8-K
PDS Biotechnology Corp (PDSB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 9, 2020
PDS BIOTECHNOLOGY CORPORATION
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-37568 | 26-4231384 |
|---|---|---|
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
25B Vreeland Road
Florham Park NJ 07932
(Address of Principal Executive Offices, and Zip Code)
(800) 208-3343
Registrant’s Telephone Number, Including Area Code
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.00033 per share | PDSB | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 2.02 | Results of Operations and Financial Conditions. |
|---|
On November 11, 2020, PDS Biotechnology Corporation (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2020 and an update on the Company’s operations. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information set forth in this Current Report on Form 8-K (including Exhibit 99.1) is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
| Item 8.01 | Results of Operations and Financial Conditions. |
|---|
On November 9, 2020, the Company issued a press release announcing the opening of the Company’s VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 and KEYTRUDA® (pembrolizumab) for the first-line treatment of head and neck cancer. A copy of the press release is filed as Exhibit 99.2 hereto and incorporated herein by reference.
On November 10, 2020, the Company issued a press release announcing progress on the Company’s co-development program with Farmacore Biotechnology for a Versamune®-based vaccine aimed at preventing COVID-19 infection. A copy of the press release is filed as Exhibit 99.3 hereto and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit<br><br> <br>Number | Description |
|---|---|
| 99.1 | Press release dated November 11, 2020. |
| 99.2 | Press release dated November 9, 2020. |
| 99.3 | Press release dated November 10, 2020. |
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| PDS BIOTECHNOLOGY CORPORATION | ||
|---|---|---|
| Date: November 12, 2020 | By: | /s/ Frank Bedu-Addo, Ph.D. |
| Name: | Frank Bedu-Addo, Ph.D. | |
| Title: | President and Chief Executive Officer |
Exhibit 99.1
PDS Biotechnology Reports Financial Results for the Third Quarter 2020 and Provides Business Update
Florham Park, NJ, November 11, 2020 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^®^ T-cell activating technology, today announced its financial results for the third quarter ended September 30, 2020 and provided a business update.
Third Quarter 2020 and Recent Business Highlights
| • | Successfully raised approximately $19 million via a public offering of common stock. |
|---|---|
| • | Initiated VERSATILE-002, a Phase 2 trial of PDS0101, our investigational drug candidate, in combination with standard of care KEYTRUDA^®^ for first-line treatment of patients with metastatic or recurrent HPV-positive head and<br> neck cancer. |
| --- | --- |
| • | Initiated a Phase 2 study of PDS0101 in combination with standard of care chemoradiotherapy at the MD Anderson Cancer Center for treatment of locally advanced cervical cancer. |
| --- | --- |
| • | Continued development of PDS0103 in partnership with the National Cancer Institute. |
| --- | --- |
| • | Advanced co-development program with Farmacore with plans to move the PDS0203 COVID-19 vaccine into clinical development with the support of the Brazilian government. |
| --- | --- |
| • | Expanded Board of Directors with appointment of preeminent oncologist, Otis Brawley, M.D. |
| --- | --- |
“As a result of our team’s dedicated efforts during the third quarter and our clinical partnerships with leading institutions in immuno-oncology, today PDS0101 is being evaluated in three phase 2 clinical trials for multiple HPV-associated cancers,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotechnology. “Furthermore, the successful equity raise we completed in August strengthened our balance sheet, ensuring we can continue to progress the clinical development of our oncology programs as well as to expand both our oncology and infectious disease programs despite the challenges posed by the COVID-19 pandemic.”
Third Quarter 2020 Financial Review
For the third quarter of 2020, net loss was approximately $3.9 million, or $0.23 per basic share and diluted share, compared to a net loss of approximately $5.8 million, or $1.10 per basic share and diluted share for the third quarter of 2019.
Research and development expenses totaled approximately $2.1 million for the third quarter of 2020, compared to approximately $1.8 million for the same period in 2019, an increase of 12%. The increase was primarily attributable to an increase of $0.1 million in technical operations (manufacturing) and $0.3 million in clinical studies, offset by a decrease of $0.1 million in professional fees and $0.1 million in regulatory expenses.
For the third quarter of 2020, general and administrative expenses were approximately $1.8 million compared with approximately $3.0 million during the third quarter of 2019, a decrease of 40%. The decrease was primarily attributable to a decrease of $0.2 million in salary and benefits, $0.1 million in facilities and office expense, $0.3 million in insurance expense, $0.6 million in professional fees, and $0.1 million in legal fees offset by an increase of $0.1 million in licenses, taxes and fees.
Total operating expenses for the third quarter of 2020 were approximately $3.9 million, compared to total operating expenses of approximately $5.8 million during the same period of 2019, a decrease of 33%.
As of September 30, 2020, the Company’s cash balance was approximately $33.5 million.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am ET on Thursday, November 12, 2020. 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 www.pdsbiotech.com.
After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13712632.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^®^ T-cell activating technology platform. Versamune^®^ effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune^®^ and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. 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 its lead asset PDS0101 and other Versamune^®^based products; 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 and other Versamune^®^based products 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 acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; 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.
Media & Investor Relations Contact:
Deanne Randolph
PDS Biotechnology
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com
Jacob Goldberger
CG Capital
Phone: +1 (404) 736-3841
Email: jacob@cg.capital
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
| December 31, 2019 | |||||
|---|---|---|---|---|---|
| ASSETS | |||||
| Current assets: | |||||
| Cash and cash equivalents | 33,468,935 | $ | 12,161,739 | ||
| Prepaid expenses and other | 373,395 | 2,308,462 | |||
| Total current assets | 33,842,330 | 14,470,201 | |||
| Property and equipment, net | 9,345 | 21,051 | |||
| Operating lease right-to-use asset | 593,580 | - | |||
| Total assets | 34,445,255 | $ | 14,491,252 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
| LIABILITIES | |||||
| Current liabilities: | |||||
| Accounts payable | 1,559,591 | $ | 1,197,720 | ||
| Accrued expenses | 1,222,773 | 1,097,640 | |||
| Restructuring reserve | – | 498,185 | |||
| Operating lease obligation - short term | 116,240 | - | |||
| Total current liabilities | 2,898,604 | 2,793,545 | |||
| Noncurrent liability: | |||||
| Operating lease obligation - long term | 521,692 | - | |||
| STOCKHOLDERS' EQUITY | |||||
| Common stock, 0.00033 par value, 75,000,000 shares authorized at September 30, 2020 and December 31, 2019, 22,261,619 shares and 5,281,237 shares issued and<br> outstanding at September 30, 2020 and December 31, 2019, respectively | 7,346 | 1,742 | |||
| Additional paid-in capital | 70,775,892 | 40,633,670 | |||
| Accumulated deficit | (39,758,279 | ) | (28,937,705 | ) | |
| Total stockholders' equity | 31,024,959 | 11,697,707 | |||
| Total liabilities and stockholders' equity | 34,445,255 | $ | 14,491,252 |
All values are in US Dollars.
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development expenses | $ | 2,060,815 | $ | 1,834,371 | $ | 5,446,718 | $ | 4,751,308 | ||||
| General and administrative expenses | 1,846,214 | 3,068,581 | 5,428,098 | 9,358,429 | ||||||||
| Lease termination costs | – | 944,445 | – | 944,445 | ||||||||
| Total operating expenses | 3,907,029 | 5,847,397 | 10,874,816 | 15,054,182 | ||||||||
| Loss from operations | (3,907,029 | ) | (5,847,397 | ) | (10,874,816 | ) | (15,054,182 | ) | ||||
| Other income (expense): | ||||||||||||
| Gain on bargain purchase upon merger | – | – | – | 11,939,331 | ||||||||
| Interest income | 1,207 | 95,787 | 54,242 | 294,694 | ||||||||
| Interest expense | – | – | – | (606 | ) | |||||||
| Net loss and comprehensive loss | (3,905,822 | ) | (5,751,610 | ) | (10,820,574 | ) | (2,820,763 | ) | ||||
| Per share information: | ||||||||||||
| Net loss per share, basic and diluted | $ | (0.23 | ) | $ | (1.10 | ) | $ | (0.73 | ) | $ | (0.60 | ) |
| Weighted average common shares outstanding, basic and diluted | 17,169,257 | 5,246,829 | 14,892,764 | 4,729,153 |
Exhibit 99.2
PDS Biotech Initiates VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Recurrent/Metastatic Head and Neck Cancer in Collaboration with Merck
VERSATILE-002 Trial for First Line Treatment of Recurrent/Metastatic Head and Neck Cancer with Combination PDS0101-KEYTRUDA® is Now Open and Recruiting Patients
Florham Park, NJ, November 9, 2020 – PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced that its VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 and KEYTRUDA® (pembrolizumab) for the first-line treatment of head and neck cancer that has returned or spread is now open. The trial is being conducted in collaboration with Merck.
The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm, non-randomized trial that plans to enroll approximately 100 patients across 25 sites in the U.S. The University of Tennessee Medical Center is the first site to open. The studies to be performed at the UT Medical Center will be led by Principal Investigator Dr. Timothy Panella, M.D. The clinical study will evaluate the efficacy and safety of PDS0101, PDS Biotech’s lead Versamune®-based immunotherapy targeting human papillomavirus (HPV)-associated cancers, in combination with KEYTRUDA® (pembrolizumab), Merck's checkpoint inhibitor, in the first-line treatment of patients with HPV16-positive head and neck cancer that has returned or spread. KEYTRUDA® was approved by the FDA in June 2019 as first-line treatment for recurrent or metastatic head and neck cancer. VERSATILE-002 will study if combining PDS0101 with KEYTRUDA® is more effective than what has been previously shown with KEYTRUDA® alone. The main efficacy endpoint in this study is shrinkage of the tumor referred to as the objective response rate (ORR) at nine months following the initiation of treatment with the combination.
“The launch of the VERSATILE-002 Phase 2 trial demonstrates our commitment to developing a safe and effective treatment option that builds upon the current standard of care for patients with this aggressive cancer and further strengthens our collaboration with Merck,” commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. “Though the COVID-19 pandemic impacted our initial timeline, we are pleased to open up this trial to patients.”
Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech added, “Initial studies suggest that Versamune®-based immunotherapies administered in combination with checkpoint inhibitors, such as KEYTRUDA®, have the potential to enhance the immune system’s ability to induce a more powerful and targeted anti-tumor response. We look forward to sharing updates as this study progresses.”
“We are thrilled to offer our patients with recurrent or metastatic head and neck cancer such an exciting and potentially safe treatment option,” commented Dr. Timothy Panella, who is the VERSATILE-002 Principal Investigator at the UT Medical Center, “this type of combination approach is attractive to patients and offers a novel targeted therapy in the fight against this very challenging disease.”
Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email info@pdsbiotech.com or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About PDS0101
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck and Co., PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. In separate partnership with the National Cancer Institute (NCI), and The University of Texas MD Anderson Cancer Center, PDS Biotech is conducting additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer respectively.
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 its lead asset, PDS0101; 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 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 acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; 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.
Media & Investor Relations Contact:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com
Jacob Goldberger
CG Capital
Phone: +1 (404) 736-3841
Email: jacob@cg.capital
Exhibit 99.3
PDS Biotech and Farmacore Announce Updates to Co-Development of Versamune®-Based COVID-19 Vaccine
PDS0203 prioritized for clinical development by PDS Biotech and Farmacore after successful meeting with Brazilian Drug Regulatory Agency
Florham Park, NJ, November 10, 2020 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced progress on its co-development program with Farmacore Biotechnology for a Versamune®-based vaccine aimed at preventing COVID-19 infection.
Based on promising and robust preclinical data with PDS0203, and in the interest of rapid development, PDS Biotech and Farmacore have jointly prioritized advancement of PDS0203 to human clinical trials. PDS Biotech had previously announced the parallel development of two Versamune®-based COVID-19 vaccines PDS0203 and PDS0204 each containing different SARS-CoV-2 proteins. The decision to jointly develop PDS0203 was made with the support of the Agência Nacional de Vigilância Sanitária (ANVISA) following a successful pre-investigational new drug meeting on November 06, 2020. ANVISA and Farmacore reviewed the PDS0203 data and agreed on the path forward for official submission of a final data package and the phase 1/2 human clinical trial protocol. Farmacore is in discussions with specific agencies of the government to extend the preclinical funding to cover the upcoming human clinical trial anticipated to begin during the first half of 2021.
As previously disclosed, PDS Biotech has generated robust preclinical data demonstrating that PDS0203 elicits a 30-45 fold increase in the induction of highly active and potent virus-specific T-cells within 14 days of treatment compared to the vaccine without Versamune®. Importantly, the study also demonstrated induction of the long-lasting virus-specific memory T-cells necessary for longer term protection. The vaccine has also demonstrated strong and long-lasting induction of neutralizing antibodies. The PDS0203 subunit vaccine is based on recombinant proteins and does not require the use of inactivated viruses, traditional adjuvants, DNA or RNA to induce robust protective immune responses.
“PDS0203 may present strong potential to provide the breadth and level of immune responses necessary for a safe and effective vaccine with long-term protection against COVID-19," said Dr. Greg Conn, Chief Scientific Officer of PDS Biotechnology.
“PDS Biotech and Farmacore are now one step closer to advancing our Versamune®-based COVID-19 vaccine into the clinic,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “The preclinical results of PDS0203 demonstrate its potential to induce a robust and broad immune response. We look forward to evaluating our next-generation vaccine in planned human clinical trials in partnership with Farmacore and to advance our understanding of the potential of novel Versamune®-based vaccines like PDS0203 to provide long-term protection against infection with viruses such as SARS-CoV-2.”
“In this global pandemic, it is incumbent upon the scientific community to be flexible and to ensure we are prioritizing the vaccine with the most clinical potential and that we can progress most quickly,” said Helena Faccioli, CEO of Farmacore. “We are excited to continue advancing the partnership with PDS Biotech, and we are thrilled to have the support of ANVISA to provide the opportunity to develop a treatment in Brazil in the fight against this pandemic.”
The companies plan to utilize multiple research and development sites in the United States and Brazil to progress preclinical and clinical development PDS0203. Farmacore will lead the regulatory and clinical trial efforts in Brazil while PDS Biotech will continue to contribute scientific expertise and operational support.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About Farmacore
Farmacore is a biotechnology company, founded in 2005 as a startup, focusing on R&D of innovative immunobiological products for use in the human and veterinary health sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them in all stages of development, from project design to biomolecule production www.farmacore.com.br.
About PDS0203
PDS0203 is an investigational vaccine designed for the prevention of COVID-19 being jointly developed by PDS Biotech and Farmacore. PDS0203 combines the utility of PDS Biotech’s Versamune® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein recognizable by our immune system (antigen). The Versamune® platform, due to its unique ability to induce both antibody and T-cell responses is being utilized to develop a next generation vaccine that may more effectively prevent COVID-19.
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 its lead asset PDS0101; 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 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 acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; 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.
Media & Investor Relations Contact:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com
Jacob Goldberger
CG Capital
Phone: +1 (404) 736-3841
Email: jacob@cg.capital