On October 30, 2019 Lannett Company, Inc. (NYSE: LCI) reported that it will report financial results for its fiscal 2020 first quarter on Wednesday, November 6, 2019, after the market closes (Press release, Lannett, OCT 30, 2019, https://www.prnewswire.com/news-releases/lannett-to-report-fiscal-2020-first-quarter-financial-results-host-conference-call-on-wednesday-november-6-300947807.html [SID1234550081]). Lannett management will host a conference call that same afternoon at 4:30 p.m. Eastern Time to review the company’s performance and answer questions.

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The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49151826. The call will be broadcast via the Internet at www.Lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

On October 30, 2019, Protagonist Therapeutics, Inc. (the "Company") entered into a Credit and Security Agreement, dated as of October 30, 2019 (the "Closing Date") by and among the Company, MidCap Financial Trust, as a lender, Silicon Valley Bank, as a lender, the other lenders party thereto from time to time and MidCap Financial Trust, as administrative agent and collateral agent ("Agent") (the "Term Loan Credit Agreement"), which provides for a $50.0 million term loan facility (Filing, 8-K, Protagonist, OCT 30, 2019, View Source [SID1234550125]). The Term Loan Credit Agreement provides for (i) on the Closing Date, $10.0 million aggregate principal amount of term loans, (ii) at the Company’s option, until December 31, 2020, an additional $20.0 million term loan facility subject to the satisfaction of certain conditions and (iii) at the Company’s option, until September 30, 2021, an additional $20.0 million term loan facility subject to the satisfaction of certain conditions (collectively, the "Term Loans"). The Company intends to use the proceeds of the Term Loans for general corporate purposes.

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The obligations under the Term Loan Credit Agreement are secured by a perfected security interest in all of the Company’s assets except for intellectual property and certain other customary excluded property as set forth therein.

The Term Loans are subject to an origination fee of 0.25% of each funded tranche of Term Loans. The Term Loans may be prepaid in full or in part through October 30, 2020 with payment of a 3.0% prepayment premium, after which they may be prepaid in full or in part through October 30, 2021 with payment of a 2.0% prepayment premium, after which they may be prepaid in full or in part with payment of a 1.0% prepayment premium. An additional 2.85% of the amount of Term Loans advanced by the lenders will be due upon prepayment or repayment of the Term Loans.

The interest rate applicable to the Term Loans is the WSJ Prime Rate plus 2.91%, subject to a floor of 4.94%. Commencing November 1, 2019, the Company initially will make interest-only payments for 24 months, followed by 24 months of amortization payments. All unpaid principal and accrued interest is due and payable in full no later than October 1, 2023.

The Term Loan Credit Agreement requires that the Company maintain cash and cash equivalents of at least 35% of the outstanding Term Loans at all times. The Term Loan Credit Agreement also contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness and dividends and other distributions.

Events of default under the Term Loan Credit Agreement include: (i) failure by the Company to timely make payments due under the Term Loan Credit Agreement; (ii) material misrepresentations or misstatements in any representation or warranty by the Company when made; (iii) failure by the Company or its subsidiaries to comply with the covenants under the Term Loan Credit Agreement and other related agreements; (iv) certain defaults under a specified amount of other indebtedness of the Company or its subsidiaries; (v) insolvency or bankruptcy-related events with respect to the Company or any of its subsidiaries; (vi) certain undischarged judgments against the Company or its subsidiaries; (vii) certain ERISA-related events with respect to the Company or its subsidiaries above a specified amount; (viii) certain security interests or liens under the loan documents ceasing to be, or being asserted by the Company not to be, in full force and effect; (ix) the institution of criminal proceedings against the Company; (x) an event of default under the guarantee of the obligations under the Term Loan Credit Agreement; (xi) the prepayment of any subordinated debt other than as specifically permitted by the terms of such subordination; (xii) the occurrence of a Material Adverse Change (as defined in the Term Loan Credit Agreement); (xiii) certain adverse actions by the FDA or DEA with respect to certain products or which could be reasonably expected to result in a Material Adverse Change (as defined in the Term Loan Credit Agreement); (xiv) a default or material breach under certain specified material contracts and (xv) any loan document ceasing to be, or any challenge or assertion by the Company that such loan document is not, in full force and effect. If one or more events of default occurs and continues beyond any applicable cure period, the Agent may, with the consent of the lenders holding a majority of the loans and commitments under the facilities, or will, at the request of such lenders, terminate the commitments of the lenders to make further loans and declare all of the obligations of the Company under the Term Loan Credit Agreement to be immediately due and payable.

On October 30, 2019 Cotinga Pharmaceuticals Inc. (TSX Venture: COT; OTCQB: COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported its financial and operating results today for the three months ended July 31, 2019 (Press release, Cotinga, OCT 30, 2019, View Source [SID1234550034]). Recent highlights are outlined below. The Company also announces the reinstatement of Victor Hugo, of Marrelli Services Inc, as CFO, effective October 10, 2019; and the resignation of John Yoo, MD, from the Board of Directors, effective September 24, 2019. Dr. Yoo will remain as an advisor to the Company.

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Advanced the clinical development of COTI-2:

• Cotinga announced the initiation of dosing patients in the first three cohorts in the combination therapy trial at MD Anderson Cancer Center evaluating COTI-2 and cisplatin in a wide spectrum of cancers.

• The Company announced early interim data from cohorts 1 and 2, reporting signs of clinical activity in both cohorts determined by disease stabilization or regression. Additionally, the Company announced the closings of a two-tranche debenture in May and June, 2019, bringing $300,000 CDN into the company to fund the clinical trial and general operations. Upcoming Milestones COTI-2:

• Continue the dose escalation Phase 1b/2a combination therapy trial evaluating the effect of COTI2 plus cisplatin in patients with solid tumors;

• Contingent on the raising of necessary funds, initiate the TNBC trial with COTI-2 plus eribulin. Corporate:

• Strengthen the balance sheet;

• Opportunistically pursue regional or co-development partnerships for COTI-2, pipeline programs and other technologies.

Financial Results

The Company’s operational activities during the quarter were primarily focused on advancing the Phase 1b/2a clinical trial of COTI-2.

For the three-months ended July 31, 2019, the Company incurred a net loss of $0.527 million, or $0.02 per share, compared to a net loss of $0.982 million, or $0.04 per share, for the three-months ended July 31, 2018. The decrease in net loss during the three-month period is primarily due to decreases in Research and Development (R&D) expense and General and Administrative (G&A) expense. Press Release Page | 2

There was no revenue for the three months ended July 31, 2019 or in the comparative periods in the prior year.

R&D expense in the three-month period ended July 31, 2019 decreased by $0.218 million over the same period in the prior year. The decrease in R&D expense in the three-month period is primarily due to a decrease in clinical trial expenses and synthesis and miscellaneous R&D expenses.

S&M expense in the three-month period ended July 31, 2019 decreased by $0.028 million over the same period in the year prior. The decrease in S&M expense in the three-month period is primarily due to less travelling and conferences and in 2019, and professional fees on marketing.

G&A expense in the three-month period ended July 31, 2019 decreased by $0.158 million over the same period in the year prior. The decrease in G&A expense in the three-month period is primarily due to primarily due to lower professional fees and share-based compensation.

Detailed operating and financial results can be found in the Company’s Unaudited Condensed Interim Financial Statements and Management Discussion and Analysis for the three months ended July 31, 2019, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.

On October 30, 2019 Amgen (NASDAQ: AMGN) reported a publication in Nature unveiling the discovery of AMG 510, a small molecule inhibitor of KRASG12C being investigated as a treatment for a variety of solid tumors with KRAS G12C mutation (Press release, Amgen, OCT 30, 2019, View Source [SID1234550066]). AMG 510 is the first investigational KRASG12C inhibitor to advance to the clinic and is currently enrolling in a potentially registrational Phase 2 study.

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Titled "The Clinical KRASG12C Inhibitor AMG 510 Drives Anti-Tumor Immunity," the paper highlights novel structural insights that led to the discovery of AMG 510, the preclinical evidence of AMG 510 activity, its potential ability to induce tumor-cell killing as both a monotherapy and in combination with other therapies, and its impact on the immune system that may render tumor cells particularly sensitive to immunotherapy. Early evidence of clinical activity of AMG 510 is also presented in the paper.

"We are pleased to share how our team of scientists at Amgen were the first to exploit the previously hidden groove on the protein surface to finally identify a potential drug against this important oncogenic protein," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "These scientific insights, coupled with superb molecular engineering, paved the way for AMG 510 to be first to clinic, where it has demonstrated early evidence of clinical activity."

KRAS, identified over 30 years ago as a proto-oncogene, is one of the most frequently mutated oncogenes in human cancer.1,2 Amgen researchers first identified the novel histidine 95 (H95) groove located on an inactive KRASG12C protein. Through extensive compound screening and structure-based design, AMG 510 emerged as the top investigational candidate from the optimization of a series of H95 groove-binding molecules. It is designed to irreversibly bind to KRASG12C protein and permanently lock it in an inactive state, leading to inhibition of tumor cell growth in KRASG12C driven tumors. In preclinical experiments, AMG 510 demonstrated favorable potency and selectivity, and induced regression in mice bearing KRASG12C mutated tumors.

"There is a significant unmet need for tumor-selective therapies that minimize a negative impact on normal cells, and many patients diagnosed with KRAS-mutated solid tumors have typically faced a challenging prognosis with limited targeted treatment options," said David S. Hong, M.D., one of the paper’s authors, AMG 510 clinical study investigator and deputy chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine at University of Texas MD Anderson Cancer Center, Houston. "This publication shows investigational AMG 510 has high selectivity in non-clinical experiments, binding only to KRASG12C out of more than 6,000 proteins and likely contributing to the absence of dose-limiting toxicities in the clinical study to date, supporting the potential for an encouraging safety profile."

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to AMG 510 for previously treated metastatic non-small cell lung cancer (NSCLC) and colorectal cancer with KRAS G12C mutation and Fast Track Designation for previously treated metastatic NSCLC with KRAS G12C mutation. Additional data from the ongoing Phase 1 clinical trial evaluating AMG 510 was recently presented at the 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and at the European Society for Medical Oncology 2019 Congress, both of which were held in Barcelona, Spain.

About KRAS
The subject of more than three decades of research, the RAS gene family are the most frequently mutated oncogenes in human cancers.1,2 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.2 A specific mutation known as KRAS G12C accounts for approximately 13% of non-small cell lung cancers, three to five percent of colorectal cancers and one to two percent of numerous other solid tumors.3 Approximately 30,000 patients are diagnosed each year in the United States with KRAS G12C-driven cancers.4 KRASG12C has been considered "undruggable" due to a lack of traditional small molecule binding pockets on the protein. Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

On October 30, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that a poster entitled "MIV-818 stimulates an anti-tumor immune response in vitro and enhances the effects of pembrolizumab" was presented at the AACR (Free AACR Whitepaper)-NCI-EORTC conference in Boston (Press release, Medivir, OCT 30, 2019, View Source [SID1234550082]). The data shows that MIV-818 exerts favorable immunomodulating effects in vitro by increasing immune cytokine levels in complex tumor microenvironment models, and the white blood cell mediated killing of cancer cells. These effects are further enhanced in combination with the anti-PD1 check-point inhibitor pembrolizumab.

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"It is exciting that MIV-818, in addition to directly targeting cancer cells, also modulates the anti-tumor immune-response. This opens the possibility for potential future combinations with immunotherapy" – says Dr Fredrik Öberg, CSO.

For further information, please contact:
Dr Uli Hacksell
CEO
Medivir AB
phone: +46(0)8-5468-3100.

About MIV-818

MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer. A phase I study in patients with liver cancer is ongoing.

About liver cancer

Liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC are capable of extending the lives of patients, treatment benefits are low while death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without specific mutations seen in other tumor types. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.