Avivagen Inc. Announces Results for the Second Quarter Ending April 30, 2021

Posted on June 3, 2021 by Admin

Avivagen Inc. Announces Results for the Second Quarter Ending April 30, 2021

• Record 64.5 tonne order for OxC-betaTM Livestock over 18 months
• New expansion efforts and customer wins in Central and South America
• Launch of first product for human health.

Ottawa, ON /Business Wire/ June 2, 2021/ Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, has announced its unaudited financial results for the second quarter of 2021.

Milestones achieved in Q2 2021 include:
• Secured its largest recurring order to date for OxC-betaTM Livestock, an 18-month contract at four tonnes per month for use in Mexico. The 64.5 tonne total order is the largest to date in both size and length of contract, and a direct result of the Meyenberg International Group agreement finalized in Q2.
• Selected Meyenberg International Group to spearhead expansion efforts in Central and South America.
• In conjunction with Mimi’s Rock Corp., announced the launch of Dr. Tobias Beta Blend on Amazon.com – Avivagen’s first product designed for human consumption.
• Announced the closing of its oversubscribed $7.5 million bought deal unit offering.
• Announced the publication of its New Zealand OxC-betaTM Livestock dairy trial for use against sub-clinical mastitis in the New Zealand Veterinary Journal, and its upcoming publication of research highlighting the benefits of OxC-betaTM Livestock for Broiler Poultry in Poultry Science.

Since the end of the quarter Avivagen also announced it had:
• Secured a new customer win in Western Mexico.
• Terminated its previous exclusive U.S. sales and distribution agreement and initiated discussions with potential partners to ramp up sales efforts in the lucrative region.
• Recorded its first order from Brazil, received on May 28, 2021.
• Secured first order with major swine and poultry producer in Thailand following numerous trials.

Second Quarter April 30, 2021, Financial Results
The Company’s unaudited Financial Statements for the second quarter ended April 30, 2021 and the accompanying Management’s Discussion and Analysis have been filed on the System for Electronic Document Analysis and Retrieval and are available via its website (www.sedar.com). The financial information for the second quarter ended April 30, 2021, should be read in conjunction with the Company’s unaudited Financial Statements as well as its Management’s Discussion and Analysis for the second quarter ended April 30, 2021.

The Company reported revenues of $159,614 ($29,625 in the quarter ending April 30, 2020) and a comprehensive loss of $(2,197,649) for the quarter ending April 30, 2021. This compares to a comprehensive loss in the quarter ending April 30, 2020 of $(1,393,497).

As reported in the statements of cash flows, the April 30, 2021 quarter comprehensive loss of $(2,197,649) consists of $1,181,373 in non-cashflow items such as share-based payment expense, depreciation, and adjustments to the Company’s ACOA loans. The Company reported $724,505 in interest accretion and adjustments related to the ACOA loans as a result of an increase in management’s estimate of future revenues. As noted, this ACOA adjustment is a non-cash adjustment in the quarter ending April 30, 2021.

The ACOA loans are interest-free and repayments are calculated as 10% of the future revenues and are payable on June 30th of each year. The carrying value has been discounted using a rate of 35% based on the expected timing and amounts of future repayments of the loans. Consequently, the carrying value of the ACOA loans requires regular assessment and adjustment based on management’s estimate of future revenues, with any adjustment being recorded as finance cost on the statement of comprehensive income with an equal increase in the ACOA debt liability on the statement of financial position. In light of the recent press releases announcing future and recurring order for customers in Mexico, Philippines, and Thailand, management increased its estimate of future revenues and therefore adjusted the carrying value of the ACOA loans accordingly.

The Company’s working capital increased by $949,353 as management invested in additional volumes of inventory to support future sales and increased prepaids expenses and trade receivables.

As at April 30, 2021, the Company reported total assets of $5,985,104 (current assets of $5,675,117), total liabilities of $7,163,307, and shareholders’ deficit of ($1,178,203).

Significant financing inflows during the quarter ending April 30, 2021, was an offering of 15,000,000 units of the Company at $0.50 per unit for aggregate gross proceeds of $7,500,000. The offering closed on February 16th, 2021.

Each unit consisted of one common share in the capital of the Company (each a “Common Share”) and one half of one Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant will be exercisable to acquire one Common Share until February 16, 2024 at an exercise price of $0.75 per share. The net proceeds of the Offering have been and will be used to fund research and development expenses, sales and marketing costs, product registration, interest expense, working capital and general corporate purposes.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to Avivagen’s expectations as to future growth and results, the anticipated continuation of shipments to customers based on recurring orders, future plans for sales in the United States, the planned use of proceeds of the financing discussed above, Avivagen’s expectations as to growth in demand for Avivagen’s products, the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded and the size of market opportunities are all forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, initial orders may not result in new orders for Avivagen’s products, despite receipt of the purchase order timing, delivery or fulfilment of orders of product could be delayed for a number of reasons, some of which are outside of Avivagen’ s control, which could result in anticipated revenues from such sales being delayed or in the most serious cases eliminated, actions taken by Avivagen’ s customers and factors affecting the business and financial viability of Avivagen’ s customers can have a negative impact on the expectation of future sales and revenues, customer plans may change due to many reasons, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics in livestock feeds, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com
Copyright © 2021 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Release – electroCore Announces Publication of Study on nVNS to Improve Clinical Outcomes and Molecular Biomarkers in Parkinsons Disease Patients

Posted on June 2, 2021 by Admin

electroCore Announces Publication of Study on Non-Invasive Vagus Nerve Stimulation (nVNS) to Improve Clinical Outcomes and Molecular Biomarkers in Parkinson’s Disease Patients

ROCKAWAY, N.J.,
June 02, 2021 (GLOBE NEWSWIRE) —
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed paper, entitled “Non-Invasive Vagus Nerve Stimulation Improves Clinical and Molecular Biomarkers of Parkinson’s Disease in Patients with Freezing of Gait” in the journal NPJ Parkinson’s Disease. The paper reports the results of a randomized, double-blind, sham-controlled crossover trial conducted at the
Institute of Neurosciences in
Kolkata, India in collaboration with the Faculty of Medical Sciences at
Newcastle University in
England using gammaCore Sapphire^TM. The study was funded by the
Institute of Neurosciences,
Kolkata, India.

Neurological disorders are now the leading source of disability in the world, and Parkinson’s disease is the fastest-growing of these disorders. As populations age and life expectancy increases, the number of individuals with Parkinson’s disease and the duration of the disease will increase, leading to more patients with advanced Parkinson’s disease. To address this burden, primary prevention strategies based on the underlying causes of Parkinson’s disease and more effective symptomatic treatments are needed.¹ There are over 1 million individuals diagnosed with Parkinson’s disease in
the United States with an estimated total annual economic burden of
$51.9 billion.²

The study, which enrolled thirty-six subjects, was undertaken to explore the safety, feasibility and efficacy of self-administered non-invasive vagus nerve stimulation (nVNS) in the treatment of gait and other motor symptoms in Parkinson’s disease (PD) patients. In a subgroup of study patients, levels of selected neurotrophins, markers of inflammation and oxidative stress were measured in blood before and after nVNS.

Vagus Nerve Stimulation (VNS) has been found to be beneficial in improving locomotion in a rat model of PD,³ and two independent preliminary studies found improvement in gait in patients with PD after a single application of cervical nVNS.⁴^,⁵

The study provides preliminary evidence supporting the safety and efficacy of nVNS in treating motor and non-motor symptoms of PD. Patients were satisfied with the treatment and the majority were able to self-administer nVNS. Adverse events were infrequent, non-serious, and similar across both Active and Sham groups. Significant increases in velocity (p=0.003), step length (p=0.007), and a reduction in stance time (p=0.001) were seen in the nVNS treated group compared to sham stimulation, indicating that PD patients were walking not only with a faster pace but also with improved rhythm. Other gait parameters also showed significant improvement from baseline in all five domains, specifically after nVNS treatment, suggesting that nVNS may result in an overall improvement in the quality of gait in PD patients. Treatment with nVNS significantly reduced TNF-? levels (p<0.05) and increased concentrations of reduced glutathione (p<0.05), which are both markers of inflammation in PD patients. Brain Derived Neurotrophic Growth Factors, which are reduced in PD, were significantly increased by nVNS (p<0.05) suggesting a possible disease modifying effect.

Dr. Hrishikesh Kumar, Director of Research and Vice Chairman of the
Institute of Neurosciences Kolkata and lead investigator of the study, commented, “We are pleased to have successfully completed the first randomized, double-blind sham-controlled trial to demonstrate the efficacy of cervical nVNS as an adjunctive therapy in PD. Improvements in motor function and gait after one month of treatment with nVNS were significant. Our results clearly support additional work to further understand the potential for nVNS in this indication.”

“We congratulate and thank Dr. Kumar, Dr. Baker and the clinical and research teams in
Kolkata, India and
Newcastle, England, as well as the patients and families that participated in this study,” commented Eric Liebler, Senior Vice President of Neurology at electroCore. “Parkinson’s disease is the fastest growing neurodegenerative disease in
the United States. The impact of PD on patients and their families is devastating and the cost to the healthcare system is staggering. electroCore is looking forward to continuing research to bring nVNS to patients with PD.”

The full publication is available at: https://www.nature.com/articles/s41531-021-00190-x

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCore^TMgammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:
- Have an active implantable medical device, such as pacemaker, hearing aid implant, or implanted electronic device
- Have a metallic device such as a stent, bone plate, or bone screw, implanted at or near the neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Pediatric patients (less than 12 years of age)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat Parkinson’s disease or patients with freezing of gait and related disorders and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the
SEC available at www.sec.gov.

¹ GBD 2016 Parkinson’s Disease Collaborators. Global, regional, and national burden of Parkinson’s disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953.

² Yang W, Hamilton JL, Kopil C, Beck JC, Tanner CM, Albin RL, Ray Dorsey E, Dahodwala N, Cintina I, Hogan P, Thompson T. Current and projected future economic burden of Parkinson’s disease in the
U.S. NPJ Parkinsons Dis. 2020
Jul 9;6:15.

³ Farrand, A. Q. et al. Vagus nerve stimulation improves locomotion and neuronal populations in a model of
Parkinson’s disease. Brain stimulation 10, 1045-1054 (2017).
⁴ Mondal, B. et al. Analysis of gait in Parkinson’s disease reflecting the effect of l-DOPA. Annals of
Movement Disorders 2, 21 (2019).
⁵ Morris, R. et al. Noninvasive vagus nerve stimulation to target gait impairment in Parkinson’s disease.
Movement Disorders (2019).

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

-or-

Media Contact:
Summer Diaz
electroCore
973-290-0097
summer.diaz@electrocore.com

Therapeutic Research Advanced by Stem Cell Science

Posted on June 2, 2021 by Admin

Stem Cell Science and The New Age of Therapeutic Discovery

Recent advances in stem cell technologies, armed with the ability to generate almost any tissue-specific cell types of the body in a dish, human pluripotent stem cells (hPSCs) have drastically moved therapeutic research forward in unprecedented ways. Stem cell-derived cells are increasingly recognized for their potential in cell replacement therapy – that is the replacement of dying or damaged tissues in the treatment of chronic diseases and injuries, but stem cells are also playing important roles in driving drug discovery, screening, research, and development efficiently and cost-effectively [1].

Advantages Over Traditional Methods

Traditional methods of drug development involve pre-clinical trials on animals, primary cells, or even transformed cell lines. However, there are limitations to such methods. Firstly, animal physiology differs from that of humans, therefore disease manifestations [2], as well as responses towards compounds and drugs, may vary from humans [3]. Results from animal studies rarely correlate with human clinical trials [4]. In addition, animal research is very costly and highly variable [5]. Next, primary cells (either isolated from living or cadaveric donors) are finite in numbers; only a limited number of tests can be performed on these cells. Lastly, transformed cell lines are genetically manipulated so that they remain proliferative in order to obtain large quantities of material for drug screening and testing. However, these cells do not accurately represent native cells present in patients.

Because hPSCs are highly proliferative and capable of self-renewal, they can be easily expanded, providing an essentially unlimited source of cells. At present, it is estimated that we can generate more than 200 cell types from hPSCs [5]. This translates into the ability to produce large quantities of any cell type from hPSCs for therapeutic research. Not only does this mean that studies can be performed on various types of cells for various diseases, testing efforts can also be scaled up and accelerated while remaining to be affordable and sustainable. In vitro toxicity tests can also be easily conducted in tandem [6].

Generating ‘Diseased’ Stem Cells

Before we can begin screening and test therapeutics, we need to produce cells or tissues from diseased hPSCs. There are a few ways this can be achieved. Firstly, the discovery of induced pluripotent stem cells (iPSCs) by Nobel Prize winner Shinya Yamanaka and colleagues in 2017 [7,8] has allowed us to generate patient-specific stem cells from any patients’ cells [9] (from blood, skin biopsies, urine, etc) by simply introducing four key transcription factors into the cells. This process is termed cellular reprogramming. Despite undergoing this process of cellular reprogramming, iPSCs and their associated iPSC-derived cells, are able to preserve the original genetic mutations (if any) and disease phenotypes, therefore faithfully mimicking human disease in vitro. Over the past decade, disease-specific iPSCs have been successful in modeling a wide range of complex human diseases[1], and are therefore poise as an attractive cellular model for pharmacological testing.

Secondly, the discovery of the CRISPR-Cas9 technology [10] has revolutionized genetic editing. CRISPR-Cas9 editing system can be employed to induce genetic mutations into either healthy human embryonic stem cells or iPSCs that are known to cause certain diseases, thereby creating ‘diseased’ stem cells. These genetically edited stem cells can then be propagated and differentiated into ‘diseased’ cells (e.g. cardiomyocytes, neurons, etc.) for therapeutic discovery and screening [11].

Success Stories

In 2018, Tabata et al. [12] differentiated Parkinson disease (PD) patient-iPSCs (harboring PARK2 mutations; familial PD) into dopaminergic neurons and screened the diseased neurons with an FDA-approved drug library. They discovered that a drug, a calcium channel antagonist, was able to prevent neuronal death associated with the disease.

Interestingly, researchers have recently devised a co-culture system comprising of hPSC-derived endothelial cells and hepatocytes (liver cells) to test nutraceuticals. This endothelial-hepatic platform allows for the systemic effects of drug metabolism to be included in the study, which will otherwise be excluded if only endothelial cells were tested on [13].

Most recently, a group of researchers utilized iPSCs of patients with cardiac rhythm disorder long QT syndrome 3 (LQT3) and differentiated the cells into cardiomyocytes to perform HTS for anti-arrhythmic drugs. Using the LQT3-cardiomyocytes, they were able to improve their drug design and successfully tested their drug on the diseased cardiomyocytes of diverse backgrounds [14].

Moving Forward

hPSCs and the advancements of stem cell research have given us the capacity to generate large volumes of healthy and diseased tissue-specific cells that are true to human physiology. This has opened doors to large-scale, high-throughput drug discovery and screening, facilitating pre-clinical drug development efforts. Unlike traditional methods, hPSC-based drug development platforms are more scalable, accurate, and cost-effective.

As the field of stem cell research progresses, we can look forward to improved iPSC reprogramming protocols that increase the efficiency of obtaining patient-specific iPSCs, as well as differentiation protocols that improve the quality of differentiated cells. Efforts are also currently channeled towards devising methods to better grow and maintain stem cell-derived cells in culture. This will permit a longer duration of therapeutic and toxicity testing without cells losing their cellular identity or molecular signatures. To address concerns related to the discrepancy between the effects of drugs in vitro and in vivo, researchers have also recently explored the use of hPSC-derived organoids to model human diseases, and then perform therapeutic testing on these three-dimensional ‘mini organs’ [15]. hPSC-derived organoids are composed of multiple cell types and can better recapitulate tissue physiology and hence, clinical features of diseases.

Therefore, stem cells have opened doors to a new age of therapeutic discovery and development that promises more treatment options in the coming years, even for rare and complex human diseases.

About the Author:

Nicole Pek is a stem cell biologist and enthusiastic science
communicator. She has worked on using human pluripotent stem cells to study
cellular development in multiple organ systems, to model complex human
diseases, and screen for therapeutics that could treat the diseases. Outside of
the lab, Nicole plays a pro-active role in communicating to the public through
her science blog ‘Two Cells’ and her education podcast ‘The Diploid Duo’.

Suggested Reading:


The Case for Investing in Regenerative Medicine in 2021	Cells That Can be Made from Stem Cells


Improving Mortality Rates Through Genetic Research	Preventing the Immune System from Rejecting Gene Therapy

About the Image:

Restoration of Dystrophin in Duchenne Muscular Dystrophy Cells with Gene Editing

This image shows the restoration of
dystrophin (stained green) in Duchenne muscular dystrophy (DMD) muscle cells derived
from human induced pluripotent stem cells. DMD is caused by mutations in the
DMD gene that affect the production of dystrophin, a protein involved in muscle
cell membrane structure. Researchers used CRISPR/Cas9 gene editing technology
to correct a mutation, resulting in dystrophin restoration. This technology
could be therapeutic in up to 60% of DMD patient mutations. Nuclei in the
muscle cells are stained blue and the contractile protein myosin is stained
red.

Credit: Courtney Young, M.S., Melissa Spencer lab, University of California, Los Angeles.

References

1. Inoue H, Yamanaka S. The Use of Induced Pluripotent Stem Cells in Drug Development. Clin Pharmacol Ther 2011;89:655–61.

2. Justice MJ, Dhillon P. Using the mouse to model human disease: increasing validity and reproducibility. Dis Model
Mech 2016;9:101–3.

3. Zimmerman S. Why Drugs Tested in Mice Fail in Human Clinical Trials. Sci News 2020.

4. Van Norman GA. Limitations of Animal Studies for Predicting Toxicity in Clinical Trials: Is it Time to Rethink Our Current Approach? JACC Basic Transl Sci 2019;4:845–54.

5. Boheler KR. Stem Cell Pluripotency: A Cellular Trait that Depends on Transcription Factors, Chromatin State and a Checkpoint Deficient Cell Cycle. J Cell Physiol 2009;221:10–7.

6. Hook LA. Stem cell technology for drug discovery and development. Drug Discov Today 2012;17:336–42.

7. Takahashi K, Tanabe K, Ohnuki M et
al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell 2007;131:861–72.

8. Takahashi K, Yamanaka S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 2006;126:663–76.

9. Liu G, David BT, Trawczynski M et
al. Advances in Pluripotent Stem Cells: History, Mechanisms, Technologies, and Applications. Stem Cell Rev Rep 2020;16:3–32.

10. Ran FA, Hsu PD, Wright J et al. Genome engineering using the CRISPR-Cas9 system. Nat Protoc 2013;8:2281–308.

11. Patmanathan SN, Gnanasegaran N, Lim MN et al. CRISPR/Cas9 in Stem Cell Research: Current Application and Future Perspective. Curr Stem Cell Res Ther 2018;13:632–44.

12. Tabata Y, Imaizumi Y, Sugawara M et
al. T-type Calcium Channels Determine the Vulnerability of Dopaminergic Neurons to Mitochondrial Stress in Familial Parkinson Disease. Stem Cell Rep 2018;
11:1171–84.

13. Narmada BC, Goh YT, Li H et al. Human Stem Cell?Derived Endothelial?Hepatic Platform for Efficacy Testing of Vascular?Protective Metabolites from Nutraceuticals. Stem Cells Transl Med 2017;
6:851–63.

14. McKeithan WL, Feyen DAM, Bruyneel AAN
et al. Reengineering an Antiarrhythmic Drug Using Patient hiPSC Cardiomyocytes to Improve Therapeutic Potential and Reduce Toxicity. Cell
Stem Cell 2020;27:813-821.e6.

15. Ho BX, Pek NMQ, Soh B-S. Disease Modeling Using 3D Organoids Derived from Human Induced Pluripotent Stem Cells. Int J Mol Sci 2018;19, DOI: 10.3390/ijms19040936.

Stay up to date. Follow us:

Release – Helius Medical Technologies Inc. Appoints Frederick Fantazzia as Vice President of Sales and Marketing North America

Posted on June 2, 2021 by Admin

Helius Medical Technologies, Inc. Appoints Frederick Fantazzia as Vice President of Sales & Marketing, North America

NEWTOWN, Pa., June 02, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the appointment of Frederick Fantazzia to the position of Vice President of Sales & Marketing, North America, effective June 1, 2021.

“Fred is a dynamic leader with 16 years of sales and marketing experience in the field of neuromodulation, and a specific focus on developing the market for new neuromodulation technologies by building and leading high-quality sales team to raise awareness and facilitate commercial adoption,” said Dane Andreeff, Interim President and Chief Executive Officer of Helius. “We are pleased to welcome him to our leadership team and look forward to his contributions as we continue our pre-commercialization initiatives and prepare to commercialize our PoNS Treatment in the United States.”

“I believe Helius is a rising star in the development of innovative neuromodulation technologies to treat conditions related to the effects of neurological disease and trauma,” said Mr. Fantazzia. “With the Company’s PoNS device now authorized for sale in the U.S., I am excited to join the team at this important inflection point. I look forward to developing the market for PoNS Treatment and bringing it to U.S. patients suffering from the effects of multiple sclerosis.”

Prior to joining Helius, Mr. Fantazzia worked for LivaNova, PLC (Nasdaq: LIVN), a global medical technology company that designs, develops, manufactures and sells innovative therapeutic solutions in the fields of neuromodulation and cardiovascular disease, from 2016 until 2021. He most recently served as Vice President of North America Sales and Marketing for LivaNova’s Epilepsy business, where he managed all aspects related to its commercialization of a neuromodulation technology for the treatment of drug-resistant epilepsy. During his time with LivaNova/Cyberonics Inc., Mr. Fantazzia also served as Vice President of Global Sales and Marketing for its Neuromodulation segment from 2015 to 2016 and Vice President of U.S. Sales from 2016 to 2018.

Prior to the merger between Sorin S.p.A. and Cyberonics Inc., which combined to form LivaNova in 2015, Mr. Fantazzia worked for Cyberonics Inc. (Nasdaq: CYBX) a medical device company with core expertise in neuromodulation. He joined the company as a Regional Sales Manager in 2005, and subsequently held a series of positions of increasing responsibility, culminating in his promotion to Vice President of Global Sales and Marketing for Neuromodulation in 2015.

Mr. Fantazzia holds a B.S. in Business Administration from Villanova University.

About Helius Medical Technologies, Inc.

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 (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Investor Relations Contact:

Westwicke on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
investorrelations@heliusmedical.com

Cautionary Disclaimer Statement:

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future growth and operational progress, the next phase of the Company’s market development activities, clinical and regulatory development plans for the PoNS device, the timing and success of the Company’s commercialization efforts in the United States, and the ability for the Company to develop the market for PoNS Treatment and bringing it to U.S. patients suffering from the effects of multiple sclerosis.

These statements involve substantial known and unknown risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include , uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the filings made by the Company with securities regulators, including the risks and uncertainties described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com. The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Helius Medical Technologies, Inc. Appoints Frederick Fantazzia as Vice President of Sales & Marketing, North America

Posted on June 2, 2021 by Admin

Helius Medical Technologies, Inc. Appoints Frederick Fantazzia as Vice President of Sales & Marketing, North America

Mr. Fantazzia holds a B.S. in Business Administration from Villanova University.

About Helius Medical Technologies, Inc.

About the PoNS™ Device and PoNS Treatment™

Investor Relations Contact:

Westwicke on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
investorrelations@heliusmedical.com

Cautionary Disclaimer Statement:

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

electroCore Announces Publication of Study on Non-Invasive Vagus Nerve Stimulation (nVNS) to Improve Clinical Outcomes and Molecular Biomarkers in Parkinson’s Disease Patients

Posted on June 2, 2021 by Admin

electroCore Announces Publication of Study on Non-Invasive Vagus Nerve Stimulation (nVNS) to Improve Clinical Outcomes and Molecular Biomarkers in Parkinson’s Disease Patients

The full publication is available at: https://www.nature.com/articles/s41531-021-00190-x

For more information, visit www.electrocore.com.

gammaCore is contraindicated for patients if they:
- Have an active implantable medical device, such as pacemaker, hearing aid implant, or implanted electronic device
- Have a metallic device such as a stent, bone plate, or bone screw, implanted at or near the neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Pediatric patients (less than 12 years of age)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

-or-

Media Contact:
Summer Diaz
electroCore
973-290-0097
summer.diaz@electrocore.com

Release – Lineage Cell Therapeutics Reports Additional Cases Of Retinal Tissue Restoration In Dry AMD Patients Treated With Opregen RPE Cells

Posted on June 1, 2021 by Admin

Lineage Cell Therapeutics Reports Additional Cases Of Retinal Tissue Restoration In Dry AMD Patients Treated With Opregen RPE Cells

Restoration Was Observed in Two Additional Patients in a Phase 1/2a Clinical Study of OpRegen
An Earlier and First-Known Clinical Report of Restoration Has Been Maintained for 3 Years
Restoration Has Been Observed in Three of Four Patients Who Received OpRegen RPE Cells Across a Wide Area of Atrophy

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 1, 2021–

Lineage Cell Therapeutics, Inc.
(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that restoration of retinal tissue was observed in two additional patients enrolled in the Company’s Phase 1/2a study of its lead product candidate, OpRegen. OpRegen is an allogeneic retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of age-related macular degeneration (AMD) with geographic atrophy (GA), or dry (atrophic) AMD. These new findings occurred in two of the three Cohort 4 patients treated in November of 2020, where surgeons successfully covered the majority of the area of atrophy with a suspension of OpRegen cells. Outer retinal layer restoration, which was observed using clinical high-resolution Optical Coherence Tomography (OCT), was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These findings suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of any of these cells. These effects were most prominent in the transitional areas around the primary area of GA. In addition to positive anatomical changes, all three patients’ visual acuity increased above baseline levels within 6 months post-transplant. The totality of these findings supports the view that atrophic AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable.

In connection with these findings, Lineage has filed a Patent Cooperation Treaty (PCT) patent application which describes restoration of the anatomy and/or functionality of diseased retinas. The application is based on clinical trial data demonstrating, for the first time, administration of RPE cells to an atrophic retina restores structure and function to one or more retinal layers. Allowed claims of a national patent application based on the PCT application would have an estimated expiration date of at least
May 24, 2041.

“After reporting the first case of retinal restoration last year, it is extremely exciting for me to see retinal restoration replicated in additional OpRegen-treated patients. Confirmation of restoration was performed by independent experts using multimodality imaging techniques and these new cases reinforce earlier findings that treatment with OpRegen can save dysfunctional photoreceptors and replace RPE cells in areas of geographic atrophy, which could provide a remarkable treatment opportunity for this patient population,” stated Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula and Director, Principal Investigator and Founder,
Barcelona Macula Foundation. “It has long been hypothesized that in atrophic AMD patients, cells in the transition areas at the boundaries of the GA are dysfunctional and dying, but not completely lost. These unprecedented findings provide further evidence that the addition of new RPE cells may restore the microenvironment of the surrounding tissue and contribute to the survival and function of existing cells that otherwise, if left untreated, would inevitably progress to further expansion of the atrophic region.”

“To our knowledge, these three patients represent the only examples of an experimental treatment for dry AMD demonstrating a reduction, rather than attenuating further expansion, of an area of atrophy in humans,” stated Brian M. Culley, Lineage CEO. “Now that these findings of retinal restoration have been confirmed in multiple patients over clinically meaningful time periods, we believe we are in a position to pioneer a new paradigm for how we and others evaluate and treat atrophic AMD. Notably, 75% of patients who received broad coverage of OpRegen across the area of GA exhibited evidence of restoration, indicating that clinical benefits may be improved by a more central and complete placement of OpRegen cells across the atrophic area. Importantly, in addition to thickening of the outer nuclear layers and restoration of retinal structures in these patients, we also have observed durable improvements in visual acuity. Additional evidence collected recently supports our belief that treatment with OpRegen can provide patients not only with improvements in the anatomy and the structure of their retina and visual acuity, but also enhance quality of life. We will discuss these new findings with our advisors in the coming weeks and months to assess implications for the clinical development and regulatory approval pathways for OpRegen. We believe these findings represent a significant advancement in the field of cell therapy, in which the directed differentiation and transplant of specific cell types to treat severe diseases and conditions may generate outcomes which have remained out of the reach of traditional molecular approaches.”

The loss of RPE cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as atrophic AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which led to a presumption that progression of GA may someday be slowed or halted but could not be reversed. The unique findings from the ongoing OpRegen clinical study support a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. Notably, in the two additional Cohort 4 patients evidencing retinal restoration, in peripheral areas of incomplete RPE and outer retinal atrophy (iRORA), away from the primary atrophic lesion, there were examples of complete resolution following OpRegen transplant in some of the iRORA lesions. Additionally, in some areas of complete RPE and outer retinal atrophy (cRORA), similar, full-thickness restoration of retinal layers was observed, particularly in areas of the outer periphery of the transition zone. The transition zone may represent the ideal area to target with cell therapy as the surviving photoreceptors may be restored to normal function with the transplant of new, allogeneic RPE. The first Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, first reported last year, continues to demonstrate areas of retinal restoration through that patient’s most recent clinical visit, which occurred approximately 3 years post-transplant. These new findings have been confirmed utilizing multiple imaging technologies, including OCT, a non-invasive test which uses light waves to take cross-sectional images of the retina, allowing for visualization of each of the distinctive layers. The use of multiple imaging modalities differs from traditional assessment of GA progression, which employs only fundus autofluorescence (FAF) to assess changes in the total surface area of the apparent GA over time. Using only FAF may fail to identify structural changes that can be observed only with the addition of OCT imaging. The use of OCT allows for a more precise determination of changes in retinal thickness, organization, and overall health of the retina in areas of potential atrophy, which are possible with cell therapy. These changes may be more likely to be associated with improvements in visual acuity, reading speed, and quality of life over time.

Overall, OpRegen has been well tolerated with no unexpected adverse events or serious adverse events, and evidence of durable engraftment of OpRegen RPE cells have extended to more than 5 years post-transplant in earliest treated patients.

Dr. Monés has served as an external expert consultant for the OpRegen program for approximately 5 years. Dr. Monés completed his retinal specialist training at the
Massachusetts Eye and Ear Infirmary at
Harvard University, and earned his Ph.D. degree in Medicine and Surgery at the
University of Barcelona.

Lineage plans to host a webinar with external therapeutic area experts to discuss the findings in detail, including a review of anatomical improvements, functional activity, and additional results of treatment with OpRegen. The Company will announce the date and time for this event in the coming days. The webinar will be available in the Events and Presentations section of Lineage’s website.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with Best Corrected Visual Acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no
U.S. Food and Drug Administration, or
European Medicines Agency, approved treatment options available for patients with atrophic AMD.

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 the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date, including the findings of retinal restoration, from the ongoing Phase 1/2a of OpRegen, and the potential for issuance of new patents relating to OpRegen. 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.

Release – Onconova Therapeutics Announces The Appointment Of Mark Gelder, M.D., As Chief Medical Officer

Posted on June 1, 2021 by Admin

Onconova Therapeutics Announces The Appointment Of Mark Gelder, M.D., As Chief Medical Officer

NEWTOWN, Pa., June 01, 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 that Mark Gelder, M.D. will be joining Onconova as Chief Medical Officer (CMO), effective as of June 14, 2021.

“Mark’s extensive experience leading clinical oncology programs at all stages of development makes him an ideal fit for Onconova. He will add great depth to our management team,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “His wide ranging medical and scientific expertise, which notably covers the development of kinase inhibitors as cancer therapeutics, will be invaluable as we work to advance ON 123300’s clinical development, facilitate the progression of rigosertib’s investigator-initiated trials, and evaluate potential candidates for in-licensing. I am thrilled that Mark will be joining Onconova and eager to begin working together.”

Dr. Gelder is an accomplished industry leader with more than 35 years of experience in clinical development, medical affairs, and medical marketing. He was most recently the CMO of Elevar Therapeutics, where he led the company’s clinical development, medical affairs, regulatory affairs, and preclinical teams. Prior to his time at Elevar, Dr. Gelder served as the CMO of Pierian Biosciences (formerly DiaTech Oncology), Accelovance, Inc., and Heron Therapeutics, Inc. Dr. Gelder also has extensive experience at large pharmaceutical companies, as he previously worked in global medical affairs and led therapeutic oncology programs for Pfizer, Wyeth, and Bayer. Dr. Gelder has led successful early- and late-stage global clinical trials and has been involved in the approval and launch of several cancer therapeutics. Prior to his career in the biopharmaceutical industry, Dr. Gelder was an investigator in multiple clinical trials and authored numerous scientific papers in the areas of women’s health and oncology. He earned his M.D. from the University of Virginia School of Medicine and completed a fellowship in gynecologic oncology. He is a Fellow of the American College of Physicians and the American College of Obstetrics and Gynecology.

Dr. Gelder commented, “The opportunity to serve as Onconova’s CMO is truly exciting, and I look forward to leading the continued development of the Company’s pipeline at this important time. ON 123300 is rapidly progressing through its two Phase 1 trials and the potential to bring a best-in-class novel agent to women with HR+ HER2- metastatic breast cancer and additional oncologic indications is a unique opportunity based on its mechanism of action to overcome CKD 4/6 resistance mechanisms. I am also highly impressed with rigosertib’s investigator-initiated program and am eager to apply my expertise towards the Company’s in-licensing strategy to expand its pipeline. I believe that my skill set and those of my new colleagues are highly complementary, which will serve us well as we seek to deliver new therapeutics to cancer patients in need.”

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 commencement of employment, Onconova’s clinical development plans, and the mechanisms 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,” “appoints,” “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

Release – PDS Biotech to Host Oncology RD Day on June 16 2021

Posted on June 1, 2021 by Admin

PDS Biotech to Host Oncology R&D Day on June 16, 2021

FLORHAM PARK, N.J., June 01, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced it will host an Oncology R&D Day for analysts, investors, and the scientific community from 8:00 – 10:00 AM ET on Wednesday, June 16^th.

PDS Biotech’s Oncology R&D Day will focus on the Company’s advancements in its ongoing preclinical and clinical work and will feature presentations from:

Dr. Frank Bedu-Addo, President and CEO, PDS Biotech
Dr. Lauren V. Wood, Chief Medical Officer, PDS Biotech
Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health
Dr. Julius Strauss, Principal Investigator, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health
Dr. Caroline Jochems, Staff Scientist, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health

A copy of the presentations will be available on June 17^th on the scientific presentations and publications page of PDS Biotech’s website. Registration for PDS Biotech’s Oncology R&D Day is now open and a live webcast of the event will be available online in the investor relations section of the company’s website at https://pdsbiotech.com/investors/news-center/events. A replay will be available on the company website for 90 days following the webcast.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products may 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 investigational 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. 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^®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 Biotech to Host Oncology R&D Day on June 16, 2021

Posted on June 1, 2021 by Admin

PDS Biotech to Host Oncology R&D Day on June 16, 2021

PDS Biotech’s Oncology R&D Day will focus on the Company’s advancements in its ongoing preclinical and clinical work and will feature presentations from:

Dr. Frank Bedu-Addo, President and CEO, PDS Biotech
Dr. Lauren V. Wood, Chief Medical Officer, PDS Biotech
Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health
Dr. Julius Strauss, Principal Investigator, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health
Dr. Caroline Jochems, Staff Scientist, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health

About PDS Biotechnology

Forward Looking Statements

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

Onconova Therapeutics Announces The Appointment Of Mark Gelder, M.D., As Chief Medical Officer

Posted on June 1, 2021 by Admin

Onconova Therapeutics Announces The Appointment Of Mark Gelder, M.D., As Chief Medical Officer

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

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 Cell Therapeutics Reports Additional Cases Of Retinal Tissue Restoration In Dry AMD Patients Treated With Opregen RPE Cells

Posted on June 1, 2021 by Admin

Lineage Cell Therapeutics Reports Additional Cases Of Retinal Tissue Restoration In Dry AMD Patients Treated With Opregen RPE Cells

Restoration Was Observed in Two Additional Patients in a Phase 1/2a Clinical Study of OpRegen
An Earlier and First-Known Clinical Report of Restoration Has Been Maintained for 3 Years
Restoration Has Been Observed in Three of Four Patients Who Received OpRegen RPE Cells Across a Wide Area of Atrophy

About OpRegen

About Age-Related Macular Degeneration

About Lineage Cell Therapeutics, Inc.

Forward-Looking Statements

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.

Release – Cocrystal Pharma Announces the Passing of Chairman CEO and Co-founder Dr. Gary Wilcox

Posted on May 28, 2021 by Admin

Cocrystal Pharma Announces the Passing of Chairman, CEO and Co-founder Dr. Gary Wilcox

BOTHELL, Wash., May 28, 2021 (GLOBE NEWSWIRE) — With great sadness, Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”) announces that Gary Wilcox, Ph.D., Chairman, CEO and co-founder, suddenly passed away Wednesday, May 26 at the age of 74. The Board of Directors and staff of Cocrystal extend their deepest condolences to the Wilcox family and express their gratitude for Gary’s contributions to Cocrystal and to human health.

The Cocrystal Board of Directors has designated Sam Lee, Ph.D., President, and James Martin, CFO, to share the CEO responsibilities while seeking a successor for the position. Roger Kornberg, Ph.D., Cocrystal co-founder, Chief Scientist, Director and Chairman of the Scientific Advisory Board, has been named Chairman of the Board, and Steve Rubin, Director of Cocrystal and its predecessor company since 2008, has been named Vice Chairman. Cocrystal also announces the appointment of Richard C. Pfenniger, Jr. to the Board of Directors, maintaining membership at five. Mr. Pfenniger brings significant industry knowledge and corporate governance expertise, having served as chief executive officer, chief operating officer, general counsel, director and chairman at multiple healthcare companies.

“We are fortunate to have two highly qualified and dedicated executives in Sam and Jim to assume the CEO duties on an interim basis. Our Board has full confidence in a smooth transition and in their ability to advance our antiviral programs into clinical development,” said Dr. Kornberg. “We also welcome Richard to our Board. We will call upon his insights regarding many aspects of our business and to provide valuable operational, leadership and management advice to the Board in critical areas.

“The Cocrystal team is committed to carrying on Gary’s quest to address the growing global need for new antiviral treatments,” added Dr. Kornberg. “We will deeply miss Gary. He possessed a rare combination of scientific brilliance, business acumen and personal humility. He was an accomplished leader and earned respect throughout the biotechnology community, having achieved more in his 35 years in the industry than I can list. He brought an entrepreneurial spirit to Cocrystal that has been instrumental in deploying our novel replication technology to advance the discovery and development of antiviral candidates, and he sustained that spirit each and every day.”

Richard Pfenniger, Jr.

Mr. Pfenniger is a private investor who served as Interim CEO of Vein Clinics of America, Inc., a privately held company that specializes in the treatment of vein disease, from May 2014 to February 2015 and as Interim CEO of IntegraMed America, Inc., a privately held company that manages outpatient fertility medical centers, from January 2013 to June 2013. He served as Chief Executive Officer and President of Continucare Corporation, a provider of primary care physician and practice management services, from 2003 until 2011, and as Chairman of the Board of Directors of Continucare Corporation from 2002 until 2011. Previously, Mr. Pfenniger served as the Chief Executive Officer and Vice Chairman of Whitman Education Group, Inc. from 1997 through June 2003. Prior to joining Whitman, he served as the Chief Operating Officer of IVAX from 1994 to 1997, and, from 1989 to 1994, he served as the Senior Vice President-Legal Affairs and General Counsel of IVAX Corporation. Prior thereto he was engaged in the private practice of law.

Mr. Pfenniger currently serves as a director of OPKO Health (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, GP Strategies Corporation (NYSE: GPX), a corporate education and training company, and Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company. He also serves as the Vice Chairman of the Board of Trustees and as a member of the Executive Committee of the Phillip and Patricia Frost Museum of Science in Miami.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

Avivagen Inc. Announces Results for the Second Quarter Ending April 30, 2021

electroCore Announces Publication of Study on Non-Invasive Vagus Nerve Stimulation (nVNS) to Improve Clinical Outcomes and Molecular Biomarkers in Parkinson’s Disease Patients

Stem Cell Science and The New Age of Therapeutic Discovery

The Case for Investing in Regenerative Medicine in 2021

Cells That Can be Made from Stem Cells

Improving Mortality Rates Through Genetic Research

Preventing the Immune System from Rejecting Gene Therapy

Helius Medical Technologies, Inc. Appoints Frederick Fantazzia as Vice President of Sales & Marketing, North America

Helius Medical Technologies, Inc. Appoints Frederick Fantazzia as Vice President of Sales & Marketing, North America

electroCore Announces Publication of Study on Non-Invasive Vagus Nerve Stimulation (nVNS) to Improve Clinical Outcomes and Molecular Biomarkers in Parkinson’s Disease Patients

Lineage Cell Therapeutics Reports Additional Cases Of Retinal Tissue Restoration In Dry AMD Patients Treated With Opregen RPE Cells

Onconova Therapeutics Announces The Appointment Of Mark Gelder, M.D., As Chief Medical Officer

PDS Biotech to Host Oncology R&D Day on June 16, 2021

PDS Biotech to Host Oncology R&D Day on June 16, 2021

Onconova Therapeutics Announces The Appointment Of Mark Gelder, M.D., As Chief Medical Officer

Lineage Cell Therapeutics Reports Additional Cases Of Retinal Tissue Restoration In Dry AMD Patients Treated With Opregen RPE Cells

Cocrystal Pharma Announces the Passing of Chairman, CEO and Co-founder Dr. Gary Wilcox