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. 

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.

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
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:

Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.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
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:

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