Penumbra, Inc. to Present at the 38th Annual J.P. Morgan Healthcare Conference

On December 31, 2019 Penumbra, Inc. (NYSE: PEN) reported that its management team is scheduled to present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Tuesday, January 14, 2020 (Press release, Penumbra, DEC 31, 2019, View Source [SID1234552644]).

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Event:

38th Annual J.P. Morgan Healthcare Conference

Date:

Tuesday, January 14, 2020

Time:

5:00pm ET / 2:00pm PT

A webcast of the presentation will be available by visiting the investors’ section of the company’s website at www.penumbrainc.com. The webcast will be available on the company’s website for at least two weeks following the event.

Entry into a Material Definitive Agreement.

On December 31, 2019, Kaleido Biosciences, Inc. (the "Company") and Cadena Bio, Inc. ("Cadena", and together with the Company, the "Borrowers") reported that it has entered into a Credit Agreement (the "Credit Agreement") with Hercules Capital, Inc. (the "Lender") (Filing, 8-K, Kaleido Biosciences, DEC 31, 2019, View Source [SID1234552682]). Under the Credit Agreement, the Lenders will extend an initial $22.5 million to the Borrowers, with the option to draw down an additional $12.5 million if certain milestones and conditions are met.

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The Credit Agreement replaced the Company’s previous $15 million credit facility (the "Former Loan and Security Agreement") by and between the Company and JPMorgan Chase Bank, N.A., dated October 25, 2019. The Former Loan and Security Agreement was repaid in connection with this refinancing.

The Credit Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including, among others, covenants that limit or restrict the Borrower’s ability to, among other things, incur additional indebtedness, merge or consolidate, make acquisitions, pay dividends or other distributions or repurchase equity, make investments, dispose of assets and enter into certain transactions with affiliates, in each case subject to certain exceptions. As security for its obligations under the Credit Agreement, the Borrowers granted the Lender a first priority security interest on substantially all of the Borrowers’ assets (other than intellectual property), and subject to certain exceptions.

The facility carries a 48-month term with interest only payments on the term loan for the first 15 months, which period can be extended to up to 24 months, depending on the achievement of certain performance milestones. The Term Loan will mature in January 2024 and bears an interest rate of equal to the greater of (i) 8.95% plus the prime rate last quoted in The Wall Street Journal (or a comparable replacement rate if The Wall Street Journal ceases to quote such rate) minus 4.75% and (ii) 8.95%. The Term Loan is subject to mandatory prepayment provisions that require prepayment upon the occurrence of a Change in Control event (as defined in the Credit Agreement).

The above description of the Credit Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Credit Agreement, a copy of which is filed as Exhibit 10.1 hereto and is incorporated by reference herein.

Entry into a Material Definitive Agreement

On December 31, 2019, DURECT Corporation (the "Company") and Oxford Finance LLC ("Oxford Finance") reported that it has entered into a Third Amendment (the "Third Amendment") of the $20.0 million Loan and Security Agreement (the "Loan Agreement") entered into on July 28, 2016, which was previously amended by a First Amendment entered into on February 28, 2018 and a Second Amendment entered into on November 1, 2018 (Filing, 8-K, DURECT, DEC 31, 2019, View Source [SID1234552717]). The Third Amendment modified the terms of the Loan Agreement to extend the first principal payment date from June 1, 2020 to December 1, 2021 (with interest only payments until that date) and to extend the final maturity date from November 1, 2022 to May 1, 2024. If the Company elects to prepay the loan, there is also a prepayment fee of between 0.75% and 2.5% of the principal amount of the term loan depending on the timing of prepayment. In connection with the entry into the Third Amendment, the Company paid Oxford Finance a loan modification fee of $825,000.

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OncoImmune Announces Approval of IND Application for ONC-392 – The anti-CTLA-4 Antibody that Preserves CTLA-4 Recycling for Better Safety and Efficacy

On December 30, 2019 OncoImmune, Inc. reported that its Investigational New Drug ("IND") application for ONC-392, its novel, next generation anti-CTLA-4 antibody, has been approved by the U.S. Food and Drug Administration ("FDA") (Press release, ONCOIMMUNE, DEC 30, 2019, View Source [SID1234552635]). The IND approval enables OncoImmune to begin a Phase 1A/1B clinical trial of ONC-392 that is designed to assess the safety, pharmacokinetics, and efficacy of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care in Non- Small Cell Lung Cancer. This open label trial is expected to begin in early 2020.

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ONC-392 was developed based on the research of OncoImmune’s Founders, Drs. Yang Liu and Pan Zheng, who proposed a new theory to improve both the efficacy and safety of immunotherapy drugs. The theory calls for preservation of the CTLA-4 immune checkpoint for safer and more effective immunotherapy. (https://www.sciencedirect.com/science/article/pii/S0165614719302639). This groundbreaking research was published in three papers in Cell Research in 2018 and 2019. The two 2018 papers were recognized with the Sanofi-Cell Research Outstanding Paper Award of 2018 (View Source).

"ONC-392 is OncoImmune’s second drug product candidate and the approval of this IND is an important milestone for OncoImmune," said Yang Liu, President and CEO of OncoImmune. "Unlike other anti-CTLA-4 antibodies that cause lysosomal degradation of CTLA-4, ONC-392 preserves CTLA-4 recycling and thus maintains CTLA-4 function outside of the tumor microenvironment while allowing more effective CTLA-4-targeted depletion of regulatory T cells within the tumor. The truly novel and differentiated mechanism of action of this drug has the potential to improve therapeutic outcomes while significantly reducing toxicity."

"We are very excited to test the potential of this novel antibody in cancer patients," said Pan Zheng, Chief Medical Officer of OncoImmune, Inc.

The CMC development and GMP manufacturing of the drug substance and drug product were performed by WuXi Biologics, a leading global open-access biologics technology platform for the ONC-392 program. "Throughout the development program from DNA to IND, we were very impressed by WuXi Biologics’ expertise and professionalism, and we could not have picked a better partner for this project," said Martin Devenport, OncoImmune’s Chief Operating Officer.

Gracell to Present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco

On December 30, 2019 Gracell Biotechnologies Co. Ltd., a clinical-stage immune cell therapy company, reported it will present at leading healthcare conferences in San Francisco, California at the beginning of January 2020 (Press release, Gracell Biotechnologies, DEC 30, 2019, View Source [SID1234552636]). Gracell will present at the 38th Annual J.P. Morgan Healthcare Conference, held between January 13-16, 2020 at The Westin St. Francis Hotel on Union Square.

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Focused exclusively on companies defining the healthcare industry, the J.P. Morgan Healthcare Conference is the largest of its kind and will welcome over 400 public and private companies to deliver presentations to over 8,000 attendees, including investors and industry leaders.

"We are delighted to be invited to present at some of the most recognized and regarded events in the healthcare industry," said Dr. William Cao, CEO of Gracell. "The invaluable data from Gracell’s clinical trials demonstrates our strong capabilities to bring multiple novel technologies to the forefront of immune cell therapy field. We are eager to share these findings with the global healthcare community."

Gracell will also present at the following conference in January.

China Showcase
Presentation time: 4:00pm, Sunday, January 12
Location: Parc 55 San Francisco – A Hilton Hotel
Track: Cyrill Magnin III (4th floor)

Biotech Showcase
Presentation time: 10:00am, Monday, January 13
Location: Hilton San Francisco Union Square Hotel
Track: Franciscan B (Ballroom Level)