On January 7, 2019 Coherus BioSciences, Inc. (the "Company") reported that it has entered into a credit agreement (the "Agreement") with affiliates of Healthcare Royalty Partners (together, the "Lenders") (Press release, Coherus Biosciences, JAN 7, 2019, View Source [SID1234532628]). The Agreement consists of a six-year term loan facility for an aggregate principal amount of $75,000,000 (the "Borrowings"). The obligations of the Company under the loan documents are guaranteed by the Company’s material domestic U.S. subsidiaries (the "Guarantors").

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The Borrowings under the Agreement bear interest through maturity at 7.00% per annum plus LIBOR (customarily defined). If the consolidated net sales (customarily defined) for UDENYCA, the Company’s pegfilgrastim (Neulasta) biosimilar, for the fiscal year ending December 31, 2019, are in excess of $250,000,000, then the interest rate will be reduced as of January 1, 2020 to 6.75% per annum plus LIBOR. Interest is payable quarterly in arrears.

Principal payments on the Borrowings are required to be paid in equal quarterly installments beginning on the four year anniversary of the Closing Date (or, if consolidated net sales of UDENYCA in the fiscal year ending December 31, 2021 are less than $375,000,000, beginning on the three year anniversary of the Closing Date), with the outstanding balance to be repaid on January 7, 2025 (the "Maturity Date").

The Company is also required to make mandatory prepayments of the Borrowings under the Agreement, subject to specified exceptions, with the proceeds of asset sales, extraordinary receipts, debt issuances and specified other events including the occurrence of a change in control.

If all or any of the Borrowings are prepaid or required to be prepaid under the Agreement, then the Company shall pay, in addition to such prepayment, a prepayment premium (the "Prepayment Premium") equal to (i) with respect to any prepayment paid or required to be paid on or prior to the three year anniversary of the Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, plus all required interest payments that would have been due on the Borrowings prepaid or required to be prepaid through and including the three year anniversary of the Closing Date, (ii) with respect to any prepayment paid or required to be paid after the three year anniversary of the Closing Date but on or prior to the four year anniversary of the Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, (iii) with respect to any prepayment paid or required to be paid after the four year anniversary of the Closing Date but on or prior to the five year anniversary of the Closing Date, 2.50% of the Borrowings prepaid or required to be prepaid, and (iv) with respect to any prepayment paid or required to be prepaid thereafter, 1.25% of the Borrowings prepaid or required to be prepaid.

In connection with the Agreement, the Company paid a closing fee to the Lenders of $1,125,000. Upon the prepayment or repayment of the Borrowings (or upon the date such prepayment or repayment is required to be paid), the Company is required to pay an additional exit fee in an amount equal to 4.00% of the total principal amount of the Borrowings.

The obligations under the Agreement are secured by a lien on substantially all of the Company’s and the Guarantors’ tangible and intangible property, including intellectual property. The Agreement contains certain affirmative covenants, negative covenants and events of default, including, covenants and restrictions that among other things, restrict the ability of the Company and its subsidiaries to, incur liens, incur additional indebtedness, make loans and investments, engage in mergers and acquisitions, in asset sales, and declare dividends or redeem or repurchase capital stock. Additionally, the consolidated net sales for UDENYCA must not be lower than $70,000,000 for the fiscal year ending December 31, 2019, (b) $125,000,000 for the fiscal year ending December 31, 2020, and (c) $150,000,000 for each fiscal year thereafter. A failure to comply with these covenants could permit the Lenders under the Agreement to declare the Borrowings, together with accrued interest and fees, to be immediately due and payable.

On January 7, 2019 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies, reported it has raised $100 million in a Series B financing (Press release, Apollomics, JAN 7, 2019, View Source [SID1234532916]). The financing is led by CMB International ("CMBI"), a subsidiary of China Merchants Bank, with participation from existing Series A investor OrbiMed Asia, and several new investors.

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The infusion of capital will accelerate the growth of the Company with a focus on advancing multiple oncology programs, exploring new treatment areas, increasing the pipeline of assets, and adding the necessary talent and infrastructure to support these programs. In conjunction with the financing, Apollomics has added Kexiang Zhou, M.D., Managing Director, CMBI to its Board of Directors.

To accommodate its expansion in the U.S., Apollomics will relocate its headquarters to Foster City, CA. In 2018 the Company established its presence in Hangzhou, China to build a state-of-the-art research and development facility as well as manufacturing capabilities to advance its pipeline programs in China and the rest of the world.

"We founded Apollomics with the vision to become a global leader in the development of novel medicines for cancer patients," said Guo-Liang Yu, PhD, Apollomics CEO and OrbiMed Venture Partner. "With this Series B funding and a physical presence in the United States, China, and Australia, Apollomics is poised to expand its clinical development programs globally. We welcome CMBI and our other new investors, and Dr. Zhou’s expertise in developing medicines in China and internationally will be instrumental as we enter the next stage for the Company. Together with our established partners in China, we currently have over ten clinical trials ongoing, and we will continue creating value for our investors by developing innovative solutions in the fight against cancer."

The Company also announced a corporate name change and rebranding from CBT Pharmaceuticals, Inc. to Apollomics, Inc. and has launched a new logo and website: www.apollomicsinc.com.

Sanjeev Redkar, PhD, President of Apollomics, stated, "Rebranding the company to Apollomics truly captures our spirit and values. The name is derived from the Greek verb ‘apollymi’ which means ‘to destroy’, and ‘omics’ is a term used for large amounts of biological data. In Greek mythology, Apollo is the god of healing. Our new identity reinforces our mission to utilize sound scientific rationale to eradicate cancer and improve the lives of cancer patients."

"We believe in the mission of Apollomics that through combination regimens we can achieve clinically meaningful, durable responses that will allow us to enhance outcomes for patients. Apollomics’ cross-border presence, diverse pipeline, proven track record, and seasoned management team creates a highly compelling investment for CMBI, and we are delighted to join their team," added Dr. Kexiang Zhou.

About CMB International Capital Co., Ltd.

Incorporated in Hong Kong, CMB International Capital Corporation Limited ("CMBI") is an integrated financial institution providing comprehensive and professional services to institutional, corporate and individual customers both domestically and overseas. As a wholly-owned subsidiary of China Merchants Bank ("CMB"), CMBI leverages CMB’s synergy and coordination in domestic and overseas markets as well as CMB’s strong resources and outstanding social reputation. CMBI and its subsidiaries have been actively implementing diversified business strategies and have established main business segments including Corporate Finance, Asset Management, Wealth Management, and Equity and Structured Finance.

On January 7, 2019 Iovance Biotherapeutics, Inc is presented the corporate presentation (Presentation, Iovance Biotherapeutics, JAN 7, 2019, View Source [SID1234532507]).

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On January 7, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company expects to report revenue between $142.5 million and $143.5 million for the fourth quarter ended Dec. 31, 2018, an increase of 64 percent from the same quarter of 2017 (Press release, Exact Sciences, JAN 7, 2019, View Source [SID1234532523]). The company completed approximately 292,000 Cologuard tests during the fourth quarter of 2018, which represents 66-percent growth from the same period of 2017.

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For full-year 2018, the company anticipates reporting total revenue between $454 million and $455 million, a year-over-year increase of 71 percent. Completed Cologuard test volume during 2018 was approximately 934,000 tests, a 64-percent increase from 2017.

Nearly 15,000 health care providers ordered Cologuard for the first time during the fourth quarter of 2018. The number of providers who have ordered Cologuard since its launch increased to nearly 147,000 during 2018.

"2018 was a landmark year for Exact Sciences," said Kevin Conroy, chairman and CEO of Exact Sciences. "We helped more than 930,000 people get screened for colorectal cancer, launched a partnership with Pfizer to help bring Cologuard to more patients, and scaled our operations to meet rising demand. Our team continues working hard to deliver life-changing innovations in early cancer detection. In 2019, we expect to open a new clinical lab, integrate Epic software into our operations, and advance our pipeline of liquid biopsy tests."

Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2018. The revenue ranges presented in this news release for the fourth quarter of 2018 and for the year ended Dec. 31, 2018 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2018. We are in the process of completing our customary year-end close and review procedures as of and for the year ended Dec. 31, 2018, and there can be no assurance that our final results for this period will not differ from these estimates. During the course of the preparation of our consolidated financial statements and related notes as of and for the year ended Dec. 31, 2018, we or our independent registered public accountants may identify items that could cause our final reported results to be materially different from the preliminary financial estimates presented herein.

Exact Sciences plans to report 2018 financial results and provide guidance during its February 2019 earnings call.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On January 7, 2019 Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, reported that its targeted antibody vofatamab has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treatment of patients with advanced or metastatic urothelial cell carcinoma (bladder cancer) that is positive for FGFR3 mutation and/or fusion (Press release, Rainier Therapeutics, JAN 7, 2019, View Source [SID1234532539]).

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"This Fast Track designation underscores the great unmet medical need that exists for the treatment of bladder cancer," said Scott Myers, Chairman and CEO of Rainier Therapeutics. "As the only antibody specifically targeted to FGFR3 we know to be in clinical development, we believe vofatamab offers a promising therapeutic option. We look forward to further data from our ongoing trials and working to advance our development efforts."

The FDA’s Fast Track designation is a process to facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Through the Fast Track program, more frequent meetings may be scheduled with the FDA to discuss the drug’s development plan and to ensure the collection of appropriate data needed to support approval. Additionally, the drug may qualify for accelerated approval and priority review and, at the time of a biologics license application (BLA) filing, the drug candidate’s sponsor may be eligible to submit completed sections of the BLA on a rolling basis before the complete application is submitted.

"Fast Track designation offers the potential to reduce development time and cost associated with bringing a drug to patients," said Valerie Fauvelle, Vice President, Regulatory Affairs at Rainier Therapeutics. "We look forward to working with the FDA to rapidly advance vofatamab through the clinical development and regulatory processes."

Vofatamab (B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and other cancers. Vofatamab is the most advanced targeted biologic specific for FGFR3 known by Rainier to be in clinical development.

Rainier Therapeutics has ongoing Phase 1b and Phase 2 clinical studies of vofatamab in metastatic bladder cancer – the Fierce 21 and Fierce 22 studies. In addition, Rainier Therapeutics plans to study vofatamab in early stage bladder cancer – the Fierce 23 trial.

The Fierce 21 trial is evaluating vofatamab alone and in combination with docetaxel versus docetaxel alone to determine safety and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer with FGFR3 mutant/fusion who have relapsed after, or are refractory to, at least one prior line of chemotherapy. For more on this trial, visit www.clinicaltrials.gov (NCT0240542).

The Fierce 22 trial is evaluating vofatamab in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy. For more on this trial, visit www.clinicaltrials.gov (NCT03123055).

The Fierce 23 trial will evaluate vofatamab monotherapy in non-muscle invasive bladder cancer (NMIBC). This trial is planned to start in 2019.