Author: cpatches

Release – Tonix Pharmaceuticals Appoints Zeil Rosenberg, M.D., M.P.H., as Executive Vice President, Medical for Infectious Disease Programs

Posted on by cpatches

Research News and Market Data on TNXP

Dr. Rosenberg Will Lead Clinical Development of Tonix’s Vaccine and Antiviral Programs

CHATHAM, N.J., Jan. 04, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Zeil Rosenberg, M.D., M.P.H. as its new Executive Vice President, Medical. In this role, Dr. Rosenberg will be responsible for leading Tonix’s clinical development efforts for vaccines and antivirals. Dr. Rosenberg will be based in the Company’s Chatham, N.J. headquarters, and as part of his role will oversee the clinical development of Tonix’s vaccine for smallpox and monkeypox, TNX-801, the vaccine for COVID-19, TNX-1850, and the antiviral anti-SARS-CoV-2 spike protein monoclonal antibodies, TNX-3600 and TNX-3800, to protect immunocompromised individuals from severe COVID-19.

“We are pleased to welcome Dr. Rosenberg to Tonix’s clinical team to lead the development of our infectious disease programs at a time when Tonix continues to make meaningful progress in the clinical development of multiple programs within its robust pipeline,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.

“Dr. Rosenberg brings to our team expertise as an infectious disease drug developer and we are fortunate to have someone with Dr. Rosenberg’s skills, vision and operational expertise join at a pivotal time in the evolution of our infectious disease product portfolio, with our vaccine candidate for monkeypox, TNX-801, expected to enter clinical testing in 2023, and TNX-3600 and TNX-3800 moving ahead in pre-clinical development to address the need for anti-SARS-CoV-2 monoclonal antibodies for immune-compromised individuals,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “At Becton, Dickinson and Company (BD), Dr. Rosenberg worked on the development of the BD Bifurcated Needle, a safety-engineered improved bifurcated needle device for the percutaneous administration of live virus vaccinia vaccines, as well as BD VaxiNet™, a data monitoring system to improve patient safety in smallpox vaccine mass immunization efforts, which we believe have direct relevance to our recombinant poxvirus (RPV) platform.”

“I am thrilled to join Tonix’s executive management team and lead the clinical development of its infectious disease portfolio,” said Dr. Rosenberg. “I look forward to working together with the talented Tonix team to advance the Company’s portfolio of promising vaccines and antiviral therapies and help bring them to as many appropriate patients as possible.”

Dr. Rosenberg was most recently at PPD, part of Thermo Fisher Scientific, serving as Executive Director, Biotech and as Therapeutic Area Head for Vaccines at its Accelerated Enrollment Solutions Group, where he provided leadership on multiple successful COVID-19 vaccine clinical trials. At BD he was Worldwide Business Leader and Medical Director for Immunization, and was Vice President for Medical Affairs at Admera Health, a medical diagnostics company focused on precision medicine. He was key to the launch of a global public private partnership, including UNICEF and WHO, to help eliminate maternal and neonatal tetanus through immunization, resulting in the significant reduction of neonatal mortality. He served as National Immunization Advisor to the Indonesian Ministry of Health in Jakarta, sponsored by the U.S. Agency for International Development (USAID), and as Chief Technical Officer for Immunization at USAID, Washington, D.C.

Dr. Rosenberg received his B.A. with Honors and Distinction at Stanford University, earned his M.D. at the University of California, San Francisco and completed his internship and residency at Mount Sinai and Cornell University Medical College, respectively. He holds a Masters of Public Health from Columbia University. Dr. Rosenberg is an elected Fellow of both the American College of Preventive Medicine and the New York Academy of Medicine, and Specialty Fellow of the American Academy of Pediatrics. He has served as AAS Science, Engineering and Diplomacy Fellow.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801, a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

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

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Release – Genprex Announces Selection of Preclinical Data for Oral Presentation at 16th International Conference on Advanced Technologies & Treatments for Diabetes

Posted on by cpatches

Research News and Market Data on GNPX

Exciting Data from University of Pittsburgh Researchers in Non Human Primates that Underpins Genprex’s Gene Therapy Program in Diabetes to be Showcased

AUSTIN, Texas — (January 4, 2023) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators at the University of Pittsburgh will present preclinical data highlighting the therapeutic potential of Genprex’s gene therapy for Type 1 diabetes at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023) being held February 22-25 in Berlin, Germany and online.

“ATTD 2023 presents an ideal opportunity for the results of this important study to be presented to the diabetes community. The data further support the potential of Genprex’s novel gene therapy being developed for the treatment of Type 1 diabetes to change the trajectory of this devastating disease,” said Mark Berger, MD, Genprex’s Chief Medical Officer. “Using the expression of Pdx1 and MafA transcription factors, this approach has been shown first in mice and then in non human primate studies to lead to the creation of new beta-like cells that produce insulin and may provide long-term replacement of beta-cells.”

The diabetes gene therapy approach is comprised of a novel infusion process that uses endoscopic delivery of an adeno-associated virus (AAV) vector to bring therapeutic genes directly to the pancreas. In models of Type 1 diabetes, these genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. In Type 2 diabetes, where autoimmunity is not at play, it is believed that using a similar approach the exhausted beta cells will be rejuvenated and replenished. 

Presentation Details:

Abstract Number: 203

Abstract Title: Pancreatic Intraductal Infusion of Adeno-Associated Virus To Treat Non-Human Primates in a Toxin-Induced Diabetes Model

Format: Oral Presentation

Presenter: Ranjeet Kalsi, DO, representing the laboratory of  George Gittes, MD, Professor of Surgery and Pediatrics and Chief of the Division of Pediatric Surgery, University of Pittsburgh School of Medicine

Time/Date: 1:45 pm Central European Standard Time on Saturday, February 25, 2023

The abstract will be made available on the ATTD conference website at https://attd.kenes.com. 

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body. The Company’s lead product candidate, REQORSA® (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC) (with each of these clinical programs receiving a Fast Track Designation from the Food and Drug Administration) and for small cell lung cancer. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. In models of Type 1 diabetes, the genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. In a similar approach used in Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells are rejuvenated and replenished.

For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K for the year ended December 31, 2021.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals, including the extent and impact of the COVID-19 pandemic; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships, including those with its third party manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex’s intellectual property and licenses. 

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.

(877) 774-GNPX (4679)

GNPX Investor Relations

investors@genprex.com

GNPX Media Contact

Kalyn Dabbs

media@genprex.com

Release – Eagle Bulk Shipping Inc. Completes Transfer of Listing to the New York Stock Exchange

Posted on by cpatches

Research News and Market Data on EGLE

STAMFORD, Conn., Jan. 04, 2023 (GLOBE NEWSWIRE) — Eagle Bulk Shipping Inc. (NYSE: EGLE) (“Eagle Bulk”, “Eagle”, or the “Company”), one of the world’s largest owner-operators within the midsize drybulk vessel segment, today announced that it has completed the transfer of its stock listing to the New York Stock Exchange (“NYSE”) from the Nasdaq Global Select Market (“Nasdaq”).

Eagle shares will start trading on the NYSE when the market opens on January 4, 2023, under the existing ticker symbol, “EGLE”.

About Eagle Bulk Shipping Inc.

Eagle Bulk Shipping Inc. (“Eagle” or the “Company”) is a US-based fully integrated shipowner-operator providing global transportation solutions to a diverse group of customers including miners, producers, traders, and end users. Headquartered in Stamford, Connecticut, with offices in Singapore and Copenhagen, Eagle focuses exclusively on the versatile midsize drybulk vessel segment and owns one of the largest fleets of Supramax / Ultramax vessels in the world. The Company performs all management services in-house (including: strategic, commercial, operational, technical, and administrative) and employs an active management approach to fleet trading with the objective of optimizing revenue performance and maximizing earnings on a risk-managed basis. For further information, please visit our website: www.eagleships.com.

Investor and Media Contact
investor@eagleships.com
+1 203 276 8100

Source: Eagle Bulk Shipping Inc.

Energy Industry Report – Energy Stocks Resume Their Upward Trend – Is $80 Oil The New Norm?

Posted on by cpatches

Wednesday, January 04, 2023

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

Refer to the bottom of the report for important disclosures

Energy Stocks Were Strong. Energy stocks rose 21.5% in the fourth quarter far outpacing a 7.1% rise for the S&P 500 Index. For the year, energy stocks were up an impressive 57% versus a 20% decline in the overall market. The strength can largely be attributed to rising energy prices, although we would note that energy prices have largely leveled out after a strong first half of the year.

Oil prices are near $80. Near month oil future contracts are now almost $80 per barrel, below peak prices but significantly higher than historic prices.  At $80 per barrel, most energy companies are very profitable and generating significant excess free cash flow. Despite the favorable economics, energy companies have been slow to drill new wells, and modest production increases have come mainly from improved efficiencies. In addition, there is a growing belief that OPEC’s spare capacity is declining questioning its ability to meet demand increases. As time passes, $80 oil is starting to feel like the new equilibrium level with $40-$60 oil prices a thing of the past.

Gas prices are rising even more than oil prices. Natural gas prices have risen steadily over the last two years even as production levels have been steady. Storage levels, which were running below historical levels, have improved in recent months.

Energy industry fundamentals remain strong. Oil and gas prices are near historical highs and above the levels assumed in our financial and valuation models. Energy company cash flow generation is high, and companies are facing the envious position of trying to decide what to do with the cash. Debt levels have been pared down and managements have been raising dividend levels and repurchasing shares. Drilling is increasing but at a controllable pace that doesn’t seem likely to put prices into a downcycle. We believe the case for smaller cap energy stocks is especially strong. If our belief that a world-wide recession is already factored into energy prices is correct, small cap energy companies will be in the best position to take advantage of any price increase.

Energy Stocks

Energy stocks, as measured by the XLE Energy Index, rose sharply in the most recent quarter after logging in a flat third quarter. In the fourth quarter, energy stocks rose 21.5% far outpacing a 7.1% rise for the S&P 500 Index. For the year, energy stocks were up an impressive 57% versus a 20% decline in the overall market. This year’s strong performance comes after last year’s 50% rise. The strength can largely be attributed to rising energy prices, although we would note that energy prices have largely leveled out after a strong first half of the year.

Oil Prices

Oil prices rose steadily over a two-year period beginning the spring of 2020. WTI prices peaked at $120 per barrel in the first week of June. Prices declined in the third quarter but seem to have leveled off in recent months. Near month oil future contracts are now almost $80 per barrel, below peak prices but significantly higher than historic prices.  At $80 per barrel, most energy companies are very profitable and generating significant excess free cash flow. As time passes, $80 oil is starting to feel like the new equilibrium level with $40-$60 oil prices a thing of the past.

Figure #1

Despite the favorable economics, energy companies have been slow to drill new wells. U.S. rig count, as reported by Baker Hughes, crept up to 779 rigs by the end of the year. This compares to a peak level of 1,600 in 2014. The disparity between increased profitability and increased capital expenditures is shown in the chart below. Operating cash flow has soared over the last two years, but capital expenditures have barely increased. The result has been a large increase in dividend payments, share repurchases and debt reduction.

Figure #2

While capital expenditures have not increased in line with cash flow, it would be unfair to say that oil production has not increased. Indeed, current production levels are above that during peak drilling periods in 2014. The implication is that drilling has become more productive. While drilling advances such as the use of horizontal drill and fracking in shale deposits may be old hat, it is worth noting that drillers have been refining drilling techniques for individual drilling locations. Drillers continue to perfect the ideal number of fracking targets and the materials used to frack. In addition, as we discussed in our September quarter comments, there has been a sharp increase in the number of well recompletions, which are less expensive to complete but not a long-term solution.

Figure #3

Meanwhile, OPEC has been increasing production in recent years after making sharp reductions during the COVID years. However, there are growing concerns that OPEC’s overall capacity is declining and that its spare capacity has consequentially declined. If this is indeed true, OPEC’s ability to fulfill increased demand for oil may be limited. This would bode well, not only for oil prices, but for the role domestic producers will have in meeting demand.

Figure #4

Natural Gas Prices

The chart below shows natural gas prices against production levels. As the chart shows, natural gas prices have risen steadily over the last two years even as production levels have remained steady. To that extent, natural gas prices are acting like oil prices. Natural gas prices tend to track oil prices but with a few distinctions. Natural gas demand and supply is less global than oil. Imports (and now exports) of liquefied natural gas represent a small portion of domestic supply and demand. Secondly, natural gas is used primarily for space heating. That means demand is more seasonal. It also means demand can be affected by weather conditions. On the other hand, natural gas demand is less affected by general economic conditions than oil.

Figure #5

Storage levels, which were running below historical levels, have improved in recent months. We would note that the most recent storage numbers do not reflect the cold snap across the country during the last week of the year. Cold temperatures may send storage levels lower than is reflected in the chart below.

Figure #6

Outlook

Energy industry fundamentals remain strong. Oil and gas prices are near historical highs and above the levels assumed in our financial and valuation models. Energy company cash flow generation is high, and companies are facing the envious position of trying to decide what to do with the cash. Debt levels have been pared down and managements have been raising dividend levels and repurchasing shares. Drilling is increasing but at a controllable pace that doesn’t seem likely to put prices into a downcycle.

 We believe the case for smaller cap energy stocks is strong. Major oil companies are facing increasing pressure to focus on renewable energy instead of producing more carbon-based fuel. Smaller cap energy companies are less tethered and often able to acquire and exploit properties being ignored by the majors. If our belief that a world-wide recession is already factored into energy prices is correct, small cap energy companies will be in the best position to take advantage of any price increase.

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All statements or opinions contained herein that include the words “we”, “us”, or “our” are solely the responsibility of Noble Capital Markets, Inc.(“Noble”) and do not necessarily reflect statements or opinions expressed by any person or party affiliated with the company mentioned in this report. Any opinions expressed herein are subject to change without notice. All information provided herein is based on public and non-public information believed to be accurate and reliable, but is not necessarily complete and cannot be guaranteed. No judgment is hereby expressed or should be implied as to the suitability of any security described herein for any specific investor or any specific investment portfolio. The decision to undertake any investment regarding the security mentioned herein should be made by each reader of this publication based on its own appraisal of the implications and risks of such decision.

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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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transactions effected on the recipients behalf, details of which will be available on request in regard to a transaction that involves a personalized securities recommendation. Additional risks associated with the security mentioned in this report that might impede achievement of the target can be found in its initial report issued by Noble Capital Markets, Inc.. This report may not be reproduced, distributed or published for any purpose unless authorized by Noble Capital Markets, Inc..

RESEARCH ANALYST CERTIFICATION

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appearance and/or research report.

Ownership and Material Conflicts of Interest
Neither I nor anybody in my household has a financial interest in the securities of the subject company or any other company mentioned in this report.

Release – FAT Brands Inc. Announces Participation in the 2023 ICR Conference

Posted on by cpatches

Research News and Market Data on FAT

LOS ANGELES, Jan. 03, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT), a leading global franchising company and parent company of iconic brands including Round Table Pizza, Fatburger, Johnny Rockets, Twin Peaks, Fazoli’s and 12 other restaurant concepts, today announced their participation in the 2023 ICR Conference. Andy Wiederhorn, President and CEO, and Jim Neuhauser, Executive Chairman of the Board of Directors, will host a fireside chat on Monday, January 9th, 2023 at 4:00 PM ET. Institutional investors interested in scheduling a 1×1 meeting with management should contact their ICR representative.

The fireside chat will be webcast live and available for replay for 90 days. It can be accessed under the Events & Presentations section of the FAT Brands Investor Relations website at https://ir.fatbrands.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, casual and polished casual dining restaurant concepts around the world. The Company currently owns 17 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, Native Grill & Wings, Pretzelmaker, Elevation Burger, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit http://www.fatbrands.com.

Investor Relations:
ICR
Michelle Michalski
IR-FATBrands@icrinc.com
646-277-1224

Media Relations:

Erin Mandzik
emandzik@fatbrands.com
860-212-6509

Release – Seanergy Maritime Announces Acquisition of a Scrubber-Fitted Capesize Vessel with Immediate Period Employment and the Sale of the two Oldest Vessels of the Fleet

Posted on by cpatches

Research News and Market Data on SHIP

January 3, 2023 – Glyfada, Greece – Seanergy Maritime Holdings Corp. (the “Company” or “Seanergy”) (NASDAQ: SHIP) announced today the acquisition of a 2012-built Capesize vessel (the “Vessel”) from a major Japanese company and the simultaneous commencement of its period employment.

In addition, the Company has entered into definitive agreements to sell the 2005-built M/V Goodship and the 2006-built M/V Tradership, the oldest vessels in its fleet, to United Maritime Corporation (“United”), a related party.

The Company expects to record a profit of approximately $8 million in connection with the sale of the two vessels in the first quarter of 2023. In addition, the aforementioned transactions will reduce the average age of Seanergy’s fleet. 

Stamatis Tsantanis, the Company’s Chairman & Chief Executive Officer, stated:

“We are pleased to announce the acquisition of another high-quality Japanese Capesize vessel, which will effectively replace the older M/V Goodship and M/V Tradership. The sale of the two oldest vessels in our fleet will result in a substantial profit of more than $8 million for Seanergy, whilst benefiting the average age of our fleet.

“The M/V Paroship will increase the number of the scrubber-fitted vessels in our fleet to nine, enhancing our cash-flow generating capacity based on the significant differential between high and low-sulfur fuel prevailing currently.

“The delivery of the M/V Paroship and the underlying T/C agreement are well-timed, considering the recent improvement in the freight market and what we believe to be strong fundamentals in our sector. 

“Seanergy remains committed to the Capesize sector with a solid operational structure and consistent capital allocation, focusing predominantly on shareholder rewards and sustainable growth.”

Acquisition of a modern Japanese Capesize vessel & Period Employment

The Vessel was built in 2012 at a reputable shipyard in Japan, with a cargo-carrying capacity of approximately 181,415 deadweight tons and has been renamed M/V Paroship. The Vessel is fitted with an exhaust gas cleaning system (scrubber). 

The M/V Paroship was delivered to the Company on December 27, 2022 and its gross purchase price of US$31 million was funded through a combination of cash on hand and a new senior credit facility.

The Vessel has been fixed on a time charter (“T/C”) with a leading European operator, which is an existing charterer of Seanergy, for a period of minimum ten (10) months to maximum December 31, 2023. The T/C commenced promptly, upon finalization of the customary transition process. The gross daily rate is set at a premium over the Baltic Capesize Index, while the Company has the option to convert the daily hire from index-linked to fixed for a period of minimum three (3) months to maximum nine (9) months based on the prevailing Capesize Freight Futures Agreements curve. In addition, the T/C includes a scrubber profit sharing scheme with the majority of the benefit from the differential between high sulfur and low sulfur fuel being attributed to Seanergy.

Sale of our two oldest Capesize vessels

The aggregate sale price of the two vessels is US$36.25 million and was agreed upon on the basis of the average of three independent broker valuations. The transaction was made pursuant to United’s exercise of a right of first offer granted by the Company on its Capesize vessels pursuant to an agreement entered into between the Company and United on July 5, 2022. The sale of the M/V Tradership and the M/V Goodship was approved by a special independent committee of the Company’s Board of Directors. The deliveries of the two vessels are expected to be concluded by the end of the first quarter of 2023, subject to the satisfaction of certain customary closing conditions.

Financing facility for the M/V Paroship

Seanergy concluded a new senior credit facility with an existing lender of the Company, a major European bank, secured by the M/V Paroship. The US$16.5 million loan bears interest of SOFR + 2.90% per annum and has a four-year tenor. The principal amount will be amortized through 16 consecutive quarterly installments averaging approximately US$0.43 million each, and a US$9.6 million final balloon payment at maturity.

About Seanergy Maritime Holdings Corp.

Seanergy Maritime Holdings Corp. is the only pure-play Capesize ship-owner publicly listed in the US. Seanergy provides marine dry bulk transportation services through a modern fleet of Capesize vessels. Including the newly delivered M/V Paroship and upon completion of the sale of the M/V Goodship and M/V Tradership, the Company’s operating fleet will consist of 16 Capesize vessels with an average age of 11.9 years and an aggregate cargo carrying capacity of approximately 2,846,965 dwt.

The Company is incorporated in the Republic of the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP”.

Please visit our company website at: www.seanergymaritime.com.

Link to press release:  https://www.capitallink.com/press/seanergy010323.pdf

Seanergy Investor Relations
Tel: +30 213 0181 522
E-mail: ir@seanergy.gr


This information is distributed by Capital Link, Inc. – Investor Relations
230 Park Avenue, Suite 1540
New York, NY 10169
Tel: (212) 661-7566
Email: pressrelease@capitallink.com

Release – Entravision Announces the Unexpected Passing of Chairman and Chief Executive Officer Walter F. Ulloa

Posted on by cpatches

Research News and Market Data on EVC

SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision (NYSE: EVC), a leading global advertising solutions, media and technology company, today announced that Walter F. Ulloa, the Company’s Chairman and Chief Executive Officer, passed away of a sudden heart attack on December 31, 2022. He was 74 years old.

Entravision’s Board of Directors issued the following statement:

“We are profoundly saddened by the sudden passing of Walter Ulloa and extend our heartfelt condolences to Walter’s wife, son and entire family. Since founding Entravision more than 25 years ago, Walter has been an exceptional leader who transformed the company from a traditional multi-linear Spanish-language company that currently owns and operates approximately 100 domestic television and radio stations, to a global digital media powerhouse with a footprint that today reaches across more than 40 countries. Well-known and respected throughout the media industry, Walter’s passion, energy, and devotion to our company will be greatly missed. We have lost a leader and a friend.

Thanks to Walter’s dynamic leadership, Entravision has assembled an experienced management team that will continue to drive the company’s long-term growth strategy as we serve our customers, our partners, and our shareholders.”

The Board also announced today that it has appointed Chris Young, Chief Financial Officer and Treasurer, as Interim Chief Executive Officer, effective immediately. Mr. Young has over two decades of experience in banking and corporate finance across the media, advertising and technology industries and has served as Treasurer and CFO of Entravision since 2008. He originally joined Entravision in August 2000 as CFO of the Company’s outdoor advertising division, of which he became President in February 2004 prior to the division’s sale in May 2008.

The Board of Directors will continue to meet to discuss matters related to the orderly transition and is currently conducting a search for a full-time replacement for the role of Chief Executive Officer.

Mr. Ulloa was a visionary in Spanish language broadcasting with nearly five decades of experience in television, radio and digital media. He co-founded Entravision in 1996, becoming the Chairman and Chief Executive Officer of the Company, roles he held until his passing. Mr. Ulloa served as director and Chairman of Entravision’s Board of Directors since February 2000. From 1976 to 1989, Mr. Ulloa worked at KMEX-TV, Los Angeles, California as Operations Manager, Production Manager, News Director, Local Sales Manager and Account Executive. This was followed by seven successful years in development, management and ownership of Entravision’s predecessor entities.

About Entravision

Entravision is a leading global advertising, media and ad-tech solutions company connecting brands to consumers by representing top platforms and publishers. Our dynamic portfolio includes digital, television and audio offerings. Digital, our largest revenue segment, is comprised of four business units: our digital sales representation business; Smadex, our programmatic ad purchasing platform; our branding and mobile performance solutions business; and our digital audio business. Through our digital sales representation business, we connect global media companies such as Meta, Twitter, TikTok and Spotify with advertisers in primarily emerging growth markets worldwide. Smadex is our mobile-first demand side platform, enabling advertisers to execute performance campaigns using machine learning. We also offer a branding and mobile performance solutions business, which provides managed services to advertisers looking to connect with global consumers, primarily on mobile devices, and our digital audio business provides digital audio advertising solutions for advertisers in the Americas. In addition to digital, Entravision has 49 television stations and is the largest affiliate group of the Univision and UniMás television networks. Entravision also manages 45 primarily Spanish-language radio stations that feature nationally recognized, Emmy award-winning talent. Shares of Entravision Class A Common Stock trade on the NYSE under ticker: EVC. Learn more about our offerings at entravision.com or connect with us on LinkedIn and Facebook.

Forward-Looking Statements

This press release contains certain forward-looking statements. These forward-looking statements, which are included in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, may involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results and performance in future periods to be materially different from any future results or performance suggested by the forward-looking statements in this press release. Although the Company believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that actual results will not differ materially from these expectations, and the Company disclaims any duty to update any forward-looking statements made by the Company. From time to time, these risks, uncertainties and other factors are discussed in the Company’s filings with the Securities and Exchange Commission.

Christopher T. Young
Interim Chief Executive Officer
Entravision
310-447-3870

Kimberly Esterkin
Addo Investor Relations
310-829-5400
evc@addo.com

Source: Entravision

Release – Schwazze Ends 2022 Strong With Additional Cannabis Dispensary Opening In New Mexico, Bringing R.Greenleaf Dispensary Store Count To 16

Posted on by cpatches

Research News and Market Data on SHWZ

DENVER, Jan. 3, 2023 /CNW/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), a premier vertically integrated, multi-state operating cannabis company with assets in Colorado and New Mexico, announces the grand opening of its adult-use dispensary, R.Greenleaf, located in Alamogordo, New Mexico. The new store, located at 101 N. White Sands Blvd in Alamogordo, officially opened its doors for business on December 29, 2022. Store operating hours are 9a to 9p Monday through Saturday; 9a to 8p on Sunday. 

   

The Alamogordo R.Greenleaf store opening continues the intentional expansion throughout the state of New Mexico and comes on the heels of a total of five R.Greenleaf store openings since Schwazze’s acquisition in February 2022. This brings R.Greenleaf’s total number of New Mexico retail dispensaries to 16. All locations serve the needs of medical patients as well as recreational adult-use consumers.

“We are excited to open up our sixth R.Greenleaf dispensary since late September, this one specifically in Alamogordo. The team has been hard at work to get this completed in time for the holiday season to serve this local community,” said Steve Pear, New Mexico Division President for Schwazze. “R.Greenleaf, offering a wide variety of quality products serviced by top-notch, knowledgeable staff, has grown from 10 locations to now 16 in New Mexico since Schwazze purchased the retail banner earlier this year.”

R.Greenleaf Alamogordo will also offer introductory pricing on flower, edibles, and vapes. Enrollment in the Gratify Rewards customer loyalty program, which can be used at any Schwazze-owned retail dispensary in either New Mexico or Colorado, is already open.

Alamogordo Store Location

R.Greenleaf
101 N. White Sands Blvd
Alamogordo, NM 88310

Since April 2020, Schwazze has acquired, opened or announced the planned acquisition of 41 cannabis retail dispensaries as well as seven cultivation facilities and two manufacturing plants in Colorado and New Mexico. In May 2021, Schwazze announced its Biosciences division and in August 2021 it commenced home delivery services in Colorado.

About Schwazze

Schwazze (OTCQX: SHWZ  NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to consummate the acquisition described in this press release or to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses, including the acquisition described in this press release, and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, and (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

Release – PDS Biotech Announces Exclusive Global License Agreement for Investigational IL-12 Tumor-Targeted Cytokine from Merck KGaA, Darmstadt, Germany

Posted on by cpatches

Research News and Market Data on PDSB

PDS Biotech bolsters immuno-oncology portfolio with a clinical-stage product synergistic with its Versamune® platform

PDS Biotech to host conference call and webcast on Tuesday, January 3, 2023, at 8:00 AM EST

FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301. M9241 appears to enhance the proliferation, potency and longevity of T cells in the tumor. The combination of Versamune® and IL-12 is patented by PDS Biotech and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.

Under the terms of the agreement, PDS Biotech will receive from Merck KGaA, Darmstadt, Germany an exclusive license to M9241. PDS Biotech will assume responsibility for future development, commercialization, and manufacturing of M9241.

Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will receive an upfront cash payment of $5 million and will be entitled to up to $11 million in development and regulatory milestone payments including first commercial sales for the first 2 indications, and up to $105 million in commercial milestones, and a 10% royalty on future sales of M9241 with standard step-down provisions. Merck KGaA will receive 378,787 shares of PDS Biotech’s common stock having a value of $5 million, based on the closing price of PDS Biotech’s common stock on December 30, 2022.

“We are pleased to have partnered with Merck KGaA, Darmstadt, Germany to advance the development of M9241, a highly innovative cytokine therapy,” said Dr. Frank Bedu-Addo, PDS Biotech CEO. “Under the licensing arrangement between Merck KGaA, Darmstadt, Germany and PDS Biotech, assumption of an equity stake by Merck KGaA, Darmstadt, Germany in PDS Biotech further confirms the potential of the Versamune® platform and the data generated to date with this combination therapy. I’d like to thank the Merck KGaA, Darmstadt, Germany team for their support of PDS Biotech’s mission to potentially offer more cancer patients improved treatment options.”

M9241 was studied in a novel triple combination at the National Cancer Institute in a Phase 2 trial (NCT04287868) in combination with PDS0101, a Versamune® based HPV16-targeted immunotherapy, and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β). The triple combination was studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy.

Data highlights for patients who had failed prior treatments including CPIs:

  • Median overall survival for treated patients is 21 months in 29 CPI refractory patients. The reported historical median OS in patients with CPI refractory disease is 3-4 months.
  • 63% (5/8) of treated patients with the optimal dose combination had significant tumor shrinkage of over 30% (objective response). With the standard of care, the reported percentage of patients having an objective response is less than 10%.
  • 79% (11/14) of treated patients demonstrated a greater than two-fold increase in HPV16-targeted T cells.

Results for patients who had failed prior treatments but were CPI-naïve also continue to appear to be encouraging:

  • 88% (7/8) of CPI naïve patients had an objective response.
  • 38% (3/8) of responders had a complete response.
  • In CPI naïve subjects, 75% (6/8) remain alive at a median follow-up of 27 months. As a result, median OS has not yet been reached. Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.

PDS Biotech has a scheduled meeting with the Food and Drug Administration (FDA) to discuss a registrational trial for investigating the triple combination of M9241, PDS0101 and a checkpoint inhibitor in recurrent/metastatic HPV-positive cancers.

Dr. Lauren V. Wood, Chief Medical Officer at PDS Biotech, commented, “M9241 seems to be unique in its ability to target the tumor’s microenvironment and appears to further promote proliferation of Versamune®-induced T cells in the tumors while also potentially enhancing the killing potency of the T cells. With the addition of M9241 to our Versamune®-based pipeline products, our goal is to develop and achieve checkpoint inhibitor-agnostic and independent combinations in advanced cancers. We look forward to expanding clinical development of our novel investigational combination products.”

Conference Call and Webcast
PDS Biotech will host a conference call and webcast on Tuesday, January 3, 2023, beginning at 8:00 AM EST. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13734890. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months. 

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® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. 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 PDS0301
PDS0301 is a tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor. Together with Versamune® based immunotherapies, PDS0301 works to promote a targeted T cell attack against cancers and also overcome tumor-induced immune suppression. Clinical data suggest this combination may demonstrate significant disease control by shrinking tumors and/or prolonging survival in recurrent/metastatic cancers with poor survival prognosis. A National Cancer Institute-supported Phase 2 clinical study of PDS0301 in a triple combination therapy is being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers.

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 our 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; the success of the Company’s license agreements, including the potential for the clinical and nonclinical data available under the Company’s exclusive license agreement with Merck KGaA to aid in the development of the Versamune® platform; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

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

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

Media Contacts:
Bill Borden
Tiberend Strategic Advisors, Inc.
Phone: +1 (732) 910-1620
Email: bborden@tiberend.com

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

Release – Tonix Pharmaceuticals to Present at Biotech Showcase 2023

Posted on by cpatches

Research News and Market Data on TNXP

CHATHAM, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at Biotech Showcase 2023 being held January 9-11, 2023, at the Hilton San Francisco Union Square.

Details of the Tonix presentation are as follows:

Event:Biotech Showcase 2023
Date:Tuesday, January 10, 2023
Time:3:00 p.m. PT (6:00 p.m. ET)
Location:Hilton San Francisco Union Square
Track:Yosemite C (Ballroom Level)

A live webcast and subsequent archived recording of the Company presentation will be available under the IR Events tab of the Investors section of the Tonix Pharmaceuticals website at www.tonixpharma.com or can be found here. Investors interested in arranging a meeting with the Company’s management during the conference should contact Brandon.Weiner@Westwicke.com.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801, a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

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

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com 
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Released January 3, 2023

Metals & Mining Fourth Quarter 2022 Review and Outlook

Posted on by cpatches

Monday, January 03, 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 fourth quarter, mining companies (as measured by the XME) appreciated 17.2% compared to a gain of 7.1% for the S&P 500 index. The VanEck Vectors Gold Miners (GDX) and Junior Gold Miners (GDXJ) ETFs were up 18.8% and 21.0%, respectively. Gold, silver, copper, and lead futures prices gained 9.2%, 26.3%, 12.3%, and 6.1%, respectively, while zinc declined 1.1%. For the full year 2022, all indices outperformed the S&P 500 which declined 19.4%. Despite aggressive rate hikes by the Federal Reserve and U.S. dollar strength, gold performed as a store of value with the price ending just under where it began the year.

Will precious metals break out to the upside? The U.S. Dollar Index declined 7.7% during the fourth quarter, while the yield on the 10-year treasury note increased from 3.80% to 3.88%. While the Federal Reserve has signaled higher rates, an inflection point may have been reached as investors sought to preserve value amid deteriorating economic conditions, geopolitical uncertainty and market volatility. In our view, interest rates could peak by mid-year with the potential for easing depending on economic conditions. We think precious metals prices around current levels are sufficient for mining companies to be profitable and attract new investment. Our outlook is for range-bound pricing around current levels with a modest upward bias in the first half of 2023.

Less certain near-term outlook for industrial metals. While the price of copper declined 13.2% in 2022, the price rebounded in the fourth quarter. On a full year basis, zinc and lead prices were down 6.1% and up 1.2%, respectively. While the long-term investment case for owning industrial metals mining companies remains favorable, it may be too early to offer a bullish call due to near-term concerns about economic growth in the U.S. and abroad.

Putting it all together. In our view, precious metals mining companies, notably exploration companies, continue to offer attractive return potential. Should gold and silver prices hold recent gains, investors may begin to invest more confidently and aggressively. While the near-term outlook for industrial metals could be negatively impacted by near-term macroeconomic factors, an eventual return to economic growth could result in strong prices due to potential supply and demand imbalances.

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All statements or opinions contained herein that include the words “we”, “us”, or “our” are solely the responsibility of Noble Capital Markets, Inc.(“Noble”) and do not necessarily reflect statements or opinions expressed by any person or party affiliated with the company mentioned in this report. Any opinions expressed herein are subject to change without notice. All information provided herein is based on public and non-public information believed to be accurate and reliable, but is not necessarily complete and cannot be guaranteed. No judgment is hereby expressed or should be implied as to the suitability of any security described herein for any specific investor or any specific investment portfolio. The decision to undertake any investment regarding the security mentioned herein should be made by each reader of this publication based on its own appraisal of the implications and risks of such decision.

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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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ChitogenX Inc. (CHNXF) – FQ3 2023 Reported; Advancing The Opportunities

Posted on by cpatches


Friday, December 30, 2022

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

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

FQ3 2023 reported for the period ending October 31, 2022.  As expected, no revenues were reported by the Company yesterday.  Overall, expenses were higher than expectations, with lower than expected G&A and R&D expenses reported. Fair value adjustments in embedded derivatives, higher share based compensation and financing costs accounted for the difference in reported loss per share of $0.04 vs. our expected $0.03 loss per share. Our full fiscal year 2023 loss per share moves to $0.11 from prior $0.10.

ORTHO-R Phase I trial for rotator cuff completed. The initial portion was completed in early November.  There were no safety issues reported, opening up Phase II enrollment at all 10 clinical sites.  Phase II enrollment is now expected to be completed by end of calendar second quarter 2023, although this is a slight slippage from our earlier expectations.  Patient assessment and scoring will occur after 12-month follow-up.


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

PDS Biotechnology Corp (PDSB) – Triple Therapy Data Shows Large Improvements Over Standard of Care

Posted on by cpatches


Thursday, December 29, 2022

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

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

New Data From The Phase 2 Triple Therapy Trial Shows Better Response And Survival Data. PDS Bio announced new data from its Phase 2 trial testing PDS0101 in combination with two immunomodulating drugs. Patients with HPV16-positive cancer received the “Triple Therapy” consisting of PDS0101, an IL-12 fusion protein, and a bivalent checkpoint inhibitor. One of two arms in the trial reached its median objective survival (OS) of 21 months, an improvement over the last interim update and the historical survival of 3 to 4 months.

New Overall Survival Data Shows Improvement Over Last Interim Update. Patients enrolled in the trial had HPV16-positive cancer with progressive disease after standard therapies. Patients who received previous checkpoint inhibitor therapy  but no longer responded (checkpoint inhibitor refractory) reached a medial Overall Survival (OS) of 21 months. This compares to the last interim update of 16 months OS with 66% remaining alive. Expected survival for patients at this stage is 3 to 4 months. In the group that was naïve to checkpoint inhibitors, 75% remained alive at a median follow-up of 27 months, so the median OS has not been reached. Expected survival for similar patients is 7 to 11 months.


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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.