On February 26, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases, reported the commencement of a Phase I first-in-human trial of TG-1801, the Company’s novel first-in-class anti-CD47/CD19 bispecific antibody, in patients with relapsed or refractory B-cell lymphoma (Press release, TG Therapeutics, FEB 26, 2019, View Source [SID1234533673]).

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TG-1801 is the first therapy to target both CD19, a B-cell specific marker widely expressed across B-cell malignancies, and CD47, the "don’t eat me" signal used by both healthy and tumor cells to evade macrophage mediated phagocytosis. CD47 is expressed ubiquitously on normal cells, including red blood cells and platelets. By co-targeting both CD47 and CD19, TG-1801 has the potential to overcome the limitations of existing CD47 targeted therapies by avoiding the side effects caused by indiscriminate blockade of CD47 on healthy cells.

This Phase I open label, multi-center trial is designed to assess the safety, pharmacokinetics, efficacy and recommended Phase 2 dose of TG-1801. The primary objective of the study is to determine the Maximum Tolerated Dose (MTD) and characterize the safety profile of TG-1801, with secondary endpoints including characterization of pharmacokinetics and preliminary anti-cancer activity.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are extremely pleased to announce the commencement of clinical development for TG-1801, our proprietary first-in-class anti-CD47/CD19 bispecific antibody which we licensed from Novimmune last year." Mr. Weiss continued, "CD47 targeted therapy has yielded promising early clinical results, and we look forward to exploring the potential of this dual targeted immunotherapy with a long-term goal of combining TG-1801 with our other in-house immunotherapies and targeted agents to create novel treatment options for patients with B-cell cancers."

On February 26, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported financial results and provided a business update for the fourth quarter and full year ended December 31, 2018 (Press release, Blueprint Medicines, FEB 26, 2019, View Source [SID1234533689]).

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Print

"Following a year of remarkable clinical progress across our portfolio in 2018, we are focused on executing our ‘2020 Blueprint’ vision to transform Blueprint Medicines into a fully-integrated global precision therapy company," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "The cornerstone of this effort is our planned NDA submission for avapritinib for patients with PDGFRA Exon 18 mutant GIST and fourth-line GIST in the second quarter. As we work to bring this new therapy to GIST patients who currently have no approved treatment options, we are also partnering with treating physicians, the patient community and testing companies to evolve the GIST treatment paradigm toward precision medicine, with the shared goals of maximizing patient outcomes, enabling efficient clinical trials and delivering value to the healthcare system."

Fourth Quarter 2018 Highlights and Recent Progress:

Avapritinib: Gastrointestinal stromal tumors (GIST):

Locked the registration database and reported top-line results from the Phase 1 NAVIGATOR trial of avapritinib in patients with PDGFRA Exon 18 mutant GIST and fourth-line GIST in preparation for the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second quarter of 2019. Read the top-line data here.
Presented updated data from the Phase 1 NAVIGATOR trial across treatment lines at the Connective Tissue Oncology Society 2018 Annual Meeting in November 2018 and disclosed plans to conduct the registration-enabling Phase 3 COMPASS-2L precision medicine trial of avapritinib in second-line GIST. Read the full data here.
Under Blueprint Medicines’ collaboration with CStone Pharmaceuticals, announced the China National Medical Products Administration (NMPA) cleared an Investigational New Drug (IND) application for the ongoing Phase 3 VOYAGER trial of avapritinib in third-line GIST.
Avapritinib: Systemic mastocytosis (SM):

Presented updated data from the Phase 1 EXPLORER trial at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2018. Read the full data here.
Initiated patient dosing in two registration-enabling trials: the Phase 2 PATHFINDER trial in advanced SM and the Phase 2 PIONEER trial in indolent and smoldering SM.
BLU-667: RET-altered solid tumors:

Today announced the FDA has granted Breakthrough Therapy Designation to BLU-667 for the treatment of RET-mutation-positive medullary thyroid cancer (MTC) that requires systemic treatment and for which there are no acceptable alternative treatments.
BLU-554: Hepatocellular carcinoma (HCC):

Under Blueprint Medicines’ collaboration with CStone Pharmaceuticals, announced the China NMPA cleared an IND application for the ongoing Phase 1 trial of BLU-554 as a monotherapy in advanced HCC.
BLU-782: Fibrodysplasia ossificans progressiva (FOP):

Initiated participant dosing in a Phase 1 trial of BLU-782 in healthy volunteers in the first quarter of 2019.
Today announced the FDA has granted Fast Track Designation to BLU-782 for the treatment of FOP.
Corporate:

Announced "2020 Blueprint," a two-year global business strategy under which Blueprint Medicines expects to have two marketed products, four pending marketing applications in the United States or Europe, six clinical-stage therapeutic candidates and eight research programs by the end of 2020.
Announced the promotion of Michael Landsittel to Chief Financial Officer and the promotion of Kate Haviland to Chief Operating Officer in February 2019.
Key Upcoming Milestones:

The company expects to achieve the following milestones by the end of the second quarter of 2019.

Submit an NDA for avapritinib for PDGFRA Exon 18 mutant GIST and fourth-line GIST.
Present the registration dataset for avapritinib in PDGFRA Exon 18 mutant GIST and fourth-line GIST.
Present updated data from the Phase 1 EXPLORER trial of avapritinib in advanced SM.
Present updated data from the Phase 1 ARROW trial of BLU-667 in RET-altered cancers.
Complete enrollment of previously treated NSCLC and MTC patient cohorts in the Phase 1 ARROW trial of BLU-667.
Fourth Quarter and Year End 2018 Financial Results:

Cash Position: As of December 31, 2018, cash, cash equivalents and investments were $494.0 million, as compared to $673.4 million as of December 31, 2017. This decrease was primarily related to cash used in operating activities, partially offset by the $40.0 million upfront payment received in connection with entering into the collaboration with CStone Pharmaceuticals and the $10.0 million milestone payment achieved under the Roche collaboration in June 2018.
Collaboration Revenues: Collaboration revenues were $1.0 million for the fourth quarter of 2018 and $44.5 million for the year ended December 31, 2018, as compared to $1.6 million for the fourth quarter of 2017 and $21.4 million for the year ended December 31, 2017. This increase for the year was primarily due to revenue recognized under the collaboration agreement with CStone Pharmaceuticals, partially offset by the termination of the Alexion agreement in 2017.
R&D Expenses: Research and development expenses were $70.5 million for the fourth quarter of 2018 and $243.6 million for the year ended December 31, 2018, as compared to $43.6 million for the fourth quarter of 2017 and $144.7 million for the year ended December 31, 2017. This increase was primarily due to increased clinical and manufacturing expenses driven by Blueprint Medicines’ lead development candidates and increased personnel-related expenses. Research and development expenses included $4.9 million in stock-based compensation expenses for the fourth quarter of 2018 and $17.0 million in stock-based compensation expenses for the year ended December 31, 2018.
G&A Expenses: General and administrative expenses were $13.6 million for the fourth quarter of 2018 and $47.9 million for the year ended December 31, 2018, as compared to $8.1 million for the fourth quarter of 2018 and $28.0 million for the year ended December 31, 2017. This increase was primarily due to increased personnel-related expenses and increased professional fees, including pre-commercial planning activities. General and administrative expenses included $3.9 million in stock-based compensation expenses for the fourth quarter of 2018 and $13.5 million in stock-based compensation expenses for the year ended December 31, 2018.
Net Loss: Net loss was $80.3 million for the fourth quarter of 2018 and $236.6 million for the year ended December 31, 2018, or a net loss per share of $1.83 and $5.39, respectively, as compared to a net loss of $49.0 million for the fourth quarter of 2017 and $148.1 million for the year ended December 31, 2017, or a net loss per share of $1.23 and $3.92, respectively.
Financial Guidance:

Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaborations with Roche and CStone Pharmaceuticals, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2020.

Conference Call Information:

Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss fourth quarter and full year 2018 financial results and recent business activities. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international) and referring to conference ID 26735762. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On February 26, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that Ron Cohen, M.D., Acorda’s President and Chief Executive Officer, will present at the Cowen and Company Global Health Care Conference on Monday, March 11 at 1:30PM EST (Press release, Acorda Therapeutics, FEB 26, 2019, View Source [SID1234533707]). A live audio webcast of the presentation can be accessed under "Investor Events" in the Investor section of the Acorda website at www.acorda.com, or you may use the link:

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http://wsw.com/webcast/cowen52/acor/

On February 26, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported financial results for the fourth quarter and full year ended December 31, 2018, and recent operational highlights (Press release, Atara Biotherapeutics, FEB 26, 2019, View Source [SID1234533690]).

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"2018 was a year of pipeline expansion and strong operational execution for Atara as we advanced our T-cell immunotherapy programs across all three of our major value drivers: tab-cel, multiple sclerosis and next-generation CAR T," said Isaac Ciechanover M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Notably, we successfully executed on our strategy to build a leading next-generation and off-the-shelf, allogeneic CAR T portfolio. Our collaborations with academic leaders leverage technologies at the forefront of CAR T innovation for hematologic malignancies and solid tumors. We also opened a state-of-the-art T-cell operations and manufacturing facility and expanded our R&D, operational and commercial leadership. I am extremely gratified with where the Company is today and wish to acknowledge the many extraordinary contributions by Atara employees that enabled us to reach this point. I anticipate 2019 to be another pivotal year with multiple clinical and regulatory milestones, moving Atara closer to realizing our mission of transforming the lives of patients with serious medical conditions."

Atara continues to progress tab-cel (tabelecleucel) Phase 3 studies for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease (EBV+ PTLD) and anticipates initial tab-cel Phase 3 results to be available to the company in the first half of 2019.

Discussions with the European Medicines Agency (EMA) and U.S. Food & Drug Administration (FDA) regarding the development of tab-cel are ongoing and Atara’s intention is to align on a global regulatory strategy for patients with EBV+ PTLD. Outcomes of these discussions are expected in the first half of 2019.

Atara plans to submit a tab-cel EU conditional marketing authorization (CMA) application in the second half of 2019. To ensure the integrity of the ongoing, open-label tab-cel Phase 3 studies, the Company anticipates disclosing initial top-line EBV+ PTLD results in the second half of 2019 following submission of the EMA CMA application.

Atara expects initial safety results from the ongoing off-the-shelf, allogeneic ATA188 Phase 1 study in patients with progressive multiple sclerosis (MS) in the first half of 2019. Additional safety and efficacy results from this study are expected in the second half of 2019.

The Company is also rapidly advancing its next-generation chimeric antigen receptor T-cell (CAR T) pipeline across multiple therapeutic areas and expects results to be presented at upcoming scientific conferences.

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel (tabelecleucel)

Two Phase 3 clinical studies are ongoing (MATCH and ALLELE) to evaluate tab-cel for patients with EBV+ PTLD who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
Expanded MATCH and ALLELE study sites, with 30 sites available for enrollment in the United States and Australia, and with additional sites expected to open in the United States and other geographies.
ATA188 & ATA190 for Multiple Sclerosis (MS)

A Phase 1 clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive MS is ongoing across clinical sites in the United States and Australia.
Atara also plans to initiate a randomized autologous ATA190 study in progressive MS patients in the second half of 2019.
Next-Generation CAR T Development Pipeline

Licensed worldwide rights to a mesothelin-targeted chimeric antigen receptor T-cell (CAR T) immunotherapy for solid tumors from Memorial Sloan Kettering Cancer Center (MSK).
Development with MSK will focus on a next-generation, mesothelin-targeted CAR T using novel 1XX CAR signaling domain and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies for patients with mesothelin-associated solid tumors.
Expect clinical and preclinical results supporting Atara’s next-generation CAR T programs to be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 to be held March 29 to April 3 in Atlanta, Georgia.
First IND submission for Atara’s next-generation CAR T program expected in the fourth quarter of 2019 or first quarter of 2020.
Other Pipeline

Conducting IND-enabling manufacturing process development for ATA621, targeting both JC and BK viruses for patients with progressive multifocal leukoencephalopathy (PML).
Corporate

Atara’s Board of Directors is currently conducting a search for a new Chief Executive Officer following Dr. Ciechanover’s transition plan announced in January. Dr. Ciechanover will remain in his role as President and CEO until the earlier of the appointment of his successor or June 30, 2019.
Fourth Quarter and Full Year 2018 Financial Results

Cash, cash equivalents and short-term investments as of December 31, 2018 totaled $309.6 million, which we believe will be sufficient to fund planned operations to mid-2020. The balance excludes the impact of one-time license fees of $12.5 million paid in the first quarter of 2019 for worldwide rights to the next-generation allogeneic CAR T program targeting mesothelin.
The Company reported net losses of $80.0 million, or $1.75 per share, and $230.7 million, or $5.27 per share, for the fourth quarter and fiscal year 2018, respectively, as compared to $35.3 million, or $1.15 per share, and $119.5 million, or $4.00 per share, for the same periods in 2017.
Total operating expenses include total non-cash expenses of $11.0 million and $37.5 million for the fourth quarter and fiscal year 2018, respectively, as compared to $6.4 million and $24.1 for the same periods in 2017.
Research and development expenses were $62.3 million and $167.5 million for the fourth quarter and fiscal year 2018, respectively, as compared to $24.8 million and $81.2 million for the same periods in 2017. The increases in the fourth quarter and fiscal year 2018 were due to costs associated with the Company’s continuing expansion of research and development activities, including:
clinical study, manufacturing and outside service costs related to the two Phase 3 clinical studies of tab-cel in patients with EBV+ PTLD and the Phase 1 clinical study of allogeneic ATA188 in patients with progressive MS;
one-time license fees of $12.5 million incurred in the fourth quarter of 2018 for exclusive rights to a next-generation allogeneic CAR T program targeting mesothelin from MSK;
higher employee-related and overhead costs from increased headcount and operations, and
an increase in facilities and information technology expenses that are allocated to our research and development function.
Research and development expenses include $5.2 million and $16.2 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2018, respectively, as compared to $2.5 million and $8.8 million for the same periods in 2017.
General and administrative expenses were $19.6 million and $69.7 million for the fourth quarter and fiscal year 2018, respectively, as compared to $11.0 million and $40.3 million for the same periods in 2017. The increases in the fourth quarter and fiscal year 2018 were primarily due to increases in professional services costs and employee-related costs driven by increased headcount to support the Company’s expanding operations.
General and administrative expenses include $4.3 million and $17.6 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2018, respectively, as compared to $3.6 million and $14.3 million for the same periods in 2017.

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".