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 30, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China ("NMPA") for the treatment of non-pancreatic neuroendocrine tumors ("NETs") (Press release, Hutchison China MediTech, DEC 30, 2020, https://www.chi-med.com/chi-med-announces-the-nmpa-approval-of-surufatinib-sulanda-in-china-for-epnet/ [SID1234573325]). Surufatinib will be marketed in China under the brand name Sulanda. Surufatinib is Chi-Med’s first self-discovered oncology drug to be approved in China without the support of a development partner, and follows the approval of Chi-Med’s first oncology drug, Elunate (fruquintinib capsules), in 2018.

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Christian Hogg, Chief Executive Officer of Chi-Med commented, "We are very pleased to have achieved this major milestone for Chi-Med. The approval of surufatinib, our first un-partnered oncology drug, is a strong testament to our in-house research and development capability."

"Today’s approval also marks an important development for NET patients, for whom there are currently limited treatment options. Compared with other NET therapies available in the market, surufatinib has a unique mode of action by both inhibiting angiogenesis and promoting the body’s immune response against tumor cells. If our second new drug application ("NDA") in pancreatic NET is successful, this therapy would be approved in China to address all NET patients regardless of the tumor origin."

"We look forward to making this unique therapy available to patients as quickly and broadly as possible through our own expanded oncology commercial team."

Chi-Med has established an oncology commercial team that today covers more than 2,000 hospitals across China. The team is led by a leadership team highly experienced in oncology products commercialization in China with deep knowhow in the field of NETs.

The NMPA approval of Sulanda was based on results from the SANET-ep[1] study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced non-pancreatic NETs conducted in China. The study met the pre-defined primary endpoint of progression-free survival ("PFS") at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO (Free ESMO Whitepaper) Congress and published in The Lancet Oncology in September 2020.[2] Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment-related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

In China, there were an estimated 67,600 newly diagnosed NET patients in 2018. Considering the current incidence to prevalence ratio, there may be as many as 300,000 patients living with the disease.[3]

About NETs
NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NETs are typically classified as pancreatic NET ("pNET") or non-pancreatic NET ("epNET"). Approved targeted therapies include Sutent (for pNET only) and Afinitor for pNET and well-differentiated, non-functional gastrointestinal or lung NET.

According to Frost and Sullivan, there were 19,000 newly diagnosed cases of NETs in the U.S. in 2018. Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with NETs in the U.S. in 2018.

About Surufatinib (Sulanda in China)
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

Chi-Med currently retains all rights to surufatinib worldwide.

About Surufatinib Development
NETs in the U.S. and Europe: In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019. A U.S. FDA NDA rolling submission was initiated in December 2020, to be followed by a marketing authorization application (MAA) submission to the European Medicines Agency (EMA) in Europe. The basis to support these filings includes the completed SANET-ep and SANET-p[4] studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients (clinicaltrials.gov identifier: NCT02549937).

Pancreatic NETs in China: The SANET-p study is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pNET in China. It was terminated early as the pre-defined primary endpoint of PFS was met (clinicaltrials.gov identifier: NCT02589821) at an preplanned interim analysis, leading to a second NDA accepted by the China NMPA in September 2020. The results of this study were presented at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 and published simultaneously in The Lancet Oncology. [5]

Biliary tract cancer in China: A Phase IIb/III study was initiated in March 2019, comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).

Immunotherapy combinations: Chi-Med has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd.), Tuoyi (toripalimab, developed by Shanghai Junshi Biosciences Co. Ltd.) and Tyvyt (sintilimab, developed by Innovent Biologics, Inc.), which are approved as monotherapies in China.

On December 30, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that on December 31, 2020, it will give notice of its intention to redeem the following Senior Notes, representing an aggregate total principal amount of approximately $2.6 billion, on January 15, 2021 (the "Redemption Date") (Press release, Thermo Fisher Scientific, DEC 30, 2020, View Source [SID1234573342]):

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€0.5 billion aggregate principal amount of 2.150% Senior Notes due 2022 (NYSE: TMO 22A) (the "2022 Notes")
$1.0 billion aggregate principal amount of 3.000% Senior Notes due 2023 (the "2023 Notes")
$1.0 billion aggregate principal amount of 4.150% Senior Notes due 2024 (the "2024 Notes" and, together with the 2022 Notes and the 2023 Notes, the "Notes")
The Notes will be redeemed at a redemption price equal to the greater of (1) 100% of the principal amount of the Notes to be redeemed and (2) the sum of the present values of the remaining scheduled payments of the Notes to be redeemed discounted to the Redemption Date (a) on an annual basis at a comparable bond rate plus 25 basis points in the case of the 2022 Notes, (b) on a semi-annual basis at a comparable treasury rate plus 25 basis points in the case of the 2023 Notes and (c) on a semi-annual basis at a comparable treasury rate plus 20 basis points in the case of the 2024 Notes, plus, in each case, accrued and unpaid interest on the Notes to be redeemed to, but excluding, the Redemption Date. Thermo Fisher intends to fund the redemption using cash on hand.

On December 30, 2020 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Proenzymes Optimization Project 1 ("POP1") joint research and drug discovery program advanced towards producing commercial scale quantities of the two proenzymes trypsinogen and chymotrypsinogen (Press release, Propanc, DEC 30, 2020, View Source [SID1234573326]). The Company’s product candidate is targeting the global metastatic cancer treatment market, projected to be worth US$111.2 Billion by 2027, according to current analysis by Emergen Research.

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The program’s lead research scientist, Mr. Aitor González, synthesized and purified both proenzymes in the laboratory. Once purified, the proenzymes were lyophilized (freeze dried) and each formed a stable, dry white powder. Mr. González then determined the sequence of proteins of each proenzyme by mass spectrometry. He recently started to produce larger quantities of the proenzymes with the objective of establishing their combined anti-cancer effects against pancreatic and colorectal cancers. In addition, research activities were transferred to the MEDINA Foundation Research Center to scale up production. MEDINA is a Non-Profit Research Organization established in 2008 through a public-private alliance between the Regional Government of Andalusia, Spain, the pharmaceutical company Merck Sharp & Dohme de España S.A. (MSD), and the University of Granada. Medina’s scientific platforms support the development of multidisciplinary research programs in Microbiology, Natural Product Chemistry and Screening & Target Validation. For further information, please click on the following link: View Source

The POP1 program is designed to produce a backup clinical compound to the lead product candidate, PRP. The objective is to produce large quantities of trypsinogen and chymotrypsinogen for commercial use that exhibits minimal variation between lots and without sourcing the proenzymes from animals. Propanc is undertaking the challenging research project in collaboration with the Universities of Jaén and Granada, led by research scientist Mr. Aitor González, supported by Dr. Macarena Perán, Ph.D., representing the Universities and Propanc’s Chief Scientific Officer, Dr. Julian Kenyon, M.D.

Mr. James Nathanielsz, Propanc’s Chief Executive Officer said, "By expanding our product pipeline, our vision is to establish a new product class that provides a solution for the treatment and prevention of many recurring and spreading malignant tumors, perceived as untreatable, with less toxicity compared to standard treatments and no immune suppression. This is critical for patients who are at risk of dying from secondary infection, especially in the context of a global pandemic. Through our PRP development and POP1 drug discovery programs we are making positive steps towards achieving our vision."

"Despite a challenging year due to the global pandemic, we made significant advancements in producing synthetic recombinant versions of trypsinogen and chymotrypsinogen," said Dr. Julian Kenyon. "These two active pharmaceutical ingredients combine to form our lead product candidate, PRP, which are currently of animal origin. Our objective is to further stabilize and enhance the combined effects of the two proenzymes when administered to patients."