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.

On February 26, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported financial results for the fourth quarter and year ended December 31, 2018 (Press release, Dynavax Technologies, FEB 26, 2019, View Source [SID1234533718]).

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"I am proud of our 2018 achievements, particularly the launch of HEPLISAV-B, which enabled us to generate revenue of $3.9 million in the fourth quarter," said Eddie Gray, chief executive officer of Dynavax. "HEPLISAV-B is the only two-dose hepatitis B vaccine, and it consistently protects more than 90% of adult patients. We are confident that it is poised to become the standard of care hepatitis B adult vaccine, and remain firm in our expectation that HEPLISAV-B operations will become profitable by the end of 2019."

Mr. Gray continued. "In immuno-oncology, we are focused on paths to approval where we believe our TLR9 technology has a competitive advantage. SD-101, in combination with pembrolizumab has consistently demonstrated response rates in melanoma and head and neck cancer that are higher than those reported for pembrolizumab alone. We are actively evaluating a number of opportunities, including partnerships, to advance SD-101 into registrational studies, and are committed to being thoughtful and diligent in determining the best path forward to drive value for our shareholders and provide better options for patients."

2018 and Recent Business Highlights

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

Fourth quarter 2018 sales of $3.9 million compared to $1.5 million in the third quarter 2018

More than 1,200 individual customers purchased HEPLISAV-B in 2018

More than 80% of doses sold to date were purchased by repeat customers

592 of the largest targeted customers, which represent more than 36% of the targeted doses, have received P&T committee approval; 354 have progressed to purchase

Purchase contracts have been executed with 3 of the top 10 retail pharmacies

Initial purchases by state and county health departments through the CDC Vaccines for Adults program began in the first quarter of 2019

Immuno-oncology

SD-101

SD-101 adds meaningful clinical benefit to KEYTRUDA (pembrolizumab) therapy.

In November, the company presented encouraging and consistent results from the Phase 1b/2 trial of SD-101 in combination with KEYTRUDA at the ESMO (Free ESMO Whitepaper) 2018 Congress:

In patients with advanced melanoma who are naïve to anti-PD-1 therapy

70% overall response rate (ORR) in the 2-milligram dose cohort

Tumor shrinkage occurred in both injected target lesions and non-injected target lesions; non-injected lesions demonstrated an ORR of 68%, including visceral metastases in the lung and liver

The ORR is identical to that reported at ASCO (Free ASCO Whitepaper) 2018, despite increasing the patient population by more than 50%, from 30 to 47 patients

85% 6-month progression-free survival (PFS) rate

Observed responses in injected lesions and non-injected distant lesions

Responses were independent of baseline PD-L1 expression

In patients with melanoma refractory or resistant to anti-PD-1 therapy

20.7% ORR in 29 patients in the 8-milligram dose cohort

In patients with head and neck squamous cell carcinoma who were naïve to anti-PD-1 therapy

27.3% ORR in 22 patients in the 8-milligram dose cohort

Dynavax has fully enrolled the 2-milligram cohort in patients with melanoma refractory or resistant to anti-PD-1 therapy and in patients with head and neck squamous cell carcinoma who were naïve to anti-PD-1 therapy. Data from these cohorts are expected later this year.

SD-101 and KEYTRUDA are being evaluated in a new randomized, controlled, investigational treatment arm for the ongoing I-SPY 2 TRIAL for neoadjuvant treatment of locally advanced breast cancer.

Adverse events related to SD-101 treatment have been transient, mild to moderate flu-like symptoms.

DV281

DV281 is a TLR9 agonist designed for delivery to lung cancer patients by inhalation.

Dynavax is conducting a Phase 1b/2 clinical trial in subjects with advanced non-small cell lung cancer to investigate the safety and tolerability of DV281 as monotherapy and in combination with OPDIVO (nivolumab) and to identify a recommended dose for the expansion part of the study.

Studies in preclinical animal models of metastatic cancer show that direct delivery of DV281 to tumor-bearing lungs results in induction of interferons and cytokines and infiltration of T cells, responses similar to those observed after intratumoral injection of SD-101.

Dynavax will present a poster (Abstract 8304) from the safety portion of the inhaled DV281 study at the AACR (Free AACR Whitepaper) Annual Meeting. The poster titled "Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non small cell lung cancer (NSCLC)" will be presented Tuesday, April 2, 2019, from 1 to 5 p.m. ET.

Preclinical Research

Dynavax has multiple immuno-oncology preclinical research programs including a cancer vaccine program and a multi-pronged program to develop TLR7 and TLR8 agonists, both as anti-cancer agents and as vaccine adjuvants. The company is also evaluating additional candidates to leverage the hepatitis B 1018 adjuvant in additional vaccines.

Financial Results

Product Revenue, Net. Dynavax’s first commercial product, HEPLISAV-B, was launched in the first quarter of 2018. Net product revenue for the fourth quarter of 2018 was $3.9 million, compared to $1.5 million in the third quarter of 2018. Net product revenue for the full year 2018 was $6.8 million. Product revenue from sales is recorded at the net sales price, which includes estimates of product returns, chargebacks, discounts and other fees.

Cost of Sales, Product. Cost of sales, product, for the fourth quarter of 2018 was $1.6 million and $10.9 million for the year ended December 31, 2018. Included in cost of sales, product, are inventory reserves and fill, finish and overhead costs for HEPLISAV-B incurred after FDA approval. Also included are costs associated with resuming operations at the manufacturing facility in Düsseldorf after receiving regulatory approval for the pre-filled syringe presentation, which costs previously were included in research and development expense.

R&D Expenses. Research and development expenses for the fourth quarter of 2018 totaled $22.9 million compared to $17.4 for the fourth quarter 2017. Full year 2018 research and development expenses totaled $75.0 million compared to $65.0 million in 2017. The increase

reflects increased compensation and related personnel costs and clinical trial and research expenses related to the ongoing development of SD-101, DV281 and earlier stage oncology programs. Upon approval of pre-filled syringes in the first quarter 2018, costs associated with resuming activities at the manufacturing facility in Düsseldorf were charged to cost of sales, product while costs incurred to manufacture HEPLISAV-B for commercial sale were accounted for as inventory.

SG&A. Selling, general and administrative expenses for the fourth quarter of 2018 totaled $16.4 million compared to $9.3 million for the fourth quarter of 2017. Full year 2018 selling, general and administrative expenses totaled $64.8 million compared to $27.4 million in 2017. The increase in full year 2018 is primarily due to an overall increase in HEPLISAV-B sales, marketing and commercial activities, including full-deployment of a contract sales force, post-marketing studies and consultants for commercial development services.

Net Loss. Net loss for the fourth quarter of 2018 was $40.0 million, or $0.64 per basic and diluted share, compared to a net loss of $27.4 million, or $0.45 per basic and diluted share, for the fourth quarter of 2017. Full year 2018 net loss was $158.9 million, or $2.55 per basic and diluted share, compared to a net loss of $95.2 million, or $1.81 per basic and diluted share for the full year 2017.

Cash Position. Cash, cash equivalents and marketable securities totaled $145.5 million at December 31, 2018, compared to $191.9 million at December 31, 2017. Dynavax plans to borrow $75.0 million under its non-dilutive term loan agreement in the first quarter of 2019 to support commercial efforts and advance its immuno-oncology platform.

Conference Call and Webcast Information

Dynavax will hold a conference call today at 4:30pm ET/1:30pm PT. To access the call, participants must dial (877) 423-9813 in the U.S. or (201) 689-8573 internationally, and use the conference ID 13687416. The live call will be webcast and can be accessed in the "Investors and Media" section of the company’s website at www.dynavax.com. A replay of the webcast will be available for 30 days following the live event.

About Hepatitis B

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally.ii There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.iii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination

for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.iv Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.v

About HEPLISAV-B

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

For more information about HEPLISAV-B, visit View Source

About SD-101

SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 1b/2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

On February 26, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that its Board of Directors is conducting a review of strategic options focusing on maximizing shareholder value (Press release, Sellas Life Sciences, FEB 26, 2019, View Source [SID1234533716]). The Company has engaged Cantor Fitzgerald & Co. to act as its strategic and financial advisor for this process.

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"We are committed to identifying a strategic plan which will enhance shareholder value while allowing for the acceleration of our development programs, so that our novel immunotherapeutics, GPS and NPS, may benefit cancer patients," commented Angelos M. Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS.

The Company plans to explore a wide range of strategic alternatives that include, among others, a sale of the Company, business combination, merger or reverse merger with another company, strategic investment/financing, or a funded collaboration or partnership which would allow the Company to continue with its current business plan of advancing the clinical development of its lead product candidates, GPS and NPS.

SELLAS recently initiated a Phase 1/2 prospective multi-arm (‘basket’ type), open-label, multi-institutional, U.S.-only clinical study of GPS in combination with Merck & Co., Inc.’s anti-PD-1 therapy, pembrolizumab (Keytruda). The ongoing study is investigating GPS’s effects on the rate of morphological partial to complete response conversion in patients with AML on hypomethylating agents and on the overall response rate in adult patients with ovarian cancer, TNBC, small cell lung cancer, and colorectal cancer with measurable metastatic disease. The study is being led by Drs. Richard Maziarz of Oregon Health and Science University and Roisin O’Cearbhaill of Memorial Sloan Kettering Cancer Center.

The Company also has planned a Phase 3 prospective open-label, randomized, controlled, global, registration-enabling clinical study of GPS monotherapy versus predefined investigator’s choice best available maintenance therapy in adult patients with AML who have achieved their morphological second complete response (with or without complete platelet count recovery; CR2/CR2p) following successful second-line antileukemic therapy. This study is being led by Drs. Hagop Kantarjian of MD Anderson Cancer Center and Gert Ossenkoppele of Amsterdam University Medical Center (VUMC) and the HOVON network.

The Company’s second clinical candidate, NPS, is being developed for TNBC. The Company is currently engaged in discussions with the FDA regarding trial design for a Phase 3 registrational study in TNBC.

The Company has not set a timeline for this process and there can be no assurance that a transaction will be entered into or consummated or, if a transaction is undertaken, as to its terms, structure or timing. The Company does not expect to discuss or disclose further developments regarding the strategic process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate or required by law.

Keytruda is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

On February 26, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its Board of Directors has authorized a quarterly cash dividend of $0.19 per common share, payable on April 16, 2019, to shareholders of record as of March 15, 2019 (Press release, Thermo Fisher Scientific, FEB 26, 2019, View Source [SID1234533714]). This reflects a 12% increase over the previous dividend payment of $0.17.

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On February 26, 2019 Immunomic Therapeutics, Inc. reported that its’ Senior Vice President and Co-Founder, Teri Heiland, Ph.D., will participate in the closing plenary on Innovation and Technology in Healthcare at the Congressional Hispanic Caucus Initiative (CHCI) Health Summit on March 14, 2019 at 2:00 pm EST at the Newseum, Knight Conference Center in Washington, DC (Press release, Immunomic Therapeutics, FEB 26, 2019, View Source [SID1234533713]).

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As a sponsor of the CHCI Health Summit, Immunomic Therapeutics is pleased to support the initiatives of the event which include attracting and retaining greater diversity in clinical trials, ensuring equitable health outcomes for the Latino community and considering how the latest technological innovations will support Latino’s health needs. Dr. Heiland will discuss innovation during the closing plenary session and what companies like Immunomic can do to accelerate the development and approval of novel therapies, such as Immunomic’s investigational vaccines, for illnesses that greatly affect Latinos including cancer, allergy and infectious diseases.

For more information, please visit the CHCI summit website at View Source

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.