Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
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Initiating Research Coverage. We are initiating research coverage of MariMed, Inc. with an Outperform rating and a $0.25 price target. MariMed is a cannabis brand powerhouse, in our view, with leading market shares in current markets and significant expansion potential both within existing markets and new greenfield markets.
MSO. With operations in six states, MariMed is a vertically integrated seed-to-sale cannabis provider. Following in the footsteps of successful consumer brands companies, MariMed has three market leading brands across its operations. We expect the Company to benefit from the growth of its brands in growing markets as well as the addition of new markets in Ohio, Illinois, and Delaware in 2025.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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FY2025 Made Significant Progress. Unicycive reported a 4Q loss of $21.7 million or $(0.20) per share and a loss of $37.8 million or $(0.56) per share for FY2024. Cash on December 31, 2024 was $26.1 million. The most significant development, in our opinion, is the June 28, 2025, PFUFA date by which the FDA is required to answer to the Oxylanthanum (OLC) NDA.
OLC Launch is expected in Late 2025. The PDUFA date of June 28, 2025, is the statutory date by which the FDA is required to answer the NDA application. We expect OLC to be approved, based on its clinical trial data showing equivalence to lanthanum (Fosrenol, from Shire) with easier dosing, better patient compliance, and more patients reaching the target range for phosphate levels. An estimated 70% of the renal dialysis patients do not have adequate phosphate control. We believe its lower pill burden and improved patient compliance will lead to better outcomes with fewer morbidity events, leading to a strong market share.
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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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Fourth Quarter and FY2024 Reported. Cocrystal reported a 4Q24 loss of $3.1 million or $(0.31) per share and a FY2024 loss of $17.5 million or $(1.72) per share. The company reviewed the progress it has made in 4Q24 and YTD with CC-988 for norovirus/coronavirus and with CPI-42344 for influenza. The cash balance on December 31, 2024, was $9.9 million.
Human Challenge Study Planned For CC-988 In Norovirus. Cocrystal is planning a human challenge study to test CC-988, its protease inhibitor for norovirus and coronaviruses. The new trial follows the results of the Phase 1 ascending dose studies announced in December 2024, showing safety and tolerability. Results from an additional high-dose cohort are expected in 2Q25. The Phase 2a human challenge study is expected to begin later in 2025.
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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.
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4Q24 Meets Expectations As Pipeline Advances. GeoVax reported 4Q24 loss of $8.3 million or $(0.88) per share and a loss of $25.0 million or $(4.82) per share for FY2024. The company updated its three clinical programs with CM04S1, the Gedeptin Phase 2, and the MVA program, which continue to make progress as expected. On December 31, 2024, cash on hand was $5.5 million, excluding the proceeds of a $4.5 million offering completed in March 2025.
Clinical Supplies Were Made for the CM04S1 Phase 2b BARDA Trial. Geovax has manufactured clinical supplies for the Phase 2b trial, testing CM04S1 as a booster for healthy adults who have received an mRNA vaccine against COVID-19. This trial is sponsored by a BARDA grant, with estimated revenues of $25 to $45 million for the company, plus about $350 million allocated for direct clinical trial expenses. The trial is now expected to begin late in 2025 to early 2026.
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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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No Advisory Panel Required. Tonix has been informed that the FDA will not require an Advisory Committee Meeting to determine approvability of the NDA for Tonmya (TNX-102 SL). We see this as a sign that the NDA review has not raised questions about the clinical trial data, potential patient use, or other factors that would be answered by an Advisory Committee. Since the trial met its primary endpoint and all six secondary endpoints with high statistical significance, we interpret this to be a positive sign.
FDA Advisory Panel Hearings Evaluate and Provide Insight To Trial Data. As part of its NDA review process, the FDA may schedule an Advisory Committee hearing. The committee members each bring expertise in aspects of clinical practice, research, or statistical analysis. At a hearing, the company presents its analysis of the trial and the data, followed by the FDA’s analysis. The Committee members then ask questions to make recommendations for or against NDA approval and/or product labeling. We see the review without an Advisory Committee as a sign that the FDA does not need additional information on efficacy or safety.
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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.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Eledon Reported 4Q24 Results and Reviewed Progress During The Quarter. Eledon reported a loss for 4Q24 of $44.6 million or $(0.64) per share and $36.2 million or $(0.75) per share for FY2024. Cash and equivalents on December 31, 2024 was $140.2 million, which is expected to fund operations through YE2026. Based on our estimated loss for 1Q25, we project the cash balance on March 31, 2025 to be about $115 million to $120 million.
Tegoprubart Has Clinical Trial Milestones Ahead. Enrollment in the Phase 2 BESTOW trial for prevention of kidney transplant rejection was completed ahead of schedule in August 2024 due to higher than anticipated interest from transplant surgeons. We anticipate top-line results in 4Q25. The Phase 1b open-label trial continues to evaluate patients and is expected to provide an interim data update in mid-year 2025.
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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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Fourth Quarter Reported With Product Development Updates. Tonix reported 4Q Net Loss to Common Shareholders of $22.1 million or $(9.77) per share and $130.0 million or $(176.60) per share for FY2024. Total Product sales were $10.1 million with Gross Margin averaging 23% for the full year. The company ended FY2024 with $98.8 million in cash then raised $46.3 million in 1Q25. Including our expected loss for 1Q25, we estimate cash on March 31 to be around $125 million and believe the company has sufficient operating funds into FY2026.
Preparations For Tonmya Are In Progress. Tonix has been assigned a PDUFA date of August 15, 2025, the statutory date for the FDA to answer its NDA for Tonmya (TNX-102 SL). We believe the Phase 3 trials justify approval for fibromyalgia and anticipate broad use for relief of its multiple symptoms. Based on its patient population of over 10 million patients, we believe Tonmya could be a significant revenue generator for Tonix.
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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.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Net Income Was Within Expectations. Gyre Therapeutics reported 4Q24 Net Income Attributable to Common Shareholders of $(0.1) million or $(0.00) per share and FY2024 Net Income of $12.1 million, or $0.14 per basic share and $0.05 per fully diluted share. Revenues were $105.8 million in FY2024 with gross margins of 96.3%, consistent with our revenue estimates of $101.4 million and 96.2% gross margins. As of December 31, 2024, cash on hand was $51.2 million. Separately, results of the Phase 3 clinical trial for Hydronidone will be announced in 2Q25.
Hydronidone Data Announcement Pushed To 2Q25. In its quarterly press release, the company stated that data from the Phase 3 clinical trial for Hydronidone will be announced in 2Q25, although we had expected the data in 1Q25. We do not see this as a significant delay, as it extends the timeframe by 2 to 14 weeks. We believe this can still allow for regulatory filing in China during FY2025.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Product Sales Drove Revenue Growth. Zomedica reported 4Q24 revenues of $7.9 million and FY2024 revenues $27.3 million, in line with our estimates of $8.0 million and $27.5 million. Gross Margins were 70.0% as expected, with a loss for FY2024 of $46.9 million or $(0.05) per share. Cash and equivalents on December 31 was $71.4 million.
CEO Addressed Recent Stock Delisting. At the beginning of the quarterly conference call, CEO Larry Heaton spoke about the events leading to the delisting from the New York American Exchange earlier this month. As discussed in our Research Note on March 11, the recent market weakness brought the stock below the threshold for continued listing. This weakness led to a move to the OTCQB Venture Market, causing further weakness.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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FY2024 Was A Productive Year. Cadrenal reported a 4Q24 loss of $4.2 million or $(2.55) per share and FY2024 loss of $10.7 million or $(8.73) per share. An important development discussed in our Research Note on March 5 was Cadrenal’s announcement of a collaborative agreement with Abbott (ABT, Not Rated) for support of its pivotal trial testing tecarfarin in patients with left ventricular assist (LVAD) devices. Cash and equivalents on December 31 were $10.0 million.
Tecarfarin Is In Development For Several Patient Populations With Coagulation Needs. Many patients that are at risk for cardiovascular events (stroke, embolism, deep vein thrombosis) take anticoagulants in the direct oral anticoagulant class (DOACs, such as Eliquis or Xarelto). However, there are several patient populations that must take warfarin, an older drug, due to lack of efficacy or high bleeding risk. Tecarfarin is being developed to replace warfarin in these populations. Cadrenal has Orphan Drug designation from the FDA for implanted mechanical devices (LVADs) and prevention of systemic thromboembolism in end-stage kidney disease (ESKD) and atrial fibrillation (AFib).
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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.
Recent Price Weakness Forces Move To The OTC Bulletin Board. As the recent decline in the overall markets was affecting companies in many sectors, the closing price of Zomedica stock fell below $0.10 per share on March 3. This crossed a threshold set by the New York American exchange, forcing the delisting of ZOM shares. Zomedica shares began trading on the OTCQB Venture Market under the symbol ZOMDF. There were no other events or crisis that caused the delisting.
During 2024, Zomedica Has Met All Of The Product Goals We Expected. Over the past year, Zomedica has introduced several new assays for use with its TRUFORMA diagnostics platform. These assays are sold to veterinary practices for use with TRUFORMA diagnostic instruments, allowing the veterinarian to run tests without sending samples to an outside lab. This allows the diagnosis in a few minutes and allows the practice to capture the profit from the tests. The TRUFORMA assays, reported as diagnostic consumables, have been one of the sources of sales growth over the past year.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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We Are Initiating Coverage Of Gyre Therapeutics With An Outperform Rating. Gyre Therapeutics is a pharmaceutical company developing drugs for inflammatory diseases that lead to fibrosis. It currently markets Etuary (pirfenidone) in China for idiopathic pulmonary fibrosis. The lead drug in the pipeline is Hydronidone, a new molecule derived from pirfenidone, that is in a Phase 3 clinical trial in China. The data announcement is expected to report Phase 3 clinical trial results in March 2025.
Hydronidone Was Developed To Improve Efficacy and Side Effects. Hydronidone is a structural analogue of pirfenidone that was developed to improve efficacy with a more tolerable side effect profile. It is in Phase 3 trial in China for fibrosis of the liver after hepatitis B (HBV) infections. Hydronidone targets steps in the Transforming Growth Factor (TGF)-ß1 pathway as well as the downstream genes and liver cells it activates to produce fibrotic tissue. Data from the Phase 3 in China will be used to design a Phase 2a trial in the US, expected to begin in late FY2025.
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Key Points: – Kestra Medical Technologies has priced its upsized initial public offering (IPO) of 11,882,352 common shares at $17.00 per share, aiming to raise approximately $202 million. – Shares are set to begin trading on the Nasdaq Global Select Market on March 6, 2025, under the ticker symbol “KMTS.” – Kestra specializes in wearable medical devices and digital healthcare solutions, particularly for cardiovascular disease monitoring and intervention.
Kestra Medical Technologies, a Kirkland, Washington-based company specializing in wearable medical devices and digital healthcare solutions, has announced the pricing of its upsized initial public offering (IPO). The company is offering 11,882,352 common shares at a public offering price of $17.00 per share, with gross proceeds expected to be approximately $202 million, excluding any exercise of the underwriters’ option to purchase additional shares. This option allows underwriters a 30-day period to acquire up to 1,782,352 additional common shares at the IPO price, less underwriting discounts and commissions.
Trading of Kestra’s common shares is scheduled to commence on March 6, 2025, on the Nasdaq Global Select Market under the ticker symbol “KMTS.” The closing of the offering is anticipated to occur on March 7, 2025, contingent upon the fulfillment of customary closing conditions.
The IPO is being led by prominent financial institutions, with BofA Securities, Goldman Sachs & Co. LLC, and Piper Sandler acting as lead bookrunners. Wells Fargo Securities and Stifel are serving as bookrunners, while Wolfe | Nomura Alliance is participating as co-manager for the offering.
Kestra Medical Technologies is a commercial-stage company focused on transforming patient outcomes in cardiovascular disease through intuitive, intelligent, and connected monitoring and therapeutic intervention technologies. Their flagship product, the ASSURE® Wearable Cardioverter Defibrillator (WCD) system, is designed to provide automatic detection and defibrillation for ventricular arrhythmias, offering a modern approach to sudden cardiac arrest protection. The ASSURE system integrates with the Kestra CareStation™ remote patient data platform, enabling configurable notifications for clinical events and trending of physiological and device data at any time.
The company’s decision to go public comes amid increasing demand for wearable medical technology, particularly in the cardiovascular sector. As heart disease remains one of the leading causes of death globally, there is a growing market for advanced monitoring and intervention solutions. Kestra’s innovative approach to real-time monitoring and emergency response through connected devices positions it as a competitive player in this expanding industry. The funds raised through the IPO will likely support further research and development, product expansion, and potential strategic partnerships to enhance its market presence.
Investors will be closely watching the stock’s performance following its debut on the Nasdaq. Given the strong interest in digital healthcare and the increasing adoption of wearable medical devices, Kestra’s IPO could attract significant attention from both institutional and retail investors. The success of this offering could also signal broader investor confidence in the future of digital health solutions, particularly those that leverage artificial intelligence and real-time data tracking to improve patient outcomes.
