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Cardinal Health™ Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New LYMPHOSEEK® Pediatric Indication

On June 10, 2021 Cardinal Health (NYSE: CAH) reported that LYMPHOSEEK (technetium Tc 99m tilmanocept) injection – the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB) – has been approved for pediatric use by the U.S. Food and Drug Administration (FDA) (Press release, Cardinal Health, JUN 10, 2021, View Source;Precision-Health-Solutions-Receives-U.S.-Food-and-Drug-Administration-Approval-for-New-LYMPHOSEEK-Pediatric-Indication/default.aspx [SID1234583821]).

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

"This new indication opens the door for physicians, oncologists and nuclear medicine specialists to more accurately stage the spread of disease using lymphatic mapping in pediatric cancer patients," said Tiffany Olson, President of Nuclear & Precision Health Solutions at Cardinal Health. "Ultimately, this may help more families to be able to get answers to some of their most concerning questions."

In addition to adult use, this new indication will provide accurate and precise lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma (RMS) or other types of solid tumors. This will offer physicians, oncologists and nuclear medicine specialists an efficient, accurate and safe option to enhance lymphatic mapping and SLNB in pediatric melanoma cases, the most common skin cancer in children, which results in around 500 new cases per year [1].

Approximately the same number of pediatric cases of RMS, a rare type of cancer that forms in soft tissues, such as eyes, occurs each year in the United States. RMS is most often diagnosed in children and teens, with more than half of diagnoses in children younger than 10 years old [2].

LYMPHOSEEK is a radioactive diagnostic agent. A clinical study to evaluate LYMPHOSEEK in pediatric patients has shown that the radiopharmaceutical is safe and effective for patients one month and older. Less than one percent of patients reported injection site irritation and/or pain in clinical trials, with no serious adverse reactions to the drug being reported.

With the largest national pharmacy network and the industry’s most comprehensive portfolio of radiopharmaceuticals – with best-in-class service, accuracy and reliability to deliver on-demand prescriptions across the country – Cardinal Health Nuclear & Precision Health Solutions is helping shape the future of precision healthcare.

Werewolf Therapeutics Reports First Quarter 2021 Financial Results

On June 10, 2021 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (NASDAQ: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, reported financial results for the quarter ended March 31, 2021 (Press release, Werewolf Therapeutics, JUN 10, 2021, View Source [SID1234583820]).

"Our recently completed IPO will help us advance our two lead programs to the clinic and will enable us to continue to build our immuno-oncology R&D organization," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. "Despite important recent advances in the treatment of cancer, using the body’s immune system without eliciting off-target side effects remains a challenge. We are leveraging our novel PREDATOR platform to engineer conditionally activated proinflammatory immunomodulators, or INDUKINE molecules, which are delivered systemically but activated only in the tumor microenvironment, with the goal of generating potent anti-tumor response while minimizing toxicities."

Successful Initial Public Offering Completed: On May 4, 2021, Werewolf completed its initial public offering (IPO). In connection with the offering, the Company issued and sold 7,500,000 shares of common stock at a public offering price of $16.00 per share, resulting in net proceeds of approximately $108.9 million.

First Quarter 2021 Financial Highlights

Cash position: As of March 31, 2021, cash and cash equivalents decreased to $84.6 million, compared to $92.6 million as of December 31, 2020. The Company expects that its existing cash and cash equivalents, together with the net proceeds from the IPO, will be sufficient to fund its operations for at least the next twenty-four months.
Research and development expenses: Research and development expenses were $4.8 million for the first quarter of 2021, compared to $2.8 million for the same period in 2020. The increase in research and development expenses was primarily due to manufacturing expenses incurred to support the production of preclinical and future clinical trial materials associated with the Company’s product candidates WTX-124, WTX-330 and WTX-613 and increased employee compensation costs related to increased headcount.
General and administrative expenses: General and administrative expenses were $2.6 million for the first quarter of 2021, compared to $1.1 million for the same period in 2020. The increase in general and administrative expenses was primarily due to increased personnel, consulting and recruiting costs in preparation for increased requirements of operating as a public company.
Net loss: Net loss was $7.4 million for the first quarter of 2021, compared to $3.8 million for the same period in 2020.

Post-ASCO 2021 Investor & Analyst Event: Zandelisib in Focus

On June 10, 2021 MEI Pharma Presented the Corporate Presentation (Press release, MEI Pharma, JUN 10, 2021, file:///C:/Users/komal/Downloads/ASCO.2021.IR_Webcast.FINAL%20(3).pdf [SID1234583819])

Dr. Jennifer Bath and ImmunoPrecise Team attending BIO Digital

On June 10, 2021 Dr. Jennifer Bath, Frederic Chabot, Dr. Barry Duplantis, and Timothy Miller of ImmunoPrecise reported that it will be attending BIO Digital June10-11 & June 14-18, 2021 (Press release, ImmunoPrecise Antibodies, JUN 10, 2021, View Source [SID1234583818]). The event will host multiple speakers and one-on-one partnering meetings. BIO Digital will discuss how the biotech space has been changed by COVID, and we will take the opportunity to meet with potential partners about our COVID, and other Talem Therapeutic Assets.

ImmunoPrecise Attending HubXchange West 2021

On June 10, 2021 ImmunoPrecise Antibodies reported that it will be attending US West Coast HubXchange from September 20th-22nd 2021 (Press release, ImmunoPrecise Antibodies, JUN 10, 2021, View Source [SID1234583817]). HubXchange specializes in delivering high-level content, intelligence and connections to the global Life Sciences community by hosting outstanding business Xchanges. These meetings are a series of highly-interactive roundtable discussions bringing together executives and senior academics over the course of one day.