On October 30, 2019 CytoSorbents Corporation (CTSO), a critical care immunotherapy leader commercializing its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reported that it will report Q3 2019 financial results after the market close on Tuesday, November 5, 2019 (Press release, Cytosorbents, OCT 30, 2019, View Source [SID1234550080]).

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CytoSorbents’ management will host a live conference call and presentation webcast that will recount both operational and financial progress during Q3 2019 followed by a question and answer session.

Conference Call Details:
Date: Tuesday, November 5, 2019
Time: 4:45 PM Eastern
Participant Dial-In: 877-451-6152
Conference ID: 13695453
Live Presentation Webcast: View Source

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: View Source

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at View Source

On October 30, 2019 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported early completion of patient enrollment of its Phase 3 ProVent clinical trial. More than 450 subjects were randomized in the large-scale clinical trial, which is evaluating the effectiveness of sipuleucel-T (PROVENGE) in reducing disease progression in men with early-stage prostate cancer on active surveillance (AS) (Press release, Dendreon, OCT 30, 2019, View Source [SID1234550065]).

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"The rapid pace of enrollment in the ProVent trial is a significant milestone for Dendreon, and underscores a strong interest by patients and physicians in the potential clinical benefit of sipuleucel-T in men on AS," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "PROVENGE has been proven to extend life in men with mCRPC, and we intend to change the way prostate cancer is treated by showing that immunotherapy can reduce disease progression and the need for aggressive intervention in men with early-stage disease."

Nearly 175,000 men are diagnosed with prostate cancer every year.1 Of these, about 30 to 40% with a lower risk of prostate cancer will opt for AS, which includes regular monitoring to assess whether the cancer is progressing, instead of more aggressive treatment options such as surgery or radiation.2,3

"For men with low-risk, localized prostate cancer, the option of AS is regularly recommended; however, variation in PSA monitoring and the anxiety of having a ‘cancer’ diagnosis causes many men to leave surveillance management and undergo interventional treatment," said Neal D. Shore, M.D., FACS, ProVent principal investigator, medical director for the Carolina Urologic Research Center and a practicing urologist at Atlantic Urology Clinics in Myrtle Beach, S.C. "Both patients and physicians have desired a proactive therapy for appropriate AS patients in order to optimize their long-term outcomes. Given the numerous studies describing the effectiveness of sipuleucel-T immunotherapy for advanced prostate cancer, we are optimistic that data from ProVent may lead to the first-ever immunotherapy treatment option for men with early-stage prostate cancer."

About the ProVent Trial
The randomized, multicenter Phase 3 ProVent trial is assessing the efficacy of sipuleucel-T in reducing histopathologic disease progression in men on AS. Men age 18 or older who have histologically-proven adenocarcinoma of the prostate diagnosed within 12 months of randomization were eligible to enroll in the study, which is being conducted at approximately 60 sites across the United States. Study participants were randomized 2:1 to receive sipuleucel-T or remain on AS.

The primary endpoint is histological upgrade from ISUP Grade Group 1 to Grade Group 2 or higher, or Grade Group 2 upgraded to Grade Group 3 or higher at 33-39 months after randomization. Secondary endpoints include the number of study participants who receive subsequent prostate cancer treatment (e.g., surgery, radiation, hormone therapy), the percentage of participants with a negative biopsy, and safety. Exploratory objectives will evaluate quality of life and the association of immunologic responses with efficacy.

Enrollment in the ProVent study began in late 2018, and topline results are expected in 2023.

For more information, visit www.ProVentStudy.com or clinicaltrials.gov (NCT03686683).

About Active Surveillance (AS)
During AS, prostate tumors are not treated, but are regularly monitored via biopsies (every one to two years) and regular prostate-specific antigen (PSA) testing to determine disease progression. AS reduces the risk of overtreatment of clinically-insignificant prostate cancer while retaining the option of definitive therapy. AS is increasingly accepted as a treatment option for certain categories of prostate cancer.4 It is included in treatment guidelines from organizations including the American Urological Association, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and National Comprehensive Cancer Network.

About PROVENGE (sipuleucel-T)
PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION
Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

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.