Genetics Now Touch on All Areas of Life Sciences

 

The institutions and companies involved in genetics now lend support to most other areas of life sciences.  The contributions include the discovery of genetic markers of disease and gene therapy. The market for genetic testing continues to grow in leaps and bounds and has gained momentum as the field benefits from the compounding effect of past advances in understanding and technology. In addition, there’s been an increase in the study of chronic diseases for as-yet unmet therapeutic needs, including the development of testing kits to better assess patients’ needs.

The genetics market is expanding with new gene therapies, which has been a big of innovation and growth.  It’s estimated that this market’s worth is US$3.8 billion, and it is expected to reach US$13 billion by 2024. That’s a compound annual growth rate of 27.8 percent. The growing segment of healthcare or life sciences focuses on using genes to detect, prevent, and treat conditions to improve patient experience. More recent innovations include the potential for healthcare professionals to use genes at the cellular level instead of using surgery or medicines. The advanced method replaces “diseased” genes to potentially cure the ailment or disease.

Pharmaceutical and biotech companies involved in genetics include companies of every size and seemingly in every part of life sciences. Companies with the most potential to impact investors exist among smaller and more nimble companies in this space. Below are publicly traded genetics stocks listed on the Nasdaq or AMEX exchanges. They are small companies able to make a big impact with products related to gene therapy, cell therapy, genetic testing, and therapies for genetic diseases.

 

Genprex (NASDAQ:GNPX)

Genprex is a clinical-stage gene therapy company developing new therapies for patients with cancer and diabetes. Its therapies are based on the company’s proprietary ONCOPREX nanoparticle delivery system, which delivers cancer-fighting genes to tumor cells.

Market cap: US$168.68 million; current share price: US$3.90

In January, the company’s lead product candidate, the REQORSA immunogene therapy, was granted fast-track designation by the US Food and Drug Administration (FDA) for use in combination with AstraZeneca’s (NYSE:AZN) Tagrisso for the treatment of non-small cell lung cancer. The active ingredient in REQORSA is the tumor suppressor gene TUSC2.

 

Co-Diagnositics (NASDAQ:CODX)

Co-Diagnostics describes itself as a low-cost provider of molecular diagnostic services. The company’s technology is used in tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). Its molecular diagnostic tools detect infectious diseases, allow for liquid biopsy for cancer screening and have agricultural applications.

Market cap: US$257.99.81 million; current share price: US$9.00

In mid-December, Co-Diagnostics reported that it sold over 10 million Covid-19 test kits to its domestic and international network of laboratories, hospitals and distributors.

 

Lineage Cell Therapeutics (NYSE American:LCTX)

As a clinical-stage biotech company, Lineage develops new cell therapies for unmet medical needs. Their programs are based on a proprietary cell-based therapy platform and in-house development and manufacturing capabilities. Lineage develops and manufactures specialized, terminally differentiated human cells 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.

Market cap: US$ 448.65 million; current
share price: US$2.52

Lineage’s clinical programs are in markets with billion-dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates. 

 

Capricor Therapeutics (NASDAQ:CAPR)

Capricor Therapeutics is a clinical-stage biotechnology company working to develop and commercialize cell and exosome-based therapeutics for the treatment and prevention of diseases.

 Market cap: US$91.53; current share price:
US$4.02

In May 2020, Capricor announced positive top-line final results from a HOPE-2 study in patients with Duchenne muscular dystrophy who were treated with the company’s lead candidate, CAP-1002, an allogeneic cell therapy. In August, the FDA accepted Capricor’s investigational
new drug (IND) application for a Phase 2 clinical trial of CAP-1002 in patients with COVID-19.

 

OncoSec Medical (NASDAQ:ONCS)

OncoSec Medical is a late-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body’s immune system to target and attack cancer.

Market cap: US$54.83 million; current
share price: US$4.78

In October 2020, OncoSec announced FDA clearance of an IND application to begin a Phase 1 clinical trial of its CORVax12 coronavirus vaccine candidate. CORVax combines OncoSec’s TAVO with a DNA-encodable stabilized trimeric SARS-CoV-2 spike glycoprotein developed by researchers at the National Institute of Health’s National Institute of Allergy and Infectious Diseases.

Suggested Reading:

What is the Approval Process for Medical Devices	Small-Caps in the Covid19 and Treatment Space

Scientists Now Better Understand Viral Mutations	The Lifecycle of a SPAC

 Sources:

https://www.marketsandmarkets.com/Market-Reports/gene-therapy-market-122857962.html?gclid=CjwKCAiA_eb-BRB2EiwAGBnXXuuMTUruQFdj5KL8TAfbMXS4xxjO1aSr-oYOTXmH-c77bqkZNsAO8RoC1O8QAvD_BwE

https://www.irdirect.net/prviewer/release_only/id/4433141

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Lineage Announces Appointment Of Dr. Dipti Amin To Its Board Of Directors

 

Medically Trained Senior Executive/Board Member with Extensive Experience in Clinical Research and Drug Development

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

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, today announced the appointment of Dr.  Dipti Amin, MBBS, FFPM, MRCGP, DCPSA, DCH, DRCOG, DGM, to the Company’s Board of Directors, effective as of 
April 20, 2021.  Dr. Amin is an experienced Non-Executive Director and a medically trained senior executive with broad expertise in medicine, pharmacology, healthcare, research, and product development.  Dr. Amin has more than 26 years of experience within the pharmaceutical sector and is accomplished across diverse functional areas including clinical research, drug development, ethics and compliance, and commercial operations. She currently serves as a Non-Executive Director on the board of directors of 

Buckinghamshire Healthcare National Health Service Trust
 and the 
University of Hertfordshire in the 
UK.

“We are honored that  Dr. Amin will be joining Lineage’s Board of Directors at this important time in the advancement of our mission to become the leading allogeneic cell transplant company,” stated  Al Kingsley, Lineage’s Chairman of the Board. “Dr. Amin has had leadership responsibility for many aspects of pharmaceutical product development and clinical trials and has worked with numerous sponsors on countless product candidates while at Quintiles (now IQVIA). We believe her breadth of experience in clinical research and drug development, as well as her medical expertise and practical operational experience, will be particularly valuable to our Board and management team as Lineage continues to advance its three product candidates toward later stage clinical trials. We look forward to her support in guiding our corporate, product, and clinical strategy as we position ourselves for years of growth in the field of cell therapy.”

“Lineage’s clinical-stage programs and platform technologies have the potential to transform outcomes for patients suffering from serious medical conditions,” stated  Dr. Amin. “I am excited about the opportunity to contribute to the Company’s future growth. I particularly look forward to helping guide the advancement of Lineage’s novel cell therapy product candidates toward later-stage clinical trials and the execution of other potentially valuable development activities, with an ultimate focus on transforming the lives of patients and creating value for the Company’s shareholders.”

Dipti Amin, MBBS, FFPM, MRCGP, DCPSA, DCH, DRCOG, DGM

Dipti Amin  is an experienced Non-Executive Director and medically trained senior executive with a passion for high quality pharmaceutical research and healthcare, and extensive commercial, leadership, operational experience, in the private & public sectors, in medicine, pharmacology and the highly-regulated healthcare & research sectors, as well as compliance expertise. Over a span of more than 26 years,  Dr. Amin has held positions of operational and strategic responsibility within Pharmaceutical Services at the C-suite and Board level, delivering consistently on growth, quality, customer, employee and process targets. Her broad experience covers Clinical Pharmacology, ethical issues in clinical research, drug development, ethics and compliance programs as well as leadership and management of large, multi-functional, multi-geography, global groups to deliver value-added, efficient growth and achieving business turnarounds.  Dr. Amin has extensive international operational experience, including in the 
U.S., 
India, 
East Asia and 
Africa.

Dr. Amin spent more than 20 years at Quintiles Transnational (now IQVIA), the world’s largest provider of biopharmaceutical development & commercial outsourcing services. During her tenure,  Dr. Amin served in a number of senior executive roles including: Compliance; Ethics & Quality; Drug Safety and Medical Affairs; Medical and Scientific Services; Regulatory Affairs, Medical Writing and Strategic Drug Development; and Clinical Development and Scientific Operations.  Dr. Amin has successfully developed strategy and helped grow the P&L, sales & management for business units generating up to 
$600 million in revenue, while employing internationally based, multi-functional groups of highly qualified personnel.  Dr. Amin is an Honorary Lecturer in Clinical Pharmacology at Guy’s, King’s, and St. Thomas’ Hospitals Medical & Dental Schools.  Dr. Amin has also served on the Boards of 
Cambridge Innovation Capital and the Faculty of Pharmaceutical Medicine of the 
Royal College of Physicians, on the Innovation Board and Medical Expert Network of the 
Association of the British Pharmaceutical Industry, on a 
Department of Health Multi-centre Research Ethics Committee, on the 
Emerging Science and Bioethics Advisory Committee of the Dept. of Health, and on the 
Board of Governors of Heathfield School for Girls (The Girls’ 
Day School Trust).

Dr. Amin received her MB, BS (Bachelor of Medicine; Bachelor of Surgery) from 
Guys Hospital and St Thomas’ Hospitals (now GKT) 
Medical School in 1987. She holds the following certifications: DRCOG (Diploma of the 
Royal College of Obstetrics & Gynaecologists), DGM (Diploma in Geriatric Medicine of the 
Royal College of Physicians), MRCGP (Member of the 
Royal College of General Practitioners), DCH (Diploma in 
Child Health of the 
Royal College of Physicians), DCPSA (Diploma in Clinical Pharmacology), MFPM (Awarded Membership by Distinction of the Faculty of Pharmaceutical Medicine) and FFPM (Fellow of the Faculty of Pharmaceutical Medicine). Her clinical research work has been widely published in professional journals and textbooks, and she is a recognized presenter at international conferences.

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) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in 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,” “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 Lineage’s clinical advancement of its three product candidates, Lineage’s potential growth in the field of cell therapy, the potential of Lineage’s clinical-stage programs and platform technologies to help patients, and Lineage’s positioning for future success. 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 described 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 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.

Ceapro Inc. Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Highlights

 

• Maintained production operations during COVID-19 pandemic, providing customers with essential products and completing integration of manufacturing site, while ensuring the health and safety of employees
• Substantially increased sales, net profits and cash generated from operations during the year 2020, representing one of Ceapro’s best performances in company history
• R&D activities focused on advancing the development of innovative delivery systems and yeast beta glucan as a potential inhalable therapeutic for COVID-19
  

EDMONTON, Alberta, April 22, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO, OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced operational highlights and financial results for the fourth quarter and full year ended December 31, 2020.

“We could not be prouder of our resilient employees who worked tirelessly to deliver one of the best ever performances in the Company’s history during such a stressful year marked by the ongoing COVID-19 pandemic. While ensuring safety of our employees as our first priority, we were able to secure business continuity by putting more emphasis on production operations to serve our customers in the cosmetic sector. This approach, which has resulted in significant increase in sales, net profits and cash on hand, also allowed us to maintain investments in Research and Development as per our strategy to expand Ceapro’s business model from a contract manufacturer/commodity company to a high-value life science/biopharmaceutical company offering innovative products and delivery systems to the healthcare sector,” stated Gilles Gagnon, M.Sc., MBA, President and CEO, of Ceapro.

“In addition to excellent financial and operational results, main highlights of the year include the development of beta glucan from yeast and its potential as an inhalable therapeutic for COVID-19 patients as well as the development of new chemical complexes through the use of the PGX Technology. We are thrilled with the achievements made in 2020,” added Mr. Gagnon.

2020 Corporate and Operational Highlights

Pipeline Development

Oat Beta Glucan:

• Resumed enrollment of patients for the clinical trial with beta glucan as a cholesterol reducing natural pharmaceutical product. The study will enroll approximately 264 patients. To date, two thirds of the patients have been screened and randomized.
  
  
• Received approval from Health Canada for an amendment to the protocol to allow evaluation of subjects with confirmed pathophysiological condition of hyperlipidemia who voluntarily request to be treated with beta glucan only, without regular dosing of statins. This significant change, allowing patients to receive beta glucan as a stand-alone therapy, has accelerated patient enrollment and is expected to expand the target addressable patient population.
  

Avenanthramides:

• Announced the publication of positive results from study evaluating avenanthramides in exercise-induced inflammation in the international, peer-reviewed Journal of the International Society of Sports Nutrition. Positive results support anti-inflammatory claims for avenanthramides as a nutraceutical product and pave the way for a Phase 1 clinical trial as a potential pharmaceutical product.
  
  
• Continued to monitor stability studies for liquid avenanthramides produced at a new manufacturing site as well as for the pharmaceutical-grade dry powder formulation of avenanthramides to be used in a human Phase 1 bioavailability and safety study.
  

New Products:

Cannabis

• Received approval from Health Canada Controlled Substances and Cannabis Branch for a five-year research license with medical cannabis for the formulation of unique solid cannabinoid delivery systems using PGX technology.
  

Yeast Beta Glucan (YBG)

• Developed an optimal formulation of YBG coming from various sources.
  
  
• Confirmed capability of PGX Technology to optimize and standardize the size and morphology of yeast beta-glucan (PGX-YBG) suitable for lung inhalation.
  
  
• Achieved the first milestones in successful development of PGX-processed yeast beta glucan product as a potential inhalable therapeutic for COVID-19 and other fibrotic endpoint diseases of the lung.
  
  
• Conducted an in-vitro study with human cell lines demonstrating that PGX-YBG obtained from different sources exhibited significant stimulatory effect on human immune response through activation of beta glucan specific Dectin 1 receptors.
  
  
• Ongoing PGX-YBG project with McMaster University conducted in parallel for naïve and preclinical animal models. To date, no safety issues have been encountered. The preclinical phase has been extended to identify the maximum tolerated dose.
  
  
• Conducted additional in vitro PGX-YBG dose response study to correlate with upcoming McMaster animal study results. YBG induces immunomodulation without affecting inflammation pathways. This product is poised to become a key strategic asset for the Company.
  

New Chemical Complexes:

• Developed new PGX-dried chemical complexes like sodium alginate and gum arabic impregnated with co-enzyme Q10 (CoQ10). Positive results published in peer-reviewed journals demonstrate the versatility of the PGX Technology and the potential to develop significant bioactive delivery systems. Key learnings from these studies pave the way for the scale-up of the technology at the commercial level.
  
  
• Subsequent to year-end, Ceapro announced the successful completion of a long-term research program conducted with University of Alberta. This screening program allowed Ceapro to retain the most promising products and expand the PGX-based products pipeline.
  

Technology:

• Performed significant technical upgrades of PGX pilot plant in Edmonton to allow production of yeast beta glucan for a potential clinical trial with COVID-19 patients.
  
  
• Completed a feasibility study for the commercial scale up of the PGX Technology. Several manufacturers and existing supercritical plants were contacted in 2020 for the choice of equipment and location. Given excellent results obtained with the new yeast beta glucan product, it became clear that location of the first large scale PGX unit should be close to the best source of raw material which was found in Germany where the Company also acquired pieces of equipment suitable for the assembling of such unit. Production at the retained site will be mostly for the commercialization of yeast beta glucan as an immune booster and for alginate as a carrier for other bioactives.
  
  
• Initiated installment in Edmonton of a commercial scale unit for impregnation of bioactives with PGX-processed biopolymers.
  
  
• Pursued research collaboration projects with University of Alberta and McMaster University for the impregnation of various bioactives using PGX-processed biopolymers as potential delivery systems for multiple applications in healthcare.
  

Bioprocessing Operations

• Completed the integration of production operations under one roof in Edmonton. Ceapro’s dedicated production team successfully responded to the growing market demand for the cosmeceutical base business by producing over 250 metric tons of active ingredients in 2020, a 25% increase over the previous year.
  
  
• Received renewal of the Site License from the Health Canada Natural Product Directorate. This License enables the Company to manufacture, package, label, release and distribute final products.
  

Corporate

• Fully repaid loan with Agriculture Financial Services Corporation.
  
  
• Announced expansion of a grant from National Research Council of Canada for the optimization and mass production of yeast beta glucan as a potential inhalable therapeutic for COVID-19 and other fibrotic end-point disease of the lung.
  
  
• Pursued out-licensing discussions for PGX-processed new chemical complexes.
  
  
• Secured DTC Eligibility for publicly traded shares under Ticker OTCQZ: CRPOF and to expand Company exposure to other markets with an emphasis in USA.
  

Financial Highlights for the Fourth Quarter and the Full Year 2020 Ended December 31, 2020

• Total sales of $2,706,000 for the fourth quarter of 2020 and $15,121,000 for the full year of 2020 compared to $3,721,000 and $12,880,000 for the comparative periods in 2019. The 17% increase in revenue for the full year 2020 results from an 33% increase in sales of avenanthramides (mostly made to USA) partially offset by a 16% decrease in sales of beta glucan.
  
  
• Net loss of $539,000 for the fourth quarter of 2020 and a net profit of $1,856,000 for the full year of 2020 compared to a net profit of $166,000 and a net loss of $1,133,000 for the comparative periods in 2019, a year over year improvement of $2,989,000 Third and fourth quarter 2020 were marked by the completion of the decommissioning of Leduc manufacturing site and the final integration of production operations in the Edmonton facility. These time-consuming moves resulted in some necessary adjustments in equipment at the new site. It also required additional training of relocated employees.
  
  
• Cash generated from operations of $4,453,000, for the full year 2020 vs cash generated from operations of $882,000 for the full year 2019.
  
  
• Positive working capital balance of $7,659,000 as of December 31, 2020.
  

“I strongly believe 2021 holds a lot of opportunity for Ceapro. Our focus remains on the health and safety of our associates during this COVID-19 pandemic crisis, followed by business continuity. Depending on the evolution of the COVID-19 pandemic, we expect Ceapro’s cosmeceuticals base business to continue to grow and provide positive operating cash flows to support the expansion to a new business model from a contract manufacturer to a biopharmaceutical development company involved in nutraceuticals and pharmaceuticals. Based on a very solid foundation, a highly competent team, a healthy balance sheet and a very strong technology and product portfolio with the potential to access key large markets, we have all the key components for success,” concluded Mr. Gagnon.

CEAPRO INC.
Consolidated Balance Sheets
	December 31,	December 31,
	2020	2019
	$	$
ASSETS
Current Assets
Cash and cash equivalents	5,369,029	1,857,195
Trade receivables	2,019,723	3,659,541
Other receivables	102,224	46,812
Inventories (note 3)	1,210,079	669,005
Prepaid expenses and deposits	348,845	178,908
	9,049,900	6,411,461
Non-Current Assets
Investment tax credits receivable	607,700	607,700
Deposits	82,124	85,755
Licences (note 4)	18,514	21,477
Property and equipment (note 5)	18,591,189	19,764,122
Deferred tax assets (note 14 (b))	874,304	378,643
	20,173,831	20,857,697
TOTAL ASSETS	29,223,731	27,269,158
LIABILITIES AND EQUITY
Current Liabilities
Accounts payable and accrued liabilities	1,067,622	1,291,204
Current portion of long-term debt (note 6)	–	111,865
Current portion of lease liabilities (note 7)	250,658	265,123
Current portion of CAAP loan (note 9)	72,263	72,942
	1,390,543	1,741,134
Non-Current Liabilities
Long-term lease liabilities (note 7)	2,648,917	2,775,627
CAAP loan (note 9)	–	61,580
Deferred tax liabilities (note 14 (b))	874,304	378,643
	3,523,221	3,215,850
TOTAL LIABILITIES	4,913,764	4,956,984
Equity
Share capital (note 8 (b))	16,511,067	16,401,677
Contributed surplus (note 8 (e))	4,682,393	4,650,090
Retained earnings	3,116,507	1,260,407
	24,309,967	22,312,174
TOTAL LIABILITIES AND EQUITY	29,223,731	27,269,158

CEAPRO INC.
Consolidated Statements of Net Income (Loss) and Comprehensive Income (Loss)
	2020		2019
Year Ended December 31,	$		$
Revenue (note 16)	15,121,282		12,880,006
Cost of goods sold	7,498,996		7,434,654
Gross margin	7,622,286		5,445,352
Research and product development	1,881,883		2,393,607
General and administration	3,282,754		2,952,488
Sales and marketing	111,044		425,230
Finance costs (note 12)	231,271		260,684
Income (loss) from operations	2,115,334		(586,657	)
Other expenses (note 11)	(259,234	)	(549,379	)
Income (loss) before tax	1,856,100		(1,136,036	)
Income taxes
Current tax recovery	–		–
Deferred tax benefit	–		3,408
Income tax benefit	–		3,408
Total comprehensive income (loss) for the year	1,856,100		(1,132,628	)
Net income (loss) per common share (note 21):
Basic	0.02		(0.01	)
Diluted	0.02		(0.01	)
Weighted average number of common shares outstanding (note 21):
Basic	77,594,629		77,188,505
Diluted	78,143,033		77,188,505

CEAPRO INC.
Consolidated Statements of Cash Flows
	2020		2019
Year Ended December 31,	$		$
OPERATING ACTIVITIES
Net income (loss) for the year	1,856,100		(1,132,628	)
Adjustments for items not involving cash
Finance costs	153,538		171,249
Transaction costs	1,108		4,187
Depreciation and amortization	1,841,033		1,831,744
Foreign exchange gain on long-term debt	–		(307	)
Accretion	21,625		30,248
Deferred tax benefit	–		(3,408	)
Share-based payments	136,796		212,517
Net income (loss) for the year adjusted for non-cash items	4,010,200		1,113,602
CHANGES IN NON-CASH WORKING CAPITAL ITEMS
Trade receivables	1,639,818		(644,197	)
Other receivables	(55,412	)	87
Inventories	(541,074	)	41,703
Prepaid expenses and deposits	(88,839	)	154,106
Accounts payable and accrued liabilities relating to operating activities	(358,136	)	388,064
Total changes in non-cash working capital items	596,357		(60,237	)
Net income (loss) for the year adjusted for non-cash and working capital items	4,606,557		1,053,365
Interest paid	(153,538	)	(171,249	)
CASH GENERATED FROM OPERATIONS	4,453,019		882,116
INVESTING ACTIVITIES
Purchase of property and equipment	(528,707	)	(332,186	)
Purchase of leasehold improvements	(12,870	)	(6,007	)
Proceeds from sale of equipment	353		–
Deposits relating to investment in equipment	(77,467	)	187,790
Accounts payable and accrued liabilities relating to investing activities	134,554		(46,738	)
CASH USED IN INVESTING ACTIVITIES	(484,137	)	(197,141	)
FINANCING ACTIVITIES
Stock options exercised	4,897		17,284
Repayment of long-term debt	(112,973	)	(339,321	)
Repayment of CAAP loan	(83,884	)	(83,884	)
Repayment of lease liabilities	(265,088	)	(265,993	)
CASH USED IN FINANCING ACTIVITIES	(457,048	)	(671,914	)
Increase in cash and cash equivalents	3,511,834		13,061
Cash and cash equivalents at beginning of the year	1,857,195		1,844,134
Cash and cash equivalents at end of the year	5,369,029		1,857,195

The complete financial statements are available for review on SEDAR at https://sedar.com/Ceapro and on the Company’s website at www.ceapro.com.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: czo@jtcir.com

Issuer:
Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555

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

Source: Ceapro Inc.

Ayala Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Trial of AL102 in Combination with BCMA Targeting Agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma

 

REHOVOT, Israel and WILMINGTON, Del., April 21, 2021 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced the dosing of the first patient in the ongoing Phase 1 clinical trial evaluating its potent investigational gamma secretase inhibitor (GSI), AL102, in combination with Novartis’ investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).

AL102 is an oral small molecule that inhibits gamma secretase. Inhibition of gamma secretase prevents the cleavage and shedding of BCMA, which are ubiquitously expressed on MM cells. Preclinical data have demonstrated that treatment with AL102 increases expression of membrane-bound BCMA on the surface of MM cells and could enhance activity of WVT078.

“The dosing of the first patient in this Phase 1 trial marks an important milestone in our collaboration with Novartis. We view this trial, not only as a significant opportunity to explore the clinical viability of enhancing BCMA-targeting agents with GSIs such as AL102, but also as an important step forward in bringing a novel treatment option to patients with MM,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Despite numerous advances in the treatment landscape for MM, the disease remains incurable. BCMA is ubiquitously expressed on myeloma cells. Increasing BCMA expression on target cells and reducing the shedding in circulation is believed to potentially enhance therapies and increase responses. We look forward to further evaluating this potential as we bring this program into the clinic.”

The Phase 1, open-label, multicenter trial of AL102 in combination with Novartis’ WVT078 is currently enrolling patients with relapsed and/or refractory multiple myeloma who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent. The first-in-human dose escalation trial is designed to assess the safety, tolerability and recommended dose regimen(s) of WVT078 alone and in combination with AL102. In addition, the trial will assess preliminary anti-MM response and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with AL102.

Under the terms of the option and license agreement established in December 2018, Novartis is responsible for the conduct and expenses of any trials of AL102 in combination with their BCMA-targeting agents, as well as potential commercialization, in multiple myeloma. Ayala retains worldwide license rights to AL102 in all other indications.

About AL102
AL102 is a potent, selective and oral gamma secretase inhibitor (GSI). AL102 is currently being developed for the treatment of desmoid tumors, as well as in combination with Novartis’ BCMA-targeting agents for the treatment of multiple myeloma (MM).

About WVT078
WVT078 is a bispecific antibody that engages both BCMA and CD3, resulting in the recruitment of cytotoxic T cells that target BCMA-positive MM cells.

About Multiple Myeloma
Multiple myeloma is a rare and aggressive blood cancer that accounts for approximately one percent of all cancers. In the U.S., there are nearly 90,000 people living with, or in remission from, multiple myeloma. Approximately, 26,850 Americans are diagnosed with multiple myeloma each year and 11,240 patient deaths are reported on an annual basis.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101 has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently being advanced to a Phase 2/3 clinical trial for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Julie Seidel
Stern Investor Relations, Inc.
+1-212-362-1200
Julie.seidel@sternir.com

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com

Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech, Shares Second Interim Results demonstrating 100% Protection against Severe Disease including Hospitalization

 

• Primary efficacy in the second interim analysis demonstrates COVAXIN to be 78% effective after the second dose in preventing COVID-19 in those without prior infection
  
  
• Demonstrates 70% efficacy against asymptomatic COVID-19 infections; indicates potential to significantly reduce virus transmission
  
  
• COVAXIN has been administered to several million people in India and is playing a critical role in combating the pandemic
  

MALVERN, Pa., April 21, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that its co-development partner, Bharat Biotech, shared positive results of the second interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN demonstrated a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 78% with efficacy against severe COVID-19 disease alone of 100%.

“We continue to be excited by the compelling second interim results of Bharat Biotech’s Phase 3 clinical trial. We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease including hospitalizations by 100% as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date. We are dedicated to being a part of the solution to save lives from COVID-19 by bringing COVAXIN to the U.S. market. Based on a traditional vaccine platform that has a long-established safety profile, we believe COVAXIN is an important tool to add to our national arsenal in ending the pandemic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“The safety and efficacy demonstrated by COVAXIN is remarkable because of the prevalence of several variants of the coronavirus circulating at the time of the trial. This vaccine is based on a proven technology platform and the company plans to consider clinical development in special populations such as children,” said Dr. Bruce Forrest, member of the vaccine scientific advisory board of Ocugen.

Second Interim Phase 3 Results as Reported by Bharat Biotech

Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age in India, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

The second interim analysis is based on accruing more than 87 symptomatic cases of COVID-19. However, due to the recent surge in cases in India, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. The trial will be continuing to its pre-planned conclusion.

The efficacy against asymptomatic COVID-19 infection was 70%, based on a subgroup of approximately 8,000 participants who visited the clinical trial site each month for an RT-PCR test.

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to available data for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8^?C.

About Ocugen, Inc.

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

About Bharat Biotech

Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data that is the subject of this release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970

Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech, Shares Second Interim Results demonstrating 100% Protection against Severe Disease including Hospitalization

 

• Primary efficacy in the second interim analysis demonstrates COVAXIN to be 78% effective after the second dose in preventing COVID-19 in those without prior infection
  
  
• Demonstrates 70% efficacy against asymptomatic COVID-19 infections; indicates potential to significantly reduce virus transmission
  
  
• COVAXIN has been administered to several million people in India and is playing a critical role in combating the pandemic
  

MALVERN, Pa., April 21, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that its co-development partner, Bharat Biotech, shared positive results of the second interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN demonstrated a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 78% with efficacy against severe COVID-19 disease alone of 100%.

“We continue to be excited by the compelling second interim results of Bharat Biotech’s Phase 3 clinical trial. We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease including hospitalizations by 100% as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date. We are dedicated to being a part of the solution to save lives from COVID-19 by bringing COVAXIN to the U.S. market. Based on a traditional vaccine platform that has a long-established safety profile, we believe COVAXIN is an important tool to add to our national arsenal in ending the pandemic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“The safety and efficacy demonstrated by COVAXIN is remarkable because of the prevalence of several variants of the coronavirus circulating at the time of the trial. This vaccine is based on a proven technology platform and the company plans to consider clinical development in special populations such as children,” said Dr. Bruce Forrest, member of the vaccine scientific advisory board of Ocugen.

Second Interim Phase 3 Results as Reported by Bharat Biotech

Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age in India, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

The second interim analysis is based on accruing more than 87 symptomatic cases of COVID-19. However, due to the recent surge in cases in India, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. The trial will be continuing to its pre-planned conclusion.

The efficacy against asymptomatic COVID-19 infection was 70%, based on a subgroup of approximately 8,000 participants who visited the clinical trial site each month for an RT-PCR test.

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to available data for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8^?C.

About Ocugen, Inc.

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

About Bharat Biotech

Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data that is the subject of this release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970

Ayala Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Trial of AL102 in Combination with BCMA Targeting Agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma

 

REHOVOT, Israel and WILMINGTON, Del., April 21, 2021 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced the dosing of the first patient in the ongoing Phase 1 clinical trial evaluating its potent investigational gamma secretase inhibitor (GSI), AL102, in combination with Novartis’ investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).

AL102 is an oral small molecule that inhibits gamma secretase. Inhibition of gamma secretase prevents the cleavage and shedding of BCMA, which are ubiquitously expressed on MM cells. Preclinical data have demonstrated that treatment with AL102 increases expression of membrane-bound BCMA on the surface of MM cells and could enhance activity of WVT078.

“The dosing of the first patient in this Phase 1 trial marks an important milestone in our collaboration with Novartis. We view this trial, not only as a significant opportunity to explore the clinical viability of enhancing BCMA-targeting agents with GSIs such as AL102, but also as an important step forward in bringing a novel treatment option to patients with MM,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Despite numerous advances in the treatment landscape for MM, the disease remains incurable. BCMA is ubiquitously expressed on myeloma cells. Increasing BCMA expression on target cells and reducing the shedding in circulation is believed to potentially enhance therapies and increase responses. We look forward to further evaluating this potential as we bring this program into the clinic.”

The Phase 1, open-label, multicenter trial of AL102 in combination with Novartis’ WVT078 is currently enrolling patients with relapsed and/or refractory multiple myeloma who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent. The first-in-human dose escalation trial is designed to assess the safety, tolerability and recommended dose regimen(s) of WVT078 alone and in combination with AL102. In addition, the trial will assess preliminary anti-MM response and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with AL102.

Under the terms of the option and license agreement established in December 2018, Novartis is responsible for the conduct and expenses of any trials of AL102 in combination with their BCMA-targeting agents, as well as potential commercialization, in multiple myeloma. Ayala retains worldwide license rights to AL102 in all other indications.

About AL102
AL102 is a potent, selective and oral gamma secretase inhibitor (GSI). AL102 is currently being developed for the treatment of desmoid tumors, as well as in combination with Novartis’ BCMA-targeting agents for the treatment of multiple myeloma (MM).

About WVT078
WVT078 is a bispecific antibody that engages both BCMA and CD3, resulting in the recruitment of cytotoxic T cells that target BCMA-positive MM cells.

About Multiple Myeloma
Multiple myeloma is a rare and aggressive blood cancer that accounts for approximately one percent of all cancers. In the U.S., there are nearly 90,000 people living with, or in remission from, multiple myeloma. Approximately, 26,850 Americans are diagnosed with multiple myeloma each year and 11,240 patient deaths are reported on an annual basis.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101 has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently being advanced to a Phase 2/3 clinical trial for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Julie Seidel
Stern Investor Relations, Inc.
+1-212-362-1200
Julie.seidel@sternir.com

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com

 

Lineage Announces Worldwide License Agreement With Immunomic Therapeutics For An Allogeneic Cell-Based Cancer Immunotherapy Based On Its Vac Platform

 

electroCore, Inc. Announces Exclusive Distribution Agreement with East Agency For Qatar

 

ROCKAWAY, NJ, 
April 20, 2021 (GLOBE NEWSWIRE) —  electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into an agreement with East Agency to serve as the exclusive distributor of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) to patients suffering from primary headache disorders in 
Qatar.

“East Agency is a dedicated healthcare company focusing on high-end technologies and innovations targeting the Qatari market, and the addition of such an innovative technology in electroCore’s nVNS therapy is a matter of pride for us” said Mohammed Abdul Moqeeth, Head of the 
Medical Division of East Agency. “nVNS therapy can save patients from traumatic situations with no present solutions and it is always exciting to offer solutions rather than just products. 
East Agency is determined to honor its commitment to establish gammaCore in the region.”

“We are excited to be working with 
East Agency as we bring our nVNS therapy to the 
Middle East region initially in the State of Qatar” said Iain Strickland, electroCore’s Vice President of European Operations. “East Agency is experienced in introducing innovative medical technologies within 
Qatar and we look forward to supporting them in introducing our nVNS therapy, gammaCore Sapphire, in the region.”

The initial term of the agreement is three years, and it contains customary terms and conditions, including minimum purchase commitments.

        
About East Agency

East Agency was founded in 1997 as a sister concern of 
AlAli Holdings. The company is privately owned and has diversified business activities marking its presence in almost every sector of the medical industry.

East Agency has been providing quality healthcare services to 
Qatar in government, Public and Private sectors dealing in Dental, Medical Devices, Hospital consumables, Pharma, Derma, Lab Chemicals and Diagnostic Equipment & Reagents.

For more information, visit http://medical.eastagency.com/about-us.html

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^TM

gammaCore^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 with:
  • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
• 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 (younger than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
    
    

Please refer to the gammaCore Instructions for Use for all of 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 Company’s business prospects in 
Qatar and other new markets 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.

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

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Genprex to Receive Inaugural “License of the Year” Award from University of Pittsburgh Innovation Institute in Recognition of Advances Made with Gene Therapy Program in Diabetes

 

Genprex to Receive Inaugural “License of the Year” Award from University of Pittsburgh Innovation Institute in Recognition of Advances Made with Gene Therapy Program in Diabetes

 

electroCore, Inc. Announces Exclusive Distribution Agreement with East Agency For Qatar

 

ROCKAWAY, NJ, 
April 20, 2021 (GLOBE NEWSWIRE) —  electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into an agreement with East Agency to serve as the exclusive distributor of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) to patients suffering from primary headache disorders in 
Qatar.

“East Agency is a dedicated healthcare company focusing on high-end technologies and innovations targeting the Qatari market, and the addition of such an innovative technology in electroCore’s nVNS therapy is a matter of pride for us” said Mohammed Abdul Moqeeth, Head of the 
Medical Division of East Agency. “nVNS therapy can save patients from traumatic situations with no present solutions and it is always exciting to offer solutions rather than just products. 
East Agency is determined to honor its commitment to establish gammaCore in the region.”

“We are excited to be working with 
East Agency as we bring our nVNS therapy to the 
Middle East region initially in the State of Qatar” said Iain Strickland, electroCore’s Vice President of European Operations. “East Agency is experienced in introducing innovative medical technologies within 
Qatar and we look forward to supporting them in introducing our nVNS therapy, gammaCore Sapphire, in the region.”

The initial term of the agreement is three years, and it contains customary terms and conditions, including minimum purchase commitments.

        
About East Agency

East Agency was founded in 1997 as a sister concern of 
AlAli Holdings. The company is privately owned and has diversified business activities marking its presence in almost every sector of the medical industry.

East Agency has been providing quality healthcare services to 
Qatar in government, Public and Private sectors dealing in Dental, Medical Devices, Hospital consumables, Pharma, Derma, Lab Chemicals and Diagnostic Equipment & Reagents.

For more information, visit http://medical.eastagency.com/about-us.html

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^TM

gammaCore^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 with:
  • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
• 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 (younger than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
    
    

Please refer to the gammaCore Instructions for Use for all of 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 Company’s business prospects in 
Qatar and other new markets 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.

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

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

 

Lineage Announces Worldwide License Agreement With Immunomic Therapeutics For An Allogeneic Cell-Based Cancer Immunotherapy Based On Its Vac Platform