Tag: Health

Unicycive Therapeutics (UNCY) – Results From Phase 1 Trial Testing UNI-494 In Acute Kidney Injury Announced

Posted on by cpereira@noblefcm.com


Thursday, October 10, 2024

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 1 Trial Tested Safety, Tolerability, and Pharmacokinetics At Multiple Doses. Unicycive announced completion of the Phase 1 trial testing UNI-494, its product in development for protecting against acute kidney injury. The study was designed to determine tolerability, safety, and pharmacokinetic data for the design of Phase 2. Unicycive plans to present the study at an upcoming scientific meeting.

UNI-494 Is In Development For Preventing Acute Kidney Injury. UNI-494 is a proprietary formulation of nicorandil to protect against the mitochondrial dysfunction and prevent pathways that lead to cell death in acute kidney injury. The proprietary formulation increases the half-life and makes it practical for administration, while maintaining its properties as a nicotinamide ester derivative and selective activator of the ATP-sensitive mitochondrial potassium channel.


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

Traws Pharma (TRAW) – Phase 1 Study In Influenza Shows Positive Data With Plans To Move To Phase 2

Posted on by cpereira@noblefcm.com


Wednesday, October 09, 2024

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

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

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

Positive Results Announced From Tivoxavir Marboxil Study. Positive data was announced from the Phase 1 clinical trial testing safety and pharmacokinetics of Tivoxavir Marboxil, Traw’s drug in development for seasonal and pandemic influenza. The study showed tolerability and bloodstream levels within the expected range, supporting use as a one-time treatment for flu. The dose for Phase 2 has been selected with the trial planned to begin in 1H2025.

Tivoxavir Inhibitor A Protease Needed For Viral Replication. Tivoxavir acts through inhibition of CAP-dependent endonucleases (CEN), a highly conserved influenza protein needed for the synthesis of its viral mRNA. Tivoxavir was designed for use across a broad range of flu viruses including the H5N1 bird flu virus. Preclinical studies have shown potent inhibition of drug-resistant influenza viruses.


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

PDS Biotechnology (PDSB) – Clinical Trial in Cervical Cancer Shows Improved Survival and Supports Use In Other Tumors

Posted on by cpereira@noblefcm.com


Monday, October 07, 2024

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.

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

Interim Data From Phase 2 Cervical Cancer Trial Presented. An interim analysis from the Phase 2 ImmunoCerv Trial in locally advanced cervical cancer was presented at the American Society For Radiation Oncology (ASTRO) annual meeting on October 1, 2024. Overall survival (OS) and progression free survival (PFS) showed clinically meaningful improvements over published studies. We believe this supports the efficacy of Versamune HPV in cervical cancer as well as other HPV16+ tumors in other tissues.

Study Design. The ImmunoCerv study was an investigator-initiated trial (ITT) conducted at MD Anderson Cancer Center in Houston, Texas. The study enrolled 17 patients with newly diagnosed high-risk HPV-related cervical tumors at least 5 cm in size. Patients received up to 5 doses of Versamune HPV along with standard of care chemotherapy and radiation.


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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.

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

Release – Zomedica Announces Expansion of Exclusive Equine Distribution Agreement with Grovet in Europe

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZOM

Expansion adds new countries to Grovet’s existing PulseVet distribution coverage and enables launch of the TRUFORMA® equine platform in Europe

ANN ARBOR, MI / ACCESSWIRE / October 3, 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 the expansion of its distribution partnership in Europe with Grovet, a leading equine-focused veterinary distributor.

The terms of the updated agreement offer Grovet equine distribution rights for Zomedica’s equine PulseVet® and TRUFORMA product platforms throughout most of Europe. Grovet will exclusively distribute these equine products in 27 countries, including Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and Switzerland, and will distribute these products on anon-exclusive basis in Italy and the UK.

In addition to expanding the distribution of PulseVet products to equine veterinarians into additional European countries, this agreement also expands their product offerings to include the TRUFORMA platform as well as the Company’s current equine assays for eACTH and Cortisol, and equine Insulin when it launches later this year.

“We are very pleased to expand our relationship with Grovet for all of Zomedica’ s equine products in Europe,” stated Kevin Klass, Zomedica’s Senior Vice President of Sales. “Grovet has been a terrific partner since inception. Having them lead the way for us in equine by introducing the TRUFORMA equine product line to the market in 29 countries is a natural recipe for success,” continued Klass.

“Working with Zomedica and selling the PulseVet device has been a great experience for us,” stated Koen Schmitz-Managing Director of Grovet. “We only partner with companies whose products are rooted in scientific studies, and all of Zomedica’s products we are carrying are exactly just that, rooted in science and steeped in research,” continued Schmitz.

“Grovet has been a great partner to Zomedica for the equine PulseVet product line over the last several years, and they were the perfect partner to help expand the reach of our TRUFORMA equine platform within Europe,” stated Brandon Marino, Senior Director of Global Channels for Zomedica.

“PPID, or Cushing’s disease, is one of the most common endocrine disorders in horses and ponies. Left undiagnosed and untreated, quality of life for these animals will rapidly decline and their life expectancy will shorten. The TRUFORMA eACTH assay for equine plasma offers equine veterinarians the ability to diagnose and screen for PPID as well as monitor patients during treatment, in minutes in their own labs or stall-side. The equine Cortisol assay provides critical data to veterinarians treating foals, and the upcoming equine insulin assay will be of benefit for assessing insulin issues commonly faced by horses. The compact, easy to use, and durable TRUFORMA device offers reference lab accuracy with point of care convenience, making it a great fit for the unique challenges that face equine practitioners,” concluded Marino.

For more information on these products or any of Zomedica’s other products please visit, wwww.zomedica.com.

About Grovet – Equine health company
Grovet has been supporting equine veterinarians with high-quality products for over 25 years. Our team consists of people who are passionate about horses, which is why horse health is at the heart of everything we do.

With our extensive experience and knowledge, we offer a wide range of innovative products, including instruments, medicines, MedTech and supplements to support equine veterinarians. We are committed to continuously improving and expanding our product line to meet the evolving needs of equine practitioners. By working closely with veterinarians and industry experts, we stay up to date on the latest trends and challenges, allowing us to provide effective solutions that help vets deliver the best care possible.

A key example of our ongoing commitment to innovation is our successful collaboration with Zomedica. This partnership has allowed us to expand our product offerings with the PulseVet and now the TRUFORMA equine line of products. PulseVet products are highly regarded by our clients and fit seamlessly into Grovet’s existing range and customer base. Our clients are pleased to have access to these products through a European distributor, making it easier than ever to incorporate them into their veterinary practices.

For more information about our products or to explore partnership opportunities, please visit www.grovet.com or contact us directly.

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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 $83 million in liquidity as of June 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.

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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 our 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 TRUFORMA platform by veterinarians in Europe; 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.

Traws Pharma (TRAW) – Phase 1 Ratutrelvir Results Announced With Plans To Move To Phase 2a

Posted on by cpereira@noblefcm.com


Tuesday, October 01, 2024

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

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

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

Phase 1 Topline Data Shows Safety and Tolerability. Traws Pharma announced results from its Phase 1 trial testing ratutrelvir, its oral protease inhibitor for COVID-19. The trial was designed to determine pharmacokinetics and safety, with results showing consistent plasma levels within the expected range with no adverse events. A Phase 2a trial is being planned to begin in 1H2025.

Ratutrelvir Could Become A Category-Leading Drug. Ratutrelvir is an inhibitor of the SARS-CoV-2 Main protease (Mpro or 3CL protease). It has demonstrated in vitro activity against the original viral strain and numerous variants, including delta and omicron. Ratutrelvir does not require co-administration of ritonavir as a metabolic inhibitor and avoids the drug-drug interactions and potential side effects. In comparison, Pfizer’s Paxlovid is a combination of its Mpro inhibitor, nirmatrelvir, with ritonavir as a metabolic (cytochrome P450) inhibitor.


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

Eledon Pharmaceuticals (ELDN) – Virtual Roadshow Discussions Focus On Kidney Transplantation

Posted on by cpereira@noblefcm.com


Monday, September 30, 2024

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.

Client Meetings Answered Questions About Tegoprubart. We held a Virtual Non-Deal Road Show with Eledon’s CEO, Dr. DA Gros. The discussions with clients covered tegoprubart history of development, mechanism of action, clinical trials, and its upcoming milestones. Some of the points raised and common questions are highlighted below.

The Phase 2 BESTOW Trial Completed Enrollment In August. Eledon announced the completion of enrollment for its Phase 2 BESTOW trial that tests tegoprubart against tacrolimus for prevention of kidney transplant rejection. The enrollment was  completed ahead of the expected YE2024 timeframe due to higher than expected interest from the transplant surgeons.


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

MustGrow Biologics Corp. (MGROF) – Transitioning from R&D to Commercialization

Posted on by cpereira@noblefcm.com


Thursday, September 26, 2024

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

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

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

Update and Presentation. On Tuesday, we had the opportunity to participate in a webinar presentation and interview with MustGrow’s management providing an update on the current progress of the Company’s pipeline and its future. Key takeaways of the update, in our view, were the progress towards sales of its TerraSante product, advancing towards commercialization of its TerraMG product, and the expansion of the Company’s intellectual property portfolio.

TerraSante. The Company has been underway in its planning for larger-scale production on TerraSante. The Company had its initial commercial production run in 2023 and had its first sales during the third quarter this year. Management is seeing strong initial interest in the product, primarily from California, and has the opportunity for multiple applications per year for various crop markets, which could potentially triple acre coverage. We believe that we will continue to see more state approvals for the product in the near term as management has focused on getting such approvals.


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

MustGrow Biologics Corp. (MGROF) – A New Opportunity

Posted on by cpereira@noblefcm.com


Wednesday, September 18, 2024

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

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

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

New Funding. MustGrow announced yesterday that the Company is receiving funding from Agriculture and Agri-Food Canada (AAFC) to investigate its mustard-derived ingredient. The ingredient could potentially be used in human and animal health and food applications. The funding amount was not disclosed. The Company will continue to focus on its core business outside of the program, with the anticipation of more state approvals for TerraSante, in our view.

The Program. Under the program, the Company and AAFC will look at bioactive components in mustard seed and assess yellow mustard extracts for potential antibiotic and gut health applications in both humans and animals. They will also test the selected bioactive components for antifungal and antibacterial activities against food spoilage microbes and disease pathogens and for use as ingredients in functional foods and nutraceuticals for improved immunity and gut health in both humans and animals.


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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. 

PDS Biotechnology (PDSB) – PDS Presents Phase 2 Data Update At ESMO Conference

Posted on by cpereira@noblefcm.com


Tuesday, September 17, 2024

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.

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

Additional Clinical Details Presented At ESMO Conference. PDS Biotech presented an update to its Phase 2 VERSATILE-002 trial at the European Society for Medical Oncology (ESMO), adding detail to the data announced in June 2024. We see these Phase 2 data as highly encouraging for the Phase 3 VERSATILE-003 trial testing the doublet combination and the triplet combination (Versamune HPV with PDS01ADC and Keytruda) against Keytruda alone.

Trial Continues As Patient Survival Continues To Surpass Other Treatments. The VERSATILE-002 enrolled 53 patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). As of the May 17, 2024, analysis date, 27 patients remain alive with some reaching the 3-year survival point. Out of those alive, 10 remain on treatment and 17 are followed for survival.


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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. 

Biotech IPOs Raise $700 Million, Led by MBX Biosciences, Bicara Therapeutics, and Zenas BioPharma

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– MBX Biosciences raised $163.2 million, focusing on metabolic and endocrine disorders.
– Bicara Therapeutics and Zenas BioPharma raised $315M and $225M, respectively.
– These IPOs reflect renewed investor interest in biotech amid a sluggish broader market.

In a significant boost to the biotech IPO market, three emerging biotech companies—MBX Biosciences, Bicara Therapeutics, and Zenas BioPharma—collectively raised over $700 million through initial public offerings (IPOs). This surge in biotech IPOs, after a quiet summer, underscores the sector’s ability to attract investor attention despite broader market challenges.

MBX Biosciences successfully raised $163.2 million by pricing 10.2 million shares at $16 each, the high end of its expected range. MBX is developing peptide-based therapies for treating metabolic and endocrine disorders, including its lead candidate, MBX 2109, which targets chronic hypoparathyroidism. The company is also developing a preclinical therapy, MBX 4291, aimed at treating obesity by mimicking the effects of gut hormones GLP-1 and GIP. These advances in weight-loss therapies have garnered significant investor interest, especially as obesity treatments like Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy continue to show potential for reducing risks such as stroke and heart attacks.

Another notable IPO, Bicara Therapeutics, raised $315 million, positioning itself as the third-largest biotech IPO of the year. Bicara is focused on developing bifunctional antibody drugs for treating cancers, including head and neck cancers. With plans to launch a late-stage trial alongside Merck’s Keytruda, Bicara is well-positioned to explore treatments for other solid tumors as well.

Zenas BioPharma raised $225 million through its IPO and is gaining traction in the immunology space. Zenas is developing a dual-targeting antibody currently in Phase 3 testing for treating IgG4-related diseases and anemia. With potential applications for multiple sclerosis and lupus, the company is riding a wave of enthusiasm for immune therapies, contributing to its successful public offering.

These IPOs reflect a growing interest in later-stage biotech companies, with all three firms advancing drugs already in human testing. The renewed confidence in the sector could also signal more biotech IPOs on the horizon, particularly as companies look to capitalize on robust investor demand for novel therapies in metabolic diseases, cancer, and immunology.

In a market that has been challenging for biotech firms, these successful IPOs highlight the resilience of companies with strong pipelines and innovative approaches to medical treatment. With MBX Biosciences set to trade under the symbol “MBX” on the Nasdaq Global Select Market, investors are closely watching the sector, hopeful that this uptick in activity is a sign of better things to come for biotech in 2025.

Take a moment to take a look at Noble Capital Markets Senior Research Analyst Robert LeBoyer’s coverage list of emerging growth biotechnology companies.

MustGrow Biologics Corp. (MGROF) – Onto the East Coast

Posted on by cpereira@noblefcm.com


Thursday, September 12, 2024

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

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

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

Another Approval. Following the approval from the state of Arizona late last month, MustGrow announced receipt from the Florida Department of Agriculture and Consumer Services (FDACS) for the registration approval of its TerraSante product. Florida now becomes the sixth state to approve the Company’s product alongside Arizona, Idaho, California, Oregon, and Washington.

Florida Market. The state consists of around 47,300 farms which utilized 9.7 million acres, 5,000 farms of which had sales exceeding $100,000 according to the FDACS. Florida ranked first in 2022 in value of the production of bell peppers, Valencia oranges, grapefruit, sugarcane, fresh market tomatoes, and watermelons. The average farm size in the state is around 205 acres. The state adds plenty of opportunity to MustGrow’s expanding pipeline and we expect more states to be added in the future.


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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.

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

MAIA Biotechnology (MAIA) – New THIO Data Shows Improved Survival and Meets Trial Goals

Posted on by cpereira@noblefcm.com


Thursday, September 12, 2024

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

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

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

New Data Announced For Additional Patients. MAIA announced new interim data from its Phase 2 THIO-101 open-label trial testing the combination of THIO and Libtayo in non-small cell lung cancer. The new data shows that as of August 1, 2024, 16 patients had passed the 12-month survival point with reported median survival of 10.2 months. This greatly exceeds published data for comparable patients with survival of 5.8 months.

THIO-101 Treated Third-Line Patients With Advanced Disease. Patients in the trial had advanced non-small cell lung cancer (NSCLC) and were treated with the combination of THIO and cemiplimab (Libtayo, an anti-PD-1 checkpoint inhibitor from Regeneron) after failing 2 or more standard-of-care therapy regimens. Patients received 3-week cycles of THIO 60 mg administered on days 1, 2 and 3 (180 mg total), rest on day 4, and cemiplimab 350mg administered on day 5. Patients on treatment for 12-months have received up to 21 cycles.


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Release – Zomedica Secures CE Mark for TRUVIEWTM Digital Microscope & Telepathology System, Expanding Global Market Opportunities

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZOM

CE Mark approval opens European market for TRUVIEW system

ANN ARBOR, MI / ACCESSWIRE / September 5, 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 it has secured the CE Mark for its revolutionary TRUVIEW™ digital microscopy and telepathology platform. The CE Mark certification affirms the system’s compliance with the stringent health, safety, and environmental standards required by the European Union, enabling Zomedica to commercialize the TRUVIEW microscope across the European Economic Area (EEA).

The TRUVIEW platform integrates advanced diagnostic features, including LiquiView™ liquid lens technology for superior imaging and the proprietary TRUprep™ automated slide preparation system. This all-in-one solution empowers veterinary professionals with advanced capabilities that enhance both diagnostic accuracy and efficiency.

“The TRUVIEW microscope represents the latest leap in veterinary diagnostic technology,” commented Bill Campbell, VP of Imaging at Zomedica. “By automating slide preparation and offering telepathology services, we are revolutionizing how veterinarians approach diagnostics, delivering unparalleled precision and operational efficiency.”

Microscopic examination is a cornerstone of veterinary care, and the TRUVIEW system optimizes workflow by providing consistently high-quality slide preparation while saving valuable technician time. Additionally, the platform’s telepathology feature enables real-time remote consultation, fostering collaboration among veterinary professionals and enhancing diagnostic confidence.

“Securing the CE Mark is a significant milestone for Zomedica,” stated Larry Heaton, CEO of Zomedica. “Our TRUVIEW microscope’s cutting-edge optics, automated slide preparation, and telepathology services set a new standard for veterinary diagnostics in Europe and throughout the world. We are excited to bring this transformative technology to veterinary practices across the EEA.”

To learn more about the TRUVIEW digital microscope and its transformative capabilities, visit Zomedica’s website at www.zomedica.com/truview.

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 $83 million in liquidity as of June 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.

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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 our 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; 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 product manufacturing 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.