ConcertAI Names Claudio D'Ambrosio, PhD, as Head of Biopharma Partnerships and RWE Solutions

Prnewswire | September 10, 2020

ConcertAI has hired Claudio D'Ambrosio, PhD, as head of biopharma partnerships and real-world evidence Solutions. Claudio brings over 15 years of experience as a cancer researcher, commercial leader, and strategic scientific partner to the life sciences industry to help advance the goals of ConcertAI of bringing rapid innovation and precision real-world evidence oncology to the world's top global pharmaceutical companies. ConcertAI is a fast-growing company with the leading technology for integrated Real-World Data (RWD), AI cloud solutions, and advanced outcomes, and data science services for oncology RWE). The mission of ConcertAI is to advance the regulatory and market access applications of precision RWE through a unique set of validated RWD solutions and complementary eurekaHealth technologies.

Spotlight

Shares of pharmaceutical company Hospira (HSP) jumped 35% on Thursday, making it TheStreet's move of the day. The stock soared after drug company Pfizer (PFE) announced plans to acquire the company for about $17 billion, with a valuation of $90 per Hospira share. Hospira specializes in providing injectable drugs, a business Pfizer says is expected to grow to $70 billio

Spotlight

Shares of pharmaceutical company Hospira (HSP) jumped 35% on Thursday, making it TheStreet's move of the day. The stock soared after drug company Pfizer (PFE) announced plans to acquire the company for about $17 billion, with a valuation of $90 per Hospira share. Hospira specializes in providing injectable drugs, a business Pfizer says is expected to grow to $70 billio

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PHARMACY MARKET

Kedalion Therapeutics Secures Series B Funding and Announces Signing of Option to Acquire Agreement

Kedalion Therapeutics, | November 16, 2021

Kedalion Therapeutics is pleased to announce the completion of its Series B financing led by Novartis and involving a combination of new and existing investors. The Novartis investment includes an Exclusive Option to Acquire the company and its AcuStream™ technology. This agreement follows a Feasibility Study agreement with the AcuStream™ technology signed earlier this year. The subsequent feasibility study has been completed with successful results. Collaboration between the two parties is ongoing. The financial and other terms of this transaction are not disclosed. Kedalion’s AcuStream™ platform is a highly innovative, digitally connected, electromechanical topical ocular delivery device that aims to address a potential unmet need for a convenient, user-friendly device that reliably, accurately, and comfortably delivers topical ocular therapy with improved efficiency and patient comfort, and reduced reliance on patient skill and instillation technique when administered by a physician.1 The multi-dose, preservative-free platform strives to enable intended aim, potential for a comfortable patient experience, micro-dosing capability, and in phase 1 proof of concept studies, has shown a potential for a reduction in delivery dose of an intended therapy.1-4 Kedalion will continue to move forward with the development of the AcuStream™ platform across multiple disease categories, drug classes and compositions, including the treatment of presbyopia. The AcuStream™ technology has a potential to enhance the patient experience and optimize treatment outcomes of the company’s highly advanced portfolio of topical ocular drug products in development. The company looks forward to the opportunity to collaborate with Novartis Innovative Medicines as a valued investor and partner in developing our technology platform and therapeutic targets. “At Novartis, we are committed to reimagining medicine and investigating innovative approaches that have the potential to address unmet patient needs. The AcuStream™ technology is a novel platform with broad applicability in ophthalmics and we envisio that it could help us deliver transformative solutions to the patients who rely on our therapeutics to treat a range of eye conditions.” Jill Hopkins, Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals Dr. Mark Blumenkranz, the Chairman and Chief Executive of Kedalion Therapeutics, commented that “this transaction and associated further studies will help us accomplish our goal of revolutionizing the way drugs are delivered to the eye. The AcuStream™ technology, which strives to enable easier aiming, micro-dosing capability, and a potential for a reduction in delivery dose of an intended therapy, has the potential for a comfortable patient experience for patients worldwide.1 The platform could potentially provide convenience and enable micro-dosing capability for various ocular diseases.1 We see our capabilities coupled with the scientific and market leadership of Novartis in ophthalmics to be a winning formula for both organizations.” About Kedalion Therapeutics Kedalion Therapeutics is a venture-backed, clinical-stage biotechnology company whose mission is to bring to market transformative topical ophthalmic therapies for new and existing indications. Kedalion’s proprietary AcuStream™ platform technology delivers topical drugs to the eye in a precise and accurate manner that enables comparable effect with up to an 80% reduction in dose compared to standard eye drops. Kedalion is based in Menlo Park, CA.

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PHARMACY MARKET

AIkido Pharma Announces Strategic Interest in ASP Isotopes Inc.

AIkido Pharma Inc. | December 07, 2021

AIkido Pharma Inc. announced that the Company secured a strategic equity interest in ASP Isotopes, Inc., which focuses on the non-nuclear supply of enriched isotopes. ASP Isotopes' Aerodynamic Separation Process is a method of enriching molybdenum-100 which is a stable isotope of molybdenum. Technetium-99m is the most used radioisotope in the nuclear imaging industry, but the supply chain, which involves the radioactive decay of molybdenum-99 has been fraught with problems during the last 20 years. Mo-100 can be converted into Technetium-99m closer to the point of care thus eliminating the complex supply chain that currently exists and the risk of a supply interruption to the hospital and radiological pharmacy. ASP Isotopes is currently constructing a 20 Kg/year production plant in South Africa during 2021/22. There has been significant interest from potential customers for volumes exceeding 100% of the capacity of the first manufacturing plant. The company intends to enter into "take or pay" style offtake agreements with customers and by 2028, ASP Isotopes Inc intends to be a leading supplier of non-nuclear enriched isotopes generating over $150 million in EBITDA per annum. "The ASP Technology has been developed over the last 18 years. Following this capital raise, we believe that we are in a strong position to complete our first manufacturing plant for Molybdenun-100. Given the inherent challenging nature of the current supply chain, there has been considerable interest from potential customers, and we look forward to beginning commercial operations in the future. We would like to thank AIkido Pharma for their strategic investment in ASP Isotopes and we look forward to delivering extraordinary shareholder returns during the next several years". Paul Mann, Chairman and CEO of ASP Isotopes Anthony Hayes, CEO of AIkido, noted, "This clearly exemplifies another high growth opportunity for us with a potential monetization event in the first half of 2022. ASP's unique technology, large market opportunity, notable investors and well accomplished management team are what initially attracted us to this opportunity. Our strategic investment in ASP Isotopes is exciting as they may have the best solution to help solve the current supply chain issue of a potential supply side shock with their Aerodynamic Separation Process. The Mo-99 market is currently estimated to be valued at $3.8 billion per year but with nine out of ten facilities expected to close within 10 years many governments and companies are exploring alternative methods of producing MO-99. We remain focused on continuing to acquire assets in our space that we believe will create shareholder value and possible monetization in the next 6-9 months." About ASP Isotopes Inc. ASP Isotopes Inc. was incorporated in 2021 and is an isotope enrichment company. The company utilizes technology developed in South Africa over the past 20 years to enrich isotopes of elements or molecules with low atomic masses. Many of these elements are unsuitable for enrichment using traditional methods such as centrifuges. The company's first commercial product will be Molybdenum 100, which has the potential to replace Molybdenum 99, a commonly used product in the diagnostic imaging market. About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anti-cancer therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer and prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus. Additionally, the Company has interests in high growth opportunities in diverse sectors with potential near term monetization events.

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PHARMA TECH

Fusion Pharmaceuticals Announces Presentation of Preclinical Data Supporting its FPI-1966 and FPI-2059 Targeted Alpha Therapies

Fusion | October 23, 2021

Fusion Pharmaceuticals a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies at the 34th Annual European Association of Nuclear Medicine Congress. These data reinforce the clinical dosing regimen of FPI-1966 and highlight the potential of FPI-2059 as an actinium-225 labelled precision medicine targeting NTSR1. "These data demonstrate the broad potential of our TAT platform across multiple validated targets overexpressed in a variety of solid tumors, We are pleased to share preclinical efficacy and tumor uptake data resulting from the administration of FPI-1966, and we believe strongly that this data will translate into meaningful results for patients with solid tumors overexpressing FGFR3 – a population with high unmet medical need. We look forward to initiating the Phase 1 study around the end of this year." Chief Executive Officer John Valliant, Ph.D Data from preclinical studies of FPI-1966, a TAT designed to target and deliver actinium-225 to cancer cells expressing FGFR3, were presented in an oral presentation titled, "FGFR3 Targeted Alpha Therapeutic [225Ac]-FPI-1966 induces regression in preclinical bladder xenograft model". Outcomes demonstrated that FPI-1966 when administered with vofatamab results in high tumor delivery and low off-target uptake. Further, the data showed therapeutic efficacy of FPI-1966 at both single and multiple doses in a preclinical bladder cancer xenograft model. Data from preclinical studies of FPI-2059, a TAT designed to target and deliver actinium-225 to cancer cells expressing neurotensin receptor 1 (NTSR1), were presented in an oral presentation titled "NTSR1 Targeted Alpha Therapeutic [225Ac]-FPI-2059 induces regression in preclinical colorectal xenograft model". The study results include a head-to-head comparison of therapeutic efficacy obtained from FPI-2059, which delivers an alpha emitting isotope, with [177Lu]-IPN-1087, which delivers a beta emitting isotope on the same targeting molecule. Results demonstrate superior efficacy with [225Ac]-FPI-2059 in a mouse xenograft model of colorectal cancer. Dr. Valliant continued, "Our science is based on the belief that alpha-emitting isotopes can provide significant therapeutic advantages compared to other commonly used radioisotopes. Preclinical results from our FPI-2059 product candidate provide further validation of this belief and support the diversification of our product portfolio to comprise multiple targeting vehicle types, including small molecules. We are pleased to be advancing further preclinical studies of FPI-2059 as we approach an investigational new drug (IND) filing in the first half of 2022." About FPI-1966 [225Ac]-FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including head and neck and bladder cancers. FPI-1966 utilizes Fusion's Fast-Clear™ linker to connect vofatamab, the human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated. FPI-1966 is advancing to a Phase 1 study following the recent investigational new drug (IND) clearance About FPI-2059 FPI-2059 is a targeted alpha therapy combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors. IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1. Fusion expects to submit an IND for FPI-2059 in the first half of 2022. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the recent investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs. Forward Looking Statements This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion Pharmaceuticals Inc.'s (the "Company") future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the uncertainties inherent in the drug development process, including FPI-1966 and FPI-2059 early stage of development; the ability to move in-licensed targets forward in the clinic; the process of designing and conducting preclinical and clinical trials; the regulatory approval processes; the timing of regulatory filings; and the challenges associated with manufacturing drug products generally and radiopharmaceuticals specifically. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2021 as filed with the SEC and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

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