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.
3Q24 Reported With Product Updates. ZyVersa reported a loss of $2.4 million or $(2.43) per share and updated its clinical trial plans for the two products in development. During the quarter, several scientific papers were published showing the role of inflammation in obesity, diabetes, and neurodegeneration. These studies all support previous work by the company and are consistent with the mechanism of action for IC 100.
VAR 200 To Start Phase 2a In Diabetic Kidney Disease. The Cholesterol Efflux Mediator™ VAR 200 has shown reductions in the initial damage that starts a cycle of damage and repair that leads to progressive scarring and loss of kidney function. A Phase 2a trial enrolling patients with diabetic kidney disease (DKD) is expected to begin in 1Q25 with initial data announcement around mid-2025.
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*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 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.
Progress Toward Phase 3 With New Phase 2 VERSATILE-002 Data. PDS Biotech Reported 3Q24 loss of $10.7 million or $(0.29) per share, a slightly lower loss than we estimated. Earlier this week, modifications to the IND protocol for the Phase 3 VERSATILE-003 trial were submitted to the FDA. Approval is expected by mid-December, which would allow the trial to begin in early 2025.
New Phase 2 VERSATILE-002 Data Analysis Shows Outcomes Were Maintained Or Improved. As additional patients complete their follow-up periods, further analysis of the data has shown improvements over the previous interim reports. The overall survival has been unchanged at 30.0 months, although the lower limit of the confidence interval has increased to 20 months. This compares with 17.9 months for published Keytruda studies. Overall response rate, complete response rate, and disease control rates have improved as well.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
OLC Achieved Significant Milestones In 3Q24. Unicycive reported a 3Q24 loss of $4.1 million or $(0.05) per share. During the quarter, the NDA was submitted for approval of oxylanthanum carbonate (OLC), its phosphate binder for patients on renal dialysis. After the close of the quarter, the acceptance for filing was announced with a PDUFA date of June 28, 2025. The quarter ended with $32.3 million in cash, which we believe is sufficient to fund operations and launch of OLC in 2025-26.
NDA Submission Was Completed As Expected. In early September, Unicycive submitted the new drug application (NDA) for OLC, its phosphate binder for patients on renal dialysis. On November 11, the company announced FDA acceptance of the application for review and assigned a PDUFA date of June 28, 2025. This is the statutory date for the FDA to answer the application with Market Approval or a denial known as a Complete Response Letter (CRL).
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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.
Two Trials Expected To Report Data Shortly. Cocrystal reported a 3Q24 loss of $4.9 million or $(0.49) per share. The company made progress in its clinical programs during the quarter, including CC42344, its oral PB2 inhibitor for seasonal and pandemic influenza. We see this an increasingly important product, given the spread of a new variant of the virus known as H5N1, or the avian flu. Data from its Phase 2a human challenge study is expected before year-end.
CC-42344 Could Be Effective Against The New Bird Flu. As discussed in our Research Note on June 21, a new virulent strain of influenza known as avian flu (H5N1) had been detected in dairy cattle. Earlier this year, the first infections in dairy workers showed the virus had mutated enough to begin infecting humans. Preclinical testing with CC-42344 showed it was able to inhibit the virus and has potential for human use against the strain.
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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 Held A Meeting With Scientists, Doctors, and Patients. On November 12, Ocugen held a Clinical Showcase meeting to present the scientific basis of its Gene Modifier technology, interim data updates from its clinical trials, and allow patients to discuss their experiences with the treatments.
First OCU410 Data Shows Efficacy. The Phase 2 ArMaDa trial is testing OCU410 in Geographic Atrophy (GA), a lesion in patients with dry age-related macular degeneration that leads to blindness. The presentations included its four mechanisms of action and the clinical outcomes from the initial patient cohorts in the dose-escalation stage of the trial. These data at 6 months compare favorably to approved complement inhibitors for GA.
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GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
3Q24 Report Reviews Progress During The Quarter. GeoVax reported a loss of $5.8 million or $(0.91) per share. The quarter included first revenues from its BARDA contract for the Project NextGen Phase 2b trial testing CM04S1 as a preventive vaccine for COVID-19. The company gave updates and data timeframes for clinical trials with CM04S1, MVA, and Gedeptin. During the quarter, it raised $13.5 million and ended with a cash balance of $8.6 million on September 30, 2024.
Gedeptin Trial Design Announced. GeoVax announced that the Phase 2 trial in head and neck squamous cell carcinoma (HNSCC) will test Gedeptin in combination with an immune checkpoint inhibitor (ICI) in recurrent patients before surgery. A single-cycle of Gedeptin will be given with a standard dose of Keytruda (pembrolizumab), followed by a second cycle of Keytruda alone, then surgery. Endpoints will include standard measures of response, tumor shrinkage, and survival that would make the data comparable to other treatments. The trial is expected to begin in 1H25.
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ANN ARBOR, MI / ACCESSWIRE / November 12, 2024 / Zomedica Corp. (NYSE American:ZOM), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, is pleased to announce that Noble Capital Markets has initiated company-sponsored equity research coverage on the Company. The full report by Noble Capital Markets Research Analyst Robert LeBoyer, as well as news and advanced market data on Zomedica Corp., is available on Channelchek.
About Zomedica
Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet ® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi ® Loop line of therapeutic devices and the TRUFORMA ® diagnostic platform, the TRUVIEW ® digital cytology system, and the VetGuardian ® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $78 million in liquidity as of September 30, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.
Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 37 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email: contact@noblecapitalmarkets.com
About Channelchek
Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email: contact@channelchek.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.
Initiating Coverage of Zomedica Corp. With An Outperform Rating. We are initiating coverage of Zomedica, a company that makes and sells veterinary therapeutic devices and diagnostics. These products are used to diagnose and treat animals ranging from horses to cats, dogs, and other pets. Veterinarians use these products to improve the outcome and quality of care for the pet as well as to streamline workflow and profitability of their practice.
Zomedica Has Made Several Acquisitions To Build Its Product Lines Zomedica has grown by acquiring complementary businesses that broaden its product line and leverage its existing infrastructure. It has five product lines in therapeutic devices and diagnostics, two fast-growing segments of the animal health market. These products are marketed by its own sales force and commercial partnerships. We expect near-term growth to come from the introduction of new internally-developed applications that increase uses and grow sales of existing products.
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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.
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 Trials Continued, Capital Was Raised, and New Data Expected. Ocugen reported a loss for 3Q24 of $13.0 million or $(0.05) per share. The company reported continued enrollment in all of its ongoing clinical trials and has scheduled a Clinical Showcase meeting in New York on Tuesday, November 12, 2024. We expect the meeting presentations to include data updates from the clinical trials. In August, Ocugen completed a stock offering that raised $35 million to end 3Q24 with $38.7 million in cash. After the quarter ended, the company added $30 million in debt funding.
OCU400 in Retinitis Pigmentosa (RP) Is On Schedule. The company confirmed that the Phase 3 liMeliGhT (pronounced “Limelight”) trial continues to enroll patients and is on schedule to complete enrollment in 1H25. An approval by Health Canada will allow patient enrollment at up to 5 Canadian sites. The FDA has approved an expanded access program (EAP) to allow patients to be treated outside of the clinical trials before OCU400 receives market approval.
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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.
Refer to the full report for the price target, fundamental analysis, and rating.
Financial Condition Improved In 3Q24. Cadrenal reported a loss of $2.4 million or $(2.18) per share, adjusted for the 1-for-15 reverse split on August 20, 2024. This loss was slightly less than our projections. Cash on September 30 was $4.4 million, excluding financing that brought in $9.8 million after the close of the quarter. The company reported that its current cash balance was approximately $11.3 million on November 7, 2024.
The Tecarfarin Made Progress In Its Next Indication. Cadrenal held a Type-B meeting with the FDA to discuss the planned Phase 3 trial for use of tecarfarin in patients with left ventricular assist devices. The company will use the guidance and comments from the meeting to design the pivotal trial. Cadrenal also continued to discuss collaborating with Abbott about a clinical trial with patients that have the Abbott HeartMate 3, the only LVAD available in the United States. Cadrenal has Orphan Drug designation for the LVAD indication, providing a strong incentive for collaborations.
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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.
Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.
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.
Preliminary 3Q24 Results. Last night, Schwazze reported preliminary 3Q24 results. We believe the ongoing audit of past results is likely causing a delay in reporting results. According to the release, 3Q24 revenue is expected to be approximately $42 million, and adjusted EBITDA is expected to be approximately $11 million. In 3Q23, Schwazze reported revenue of $46.7 million and adjusted EBITDA of $14.1 million. We had estimated revenue of $44.5 million and adjusted EBITDA of $10.3 million.
Making Progress. In spite of the challenging operating environment, Schwazze continued to generate momentum from its retail growth and optimization initiatives in the quarter, reflected by the Company once again outpacing two highly competitive markets while generating sequential improvements in profitability and positive cash flow from operations. Management noted increased store traffic in both Colorado and New Mexico.
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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.
Interim Update From Phase 2 Trial Scheduled For SITC. MAIA is scheduled to present a data update from the ongoing THIO-001 trial at a Late-Breaker session of the STIC (Society For The Immunotherapy of Cancer) Annual meeting on Saturday, November 9. The presentation could include data on endpoints and measures of efficacy such as disease control rate, overall survival, and median survival with additional patients and longer treatment times.
Trial Treats Patients With THIO and A Checkpoint Inhibitor. The THIO-001 trial enrolled advanced non-small cell lung cancer (NSCLC) patients that had progressive disease and no longer responded after two or more standard-of-care therapy regimens. Patients were treated with the combination of 3-week cycles of THIO and the standard dose of cemiplimab (350 mg Libtayo, an anti-PD-1 checkpoint inhibitor from Regeneron). Patient enrollment was completed in February 2024.
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Proposed clinical study in Kenya intended to test the safety, tolerability, and immunogenicity of TNX-801, a vaccine being developed to prevent mpox (formerly called monkeypox)
The World Health Organization (WHO) declared mpox a public health emergency of international concern (PHEIC)1-4: cases of the new Clade Ib mpox detected in Sweden, Thailand, Singapore, India, Germany and England
In preclinical data, TNX-801, Tonix’s attenuated live-virus vaccine candidate, demonstrated efficacy as a vaccination against mpox in animal models
CHATHAM, N.J., Nov. 04, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it has entered into a sponsored research agreement with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study in Kenya to test the safety, tolerability, and immunogenicity of TNX-801 (horsepox, live virus) as a vaccine to prevent mpox and smallpox. Tonix will be the sponsor and KEMRI will lead the execution of the proposed clinical trial.
“We are excited to advance development of TNX-801 under this research agreement with KEMRI,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There is an urgent need for the worldwide availability of a single dose mpox vaccine with durable protection. TNX-801 has demonstrated encouraging preclinical data and was recently shown to align with the World Health Organization’s (WHO’s) newly issued preferred target product profile (TPP) for mpox vaccines. Further, TNX-801 can be scaled up for manufacturing, distribution and storage without a costly supply chain. We believe TNX-801 has the potential to address and help interrupt the spread of mpox worldwide.”
In September 2024, Tonix announced that the preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference, aligns with the potential characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.
In August 2024, Tonix announced a collaboration with Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for TNX-801. Bbio is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.
About TNX-801*
TNX-801 is a live minimally-replicating attenuated horsepox vaccine that is believed to provide immune protection against mpox in animals with better tolerability than 20th century vaccinia viruses. Vaccinia vaccines from the 20th century are descendants of Edward Jenner’s circa 1800 that have become more virulent in connection with losing regulatory elements in their genomes. Given the modern understanding that Jenner’s circa 1800 vaccine would be called “horsepox” today, TNX-801 was designed to be similar to Jenner’s vaccine. After a single dose vaccination, TNX-801 protected animals against lethal challenge with intratracheal Clade Ia monkeypox virus.5 In this experiment, TNX-801 vaccination prevented clinical disease and skin lesions and also decreased shedding in the mouth and lungs. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission. In addition, TNX-801 has decreased virulence in immunocompromised animals relative to 20th Century vaccinia viruses.6 Based on animal studies, TNX-801 combines immune protection with improved tolerability compared to live-virus vaccinia vaccines. TNX-801 is administered with a single dose which has advantages over two-dose regimens. The focus on single-dose vaccines confirms early recommendations by the Bipartisan Commission on Biodefense, 7 and the U.S. National Academies of Science.7,8 The National Academies of Science (NAS) report highlights the difficulty of a ring vaccination strategy with even a two-dose regimen.7 TNX-1800 is an engineered version of horsepox that expresses the spike protein of SARS-CoV-2. 9,10 The U.S. National Institutes of Health (NIH) selected Tonix’s COVID-19 vaccine, TNX-1800 for Project NextGen.
About Mpox* On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a PHEIC, the second such declaration in the past two years called in response to an mpox outbreak.1 The current outbreak is caused by Clade Ib monkeypox virus while the 2022 outbreak was caused by Clade IIb monkeypox virus. The 2022 global mpox outbreak, which is ongoing, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The rapid spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade Ib strain of mpox appears to be spreading in Africa, particularly those neighboring the Democratic Republic of the Congo, including Burundi, Rwanda, and Uganda, but now affecting 16 countries. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the Clade Ib monkeypox may appear in the U.S.2,3
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has 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 U.S. National Institude of Drug Abuse and Addiction. 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 the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix has 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.
1WHO Press Release August 14, 2024. “WHO Director-General declares mpox outbrfeak a public health emergency of international concern”. URL: www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern (accessed 8-15-24) 2McQuiston JH, et al. U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morbi Mortal Wkly Rep: United States. p. 435-440 3CDC. 2022-2023 Mpox: US Map and Case Count. https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html 4World Health Organization SAGE meeting highlights on updated mpox vaccine recommendations. 2024, March 5Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. Doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234 6Trefry, SV et al. bioRxiv 2023.10.25.564033; doi: https://doi.org/10.1101/2023.10.25.564033 7Bipartisan Commission on Biodefense. Box the Pox: Reducing the risk of Smallpox and Other Ortho poxviruses, Washington:2024 8U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington:2024 9Awasthi M, et al. Viruses. 2023 Oct 21;15(10):2131. Doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059. 10Awasthi M et al Vaccines (Basel). 2023 Nov 2;11(11):1682. Doi: 10.3390/vaccines11111682.PMID: 38006014
Forward Looking Statements
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