Puma Biotechnology Secures $125 Million Note Purchase by Athyrium Capital

On July 26, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it has entered into a note purchase agreement with a fund of Athyrium Capital Management, LP, a specialized asset management company focused on opportunities in the global healthcare sector, for the issuance of up to $125 million of notes thereunder, subject to funding in two tranches (Press release, Puma Biotechnology, JUL 26, 2021, View Source [SID1234585200]).

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Puma received gross proceeds of $100 million from the first tranche of notes issued by Puma under the note purchase agreement upon closing on July 23rd and intends to use the funds, together with cash on hand, to retire its existing loan with Oxford Finance LLC. The second tranche of $25 million may be drawn at a later date; if drawn down these proceeds would be used for general corporate purposes and to further support NERLYNX commercial initiatives. Armentum Partners served as the Company’s financial advisor in connection with the note purchase agreement. The notes will become due in July 2026. Additional information on the note purchase agreement will be filed with the Securities and Exchange Commission as a Current Report on Form 8-K.

Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma Biotechnology, said, "We are pleased to enter into this note purchase transaction with Athyrium Capital and to have their support with the continued commercialization of NERLYNX. This financing will be used to continue to support NERLYNX commercial activities as well as ongoing research with neratinib."

"We are excited to partner with Puma Biotechnology in supporting NERLYNX in its current indications, as well as its clinical development programs for additional indications," said Laurent D. Hermouet, Partner at Athyrium. "With the Company’s track record of in-licensing successes, we are also thrilled at the potential to help finance inorganic growth activities as they may present themselves to the Company."

Da Volterra Announces First Patient Randomized in Phase 3 Clinical Trial Evaluating the Gut Microbiome Protector DAV132 in Patients with Hematologic Malignancies

On July 26, 2021 Da Volterra, a late-stage biopharmaceutical company developing novel intestinal microbiome-protective therapies, and COMBACTE-NET, a public-private partnership co-funded by Innovative Medicines Initiative to stoke the pharmaceutical pipeline in Europe, reported that the first patient had been randomized in the MICROCARE Phase 3 clinical trial (Press release, Da Volterra, JUL 26, 2021, View Source [SID1234585199]). This follows the authorizations obtained from 7 regulatory authorities in Europe, including France, Germany, Spain and Denmark.

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The MICROCARE trial is evaluating DAV132, a first-in-class and strongly innovative microbiome protector, and shall enroll 900 patients newly-diagnosed with acute myeloid leukemia or high-risk myelodysplastic syndrome treated with intensive chemotherapy in approximately 80 centers worldwide.

"We believe that protecting the microbiome of patients with acute myeloid leukemia is a clinically meaningful goal, as patients with disrupted microbiome have more life-threatening complications and a lower survival rate", said Fabien Vitry, M.D., Chief Medical Officer of Da Volterra. "This study is a stepping stone for microbiome-oriented therapies and could pave the way to new treatment options for all patients with cancer."

MICROCARE is a randomized, placebo-controlled, parallel-group trial. Its overarching objective is to demonstrate that DAV132 contributes to decreasing the occurrence of life-threatening complications and to reducing the mortality of patients with hematologic malignancies undergoing several cycles of chemotherapy.

"With all my team, we are glad to have recruited the first patient in MICROCARE.", said Dr. Christine Robin, principal investigator at the Henri-Mondor Hospital (Creteil, France).

The primary endpoint will be the occurrence of Clostridioides difficile infection, a severe and life-threatening complication which is triggered by the disruption of the intestinal microbiome. The study will also assess the efficacy of DAV132 in protecting intestinal microbiome diversity, preventing intestinal colonization with potentially pathogenic bacteria, preventing bloodstream infections and improving Overall Survival.

"The MICROCARE trial offers an opportunity for change for patients and physicians alike, and it is also the proof that the clinical network of COMBACTE-NET, bolstered by IMI support, is up to the challenge of performing high-stake clinical studies." commented Prof. Marc Bonten, M.D., Ph.D., Academic Coordinator of COMBACTE-NET. "All the partners of COMBACTE-NET are committed to making MICROCARE a real success for all stakeholders."

Tyme Granted U.S. Patent Claims Covering Use of Tyrosine-Based Drug Delivery Method to Treat Cancer

On July 26, 2021 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that it has received notification that the United States Patent and Trademark Office has granted additional patent claims related to the Company’s metabolomic technology platform (Press release, TYME, JUL 26, 2021, View Source [SID1234585198]). The patent, U.S. Patent No. 11,058,638, involves a targeted delivery of therapeutics to cancer cells.

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Tyme has developed a technology by which the tyrosine isomer racemetyrosine (α-methylparatyrosine) can be fused with a second therapeutic agent in a manner that creates a fusion compound that may allow targeted delivery to the cancer cells in a novel manner. This method of delivery, is predicated on the metabolic phenomenon in which cancer cells consume higher quantities of non-essential amino acids, including tyrosine, from their surrounding environment to support their growth because they cannot make enough of these amino acids.

"This technology could provide Tyme an opportunity to expand its current cancer-metabolism based approach with a drug delivery platform that’s aimed to deliver toxic therapies in a targeted manner that could offer improved safety and efficacy for a range of anticancer drugs." said Steve Hoffman, Tyme’s Chief Scientific Officer.

"This delivery technology is another example of our innovative spirit at Tyme. Even though this approach is still in its early stages, if proven, it has the potential to be a broadly leveraged platform technology." said Richie Cunningham, CEO of Tyme.

The delivery technology is an investigational method of drug delivery in the pre-clinical phase of development that is not approved in the U.S. for any disease indication and requires further studies, which the Company plans to initiate this year.

McKesson Raises Quarterly Dividend by 12% to $0.47 Per Share

On July 26, 2021 The Board of Directors of McKesson Corporation (NYSE:MCK) reported that a regular dividend of $0.47 per share of common stock, a 12% increase from $0.42 per share in the prior quarter (Press release, McKesson, JUL 26, 2021, View Source [SID1234585197]). The dividend will be payable on October 1, 2021, to stockholders of record on September 1, 2021.

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Twist Bioscience Incorporates MOLCURE AI Technology to Augment Therapeutic Antibody Discovery

On July 26, 2021 Twist Bioscience Corporation (Nasdaq: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and MOLCURE Inc., reported they generated potent, binding antibodies to an undisclosed oncology target for Twist’s internal pipeline of antibody candidates (Press release, Twist Bioscience, JUL 26, 2021, View Source [SID1234585196]). The collaborative research project resulted from a technology agreement between the companies to pursue novel antibody targets through Twist’s antibody discovery and optimization together with MOLCURE’s AI technology.

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"We are proud to have engaged in collaborative research with Twist Bioscience, selected by Fast Company as one of the most innovative companies in 2021," said Ryu Ogawa, Ph.D., CEO of MOLCURE. "Our expectations that this would reinforce our partner’s therapeutic antibody pipelines and further strengthen our AI driven molecule design service were confirmed in this project."

"Twist Bioscience continues to innovate and incorporate the most advanced methods of antibody discovery and optimization into our processes," said Emily Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "MOLCURE’s AI approach complements our proprietary antibody discovery and optimization efforts, leveraging technology to refine our internal antibody pipeline. Their platform enables us to find more leads derived from NGS sequencing from our library. We look forward to taking leads generated from this collaboration forward within our internal pipeline."