Month: August 2024

Release – SKYX to Collaborate with EGLO, European World Leading Design and Manufacturer of Decorative Lighting and Ceiling Fans

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on SKYX

The Collaboration Provides for the Joint Exploration and Product Development Potential for European and International markets for leveraging SKYX’s Technology, Product and Manufacturing Expertise of the Two Companies

MIAMI, Aug. 19, 2024 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive smart platform technology company with more than 97 issued and pending patents globally and over 60 lighting and home décor websites, announces a new collaboration with EGLO, an international market leading designer and manufacturer of decorative and functional lighting and ceiling fans.

The collaboration provides for the two companies to explore and evaluate the development of products that integrate SKYX’s technology for European and global markets, and the product driven needs of EGLO’s international customer base.

The collaboration is expected to further enhance SKYX’s U.S. and global market penetration through online, retail and builder segments.

SKYX’s advanced and smart technologies make homes and buildings smart and safe, while saving time, cost, and creating significant value for property developers and homeowners.

Rani Kohen, Founder and Executive Chairman of SKYX, said: “This collaboration opportunity is just another step in expanding the applicability and penetration of our technology to European and global markets and distribution channels. Aligning with industry leaders who support our vision for growth and innovation in smart home and lighting sectors is significant to our global expansion strategy.

About SKYX Platforms Corp.

As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.

Forward-Looking Statements
Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

Investor Relations Contact:

Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com

Release – Graham Corporation Announces Groundbreaking Ceremony for $17.6 Million Manufacturing Facility on Batavia, New York Campus

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GHM

New 29,000 square foot building will create 24 new full-time positions; expect to begin commercial operation summer of 2025

BATAVIA, N.Y.–(BUSINESS WIRE)– Graham Corporation (NYSE: GHM) (“GHM” or “the Company”), a global leader in the design and manufacture of mission critical fluid, power, heat transfer, and vacuum technologies for the defense, space, energy, and process industries, announced that its operating company, Graham Manufacturing, will hold a groundbreaking ceremony today for its new 29,000-square-foot facility in Batavia, NY. This event marks a significant milestone in the Company’s ongoing growth and commitment to serving its customers and the community. The project represents a total investment of approximately $17.6 million, which includes a strategic investment of $13.5 million from one of the Company’s valued customers, with the remaining investment provided by Graham.

State and local officials will join Graham’s executive leadership and construction managers in turning the first ceremonial shovels of dirt, officially launching the building project.

The construction of the new facility is expected to be completed over the next twelve months with operations beginning shortly thereafter. The building will be equipped with state-of-the-art technology and designed with sustainability in mind, aligning with Graham’s broader environmental goals.

Dan Thoren, Graham Corporation President and Chief Executive Officer, commented, “Our new facility will play a key role in enhancing our operational capabilities, providing the expanded capacity to accelerate production to meet our customers’ growing requirements, particularly the U.S. Navy. Moreover, it will enable us to make a positive impact on the Batavia community. Once operational, the expanded operations are expected to create 24 new full-time skilled positions, reinforcing our commitment to job creation and community development.”

U.S. Senator Charles Schumer said, “Graham’s Batavia, NY workforce and the products they make are integral to supporting our nation’s national defense, and today’s $18 million expansion doubles down on their world-class work as a strategic supplier for the U.S. Navy. I’ve been proud to secure vital federal funding for the U.S. Navy’s Submarine and Aircraft Carriers Industrial Base supply chain that the Navy relies on to purchase technology and equipment made right here in Batavia by Graham’s existing 367-employee local workforce. This not only supports these local jobs, but enables the new 24-job $18 million expansion that we break ground on today. With today’s expansion, I commend Graham for setting sail to reach new horizons not only in this company’s growth but in support of our national defense.”

Claudia Tenney, U.S. Representative for New York’s 24th Congressional District, said, “Congratulations to Graham Corporation on breaking ground on this new manufacturing facility here in Batavia. Graham Corporation’s commitment to creating quality and innovative technologies for our military and providing 24 new job opportunities in our community is commendable. I am eager to witness the continued growth and positive impact Graham Corporation will have in our community and around the world.”

Graham is working with Ciurzynski Consulting, Montante Construction and Wolfe Architecture to design and build the advanced manufacturing facility.

About Graham Corporation

Graham is a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy, and process industries. Graham Corporation and its family of global brands are built upon world-renowned engineering expertise in vacuum and heat transfer, cryogenic pumps, and turbomachinery technologies, as well as its responsive and flexible service and the unsurpassed quality customers have come to expect from the Company’s products and systems. Graham Corporation routinely posts news and other important information on its website, grahamcorp.com, where additional information on Graham Corporation and its businesses can be found.

Safe Harbor Regarding Forward Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “will,” and other similar words. All statements addressing operating performance, events, or developments that Graham Corporation expects or anticipates will occur in the future, including but not limited to, timing on the completion of construction, potential expansion of operations, potential job creation, the timing on beginning new operations, and delivering timely or otherwise on schedule are forward-looking statements. Because they are forward-looking, they should be evaluated in light of important risk factors and uncertainties. These risk factors and uncertainties are more fully described in Graham Corporation’s most recent Annual Report filed with the Securities and Exchange Commission, including under the heading entitled “Risk Factors,” its quarterly reports on Form 10-Q, and other filings it makes with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize or should any of Graham Corporation’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on Graham Corporation’s forward-looking statements. Except as required by law, Graham Corporation disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this news release.

Christopher J. Thome
Vice President – Finance and CFO
Phone: (585) 343-2216

Deborah K. Pawlowski
Kei Advisors LLC
Phone: (716) 843-3908
dpawlowski@keiadvisors.com

Source: Graham Corporation

Released August 19, 2024

Release – Gray Media Announces Coverage Plans for 2024 Democratic National Convention

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GTN

ATLANTA, Aug. 19, 2024 (GLOBE NEWSWIRE) — Gray Media (NYSE: GTN) today announced comprehensive coverage plans for the 2024 Democratic National Convention.  

Starting Monday, August 19, through the conclusion of the convention on Thursday, August 22, Gray’s Washington DC Bureau and news teams from 13 Gray affiliates will report from Chicago on the local impact of the presidential and vice presidential nomination process and the Democratic party platform.   Coverage will be carried on Gray’s local affiliates and Local News Live, Gray’s national news network that provides live streaming coverage on more than 500 Gray station websites, connected TV apps, and mobile apps.

“The combined reporting power of Local News Live, the DC Bureau, and Gray newsrooms will provide substantial DNC coverage with a unique local perspective to our 113 markets across the country,” Gray’s Chief Operating Officer Sandy Breland said.  

All Gray-owned Wisconsin news operations will send reporting teams to the convention, including WMTV in Madison, WBAY in Green Bay, WEAU in Eau Claire, WSAW in Wausau, and KBJR in Superior (Duluth).  In addition, news crews from Gray affiliates WANF in Atlanta, Georgia, AZ Family in Phoenix, Arizona, WNDU in South Bend, Indiana, KHNL in Honolulu, Hawaii, WCAX in Burlington, Vermont, KTTC in Rochester, Minnesota, KEYC in Mankato, Minnesota, and KVLY in Fargo, North Dakota will be on site to provide daily coverage.

“We are dedicated to covering the biggest stories through a local lens,” explained Lisa Allen, General Manager of Gray’s Washington Operation. “With journalists in more than 100 markets, Gray’s teams can cover more ground than any other news source through Election Day.”

About Gray Media:

Gray Media, or Gray, is a multimedia company headquartered in Atlanta, Georgia, formally known as Gray Television, Inc.  The company is the nation’s largest owner of top-rated local television stations and digital assets serving 113 television markets that collectively reach approximately 36 percent of US television households. The portfolio includes 77 markets with the top-rated television station and 100 markets with the first and/or second highest rated television station, as well as the largest Telemundo Affiliate group with 43 markets totaling nearly 1.5 million Hispanic TV Households.  The company also owns Gray Digital Media, a full-service digital agency offering national and local clients digital marketing strategies with the most advanced digital products and services.  Gray’s additional media properties include video production companies Raycom Sports, Tupelo Media Group, and PowerNation Studios, and studio production facilities Assembly Atlanta and Third Rail Studios. Gray owns a majority interest in Swirl Films. For more information, please visit www.graymedia.com.

Gray Contact:

Sandy Breland, Executive Vice President, Chief Operating Officer, 404-266-8333

Release – Tonix Pharmaceuticals Reports Second Quarter 2024 Financial Results and Operational Highlights

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on TNXP

On track to submit NDA in second half 2024 for TNX-102 SL for fibromyalgia; completed successful pre-NDA meetings with FDA in second quarter 2024

FDA granted Fast Track designation for TNX-102 SL for fibromyalgia

Commercial planning continues for U.S. launch of TNX-102 SL, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia

U.S. Department of Defense contract awarded for up to $34 million over 5 years to develop a broad-spectrum antiviral drug

World Health Organization (WHO) recently declared spread of mpox in multiple African countries a public health emergency of international concern – Tonix’s TNX-801 is an mpox vaccine in development which protects animals against lethal challenge of monkeypox virus

CHATHAM, N.J., Aug. 19, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced financial results for the second quarter ended June 30, 2024, and provided an overview of recent operational highlights.

“In the second quarter of 2024, we made significant progress advancing our New Drug Application (NDA) and market access strategy for TNX-102 SL (cyclobenzaprine HCl sublingual tablets),” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We are working diligently on the regulatory submission and are pleased to have been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and to be in alignment with the agency regarding the content of our proposed NDA package. Fast Track is designed to facilitate the development and expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. We are hopeful that TNX-102 SL can be the first new drug to treat fibromyalgia in more than 15 years.”

Dr. Lederman continued, “Additionally, we continue to advance other key pipeline candidates through a capital efficient strategy, including TNX-4200, our broad-spectrum antiviral program for which we were awarded up to $34 million over five years from the U.S. Department of Defense (DoD) to advance its development.”

Recent Highlights – Key Product Candidates*

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual tablets): a centrally-acting, non-opioid, analgesic taken once-daily at bedtime for the management of fibromyalgia.

  • In July 2024, the FDA granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. The designation validates that fibromyalgia is a serious condition and that TNX-102 SL has the potential to address this unmet medical need. The Company continues to guide for submission of the NDA for TNX-102 SL in the second half of 2024 which would allow for a potential FDA approval in 2025.
  • In July 2024, Tonix announced that, based on the new definition of Long COVID by the U.S. National Academies of Sciences, Engineering and Medicine (NASEM), fibromyalgia is a ‘diagnosable condition’ in people suffering from Long COVID. The Company believes that diagnosing fibromyalgia in Long COVID patients will increase the potential market for TNX-102 SL following approval as compared to market estimates from before the COVID-19 pandemic.
  • During the second quarter, Tonix successfully completed two positive pre-NDA meetings with the FDA for TNX-102 SL for the management of fibromyalgia. The first, with minutes announced in June 2024, was a Type B Chemistry, Manufacturing, and Controls (CMC) meeting to seek alignment and agreement with the FDA on key CMC topics to support the planned NDA submission for TNX-102 SL. Based on formal meeting minutes, the Company believes it is aligned with the FDA on proposed drug substance and drug product commercial specifications, shelf life assignment, manufacturing and commercial drug packaging. At the second pre-NDA meeting announced in July 2024, the Company and the FDA aligned on nonclinical, clinical pharmacology and clinical matters and agreed that the proposed data package is sufficient to support the NDA submission.
  • In June 2024, at the American Society of Clinical Psychopharmacology (ASCP) meeting the Company presented new, additional data on TNX-102 SL, highlighting improvement in depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) as well as improvements in anxiety, memory and energy items on the Fibromyalgia Impact Questionnaire-Revised (FIQR). Depression was frequent among patients enrolled in the Phase 3 RESILIENT study, as ~47% reported experiencing depression within the past six months upon fibromyalgia diagnosis and ~25% of the intent-to-treat (ITT) population had experienced a lifetime major depressive episode (MDE). However, by Week 14 of the trial, the total BDI-II score in the TNX-102 SL group improved over placebo with a nominal p-value of 0.005 and an effect size of 0.27. On the FIQR, exploratory analyses uncorrected for multiplicity demonstrated improvement in the TNX-102 SL group over placebo in depression (p < 0.001), anxiety (p = 0.001), sensitivity (p = 0.020), memory problems (p = 0.001) and energy (p < 0.001). TNX-102 SL was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablet under the tongue. Together these findings provide further support that TNX-102 SL has broad-spectrum activity against fibromyalgia symptoms and may improve fibromyalgia at the syndromal level.
  • EVERSANA® Life Science Services, LLC, a leading provider of commercialization services to the global life sciences industry, completed the initial phase of an assessment of the U.S market opportunity for TNX-102 SL. Tonix had previously announced that EVERSANA was selected to support the launch strategy and commercial planning of TNX-102 SL. Specifically, EVERSANA is working with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market strategy. EVERSANA conducted primary research, analyzed potential market size, surveyed currently marketed treatment options and their market shares and interviewed physicians for feedback regarding the currently prescribed treatments and their interest in TNX-102 SL as a potential new treatment option. This physician feedback demonstrated high levels of dissatisfaction with currently prescribed drugs, a high unmet need for their fibromyalgia patients, and high levels of interest in TNX-102 SL’s favorable activity and tolerability profile. Further analysis showed that addictive opioids are prescribed more frequently than the currently approved drugs following fibromyalgia diagnosis. Physicians also indicated they would intend to use TNX-102 SL in 40% of their fibromyalgia patients.1

TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

  • In May 2024, Tonix announced a plan for a Phase 2, investigator-initiated OASIS trial, designed to examine the safety and efficacy of TNX-102 SL in treating Acute Stress Disorder (ASD) after motor vehicle collision. The trial is sponsored by the University of North Carolina Institute for Trauma Recovery and supported by a $3 million contract from the DoD, which was awarded in September 2023.   TNX-102 SL will be evaluated for the reduction in severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in civilians after a motor vehicle collision. Previous trials of TNX-102 SL showed that it reduced military PTSD symptoms within two weeks while evidencing similar favorable tolerability as in fibromyalgia patients.
  • Tonix expects to enroll the first patient in the Phase 2 OASIS trial in the third quarter of 2024.

TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication

  • Tonix expects to initiate a Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in emergency rooms in the third quarter of 2024. In 2022, Tonix was awarded a Cooperative Agreement grant from the National Institutes of Health (NIH)’s National Institute of Drug Abuse (NIDA) to support development of TNX-1300.
  • TNX-1300 has been granted Breakthrough Therapy designation by the FDA.  

TNX-1900 (intranasal potentiated oxytocin): small peptide in development through investigator-initiated studies for adolescent obesity, binge eating disorder (BED), bone health in autism and social anxiety disorder (SAD).

  • TNX-1900 continues to be studied in four ongoing investigator-initiated Phase 2 studies. There are three studies at Massachusetts General Hospital: the POWER study for the treatment of adolescent obesity, the STROBE study for the treatment of BED, and the BOX study for the treatment of bone health in pediatric autism. In addition, Tonix is conducting an investigator-initiated study of TNX-1900 for the treatment of SAD at the University of Washington.

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)

  • In March 2024, Tonix announced that it received Rare Pediatric Disease designation from the FDA for TNX-2900 for the treatment of PWS. Tonix has an investigational new drug (IND) to support clinical development of TNX-2900 to treat PWS in children and adolescents, including a planned Phase 2, dose-finding study involving approximately 36 PWS patients. TNX-2900 for the treatment of PWS was granted Orphan Drug designation by the FDA in 2022. PWS is a rare genetic disorder which causes cognitive and behavioral symptoms including pathological over-eating in childhood, which leads to severe metabolic sequelae in adolescence and adulthood.

Immunology Pipeline

TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.

  • The first proposed indication for TNX-1500 is prophylaxis of organ rejection in adult patients receiving a kidney transplant; but multiple additional indications are possible, including autoimmune diseases. Preclinical studies have shown that TNX-1500 maintains the activity of first-generation monoclonal antibodies (mAbs), yet with reduced risk of thrombotic complications.2-4 Modeling studies from animal pharmacokinetic data2 predict a half-life of greater than three weeks for TNX-1500 in humans, which supports a monthly i.v. dosing regimen5,6. This analysis together with TNX-1500’s activity and tolerability in animals, suggests that the protein engineering of TNX-1500’s Fc region has achieved its design goals.
  • In June 2024, at the American Transplant Congress 2024, Tonix announced data demonstrating the combined use of TNX-1500 and anti-CD28 monoclonal antibody, VEL-101 is associated with durable protection and graft survival and function in a nonhuman primate model. Further data demonstrated that TNX-1500 has promise to prevent rejection of 9-, or 10-gene-edited (GE) pig hearts.7,8 All research has been directed by the faculty of the Center for Transplantation Sciences at Massachusetts General Hospital.
  • Tonix completed the clinical stage of its Phase 1 single ascending dose study of TNX-1500 in healthy volunteers. The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous TNX-1500. This first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients.

Infectious Disease Pipeline

TNX-4200 (orally available CD45 antagonist), TNX-3900 (cathepsin inhibitor), TNX-4000 (glycan-targeted biologic)

  • Tonix is developing potential broad-spectrum antiviral drugs in three programs: CD45-targeted therapeutics (TNX-4200), cathepsin inhibitors (TNX-3900) and viral glycan-targeted engineered biologics (TNX-4000).
  • In July 2024, the Company announced that the DoD’s Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA). The objective of the contract is to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. The $34 million five-year contract will help fund and accelerate the development of Tonix’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. The Company’s program will focus on optimization and development of its TNX-4200 program, to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an IND submission and to fund a first-in-human Phase 1 clinical study.

TNX-801 (recombinant horsepox virus, live vaccine): potential vaccine to protect against mpox disease and smallpox.

  • In June 2024, Tonix announced data at an oral keynote presentation at the Vaccine Congress 2024, detailing the company vaccine platform, including TNX-801 (horsepox, live virus) vaccine for preventing mpox (formerly known as monkeypox). TNX-801 is a live replicating attenuated vaccine based on horsepox that is believed to provide immune protection with better tolerability than modern vaccinia viruses. In the data, Tonix highlighted positive preclinical efficacy, demonstrating that TNX-801 protected non-human primates against lethal challenge with intratracheal Clade 1 monkeypox virus.9 After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates. These findings are consistent with mucosal immunity and suggest the ability to block forward transmission.  
  • The WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern, the second such declaration in the past two years called in response to transmission of the virus.
  • Mpox is epidemic in Central Africa and experts fear the new Clade 1 strain may spread to the U.S.
  • The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency.

TNX-1800 (modified recombinant horsepox virus, live vaccine): potential vaccine to protect against COVID-19 designed to express the SARS-CoV-2 spike protein

  • In June 2024, the Company announced preclinical data, demonstrating immunity and tolerability, during an oral keynote talk at the Vaccine Congress 2024.10,11 Like TNX-801, TNX-1800 is a live replicating attenuated vaccine based on horsepox that is believed to provide immune protection with better tolerability than modern vaccinia viruses. TNX-1800 was selected by the NIH’s Project NextGen for inclusion in clinical trials as part of a select group of next generation COVID-19 vaccine candidates with the intent to identify promising vaccine platforms. NIH plans to conduct a Phase 1 trial and cover the full cost, while Tonix provides the vaccine candidate.

Marketed Products – Recent Highlights

  • As of April 1, 2024, Tonix completed the transition to becoming a fully integrated biopharmaceutical company. Tonix Pharmaceuticals has implemented personnel, systems and contracts required to support a commercial organization and has assumed responsibility for distribution, selling and marketing of Zembrace SymTouch® and Tosymra®, as well as supply chain, regulatory and quality control of the two products.
  • In June 2024, the Company presented data at the 66th Annual Scientific Meeting of the American Headache Society (AHS) comparing real-world data with real-world usage of non-oral migraine products with the most recent AHS consensus statement. This data stressed the need for customizing treatment of migraine headaches to the needs of patients. Thus far, real world data show that conformity with the guidelines and the consensus statement have yet to be achieved but has the potential to be increased. The data show the use of non-oral drugs for treating an acute migraine attack was only 7% in 2012 and has decreased to below 4% in 2023, when the potential need for such drugs is anticipated to be a more substantial percentage of migraineurs based on epidemiological data.

TNX-102 SL has not been approved for any indication.

1EVERSANA primary physician research, May 2024; commissioned by Tonix

2Lassiter G., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.022

3Miura S., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025

4Anand RP., et al. Nature. 2023:622, 393–401. https://doi.org/10.1038/s41586-023-06594-4

5Deng R., et al. Mabs. 2011. https://doi.org/10.4161/mabs.3.1.13799

6Tonix Pharmaceuticals – Data on File

7Revivicor 9-GE pigs: GalKO.β4GalNT2KO.GHRKO.hCD46.hCD55.hTBM.hEPCR.hCD47.hHO-1

8 Revivicor 10-GE pigs: GalKO.β4GalNT2KO.CMAHKO.GHRKO.hCD46.CD55.hTBM.hEPCR.hCD47.hHO-1.

9Noyce RS, et al. Viruses. 2023;15(2):356. doi:10.3390/v15020356.

10Awasthi M., et al. Viruses. 2023;15(10):2131. doi:10.3390/v15102131.

11Awasthi M., et al. Vaccines (Basel). 2023;11(11):1682. doi:10.3390/vaccines11111682.

      Recent Highlights – Financial

As of June 30, 2024, Tonix had $4.2 million of cash and cash equivalents, compared to $24.9 million as of December 31, 2023. Net cash used in operations was approximately $30.5 million for the six months ended June 30, 2024, compared to $56.3 million for the same period in 2023.

Subsequent to the quarter ending June 30, 2024, Tonix received net proceeds of approximately $3.5 million in a securities purchase agreement with certain institutional and retail investors, and sold 0.8 million shares of common stock under the ATM Sales Agreement, for net proceeds of approximately $0.4 million.

Second Quarter 2024 Financial Results

Net product revenue for the second quarter 2024 was approximately $2.2 million. Net product revenue consisted of combined net sales of Zembrace® SymTouch® and Tosymra®, which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of Sales for the second quarter 2024 was approximately $3.4 million, which included a write-down related to Tosymra and Zembrace finished goods inventory of approximately $1.7 million based on an assessment of inventory on hand and projected sales prior to the respective expiration dates.

Research and development expenses for the second quarter 2024 were $9.7 million, compared to $22.0 million for the same period in 2023. This decrease is predominantly due to decreased clinical, non-clinical and manufacturing expenses aligned with the Company’s capital efficient strategy.

Selling, general and administrative expenses for the second quarter 2024 were $7.5 million, compared to $7.0 million for the same period in 2023. The increase was primarily due to sales and marketing and the transition services expenses associated with the Company’s recently acquired marketed products offset by a decrease in financial reporting expenses.

Net loss available to common stockholders was $78.8 million, or $19.28 per share, basic and diluted, for the second quarter 2024, compared to net loss of $28.4 million, or $49.23 per share, basic and diluted, for the same period in 2023. Included in the net loss for the three months ended June 30, 2024, are non-cash asset impairment charges totaling $58.9 million. The basic and diluted weighted average common shares outstanding for the second quarter 2024 was 4,085,132 compared to 576,047 shares for the same period in 2023.

The impairment of the Tosymra and Zembrace inventory, intangibles and goodwill was driven by our delayed investment in the sales personnel required to drive growth in the business as we are focusing our cash resources to further our efforts to bring TNX-102 SL through the FDA approval process and to market. However, we believe that the benefits and long-term value proposition of the 2023 acquisition of Tosymra and Zembrace remain, in that we now have the infrastructure to be ready to manufacture and sell TNX-102 SL under an expedited timeline pending FDA approval for which we expect an FDA decision in 2025.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD, instrumental in progressing this development. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

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GeoVax Labs (GOVX) – Raising Price Target To $10 Based On Program Progress

Posted on by cpereira@noblefcm.com


Monday, August 19, 2024

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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

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

GeoVax Has Made Substantial Clinical and Manufacturing Process. We are raising our Price Target on GEOX to $10 based on the recent progress that has driven the stock through our previous $6 target. The company recently announced a DARPA grant for CM04S1 and its Phase 2 plans for Gedeptin in HNSCC. Last week, Mpox news highlighted recent advances in GeoVax’s manufacturing platform and its MVA-based vaccine for smallpox and Mpox.

Mpox News Draws Attention To GeoVax’s MVA Manufacturing Platform. On August 14, WHO declared Mpox to be a “public health emergency of international concern”, or PHEIC, due to a new type of Mpox (formerly monkeypox) spreading in West Africa. The new type is more infectious and more fatal than the type seen 2022. The previous virus spread through sexual contact (bodily fluids), while the current strain has also spread to health care workers through contact with patients’ clothing and bedding.


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

*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. 

Wall Street Rallies: Stocks Poised for Best Week of 2024 as Recession Fears Fade

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– S&P 500 and Nasdaq on track for seventh consecutive day of gains
– Markets recovering from recent downturn, buoyed by positive economic data
– Investors eye Jackson Hole symposium for insights on Fed’s rate cut trajectory

Wall Street is gearing up to close its most impressive week of 2024, with major indices rebounding strongly as concerns about an economic slowdown dissipate. The S&P 500 and Nasdaq are set to mark their seventh straight day of gains, erasing losses from a recent market tumble and signaling renewed investor confidence.

This remarkable turnaround comes on the heels of encouraging economic data that has alleviated fears of an imminent recession. The week’s positive momentum has been fueled by reports indicating that inflation continues to trend downward towards the Federal Reserve’s target, while American consumer spending remains robust.

Oliver Pursche, senior vice president at Wealthspire Advisors, commented on the market’s resilience: “It has been a great week, and it has been a great year. There’s been some volatility, but major indices are all up nicely. What we saw a couple weeks ago was the market blowing off some steam.”

The rally has been broad-based, with the financial sector leading gains among S&P 500 components. However, not all sectors have participated equally, with real estate showing some weakness. This divergence highlights the nuanced nature of the current market environment, where investors are carefully weighing various economic indicators and sector-specific factors.

Looking ahead, market participants are eagerly anticipating the upcoming Jackson Hole Economic Symposium. This annual gathering of global central bank officials, scheduled for next week, could provide crucial insights into future monetary policy decisions. Federal Reserve Chair Jerome Powell’s keynote speech on Friday is expected to be a focal point, potentially setting expectations for the U.S. interest rate trajectory.

Austan Goolsbee, President of the Federal Reserve Bank of Chicago, has already set a dovish tone, cautioning against maintaining restrictive policy longer than necessary. This sentiment, coupled with recent economic data, has led to increased speculation about potential rate cuts. According to CME’s FedWatch tool, there’s a 74.5% probability that the Fed will implement a 25 basis point cut at its September meeting.

The market’s optimism is reflected in the performance of major indices. As of early afternoon trading, the Dow Jones Industrial Average was up 0.27%, the S&P 500 gained 0.21%, and the Nasdaq Composite added 0.25%. These gains put all three indices on track for their most substantial weekly percentage increases since October.

Despite the overall positive sentiment, some individual stocks faced headwinds. Applied Materials saw its shares decline by 1.7% despite forecasting stronger-than-expected fourth-quarter revenue. Similarly, packaging company Amcor’s U.S.-listed shares dropped 4.9% following a larger-than-anticipated decline in fourth-quarter sales.

As the trading week draws to a close, the market’s resilience in the face of recent volatility has been noteworthy. The shift from recession fears to recovery hopes underscores the fluid nature of investor sentiment and the importance of economic data in shaping market narratives.

With the Jackson Hole symposium on the horizon, investors will be keenly watching for any signals that might influence the Fed’s approach to monetary policy. The coming weeks could prove crucial in determining whether this rally has staying power or if new challenges lie ahead for Wall Street.

Release – Comtech Relocates Corporate Headquarters to Chandler, AZ

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on CMTL

Arizona Governor, Chandler Mayor, and Local Leaders to Attend August 16 Ribbon Cutting to Celebrate the Relocation of Comtech’s Headquarters to Arizona

CHANDLER, Ariz. – Aug. 16, 2024– Comtech (NASDAQ: CMTL) (the “Company”), a global technology leader, today announced the relocation of its corporate headquarters from Melville, NY to Chandler, AZ. Comtech’s new corporate headquarters in Chandler boasts approximately 150,000 square feet of state-of-the-art office, engineering and manufacturing space that is designed to enhance operations, improve collaboration and accelerate the delivery of new technologies, systems and services to a variety of customers across global markets.

The decision to relocate Comtech’s headquarters to Chandler, first disclosed in March 2024, is rooted in the Company’s continued commitment to optimizing its corporate infrastructure and enhancing Comtech’s culture of innovation. The City of Chandler is already home to several of Comtech’s largest customers and provides easy access to a leading technology corridor that is renowned for yielding the talent needed to develop and execute the Company’s vision, which is centered on delivering trusted and resilient communications solutions to commercial and government customers across the globe.

“Chandler has established itself as a leading technology corridor in the United States,” said John Ratigan, Interim CEO of Comtech. “We are thrilled to expand our footprint in Arizona and excited to benefit from the City of Chandler’s continued commitment to innovation. This strategic move marks a significant milestone for the Company, and our new headquarters will play a central role in helping Comtech deliver new resilient, network agnostic, software-defined communications capabilities to some of the world’s most demanding customers, including the Department of Defense (“DoD”).”

To mark the milestone, the company will host a formal ribbon cutting ceremony today with Arizona Governor, Katie Hobbs, Chandler Mayor, Kevin Hartke, and other Arizona business and community leaders. While Comtech started welcoming employees to its new Chandler office in 2023, the Company has had a presence in Arizona and served local commercial, defense and government customers for over 25years.

“Today marks a momentous day for Arizona as we welcome Comtech, a leading global technology company, to its new home in Chandler,” said Arizona Governor Katie Hobbs. “Comtech’s Chandler headquarters will bring enhanced economic growth opportunities and highlights Arizona’s attractive business environment and reputation as a top hub for innovation and technology. We are proud to support Comtech in their new chapter and look forward to supporting Comtech’s success in Arizona.”

The technologies, solutions and services developed at Comtech’s Chandler headquarters currently serve a variety of commercial and government customers, including the U.S. government, the DoD, humanitarian agencies, satellite service providers, some of the nation’s largest cellular carriers, cruise lines, and emergency response agencies, among others. New offerings being developed at Comtech’s Chandler headquarters are designed to expand access to new connectivity services; connect the end users in some of the world’s most challenging geographic regions; and empower customers with new, integrated communications capabilities that can significantly enhance decision making capabilities when seconds matter most.

“I am thrilled that Comtech has chosen Chandler as the site for their new global headquarters,” said U.S. Representative Greg Stanton. “The investment Comtech is making in our community underscores the potential they see in our workforce, our infrastructure, and our economic climate. With over 50 years of technology leadership across global satellite, space, terrestrial, and wireless markets, Comtech is uniquely positioned to lead the way in connecting the unconnected and empowering the world with new technologies and services.”

Comtech is committed to continuing to enhance the Chandler community through local partnerships, strategic sponsorships and workforce development programs. Over the past two years, a variety of Arizona students participated in the Company’s summer internship program. In February, in partnership with the Society of Women Engineers at Arizona State University, Comtech sponsored and participated in the annual Chandler Innovation Fair. Last October, the Chandler Chamber of Commerce recognized Comtech as one of the Top 100 businesses in the city. And in March 2023, Comtech hosted its first-ever EXCHANGE event, an educational series inspiring woman of all ages to pursue STEAM career fields, in Chandler.

“We are excited to join Comtech in celebrating their new global headquarters in Chandler,” said Chandler Mayor Kevin Hartke. “Publicly traded headquarters do not relocate often, but we have found that Chandler’s robust talent pipeline and pro-business operating environment make a compelling case for corporate decision makers. Comtech adds to a growing list of headquarters that have landed in Chandler over the last few years. It has been a real pleasure working with the Comtech team during this process and we look forward to building a strong partnership in the years to come.”

As Comtech’s presence in Arizona continues to grow, the Company is currently hiring for a variety of Chandler-based positions. If you are interested in joining Comtech, please visit the careers page of the Company’s website for more information.

To learn more about the Company’s new Chandler, Arizona headquarters, please visit: https://comtech-ssd.hs-sites.com/az24

About Comtech

Comtech Telecommunications Corp. (Comtech) is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

Investor Relations

Maria Ceriello

631-962-7102

investors@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Release – Tonix Pharmaceuticals Provides Update on the Development of Its Single Dose Live Attenuated Virus Vaccine Candidate for Mpox, TNX-801, as WHO Declares Mpox Outbreak a Global Health Emergency

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on TNXP

World Health Organization (WHO) has declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) 1

Tonix’s live virus vaccine candidate, TNX-801, is designed to provide long-term protection from mpox and smallpox with one dose

TNX-801 vaccination demonstrated efficacy in protecting animals from lethal challenge with intratracheal monkeypox virus

Clade II mpox is now endemic in the U.S. with >30,000 cases reported since May 20222 and Clade I mpox is endemic in the Democratic Republic of the Congo3

Tonix’s vaccine platform has been selected by NIH’s Project NextGen for clinical testing

CHATHAM, N.J., Aug. 16, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, has reiterated its commitment to advance development of its live attenuated virus vaccine, TNX-801 (recombinant horsepox virus), for preventing mpox (formerly known as monkeypox) and other infectious diseases. On August 14, 2024, the World Health Organization (WHO) determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern, the second such declaration in the past two years called in response to an mpox outbreak. The current outbreak was caused by Clade 1 monkeypox virus, while the 2022 outbreak was Clade 2 monkeypox virus.

TNX-801 is a live replicating attenuated vaccine candidate based on horsepox that is believed to provide immune protection with better tolerability than 20th century vaccinia viruses. The same vaccine platform upon which TNX-801 is based was selected by the U.S. National Institutes of Health (NIH) for Project NextGen for an engineered version that expresses the spike protein of SARS-CoV-2.

As previously disclosed, TNX-801 protected animals against lethal challenge with intratracheal Clade 1 monkeypox virus4. After a single-dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates4. These findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccinia vaccine, which eradicated smallpox and kept mpox out of the human population.

“The recent WHO declaration underscores the urgent need for additional treatments to stop these outbreaks and save lives,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We are motivated to advance development for our mpox vaccine with urgency given the global public health emergency. Preclinical trials demonstrate that TNX-801 combines immune protection with improved tolerability and safety compared to other vaccines based on orthopoxviruses, and is administered with a single dose which has advantages over two-dose regimens. The durability of protection from 19th century live virus vaccinia vaccines suggests that our attenuated TNX-801 will not require multiple repeated doses at six-month intervals like mRNA vaccines. Also, the stability of live virus vaccines eliminates the need for ultra-cold storage which complicates the widespread use of mRNA vaccines in Africa, where they are needed most right now.”

The global mpox outbreak, which commenced in 2022, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the U.S. The spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade I strain of mpox appears to be spreading to countries neighboring the Democratic Republic of the Congo. Clade I mpox is typically associated with approximately 20 times the case fatality rates than Clade IIb mpox in Africa. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the deadlier Clade I strain may appear in the U.S.2,8

Further, the Bipartisan Commission on Biodefense recently highlighted the renewed dual threats of a more virulent mpox epidemic and a smallpox re-introduction from lab accidents or bad actors9. The National Academies of Science, in its review of smallpox preparedness, highlighted the need for new single dose vaccines, like TNX-801 against smallpox10.

About TNX-801* and Tonix’s RPV Platform

TNX-801 (recombinant horsepox virus) is a live virus vaccine for percutaneous administration that is being developed to target smallpox, and mpox (monkeypox). TNX-801 is also the basis of the RPV platform based on a horsepox vector, which is being adapted as a COVID-19 vaccine, term TNX-1800*. Horsepox is a live replicating, attenuated virus that has been shown to be >1,000-fold more attenuated than 20th century vaccinia (VACV) strains in immunocompromised mice. Horsepox and the vaccinia vaccine viruses are closely related orthopoxviruses that are believed to share a common ancestor. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice. The current formulation is a frozen liquid, but we believe that future lyophilized versions can be stored and shipped at standard refrigeration. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines that can be administered without sterile injection, manufactured using conventional cell culture systems with the potential for mass scale production, and packaged in multi-dose vials.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) to develop TNX-4200 small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

1WHO Press Release August 14, 2024. “WHO Director-General declares mpox outbreak a public health emergency of international concern”. URL: www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern (accessed 8-15-24)
2McQuiston JH, et al. U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morb Mortal Wkly Rep: United States. p. 435-440
3CDC. 2022-2023 Mpox: US Map and Case Count. https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html
4Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. doi: 10.3390/v15020356
5Trefry, SV et al. bioRxiv 2023.10.25.564033; https://doi.org/10.1101/2023.10.25.564033
6Awasthi M, et al. Viruses. 2023 Oct 21;15(10):2131. doi: 10.3390/v15102131.
7Awashti M et al Vaccines (Basel). 2023 Nov 2;11(11):1682. doi:10.3390/vaccines11111682.
8World Health Organization SAGE meeting highlights on updated mpox vaccine recommendations. 2024, March
9Bipartisan Commission on Biofense. Box the Pox: Reducing the risk of Smallpox and Other Orthopoxviruses, Washington: 2024
10U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington: 2024

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

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

Media Contact

Lisa DeScenza
LaVoieHealthScience
ldescenza@lavoiehealthscience.com
(617) 351-0243

Source: Tonix Pharmaceuticals Holding Corp.

Released August 16, 2024

Xcel Brands (XELB) – Near Term Moving Parts, But 2025 Revenue Trends Appear Favorable

Posted on by cpereira@noblefcm.com


Friday, August 16, 2024

Xcel Brands, Inc. 1333 Broadway 10th Floor New York, NY 10018 United States https:/Sector(s): Consumer Cyclical Industry: Apparel Manufacturing Full Time Employees: 84 Key Executives Name Title Pay Exercised Year Born Mr. Robert W. D’Loren Chairman, Pres & CEO 1.27M N/A 1958 Mr. James F. Haran CFO, Principal Financial & Accou

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

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

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

Q2 Results. Total company revenues of $2.95 million was in line with our $3.0 million estimate. Adj. EBITDA, which was essentially flat at a loss of $40,000, was in line with our loss estimate of $44,000. Q2 reflected sequential quarterly improvement from the Q1 adj. EBITDA loss of $1.6 million. 

A Lot of moving parts. We anticipate some noise in Q3 from the absence of Lori Goldstein’s brand. But, we expect a lift in Q4 revenue from holiday spending, particularly in Jewelry. Furthermore, the company has a lot in the pipeline; a launch of a food and kitchen products brand in Q1, expansion of Christie Brinkley’s brand, TWRHLL, including a possible launch into two big box retailers, and contributions from Halston, slated for Spring of 2025.


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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. 

Traws Pharma (TRAW) – Traws Reports 2Q24 and Gives Post-Acquisition Update

Posted on by cpereira@noblefcm.com


Friday, August 16, 2024

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

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

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

Operations Were Integrated During The Second Quarter. Traws Reported a 2Q24 loss of $123.1 million or $(4.87) per share, including a $117.5 million charge for in-process research and development related to the acquisition of Transfynydd. Excluding the charge, net loss would have been around $5.7 million or about $(0.22) per share. The company ended the quarter with $16.4 million in cash, which we expect to fund operations and clinical milestone announcements through the end of 2024.

Influenza Program Is In Phase 1.TRX100 (tivoxavir marboxil) is a cap-dependent endonuclease inhibitor for influenza. Inhibition of this enzyme in the influenza virus inhibits viral replication of both influenza A and B strains. Early dosing studies have shown safety and tolerability, with data to support a single oral dose for therapeutic or prophylactic use. A Phase 1 dose single-dose escalation study is currently in progress.


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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. 

QuoteMedia Inc. (QMCI) – Revenue Remains Lackluster

Posted on by cpereira@noblefcm.com


Friday, August 16, 2024

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

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

Hans Baldau, Research Associate, Noble Capital Markets, Inc.

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

Weak Q2 Results. The company reported revenue of $4.7 million and adjusted EBITDA of $0.5 million, lighter than our estimates of $5.0 million and $0.9 million, respectively. Figure #1 Q2 Variance highlights the company’s results against our expectations. Revenues stayed flat from the first quarter and decreased by 1.0% from the year earlier Q2 2023. 

Lackluster revenue outlook. Management indicated the lackluster revenue trends appear to be continuing into the third quarter in spite of a building pipeline of business. We believe that the company is being buffeted by clients switching to cheaper data alternatives (although this is low margin business) and lower volumes. 


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

*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. 

InPlay Oil (IPOOF) – Updating Estimates to Reflect Revised Guidance

Posted on by cpereira@noblefcm.com


Friday, August 16, 2024

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

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.

Second quarter financial results. InPlay Oil reported second quarter net income of C$5.4 million or C$0.06 per compared to C$4.3 million or C$0.05 per during the prior year period. We had forecast net income of C$3.6 million or C$0.04 per share. Average quarterly production increased 2.2% to 8,657 barrels of oil equivalent per day (boe/d) compared to 8,474 in the second quarter of 2023.

Corporate guidance. InPlay trimmed its 2024 production guidance to a range of 8,700 to 9,000 boe/d from 9,000 to 9,500, and lowered expectations for crude oil prices. Lower production reflects foregone production from a Glauconite well that was drilled but experienced casing failure, downtime, and a decision to bring wells on later in the year. Expense guidance is mostly unchanged on a dollar per barrel of oil equivalent basis. Adjusted funds flow is expected to be in the range of C$80 million to C$85 million compared to prior guidance of C$90 million to C$97 million.


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. 

Conduent Inc. (CNDT) – Nearing the Trough, Looking Towards the Future

Posted on by cpereira@noblefcm.com


Friday, August 16, 2024

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

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

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

Q2 beat. The company delivered solid Q2 with revenue of $828 million, slightly better than our forecast of $812 million, and adj. EBITDA of $35 million, 84% better than our estimate of $19 million. Importantly, we believe the company is nearing the trough of its operating results as its divestiture activity appears to be winding down.

Favorable trends emerging. Importantly, the Commercial segment, the company’s largest by revenue, appears to be trending positively. Management highlighted that new business signings rebounded in Q2. Additionally, the Transportation segment is positioned for sequential revenue growth in the back half of the year, buoyed by a large contract in Australia.


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.