Month: December 2024

Release – Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

December 23, 2024 8:00am ESTDownload as PDF

Tonix received FDA’s Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025

TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA

Fibromyalgia affects more than 10 million adults in the U.S., who are mostly women

TNX-102 SL has the potential to be the first member of a new class of analgesic drugs for fibromyalgia and first new drug for its treatment in more than 15 years

NDA based on two statistically significant Phase 3 studies of TNX-102 SL for the management of fibromyalgia, in which TNX-102 SL was generally well tolerated

CHATHAM, N.J., Dec. 23, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company) today announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing approval for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic. Fibromyalgia is a common chronic pain condition that affects mostly women.

“We look forward to working closely with the FDA throughout the review period in advance of the August 15, 2025, PDUFA goal date,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe that TNX-102 SL has the potential to be the first member of a new class of medicines for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the U.S. Data from our pivotal Phase 3 trials support that TNX-102 SL can provide fibromyalgia patients with significant reduction in pain with favorable tolerability, helping to address the significant unmet need in this community.”

Dr. Lederman continued, “TNX-102 SL was previously granted Fast Track designation for fibromyalgia by the FDA in July of 2024. Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. This recognition from FDA confirms that the Agency recognizes the significant unmet needs of the fibromyalgia community, who have been waiting for a new drug for over 15 years.”

The accepted NDA is supported by data from two 14-week double-blind, randomized, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of TNX-102 SL as a bedtime treatment for fibromyalgia. The first Phase 3 trial, RELIEF, of TNX-102 SL 5.6 mg in fibromyalgia, completed in December 2020, met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p=0.010). In the confirmatory Phase 3 RESILIENT study in fibromyalgia, completed in December 2023, TNX-102 SL again met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p =0.00005). In both trials, TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and with no new safety signals observed. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). Excluding COVID-19, rates of systemic adverse events in each of the two studies were all below 4.0%. Tonix believes the submitted dossier contains the requisite safety and efficacy data from two adequate and well-controlled studies to support NDA approval.

About Fibromyalgia

Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insula and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety, headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, which is a group of related conditions that include chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), irritable bowel syndrome, endometriosis, low back pain, post-concussive syndrome (also known as mild traumatic brain injury), chronic Lyme Disease, chronic diabetic neuropathy and chronic post-herpetic neuralgia.

About TNX-102 SL

TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia. The FDA has accepted the NDA filing for TNX-102 SL for fibromyalgia and assigned a PDUFA goal date of August 15, 2025. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the U.S. National Institute of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. In July 2024, Tonix announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years 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. 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; their efficacy and safety have not been established 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.

Investor Contact

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

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Indication and Usage

Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released December 23, 2024

Maple Gold Mines (MGMLF) – Setting Up for an Eventful 2025

Posted on by slightbourne@noblecapitalmarkets.com


Monday, December 23, 2024

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.

Completion of the restructuring transaction. As expected, Maple Gold Mines recently completed its joint venture restructuring transaction with Agnico Eagle Mines Ltd. (NYSE, AEM). Maple has legal title to and a 100% ownership interest in the Douay Gold Project with gold mineral resources exceeding 3.0 million ounces and the past-producing, high-grade Joutel Gold Project. Both projects are located along the Casa Berardi-Douay Gold Trend in the renowned Abitibi Greenstone Gold Belt in Quebec, Canada.

Upcoming drilling program. Maple Gold’s fully funded drilling program is expected to commence shortly and run through March. The company is using a data-driven approach toward exploration that is focused on expanding the company’s gold mineral resource from approximately three million ounces to five million ounces across the combined Douay/Joutel projects, along with making new discoveries. An updated resource estimate and scoping study is expected to be completed within the next 12 to 18 months (Refer to our research note dated December 12 for more details).


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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. 

Probe Gold Expands its Monique Gold Deposit with Key Acquisition

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Probe Gold acquires Bermont Claims to extend Monique Deposit’s strike length by 750 meters, adding exploration potential.
– Historical drilling identified high-grade gold zones, including intercepts of up to 30.9 g/t gold over 1.6 meters.
– The acquisition expands surface mine infrastructure, facilitating operational efficiencies and reduced costs.

Probe Gold Inc. has announced the acquisition of the Bermont Claims property, strategically located adjacent to its Monique Gold Deposit in Val-d’Or, Quebec. This move is poised to extend the strike length of the Monique Deposit by 750 meters, offering significant opportunities for resource expansion and exploration. The transaction aligns with Probe Gold’s commitment to maximizing the potential of its Novador Development Project and advancing high-quality gold resources.

The newly acquired property spans ten contiguous claims and adds critical exploration upside. Historical drilling has identified high-grade gold zones, including the Bermont and Adelemont zones, which remain open laterally and at depth. Despite limited exploration, previous results from the property demonstrate promising grades, such as 30.9 g/t gold over 1.6 meters and 5.7 g/t gold over 3.2 meters. Probe Gold plans to incorporate this land into its 2025 exploration and resource expansion programs, focusing on uncovering additional high-grade mineralization.

David Palmer, President and CEO of Probe Gold, emphasized the strategic value of this acquisition. “This new land enhances our Monique Deposit by increasing exploration potential by 30%, while also offering critical space for surface mine infrastructure,” Palmer stated. He further highlighted the acquisition’s potential to unlock new high-grade discoveries and contribute to an even more robust Novador Development Project.

The transaction includes an upfront payment of $3 million, split evenly between cash and common shares of Probe Gold. Additionally, a $1.5 million milestone payment, in cash or shares, will be made upon confirming a resource of at least 1 million ounces of gold on the property. Jadmine, the seller, will retain a 3.5% net smelter return royalty, of which 2.5% can be purchased by Probe Gold for $2.5 million.

The Bermont Claims property complements the Monique Deposit, which currently hosts 3.56 million ounces of measured and indicated resources and 677,300 ounces of inferred resources. Geological similarities between the Bermont Claims and Monique Deposit strengthen the potential for integrating new discoveries into Probe’s existing operations. Moreover, the property’s expanded surface area is expected to facilitate mine design improvements, reducing costs and increasing operational efficiency.

Since 2016, Probe Gold has been consolidating its position in the Val-d’Or mining district, known for its prolific gold production and mining-friendly environment. The Novador Development Project, which hosts four past-producing mines and accounts for 80% of the company’s gold resources, is central to Probe Gold’s strategy. This acquisition aligns with the company’s focus on advancing resource-rich properties in politically stable and low-cost regions.

The deal is expected to close in the coming weeks, subject to regulatory approvals and customary closing conditions. With an aggressive exploration plan set for 2025, Probe Gold aims to leverage this acquisition to enhance its production profile and create long-term value for shareholders.

As the Monique Deposit grows in scope and potential, Probe Gold solidifies its position as a leader in the Canadian gold mining industry, driving forward with a vision for sustainable growth and innovation.

Release – LODE: Comstock Sells Northern Mining Targets to Mackay Precious Metals

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on LODE

VIRGINIA CITY, NEVADA, December 20, 2024 – Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) today announced it has executed a Membership Interest Purchase Agreement (the “MIPA”) to sell 100% of the northernmost patented and unpatented mining claims, mineral exploration rights and town lots (the “Northern Targets”) currently owned by Comstock’s wholly-owned subsidiary Comstock Northern Exploration, LLC., plus all of the 25% issued and outstanding membership interest that Comstock owns in Pelen LLC (“Pelen”) to Mackay Precious Metals Inc. (“Mackay”) for an aggregate purchase price of $2.75 million (the “Purchase Price”) and a 1.5% NSR production royalty from the sales of silver, gold, and all other valuable minerals and products extracted from these properties, in perpetuity. 

The Company was paid $1.3 million in cash with another $0.45 million due before February 15, 2025, plus an additional $1.0 million that will be paid within 45 days of the completion of Mackay’s public listing, at the election of Mackay, in either cash or their publicly registered common shares. The monetized value of $1.0 million from the public listed shares is guaranteed by the value date of October 31, 2025. 

On June 30, 2023, Comstock executed a Mineral Exploration and Mining Lease Agreement (“Mackay Lease”) with Mackay. Since June 30, 2023, Comstock has received cash of $3.2 million in initial and ongoing lease payments and will also receive an additional, final pro-rata lease payment associated with these properties of $0.5 million before February 15, 2025. The $3.7 million in total lease payments are in addition to the $2.75 million sale price. The parties terminated the Mackay Lease on December 18, 2024.

The Northern Targets encompass both the Gold Hill and Occidental Lode claim groups in Storey County, Nevada. Pelen owns certain claims adjacent to and/or relevant to these northern claim groups. 

“Our Northern Targets were never an effective part of our district-wide development plans, so realizing nearly $6.5 million in consideration from this lease and subsequent sale, plus the retention of royalties in perpetuity, is extremely positive for Comstock, especially as we activate our plans for advancing the S-K 1300 compliant Dayton Consolidated and permitted Lucerne resources, and more aggressively expand the gold and silver potential in the southern part of the district,” said Corrado De Gasperis, Comstock’s executive chairman and chief executive officer. “We are bullish on our gold and silver resources, especially as both our hard rock and metal recycling activities aggressively expand into this silver cycle.”

About Comstock Inc.

Comstock Inc. (NYSE: LODE) commercializes innovative technologies that contribute to global decarbonization and the clean energy transition by efficiently converting under-utilized natural resources, primarily, woody biomass into low-carbon renewable fuels, end-of-life metal extraction and renewal, and generative AI-enabled advanced materials synthesis and mineral discovery for sustainable mining. To learn more, please visit www.comstock.inc. 

Comstock Social Media Policy

Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its Twitter, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Contacts

For investor inquiries:
RB Milestone Group LLC
Tel (203) 487-2759
ir@comstockinc.com

For media inquiries:
Comstock Inc., Tracy Saville
Tel (775) 847-7573
media@comstockinc.com

Forward-Looking Statements 

This press release and any related calls or discussions may include 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. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

Steelcase (SCS) – Reports Third Quarter Results

Posted on by cpereira@noblefcm.com


Friday, December 20, 2024

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

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

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

3Q25 Results. Revenue was $794.9 million, up 2.1% y-o-y, with higher revenue from government, large corporate, healthcare, and education customers as the drivers. Organic revenue was up 3%, with Americas up 7% and International off 8%. Gross margin came in at 33.4%, up 100 bp y-o-y. GAAP EPS totaled $0.16 versus $0.26, while adjusted EPS was $0.30 versus $0.29.

Green Shoots. Orders in the first three weeks of 4Q25 grew 15% y-o-y. Internationally, Steelcase is seeing higher project activity levels, with recent wins related to large opportunities with national accounts in France, Germany, and the Middle East. Continuation of such trends would bode well for future performance.


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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. 

Great Lakes Dredge & Dock (GLDD) – $182 Million of Awarded Work

Posted on by cpereira@noblefcm.com


Friday, December 20, 2024

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

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

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

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

Awarded Work. Great Lakes announced an additional $182 million of awarded work across four projects. The new projects were part of the $465 million of low bids and options pending as of the end of the third quarter. The new awards will add to a record backlog of work for 2025 and are likely to keep Great Lakes’ fleet fully engaged during the year. The projects are all for coastal protection.

Projects. Ocean City Beach Renourishment in New Jersey is valued at $73.6 million. This project also includes an additional $41.4 million in open options pending award. This project will start in 1Q25 and is expected to be completed in 3Q25. Myrtle Beach Renourishment in South Carolina is valued at $72.3 million. Work is expected to start in 4Q25 and be completed in 1Q26. Both projects were awarded by the U.S. Army Corps of Engineers.


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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. 

Banzai Acquires Vidello, Expanding Revenue and Market Reach

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Banzai acquires Vidello, adding $6.5M in revenue and $2.3M in EBITDA, representing 59% revenue growth.
– Vidello’s suite includes CreateStudio, PhotoVibrance, and a flagship video hosting platform serving 90,000+ customers.
– The acquisition enhances Banzai’s AI-powered platform with advanced video creation and hosting tools.

Banzai International, Inc. (NASDAQ: BNZI), a leading marketing technology company, has signed a definitive agreement to acquire Vidello, a London-based video hosting and marketing suite provider. The acquisition is expected to boost Banzai’s trailing twelve-month (TTM) revenue by 59%, adding $6.5 million, and increase EBITDA by $2.3 million, reflecting the strategic impact of this transaction on Banzai’s growth trajectory.

The acquisition, valued at up to $7 million, includes a mix of cash and equity payments to Vidello’s shareholders, with performance-based targets shaping the final payout. Vidello brings a robust suite of video content creation and marketing tools to Banzai’s portfolio, including CreateStudio, PhotoVibrance, Twinkle, and its flagship Vidello video hosting platform. Vidello’s offerings cater to over 90,000 customers globally, further strengthening Banzai’s reach in the video marketing sector.

Vidello’s standout products are tailored to enhance the video creation and hosting experience for businesses. CreateStudio enables users to craft professional 3D character videos for social media and websites. PhotoVibrance animates static images, turning them into dynamic motion visuals, while Twinkle offers a comprehensive audio platform with royalty-free music for video projects. Vidello, the flagship product, combines video hosting, playback, and collaboration tools, featuring built-in marketing functionalities such as calls-to-action for lead generation.

Joe Davy, Founder and CEO of Banzai, expressed his enthusiasm for the acquisition, stating, “We’re doubling down on building the best suite of video products by adding Vidello. Video content is the future of marketing across every platform. Vidello’s tools make it significantly easier to create attention-grabbing video content without technical expertise.”

Vidello’s Co-Founder and CEO, Josh Ratta, highlighted the synergy between the two companies. “This partnership comes at the perfect time, offering an exciting opportunity to expand our video tools and reach a wider audience. By integrating Vidello’s capabilities with Banzai’s AI-powered platform, we strive to help businesses create and host engaging videos that elevate their marketing efforts,” Ratta said.

The acquisition positions Banzai to capitalize on the growing importance of video in digital marketing strategies. Vidello’s high ratings on platforms such as Capterra and G2 reflect its strong product-market fit and user satisfaction. The integration of Vidello’s tools with Banzai’s existing AI-driven platform is expected to create significant synergies, enhancing customer engagement and reducing churn.

The transaction is set to close in December 2024, subject to customary conditions. The structure includes $5.5 million in cash and $1.5 million in equity or warrants, providing a balanced approach to preserving liquidity while aligning interests.

With this acquisition, Banzai not only strengthens its financial position, growing TTM revenue to $17.3 million, but also expands its technological capabilities, reinforcing its vision of becoming a leader in AI-powered marketing solutions.

Agnico Eagle to Acquire O3 Mining in Strategic $204 Million Transaction

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Agnico Eagle is acquiring O3 Mining for $204 million at a 58% premium to its recent share price.
– The deal integrates O3’s Marban Alliance project with Agnico’s Canadian Malartic complex to boost production.
– The transaction has full board approval and support from 22% of O3 shareholders.

Agnico Eagle Mines Limited has announced a definitive agreement to acquire O3 Mining Inc., a gold exploration and development company based in Québec, Canada. This $204 million all-cash transaction marks a pivotal step for both companies, with Agnico Eagle enhancing its regional strategy and O3 Mining securing substantial value for its shareholders.

Under the terms of the agreement, O3 Mining shareholders will receive $1.67 per share, representing a 58% premium to the company’s closing price as of December 11, 2024. The transaction has been unanimously endorsed by O3 Mining’s Board of Directors and Special Committee, with support from shareholders owning approximately 22% of the company’s outstanding shares.

This acquisition focuses on O3 Mining’s flagship property, the Marban Alliance project, located near Agnico Eagle’s Canadian Malartic complex in Québec’s Abitibi region. The Marban Alliance includes the Marban deposit, which boasts 1.7 million ounces of gold in indicated mineral resources and an additional 32,000 ounces in inferred resources. This advanced exploration project has the potential to support a large-scale open-pit mining operation, making it an ideal fit for Agnico Eagle’s existing infrastructure and expertise.

Agnico Eagle President and CEO, Ammar Al-Joundi, described the acquisition as a continuation of the company’s regional strategy. “The Marban deposit complements our ‘Fill-the-Mill’ initiatives at the Canadian Malartic complex. With our operational expertise and established infrastructure, we aim to unlock the full potential of this asset while driving sustainable value for stakeholders.”

The integration of the Marban Alliance property into Agnico Eagle’s operations is expected to generate significant synergies by leveraging existing facilities, including the Canadian Malartic mill and equipment fleet. These efficiencies will enhance production capabilities, improve the overall production profile, and create long-term benefits for the region.

O3 Mining President and CEO, José Vizquerra, expressed enthusiasm about the transaction. “This offer provides exceptional value for our shareholders and validates the efforts of the O3 Mining team over the past five years. Agnico Eagle’s financial strength and commitment to stakeholder collaboration make it the ideal partner to advance the Marban Alliance project through permitting and construction.”

The transaction will formally commence with Agnico Eagle’s mailing of a takeover bid circular on December 19, 2024, and O3 Mining’s directors will respond with their recommendation. Shareholders have until January 23, 2025, to tender their shares. The agreement includes customary conditions, such as the approval of at least two-thirds of O3 Mining’s shareholders.

In addition to the Marban Alliance project, O3 Mining’s portfolio includes the Alpha and Kinebik properties, offering further exploration opportunities. The deal underscores Agnico Eagle’s position as a leader in the precious metals industry, with operations spanning Canada, Australia, Finland, and Mexico.

This acquisition signifies a major milestone in Agnico Eagle’s growth strategy and reinforces its commitment to sustainable mining practices, operational excellence, and community partnership. As the two companies move forward, the transaction is poised to unlock new opportunities and solidify Agnico Eagle’s leadership in the global gold mining sector.

Take a moment to take a look at more emerging growth metals & mining companies by taking a look at Noble Capital Markets’ Research Analyst Mark Reichman’s coverage list.

Tripadvisor and Liberty TripAdvisor Announce Merger to Simplify Corporate Structure

Posted on by slightbourne@noblecapitalmarkets.com

Tripadvisor, Inc. (NASDAQ: TRIP) and Liberty TripAdvisor Holdings, Inc. (OTCMKTS: LTRPA, LTRPB) have announced a definitive agreement to merge. The merger will see Tripadvisor acquiring Liberty TripAdvisor, resulting in a simplified capital structure for the global travel platform. The transaction, valued at approximately $435 million, includes the conversion of Liberty TripAdvisor’s Series A and Series B Common Stock into cash, alongside the redemption of its 8% Series A Cumulative Redeemable Preferred Stock and the repayment of its 0.50% Exchangeable Senior Debentures. Liberty TripAdvisor’s shareholders will receive approximately $20 million in cash for their common stock and $42.5 million in cash, along with 3,037,959 shares of Tripadvisor common stock for their preferred stock.

This merger enables Tripadvisor to retire about 27 million shares of its common stock held by Liberty TripAdvisor, net of shares pledged as collateral. The effective repurchase price of these shares stands at $16.21, representing a 16% premium based on the 10-day volume-weighted average price as of December 17, 2024. The agreement marks a pivotal move to create strategic flexibility and unlock value for stakeholders.

Matt Goldberg, President and CEO of Tripadvisor, highlighted the significance of the transaction as a step toward simplifying Tripadvisor’s corporate structure. He emphasized the opportunity to retire a significant portion of shares while maintaining a healthy balance sheet. According to Goldberg, this transaction will empower Tripadvisor to pursue its strategic vision and expand its role in the travel and experiences sector. The deal also represents an important milestone for Liberty TripAdvisor, allowing the entity to address challenges stemming from its complex capital structure and financial obligations, especially in the wake of the COVID-19 pandemic.

Greg Maffei, Chairman and CEO of Liberty TripAdvisor, praised the agreement, emphasizing its alignment with the company’s goals to maximize stakeholder value and enhance Tripadvisor’s ability to adapt and grow. By removing the dual-class share structure, Tripadvisor will gain greater strategic and operational agility, enabling it to better compete and innovate within the travel industry.

The merger was unanimously approved by the boards of both companies following a thorough evaluation by Tripadvisor’s Special Committee of independent directors. This committee, supported by financial and legal advisors, played a critical role in securing terms favorable to all parties involved. Liberty TripAdvisor’s stakeholders, including those holding Exchangeable Debentures, are expected to benefit from the streamlined structure and improved financial position post-merger.

The transaction is subject to customary closing conditions, including approval by a majority of Liberty TripAdvisor’s voting shareholders. The companies anticipate finalizing the merger by the second quarter of 2025. If the deal encounters delays beyond March 27, 2025, Tripadvisor has agreed to provide a secured loan to Liberty TripAdvisor to address any financial obligations related to its Exchangeable Debentures. This loan will be canceled upon the successful closing of the transaction or will become due shortly thereafter if the merger is not completed.

Tripadvisor operates as a family of brands connecting people with travel experiences worldwide. Its portfolio includes Viator and TheFork, along with Tripadvisor’s core platform, which provides travel guidance and booking services for accommodations, restaurants, and attractions. The merger with Liberty TripAdvisor is expected to enhance Tripadvisor’s strategic flexibility and solidify its position as a leading player in the travel industry, unlocking new opportunities for growth and innovation.

Release – Data and Safety Monitoring Board Reviews Interim Safety Data of Phase 2 Subjects of OCU410 ArMaDa Clinical Trial for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

December 19, 2024

PDF Version

  • OCU410 has a very favorable safety and tolerability profile
  • No serious adverse events related to the study drug have been reported, such as exudation, infectious endophthalmitis, intraocular Inflammation, anterior ischemic optic neuropathy, or vasculitis

MALVERN, Pa., Dec. 19, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the OCU410 ArMaDa clinical trial recently convened and approved continuation of the second phase of the Phase 1/2 study. OCU410 (AAV5-hRORA) is a novel modifier gene therapy candidate being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD).

“The DSMB assessed data on 15 subjects from Phase 2. Initial data indicates that OCU410 appears to be safe and well-tolerated,” said Peter Chang, MD, FACS, Co-President and Partner of the Massachusetts Eye Research and Surgery Institution (MERSI). “No serious adverse events (SAEs) related to OCU410 have been reported to date.”

The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA. Phase 2 is an ongoing, randomized, outcome assessor-blinded, dose-expansion study in which 45 subjects are randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups (5×1010 vg/mL or 1.5 ×1011 vg/mL) or an untreated control group.

“Currently approved treatments for GA require 6-12 intravitreal injections annually and frequent injections are a burden on patients and caregivers,” said Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen. “We are very enthusiastic about the potential of OCU410 to serve as a game-changing, one-time treatment for life for patients with GA.”

Positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the ArMaDa clinical trial demonstrated: no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and—most importantly—there was a positive effect on the functional visual measure of low luminance visual acuity (LLVA).

dAMD is a multifactorial disease involving genetic and environmental factors that is one of the world’s leading causes of blindness in people aged 50 years and older. Four cellular pathways drive the pathology of dry AMD: lipid metabolism, inflammation, oxidative stress, and complement. Currently approved therapies target only the latter, while OCU410 addresses all four and thereby helps reestablish retinal homeostasis.

The ArMaDa clinical trial is currently being performed at 13 leading retinal surgery centers across the U.S. Dosing in the OCU410 ArMaDa clinical trial will be completed in early 2025 and the Company will continue to provide 9- and 12-month efficacy updates from Phase 1.  

About dAMD and GA
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.

About OCU410
OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role in vitro and in vivo (animal model) studies. These results demonstrate the ability of OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV5–hRORA as a one-time gene therapy for the treatment of GA.

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

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

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

Cara Therapeutics and Tvardi Therapeutics to Merge, Forming New Biopharma Leader

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Cara Therapeutics and Tvardi Therapeutics announce an all-stock merger, set to create a Nasdaq-listed biopharmaceutical company.
– Tvardi’s recent $28 million financing strengthens the combined company’s financial outlook, funding operations into 2026.
– The new entity will focus on developing STAT3 inhibitors for fibrosis-driven diseases, with Phase 2 data expected in 2025.

Cara Therapeutics (Nasdaq: CARA) and Tvardi Therapeutics have announced a definitive merger agreement, marking a significant step in the development of innovative treatments for fibrosis-driven diseases. The all-stock transaction will combine Cara’s resources with Tvardi’s promising pipeline, including its lead candidate, TTI-101, a small-molecule STAT3 inhibitor. The combined entity will be Nasdaq-listed under the name Tvardi Therapeutics, Inc. and is expected to trade under the ticker symbol “TVRD” once the deal closes in the first half of 2025, subject to regulatory and shareholder approvals.

The merger will give pre-merger Cara stockholders an estimated 17% stake in the new company, while Tvardi investors will own around 83%, assuming Cara’s cash balance at closing falls within the expected range. This transaction comes after Tvardi completed a $28 million private financing round, which, alongside the combined company’s cash, will provide funding into 2026, supporting clinical development through critical data readouts expected in 2025.

Tvardi’s pipeline, which is focused on fibrosis-driven diseases, will be the cornerstone of the merged company’s future. The lead candidate, TTI-101, is currently in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and Phase 1b/2 trials for hepatocellular carcinoma (HCC). The drug is designed to inhibit STAT3, a central transcription factor involved in the progression of these diseases. Early-stage data from the clinical trials is expected to be reported in the second half of 2025, potentially marking significant inflection points for the company.

In addition to TTI-101, Tvardi is developing TTI-109, another STAT3 inhibitor that is set to enter clinical trials in 2025. Tvardi’s innovative approach to targeting STAT3 positions the combined company as a key player in addressing serious, chronic diseases with significant unmet medical need.

The new company will be headquartered in Houston, Texas, and led by Tvardi CEO Imran Alibhai, Ph.D. The board will consist of members from both Cara and Tvardi, with six directors from Tvardi and one from Cara. This leadership structure is expected to ensure a seamless transition as the combined company moves forward with its mission to develop novel, oral therapies for fibrosis-driven diseases.

This merger comes at a time when the biopharmaceutical sector is increasingly focused on addressing complex diseases with limited treatment options. With a strong financial foundation, a promising pipeline, and a leadership team well-versed in the challenges of drug development, the combined company is poised to make significant strides in the field.

As the merger progresses, investors and industry watchers will be closely monitoring upcoming clinical trial results and further developments in the company’s pipeline, which could position Tvardi Therapeutics as a leader in the treatment of fibrosis-driven diseases.

Tonix Pharmaceuticals (TNXP) – Tonix Announces FDA Acceptance Of NDA For Review

Posted on by cpereira@noblefcm.com


Wednesday, December 18, 2024

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand 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 second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

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.

New Drug Application For Tonmya Accepted For Review. Tonix announced that the FDA has accepted the filing of the Tonmya NDA, showing that the application met the requirements for a full review. Tonmya received Fast Track designation, and an application for Priority Review was filed. Next, notification of the assigned PDUFA date (the statutory date for completing a review under the Prescription Drug User Fee Act) and Priority Review status are expected in about 14 days.

We Believe Tonmya Can Have A Significant Impact On Fibromyalgia Treatment. Symptoms of fibromyalgia include chronic pain, insomnia, depression, brain fog, fatigue, and abdominal cramps with varying severity. This variety of physical and cognitive symptoms has been treated with a combination of pain medications, anti-depressants, insomnia drugs, and neurological drugs. Tonmya is the first drug that was developed for fibromyalgia. Its clinical trials showed strong statistical significance in its primary endpoint (pain reduction) and all six secondary endpoints. No other single drug has shown this broad effect on multiple fibromyalgia symptoms.


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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).

MAIA Biotechnology (MAIA) – Pediatric Designation Qualifies THIO For A Priority Review Voucher

Posted on by cpereira@noblefcm.com


Wednesday, December 18, 2024

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

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

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

Successful Development Could Qualify For A Valuable Asset. Maia announced that THIO has received FDA designation as a drug for a rare pediatric disease (RPD) when used to treat pediatric-type diffuse high-grade gliomas (PDHGG). This designation makes MAIA eligible to receive a Priority Review Voucher (PRV) upon approval. The PRV can be redeemed for priority review for a different new drug application or sold to another company. During 2024, PRVs have been sold for between $100 million and $158 million.

Data In Pediatric Brain Cancer Was Presented In April 2024. MAIA presented clinical data testing THIO in the PDHGG indication at the American Association for Cancer Research (AACR) Annual Meeting in April 2024. Patients with a highly aggressive subtype of PDHGG known as diffuse intrinsic pontine glioma (DIPG) were treated with ionizing radiation and THIO. The results showed significant decreases in cell proliferation and anti-cancer effects.


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.