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.
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.
Refer to the full report for the price target, fundamental analysis, and rating.
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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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.
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.
Refer to the full report for the price target, fundamental analysis, and rating.
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.
Refer to the full report for the price target, fundamental analysis, and rating.
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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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.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
We Are Initiating Coverage 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.
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.
Refer to the full report for the price target, fundamental analysis, and rating.
Clinical Progress Expected To Lead To Filings For Three Product Approvals. Ocugen reported a 4Q24 loss of $13.9 million or $(0.05) per share and FY2024 loss of $54.1 million or $(0.20) per share. The company made significant progress in its clinical trials during the quarter and since the start of FY2025. It has also received regulatory designations that accelerate product approval. The company had $58.5 million in cash on December 31, sufficient to fund operations through 1Q26.
Clinical Trial Advances Point To Three BLAs In 3 Years. Ocugen has made significant progress with three products for three diseases that lead to vision loss. The three ongoing trials are Phase 3 for OCU400, the Phase 2/3 for OCU410ST in Stargardt disease, and the Phase 1/2 trial for GA. These trials are on schedule for filing applications for approval in 2026, 2027, and 2028 respectively. OCU400 and OCU410ST have Orphan Drug designations that can accelerate approval, while GA is a large market of over 10 million patients in the US alone.
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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.
Cadrenal and Abbott Announce The LVAD Collaboration We’ve Been Waiting For. Cadrenal announced a development agreement with Abbott (ABT, Not Rated) to develop Tecarfarin in patients with Abbott’s HeartMate3 LVAD (left ventricle assist device). Under the agreement, Abbott will support Cadrenal’s pivotal TECH-VLAD (TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices) trial in its design, site selection, recruitment, and its HeartMate3 experience.
LVAD Patients Have An Unmet Need For A New Anticoagulant. While Direct Oral Anticoagulation Drug (DOAC) category has been highly successful, there are several populations where they are not effective or have safety risks. Patients with LVAD devices can only use warfarin, a drug that has variable efficacy with several drawbacks, including a requirement for frequent patient monitoring. LVAD patients have less effective anticoagulation and remain at high risk for coagulation events (bleeding, stroke, myocardial infarct).
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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.
Refer to the full report for the price target, fundamental analysis, and rating.
Ocugen Now Has Three Products With ATMP Designation. Two Ocugen products, OCU410 and OCU410ST, received Advanced Therapy Medicinal Product (ATMP) designation from the European Medicines Agency Committee for Advanced Therapies (EMA-CAT). These join OCU400, which received this designation for retinitis pigmentosa (RP) in February 2025. The designation is similar to the Breakthrough Therapy designation from the FDA, allowing increased interactions with the regulators and accelerating regulatory review.
OCU410 Has Completed Phase 2 Dosing In GA. The Phase 2 portion of the ArMaDa (pronounced ‘Armada”) trial has completed enrollment for OCU410 in geographic atrophy (GA), a lesion that results from advancing dry Age-related Macular Degeneration (dry AMD). The study has enrolled 51 patients randomized into a high dose arm, medium dose arm, or control. The completion of the dosing phase was ahead of our expected time frame, keeping the company on schedule to conduct Phase 3 in 2026 and potentially file for regulatory approval in 2028.
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Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Strong Q4. The company delivered impressive Q4 results driven by strong market dynamics during the Medicare Advantage Annual Enrollment Period (AEP). Quarterly revenue of $389.1 million was 16% stronger than our estimate of $336.0 million, and adj. EBITDA of $117.8 million exceeded our estimate of $80.4 million by 47%.
Improved efficiency. Average agent handle time was down roughly 9% from the prior year period and direct operating cost per policy submission was down 27% to $501. We believe these improvements are attributable to the company’s agent training and technology tool enhancements. Moreover, we believe the company’s focus on increasing productivity per agent could drive additional margin improvement over time.
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Key Points: – Eli Lilly (LLY) is acquiring Organovo’s (ONVO) FXR program, including lead drug candidate FXR314, for further development. – Organovo will receive an upfront payment along with milestone-based regulatory and commercial payouts. – ONVO stock surged over 200% following the announcement.
In a significant move for the biotechnology sector, Organovo Holdings, Inc. (Nasdaq: ONVO) announced the sale of its FXR program, including its lead candidate FXR314, to pharmaceutical giant Eli Lilly and Company (NYSE: LLY). The acquisition, disclosed on Tuesday, marks a pivotal moment for Organovo as it aligns its proprietary 3D human tissue technology with a global leader in drug development.
The FXR program, focused on inflammatory bowel disease (IBD), is a major step toward advancing novel treatment approaches. Organovo’s Executive Chairman, Keith Murphy, expressed confidence in Lilly’s ability to further develop FXR314, highlighting the company’s world-class expertise and commitment to patient care.
Under the agreement, Organovo will receive an upfront cash payment, with additional milestone payments contingent on regulatory approvals and commercial success. While the specific financial terms remain undisclosed, the market’s response has been overwhelmingly positive.
Following the announcement, ONVO shares skyrocketed by over 200%, reflecting investor optimism about the deal’s potential impact. Lilly’s stock also saw a modest gain of 2.32% as the acquisition strengthens its pipeline in the IBD treatment space.
For Organovo, this transaction reinforces its ability to leverage its cutting-edge 3D tissue technology for drug development partnerships. The company, known for pioneering bioprinting innovations, has been positioning itself as a key player in personalized medicine and regenerative therapies.
For Eli Lilly, the acquisition aligns with its broader strategy of expanding its immunology portfolio. FXR314’s development complements Lilly’s existing research efforts in inflammatory diseases, further cementing its position as a leader in next-generation therapeutics.
With FXR314 now under Lilly’s stewardship, the biotech industry will closely monitor its progression into Phase 2 trials. If successful, the drug could represent a breakthrough in IBD treatment, addressing a significant unmet medical need.
As Organovo pivots towards future innovation, and Lilly integrates this promising asset into its pipeline, investors and analysts alike will be watching closely to gauge the long-term benefits of this high-profile acquisition.
