Onconova Therapeutics Regains Compliance With Nasdaq Continued Listing Requirement

 

NEWTOWN, Pa., June 22, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a biopharmaceutical company focused on discovering and developing novel products for patients with cancer, announced that on June 17, 2021 it received a letter from The Nasdaq Stock Market LLC stating that the Company has regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2), as the Company’s common stock had a closing bid price of at least $1.00 per share for 18 consecutive business days, from May 21, 2021 to June 16, 2021.

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 1/2a 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 registered direct offering, its patents and clinical development plans including [patient enrollment timelines and] indications for its 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, Onconova’s ability to maintain its Nasdaq listing, the timing of the Company’s annual stockholder meeting, market conditions and those 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
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:

Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Lineage’s OPC1 Cell Therapy for the Treatment of Spinal Cord Injury to Return to Clinical Testing

 

• RMAT Interaction with FDA Held to Propose Clinical Testing of a Novel Delivery Device for OPC1
• Safety Study Eligibility is Expected to Include Patients with Chronic Injury
• Late-Stage Clinical Study Continues to be Planned for 2022

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 22, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided an update on the clinical advancement of OPC1, its investigational allogeneic oligodendrocyte progenitor cell (OPC) transplant therapy for the treatment of spinal cord injury (SCI). Following feedback received from an interaction held with the 
U.S. Food and Drug Administration (FDA) last week under the FDA’s Regenerative Medicine Advanced Therapy (RMAT) program, Lineage intends to submit an amendment to its Investigational New Drug application (IND) for OPC1 to support a Phase 1 clinical study to evaluate the safety and performance of Neurgain Technologies Inc.’s Parenchymal Spinal Delivery System (“Neurgain PSD system”) to deliver OPC1 cells to the spinal cord. In February, the Company entered into an exclusive option and license agreement with Neurgain to evaluate its novel PSD system in both preclinical and clinical settings. The IND amendment is expected to be submitted to the FDA in the fourth quarter of 2021. The data from the Phase 1 clinical study is intended to validate the Neurgain PSD system for use in a late-stage clinical study, expected to begin in 2022 following the completion of the Phase 1 study.

“It is a privilege to report that our novel OPC1 program will be returning to clinical testing earlier than anticipated. There currently are few opportunities for SCI patients to participate in clinical trials, so we are excited to re-engage with these patients and their advocacy community as part of our efforts to improve outcomes for individuals with this debilitating condition, for which there are no FDA-approved treatments,” stated  Brian M. Culley, Lineage’s CEO. “In the past 18 months, we have significantly increased the purity and production scale of the OPC1 cells utilized in a prior clinical study. This improved production process has been transferred to our in-house Current Good Manufacturing Practice (cGMP) suite and will support production of clinical study material for later-stage clinical work. In parallel, we are finalizing plans to test the safety of the Neurgain PSD system to deliver OPC1 in SCI patients. We believe this device can improve the ease and precision of delivering our cells to the spinal parenchyma. As an added benefit, based on feedback from the FDA, in addition to patients with subacute SCI, we anticipate that patients with chronic SCI also will be eligible for enrollment in this study. Gaining additional OPC1 safety and device performance data across a broader range of patients and injury types will be more informative to the program and support further product and device development. Our recent accomplishments in areas of production and delivery contributed real-world feasibility to the promising clinical results previously reported with this program, in which OPC1 demonstrated improvements to quality of life and motor function for certain SCI patients. Importantly, we are working to be in a position to initiate a late-stage clinical study in SCI next year.”

The Neurgain PSD system has been designed to allow for the administration of cells to the spinal cord without stopping the patient’s ventilator during the procedure. Elimination of the need to stop respiration during surgery is expected to reduce the complexity, risk, and variability of administering cells to the area of injury. The Neurgain PSD system has been designed to provide delivery of cells with accurate anatomical positioning and dosing, is more compact than existing devices and is attached directly to the patient during the procedure. This innovative delivery system is expected to provide a significant improvement in usability and provide more flexibility to the surgeon when compared to the methods and tools utilized to deliver OPC1 cells in the completed Phase 1/2a SCiStar study of OPC1 for the treatment of cervical SCI. 
Neurgain Technologies, Inc. is a medical device company that is developing technologies developed by neurosurgeons at the 
University of California San Diego.

Lineage plans to evaluate the safety and performance of the Neurgain PSD system to deliver OPC1 to the spinal cord in both the preclinical and clinical setting. If results of these studies are positive, Lineage may exercise its option to enter into a pre-negotiated license and commercialization agreement with Neurgain. Pursuant to that agreement, Lineage may integrate the Neurgain PSD system into a late-stage clinical trial and, if approved, commercial use of OPC1 for the treatment of patients with spinal cord injury. There currently are no FDA approved treatments for spinal cord injury.

About Spinal Cord Injuries
A spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the 
U.S. The cost of a lifetime of care for a severe spinal cord injury can be as high as 
$5 million.

About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements in motor recovery in individuals with subacute spinal cord injuries. OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. While variability exists for the precise duration of each phase, subacute SCI generally refers to the phase that is three to six weeks post-injury and chronic SCI refers to the phase beginning after the subacute phase. The OPC1 program has been partially funded by a 
$14.3 million grant from the 

California Institute for Regenerative Medicine (CIRM). OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for its use in subacute cervical SCI and Orphan Drug designation from the FDA.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to advancement of the clinical development of OPC1 to treat SCI, OPC1’s potential to improve quality of life and/or motor function for patients with SCI, the potential benefits of using the Neurgain PSD system to deliver OPC1 for the treatment of SCI, OPC1’s regulatory approval pathway, and Lineage’s potential exclusive license and commercialization agreement with Neurgain. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Lineage’s OPC1 Cell Therapy for the Treatment of Spinal Cord Injury to Return to Clinical Testing

 

• RMAT Interaction with FDA Held to Propose Clinical Testing of a Novel Delivery Device for OPC1
• Safety Study Eligibility is Expected to Include Patients with Chronic Injury
• Late-Stage Clinical Study Continues to be Planned for 2022

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 22, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided an update on the clinical advancement of OPC1, its investigational allogeneic oligodendrocyte progenitor cell (OPC) transplant therapy for the treatment of spinal cord injury (SCI). Following feedback received from an interaction held with the 
U.S. Food and Drug Administration (FDA) last week under the FDA’s Regenerative Medicine Advanced Therapy (RMAT) program, Lineage intends to submit an amendment to its Investigational New Drug application (IND) for OPC1 to support a Phase 1 clinical study to evaluate the safety and performance of Neurgain Technologies Inc.’s Parenchymal Spinal Delivery System (“Neurgain PSD system”) to deliver OPC1 cells to the spinal cord. In February, the Company entered into an exclusive option and license agreement with Neurgain to evaluate its novel PSD system in both preclinical and clinical settings. The IND amendment is expected to be submitted to the FDA in the fourth quarter of 2021. The data from the Phase 1 clinical study is intended to validate the Neurgain PSD system for use in a late-stage clinical study, expected to begin in 2022 following the completion of the Phase 1 study.

“It is a privilege to report that our novel OPC1 program will be returning to clinical testing earlier than anticipated. There currently are few opportunities for SCI patients to participate in clinical trials, so we are excited to re-engage with these patients and their advocacy community as part of our efforts to improve outcomes for individuals with this debilitating condition, for which there are no FDA-approved treatments,” stated  Brian M. Culley, Lineage’s CEO. “In the past 18 months, we have significantly increased the purity and production scale of the OPC1 cells utilized in a prior clinical study. This improved production process has been transferred to our in-house Current Good Manufacturing Practice (cGMP) suite and will support production of clinical study material for later-stage clinical work. In parallel, we are finalizing plans to test the safety of the Neurgain PSD system to deliver OPC1 in SCI patients. We believe this device can improve the ease and precision of delivering our cells to the spinal parenchyma. As an added benefit, based on feedback from the FDA, in addition to patients with subacute SCI, we anticipate that patients with chronic SCI also will be eligible for enrollment in this study. Gaining additional OPC1 safety and device performance data across a broader range of patients and injury types will be more informative to the program and support further product and device development. Our recent accomplishments in areas of production and delivery contributed real-world feasibility to the promising clinical results previously reported with this program, in which OPC1 demonstrated improvements to quality of life and motor function for certain SCI patients. Importantly, we are working to be in a position to initiate a late-stage clinical study in SCI next year.”

The Neurgain PSD system has been designed to allow for the administration of cells to the spinal cord without stopping the patient’s ventilator during the procedure. Elimination of the need to stop respiration during surgery is expected to reduce the complexity, risk, and variability of administering cells to the area of injury. The Neurgain PSD system has been designed to provide delivery of cells with accurate anatomical positioning and dosing, is more compact than existing devices and is attached directly to the patient during the procedure. This innovative delivery system is expected to provide a significant improvement in usability and provide more flexibility to the surgeon when compared to the methods and tools utilized to deliver OPC1 cells in the completed Phase 1/2a SCiStar study of OPC1 for the treatment of cervical SCI. 
Neurgain Technologies, Inc. is a medical device company that is developing technologies developed by neurosurgeons at the 
University of California San Diego.

Lineage plans to evaluate the safety and performance of the Neurgain PSD system to deliver OPC1 to the spinal cord in both the preclinical and clinical setting. If results of these studies are positive, Lineage may exercise its option to enter into a pre-negotiated license and commercialization agreement with Neurgain. Pursuant to that agreement, Lineage may integrate the Neurgain PSD system into a late-stage clinical trial and, if approved, commercial use of OPC1 for the treatment of patients with spinal cord injury. There currently are no FDA approved treatments for spinal cord injury.

About Spinal Cord Injuries
A spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the 
U.S. The cost of a lifetime of care for a severe spinal cord injury can be as high as 
$5 million.

About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements in motor recovery in individuals with subacute spinal cord injuries. OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. While variability exists for the precise duration of each phase, subacute SCI generally refers to the phase that is three to six weeks post-injury and chronic SCI refers to the phase beginning after the subacute phase. The OPC1 program has been partially funded by a 
$14.3 million grant from the 

California Institute for Regenerative Medicine (CIRM). OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for its use in subacute cervical SCI and Orphan Drug designation from the FDA.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to advancement of the clinical development of OPC1 to treat SCI, OPC1’s potential to improve quality of life and/or motor function for patients with SCI, the potential benefits of using the Neurgain PSD system to deliver OPC1 for the treatment of SCI, OPC1’s regulatory approval pathway, and Lineage’s potential exclusive license and commercialization agreement with Neurgain. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Onconova Therapeutics Regains Compliance With Nasdaq Continued Listing Requirement

 

NEWTOWN, Pa., June 22, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a biopharmaceutical company focused on discovering and developing novel products for patients with cancer, announced that on June 17, 2021 it received a letter from The Nasdaq Stock Market LLC stating that the Company has regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2), as the Company’s common stock had a closing bid price of at least $1.00 per share for 18 consecutive business days, from May 21, 2021 to June 16, 2021.

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 1/2a 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 registered direct offering, its patents and clinical development plans including [patient enrollment timelines and] indications for its 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, Onconova’s ability to maintain its Nasdaq listing, the timing of the Company’s annual stockholder meeting, market conditions and those 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
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:

Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

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
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+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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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
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 978-395-5970

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 prospectus@cantor.com.

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: drandolph@pdsbiotech.com

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

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 prospectus@cantor.com.

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: drandolph@pdsbiotech.com

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

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. 

Thursday, June 17, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
Andreeff Appointed Full-time CEO, Names New CFO

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Kevin Wahle, Research Associate, Noble Capital Markets, Inc.

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

Permanent CEO. Helius has named interim CEO and President Dane Andreeff as full-time CEO and President. Mr. Andreeff was appointed to the interim roles in August 2020. Since assuming the roles, Mr. Andreeff guided Helius to FDA approval of the PoNS treatment for MS in the U.S. and is positioning the Company to capitalize on its key technology. Mr. Andreeff remains a significant owner of Helius with approximately 5% of the outstanding shares through his Maple Leaf Partners fund.


New CFO.  In addition, the Board appointed Jeffrey Mathiesen as CFO. Mr. Mathiesen served as a member of Helius’ Board from June 2020 until June 2021. A CPA with over 30 years experience, Mr. Mathiesen brings a solid background as CFO for a number of growth oriented, technology-based companies across a wide range of industries, including biopharmaceutical and medical device companies …

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. 

Lineage Announces Exclusive Option Agreement With Amasa Therapeutics For Supply And Use Of Clinical-Grade Hystem®

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 17, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced it granted an exclusive option to 

Amasa Therapeutics, Inc.
 (Amasa), a privately-held biopharmaceutical company focused on the development of novel cell-based targeted biological therapeutics to treat cancer patients with unmet need, to acquire an exclusive, royalty-bearing license to use Lineage’s HyStem technology for the development and commercialization of therapies for local treatment of solid tumors under pre-negotiated terms. Under the option agreement, Amasa will purchase certain amounts of Lineage’s existing supply of clinical-grade HyStem biomaterial and has the right to purchase additional amounts in connection with its up to 12-month option to acquire the exclusive license. Lineage will receive an upfront cash payment and, if the option is exercised, would be entitled to additional payments, including event-specific payments, royalties on net sales and sublicense fees and royalties.

“Lineage is a clinical-stage cell therapy company supported by a vast intellectual property portfolio. From this portfolio, we continue to find opportunities to unlock value from non-core assets through option and license agreements for assets such as HyStem,” stated  Brian Culley, Lineage CEO. “Many tissue engineering and regenerative cell-based therapies will require the delivery of therapeutic cells in a matrix or scaffold for accurate anatomical placement, cell retention, and engraftment. This option agreement represents an opportunity to provide Amasa with access to our clinical-grade HyStem material for future development of oncology-related products delivered via HyStem and, alongside a previously announced deal with Advanced BioMatrix, is the second HyStem-related transaction we have entered into.”

HyStem is a patented biomaterial that is made from and structurally mimics naturally occurring extracellular matrix, the structural network of molecules surrounding cells in organs and tissues that is essential to cellular function and tissue structure. The technology underlying the HyStem hydrogels is based on a unique thiol cross-linking strategy. Building upon this technology, the HyStem family of hydrogels are novel biomaterials that offer unique strategies for cell therapy and bioactive molecule delivery. A distinctive feature of the HyStem hydrogel is that it allows the mixture of cells with the matrix in a liquid form such that the cells and matrix can be injected easily through a small gauge syringe, and then the matrix can polymerize around the cells to create a three-dimensional tissue within the body. When implanted in HyStem hydrogels, cells remain attached and localized within the hydrogel and slowly degrade the implanted matrix and replace it with their natural extracellular matrices. Current research at leading medical institutions has shown that HyStem is compatible with a wide variety of cells and tissue types including brain, bone, skin, cartilage, vascular and heart tissues.

“We believe use of Lineage’s clinical-grade HyStem hydrogels will allow us to quickly move candidates into the clinic with our novel approach of using receptor-targeted cell therapies to address intractable solid tumors such as glioblastoma,” stated  Arthur Hiller, Amasa CEO. “The physiochemical properties of the HyStem hydrogel and its ability to provide a suitable extracellular matrix give our cell therapies the best opportunity to remain viable, be retained in the targeted tumor resection cavity, and eradicate residual tumor cells,” stated  Khalid Shah, founder of Amasa.

About HyStem^®

Lineage has developed a family of hyaluronan based hydrogels (HyStem) that mimics the natural extracellular matrix and has potential applications in 
3-D cell culture, stem cell propagation and differentiation, tissue engineering, regenerative medicine, cell-based therapies, and as delivery vehicles for bioactive molecules. HyStem hydrogels were designed to recapitulate the minimal composition necessary to obtain a functional extracellular matrix (ECM). The individual components of the hydrogels are cross-linkable over time, and thus may be seeded with cells prior to in vivo injection, without compromising either the cells or the recipient tissues. HyStem hydrogels have been shown to support attachment and proliferation of a wide variety of cell types in both 2-D and 
3-D cultures and provide timed release of proteins and other bioactive moieties. HyStem hydrogels exhibit a high degree of biocompatibility when implanted in vivo and are readily degraded in vitro and biodegrade in vivo through hydrolysis via naturally occurring enzymes. When implanted in HyStem hydrogels, cells remain attached and localized within the hydrogel and slowly degrade the implanted matrix and replace it with their natural ECMs. When used as a delivery vehicle, bioactive molecules are released by both diffusion as well as degradation of the hydrogel. The patented technology underlying Lineage’s HyStem hydrogel products in development, such as Renevia^®, has been exclusively licensed to Lineage for human therapeutic uses. Since the first published report in 2002, there have been over 300 academic scientific publications supporting the biocompatibility of thiol cross-linked hyaluronan-based hydrogels and their applications as medical devices and in cell culture, tissue engineering, and animal models of cell-based therapies. Due to the unique cross-linking chemistry, HyStem hydrogels have the ability to be formulated with cells and can be injected or applied as a liquid and form a gel in situ, which allows the hydrogel to conform to a cavity or space. This property of HyStem hydrogels is expected to offer several distinct advantages over other hydrogels, including the possibility of combining bioactive materials with the hydrogel at the point of use.

About Amasa Therapeutics, Inc.

Amasa Therapeutics is a biopharmaceutical company focused on the development of novel stem cell-based targeted biological therapeutics to treat cancer patients with unmet need. With a vision to develop innovative off-the-shelf cellular therapies possessing wide applicability, Amasa is committed to improving quality of life and increasing progression-free survival for all patients suffering from a variety of advanced cancers, starting with malignant brain tumor, glioblastoma. Amasa’s technology is built upon a unique platform of receptor-targeted cell-based therapies intended to treat the greatest unmet needs within oncology. For more information visit: https://www.amasatx.com/.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to opportunities to add value to Lineage by licensing non-core assets, including HyStem, HyStem’s potential to serve as a safe and effective delivery vehicle for cell therapies and potential payments to Lineage under its option agreement and potential license agreement with Amasa. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.