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Release – Liz Truss Signs with Regnery

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SALM

September 13, 2023 11:59am EDT

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today that Regnery Publishing signed a book deal with Liz Truss, the 56th Prime Minister of the United Kingdom. Ten Years to Save the West is scheduled to publish on April 16, 2024.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230912443070/en/

Liz Truss (Photo: Business Wire)

Around the world, many supposedly conservative political parties have been captured by the same left-wing influences that set the agenda and frame the debate in so many institutions, including the media, academia and the corporate world. Drawing on her ten years of service in Tory governments – when she often found herself to be the only conservativein the room – the scrappy champion of limited government and individual freedom exposes the threat of the massive, unaccountable administrative state and the complacent political and corporate establishment.

Ahead of the Presidential election in the fall of 2024, Truss will in particular sound a timely alarm bell that failing to learn from her experiences in the UK – where the state is now spending 47% of national income – could lead to the same mistakes being made in the U.S., with disastrous consequences for American families.

Peppered with newsworthy anecdotes from her time in public life – such as her memorable last meeting with Queen Elizabeth II, her challenges to Vladimir Putin and Xi Jinping as Foreign Secretary, her encounters with the Trump administration as Trade Minister, and her dismay at the political class’s attempts to betray Brexit – this book will be a timely warning about the perils to conservatism posed by the global left in the years ahead.

Liz Truss said, “After more than ten years as a British government minister, I’ve seen up close the threats posed to global democracy. Across the free world, we face massive, unaccountable administrative states and complacent political and corporate establishments which are not only putting the brakes on economic growth, but also hampering our ability to stand up to authoritarian regimes like China and Russia. I want to share the lessons from my experience in government and those international meetings where I was often the only conservative in the room and demonstrate that we have stark choices to make if we wish to avoid a managed decline of the Western architecture that has presided over generations of relative peace and prosperity.”

The UK edition of this book will be published by Biteback Publishing.

ABOUT LIZ TRUSS:

Liz Truss has been the Conservative Member of Parliament for South West Norfolk since 2010 and served as the 56th Prime Minister of the United Kingdom, during which time she led the nation in mourning Her Late Majesty Queen Elizabeth II as King Charles III acceded to the throne. She continuously held ministerial office for more than ten years between 2012 and 2022 and sat at the Cabinet table in six different roles prior to becoming Prime Minister.

ABOUT REGNERY PUBLISHING:

Regnery Publishing, a Salem Media Group company, is the country’s preeminent publisher of conservative books. In its seventy-five years, Regnery has published many of the seminal works of the conservative movement, including Russell Kirk’s The Conservative Mind and William F. Buckley Jr.’s God and Man at Yale. More recently, Regnery has published bestsellers by Mollie Hemingway, George Gilder, Dennis Prager, Josh Hawley, Ted Cruz, and David Limbaugh.

ABOUT SALEM MEDIA GROUP:

Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.com, Facebook and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230912443070/en/

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

Source: Salem Media Group, Inc.

Released September 13, 2023

Release – Travelzoo META’s Travel Companions Take Over NASDAQ Headquarters in Times Square

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TZOO

September 13, 2023

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NEW YORK, Sept. 13, 2023 /PRNewswire/ — Thousands of people visiting Times Square were stopped in their tracks. Splashed across the façade of NASDAQ’s headquarters yesterday were fantastical animals from the Metaverse. Travelzoo META’s Travel Companions gazed out at onlookers and announced with their presence that the future of travel is here. Travelzoo® (NASDAQ: TZOO), a global Internet media company that provides exclusive offers and experiences for members, recently announced the launch of Travelzoo META, a members-only service offering groundbreaking Metaverse travel experiences.

With its launch, Travelzoo META opened registrations for Founding Membership. Founding Members of Travelzoo META will have the opportunity to be the first to experience travel in the Metaverse. Each Founding Member will also be entitled to one of the world’s first personality-based, emotionally-driven Travel Companions (NFTs) that match their personal Metaverse travel style.

Travelzoo META’s experiences are intended to allow its members to explore hard-to-reach corners of the world, like summiting Mount Everest, or travel back in time, to Ancient Rome perhaps. They can also discover new spaces beyond imagination. All this is possible using a mobile or desktop device and a simple browser.

“The Metaverse is too big for companies to ignore,” states global management consulting firm McKinsey & Company. The firm has recently confirmed its estimate of the Metaverse becoming a $5 trillion market by 2030. One of the business segments which McKinsey & Company is particularly bullish on is travel. The Metaverse is expected to have a major impact on the travel industry and change travel experiences for consumers.

Find out how you can be part of the future of travel. Become a Travelzoo META Founding Member at http://meta.travelzoo.com.

About Travelzoo META
Travelzoo META is a paid members-only service offering groundbreaking Metaverse travel experiences. Working in partnership with cutting-edge creators, we have access to the latest immersive experiences that are intended to allow members to explore hard-to-reach corners of the world, travel back in time, or discover new spaces beyond imagination.

Travelzoo and Travelzoo META are registered trademarks of Travelzoo. All other names are trademarks and/or registered trademarks of their respective owners.

Paige Cram – Los Angeles
+1 609 668 0645
pcram@travelzoo.com

Cat Jordan – London
+44 77 7678 1525
cjordan@travelzoo.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/travelzoo-metas-travel-companions-take-over-nasdaq-headquarters-in-times-square-301926585.html

SOURCE Travelzoo

Release – PDS Biotech to Host Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101 on September 27, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Company to provide updated VERSATILE-002 data on combination of PDS0101 and KEYTRUDA®

PRINCETON, N.J., Sept. 13, 2023 (GLOBE NEWSWIRE) —

Company to provide updated VERSATILE-002 data on combination of PDS0101 and KEYTRUDA®

PRINCETON, N.J., Sept. 13, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or 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 it will host a Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101, including an update from the Phase 2 VERSATILE-002 trial, for analysts, investors and the scientific community from 8:00 – 9:00 AM EDT on Wednesday, September 27, 2023.

The Company-sponsored event will focus on current and potential treatments for HPV16-positive head and neck cancer, including the emerging use of circulating tumor DNA (ctDNA), and unmet needs of this growing patient population. The event will also include a presentation on updated data from the VERSATILE-002 study of the combination of KEYTRUDA® (pembrolizumab) and PDS0101, PDS Biotech’s novel investigational HPV-targeted immunotherapy, as well as the design for the planned VERSATILE-003 Phase 3 clinical trial due to be initiated in the fourth quarter of 2023. The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren V. Wood, and will feature presentations from the following head and neck cancer KOLs:

  • Dr. Glenn Hanna, Assistant Professor, Harvard University and Medical Oncologist, Dana-Farber Cancer Institute
  • Dr. John Kaczmar, Associate Professor, Medical University of South Carolina
  • Dr. Ricard Mesía, Head of Medical Oncology, Catalan Institute of Oncology
  • Dr. Katharine Price, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center

Registration of PDS Biotech’s KOL Roundtable is now open, and a live webcast of the event will be available online in the investor relations section of the Company’s website at https://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

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 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 VERSATILE-003

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) compared with KEYTRUDA® monotherapy as the control arm. The primary end point for the study is patient overall survival (OS). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.  

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 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

(Nasdaq: PDSB) (PDS Biotech or 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 it will host a Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101, including an update from the Phase 2 VERSATILE-002 trial, for analysts, investors and the scientific community from 8:00 – 9:00 AM EDT on Wednesday, September 27, 2023.

The Company-sponsored event will focus on current and potential treatments for HPV16-positive head and neck cancer, including the emerging use of circulating tumor DNA (ctDNA), and unmet needs of this growing patient population. The event will also include a presentation on updated data from the VERSATILE-002 study of the combination of KEYTRUDA® (pembrolizumab) and PDS0101, PDS Biotech’s novel investigational HPV-targeted immunotherapy, as well as the design for the planned VERSATILE-003 Phase 3 clinical trial due to be initiated in the fourth quarter of 2023. The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren V. Wood, and will feature presentations from the following head and neck cancer KOLs:

  • Dr. Glenn Hanna, Assistant Professor, Harvard University and Medical Oncologist, Dana-Farber Cancer Institute
  • Dr. John Kaczmar, Associate Professor, Medical University of South Carolina
  • Dr. Ricard Mesía, Head of Medical Oncology, Catalan Institute of Oncology
  • Dr. Katharine Price, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center

Registration of PDS Biotech’s KOL Roundtable is now open, and a live webcast of the event will be available online in the investor relations section of the Company’s website at https://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

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 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 VERSATILE-003

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) compared with KEYTRUDA® monotherapy as the control arm. The primary end point for the study is patient overall survival (OS). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.  

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 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 – Ocugen Announces Positive Clinical Study Update From The Phase 1/2 Trial Of OCU400, A Modifier Gene Therapy Product Candidate, For The Treatment Of Retinitis Pigmentosa (RP) And Leber Congenital Amaurosis (LCA)

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

September 13, 2023

PDF Version

  • Favorable safety and tolerability profile of OCU400 investigational drug product in RP and LCA subjects to date
  • Clinical study update suggests continued positive trends in Best-Corrected Visual Acuity (BCVA) and Multi-Luminance Mobility Testing (MLMT), as well as positive trends in Low-Luminance Visual Acuity (LLVA) among treated eyes
  • 83% (10/12) of subjects demonstrated stabilization or improvement in treated eye either on BCVA or LLVA or MLMT scores from baseline
  • Notably, 86% (6/7) of RHO mutation subjects experienced either stabilization of or increase in MLMT scores from baseline including a subset of 29% (2/7) that demonstrated a 3 Lux luminance level improvement

MALVERN, Pa., Sept. 13, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced a clinical study update for Retinitis Pigmentosa (RP) participants treated in the Phase 1/2 trial to assess the safety and efficacy of OCU400 for RP associated with NR2E3 and Rhodopsin (RHO) mutations and Leber congenital amaurosis (LCA) with mutation(s) in the CEP290 gene. This clinical study update is an extension of results provided by Ocugen on April 14, 2023, and includes additional subjects from the high dose group. The Company believes that OCU400—Ocugen’s therapeutic approach, utilizing a proprietary modifier gene therapy platform—has the potential to be a gene-agnostic therapeutic for RP and LCA patients with inherited retinal degeneration.

“This clinical study update supports our vision to help change the lives of patients suffering from inherited retinal diseases,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “We remain dedicated to our mission of pioneering breakthroughs in biotechnology and believe that OCU400 has the potential to have an impact on the future treatment of patients with RP and LCA.” 

This Phase 1/2 trial is a multicenter, open-label, dose ranging study. A total of 18 subjects with vision impairment due to RP associated with RHO and NR2E3 gene mutations received a unilateral subretinal injection of either a low dose (1.66 x 1010 vg/mL), medium dose (3.33 x 1010 vg/mL), or high dose (1.66 x 1011 vg/mL) of OCU400. The study profile included a diverse group of subjects aged 18-77 years old, with varied disease stages, racial and ethnic profiles, medical histories, and mutation subgroups. Ocugen further expanded this Phase1/2 trial to enroll LCA patients with CEP290 gene mutation and pediatric patients with NR2E3, RHO and CEP290 mutations.

Inherited retinal diseases (IRDs) such as RP and LCA encompass a group of genetic disorders that affect the retina, the light-sensitive tissue at the back of the eye. These diseases often lead to a gradual loss of vision over time and can ultimately result in blindness. Stabilization of vision is crucial for patients with IRDs due to the progressive and degenerative nature of these conditions.

Preserving remaining vision, slowing disease progression, or improving the vision can significantly impact patients’ quality of life. It not only enhances the quality of life for affected individuals but also provides hope for future treatments that may ultimately lead to vision restoration. Comprehensive care, early diagnosis, and access to emerging therapies are essential components of a strategy to stabilize vision in IRD patients.

“I am gratified to see the progress we have made in our pursuit of developing a novel gene-agnostic therapy for RP and LCA. Our team’s unwavering dedication to advancing modifier gene therapy research demonstrated positive preliminary clinical results that offer renewed hope to patients and their families. We remain resolute in our mission and vision to bring a bright future to those with inherited or age-related retinal diseases through courageous innovation and unwavering determination,” said Dr. Arun Upadhyay, Chief Scientific Officer, Head of Research, Development and Medical at Ocugen.

This clinical study update is based on the currently available data from Phase 1 (dose-escalation: Cohort 1, 2 and 3) and the Phase 2 (open enrollment) portion of the study. The exploratory efficacy update includes data for 12 subjects who have completed a minimum of 6-month follow up. The data set comprised of 2 subjects [Cohort 1] with 12-month follow-up, 5 subjects [N=2 from Cohort 1 and N=3 from Cohort 2] with 9-month follow-up, and 5 subjects [N=2 from Cohort 3 and N=3 from Open Enrollment/Phase 2] with 6-month follow-up.

“It is an important steppingstone for Ocugen and its mission to help the nearly 1.6 million patients affected by RP and LCA worldwide. For those suffering from these IRDs, this clinical trial update provides hope. It is encouraging to see a favorable safety and tolerability profile and positive efficacy readout for OCU400 in RP patients,” said Dr. Lejla Vajzovic, Associate Professor of Ophthalmology with Tenure, Director of Duke Vitreoretinal Fellowship Program at Duke Eye Center and Duke University School of Medicine and leader in gene-therapy research.

Key efficacy outcomes from 12 subjects demonstrated:
BCVA:

  • 83% (10/12) of subjects demonstrated stabilization or improvements in treated eyes in BCVA scores from baseline
  • 42% (5/12) of OCU400 treated eyes experienced 4-letter improvement and 33% (4/12) treated eyes experienced 7-letter improvement in BCVA from baseline
  • 57% (4/7) of RHO subjects’ treated eyes experienced 4-letter improvement and 43% (3/7) treated eyes experienced 7-letter improvement in BCVA scores from baseline

LLVA:

  • 83% (10/12) of subjects demonstrated stabilization or improvement in treated eyes in LLVA scores from baseline
  • 42% (5/12) of OCU400 treated eyes experienced 5-letter improvement (1 line) in LLVA from baseline, with 25% (3/7) increasing by 10 letters (2 lines)
  • 43% (3/7) of RHO subjects experienced 5-letter improvement (1 line) in treated eyes in LLVA scores from baseline, among which 29% (2/7) increased by 10 letters (2 lines)

MLMT:

  • 75% (9/12) of subjects demonstrated stabilization or improvement in treated eyes in MLMT scores from baseline
  • 33% (4/12) of subjects in the low, medium, and high dose cohorts experienced at least 1 Lux luminance level improvement from baseline in treated eyes, among which 17% (2/12) increased by 3 Lux luminance levels
  • 86% (6/7) of RHO subjects experienced either stabilization or increases in MLMT scores from baseline, among which 29% (2/7) improved by 3 lux levels

“The RHO mutation affects more than 10,000 people in the US,” said Dr. David Birch, Scientific Director, Retina Foundation of the Southwest and Principal investigator of the study. “In my view, the clinical study update supports the gene-agnostic mechanism of action of OCU400 in RHO patients. The improvements in BCVA, LLVA and MLMT in this patient population are very exciting and encouraging because stabilization alone could be considered as a treatment benefit.”

The clinical study update from the Phase 1/2 clinical trial demonstrated that OCU400 continued to be generally safe and well-tolerated in subjects across different mutations and dose levels. There were no serious adverse events (SAEs) related to the investigational product in the low and medium-dose cohorts. In the high-dose and open-enrollment cohorts, SAEs were reported for two subjects. Adverse events were mostly deemed related to the surgical procedure and resolved within a few days to weeks.

“The clinical study update released by Ocugen appears to have a tangible biological impact on Retinitis Pigmentosa associated with NR2E3 and RHO mutations,” said Dr. David Boyer, Clinical Professor of Ophthalmology USC/Keck School of Medicine Los Angeles, CA and Partner, Retina Vitreous Associates Medical Group. “These findings may indicate a huge step forward in the way we approach and treat this condition. We remain optimistic and eager to continue the trial and understand the full potential of OCU400.”

Ocugen will continue to monitor long-term safety and efficacy data from the treated patients and provide additional updates.

A webcast and conference call will take place today at 8:30 a.m. ET:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 7803227

Webcast: Available on the events section of the Ocugen investor site

About Modifier Gene Therapy
Modifier gene therapy is designed to fulfill unmet medical needs related to retinal diseases, including IRDs, such as RP, LCA, and Stargardt disease, as well as dry AMD. Our modifier gene therapy platform is based on the use of Nuclear hormone receptors (NHRs), master gene regulators, which have the potential to restore homeostasis — the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, we believe that our modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and to address complex diseases that are potentially caused by imbalances in multiple gene networks. Currently Ocugen has three modifier gene therapy programs OCU400 (RP, LCA), OCU410 (dry AMD), OCU410ST (Stargardt disease).

About OCU400
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene-networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with inherited retinal diseases.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trial results, and anticipated timing of clinical trial updates and regulatory interactions. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward- looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in the Phase 1/2 clinical trial or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com

Release – The ODP Corporation to Participate in the B. Riley Securities Consumer Conference Thursday, September 14th, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ODP

PDF Version

BOCA RATON, Fla.–(BUSINESS WIRE)–Sep. 12, 2023– The ODP Corporation (“ODP,” or the “Company”) (NASDAQ:ODP), a leading provider of business services, products and digital workplace technology solutions to businesses and consumers, announced today that its executive vice president and chief financial officer, D. Anthony Scaglione, and vice president of investor relations and treasurer, Tim Perrott, will participate in the B. Riley Securities Consumer Conference on September 14th, 2023.

About The ODP Corporation

The ODP Corporation (NASDAQ:ODP) is a leading provider of products, services, and technology solutions through an integrated business-to-business (B2B) distribution platform and omni-channel presence, which includes world-class supply chain and distribution operations, dedicated sales professionals, a B2B digital procurement solution, online presence, and a network of Office Depot and OfficeMax retail stores. Through its operating companies Office Depot, LLC; ODP Business Solutions, LLC; Veyer, LLC; and Varis, Inc., The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.

ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc. Veyer is a trademark of Veyer, LLC. Varis is a trademark of Varis, Inc. Grand&Toy is a trademark of Grand & Toy, LLC in Canada. ©2023 Office Depot, LLC. All rights reserved. Any other product or company names mentioned herein are the trademarks of their respective owners.

Tim Perrott
Investor Relations
561-438-4629
Tim.Perrott@theodpcorp.com

Source: The ODP Corporation

Release – MustGrow Announces Investor Relations Agreement with Harbor Access

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGROF

SASKATOON, Saskatchewan, Canada, September 12, 2023 – MustGrow Biologics Corp. (TSXV: MGRO) (OTC: MGROF) (FRA: 0C0) (the “Company” or “MustGrow”) is pleased to announce the engagement of Harbor Access LLC (“Harbor Access”) to perform investor relations services and activities, as defined in accordance with the policies of the TSX Venture Exchange (“TSXV”) and applicable securities laws.

“In connection with recent Company announcements including our significant project expansion with Janssen PMP, it is timely to refresh our investor relations and communications efforts, ” said Corey Giasson, CEO of MustGrow. “We believe that having an investor relations firm with broad experience in both the Canadian and US markets can provide strong support in creating wider awareness and expanding our investor base.”

“We are delighted to be working with Corey and the MustGrow team to enable more investors to be familiar with this unique and compelling investment opportunity given the growing importance of securing the global food supply,” stated Jonathan Paterson, Founder of Harbor Access

Pursuant to the agreement with Harbor Access, the Company will pay a cash fee of USD$8,000 per month over an initital period of 12 months, subject to renewal. Harbor Access does not control any common shares in the Company.

———

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Concurrently, with new formulations derived from food- grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility. MustGrow has approximately 50.1 million basic common shares issued and outstanding and 56.3 million shares fully diluted. For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

About Harbor Access 

Harbor Access represents and advises micro to mega cap companies. The Company has a measured approach to creating a capital markets communications program, which helps optimize their clients’ visibility. Harbor Access brings extensive global experience and professionalism to each client and customizes every solution to meet their clients’ goals.

For more information about Harbor Access, please visit www.harbor-access.com

Contact Information

Jonathan Paterson
Founder & Managing Partner
Phone: +1-475-477-9401
Jonathan.Paterson@Harbor-access.com

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding creating wider awareness and expanding its investor base.

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2023 MustGrow Biologics Corp. All rights reserved.

Release – Ocugen To Host Virtual Investor & Analyst Event on September 13, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

September 12, 2023

PDF Version

COMPANY TO SHARE UPDATED RESULTS FROM ONGOING PHASE 1/2 TRIAL OF OCU400 FOR THE TREATMENT OF RETINITIS PIGMENTOSA AND LEBER CONGENITAL AMAUROSIS

MALVERN, Pa., Sept. 12, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host an Investor and Analyst Event on September 13, 2023 at 8:30 a.m. ET. During the webcast and conference call, members of the Ocugen leadership team and key opinion leaders will discuss updated results from the Phase 1/2 trial of OCU400 for the treatment of retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA).

The event will feature:

Shankar Musunuri, PhD, MBA, Chairman, CEO and Co-founder, Ocugen

Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research, Development & Medical, Ocugen

Huma Qamar, MD, MPH, Head of Clinical Development and Medical Affairs, Ocugen

David Birch, PhD, Scientific Director, Retina Foundation of the Southwest, Principal investigator of the study

Byron L. Lam, MD, Mark J. Daily Professor, Bascom Palmer Eye Institute, University of Miami, Principal investigator of the study

Lejla Vajzovic, MD, FASRS, Associate Professor of Ophthalmology with Tenure, Director of Duke Vitreoretinal Fellowship Program at Duke Eye Center and Duke University School of Medicine and leader in gene-therapy research

Webcast and Conference Call Details

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 7803227

Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements include, but are not limited to, statements regarding our clinical development activities and related anticipated timelines. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation. Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation whether as a result of new information, future events, or otherwise, after the date of this presentation.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com 

Tesla’s Dojo Supercomputer Presents Massive Upside for Investors

Posted on by slightbourne@noblecapitalmarkets.com

Tesla’s new Dojo supercomputer could unlock tremendous value for investors, according to analysts at Morgan Stanley. The bank predicts Dojo could boost Tesla’s market valuation by over $600 billion.

Morgan Stanley set a sky-high 12-18 month price target of $400 per share for Tesla based on Dojo’s potential. This implies a market cap of $1.39 trillion, which is nearly 76% above Tesla’s current $789 billion valuation.

Tesla only began producing Dojo in July 2022 but plans to invest over $1 billion in the powerful supercomputer over the next year. Dojo will be used to train artificial intelligence models for autonomous driving.

Morgan Stanley analysts estimate Dojo could enable robotaxis and software services that extend far beyond Tesla’s current business of vehicle manufacturing. The bank nearly doubled its 2040 revenue projection for Tesla’s network services division from $157 billion to $335 billion thanks to Dojo.

By licensing self-driving software powered by Dojo to third-party transportation fleets, Tesla could generate tremendous high-margin revenues. Morgan Stanley sees network services delivering over 60% of Tesla’s core earnings by 2040, up from just 30% in 2030.

Thanks to this upside potential, Morgan Stanley upgraded Tesla stock from Equal-Weight to Overweight. The analysts stated “Dojo completely changes the growth trajectory for Tesla’s autonomy business.”

At its current $248.50 share price, Tesla trades at a lofty forward P/E ratio of 57.9x compared to legacy automakers like Ford at 6.3x and GM at 4.6x. But if Morgan Stanley’s bull case proves accurate, Tesla could rapidly grow into its valuation over the next decade.

In summary, Tesla’s AI advantage with Dojo makes the stock’s premium valuation more reasonable. Investors buying at today’s prices could reap huge gains if Dojo unlocks a new $600 billion revenue stream in autonomous mobility services.

The Power and Potential of Dojo

Dojo represents a massive investment by Tesla as it aims to lead the future of autonomous driving. The specialized supercomputer is designed to train deep neural networks using vast amounts of visual data from Tesla’s fleet of vehicles.

This differentiated AI training will allow Tesla to improve perceptions for full self-driving at a faster pace. As self-driving functionality becomes more robust, Tesla can unlock new revenue opportunities.

Morgan Stanley analyst Adam Jones stated: “If Dojo can help make cars ‘see’ and ‘react,’ what other markets could open up? Think of any device at the edge with a camera that makes real-time decisions based on its visual field.”

Dojo’s processing power will permit Tesla to develop advanced simulations that speed up testing. The supercomputer’s capacity is expected to exceed that of the top 200 fastest supercomputers combined.

Tesla claims Dojo will drive down the costs of training networks by orders of magnitude. This efficiency can translate into higher margins as costs drop for autonomous AI development.

Dojo was designed in-house by Tesla AI director Andrej Karpathy and his team. Karpathy called Dojo the “most exciting thing I’ve seen in my career.” With Dojo, Tesla is aiming to reduce reliance on external cloud providers like Google and Amazon.

Morgan Stanley Boosts Tesla Price Target by 60%

The potential of monetizing Tesla’s self-driving lead through Dojo led analysts at Morgan Stanley to dramatically increase their expectations.

Led by analyst Adam Jones, Morgan Stanley boosted its 12-18 month price target on Tesla stock by 60% to $400 per share. This new level implies a market value for Tesla of nearly $1.39 trillion.

Hitting this price target would mean Tesla stock gaining about 76% from its current level around $248.50. Tesla shares jumped 6% on Monday following the report as investors reacted positively.

Jones explained the sharply higher price target by stating: “Dojo completely changes the growth trajectory for Tesla’s autonomy business.”

He expects Dojo will open up addressable markets for Tesla that “extend well beyond selling vehicles at a fixed price.” In other words, Dojo can turn Tesla into more of a high-margin software and services provider.

Take a look at One Stop Systems (OSS), a US-based company that designs and manufactures AI Transportable edge computing modules and systems that are used in autonomous vehicles.

EuroDry (EDRY) – EuroDry doubles down on shipping recovery

Posted on by cpereira@noblefcm.com


Wednesday, September 13, 2023

EuroDry Ltd. was formed on January 8, 2018 under the laws of the Republic of the Marshall Islands to consolidate the drybulk fleet of Euroseas Ltd. into a separate listed public company. EuroDry was spun-off from Euroseas Ltd. on May 30, 2018; it trades on the NASDAQ Capital Market under the ticker EDRY. EuroDry operates in the dry cargo, drybulk shipping market. EuroDry’s operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company and Eurobulk (Far East) Ltd. Inc., which are responsible for the day- to-day commercial and technical management and operations of the vessels. EuroDry employs its vessels on spot and period charters and under pool agreements.

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.

EuroDry announced the acquisition of three ships for $65 million. The three Ultramax ships are smaller than the fleet average but newer having been built in 2014-15. The ships are expected to be delivered in Oct-Nov and are yet to be commissioned. We have assumed the ships will be commissioned at a TCE rate of $12,000/day beginning in the 2024-1Q. This assumes an improvement in drybulk shipping rates in the next three months. Our models estimate that the three ships will add $4 million to EBITDA in 2024 implying a cost of 16 times EBITDA.

Of course this is not just about 2024 results. Chairman and CEO Aristides Pittas used the opportunity of the acquisition to reiterate his belief that market fundamentals will improve in the next two to three years due to a low orderbook. We agree with Mr. Pittas’s assessment but note that the prolonged war in Ukraine (lower grain trade) and a slower-than-expected economic rebound in China (steel and ore trade) could mean improvements are not seen in 2024.


Get the Full Report

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

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

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

Defense Metals Corp. (DFMTF) – Wicheeda REE Mineral Resource Estimate Upgraded and Expanded

Posted on by cpereira@noblefcm.com


Wednesday, September 13, 2023

Defense Metals Corp. is a mineral exploration and development company focused on the acquisition, exploration and development of mineral deposits containing metals and elements commonly used in the electric power market, defense industry, national security sector and in the production of green energy technologies, such as, rare earths magnets used in wind turbines and in permanent magnet motors for electric vehicles. Defense Metals owns 100% of the Wicheeda Rare Earth Element Property located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Mineral resource estimate. Defense Metals released results from its updated mineral resource estimate (MRE) for the Wicheeda Rare Earth Element (REE) Project. The 2023 mineral resource estimate is based on an updated geological model incorporating the results from 10,350 meters of drilling within 45 holes drilled by Defense Metals during 2021 and 2022.

Larger and higher-quality resource base. The 2023 resource estimate includes a 6.4 million tonne measured mineral resource averaging 2.86% total rare earth oxide (TREO), a 27.8 million tonne indicated mineral resource averaging 1.84% TREO, and an 11.1 million tonne inferred mineral resource averaging 1.02% TREO. The 2023 mineral resource estimate represents an 18.2% increase in TREO and a 31.3% in tonnage compared to the 2021 MRE. Total measured and indicated mineral resources of 34.2 million tonnes, averaging 2.02% TREO is a significant upgrade compared to the previous estimate and can be included in the mine plan for the preliminary feasibility study that is expected to be completed in the first half of 2024.


Get the Full Report

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

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

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

Uranium Bull Run Continues with Prices Hitting New Highs

Posted on by slightbourne@noblecapitalmarkets.com

Uranium prices have entered a new bull market in 2023, surging 20% so far this year. The nuclear fuel recently hit $60 per pound for the first time in over a decade. This milestone comes on the back of rosier demand forecasts from the World Nuclear Association (WNA) and vastly outperforms other metals markets.

The WNA recently released its biennial report at the World Nuclear Symposium in London. The report provides insights into future uranium demand, underscoring the role nuclear power will play in the global energy transition. It predicts world reactor requirements for uranium will reach almost 130,000 tonnes by 2040, up from 65,650 tonnes in 2023.

Even the WNA’s most conservative projection of 87,000 tonnes in 2040 represents robust demand growth. This is driven by an expected expansion of nuclear capacity from 391 gigawatts currently to 686 gigawatts by 2040 under its base case scenario. The bulk of new reactors will be located in China, which is aggressively decarbonizing by replacing coal plants with nuclear.

China has 23 reactors under construction, 23 more planned, and 168 proposed to add to its existing fleet of 53 reactors. The WNA report increased its overall uranium demand growth projections to 4.1% annually through 2040, up from 3.1% in its 2021 forecast.

This surging demand presents a huge opportunity for growth in the uranium mining sector. As the market transitions from oversupply to undersupply, uranium companies are poised to benefit tremendously. Their revenues, earnings, and valuations could rapidly improve as prices rise. Many junior miners could become acquisition targets for larger producers looking to add resources.

Take a moment to take a look at more uranium and vanadium and mining companies by viewing Michael Heim’s coverage list.

A key driver of demand is the accelerated adoption of small modular reactors (SMRs). These compact, modular designs allow nuclear plants to be constructed faster and cheaper. The WNA sees SMRs reaching 31 gigawatts of installed capacity by 2040, significantly boosting uranium demand. However, forecasts remain relatively conservative given SMRs’ potential applications in shipping, data centers, and other sectors.

According to BMO Capital Markets, SMRs could play a pivotal role in powering remote mines looking to replace diesel generators with cleaner energy solutions. With ample space and ideal climates, mines are adding solar and wind power. But in colder regions like Canada, SMRs may be the only viable zero-carbon option.

In much the same way platinum miners are testing hydrogen trucks onsite, uranium producers could pioneer SMR installations at operations. This would create new demand from uranium miners themselves. BMO estimates SMR capacity could reach 58 gigawatts by 2030, or around 10% of total nuclear generation.

While secondary supplies like reprocessed fuel and stockpiles have bridged the supply-demand gap for decades, the WNA report acknowledges these inventories are diminishing. With roughly 3.7 years of reactor requirements in current stockpiles, the WNA projects secondary supplies will fall from 11-14% of demand now to just 4-11% by 2050.

This decline underscores the need for new mine supply to meet growing reactor demand in the long run. With secondary sources drying up, uranium prices must rise to incentivize investment in expansion and new projects. The uranium bull run still appears to be in its early innings, as rosier demand forecasts confront constrained mine supply. Nuclear energy’s role in global decarbonization efforts continues to expand, brightening the outlook for uranium markets and uranium mining companies.

Mainz Biomed Reports Strong ColoAlert Data, Identifies Biomarkers for FDA Trial

Posted on by slightbourne@noblecapitalmarkets.com

Mainz Biomed (NASDAQ:MYNZ) announced highly positive results this week from its ColoFuture clinical trial evaluating the integration of novel mRNA biomarkers into its ColoAlert screening test for colorectal cancer. The results demonstrated ColoAlert’s strong performance for detecting colorectal cancer and advanced adenomas, while also identifying promising biomarkers to further improve early detection capabilities.

The ColoFuture study is a multi-center international trial assessing whether integrating recently acquired mRNA biomarkers from Université de Sherbrooke can enhance ColoAlert’s sensitivity and specificity profile. ColoAlert is Mainz’s flagship product, a simple yet highly accurate home-based test using stool samples to detect colorectal cancer and advanced precancerous adenomas.

The product is already commercialized across Europe and select international territories. However, ColoFuture aimed to identify ways to further extend ColoAlert’s technical capabilities in preparation for an upcoming U.S. clinical trial that could lead to FDA approval.

Interim analysis from the ColoFuture trial included 220 subjects across centers in Germany, Norway and Denmark. On the primary endpoints for colorectal cancer detection, ColoAlert achieved 94% sensitivity and 97% specificity after integrating the novel mRNA biomarkers.

For identifying advanced adenomas, a key precursor to cancer, the updated test demonstrated 81% sensitivity. According to Mainz Biomed CEO Guido Baechler, “The power to detect lesions in a pre-cancerous stage can change the entire CRC diagnostic landscape. If advanced adenomas are identified early, they are curable.”

The positive data catalyzed strong trading volume as Mainz Biomed’s stock price rose 15% on over 1.5 million shares traded. The market enthusiastically welcomed the results.

The mRNA biomarkers evaluated in ColoFuture were specifically selected from research at Université de Sherbrooke. Published analysis of the biomarkers showed ability to detect signals from patients with either colorectal cancer or advanced adenomas. Mainz Biomed acquired these biomarker rights in January 2022.

By treating patients before polyps progress to cancer, integrating these biomarkers into ColoAlert could help prevent colorectal cancer altogether. This could greatly improve patient outcomes and reduce the burden of this deadly disease.

The positive data provides validation of ColoAlert’s accuracy as a non-invasive screening tool. It also gives Mainz Biomed multiple novel mRNA biomarkers to integrate into its upcoming U.S. clinical trial, dubbed ReconAAsense, which could support FDA approval under the PMA pathway.

According to Baechler, “As we look forward to publishing and presenting the full dataset, we eagerly await the outcome from our ReconAAsense clinical trial which remains on track to report results in Q4 of this year.”

With colorectal cancer remaining a leading cause of cancer deaths, early detection is critical. ColoAlert offers a simple, at-home solution that people can easily incorporate into routine wellness screenings. The new biomarkers identified in ColoFuture could make the test accessible to even more patients.

Mainz Biomed continues to spearhead innovation in the field, leveraging the latest advances in genetics to improve detection. The impressive ColoFuture results provides further validation of ColoAlert’s accuracy, while also charting a path forward to commercialization in the U.S.

With pivotal FDA trial data on the horizon, Mainz Biomed is positioned to disrupt the market, offering an easy yet cutting-edge approach to potentially save lives through early colorectal cancer detection.

Take a look at more biotechnology companies by viewing Robert LeBoyer’s coverage list.

Consumer Prices Rise at Faster Pace in August

Posted on by slightbourne@noblecapitalmarkets.com

The Consumer Price Index (CPI) increased 0.6% in August on a seasonally adjusted basis, quickening from the 0.2% rise seen in July, according to the Bureau of Labor Statistics’ latest report. Over the past 12 months through August, headline CPI inflation stands at 3.7% before seasonal adjustment, up from 3.2% for the 12-month period ending in July.

The August monthly gain was primarily driven by a spike of 10.6% in the gasoline index. Gasoline was coming off a tamer 0.2% increase in July. Food prices also contributed to inflationary pressures, with the food at home index edging up 0.2% again last month. The food away from home index rose 0.3%.

Meanwhile, the energy index excluding gasoline picked up as well. Natural gas costs ticked up 0.1%, electricity prices rose 0.2%, and fuel oil prices surged 9.1%.

The core CPI, which removes volatile food and energy categories, rose 0.3% in August after a 0.2% gain in July. The shelter index has been a main driver of core inflation. It covers rental costs and owners’ equivalent rent, both of which have rapidly increased due to imbalances between housing supply and demand.

On an annual basis, the energy index has fallen 3.6%, as gasoline, natural gas and fuel oil costs are down over the past 12 months. However, the food and core indexes are up 4.3% and 4.3% year-over-year, respectively.

Within the core CPI, the main drivers have been shelter costs, up 7.3% over the last 12 months, along with auto insurance (+19.1%), recreation services (+3.5%), personal care (+5.8%) and new vehicles (+2.9%). Medical care services inflation has also accelerated to 6.6% over the past year.

Geographically, inflation varies significantly by region. The Northeast has seen 4.2% CPI inflation over the past year, the Midwest 3.9%, the South 3.7%, and the West just 2.9%. By city size, larger metropolitan areas over 1.5 million people have experienced 3.8% inflation, compared to 3.6% for mid-sized cities and 3.7% in smaller cities.

August’s monthly data shows inflation quickened after signs of cooling in July. While gasoline futures retreated in September, shelter inflation remains stubbornly high with no meaningful relief expected until mortgage rates decline substantially.

With core inflation running well above the Fed’s 2% target, further interest rate hikes are anticipated to combat still-high inflation. But the path to a soft economic landing appears increasingly narrow amid recession risks.

The next CPI update will be released in mid-October, shedding light on whether persistent pricing pressures are continuing to squeeze household budgets. For now, the August report shows inflation picking up steam after the prior month’s encouraging data.

Looking Ahead

Consumers may get temporary relief in the near term at the gas pump, as oil and gasoline futures prices pulled back in September following OPEC’s modest production cut.

Yet the larger concern remains the entrenched inflation in essentials like food, rent and medical care. Shelter inflation in particular has shown little sign of abating, as rental rates and housing prices remain disconnected from incomes.

Mortgage rates have soared above 6% in 2023 after starting the year around 3%. The sharp rise in financing costs continues to shut many homebuyers out of the market. Until mortgage rates meaningfully decline, shelter inflation is likely to persist.

And that will be challenging as long as the Fed keeps interest rates elevated. Monetary policy has lagged in responding to inflation, putting central bankers in catch-up mode. Further rate hikes are expected in the coming months absent a significant cooling in pricing pressures.

But the risks of the Fed overtightening and spurring a recession continue to intensify. The path to a soft landing for the economy is looking increasingly precarious.

For consumers, it means further inflationary pain is likely in store before a sustained moderation emerges. Budgets will remain pressured by pricier essentials, leaving less room for discretionary purchases.

While the monthly data will remain volatile, the overall trend points to stubborn inflation persisting through year-end. The Fed will be closely watching to see if their actions to date have slowed price gains enough. If not, consumers should prepare for more rate hikes and resulting economic uncertainty into 2024.