Ocugen, Inc. Announces Ken Inchausti as Head, Investor Relations & Communications

 

MALVERN, Pa., June 21, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that Ken Inchausti has joined the company as Head, Investor Relations & Communications. Mr. Inchausti will oversee the company’s investor relations activities, corporate communications and strategic positioning, leading issues management strategy and proactive media and social media relations programming.

A senior executive with over 25 years of strategic healthcare communications experience, Mr. Inchausti joins Ocugen from Novo Nordisk Inc., where he was Senior Director, Reputation & Brand, leading corporate media relations, executive visibility, reputation strategy and research, crisis and issues management and corporate communications for the US affiliate.

“Ken is joining us at a critical time where we are continuing our plans for obtaining regulatory approval for and potentially commercializing COVAXIN^® in the US and Canada, as well as the planned initiation our Phase 1/2a clinical trial for OCU400. His talents and expertise will be key as we seek to find new ways of raising our profile with multiple stakeholders as a leader committed to global public health and fighting this pandemic, and also driving innovation through our gene therapy platform to find cures for leading causes of blindness,” said Sanjay Subramanian, MBA, Chief Financial Officer and Head of Corporate Development at Ocugen, Inc.

Mr. Inchausti has worked across multiple sectors within healthcare – from pharmaceuticals to hospitals and providers to patient advocacy. Prior to Novo Nordisk, he held communications positions at GSK, Premier, Inc., Fleishman Hillard, and the American Diabetes Association.

Mr. Inchausti holds a bachelor’s degree in Communications from Old Dominion University.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug — “one to many,” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, the intended use of net proceeds from the registered direct offering. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Ken Inchausti
Head, Investor Relations and Communications
[email protected]

Please submit investor-related inquiries to: [email protected]

Media Contact:
LaVoieHealthScience
Lisa DeScenza
[email protected]
+1 978-395-5970

Ocugen, Inc. Announces Ken Inchausti as Head, Investor Relations & Communications

 

MALVERN, Pa., June 21, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that Ken Inchausti has joined the company as Head, Investor Relations & Communications. Mr. Inchausti will oversee the company’s investor relations activities, corporate communications and strategic positioning, leading issues management strategy and proactive media and social media relations programming.

A senior executive with over 25 years of strategic healthcare communications experience, Mr. Inchausti joins Ocugen from Novo Nordisk Inc., where he was Senior Director, Reputation & Brand, leading corporate media relations, executive visibility, reputation strategy and research, crisis and issues management and corporate communications for the US affiliate.

“Ken is joining us at a critical time where we are continuing our plans for obtaining regulatory approval for and potentially commercializing COVAXIN^® in the US and Canada, as well as the planned initiation our Phase 1/2a clinical trial for OCU400. His talents and expertise will be key as we seek to find new ways of raising our profile with multiple stakeholders as a leader committed to global public health and fighting this pandemic, and also driving innovation through our gene therapy platform to find cures for leading causes of blindness,” said Sanjay Subramanian, MBA, Chief Financial Officer and Head of Corporate Development at Ocugen, Inc.

Mr. Inchausti has worked across multiple sectors within healthcare – from pharmaceuticals to hospitals and providers to patient advocacy. Prior to Novo Nordisk, he held communications positions at GSK, Premier, Inc., Fleishman Hillard, and the American Diabetes Association.

Mr. Inchausti holds a bachelor’s degree in Communications from Old Dominion University.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug — “one to many,” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, the intended use of net proceeds from the registered direct offering. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Ken Inchausti
Head, Investor Relations and Communications
[email protected]

Please submit investor-related inquiries to: [email protected]

Media Contact:
LaVoieHealthScience
Lisa DeScenza
[email protected]
+1 978-395-5970

Why Would Researchers do Gain-of-Function Work on Potentially Dangerous Pathogens?

 

What Does Gain of Function Mean?

Any organism can acquire a new ability or property, or “gain” a “function.” This can happen through natural selection or a researcher’s experiments. In research, many different types of experiments generate functions, and some pose certain safety and security concerns.

Scientists use a variety of techniques to modify organisms depending on the properties of the organism itself and the end goal. Some of these methods involve directly making changes at the level of genetic code. Others may involve placing organisms in environments that select for functions linked to genetic changes.

Gain of function can occur in an organism in either nature or the laboratory. Some lab examples include creating more salt- and drought-resistant plants or modifying disease vectors to produce mosquitoes that are resistant to transmitting dengue fever. Gain of function can also be useful for environmental reasons, such as modifying E. coli so that it can convert plastic waste into a valuable commodity.

In the current debate around SARS-CoV-2, the virus that causes COVID-19, gain of function has a much narrower meaning related to a virus becoming easier to move between humans, or becoming more lethal in humans. It is important to remember, though, that the term “gain of function” by itself covers much more than this type of research.

 

Why would Researchers do Gain-of-Function Work on Potentially Dangerous Pathogens?

Gain-of-function experiments may help researchers test scientific theories, develop new technologies and find treatments for infectious diseases. For example, in 2003, when the original SARS-CoV outbreak occurred, researchers developed a method to study the virus in the laboratory. One of the experiments was to grow the virus in mice so they could study it. This work led to a model for researching the virus and testing potential vaccines and treatments.

Gain-of-function research that focuses on potential pandemic pathogens has been supported on the premise that it will help researchers better understand the evolving pathogenic landscape, be better prepared for a pandemic response and develop treatments and countermeasures.

But critics argue that this research to anticipate potential pandemic pathogens does not lead to substantial benefit and is not worth the potential risks. And they say getting out ahead of such threats can be achieved through other means – biological research and otherwise. For instance, the current pandemic has provided numerous lessons on the social and behavioral dynamics of disease prevention measures, which could lead to robust new research programs on the cultural aspects of pandemic preparedness. Understanding when the risks of gain-of-function research outweigh the potential benefits and alternatives, therefore, continues to be subject to debate.

 

What are Some Examples of Gain-of-Function Research, and How Risky is It?

Some potential outcomes of gain-of-function research may include the creation of organisms that are more transmissible or more virulent than the original organism or those that evade current detection methods and available treatments. Other examples include engineering organisms that can evade current detection methods and available treatments, or grow in another part of an organism, such as the ability to cross the blood-brain barrier.

There is no such thing as zero risk in conducting experiments. So the question is whether certain gain-of-function research can be performed at an acceptable level of safety and security by utilizing risk-mitigation measures. These strategies for reducing risk include the use of biocontainment facilities, exposure control plans, strict operating procedures and training, incident response planning and much more. These efforts involve dedication and meticulous attention to detail at multiple levels of an institution.

Lab incidents will still occur. A robust biosafety and biosecurity system, along with appropriate institutional response, helps to ensure that these incidents are inconsequential. The challenge is to make sure that any research conducted – gain-of-function or otherwise – doesn’t pose unreasonable risks to researchers, the public and the environment. Determining whether specific experiments with potential pathogens should be conducted remains a difficult and contentious topic.

 

How do Experts Determine Which Gain-of-Function Research Poses Too Much Risk?

There are multiple ways to answer this question. The first is if the research is intended to develop a biological weapon. The United Nations Biological Weapons Convention, which went into effect in 1975, forbids state parties from developing, producing, stockpiling, or otherwise acquiring or sharing biological agents, toxins and equipment that have no justification for peaceful or defensive purposes. There should be no research, then, whether gain-of-function or otherwise, that seeks to purposefully develop a biological weapon.

Another way to answer the question is by focusing on the content of the research, rather than its intent. Through experience, researchers and governments have developed lists of both experiments and organisms that need additional oversight because of their potential safety and security risks. One example of this arose when flu researchers placed a self-imposed pause on gain-of-function research involving the transmissibility of highly pathogenic avian influenza H5N1 viruses in 2012. The U.S. government subsequently imposed a moratorium on the work in 2014. Both moratoriums were lifted by the end of 2017 following a lengthy debate and study of the risks and the development of additional oversight and reporting requirements.

In the past decade, the United States has developed oversight for research that could be directly misused for nefarious purposes. This includes policies on “dual-use research of concern” (DURC) and policies on “pathogens of pandemic potential” enhanced to gain transmissibility or virulence.

The main point is that our understanding is constantly evolving. Just before the COVID-19 pandemic began, the U.S. government had started to review and update its policies. It is an open question what lessons will be learned from this pandemic, and how that will reshape our understanding of the value of gain-of-function research. One thing that is likely to happen, though, is that we will rethink the assumptions we have been making about the relationships between biological research, security and society. This may be an opportunity to review and enhance systems of biosecurity and biosafety governance.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic
experts.  It was written by and represents the research-based opinions
of David Gillum Senior Director of Environmental Health and Safety and
Chief Safety Officer, Arizona State University and Rebecca Moritz, Biosafety Director and Responsible Official, Colorado
State University. Also contributing, Megan J. Palmer, Executive Director of Bio Policy & Leadership
Initiatives at Stanford University, Stanford University Sam Weiss Evans Senior research fellow, Harvard Kennedy School.

 

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PDS Biotechnology Corporation Announces Closing of Approximately $52 Million Public Offering and Full Exercise of Underwriter’s Option to Purchase Additional Shares

 

FLORHAM PARK, N.J., June 17, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotechnology” or the “Company”), a clinical-stage immunotherapy company developing a pipeline of novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the closing of its previously announced underwritten public offering of 6,088,235 shares of common stock (inclusive of the 794,117 shares that were sold pursuant to the underwriter’s full exercise of its option to purchase additional shares of common stock) at a public offering price of $8.50 per share. Certain insiders, including certain members of the Company’s board of directors and executive officers, purchased shares of PDS Biotech common stock in the offering.

The gross proceeds to PDS Biotech from this offering, before deducting underwriting discounts, commissions and other offering expenses were approximately $51.7 million.

Cantor Fitzgerald & Co. acted as the sole book-running manager for the offering.

The shares of common stock described above were offered by the Company pursuant to a registration statement on Form S-3 (File No. 333-240011) previously filed with the U.S. Securities and Exchange Commission (“SEC”) on July 22, 2020 and declared effective on July 31, 2020, and the accompanying prospectus contained therein. The offering of the shares of common stock was made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement related to the offering has been filed with the SEC and is available on the SEC’s website, located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, NY 10022, Attn: Capital Markets Department, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products 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. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. 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 & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

About PDS0102

PDS0102 combines the utility of the Versamune^® platform with the proprietary T-cell receptor gamma alternate reading frame protein (TARP), a tumor antigen identified by the National Cancer Institute (NCI) which is strongly associated with prostate cancer, breast cancer and AML. The product is in late-stage clinical development and anticipated to enter human clinical trials in 2022.

About PDS0103

PDS0103 combines the utility of the Versamune^® platform with novel and proprietary highly immunogenic agonist epitopes of mucin-1 (MUC1) oncogenic C-terminal region. MUC1 is highly expressed in multiple tumor types and has been shown to be associated with drug resistance and poor disease prognosis. The product is in late-stage clinical development as part of a collaborative research and development agreement with the National Cancer Institute and anticipated to enter human clinical trials in 2022.

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^® 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, PDS0203 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 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 our ability to fully fund our 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, 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; 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: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Friday, June 18, 2021

Onconova Therapeutics Inc. (ONTX)
New Publication Describes Rigosertib’s Mechanism For Improving Checkpoint Inhibitor Responses

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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

New Rigosertib Study Shows Mechanism Of Action A study published in the medical journal Molecular Cancer detailed how rigosertib’s action through the RAS pathway could improve the response to checkpoint inhibitors. Rigosertib is currently in a Phase 1 clinical trial in combination with the PD-1 inhibitor Opdivo (nivolumab) to improve response rates in lung cancer.


Turning “Cold” Tumors “Hot” Drugs in the checkpoint inhibitor category block the mechanism that allows cancer cells to avoid recognition by the immune system.  Response rates for checkpoint inhibitors vary from about 10% to 40% depending on the tumor. The new publication supports observations in prior rigosertib trials by demonstrating increases in immune cell populations and responses …

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, June 18, 2021

Onconova Therapeutics Inc. (ONTX)
New Publication Describes Rigosertib’s Mechanism For Improving Checkpoint Inhibitor Responses

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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

New Rigosertib Study Shows Mechanism Of Action A study published in the medical journal Molecular Cancer detailed how rigosertib’s action through the RAS pathway could improve the response to checkpoint inhibitors. Rigosertib is currently in a Phase 1 clinical trial in combination with the PD-1 inhibitor Opdivo (nivolumab) to improve response rates in lung cancer.


Turning “Cold” Tumors “Hot” Drugs in the checkpoint inhibitor category block the mechanism that allows cancer cells to avoid recognition by the immune system.  Response rates for checkpoint inhibitors vary from about 10% to 40% depending on the tumor. The new publication supports observations in prior rigosertib trials by demonstrating increases in immune cell populations and responses …

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

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

PDS Biotechnology Corporation Announces Closing of Approximately $52 Million Public Offering and Full Exercise of Underwriter’s Option to Purchase Additional Shares

 

FLORHAM PARK, N.J., June 17, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotechnology” or the “Company”), a clinical-stage immunotherapy company developing a pipeline of novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the closing of its previously announced underwritten public offering of 6,088,235 shares of common stock (inclusive of the 794,117 shares that were sold pursuant to the underwriter’s full exercise of its option to purchase additional shares of common stock) at a public offering price of $8.50 per share. Certain insiders, including certain members of the Company’s board of directors and executive officers, purchased shares of PDS Biotech common stock in the offering.

The gross proceeds to PDS Biotech from this offering, before deducting underwriting discounts, commissions and other offering expenses were approximately $51.7 million.

Cantor Fitzgerald & Co. acted as the sole book-running manager for the offering.

The shares of common stock described above were offered by the Company pursuant to a registration statement on Form S-3 (File No. 333-240011) previously filed with the U.S. Securities and Exchange Commission (“SEC”) on July 22, 2020 and declared effective on July 31, 2020, and the accompanying prospectus contained therein. The offering of the shares of common stock was made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement related to the offering has been filed with the SEC and is available on the SEC’s website, located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, NY 10022, Attn: Capital Markets Department, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products 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. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. 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 & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

About PDS0102

PDS0102 combines the utility of the Versamune^® platform with the proprietary T-cell receptor gamma alternate reading frame protein (TARP), a tumor antigen identified by the National Cancer Institute (NCI) which is strongly associated with prostate cancer, breast cancer and AML. The product is in late-stage clinical development and anticipated to enter human clinical trials in 2022.

About PDS0103

PDS0103 combines the utility of the Versamune^® platform with novel and proprietary highly immunogenic agonist epitopes of mucin-1 (MUC1) oncogenic C-terminal region. MUC1 is highly expressed in multiple tumor types and has been shown to be associated with drug resistance and poor disease prognosis. The product is in late-stage clinical development as part of a collaborative research and development agreement with the National Cancer Institute and anticipated to enter human clinical trials in 2022.

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^® 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, PDS0203 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 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 our ability to fully fund our 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, 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; 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: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Avalon Globocare President & CEO Dr. David Jin and CFO Luisa Ingargiola deliver a formal corporate overview, followed by a Q & A session moderated by a Noble Capital Markets equity research representative. Return to the Investor Forum Event Page Avalon GloboCare Corp. (NASDAQ: AVCO) is a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative, transformative immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. Avalon also provides strategic advisory and outsourcing services to facilitate and enhance its clients’ growth and development, as well as competitiveness in healthcare and CellTech industry markets. Through its subsidiary structure with unique integration of verticals from innovative R&D to automated bioproduction and accelerated clinical development, Avalon is establishing a leading role in the fields of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX™), and regenerative therapeutics. For more information about Avalon GloboCare, please visit www.avalon-globocare.com.

Onconova Therapeutics Announces The Peer-Reviewed Publication Of Preclinical Data Demonstrating The Synergistic Anti-Cancer Activity Of Rigosertib Combined With Immune Checkpoint Blockade

 

igosertib synergistically combined with immune checkpoint blockade (ICB) to improve tumor growth inhibition and survival in a murine melanoma model that did not respond to ICB alone

Rigosertib’s anti-cancer activity was due to its ability to reverse immunosuppressive tumor microenvironments

Data support the clinical evaluation of rigosertib in combination with immune checkpoint inhibitors

NEWTOWN, Pa., June 17, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the publication of a preclinical study in the journal Molecular Cancer. The study, entitled “Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade,” showed that rigosertib synergistically enhanced the efficacy of ICB in a murine melanoma model via the induction of immune-mediated cancer cell death.

“The data from this recent publication demonstrate rigosertib’s potential to address a pressing unmet need, as many patients do not respond to immune checkpoint blockade due to immunosuppressive tumor microenvironments,” said Ann Richmond, Ph.D., Ingram Professor of Pharmacology and Medicine at the Vanderbilt University School of Medicine and lead author of the study. “By reversing immunosuppressive tumor microenvironments, rigosertib overcame pro-tumor resistance mechanisms and synergistically enhanced the efficacy of immune checkpoint blockade in a difficult-to-treat murine melanoma model. These compelling findings provide preclinical proof-of-concept for rigosertib-immune checkpoint blockade combination therapy and strongly support its evaluation in clinical trials.”   

Key data and conclusions from the recent publication include:

• Rigosertib treatment enhanced the activation of anti-cancer immune cells and increased the frequency of these cells in the tumor microenvironment (TME).
• Rigosertib treatment reduced the frequency of pro-tumor CD206+ M2-like macrophages in the TME.
• Rigosertib monotherapy rapidly reduced PI3K signaling with induction of CD40 expression, leading to melanoma cell death and inhibition of tumor growth in vivo due to its ability to promote the tumor infiltration of activated anti-cancer immune cells.
• Rigosertib’s ability to remodel the TME enabled it to synergistically combine with ICB and improve tumor growth inhibition and survival in a mouse model of melanoma that did not respond to ICB alone, or a clinically used combination of ICB plus BRAF and MEK inhibitors.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, added, “We are very pleased with these recently published results, which will inform the data driven approach guiding our clinical rigosertib investigator-initiated study program. They provide strong mechanistic support for both the ongoing KRAS mutated non-small cell lung cancer trial of rigosertib in combination with a check point inhibitor and a potential trial in patients with advanced melanoma evaluating a rigosertib-checkpoint inhibitor combination that is under active consideration. Looking ahead, we plan to continue leveraging our collaborations with leading institutions such as Vanderbilt University as we pursue opportunities for rigosertib while maintaining our primary focus and resources on our lead ON 123300 multi-kinase inhibitor program.”

About Onconova Therapeutics, Inc.

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 ON 123300 is being evaluated in two separate and complementary 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-initiated study program, including in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of Onconova’s and investigator-initiated clinical development plans, and the mechanisms and indications for Onconova’s product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, the timing of the Company’s annual stockholder meeting, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:

Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:

Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
[email protected]

Mesoblast CEO & Managing Director Dr Silviu Itescu delivers a formal corporate overview, followed by a Q & A session moderated by a Noble Capital Markets equity research representative. Return to the Investor Forum Event Page Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platforms, remestemcel-L and rexlemestrocel-L, to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2040 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Rexlemestrocel-L is being developed for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

ExoProTher Co-Founder and CEO Dr. Lana Volokh delivers a formal corporate overview, followed by a Q & A session moderated by a Noble Capital Markets equity research representative. Return to the Investor Forum Event Page ExoProTher Medical is a preclinical stage company developing a first in class oncology therapeutic platform targeting cancers with mutation in gene TP53 – the most frequently observed genetic alterations in human cancer.

HealthLynked Founder and CEO Dr. Michael Dent delivers a formal corporate overview, followed by a Q & A session moderated by a Noble Capital Markets equity research representative. Return to the Investor Forum Event Page About HealthLynked Corp. It is our mission to improve healthcare by the transfer of accurate medical information between patients and their healthcare providers, improving medical practice efficiency, increasing access to quality healthcare, and facilitating accurate medical diagnosis. HealthLynked was launched in Naples, Florida, in 2016 by Dr. Michael Dent, the visionary behind NeoGenomics, now one of the largest genetic cancer testing facilities in the world. After spending nearly thirty years as a practicing physician, he wanted to find a way to make data sharing, patient management, and research easier and more accessible to more people and physicians. In the pursuit of improving healthcare, HealthLynked has created multiple apps and services for patients including the HealthLynked app, COVID-Tracker app, Oohvie, a Period Tracker and Ovulation Calendar app, DocLynk Telemedicine, CareLynk, and LYNKfit Wearable Health Sensor. For Providers, HealthLynked has created multiple applications like Patient Access Hub, QwikCheck, and more to help providers grow and improve their practice. HealthLynked is the parent company of Naples Women’s Center, Naples Center for Functional Medicine, Bridging the Gap Physical Therapy, MedOfficeDirect, and Cura Health Management, LLC. HealthLynked is improving healthcare for every patient worldwide. In the hopes of creating a better healthcare system, HealthLynked plans on improving healthcare by integrating customer histories, genetics, and demographics into an artificial intelligence-driven system that coordinates patient care and looks for trends in large populations. The end result is a healthier, more connected network of people and providers.

ImmCelz Chief Scientific Officer Dr. Thomas Ichim delivers a formal corporate overview, followed by a Q & A session moderated by a Noble Capital Markets equity research representative. Return to the Investor Forum Event Page Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company committed to improving patient lives in the areas of Immunology, Urology, Neurology and Orthopedics. Creative Medical Technology Holdings, Inc. (CELZ) is focused on regenerative medical solutions for unmet Immunological, Urological, Neurological and Orthopedic needs. We have developed an extensive intellectual property portfolio utilizing stem cells and interrelated technologies for the treatment of multiple indications and commercialized complete patented and trademarked protocols for erectile dysfunction under the CaverStem® brand and the FemCelz® brand for the treatment of female sexual dysfunction. Our StemSpine® technology has undergone a pilot study and is prepared for commercialization of it’s autologous (patients own stem cells) program with the vision of progressing it’s patented allogenic (donor cells) program through FDA clinical trial. CELZ is also breaking new ground with its ImmCelz® technology for the treatment of multiple indications. Our team consists of leading physicians and scientists specializing in regenerative medicine. Our “science-first” approach to procedures ensures that all of our technology is proven to be both safe and effective.