On December 21, 2021 Apollo Endosurgery, Inc. ("Apollo") (NASDAQ: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported that it has entered into a debt financing agreement with an affiliate of Innovatus Capital Partners, LLC ("Innovatus") to provide Apollo with up to $100 million in term loan financing (Press release, Apollo Endosurgery, DEC 21, 2021, View Source [SID1234597520]).

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"We are pleased to partner with a long-term strategic investor such as Innovatus in this transaction," said Chas McKhann, president and CEO. "This new loan facility provides us flexibility to invest in our business and fund our growth initiatives through minimally-dilutive financing. Importantly, with this additional capital source, our management team can focus on unlocking the value in our business through continued execution."

The new term loan reduces Apollo’s cost of capital, extends amortization by an additional 33 months over the prior term loan and decreases debt service cash requirements by nearly $30 million over the next three years.

"Innovatus is excited to work with Apollo and its management team," said Claes Ekstrom, Managing Director. "We believe this transaction enables Apollo to accelerate the adoption of its portfolio of highly differentiated products across a wide range of patient needs."

On December 21, 2021, Apollo entered into a loan and security agreement (the "Loan Agreement") pursuant to which Innovatus has agreed to make certain term loans in the aggregate principal amount of up to $100 million, with the first $35 million tranche (Term A Tranche) to be funded at closing and used to retire Apollo’s existing term debt facility with SLR Capital Partners.

Apollo will be eligible to draw on additional tranches commencing June 30, 2022 as follows:
•Term B Tranche of $15 million between July 1, 2023 and December 31, 2023, upon achievement of certain revenue milestones;
•Term C Tranche of $25 million between July 1, 2024 and December 31, 2024, upon achievement of certain revenue milestones; and
•Term D Tranche of up to $25 million second between June 30, 2022 and June 30, 2024, for the purposes of financing all or part of any approved acquisition.

Borrowing under the Loan Agreement will bear interest at the greater of the Wall Street Journal Prime Rate or 3.25%, plus 4.0% (currently, 7.25%). Apollo is entitled to make interest-only payments for 60 months, followed by monthly payments of principal and interest through maturity on the sixth anniversary of the initial funding date.

The Loan Agreement is secured by substantially all of Apollo’s assets.

Prior to December 21, 2025, Innovatus will have the right, but not the obligation, to make a one-time election to convert up to 10% of the outstanding aggregate principal amount of the term Loans into shares of common stock of Apollo. Such shares shall be issued at a price per share equal to $11.50.

Credo 180 acted as sole financial advisor to Apollo on this transaction.

Additional details regarding the financing will be included in a Current Report on Form 8-K, which Apollo will file with the Securities and Exchange Commission within four business days of the date of this press release.

On December 21, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, reported that the first patient has received their first dose in its home instillation study of UGN-102 in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) (Press release, UroGen Pharma, DEC 21, 2021, View Source [SID1234597537]).

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The objective of this Phase 3b study, which aims to enroll up to ten patients across four centers, is to demonstrate whether UGN-102 can be administered at home by a qualified home health professional, avoiding the need for repeated visits to a healthcare setting for instillation.

"The ease of UGN-102 instillation is of great benefit to these patients who are generally older, suffer from multiple comorbidities, and often rely on caregivers to drive them to medical appointments," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "Home instillation is especially convenient for the patient and less burdensome for caregivers as they navigate persistent challenges caused by repeated medical appointments. We look forward to demonstrating the versatility of UGN-102 in this study as we prepare to initiate the single-arm, pivotal Phase 3 ENVISION Study of UGN-102 in early 2022."

Patients in the ongoing Phase 3b study will receive six once-weekly intravesical instillations of UGN-102. The initial treatment visit will occur at the investigative site and instillation will be performed by a qualified physician. Treatment visits two to six will take place at the patient’s home and instillation will be performed by a properly trained and qualified home health professional. The primary endpoint of the study is the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, discontinuations from at home study treatment, and clinically significant abnormalities in laboratory tests (hematology, serum chemistry, and urinalysis).

About UGN-102 (mitomycin for intravesical solution)
UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.

About LG-IR-NMIBC
With 80,000 estimated cases of bladder cancer per year, approximately 35,000 are low-grade NMIBC patients comprised of both low-risk (approximately 15,000) and intermediate risk (approximately 20,000). These patients face a future of recurrence and additional surgeries. Recurrence in LG-IR-NMIBC is a pervasive and often underestimated problem. In patients who recur, it is estimated that 68 percent will experience two or more recurrence episodes throughout the course of their disease, a considerably high and frequent rate in contrast to other non-metastatic cancers.

Currently, the only effective primary treatment available is a surgical procedure known as transurethral resection of the bladder (TURBT). The more the procedure is performed, the more it imposes burden and serious risks on patients. Research shows that 25 percent of patients are not appropriate for TURBT due to physical factors such as age and comorbid conditions or an unwillingness to undergo surgery. Major challenges exist with the current standard of care and these patients deserve a new primary, non-surgical treatment option.

On December 21, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing ex vivo allogeneic CAR T therapies and in vivo therapies with its ARCUS genome editing platform, reported that it has entered into an agreement with a syndicate of investors led by ACCELR8 to separate its wholly owned Elo Life Systems subsidiary and create an independent food and agriculture business (Press release, Precision Biosciences, DEC 21, 2021, View Source [SID1234597581]).

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"The separation of Precision BioSciences and Elo Life Systems was an important 2021 corporate imperative intended to enable operational success for both companies going forward," said Michael Amoroso, Chief Executive Officer of Precision BioSciences. "Elo is now a separate food and agriculture business, with independent financial resources and focused core capabilities to support its essential mission to improve human health and wellness through food. In parallel, this transaction enables Precision to focus exclusively on human therapeutics and leverage the unique attributes of ARCUS to develop a potential new class of off-the-shelf CAR T products for cancer and in vivo gene editing therapies for patients with genetic diseases."

Pursuant to the agreement, Precision BioSciences contributed substantially all assets and liabilities of Elo Life Systems to a new entity in which Precision maintains an equity stake. All employees of Elo, including its management, transitioned to the new company as part of the agreement.

On December 21, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported William A. Geist has been appointed President, Protein Sciences Segment, effective January 3, 2022 (Press release, Bio-Techne, DEC 21, 2021, View Source [SID1234597522]). Mr. Geist succeeds N. David Eansor, who will be retiring from the Company. Mr. Eansor will remain with Bio-Techne through the end of February 2022 to ensure a smooth transition.

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Mr. Geist has over two decades of experience as a senior life science tools leader, most recently serving as Chief Operating Officer for Quanterix, where he was responsible for enterprise-wide operations and strategy deployment. Previously Mr. Geist was Vice President & General Manager for two of Thermo Fisher Scientific’s largest Business Units, Protein & Cell Analysis and qPCR. Prior to Thermo Fisher Scientific, Mr. Geist was Vice President of QuantaBiosciences, a QIAGEN company, where he held various roles of increasing responsibility from the company’s inception through its acquisition.

"I want to personally thank Dave for his leadership and significant contributions over the last seven years at Bio-Techne. He has played an integral role in the Company’s success, and I wish him the best in his retirement," said Chuck Kummeth, President and Chief Executive of Bio-Techne. "Will is joining Bio-Techne at a very exciting point in the Company’s growth trajectory. His experience running life science tools businesses generating over $1 billion in annual revenue make him the ideal candidate to take the Protein Sciences Segment through its next phase of growth."

On December 21, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported the presentation of preclinical data from its theranostic in development, VMT-alpha -NET, at the 2021 International Chemical Congress of Pacific Basin Societies (Pacifichem 2021 Congress), taking place virtually, December 16-21, 2021 (Press release, Viewpoint Molecular Targeting, DEC 21, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-presents-preclinical-data-from-vmt-net-theranostic-in-development-for-the-treatment-and-diagnosis-of-neuroendocrine-tumors-at-the-pacifichem-2021-congress/ [SID1234597538]).

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The abstract titled, "Chemical structure modifications to chelator and linker compositions for improved pharmacokinetics of 203/212Pb peptide-based radiopharmaceuticals," was presented

In the Advancements in the Chemistry of Targeted Alpha Therapy (#180) symposium session by Michael K. Schultz, PhD, Chief Science Officer of Viewpoint.

"Emerging evidence suggests that alpha-particle therapy has the potential to significantly improve tumor response. The preclinical data from VMT-alpha -NET demonstrated to-date provides strong evidence that our VMT- -NET image-guided approach can meet the need for an effective therapy with a promising toxicity profile. We are pleased with the progress of VMT-alpha -NET and are committed to advancing the development of this important theranostic forward," commented Dr. Schultz.

The preclinical study was designed to explore chemical modifications to the chelator and chelator-peptide linker of SSTN analogs to optimize for 203Pb/212Pb image-guided alpha-particle radionuclide therapy for SST2R expressing tumors. PEG linkers of varying length were explored to improve tumor cell binding/internalization, in vivo tumor targeting, and renal clearance. In vitro and in vivo performance properties (e.g., radiolabeling, renal clearance) were compared to DOTATOC (203Pb/212Pb).

VMT-a-NET was identified with significantly improved performance. [203Pb]VMT-alpha-NET significantly improved: (1) SST2R IC50 binding affinity (>2-fold); (2) cellular uptake and internalization (a factor of 20); (3) tumor accumulation/retention; and (4) renal clearance compared to [203Pb]DOTATOC. With these improvements, the tumor:kidney ratio (%ID/ gram) improved more than 8-fold (24 h post injection) in AR42J tumor bearing mice compared to [203Pb]DOTATOC. [212Pb]VMT-alpha-NET therapy was effective and well-tolerated in mice (renal injury biomarkers NGAL’ CREA), achieving a 70% complete response rate in tumor bearing mice.

Based on the preclinical data seen to-date, Viewpoint believes that VMT- -NET is well-positioned to apply the new transformative power of alpha-particle treatment to NET tumors and other cancers that express the SST2R biomarker.

The Company recently commenced an investigator-initiated Phase 1 imaging study of VMT-alpha -NET for imaging somatostatin receptor subtype 2 (SSTR2)-positive neuroendocrine tumors, being conducted at the University of Iowa Hospitals and Clinics. The images obtained from the Phase 1 imaging study will inform future therapeutic trials of [212Pb]VMT-alpha-NET alpha-particle therapy for this tumor type. In parallel to this investigator-initiated imaging trial, the Company plans to move forward with a Phase 1/2a therapy study of VMT- -NET for the treatment of neuroendocrine tumors.

About the Pacifichem 2021 Congress

The 2021 International Chemical Congress of Pacific Basin Societies will take place virtually, December 16-21, 2021. Pacifichem 2021 will be the eighth in the series of successful cosponsored scientific conferences of Pacific Basin Chemical Societies. Founded in 1984, these conferences have been held in Honolulu, Hawaii about every five years.

About Neuroendocrine Tumors

Neuroendocrine tumors are rare forms of cancers that occur most commonly in the pancreas or other areas of the gut such as the stomach, small intestine, rectum, colon, or appendix. A neuroendocrine tumor may grow slowly or aggressively and spread to other parts of the body. Diagnosis and treatment of neuroendocrine tumors depend on the type of tumor, its location, whether it produces excess hormones, how aggressive it is and whether it has spread to other parts of the body. Some approaches may include surgery, radiation, and chemotherapy.