On October 31, 2019 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported that an abstract for a preclinical investigation from its natural killer cell chimeric antigen receptor (CAR) program has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Bellicum Pharmaceuticals, OCT 31, 2019, View Source [SID1234550118]). The meeting is being held November 6-10, 2019 in National Harbor, Md.

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Details of the poster presentation are as follows:

Title: Solid Tumor Cytotoxicity by Natural Killer Cells Expressing a HER2-Directed Chimeric Antigen Receptor Enhanced by MyD88/CD40 (MC)
Poster Board: #P151
Presenter: Henri Bayle, Ph.D.
Time/Location: Friday, November 8, 2019, 7 a.m. to 8 p.m. ET

On October 31, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported that it will deliver the following poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting to take place November 6-10, 2019 at the Gaylord National Hotel & Convention Center in Baltimore, Maryland (Press release, BioLineRx, OCT 31, 2019, View Source [SID1234550134]):

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A poster titled "Combination of BL-8040, anti PD-1 and chemotherapy significantly reduced pancreatic tumor growth and changed the balance between CD4+/FOXP3+ cells and CD8+ cells in the tumor" (Abstract ID: P471) will be presented on Friday, November 8, 2019.
A poster titled "A phase IIB study of Pembrolizumab plus BL-8040 in metastatic pancreatic cancer: Clinical outcomes and biological correlates" (Abstract ID: P328) will be presented on Saturday, November 9, 2019.
About BL-8040

BL-8040 is a short synthetic peptide that functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor over-expressed in many human cancers, where it has been shown to be correlated with poor prognosis, and plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance. CXCR4 is also directly involved in the homing and retention of hematopoietic stem cells (HSCs) and various hematological malignant cells in the bone marrow.

In a number of clinical and pre-clinical studies, BL-8040 has shown a critical role in immune cell trafficking, tumor infiltration by immune effector T cells and reduction in immunosuppressive cells within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" tumors (i.e., sensitizing them to immune check point inhibitors). BL-8040-mediated inhibition of the CXCR4-CXCL12 (SDF-1) axis has also shown robust mobilization of HSCs for transplantation in hematological malignancies.

BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On October 31, 2019 AMN Healthcare Services, Inc. (NYSE: AMN), the leader and innovator in healthcare workforce solutions and staffing services, reported its third quarter 2019 financial results (Press release, AMN Healthcare Services, OCT 31, 2019, View Source [SID1234550150]). Financial highlights are as follows:

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Dollars in millions, except per share amounts.

* See "Non-GAAP Measures" below for a discussion of our use of non-GAAP items and the table entitled "Supplemental Financial and Operating Data" for a reconciliation of non-GAAP items.

Highlights

Third quarter financial results above high end of Company guidance
Strong demand continues with Nurse and Allied orders at a three-year high, while a tight labor market limits near-term volume growth
Advanced Medical, our recently acquired allied and nursing staffing business, is performing well with double-digit year-over-year revenue growth
Generated $72 million of free cash flow in Q3, driven in part by a reduction in DSO
On October 1, closed on new 8-year, $300 million unsecured debt financing to recharge the Company’s capacity for acquisitions and stock repurchases
"A solid demand environment and sound execution by the AMN team enabled us to beat expectations for revenue and earnings in the third quarter. As healthcare organizations increasingly seek total talent partners, we have been fortunate to expand and add progressive new clients. This gives us the opportunity to help clients optimize their workforce while also providing our candidates with even more attractive career opportunities," said Susan R. Salka, Chief Executive Officer of AMN Healthcare.

"The need for healthcare talent and workforce solutions by our clients has accelerated as labor market conditions remain very constrained. To ensure we have access to the best talent possible for our clients, we are continuing to utilize innovative recruitment strategies, and we have the ability to further leverage our expanded recruitment team from the recent Advanced acquisition," Ms. Salka added.

Third Quarter 2019 Results

Consolidated revenue for the quarter was $568 million, an 8% increase over prior year and 6% higher than prior quarter. On an organic basis, consolidated revenue was up 1% over prior year. Revenue for the Nurse and Allied Solutions segment was $363 million, up 18% year over year (6% organic) and 9% sequentially. Travel Nurse division revenue grew 10% year over year with 4% organic growth. Allied division revenue increased 46% year over year, 11% organic.

The Locum Tenens Solutions segment reported revenue of $84 million, down by 17% year over year but up 3% sequentially. Other Workforce Solutions segment revenue was $121 million for an increase of 1% year over year, driven by growth in our interim leadership and VMS businesses.

Gross margin was 33.5%, higher by 30 basis points year over year and flat sequentially. The year-over-year variance was driven by improved gross margins in the Nurse and Allied and Other Workforce Solutions segments.

SG&A expenses were $133 million, or 23.5% of revenue, compared with $121 million, or 23.0% of revenue, in the same quarter last year. SG&A was $122 million, or 22.7% of revenue, in the previous quarter. The year-over-year increase in SG&A costs came mainly from the recent acquisitions, a higher earn-out provision and higher employee-related expenses, partly offset by lower legal reserves.

Income from operations was $40 million, or 7.0% of revenue, compared with $43 million, or 8.1% of revenue, in the same quarter last year. Adjusted EBITDA was $69 million, a year-over-year increase of 3%. Adjusted EBITDA margin was 12.2%, representing a decrease of 60 basis points year over year.

Net income was $24 million, or $0.49 per diluted share, compared with $28 million, or $0.58 per diluted share, in the same quarter last year. Adjusted diluted EPS was $0.81.

At September 30, 2019, cash and cash equivalents totaled $41 million. Cash flow from operations was $81 million for the quarter, and capital expenditures were $9 million. The Company ended the quarter with total debt outstanding of $620 million, with a leverage ratio as calculated in accordance with the Company’s credit agreement of 2.2 to 1.

October Debt Refinancing

In October, AMN issued $300 million of 4.625% senior notes due in 2027 and used the proceeds to repay the Company’s revolving debt and term loan, which totaled $295 million. After these actions, the Company had total debt of $625 million and unused borrowing capacity of $383 million on its senior credit facility.

*Note: Guidance percentage metrics are approximate. For a reconciliation of adjusted EBITDA margin to operating margin, see the table entitled "Reconciliation of Guidance Adjusted EBITDA Margin to Guidance Operating Margin" below.

Revenue in the fourth quarter of 2019 is expected to be approximately 8-9% higher year over year. This guidance does not assume any material labor disruption revenue in the quarter.

Conference Call on October 31, 2019

AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in workforce solutions and staffing services, will host a conference call to discuss its third quarter 2019 financial results and outlook on Thursday, October 31, 2019, at 5:00 p.m. Eastern Time. A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (800) 288-8960 in the U.S. or (612) 234-9960 internationally. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available starting at 7:30 p.m. Eastern Time on October 31, 2019, and can be accessed until 11:59 p.m. Eastern Time on November 14, 2019, by calling (800) 475-6701 in the U.S. or (320) 365-3844 internationally, with access code 472944.

On October 31, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the third quarter ended September 30, 2019 (Press release, Agios Pharmaceuticals, OCT 31, 2019, View Source [SID1234550097]).

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"The third quarter was marked by strong commercial execution, now a full year since the U.S. launch of TIBSOVO, and several meaningful clinical updates spanning our early and late stage oncology programs that advance our strategy," said Jackie Fouse, Ph.D., chief executive officer at Agios. "As we look ahead to the remainder of 2019, we are focused on achieving our remaining key milestones, including completing enrollment in our mitapivat PK deficiency pivotal program, establishing proof of concept for mitapivat in thalassemia, initiating our pivotal trial of vorasidenib in low-grade glioma and submission of the TIBSOVO supplemental new drug application for IDH1 mutant cholangiocarcinoma. These milestones are critical steps toward realizing the value-creation potential for both our oncology and rare genetic disease portfolios in 2020 and beyond."

THIRD QUARTER 2019 HIGHLIGHTS & RECENT PROGRESS

Presented data from the single agent dose-escalation portion of the ongoing Phase 1 study of AG-270 in patients with methylthioadenosine phosphorylase (MTAP)-deleted tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October. The data demonstrated that AG-270 induces reductions in the biomarkers of methionine adenosyltransferase 2A (MAT2A) inhibition, notably plasma concentrations of S-adenosylmethionine (SAM) and tumor levels of symmetrically demethylated arginine (SDMA), at well tolerated doses.
Presented results from the Phase 3 ClarIDHy study of TIBSOVO in previously treated isocitrate dehydrogenase-1 (IDH1) mutant cholangiocarcinoma at the European Society for Medical Oncology Congress in September, demonstrating significant improvement in progression free survival compared to placebo.
Initiated two combination arms for the Phase 1 study of AG-270 in MTAP-deleted tumors, one evaluating AG-270 in combination with docetaxel in MTAP-deleted second-line non-small cell lung cancer and another in combination with nab-paclitaxel and gemcitabine in MTAP-deleted first or second-line pancreatic ductal adenocarcinoma.
Published new data from the core and extension phases of the DRIVE PK Phase 2 study of mitapivat in adults with pyruvate kinase (PK) deficiency in the September 5, 2019 issue of the New England Journal of Medicine, demonstrating sustained increases in hemoglobin for up to 35 months.
KEY UPCOMING MILESTONES

The company plans to achieve the following key milestones in the remainder of 2019:

Oncology:

Submit a supplemental new drug application to the FDA for TIBSOVO for previously treated IDH1 mutant cholangiocarcinoma by year-end.
Initiate the registration-enabling Phase 3 INDIGO study of vorasidenib in Grade 2 non-enhancing glioma with an IDH mutation by year-end. The study will evaluate 366 patients in 1:1 double-blind randomization to either 50 mg of vorasidenib once daily or placebo. The primary endpoint is progression free survival.
Rare Genetic Diseases:

Complete enrollment in two global pivotal trials for mitapivat in adults with PK deficiency by year-end:
ACTIVATE-T: A single-arm trial of up to 40 regularly transfused patients
ACTIVATE: A 1:1 randomized, placebo-controlled trial of up to 80 patients who do not receive regular transfusions
Achieve proof-of-concept for mitapivat in thalassemia in the second half of 2019.
REMAINING 2019 DATA PRESENTATIONS

Updated data from the perioperative study of TIBSOVO and vorasidenib in low-grade glioma have been accepted for presentation at the Society for Neuro-Oncology Annual Meeting taking place in Phoenix from November 22-24, 2019.
Data from the IDH and PKR programs have been accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place in Orlando, Fla. from December 7-10, 2019, including new data from the extension phase of the Phase 2 DRIVE PK study of mitapivat in adults with PK deficiency and important translational data from the Phase 1 combination study of TIBSOVO and azacitidine in frontline acute myeloid leukemia (AML).
THIRD QUARTER 2019 FINANCIAL RESULTS

Revenue: Total revenue for the third quarter of 2019 was $26.0 million, which includes $17.4 million of net product revenue from U.S. sales of TIBSOVO, $5.5 million in collaboration revenue and $2.7 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene. This compares to total revenue of $15.2 million for the third quarter of 2018.

Cost of Sales: Cost of sales were $0.4 million for the third quarter of 2019.

Research and Development (R&D) Expenses: R&D expenses were $101.7 million for the third quarter of 2019 compared to $82.6 million for the third quarter of 2018. The increase in R&D expense was primarily attributable to start-up costs for the Phase 3 INDIGO study of vorasidenib in IDH mutated low-grade glioma, the mitapivat pivotal program in PK deficiency and Phase 2 study in thalassemia, and costs of the ongoing Phase 3 TIBSOVO combination trials in the frontline AML setting.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $33.0 million for the third quarter of 2019 compared to $31.1 million for the third quarter of 2018.

Net Loss: Net loss was $106.2 million for the third quarter of 2019 compared to $94.7 million for the third quarter of 2018.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of September 30, 2019 were $540.5 million compared to $805.4 million as of December 31, 2018. The net decrease of $264.9 million in cash position was primarily driven by net expenditures to fund operations. The company expects that its cash, cash equivalents and marketable securities as of September 30, 2019, together with anticipated product and royalty revenue, anticipated interest income, and anticipated expense reimbursements under our collaboration and license agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2020.

CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss third quarter 2019 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 5996044. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On October 31, 2019 bluebird bio, Inc. (NASDAQ: BLUE) reported financial results and business highlights for the third quarter ended September 30, 2019 (Press release, bluebird bio, OCT 31, 2019, View Source [SID1234550119]).

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"During the third quarter we advanced our country-by-country launch plans in Europe and, with the recent approval of the commercial drug product manufacturing specifications for ZYNTEGLO, we moved one step closer to our goal of treating patients suffering from TDT in early 2020," said Nick Leschly, chief bluebird. "Also this quarter, we presented updated data from the Phase 2/3 Starbeam study in patients with CALD. To report that patients continued to be free of MFDs at up to five years of follow-up is something we’re tremendously proud to do for these families, and we look forward to advancing that program in the regulatory process next year. Looking ahead, we plan to provide clinical updates for ZYNTEGLO and across the rest of our portfolio, including LentiGlobin in sickle cell disease, bb21217 in multiple myeloma, and from our registration-enabling KarMMa study of ide-cel in patients with multiple myeloma by the end of this year. I’d like to thank all the bluebirds around the globe for their tireless focus on doing the right thing for our patients – we’ve seen amazing progress thus far in 2019 and I look forward to ending the year on a strong note."

Recent Highlights:

TDT

ZYNTEGLO COMMERCIAL READINESS – In October, bluebird bio announced that the European Medicines Agency (EMA) approved the refined commercial drug product manufacturing specifications for ZYNTEGLO (autologous CD34+ cells encoding βA-T87Q-globin gene), a one-time gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available. With this update, apceth is in the final stages of preparing to manufacture ZYNTEGLO for commercial use. The company continues to proceed with discussions on value-based payment agreements and Qualified Treatment Center contracts and expects to treat the first commercial patient in early 2020.
CALD

DATA FROM STARBEAM STUDY (ALD-102) AND ALD-103 PRESENTED – At the 13thEuropean Pediatric Neurology Society (EPNS) Congress in September 2019, bluebird bio presented new data from the clinical development program for its investigational studies of Lenti-D gene therapy in patients with cerebral adrenoleukodystrophy: updated data from the Phase 2/3 Starbeam study (ALD-102) in boys 17 years of age and under with CALD and updated data from the ongoing observational study (ALD-103) of allogeneic hematopoietic stem cell transplant (allo-HSCT) in boys 17 years of age and under with CALD. Long-term follow-up data as of April 2019 showed that the 88% of patients treated in the Starbeam study (ALD-102) were free of major functional disabilities (MFDs) at two years, and continued to remain MFD-free at up to five years of follow-up.
COMPANY

FIRST PATIENT TREATED IN PHASE 1/2 TRIAL FOR MERKEL CELL CARCINOMA (MCC) – In August 2019, Fred Hutchinson Cancer Research Center infused the first patient in their proof-of-concept phase 1/2 single-arm study evaluating Merkel Cell Polyomavirus (MCPyV) TCR-engineered autologous T cells in combination with avelumab (anti-PDL1) for the treatment of MCC. Results from the academic phase 1/2 single-arm study are expected to inform next-generation T cell approaches including TCR engineering and checkpoint inhibition. The study will enroll approximately 16 patients. Development of this program is led by Fred Hutchinson Cancer Research Center. bluebird bio retains the exclusive option to license this program.
NOVO NORDISK COLLABORATION – In October 2019, bluebird bio and Novo Nordisk announced a research collaboration to jointly develop next-generation in vivo genome editing treatments for genetic diseases, including hemophilia. During the three-year research collaboration, bluebird and Novo Nordisk will focus on identifying a development gene therapy candidate with the ambition of offering people with hemophilia A a lifetime free of factor replacement therapy.
MANAGEMENT UPDATE – In October 2019, bluebird bio announced that Jeffrey T. Walsh, chief strategy officer, has decided to transition from his current role effective January 6, 2020. Jeff has not only built a strong foundation for bluebird’s overall growth strategy but also leaves an experienced and passionate team. Both Chip Baird, chief financial officer, and Joanne Smith-Farrell, chief business officer, will assume broader corporate development and strategic responsibilities as bluebird continues to deliver on its mission for patients.
NEW BOARD APPOINTMENT – In September 2019, bluebird bio announced the appointment of William R. Sellers, M.D. to its Board of Directors.
Upcoming Anticipated Milestones:

TDT
Initiation of a rolling Biologics Licensing Application submission to the U.S. FDA for ZYNTEGLO in patients with TDT and non-β0/β0 genotypes by the end of 2019
Presentation of ZYNTEGLO clinical data from the Northstar-2 (HGB-207) clinical study in patients with TDT and non-β0/β0 genotypes by the end of 2019
Presentation of ZYNTEGLO clinical data from the Northstar-3 (HGB-212) clinical study in patients with TDT and a β0/β0 genotype or an IVS-I-110 mutation by the end of 2019
SCD
Phase 3 HGB-210 study of LentiGlobin in patients with SCD open and enrolling by the end of 2019
Presentation of LentiGlobin clinical data from the HGB-206 clinical study in patients with SCD by the end of 2019
Multiple Myeloma
Ide-cel clinical data update from the registration-enabling KarMMa study in patients with relapsed/refractory multiple myeloma by the end of 2019
Presentation of bb21217 clinical data from the CRB-402 clinical study in patients with relapsed/refractory multiple myeloma by the end of 2019
Third Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2019 and December 31, 2018 were $1.41 billion and $1.89 billion, respectively. The decrease in cash, cash equivalents and marketable securities is primarily related to cash used in support of ordinary course operating activities and cash used to purchase property, plant and equipment, including those purchases related to the company’s buildout of its manufacturing facility in Durham, North Carolina.
Revenues: Collaboration and license and royalty revenues were $8.9 million for the three months ended September 30, 2019 compared to $11.5 million for the three months ended September 30, 2018. Collaboration and license and royalty revenues were $34.7 million for the nine months ended September 30, 2019 compared to $35.3 million for the nine months ended September 30, 2018. The decrease in both periods was primarily attributable to a decrease in collaboration revenue under our arrangement with Celgene, partially offset by an increase in license and royalty revenue and collaboration revenue under our arrangement with Regeneron.
R&D Expenses: Research and development expenses were $151.4 million for the three months ended September 30, 2019 compared to $116.7 million for the three months ended September 30, 2018. Research and development expenses were $420.6 million for the nine months ended September 30, 2019 compared to $328.9 million for the nine months ended September 30, 2018. The increase in both periods was primarily driven by costs incurred to advance and expand the company’s pipeline.
G&A Expenses: General and administrative expenses were $66.3 million for the three months ended September 30, 2019 compared to $44.5 million for the three months ended September 30, 2018. General and administrative expenses were $195.2 million for the nine months ended September 30, 2019 compared to $120.6 million for the nine months ended September 30, 2018. The increase in both periods was largely attributable to costs incurred to support the company’s ongoing operations and growth of its pipeline as well as commercial-readiness activities.
Net Loss: Net loss was $206.0 million for the three months ended September 30, 2019 compared to $145.5 million for the three months ended September 30, 2018. Net loss was $566.3 million for the nine months ended September 30, 2019 compared to $406.6 million for the nine months ended September 30, 2018.