On December 31, 2020 NETRIS Pharma, a clinical-stage biopharmaceutical company developing therapeutics based on dependence receptor biology, reported that the first patient has been dosed in its GYNet Phase 1b/II clinical study (Press release, Netris Pharma, DEC 31, 2020, View Source [SID1234611185]).

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GYNet is a randomized, multicenter, open label Phase Ib/II study that will enroll up to 240 patients with locally advanced/metastatic endometrial carcinoma or cervix carcinoma progressing/relapsing after at least one prior systemic chemotherapy. In the Phase1b part, the study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NP137 administered in combination with KEYTRUDA and/or chemotherapeutic agents. The Phase 2 part will assess the clinical activity of the combination in both tumor types. More information on GYNet study can be found at View Source (NCT04652076).

NP137 is a monoclonal antibody that targets netrin-1, which is a protein overexpressed in over 80% of uterine tumors. In early clinical studies, NP137 monotherapy demonstrated encouraging clinical signs of efficacy as measured by objective response and prolonged stable disease. In addition, preclinical data confirmed that netrin-1 interference via NP137 alleviates resistance to chemotherapy and immune checkpoint inhibitors, reinforcing the strong scientific rationale of this combination trial.

"We look forward to seeing the first clinical result of the GYNet trial, given the anti-tumor activity as single agent observed in the Phase 1a trial and unique mode of action of NP137," said Professor Isabelle Ray Coquard, MD, Ph.D. from the Centre Leon Bérard in Lyon, France and Principal Investigator of the trial.

Patrick Mehlen, CEO and Founder of NETRIS Pharma added: "The inclusion of the first patient in this phase 1b/2 clinical trial is a new milestone in the development of Netris. We look forward to seeing the results of this study as well as additional clinical advances in the near future."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About NP137
NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. Most types of tumors produce an abnormal amount of dependence receptors’ ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers, including over two thirds of gynecologic cancers.

In preclinical studies, NP137 inhibited tumor growth and had a significant impact on tumoral plasticity, which potentiates the efficacy of chemotherapies and immune checkpoint inhibitors. In the phase 1 dose-escalation study, NP137 was found to be safe and very well tolerated up to 20mg/kg, with no dose limiting toxicity (DLT). In addition, patients with advanced uterine cancers exhibited encouraging signs of anti-tumor activity, including prolonged stable disease and objective responses.

On December 31, 2020 (the "Closing Date"), Paratek Pharmaceuticals, Inc. (the "Company"), through its wholly-owned subsidiary PRTK SPV2 LLC, a Delaware limited liability company (the "Subsidiary"), reported that it entered into a royalty and revenue interest-backed loan agreement (the "Loan Agreement") with an affiliate of R-Bridge Healthcare Investment Advisory, Ltd. (the "Lender") (Filing, 8-K, Paratek Pharmaceuticals, DEC 31, 2020, View Source [SID1234573411]). Pursuant to the terms of the Loan Agreement, the Subsidiary borrowed a $60.0 million term loan, secured by, and repaid with proceeds from, (i) royalties from the Company’s license agreement with Zai Labs (Shanghai) Co., Ltd. (the "License Agreement", and such royalties, the "Royalty Interest") and (ii) a revenue interest based on the Company’s United States sales of NUZYRA in an initial amount of two and a half percent (2.5%), which amount may adjust under certain circumstances up to five percent (5%), of the Company’s net United States sales, subject to an annual cap of $10.0 million, which may adjust under certain circumstances to $12.0 million (the "Revenue Interest").

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Under the Loan Agreement, the outstanding principal balance will bear interest at an annual rate of 7.0%. Payments of the obligations outstanding under the Loan Agreement will be made quarterly, beginning with the payment due in respect of the quarter ending March 31, 2021, out of the Royalty Interest payments and Revenue Interest payments received by the Subsidiary during such quarter (the "Collection Amount"). On each payment date, after payment of certain expenses, the Collection Amount shall be applied first to accrued interest, with any excess up to $15.0 million per annum applied to repay principal until the balance is fully repaid. Amounts in excess of the $15.0 million annual cap shall be shared between the Company and the Lender based on a formula set out in the Loan Agreement. Following repayment in full of the loan, the first $15.0 million per annum in Collection Amount shall be paid to the Company and any amounts in excess shall be shared between the Company and the Lender based on a formula set out in the Loan Agreement.

Prior to the eighth (8th) anniversary of the Closing Date, the Loan Agreement will automatically terminate once the Subsidiary has paid to the Lender, in the form of regularly scheduled payments or as a voluntary prepayment, a capped amount of up to 190% of the $60.0 million the loan commitment amount. After the eighth (8th) anniversary of the Closing Date, the Revenue Interest can be terminated but the Royalty Interest payments shall continue until maturity of the Loan Agreement on December 31, 2032, at which time, the outstanding principal amount of the loan, together with any accrued and unpaid interest, and all other obligations then outstanding, shall be due and payable in cash by the Subsidiary.

The Company’s subsidiary, PRTK SPV1 LLC, a Delaware limited liability company and owner of the Subsidiary’s capital stock, has entered into a Pledge and Security Agreement in favor of the Lender, pursuant to which the Subsidiary’s obligations under the Loan Agreement are secured by PRTK SPV1 LLC’s pledge of all of the Subsidiary’s capital stock.

The Loan Agreement contains certain customary affirmative covenants, including those relating to: use of proceeds; maintenance of books and records; financial reporting and notification; compliance with laws; and protection of Company intellectual property. The Loan Agreement also contains certain customary negative covenants, barring the Subsidiary from: certain fundamental transactions; issuing dividends and distributions; incurring additional indebtedness outside of the ordinary course of business; engaging in any business activity other than related to the License Agreement; and permitting any additional liens on the collateral provided to the Lender under the Loan Agreement.

The Revenue Interest Purchase Agreement contains negative covenants applicable to the Company, including restrictions on the sale or transfer of the assets of the Company related to NUZYRA and giving rise to the Revenue Interest, each subject to the exceptions set forth therein.

The Loan Agreement contains customary defined events of default, upon which any outstanding principal and unpaid interest shall be immediately due and payable by the Subsidiary. These include: failure to pay any principal or interest when due; any uncured breach of a representation, warranty or covenant; any uncured failure to perform or observe covenants; any uncured cross default under a material contract; any uncured breach of the Company’s representations, warranties or covenants under its Contribution and Servicing Agreement with the Subsidiary; any termination of the License Agreement; and certain bankruptcy or insolvency events.

The net proceeds of the term loan were used by the Subsidiary to purchase from the Company the Royalty Interest and Revenue Interest, pursuant to the terms of the Revenue Interest Purchase Agreement and the Contribution and Servicing Agreement, respectively. The Company has used the proceeds from the sale of the Royalty Interest and Revenue Interest, together with cash on hand, to prepay in full all obligations of the Company outstanding under its Amended and Restated Loan and Security Agreement dated as of June 27, 2019, as amended, with Hercules Technology III, L.P., certain other lenders and Hercules Capital, Inc. (as agent).

The foregoing description of the terms of the Loan Agreement, the Revenue Interest Purchase Agreement and the Contribution and Servicing Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Loan Agreement, the Revenue Interest Purchase Agreement and the Contribution and Servicing Agreement, copies of which are filed herewith and incorporated herein by reference.

On December 31, 2020 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), formerly AMERI Holdings, Inc. (NASDAQ: AMRH), a patient-centric biotechnology company endeavoring to enhance the lives of those who are adversely affected by the side effects of Cancer Treatments with novel cannabinoid medicines, reported the completion of the previously announced spin-off of the IT services business of the Company and the tender offer, whereby the Company purchased all of the outstanding common shares of Jay Pharma Inc. ("Jay Pharma") in exchange for shares of Company common stock, or if applicable, shares of Company preferred stock., and Jay Pharma became a wholly-owned subsidiary of the Company (Press release, AMERI Holdings, DEC 31, 2020, View Source [SID1234573363]).

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The Company has also completed its name change from AMERI Holdings, Inc. to Enveric Biosciences, Inc., and has effected a 1-for-4 reverse split of its common stock, effective as of 4:02 pm Eastern Time, December 30, 2020. Enveric will commence trading on the Nasdaq Capital Market at the opening of trading this morning, December 31, 2020, under its new ticker symbol "ENVB" on a post-reverse-stock-split basis (CUSIP No. 29405E 109).

"We are thrilled to complete this transaction and commence trading on the Nasdaq as Enveric Biosciences under the ticker symbol "ENVB." Today marks the beginning of our journey as a publicly traded company, enhancing the visibility of our business to the investment community. The support of existing and new investors will enable us to continue our dedicated work of developing innovative treatments focused on the unmet need for supportive care of cancer patients by adding life to patients’ years, not just years to their lives," said David Johnson, Chairman and CEO at Enveric Biosciences.

Palladium Capital Group, LLC acted as financial advisor to the parties in connection with the above transactions.

Additional information regarding the foregoing transactions and the reverse stock split, which were approved at the special meeting of Company stockholders held on December 29, 2020, can be found in the Company’s definitive proxy/prospectus and other relevant documents filed with the Securities and Exchange Commission ("SEC") at the SEC’s website at www.sec.gov.

Copies of the documents filed by the Company with the SEC are available free of charge on the Company’s website at www.enveric.com or by contacting Company Investor Relations.

On December 31, 2020 ImmVira Group Company ("the Company"), a biotechnology platform dedicated to the development of oncolytic virus("OV") and vector type approaches to create more effective and safer therapies against cancer, reported the signing of Series C financing (Press release, Immvira, DEC 31, 2020, View Source [SID1234573361]).

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The Company’s rapidly advancing OV programs with Best-in-class potential have drawn broad interest from renowned international and domestic institutional investors. Lead investor for Series C was Greater Bay Area Homeland Development Fund ("GBA Fund"), and Octagon Capital, China Merchants Capital (through Hui Kang Equity Fund), WinDigital Capital, LanTing Capital, and OrbiMed were co-investors. The Company’s existing investor GL Ventures, the venture capital arm of Hillhouse Capital, who invested in Series A Plus and Series B financings, also participated in this Series C round. O’Melveny & Myers acted as Company counsel with UBS and CICC as Financial Advisors.

The proceeds from the Transaction would be primarily used to fund international multi-center trial for MVR-T3011-IT, IND filing and swift initiation of clinical trials for two additional pipeline candidates, as well as the discovery and validation of new product candidates developed on the OvPENS platform.

Remarks from the executive management team, "We appreciate our new and existing investors for supporting what the company has achieved and trust in where it is heading. This group of new investors will bring tremendous resources to accelerate clinical and commercialization of our lead candidates while expanding the possibilities and viability of new pipelines developed on the OvPENS platform. We are grateful existing investors have also kindly supported in every way to make this Series C possible."

"Reflecting on 2020, ImmVira made leaps and bounds in building a solid foundation to ensure our OV programs will be successful. For MVR-T3011 intratumoural program, a landmark license program was achieved with Shanghai Pharma along with a validating strategic investment. As company’s first clinical effort, the intratumoral program expanded quickly from a single center trial in China to multiple sites in China with Australia and US multiple sites activated and synced to be a truly international trial, a first for oncolytic virus globally. For our near clinical candidates such as MVR-T3011 intravenous delivery and C5252 targeting brain tumors, we continue to accelerate our timetable for IND filing and look forward to having both candidates in clinical well before the end of second quarter of 2021."

"Our platform and corporate development also made great progress in the second half of 2020. The OvPENS platform team supported our manufacturing partner to scale and meet regulatory compliance such that production for all pre-clinical and clinical requirements ahead are secured. The OvPENS team also made several novel drug discoveries with the target to enable CAR T-cell, ADC and BiTE effective on solid tumors using an OV based vector-receptor approach. These breakthroughs will provide exciting candidate pipelines well into 2022 and beyond. For the company, the joining of highly experienced CMO and CFO would ensure our clinical and financing functions operate at the world class level. 2020 was a challenging year yet we are pleased to close the year with a new class of investors to welcome the New Year ahead."

On December 31, 2020 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported that it has completed the previously announced 1-for-6 reverse stock split of its outstanding and authorized shares of common stock (Press release, Acorda Therapeutics, DEC 31, 2020, View Source [SID1234573360]). The reverse stock split became effective at 4:01 p.m. Eastern Time today, and the Company’s common stock will begin trading on a split-adjusted basis at the market open on January 4, 2021.

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The reverse stock split was effected in accordance with the authorization adopted by Acorda’s stockholders at the Company’s Special Meeting of Stockholders held on July 31, 2020. The reverse stock split is intended to enable the Company to regain compliance with the $1.00 per share minimum bid price required for continued listing on The Nasdaq Global Select Market.

Pursuant to the reverse stock split, every six shares of Acorda’s issued and outstanding common stock were automatically combined and converted into one issued and outstanding share of common stock, and there was a proportionate reduction in the number of shares of the Company’s authorized common stock, from 370,000,000 to 61,666,666. Fractional shares resulting from the reverse stock split were rounded up to the next whole number. The reverse stock split applied equally to all outstanding shares of the common stock, and each stockholder held the same percentage of common stock outstanding immediately following the reverse stock split as that stockholder held immediately prior to the reverse stock split, except for adjustments resulting from the treatment of fractional shares.

Acorda’s common stock will continue to trade on The Nasdaq Global Select Market under the symbol "ACOR," and the new CUSIP number is 00484M601.

Acorda has appointed its transfer agent, Computershare Trust Company, N.A. ("Computershare"), to act as exchange agent for the reverse stock split. Stockholders owning shares of common stock via a bank, broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split and will not be required to take further action in connection with the reverse stock split, subject to brokers’ particular processes. Computershare will provide instructions to stockholders with physical certificates regarding the optional process for exchanging their pre-split stock certificates for post-split stock certificates.