On November 1, 2018 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of bone marrow transplant to more patients, reported that the Company will present clinical data and preclinical research at the 60th annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), taking place December 1st through 4th in San Diego, Calif (Press release, Magenta Therapeutics, NOV 1, 2018, View Source [SID1234530575]). Preliminary data in these abstracts became available on the ASH (Free ASH Whitepaper) conference website at 9:00 a.m. ET today. The Company also provided an update today on its ongoing Phase 2 study of MGTA-456 in inherited metabolic disorders, including recent data from the study.

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ASH Abstracts
"Magenta is developing potentially transformative drugs to broaden the reach of one-time, curative cell therapies – including bone marrow transplant, haploidentical transplant, cell and gene therapy and genome editing – to more patients with devastating diseases, including blood cancers, genetic diseases and autoimmune diseases," said Jason Gardner, D.Phil., president, chief executive officer and co-founder, Magenta Therapeutics. "This year’s nine data presentations at ASH (Free ASH Whitepaper) highlight our patient conditioning, mobilization and stem cell expansion programs, giving further insight into our progress in addressing the major unmet needs of the transplant process, including toxic conditioning regimens, inadequate stem cell mobilization and low cell doses. We anticipate building on this progress over the coming year as we move our mobilization program into the clinic and advance our clinical development plan for stem cell expansion in multiple diseases."

Conditioning Programs

CD117-Amanitin Antibody Drug Conjugates Effectively Deplete Human and Non-Human Primate HSCs: Proof of Concept as a Targeted Strategy for Conditioning Patients for Bone Marrow Transplant, Abstract #3314

Presenter: Brad Pearse, Ph.D., Magenta Therapeutics
Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster II
Session Date: Sunday, December 2, 2018
Session Time: 6:00 PM – 8:00 PM
Room: San Diego Convention Center, Hall GH

Targeting CD45 with an Amanitin Antibody-Drug Conjugate Effectively Depletes Human HSCs and Immune Cells for Transplant Conditioning, Abstract #4526

Presenter: Rahul Palchaudhuri, Ph.D., Magenta Therapeutics
Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster III
Session Date: Monday, December 3, 2018
Session Time: 6:00 PM – 8:00 PM
Room: San Diego Convention Center, Hall GH

Single Doses of Antibody Drug Conjugates (ADCs) Targeted to CD117 or CD45 Have Potent In Vivo Anti-Leukemia Activity and Survival Benefit in Patient Derived AML Models, Abstract #3316

Presenter: Jennifer Proctor, Magenta Therapeutics
Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster II
Session Date: Sunday, December 2, 2018
Session Time: 6:00 PM – 8:00 PM
Room: San Diego Convention Center, Hall GH

Antibody Drug Conjugates Targeted to CD45 or CD117 Enable Allogeneic Hematopoietic Stem Cell Transplantation in Animal Models, Abstract #3324

Presenter: Rahul Palchaudhuri, Ph.D., Magenta Therapeutics
Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster II
Date: Sunday, December 2, 2018
Presentation Time: 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH

Non-genotoxic conditioning facilitates robust HSPC engraftment and multi-lineage development in a dose dependent manner in Fanconi anemia

Presenter: Meera Srikanthan, Ph.D., Fred Hutchinson Cancer Research Center
Session Name: TBA
Date: TBA
Presentation Time: TBA
Location: TBA

Preclinical Data, Stem Cell Mobilization Program

MGTA-145 in Combination with Plerixafor Rapidly Mobilizes High Numbers of Hematopoietic Stem Cells and Graft-Versus-Host Disease Inhibiting Myeloid-Derived Suppressor Cells in Non-Human Primates, Abstract #116

Presenter: Kevin Goncalves, Ph.D., Magenta Therapeutics
Session Name: 711. Cell Collection and Processing I
Session Date: Saturday, December 1, 2018
Session Time: 9:30 AM – 11:00 AM
Presentation Time: 9:45 AM
Room: Manchester Grand Hyatt San Diego, Grand Hall A

Clinical Data, MGTA-456 Stem Cell Expansion Program

Preliminary Phase 2 Results Demonstrate Engraftment with Minimal Neutropenia with MGTA-456, a CD34+ Expanded Cord Blood Product in Patients Transplanted for Inherited Metabolic Disorders, Abstract #3467

Presenter: John Wagner, M.D., Director, Blood and Marrow Transplantation Division, University of Minnesota
Session Name: 732. Clinical Allogeneic Transplantation: Results: Poster II
Session Date: Sunday, December 2, 2018
Session Time: 6:00-8:00 p.m. PT
Room: San Diego Convention Center, Hall GH

MGTA-456 Contains Large Numbers of Expanded Cord Blood (CB) CD34+CD90+ Hematopoietic Stem Cells (HSC) Which Confer All Engraftment Activity and Correlate with Accelerated Neutrophil Recovery after Myeloablative Conditioning in Patients with Hematologic Malignancy, Abstract #2083

Presenter: Tony Boitano, Ph.D., Magenta Therapeutics
Session Name: 721 Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities
Session Date: Saturday, December 1, 2018
Session Time: 6:15-8:15 p.m. PTRoom: San Diego Convention Center, Hall GH

Preclinical Data, MGTA-456 Stem Cell Expansion Program

MGTA-456, A First-in-Class Cell Therapy Produced from a Single Cord Blood Unit, Enables A Reduced Intensity Conditioning Regimen and Enhances Speed and Level of Human Microglia Engraftment in the Brains of NSG Mice, Abstract #115

Presenter: Kevin Goncalves, Ph.D., Magenta Therapeutics
Session Name: 711. Cell Collection and Processing
Session Date: Saturday, December 1, 2018
Presentation Time: 9:30 a.m. PT
Room: San Diego Convention Center, Grand Hall A

MGTA-456 Clinical Development Update

MGTA-456 is a cell therapy providing a high dose of hematopoietic stem cells that are well-matched to the patient, administered through a transplant procedure. The ongoing Phase 2 study in inherited metabolic disorders aims to enroll 12 patients with Hurler’s syndrome, cerebral adrenoleukodystrophy (cALD), metachromatic leukodystrophy or globoid cell leukodystrophy. The primary endpoint is engraftment after transplantation and the secondary endpoint is transplant-related safety and tolerability.

The data as of October 22, 2018 show:

Five patients treated and evaluable: three with Hurler’s syndrome, two with cALD
Five of five patients treated with MGTA-456 met the primary endpoint of successful engraftment by day 42 following the transplant procedure.
In recent historical cohorts of patients undergoing regular cord blood transplantation with identical pre-transplant conditioning, up to 32% did not engraft at comparable time points.
The patients treated with MGTA-456 had minimal neutropenia, lasting for a median of 1 day.
In the historical cohort, neutropenia lasted for a median of 8 days.
Two patients less than 2 years of age with Hurler’s syndrome treated with MGTA-456 in the Magenta study developed autoimmune cytopenia, a known and frequent complication of transplant in these younger patients and patients with Hurler’s syndrome.
The first patient subsequently died from this complication. This was determined to be not related to the MGTA-456 product.
The second patient is currently undergoing treatment for the autoimmune cytopenia.
"Blood stem cell transplantation remains the standard of care for inherited metabolic disorders, which if untreated are generally progressive and lethal. Unfortunately, transplantation remains a difficult and complex procedure," said Paul Orchard, M.D., Medical Director of the Inherited Metabolic & Storage Disease Bone Marrow Transplantation Program, University of Minnesota and principal investigator in the MGTA-456 study. "Many patients experience significant and life-threatening complications, such as dysregulation of the immune system following transplantation, including the emergence of antibodies to components of the blood system. Patients with inherited metabolic disorders, particularly patients with Hurler’s syndrome, are at higher risk for these antibody-associated cytopenias. In a prior transplant protocol using the identical combination of chemotherapy agents for pre-transplant conditioning, evidence of cytopenias was present in 9 of 15 patients under 2 years of age (53%). This has proven less common in older patients."

In light of the elevated incidence of autoimmune cytopenias in very young patients and patients with Hurler’s syndrome, the Company announced today that it has voluntarily focused future enrollment towards pediatric patients older than 2 years of age diagnosed with leukodystrophies. The Company plans to continue enrolling patients with leukodystrophies in the study.

"MGTA-456 is a first-in-class cell therapy with high doses of stem cells, and larger doses of stem cells are correlated with more successful transplant outcomes and faster time to engraftment and immune recovery. It has demonstrated engraftment and robust immune recovery in all 41 evaluable patients that have been treated to date in our Phase 2 study in inherited metabolic disorders and our Phase 1/2 study in blood cancers," said John Davis, M.D., M.P.H., chief medical officer, Magenta Therapeutics. "We are developing MGTA-456 for patients with a broad range of diseases, including leukodystrophies, sickle cell disease and blood cancers, where we believe it has the potential to deliver transformative benefit."

The Company is on track to initiate a Phase 2 study of MGTA-456 in patients with sickle cell disease in the first half of 2019, and an investigator-initiated Phase 2 study in blood cancers is on track to start in 2018.

On November 1, 2018 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing neoantigen cancer immunotherapies, reported its financial and operating results for the third quarter ended September 30, 2018 (Press release, Genocea Biosciences, NOV 1, 2018, View Source [SID1234530574]).

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"In the year since our strategic pivot, we have made significant progress by advancing our lead cancer vaccine candidate, GEN-009, into the clinic and using our ATLAS platform to identify and characterize the T cell responses cancer patients make to both tumor-associated antigens and neoantigens," said Chip Clark, president & CEO of Genocea. "We continue to believe that ATLAS, which lets patients’ own T cells identify the optimal antigens for their cancer immunotherapies, stands apart from peer approaches that instead rely on software to predict antigens. We believe that the next evidence for this will emerge from our upcoming presentations at SITC (Free SITC Whitepaper) and then from the first patient cohort in our Phase 1/2a clinical trial for GEN-009, from which we expect to report immunogenicity data in the first half of 2019."

Recent Milestones & Events
•
October 2018: Announced multiple presentations at the upcoming meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2018) taking place November 7-11, 2018 at the Walter E. Washington Convention Center in Washington, D.C. These posters further highlight the advantages of Genocea’s ATLAS platform over in silico methods in identifying both neoantigens for vaccine inclusion and "inhibitory" neoantigens for exclusion. Genocea believes that the "inhibitory" antigen findings may point to novel biological insights only available through ATLAS. The following posters will be presented simultaneously on Saturday, November 10 from 12:20 – 1:50 p.m. and 7:00 – 8:30 p.m. ET in Poster Hall E:
◦
Poster Number: P154
Title: Empiric profiling of neoantigen-specific T cell responses in NSCLC patients with ATLAS reveals unexpected neoantigen and inhibitory antigen profiles
◦
Poster Number: P166
Title: Ex vivo ATLAS-identified inhibitory neoantigens promote mouse melanoma tumor progression
◦
Poster Number: P174
Title: A phase 1/2a study to evaluate the safety, tolerability, immunogenicity, and anti-tumor activity of GEN-009 adjuvanted neoantigen vaccine in adult patients with selected solid tumors
•
October 2018: Strengthened its leadership team with the addition of Thomas Davis, M.D. as Chief Medical Officer and Derek Meisner, J.D., as General Counsel. Dr. Davis joins Genocea with 20+ years of academic

and industry experience in immuno-oncology and cancer drug development. Mr. Meisner brings broad legal expertise to Genocea as the company’s first General Counsel.

Third Quarter 2018 Financial Results
•
Cash Position: As of September 30, 2018, cash and cash equivalents were $34.5 million compared to $12.3 million, as of December 31, 2017.
•
Research and Development (R&D) Expenses: R&D expenses were $6.4 million for the quarter ended September 30, 2018, compared to $10.2 million for the same period in 2017. The decrease was due largely to reduced headcount-related costs, external development, clinical, and consulting costs.
•
General and Administrative (G&A) Expenses: G&A expenses were $4.1 million for the quarter ended September 30, 2018, compared to $3.8 million for the same period in 2017. The increase was primarily due to increases in professional services expenses, partially offset by decreases in consulting costs.
•
Net Loss: Net loss was $7.8 million for the quarter ended September 30, 2018, compared to a net loss of $16.9 million for quarter ended September 30, 2017.

Financial Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the fourth quarter of 2019.

Genocea continues to explore strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy for the treatment of genital herpes.

Conference Call
Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 9864055. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On November 1, 2018 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a clinical stage biotechnology company developing monoclonal microbials designed to act on the gut-body network for the treatment of a wide range of diseases, reported financial results and provided a business update for the third quarter ended September 30, 2018 (Press release, Evelo Biosciences, NOV 1, 2018, View Source [SID1234530573]).

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"Our continued progress reflects our commitment to advancing a broad portfolio of product candidates to treat multiple diseases," said Simba Gill, Ph.D., CEO of Evelo. "We are enrolling patients in our Phase 1b trial of EDP1066 for psoriasis and atopic dermatitis, and recently received approval from the MHRA to start a clinical trial of EDP1815, our second candidate for inflammatory diseases. Additionally, we expect the University of Chicago’s investigator-sponsored trial of EDP1503 for the treatment of metastatic melanoma to begin enrolling patients this quarter. These activities support our goal of ten potential clinical readouts across inflammation and oncology patient groups in 2019 and 2020."

Third Quarter and Recent Business Highlights:

Pipeline:
•
In September 2018, the UK Medicines and Healthcare Regulatory Agency (MHRA) accepted Evelo’s Clinical Trial Authorisation application for a Phase 1b study of EDP1815 for the treatment of psoriasis and atopic dermatitis patients.

Upcoming Anticipated Milestones:
•
Initiation of a Phase 1b clinical trial of EDP1815, an anti-inflammatory monoclonal microbial product candidate, in healthy volunteers and patients with psoriasis and atopic dermatitis in the fourth quarter of 2018.
•
Initiation of the University of Chicago’s investigator-sponsored, open-label Phase 2a clinical trial of EDP1503 in combination with a checkpoint inhibitor in patients with metastatic melanoma in the fourth quarter of 2018.
•
Initiation of a company-sponsored Phase 2a clinical trial of EDP1503 in combination with a checkpoint inhibitor in patients with multiple cancer types in the first half of 2019.
•
Clinical data from the ongoing Phase 1b clinical trial of EDP1066 in healthy volunteers and patients with psoriasis and atopic dermatitis in the first half of 2019.

Upcoming Events:
•
Stifel 2018 Healthcare Conference on November 14, 2018 in New York, New York.
•
Evercore ISI Healthcare Conference on November 27, 2018 in Boston, Massachusetts.
•
BMO Prescriptions for Success Healthcare Conference on December 12, 2018 in New York, New York.

Corporate:
•
In October 2018, Evelo appointed Daniel Char as general counsel. Daniel joins Evelo from Smith & Nephew, where he was the associate general counsel – commercial, responsible for advising and supporting the company’s global businesses on commercial, compliance, regulatory, clinical, licensing, manufacturing and international trade matters. Daniel earned a J.D. from Harvard Law School and a B.A. in Economics from Tufts University.

Third Quarter 2018 Financial Results:
•
Cash Position: As of September 30, 2018, cash, cash equivalents and investments were $164.3 million, as compared to cash and cash equivalents of $38.2 million as of December 31, 2017. This increase was due to net proceeds of $81.3 million from the issuance of Series C Preferred Stock, net proceeds of $75.8 million from Evelo’s initial public offering and $5.0 million of additional drawings from Evelo’s existing debt facility, partially offset by cash used to fund operating activities for the first nine months of 2018. Evelo

expects that its cash, cash equivalents and investments will enable it to fund its planned operating expenses and capital expenditure requirements into the second half of 2020.
•
Research and Development Expenses: R&D expenses were $11.2 million for the three months ended September 30, 2018, compared to $5.3 million for the three months ended September 30, 2017. The increase of $5.9 million was due primarily to increases in costs related to Evelo’s inflammation and oncology clinical development programs, gut-body network platform expenses as well as increased personnel costs.
•
General and Administrative Expenses: G&A expenses were $5.2 million for the three months ended September 30, 2018, compared to $2.7 million for the three months ended September 30, 2017. The increase of $2.5 million was due primarily to increased general and administrative personnel costs, professional and consulting fees, and facility expenses supporting Evelo’s growing organization and public company infrastructure.
•
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $(15.9) million for the three months ended September 30, 2018, or $(0.50) per basic and diluted share, as compared to a net loss attributable to common stockholders of $(9.9) million for the three months ended September 30, 2017, or $(2.61) per basic and diluted share.

On November 1, 2018 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it will present data from three accepted abstracts related to MEI Pharma’s clinical stage drug development programs at the 2018 ASH (Free ASH Whitepaper) Annual Meeting to be held December 1-4, 2018 in San Diego (Press release, MEI Pharma, NOV 1, 2018, View Source [SID1234530572]).

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Study investigators will present updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma and other indolent B-cell malignancies, as well as results from a preclinical study demonstrating that voruciclib and venetoclax synergistically induce apoptosis in acute myeloid leukemia (AML) cells in vitro. The third abstract will present data from the pracinostat program, being developed in partnership with Helsinn Healthcare, SA, and will highlight an interim analysis of pracinostat in an ongoing Phase 2 study evaluating patients with high/very high-risk myelodysplastic syndrome (MDS).

"Data reported at the ASH (Free ASH Whitepaper) Annual Meeting this year continue to highlight the depth of our clinical pipeline and the progress across multiple programs, each with its own distinct mechanisms for targeting cancer biology," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Notably, the ME-401 data to be reported is supportive of our approach to evaluate both a continuous and intermittent dosing schedule in our Phase 2 study planned to start around year-end in an effort to maximize the utility of the candidate as both a single agent or in combination with other therapies."

Dr. Gold continued: "We also look forward to highlighting the preclinical data demonstrating that our CDK9 inhibitor candidate, voruciclib, synergistically enhances cancer cell death when combined with venetoclax in AML cells in vitro, adding to earlier data showing similar synergies in CLL and DLBCL preclinical models. These results are supportive of possible future studies evaluating voruciclib in combination with venetoclax in relapsed AML."

Poster Presentations at ASH (Free ASH Whitepaper) 2018

Title: Preliminary Safety and Efficacy Results with an Intermittent Schedule of the PI3K delta Inhibitor ME-401 Alone or in Combination with Rituximab for B-Cell Malignancies
Date & Time: December 2, 2018, 6:00 p.m. – 8:00 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 115670
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
Author: Andrew D. Zelenetz, M.D., Ph.D., Medical Director, Quality Informatics at Memorial Sloan Kettering Cancer Center

Title: Voruciclib, an Oral, Selective CDK9 Inhibitor, Enhances Cell Death Induced by the Bcl-2 Selective Inhibitor Venetoclax in Acute Myeloid Leukemia
Date & Time: December 1, 2018, 6:15 p.m. – 8:15 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 118372
Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster I
Author: Daniel A. Luedtke, BS, Wayne State University School of Medicine, Cancer Biology Graduate Program

Title: Planned Interim Analysis of a Phase 2 Study Evaluating the Combination of Pracinostat, a Histone Deacetylase Inhibitor (HDACi), and Azacitidine in Patients with High/Very High-Risk Myelodysplastic Syndrome (MDS)
Date & Time: December 3, 2018, 6:00 p.m. – 8:00 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 112741
Session: 637. Myelodysplastic Syndromes—Clinical Studies: Poster III
Author: Michael Keng, M.D., University of Virginia School of Medicine, Assistant Professor

Abstracts featured as part of the ASH (Free ASH Whitepaper) 2018 program may be found at: View Source

On November 1, 2018 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the third quarter ended September 30, 2018 and provided a business update (Press release, Radius, NOV 1, 2018, View Source [SID1234530571]).

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"I am very pleased with the continued strong trajectory of our launch and success in growing the U.S. anabolic osteoporosis market. Our financial guidance reflects our confidence in continuing to capture further market share gains for TYMLOS and expanding the osteoporosis anabolic market," said Jesper Hoeiland, President and Chief Executive Officer of Radius.

"With our updated Phase 3 protocol for elacestrant, we are excited to have the opportunity to address a larger patient population with unmet needs. We are on track to deliver on this key milestone and initiate the study in the fourth quarter of this year," said Dr. Charles Morris, Chief Medical Officer of Radius.

TYMLOS (abaloparatide) injection

Third quarter 2018 U.S. net sales of TYMLOS were $27.6 million, a 22% increase over the prior quarter and approximately sevenfold increase from the third quarter of 2017. TYMLOS prescriptions in the third quarter of 2018 accounted for 22% of the total U.S. anabolic osteoporosis market on average (based on Patient Months on Therapy, TRx PMOT).

In October 2018, the U.S. Food and Drug Administration (FDA) approved a labeling supplement for TYMLOS to include additional information from the ACTIVExtend study. The labeling now reflects that after 24 months of open-label alendronate therapy, the vertebral fracture risk reduction achieved with TYMLOS therapy was maintained.

The growth trajectory of the U.S. anabolic market since TYMLOS launched in May 2017 continued in the third quarter of 2018, showing 9% volume growth as compared to the third quarter of 2017, all driven by TYMLOS.

Effective January 1, 2019, TYMLOS is expected to be covered for approximately 274 million U.S. insured lives, representing approximately 95% of U.S. commercial and 64% of Medicare insured lives. 2019 Medicare Part D coverage for TYMLOS increased to approximately 26.2 million lives or 64% of those enrolled in Medicare Part D plans in the U.S., after the decisions from SilverScript Insurance Company (CVS), WellCare Health Plans, Inc., Prime Therapeutics and others to cover TYMLOS for their Medicare Part D beneficiaries. The increased access for TYMLOS in Medicare Part D Formularies for 2019 represents an incremental 28% of anabolic volume opportunity in Medicare Part D. Express Scripts, Inc., UnitedHealthcare (AARP), Kaiser Permanente, and EnvisionRx, among others, decided to continue Medicare Part D coverage of TYMLOS through 2019.

Radius maintains its guidance for TYMLOS to capture on average 19-21% of the U.S. anabolic osteoporosis market in 2018 and its expectations for the U.S. anabolic market to grow at a rate of 7-9% in volume versus 2017.

Financial Guidance

In 2018, Radius expects full-year TYMLOS U.S. net revenues to be between $95 to $98 million and its year-end cash, cash equivalents and investments balance to exceed $220 million.

In 2019, Radius expects full-year TYMLOS U.S. net revenues to be between $155 to $175 million and its year-end cash, cash equivalents and investments balance to exceed $100 million.

Pipeline Highlights

Abaloparatide-Transdermal Patch (abaloparatide-patch)

Radius remains on track with its preparations for the Phase 3 trial and expects to start the study in mid-2019. The Company is in the process of conducting development activities in preparation for the Phase 3 trial and potential NDA filing, including qualification and validation of analytical methods, process development and design control activities. Planning for the facility build-out is also ongoing at the commercial manufacturing site, including scaling up equipment and ensuring readiness for the manufacture of commercial abaloparatide-patches.

Elacestrant (RAD1901)

In the third quarter 2018, the Company finalized the Phase 3 study protocol for elacestrant based on regulatory feedback and additional considerations. The Phase 3 trial will be a single, randomized, open label, active-controlled study of elacestrant as a second- or third-line monotherapy in approximately 460 patients with ER+/HER2- advanced/metastatic breast cancer who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients in the study will be randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study will be progression-free survival ("PFS"), which the Company will analyze in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints will include evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR). Depending on the results, this single trial is intended to support applications for marketing approvals for elacestrant as a second- and third-line monotherapy in the U.S., European Union (EU), and other markets.

Radius expects to initiate the Phase 3 study in the fourth quarter of 2018 with a planned recruitment period of 18-21 months and potential data read-out in 2021.

RAD140

Patient enrollment is ongoing in the Phase 1 study evaluating the safety and maximum tolerated dose of RAD140, a nonsteroidal selective androgen receptor modulator (SARM), in patients with hormone receptor-positive, locally advanced or metastatic breast cancer. The Company expects to present two posters on RAD140 at the San Antonio Breast Cancer Symposium (SABCS) and to provide an update on the RAD140 Phase 1 development program by the end of 2018.

Anticipated Upcoming Milestones

Elacestrant

Initiate a Phase 3 clinical trial as second or third-line monotherapy in advanced/metastatic ER-positive/HER2-negative breast cancer patients in the fourth quarter of 2018

Clinical collaboration agreement for elacestrant combination therapy

RAD140

Continue enrollment in the Phase 1 study and provide a program update by the end of 2018

Abaloparatide

Enter into a partnership for the potential commercialization of abaloparatide-SC outside the U.S. and Japan

Expected Radius Presentations at Upcoming Conferences

On January 7-10, 2019, the Company will present and host one-on-one meetings at the JP Morgan Annual Healthcare Conference in San Francisco.

Third Quarter 2018 Financial Results

Three Months Ended September 30, 2018

For the three months ended September 30, 2018, Radius reported a net loss of $49.8 million, or $1.09 per share, compared to a net loss of $57.8 million, or $1.31 per share, for the three months ended September 30, 2017.

For the three months ended September 30, 2018, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, non-cash interest obligations under debt obligations, and amortization of intangible assets, was $38.8 million, or $0.85 per share, compared to non-GAAP adjusted net loss of $49.3 million, or $1.12 per share, for the three months ended September 30, 2017.

For the three months ended September 30, 2018, TYMLOS net product revenues were $27.6 million compared to approximately $3.5 million for the three months ended September 30, 2017.

Research and development expense for the three months ended September 30, 2018 was $26.8 million compared to $21.0 million for the three months ended September 30, 2017, an increase of $5.8 million, or 28%. This increase was primarily driven by a $2.8 million increase in elacestrant project costs, a $2.3 million increase in abaloparatide-patch project costs, a $1.0 million increase in abaloparatide-SC project costs, and a $0.8 million increase in RAD140 project costs. These increases were partially offset by a $0.2 million decrease in other project related spending, and $0.5 million decrease in personnel related spending attributed to a decrease in headcount from 105 research and development employees as of September 30, 2017 to 95 research and development employees as of September 30, 2018.

For the three months ended September 30, 2018, selling, general and administrative expense was $43.7 million compared to $47.7 million for the three months ended September 30, 2017, a decrease of $4.1 million, or 9%. This decrease was primarily the result of $2.8 million and $0.9 million decreases in compensation and travel related expenses, respectively.

Nine Months Ended September 30, 2018

For the nine months ended September 30, 2018, Radius reported a net loss of $180.2 million, or $3.98 per share, compared to a net loss of $183.2 million, or $4.21 per share, for the nine months ended September 30, 2017.

For the nine months ended September 30, 2018, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, non-cash interest obligations under debt obligations, litigation related payments, and amortization of intangible assets, was $134.4 million, or $2.97 per share, compared to non-GAAP adjusted net loss of $154.2 million, or $3.54 per share, for the nine months ended September 30, 2017.

For the nine months ended September 30, 2018, TYMLOS net product revenues were $64.8 million compared to approximately $4.4 million for the nine months ended September 30, 2017.

Research and development expense for the nine months ended September 30, 2018 was $76.0 million compared to $60.2 million for the nine months ended September 30, 2017, an increase of $15.8 million, or 26%. This increase was primarily driven by a $7.6 million increase in elacestrant project costs, a $4.0 million increase in abaloparatide-SC project costs, a $3.8 million increase in abaloparatide-patch project costs, and a $2.1 million increase in RAD140 project costs. These increases were partially offset by a $0.7 million decrease in other project related spending and a $0.9 million decrease in compensation and travel related expenses attributed to a decrease in headcount from 105 research and development employees as of September 30, 2017 to 95 research and development employees as of September 30, 2018.

Selling, general, and administrative expense for the nine months ended September 30, 2018, was $140.3 million compared to $135.9 million for the nine months ended September 30, 2017, an increase of $4.3 million, or 3%. This increase was primarily the result of $2.5 million and $0.7 million increases in compensation and travel related expenses, respectively attributed to an increase in headcount from 361 selling, general and administrative employees as of September 30, 2017 to 384 selling, general and administrative employees as of September 30, 2018. Additionally, there was a $0.8 million increase in professional fees and other operating expenses.

As of September 30, 2018, Radius had $276.9 million in cash, cash equivalents, restricted cash, marketable securities and investments. Based upon our cash, cash equivalents, marketable securities and investments balance as of September 30, 2018, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for not less than twelve months from the date of this press release.

Webcast and Conference Call

In connection with today’s reporting of Third Quarter Financial Results, Radius will host a conference call and live audio webcast at 8:00 a.m. ET today, November 1, 2018, to discuss the commercial outlook for TYMLOS, review the financial results and provide a Company update.

Conference Call Information:

Date: November 1, 2018

Time: 8:00 a.m. ET

Domestic Dial-in Number: (866) 323-7965

International Dial-in Number: (346) 406-0961

Conference ID: 3875777

Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available from November 1, 2018 at 11:00 a.m. ET and will be archived on the Company’s website for 90 days. To access the replay, dial (855) 859-2056 for U.S. or (404) 537-3406 for International, using conference ID number 3875777.

A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement and financial results will also be available on the Company’s website.

Use of Non-GAAP Financial Measures
To supplement our condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), we use the following non-GAAP financial measures: non-GAAP adjusted net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with Radius’ GAAP financial statements, because it provides greater transparency regarding Radius’ operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Radius’ operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three and nine months ended September 30, 2017 and 2018 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.