Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
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.
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.
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.
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.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
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.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
GeoVax Labs, 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.
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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CHATHAM, N.J., March 27, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer, will present a poster at the AAPM 2025 Annual Meeting, PainConnect, in Austin, Texas on April 5, 2025, at 11:45 a.m. CT. The meeting will take place from April 3-6, 2025.
Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced the publication of the manuscript titled “Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial” in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 trial to support the use of hydronidone in Chinese patients with liver fibrosis associated with chronic hepatitis B (“CHB”). The published protocol outlines patient inclusion criteria, randomization and blinding processes, key assessments, and the statistical analysis plan.
The randomized, double-blind, placebo-controlled, multicenter Phase 3 trial (NCT05115942) completed the enrollment of 248 patients across 44 clinical research hospitals in the People’s Republic of China (“PRC”) in October 2024. Patients were randomized 1:1 to receive either F351 or placebo in addition to entecavir antiviral basic therapy for CHB. The primary endpoint is a decrease in liver fibrosis (as measured by the Ishak Scoring System) by at least one stage after 52 weeks of treatment relative to baseline.
The PRC’s National Medical Products Administration (“NMPA”) designated F351 as a “Breakthrough Therapy” in 2021. Gyre expects to report topline results from this Phase 3 trial in the second quarter of 2025.
About Hydronidone (F351)
F351 is a next-generation anti-fibrotic compound and a structural analogue of Pirfenidone, the first approved treatment for idiopathic pulmonary fibrosis (“IPF”) in Japan, the European Union, the United States and the PRC. F351’s dual mechanism has been shown to inhibit in vitro p38γ kinase activity and TGF-β1-driven collagen overproduction—both key drivers of liver fibrosis. F351 specifically targets hepatic stellate cells (“HSCs”), which are central to the progression of fibrosis. In preclinical studies, it has shown strong anti-proliferative and anti-fibrotic effects on HSCs. These effects have been validated across multiple in vivo models of liver fibrosis, including CCl4-induced liver fibrosis in mice, DMN- and HSA-induced liver fibrosis in rats, and a mouse model of MASH fibrosis (a form of MASH with fibrosis) induced by CCl4 plus a Western high-fat diet. Together, these results highlight F351’s potential as a differentiated treatment for liver fibrosis, with a unique mechanism and strong preclinical and clinical evidence supporting its advancement into later-stage development.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company’s experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.
Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings the Company may make with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
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.
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.
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.
Key Points: – Genetic testing company 23andMe has filed for Chapter 11 bankruptcy, struggling with declining revenue, cybersecurity concerns, and failed business expansions. – Anne Wojcicki has resigned as CEO, with Joseph Selsavage stepping in as interim CEO. – The company aims to sell its assets through a court-approved process, while Wojcicki has expressed interest in bidding to regain control.
Once a trailblazer in consumer DNA testing, 23andMe has filed for Chapter 11 bankruptcy protection after years of financial struggles and failed business pivots. The company, which was once valued at $6 billion, is now worth just $25 million as it grapples with a collapsing business model, cybersecurity concerns, and increasing regulatory scrutiny.
Founder Anne Wojcicki has stepped down as CEO effective immediately but will remain on the board. In her place, the company has appointed Joseph Selsavage as interim CEO as it navigates the bankruptcy process.
Wojcicki acknowledged the company’s challenges in a statement, saying, “There is no doubt that the challenges faced by 23andMe through an evolving business model have been real, but my belief in the company and its future is unwavering.”
Founded in 2006, 23andMe gained massive popularity with its at-home genetic testing kits, allowing customers to trace their ancestry and assess genetic health risks. The company’s early success led it to go public in 2021 through a special purpose acquisition company (SPAC) merger, which valued it at $3.5 billion.
However, the business struggled to generate recurring revenue beyond its one-time test kit sales. Attempts to transition into drug discovery and research partnerships failed to gain traction. Additionally, the company was hit with privacy concerns following a 2023 data breach that exposed the genetic information of nearly 7 million users, further damaging consumer trust.
According to court filings, 23andMe has between $100 million and $500 million in both estimated assets and liabilities. The company has stated that its primary goal is to sell its assets through a court-approved process over the next 45 days.
Wojcicki has indicated that she plans to be an independent bidder in the process, potentially seeking to take the company private after her previous takeover offers were rejected by 23andMe’s special committee.
Beyond financial troubles, the company continues to face scrutiny over its handling of sensitive consumer data. Last week, California Attorney General Rob Bonta issued a warning urging customers to reconsider keeping their genetic data stored with 23andMe, citing the risks of future breaches.
Despite these concerns, 23andMe has assured customers that there will be no immediate changes to how it stores or manages genetic data throughout the bankruptcy proceedings.
The future of 23andMe remains uncertain as the company seeks a buyer for its assets. While Wojcicki has signaled her interest in reclaiming control, potential bidders may be wary of the company’s financial instability and reputational damage.
For investors, this marks another cautionary tale of once-hyped SPAC deals that failed to deliver long-term value. As 23andMe fights for survival, the broader genetic testing industry must grapple with growing privacy concerns and the challenge of building sustainable business models beyond one-time test sales.
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.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Tonix 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.
Key Points: – FOXO Technologies has signed a non-binding agreement to acquire Vector Biosource, a biospecimen sourcing provider. – Vector is expected to generate $800,000 in revenue in 2025 without additional capital. – The acquisition involves Series D Preferred Stock and milestone-based earnout payments.
FOXO Technologies Inc. (NYSE American: FOXO) has announced the execution of a non-binding agreement to acquire Vector Biosource Inc., a provider of information and biospecimen sourcing services for the biotechnology, clinical research, and pharmaceutical industries. The acquisition aligns with FOXO’s strategy of expanding its footprint in healthcare and biotechnology sectors.
The proposed transaction includes an initial payment of $750,000 in Series D Cumulative Redeemable Preferred Stock, with an additional $750,000 in Series D Preferred Stock contingent on Vector meeting specific revenue and cash collection milestones in 2025. Further earnout payments in Series D Preferred Stock are structured based on Vector’s performance in 2026 and 2027. The deal remains subject to definitive agreements, due diligence, and the provision of $1 million in working capital.
Seamus Lagan, CEO of FOXO Technologies, emphasized the strategic benefits of the deal, stating, “We are excited to have reached agreement with Vector to move forward with this strategic acquisition. We were attracted to Vector’s unique position in this healthcare sector and its growth profile, and we are focused on working closely with Vector senior leadership to aggressively expand the Vector platform.”
Vector’s CEO, Frank Dias, Jr., highlighted the advantages of the partnership, noting, “We believe the partnership with FOXO will allow Vector to achieve its near and long-term growth plans by providing growth capital, corporate infrastructure, and potential synergies with other FOXO subsidiaries. We anticipate a significant increase in expected revenues with the provision of growth capital and corporate infrastructure by FOXO.”
FOXO Technologies operates through three subsidiaries:
Rennova Community Health, Inc.: Owner and operator of Scott County Community Hospital (Big South Fork Medical), a critical access hospital in East Tennessee.
Myrtle Recovery Centers, Inc.: A 30-bed behavioral health facility offering inpatient detox, residential treatment, and outpatient services.
Foxo Labs, Inc.: A biotechnology company dedicated to advancing health and lifespan through innovative technology and product solutions.
The acquisition of Vector Biosource marks another step in FOXO’s broader growth strategy as it continues to integrate specialized healthcare and biotechnology services under its corporate umbrella. The deal is expected to close within the next 45 days, subject to regulatory approvals and standard closing conditions.
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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Key Points: – AstraZeneca is acquiring Belgium-based EsoBiotec for $425 million upfront, with an additional $575 million contingent on milestones. – The deal enhances AstraZeneca’s cell therapy capabilities through EsoBiotec’s ENaBL platform, which enables in vivo immune cell engineering. – The acquisition aligns with AstraZeneca’s broader strategy of leveraging cell therapies, gene editing, and radioconjugates for oncology and immune disorders.
AstraZeneca has announced a significant expansion of its cell therapy pipeline with the planned acquisition of EsoBiotec, a Belgium-based biotech firm specializing in immune cell engineering. The deal, valued at up to $1 billion, consists of a $425 million upfront payment with the potential for an additional $575 million based on development and regulatory milestones. The acquisition is expected to close in the second quarter of 2025.
EsoBiotec’s ENaBL platform represents a transformative approach to cell therapy. Unlike conventional ex vivo cell therapies that require the extraction, modification, and reinfusion of patient cells, ENaBL allows for direct genetic programming of immune cells within the body. This eliminates the need for invasive lymphodepletion procedures and could significantly lower costs while improving accessibility for patients.
AstraZeneca has not yet disclosed specific target indications for EsoBiotec’s platform but has emphasized its potential applications in oncology and immune-mediated diseases. The ENaBL technology could help develop novel cancer treatments or autoreactive cell therapies for conditions such as autoimmune disorders.
This acquisition marks another step in AstraZeneca’s aggressive expansion into the cell therapy space. The pharmaceutical giant has been actively pursuing high-value deals to strengthen its pipeline in this emerging field. In 2022, AstraZeneca acquired TeneoTwo for up to $1.27 billion, securing its T cell engager TNB-486, now renamed AZD0486, which is in Phase III trials for follicular lymphoma and Phase II trials for B cell non-Hodgkin lymphoma.
Further reinforcing its position, AstraZeneca made another major investment in December 2023 with the $1 billion purchase of Gracell Biotechnologies. This deal added GC012F, now known as AZD0120, an investigational CAR T therapy targeting CD19 and BCMA for multiple myeloma and systemic lupus erythematosus.
Beyond acquisitions, AstraZeneca has formed strategic collaborations in cell therapy, including a $245 million agreement with Cellectis in November 2023 and a potential $2 billion partnership with Quell Therapeutics in June 2023. These investments highlight the company’s commitment to leveraging cutting-edge biotechnologies to expand its capabilities in immune modulation and oncology.
As a relative latecomer to the cell therapy market, AstraZeneca is rapidly scaling its presence through acquisitions and partnerships. By integrating EsoBiotec’s ENaBL platform into its pipeline, AstraZeneca positions itself to compete with industry leaders in the race to develop next-generation cell therapies that offer improved efficacy, lower costs, and enhanced patient accessibility.
With this latest acquisition, AstraZeneca continues to build a robust portfolio of cell therapies that could redefine treatment approaches for cancer and immune-related diseases. Investors and industry analysts will be closely monitoring how effectively AstraZeneca integrates these new technologies and translates them into viable commercial therapies.
