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NEWS -- Navidea Biopharmaceuticals Announces Changes to Board of Directors Composition
Industry veteran Amit Bhalla appointed to the Board of Directors
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that Michael Rice, the Company’s Chair of the Board, and Adam Cutler have retired from their positions on Navidea’s Board of Directors to focus on other endeavors. Dr. Kathy Rouan has been appointed as Chair of the Board following Mr. Rice’s retirement.
Additionally, Amit Bhalla has been appointed to Navidea’s Board of Directors. Mr. Bhalla currently serves as the Chief Financial Officer of Infinity BiologiX. Prior to his current role he served as a Senior Healthcare Analyst at Lord, Abbett & Co. LLC and has held senior leadership positions at multiple Financial and Healthcare firms including Beckton Dickinson, Johnson & Johnson, Citigroup, and Morgan Stanley. Mr. Bhalla received his MBA from the Tepper School of Business and his undergraduate degree at Cornell University.
Jed Latkin, Navidea’s CEO said, "We thank both Michael and Adam for their service on the Board and the valuable insights they have provided over the years. We are excited about the addition of Amit Bhalla to the Board. His diverse background in financial services and operational roles at world class healthcare corporations will provide unique perspectives."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.
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. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210505005587/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
Joel Kaufman
Chief Business Officer
614-822-2372
mailto://jkaufman@navidea.com
NEWS -- Kintara Therapeutics to Participate at the Benzinga Global Small Cap Conference
SAN DIEGO, May 5, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today that its Chief Executive Officer Saiid Zarrabian will participate at the Benzinga Global Small Cap Conference on May 14, 2021.
Mr. Zarrabian will deliver his corporate presentation at 12:25 pm ET on May 14, 2021.
Investors can also request a one-on-one meeting with Mr. Zarrabian to be arranged following the conclusion of the conference.
Investors can register for the conference here:
https://www.benzinga.com/events/small-cap/global/
About Kintara
Located in San Diego, California, Kintara (Nasdaq: KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).
VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.
REM-001 is a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.
For more information, please visit https://www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials and the GBM AGILE study. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
CONTACTS
Investors
CORE IR
516-222-2560
mailto://ir@coreir.com
Media
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
mailto://julesa@coreir.com
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SOURCE Kintara Therapeutics
NEWS -- Lineage Announces Appointment of Anula Jayasuriya, M.D., PH.D., M.B.A., to Board of Directors
NEWS -- Heat Biologics Provides First Quarter 2021 Business Update; Reports Continued Progress on Oncology and COVID-19 Vaccine Programs
DURHAM, N.C., May 05, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today provided financial, clinical and operational updates for the first quarter ended March 31, 2021.
Jeff Wolf, Chief Executive Officer of Heat, commented, “We continue to make tremendous progress on our clinical programs, including both our oncology program and COVID-19 vaccine program, which we recently advanced into scale-up manufacturing. We are currently reviewing a variety of possible Phase 3 registration settings for HS-110 in combination with checkpoint inhibitors, following positive interim data from our Phase 2 trial in patients with advanced non-small cell lung cancer (NSCLC).”
“We recently announced promising new preclinical data around PTX-35, our potential first-in-class T-cell co-stimulatory antibody at the AACR Annual Meeting 2021. We are completing enrollment in our Phase 1 PTX-35 trial in patients with solid tumors and expect to share interim data later this year.”
“Finally, we have maintained a solid balance sheet with over $128 million of cash and short-term investments, which should provide us substantial runway to fund our current clinical programs and further expand our therapeutic portfolio. Moreover, we believe that upcoming catalysts and milestones have the potential to drive significant shareholder value in 2021,” concluded Mr. Wolf.
First Quarter 2021 Financial Results
NEWS -- Lineage Cell Therapeutics to Report First Quarter 2021 Financial Results and Provide Business Update on May 13, 2021
Lineage Cell Therapeutics, Inc. (https://lineagecell.com/)(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its first quarter 2021 financial and operating results on Thursday, May 13, 2021, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, May 13, 2021, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2021 financial and operating results and to provide a business update.
Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website (https://investor.lineagecell.com/events-and-presentations/upcoming-events). A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 21, 2021, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 4996965.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210504005098/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Kintara Therapeutics Appoints Tamara A. Seymour to Board of Directors
SAN DIEGO, May 4, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced the appointment of Tamara A. Seymour to the Company's Board of Directors replacing John Liatos, who will continue in his role as Kintara's Senior Vice President of Business Development.
"We are delighted to welcome Tamara to the Board of Directors as she brings exceptional healthcare sector experience as an accomplished financial and operational executive," commented Saiid Zarrabian, Kintara's President and Chief Executive Officer. "Tamara's insights and perspectives will be a valuable addition to the Board and the entire Company as we continue to advance our platform assets VAL-083 and REM-001. We wish to thank John for his service to the Board and are excited to continue working with him as the Company's Senior VP of Business Development."
Ms. Seymour is a corporate finance veteran with three decades of experience in the biotech and life sciences industries including 20 years as a chief financial officer. Her experience includes leading finance, investor relations, managed care and reimbursement, human resources, administration, and information technology. She has raised over $250 million in multiple private and public equity and debt financings, including spearheading an IPO. She is a member of the Board of Directors and Audit Committee of Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical stage biopharmaceutical company in La Jolla, California, and a former Chief Financial Officer (CFO) at multiple private and public companies where she played an integral role in merger and acquisition activities. Her recent CFO posts included serving as Interim CFO of Immunic, Inc., a clinical-stage drug development company, where she was instrumental in its transition from being a venture-backed private entity to a publicly-traded, post-merger company with Vital Therapies, Inc. During her illustrious career, Ms. Seymour has also served as CFO of Signal Genetics, Inc., a publicly-traded molecular diagnostics company and CFO of Favrille, Inc., a publicly-traded clinical-stage drug development company. Ms. Seymour is a certified public accountant (inactive). She received an MBA, with an emphasis in finance, from Georgia State University and earned her bachelor's degree in Business Administration, with an emphasis in accounting, from Valdosta State University.
ABOUT KINTARA
Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).
VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.
Kintara is also advancing its proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC, who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.
SAFE HARBOR STATEMENT
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
CONTACTS:
Investors:
CORE IR
516-222-2560
mailto://ir@coreir.com
Media:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
mailto://julesa@coreir.com
View original content to download multimedia: http://www.prnewswire.com/news-releases/kintara-therapeutics-appoints-tamara-a-seymour-to-board-of-directors-301282915.html
SOURCE Kintara Therapeutics
NEWS -- Plus Therapeutics Announces Key RNL™ Development and cGMP Drug Manufacturing Collaboration Agreements
May 04 2021 - 07:30AM GlobeNewswire Inc.
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced two collaboration agreements to support its process development and analytical chemistry activities for the cGMP manufacturing of Rhenium NanoLiposome (RNL™), the Company’s lead investigational asset in clinical development for recurrent glioblastoma.
Plus Therapeutics signed a pre-clinical, clinical, and process development agreement with Invicro LLC (Invicro), a Konica Minolta company, a global provider of imaging biomarkers, core lab services, advanced analytics and software solutions for drug discovery and development with best-in-class expertise in radiochemistry. Under this agreement, Invicro will characterize the current manufacturing process and develop in-process manufacturing controls for the RNL™ active pharmaceutical ingredient (API) and final drug product and provide future clinical trial imaging support and drug development consulting.
In addition, Plus Therapeutics entered into an agreement with Eurofins BioPharma Inc. (“Eurofins”), a market leader in analytical chemistry for discovery pharmacology and advanced materials sciences. Eurofins will develop and validate test methods for purity, composition, and identity of Re-BMEDA, the API in RNL™. These test methods will support release testing and compliance with cGMP requirements for new drug substances.
“Process optimization and appropriate quality controls of investigational compounds are very critical aspects in bringing novel drugs to markets,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “We have identified two best-in-class partners in Invicro and Eurofins to help us get one step further in bringing RNL to a registrational clinical trial and ultimately commercial supply.”
As previously disclosed, Plus Therapeutics entered into a master services agreement with Piramal Pharma Solutions for the development, manufacture, and supply of RNL™ intermediate of the drug product.
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
About Invicro, LLC.
Headquartered in Boston, Mass., Invicro was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro’s multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology, and systemic and rare diseases. Invicro’s quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by Invicro’s industry-leading software informatics platforms, VivoQuant® and iPACS®, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ and DaTIQ.
As part of the Konica Minolta precision medicine organization and with their sister company Ambry Genetics, Invicro develops and leverages the latest approaches in integrated diagnostics including imaging, quantitative pathology and genomics. For more information, visit https://www.invicro.com.
About Eurofins BioPharma Inc.
Eurofins is a group of international life sciences companies which provide a unique range of analytical testing services to clients across multiple industries. The Group is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company’s in-licensed portfolio of investigational drugs; the Company’s intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s history of losses; the Company’s need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company’s ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company’s partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Navidea Biopharmaceuticals to Host First Quarter 2021 Earnings Conference Call and Corporate Update
Conference Call to be Held on Tuesday, May 11, 2021 at 5:00 p.m. (EDT)
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will host a conference call and webcast on Tuesday, May 11 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the first quarter ended March 31, 2021.
Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Joel Kaufman, Chief Business Officer, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.
To participate in the call and webcast, please refer to the information below:
Event: Q1 2021 Earnings and Business Update Conference Call
Date: Tuesday, May 11, 2021
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-in: 877-407-0312
International Dial-in: +1 201-389-0899
Conference ID: 13718969
Webcast Link: https://www.webcast-eqs.com/navidbioph20210511/en
A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.
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. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210504005062/en/
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
Joel Kaufman
Chief Business Officer
614-822-2372
mailto://jkaufman@navidea.com
Always nice when we receive unsolicited support on our #evolutionary #cancer treatment for #pet cancers. Thank you US Figure Skating Icon Nancy Kerrigan – nancy3 https://t.co/Jrqevi4Xxe via @YouTube $RDGL #IsoPet #RadioGel #petcancer #savinglives #biotechnology #cancertreatment
— RadioGel™ (@RadioGel) July 23, 2019
NEWS -- OpRegen® Clinical Data Continues to Demonstrate Improvements in Patients With Dry AMD With Geographic Atrophy
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that updated interim results from its ongoing, 24-patient Phase 1/2a clinical study of its lead product candidate, OpRegen, were reported at the 2021 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2021). OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). At ARVO 2021, additional data were presented on 24 patients enrolled in the study, including all 12 patients treated in Cohort 4, which have better baseline vision and smaller areas of GA than earlier cohorts.
"I continue to be very excited about this work and the clinical data generated to date with OpRegen, especially in the better vision Cohort 4 patients," stated Principal Investigator Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute and University of Cincinnati School of Medicine. "There seems to be a significant visual acuity signal in Cohort 4 patients, with most treated eyes having stable or improved vision over time when compared to the contralateral eyes having stable or worsening vision over time. When looking at reading speed progression, treated eyes also seemed to improve while untreated eyes declined. Notably, some individual responders had impressive visual acuity improvements and reductions in GA progression compared to their contralateral eyes. Most importantly, we believe that earlier intervention in less severely affected patients along with a more central placement of transplanted OpRegen cells may increase the likelihood of a clinically beneficial effect. Overall, these results are encouraging and are of a magnitude that could be clinically very important if confirmed in further clinical studies."
"These new data continue to indicate to us that treatment with OpRegen can generate clinically meaningful outcomes in dry AMD patients with GA, particularly in those with earlier-stage disease," stated Brian M. Culley, Lineage CEO. "It also appears that earlier intervention in less severely affected patients and more central placement of the transplanted cells may increase the likelihood of observing a benefit. Additionally, among the newly reported data, it was notable that Cohort 4 patients reported improvements in a majority of the vision parameters measured by a validated quality of life questionnaire. The magnitude of these improvements was higher overall in Cohort 4 than in Cohorts 1 through 3, which is consistent with the larger clinical benefit observed among those patients. As this data set matures, our efforts turn next to evaluating the six most recently treated Cohort 4 patients for indications of retinal restoration and reductions in the size and growth of the areas of GA. Our overall objective is to position OpRegen RPE transplants as the clear leader in the race to address the large unmet need in dry AMD with GA and establish Lineage as the pre-eminent allogeneic cell therapy company."
Updated results presented at ARVO 2021 included a minimum of 4.5 months of follow-up in all 24 patients treated with OpRegen. Nine of twenty-four patients were treated with the "thaw and inject" formulation of OpRegen, two via a standard pars plana vitrectomy (PPV) and seven utilizing the Orbit™ Subretinal Delivery System (Orbit SDS).
Overall, 10/12 (83%) of the Cohort 4 patients’ treated eyes were at or above baseline visual acuity at their last assessment, based on per protocol scheduled visits ranging from 4.5 months to approximately 3 years post-transplant. Improvements in best corrected visual acuity (BCVA) for Cohort 4 patients reached up to +19 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. In contrast, 10/12 (83%) of the patients’ untreated eyes were below pre-treatment baseline values at the same time points. Among the newly reported data, three (50%) of the more recently treated Cohort 4 patients exhibited marked improvements in BCVA ranging from +7 to +16 letters at their last scheduled assessments of at least 4.5 months. Two additional Cohort 4 patients experienced a gain of 2 letters from their baseline values. One Cohort 4 patient measured 7 letters below baseline. Previously reported structural improvements in the retina, decreases in drusen density, and a trend toward slower GA progression in treated compared to untreated eyes continued. Overall, OpRegen has been well tolerated with no unexpected adverse events or serious adverse events, and evidence of durable engraftment of OpRegen RPE cells have extended to more than 5 years in earliest treated patients, supporting the potential for OpRegen to be a one-time treatment.
A Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, which was first reported 9 months following treatment, continues to demonstrate areas of retinal restoration as of their last assessment, approximately 3 years after treatment.
2021 ARVO Presentation OpRegen Data Highlights (As of April 16, 2021):
NEWS -- Oncolytics Biotech® Announces Annual General Meeting
Management will also provide its annual corporate update after the conclusion of the meeting
SAN DIEGO, Calif. and CALGARY, AB, April 30, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), (the "Company") today announced that its upcoming 2021 Annual General Meeting (the "Meeting") will be held virtually at 12:00 p.m. Eastern Daylight Time (ET) on Friday, May 7, 2021. In light of limits on larger gatherings and in the best interest of the health and safety of our employees and shareholders, the Meeting will be held as a virtual-only shareholder meeting. After the Meeting and at the conclusion of shareholder voting, the management team will provide a corporate update and Q&A for institutional investors and analysts, along with a discussion of our first quarter 2021 financial results.
The Company strongly encourages all shareholders, whether or not they plan on virtually attending the Meeting, to vote by completing and submitting their proxies or voting instruction forms, as applicable, well in advance of the Meeting. The deadline for voting or receiving proxies in relation to the Meeting is 12:00 p.m. ET on Wednesday, May 5, 2021. Information on how to vote your shares by proxy is available in the Company's Management Information Circular dated March 23, 2021 in respect of the Meeting. The information circular is available on the investor relations section of the Company's website at https://ir.oncolyticsbiotech.com/reports and can also be accessed under the Company's profile on SEDAR at https://www.sedar.com/ and EDGAR at https://www.sec.gov/edgar.shtml.
Who can Attend and Vote at the Meeting
Registered shareholders (who have not appointed a proxyholder) and duly appointed proxyholders (including non-registered shareholders who appoint themselves as proxyholders) will be able to virtually attend the Meeting, vote and ask questions, all in real-time, provided they are connected to the internet. Non-registered shareholders who have not properly appointed themselves as proxyholder will be able to attend the Meeting as guests, but will not be able to vote or ask questions at the Meeting. Non-registered shareholders who wish to vote and ask questions at the Meeting must appoint themselves as proxyholder and register with our transfer agent, AST Trust Company (Canada) ("AST") as described in the "How to Appoint and Register a Proxyholder" section below.
How to Appoint and Register a Proxyholder
Non-registered shareholders who wish to appoint themselves and all shareholders (registered and non-registered) who wish to appoint a third party (other than the management nominees identified in the form of proxy or voting information form) as proxyholder to attend the Meeting must carefully follow the instructions in the Circular and on their form of proxy or voting instruction form. After submitting their form of proxy or voting instruction form to appoint themselves or a third party as a proxyholder, shareholders MUST also complete the additional step of registering their proxyholder with AST and obtaining a control number for the Meeting by calling AST at +1-866-751-6315 (within North America) or +1-212-235-5754 (outside of North America) no later than 12:00 p.m. ET on May 5, 2021. Failure to register the proxyholder with AST will result in the proxyholder only being able to join the Meeting as a guest, with no ability to vote or ask questions.
Registered shareholders who wish to attend the Meeting themselves do no need to register a proxyholder and can use the control number provided on their proxy form.
How to Attend and Vote at the Virtual Meeting
Step 1 - Log in online to the webcast at https://web.lumiagm.com/158281614. We recommend that shareholders log in to the webcast as early as possible but not later than 15 minutes before the time of the virtual Meeting to confirm that the web browser they are using is compatible.
Step 2 - Follow these instructions:
Registered shareholders:
NEWS -- Oncolytics Biotech® Announces Upcoming Presentation at the American Society of Clinical Oncology Annual Meeting
SAN DIEGO and CALGARY, AB, April 29, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the acceptance of an abstract discussing its pancreatic adenocarcinoma trial at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place virtually from June 4 – 8, 2021. Details on the abstract and a corresponding poster presentation are shown below.
Title: Treatment with pembrolizumab in combination with the oncolytic virus pelareorep promotes anti-tumor immunity in patients with advanced pancreatic adenocarcinoma
Presentation Type: Electronic poster
Session Title: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4144
The abstract will be published on the ASCO Annual Meeting website at 5:00 p.m. ET on May 19, 2021. The corresponding poster will be made available on the meeting website at 9:00 a.m. ET on June 4, 2021.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Kirk Look
Chief Financial Officer
+1-403-670-7658
mailto://KLook@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
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SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/April2021/29/c9331.html
NEWS -- Provectus Biopharmaceuticals Announces Acceptance of PV-10® Immunotherapy Abstracts at American Society of Clinical Oncology (ASCO) 2021 Annual Meeting
NEWS -- CytoSorbents to Report Q1 2021 Operating and Financial Results
MONMOUTH JUNCTION, N.J., April 27, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, will report Q1 2021 financial results after the market close on Tuesday, May 4, 2021 at 4:45PM EST.
CytoSorbents' management will host a live conference call and presentation webcast that will recount both operational and financial progress during Q1 2021 followed by a question and answer session.
Conference Call Details:
Date: Tuesday, May 4, 2021
Time: 4:45 PM Eastern
Toll Free: 877-451-6152
International: 201-389-0879
Conference ID: 13718834
Live Presentation Webcast: http://public.viavid.com/index.php?id=144427
It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: http://public.viavid.com/index.php?id=144427
An archived recording of the conference call will be available under the Investor Relations section of the Company's website at http://cytosorbents.com/investor-relations/financial-results/
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 67 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 121,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $38 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ™, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our ability to leverage designation of CytoSorb as a breakthrough device under the FDA's Breakthrough Devices Program in order to expedite the development, assessment, and regulatory review of CytoSorb, as well as the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2021, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
CytoSorbents Contact:
Amy Vogel
(732) 398-5394
mailto://avogel@cytosorbents.com
Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
NEWS -- Lineage to Present at the B. Riley Securities’ Neuroscience Conference on April 28, 2021
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Chief Executive Officer, will be presenting at the B. Riley Securities’ Neuroscience Conference in a virtual fireside chat hosted by B. Riley Equity Research on Wednesday, April 28, 2021 at 1:30 p.m. ET.
Interested investors can access the live and archived webcast on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210426005027/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Lineage Announces Appointment of Dr. Dipti Amin to Its Board of Directors
NEWS -- FuelPositive Announces Final Approval of Intellectual Property Acquisition
TORONTO, April 21, 2021 (GLOBE NEWSWIRE) -- FuelPositive Corporation (“ FuelPositive ” or the “ Company ”) (TSX.V: NHHH) (OTCMKTS: ZNNMF) is pleased to announce that the TSX Venture Exchange has approved the intellectual property purchase agreement between the Company and Dr. Ibrahim Dincer and his team, initially announced on both March 9 and March 29, 2021.
This milestone acquisition of a first-of-its-kind technology to produce ammonia (NH 3) – a carbon-free fuel – in a zero-emission manner, by utilizing only water, air and electricity, positions FuelPositive to take a leadership position in the continued design and creation of the Hydrogen Economy.
“Until now, the production of ammonia has been one of the most carbon intense manufacturing processes on the planet, and given the amount of ammonia that is used on an annual basis in a variety of applications, ammonia is a serious negative contributor to greenhouse gases and global warming,” said Ian Clifford, CEO of FuelPositive. “This development in sustainable ammonia, and the creation of carbon-free NH 3 that is far more efficient than current manufacturing systems, could pave the way for the broad acceptance of ammonia as a fossil fuel replacement.”
In addition to the core FuelPositive team, with decades of experience in the marketing and engineering of technology-based solutions, the Company welcomes Dr. Dincer, a preeminent scientist in the NH3 and Hydrogen space, and a core group of top scientists, as Strategic Advisors to FuelPositive. This exclusive relationship will ensure that the Company is continually focused on the most relevant, timely and current thinking in state-of-the-art ammonia and hydrogen-related technologies.
“The completion of the agreement for our intellectual property marks a very exciting day for the future of carbon-free fuels and the Hydrogen Economy,” said Dr. Ibrahim Dincer. “My team and I look forward to continuing to collaborate and provide scientific guidance to the FuelPositive team as they commercialize the carbon-free NH 3 system and associated technologies. The future is bright for the consequential positive change in reducing global CO 2 emissions.”
Highlights of the expertise of the team include hydrogen and ammonia specialists; engineers and technical experts in the fields of clean energy, carbon capture, chemical fertilizers and integrated energy systems; renewable resource specialists with expertise across multiple clean energy technologies including solar, wind, geothermal, biomass, ocean thermal and hydropower.
The Company anticipates a vast number of applications that this clean NH 3 technology can replace directly, with minimal to no adaptation, including in agriculture, transportation and grid-storage. In the immediate term, FuelPositive is targeting the technology to be used within the well established and NH3-familiar agriculture industry, entering the market with a clean and sustainable solution that will reduce CO 2 emissions profoundly, and virtually overnight.
The FuelPositive system, in its current state of development, utilizes approximately 30 percent less energy than any existing ammonia production technology currently on the market (plus significant Carbon Credit value), resulting in what will be a significant savings on the energy required to produce a litre of liquid ammonia. In addition, the system can be utilized as grid storage wherever renewables are situated.
In consideration for the acquisition of all rights to the technology, the Company has agreed to issue 50,000,000 common shares to Dr. Dincer and his team, of which 35,000,000 were issued upon completion of the acquisition and the balance will be issued after 12 months. All common shares issuable in connection with the acquisition are subject to a four-month-and-one-day statutory hold period from the date of issuance.
WEBINAR INFORMATION
FuelPositive CEO, Ian Clifford, will be hosting a live Corporate Overview Webinar today, April 21, 2021, at 2:00pm ET.
During the live presentation, Ian will present the Company’s April investor presentation, provide an update on the Company’s current operations, its upcoming milestones, and share insight on the completed acquisition deal with Dr. Ibrahim Dincer and his team.
Webinar Registration:
Date: Wednesday, April 21, 2021
Time: 2:00pm ET (11:00am PT)
Register: https://7514767.hs-sites.com/www.rbmilestone.com/fuelpositive_april21webinar
Management will be available to answer questions following the presentation on the webinar platform. To ask a question, you will need to be logged into the GoToWebinar platform or by emailing your question(s) beforehand to mailto://FuelPositive@rbmilestone.com .
The Webinar will be recorded and posted to the Company’s website following the presentation.
About FuelPositive
FuelPositive is committed to providing commercially viable and sustainable energy solutions across a broad spectrum of industries and applications.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
All statements, other than statements of historical fact, contained in this press release including, but not limited to (i) generally, or the “About FuelPositive” paragraph which essentially describes the Company’s outlook and objectives, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.
For Media or Investor enquiries, please contact:
Mr. Ian Clifford
Chief Executive Officer
mailto://mailbox1@fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
NEWS -- Lineage Announces Worldwide License Agreement With Immunomic Therapeutics for an Allogeneic Cell-Based Cancer Immunotherapy Based on Its VAC Platform
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, today announced a worldwide license and development collaboration agreement with Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms. The collaboration will generate a novel product candidate derived from Lineage’s VAC allogeneic cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by ITI, for the treatment of glioblastoma multiforme (GBM). Lineage and ITI will collaborate in the manufacturing and clinical development of a novel VAC product candidate. Following the full development and delivery of Current Good Manufacturing Practice (cGMP) VAC product material, ITI will assume full and independent clinical and commercial responsibility and further advancement of the program. Under the terms of the agreement, Lineage will be entitled to upfront payments totaling $2 million anticipated in the first year and up to $67 million in development and commercial milestones across multiple indications and territories. Lineage also will be eligible to receive royalties up to 10% on net sales of future products.
"The VAC platform provides us with the opportunity to generate a broad pipeline of product candidates, each targeting a different type of cancer," stated Brian Culley, Lineage CEO. "This collaboration represents the first of many partnerships we hope to enter into with our platform and we believe it helps further validate VAC as a promising new therapeutic vaccine platform. Our objective is to leverage our technology to generate additional VAC-derived cell therapies for our pipeline, as well as in collaboration with partners, capitalizing on the strength of Lineage’s recent manufacturing and cell transplant success. These alliances also will diversify our oncology pipeline across more programs, providing new opportunities for success without the financial burden of independent development. We appreciate ITI selecting our antigen delivery platform for this collaboration and look forward to a productive partnership on this new VAC-derived product candidate. We also are eager to collaborate with additional partners on future versions of VAC."
"We’re very pleased to collaborate with Lineage, a well-recognized cell therapy company, to expand our pipeline with the development of a novel product candidate to treat GBM," commented Dr. William Hearl, CEO of ITI. "Over the last several years, ITI has invested significant capital and development resources to identifying multiple novel paths forward in GBM. By teaming up with Lineage, we are hoping to expand our efforts in this difficult to treat indication and look forward to the benefit that the VAC immunotherapy platform can bring to our antigen constructs."
About Glioblastoma multiforme (GBM)
Glioblastoma multiforme (GBM) (also called glioblastoma) is a fast-growing glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is often referred to as a grade IV astrocytoma. These are the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. GBMs can arise in the brain "de novo" or evolve from lower-grade astrocytomas or oligodendrogliomas. In adults, GBM occurs most often in the cerebral hemispheres, especially in the frontal and temporal lobes of the brain. GBM is a devastating brain cancer that typically results in death in the first 15 months after diagnosis, with only 25% of glioblastoma patients surviving more than one year, and only 5% of patients surviving more than five years.
About VAC2
VAC2 is an allogeneic, or non-patient specific "off-the-shelf," cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.
About Immunomic Therapeutics, Inc.
Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its investigational proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE platform has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including targeting viral antigens, cancer antigens, neoantigens and producing antigen-derived antibodies as biologics. In 2020, an investment of over $77M by HLB Co., LTD, a global pharmaceutical company, enabled ITI to accelerate application of its immuno-oncology platform, in particular to glioblastoma multiforme, and rapidly advance other key candidates in the pipeline, including the most recent initiative into infectious diseases with development of its vaccine candidate for COVID-19. The Company has built a large pipeline from UNITE with eight oncology programs, multiple animal health programs and a SARS-CoV-2 program to prevent and treat COVID-19. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading Immuno-oncology researchers at Duke University and the University of Florida. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit https://www.immunomix.com.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter https://twitter.com/LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to compensation to Lineage under its license agreement with ITI, the potential of the VAC platform and product candidates derived from the platform, Lineage’s plans to advance the VAC platform and expand its application, including through partnerships. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210420005316/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- U.S. FDA Approves CytoSorbents to Initiate U.S. STAR-T Trial For Ticagrelor Removal During Cardiothoracic Surgery
MONMOUTH JUNCTION, N.J., April 19, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader whose flagship E.U. approved CytoSorb® blood purification technology is intended to treat deadly conditions in critically-ill and cardiac surgery patients, announces that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its investigational device exemption (IDE) application for the U.S. Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) randomized, controlled trial. Based on this conditional approval, study initiation activities, including clinical trial agreement negotiations and institutional review board (IRB) submissions, can now commence, putting the study ahead of the Company's internal schedule. The Company has already identified and pre-screened many high-quality U.S. clinical centers that have indicated strong interest to participate in the STAR-T trial. The Company believes conditions for full IDE approval can be appropriately addressed within the 45-day timeframe outlined by the FDA, and once accepted, the Company expects to provide additional detail on the trial.
CytoSorbents Corporation (NASDAQ: CTSO) is a leader in blood purification to treat cytokine storm and deadly inflammation in life-threatening illnesses and during cardiac surgery with its flagship product, CytoSorb. CytoSorb is approved in the European Union and distributed in 67 countries worldwide.
CytoSorbents Corporation (NASDAQ: CTSO) is a leader in blood purification to treat cytokine storm and deadly inflammation in life-threatening illnesses and during cardiac surgery with its flagship product, CytoSorb. CytoSorb is approved in the European Union and distributed in 67 countries worldwide.
FDA gives green light to CytoSorbents to begin U.S. STAR-T Trial designed to support U.S. FDA marketing submission
Dr. David Cox, Vice President of Global Regulatory of CytoSorbents stated, "We are pleased that the FDA has approved our randomized, controlled clinical trial for the removal of ticagrelor (Brilinta®,AstraZeneca) during cardiothoracic surgery to reduce perioperative bleeding complications. We will promptly address FDA's conditions of approval and finalize the IDE protocol to best support a U.S. marketing submission of our FDA Breakthrough Device technology for this application."
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents added, "We are very excited to have received the go ahead from the FDA to begin the STAR-T trial, that if successful, is expected to support our first U.S. FDA marketing submission. In the future, we plan to leverage the alignment with FDA and the STAR-T study infrastructure, including the academic leadership, operational framework, and participating clinical trial sites to seek label expansions in antithrombotic removal beyond ticagrelor. This IDE approval marks a key first step forward in our long-term U.S. commercialization strategy to become the de facto standard of care therapy to remove antithrombotic drugs, generically called blood thinners, during cardiothoracic surgery, with an estimated total addressable U.S. market of $1 billion."
In April 2020, the FDA granted CytoSorbents Breakthrough Device Designation to remove ticagrelor during cardiothoracic surgery, recognizing this major unmet medical need. Each year, ticagrelor is prescribed to millions of cardiovascular patients worldwide to reduce the risk of recurrent hearts attack, stroke or cardiovascular death. Ticagrelor is frequently preferred as first line therapy in patients presenting to hospitals with an acute coronary syndrome in preparation of percutaneous coronary intervention (PCI) and stent placement. However, up to 10% of these patients will require coronary artery bypass graft (CABG) open heart surgery and as several clinical studies, such as the PLATO trial, have shown, they face a very high risk of severe or life-threatening bleeding during surgery.
Mr. Capponi continued, "CytoSorbents' blood purification technology offers a simple solution to mitigate bleeding risk by being placed in the cardiopulmonary bypass machine blood circuit to directly remove ticagrelor during cardiothoracic surgery. We are working collaboratively with FDA under Breakthrough Device Designation to aggressively pursue this opportunity and address this major unmet clinical need. This approval accelerates our internal timeline, and with the identification of clinical sites already completed, we are now in a position to move agressively forward with the execution of the STAR-T trial."
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 67 countries outside of the US, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that may result in massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death may be extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 121,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $38 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ™, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2021, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
Investor Relations Contact:
Amy Vogel
Investor Relations
(732) 398-5394
mailto://avogel@cytosorbents.com
Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
NEWS -- FuelPositive to Host Live Corporate Overview Webinar on April 21, 2021 @ 2:00pm ET
TORONTO, April 15, 2021 (GLOBE NEWSWIRE) -- FuelPositive Corporation (“FuelPositive” or the “Company”) (TSX.V: NHHH) (OTCQB: ZNNMF), is pleased to announce that CEO, Ian Clifford, will be hosting a live Corporate Overview Webinar on April 21, 2021 at 2:00pm ET.
Following the Company’s milestone acquisition of a first-of-its-kind technology to produce carbon-free ammonia (NH3) – in a zero-emission manner, FuelPositive is positioned to be an active leader in the continued design and creation of the Hydrogen Economy.
During the live presentation, Ian will present the Company’s April investor presentation, provide an update on the Company’s current operations, its upcoming milestones, and share insight on the recently announced acquisition deal with Dr. Ibrahim Dincer and his team.
Webinar Registration:
Date: Wednesday, April 21, 2021
Time: 2:00pm ET (11:00am PT)
Register: https://7514767.hs-sites.com/www.rbmilestone.com/fuelpositive_april21webinar
Management will be available to answer questions following the presentation on the webinar platform. To ask a question, you will need to be logged into the GoToWebinar platform or by emailing your question(s) beforehand to FuelPositive@rbmilestone.com.
The Webinar will be recorded and posted to the Company’s website following the presentation.
About FuelPositive
FuelPositive is committed to providing commercially viable and sustainable energy solutions across a broad spectrum of industries and applications.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
All statements, other than statements of historical fact, contained in this press release including, but not limited to (i) generally, or the “About FuelPositive” paragraph which essentially describes the Company’s outlook and objectives, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.
For Media or Investor Enquiries, please contact:
mailto://FuelPositive@rbmilestone.com
NEWS -- OncoSec to Present Encore Interim Data from the KEYNOTE-695 Phase 2b Clinical Trial at the 10th World Congress of Melanoma
PENNINGTON, N.J. and SAN DIEGO, April 15, 2021 /PRNewswire/ -- OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a biotechnology company focused on cytokine-based intratumoral immunotherapies, today announced that it will be presenting encore interim data from its KEYNOTE-695 registration-enabled Phase 2b clinical trial evaluating TAVO™ (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), in combination with KEYTRUDA® (pembrolizumab) in rigorously defined anti-PD1 checkpoint resistant metastatic melanoma patients at the 10th World Congress of Melanoma. This is an encore presentation of data presented at The Society for Immunotherapy of Cancer's (SITC) 2020 Annual Meeting. Presenters will also discuss the therapeutic potential of OncoSec's DNA medicines platform to elicit robust anti-tumor immunity via intratumoral gene electrotransfer of TAVO plus CXCL9.
"Achieving an overall response rate of 30% with several complete responses and no serious adverse events is extremely encouraging for checkpoint resistant metastatic melanoma patients who currently rely on systemic administration of immune-stimulating drugs associated with severe toxicity," said Paolo A. Ascierto, M.D., Director of the Unit of Melanoma, Cancer Immunotherapy and Innovative Therapy at the National Tumor Institute Fondazione G. Pascale in Naples, Italy. "The data reported, in addition to its ease of use, demonstrate the potential of TAVO in combination with pembrolizumab as a next-generation intratumoral IL-12 therapy that can induce regression of both locally treated and untreated distant and visceral lesions."
OncoSec's presentation is summarized below:
Introduction
Presenter: Christopher G. Twitty, Ph.D.
Session Date/Time: Saturday, April 17, 2021, 4:15 p.m. – 4:18 p.m. ET
OncoSec's KEYNOTE-695 interim data
Presenter: Paolo Ascierto, M.D.
Session Date/Time: Saturday, April 17, 2021, 4:18 p.m. – 4:28 p.m. ET
OncoSec's next generation therapies: amplification of the CRX3/CXCL9 axis via intratumoral electroporation of CXCL9 synergizes with IL-12 therapy (TAVO) to elicit robust anti-tumor immunity
Presenter: Christopher G. Twitty, Ph.D.
Session Date/Time: Saturday, April 17, 2021, 4:28 p.m. – 4:48 p.m. ET
Live Q&A
Presenters: Christopher G. Twitty, Ph.D., Paolo Ascierto, M.D.
Session Date/Time: Saturday, April 17, 4:48 p.m. – 5:15 p.m. ET
The conference will be held virtually from April 15 – 17, 2021. To access the conference virtual platform, visit: https://worldmelanoma2021.com/login-virtual-platform.
About KEYNOTE-695
KEYNOTE-695 is OncoSec's registration-directed Phase 2b trial (NCT#03132675) evaluating TAVO™ (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12) + KEYTRUDA® (pembrolizumab) in patients with rigorously confirmed anti-PD-1 checkpoint resistant metastatic melanoma. The trial aims to enroll up to 100 patients with refractory, locally advanced or metastatic disease defined as unresectable Stage III/IV metastatic melanoma that had definitively progressed on a full-course of anti-PD-1 treatment with KEYTRUDA® (pembrolizumab) or OPDIVO® (nivolumab). TAVO™ has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma following progression on KEYTRUDA or OPDIVO.
About TAVO™
OncoSec's gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO™ has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.
About OncoSec Medical Incorporated
OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy investigational product candidate – TAVO™ (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO™ have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with an acceptable safety profile, warranting further development. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visit https://www.oncosec.com.
TAVO™ is a trademark of OncoSec Medical Incorporated.
Company Contact
Brian Leuthner
Chief Operating Officer
mailto://investors@oncosec.com
Media Contact
Patrick Bursey
LifeSci Communications
+1-646-970-4688
mailto://pbursey@lifescicomms.com
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SOURCE OncoSec Medical Incorporated
NEWS -- Navidea Biopharmaceuticals Announces Acceptance of Therapeutics Focused Abstract for Presentation at the Frontiers in Cancer Immunotherapy Symposium
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the results from the Company’s preclinical studies of its targeted cancer immunotherapeutic agent will be presented as a poster at the New York Academy of Science’s (NYAS) Frontiers in Cancer Immunotherapy Symposium 2021. The poster is titled, "Targeted Delivery of Doxorubicin (DOX) to Tumor Associated Macrophages (TAMs) Beneficially Alters the Tumor Immune Microenvironment and Synergizes the Activity of Anti-CTLA4."
In these studies, Navidea’s CD206-targeted therapeutic construct containing doxorubicin linked to its mannosylated dextran backbone (Man-Dox) demonstrated the ability to drive phenotypic change in immune cells towards an activated pro-inflammatory and cell-killing state in vitro and, in conjunction with an approved immunotherapeutic, demonstrated a synergistic effect on tumor growth inhibition in a relevant animal model. The cellular target of Navidea’s Man-Dox agent is the macrophage mannose receptor, CD206. CD206 is expressed on TAMs that play a critical role in regulating the tumor microenvironment and which provide a target for immunotherapies to rally the body’s own immune system in the fight against cancer.
In in vitro studies, treatment of human macrophages with Man-Dox drove macrophages from an immunosuppressive phenotype to an immune stimulatory, pro-inflammatory state. In mouse experiments using the syngeneic CT26 tumor model, Man-Dox, in combination with anti-CTLA4 therapy, showed a significant reduction in tumor growth compared to treatments with either agent alone or with free doxorubicin. Anti-CTLA4 improves anti-tumor immune responses by blocking a check point inhibitor that prevents stimulation of adaptive immune cells by pro-inflammatory macrophages. These new findings support Navidea’s hypothesis that driving the TAM phenotype towards a pro-inflammatory state with Man-Dox in concert with an approved immunotherapy provides a synergistic effect on tumor cell killing. These results demonstrate that Navidea’s targeted Man-Dox construct can improve the efficacy of an existing immunotherapy and support further studies to help define optimal dosing strategies to maximize this synergistic effect.
This year’s conference will be virtual and will take place from May 12th through May 14th. Navidea’s presentation will provide a more detailed look at analysis of these data.
Information regarding registration for the symposium can be found on the NYAS website (https://www.nyas.org/events/2021/webinar-frontiers-in-cancer-immunotherapy-2021/?tab=description).
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the recognition of the importance of our preclinical results by the symposium committee and the opportunity to present our results at this internationally recognized meeting." Dr. Rosol continued, "This important work demonstrates both a mechanism of action as well as efficacy in relevant in vitro and in vivo model systems. These positive results help lay the foundation for moving forward into an FDA IND application followed by first in human studies."
Jed Latkin, Navidea’s Chief Executive Officer, said, "This is truly a tribute to the many hours of hard work spent by our dedicated team to hone in on a compound that shows remarkable design, enabling this and future pre-clinical clinical work."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.
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. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210415005284/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
Joel Kaufman
Chief Business Officer
614-822-2372
mailto://jkaufman@navidea.com
NEWS -- Innovation Pharma’s Broad Spectrum Antiviral Drug Candidate Brilacidin Highlighted in Biodefense and Infectious Diseases COVID-19 Presentation
WAKEFIELD, Mass., April 14, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced that Brilacidin, the Company’s defensin-mimetic drug candidate, was featured in the “Mason Science Series: Rising to the National and International COVID-19 Challenge,” a presentation of George Mason University.
The presentation covers the latest research of Dr. Aarthi Narayanan, a faculty member in George Mason’s National Center for Biodefense and Infectious Diseases, and her team’s (and associated teams) efforts, which are geared towards the development of therapeutics and vaccines against SARS-CoV-2, including Brilacidin. A video of Dr. Narayanan’s presentation can be accessed at the link below. Discussion of Brilacidin begins at approximately the 40-minute mark.
NEWS -- OncoSec Receives CE Mark Certification for its Commercial Electroporation Device "GenPulse™" for the Treatment of Solid Tumors
-- CE mark enables commercialization of GenPulse™ in EU --
PENNINGTON, N.J. and SAN DIEGO, April 14, 2021 /PRNewswire/ -- OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a biotechnology company focused on cytokine-based intratumoral immunotherapies, today announced that it has received authorization to CE mark its proprietary next generation go-to-market gene delivery device, GenPulse™, a part of the OncoSec Medical System (OMS) electroporation device platform for use in solid tumors. The CE mark certification augments the Notified Body certification to the International Organization for Standardization's (ISO) 13485 standard for the design, development, manufacture and distribution of electroporation devices, which is renewed annually, subject to a successful audit. The GenPulse is the gene electrotransfer device which OncoSec plans to deploy commercially, both in the U.S. and the European Union (EU).
"This CE certification is an essential regulatory milestone on OncoSec's road to commercialization in Europe," said Robert Ashworth, Senior Vice President, Regulatory Quality and CMC at OncoSec. "The CE mark on our proprietary GenPulse generator represents the culmination of years of work and demonstrates that OncoSec has the capability to manufacture and develop a device that meets performance, quality and safety requirements in the EU."
A CE mark indicates the OMS electroporation device complies with Directives of the European Commission (EC) and therefore can be marketed within the 31-nation European Economic Area (EEA) and Switzerland. This OMS electroporation device applies short electric impulses to a tumor, causing pores to open in the membrane of cancer cells, significantly increasing the uptake of anti-cancer agents into these cells. The CE mark certification involved a comprehensive audit of the company's quality system, as well as thorough evaluation and testing of the OMS electroporation device to assure it performs safely and as designed.
About OncoSec Medical Incorporated
OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy investigational product candidate – TAVO™ (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO™ have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with an acceptable safety profile, warranting further development. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visit https://www.oncosec.com.
GenPulse™ and TAVO™ are trademarks of OncoSec Medical Incorporated.
Risk Factors and Forward-Looking Statements
This release, as well as other information provided from time to time by the Company or its employees, may contain forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Forward-looking statements provide the Company's current beliefs, expectations and intentions regarding future events and involve risks, uncertainties (some of which are beyond the Company's control) and assumptions. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "should," "will" and "would" and similar expressions (including the negative of these terms). Although we believe that expectations reflected in the forward- looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. The Company intends these forward-looking statements to speak only at the time they are published on or as otherwise specified, and does not undertake to update or revise these statements as more information becomes available, except as required under federal securities laws and the rules and regulations of the Securities Exchange Commission ("SEC"). In particular, you should be aware that the success and timing of our clinical trials, including safety and efficacy of our product candidates, patient accrual, unexpected or expected safety events, the impact of COVID-19 on the supply of our candidates or the initiation or completion of clinical trials and the usability of data generated from our trials may differ and may not meet our estimated timelines. Please refer to the risk factors and other cautionary statements provided in the Company's Annual Report on Form 10-K for the fiscal year ended July 31, 2019 and subsequent periodic and current reports filed with the SEC (each of which can be found at the SEC's website www.sec.gov), as well as other factors described from time to time in the Company's filings with the SEC.
Company Contact
Brian Leuthner
Chief Operating Officer
mailto://investors@oncosec.com
Media Contact
Patrick Bursey
LifeSci Communications
+1-646-970-4688
mailto://pbursey@lifescicomms.com
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SOURCE OncoSec Medical Incorporated
NEWS -- Aytu BioPharma Adds Late-Stage Pediatric Onset Rare Disease Asset to Development Pipeline from Rumpus Therapeutics
ENGLEWOOD, CO / ACCESSWIRE / April 12, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today announced the acquisition of a global license to AR101 (enzastaurin), a pivotal study-ready therapeutic candidate initially targeting the treatment of vascular Ehlers-Danlos Syndrome (vEDS) from Rumpus Therapeutics (Rumpus), a privately-held biopharmaceutical company focused on the treatment of pediatric onset rare and orphan diseases. vEDS is a rare genetic disorder typically diagnosed in childhood and characterized by arterial aneurysm, dissection and rupture, bowel rupture and rupture of the gravid uterus. There are currently no U.S. Food and Drug Administration (FDA)-approved treatments for vEDS.
"This acquisition positions us to greatly accelerate our growth plans both through the addition of this novel rare disease asset to our development pipeline, as well as the expansion of our management team with co-founders Topher Brooke and Nate Massari joining the team. As we seek to expand our high-value pipeline of late-stage assets, and grow our commercial products, this milestone further solidifies our position as a leading pediatric specialty pharmaceutical company," commented Josh Disbrow, Chief Executive Officer of Aytu BioPharma. "The AR101 program is expected to progress directly to a single pivotal study, and the Rumpus team has employed numerous strategies in the development plan to minimize clinical risk associated with the trial. We are greatly encouraged by the potential speed to FDA approval, especially as we believe it can provide much needed hope for vEDS patients and their families."
"I'm excited to get to work on this important late-stage program and draw from the deep expertise of both Topher and Nate. Both of these executives have distinguished careers in rare disease, business development, and strategic planning across a range of leading pharmaceutical companies and I'm pleased to welcome them to the Aytu team," continued Mr. Disbrow.
Terms of the Transaction
Under the terms of the transaction, Aytu has acquired the vEDS enzastaurin program of Rumpus and all associated intellectual property for $1.5 million upfront in cash. In addition, Aytu paid fees associated with the transfers of third-party licenses from Rumpus to Aytu and will take over any royalty obligations under these licenses. Aytu has also agreed to make performance-based milestone payments to Rumpus upon the achievement of regulatory, clinical and commercial milestones. The Company will pay up to $22.5 million in milestone payments if certain regulatory milestones are met, including $15.0 million in milestone payments if AR101 receives approval by the FDA and another major market regulatory authority. Commercial milestones of up to an additional $45.0 million may be paid if a series of global commercial milestones are met over the life of the product. All milestone consideration may be paid in any combination of cash or stock at the Company's option, with the provision that shares will not be issued in excess of 19.9% of the now-outstanding shares of Aytu unless subsequently approved by Aytu's shareholders.
Rumpus Therapeutics co-founders and principal executive officers, Topher Brooke and Nate Massari, will join the Aytu executive team and report to CEO, Josh Disbrow. Both Mr. Brooke and Mr. Massari will lead all aspects of the AR101 vEDS program and the further development of the Company's pediatric onset rare disease pipeline.
Nate Massari has more than 20 years of healthcare experience in consulting, in-line marketing and sales, pipeline marketing, corporate strategy, sales management and corporate development across the pharmaceutical, biotech, device, health services, and distribution industries. He began his career in management consulting within the Health & Life Sciences practice at Accenture. Nate also held various leadership roles at Johnson & Johnson, AstraZeneca, Endo Pharmaceuticals, and AmerisourceBergen. He has completed numerous business development transactions totaling over $6 billion in capital deployment, and his rare disease expertise includes launching pediatric inflammatory bowel disease indications while at Johnson & Johnson as well as leading the orphan drug pediatric endocrinology franchise at Endo Pharmaceuticals. Most recently, Nate co-founded Rumpus Therapeutics to develop new medicines for pediatric onset rare and orphan diseases. Nate has a BA from Princeton University and an MBA from the Wharton School at the University of Pennsylvania.
Christopher "Topher" Brooke has over 20 years of general management experience in healthcare across all phases of development and commercialization. He has depth of experience from target selection and clinical development planning through running several blockbuster commercial pharmaceutical franchises. He has worked across several modalities (proteins, small molecules and vaccines) and across multiple therapeutic areas. Topher has held roles of increasing responsibility at Johnson & Johnson, AstraZeneca, and AmerisourceBergen. His rare disease experience includes launching pediatric inflammatory bowel disease indications while at Johnson & Johnson as well as leading the pediatric infectious disease franchise at AstraZeneca. Topher went on to lead the fully integrated Diabetes Division at AstraZeneca. Most recently, Topher co-founded Rumpus Therapeutics to develop new medicines for pediatric onset rare and orphan diseases. Topher has a BA from Colgate University and an MBA from the Wharton School at the University of Pennsylvania.
The landmark research supporting AR101 was conducted by Dr. Hal Dietz, Professor of Genetic Medicine at Johns Hopkins University School of Medicine and an Investigator at the Howard Hughes Medical Institute.
"I have dedicated my career to researching and treating patients with connective tissue disorders, and these efforts include vascular Ehlers-Danlos Syndrome and Marfan Syndrome. In particular with vEDS, patients face catastrophic vascular events without warning. There are no currently approved therapies, but our research has shown that a clear pathway exists to potentially beat this disease. Our aim is to prove that in a well-controlled clinical trial, which we hope will be underway soon," commented Dr. Hal Dietz.
Dr. Josephine Grima, Chief Science Officer of The Marfan Foundation, and Katie Wright, Director of The VEDS Movement, a division of the Foundation, added, "The unmet need for people with VEDS is massive. Many of these individuals find out they have the condition via genetic testing after suffering severe medical complications, and some find out after losing family members who weren't even diagnosed yet. Currently, there are no therapies proven to prevent the life-threatening emergencies that can occur. We are thrilled to partner with Aytu by providing education and awareness to physicians, patients and families to help maximize the success of this trial."
Lara Bloom, CEO of the Ehlers-Danlos Society added, "This community is thirsting for additional research across all types of Ehlers-Danlos Syndromes. It's also a mobilized and well-connected community that is excited to participate in advancing research and clinical development."
About vascular Ehlers-Danlos Syndrome (vEDS)
Vascular Ehlers Danlos Syndrome (vEDS) is the severe subtype of Ehlers-Danlos Syndrome, affecting 1 in 50,000 people worldwide and results from pathogenic variants in the COL3A1 gene, which encodes the chains of type III procollagen, a major protein in vessel walls and hollow organs. Twenty-five percent of vEDS patients have a first complication by the age of 20 years, and more than eighty percent have at least one complication by the age of 40. vEDS is a devastating condition, and vEDS patients have a median lifespan of 51 years. There are no FDA-approved therapies for vEDS.
About AR101 (enzastaurin)
AR101 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K and AKT pathways. AR101 has been studied in more than 3,300 patients across a range of solid and hematological tumor types. Dr. Hal Dietz developed the first preclinical model that mimics the human condition and recapitulates vEDS. This knock-in model has the same genetic mutation most prevalent in vEDS patients and is representative of the human condition in both the timing and location of vascular events. The model has generated identical structural histology and mechanical characteristics, and unbiased findings demonstrated that structure alone does not lead to vascular events. Objective comparative transcriptional profiling by high-throughput RNA sequencing of the aorta displayed a molecular signature for excessive PKC/ERK cell signaling that is the driver of disease. PKC inhibition proved efficacious in multiple pre-clinical models and indeed prevented death due to vascular rupture.
Pivotal Phase 3 studies for both newly-diagnosed diffuse large B-cell lymphoma (DLBCL) and GBM are currently being conducted by Denovo Biopharma LLC, enzastaurin's owner. Enzastaurin received orphan drug designation in DLBCL and glioblastoma multiforme (GBM) from the FDA and EMA. In July 2020, the FDA granted enzastaurin Fast Track qualification for the first-line treatment of GBM. Through this transaction Aytu has secured exclusive global rights to enzastaurin/AR101 from Denovo Biopharma LLC in the fields of rare genetic pediatric onset or congenital disorders outside of oncology. The Company expects to receive Orphan Drug Designation for AR101, allowing for seven years' marketing exclusivity in the United States and ten years in Europe and Japan. AR101 is protected by a suite of pending patents being pursued in major markets globally which have been licensed from The Johns Hopkins University and have an earliest priority date of March 2017.
Conference Call & Webcast (with Slides)
Aytu will host a conference call and webcast this afternoon, Monday, April 12, 2021 at 4:30 p.m. Eastern Time. Josh Disbrow, Chief Executive Officer of Aytu BioPharma, and Dr. Hal Dietz will discuss the Rumpus transaction and the AR101 scientific background, and they will be available to answer questions. Interested participants and investors may access the conference call by dialing (877) 407-9124 (U.S./Canada) or (201) 689-8584 (international). A live webcast presentation can also be accessed via the Investors section of the Aytu BioPharma corporate web site at: https://www.aytubio.com.
About Aytu BioPharma, Inc.
Aytu BioPharma is a specialty pharmaceutical company with a growing commercial portfolio of prescription therapeutics and consumer health products. The company's primary prescription products treat attention deficit hyperactivity disorder (ADHD) and other common pediatric conditions. Aytu markets ADHD products Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING). The company's other pediatric products include Karbinal® ER (carbinoxamine maleate), an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. The company's evolution has been driven by strategic in-licensing, acquisition-based transactions and organic product growth. As Aytu continues this trajectory, the company is building a complimentary therapeutic development pipeline that will address significant unmet needs. For more information, please visit https://aytubio.com.
About Rumpus Therapeutics
Rumpus Therapeutics is a private, specialty biopharmaceutical company dedicated to advancing innovative science for neglected pediatric diseases. Rumpus Therapeutics is focused on drug development for rare and orphan diseases that predominantly have pediatric onset and for which there are no currently approved therapies. For additional information please visit https://www.rumpustx.com.
Forward-Looking Statements
This press release includes 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, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding the results and effects of the Rumpus asset purchase, future opportunities for the newly constituted company, future financial performance and condition, guidance and any other statements regarding the newly constituted company's future expectations, beliefs, plans, objectives, financial conditions, assumptions or future events or performance including clinical trial results. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: potential adverse changes to our business, including those resulting from the completion of the Rumpus transaction, the diversion of management time on transaction-related issues, the ultimate timing, outcome and results of integrating the operations and personnel of Rumpus, the effects of the acquisition of the Rumpus assets, including the combined company's future financial condition with the addition of these assets, results of operations, strategy and plans, changes in capital markets and the ability of the combined company to finance operations in the manner expected, risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of the combined company's product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of the combined company's ongoing and future clinical trials, the anticipated designs of the combined company's future clinical trials, anticipated future regulatory submissions and events, the combined company's anticipated future cash position and future events under current and potential future collaboration. We also refer you to (i) the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission and (ii) the Risk Factors set forth in Aytu's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations, Inc.
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
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NEWS -- Kintara Presents Updates on Two Phase 2 Clinical Trials at the 2021 American Association for Cancer Research Annual Meeting
SAN DIEGO, April 12, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or resistant to, current treatment regimens, today announced interim data results from two Phase 2 clinical trials evaluating VAL-083, the Company's lead compound, for the treatment of glioblastoma multiforme (GBM). The data were presented in two posters at the 2021 American Association for Cancer Research (AACR) Annual Meeting, which is taking place virtually from April 10-15, 2021.
Poster CT238 provides an update from two patient groups receiving VAL-083 in an open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at the MD Anderson Cancer Center in Houston, Texas. The second poster, CT172, updates the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center in China.
"These interim data updates at the AACR Annual Meeting continue to demonstrate VAL-083's potential as a game-changing treatment option for GBM patients," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "Furthermore, it's important to note that both trials have provided valuable insights as we prepared to initiate the VAL-083 arm of the Global Coalition for Adaptive Research GBM AGILE registrational study which commenced patient enrollment in February 2021."
Poster CT238: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the adjuvant or recurrent setting"
In newly-diagnosed patients receiving VAL-083 as adjuvant therapy following treatment with radiation and temozolomide (TMZ), for the 33 efficacy evaluable patients (of a planned 36 patients) as of the data cut-off of March 12, 2021, median progression-free survival (PFS) is currently 10.0 months (95% confidence interval: CI 8.2-10.8). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively.
For patients in the fully enrolled recurrent group receiving second-line therapy with VAL-083 following first-line TMZ failure, 89 patients have been enrolled as of the data cut-off of March 12, 2021 with 35 patients (35 efficacy evaluable) initially receiving a dose of 40 mg/m2/day and 54 (48 efficacy evaluable) initially receiving the treatment dose that is being carried forward in the GBM AGILE study of 30 mg/ m2/day on days 1, 2 and 3 of a 21-day cycle. Median overall survival (mOS) for the 83 efficacy evaluable patients who have completed at least once cycle of treatment was 7.5 months (CI 6.0-9.0 months). Additionally, for the 48 efficacy evaluable patients initially receiving a dose of 30 mg/ m2/day, mOS is currently 7.9 months (CI 5.9-9.9 months). While this is not a head-to-head trial, historically lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months***.
Consistent with prior studies, myelosuppression is the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment settings. In the 30 mg/m2/day starting dose cohort (the dose that is being carried forward in the GBM AGILE study) seven subjects have experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient has experienced a possibly drug-related SAE in the adjuvant group as of the relevant data cut-off dates.
Poster CT172: "Phase 2 clinical trial of dianhydrogalactitol (VAL-083) in patients with newly-diagnosed MGMT-unmethylated GBM"
In the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients, median PFS for the 29 patients, as of the March 11, 2021 cut-off date, is currently 9.3 months (CI 6.4-12.0 months). Additionally, for the 25 patients initially receiving the treatment dose that is being carried forward in the GBM AGILE study of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle, median PFS was reported to be 8.7 months (CI 6.4-12.5 months). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively. Three subjects have experienced an SAE possibly related to VAL-083. Multiple treatment cycles of VAL-083 at the 30 mg/m2/day dose in combination with standard radiation treatment (2 Gy/day, 5 days/week) were shown to be generally safe and well-tolerated. This study has been fully enrolled, and all patients have completed treatment with VAL-083 and are currently in follow-up.
*Hegi et al N Eng J Med 352; 997-1003 (2005)
**Tanguturi et al. NeuroOncol. 19(7): 908-917 (2017)
*** Wick et al N.Eng.J.Med . 377:1954 1963 (2017)
About Kintara
Located in San Diego, California, Kintara (Nasdaq: KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).
VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.
REM-001 is a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.
For more information, please visit https://www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials and the GBM AGILE study. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
CONTACTS
Investors
CORE IR
516-222-2560
ir@coreir.com
Media
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
mailto://julesa@coreir.com
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SOURCE Kintara Therapeutics
NEWS -- FuelPositive Corporation Extends Term of Share Purchase Warrants
TORONTO, April 12, 2021 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (the “Corporation”) announces that it will further extend the term of an aggregate of 7,240,000 share purchase warrants (the “Warrants”) through until April 24, 2022. The Warrants are exercisable at a price of $0.60, and were previously scheduled to expire on April 24, 2021.
The Warrants were previously issued in connection with a non-brokered private placement completed by the Corporation, and not in compensation for any services provided to the Corporation. Completion of the extension remains subject to the approval of the TSX Venture Exchange and will not take effect until such time as approval has been received.
About FuelPositive
FuelPositive is committed to providing commercially viable and sustainable energy solutions across a broad spectrum of industries and applications.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
All statements, other than statements of historical fact, contained in this press release including, but not limited to (i) generally, or the “About FuelPositive” paragraph which essentially describes the Corporation’s outlook and objectives, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. The Corporation disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Mr. Ian Clifford
Chief Executive Officer
mailto://mailbox1@fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
NEWS -- OpRegen® Data Update to Be Featured at 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Presentation by Christopher D. Riemann, MD
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that updated interim results from a Phase 1/2a study of its lead product candidate, OpRegen®, a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), will be presented at the 2021 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2021), to be held virtually (May 1 – 7, 2021). The presentation, "Phase I/IIa Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD): Interim Results" will be featured as part of the Stem cells/Gene Therapy/Transplantation Session, on May 6, 2021 between 5:15 pm and 6:45 pm EDT by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine. (abstract number 3538173).
The Association for Research in Vision and Ophthalmology, Inc. (ARVO) was founded in 1928 in Washington, DC by a group of 73 ophthalmologists. ARVO is the largest and one of the most respected eye and vision research organizations in the world and its members include nearly 11,000 researchers from over 75 countries. The membership is multidisciplinary and consists of both clinical and basic researchers. ARVO advances research worldwide into understanding the visual system and preventing, treating and curing its disorders. For more information, please visit https://www.arvo.org/ or follow the association on Twitter @ARVOInfo.
About OpRegen
OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (vision from 20/65 to 20/250 with smaller areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additional objectives include the evaluation of the safety of delivery of OpRegen using the Orbit Subretinal Delivery System (Orbit SDS). OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.
About Dry AMD
Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210412005113/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Heat Biologics Announces New Preclinical Data on PTX-35, Demonstrating Decreased Regulatory T-cell (Treg) Activity and Delayed Tumor Progression at American Association for Cancer Research (AACR) Annual Meeting 2021
DURHAM, NC / ACCESSWIRE / April 12, 2021 / Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today reported that promising new preclinical data of PTX-35 is presented at the AACR Annual Meeting 2021.
PTX-35 is the company's first antibody-based product, currently in a Phase 1 clinical trial for the treatment of patients with solid tumors. PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T-cells. In a B16F10 melanoma mouse model, PTX-35 in the presence of tumor antigen supplied by Heat's HS-110 immunotherapy, resulted in decreased regulatory T-cell suppression and enhanced T effector responses. These changes were associated with delayed tumor progression.
Jeff Wolf, Chief Executive Officer of Heat, commented, "PTX-35 is designed to harness the body's natural antigen-specific immune activation. We believe our latest data suggest that PTX-35 can help overcome certain mechanisms of cancer immune evasion. We continue to advance our first-in-human Phase 1 study of PTX-35 in patients with solid tumors and look forward to sharing interim data later this year."
Details of the poster presentation are as follows:
Title: PTX-35, a Potential First-in-class Agonist, Reduced the Suppressive Activity of Regulatory T cells and Enhanced CD4+ T cell Effector Responses in the Presence of Tumor Antigens in a Murine Melanoma Model
Abstract Number: 604
Session: Modifiers of the Tumor Microenvironment
Presenter: Eric Dixon, Director of Discovery Sciences, Heat Biologics
About the AACR Annual Meeting
The 2021 AACR Annual Meeting program covers the latest discoveries across the spectrum of cancer research-from population science and prevention to cancer biology, translational, and clinical studies, as well as survivorship and advocacy-and highlights the work of the best minds in research and medicine from institutions all over the world.
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat's gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such asthe latest data suggesting that PTX-35 can help overcome certain mechanisms of cancer immune evasion and sharing interim data later this year. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of PTX-35 to help overcome certain mechanisms of cancer immune evasion, the ability to provide interim data when planned, Heat's vaccine platform to provide protection against COVID-19, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, especially in light of COVID-19, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com
SOURCE: Heat Biologics, Inc.
View source version on accesswire.com:
https://www.accesswire.com/639842/Heat-Biologics-Announces-New-Preclinical-Data-on-PTX-35-Demonstrating-Decreased-Regulatory-T-cell-Treg-Activity-and-Delayed-Tumor-Progression-at-American-Association-for-Cancer-Research-AACR-Annual-Meeting-2021
NEWS -- Oncolytics Biotech® and SOLTI Achieve Primary Endpoint in AWARE-1 Study
NEWS -- Oncolytics Biotech® Presents Preclinical Data on Pelareorep-based Combination Therapies at the AACR Annual Meeting
NEWS -- Plus Therapeutics to Announce First Quarter 2021 Financial Results and Host Conference Call on April 22, 2021
AUSTIN, Texas, April 08, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, announced that the Company will report first quarter 2021 financial results on Thursday, April 22, 2021, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. Eastern Time to discuss the financial results and provide a corporate update.
A live webcast will be available at https://ir.plustherapeutics.com/events
Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.
Conference dial-in: 877-402-3914
International dial-in: 631-865-5294
Conference ID: 3084418
Conference Call Name: Plus Therapeutics First Quarter 2021 Results Conference Call
Following the live call, a replay will be available on the Company’s website under the 'Investor Relations' section (https://ir.plustherapeutics.com/overview/default.aspx). The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements about: the Company’s potential to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers; the Company’s potential to develop drug candidates currently in its product pipeline; and the Company’s potential to develop additional drugs outside of its current pipeline. The forward-looking statements included in this press release are subject to a number of additional material risks and uncertainties, including but not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the U.S. FDA’s accelerated regulatory pathways; and the risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Oncolytics Biotech® to Participate in a Panel Discussion at the Canaccord Genuity Horizons in Oncology Virtual Conference
SAN DIEGO and CALGARY, Alberta, April 8, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Dr. Matt Coffey, the Company's President and Chief Executive Officer, will be participating in a panel discussion at the Canaccord Genuity Horizons in Oncology Virtual Conference. Details on the panel discussion are provided below.
Title: Off-the-Shelf CAR T - solid tumors, myeloma, lymphoma
Date: Thursday, April 15, 2021
Time: 8:15 am ET
Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Canaccord representative or email mailto://tim@lifesciadvisors.com.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Contact:
Company Contact
Kirk Look
Chief Financial Officer
+1-403-670-7658
mailto://KLook@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-panel-discussion-at-the-canaccord-genuity-horizons-in-oncology-virtual-conference-301264756.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/April2021/08/c9872.html
NEWS -- Innovation Pharma Announces Brilacidin Abstract Accepted for Oral Presentation at the American Society for Virology’s Annual Meeting
NEWS -- Aytu BioPharma Strengthens Leadership Team with Appointment of Richard Eisenstadt as Chief Financial Officer
ENGLEWOOD, CO / ACCESSWIRE / April 5, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today announced the appointment of Richard Eisenstadt as Chief Financial Officer. Mr. Eisenstadt is an accomplished pharmaceutical industry executive with more than 20 years of experience in leading finance and accounting operations, supporting clinical development and commercialization, and raising capital within the life sciences sector.
Mr. Eisenstadt replaces David Green who has stepped down as Chief Financial Officer as of March 31, 2021.
Mr. Eisenstadt most recently was Chief Financial Officer at Neos Therapeutics, Inc. where he raised over $340 million in private and public equity and debt financings and supported the transition of the company from clinical stage to commercial operations prior to its merger with Aytu in March 2021. Prior to Neos, Mr. Eisenstadt served as Chief Financial Officer at Arborgen, Inc., and prior to that, Chief Financial Officer at Tranzyme, Inc., where he led its IPO, negotiated several licensing agreements, and financed the company through late-stage clinical development. Mr. Eisenstadt received an M.B.A. from James Madison University and a B.A. in Economics from the University of North Carolina at Chapel Hill.
"Rich's deep experience with financial planning and accounting, raising capital, investor relations, clinical development, and commercial operations will be a tremendous asset to Aytu, especially as we continue to grow our commercial portfolio of prescription therapeutics and consumer health products and expand our development pipeline. His appointment comes at a pivotal time for the company, and we are very pleased to have him join the team," commented Josh Disbrow, Chief Executive Officer of Aytu BioPharma. "Also, as Dave departs the company, the Board and I wish to express our sincere gratitude to Dave for his many contributions and service to Aytu and wish him well."
Mr. Eisenstadt commented, "I am honored to be asked to join Aytu to support the combination of the Neos and Aytu branded prescription therapeutic portfolios. Together with Josh and the incumbent management team, I look forward to continuing to build value through both organic growth in our product offerings and through strategic acquisitions of late-stage product candidates and on-market assets."
About Aytu BioPharma, Inc.
Aytu BioPharma is a specialty pharmaceutical company with a growing commercial portfolio of prescription therapeutics and consumer health products. The company's primary prescription products treat attention deficit hyperactivity disorder (ADHD) and other common pediatric conditions. Aytu markets ADHD products Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING). The company's other pediatric products include Karbinal® ER (carbinoxamine maleate), an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. The company's evolution has been driven by strategic in-licensing, acquisition-based transactions and organic product growth. As Aytu continues this trajectory, the company is building a complimentary therapeutic development pipeline that will address significant unmet needs. For more information, please visit https://aytubio.com.
Forward-Looking Statements
This press release includes 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, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding future growth of the company's product offerings and expansion of its development and commercial pipeline. Please also refer to the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations, Inc.
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/638696/Aytu-BioPharma-Strengthens-Leadership-Team-with-Appointment-of-Richard-Eisenstadt-as-Chief-Financial-Officer
NEWS -- Innovation Pharma Completes Interim Safety Data Review—DMC Approves Increased Dosing Frequency in Phase 2 Clinical Trial of Brilacidin in Hospitalized COVID-19 Patients
NEWS -- Oncolytics Biotech® to Host Key Opinion Leader Webinar to Discuss AWARE-1 Data, the Immunotherapeutic Effects of Pelareorep in Breast Cancer, and its Synergistic Activity with CAR T Cells in Solid Tumors
Webinar will take place Monday April 12, 2021 at 2:00 pm ET
SAN DIEGO and CALGARY, AB, April 5, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a Key Opinion Leader (KOL) webinar discussing AWARE-1 data, the immunotherapeutic effects of pelareorep in breast cancer, and its synergistic activity with CAR T cells in solid tumors. The webinar will take place on Monday, April 12, 2021 at 2:00 pm ET.
The webinar will feature presentations by Key Opinion Leaders Aleix Prat, M.D., Ph.D. (Clínic Barcelona) and Richard Vile, Ph.D., (Mayo Clinic). Dr. Prat's portion of the presentation will focus on data from the AWARE-1 window-of-opportunity clinical trial evaluating pelareorep with and without atezolizumab (Tecentriq®) in early-stage breast cancer, which will be presented at this year's American Association for Cancer Research (AACR) Annual Meeting. Dr. Vile will then discuss the results of a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors (link to PR (https://ir.oncolyticsbiotech.com/press-releases/detail/527/oncolytics-biotech-reports-preclinical-data-demonstrating), link to poster(https://d1io3yog0oux5.cloudfront.net/_49b86442664963185633ed190bda2d58/oncolyticsbiotech/db/343/2550/pdf/CAR+TCR+POSTER.pdf)).
During the event, Oncolytics' management team will also give a corporate update and discuss the company's upcoming milestones. Dr. Prat, Dr. Vile, and company management will be available to answer questions following the formal presentations.
To register for the event, please click here (https://media.rampard.com/20210412/).
About the KOLs
Aleix Prat, M.D., Ph.D. is the Head of the Medical Oncology Department of the Hospital Clínic Barcelona (Spain), Associate Professor at the University of Barcelona, Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Lab at IDIBAPS, and President of the governing board of the Spanish Breast Cancer Cooperative Research Group (SOLTI), which performs clinical trials of excellence in oncology. He was also named a member of the Executive Board of The Breast International Group (BIG) in 2018. BIG is an international non-profit organization that is linked to more than 3,000 hospitals and includes more than 10,000 experts and more than 56 cooperative groups from around the world.
Over his career, Dr. Prat obtained worldwide prestige as a research scientist in the field of breast cancer genomics and biomarker development. In 2008, he became a postdoctoral research associate (2008-2012) at the Lineberger Comprehensive Cancer Center (University of North Carolina at Chapel Hill, USA) in the Laboratory of Prof. Charles M. Perou, a world-renowned translational researcher in breast cancer. During this postdoctoral experience, he discovered and characterized a new molecular subtype of breast cancer, known as a Claudin-low (Prat et al. Breast Cancer Research 2010; Citations: 1,518). In addition, he contributed to the breast cancer portion of The Cancer Genome Atlas (Nature 2012; Citations: 4,661), which was a landmark molecular characterization study in the field of cancer research.
Richard Vile, Ph.D. is a world-renowned scientist and member of the Oncolytics Scientific Advisory Board with extensive experience studying pelareorep. As a recognized KOL, his research focuses on several areas of immuno-oncology, including oncolytic viruses, adoptive cell therapies (ACTs) such as chimeric antigen receptor (CAR) T cells, and potential synergistic interactions between oncolytic viruses and ACTs. In addition to his role as a professor at the Mayo Clinic ("Mayo"), Dr. Vile is the Director of Mayo's Immuno-oncology and Gene and Virus Therapy programs and Co-Director of the Cancer Immunology and Immunotherapy program. He also serves on the editorial board of several prestigious scientific journals, including Molecular Therapy, Gene Therapy, The Journal of Gene Medicine, and OncoImmunology. Dr. Vile received his B.A. in Biochemistry from the University of Oxford and his Ph.D. in Viral Vectors from the University of London.
About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:
NEWS -- Aytu BioPharma Divests U.S. Rights to Natesto(R) to Acerus Pharma
Strategic Transaction Provides $7.5M in Non-Dilutive Capital and Enables Pediatric and ADHD Product Focus Following the Recently Closed Merger with Neos Therapeutics
ENGLEWOOD, CO / ACCESSWIRE / April 1, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU) a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today announced the signing of an agreement with Acerus Pharmaceuticals Corporation (ASP)(ASPCF) whereby Acerus will acquire all remaining rights to Natesto in the United States from Aytu. In consideration, Aytu will receive $7.5M in cash from Acerus, which is payable in $250,000 monthly payments over 30 months. Additionally, Acerus will assume all product responsibilities associated with Natesto following the April 1, 2021 effective date. Aytu will provide transition support to Acerus over a 120-day transition period.
"This strategic transaction is an important milestone for Aytu BioPharma as it solidifies our go-forward therapeutic focus on pediatric medicine and plan to become a leading specialty pediatrics company," said Josh Disbrow, Chief Executive Officer of Aytu BioPharma. He further commented, "In conjunction with finalizing and closing the merger with Neos Therapeutics, we conducted a strategic review of our legacy Rx business. Following that review, we believe focusing commercial efforts on our newly expanded portfolio of ADHD and pediatric products provides the best opportunity to increase shareholder value. As such we will deploy our resources and sales force accordingly against pediatricians and ADHD clinicians as the newly formed Aytu BioPharma." Along with receiving $7.5M in cash, Acerus will purchase all on-hand Natesto inventory from Aytu.
About Aytu BioPharma, Inc.
Aytu BioPharma is a specialty pharmaceutical company with a growing commercial portfolio of prescription therapeutics and consumer health products. The company's primary prescription products treat attention deficit hyperactivity disorder (ADHD) and other common pediatric conditions. Aytu markets ADHD products Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING). The company's other pediatric products include Karbinal® ER (carbinoxamine maleate), an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. The company's evolution has been driven by strategic in-licensing, acquisition-based transactions and organic product growth. As Aytu continues this trajectory, the company is building a complimentary therapeutic development pipeline that will address significant unmet needs. For more information, please visit https://aytubio.com.
Forward-Looking Statements
This press release includes 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, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding future growth of the company's product offerings and expansion of its development and commercial pipeline. Please also refer to the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/638540/Aytu-BioPharma-Divests-US-Rights-to-NatestoR-to-Acerus-Pharma