On March 11, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of fibrosis and cancer, reported a presentation of AVID200 preclinical data at the Keystone Symposia on Cancer Immunotherapy, March 10 – 14 (Press release, Forbius, MAR 11, 2019, View Source [SID1234534195]).

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This presentation describes AVID200’s immuno-oncology mode of action and ability to increase T-cell-mediated cytotoxicity and immune cell infiltration, resulting in enhanced efficacy of immune checkpoint inhibitors in syngeneic mouse tumor models.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to anti-PD-(L)1 therapies such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

On March 11, 2019 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the fourth quarter and full year ended December 31, 2018 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, MAR 11, 2019, View Source [SID1234534214]).

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"We at CCXI marched through 2018, achieving essential objectives both tactical and strategic," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Those 2018 achievements now set the stage for a suite of successive late-stage data readouts starting in the fourth quarter of this year with top-line results from the pivotal ADVOCATE Phase III trial of avacopan in ANCA-associated vasculitis."

"But ADVOCATE was just the beginning of the pipeline in a drug strategy for avacopan. Another step was the launching in December of the AURORA trial of avacopan in hidradenitis suppurativa, a disfiguring and debilitating skin disorder. AURORA is a large, potentially registration-supporting clinical trial of avacopan, and we aim for top-line data as soon as mid-2020. The third step in the strategy is avacopan in C3 glomerulopathy. The C3G trial has shown strong enrollment trends; putting us again in a position to obtain top-line data for this devastating condition in 2020. Keen observers will be mindful that our renal orphan disease franchise has a second unique asset: the CCR2 inhibitor CCX140 for the treatment of focal segmental glomerulosclerosis in our LUMINA trials program."

"CCXI’s financial position remains strong and provides us the financial foundation to run these trials simultaneously, and to achieve the data objectives outlined here. Our basic science and discovery platform continues to create value – identifying novel modes of action of our late stage pipeline assets avacopan and CCX140, while also moving toward additional, novel pipeline candidates in renal and dermal disease. For all of these reasons, I think this is one of the most exciting and most promising times in the history of the enterprise."

Recent Highlights

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Launched the Company’s Phase IIb clinical trial of avacopan for the treatment of Hidradenitis Suppurativa (HS), called the AURORA trial. HS is a chronic disabling skin autoimmune disease characterized by recurrent, painful, nodules, boils and abscesses. A proof-of-concept study has demonstrated that HS is driven by neutrophils produced by C5a. The AURORA trial aims to enroll 390

patients with moderate to severe HS. The primary endpoint will assess avacopan against placebo at 12 weeks of treatment, using the HiSCR (hidradenitis suppurativa clinical response) scale, which has been validated by the FDA. All groups will be followed for an additional 24 weeks. Secondary endpoints include percent improvement from baseline to week 12 between groups, validated secondary measurements and quality of life measured using the HS Quality of Life Instrument (HiSQOL) and SF36 health assessment.

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Advanced enrollment in the Company’s clinical trial of avacopan in patients with the kidney disease C3 Glomerulopathy (C3G). Enrollment in this randomized control trial of 88 C3G patients now approaches 50%. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant with recurring disease common. There is no approved effective treatment for C3G.

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Reached a milestone in the Company’s clinical trials of CCX140 in two sub-populations of Focal Segmental Glomerulosclerosis (FSGS), a rare kidney disease: the LUMINA 1 trial, evaluating patients with sub-nephrotic primary FSGS, is over 50% enrolled. Enrollment in LUMINA 2, evaluating nephrotic syndrome primary FSGS, continues.

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Maintained a robust balance sheet, with reported cash and investments exceeding $175 million at December 31, 2018, excluding an additional cash raise of $20 million in January 2019.

Fourth Quarter and Full Year 2018 Financial Results

Cash and investments, totaled $177.0 million at December 31, 2018, excluding $20.0 million in gross proceeds from the January 2019 issuance of common stock under the Company’s equity distribution agreement.

Revenue was $9.3 million for the fourth quarter of 2018, compared to $56.3 million for the same period in 2017. For the full year ended December 31, 2018, revenue was $42.9 million, compared to $82.5 million for 2017. The decrease in revenue from 2017 to 2018 was due to the adoption of ASC 606 under the modified retrospective transition method and reflected the cumulative effect of initially applying the new revenue standard of $47.3 million as an adjustment to the opening balance of accumulated deficit and an increase in deferred revenue. Revenue recognized prior to January 1, 2018 has not been restated and continues to be reported under the accounting standards in effect for those periods.

Research and development expenses were $15.1 million for the fourth quarter of 2018, compared to $12.9 million for the same period in 2017. Full year 2018 research and development expenses were $62.7 million compared to $49.5 million in 2017. The increase in research and development expenses from 2017 to 2018 was primarily due to the advancement of the avacopan ADVOCATE Phase III pivotal trial which completed enrollment in July 2018, initiation and patient enrollment of the avacopan Phase II clinical trials in patients with C3G and HS and the CCX140 Phase II clinical trials in patients with FSGS.

General and administrative expenses were $5.6 million for the fourth quarter of 2018, compared to $4.1 million for the same period in 2017. Full year 2018 general and administrative expenses were $20.4 million, compared to $16.5 million in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net loss for the fourth quarter of 2018 was $10.8 million, compared to net income of $39.7 million for the same period in 2017. Full year 2018 net loss was $38.0 million, compared to net income of $17.9 million in 2017.

Total shares outstanding at December 31, 2018 were approximately 50.7 million shares.

The Company expects to utilize cash and investments in the range of $75.0 million and $85.0 million in 2019.

Conference Call and Webcast

The Company will host a conference call and webcast today, March 11, 2019 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 2269237. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On March 11, 2019, Idera Pharmaceuticals, Inc. (the "Company") reported that from this date they entered into a clinical trial collaboration and supply agreement (the "Collaboration and Supply Agreement") with Bristol-Myers Squibb Company ("BMS") to clinically evaluate the combination of the Company’s TLR-9 agonist, tilsotolimod (IMO-2125), with BMS’s therapy YERVOY (ipilimumab) and OPDIVO (nivolumab) (Press release, Bristol-Myers Squibb, MAR 11, 2019, View Source [SID1234534280]).

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Under the Collaboration and Supply Agreement, the Company will sponsor, fund and conduct the Company’s Phase 2, open-label, global, multi-center, multi-cohort study of intratumoral tilsotolimod in combination with YERVOY and OPDIVO entitled "Study of Tilsotolimod in Combination with Nivolumab and Ipilimumab For the Treatment of Solid Tumors" in accordance with an agreed-upon protocol (the "Trial"). The Company refers to the Trial as ILLUMINATE-206. Under the Collaboration and Supply Agreement, BMS has granted to the Company a non-exclusive, non-transferrable, royalty-free license (with a right to sublicense) under its intellectual property to use YERVOY and OPDIVO in the Trial and has agreed to manufacture and supply YERVOY and OPDIVO, at its cost and for no charge to the Company, for use in the Trial.

Unless earlier terminated, the Collaboration and Supply Agreement will remain in effect until (a) the completion of the Trial, (b) all related Trial data has been delivered to both parties and (c) the completion of any statistical analyses and bioanalyses contemplated by the Trial protocol or any analysis otherwise agreed upon by the parties. The Collaboration and Supply Agreement may be terminated by either party (i) in the event of an uncured material breach by the other party, (ii) in the event the other party is insolvent or in bankruptcy proceedings or (iii) for safety reasons. Upon termination, the licenses granted to the Company to use YERVOY and OPDIVO in the Trial will terminate.

The foregoing description of the Collaboration and Supply Agreement does not purport to be complete and is qualified in its entirety by reference to the Collaboration and Supply Agreement, which the Company intends to file with the Securities and Exchange Commission as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2019.

On March 11, 2019 Horizon Pharma plc (Nasdaq: HZNP) reported the closing of its underwritten public offering of 14,081,632 of its ordinary shares at a price to the public of $24.50 per share (Press release, Horizon Pharma, MAR 11, 2019, View Source [SID1234534254]). This includes the exercise in full by the underwriters of their option to purchase up to 1,836,734 additional ordinary shares. The estimated net proceeds to the Company from this offering are approximately $326.8 million, after deducting underwriting discounts and other estimated offering expenses payable by the Company.

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Citigroup, Morgan Stanley, Goldman Sachs & Co. LLC and Cowen acted as joint book-running managers for the offering.

Also on March 11, 2019, the Company secured incremental revolving loan commitments pursuant to an amendment to its existing credit agreement. The new incremental revolving commitments have been established pursuant to a revolving credit facility, and provide an additional $200 million of borrowing capacity.

A registration statement relating to the ordinary shares described above was previously filed with and became effective by rule of the Securities and Exchange Commission ("SEC"). A final prospectus supplement and accompanying prospectus related to the offering was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and accompanying prospectus may be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by phone at 800-831-9146; Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department; Goldman Sachs & Co. LLC, c/o: Prospectus Department, 200 West Street, New York, NY 10282, by email at [email protected] or by phone at 866-471-2526; or Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department or by phone at 631-274-2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the shares in any state or other jurisdiction which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 11, 2019 With an estimated 1.8 million new cancer cases a year in India expected by 20251, Tata Trusts and Varian (NYSE: VAR) announced the signing of a framework agreement intended to increase patient access to advanced radiation therapy treatments in the country (Press release, Varian Medical Systems, MAR 11, 2019, View Source [SID1234553812]). The three-year agreement is focused on world-class cancer care delivery through the installation of radiation therapy treatment systems across India where Varian has been selected as the preferred supplier by Tata Trusts.

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The agreement is part of a program undertaken by Tata Trusts with the goal of creating patient-centric cancer institutions to deliver standardized and affordable care closer to patients’ homes in different regions in India, including rural areas where many patients do not have the financial means to access existing care options. Included in the scope of the agreement, is the creation of a significant number of new cancer centers, as well as the installation of advanced radiotherapy equipment in already existing centers in these areas. At its culmination, the program is targeted to bring world-class cancer care to an estimated quarter million patients per year that previously did not have easy or affordable access to treatment options.

In addition to the installation of the radiation therapy treatment systems, the Varian ARIA oncology information system and Eclipse treatment planning system will be implemented in a secure network hosted on a private cloud, to assist in elevating the level of care across India. The first systems are estimated to begin installation later in 2019.

"We are delighted to work together with Tata Trusts to achieve innovative, sustainable and world class standards of cancer care, while making a real difference in communities across India, beginning with the initial installations of systems over the coming months," said Dow Wilson, president and chief executive officer of Varian. "Working with Tata Trusts on this project is perfectly aligned with our core strategy of increasing access to high-quality care and creating a world without fear of cancer. We are proud that the Tata Trusts have put their faith in our solutions with this commitment to both our hardware and software platforms."