On July 24, 2024 Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, and Pieris Pharmaceuticals, Inc. (Nasdaq: PIRS) (Pieris) reported they have entered into a definitive merger agreement to combine the companies in an all-stock transaction (Press release, Pieris Pharmaceuticals, JUL 24, 2024, View Source [SID1234645042]). The combined company will focus on developing and commercializing Palvella’s lead clinical product candidate, QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin), for the treatment of microcystic lymphatic malformations (microcystic LMs), cutaneous venous malformations, and other serious, functionally debilitating skin diseases driven by the overactivation of the mammalian target of rapamycin (mTOR) pathway. Upon completion of the proposed merger, the combined company will operate under the name Palvella Therapeutics, Inc., will be headquartered in Wayne, PA, and is expected to trade on The Nasdaq Capital Market (Nasdaq).

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In connection with the proposed merger, Palvella has secured commitments from a syndicate of leading healthcare-dedicated investors in an oversubscribed $78.9 million concurrent private financing co-led by BVF Partners, L.P., an existing investor, and Frazier Life Sciences, a new investor. Additional new investors include Blue Owl Healthcare Opportunities, Nantahala Capital, DAFNA Capital Management, ADAR1 Capital Management, and a healthcare dedicated fund. Existing investors Samsara BioCapital, Petrichor, CAM Capital, Ligand Pharmaceuticals (Nasdaq: LGND), Integrated Finance Group (an AscellaHealth partner company), BioAdvance, and Gore Range Capital also committed to participate in the financing. The concurrent private financing includes approximately $18.9 million in principal and interest from Palvella convertible notes that will be funded prior to the close and convert into shares of common stock of the combined company. The concurrent private financing is expected to close immediately following the completion of the proposed merger.

The combined company is expected to have approximately $80.5 million of cash and cash equivalents at closing of the proposed merger and concurrent private financing, inclusive of the net proceeds expected to be received in the concurrent private financing and after deducting operating expenses incurred prior to closing and estimated transaction expenses. These cash resources are expected to be used to advance Palvella’s product candidate QTORIN rapamycin through multiple clinical data milestones and are expected to fund the combined company’s operations into the second half of 2027. The proposed merger and concurrent private financing are expected to close in the fourth quarter of 2024, subject to stockholder approval of both companies, the effectiveness of a registration statement to be filed with the U.S. Securities and Exchange Commission (SEC) to register the shares of Pieris common stock to be issued in connection with the merger, and the satisfaction of customary closing conditions. Pieris pre-merger stockholders will also be issued a contingent value right (CVR) representing the right to receive payments from proceeds received by the combined company, if any, under Pieris’ existing partnership agreements with Pfizer and Boston Pharmaceuticals.

"We are pleased to announce our merger with Pieris, allowing Palvella to become a publicly traded company and pursue our vision of becoming the leading rare disease company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases," said Wes Kaupinen, Founder and Chief Executive Officer (CEO) of Palvella. "The expected proceeds from the merger and concurrent private financing are expected to fund us through multiple clinical trial milestones, including generating results from the single-arm, baseline-controlled Phase 3 clinical trial of QTORIN rapamycin for the treatment of microcystic lymphatic malformations, a serious, rare and chronically debilitating genetic disease for which there are currently no FDA-approved therapies."

"This transaction represents Pieris’ deep commitment to delivering value to its stockholders by preserving the future potential milestone and royalty streams from our partnered immuno-oncology bispecifics franchise for Pieris legacy stockholders through the CVRs, while also providing the opportunity for upside in an attractive, late-stage, rare disease company," said Stephen S. Yoder, President and CEO of Pieris. "With the anticipated funding and an accomplished management team, we believe Palvella is well-positioned to advance a Phase 3 clinical program with the FDA’s Breakthrough, Fast Track, and Orphan Drug Therapy Designations. This transaction is the culmination of a comprehensive review of strategic alternatives, and our board of directors believes that the merger with Palvella is in the best interests of our stockholders."

Palvella’s QTORIN Platform and QTORIN rapamycin

Palvella’s research team developed QTORIN, a patented and versatile platform designed to generate novel topical therapies that penetrate the deep layers of the skin to locally treat a broad spectrum of serious, rare genetic skin diseases.

QTORIN rapamycin is the lead product candidate from Palvella’s QTORIN platform. QTORIN rapamycin is a novel, patented 3.9% rapamycin anhydrous gel, which aims to harness the potential therapeutic benefits of rapamycin, an mTOR inhibitor, while minimizing systemic exposure of rapamycin and potential adverse reactions associated with systemic therapy. QTORIN rapamycin is currently under development for the treatment of microcystic LMs, cutaneous venous malformations, and other serious, functionally debilitating skin diseases driven by the overactivation of the mammalian target of rapamycin (mTOR) pathway. QTORIN rapamycin is protected by multiple issued composition patents in the U.S. and Japan and pending patent applications broadly covering anhydrous gel formulations of rapamycin in the U.S., Europe, and Japan.

QTORIN Rapamycin for the Treatment of Microcystic LMs

Palvella initiated research on QTORIN rapamycin as a targeted therapy for microcystic LMs in 2017 based on scientific insights implicating abnormal activation of the mTOR pathway in this disease. Microcystic LMs is a rare, chronically debilitating genetic disease caused by dysregulation of the phosphatidylinositol 3-kinase (PI3K)/mTOR pathway. The disease is characterized by malformed lymphatic vessels that protrude through the skin and persistently leak lymph fluid (lymphorrhea) and bleed, often leading to recurrent serious infections and cellulitis. The natural history of microcystic LMs is progressive, with symptoms generally worsening during life, including increases in the number and size of malformed vessels that lead to complications and lifetime morbidity. There are currently no FDA-approved treatments for the estimated more than 30,000 diagnosed patients with microcystic LMs in the United States.

In November 2023, based on Phase 2 clinical trial results, Palvella received FDA Breakthrough Therapy Designation for QTORIN rapamycin for microcystic LMs. Palvella previously announced positive topline Phase 2 clinical trial results from the multi-center, open-label study of 12 subjects receiving QTORIN rapamycin once-daily for 12-weeks. The Phase 2 clinical trial featured multiple pre-specified efficacy assessments, including clinician and patient global impression assessments as well as assessments of individual clinical manifestations that are important disease burdens for individuals living with microcystic LMs. All participants in the Phase 2 clinical trial demonstrated improvements on the Clinician Global Impression of Change scale, with all participants in the study rated as either "Much Improved" (n=7, 58%) or "Very Much Improved" (n=5, 42%) after 12-weeks of treatment compared to the pre-treatment baseline period. In addition to Breakthrough Therapy Designation, the FDA has granted both Fast Track Designation and Orphan Drug Designation to QTORIN rapamycin for the treatment of microcystic LMs.

In February 2023, Palvella had an End of Phase 2 meeting and, in April 2024, a Type B Breakthrough Therapy Designation meeting with FDA regarding the clinical trial program. Palvella considered FDA feedback on study ethics and other considerations related to selection of key study design features, site feedback on study ethics and feasibility, and input from expert regulatory advisors, and Palvella initiated SELVA, a 24-week, pivotal Phase 3, single-arm, baseline-controlled clinical trial of QTORIN rapamycin for the treatment of microcystic LMs, in the third quarter of 2024. The study’s primary and key secondary endpoints are clinician-reported outcomes and will enroll 40 subjects at leading vascular anomaly centers across the U.S.

QTORIN Rapamycin for the Treatment of Cutaneous Venous Malformations

Palvella is also developing QTORIN rapamycin for the treatment of cutaneous venous malformations. Cutaneous venous malformations are a rare genetic disease that results from overactivation of the PI3K/mTOR signaling pathway in the development of the venous network, leading to dilated and dysfunctional veins within the skin. Cutaneous venous malformations cause functional impairment, significantly impact quality of life, and are associated with severe long-term complications. In April 2024, the FDA granted Fast Track Designation to QTORIN rapamycin for the treatment of venous malformations. Palvella plans to initiate a Phase 2 baseline-controlled clinical trial of QTORIN rapamycin for the treatment of cutaneous venous malformations in the second half of 2024.

About the Proposed Merger

Under the terms of the merger agreement, Pieris will issue shares of Pieris common stock to pre-merger Palvella stockholders as merger consideration in exchange for the cancellation of shares of capital stock of Palvella, and Palvella will become a wholly-owned subsidiary of Pieris.

Pre-merger Pieris stockholders are expected to own approximately 18% of the combined company and pre-merger Palvella stockholders are expected to own approximately 82% of the combined company, in each case, prior to the issuance of the shares under the concurrent private financing. The percentage of the combined company that pre-merger Palvella stockholders and pre-merger Pieris stockholders will own upon the closing of the merger is subject to further adjustment based on the amount of Pieris’ net cash at the time of closing. In connection with the closing of the proposed transactions under the merger agreement, Pieris pre-merger stockholders will also be issued a contingent value right (CVR) representing the right to receive payments from proceeds received by the combined company, if any, under Pieris’ existing partnership agreements with Pfizer and Boston Pharmaceuticals, in addition to other potential licensing agreements involving certain of Pieris’ legacy assets, as well as certain potential payments related to historical research and development tax credits, which may or may not be realized.

The transactions contemplated by the merger agreement have been unanimously approved by the boards of directors of both companies and are expected to close in the fourth quarter of 2024, subject to approvals by the stockholders of each company, the effectiveness of a registration statement to be filed with the SEC to register the shares of Pieris common stock to be issued in connection with the merger, and other customary closing conditions. Additional information about the transaction will be provided in a Current Report on Form 8-K that will be filed by Pieris with the SEC and will be available at www.sec.gov.

Management and Organization

Following the merger, the combined company will be led by Wes Kaupinen, Founder and CEO of Palvella, and other members of the Palvella management team. The combined company’s board of directors will be comprised of four of the current directors of Palvella’s board of directors, and one director designated from Pieris’ current board of directors, who is expected to be Christopher Kiritsy, the chair of Pieris’ audit committee. Pieris will be renamed "Palvella Therapeutics, Inc."

Conference Call Information

The companies will host a webcast call and presentation to discuss the proposed transactions, as well as Palvella’s pipeline assets on Wednesday, July 24 at 8:30 am ET. The live webcast can be accessed here and on the Pieris website at www.pieris.com/investors in the ‘Investors’ section or by calling 877-407-8920 or +1 412-902-1010. A replay of the webcast will be archived and available following the event.

Advisors

TD Cowen is serving as lead placement agent and Cantor is serving as a placement agent for Palvella’s planned concurrent financing. Troutman Pepper Hamilton Sanders LLP is serving as legal counsel to Palvella. Cooley LLP is serving as legal counsel to the placement agents. Stifel is serving as the exclusive financial advisor to Pieris and Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo, P.C. is serving as legal counsel to Pieris.

On July 24, 2024 Notable Labs, Ltd. (Nasdaq: NTBL) ("Notable", "Notable Labs" or the "Company"), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Medicine Platform (PMP), reported progress for the Phase 2 volasertib program following receipt of "Clearance to Proceed" from the FDA and agreement on the dosing plan for its Phase 2 clinical trial (Press release, Notable Labs, JUL 24, 2024, View Source [SID1234645041]). With trial start-up activities launched in the first quarter of this year, Notable intends to initiate enrollment in the Phase 2 study for PMP-enabled development of volasertib for relapsed refractory (R/R) acute myeloid leukemia (AML) in the coming months.

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"We are pleased to report positive progress in our clinical development program to evaluate the use of volasertib, in combination with decitabine, for patients with R/R AML. Receiving FDA’s clearance and agreement on a Phase 2 dosing plan positions us to move forward to activate study sites," said Thomas Bock, M.D., Chief Executive Officer of Notable. "AML remains a devastating and life-threatening unmet need, especially for patients whose disease has progressed after first-line treatment, and especially in those who have received venetoclax-based therapies. Advancing the volasertib program through the next Phase 2 implementation steps represents meaningful progress for the Company. We are excited about the potential of volasertib, our predictive platform, and our carefully designed clinical program to enhance patient clinical outcomes and tolerability. We look forward to updating our investors and key stakeholders as we proceed."

Glenn Michelson, M.D., Chief Medical Officer of Notable commented, "Our study design and enrollment strategy for volasertib has been informed by our robust clinical validation trials conducted at Stanford University, the University of Texas MD Anderson Cancer Center and other recognized institutions. In addition, our program incorporates learnings from the agent’s originator, Boehringer Ingelheim, and leverages their extensive post-hoc analysis of the initial Phase 3 AML study. These valuable data guided our decision to in-license volasertib and the overall development strategy. We are enthusiastic to advance a promising new treatment option for patents with R/R AML, building on our platform."

Amer Zeidan, MBBS, Associate Professor of Medicine (Hematology), Chief of Hematologic Malignancies at Yale Cancer Center and study co-chair shared, "As a clinical researcher with experience in acute myeloid leukemia, I am excited about the potential of volasertib, in combination with Notable’s platform and the enhanced trial design, to overcome some of the problems experienced in prior trials of this agent. This study will allow us to understand if volasertib could offer promise to advance care for patients with acute myeloid leukemia."

The Phase 2 study will begin with a dose optimization lead-in and incorporate body-surface area (BSA) dosing, prophylactic antibiotic treatment and best supportive care. The second part of the study is planned to enroll patients with R/R AML who are PMP-predicted responders. The Company is working towards initiating dosing of the first subjects in the Phase 2 trial. Based on our plan, Notable expects to have initial data from the dose optimization lead-in during the fourth quarter of 2024, initiate selective enrollment of PMP-predicted responders after that, and start to report initial efficacy results during H1 2025.

About Volasertib

Volasertib is a PLK-1 inhibitor with demonstrated activity in AML and other tumor types, including solid tumors, with significant unmet medical need. Building on the performance of volasertib on PMP, an important and proprietary step during Notable’s targeted in-licensing strategy and decision making, Notable will utilize its PMP to predict volasertib-responsive patients prior to their treatment, with the goal of selectively enrolling and treating those predicted responders, increasing volasertib’s response rates and overall patient outcomes, and fast-tracking volasertib’s remaining clinical development in this patient population. Volasertib was originally developed and manufactured by Boehringer Ingelheim and previously granted Breakthrough Therapy designation by the FDA. Notable in-licensed volasertib and obtained exclusive worldwide development and commercialization rights, except for certain rare pediatric cancers.

On July 24, 2024 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, reported that it awarded inducement grants on July 22, 2024 to its Executive Vice President and Chief Financial Officer, Edward Dulac, under Intellia’s 2024 Inducement Plan as a material inducement to employment (Press release, Intellia, JUL 24, 2024, View Source [SID1234645040]).

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The inducement grants consisted of non-qualified stock options to purchase 96,219 shares of Intellia’s common stock with an exercise price of $25.33 per share, the closing price of Intellia’s common stock as reported by Nasdaq on July 22, 2024, with 33% of the options underlying the option award vesting on the first anniversary of the grant date and the remainder vesting monthly thereafter until fully vested on the third anniversary of the grant date; time-based restricted stock units ("RSUs") for 66,324 shares of Intellia’s common stock, with one-third of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the grant date; performance-based RSUs for 33,162 shares of Intellia’s common stock, with vesting criteria linked directly to Intellia’s total stockholder return over a three-year period compared to the companies comprising the Nasdaq Biotechnology Index at the beginning of the performance period; and performance-based RSUs for 30,000 shares (at target) of Intellia’s common stock, with vesting criteria linked directly to certain development milestones over a three-year period.

All equity vesting is subject to Mr. Dulac’s continued service as an employee of, or other service provider to, Intellia through the applicable vesting dates.

All of the above-described awards were granted outside of Intellia’s stockholder-approved equity incentive plans pursuant to Intellia’s 2024 Inducement Plan, which was adopted by the board of directors in June 2024. The awards were approved by a majority of the independent directors of Intellia’s board of directors as a material inducement to Mr. Dulac’s entering into employment with Intellia in accordance with Nasdaq Listing Rule 5635(c)(4).

On July 24, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported it will host a virtual key opinion leader (KOL) event on Friday, August 2 at 9:00 AM ET featuring J. Randolph Hecht, MD, (Professor, UCLA Gastrointestinal Oncology Program) and Howard Brown (CRC Survivor, Patient and Advocate) who will discuss the unmet need and current treatment landscape for patients with metastatic microsatellite stable colorectal cancer (MSS-CRC) (Press release, Gritstone Bio, JUL 24, 2024, View Source [SID1234645039]).

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Gritstone management will also highlight the development of Gritstone’s personalized neoantigen vaccine program, GRANITE, as a potential treatment for immunologically "cold" tumors including MSS-CRC. Mature progression-free survival data from a randomized Phase 2 study of GRANITE in frontline MSS-CRC are expected in the third quarter of 2024.

A live Q&A session will follow the formal presentations.

About J. Randolph Hecht, MD
J. Randolph Hecht, MD is a Professor of Clinical Medicine in the David Geffen School of Medicine at UCLA School of Medicine. He holds the Carol and Saul Rosenzweig Chair for Cancer Therapies Development and is the Director of the UCLA Gastrointestinal Oncology Program. Dr. Hecht attended medical school at Eastern Virginia Medical School. He took his internal medicine residency at Northwestern and completed fellowships in gastroenterology research at the University of Chicago, and in gastroenterology and medical oncology at UCLA. Dr. Hecht is an internationally known clinical and translational researcher in the field of gastrointestinal cancers. He has published widely on the molecular biology, early detection, and treatment of gastrointestinal malignancies. He has led and is currently directing small trials with new molecules as well as large international randomized trials. Current ongoing research includes preclinical models of therapy with biological agents, early studies with gene therapy vectors and tyrosine kinase inhibitors, and leading phase II and phase III trials with novel agents.

About Howard Brown
Howard Brown is a two-time Stage IV cancer patient, survivor, advocate, technology entrepreneur, husband, dad and avid basketball player. In 1989 at the age of 23, Howard was diagnosed with Stage IVe Non-Hodgkin’s Lymphoma. After failing three chemotherapy regimens, he had an allogeneic (from a donor) bone marrow transplant from his twin sister who was an exact HLA match. That, along with massive chemotherapy and full body radiation saved his life. Twenty-six years after achieving remission, Howard was diagnosed with Stage III Colon Cancer at age fifty via a standard colonoscopy. After two colon resection surgeries, intense chemotherapy and a failed clinical trial he turned metastatic Stage IV and discovered the cancer had spread to his liver, peritoneum, omentum and small bowel. After salvage second line chemotherapy showed some regression (shrinkage), Howard underwent Cytoreduction Surgery (debulking / removal of live and dead cancer cells) with Heated intra-peritoneal chemotherapy (hot chemo wash to kill micro cancer cells– (CRS HIPEC). Howard is currently considered No Evidence of Disease (NED) at this time after 9 consecutive CT scans. He serves as the Board Chair and President of Colontown, an organization that serves over 11,000 patients and caregivers with colorectal cancer. Howard is a proud graduate and past trustee of Babson College, #1 for entrepreneurship, and lives with his family in Birmingham, Michigan.

On July 24, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported that its Canadian Nuclear Research Initiative Health ("CNRI-H") Program application was retained and approved by the Canadian Nuclear Laboratories ("CNL") to accelerate Defence’s radio-immuno-conjugates project (Press release, Defence Therapeutics, JUL 24, 2024, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-granted-cnri-h-from-the-canadian-nuclear-laboratories-to-accelerate-the-development-of-its-radio-immuno-conjugates-program [SID1234645036]).

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Defence’s CNRI-H project will focus on the synthesis and evaluation of novel constructs, variations of 111In-AccuTOX-Trastuzumab. The objective is to demonstrate that AccuTOX moiety is an essential modification to conventional 111In-Trastuzumab constructs to evade an endosome entrapment and ensure nuclear localization, where 111In will emit Auger Electrons ("AEs") to kill cancer cells, and providing a synergistic effect by unleashing AccuTOX immune-boosting power. It is expected that these constructs will be lethal to HER2-positive cancer cells specifically and will produce high potency.

Selected AccuTOX constructs, based on stability, solubility, and biochemical properties, will be conjugated to the trastuzumab antibody, followed by radiolabeled with 111In, and then characterized, in vitro and in vivo, for its efficacy in killing cancer. The main goal is to identify the biologically active 111In-AccuTOX-Trastuzumab molecule that will be more potent to treat solid tumor resistant to current HER2-targeting therapy such as therapeutic antibodies (e.g., trastuzumab alone) and antibody-drug conjugate (e.g., Kadcyla).

In summary, the aim of this CNRI-H collaborative project is:

1. To synthesize AccuTOX-Trastuzumab antibody conjugates, radiolabel with 111In, and characterize, including structure and cellular analysis (e.g. identification, drug-antibody ratio, specific activity), stability, and cytotoxic effects, in vitro.

2. To perform animal studies in rodents, in vivo, namely biodistribution, pharmacokinetic profile, and therapeutic potency, using selected 111In-AccuTOX-Trastuzumab constructs.

"We are proud to have this opportunity to collaborate with the Canadian Nuclear Laboratories and to advancing Defence’s radio-immuno-conjugates program for the benefit of the cancer’s patients. The CNL scientific team dedicated to our project is very strong and will definitely accelerate and reinforce Defence’s strength in this renowned and fast-growing radiopharmaceuticals field," said Sebastien Plouffe, Chief Executive Officer of Defence Therapeutics.

CNRI-H is a program developed by CNL to further the realization of its mission of contributing to the health of Canadians. Through CNRI-H, CNL provides financial support along with its expertise, experience, capabilities and makes this available and accessible to the healthcare community to advance new life saving radiopharmaceutical solutions. CNRI-H is a turnkey solution that integrates both funding and project execution in one award. The goal of the program is to accelerate the optimization of therapeutic isotopes production and the clinical translation of targeted radiopharmaceuticals for the benefit of Canadians whilst increasing the safety and efficacy of therapies that involve radiopharmaceuticals.

According to Allied Market Research, the global radiopharmaceuticals market was valued at $7.9 billion in 2023, and is projected to reach $21.8 billion by 2033, growing at a CAGR of 10.6% from 2024 to 2033. And according to Straits Research, the global radioligand therapy market size was valued at USD 12.55 billion in 2023, and it is anticipated to reach USD 21.55 billion by 2032 with a CAGR of 4.62%. The use of radioligands to treat specific cancers is a novel method. It delivers radiation to cancer cells with pinpoint accuracy and minimal side effects on healthy cells, resulting in higher treatment efficacy.