Market Newsdesk

Elanco Announces Public Offering of Common Stock by Selling Shareholder

GREENFIELD, Ind.–(BUSINESS WIRE)–
Elanco Animal Health Incorporated (NYSE: ELAN) announced today the launch of a public offering of 54,500,000 shares of its common stock held by Bayer World Investments B.V, an affiliate of Bayer AG. Bayer World Investments B.V. will be the sole selling shareholder and will also grant to the underwriters an option to purchase up to an additional 8,175,000 shares of common stock. Elanco will not issue shares in the offering and will not receive any proceeds from the sale of the shares by the selling shareholder in this offering.

Bayer World Investments B.V. received approximately 72.9 million shares of Elanco common stock in connection with the completion of Elanco’s acquisition of the Bayer animal health business on August 1, 2020.

The offering will be made under Elanco’s existing registration statement on Form S-3 as filed with the Securities and Exchange Commission. BofA Securities, Goldman Sachs & Co. LLC and Credit Suisse are the joint book-running managers for the offering.

This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor does it constitute an offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale is unlawful. The offering may be made only by means of a prospectus and a related prospectus supplement. Copies of the preliminary prospectus supplement and the accompanying prospectus can be obtained from: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282-2198, by telephone at 1-866-471-2526, or by e-mail at [email protected]; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at 1-800-221-1037 or by email at [email protected].

About Elanco

Elanco Animal Health (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we’re driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet.

Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Elanco’s current expectations and assumptions regarding the proposed offering, capital market conditions, its business and other future conditions. Forward-looking statements are based on our current expectations and assumptions regarding our business and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, our actual results may differ materially from those contemplated by the forward-looking statements. For further discussion of these and other risks and uncertainties, see Elanco’s most recent filings with the United States Securities and Exchange Commission. Except as required by law, Elanco undertakes no duty to update forward-looking statements to reflect events after the date of this release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201130005495/en/

Media: Colleen Parr Dekker +1.317.989.7011 [email protected]

Investor Relations: Tiffany Kanaga +1.302.897.0668 [email protected]

KEYWORDS: Indiana United States North America

INDUSTRY KEYWORDS: Agriculture Health Natural Resources Veterinary

MEDIA:

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Can-Fite Reports Third Quarter 2020 Financial Results & Provides Clinical Update

Company to host conference call at 9:15 a.m. ET Monday, November 30, 2020

PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the nine months ended September 30, 2020.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201130005411/en/

Clinical Developments and Corporate Highlights for the Third Quarter and Recent Weeks Include:

Positive Interim Analysis in Phase III Comfort™ Trial of Piclidenoson in the Treatment of Psoriasis – The Independent Data Monitoring Committee (IDMC) for Can-Fite’s Phase III trial of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis recommended the Company continue the study with the original sample size and drop one dose group based on the positive data from its interim analysis. While the interim data continue to be blinded to Can-Fite, the Company considers the IDMC’s recommendations highly encouraging. As the optimal dose has been identified, Can-Fite believes the study can be concluded earlier than originally planned. The majority of costs associated with the Phase III Comfort™ study have been previously paid. Piclidenoson is out-licensed for the indication of psoriasis in nine countries through agreements that include milestone payments and royalties on revenues upon regulatory approval.

Data from the Interim Analysis of the Acrobat™ Rheumatoid Arthritis Study – The IDMC recommended not to continue this study. The Company conducted a detailed analysis which showed that although Piclidenoson efficacy was significantly superior to placebo, the study missed the primary endpoint which was non-inferiority vs. the comparator methotrexate. The Company decided to stop this Phase III study and to focus on the developments that showed promising data including psoriasis, NASH and liver cancer.

Phase II COVID-19 IND Application for Piclidenoson Approved by FDA – The U.S. Food and Drug Administration (FDA) issued a “safe to proceed” notice for Can-Fite’s Investigational New Drug (IND) application for a Phase II study of Piclidenoson in the treatment COVID-19. The 28-day study will enroll 40 patients hospitalized with “moderate” COVID-19 per U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. The randomized, double blind study will evaluate patients who will receive Piclidenoson in addition to standard supportive care, as compared to patients who receive standard supportive care with placebo. The Company expects to commence patient enrollment in Q4 2020.

Namodenoson Abstract of Phase II Data Selected as ‘Best of The Liver Meeting’ in the NASH Category of the American Association of Liver Diseases (AASLD) – Dr. Rifaat Safadi, Principal Investigator of Can-Fite’s Phase II study of Namodenoson in the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) delivered a late-breaking oral presentation at the prestigious American Association for the Study of Liver Diseases (AASLD) conference, The Liver Meeting Digital Experience™ 2020. Presenting to the world’s leading scientists and health care professionals committed to preventing and curing liver diseases, Dr. Safadi concluded that “Namodenoson’s very impressive study data may result in a promising drug for the treatment of NAFLD/NASH due to the combination of good efficacy and favorable safety.” Can-Fite’s presentation was selected as ‘Best of The Liver Meeting’ in the NAFLD/NASH category. This selection is a singular honor and indicates the high level with which the AASLD review committee regards Can-Fite’s research.

Patent Protecting Namodenoson in Treatment of NASH Approved in Europe – A patent titled “An A3 Adenosine Receptor For Use In Treating Ectopic Fat Acculturation” was issued to Can-Fite by the European Patent Office. The patent’s claims include use of the A3 adenosine receptor (A3AR), the target of Can-Fite’s platform technology, in reducing ectopic fat accumulation particularly in fatty liver as manifested in NAFLD and NASH.

Completed Development of Assay to Identify Clinically Active Cannabis Derived Compounds – Can-Fite completed the development of a biological cell-based in vitro assay which can identify clinically active cannabis derived compounds that bind to and activate A3AR, the target of Can-Fite’s platform technology. In addition to using this assay in the development of its own cannabis derived compound-based therapeutics, Can-Fite plans to market the assay on a ‘fee for service’ basis to researchers and other cannabis companies worldwide.

“We are very pleased with the results of the IDMC’s interim analysis and recommendation for our Phase III psoriasis study. Piclidenoson has a clear value proposition in the psoriasis market we believe, based on its demonstrated safety and efficacy to date, and the benefit of being an oral drug among a growing number of injectable biologics. Oral drugs are cost effective and more convenient for the patient. Both of these factors are preferred by psoriasis patients based on a 2018 study published in an industry journal,” stated Can-Fite CEO Dr. Pnina Fishman. “This quarter we anticipate enrolling the first COVID-19 patient in our U.S. FDA Phase II study. Piclidenoson’s anti-inflammatory and anti-viral properties make it a promising candidate in the fight against this pandemic. We are also very encouraged by the level of interest in Namodenoson in the treatment of NAFLD/NASH from the scientific and business communities.”

Financial Results

Revenues for the nine months ended September 30, 2020 were $0.61 million compared with $1.84 million for the same period of 2019. The decrease in revenues was mainly due to the recognition of a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.

Research and development expenses for the nine months ended September 30, 2020 were $9.05 million compared with $7.01 million for the same period of 2019. Research and development expenses for the nine months ended September 30, 2020 comprised primarily of expenses associated with the Phase II studies for Namodenoson in the treatment of NASH and HCC, as well as expenses for ongoing Phase III studies of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis. The increase is primarily due to increased costs associated with the accelerating rate of absorption of patients for the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis and for psoriasis during this period.

General and administrative expenses were $2.14 million for the nine months ended September 30, 2020 compared to $2.22 million for the same period in 2019. The decrease is primarily due to a decrease in professional services and travel expenses which was partly offset by an increase in salaries and related benefits and insurance expenses.

Financial expenses, net for the nine months ended September 30, 2020 was $0.22 million compared to $0.44 million for the same period in 2019. The decrease in financial expenses, net is mainly due to fair value revaluation of the investment in Wize Pharma Inc’s shares which is classified under short term investment.

Can-Fite’s net loss for the nine months ended September 30, 2020 was $10.81 million compared with a net loss of $7.84 million for the same period in 2019. As of September 30, 2020, Can-Fite had cash and cash equivalents of $10.22 million as compared to $2.69 million at December 31, 2019. The increase in cash during the nine months ended September 30, 2020 is due to an aggregate of $17.68 million net proceeds received through a warrant exercise transaction in January 2020, a public offering in February 2020, partial exercises in March, April and May 2020 of warrants issued in the February 2020 public offering, and a registered direct offering in June and July 2020 which was offset by net cash used in operating activity of $10.16 million.

The Company’s consolidated financial results for the nine months ended September 30, 2020 are presented in accordance with US GAAP Reporting Standards.

Conference Call

Management will host a conference call today, November 30, 2020 at 9:15 a.m. ET. Investors in the U.S. are invited to dial 877-423-9813. International investors may dial 201-689-8573. The conference ID is 13713545. Investors may also participate via webcast: http://public.viavid.com/index.php?id=142533

A replay of the webcast will be archived on Can-Fite’s website for a period of time. 

CONSOLIDATED STATEMENTS OF BALANCE SHEETS
In thousands (except for share and per share data)
		September 30,				December 31,
		2020				2019
		Unaudited				Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	10,222			$	2,697
Other receivable and prepaid expenses			2,961				4,383
Short-term investment			57				64
Total current assets			13,240				7,144
NON-CURRENT ASSETS:
Other non-current receivables			–				912
Operating lease right of use assets			58				82
Property, plant and equipment, net			28				36
Total long-term assets			86				1,030
Total assets		$	13,326			$	8,174

CONSOLIDATED STATEMENTS OF BALANCE SHEETS
In thousands (except for share and per share data)
		September 30,				December 31,
		2020				2019
		Unaudited				Audited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables		$	784			$	2,156
Current maturity of operating lease liability			34				36
Deferred revenues			603				469
Other accounts payable			398				610
Total current liabilities			1,819				3,271
NON-CURRENT LIABILITIES:
Long-term operating lease liability			15				39
Deferred revenues			1,951				2,422
Total long-term liabilities			1,966				2,461
CONTINGENT LIABILITIES AND COMMITMENTS
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY:
Ordinary shares of NIS 0.25 par value – Authorized: 500,000,000 shares at September 30, 2020 and December 31, 2019; Issued and outstanding: 462,419,463 shares as of September 30, 2020; 120,652,683 shares as of December 31, 2019			32,936				8,225
Additional paid-in capital			97,314				103,401
Accumulated other comprehensive income			1,127				1,127
Accumulated deficit			(121,836	)			(110,311	)
Total equity			9,541				2,442
Total liabilities and equity		$	13,326			$	8,174

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
In thousands (except for share and per share data)
		Nine months ended September 30,
		2020				2019
		Unaudited
Revenues		$	613			$	1,840
Research and development expenses			(9,055	)			(7,016	)
General and administrative expenses			(2,144	)			(2,220	)
Operating loss			(10,586	)			(7,396	)
Total financial expenses, net			(224	)			(445	)
Net loss			(10,810	)			(7,841	)
Total comprehensive loss			(10,810	)			(7,841	)
Deemed dividend			(715	)			–
Net loss attributed to ordinary shareholders		$	(11,525	)		$	(7,841	)
Basic and diluted net loss per share			(0.03	)			(0.11	)
Weighted average number of ordinary shares used in computing basic and diluted net loss per share			323,360,926				74,451,754

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, inflammatory disease and COVID-19. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite’s liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and successfully achieved its primary endpoint in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201130005411/en/

Can-Fite BioPharma

Motti Farbstein

[email protected]

+972-3-9241114

US Investors:

Dave Gentry

RedChip Companies Inc.

[email protected]

407-491-4498

KEYWORDS: Israel Middle East

INDUSTRY KEYWORDS: Biotechnology General Health Health Pharmaceutical Clinical Trials

MEDIA:

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RA Primary Endpoint: Low Disease Activity (Graphic: Business Wire)

BBTV Signs Major International Gaming Content Partners and Expands Global Footprint with Additional 217 Million Monthly Views

VANCOUVER, British Columbia–(BUSINESS WIRE)–
BBTV Holdings Inc. (TSX: BBTV), a media tech company that uses technology enabled solutions to help content owners become more successful, provides the following updates:

• BBTV signs new international gaming partners L’étoile Noire, Acenix, Games EduUu, Mustafa GAME OVER, and VinhMC, who collectively achieve 217 million monthly YouTube views and over 23 million YouTube subscribers.
• L’étoile Noire is 6th largest YouTube gaming creator in France, Games EduUu is the 12th largest gaming creator in Brazil. In addition, BBTV has partnerships in place with three of the top 10 Gaming channels on YouTube, and five of the top 20 Gaming channels on YouTube, based on total subscribers¹.
• BBTV’s gaming content has achieved 78 Billion views LTM September 2020, with the most consumable formats like eSports (such as Fortnite and League of Legends), Casual Games (such as Minecraft, Roblox), GTA² and PUBG³ generating significant viewership and engagement from audiences.
• According to a report released this year, the global gaming market will generate $159.3 billion in revenue in 2020. Newzoo projects the industry to surpass $200 billion in revenue in 2023⁴.

“Global TAM⁵ for gaming revenues is forecasted to reach nearly $160 billion in 2020, surpassing books, music and movies,” comments Shahrzad Rafati, Chairperson and CEO, BBTV. “We are proud to grow our diversity of content, including this dynamic group of international content owners in the gaming vertical. BBTV’s Gaming content partners command some of the largest audiences globally, and we’re poised to benefit from this as advertisers continue to shift their advertising dollars to this highly sought after segment.”

BBTV has partnered with L’étoile Noire (1.24M YouTube subscribers, 16.8M monthly YouTube views, 203k Instagram followers), the sixth largest gaming creator in France, and a prolific thought leader on the cult game, Fortnite. He regularly publishes thoughts and insights to his engaged community on the latest Fortnite news, Fortnite games updates, and its merch store.

Acenix (4.2M YouTube subscribers, 50.02M monthly YouTube views, 268k Instagram followers, 66k Twitter followers) is one of the most charismatic, entertaining, and fastest growing gamers in the Spanish speaking world and is the 19th largest YouTube gaming creator in Spain.

A finalist for the 2020 iBest award in the Game Content category by IGN Brazil, Games EduUu (8.75M YouTube subscribers, 54.6M monthly YouTube views, and 567k Facebook followers) one of the most dynamic, passionate and entertaining Brazilian influencers, the 12th largest gaming creator in the country, and one of the fastest growing in the category.

“International expansion is an important driver of BBTV’s overarching growth strategy and these latest partnerships demonstrate our ability to deliver value to content owners around the globe in one of the largest, and most engaging content verticals,” comments Ali Adab, VP Content and Partnerships, BBTV.

Mustafa Jamal is the largest Minecraft gaming channel in the MENA region with an average of more than 1M views per video (8.13M YouTube subscribers, 81.2M monthly YouTube views, 483k Instagram followers), with Mustafa GAME OVER. Finally, BBTV welcomes VinhMC, a popular gamer from Vietnam, known for his humorous Minecraft walkthroughs and commentary (853k YouTube subscribers, 14.09M monthly YouTube views and 3.6M TikTok followers).

Gaming is just one of a number of popular and high growth content verticals at BBTV, others include: entertainment, music, kids and family, and sports.

For more information please visit: www.bbtv.com

Footnotes

• ¹ Source SocialBlade Nov 23rd 2020, most subscribed categories; gaming: https://socialblade.com/youtube/top/category/games/mostsubscribed
• ² Grand Theft Auto
• ³ PlayerUnknown’s Battlegrounds
• ⁴ Source Reuters May 2020, Newzoo report: https://ca.reuters.com/article/idUSFLM8jkJMl
• ⁵ TAM = Total Addressable Market

References/sources:

• Global and Country specific ranking are from: Tubular Labs – October 2020
• YouTube Monthly Views Source: SocialBlade – November 29th, 2020
• YouTube Subs Source: YouTube – November 29th, 2020
• Instagram Followers Source: Instagram – November 29th, 2020
• Twitter Followers Source: Twitter – November 29th, 2020
• Facebook Followers Source: Facebook – November 29th, 2020

About BBTV

BBTV is a media and technology company headquartered in Vancouver, Canada. BBTV is an enabling platform with a stated mission of advancing the world through the democratization of content. From individual content creators to global media companies, BBTV monetizes the media of content owners through end-to-end management, distribution and monetization solutions, powered by its innovative VISO Platform, including related proprietary technology, while allowing content owners to focus on their core competency – content creation. In August 2020, BBTV had the second most unique monthly viewers among digital platforms with 615 million globally, who consumed more than 55 billion minutes of video content, the most among media companies^*. www.bbtv.com

*Calculations and classifications made by BBTV based on data from Comscore contained in Comscore’s “Top 12 Countries = August 2020 comScore Video Metrix Media Trend – Multi-Platform – Top 100 Video Properties Report”.

Forward-Looking Statements

This press release may contain forward looking information within the meaning of applicable securities legislation, which reflects the Company’s current expectations regarding future events including the expected continuation of content consumption and continued expansion of multiple partnerships from Base to Plus solutions. Forward looking information is based on a number of assumptions, including but not limited to assumptions regarding the changes and trends in our industry or the global economy, that are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, and which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward looking information. Such risks and uncertainties include, but are not limited to the factors discussed under “Risk Factors” in the final prospectus of the Company dated October 22, 2020. The Company does not undertake any obligation to update such forward looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable law.

BBTV-C

View source version on businesswire.com: https://www.businesswire.com/news/home/20201130005407/en/

Dan Gamble

Head of PR & Corporate Communications

[email protected]

+1778 873 0422

Ashley Buck

PR and Corporate Communications Specialist

[email protected]

+17788751346

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Entertainment Social Media Blogging Technology Other Entertainment Other Communications Publishing Public Relations/Investor Relations Marketing Communications Other Technology Electronic Games

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Applied DNA, EvviVax, and GVS Receive Regulatory Approval to Conduct Veterinary Clinical Trial for Linear COVID-19 Vaccine Candidate

– Trial Redesigned to Accelerate Development of Clinical Path to Potential USDA APHIS Conditional License for Commercial Veterinary Sales –

STONY BROOK, N.Y.–(BUSINESS WIRE)–
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, EvviVax, S.R.L. (“EvviVax”), a spin-off of Takis Biotech with expertise in engineered veterinary cancer immunotherapy and targeted vaccines, and Veterinary Oncology Services at Guardian Veterinary Specialists (GVS), a multi-specialty veterinary hospital, announced the receipt of approvals from the New York State Department of Agriculture and Markets and the U.S. Department of Agriculture on an advanced clinical strategy to conduct a previously reported, New York State-based, veterinary trial of a lead LinearDNA™ COVID-19 vaccine candidate. The vaccine candidate is jointly developed by Applied DNA and EvviVax.

Applied DNA, EvviVax, and GVS also announced a redesign of the veterinary trial to allow for an acceleration of the lead candidate’s development path with the end goal of applying for a U.S. Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS) conditional license to enable commercial veterinary sales for domestic felines.

The goal of the trial remains to evaluate the vaccine candidate as a strategy for the prevention of SARS-CoV-2, the virus that causes COVID-19, in feline companions of humans that would mitigate the animals as a potential reservoir for infections in humans. Domestic felines are a known COVID-19 reservoir and can transmit the virus to other felines. No transmission back to humans has been documented, though the scientific possibility remains given the virus’s zoonotic origin. The trial will take place at GVS in Brewster, N.Y., and is expected to begin within the next 90 days.

The trial will now recruit a smaller number of healthy domestic feline companion animals that will receive two doses of the vaccine candidate and follow the enrolled cohort for up to six months. The trial’s primary endpoint is to demonstrate the safety and immunogenicity (detection of neutralizing antibodies and T-cell response) of the vaccine candidate in domestic felines. The vaccine candidate previously yielded strong antibody and T-cell responses even at very low doses in mice.

Trial Supervising Investigator and Diplomate of the American College of Veterinary Internal Medicine, Dr. Joseph Impellizeri, of GVS, stated, “By studying the immune response after immunizing an important host that resides with human counterparts, we hope to understand better the potential clinical response against the virus using a specially designed vaccine and delivery system that may translate to both human and animal protection.”

Accelerated Development of Clinical Path

The redesigned trial allows for immunologic data to be gathered faster across a smaller cohort that would also support the near-concurrent pursuit of a parallel trial (the “proposed trial”) currently being finalized to advance further data by challenging an additional cohort in a controlled environment with the lead vaccine candidate. Upon seroconversion, the vaccinated felines would then be placed among an infected COVID-19 feline cohort. The rates of transfer of the infection among the vaccinated cohort will be studied with a planned endpoint of revealing the vaccine candidate’s overall efficacy against active disease. The data from the redesigned and proposed trials may also provide additional support for requisite toxicology and bio-distribution studies to potentially initiate human SARS-CoV-2 vaccine candidate trials.

On the assumption that both trials’ primary endpoints are met, the Company and EvviVax expect to apply for a USDA APHIS conditional license (9 CFR 102.6) for a LinearDNA COVID-19 vaccine candidate for domestic felines. Conditional licensure is afforded to products that meet emergency needs, such as the COVID-19 outbreak, and potentially accelerates the vaccine candidate’s time-to-market.

“In accelerating our vaccine development program for veterinary application, we seek to elevate our work with EvviVax in the emerging field of SARS-CoV-2 susceptibility in animals,” said Dr. James A. Hayward, president and CEO, Applied DNA. “With the initiation of the redesigned veterinary trial, we progress towards potentially commercializing our lead LinearDNA vaccine candidate for use on domestic felines while also generating valuable complementary data for potential human COVID-19 vaccine candidate trials and charting a possible development path to other animals, such as mink. The virus’s impact on farmed mink populations globally has been especially devastating and has resulted in the collapse of Denmark’s $800 million mink fur industry¹. Further, mink-linked SARS-CoV-2 virus mutations identified in humans have now spread to at least seven countries². Should our veterinary COVID-19 vaccine gain conditional licensure, we believe it could have significant economic and public utility.”

Footnotes:

¹https://www.reuters.com/article/us-health-coronavirus-denmark-mink-farme/it-stops-here-danish-mink-farmer-sees-no-future-after-mass-cull-idUSKBN27L2BN

² https://amp.theguardian.com/environment/2020/nov/18/covid-19-mink-variants-discovered-in-humans-in-seven-countries

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.

Applied DNA is a member of the Russell Microcap® Index.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA), U.S. Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown ability to manufacture the vaccine candidates in large quantities, the fact that the safety and efficacy of the vaccine candidates has not yet been established, the unknown ability of the vaccine candidates to generate revenue or profit for Applied DNA, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020, May 14, 2020 and August 6, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201130005340/en/

Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, [email protected]
Program contact: Brian Viscount, Applied DNA Sciences, 631-240-8877, [email protected]

Web:www.adnas.com

Twitter: @APDN

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Stem Cells Veterinary Biotechnology Pharmaceutical Health Infectious Diseases Genetics Clinical Trials

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