On February 26, 2019 Selexis SA and Turgut Pharmaceuticals (Turgut Ilaclari AS) reported that they have signed two trademark license agreements (CLMs) through which Turgut will operate the SURE Technology Platform and SURE CHO-M Cell Line by Selexis for the development of two high-end biosimilar antibodies: a control point inhibitor for the treatment of certain cancers and a monoclonal antibody for the treatment of HER2-positive metastatic breast cancer (Press release, Selexis FEB 26, 2019, View Source [SID1234533699]). With the addition of these CLMs, companies are now collaborating on the development of multiple biosimilars for cancer and inflammatory diseases. The companies announced the signing of the most recent CLMs in December 2017 .

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"In just under three years, we have signed five brand license agreements, in collaboration with the Turgut team, to advance its high-end biosimilar pipeline. Our technology and our cell line have proven their impact on biosimilar development, which is very important given the huge demand to offer patients expanded access to life-changing organic products, "said Marco Bocci., PhD at DPharm, Vice President of Licensing and Business Development at Selexis. "Turgut shares our passion for bringing advanced medicines to patients faster and at a lower cost. The success we have had with Turgut so far has been fueled by our collaboration and we are very pleased to continue supporting their efforts to bring biosimilars to the market under these new licenses. "

Selexis’ proprietary SURE technology platform facilitates the rapid, stable and cost-effective production of virtually all recombinant proteins, including biosimilars, and provides a seamless integration of the organic product development continuum, from discovery to commercialization. Using the SURE technology platform, Selexis has managed to generate many biosimilars, including marketed products, whose glycan profiles correspond to the originator drugs.

"These two products are innovative treatments that can improve accessibility for a much larger patient population," said Serdar Alpan, MD, PhD, head of the Biotechnology Group at Turgut Pharmaceuticals. "As a cell line development specialist and Turgut’s strong partner, Selexis’ tools and technologies provide us with the competitiveness we need to move forward on our biosimilar programs. We look forward to moving these programs forward. "

The SURE CHO-M cell line from Selexis is a high performance mammalian cell line derived from CHO-K1 cells and used for the production of recombinant therapeutic proteins and monoclonal antibodies. The growth and production properties of the Selexis SURE CHO-M cell line are well defined and the feeding strategy has been optimized to allow for faster and more efficient scaling of the bioreactors. Therapies generated with Selexis SURE CHO-M cells undergo clinical trials and are transformed into marketed products.

On February 26, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported that senior management will present at two upcoming investor healthcare conferences (Press release, Coherus Biosciences, FEB 26, 2019, View Source [SID1234533743]).

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Management will deliver a company presentation at the 38thCowen & Company Healthcare Conference on Tuesday, March 12th at 10 a.m. ET taking place in Boston, Massachusetts.
Management will deliver a company presentation at Barclays Global Healthcare Conference on Wednesday, March 13th at 8:00 a.m. ET taking place in Miami, Florida.
The audio portion of the presentations will be available on the investors page of the Coherus BioSciences website at View Source

On February 26, 2019 Medigene AG (FSE: MDG1, Prime Standard, SDAX), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that it has dosed the first patient in its first-in-human clinical trial with its TCR therapy candidate MDG1011 (Press release, MediGene, FEB 26, 2019, View Source [SID1234533684]). The Phase I/II trial investigates the safety and feasibility of MDG1011 for the treatment of various types of blood cancer, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). MDG1011 is a novel immunotherapy candidate using patient-derived, T cell receptor (TCR)-modified T cells targeting the tumor antigen PRAME (PReferentially expressed Antigen in MElanoma) and was administered for the first time to a multiple myeloma patient in the Department of Medicine 5 (Director Prof. Dr. Andreas Mackensen) at the Universitätsklinikum Erlangen, Germany. MDG1011 is designed as a one-time treatment.

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Dr. Kai Pinkernell, CMO/CDO of Medigene, comments: "Hematologic cancers such as AML, MDS and MM in advanced stages are difficult to treat and usually associated with a very poor prognosis for patients. With our TCR therapy, we hope to open new treatment options for seriously ill patients and the first-time use on patients is a very important step in the development of this new therapeutic candidate."

In the Phase I portion of the trial, approximately 12 patients who are suffering from advanced stage AML, MDS and MM and have previously undergone several cycles of standard therapies will be treated with MDG1011. PRAME expression on the tumor cells as well as the blood serotype HLA-A * 02:01 are further inclusion criteria for patients who can participate in this multicenter, open-label, dose escalation study using a 3 + 3 design. Three dose cohorts and an optional fourth dose cohort will test dose ranges from 100,000 to 10,000,000 transduced T cells per kg of body weight. Each dose cohort consists of 3 patients. At least one MM patient and at least one AML or MDS patient need to be included in each cohort. Patients will undergo preconditioning treatment with cyclophosphamide and fludarabine. After completing treatment of all patients in a dose cohort and a four-week safety follow-up period, dose escalation will be determined by an independent Data and Safety Monitoring Board (DSMB). The primary endpoint for the Phase I portion of this clinical trial will be safety and feasibility at three months with a total follow-up period of up to 12 months. Several secondary endpoints (i.e. overall response rate (ORR)) will be assessed as well.

In the Phase II portion of the trial, presumably two of the three indications will be carried forward after a positive DSMB assessment regarding the safety of MDG1011 and review by the competent authority and central ethics committee. In the Phase II portion, 40 HLA-A*02:01 and PRAME positive patients will be treated with MDG1011; another 40 patients, who are positive for PRAME but negative for HLA-A*02:01, will be included in the control groups (20 treated and 20 control patients per indication) and treated with investigator choice therapy. Co-primary endpoints of the Phase II portion are safety and preliminary efficacy, where efficacy is measured as ORR at 3 months. Several secondary endpoints will be assessed here as well.

The clinical trial is being conducted by the Department of Internal Medicine III of the University Hospital Regensburg (Director: Prof. Dr. Wolfgang Herr) under the leadership of the coordinating investigator PD Dr. Simone Thomas, as well as by the University Hospitals of Erlangen and Würzburg, Germany. Up to five additional clinical centers in Germany are currently being opened and are anticipated to open recruitment within the next three to five months and screen additional patients for their suitability to participate in the study.

About Medigene’s TCR therapy: The TCR-T cell technology aims at arming the patient’s own T cells with tumor-specific T cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient’s T cells outside the body (ex vivo). TCR-T therapy is developed to utilize a higher number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR-T) therapy. Medigene is establishing a pipeline of recombinant T cell receptors and has a collaboration with bluebird bio, Inc. for the development of six TCR-Ts.

About acute myeloid leukemia (AML): AML is a malignant disease of the hematopoietic system. The cause of the disease is the uncontrolled growth of nonfunctioning hematopoietic progenitor cells in the bone marrow. Typical symptoms of AML are anemia, fever, increased susceptibility to infection and bleeding. The disease develops rapidly and, if left untreated, can lead to death within a few weeks or months. AML therapy is usually started with intensive chemotherapy, often followed by consolidation therapy, with or without allogeneic hematopoietic stem cell transplantation. In a significant number of patients, relapse of the disease is expected.

About multiple myeloma (MM): Multiple myeloma (MM) is a malignant disease characterized by monoclonal plasma cell proliferation in the bone marrow, with increased production of complete or incomplete monoclonal immunoglobulins. These proteins are detectable in serum and / or urine. Every year around 3,000 men and about 2,700 women in Germany develop multiple myeloma. MM is thus the third most frequent hematological neoplasia after leukemia and non-Hodgkin’s lymphoma and responsible for about 1% of all cancers in Germany.

About myelodysplastic syndrome (MDS): The term myelodysplastic syndrome is a group of diseases of the bone marrow, in which blood formation does not originate from healthy, but from mutated cells of origin (stem cells). The bone marrow of patients suffering from myelodysplastic syndromes is no longer able to produce fully mature and functional blood cells from these stem cells. In advanced stages of these diseases, more and more immature blood cells are produced. The blood formation process is therefore permanently disturbed and may also lead to acute myeloid leukemia (AML) in some patients at a later date.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, SDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies with the focus on T cell-receptor modified T cells (TCR-Ts) and has associated projects currently in pre-clinical and clinical development. For more information, please visit View Source

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

On February 26, 2019 Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Theravance, FEB 26, 2019, View Source [SID1234533700]). Revenue for the fourth quarter and full year 2018 was $15.7 million and $60.4 million, respectively. Full year operating loss was $238.8 million or $187.4 million excluding share-based compensation expense, in line with the Company’s previously stated financial guidance. Cash, cash equivalents, and marketable securities totaled $517.1 million as of December 31, 2018.

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Rick E Winningham, chairman and chief executive officer, commented: "Following a highly productive 2018, we begin the year with great momentum and continue to make meaningful progress towards our goal of designing more effective and safer medicines to address unmet patient needs. Early in 2018, we entered into a global collaboration with Janssen for TD-1473, our gut-selective pan-JAK inhibitor for inflammatory intestinal diseases, for which we are beginning late-stage clinical trials. In the middle of the year, we showed positive four-week results for ampreloxetine in neurogenic orthostatic hypotension, providing us with the confidence to advance into a registrational Phase 3 program which is now underway. In the latter part of 2018, we and our partner Mylan achieved product approval for YUPELRI in COPD, and formal launch efforts are now underway. We closed out the year with R&D Day where we described our innovative research and development strategy of organ-selective medicines designed to expand the therapeutic index beyond that of conventional therapy and introduced several new research programs. Underpinning the progress of our own business, GSK’s TRELEGY ELLIPTA for COPD continues its impressive sales trajectory, and we await the results of the Phase 3 CAPTAIN study in asthma in the first half of 2019.

"We anticipate multiple clinical readouts and milestones over the next several months, including supplemental data presentations at upcoming scientific meetings for TD-1473 in ulcerative colitis and ampreloxetine in nOH, as well as Phase 1 data for TD-8236, and initial commercial metrics for YUPELRI. Following our recently completed note financing tied to our economic interest in TRELEGY ELLIPTA, we enter 2019 with a strong cash balance and are well-positioned to execute against our milestones and continue to deliver value to stakeholders."

Program and Corporate Updates

YUPELRITM (revefenacin) inhalation solution (lung-selective nebulized long-acting muscarinic antagonist (LAMA)):

First and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Formal launch activities underway with partner Mylan; combined sales infrastructures covering the hospital, hospital discharge, and home health settings
TD-1473 (gut-selective pan-Janus kinase (JAK) inhibitor):

First patients dosed in Phase 2 DIONE induction study in Crohn’s disease
Sites initiated in registrational Phase 2b/3 RHEA induction and maintenance study in ulcerative colitis
Results from the Phase 1b study of TD-1473 in patients with ulcerative colitis accepted as an oral presentation at Digestive Disease Week (DDW) in May 2019
Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI)):

Recently announced initiation of dosing in registrational Phase 3 program in symptomatic neurogenic orthostatic hypotension (nOH)
Phase 2 study in patients with nOH complete; 5-month data further support previously-announced clinical observations after four weeks of treatment. Detailed study data to be submitted for presentation at mid-year scientific meeting
TD-8236 (novel, lung-selective inhaled pan-JAK inhibitor for serious respiratory diseases):

Discovery leverages organizational expertise in respiratory diseases and JAK inhibition
Phase 1 clinical study underway; designed to evaluate safety and provide biomarker data of TD-8236 in healthy volunteers and asthma patients; completion expected in mid-2019
Multiple JAK-dependent pathways clinically validated in asthma and COPD
Potentially broad activity with JAK inhibition across a range of respiratory indications and phenotypes
TD-8236 shown to potently inhibit targeted mediators of Th2-high and Th2-low asthma in human cells in preclinical studies
R&D Day in December 2018:

Highlighted our innovative research and development strategy of organ-selective medicines and introduced several new research programs that we plan to advance towards clinical development, each specifically tailored to the organ of interest
TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)1:

GSK reported fourth quarter 2018 net sales of $100 million and $207 million for the full year 2018; Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product
Currently available in 26 countries, with additional countries expected over the course of 2019; recent regulatory filings include Japan and China
Expanded COPD indication in Europe for patients not adequately treated with dual bronchodilation, making it the first single inhaler triple therapy indicated for patients with moderate to severe COPD
Completion of Phase 3 CAPTAIN study in asthma patients expected in 1H 2019; if positive, submission of supplemental New Drug Application (sNDA) for TRELEGY ELLIPTA in asthma anticipated in 2H 2019
Completed a non-dilutive private placement of $250.0 million in aggregate principal amount of non-recourse notes secured by a portion of the future payments the Company expects to receive related to royalties due on net sales1 of TRELEGY ELLIPTA
75% share of the payments will be used to satisfy the debt obligations until notes repaid
Remaining 25% of the payments will be directed to benefit the Company on an ongoing basis
Proceeds were approximately $229.0 million net of debt issuance costs and a 5% retention of the notes by the Company
Strategic infusion of cash in late 2018 with retained economics over TRELEGY ELLIPTA’s commercial lifespan; proceeds to support key strategic priorities
VIBATIV (telavancin): Sale of VIBATIV to Cumberland Pharmaceuticals Inc. completed in November 2018

Notes:
1 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY ELLIPTA (the combination of fluticasone furoate, umeclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (net of TRC LLC expenses paid and the amount of cash, if any, expected to be used by TRC pursuant to the TRC LLC Agreement over the next four fiscal quarters)

Fourth Quarter and Full Year Financial Results

Revenue

Revenue for the fourth quarter of 2018 was $15.7 million, comprised of collaboration revenue primarily related to our global collaboration with Janssen for TD-1473 of $10.0 million, profit sharing revenue related to YUPELRI of $3.3 million, and product sales of VIBATIV (telavancin) of $2.4 million. Revenue in the fourth quarter represents an increase of approximately $11.2 million over the same period in 2017. The increase was primarily related to revenue recognized from the upfront payment associated with the global collaboration agreement with Janssen for TD-1473. The increase was partially offset as a full quarter of Product Sales was not recognized due to the sale of VIBATIV to Cumberland Pharmaceuticals in November 2018. Full year 2018 revenue was $60.4 million, comprised of collaboration revenue of $41.8 million primarily associated with the upfront payment from Janssen for TD-1473, product sales of VIBATIV of $15.3 million and profit sharing revenue related to YUPELRI of $3.3 million.

Research and Development (R&D) Expenses

R&D expenses for the fourth quarter of 2018 were $52.3 million, compared to $51.1 million in the same period in 2017. The increase was primarily due to higher external expenses to support our key programs and was partially offset by lower employee-related and share-based compensation expenses. Full year 2018 R&D expenses were $201.3 million, or $175.8 million excluding non-cash share-based compensation.

Selling, General and Administrative (SG&A) Expenses

SG&A expenses for the fourth quarter of 2018 were $25.5 million, compared to $29.5 million in the same period in 2017. The decrease was primarily due to lower expenses related to share-based compensation. Full year 2018 SG&A expenses were $97.1 million, or $71.3 million excluding non-cash share-based compensation.

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities totaled $517.1 million as of December 31, 2018, which includes net proceeds of $229.4 million resulting from the private placement of notes secured by a portion of the future payments related to royalties due on net sales of TRELEGY ELLIPTA.

2019 Financial Guidance

The Company expects full-year 2019 operating loss, excluding share-based compensation, of $210 million to $230 million. Operating loss guidance does not include royalty income for TRELEGY ELLIPTA which we recognize in our statement of operations as "income from investment in TRC, LLC." Our share of US profits and losses related to the commercialization of YUPELRI, potential future business development collaborations as well as the timing and cost of clinical studies associated with our key programs, among other factors, could impact our financial guidance.

Conference Call and Live Webcast Today at 5:00 pm ET

Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET. To participate in the live call by telephone, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, and use the confirmation code 8086288. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events. Please go to the website 15 minutes prior to the start of the call to register, download, and install any necessary audio software.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through March 28, 2019. An audio replay will also be available through 8:00 pm ET on March 5, 2019 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 8086288.

On February 26, 2019 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on gastrointestinal (GI) diseases, reported its full-year 2018 financial results and operational highlights (Press release, RedHill Biopharma, FEB 26, 2019, View Source [SID1234533728]).

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Key Highlights:

Positive top-line results from the confirmatory Phase 3 study with TALICIA for eradication of H. pylori infection; NDA filing expected in H1/19 with potential U.S. commercial launch in Q4/19

Positive top-line results from a first Phase 3 study with RHB-104 for Crohn’s disease; FDA meeting planned mid-2019

Initiation of pivotal Phase 3 study with RHB-204 for first-line treatment of pulmonary nontuberculous mycobacteria (NTM) infections expected in H2/19

Strengthening of commercial management team with appointment of Rick D. Scruggs, former executive VP at Salix Pharmaceuticals, as RedHill’s chief operating officer, U.S. operations

Debt-free balance sheet with approximately $53 million in cash as of December 31, 2018

Net revenues of $8.4 million and gross margin of 66% in 2018, compared to net revenues of $4.0 million and gross margin of 47% in 20171
Micha Ben Chorin, RedHill’s chief financial officer, said: "We had a successful 2018 with positive data reported from our two key Phase 3 studies: the confirmatory Phase 3 study with TALICIA for eradication of H. pylori infection and the first Phase 3 study with RHB-104 for Crohn’s disease."

Mr. Ben Chorin added: "We enter 2019 with a solid cash position of $53.2 million and a debt-free balance sheet. One of our potential key upcoming milestones this year is the planned filing of a U.S. NDA for TALICIA in the first half of 2019, which is expected to support a potential commercial launch in the fourth quarter of 2019, subject to FDA approval. Additionally, we expect to meet with the FDA to discuss the development path to potential approval of RHB-104 for Crohn’s disease following the positive Phase 3 study results. We also plan to initiate a pivotal Phase 3 study with RHB-204 for potential first-line treatment of pulmonary nontuberculous mycobacteria (NTM) infections, an orphan disease with a strong unmet medical need, in the second half of 2019."

"We continue to strengthen our commercial management team with senior industry executives and are pleased to have Rick D. Scruggs, a former senior executive at Salix Pharmaceuticals, expand his role as chief operating officer, U.S. operations to lead our growing U.S. commercial operations. For 2019, our established sales team is positioned to drive revenue growth with a lineup of four commercial products. In an effort to drive additional revenue growth and further leverage our existing U.S. commercial operations, we continue to evaluate opportunities to in-license and acquire additional U.S commercial products," concluded Mr. Ben Chorin.

Select 2018 operational highlights:

TALICIA (RHB-105)2 – Eradication of H. pylori Infection
Following the positive results from the confirmatory Phase 3 study with TALICIA for eradication of H. pylori infection (ERADICATE Hp2 study), RedHill plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the first half of 2019, with eligibility for six-month priority review and potential U.S. commercial launch in the fourth quarter of 2019, subject to FDA approval.

RHB-104 – Crohn’s Disease
The first Phase 3 study with orally-administered RHB-104 for the treatment of Crohn’s disease (MAP US study) successfully met both its primary endpoint and key secondary endpoints and confirmed the broad benefit of RHB-104 as an add-on therapy to standard-of-care treatments for Crohn’s disease. RedHill continues to assess additional data from the positive study as it becomes available and plans to meet with the FDA mid-2019 to discuss the development path towards potential approval.

RHB-204 – Pulmonary Nontuberculous Mycobacteria (NTM) Infections
A pivotal Phase 3 study with RHB-204 for the treatment of pulmonary nontuberculous mycobacteria infections is expected to be initiated in the second half of 2019, subject to completion of the ongoing supportive non-clinical program and additional input from the FDA. The study is intended to assess the efficacy and safety of RHB-204 and potentially support its approval as a first-line treatment for pulmonary NTM infections caused by Mycobacterium avium complex (MAC).

BEKINDA (RHB-102) – Gastroenteritis and Gastritis and Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Following the successful completion of a first Phase 3 study with BEKINDA for gastroenteritis and gastritis and guidance provided by the FDA, RedHill is currently working to design a confirmatory Phase 3 study to support a potential NDA for BEKINDA for acute gastroenteritis and gastritis.

RedHill held a positive end-of-Phase 2/pre-Phase 3 (Type B) meeting with the FDA discussing the clinical and regulatory pathway towards potential U.S. approval of BEKINDA for the treatment of IBS-D. RedHill is currently finalizing the design of two pivotal Phase 3 studies with BEKINDA for IBS-D.

YELIVA (opaganib, ABC294640) – Cholangiocarcinoma
The ongoing Phase 2a study evaluating the activity of orally-administered YELIVA in advanced cholangiocarcinoma (bile duct cancer) achieved its pre-specified efficacy goal for the first stage of the two-stage study design and advanced to its second stage. Enrollment of the full cohort of 39 evaluable patients is expected to be completed in the second half of 2019.

U.S. Commercial Highlights:

RedHill currently commercializes and promotes four GI-specialty products in select U.S. territories, Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)3, EnteraGam (serum-derived bovine immunoglobulin/protein isolate SBI)4, Mytesi (crofelemer 125 mg delayed-release tablets)5 and Esomeprazole Strontium DR Capsules 49.3 mg6.

RedHill expanded its leadership team with the appointment of Rick D. Scruggs as chief operating officer, U.S. operations. With more than 25 years of experience in the pharmaceutical industry, Rick has extensive experience in commercial operations and business development, having served as executive vice president of business development at Salix Pharmaceuticals, Inc., up to its acquisition by Valeant Pharmaceuticals International, Inc. (now Bausch Health Companies Inc.).

Full-Year 2018 Results7

Net Revenues of $8.4 million for 2018, compared to $4.0 million for 2017 8.

Cost of Revenues of $2.8 million for 2018, compared to $2.1 million for 2017.

Gross Profit of $5.5 million for 2018, compared to $1.9 million for 2017; with gross margin increased from 47% to 66%.

Research and Development Expenses of $24.9 million for 2018, compared to $33.0 million for 2017. The decrease was mainly due to the finalization of the Phase 3 study with RHB-104 and completion of the clinical studies with BEKINDA.

Selling, Marketing and Business Development Expenses were $12.5 million for 2018, compared to $12.0 million for 2017.

General and Administrative Expenses were approximately $7.5 million for 2018, compared to $8.0 million for 2017.

Operating Loss of $39.3 million for 2018, compared to $52.0 million for 2017.

Net Cash Used in Operating Activities was $34.5 million for 2018, compared to $44.8 million for 2017.

Net Cash Provided by Financing Activities was $41.8 million for 2018, compared to $25.7 million for 2017. The increase was mainly due to higher gross proceeds raised in underwritten public offerings.

Cash Balance9 as of December 31, 2018, was $53.2 million, compared to $46.2 million as of December 31, 2017.
Conference Call and Webcast Information:

The Company will host a conference call today, February 26, 2019, at 8:30 a.m. EST to review the financial results and operational highlights.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-866-966-1396; International: +1-631-510-7495; and Israel: +972-3-721-7998. The access code for the call is: 3459887.

The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, View Source Please access the Company’s website at least 15 minutes ahead of the conference call to register.

Availability of RedHill’s Annual Report on Form 20-F Through its Website

RedHill’s Annual Report on Form 20-F, containing audited financial statements for the year ended December 31, 2018, as filed with the Securities and Exchange Commission on February 26, 2019, is available on its website (View Source). Shareholders may receive a hard copy of the annual report free of charge upon request.