PDS Biotechnology Corp. (PDSB) – New PDS0301 Combination Data To Be Presented


Tuesday, July 18, 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.

First Data From Prostate Cancer. PDS announced that it will present interim data from its first trial testing PDS301 with docetaxel (Taxotere) in prostate cancer patients. The presentation will be at the International Cytokine and Interferon Society annual meeting in October 2023. We see acceptance of the PDS0301 data for presentation as positive sign for proof-of-concept and expansion into new indications.

Data Will Be From A Dose-Finding Trial To Establish Responses and Safety. The trial tests the combination of PDS0301 with docetaxel in metastatic prostate cancer. The regimen was given in 3-week cycles consisting of a standard dose of docetaxel with one of three dose levels of PDS0301. The presentation abstract is based on safety, immune responses, and clinical activity data from 18 patients.


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MAIA Biotechnology (MAIA) – THIO-101 Part A Survival Data Reaches 12 Months


Tuesday, July 11, 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.

Survival Data From The First Two Patients Announced. MAIA Biotechnology announced updated survival data from the first two patients treated in its Phase 2 THIO-101 trial. The patients remain alive without disease progression for 12.2 and 11.5 months from treatment initiation and 10.2 months and 8.5 months after completing THIO treatment. These results compare with expected survival of about 3 months to 4 months after disease progression or about 6 months if a third line of therapy is given. We see these positive results as consistent with the preclinical data.

Patients Were From The Safety Lead-In Stage. The THIO-101 trial enrolls patients with recurrent or metastatic Stage 4 non-small cell lung cancer that have failed 2 lines of therapy. These prior therapies include an immune checkpoint inhibitor and a platinum-based (standard) chemotherapy regimen. The two patients were from the Part A safety verification stage. The patients were treated with 360 mg of THIO followed by a standard regimen of Libtayo (cemiplimab, an immune checkpoint inhibitor from Regeneron). The patients have not received any new cancer therapies.


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GeoVax Labs, Inc. (GOVX) – First Gedeptin Data From Phase 1/2 Presented


Tuesday, July 11, 2023

GeoVax Labs, Inc., a clinical-stage biotechnology company, develops human vaccines for infectious diseases and cancer in the United States and internationally. The company through its patented Modified Vaccinia Ankara-Virus Like Particle vaccine platform develops various vaccines. It is developing various vaccines that are in human clinical trials, and preclinical research and development phases, including vaccines against human immunodeficiency virus (HIV); Zika virus; malaria; and hemorrhagic fever viruses, such as Ebola, Sudan, Marburg, and Lassa, as well as therapeutic vaccines for chronic Hepatitis B infections and cancers. The company has collaboration and partnership agreements with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health; the HIV Vaccines Trial Network; Centers for Disease Control and Prevention; United States Army Research Institute of Infectious Disease; U.S. Naval Research Laboratory; Emory University; University of Pittsburgh; Georgia State University Research Foundation; Peking University; University of Texas Medical Branch; the Institute of Human Virology at the University of Maryland; the Scripps Research Institute; the Burnet Institute; American Gene Technologies, Inc.; Viamune, Inc.; Vaxeal Holding SA; CaroGen Corporation; Virometix AG; and Leidos, Inc. GeoVax Labs, Inc. was founded in 2001 and is based in Smyrna, Georgia.

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.

GeoVax Presents Preliminary Phase 1/2 HNSCC data GeoVax presented first data from its Gedeptin Phase 1/2 trial at the AACR (American Association for Cancer Research) and AHNS (American Head and Neck Society) joint cancer conference. The results show that the Gedeptin regimen was able to achieve Stable Disease according to RECIST 1.1 criteria in 5 out of 7 evaluable patients.  

Study Design and First Data. Gedeptin delivers the PNP gene from E. coli to convert a prodrug, fludarabine, into an active cytotoxic drug, fluoroadenine, inside the tumor cells. The trial enrolled patients with refractory head and neck squamous cell carcinoma (HNSCC) to receive up to 5 cycles of the combination, consisting of 3 intratumoral injections of Gedeptin over two days followed by daily infusions of fludarabine for three days. The presentation reported on the first 8 patients out of a planned enrollment of 10 patients. 


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


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


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


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


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


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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MustGrow Biologics Corp. (MGROF) – Growing Production


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


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


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


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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*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


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.