NeuroOne CEO David Rosa provides a preview of their upcoming presentation at NobleCon18 NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events Free Registration Available – More Info News and Advanced Market Data on NMTC NobleCon18 Presenting Companies About NeuroOne Medical Technologies Corporation NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. For more information, visit https://www.n1mtc.com .

BioSig Technologies CEO Kenneth Londoner provides a preview of their upcoming presentation at NobleCon18 NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events Free Registration Available – More Info Research News and Advanced Market Data on BSGM NobleCon18 Presenting Companies About BioSig 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™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Genprex CFO Ryan Confer provides a preview of their upcoming presentation at NobleCon18 NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events Free Registration Available – More Info Research News and Advanced Market Data on GNPX NobleCon18 Presenting Companies About Genprex Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is then administered intravenously, where it is then taken up by tumor cells that express proteins that are deficient. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA for NSCLC in combination therapy with Merck & Co’s Keytruda® (pembrolizumab) for patients whose disease progressed after treatment with Keytruda

Healthcare Triangle CEO Suresh Venkatachari provides a preview of their upcoming presentation at NobleCon18 NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events Free Registration Available – More Info News and Advanced Market Data on HCTI NobleCon18 Presenting Companies About Healthcare Triangle Healthcare Triangle is a leading healthcare information technology company focused on advancing innovative, industry-transforming solutions in the areas of cloud services, data science, professional and managed services for the healthcare and life sciences industry. Healthcare Triangle is an AWS Partner.

Monday, April 04, 2022

GABY Inc. (GABLF)
GABY Inc.: Focused on California Cannabis Consolidation

Gaby Inc is a wellness company that is engaged in the marketing of a variety of cannabis products, including flowers, concentrates, pre-rolls, edibles, topicals, tinctures, and other products. Some of its brands are Mankind, Sonoma Pacific, 2Rise, Lulu’s, and the Kind Republic. The company operates in two segments, namely licensed and unlicensed channels, both of which are in the manufacturing, distribution, and marketing of wellness products to address a variety of dietary and health concerns. All of its revenue comes from the United States.

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.

Initiating Coverage. We are initiating research coverage on GABY Inc. GABY Inc. is a California-focused cannabis retail consolidator and the owner of San Diego-based Mankind Dispensary, one of the oldest and largest licensed dispensaries in the state. With significant organic and inorganic growth opportunities, we believe GABLF shares present an attractive risk/reward situation.

Focus on California Consolidation.  GABY’s overarching strategy is to consolidate dispensaries in California. The Company’s first step was the April 2021 acquisition of Mankind Dispensary. The California market remains highly fragmented. No brand owns more than 2.5% of the retail dispensary locations and 4% of overall market share. Ripe for consolidation, in our view …

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. 

 

Friday, April 01, 2022

BioSig Technologies (BSGM)
Q4 2021 Misses But Pieces Are Falling In Place

BioSig Technologies, Inc. is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace. PURE EP is a computerized system designed to reveal the full range of cardiac signals and to provide physicians with signal clarity during procedures performed to address cardiac arrhythmias. The PURE EP System has received FDA 510(k) clearance and installed its first commercial sale in February 2021. The company looks to apply their unique bioelectronic technology across additional disease conditions, including nervous system disorders, auto-immune diseases, hypertension, and pain.

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.

Q4 2021 reported. Yesterday, BioSig Technologies reported their fourth quarter, missing on top-line expectations, with no unit sales reported. That said, the company continues to roll out a phased commercialization strategy to promote faster revenue growth longer term.

Recent hires are expected to move the needle.  In December 2021, the company introduced Gray Fleming as Chief Commercial Officer and acquired the services of Access Strategy Partners to assist in relationship management. Just last week, the company introduced John Sieckhaus as Chief Operating Officer. All these filled positions are upgrades or new positions that are expected to produce better …

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. 

 

Friday, April 01, 2022

PDS Biotechnology Corp (PDSB)
FY2021 Reported With Clinical Trial Progress

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

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.

FY2021 Results Were Within Expectations.  PDS Biotech reported 4Q21 loss of $6.3 million or $(0.23) per share, bringing the FY2021 loss to $16.9 million or $(0.66) per share. On its quarterly conference call, the company discussed pipeline developments in several HPV-positive cancer trials, preclinical products, and its infectious disease platform. Cash at December 31, 2021 was $65.2 million.

PDS0101 Has Recently Achieved Important Milestones.  The VERSATILE-002 trial is testing PDS0101 in combination with Keytruda (pembrolizumab), the PD-1 checkpoint inhibitor. The company has recently presented safety data, announced a preliminary efficacy milestone that allows the trial to continue to completion, and continues to enroll patients …

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. 

 

Image Source: nih.gov

Human Genome Gaps in Understanding are Now Filled by Six New Reports

 

When it was announced in 2003 that the human genome had been mapped, the accomplishment was and continues to be life-changing for the species. But the mapping wasn’t fully complete. While it opened doors to understanding and continues to open doors to medical breakthroughs, it was only 92% complete. That is no longer the case. Yesterday (March 31), the official reports on the first end-to-end human genome map was published.

Now that scientists have a complete map with no significant gaps, the enhanced knowledge will no doubt lead to filling in evolutionary questions while providing insights into birth defects, auto-immune problems, cancer, and aging. The six separate papers just published include parts of the genome that were left uncharacterized because of available DNA sequencing technology two decades ago. After 20 years, these limits have been overcome. This is again momentous for the species as it will lead to discoveries and techniques that will only be realized over time.

While filling gaps in understanding and discovering 99 more new genes believed to code for proteins, the scientists also corrected thousands of errors in an earlier map of human DNA. This map from 2003 has been serving those in the field, including researchers, geneticists, and medical doctors. The original $3 billion Human Genome Project sought to unveil the purpose of every letter of a human’s DNA, but even with refinements made after the original conclusions, it is believed to have found only about 92% of them.

 

Exploiting the new map for medical care or evolution discovery provides another exciting start with new information to assess when figuring out diseases that are known to be inherited, but uncertainty exists as to where the faulty gene resides.

The new map cost a few million dollars to create, according to Adam Phillippy, a computational biologist at the National Human Genome Research Institute. This reflects how technology and understanding have brought down gene sequencing costs.

The twin strands of DNA in human cells contain about three billion letter pairs spread among 23 pairs of chromosomes. The genetic material helps determine eye and hair color, stature, and other physical characteristics, as well as risks for certain diseases. Scientists liken sequencing to solving a jigsaw puzzle, they look at a few segments and try to find what fits. Since there are two strands (one contributed by the mother, the other by the father) they used their computers to focus on only one puzzle, paternal DNA.

Paul Hoffman

Managing Editor, Channelchek

 

Suggested Reading

Ultra-Rapid DNA Sequencing Identifies Rare Diseases in Hours

Pros and Cons of FDA Funded in Part by Companies

Cells that Can be Produced from Stem Cells

Stem-Cell Based Therapy for Alzheimer’s Disease

 

Sources

https://www.science.org/doi/10.1126/science.abj6987

https://www.genome.gov/about-genomics/telomere-to-telomere

https://www.wsj.com/articles/first-gapless-human-genome-map-is-unveiled-years-after-earlier-effort-11648750303

https://theconversation.com/us/technology

https://www.genome.gov/

 

Stay up to date. Follow us:

Image Source: nih.gov

Human Genome Gaps in Understanding are Now Filled by Six New Reports

 

When it was announced in 2003 that the human genome had been mapped, the accomplishment was and continues to be life-changing for the species. But the mapping wasn’t fully complete. While it opened doors to understanding and continues to open doors to medical breakthroughs, it was only 92% complete. That is no longer the case. Yesterday (March 31), the official reports on the first end-to-end human genome map was published.

Now that scientists have a complete map with no significant gaps, the enhanced knowledge will no doubt lead to filling in evolutionary questions while providing insights into birth defects, auto-immune problems, cancer, and aging. The six separate papers just published include parts of the genome that were left uncharacterized because of available DNA sequencing technology two decades ago. After 20 years, these limits have been overcome. This is again momentous for the species as it will lead to discoveries and techniques that will only be realized over time.

While filling gaps in understanding and discovering 99 more new genes believed to code for proteins, the scientists also corrected thousands of errors in an earlier map of human DNA. This map from 2003 has been serving those in the field, including researchers, geneticists, and medical doctors. The original $3 billion Human Genome Project sought to unveil the purpose of every letter of a human’s DNA, but even with refinements made after the original conclusions, it is believed to have found only about 92% of them.

 

Exploiting the new map for medical care or evolution discovery provides another exciting start with new information to assess when figuring out diseases that are known to be inherited, but uncertainty exists as to where the faulty gene resides.

The new map cost a few million dollars to create, according to Adam Phillippy, a computational biologist at the National Human Genome Research Institute. This reflects how technology and understanding have brought down gene sequencing costs.

The twin strands of DNA in human cells contain about three billion letter pairs spread among 23 pairs of chromosomes. The genetic material helps determine eye and hair color, stature, and other physical characteristics, as well as risks for certain diseases. Scientists liken sequencing to solving a jigsaw puzzle, they look at a few segments and try to find what fits. Since there are two strands (one contributed by the mother, the other by the father) they used their computers to focus on only one puzzle, paternal DNA.

Paul Hoffman

Managing Editor, Channelchek

 

Suggested Reading

Ultra-Rapid DNA Sequencing Identifies Rare Diseases in Hours

Pros and Cons of FDA Funded in Part by Companies

Cells that Can be Produced from Stem Cells

Stem-Cell Based Therapy for Alzheimer’s Disease

 

Sources

https://www.science.org/doi/10.1126/science.abj6987

https://www.genome.gov/about-genomics/telomere-to-telomere

https://www.wsj.com/articles/first-gapless-human-genome-map-is-unveiled-years-after-earlier-effort-11648750303

https://theconversation.com/us/technology

https://www.genome.gov/

 

Stay up to date. Follow us:

Thursday, March 31, 2022

Avivagen Inc. (VIVXF)(VIV:CA)
Reports First Quarter 2022 Results

Avivagen Inc is a Canadian based company operating in the healthcare sector. It develops science-based, natural health products for animals. It develops and commercializes products for livestock feeds to replace antibiotics for growth promotion and to help prevent disease by supporting the animal’s own health defenses. Its product range includes OxC-beta, Vivamune health chews, Oximunol chewable tablets, and Carotenoid Oxidation products.

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.

1Q22 Results. Avivagen reported revenue of $271,157 (all figures in Canadian $) in the quarter, up from $261,987 last year, and compared to our $300,000 estimate. Net loss for the quarter was $1.6 million, or $0.03 per share versus a net loss of $1.3 million, or $0.03 per share, in the first quarter of 2021. We had forecasted a net loss of $1.4 million, or $0.03 per share. Increased operating expenses due to impairment expenses were the main driver in the increased loss.

Market Still Challenging.  While sales in the Philippines continue apace, Mexico remains frozen. In fact, quarterly revenues were reduced by $89,658 due to returned product from Mexico. Average price per kg of OxC-Beta remained flat at $106.33. While Avivagen has made strides in receiving approvals in other nations, the Company needs to translate approvals into steady, and increasing, sales in more …

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. 

 

Thursday, March 31, 2022

Axcella Therapeutics (AXLA)
Axcella Reports FY2021 With Clinical Data Expected In 2H22

Axcella Health Inc. is a clinical-stage biotechnology company focused on treating complex diseases and improvinge health using endogenous metabolic modulator, or EMM, compositions. Its product candidates are comprised of multiple EMMs that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. The company’s pipeline includes two lead therapeutic candidates:, AXA1665 for the reduction in risk of recurrent overt hepatic encephalopathy (OHE) , and AXA1125 for the treatment of non-alcoholic steatohepatitis (NASH).

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 for 4Q and FY2021.  Axcella Reported a 4Q21 loss of $17.9 million or $(0.46) per share, bringing the full year loss to $64.6 million or $(1.70) per share. Clinical trial enrollment is progressing as expected, with data announcements expected in 2H22. The company reported cash of $55.0 million on December 31, excluding the registered direct offering of $25.0 million completed in March 2022.

Long COVID Phase 2a Trial Has Begun Axcella has begun enrolling patients in a Phase 2a trial designed to test AXA1125 on Long COVID symptoms of fatigue and muscle weakness.  This double-blind placebo-controlled trial treats patients with either AXA1125 or placebo for 28 days. It has a target enrollment of 40 patients, with endpoints including measures of muscle recovery time after exertion …

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. 

 

Wesana Health CEO Daniel Carcillo provides a preview of their upcoming presentation at NobleCon18 NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events Free Registration Available – More Info News and Advanced Market Data on WSNAF NobleCon18 Presenting Companies About Wesana Wesana Health?helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at?www.wesanahealth.com.

PDS Biotech Provides Business Update and Reports Fourth-Quarter and Full-Year 2021 Financial Results

Research, News, and Market Data on PDS Biotech

 

Company to host conference call and webcast today, March 31, 2022, at 8:00 AM EDT

FLORHAM PARK, N.J., March 31, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today provided a business update and announced its financial results for the year ended December 31, 2021.

“I’m very pleased to report that we have undergone a 12-month period of incredible productivity here at PDS Biotech,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. “We’ve made significant clinical progress on our lead oncology candidate, PDS0101, and presented at leading oncology conferences on the promising efficacy and safety results of PDS0101 from two of our ongoing Phase 2 clinical trials. Another phase 2 clinical study of PDS0101 to be led by Mayo Clinic was initiated this month, to evaluate PDS0101 as a potential first-line neo-adjuvant treatment for patients with oropharyngeal cancer prior to transoral robotic surgery. We also recently announced encouraging pre-clinical data from our NIAID-funded universal flu vaccine program. We continue to leverage our unique T-cell activating platforms to advance additional pre-clinical oncology and infectious disease candidates.”

Dr. Bedu-Addo continued: “Over the past year, we completed two licensing transactions and secured additional intellectual property for our expanding pipeline. We also received approval of a US composition of matter and use patent for PDS0101. We strengthened our scientific advisory and leadership teams by adding distinguished immuno-oncology experts to our scientific advisory board and welcomed Matthew Hill as our Chief Financial Officer. We also added more than $52 million to our balance sheet in 2021, significantly extending our cash runway and ability to continue to advance our clinical and pre-clinical programs. We look forward to an equally productive 2022, during which we expect to announce additional data from our ongoing Phase 2 oncology trials for PDS0101, as well as plan to progress at least one of our preclinical programs, PDS0103 into the clinic.”

Fourth Quarter 2021 and Recent Business Highlights:

• Achieved several milestones in the VERSATILE-002 Phase 2 combination trial of PDS0101-KEYTRUDA^® (pembrolizumab) for recurrent and/or metastatic human papillomavirus (HPV)16-associated head and neck cancer. These milestones include:
  • Presented preliminary safety data on a total of 18 checkpoint inhibitor naïve patients at the 2022 Multidisciplinary Head and Neck Cancers Symposium. Highlights from the presentation include the absence of dose-limiting toxicities, drug discontinuation related to toxicity, or any significant immune-related adverse events. Subjects received a median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA^® (range 1-13).
  • Achieved preliminary objective response benchmarks that enabled us to advance towards full enrollment of 54 patients in the checkpoint inhibitor naïve patient cohort.
  • Initiated enrollment in the checkpoint inhibitor-refractory cohort.
• Announced initiation of an investigator-initiated trial with Mayo Clinic for patients with HPV-associated oropharyngeal cancer at high risk of recurrence. The trial will evaluate PDS0101 as monotherapy and in combination with KEYTRUDA^®.
• Announced encouraging preclinical data for the universal flu vaccine that demonstrated a potent neutralization response against multiple strains of the influenza virus and provided protection against infection after challenge with a live H1N1 pandemic strain of influenza in preclinical animal subjects.
• Granted U.S. Patent Application by the United States Patent and Trademark Office for composition of matter and use of PDS0101, extending its U.S. patent protection into 2037.
• Achieved enrollment objective of 30 patients in the checkpoint inhibitor refractory arm of the NCI-led triple combination trial in March 2022.
• Achieved median overall survival at December 31, 2021 of 12 months for 30 HPV16-positive patients who had received at least one evaluation in the NCI-led triple combination trial. Approximately 73% of the patients had failed 3 prior treatment regimens including checkpoint inhibitor therapy.
  
  

Full-Year 2021 Financial Results

For the year ended December 31, 2021, the net loss was approximately $16.9 million, or $0.66 per basic share and diluted share, compared to a net loss of approximately $14.8 million, or $0.89 per basic share and diluted share for the year ended December 31, 2020.

For the year ended December 31, 2021, research and development expenses increased to approximately $11.3 million compared to approximately $7.9 million for the year ended December 31, 2020. The increase of $3.4 million was primarily attributable to an increase in regulatory and clinical costs of $2.6 million, non-cash stock-based compensation of $1.1 million and personnel costs of $0.4 million, partially offset by an overall decrease in manufacturing and facility costs of $0.7 million.

For the year ended December 31, 2021, general and administrative expenses increased to approximately $10.2 million compared to approximately $7.0 million for the year ended December 31, 2020. The $3.2 million increase was primarily attributable to an increase in personnel costs of $1.0 million, non-cash stock-based compensation of $2.5 million, and facilities costs of $0.1 million, partially offset by a decrease in professional fees of $0.4 million.

Total operating expenses for the year ended December 31, 2021 were approximately $21.4 million, an increase of approximately 44% compared to total operating expenses of approximately $14.9 million for the year ended December 31, 2020.

The Company’s cash balance as of December 31, 2021 was $65.2 million. Based on the Company’s available cash resources and cash flow projections, the Company believes this balance is sufficient to fund Company operations and research and development programs through the end of 2023.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT on Thursday, March 31, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at https://pdsbiotech.com/investors/news-center/events. After the live webcast, the event will be archived on PDS Biotech’s website for six months. 

About PDS Biotechnology
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.  

Our Infectimune™ -based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune and Infectimune-based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune and Infectimune-based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune^® is a registered trademark and Infectimune is a trademark of PDS Biotechnology. KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Balance Sheets

	December 31, 2021				December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	65,242,622			$	28,839,565
Prepaid expenses and other		1,597,569				1,497,665
Total current assets		66,840,191				30,337,230
Property and equipment, net		86				5,443
Operating lease right-to-use asset		357,611				547,706
Total assets	$	67,197,888			$	30,890,379
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,309,403			$	1,415,224
Accrued expenses		2,187,704				1,735,322
Operating lease obligation – short term		258,924				119,904
Total current liabilities		3,756,031				3,270,450
Noncurrent liability:
Operating lease obligation – long term		231,430				490,353
Total liabilities		3,987,461				3,760,803
STOCKHOLDERS’ EQUITY
Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2021 and December 31, 2020, 28,448,612 shares and 22,261,619 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively		9,387				7,346
Additional paid-in capital		123,904,602				70,907,315
Accumulated deficit		(60,703,562	)			(43,785,085	)
Total stockholders’ equity		63,210,427				27,129,576
Total liabilities and stockholders’ equity	$	67,197,888			$	30,890,379

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Statements of Operations and Comprehensive Loss

	Year Ended December 31,
	2021				2020
Operating expenses:
Research and development expenses	$	11,254,538			$	7,924,450
General and administrative expenses		10,184,773				6,977,936
Total operating expenses		21,439,311				14,902,386
Loss from operations		(21,439,311	)			(14,902,386	)
Other income
Interest income		4,346				55,006
Loss before income taxes		(21,434,965	)			(14,847,380	)
Benefit from income taxes		4,516,488				–
Net loss and comprehensive loss	$	(16,918,477	)		$	(14,847,380	)
Per share information:
Net loss per share, basic and diluted	$	(0.66	)		$	(0.89	)
Weighted average common shares outstanding basic and diluted		25,597,125				16,745,044

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Statements of Cash Flows

	Year Ended December 31,
	2021				2020
Cash flows from operating activities:
Net loss	$	(16,918,477	)		$	(14,847,380	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		4,074,458				432,321
Stock-based 401K company common match		35,747				19,967
Depreciation expense		5,357				15,608
Operating lease expense		241,031				160,684
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(99,904	)			810,797
Accounts payable		(105,821	)			217,504
Accrued expenses		452,382				637,682
Restructuring reserve		–				(498,185	)
Operating lease liabilities		(170,839	)			(98,133	)
Net cash used in operating activities		(12,486,066	)			(13,149,135	)
Cash flows from financing activities:
Proceeds from exercise of warrants		–				70,459
Proceeds from exercise of stock options		344,125				–
Proceeds from issuances of common stock, net of issuance costs		48,544,998				29,756,502
Net cash provided by financing activities		48,889,123				29,826,961
Net increase in cash and cash equivalents		36,403,057				16,677,826
Cash and cash equivalents at beginning of period		28,839,565				12,161,739
Cash and cash equivalents at end of period	$	65,242,622			$	28,839,565