On November 6, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that data from the clinical program evaluating its lead candidate melflufen in multiple myeloma and Light Chain (AL) Amyloidosis have been selected for six poster presentations to be featured at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting taking place December 7-10 in Orlando, Florida (Press release, Oncopeptides, NOV 6, 2019, View Source [SID1234550482]). Melflufen is a peptide-conjugated alkylator belonging to the novel class of Peptidase Enhanced Cytotoxics (PEnC).

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A wide range of clinical and preclinical data for melflufen in both multiple myeloma and AL amyloidosis will be presented at the ASH (Free ASH Whitepaper) annual meeting. Two key data sets that will be presented are;

Updated efficacy and safety data from pivotal phase 2 HORIZON trial evaluating melflufen in patients with relapsed/refractory multiple myeloma (RRMM). The data will support the New Drug Application filing with U.S. FDA late in the first quarter of 2020.
First presentation of Progression-Free Survival (PFS) data from the ANCHOR phase 2 combination trial in RRMM patients.
"The acceptance of six abstracts from our robust clinical development program evaluating melflufen in multiple myeloma and AL amyloidosis is a significant validation of Oncopeptides’ progress in advancing our pipeline and conducting thorough scientific exploration of the compound. Of particular interest will be long-term follow up data from the HORIZON Phase 2 pivotal trial which is evaluating melflufen in RRMM. These data will form the basis of our New Drug Application for submission to the FDA late in the first quarter of 2020. The update on ANCHOR data will be of high importance as this will be the first time that we present progression free survival (PFS) data with longer term follow up from the combination study," said Jakob Lindberg, CEO of Oncopeptides. "This ASH (Free ASH Whitepaper) Annual Meeting also represents the first time in which we will be presenting data from our early-stage development of melflufen in the treatment of AL Amyloidosis, which is an area of significant unmet need as there are currently no approved therapies available to patients."

The full ASH (Free ASH Whitepaper) Annual Meeting 2019 abstract book can be found at:

View Source

The six abstracts detailing melflufen clinical program data and updates that have been accepted for poster presentations at this year’s ASH (Free ASH Whitepaper) Annual Meeting and can be found at:

www.oncopeptides/investor&media/presentations/ASH Abstracts 2019

Data included in the abstracts currently available on the ASH (Free ASH Whitepaper) Annual Meeting website is based on data cut-off dates in second quarter 2019. The final conference presentations will include additional data collected between the abstract submission cutoff and the presentation itself.

Details about the upcoming poster presentations.

Title: Clinical Activity of Melflufen in Patients with Triple-Class Refractory Multiple Myeloma and Poor-Risk Features in an Updated Analysis of HORIZON (OP-106), a Phase 2 Study in Patients with Relapsed/Refractory Multiple Myeloma Refractory to Pomalidomide and/or Daratumumab
Presenter: Maria-Victoria Mateos, Hospital Clínico Universitario de Salamanca, Salamanca, Spain
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Date/Time: Saturday, December 7 at 5:30 – 7:30 p.m.
Location: Hall B

Title: Updated Progression-Free Survival (PFS) and Overall Survival (OS) with Melflufen and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Results from the Phase 2 Study O-12-M1
Presenter: Sara Bringhen, MD, Division of Hematology University of Torino, Torino, Italy
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Date/Time: Saturday, December 7 at 5:30 – 7:30 p.m.
Location: Hall B

Title: OP201: A Phase 1/2 Study of Melflufen and Dexamethasone in Patients with Immunoglobulin Light Chain (AL) Amyloidosis
Presenter: Stefan Schönland, MD, Medizinische Klinik V and Amyloidosis Center, Universitätsklinikum Heidelberg, Heidelberg, Germany
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date/Time: Sunday, December 8 at 6:00 – 8:00 p.m.
Location: Hall B

Title: ANCHOR (OP-104): Updated Efficacy and Safety from a Phase 1/2 Study of Melflufen and Dexamethasone Plus Bortezomib or Daratumumab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to an IMiD or a Proteasome Inhibitor (PI)
Presenter: Enrique M. Ocio, MD, University Hospital Marqués de Valdecilla (IDIVAL), University of Cantabria, Santander, Spain
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date/Time: Sunday, December 8 at 6:00 – 8:00 p.m.
Location: Hall B

Title: In Vitro and in Vivo Activity of Melflufen in Amyloidosis
Presenter: Kenneth Flanagan, PhD, Oncopeptides AB, Stockholm, Sweden
Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II Date/Time: Sunday, December 8 at 6:00 – 8:00 p.m.
Location: Hall B

Title: The Burden of Relapsed/Refractory Multiple Myeloma: An Indirect Comparison of Health-Related Quality of Life Burden across Different Types of Advanced Cancers at Baseline and after Treatment Based on HORIZON (OP-106) Study of Melflufen Plus Dexamethasone
Presenter: Paul G. Richardson, MD, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA
Session: 905. Outcomes Research—Malignant Conditions (Lymphoid Disease): Poster II
Date/Time: Sunday, December 8 at 6:00 – 8:00 p.m.
Location: Hall B

For more information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

This information was submitted for publication at 15.00 CET on November 6, 2019.

On November 6, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2019 (Press release, Nektar Therapeutics, NOV 6, 2019, View Source [SID1234550481]).

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Cash and investments in marketable securities at September 30, 2019 were approximately $1.7 billion as compared to $1.9 billion at December 31, 2018.

"We continue to make steady progress with our diverse portfolio of immuno-oncology and immunology programs," said Howard W. Robin, President and CEO of Nektar. "With our partner Bristol-Myers Squibb, we are conducting registrational trials evaluating the combination of bempegaldesleukin with nivolumab in melanoma, urothelial cancer and renal cell carcinoma. We are also working collaboratively with BMS to finalize the next set of registrational studies. This weekend at the SITC (Free SITC Whitepaper) Annual Meeting, we are excited to present an 18-month follow-up for patients with metastatic melanoma enrolled in our PIVOT-02 study. This follows the recent announcement of our Breakthrough Therapy Designation for the doublet which was granted by FDA in August for patients with previously untreated metastatic melanoma. For NKTR-358, we now have three separate Phase 1b clinical trials ongoing in lupus, psoriasis and atopic dermatitis with our partner Eli Lilly, with plans to add an additional autoimmune indication to the development program in 2020. And importantly, we initiated our first clinical trial for NKTR-255, our novel IL-15 agonist, in patients with non-Hodgkin lymphoma and multiple myeloma."

Revenue in the third quarter of 2019 was $29.2 million as compared to $27.8 million in the third quarter of 2018. Year-to-date revenue for 2019 was $80.8 million as compared to $1.15 billion in the first nine months of 2018. Revenue was higher in the third quarter of 2019 as compared to the same period in 2018 primarily due to non-cash royalty revenue and an increase in product sales. Revenue was lower in the first nine months of 2019 as compared to the same period in 2018 primarily because of the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement in the second quarter of 2018.

Total operating costs and expenses in the third quarter of 2019 were $128.0 million as compared to $126.4 million in the third quarter of 2018. Total operating costs and expenses in the first nine months of 2019 were $411.2 million as compared to $365.3 million in the same period of 2018. Total operating costs and expenses increased marginally in the third quarter of 2019 as compared to the third quarter of 2018 due to a decrease in research and development (R&D) expense, offset by an increase in general and administrative (G&A) expense. Total operating costs and expenses increased in the first nine months of 2019 as compared to the same period in 2018 due to increases in both R&D and G&A expense.

R&D expense in the third quarter of 2019 was $99.0 million as compared to $102.9 million for the third quarter of 2018. For the first nine months of 2019, R&D expense was $324.2 million as compared to $290.7 million in the first nine months of 2018. R&D expense was lower in the third quarter of 2019 as compared to the same period in 2018 due to decreased expense for the bempegaldesleukin program. R&D expense was higher in the first nine months as compared to the same period in 2018 primarily because of expenses for our pipeline programs, including the continued development of bempegaldesleukin in Phase 2 and registrational studies and related manufacturing costs, costs related to Phase 1 clinical studies of NKTR-358 and IND-enabling activities for NKTR-255.

G&A expense was $24.0 million in the third quarter of 2019 as compared to $18.7 million in the third quarter of 2018. G&A expense in the first nine months of 2019 was $71.6 million as compared to $57.7 million in the first nine months of 2018. G&A expense was higher in the third quarter and first nine months of 2019 as compared to the same periods in 2018 due to costs related to commercialization readiness activities for NKTR-181 and bempegaldesleukin, and increased non-cash stock-based compensation.

Net loss in the third quarter of 2019 was $98.8 million or $0.56 basic and diluted loss per share as compared to net loss of $96.1 million or $0.56 basic and diluted loss per share in the third quarter of 2018. Net loss in the first nine months of 2019 was $327.2 million or $1.87 basic and diluted loss per share as compared to net income of $779.5 million or $4.34 diluted income per share in the first nine months of 2018.

Third Quarter 2019 and Recent Business Highlights

·In September, Nektar presented clinical data from its PIVOT-02 study for bempegaldesleukin in combination with Opdivo (nivolumab) at the 2019 CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) demonstrating the promising clinical activity of the combination in patients with advanced or metastatic triple-negative breast cancer, particularly in patients with PD-L1 negative baseline tumors.

·In October, Nektar announced that its partner Eli Lilly initiated two Phase 1b studies of NKTR-358, a novel T regulatory (Treg) cell stimulator, one in patients with psoriasis and one in patients with atopic dermatitis. NKTR-358 is designed to treat autoimmune and inflammatory conditions by correcting the immune system imbalance that results from reduced numbers and impaired function of immune regulating Treg cells.

·In October, Nektar announced the initiation of a first-in-human, Phase 1 clinical study evaluating NKTR-255, an interleukin-15 (IL-15) receptor agonist, as monotherapy for patients with relapsed or refractory non-Hodgkin lymphoma or multiple myeloma (MM). The study will also combine NKTR-255 with multiple targeted antibodies that function through an antibody-dependent cell-mediated cytotoxicity mechanism to evaluate the safety and efficacy in adults with relapsed or refractory MM.

The company also announced upcoming presentations at the following scientific congresses:

2019 Society for Immunotherapy and Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, National Harbor, MD:

·Oral Presentation: "Clinical activity of BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: updated results from the phase 1/2 PIVOT-02 study"
oPresenter: Dr. Adi Diab, MD Anderson Cancer Center
oSession: Concurrent Session 310: Combination Phase 1-2 Clinical Trials
oDate: Saturday, November 9, 2019, 5:15 p.m. – 5:30 p.m. Eastern Standard Time

·Poster: "NKTR-255, a polymer-conjugated IL-15 receptor agonist, enhances efficacy of therapeutic monoclonal antibodies with ADCC activity in solid tumor models", Kivimäe, S., et al.
oSession Date and Time: Friday, November 8, 2019, 7:00 a.m. – 8:00 p.m. Eastern Standard Time

·Poster: "Bempegaldesleukin in combination with local radiation and systemic checkpoint blockade induces a robust systemic anti-tumor immunity", Pieper, A., et al.
oSession Date and Time: Friday, November 8, 2019, 7:00 a.m. – 8:00 p.m. Eastern Standard Time

·Poster: "Characterization and comparison of NKTR-255, a polymer-conjugated IL-15 versus IL-15 superagonist", Miyazaki, T., et al.
oSession Date and Time: Saturday, November 9, 2019, 7:00 a.m. – 8:00 p.m. Eastern Standard Time

·Trials in Progress Poster: "A multicenter, open-label, exploratory platform study to evaluate biomarkers and immunotherapy combinations for the treatment of patients with metastatic castration-resistant prostate cancer (PORTER)", Nissola, L., et al.
oSession Date and Time: Friday, November 8, 2019, 7:00 a.m. – 8:00 p.m. Eastern Standard Time

ACR 2019 American College of Rheumatology Annual Meeting, Atlanta, GA:

·Poster: "Selective induction of functional regulatory T-cells in healthy volunteers by NKTR-358, a novel IL-2 conjugate Treg stimulator, in development for the treatment of autoimmune diseases", Fanton, C., et al.
oSession: T Cell Biology & Targets in Autoimmune & Inflammatory Disease Poster
oDate: Sunday, November 10, 2019, 9:00 a.m. – 11:00 a.m. Eastern Standard Time

The Promise of Interleukin-2 Therapy 2019, Paris, France:

·Presentation: "NKTR-358: A polymer-conjugated IL-2 that drives the selective expansion of endogenous Tregs for the treatment of autoimmune diseases"
oPresenter: Christine Fanton, Ph.D., Nektar Therapeutics
oSession: Session V.a – Novel IL-2s
oDate: Friday, November 15, 2019, 2:00 p.m. Central European Time

·Presentation: "Bempegaldesleukin: A polymer-conjugated IL-2 prodrug for multiple immune oncology applications"
oPresenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
oSession: Session VI – IL-2 in cancer therapy
oDate: Friday, November 15, 2019, 4:30 p.m. Central European Time

11th Annual PEGs Europe, Lisbon, Portugal:

·Presentation: "TLR Agonist NKTR-262 Immunotherapy Combination with Bempegaldesleukin (NKTR-214) Harnessing Innate and Adaptive Immune System for the Treatment of Solid Tumors"
oPresenter: Saul Kivimäe, Ph.D., Nektar Therapeutics
oSession: Reprogramming the Microenvironment/The Innate Immune System/Glyco-immune Checkpoints
oDate: Tuesday, November 19, 2019, 5:30 p.m. Western European Time

·Presentation: "NKTR-255: A Polymer-Conjugated IL-15 that Enhances CAR T Efficacy in Murine Models"
oPresenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
oSession: TILs and Gamma Delta Therapy
oDate: Thursday, November 21, 2019, 11:15 a.m. Western European Time

Melanoma Bridge 2019, Naples, Italy:

·Presentation: "Clinical activity of BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: updated results from the phase 1/2 PIVOT-02 study"- [Encore Presentation]
oPresenter: Igor Puzanov, M.D., Roswell Park Comprehensive Cancer Center, Melanoma Bridge Co-chair
oSession: Emergent Strategies Session
oDate: Saturday, December 7, 2019, 12:00 p.m. – 12:15 p.m. Central European Time

61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, Orlando, FL:

·Poster: "Combination of NKTR-255, a Polymer Conjugated Human IL-15, with CD19 CAR T Cell Immunotherapy in a Preclinical Lymphoma Model", Chou, C., et al.
oSession: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II
oDate: Sunday, December 8, 2019, 6:00 p.m. – 8:00 p.m. Eastern Standard Time

·Poster: "Restoring Innate and Adaptive Immune Repertoire in Multiple Myeloma for Therapeutic Application", Fernandez, R., et al.
oSession: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, Excluding Therapy: Poster III
oDate: Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. Eastern Standard Time

·Trials in Progress Poster: "A Phase 1, Open-Label, Multi-Center, Dose Escalation and Dose Expansion Study of NKTR-255 As a Single Agent in Relapsed or Refractory Hematologic Malignancies and in Combination with Daratumumab As a Salvage Regimen for Multiple Myeloma", Shah, N. et al.
oSession: 704. Immunotherapies: Poster III
oDate: Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. Eastern Standard Time

Conference Call to Discuss First Quarter 2019 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Standard Time/2:00 p.m. Pacific Standard Time, Wednesday, November 6, 2019.

This press release and a Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, December 9, 2019.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)

Conference ID: 3079832 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On November 6, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported presentation of so far unpublished data on tafasitamab, its proprietary key asset and investigational hemato-oncological drug candidate, at the upcoming 61th American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting, taking place from December 7-10, 2019 in Orlando, Florida (Press release, MorphoSys, NOV 6, 2019, View Source [SID1234550480]).

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This year, overall four abstracts feature the clinical development of tafasitamab in diffuse large B-cell lymphoma (DLBCL) as well as other blood cancer indications. In addition, three abstracts feature preclinical data.

Abstracts on the clinical development of tafasitamab in DLBCL:

Subgroup analysis from the L-MIND trial, a phase 2 study assessing tafasitamab in combination with lenalidomide in patients with relapsed or refractory DLBCL
Trial in progress update for the First-MIND trial, an open label, randomized study in patients with newly diagnosed DLBCL
Abstracts on the clinical development of tafasitamab in other blood cancer indications:

Results from the COSMOS trial, assessing tafasitamab in combination with idelalisib or venetoclax in patients with relapsed of refractory chronic lymphocytic leukemia (CLL)
Final analysis and long term follow-up of tafasitamab monotherapy in patients with relapsed or refractory B-Cell Non-Hodgkin’s Lymphoma (NHL)
Preclinical abstracts on in vitro studies:

Study investigating gamma delta T cells and allogeneic activated NK cells as effector cells for tafasitamab
Study investigating the influence of tafasitamab on CAR-T cell activity
Study investigating tumor-associated macrophages as effector cells for tafasitamab
"We are excited to present a number of important updates on our investigational compound tafasitamab at this year’s ASH (Free ASH Whitepaper)," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "The seven accepted abstracts provide insights into our scientific and clinical activities to evaluate the efficacy and safety of tafasitamab. The data highlight our commitment to patients with high unmet medical needs."

MorphoSys will meet ASH (Free ASH Whitepaper) attendees at the Orange County Convention Center, at Booth #1261.

Details about MorphoSys’s abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2019:

Subgroup analysis from L-MIND, a Phase II Study of Tafafsitamab (MOR208) Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Abstract publication number: 1582
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Poster I
Session date and time: Saturday, December 7th, 2019; 9:00am – 7:30pm ET
Poster presentation time: 5:30pm – 7:30pm ET

A Phase Ib, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab (MOR208) or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: The First-MIND Trial

Abstract publication number: 2877
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Poster II
Session date and time: Sunday, December 8th, 2019; 9:00am – 8:00pm ET
Poster presentation time: 6:00 pm – 8:00 pm ET

Primary Analysis of Anti-CD19 Tafasitamab (MOR208) Treatment in Combination with Idelalisib or Venetoclax in R/R CLL Patients Who Failed Prior BTK Inhibitor Therapy (COSMOS Trial)

Abstract publication number: 1754
Session: 642. CLL: Therapy, excluding Transplantation: Poster I
Session date and time: Saturday, December 7th, 2019; 9:00am – 7:30pm ET
Poster presentation time: 5:30pm – 7:30pm ET

A Phase IIa, Open-label, Multicenter Study of Single-Agent Tafasitamab (MOR208), an Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma: Long-term Follow-up, Final Analysis

Abstract publication number: 4078
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Poster III
Session date and time: Monday, December 9th, 2019; 10:00am – 8:00pm ET
Poster presentation time: 6:00 pm – 8:00 pm ET

Targeting of CD19 by Tafasitamab Does Not Impair CD19 Directed Chimeric Antigen Receptor T Cell Activity In Vitro

Abstract publication number: 2859
Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster II
Session date and time: Sunday, December 8th, 2019; 9:00am – 8:00pm ET
Poster presentation time: 6:00 pm – 8:00 pm ET

Functional Characterization of Gamma Delta T Cells and Allogeneic Activated NK Cells as Effector Cells for Tafasitamab (MOR208)

Abstract publication number: 3801
Session: 605. Molecular pharmacology drug resistance – lymphoid and other diseases: Poster III
Session date and time: Monday, December 9th, 2019; 10:00am – 8:00pm ET
Poster presentation time: 6:00 pm – 8:00 pm ET

Mechanistic Characterization of Tafasitamab-Mediated Antibody-Dependent Cellular Phagocytosis Alone or in Combination with Lenalidomide

Abstract publication number: 4064
Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster III
Session date and time: Monday, December 9th, 2019; 10:00am – 8:00pm ET
Poster presentation time: 6:00 pm – 8:00 pm ET

The abstracts will also be available online in a supplemental issue of Blood. Additional information, including the abstracts, can be found in the online meeting program of the American Society of Hematology (ASH) (Free ASH Whitepaper).

On November 6, 2019 MannKind Corporation (NASDAQ:MNKD) reported preliminary financial results for the quarter and nine months ended September 30, 2019 (Press release, Mannkind, NOV 6, 2019, View Source [SID1234550479]).

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"I am excited to see MannKind continue its transformation, with another quarter of double-digit growth in Afrezza revenue, year over year, and aggregate net revenue of $14.6 million," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "In the third quarter, we completed our recapitalization and achieved several key milestones, such as booking our first international sale of Afrezza to Brazil, seeing the first PAH patient dosed with TreT and progressing two pipeline compounds into nonclinical testing."

Third Quarter 2019 Results

Net revenues were $14.6 million for the third quarter of 2019, reflecting Afrezza net revenue of $6.4 million and collaborations and services revenue of $8.2 million. Afrezza net revenue increased 46% compared to $4.4 million in the third quarter of 2018, primarily driven by higher product demand (including the first shipment to Brazil), a more favorable mix of Afrezza cartridges and price.

Collaborations and services revenue increased $8.1 million compared to the third quarter of 2018, primarily driven by the license agreement with United Therapeutics, which began in the fourth quarter of 2018.

On a GAAP basis, Afrezza gross loss was $0.7 million for the third quarter of 2019 compared to a gross loss of $0.9 million in the same period in 2018. Afrezza cost of goods sold for the third quarter of 2019 included a one-time fee of $2.75 million recorded in connection with the amendment of the Company’s insulin supply agreement with Amphastar in August 2019. As a result, on a non-GAAP basis, gross profit was $2.1 million or 33% for the third quarter of 2019.

Research and development (R&D) expenses for the third quarter of 2019 were $1.6 million compared to $2.0 million for the third quarter of 2018. This 23% decrease was primarily attributable to a $0.4 million decrease in clinical trial spending.

Selling, general and administrative (SG&A) expenses for the third quarter of 2019 were $16.7 million compared to $19.4 million for the third quarter of 2018. This decrease of $2.7 million, or 14%, was primarily attributable to a $0.8 million decrease in personnel-related costs and a $1.9 million decrease in Afrezza marketing costs.

Interest expense on notes for the third quarter of 2019 was $4.1 million compared to $1.0 million for the third quarter of 2018. This $3.1 million increase or 316% was primarily attributable to a $3.4 million charge realized as a result of achieving of a sales milestone in the third quarter of 2019 under the Company’s milestone agreement with Deerfield.

The net loss for the third quarter of 2019 was $10.4 million, or $0.05 per share compared to a $24.2 million net loss in the third quarter of 2018 or $0.16 per share. The decrease was primarily the result of increased total revenues from higher Afrezza commercial demand and from the licensing and research agreements with United Therapeutics.

Nine Months Ended September 30, 2019

Net revenues were $47.0 million for the nine months ended September 30, 2019, reflecting Afrezza net revenue of $17.5 million and collaborations and services revenue of $29.5 million. Afrezza net revenue increased 52% compared to $11.5 million for the nine months ended September 30, 2018, primarily due to higher product demand (including the first shipment to Brazil), a more favorable mix of Afrezza cartridges and price. Collaborations and services revenue increased $29.3 million compared to the nine months ended September 30, 2018, which was primarily attributed to the licensing agreement ($23.3 million) and research agreement ($5.9 million) with United Therapeutics, both of which began in the fourth quarter of 2018.

On a GAAP basis, Afrezza gross profit was $2.1 million for the nine months ended September 30, 2019, an improvement of $5.0 million or 173% compared to a gross loss of $2.9 million in the same period in 2018, primarily due to an increase of $6.0 million in net revenue, a $1.8 million decrease in inventory write-offs, partially offset by increased costs due to higher sales and the Amphastar one-time amendment fee of $2.75 million in the third quarter of 2019. As a result, on a non-GAAP basis, gross profit was $4.9 million or 28% for the nine months ended September 30, 2019.

R&D expenses for the nine months ended September 30, 2019 were $4.9 million compared to $7.7 million for the nine months ended September 30, 2018. This $2.8 million or 36% decrease was primarily attributable to a $1.0 million decrease in personnel-related costs and a $1.1 million decrease in clinical trial spending.

SG&A expenses for the nine months ended September 30, 2019 were $58.9 million compared to $61.7 million for the nine months ended September 30, 2018. This decrease of $2.7 million or 5% was primarily attributable to a $6.1 million decrease in personnel related costs, $1.9 million decrease in professional fees, a $1.0 million decrease in stock-based compensation costs offset by a $6.8 million increase in costs for a television campaign for Afrezza.

Interest income increased by $0.5 million or 160% for the nine months ended September 30, 2019 primarily attributable to a higher balance on money market funds and other short-term investments.

Interest expense on notes for the nine months ended September 30, 2019 was $5.3 million compared to $4.5 million for the nine months ended September 30, 2018. This $0.8 million increase was primarily attributable to a $3.4 million charge realized as a result of achieving of a sales milestone in the third quarter of 2019 under the Company’s milestone agreement with Deerfield, partially offset by a reduction in debt principal balances.

The net loss for the nine months ended September 30, 2019 was $37.6 million, or $0.20 per share compared to a $77.2 million net loss for the nine months ended September 30, 2018 or $0.56 per share. The lower net loss was mainly attributable to a $35.2 million increase in total revenues.

Cash, Cash Equivalents, Restricted Cash and Short Term Investments

Cash, cash equivalents, restricted cash, and short-term investments at September 30, 2019 was $50.4 million compared to $71.7 million at December 31, 2018.

Non-GAAP Measures

Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis. Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. To participate in the live call by telephone, please dial (866) 548-4713 or (323) 794-2093 and use the participant passcode: 8987532. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 8987532. A replay will also be available on MannKind’s website for 14 days.

On November 6, 2019 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported that new data from across its pipeline will be presented at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Magenta Therapeutics, NOV 6, 2019, View Source [SID1234550478]).

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"The breadth of new results we are presenting at ASH (Free ASH Whitepaper) illustrates our progress toward enabling patients with autoimmune diseases, blood cancers and genetic diseases to benefit from curative stem cell transplant. In today’s abstracts we are particularly excited to share the first clinical data from our MGTA-145 program, which we are developing as a first-line stem cell mobilization drug. The data in the abstract show that MGTA-145 in combination with plerixafor was well-tolerated and successfully mobilized the target stem cell dose in 11 of 12 subjects within hours of administration. At ASH (Free ASH Whitepaper) we anticipate sharing initial data from mobilization and collection of the target number of cells in subjects in a single-day procedure for the first time," said Jason Gardner, D.Phil., Chief Executive Officer and President, Magenta Therapeutics. "We are also pleased to show groundbreaking data from our most advanced patient preparation program, CD117-ADC, in today’s abstract. These data, which will be shared in an oral presentation at ASH (Free ASH Whitepaper) by Dr. John Tisdale of the National Institutes of Health, show the first-ever successful transplant in non-human primates using a targeted, single-agent antibody-drug conjugate, without the use of chemotherapy or radiation. These data provide additional validation for both our CD117-ADC program as well as our entire ADC-based patient preparation portfolio."

First Data from MGTA-145 Clinical Program

Title: Rapid and Robust Mobilization of CD34+ HSCs without G-CSF Following Administration of MGTA-145 Alone and in Combination with Plerixafor (Abstract #1961)
Presenter: John DiPersio, M.D., Ph.D., Professor of Medicine and Chief of the Oncology Division, Washington University School of Medicine, St. Louis, Missouri
Date and Time: Saturday, December 7th, 5:30 to 7:30 p.m.

Mobilized peripheral blood is used for the majority of the 65,000 stem cell transplants performed each year across the United States and Europe, but the current standard of care, G-CSF, requires at least five days of dosing and is associated with significant side effects, including bone pain that often requires narcotics. Further, patients with autoimmune diseases or sickle cell disease can have severe side effects with G-CSF, including potentially fatal complications.

Magenta is developing MGTA-145 as the new first-line standard of care for stem cell mobilization in a broad range of diseases, including autoimmune diseases and genetic diseases. MGTA-145 works in combination with plerixafor to harness the physiological mechanism of stem cell mobilization. The MGTA-145-based combination has the potential to reliably mobilize robust numbers of high-quality stem cells with single-day dosing and collection. Importantly, the MGTA-145-based combination also avoids the need for G-CSF.

The ASH (Free ASH Whitepaper) abstract includes early results from the Phase 1 study, as of the late July data cut-off. MGTA-145 was safe and well-tolerated as a single agent and in combination with plerixafor, and showed the expected target pharmacology. Eleven of the 12 subjects who received the combination of MGTA-145 and plerixafor mobilized more than 20 CD34+ cells/microliter, the clinically accepted threshold for successful mobilization. This number is considered predictive of collection of at least 2 million CD34+ stem cells/kg through apheresis, the threshold for cell dose for a successful transplant. Magenta anticipates that initial data from additional subjects and apheresis collection results will be presented at ASH (Free ASH Whitepaper).

Data from CD117-ADC Patient Preparation Program

Current methods to condition patients before transplant and gene therapy are dependent on toxic, non-specific chemotherapy or radiation. These pre-transplant treatments are associated with significant side effects, including infertility, cancer, organ damage, and death. Magenta is the only company developing targeted antibody-drug conjugates (ADCs) designed to precisely remove the disease-causing cells in the body, without the need for chemotherapy or radiation.

Title: A Single Dose of CD117 Antibody Drug Conjugate Enables Autologous Gene-Modified Hematopoietic Stem Cell Transplant (Gene Therapy) in Nonhuman Primates (Abstract #610)
Presenter: John Tisdale, M.D., Director, Molecular and Clinical Hematology Section, National Institutes of Health, Bethesda, Md.
Date and Time: Monday, December 9th, 7:45 a.m.

Magenta’s most advanced patient preparation program, CD117-ADC, targets CD117, a protein expressed on hematopoietic stem cells. CD117-ADC is designed to remove the genetically mutated cells that cause certain genetic diseases, such as sickle cell disease, enabling curative stem cell transplant or gene therapy.

Data in the ASH (Free ASH Whitepaper) abstract showed that a single dose of CD117-ADC enabled successful transplant of gene-modified stem cells for gene therapy in non-human primates without the need for chemotherapy or radiation. CD117-ADC removed stem cells in the non-human primates, with a favorable safety profile. The ADC spared the immune system and was cleared rapidly as designed. In a rhesus model of gene therapy, a single dose of the ADC enabled engraftment of stem cells modified with the β-globin gene, the gene that causes sickle cell disease and β-thalassemia when mutated. These proof-of-concept studies validate the use of CD117-ADC for targeted stem cell depletion prior to transplant and support its use as a new conditioning agent for gene therapy and stem cell transplant without toxic chemotherapy or radiation.

Additional Posters and Presentations

Title: A Novel Targeted Approach to Achieve Immune System Reset: Magenta’s CD45-Targeted Antibody-Drug Conjugates Enable Autologous HSCT, Ameliorate Disease in Autoimmune Models, Potently Kill Human Immune Cells from Normal Donors and MS patients, and Achieve Immune Depletion in Non-human Primates (NHP) (Abstract #3208)
Presenter: Geoff Gillard, Ph.D., Magenta Therapeutics, Cambridge, Mass.
Date and Time: Sunday, December 8th, 6:00 to 8:00 p.m.

Title: MGTA-456, an Aryl Hydrocarbon Receptor (AHR) Antagonist Based Expansion of CD34+ Hematopoietic Stem Cells (HSC), Permits Selection of Better HLA Matched Cord Blood Units (CBUs) and Promotes Faster Neutrophil Recovery and Uniform Engraftment with Potentially Less Acute Graft-vs-Host Disease (GVHD) (Abstract #804)
Presenter: John Wagner, M.D., Executive Medical Director, Bone Marrow Transplant Program, University of Minnesota, Minneapolis, Minn.
Date and Time: Monday, December 9th, 4:00 p.m.

Title: High Dose Hematopoietic Stem Cell Transplantation Leads to Rapid Hematopoietic and Microglia Recovery and Disease Correction in a Mouse Model of Hurler Syndrome (Abstract #4424)
Presenter: Kevin Goncalves, Ph.D., Magenta Therapeutics, Cambridge, Mass.
Date and Time: Monday, December 9th, 6:00 p.m. to 8:00 p.m.

Title: Ex Vivo Hematopoietic Stem Cell Expansion with E478 Increases the Rate of CRISPR- mediated Homology Directed Repair of the Beta Globin Gene in Human Stem Cells by >10-fold and Improves In Vivo Engraftment by > 120-fold (Abstract #4634)
Presenter: Kevin Goncalves, Ph.D., Magenta Therapeutics, Cambridge, Mass.
Date and Time: Monday, December 9th, 6:00 p.m. to 8:00 p.m.

ASH Investor Event and Webcast to Review ASH (Free ASH Whitepaper) Data and Updated MGTA-456 Phase 2 Clinical Data

Magenta will host a live webcast of an investor and analyst event at 8:30 p.m. ET on Saturday, December 7th, during the ASH (Free ASH Whitepaper) Annual Meeting. During this event, Magenta will review data presented at the ASH (Free ASH Whitepaper) meeting and present updated data from the ongoing Phase 2 clinical trial of MGTA-456 in inherited metabolic disorders.

To access the webcast, please visit the "News & Events" page within the Investors & Media section of the Magenta website at www.magentatx.com. A replay of the webcast will be available on the Magenta website for 90 days following the call.