Tag: Health

Schwazze (SHWZ) – CEO Dye Adding Shares

Posted on by cpereira@noblefcm.com


Tuesday, November 29, 2022

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, Senior Research Analyst, 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.

Insider Buying. In a series of Form 4 filings, between November 14th and November 23rd Schwazze CEO Justin Dye purchased 1,325,852 SHWZ shares at a cost of $2.36 million, or a per share average of $1.78. According to the most recent Form 4 filed on November 25th, Mr. Dye directly currently owns 1,368,062 SHWZ common shares and indirectly owns 9,287,500 SHWZ common shares through Dye Capital & Company.

Details. Through three Form 4 filings, Mr. Dye reported transactions from November 14th through November 23rd. The largest daily purchase of 509,700 shares occurred on November 23rd, which also included the highest average price at $2.00 per share. The recent transactions occurred at prices ranging from $1.13 to $2.10 per share.  


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PDS Biotechnology Corp (PDSB) – Raising Price Target to $19 Based On Clinical Progress

Posted on by cpereira@noblefcm.com


Monday, November 28, 2022

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, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Raising Our Price Target to $19 Per Share. Data presentations from clinical trials for PDS0101 have driven PDSB within 10% of our previous price target. We continue to see PDS0101 as a highly promising treatment for HPV-positive cancers and see several important milestones to drive the stock higher in the coming year.

Price Target Is Based On PDS010 Sales Potential.  Our new price target is based on discounted sales estimates for PDS010 sales in HPV-positive cancer. Following an End-of-Phase 2 meeting with the FDA following the June 2022 VERSATILE-002 data presentation, the company announced that it was accelerating its timetable for the pivotal trial for PDS0101. We expect this trial to begin in 2023 and project product launch in 2026.


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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. 

Cocrystal Pharma (COCP) – 3Q22 Reported – First Influenza Vaccine Data To Be Presented

Posted on by cpereira@noblefcm.com


Wednesday, November 16, 2022

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, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

3Q22 Reported With Pipeline Update. Cocrystal reported a 3Q22 loss of $5.7 million or $0.70 per share. The product pipeline continues to make progress, with the first data from its influenza vaccine, CC-42344, scheduled for presentation in December. Two COVID-19 programs continue in preclinical studies, with an IND filing expected in 1Q23. The company ended the quarter with $42.1 million in cash.

Influenza Trial Data To Be Presented. Enrollment has been completed in the Phase 1 study for CC-42344 for seasonal and pandemic influenza. Safety and pharmacokinetic data is scheduled for presentation at the World Antiviral Congress in December 2022. The trial results will be submitted to regulatory authorities in the United Kingdom for a Phase 2a human challenge study to determine efficacy, expected to begin in 2H23.


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BioSig Technologies (BSGM) – BioSig reports 3Q 2022; Lots of Activity; Target Price Reduced

Posted on by cpereira@noblefcm.com


Wednesday, November 16, 2022

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com). The Company’s first product, PURE EP(TM) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

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

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

BioSig reported 3Q 2022 results.  The Company reported $135,000 of revenues in the quarter that recognized $127,000 in product sales and $8,000 in service revenue.  We were looking for $980,000 in product revenues and $49,000 in service revenue.  The third quarter EPS loss of $0.14 matched our expected loss per share.

Marketing activities are ramping up.  PURE EP technology was featured in a physician presentation at the Kansas City Heart Rhythm Symposium held August 20-21, 2022.  In late September 2022, the Company released its most advanced software, known as PURE EP Software Version 6 with ACCUVIZ Module. The new Version 6 software was introduced at the Cleveland Clinic Global EP Summit held September 23-24, 2022.  In addition, the Company was invited to attend and sponsor the Venice Arrhythmias 2022 Congress that met October 13-15 in Venice Italy.


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Schwazze (SHWZ) – Blocking and Tackling

Posted on by cpereira@noblefcm.com


Tuesday, November 15, 2022

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, Senior Research Analyst, 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.

3Q22 Results. Revenue was $43.2 million, up 36% y-o-y from $31.8 million. Adjusted EBITDA was $15.9 million, or 36.7% of revenue in the quarter, up from $8.8 million, or 26.7%, a year ago. Schwazze reported operating income of $11.1 million and net income of $25,124, or breakeven EPS, versus $3.8 million, $968,756 and $0.02 last year.

Quarterly Drivers. The most influential factor driving revenue increases in the third quarter  2022 was the inclusion of four consummated acquisitions in Colorado and revenue from R. Greenleaf. Revenue from wholesale sales decreased, due in large part to continued pricing pressure in the Colorado wholesale market as a result of supply saturation in flower and bulk distillate products.


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PDS Biotechnology Corp. (PDSB) – PDS Bio Reports 3Q22 and Reviews Full SITC Data

Posted on by cpereira@noblefcm.com


Tuesday, November 15, 2022

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, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Financial Results Reported With Full Data. PDS Biotech reported a 3Q22 loss of $7.4 million or $(0.26) per share, with cash on September 30 of $71.6 million. PDS Management reviewed two presentations at last week’s Society for Immunotherapy of Cancer (SITC) meeting, providing additional information to the data published in the abstracts. These data continue to show improved efficacy for PDS0101 over current treatments.

Data From Two Studies Was Presented At SITC. As discussed in our Research Note on November 8, the response rate and patient survival for the Phase 2 IMMUNOCERV trial in cervical cancer exceeded the standard of care.  Data presented from the Phase 2 Triple Therapy trial showed anti-tumor action by PDS0101, with increases in immune response markers against the tumors and decreases in markers of immune suppression.


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Onconova Therapeutics (ONTX) – Onconova Announces A New Trial With 3Q22 Results

Posted on by cpereira@noblefcm.com


Tuesday, November 15, 2022

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, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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3Q22 Showed Continued Progress In Ongoing Trials. Onconova announced a loss of $5.4 million or $(0.26) per quarter for 3Q22, ending the quarter with $42.6 million in cash. In addition to updates on its current clinical trials, the company announced its intentions to start a new Phase 1/2a trial testing narazaciclib in low-grade endometrioid endometrial cancer (LGEEC). This new trial is expected to begin in 1Q23 with first data announced in 4Q23.

New Trial Planned In Endometrial Cancer. The Phase 1/2a trial will test the combination of narazaciclib with letrozole (Femara, an aromatase inhibitor from Novartis) in recurrent low-grade endometrioid endometrial cancer (LGEEC). The trial will start with safety cohorts testing the combination, with a 200 mg dose of narazaciclib with the standard 2.5 mg dose of letrozole. This is the narazaciclib dose that is in its fifth cohort in the Phase 1 trial for solid tumors.


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Baudax Bio (BXRX) – Feeling the Pain; Focus on NMBs

Posted on by cpereira@noblefcm.com


Thursday, November 10, 2022

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 Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Baudax reported 3Q 2022 results. 3Q revenues reported of $0.238 million were well below our expectation of $0.965 million.  While vials sold increased year-over-year approximately 16%, much of the 3Q volume was discounted into 340B hospitals causing revenues to decline 15% from the prior year.

Feeling the pain. In the Covid environment that doesn’t seem to go away, hospitals face financial pressures as they struggle to curtail costs. For a single product company like Baudax Bio, the hospital issues have inflicted continued pain that is difficult to overcome. Hospitals look for less expensive alternatives in pain management. Recognizing that Covid-related issues facing hospitals now could continue into and through 2023, the Company eliminated the remaining commercial team in September 2022.


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Ocugen (OCGN) – 3Q22 Reported With Pipeline Updates

Posted on by cpereira@noblefcm.com


Wednesday, November 09, 2022

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Financial Results Met Expectations. Ocugen reported a 3Q loss of $21.9 million or $(0.10) per share, close to our estimates of $21.2 million and $(0.10) for the quarter. Cash on hand at September 30, 2022 was $101.6 million, which the company expects to last through 2023. 

COVID-19 Programs Are Moving Forward. The Phase 2/3 immuno-bridging study for COVAXIN has completed enrollment with data release expected in early 2023. This study is testing COVAXIN to determine the immune response in the current US population, providing a “bridge” for comparability with the Phase 3 trial conducted in India. The study enrolled patients who were unvaccinated and patients that received mRNA vaccines to determine both initial and booster efficacy. Once completed, Ocugen plans to work with government agencies for support and funding for regulatory approval of its COVID-19 products.


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PDS Biotechnology Corp (PDSB) – SITC Abstracts Released For Two Studies

Posted on by cpereira@noblefcm.com


Tuesday, November 08, 2022

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, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Data To Be Presented At SITC.  PDS Biotechnology released two PDS0101 abstracts to be presented at the SITC (Society for Immunotherapy of Cancer) meeting later this week. Data will be from the Phase 2 IMMUNOCERV trial in cervical cancer in combination with chemotherapy and radiation and the trial known as the Triple Combination Study or NCI Study, testing PDS0101 in combination with two immunomodulating agents. We believe both studies show positive results that are consistent with our expectations. 

IMMUNOCERV Trial Highlights. The Phase 2 IMMUNOCERV trial is testing PDS0101 in combination with standard-of-care chemotherapy in advanced cervical cancer. Out of 17 patients enrolled in the study, 8 had been reached the 170-day status evaluation for by PET CT. Complete responses (CR) were seen in 7 out of 8 (87.5%) of the patients. One year survival was all 8 out of 8 (100%), with 7 out of 8 disease free (87.5%). One patient who only received 3 out of 5 doses showed signs of residual disease. The study is still ongoing.


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Ocugen (OCGN) – R&D Day Highlights Gene Therapy and COVID Programs

Posted on by cpereira@noblefcm.com


Wednesday, November 02, 2022

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Gene Therapy In The Spotlight.  Ocugen held an R&D Day to highlight its programs in gene therapy and COVID-19.  The presentations discussed the novel mechanisms behind its gene therapy products and the nature of the ophthalmic disease indications in development.  While the company has been best known for COVAXIN and COVID-19, we have always seen the gene therapy indications as highly promising and underappreciated.

Modifier Gene Therapy Platform.  The first presentations discussed the company’s novel approach to gene therapy.  In contrast to other approaches that seek to transfer a functional copy of a gene to replace a gene that has mutated or become dysfunctional, Ocugen’s Modifier Gene Therapy targets a “master control gene” that controls the expression of multiple gene pathways, allowing products to be developed for diseases caused by downstream gene pathways and combinations of genetic mutations.


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Axcella Therapeutics (AXLA) – 3Q22 Reported After An Eventful Quarter

Posted on by cpereira@noblefcm.com


Wednesday, November 02, 2022

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Financial Results.  Axcella reported a 3Q22 loss of $17.8 million or $(0.34) per share, compared with our estimate of a loss of $21.7 million or $(0.43) per share.  The company sold convertible notes raising $6.0 million to end the quarter with $25.4 million in cash and equivalents.  After the quarter ended, it added $28.2 million in cash through a direct offering of common stock.  Based on our 4Q22 estimate of a loss of $18.1 million, we project the cash balance at YE22 to be around $35.5 million.

Long COVID Study Results Were Encouraging.  Results from a Phase 2a study testing AXA1125 in Long COVID were announced in early August, as discussed in our note from August 3. The data showed statistically significant improvements in both physical and mental fatigue symptoms.  We believe this is clinically relevant for an estimated 20% to 30% of the people who have been infected with COVID-19.  Axcella is in currently in discussions with regulatory authorities to design the next study, planned to begin in 2023.


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PDS Biotechnology Corp (PDSB) – KOL Event Held To Discuss Head and Neck Cancer

Posted on by cpereira@noblefcm.com


Thursday, October 27, 2022

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, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Roundtable Discussion of Head and Neck Cancer.  PDS Biotech held a Head and Neck Cancer Roundtable with KOLs to discuss treatments and PDS0101.  Although no new data was released, there was a discussion of the cancer, its prognosis, the drugs, and adverse events that showed the need for a new treatment like PDS0101.

Head and Neck Cancer Discussion Included Incidence and Market Size.  The presentations discussed the patient population, current drugs, survival and recurrence rates.  Newly diagnosed cases of head and neck cancer are often associated with HPV, in contrast to previous generations when it was associated with tobacco and alcohol.  Although vaccinations against HPV have  been introduced, millions have been already been exposed so that incidence is expected to rise in the coming decades.


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