Tag: Health

Tonix Pharmaceuticals (TNXP) – Migraine Drug Acquisitions Will Transform Tonix

Posted on by cpereira@noblefcm.com


Tuesday, June 27, 2023

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.

Two Products To Be Acquired. Tonix announced that it will acquire two currently marketed migraine drugs from Upsher-Smith Laboratories. The two drugs, Zembrace SymTouch and Tosymyra, are proprietary formulations of sumatriptan, the most commonly prescribed drug for migraine headaches. The deal is expected to close on June 30, 2023. We believe these two products fit well into the company’s CNS strategy and the expected data announcement from the Phase 3 RESILIENT trial in fibromyalgia expected in 4Q23.

Two Sumatriptan Formulations For Migraine Headaches. Both drugs contain sumatriptan as the active compound with proprietary technologies for improved delivery. Zembrace SymTouch is an injectable packaged with an autoinjector. Tosymyra is a nasal spray with a permeation enhancer that provides rapid and efficient absorption of sumatriptan. Both drugs have clinical data showing onset of migraine pain relief as fast as 10 minutes from administration with response rates comparable or better than other sumatriptan formulations.


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

MAIA Biotechnology (MAIA) – Phase 2 THIO-101 Trial Reaches Recruitment Milestone

Posted on by cpereira@noblefcm.com


Wednesday, June 21, 2023

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.

Patient Enrollment Updated. MAIA Biotechnology announced that the THIO-101 trial has enrolled 29 patients (out of 57 total patients) in Part B of the trial. Enrollment has been increasing since the recent opening of 13 new clinical trial sites in Eastern Europe. This stage of the trial is evaluating the safety, tolerability, and dosing for the Part C efficacy stage. The trial is on schedule to announce data in 3Q/4Q23.

MAIA Continues To Make Clinical Progress. The THIO-101 trial is testing THIO, a nucleoside analogue targeted at  the telomeres of cancer cells. When THIO is taken up by the reproducing DNA, it stops the replication and leads to cell death, then starts an inflammatory response in the tumor. Preclinical models have demonstrated efficacy in several tumor types.


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

PDS Biotechnology Corp. (PDSB) – Answering Questions About The VERSATILE-002 Data

Posted on by cpereira@noblefcm.com


Friday, June 16, 2023

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.

The Phase 2 VERSATILE-002 Trial Remains Misunderstood. We have received inquiries from investors about the data in the recent ASCO presentation by PDS Biotech. We believe there is some misunderstanding of the trial design, outcome data, and the trial’s definition of efficacy. In view of the fundamental progress and stock price decline, we believe this is a buying opportunity.

Trial Data Has Led To Misinterpretation. The Phase 2 VERSATILE-002 trial has a primary endpoint of best overall response rate (ORR). To be considered a responder, patients need to have tumor shrinkage of at least 30% in two MRI scans. Patients with one positive scan are considered unconfirmed responses until they have a second confirming scan at least 9 weeks later. Both confirmed and unconfirmed responses were reported at the recent ASCO conference.


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

PDS Biotechnology Corp. (PDSB) – Reiterating Outperform – Phase 2 Trial Meets Efficacy Endpoint

Posted on by cpereira@noblefcm.com


Thursday, June 15, 2023

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.

ASCO Efficacy Data Has Been Updated. PDS Bioscience announced that the Phase 2 VERSATILE-002 trial has met the threshold for efficacy. This is good news for the trial and should help clarify misunderstandings of the data presented at the ASCO conference earlier this month. The Phase 3 trial is expected to begin in 3Q23.

New Data Should Clarify Trial Results.  In our June Research Note, we discussed data from the VERSATILE-002 trial presented at the ASCO annual meeting. This presentation showed a 12-month survival rate of 87% and a progression-free survival rate of 10.4 months. Responses were determined by the RECIST 1.1 criteria, requiring 30% tumor shrinkage. According to the trial protocols, responses seen in the first scan were considered unconfirmed responses until a second confirmatory scan 9 weeks later.


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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. 

Onconova Therapeutics (ONTX) – New Leukemia Data Presented Supports Wide Range Of Action

Posted on by cpereira@noblefcm.com


Thursday, June 15, 2023

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China. Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

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.

Data In Mantle Cell Lymphoma Updated. Onconova presented new data testing narazaciclib in mantle cell lymphoma (MCL) at the annual International Conference on Malignant Lymphoma, adding to data presented at the AACR meeting in April 2023. The preclinical studies tested the combination of narazaciclib as a single agent or in combination with ibrutinib (Imbruvica from AbbVie, an inhibitor of BTK or Bruton tyrosine kinase), a drug widely used to treat mantle cell lymphoma. Narazaciclib also was tested against approved CDK4/6 inhibitors and showed superior efficacy. 

Presentation Expands On Previous Data. Narazaciclib was tested with ibrutinib in multiple cell lines that are sensitive or resistant to ibrutinib. The combination showed anti-tumor activity that was synergistic compared with either drug alone. The drugs were shown to use separate pathways to downregulate cell cycle checkpoints and lead to G1 cell cycle arrest. This stops the cancer cells reproduction cycle, causing the cell to die. The combination inhibited tumor growth and reduced infiltrations of malignant B-cells in the bone marrow.


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

MustGrow Biologics Corp. (MGROF) – Growing Production

Posted on by cpereira@noblefcm.com


Wednesday, June 14, 2023

Joe Gomes, 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.

Completed Run. Yesterday, MustGrow filed a press release stating the Company successfully completed its initial commercial run-rate production of its mustard plant-based biocontrol liquid via a contract manufacturer. The run-rate of the production reached greater than 5,000 litres per day of the biocontrol liquid.

Revenue Translation. The production of the mustard plant-based biocontrol liquid technology is estimated to equal approximately USD$25 million of annual revenue at a retail level, along with creating zero residual waste through generating a high protein ingredient for animal feed. Based on the trial run, we believe the estimated annual production of the liquid would cover a fraction of the demand, and we estimate the trial run annual production liquid would cover some 25,000-50,000 acres.


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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. 

Baudax Bio (BXRX) – More Positive Top-Line Results From Phase II BX1000 Trial

Posted on by cpereira@noblefcm.com


Thursday, June 08, 2023

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Deeper dive into the results.  The electomyography (EMG) detailed analysis confirmed the earlier top-line data released showing the highest dose of BX1000 was comparable to rocuronium (current standard). There was a clear dose response for BX1000 on maximum T1 suppression, with comparable results for the 1.5x ED95  dose of BX1000 and the 2x ED95 dose of rocuronium, strongly suggesting lower BX1000 dosing needed.

What is T1 suppression?  Train of Four (TOF) testing is a method of peripheral nerve stimulation, using electrodes placed along the nerve pathway. An electrical impulse will cause a contraction (twitch). With increased NMB dosing, the twitch response fades, with the fourth (T4) response lost first, then T3, then T2, and finally the first (T1). The number of twitches observed indicates the NMB level achieved, determining the minimum amount needed to achieve the desired effect, while reducing the likelihood of over-paralysis and prolonged muscle weakness. A T1 level of suppression (or one twitch) represents approximately 90% block, a level suitable for short term procedures including intubation. 


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

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

PDS Biotechnology Corp. (PDSB) – Phase 2 VERSATILE-002 Data Reviewed On Conference Call

Posted on by cpereira@noblefcm.com


Wednesday, June 07, 2023

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.

ASCO Presentation On Head and Neck Cancer Reviewed. PDS Biotechnology held a conference call to review data from the Phase 2 VERSATILE-002 trial that was presented at the annual ASCO meeting on Monday, June 5. Management also briefly commented on a misinterpretation posted on social media sites that caused a sharp price decline and a trading halt in the stock.

VERSATILE-002 Data Consistent With Previous Results. As discussed in our Research Note from May 30, the presentation updated the Phase 2 VERSATILE trial data presented at ASCO ’22. At that time, preliminary data from the first 17 patients to reach the 9-month evaluation post was presented. The update included data from 34 patients that had reached the 12-month evaluation point. 


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

MustGrow Biologics Corp. (MGROF) – Setting Up the Seeds to Sprout

Posted on by cpereira@noblefcm.com


Tuesday, June 06, 2023

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

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

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

New Agreement. MustGrow announced the Company has agreed to a Contract Services Agreement with Bio Ag Product Strategies to develop and commercialize MustGrow’s soil amendment and biofertility technologies, including TerraSante. The agreement is a non-exclusive contract, enabling MustGrow to seek out additional commercial collaborations and funding partnerships. Neither the length of the agreement nor any financials were disclosed.

Who is Bio Ag? Bio Ag Product Strategies is a consulting firm that provides consultation to manufacturers of microbial products for agriculture and support products including biostimulants and prebiotics. According to MustGrow, Bio Ag Product Strategies has tremendous knowledge and a great track record of working with organizations to help develop, market, and target key retailers and farmers.


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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. 

Schwazze (SHWZ) – A Succession Plan Finalized

Posted on by cpereira@noblefcm.com


Thursday, June 01, 2023

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, 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.

A New CEO. Yesterday, Schwazze announced the Company has promoted President Nirup Krishamurthy to the role of CEO, with former CEO Justin Dye continuing to lead the Board of Directors as its non-executive Chairman.

Part of the Plan. Mr. Krishamurthy has been part of a succession plan created nearly a year ago when Mr. Dye informed the Board of Directors of his desire to transition into a Chairman role. The appointment of Mr. Krishamurthy to be President in October of 2022 was part of Mr. Dye’s decision, as he handpicked Mr. Krishamurthy as his successor with support of the Board. As President, Mr. Krishamurthy steered the day-to-day operations and worked with Mr. Dye to successfully transition daily operations. We believe that Mr. Krishamurthy has the ability to continue what Mr. Dye has created.


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

MustGrow Biologics Corp. (MGROF) – 1Q23 Results

Posted on by cpereira@noblefcm.com


Thursday, June 01, 2023

Joe Gomes, 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.

Financial Results. Zero revenue and a loss of CAD$1.0 million, or a loss of $0.02/sh for 1Q23, similar to the 4Q22 loss. We had forecast revenue of CAD$1,000 and a net loss of CAD$924,066, or $0.02 per share. Until MustGrow receives regulatory approval in at least one market, we anticipate similar quarterly results going forward.

Janssen Re-Ups. Last week, Janssen PMP, a unit of Janssen Pharmaceuticals, signed an extension to test and develop MustGrow’s biological mustard plant-based technologies for certain postharvest food preservation storage applications globally. According to Janssen, “In post-harvest, the need for technologies derived from nature remains very high. Janssen PMP sees a great potential in the use of the MustGrow technology in extending shelf life of fruits and vegetables. This is the reason why we decided to extend our global exclusive partnership with MustGrow…” We believe such actions reflect positively on MustGrow and its products.


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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. 

ChitogenX Inc. (CHNXF) – FY2023 Ending January 31, 2023 Reported

Posted on by cpereira@noblefcm.com


Thursday, June 01, 2023

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Reported Full Year Fiscal 2023.  Yesterday, ChitogenX reported a loss per share of $0.13 (currencies in Canadian $), versus our expected $0.12 loss per share.  The difference was primarily due to a $768,000 charge on converting the $3 million non-convertible debt into a convertible debenture, taken during the fourth quarter. Operationally, fourth quarter expenses were lower at $1.09 million versus our estimate of $1.29 million, with lower than estimated R&D costs the biggest factor. 

Subsequent News. At fiscal yearend, the Company reported $108,000 in cash and equivalents. Subsequent to the yearend, ChitogenX raised about $5.3 million giving the Company some runway to develop both orthopedic and non-orthopedic applications.  As a reminder, ChitogenX also secured a $3.47 million 4-year grant in February 2023 for regenerative medicine development and to accelerate the commercial readiness of the ORTHO-R platform.


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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. 

Tonix Pharmaceuticals (TNXP) – New Data To Be Presented For TNX-601 In Major Depressive Disorder

Posted on by cpereira@noblefcm.com


Tuesday, May 30, 2023

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.

New Data Puts TNX-601 ER In The Spotlight. Tonix will be presenting data from the Phase 2 UPLIFT study at the American Society of Clinical Psychopharmacology (ASCP) meeting from May 30 to June 2, 2023. The presentation will provide an update on the UPLIFT trial testing TNX-601 EP, including data on the mechanism of action and the development of TNX-4300, the purified (S)-isomer of tianeptine.

Phase 2 UPLIFT Trial In Major Depression Disorder. TNX-601 is an extended-release formulation of tianeptine hemioxalate, a drug used for depression in Europe for over 30 years. The Phase 2 UPLIFT trial is a placebo-controlled trial with 6 weeks of once-daily dosing. The primary endpoint is mean change from baseline in the MADRS (Montgomery-Asberg depression rating scale) at week 6. Top-line results expected in 4Q23.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

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