On February 26, 2019 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported record financial results for the fourth quarter and full year 2018 and associated Company developments (Press release, Supernus, FEB 26, 2019, View Source [SID1234533734]).

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Commercial Update

Fourth quarter 2018 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IQVIA, totaled 209,901, a 16.7% increase over the fourth quarter of 2017. Full year 2018 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IQVIA, totaled 786,411, a 29.1% increase over full year 2017.

"We reported another year of strong operating results in 2018, driven by continued double-digit prescription growth for both Trokendi XR and Oxtellar XR," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "In addition, we recently reached a key milestone by launching Oxtellar XR, in January 2019, with an expanded indication to include monotherapy for partial seizures, which could be a meaningful long term growth opportunity."

Progress of Product Pipeline

SPN-812 — Novel non-stimulant for the treatment of ADHD

· During December 2018, the Company announced positive topline results from the two pediatric Phase III trials (P301 and P303) and from the first adolescent Phase III trial (P302). All three trials met the primary endpoint with robust statistical significance. Topline data from the second and final adolescent Phase III trial (P304) are expected by the end of the first quarter of 2019.

· The Company continues to expect to submit a New Drug Application (NDA) for SPN-812 in the second half of 2019, and to launch it, pending U.S. Food and Drug Administration (FDA) approval, in the second half of 2020.

·A Phase III program in adult patients is anticipated to start in the second half of 2019.

SPN-810 — Novel treatment of Impulsive Aggression in patients with ADHD

· Enrollment in the Phase III trials (P301 and P302) continues with data from both trials expected in the second half of 2019.

· The Company continues to expect to submit an NDA for SPN-810 in the second half of 2020, and to launch it, pending FDA approval, in the second half of 2021.

· Enrollment in the Open Label Extension (OLE) study continues at 90% or higher. On average, a patient in the OLE study remains on SPN-810 treatment for approximately 10 months, which we believe is an encouraging sign of the tolerability and efficacy of SPN-810.

· Patient dosing continues in the Phase III trial (P503) in adolescent patients.

SPN-604 — Novel treatment of bipolar disorder

· The Company expects to start pivotal Phase III studies for the treatment of bipolar disorder in the second half of 2019.

"We made significant progress in 2018 advancing our late-stage programs through clinical development, including announcing positive topline results from three Phase III trials for SPN-812 for treatment of ADHD," said Jack Khattar. "We are focused in 2019 on submitting the NDA for SPN-812 and completing the Phase III trials for SPN-810, moving us closer to our goal of

delivering, in the next several years, two novel products, both addressing billion-dollar market opportunities. In addition, we look forward to starting another Phase III program this year, with SPN-604 for the treatment of bipolar disorder."

Operating Expenses

Fourth Quarter

Research and development expenses in the fourth quarter of 2018 were $29.8 million, as compared to $16.2 million in the same quarter last year. This increase was primarily due to the one-time upfront expense of approximately $14 million in the fourth quarter of 2018 for the acquisition of Biscayne Neurotherapeutics, Inc. (Biscayne).

Selling, general and administrative expenses in the fourth quarter of 2018 were $42.1 million, as compared to $33.8 million in the same quarter last year. This increase was primarily due to the development and production of promotional materials and marketing programs associated with the launch of the monotherapy indication for Oxtellar XR, and an increase in share-based compensation expense.

Full Year

Research and development expenses for the full year 2018 were $89.2 million, as compared to $49.6 million for 2017. This increase was primarily due to the initiation of the four Phase III clinical trials for SPN-812 in the second half of 2017, the OLE trials for SPN-812 and SPN-810, and the one-time upfront expense of approximately $14 million for the acquisition of Biscayne.

Selling, general and administrative expenses for full year 2018 were $159.9 million, as compared to $137.9 million in 2017. This increase was primarily due to the expansion of the salesforce by 40 salespeople, who were fully deployed in the fourth quarter of 2017, increased marketing spend to support Trokendi XR, as well as the factors impacting the fourth quarter as described above.

Operating Earnings and Earnings Per Share

Operating earnings in the fourth quarter of 2018 were $39.9 million, a 16% increase over $34.3 million in the same period the prior year. Operating earnings in full year 2018 were $144.4 million, a 45.1% increase over $99.5 million in 2017. The improvement in operating earnings in both periods was primarily due to increased net product sales, offset by the aforementioned one-time upfront expense of approximately $14 million for the acquisition of Biscayne.

Net earnings (GAAP) in the fourth quarter of 2018 were $25.9 million, or $0.48 per diluted share, an increase of 85% on diluted share amount, as compared to $13.7 million, or $0.26 per diluted share, in the same period last year. Net earnings (GAAP) were $111.0 million in 2018, or $2.05 per diluted share, an increase of 90% on diluted share amount, as compared to $57.3 million, or $1.08 per diluted share, in 2017. In addition to higher operating income for the fourth quarter and full year 2018, net earnings (GAAP) benefited from the reduction in the statutory U.S. Federal income tax rate and, to a lesser extent, from stock option exercises. The reduction in income tax rate had an unfavorable impact of $9.7 million in both the fourth quarter and full year 2017.

Weighted-average diluted common shares outstanding were approximately 54.1 million in the fourth quarter and full year 2018, as compared to approximately 53.5 million and 53.3 million in each of the respective prior year periods.

Balance Sheet Highlights

As of December 31, 2018, the Company had $774.8 million in cash, cash equivalents, marketable securities, and long term marketable securities, compared to $273.7 million at December 31, 2017. This increase reflects net proceeds of $364.9 million from the issuance of convertible senior notes and warrants in March 2018, partially offset by purchases of convertible note hedges, the aforementioned one-time upfront payment of $15 million for the acquisition of Biscayne, and increased cash from operations in 2018.

Financial Guidance

For full year 2019, the Company estimates net product sales, research and development expenses, operating earnings, and an effective tax rate as set forth below. This guidance assumes that the short-term higher levels of wholesaler and pharmacy channel inventory experienced in the fourth quarter of 2018 will revert to historical levels in 2019.

· Net product sales in the range of $435 million to $455 million. Guidance reflects the Company’s expectation that wholesaler and pharmacy channel inventory levels will revert to historical 2018 levels, thereby affecting 2019 net product sales by approximately $10 million.

· Research and development expenses in the range of $70 million to $80 million.

· Operating earnings in the range of $160 million to $180 million.

· Effective tax rate of approximately 23% to 25%.

Investor Day

The Company is pleased to announce that it will hold an Investor Day in New York City on April 16, 2019. The management team plans to provide an overview of the Company including a detailed discussion on its clinical programs and an assessment of the associated market opportunities.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, February 27, 2019. An accompanying webcast also will be provided.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in:

(877) 288-1043

International dial-in:

(970) 315-0267

Conference ID:

2170478

Conference Call Name:

Supernus Pharmaceuticals Fourth Quarter and Full Year 2018 Earnings Conference Call

Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".

On February 26, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or the Company), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported its participation in various upcoming industry conferences (Press release, Immutep, FEB 26, 2019, View Source [SID1234533730]).

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The Company will be presenting updated clinical data from the Phase I TACTI-mel trial in metastatic melanoma for its lead product candidate eftilagimod alpha ("efti" or "IMP321") and new data relating to its pre-clinical product candidate, IMP761, a novel anti-LAG-3 agonist antibody for the treatment of auto-immune diseases, at industry conferences in March 2019.

Conference:

World Immunotherapy Congress USA 2019

Dates:

3-5 March 2019

Venue:

Grand Hyatt, San Diego, USA

Presentation Title:

Two ACTive Immunotherapies (TACTI): Results of a Phase I trial with metastatic melanoma patients

Presenter:

Dr. Frédéric Triebel, CSO and CMO of Immutep

Conference:

14th Congress of ECCO (European Crohn’s and Colitis Organisation)

Dates:

6-9 March 2019

Venue:

Bella Center, Copenhagen, Denmark

Presentation Title:

IMP761, a novel anti-LAG-3 agonist antibody for the treatment of auto-immune diseases

Presenter:

Mathieu Angin, Phd, Immutep Research Scientist

On February 26, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported financial results for the year ended December 31, 2018 (Press release, MacroGenics, FEB 26, 2019, View Source [SID1234533729]).

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"If the positive progression-free survival (PFS) data from our Phase 3 SOPHIA trial supports approval of margetuximab, this would provide a new treatment option for patients with HER2+ metastatic breast cancer," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We have designed an antibody that, through optimization of the molecule’s Fc domain, performed better than HERCEPTIN in the SOPHIA study. This molecule was created using the same Fc Optimization technology that is used in the most advanced asset in our B7-H3 franchise, enoblituzumab. During the fourth quarter, we reported encouraging initial results in our trial of enoblituzumab plus anti-PD-1 in patients with either squamous cell carcinoma of the head and neck (SCCHN) or non-small cell lung carcinoma (NSCLC) and we intend to further pursue this signal starting later this year. Beyond these two molecules, we continue to advance our pipeline of promising immuno-oncology product candidates."

Key Pipeline Updates

Margetuximab. Recent highlights related to the Company’s investigational, Fc-optimized monoclonal antibody (mAb) that targets the human epidermal growth factor receptor 2, or HER2, include:
•Positive Phase 3 Metastatic Breast Cancer Study: In February 2019, MacroGenics announced positive results from SOPHIA, the Phase 3 clinical trial of margetuximab in HER2-positive metastatic breast cancer patients. The SOPHIA clinical trial met the trial’s first primary endpoint of prolongation of PFS in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. Results of the SOPHIA study have been submitted for presentation later this year at a major scientific conference. Follow-up for determination of the impact of therapy on the sequential second primary endpoint of overall survival (OS) is ongoing, as pre-specified in the study protocol. MacroGenics anticipates submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for margetuximab on the basis of the PFS results in the second half of 2019.
•Updated Phase 2 Gastric Cancer Study Data: The Company is also evaluating margetuximab in a Phase 2 clinical trial in patients with HER2-positive gastric or gastroesophageal junction cancer in combination with an anti-PD-1 mAb. In January 2019, data demonstrating encouraging anti-tumor activity and acceptable safety and tolerability were presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. During the first quarter of 2019, MacroGenics discussed with the FDA its development plans for a proposed Phase 2/3 registration-directed study of margetuximab in combination with checkpoint inhibitor molecules, including MGA012 and MGD013. The Company expects to initiate the study in the second half of 2019.
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. Recent program highlights include:

•Enoblituzumab Oral Presentation at 2018 SITC (Free SITC Whitepaper): MacroGenics’ most advanced product candidate in its B7-H3 franchise, enoblituzumab, is a mAb that targets B7-H3 and has been enhanced using the same Fc domain modifications used in margetuximab. The Company believes that this technology could promote activation of both innate and adaptive immunity in the treatment of cancer. In November 2018, encouraging data from a clinical study of the combination of enoblituzumab and an anti-PD-1 mAb were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. In the study, cohorts of patients who were naïve to anti-PD-1 therapy with either SCCHN or NSCLC had objective responses at rates that benchmarked favorably with data reported in prior studies in which patients were treated with anti-PD-1 monotherapy. The combination of enoblituzumab and an anti-PD-1 mAb demonstrated acceptable safety and tolerability in patients treated to date. Encouraged by these results, MacroGenics intends to commence a Phase 2 study of enoblituzumab in combination with MGA012 in patients with SCCHN beginning in the second half of 2019.
•MGD009 Studies Ongoing: MGD009 is a bispecific DART molecule that is designed to target both B7-H3 expressed on tumor cells as well as CD3, which is expressed on normal T cells. MacroGenics is conducting a Phase 1 clinical trial with MGD009 as monotherapy and in a separate study that combines MGD009 and MGA012.

•MGC018 Dose Escalation Initiated: The Company’s third B7-H3-directed molecule is MGC018, an antibody-drug conjugate (ADC) that is designed to target solid tumors expressing B7-H3. MacroGenics initiated a Phase 1 dose escalation study of MGC018 in the fourth quarter of 2018.
PD-1 Franchise. MacroGenics is advancing multiple PD-1-directed programs to provide further differentiation from existing PD-1-based treatment options and enable a broad set of combination opportunities across the Company’s portfolio. Recent program highlights include:
•MGA012 in Registration-directed Studies: MGA012, also known as INCMGA0012, is an anti-PD-1 mAb licensed to Incyte Corporation in 2017, but for which MacroGenics retains the rights to develop in combination with its pipeline of product candidates. At the November 2018 SITC (Free SITC Whitepaper) meeting, Incyte presented encouraging initial anti-tumor and safety and tolerability data in the following tumor cohorts: NSCLC, cervical cancer, endometrial cancer and soft tissue sarcoma. Incyte is pursuing development of MGA012 through three monotherapy registration-directed studies with initial data anticipated in 2020, in the case of MSI-high endometrial cancer and Merkel cell carcinoma, and in 2021, in the case of anal cancer. In addition, MacroGenics and Incyte are each studying MGA012 in combination with other agents.
•MGD013 Dose Expansion Ongoing: MGD013 is a first-in-class bispecific DART molecule that is designed to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies. MacroGenics’ Phase 1 dose expansion study in up to nine tumor types is ongoing and the Company expects to present data from this study in 2019.
•MGD019 Dose Escalation Initiated: MGD019 is a bispecific DART molecule designed to provide co-blockade of both PD-1 and CTLA-4, two immune checkpoint inhibitors, on T cells. The Company is currently evaluating MGD019 in a Phase 1 dose escalation study.
Flotetuzumab. Recent highlights of the Company’s bispecific, humanized DART molecule that recognizes both CD123 and CD3, include:
•Oral Presentations at ASH (Free ASH Whitepaper): In December 2018, MacroGenics presented both updated clinical data as well as gene signature data from its completed acute myeloid leukemia (AML) dose expansion cohort in two oral presentations at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In the study, flotetuzumab demonstrated anti-leukemic activity and acceptable tolerability in patients with relapsed/refractory AML, with a higher response rate observed in primary refractory patients, an extremely challenging population to treat. MacroGenics plans to enroll additional patients in this ongoing study and announce data in 2019. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Korea and India for flotetuzumab, also known as S80880.
Recent Corporate Developments

Exhibit 99.1
•Collaboration with Zai Lab: In November 2018, MacroGenics entered into an exclusive collaboration and license agreement with Zai Lab Limited (Zai Lab) pursuant to which it licensed to Zai Lab the right to develop and commercialize margetuximab, MGD013 and an undisclosed preclinical TRIDENT binding molecule in mainland China, Hong Kong, Macau and Taiwan. Zai Lab will lead clinical development in its territory by leveraging its regulatory and clinical development expertise and broad regional network of investigators. Under its agreement with Zai Lab, MacroGenics received an upfront cash payment of $25 million, less foreign withholding, in January 2019 and is eligible to receive up to $140 million in potential development and regulatory-based milestone payments. In addition, Zai Lab has agreed to pay the Company double-digit royalties on annual net sales of the assets, which may be subject to adjustment in specified circumstances.
•Completed Follow-on Offering of Common Stock: In February 2019, MacroGenics completed a public offering of 6,325,000 shares of its common stock, raising net proceeds to the Company of $118.5 million, net of underwriting discounts and commissions and estimated offering expenses. This included $15.5 million of additional net proceeds following the full exercise of the over-allotment option by the underwriters.

2018 Financial Results

•Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2018 were $232.9 million, compared to $305.1 million as of December 31, 2017. Cash, cash equivalents and marketable securities as of December 31, 2018 did not include the $25 million, less foreign withholding, upfront payment from Zai Lab or the $118.5 million net proceeds from the follow-on offering recently completed.
•Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $60.1 million for the year ended December 31, 2018, compared to $157.7 million for the year ended December 31, 2017. This decrease was primarily due to the $150.0 million upfront payment recognized under the Incyte agreement in 2017, compared to $41.0 million recognized in 2018 under the Incyte agreements. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.
•R&D Expenses: Research and development expenses were $190.8 million for the year ended December 31, 2018, compared to $147.2 million for the year ended December 31, 2017. This increase was primarily due to continued enrollment in multiple ongoing clinical trials, including the SOPHIA Phase 3 study of margetuximab, increased development/manufacturing costs related to MGA012 and increased headcount to support expanded manufacturing and development activities.
•G&A Expenses: General and administrative expenses were $40.5 million for the year ended December 31, 2018, compared to $32.7 million for the year ended December 31, 2017. This increase was primarily due to increased labor-related costs including stock-based compensation expense, patent-related expenses and information technology-related expenses.
•Net Loss: Net loss was $171.5 million for the year ended December 31, 2018, compared to net loss of $19.6 million for the year ended December 31, 2017.
•Shares Outstanding: Shares outstanding as of December 31, 2018 were 42,353,301.
•Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of December 31, 2018, combined with the estimated net proceeds from its recently completed equity offering as well as proceeds from collaboration payments the Company anticipates receiving, will enable it to fund its operations into 2021, assuming all of the Company’s programs and collaborations advance as currently contemplated.

Conference Call Information

Exhibit 99.1
MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the year ended December 31, 2018 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 4399964.

The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

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.