Global Water Technologies and Envirologics bring new pipeline rehabilitation technology to the United States for sustainable infrastructure program

INDIANAPOLIS, April 01, 2021 (GLOBE NEWSWIRE) — Global Water Technologies (OTC: GWTR) and Envirologics Engineering, Inc. are pleased to announce their collaboration to bring a new pipeline rehabilitation technology to the United States, where sustainable infrastructure investment was just announced as a national priority for renewing the economy.

“This new system is an exciting tool for protecting our nation’s drinking water while extending the life of existing infrastructure in a cost-effective manner,” said Erik Hromadka, CEO of Global Water Technologies.

“Our evidence-based asset management system is the first to clean, evaluate, line and protect drinking water pipelines in a sustainable manner,” said Randy Cooper, CEO of Envirologics.

The two companies have been working together since 2016, when they hosted an initial demonstration of the technology in the 16 Tech innovation district of Indianapolis. Since then, the patented technology has been deployed in several water systems in the U.S., Canada and the United Kingdom.

Although the pandemic and subsequent border closing impacted projects over the past year, this week’s infrastructure announcement by the White House has prompted a greater focus on the need for this system to help renew America’s drinking water distribution pipes.

Envirologics’ patented technology uses an airborne stream of aggregate to quickly remove tuberculation, corrosion and contaminants from the inside of water distribution pipes. That is followed by a live-streaming evaluation of pipe wall thickness, an application of drinking-water approved pipe lining and external corrosion protection. The technology can also be used to encapsulate any lead found in drinking water pipe joints.

More information is available at: gwtr.com and envirologics.ca.

FORWARD-LOOKING STATEMENT:

Statements relating to plans, strategies, economic performance, projections of results of specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors. Although we believe expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. The company has no obligation to update these forward-looking statements.

 



TYME Announces Appointment of Dr. Jan M Van Tornout as Acting Chief Medical Officer

TYME Announces Appointment of Dr. Jan M Van Tornout as Acting Chief Medical Officer

BEDMINSTER, N.J.–(BUSINESS WIRE)–Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), today announced the appointment of Jan M Van Tornout, MD, MSc, as acting Chief Medical Officer, effective April 1, 2021. Dr. Van Tornout will provide leadership and direction for all medical and related preclinical programs in development. He will be replacing Dr. Giuseppe Del Priore. “On behalf of the board of directors, we truly appreciate Giuseppe’s many contributions towards advancing our programs and we wish him continued success in his future endeavors,” said Richie Cunningham, TYME’s CEO.

Dr. Van Tornout brings over 25 years of medical experience in academia and industry, including over 15 years of global drug development in pharmaceutical and biotech settings and encompassing preclinical, IND, FIH, phase II-IV, (s)NDA, BLA, safety, medical affairs, clinical operations and regulatory experience. He has led clinical management and oncology teams at Natera, INOVIO Pharmaceuticals, Astellas Pharma, Bristol Myers Squibb and Amgen. Dr. Van Tornout has also served as a medical strategy consultant for various biotech companies including Cyclacel Pharmaceuticals, GlaxoSmithKline, Puma Biotechnology, Maverick Therapeutics, ERT, Huya Bioscience, and Gradalis.

Dr. Van Tornout previously held academic appointments at the University of Southern California (USC) with clinical appointments at Children’s Hospital Los Angeles as attending pediatric hematologist-oncologist. Dr. Van Tornout received his MD from the Katholieke Universiteit Leuven (KUL), Leuven, Belgium, an MS in classical philosophy from KUL, and a BS from the Faculté Notre-Dame de la Paix, Namur, Belgium. He obtained his certification as a paediatrician from the Gasthuisberg University Hospitals, KUL, and subsequently completed his training as a pediatric hematologist-oncologist at Children’s Hospital Los Angeles, USC. He earned an MSc. in applied biometry from USC and completed a post-doctoral fellowship in molecular epidemiology at USC. Subsequently his National Institutes of Health-sponsored laboratory focused on genetic epidemiology of childhood cancer (EWS) and the application of neural networks to the analysis of large pediatric cancer datasets.

“We are delighted and fortunate to be able to bring on an individual with Dr. Van Tornout’s vast experience at this important juncture for TYME. Jan has played an integral role in the approval of multiple drug candidates and has served as a key advisor in all facets of drug development. We will greatly benefit from his expertise on how best to advance our pipeline, as well as his guidance on the components that comprise high quality submissions to the FDA. We expect the end result to benefit both TYME and the patients we intend to help,” said Richie Cunningham. Dr. Van Tornout stated, “I am excited to work with TYME and its leadership team during this pivotal period. TYME has multiple novel programs underway that have the potential to make a meaningful difference in the lives of many people with unmet medical needs. I am confident my background is very well-suited to help guide TYME in the next phase of clinical development across its various clinical and preclinical compounds.”

About Tyme Technologies

Tyme Technologies, Inc., is an emerging biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system. With the development of TYME-18 and TYME-19, the Company believes that it is also emerging as a leader in the development of bile acids as potential therapies for cancer and viruses such as COVID-19.

For more information, visit www.tymeinc.com. Follow us on social media: Facebook, LinkedIn, Twitter, YouTube and Instagram.

Forward-Looking Statements/Disclosure Notice

In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates (including SM-88 and TYME- 18) and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned preclinical or clinical trials, including the proposed TYME-19 proof-of-concept study, preliminary data results and the therapeutic design and mechanisms of our drug candidates. The words “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” “anticipates,” and similar expressions (including their use in the negative) are intended to identify forward-looking statements. Forward-looking statements can also be identified by discussions of future matters such as: the effect of the novel coronavirus (COVID-19) pandemic and the associated economic downturn and impacts on the Company’s ongoing clinical trials and ability to analyze data from those trials; the cost of development and potential commercialization of our lead drug candidate and of other new products; expected releases of interim or final data from our clinical trials; possible collaborations; and the timing, scope, status, objectives and strategy of our ongoing and planned trials; the success of management transitions; and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations and projections which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include but are not limited to: the severity, duration, and economic and operational impact of the COVID-19 pandemic; that the information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply, and in the ability to achieve adequate start and completion dates, as well as uncertainties in clinical trial design and patient enrollment, dropout or discontinuation rates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final data from any clinical trials may differ from prior or preliminary study data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on May 22, 2020, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission available at www.sec.gov.

The information contained in this press release is as of its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.

For Investor Relations & Media Inquiries:

1-212-461-2315

Investor Relations

[email protected]

[email protected]

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

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Builders FirstSource Announces Completion of Planned CEO Transition

Dave Flitman succeeds Chad Crow following planned retirement and transition after completion of BMC merger

DALLAS, April 01, 2021 (GLOBE NEWSWIRE) — Builders FirstSource, Inc. (Nasdaq: BLDR) (“Builders FirstSource”) announced today that Dave Flitman has been appointed chief executive officer. The planned transition of the CEO role is taking place 90 days after Builders FirstSource (BFS) and BMC Stock Holdings, Inc. (“BMC”) announced the completion of their all-stock merger transaction and coincides with the previously announced retirement plan of Chad Crow.

“This is truly an exciting time for Builders FirstSource. I firmly believe that growth is what’s at the heart of this merger – consolidating and expanding our reach in a fragmented industry, innovating and building on our value-add offerings, and giving our people the resources needed to deliver the enhanced service our customers expect from us,” said Mr. Flitman.

“By uniting our companies, we have increased our size and market position, and this strategic combination is a transformational step forward for our team members, customers and shareholders,” Mr. Flitman continued. “While we are still in the early phases of the integration process, the seamless transition and remarkable success that have defined our merger thus far would not have been possible without Chad’s leadership. I want to thank him for his dedication and guidance, and I wish him the very best in retirement.”

“I would like to thank everyone who supported me throughout my career at Builders FirstSource,” Mr. Crow said. “When I joined BFS more than 20 years ago, it was, of course, much smaller, having only completed a few acquisitions at that time. I could not have dreamed this company would be where it is today – an industry leader – but more importantly, such a special place to work filled with incredible people, and where I have developed life-long friendships. I’m incredibly proud of the growth we’ve achieved over the last two decades. This strategic merger marks an extraordinary new chapter for Builders FirstSource, and I’m confident it will thrive under Dave’s leadership.”

Mr. Flitman has over three decades of experience and a prolific background in leading distribution business across multiple industries. Prior to the merger, Mr. Flitman served as president and CEO of BMC. Previously, he held the titles of president and chief executive officer of Performance Foodservice; chief operating officer of Univar; president of Univar USA and chief supply chain officer; executive vice president and president of water and process services at Ecolab; and held several executive leadership roles at Nalco. Mr. Flitman also worked as president of Allegheny Power and vice president of distribution at its parent company, Allegheny Energy, after spending nearly 20 years at DuPont in various operational, commercial and global business leadership positions.

As previously announced, Mr. Crow will remain available on a consulting basis to support the integration and to ensure an orderly transition. BLDR confirmed there is no change to the business outlook for the first quarter and full fiscal year 2021 that the company provided as part of its four-quarter and full year 2020 earnings announcement on February 26, 2020.

About Builders FirstSource

Headquartered in Dallas, Texas, Builders FirstSource is the largest U.S. supplier of building products, prefabricated components, and value-added services to the professional market segment for new residential construction and repair and remodeling. We provide customers an integrated homebuilding solution, offering manufacturing, supply, delivery and installation of a full range of structural and related building products. We operate in 40 states with approximately 550 locations and have a market presence in 85 of the top 100 Metropolitan Statistical Areas, providing geographic diversity and balanced end market exposure. We service customers from strategically located distribution and manufacturing facilities (certain of which are co-located) that produce value-added products such as roof and floor trusses, wall panels, stairs, vinyl windows, custom millwork and pre-hung doors. Builders FirstSource also distributes dimensional lumber and lumber sheet goods, millwork, windows, interior and exterior doors, and other building products. For more information about Builders FirstSource, visit our website at www.bldr.com.


Contact:

Michael Neese
SVP, Investor Relations
Builders FirstSource, Inc.
(214) 765-3804

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/453291c5-7a63-4a67-85a2-0c79d76bc265



Nabriva Therapeutics to Present at the 20th Annual Needham Virtual Healthcare Conference

DUBLIN, Ireland and KING OF PRUSSIA, Pa., April 01, 2021 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that Ted Schroeder, Chief Executive Offer at Nabriva, will provide a company overview and business update at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, at 2:15p.m. ET.

The presentation may be accessed by visiting the “Investors” section of the Company’s website under the “Events and Presentations” tab at www.nabriva.com.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin), the first pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTIs), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories. For more information, please visit https://www.nabriva.com

CONTACTS:

For Investors

Kim Anderson
Nabriva Therapeutics plc
[email protected]

For Media

Mike Beyer
Sam Brown Inc.
[email protected]
312-961-2502



VPC Impact Acquisition Holdings Announces Filing of a Registration Statement on SEC Form S-4 in Connection with its Proposed Business Combination with Bakkt Holdings, LLC

VPC Impact Acquisition Holdings Announces Filing of a Registration Statement on SEC Form S-4 in Connection with its Proposed Business Combination with Bakkt Holdings, LLC

CHICAGO–(BUSINESS WIRE)–
VPC Impact Acquisition Holdings (NASDAQ: VIHAU, VIH and VIHAW) (“VIH”), announced today that it has filed with the U.S. Securities and Exchange Commission (“SEC”) a registration statement on Form S-4 (the “Registration Statement”), which includes a preliminary proxy statement of VIH in connection with the proposed Business Combination with Bakkt Holdings, LLC (“Bakkt”), a digital asset marketplace.

Upon the consummation of the proposed transaction, VIH will be renamed “Bakkt Holdings, Inc.” Bakkt Holdings, Inc. is anticipated to become a NYSE-listed public company trading under the ticker symbol “BKKT.”

The Business Combination, which was announced on January 11, 2021, has been unanimously approved by the VIH Board of Directors and is expected to close in the second quarter of 2021, subject to VIH shareholder approval, the Registration Statement being declared effective by the SEC, and other regulatory and customary closing conditions.

PJ Solomon is serving as financial advisor and Shearman & Sterling is serving as legal advisor to Bakkt. Jefferies and Citigroup are serving as financial and capital markets advisors to VIH. White & Case LLP is serving as legal advisor to VIH.

About VPC Impact Acquisition Holdings

VPC Impact Acquisition Holdings’ sponsor is an affiliate of Victory Park Capital, a global investment firm with a long track record of executing debt and equity financing transactions with some of the largest global Fintech companies. The firm was founded in 2007 and is headquartered in Chicago with additional resources in New York, Los Angeles and San Francisco. Victory Park Capital is privately held and a Registered Investment Advisor with the SEC.

About Bakkt

Bakkt is a trusted digital asset marketplace that enables institutions and consumers to buy, sell, store and spend digital assets. Bakkt’s retail platform, now widely available through the new Bakkt App, will amplify consumer spending, reduce traditional payment costs and bolster loyalty programs, adding value for all key stakeholders within the payments and digital assets ecosystem. Launched in 2018 by Intercontinental Exchange, Inc., Bakkt is headquartered in Atlanta, GA. For more information, visit: https://www.bakkt.com/

Additional Information and Where to Find It

In connection with the Business Combination, VIH has filed a Registration Statement on Form S-4 (the “Form S-4”) with the SEC which includes a prospectus with respect to changing VIH’s jurisdiction of incorporation from the Cayman Islands to the State of Delaware, and a proxy statement with respect to VIH’s stockholder meeting at which VIH stockholders will be asked to vote on the proposed Business Combination. VIH and Bakkt urge investors, stockholders and other interested persons to read the Form S-4, including the proxy statement/prospectus, as well as other documents filed with the SEC, because these documents will contain important information about the Business Combination.

When available, the definitive proxy statement/prospectus and other relevant materials for the Business Combination will be mailed to shareholders of VIH as of a record date to be established for voting on the Business Combination. VIH’s shareholders will also be able to obtain copies of the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus and other documents filed with the SEC, without charge, once available, at the SEC’s website at www.sec.gov. These documents (when they are available) can also be obtained free of charge from VIH upon written request to VIH by emailing [email protected] or by directing a request to VIH’s secretary at c/o Victory Park Capital Advisors, LLC, 150 North Riverside Plaza, Suite 5200, Chicago, IL 60606.

Participants in Solicitation

VIH, Bakkt and their respective directors, managers, executive officers and other members of their management and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of VIH stockholders in connection with the Business Combination. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to VIH’s stockholders in connection with the Business Combination is set forth in the preliminary proxy statement/prospectus contained in the Form S-4, and will also be included in the definitive proxy statement/prospectus for the Business Combination when available. Information concerning the interests of VIH and Bakkt’s participants in the solicitation, which may, in some cases, be different than those of VIH and Bakkt’s equity holders generally, is also set forth in the proxy statement/prospectus contained in the Form S-4, and will also be included in the definitive proxy statement/prospectus for the Business Combination when available.

Non-Solicitation

This communication is for informational purposes only and is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy or subscribe for any securities or a solicitation of any vote of approval, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

Forward Looking Statements

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “believe,” “intend,” “plan,” “projection,” “outlook” or words of similar meaning. These forward-looking statements include, but are not limited to, statements regarding Bakkt’s industry and market sizes, future opportunities for VIH, Bakkt and the combined company, VIH’s and Bakkt’s estimated future results and the Business Combination, including the implied enterprise value, the expected transaction and ownership structure and the likelihood and ability of the parties to successfully consummate the Business Combination. Such forward-looking statements are based upon the current beliefs and expectations of our management and are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are difficult to predict and generally beyond our control. Actual results and the timing of events may differ materially from the results anticipated in these forward-looking statements.

In addition to factors previously disclosed in VIH’s reports filed with the SEC and those identified elsewhere in this communication, the following factors, among others, could cause actual results and the timing of events to differ materially from the anticipated results or other expectations expressed in the forward-looking statements: (i) inability to meet the closing conditions to the Business Combination, including the occurrence of any event, change or other circumstances that could give rise to the termination of the definitive agreement; (ii) the inability to complete the Business Combination due to the failure to obtain approval of VIH’s shareholders or Bakkt’s members, the failure to achieve the minimum amount of cash available following any redemptions by VIH’s shareholders or the failure to meet the national stock exchange’s listing standards in connection with the consummation of the Business Combination; (iii) costs related to the Business Combination; (iv) a delay or failure to realize the expected benefits from the Business Combination; (v) risks related to disruption of management time from ongoing business operations due to the Business Combination; (vi) the impact of the ongoing COVID-19 pandemic; (vii) changes in the markets in which Bakkt competes, including with respect to its competitive landscape, technology evolution or regulatory changes; (viii) changes in the markets that Bakkt targets; (ix) risk that Bakkt may not be able to execute its growth strategies, including identifying and executing acquisitions; (x) risks relating to data security; and (xi) risk that Bakkt may not be able to develop and maintain effective internal controls. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of VIH’s final prospectus dated September 22, 2020 relating to its initial public offering, the registration statement on Form S-4 and proxy statement/prospectus discussed above and other documents filed by VIH from time to time with the SEC. These filings identify and address, or will identify and address, other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

Actual results, performance or achievements may differ materially, and potentially adversely, from any projections and forward-looking statements and the assumptions on which those forward-looking statements are based. There can be no assurance that the data contained herein is reflective of future performance to any degree. You are cautioned not to place undue reliance on forward-looking statements as a predictor of future performance as projected financial information and other information are based on estimates and assumptions that are inherently subject to various significant risks, uncertainties and other factors, many of which are beyond our control. All information set forth herein speaks only as of the date hereof in the case of information about VIH and Bakkt or the date of such information in the case of information from persons other than VIH or Bakkt, and we disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this communication. Forecasts and estimates regarding Bakkt’s industry and end markets are based on sources we believe to be reliable, however there can be no assurance these forecasts and estimates will prove accurate in whole or in part. Annualized, pro forma, projected and estimated numbers are used for illustrative purpose only, are not forecasts and may not reflect actual results.

For Bakkt:

Investors

[email protected]

Media

Rachel Ford

[email protected]

For VIH:

Investors

[email protected]

Media

Julia Fisher (Sahin)

[email protected]

KEYWORDS: Illinois United States North America

INDUSTRY KEYWORDS: Professional Services Finance

MEDIA:

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Office Properties Income Trust First Quarter 2021 Conference Call Scheduled for Friday, April 30th

Office Properties Income Trust First Quarter 2021 Conference Call Scheduled for Friday, April 30th

NEWTON, Mass.–(BUSINESS WIRE)–Office Properties Income Trust (Nasdaq: OPI) today announced that it will issue a press release containing its first quarter 2021 financial results after the Nasdaq closes on Thursday, April 29, 2021. On Friday, April 30, 2021 at 10:00 a.m. Eastern Time, President and Chief Operating Officer Christopher Bilotto and Chief Financial Officer Matthew Brown will host a conference call to discuss these results.

The conference call telephone number is (877) 328-1172. Participants calling from outside the United States and Canada should dial (412) 317-5418. No pass code is necessary to access the call from either number. Participants should dial in about 15 minutes prior to the scheduled start of the call. A replay of the conference call will be available through 11:59 p.m. on Friday, May 7, 2021. To access the replay, dial (412) 317-0088. The replay pass code is 10153730.

A live audio webcast of the conference call will also be available in a listen-only mode on the company’s website, which is located at www.opireit.com. Participants wanting to access the webcast should visit the company’s website about five minutes before the call. The archived webcast will be available for replay on the company’s website after the call.

Office Properties Income Trust is a real estate investment trust, or REIT, which primarily owns properties located throughout the United States and leased to single tenants and those with high credit quality characteristics like government entities. OPI is managed by the operating subsidiary of The RMR Group Inc. (Nasdaq: RMR), an alternative asset management company that is headquartered in Newton, MA.

A Maryland Real Estate Investment Trust with transferable shares of beneficial interest listed on the Nasdaq.

No shareholder, Trustee or officer is personally liable for any act or obligation of the Trust.

Olivia Snyder, Manager, Investor Relations

(617) 219-1410

www.opireit.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Commercial Building & Real Estate Construction & Property REIT

MEDIA:

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Applied DNA Appoints Clay Shorrock as Chief Legal Officer and Executive Director of Business Development

Applied DNA Appoints Clay Shorrock as Chief Legal Officer and Executive Director of Business Development

– Shorrock Rejoins Company; Appointment Underscores Company’s Pursuit of Commercial Activities In Highly Regulated End-Markets, Including Biotherapeutics and Diagnostics –

STONY BROOK, N.Y.–(BUSINESS WIRE)–Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that Clay Shorrock, J.D., has rejoined the Company effective immediately to serve on the executive leadership team as Chief Legal Officer and Executive Director, Business Development. In this newly created role, Mr. Shorrock will lead Applied DNA’s legal, regulatory, IP, and business development functions.

Dr. James A. Hayward, president and CEO, Applied DNA, said, “As we continue to advance the adoption of our PCR-based, LinearDNATM manufacturing platform across highly regulated markets and further develop our IP estate, especially around cancer immunotherapy, viral vectors, vaccines, and molecular diagnostics, we are thrilled to bring Clay’s expertise to the leadership team. His prior history with the Company, his deep understanding of our non-biological business coupled with his wealth of experience in life sciences and corporate strategic planning, make him ideally suited to also lead our business development efforts as we work to advance our proprietary platform across multiple business verticals. We look forward to his contributions to position Applied DNA for future success and shape sustained growth.”

Mr. Shorrock has over a decade of experience in intellectual property, patent law, and complex commercial transactions having represented clients, including Fortune 500 and development stage companies. He holds extensive legal experience in the areas of biotechnology, molecular biology, immunotherapy, and medical diagnostics. Mr. Shorrock served as in-house general and IP counsel to Applied DNA from 2016 through 2019, and thereafter as outside general and IP counsel. Mr. Shorrock has been instrumental in the development of the CertainT® platform utilized in supply chain security applications and the expansion of the Company’s core PCR-manufacturing capabilities into biotherapeutics and diagnostics. He also led the effort to secure Emergency Use Authorization for the Company’s LineaTM COVID-19 Assay Kit and subsequent amendments that increased the assay’s utility. Mr. Shorrock holds a B.A. in Biology from Franklin and Marshall College and a J.D. with a concentration in intellectual property from Seton Hall University Law School.

Clay Shorrock stated, “With a burgeoning profile in the biotherapeutics industry and supported by a recently launched, first ever LinearDNA-based clinical trial for a veterinary COVID-19 vaccine candidate, it’s an exciting time to rejoin the Applied DNA team and its extraordinary group of experts working to bring science and service to society. I look forward to contributing to the Company’s progress.”

About Applied DNA Sciences

Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.

The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.

The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

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 possibility that the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic 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) 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 or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, 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 17, 2020, and Form 10-Q filed on February 11, 2021 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.

Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, [email protected]

Web:www.adnas.com

Twitter: @APDN

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Other Health Research General Health Professional Services Pharmaceutical Oncology Other Professional Services Science Legal Biotechnology Other Science Health

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AllianzIM Announces New Upside Caps for April Buffered Outcome ETFs

AllianzIM Announces New Upside Caps for April Buffered Outcome ETFs

Reset marks the start of new 12-month outcome period for 10% and 20% buffer strategies (AZAA and AZBA)

MINNEAPOLIS–(BUSINESS WIRE)–
Allianz Investment Management LLC (AllianzIM), a wholly-owned subsidiary of Allianz Life Insurance Company of North America (Allianz Life®), announces new upside caps for the April series of its Buffered Outcome ETFs suite: the AllianzIM U.S. Large Cap Buffer10 Apr ETF (NYSE: AZAA) and the AllianzIM U.S. Large Cap Buffer20 Apr ETF (NYSE: AZBA).

Ticker

Index

Exposure

Buffer1

Cap1

Outcome

Period Start

Date

Outcome Period

End Date

AZAA

AllianzIM U.S. Large Cap Buffer10 Apr ETF

S&P 500

10% Gross / 9.26% Net

13.00% Gross / 12.26% Net

April 1, 2021

March 31, 2022

AZBA

AllianzIM U.S. Large Cap Buffer20 Apr ETF

S&P 500

20% Gross / 19.26% Net

6.45% Gross 5.71% Net

April 1, 2021

March 31, 2022

AllianzIM Buffered Outcome ETFs debuted in June 2020 and are designed to provide exposure to the S&P 500 Price Return Index up to a stated cap, while aiming to buffer investors from losses on the downside. AllianzIM currently offers two strategies on the S&P 500 Index: a 10% buffer and 20% buffer, each with quarterly offerings and 12-month outcome periods. The funds are the lowest cost defined outcome ETFs on the market today and consistently trade with some of the tightest spreads among peers in the category.2

“Despite markets reaching record highs to start 2021, investing at these levels can pose even further risks to investors amid continued uncertainties across equities and bonds, including rising bond yields and growing inflationary pressures,” notes Brian Muench, President of AllianzIM. “AllianzIM Buffered Outcome ETFs allow provide investors a way to enter the market and stay invested with a level of risk mitigation.”

AllianzIM Buffered Outcome ETFs leverage AllianzIM’s core strengths, which include risk management experience and in-house hedging capabilities. AllianzIM manages its ETF line-up on a proprietary in-house hedging platform with over $150 billion in hedged assets. Offering a new way to help investors seek to mitigate risk and reduce volatility, these new ETFs complement Allianz Life’s suite of annuity and life insurance products.

“If the pandemic has taught us anything, it’s that there is inherent uncertainty all around us and value in paving a way toward a potentially more secure future,” explains Johan Grahn, Head of ETF Product Strategy at AllianzIM. “As investors look for a better 2021 and beyond, they can rely on the strength and experience of AllianzIM to help them manage the risk in their portfolios.”

For more information on the AllianzIM Buffered Outcome ETF suite, please visit www.allianzIM.com.

1 Gross reflects the Cap and Buffer prior to taking into account the 0.74% expense ratio of the ETF while Net accounts for the expense ratio, but does not include brokerage commissions, trading fees, taxes and non-routine or extraordinary expenses. The Cap and Buffer experienced by investors may be different than the stated numbers. The funds’ website, at www.allianzIM.com, provides important fund information as well as information relating to the potential outcomes of an investment in the Fund on a daily basis.

2 Based on information from ETF Database as of 3.26.21 that includes expense data and other descriptive information for all Buffered ETFs listed on U.S. exchanges that are currently tracked by ETF Database. Additionally based on information from AllianzIM as of the week of 3.15.21 based on market data sourced from NYSE that demonstrates averages by issuer.

Investing involves risk including possible loss of principal.

Investors may lose their entire investment, regardless of when they purchase shares, and even if they hold shares for an entire Outcome Period. Full extent of Caps and Buffers only apply if held for stated Outcome Period and are not guaranteed. The Cap may increase or decrease and may vary significantly.

Investors should consider the investment objectives, risks, charges and expenses carefully before investing. For a prospectus with this and other information about the Fund, please visit www.allianzim.com or call 877.429.3837. Read the prospectus carefully before investing.

The Funds seek to deliver returns that match, at the end of a specified one-year period (outcome period) the returns of the S&P 500 Price Index up to a predetermined Cap, while limiting downside losses by the amount of a specified Buffer, before fees and expenses. There is no guarantee the funds will achieve their investment objectives. You may lose your entire investment, regardless of when you purchase shares, and even if you hold shares for an entire Outcome Period. The Fund may not be suitable for all investors.

The “S&P 500 Price Return Index” (“Index”) is a product of S&P Dow Jones Indices LLC or its affiliates (“SPDJI”) and Standard & Poor’s Financial Services LLC (“S&P”), and has been licensed for use by Allianz Investment Management LLC (“AllianzIM”). Standard & Poor’s®, S&P®, and S&P 500® are registered trademarks of S&P; Dow Jones® is a registered trademark of Dow Jones Trademark Holdings LLC (“Dow Jones”); and these trademarks have been licensed for use by SPDJI and sublicensed for certain purposes by AllianzIM. AllianzIM U.S. Large Cap Buffer10 Apr ETF and AllianzIM U.S. Large Cap Buffer20 Apr ETF are not sponsored, endorsed, sold or promoted by SPDJI, Dow Jones, S&P, or their respective affiliates, and none of such parties make any representation regarding the advisability of investing in such product(s) nor do they have any liability for any errors, omissions, or interruptions of the Index.

Distributed by Foreside Fund Services, LLC.

About Allianz Investment Management LLC

AllianzIM, a wholly owned subsidiary of Allianz Life Insurance Company of North America, is a registered investment adviser. AllianzIM provides hedging and other derivatives-based risk management solutions through its proprietary platform.

About Allianz Life Insurance Company of North America

Allianz Life Insurance Company of North America, one of the FORTUNE 100 Best Companies to Work For® and one of the Ethisphere World’s Most Ethical Companies®, has been keeping its promises since 1896 by helping Americans achieve their retirement income and protection goals with a variety of annuity and life insurance products. In 2020, Allianz Life provided additional value to its policyholders via distributions of more than $10.1 billion. As a leading provider of fixed index annuities, Allianz Life is part of Allianz SE, a global leader in the financial services industry with approximately 150,000 employees in more than 70 countries. Allianz Life is a proud sponsor of Allianz Field® in St. Paul, Minnesota, home of Major League Soccer’s Minnesota United.

Leah Katsanis

Gregory FCA for AllianzIM

610-200-0564

[email protected]

Brett Weinberg

Allianz Life

(763) 765-7160

[email protected]

KEYWORDS: United States North America Minnesota

INDUSTRY KEYWORDS: Banking Professional Services Insurance Finance

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Revance to Showcase Phase 3 Results Evaluating DaxibotulinumtoxinA for Injection for the Treatment of Cervical Dystonia at the American Academy of Neurology Annual 2021 Virtual Meeting

Revance to Showcase Phase 3 Results Evaluating DaxibotulinumtoxinA for Injection for the Treatment of Cervical Dystonia at the American Academy of Neurology Annual 2021 Virtual Meeting

NASHVILLE, Tenn.–(BUSINESS WIRE)–
Revance Therapeutics (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced the company will present an ePoster at the 2021 American Academy of Neurology (AAN) Virtual Annual Meeting taking place from April 17-22, 2021. Revance will present results from its ASPEN-1 Phase 3 clinical trial evaluating the efficacy and safety of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults.

“We’re pleased to present the efficacy and safety findings from the ASPEN-1 Phase 3 clinical trial evaluating DaxibotulinumtoxinA for Injection at this year’s 2021 AAN Virtual Meeting, specifically, the median duration of effect of up to 24 weeks, as determined by time to loss of 80% peak treatment benefit, suggested that DaxibotulinumtoxinA for Injection has the potential to reduce frequency of cervical dystonia treatments by up to 50% annually, while being generally safe and well tolerated,” said Roman Rubio, Senior Vice President of Clinical Development at Revance. “The findings being presented are part of a growing body of clinical evidence that supports DaxibotulinumtoxinA for Injection’s differentiated performance profile and underscores the potential of our therapeutics pipeline for the treatment of muscle movement and pain disorders for patients who suffer from these debilitating conditions.”

The abstracts are available online via the AAN website at www.aan.com.

ePoster Presentation:

  • Title: A Phase 3 Trial Evaluating the Efficacy, Duration of Effect, and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Cervical Dystonia

    Authors and Affiliations: Joseph Jankovic, Parkinson’s Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, TX; Cynthia Comella, Rush University Medical Center, Chicago, IL; Robert A. Hauser, Director of the University of South Florida Parkinson’s Disease and Movement Disorders Center, Tampa, FL; Atul T. Patel, Kansas City Bone & Joint Clinic, Overland Park, KS; Todd M. Gross, Roman G. Rubio, Domenico Vitarella, Revance Therapeutics, Newark, CA

ASPEN Phase 3 Clinical Program in Cervical Dystonia

In 2017, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for DaxibotulinumtoxinA for Injection to treat cervical dystonia, which provides certain developmental and financial benefits to trial sponsors.

The company’s ASPEN Phase 3 clinical program consists of two trials to evaluate the safety and efficacy of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults: 1) ASPEN-1, a randomized, double-blind, placebo-controlled, parallel group trial and 2) ASPEN-OLS, an open-label, long-term safety trial.

Randomized Trial (ASPEN-1): Patients were randomized to a single treatment of either 125 Unit or 250 Unit dose of DaxibotulinumtoxinA for Injection, or placebo. Post-treatment, patients are followed for a maximum of 36 weeks. The primary efficacy endpoint of the trial was the mean change from baseline in the TWSTRS Total Score at the average of Weeks 4 and 6. Key secondary endpoints include the duration of treatment effect, measurement of treatment response on the Clinical and Patient Global Impression of Change assessments, and adverse events. Further, the trial featured exploratory efficacy assessments including the Cervical Dystonia Impact Profile (CDIP-58), a disease-specific, patient-rated questionnaire that measures quality of life.

Open-Label Study (ASPEN-OLS): Patients receive up to four sequential treatment cycles of DaxibotulinumtoxinA for Injection over the 52-week observation period. Primary endpoints of the trial are safety and immunogenicity after multiple cycles of treatment with DaxibotulinumtoxinA for Injection. Key secondary endpoints are the change from baseline in TWSTRS Total Score and the duration of treatment effect, as well as overall treatment response based on the Clinical and Patient Global Impression of Change. The ASPEN-OLS trial is fully enrolled with a total of 354 patients at sites located in the United States, Canada, and Europe.

Additional information about the ASPEN Phase 3 program is available at www.clinicaltrials.gov.

About Cervical Dystonia

According to the Dystonia Medical Research Foundation, cervical dystonia is a painful and disabling chronic condition in which the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck. The movements may be sustained (tonic), jerky (clonic), or a combination. Cervical dystonia (also referred to as spasmodic torticollis) may be primary (meaning that it is the only apparent neurological disorder, with or without a family history) or may be the result of secondary causes (such as physical trauma).

First-line treatment for cervical dystonia is usually neuromodulator (botulinum toxin) injections, but additional treatments can include oral medications, surgery, and complementary therapies. Neuromodulators block the communication between the nerve and the muscle, relaxing the muscle, which alleviates abnormal involuntary movements and postures. Current neuromodulator treatments for cervical dystonia have a duration of effect of approximately three months. Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects a few hundred thousand adults and children in the United States alone. The global market opportunity for cervical dystonia was $390 million in 2020 and is expected to grow to $587 million by 2025.1 According to the Decision Resources Group, the global market for treating cervical dystonia and spasticity muscle movement disorders was approximately $1.0 billion in 2020.1

About Revance Therapeutics, Inc.

Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in two therapeutic indications – cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

BOTOX® is a registered trademark of Allergan, Inc.

Forward-Looking Statements

Any statements in this press release that are not statements of historical fact, including statements related to development of a biosimilar to BOTOX®; statements about our business strategy, the market for our anticipated products and plans and prospects, and potential benefits of our drug product candidates, including with respect to cervical dystonia and muscle movement and pain disorders, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including delays in the approval of our BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, clinical trials and other aspects of our business; our ability to manufacture supplies for our product candidates; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to successfully compete with other treatments and therapies; our ability to achieve, and the rate and degree of commercial acceptance and the market, size and growth potential of our drug product candidates, if approved; our ability to successfully commercialize our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to obtain and maintain regulatory approval of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled “Risks Factors” on our Form 10-K filed with the SEC on February 25, 2021. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

1 December 2020 – Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2021

Investors

Revance Therapeutics, Inc.:

Jessica Serra, 626-589-1007

[email protected]

or

Gilmartin Group, LLC.:

Laurence Watts, 619-916-7620

[email protected]

Media

Revance Therapeutics, Inc.:

Sara Fahy, 949-887-4476

[email protected]

or

General Media:

Goodfuse:

Jenifer Slaw, 347-971-0906

[email protected]

or

Trade Media:

Nadine Tosk, 504-453-8344

[email protected]

KEYWORDS: United States North America Tennessee

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Clinical Trials

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Lantern Pharma Expands Portfolio of Cancer Opportunities for LP-184 with ATRT Pediatric Brain Tumor Collaboration with Johns Hopkins

– Initiates studies in collaboration with pediatric brain cancer expert, Dr. Eric Raabe, M.D., Ph.D

– Collaboration will leverage Dr. Raabe’s large panel of brain cancer cell lines and xenografts

– ATRT may qualify under the Rare Pediatric Disease Designation which Lantern will pursue

PR Newswire

DALLAS, April 1, 2021 /PRNewswire/ — Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence (“A.I.”) platform to transform oncology drug discovery and development, today announced a collaboration with Johns Hopkins Pediatric Oncology Division of The Sidney Kimmel Comprehensive Cancer Center and Dr. Eric Raabe, M.D., Ph.D. focused on Lantern’s drug candidate LP-184 in the area of brain tumors, and specifically in Atypical Teratoid Rhabdoid Tumors (“ATRT”), an ultra-rare and fast-growing cancerous tumor of the brain that presents primarily in children.

“As we enriched our RADR® A.I. platform for additional cancer indications, we began to discover common molecular pathways that drive response to our drug candidate, LP-184, across multiple additional CNS cancers,” stated Panna Sharma, President and CEO of Lantern Pharma. “Chief among these newly identified CNS cancers was ATRT, an ultra-rare and fast-growing cancerous tumor of the brain that presents primarily in children with no effective therapies. The urgency of directing LP-184 towards helping children battle this particularly aggressive cancer was self-evident, as was the opportunity to collaborate with the Johns Hopkins’ pediatric oncologist, Dr. Eric Raabe, who has devoted his career to studying pediatric brain cancers, including ATRT.”

Rhabdoid tumors (RTs) can emerge in the brain, kidneys, liver and all compartments of the central nervous system (“CNS”). Approximately 66% of RTs occur in the CNS and are called ATRTs. ATRTs predominantly affect infants and young children, with up to 15% of ATRTs arising in the brain. Incidence of ATRT is between 1.4 and 3.0 per million, and the survival rate is between 10% and 15% depending on the age at diagnosis. Pediatric brain cancer is the second-leading cause of pediatric cancer death with the incidence rate growing at ~2.7% per year in the United States. 

Dr. Eric Raabe, M.D., Ph.D., is assistant professor of oncology in the Division of Pediatric Oncology at Johns Hopkins and a co-principal investigator at the Pacific Pediatric Neuro-Oncology Consortium. A physician-scientist, Dr. Raabe has devoted his career to the pursuit of treatment options for the most high-risk pediatric brain cancers, including ATRT where Dr. Raabe uses a unique and highly curated panel of cell lines and xenografts in preclinical studies for drug development and research. These models have had extensive molecular and genomic profiling including biomarker studies to help better understand the ATRT and other related CNS cancers.

Over 90% of cases of ATRT are caused by a mutation which drives a partial or whole loss of chromosome 22, resulting in the inactivation of the SMARCB1 gene (Switch/sucrose nonfermentable [SWI/SNF] related, Matrix-associated, Actin-dependent Regulator of Chromatin, subfamily B1). SMARCB1 is a protein encoding and tumor suppressor gene which drives downstream production of the SMARCB1 protein and other SWI/SNF protein subunits which are thought to act as tumor suppressors. While ATRT is diagnosed with standard immunochemistry staining to detect loss of the respective protein(s), no standard of care currently exists for ATRT and ATRT in the brain is typically unresectable. Treatment options are typically limited to only chemotherapy agents since radiotherapy is not advised in children.

“To support the discovery and development of innovative medicines that may help children diagnosed with rare diseases, the U.S. FDA has created a Rare Pediatric Disease Designation. We believe that the rarity of incidence of ATRT in the U.S and its prevalence in children supports the potential for LP-184 to qualify in the future for a possible grant by the US. FDA for a Rare Pediatric Disease Designation for use of LP-184 for ATRT,” continued Mr. Sharma. “Moreover, if we are successful in receiving a Rare Pediatric Disease Designation, we believe LP-184, if it receives ultimate approval, may possibly qualify for the granting by the U.S. FDA of a Rare Pediatric Disease Priority Review Voucher (“PRV”). We believe the award of a PRV would represent a significant value enhancing milestone for Lantern Pharma.”

Lantern Pharma plans on continuing to use RADR® to potentially uncover and develop other indications in brain and CNS cancers where LP-184 has the potential to show efficacy.

Contact

Marek Ciszewski, JD
Director, Investor Relations
628-777-3167
[email protected]

About Lantern Pharma
Lantern Pharma (LTRN) is a clinical-stage biopharmaceutical company leveraging its proprietary RADR® A.I. platform and machine learning to discover biomarker signatures that identify patients most likely to respond to its pipeline of genomically-targeted cancer therapeutics. RADR® A.I. platform is among the world’s largest A.I. oncology datasets. Once a drug candidate is identified and validated in silico, our collaborator-centered business model seeks out industry partners and leading scientific advisors to capital-efficiently develop genetically-targeted cancer therapeutics in areas of high unmet clinical need. Lantern is currently developing four drug candidates and an ADC program across seven disclosed tumor targets, including two phase 2 programs. By targeting drugs to patients whose genomic profile identifies them as having the highest probability of benefiting from the drug, Lantern’s approach represents the potential to deliver best-in-class outcomes. More information is available at: www.lanternpharma.com and Twitter @lanternpharma.

About LP-184
LP-184 is currently in multiple research studies in collaboration with leading cancer research institutions. With the assistance of our RADR® A.I. platform, LP-184’s mechanism of action has been well-characterized through numerous in silico and in vivo studies and described in published peer-reviewed articles. With observed nanomolar potency and blood brain barrier permeability, LP-184 is an alkylating agent that works by causing DNA damage in tumor cells. As shown by CRISPR gene editing techniques, LP-184 activity is dependent upon the expression of Prostaglandin Reductase 1 (“PTGR1”), which transforms LP-184 into its bioactive form by the oxidoreductase activity of PTGR1. Additional information on LP-184 is available at: Oncology Drug Development Pipeline – Lantern Pharma.

Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the impact of the COVID-19 pandemic, (ii) the risk that our research and the research of our collaborators in the area of ATRT may not be successful; (iii) the risk that we may never receive a Rare Pediatric Disease Designation for LP-184 in ATRT and may never qualify for the grant of a Rare Pediatric Disease Priority Review Voucher (iv) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates; (v) the risk that no drug product based on our proprietary RADR A.I. platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vi) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021. You may access our Annual Report on Form 10-K for the year ended December 31, 2020 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC’s website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.

 

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SOURCE Lantern Pharma