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WuXi Biologics Congratulates OncoImmune on FDA Clearance of IND Application for Next Generation anti-CTLA-4 Antibody ONC-392

On January 1, 2020 WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, reported its partner OncoImmune on the U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) for ONC-392, a novel, next generation anti-CTLA-4 antibody (Press release, WuXi Biologics, JAN 1, 2020, View Source [SID1234552645]).

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As part of the collaboration, WuXi Biologics provided comprehensive and integrated services for the ONC-392 program, including CMC development and GMP manufacturing of the drug substance and drug product, through its world-class development and manufacturing capacities and capabilities.

"It has been our great pleasure working with WuXi Biologics on our ONC-392 program. The clearance of ONC-392 IND by the FDA is an important milestone for OncoImmune," said Yang Liu, PhD, Founder and CEO of OncoImmune. "WuXi Biologics’ state-of-the-art and full-service biologics platform enabled us to complete a solid CMC package in support of our IND submission and clearance. We are excited about the potential of this next generation anti-CTLA-4 antibody with its novel and differentiated mechanism of action to improve therapeutic outcomes while significantly reducing toxicity."

"Congratulations to OncoImmune on reaching this milestone for the ONC-392 program. We are glad to enable OncoImmune to accelerate the development of biologics from DNA to IND," said Dr. Chris Chen, CEO of WuXi Biologics. "We wish the program a great success to benefit more patients suffering from cancers. WuXi Biologics will continue empowering global partners to provide more life-saving treatments to meet health challenges."

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.

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.

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.

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]).

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.

ProMIS Neurosciences Completes Second Closing of Private Placement

On December 31, 2019 ProMIS Neurosciences, Inc. ("ProMIS" or the "Company") (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases is reported that further to its news releases dated November 13, 2019 and November 18, 2019, it completed, on December 31, 2019 the second closing of its private placement (Press release, ProMIS Neurosciences, DEC 31, 2019, View Source [SID1234552640]). In the second closing, the Company issued 3,724,998 units (each a "Unit") for gross proceeds of approximately CDN$745,000. The total gross proceeds raised to date under the private placement are $2,800,333.

In connection with the two closings insiders of the Company have subscribed for a total of 633,332 Units under the private placement representing approximately $126,666 of the private placement.

Each Unit issued in the second closing consisted of one common share of the Company (each a "Share") and one share purchase warrant of the Company (each a "Warrant"). Each Warrant entitles the holder thereof to purchase one Share ("a "Warrant Share") at an exercise price of $0.35 per Warrant Share at any time for five years from the date of issuance.

All securities issued in the second closing will be subject to a four-month statutory hold period in accordance with applicable securities laws. Net proceeds from the second closing are intended to be used for working capital and general corporate purposes. Closing is subject to TSX approval.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Offering have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.