Tag: Health

Release – Tonix Pharmaceuticals and Makana Therapeutics Announce Collaboration Combining Tonix’s Anti-CD40L Monoclonal Antibody (TNX-1500) with Makana’s Genetically Engineered Organs in Preclinical and Clinical Xenotransplantation Studies

Posted on by aweinsoff@channelchek.com

Research News and Market Data TNXP

April 09, 2025 7:00am EDT Download as PDF

Agreement includes the use of Tonix’s TNX-1500, as part of an immunomodulatory regimen to reduce rejection of Makana’s genetically engineered pig organs in xenotransplantation

Establishes framework for Makana’s kidney, heart and islet cell programs to utilize TNX-1500 for preclinical studies in support of regulatory filings for potential use in human recipients

CHATHAM, N.J. and MIAMI, April 09, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), (“Tonix”) a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, and Makana Therapeutics, Inc. (“Makana”), a global leader in the field of xenotransplantation, today announced a collaborative research agreement under which Tonix and Makana will study Tonix’s anti-CD40L (CD40 ligand, also called CD154) monoclonal antibody candidate, TNX-1500, in combination with Makana’s human-compatible organs and cells for the treatment of organ failure. The preclinical research and development collaboration has the potential to span multiple Makana programs including kidney, heart and islet cell transplant. The goal of the preclinical studies is to support the submission of an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) to support compassionate use for patients undergoing xenotransplantation.

“We are excited to partner with Makana in support of our mutual goal to offer novel solutions for patients requiring organ or cellular transplantation,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We believe this strategic agreement is a promising step towards utilizing xenotransplantation in the clinic. Makana’s novel genetically engineered (GE) pigs, which have deleted swine leukocyte antigen (SLA)2, has shown improved human compatibility and several other advantages over other technologies including high rates of fertility and birthing, which potentially increases their ability to produce viable organs to satisfy a commercial market globally.”

“Despite significant progress and momentum in the field of xenotransplantation, improving organ compatibility to prevent rejection remains an ongoing challenge,” said Joseph Tector, M.D., Ph.D., Founder of Makana and a practicing transplant surgeon. “This collaboration provides Makana the opportunity to combine its novel GE pig organs with TNX-1500 in our ongoing and future preclinical studies. We view anti-CD40L as a critical part of an effective immunomodulatory regimen for successful xenotransplantation. This collaboration enables us to pursue co-development of our GE organs with the TNX-1500, which has shown best-in-class pharmacokinetics and pharmacodynamics in a human study after showing best-in-class results in preventing rejection in 6-month studies of allo- and xenotransplantation in animals. Our mutual goal is to obtain the best human results as soon as possible.”

“We are thrilled with this collaboration utilizing TNX-1500 as an important element of our xenotransplant therapy. The collaboration with Tonix gives Makana the right product and the right partner to bring Makana toward clinical development,” said Mark Platt, President and Chief Executive Officer of Makana. “Most organ-failure patients today will never receive a lifesaving/life-changing transplant. Our achievement in developing the SLA DR knockout pig has yielded encouraging results with preclinical kidney xenografts and positions us to deliver strong outcomes in clinical development.”

TNX-1500 is an investigational, humanized Fc-modified IgG4 anti-CD40L antibody with high affinity for the CD40 ligand. CD40L is an attractive drug development target for transplant immunomodulation since the engagement of the CD40L plays a pivotal role in immune system activation by modulating both antibody and cellular immune responses.

About Makana’s Genetically Engineered (GE) Pigs

Makana began developing pigs for xenotransplantation in 2010. Makana’s 2013 creation of the Triple Knockout (TKO) Pig, lacking three key glycans responsible for hyperacute and acute organ rejection in humans, resulted in the first 1-year preclinical xeno-kidney survivor in animals1. This discovery revitalized the xeno-field and today Makana’s TKO genetics are employed across the xenotransplantation field.

Realizing that the first clinical xenografts failed because of antibody mediated rejection, Makana deferred rushing to the clinic and employed the same stepwise scientific approach to show that these early clinical failures occur because of the development of antibodies against SLA. The final result is that Makana has developed the new TKO plus SLA DR KO pig that eliminates the next barrier to clinical success. Now Makana is poised to achieve longer term clinical success.

Makana has achieved the field’s longest and most consistent preclinical survival without the need to insert human transgenes into its pig genetics. Rejection continues as a barrier to survival in the limited number of emergency IND human transplants performed with transgenic pigs, further supporting Makana’s focus on antigen discovery and deletion in lieu of relying on inserted transgenes to evade the human immune response.

Without the need for transgenes, the future commercialization of Makana’s xeno-organs through breeding will be straightforward. When compared to transgenic animals, Makana’s knockout-only pigs will breed with greater efficiency and eliminate the challenge of retaining transgenic expression. This is an important consideration, reducing both the cost of therapy and the complexity of GE pig production.

Makana’s preclinical successes with SLA-deleted pig kidneys in animal xenotransplantation has depended on the co-administration of primatized 5c8 anti-CD40L monoclonal antibody. Tonix’s TNX-1500 is an Fc-modified version of humanized 5c8, which maintains the activity of 5c8, while improving tolerability.

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that binds and functionally inhibits the CD40-ligand (CD40L), also known as CD154 or 5c8 Ag.4 The combining sites of TNX-1500 are derived from humanized 5c8 or ruplizumab, which showed promise in treating systemic lupus erythematosus.5 Chimeric primatized 5c8 showed promise in preventing rejection of organ rejection in animals.6 TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts and renal xenografts.7-9

*TNX-1500 is an investigational new biologic and is not approved for any indication

Citations

  1. Estrada JL, et al. Xenotransplantation. 2015;22(3):194-202.
  2. Reyes LM, et al. J Immunol. 2014;193(11):5751-7.
  3. Lederman S, et al, J Exp Med. 1992;175(4):1091-101. doi: 10.1084/jem.175.4.1091. PMID: 1348081; PMCID: PMC2119166.
  4. Boumpas DT, et. al. Arthritis Rheum. 2003;48(3):719-27. doi: 10.1002/art.10856. PMID: 12632425.
  5. Pierson RN 3rd, et al. Transplantation. 1999;68(11):1800-5. doi: 10.1097/00007890-199912150-00026. PMID: 10609959.
  6. Lassiter G, et al. Am J Transplant. 2023;23(8):1171-1181. doi: 10.1016/j.ajt.2023.03.022.
  7. Miura S, et al. Am J Transplant. 2023;23(8):1182-1193. doi: 10.1016/j.ajt.2023.03.025.
  8. Anand, R.P., et al Nature. 622, 393–401 (2023). https://doi.org/10.1038/s41586-023-06594-4

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, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also 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 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 on Drug Abuse. 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 infectious disease, including a vaccine for mpox, TNX-801. Tonix recently 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.

About Makana Therapeutics

Founded in 2009, Makana Therapeutics is focused on developing swine with reduced xenoantigen expression, making human transplantation of cells, tissues and organs from these animals possible. Makana’s focus on scientifically validated genetics, optimized pig cloning techniques and careful patient selection is expected to streamline product development and result in safer more efficacious products. For more information on Makana, please visit www.makanatherapeutics.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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, 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) 799-8599

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

Media Contact

For Tonix:
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

For Makana:
Mark Leonard
Next Level Agency
mark@reachthenextlevel.com 
847-651-9682

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 April 9, 2025

Release – Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Operating and Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

March 20, 2025

PDF Version

Tegoprubart used as a key component of immunosuppression regimen in the second transplant of a genetically modified pig kidney into a human conducted at Massachusetts General Hospital

Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine

Topline results from Phase 2 BESTOW trial of tegoprubart in kidney transplantation expected in fourth quarter of 2025

Proceeds from oversubscribed $85 million underwritten offering extend cash runway to end of 2026

IRVINE, Calif., March 20, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2024 operating and financial results and reviewed recent business highlights.

“We have recently made great strides in expanding our role in bringing new options in organ transplantation to patients. Tegoprubart was a cornerstone immunosuppression component in recent historic procedures including kidney xenotransplant and islet transplants in patients with type 1 diabetes,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The results from these landmark studies together with the encouraging allograft kidney transplant clinical data we have shared continue to reinforce tegoprubart’s broad potential to protect transplanted organs and cells, regardless of the transplant type and the organ source. We are entering 2025 from a position of balance sheet strength and we are on track to deliver on multiple key milestones in the coming months, including topline results from our Phase 2 BESTOW trial in the fourth quarter of 2025.”

Fourth Quarter 2024 and Recent Business Highlights

  • Announced the use of tegoprubart as a lead component of the immunosuppression treatment regimen following the second transplant of a genetically modified pig kidney into a human in a study conducted at Massachusetts General Hospital. Following the successful transplant on January 25, 2025, the patient was discharged from the hospital without need for continued treatment with dialysis for the first time in over two years.
  • Reported positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in subjects with type 1 diabetes in an investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute. The data demonstrated potentially the first in human cases of insulin independence achieved using an anti-CD40L monoclonal antibody immunosuppression therapy without the use of tacrolimus, the current standard for care for prevention of transplant rejection.
  • Completed an oversubscribed, underwritten offering of common stock and pre-funded warrants for total gross proceeds of $85.0 million and net proceeds of approximately $79.5 million after deducting underwriting discounts, commissions, and offering expenses. The offering, which priced at a premium, included participation from both new and existing investors.

Anticipated Upcoming Milestones

  • Summer 2025: Report updated interim clinical data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients.
  • 4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
  • 2025: Report updated interim clinical data from the investigator-led clinical trial with UChicago Medicine for pancreatic islet transplantation in subjects with type 1 diabetes.

Fourth Quarter 2024 Financial Results

Cash, cash equivalents and short-term investments totaled $140.2 million as of December 31, 2024 compared to $78.2 million at September 30, 2024. The company expects current cash, cash equivalents and short-term investments to fund operations to the end of 2026.

Research and development (R&D) expenses for the fourth quarter of 2024 were $17.9 million, including $2.7 million of non-cash stock-based compensation expense, compared to $7.1 million, including $0.3 million of non-cash stock-based compensation expense, for the comparable period in 2023.

General and administrative expenses for the fourth quarter of 2024 were $6.8 million, including $3.9 million of non-cash stock-based compensation expense, compared to $3.3 million, including $1.4 million of non-cash stock-based compensation expense, for the comparable period in 2023.

Net loss for the fourth quarter of 2024 was $44.6 million, or $0.64 per basic share, compared with a net loss of $30.1 million, or $1.00 per basic share, for the comparable period in 2023. Both periods included a non-cash loss from changes in the fair value of warrant liabilities, totaling $20.9 million in 2024 and $20.5 million in 2023.

Full Year 2024 Financial Results

Research and development (R&D) expenses for the year ended December 31, 2024 were $52.0 million, including $4.3 million of non-cash stock-based compensation expense, compared to $30.3 million, including $1.5 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by a rise in clinical development expenses related to the Phase 1b, Phase 2 BESTOW and Phase 2 open-label extension trials for kidney transplantation, an increase in manufacturing costs for drug substance and drug product clinical trial supply, an increase in stock-based compensation expense and employee compensation and benefits related to increased headcount.

General and administrative expenses for the year ended December 31, 2024 were $18.6 million, including $8.8 million of non-cash stock-based compensation expense, compared to $12.7 million, including $5.0 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by an increase in stock-based compensation expense, professional services and employee compensation and benefits.

Net loss for the year ended December 31, 2024 was $36.2 million, or $0.75 per basic share, compared with a net loss of $116.5 million, or $4.73 per basic share, in 2023. The 2024 net loss included a non-cash gain of $30.9 million from changes in the fair value of warrant liabilities, whereas the 2023 net loss included a non-cash loss of $76.2 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, the company would have recorded a net loss of $67.1 million for the year ended December 31, 2024 and a net loss of $40.3 million for the year ended December 31, 2023.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward Looking Statements

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

Investor Contact:

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

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

View Full Release Here.

MAIA Biotechnology (MAIA) – Phase 2 THIO-101 Expansion and Registration Treatment Plans Announced

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, February 27, 2025

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.

Phase 2 Trial Tests THIO Against THIO With Libtayo. MAIA announced the design of the third stage of the THIO-101 Phase 2 trial, consisting of Expansion and Registration stages. Both stages will enroll patients with non-small cell lung cancer (NSCLC)  receiving the regimens as third-line treatment, expected to begin in 1Q25. Following the conclusion of the trial around 4Q25, we expect MAIA to apply for Accelerated Approval from the FDA.

Expansion Stage Is Expected To Begin In 1Q25. The THIO-101 Expansion stage will have two arms to determine the contributions of each drug to patient outcomes. In the first arm, 30 patients will receive the THIO-Libtayo (cemiplimab) combination at the 180mg dose. The second arm will treat 7 patients who were treated with THIO monotherapy to determine its efficacy. If the outcomes of THIO alone are moderate, the treatment arm will be discontinued. If sufficient efficacy is seen, up to 8 more patients will be enrolled for a total maximum enrollment of 48 patients. The primary endpoint is Overall Response Rate (ORR).


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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. 

Zimmer Biomet to Acquire Paragon 28 in $1.2 Billion Deal, Expanding Foot and Ankle Portfolio

Posted on by slightbourne@noblecapitalmarkets.com

Zimmer Biomet Holdings, Inc. (NYSE: ZBH), a global leader in medical technology, has announced a definitive agreement to acquire Paragon 28, Inc. (NYSE: FNA), a specialized medical device company focused on foot and ankle orthopedics. This acquisition, valued at approximately $1.2 billion, underscores Zimmer Biomet’s commitment to expanding into higher-growth market segments within musculoskeletal care.

Under the agreement, Zimmer Biomet will acquire all outstanding shares of Paragon 28’s common stock for $13.00 per share in cash, equating to an equity value of approximately $1.1 billion. Additionally, Paragon 28 shareholders will receive a contingent value right (CVR), allowing them to earn up to $1.00 per share in cash if specific revenue milestones are met. The CVR payout will depend on Paragon 28’s net sales performance in Zimmer Biomet’s fiscal year 2026, with payments ranging from $0.00 to $1.00 per share for sales between $346 million and $361 million.

The transaction has been unanimously approved by the boards of both companies and is expected to close in the first half of 2025, pending regulatory approvals and shareholder consent.

Zimmer Biomet’s acquisition of Paragon 28 aligns with its strategy of diversifying beyond core orthopedics into high-growth specialized markets. The global foot and ankle orthopedic segment is valued at approximately $5 billion and is growing at a high-single-digit rate annually.

“This proposed transaction further diversifies Zimmer Biomet’s portfolio outside of core orthopedics and positions us well in one of the highest growth specialized segments in musculoskeletal care,” said Ivan Tornos, President and CEO of Zimmer Biomet. “Paragon 28’s innovative portfolio, strong pipeline, and specialized sales force, combined with Zimmer Biomet’s global scale, will allow us to better serve patients with foot and ankle conditions.”

Paragon 28, established in 2010, has built an extensive suite of surgical solutions for fractures, trauma, deformity correction, and joint replacement within the foot and ankle segment. This deal will enable Zimmer Biomet to integrate Paragon 28’s specialized expertise with its existing product portfolio, creating new cross-selling opportunities, particularly in the fast-growing ambulatory surgical center (ASC) sector.

Paragon 28 reported an 18.4% year-over-year revenue increase in 2024, with full-year revenue ranging between $255.9 million and $256.2 million. Zimmer Biomet expects the acquisition to be immediately accretive to revenue growth. While it will be slightly dilutive to adjusted earnings per share (EPS) in 2025 and 2026, the deal is projected to become accretive within 24 months of closing.

Zimmer Biomet will finance the acquisition through a mix of cash on hand and available debt facilities. Despite the investment, the company aims to maintain a strong balance sheet and continue executing its capital allocation priorities.

The acquisition of Paragon 28 positions Zimmer Biomet as a major player in the foot and ankle segment, complementing its broader musculoskeletal product offerings. With regulatory approvals and shareholder consent expected in the coming months, the deal marks a strategic milestone for Zimmer Biomet’s growth trajectory in specialized orthopedic care.

Beta Bionics Unveils $112.5 Million IPO Terms, Pioneers Autonomous Insulin Delivery Technology

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Beta Bionics’ iLet Bionic Pancreas is the first FDA-approved device to autonomously determine insulin doses using adaptive algorithms.
– The company plans to raise $112.5 million by offering 7.5 million shares at a price range of $14-$16, achieving a potential market cap of $577.35 million.
– Beta Bionics is part of a surge in biotech IPOs, reflecting investor confidence in transformative medical technologies.

Beta Bionics, the California-based innovator behind the iLet Bionic Pancreas, disclosed plans for a $112.5 million IPO, marking a pivotal moment in healthcare technology. The IPO terms, filed on January 22, 2025, outline the offering of 7.5 million shares priced between $14.00 and $16.00. At the midpoint of $15.00 per share, the company would achieve a market cap of approximately $577.35 million. Trading is set to commence on January 30, 2025, under the proposed ticker symbol “BBNX” on the NASDAQ.

The iLet Bionic Pancreas represents a groundbreaking advancement in diabetes management, being the first FDA-approved insulin delivery device to use adaptive closed-loop algorithms. This innovation enables the device to autonomously determine every insulin dose without requiring users to count carbohydrates, offering a significant improvement in the quality of life for individuals with Type 1 diabetes (T1D).

T1D affects approximately 1.8 million people in the U.S., all of whom rely on daily insulin replacement. The iLet system, cleared by the FDA for patients aged six and older in May 2023, targets this market with a vision to transform diabetes care. Despite its groundbreaking potential, Beta Bionics is currently unprofitable, reporting a net loss of $55.4 million on $53.1 million in revenue for the 12 months ending September 30, 2024.

The IPO, led by BofA Securities, Piper Sandler, Leerink, and Stifel, will provide the funding necessary for Beta Bionics to expand commercialization efforts and further develop its innovative technology. This initiative positions the company at the forefront of the intersection between healthcare and technology, emphasizing the growing demand for automated and personalized solutions in chronic disease management.

Beta Bionics’ IPO is part of a broader trend highlighting the growing prominence of biotech companies in public markets. With the rapid advancements in medical technology and increasing regulatory approvals, the biotech sector has emerged as a key driver of innovation. Biotech IPOs have gained momentum, reflecting strong investor interest in companies addressing critical healthcare needs with cutting-edge solutions.

In particular, biotech firms are increasingly leveraging public funding to accelerate the development and distribution of transformative therapies and devices. The promise of addressing unmet medical needs, coupled with advancements in artificial intelligence and biotechnology, has fueled optimism in the sector. Companies like Beta Bionics exemplify how public markets can empower medical innovation to scale, potentially improving millions of lives.

Investors are drawn to biotech IPOs not only for their market potential but also for their societal impact, as these companies strive to tackle some of the world’s most pressing healthcare challenges. Beta Bionics’ iLet device is a prime example of this trend, offering a glimpse into the future of automated, patient-centric care.

Take a moment to take a look at more emerging growth healthcare companies by taking a look at Noble Capital Markets’ Research Analyst Robert LeBoyer’s coverage list.

Nutriband (NTRB) – Initiating Coverage With An Outperform Rating And $13 Price Target

Posted on by cpereira@noblefcm.com


Wednesday, January 22, 2025

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.

We Are Initiating Coverage With An Outperform Rating. Nutriband, Inc. is a pharmaceutical company developing transdermal patch technologies for drug delivery. Its proprietary technology, known as AVERSA, has abuse-deterrent features with important differences from other transdermal patches on the market. The lead product is AVERSA Fentanyl, an abuse-deterrent transdermal patch for delivering fentanyl that improves safety, compliance, and patient comfort.

Only One Clinical Trial Is Required For the 505 (b)(2) New Drug Application. AVERSA Fentanyl can follow the 505(b)(2) regulatory pathway with only a single Phase 1 clinical abuse potential study required to support the new label claims. We expect this study to begin in 1H25, announce results in 2H25, and file an NDA around YE2025 to early 2026.


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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. 

GeoVax Labs (GOVX) – Gedeptin To Begin Phase 2 Clinical Trial

Posted on by cpereira@noblefcm.com


Tuesday, January 21, 2025

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 Starts The Year By Announcing Phase 2 Trial For Gedeptin. GeoVax has announced that a Phase 2 trial for Gedeptin, its gene therapy for delivering cytotoxic cancer drugs, is planned to start in 1H25. As we expected, the trial will test Gedeptin with a checkpoint inhibitor in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN).

Gedeptin Delivers A Gene To Activate The Cancer Drug In The Tumor. Gedeptin is based on the Gene-Directed Enzyme Prodrug Therapy (GDEPT) technology platform. It uses an adenovirus vector to deliver the E. coli PNP gene to cancer cells. Once inside the cells, the gene produces an enzyme that converts an inactive prodrug (fludarabine) into an active cytotoxic drug. This increases the drug’s potency inside the cancer cells while avoiding healthy tissue. Gedeptin has completed Phase 1/2 trials in advanced head and neck cancer and has been granted Orphan Drug Designation for oral and pharyngeal cancers.


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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. 

Release – Zomedica Announces License & Supply Agreement with Cresilon Inc. to Market and Sell Vetigel(R) Hemostatic Gel in the Animal Health Market

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZOM

License Agreement Expands Zomedica’s Portfolio with Revolutionary Hemostatic Technology

ANN ARBOR, MI / ACCESSWIRE / January 7, 2025 / Zomedica Corp. (NYSE American:ZOM) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, today announced that it had entered into a license and supply agreement with Cresilon, Inc. to market and sell the Vetigel® hemostatic gel product line on an exclusive basis in the United States and on a non-exclusive basis outside the United States.

Under the terms of the agreement, Zomedica will assume responsibility for supplying U.S. customers and will collaborate with Cresilon to support customers outside the U.S. This partnership enables Zomedica to further its mission of delivering innovative solutions that enhance patient care and operational efficiency for veterinary practitioners.

Vetigel is a groundbreaking, plant-based formula designed to stop bleeding rapidly when applied directly to the source. Unlike traditional methods, Vetigel halts bleeding in seconds without becoming incorporated into the clot. The product has been validated in clinical studies reported in white papers, demonstrating its ability to save time during surgical procedures and significantly reduce blood loss in patients. Key applications include:

  • Surgical Procedures: Effective in controlling bleeding during soft organ biopsies and excisions;
  • Dental Applications: Successfully used to manage bleeding in routine and advanced dental procedures;
  • Emergency Care: Proven efficacy in treating venous and arterial bleeds; and
  • Liver Biopsy: Demonstrated to stop bleeding faster than competitive hemostatic agents.

“We are excited to add Vetigel® to Zomedica’s portfolio of innovative veterinary products,” said Kevin Klass, Senior Vice President of Sales at Zomedica. “Vetigel’s ability to rapidly stop bleeding across a variety of procedures makes it an invaluable tool for veterinarians, enabling them to enhance patient outcomes while improving surgical efficiency. This partnership with Cresilon allows us to bring cutting-edge solutions to veterinary professionals in the U.S. and beyond.”

Greg Blair, Zomedica’s Senior Vice President, Business Development & Strategic Planning, added, “This new venture with Cresilon is another way Zomedica stays true to our mission of enhancing the quality of care for pets, increasing pet parent satisfaction, and improving the workflow, cash flow, and profitability of veterinary practices. By bringing innovative solutions like Vetigel to market, we are empowering veterinarians to deliver better outcomes and experiences for their patients and clients.”

“This partnership with Zomedica is ideal for the future of Vetigel,” said Joe Landolina, CEO of Cresilon. “Zomedica’s established reputation, robust field sales team, and commitment to veterinary excellence make them the perfect match for expanding the reach of this revolutionary product. Together, we look forward to making Vetigel an essential tool for veterinary practices worldwide.”

Vetigel’s versatility and proven efficacy make it a game-changer for veterinary practices, addressing critical needs in both routine and emergency settings. Zomedica looks forward to expanding access to this exciting technology to more customers leveraging our existing field sales team, frequent trade show programs, and weekly continuing education programs.

For more information about Vetigel hemostatic gel, please visit https://zomedica.com/vetigel.

About Zomedica
Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW® digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $78 million in liquidity as of September 30, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information about Zomedica and our full range of products visit www.zomedica.com.

About Cresilon
Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping bleeding in seconds. The company’s current and future product lines target trauma care, biosurgery, and animal health. Cresilon’s mission is to save lives. For more information about Cresilon, which was named to Fast Company’s annual list of the World’s Most Innovative Companies of 2024, ranking No. 1 in the medical devices category, visit www.cresilon.com.

Follow Zomedica

Cautionary Note Regarding Forward-Looking Statements
Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.

Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to successfully integrate acquisitions; uncertainty as to Cresilon’s ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products, including acceptance of the Vetigel® hemostatic gel line; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including meeting distribution obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

Investor Relations Contact:
Zomedica Investor Relations
investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.

MustGrow Biologics Corp. (MGROF) – Completes Acquistion of NexusBioAg

Posted on by cpereira@noblefcm.com


Monday, January 06, 2025

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.

Acquisition Finalized. MustGrow announced the execution and closing of an Asset Purchase Agreement of assets representing NexusBioAg. The purchase price consists of (i) a deferred cash payment of approximately CAD$1,662,000, subject to adjustment in accordance with the terms of the APA; and (ii) earn-out payments equal to a specified percentage amount of gross margin on certain itemized products sold by MGRO in 2025 and 2026.

Financial Impact. Based on historical sales figures, management noted that NexusBioAg brings roughly CAD$15-$20 million of revenue annually to MustGrow and expects this to continue into 2025 and 2026. While no comment was made about the NexusBioAg’s margins, the expectation is that the Nexus side will be cashflow breakeven for 2025 as revenue stays the course. EBITDA is expected to be positive by 2026.


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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. 

Cocrystal Pharma (COCP) – Influenza Trial To Extend Enrollment, Norovirus Trial Data Expected in 1H25

Posted on by cpereira@noblefcm.com


Monday, January 06, 2025

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

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

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

Phase 2a Trial Enrollment To Be Extended. Cocrystal announced plans to extend enrollment for the Phase 2a clinical trial testing its influenza drug, CC-42344. The trial was designed to infect healthy volunteers with a pharmaceutically prepared H3N2 strain of influenza and then test the drug’s effects against the infection. However, the rate of infection was lower than anticipated, so the effects could not be tested.

Volunteers Did Not Develop Robust Influenza Infections. The trial administered influenza virus to healthy volunteers as planned, but there was an unexpectedly low infection rate. The subjects did not have the influenza measures needed to test CC-42344 efficacy. Cocrystal plans to submit a protocol amendment to the UK’s MHPA to extend the enrollment in the study.


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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. 

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

GeoVax Labs (GOVX) – GeoVax Receives Allowance For New Patent Covering Vaccine Platform Technologies

Posted on by cpereira@noblefcm.com


Tuesday, December 10, 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.

Intellectual Property Estate Is Expanding. GeoVax announced that the US Patent and Trademark Office has issued a Notice of Allowance for its patent application covering the expression of antigens in virus-like particles delivered with a viral vector. This is a mechanism used to stimulate an immune response from the GeoVax MVA-based vaccines. The patent allowance is the final step in the USPTO application process, and the patent will be issued after payment of fees.

The Application Covers Expression Of Immune Stimulation Antigens. The patent titled “Vaccinia Viral Vectors Encoding Chimeric Virus Like Particles” includes claims for expressing a tumor associated antigen (TAA) in virus-like particles (VLPs) from a recombinant Modified Vaccinia Ankara (MVA) viral vector. This covers vaccines that use the MVA as a vector to deliver DNA that assembles into non-infectious virus-like constructs to simulate an immune response against the targeted virus. This mechanism is used in the MVA MUC-1 (cancer) and infectious disease vaccines. A detailed description of the MVA platform and VLPs begins on page 7 of our Initiation of Coverage report.


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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. 

Release – Zomedica to Present at the NobleCon20 Twentieth Annual Emerging Growth Equity Conference December 4, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZOM

ANN ARBOR, MI / ACCESSWIRE / November 27, 2024 / Zomedica Corp. (NYSE American:ZOM) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, today announced that its Chief Executive Officer, Larry Heaton, will present and host one-on-one meetings with investors at NobleCon20 – Noble Capital Markets’ Twentieth Annual Emerging Growth Equity Conference at Florida Atlantic University, Executive Education Complex, in Boca Raton, Florida on Wednesday, December 4, 2025 at 11:00 am Eastern Standard Time.

A high-definition video webcast of the presentation will be available the following day on the Company’s website, www.zomedica.com, and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website, www.nobleconference.com, and on the investor portal created by Noble, Channelchek at www.channelchek.com. The webcast will be archived on the company’s website, at https://investors.zomedica.com/, and the NobleCon and Channelchek websites for 90 days following the event.

About Zomedica

Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW® digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $78 million in liquidity as of September 30, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

Follow Zomedica

About Noble Capital Markets, Inc.

Established in 1984, Noble Capital Markets is an SEC / FINRA registered full-service investment bank and advisory firm with an award-winning research team and proprietary investor distribution platform. We deliver middle market expertise to entrepreneurs, corporations, financial sponsors, and investors. Over the past 40 years, Noble has raised billions of dollars for companies and published more than 45,000 equity research reports. Noble launched www.channelchek.com in 2018 – an investor community dedicated exclusively to public emerging growth and their industries. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 7,000 public emerging growth companies are listed on the site, and content including equity research, webcasts, and industry articles.

Investor Relations Contact:

Zomedica Investor Relations
investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.