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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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.
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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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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.
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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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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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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.
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.
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.
3Q Results. Revenue for the quarter totaled CAD$279,182, including the Company’s CAD$272,500 in deferred revenue. Excluding this, revenue was CAD$6,682, including TerraSante sales’ impact. We estimated revenue of CAD$15,000. Net loss was CAD$1.7 million, or a loss of $0.03/sh, compared to a loss of CAD$1.9 million last year, or $0.04/sh. We estimated a net loss of CAD$1.9 million or $0.04/sh.
Sales Revenue is Here. Notably, the quarter recognized product sales revenue for the TerraSante product for the first time. We expect TerraSante revenue to begin to impact revenue in a meaningful way in the latter half of 2025. As the Company receives more approvals from different states, we believe the opportunity to showcase TerraSante to farmers can expand, along with revenue.
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Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Traws Has Made Significant Progress During 2024. In May 2024, Onconova and Transfynydd combined to form Traws Pharmaceuticals. The new company brought together the Transfynydd small molecules for respiratory viral diseases with the Onconova clinical-stage oncology pipeline. The company is planning Phase 2 clinical trials for its antivirals while looking for collaborations and/or partnerships for the oncology pipeline.
Phase 2 Trials Are Planned For Two Antivirals. Tivoxavir marboxil (TRX100) is a protease inhibitor of enzyme needed for the reproduction of the virus that causes seasonal and pandemic influenza. Ratutrelvir (TRX01) inhibits the protease Mpro (the main protease or 3CL), the main protease of SAR-CoV-2 (the COVID-19 virus), but does not require co-administration of a metabolic inhibitor. This avoids the risk of drug-drug interactions and potential side effects. Phase 2 studies for both drugs are expected to begin in 1H24.
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Key Points: – Poseida Therapeutics to be acquired by Roche for up to $1.5 billion, advancing the field of allogeneic CAR-T therapies. – Poseida’s non-viral, TSCM-rich CAR-T therapies aim to enhance clinical outcomes and expand treatment access. – Roche’s capabilities in late-stage development and commercialization will bring Poseida’s advancements to patients worldwide.
Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company pioneering allogeneic cell and genetic therapies, announced that it has entered into a definitive agreement to be acquired by Roche Holdings, Inc. in a transaction valued at up to $1.5 billion. Under the agreement, Poseida stockholders will receive $9.00 per share in cash upon closing, along with a contingent value right (CVR) for up to $4.00 per share upon achieving specified milestones. The acquisition has been unanimously approved by Poseida’s Board of Directors, which recommends that stockholders tender their shares.
The merger will bring Poseida’s advanced platform technologies and innovative therapies into Roche’s Pharmaceuticals Division. This acquisition marks a significant expansion of Roche’s capabilities in allogeneic cell therapy, a cutting-edge area of biotech innovation focused on creating “off-the-shelf” treatments. This collaboration builds on an ongoing strategic partnership between Poseida and Roche, particularly in developing CAR-T therapies for hematologic malignancies. The expanded scope will also include CAR-T programs targeting solid tumors and autoimmune diseases.
Poseida’s proprietary technology platform, which utilizes non-viral, T stem cell memory (TSCM)-rich CAR-T therapies, is at the forefront of innovation in cell therapy. TSCM cells are considered highly advantageous due to their long-lived, self-renewing, and multipotent properties, enabling potentially safer and more effective therapies. These characteristics differentiate Poseida’s therapies from other CAR-T approaches, which often rely on more differentiated cells with reduced regenerative capacity.
Highlighting Poseida’s potential, interim clinical data for P-BCMA-ALLO1, a CAR-T candidate for multiple myeloma, have shown compelling results. This reinforces the transformative potential of Poseida’s platform in addressing high unmet needs across various therapeutic areas. Kristin Yarema, Ph.D., President and CEO of Poseida Therapeutics, emphasized the importance of the acquisition: “Poseida has demonstrated the unique ability of its non-viral platform to deliver TSCM-rich CAR-T therapies with the potential to improve clinical outcomes and expand access. Joining Roche will allow us to accelerate development and bring our therapies to patients worldwide.”
The transaction terms include a tender offer for all outstanding Poseida shares, priced at $9.00 per share in cash at closing. The CVR, valued at up to $4.00 per share, will be contingent upon achieving specific clinical, regulatory, and commercial milestones. Roche plans to acquire any remaining shares not tendered during the initial offer through a second-step merger, ensuring full ownership of Poseida.
The deal is expected to close in the first quarter of 2025, subject to regulatory approvals and customary closing conditions. Centerview Partners LLC and Cooley LLP advised Poseida on the transaction, while Citi and Sidley Austin LLP served as advisors to Roche.
This acquisition represents a major milestone for Poseida and Roche alike. For Roche, it establishes a new core capability in allogeneic cell therapy and genetic medicine, areas that hold immense promise for the future of personalized healthcare. For Poseida, the merger offers an opportunity to leverage Roche’s global resources in late-stage development, commercialization, and market access, enabling its therapies to reach patients worldwide.
As the biotech industry increasingly focuses on transformative therapies, this deal underscores the growing importance of partnerships in accelerating innovation. With Poseida’s cutting-edge technology and Roche’s global expertise, the acquisition is poised to reshape the landscape of cell and genetic therapies, delivering groundbreaking treatments to patients across the globe.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Summary Of Data Announced For Products In Clinical Trials. Ocugen summarized some of the major points presented at its Clinical Showcase on November 12. As discussed in our Research Note on November 13, speakers reviewed the products’ mechanisms of action, reviewed OCU400 data from the Phase 1/2 trial, the design of the OCU400 Phase 3 liMeliGhT trial, and presented new interim data from the Phase 1/2 ArMaDa trial for OCU410.
Mechanism of Action For The Modifier Gene Therapy (MGT) Detailed. Ocugen is developing gene therapies for retinal diseases that deliver a regulatory gene to control other genes and regulate downstream pathways. Products in development are for inherited diseases that result from multiple gene mutations or conditions that result from several dysfunctional pathways.
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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.
CM04S1 Continues In Phase 2 As DSMB Determines mRNA Vaccine Arm Failed Primary Endpoint. CM04S1 is in Phase 2 testing as a COVID-19 booster against an approved mRNA vaccine in patients with chronic lymphocytic leukemia (CLL). An interim analysis conducted by an independent Data Safety Monitoring and Review Board (DSMB) determined that the mRNA arm did not meet its specified primary endpoint, but the trial will continue with the CM04S1 arm.
Study Tests CM04S1 In Immunocompromised Patients. The Phase 2 study enrolled patients that are immunocompromised due to CLL and its therapies, which often leaves them unable to mount a sufficient immune response and vulnerable to COVID-19 infection. The trial was designed to determine the immune response with Pfizer’s mRNA vaccine as the control and comparator arm. Patients were randomized at 1:1 into two arms, receiving either two injections of CM04S1 three months apart or the mRNA vaccine.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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3Q24 Reported With Product Updates. ZyVersa reported a loss of $2.4 million or $(2.43) per share and updated its clinical trial plans for the two products in development. During the quarter, several scientific papers were published showing the role of inflammation in obesity, diabetes, and neurodegeneration. These studies all support previous work by the company and are consistent with the mechanism of action for IC 100.
VAR 200 To Start Phase 2a In Diabetic Kidney Disease. The Cholesterol Efflux Mediator™ VAR 200 has shown reductions in the initial damage that starts a cycle of damage and repair that leads to progressive scarring and loss of kidney function. A Phase 2a trial enrolling patients with diabetic kidney disease (DKD) is expected to begin in 1Q25 with initial data announcement around mid-2025.
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PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Progress Toward Phase 3 With New Phase 2 VERSATILE-002 Data. PDS Biotech Reported 3Q24 loss of $10.7 million or $(0.29) per share, a slightly lower loss than we estimated. Earlier this week, modifications to the IND protocol for the Phase 3 VERSATILE-003 trial were submitted to the FDA. Approval is expected by mid-December, which would allow the trial to begin in early 2025.
New Phase 2 VERSATILE-002 Data Analysis Shows Outcomes Were Maintained Or Improved. As additional patients complete their follow-up periods, further analysis of the data has shown improvements over the previous interim reports. The overall survival has been unchanged at 30.0 months, although the lower limit of the confidence interval has increased to 20 months. This compares with 17.9 months for published Keytruda studies. Overall response rate, complete response rate, and disease control rates have improved as well.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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OLC Achieved Significant Milestones In 3Q24. Unicycive reported a 3Q24 loss of $4.1 million or $(0.05) per share. During the quarter, the NDA was submitted for approval of oxylanthanum carbonate (OLC), its phosphate binder for patients on renal dialysis. After the close of the quarter, the acceptance for filing was announced with a PDUFA date of June 28, 2025. The quarter ended with $32.3 million in cash, which we believe is sufficient to fund operations and launch of OLC in 2025-26.
NDA Submission Was Completed As Expected. In early September, Unicycive submitted the new drug application (NDA) for OLC, its phosphate binder for patients on renal dialysis. On November 11, the company announced FDA acceptance of the application for review and assigned a PDUFA date of June 28, 2025. This is the statutory date for the FDA to answer the application with Market Approval or a denial known as a Complete Response Letter (CRL).
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