Thursday, June 02, 2022

Tonix Pharmaceuticals (TNXP)
Monkeypox Patent Issuance, Share Buyback, and Data Presentation Attract Attention

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Tonix News Attracts Attention.  On June 1, Tonix stock had a significant price gain (21.9%) on volume of 169.2 million shares (compared with average trading volume of about 2.0 million shares).  This follows the issuance of a patent on the company’s monkeypox vaccine and the announcement of a share buyback program.  Also significant is the planned presentation of preclinical data at meeting of American Transplant Congress held June 4 through 8.

Share Buyback Program.  Tonix announced that it has authorized $12.5 million for repurchases of its outstanding stock.  The company reported $140.4 million in cash or $7.50 per share on March 31, 2022, with a market capitalization of only $45.6 million when announced.  At the recent prices, this could repurchase about 2.5 million to 5 million out of the 18.7 million shares outstanding.  We also believe this attracted attention to the stock’s large discount to cash on hand….

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 02, 2022

Baudax Bio (BXRX)
BX2000 Phase I First Cohort Dosed

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Phase I Neuromuscular Blocking Agent (NMB) trial advances.  The BX2000 trial is a double-blind, placebo-controlled dose escalation study with up to 10 dosing cohorts. Each cohort will enroll 8 patients and the Company yesterday announced the first cohort has been dosed.  The study will evaluate safety, pharmacokinetics, and time course of the neuromuscular blocking profile.

Baudax Bio now has two novel NMBs in the clinic. BX1000 is a rapid onset, intermediate acting agent that has completed the dose escalation Phase I and is currently moving toward Phase II. BX2000 is a rapid onset, ultra-short acting agent with Phase I dose escalation enrollment expected to be completed by early 2023.

…

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. 

Victor Segura Ibarra and Rita Serda/National Cancer Institute (Flickr)

‘Masked’ Cancer Drug Stealthily Trains Immune System to Kill Tumors While Sparing Healthy Tissues

Many cancer treatments are notoriously savage on the body. Drugs often attack both healthy cells and tumor cells, causing a plethora of side effects. Immunotherapies that help the immune system recognize and attack cancer cells are no different. Though they have prolonged the lives of countless patients, they work in only a subset of patients. One study found that fewer than 30% of breast cancer patients respond to one of the most common forms of immunotherapy.

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 Aslan Mansurov, Postdoctoral Researcher in Molecular Engineering, University of Chicago Pritzker School of Molecular Engineering.

But what if drugs could be engineered to attack only tumor cells and spare the rest of the body? To that end, my colleagues and I at the University of Chicago’s Pritzker School of Molecular Engineering have designed a method to keep one promising cancer drug from wreaking havoc by “masking” it until it reaches a tumor.

The Promise of IL-12

Cytokines are proteins that can modulate how the immune system responds to threats. One way they do this is by activating killer T cells, a type of white blood cells that can attack cancer cells. Because cytokines can train the immune system to kill tumors, this makes them very promising as cancer treatments.

One such cytokine is interleukin-12, or IL-12. Though it was discovered more than 30 years ago, IL-12 still isn’t an FDA-approved therapy for cancer patients because of its severe side effects, such as liver damage. This is in part because IL-12 instructs immune cells to produce a large amount of inflammatory molecules that can damage the body.

Scientists have since been working to reengineer IL-12 to be more tolerable while retaining its powerful cancer-killing effects.

Masking the Killer

To create a safer version of IL-12, my colleagues and I took advantage of one of the main differences between healthy and cancerous tissue: an excess of growth-promoting enzymes in cancers. Because cancer cells proliferate very rapidly, they overproduce certain enzymes that help them invade the nearby healthy tissue and metastasize to other parts of the body. Healthy cells grow at a much slower pace and produce fewer of these enzymes.

With this in mind, we “masked” IL-12 with a cap that covers the part of the molecule that normally binds to immune cells to activate them. The cap is removed only when it comes into contact with enzymes found in the vicinity of tumors. When these enzymes chop off the cap, IL-12 is reactivated and spurs nearby killer T cells to attack the tumor.

When we applied these masked IL-12 molecules to both healthy and tumor tissue donated by melanoma and breast cancer patients, our results confirmed that only the tumor samples were able to remove the cap. This indicated that masked IL-12 could potentially drive a strong immune response against tumors without causing damage to healthy organs.

We then examined how safe masked IL-12 is by measuring liver damage biomarkers in mice. We found that immune-related side effects typically associated with IL-12 were notably absent in mice treated with masked IL-12 over a period of several weeks, indicating improved safety.

In breast cancer models, our masked IL-12 resulted in a 90% cure rate, while treatment with a commonly used immunotherapy called a checkpoint inhibitor resulted in only a 10% cure rate. In a model of colon cancer, masked IL-12 showed a 100% cure rate.

Our next step is to test the modified IL-12 in cancer patients. While it will take time to bring this encouraging development directly to patients, we believe a promising new treatment is on the horizon.

Suggested Reading

Cancer’s Predator-Prey Relationship with New Treatments and the Immune System

Pros and Cons of FDA Funded in Part by Companies

Axcella Therapeutics (AXLA) NobleCon18 Presentation Replay

Genprex (GNPX) NobleCon18 Presentation Replay

 

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PsyBio Therapeutics Initiates Commercial Biosynthetic Based Process Development for Psycho-Targeted and Psychoactive Compounds

Research, News, and Market Data on PsyBio

PsyBio Therapeutics Advances Proprietary
Patent Pending Manufacturing Towards Fully Developed GMP Production Methodology

OXFORD, Ohio and DENVER, June 2, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (”
PsyBio” or the “Company“), a fully integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today reported that it has initiated formal process development for commercially scalable, patent pending manufacturing technology expected to enable Good Manufacturing Practice (“GMP”) production. PsyBio’s manufacturing process utilizes state of the art bioreactor manufacturing technology to facilitate expansion of PsyBio’s portfolio of compounds. This process methodology is another necessary component for the Chemistry, Manufacturing and Controls section (“CMC”) for its therapeutic candidate portfolio Investigational New Drug (“IND”) applications with the United States Food and Drug Administration (“FDA”).

“This latest manufacturing milestone demonstrates PsyBio’s continued progress, maintaining our role as one of the only biotechnology companies in the psychoactive therapeutic sector developing their own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “PsyBio remains committed to developing effective and scalable techniques designed to enhance our ability to produce an ever-growing number of psycho-targeted therapeutic candidates in a rapid and highly cost-efficient approach.”

PsyBio retains the global, exclusive, and perpetual right to license a platform technology enabling rapid generation of tryptamines and related compounds through a biosynthetic process using genetically modified bacteria and has demonstrated the ability to manufacture one of its first promising therapeutic candidates at commercial scale. Commercial purification process development furthers the ability to manufacture compounds with predictable and reproducible purity.

“The mark of successful product development is the ability to transfer technology from the bench to full scale GMP production. PsyBio has been working throughout the COVID-19 pandemic to develop commercial methodology for the manufacture of pipeline compounds using biotechnology. The initiation of GMP process development is an important step leading to clinical trial initiation,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “This is expected to allow us to reliably produce predictably pure drug product for clinical evaluation in order to determine its ability to potentially improve mental and neurological health.”

About PsyBio Therapeutics Corp.

PsyBio is an intellectual property driven biotechnology company developing new, bespoke, fully approved, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the impact of this manufacturing process achievement on the CMC section of PsyBio’s IND application with the FDA; the impact of this manufacturing process achievement on GMP production; PsyBio’s ability to develop compounds more readily and rapidly than competitive methods; PsyBio’s plans for filing IND applications with the FDA; PsyBio’s ability to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; PsyBio’s plans to move towards clinical trials for psycho-targeted therapeutics intended to potentially improve mental and neurological health; PsyBio’s ability to launch clinical trials; PsyBio’s ability to build its intellectual property portfolio of novel drug candidates; PsyBio’s ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and PsyBio’s ability to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: this manufacturing process will enable GMP production and will help facilitate expansion of PsyBio’s portfolio of compounds; this manufacturing process will have a positive impact on progress toward the filing of IND applications with the FDA; PsyBio will receive approval from the FDA to launch clinical trials; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in submitting IND applications and will be able to obtain all necessary approvals for clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; and the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The FDA or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (the
“TSXV”) has neither approved nor disapproved the contents of this
news release. Neither the TSXV nor its Regulation Services Provider (as that
term is defined in the policies of the TSXV) accepts responsibility for the
adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

 

PDS Biotechnology Granted FDA Fast Track Designation for Lead Candidate PDS0101

Research, News, and Market Data on PDS Biotech

PDS Biotech has been granted Fast Track designation for PDS0101 in combination with KEYTRUDA^® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer

FLORHAM PARK, N.J., June 02, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T cell activating technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab). PDS0101 in combination with KEYTRUDA^® is being studied in the VERSATILE-002 Phase 2, open-label, multicenter trial for the treatment of recurrent or metastatic HPV16-positive head and neck cancer in collaboration with Merck (known as MSD outside the US and Canada).

The FDA’s Fast Track designation program is designed to aid in the development and to expedite the review of drug candidate applications that could potentially treat serious or life-threatening conditions. In order to receive Fast Track designation, a product must also demonstrate the potential to address an unmet medical need. Treatments granted this designation are given the opportunity to have more frequent meetings and interactions with the FDA throughout the entire drug development and review process, with the goal of moving promising new drugs more rapidly through the process. It also provides the opportunity to submit sections of a New Drug Application (NDA) on a rolling basis, where the FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission. In addition, Fast Track designated products are eligible for Priority Review at the time of NDA or Biologics License Application submission.

“We are thrilled that the FDA has granted Fast Track designation for PDS0101 in combination with KEYTRUDA^®,” said Frank Bedu-Addo, Ph.D., Chief Executive Officer of PDS Biotech. “The HPV-associated head and neck cancer prevalence continues to rise, leaving this affected group with limited treatment options to date. Receiving this designation underscores the potential of the Versamune^® platform and the need for a new therapy that may improve outcomes for those with this devastating disease.”

PDS Biotech’s lead candidate, PDS0101, is a T cell HPV-specific immunotherapy delivered subcutaneously that has shown the potential to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells within patients by activating multiple immune pathways. These HPV-specific T cells have been shown to target tumors such as anal, cervical, head and neck, penile, vaginal, vulvar that are caused by HPV16 infection. The incidence of head and neck cancer cases has been increasing steadily over the last 10-15 years and over 90% of HPV-positive head and neck cancers are caused by HPV16.¹ In addition to the Phase 2 VERSATILE-002 trial, PDS Biotech is also conducting three additional Phase 2 studies in advanced HPV-associated cancers, locally advanced cervical cancer, and early-stage pre-metastatic HPV-associated oropharyngeal cancer with the National Cancer Institute (NCI), The University of Texas MD Anderson Cancer Center, and Mayo Clinic, respectively.

KEYTRUDA^® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

¹Exploring Roles of HPV16 variants
in head and neck squamous cell carcinoma: current challenges and opportunities, Daniela Cochicho, Rui Gil da Costa, Ana Felix, Virology
Journal, November 2021

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T cell activating technology platforms. We believe our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in
vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

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

To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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

Versamune^® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology Corporation.

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

 

 

Lineage Broadens Collaboration With Advanced BioMatrix for HyStem® Cell Drug Delivery Technology

Research, News, and Market Data on Lineage Cell Therapeutics

CARLSBAD, Calif.–(BUSINESS WIRE)–Lineage Cell
Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it has expanded its existing collaboration with Advanced BioMatrix, a division of BICO Group AB (STO: BICO), for Lineage’s HyStem cell/drug delivery technology. Under the expanded collaboration, Advanced BioMatrix will broaden its current focus of manufacturing and supplying R&D-grade HyStem to the research community to include the development, supply and/or licensing of clinical/commercial GMP- (Good Manufacturing Practice) grade material for its customers. The amended agreement increases the milestone payments and royalty percentages due to Lineage upon ABM reaching certain development milestones and/or product sales.

 

“We are pleased to broaden the scope of our agreement with Advanced BioMatrix and the opportunity to include the commercial supply of clinical-grade HyStem as part of ABM’s biomaterials & bioprinting portfolio which is widely available to the cell therapy product development community,” stated Brian M. Culley, Lineage CEO. “We have decided this year to place a greater emphasis on business development and licensing and we believe the decision to broaden our partnership with ABM is an example of our ability to rapidly monetize prior investments in our technology platform and its related intellectual property. Alongside our prioritized assets, other assets which are not core to our cell transplant platform can create new opportunities for cash flow and support our development pipeline. Our strategy is to identify and pursue opportunities to unlock value from our business and to utilize capital from these corporate alliances to advance our novel cell therapy programs.”

“The mission of Advanced BioMatrix is to enable the future of life-saving treatments, and the HyStem technology can now be more fully utilized as a tool towards accomplishing this mission,” added Bowman Bagley, Advanced BioMatrix CEO.

HyStem is a patented hydrogel which mimics naturally occurring extracellular matrix, the structural network of molecules surrounding cells in organs and tissues and essential to cellular function and tissue structure. HyStem biomaterial has been shown to support cellular attachment and survival as well as compatibility with a wide variety of cells and tissue types including brain, bone, skin, cartilage, vascular and heart tissues.

About Advanced BioMatrix, Inc.

Advanced BioMatrix, a San Diego based leader in the life science of three dimensional (3D) applications for tissue culture, cell assay, bioprinting and cell proliferation, was acquired by BICO Group AB in September 2021. BICO is a publicly traded bioconvergence company that designs and supplies technologies and services to enhance biology research. Advanced BioMatrix has been manufacturing and delivering high quality products for research uses and applications for over 10 years and continues to add several innovative new products each year that provide research tools for our customers worldwide. Advanced BioMatrix develops new products and technologies directly and also collaborates with many research institutes, universities and life science companies.

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 five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 1/2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, which is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a 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; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. 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,” “aim,” “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: the collaboration and license agreement with Roche and Genentech; the power and efficiency of Lineage’s platform and its competitive advantages; the potential future achievements of Lineage’s clinical and preclinical programs; and plans and expectations of Lineage’s products in development. 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, but not limited to, the risk that Advanced BioMatrix may not be successful in maintaining or expanding its market for HyStem; risks and uncertainties inherent in Lineage’s business and other risks discussed 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.

Contacts

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

Solebury Trout IR
Justin Frantz
(
jfrantz@soleburytrout.com)
(617) 221-9100

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