17 of the 24 months over the last four years.

Figure #3

Finally, it is worth noting that petroleum exports have been growing. Exports jumped after the Ukraine invasion as the United States rushed to ship petroleum to Europe to offset Russian supply disruptions. Note the large jump in propane exports since 2021 in the chart below. Propane, a component of the crude oil barrel, is one of the easier fuels to export until additional liquified natural gas export terminals are completed.

Figure #4

The combination of limited drilling, growing demand for electric generation and exports, and OPEC production cuts bodes well for oil prices.

Natural Gas Prices

The story for natural gas is less positive but improving. Sharp declines last winter bottomed out in April and have slowly begun to creep back upward. Natural gas production profitability is not great at prices near $3.00 per thousand cubic feet (mcf) but still profitable.

Figure #5

Source: Nymex, EIA

Outlook

We believe the outlook for energy companies remains favorable. Oil prices are high and do not show signs of falling due to OPEC cuts, reduced domestic drilling and rising demand for power generation and exports. We believe the case for smaller cap energy stocks is especially strong because they are less liquid and slower to react to rising energy prices. Smaller energy companies also face less political and investor pressure to shift away from carbon-based production.