On May 8, 2019 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that the Company’s management team will participate in the following upcoming investor conferences (Press release, Karyopharm, MAY 8, 2019, View Source [SID1234535930]):

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The Bank of America Merrill Lynch Health Care Conference 2019 on Wednesday, May 15, 2019.

The 2019 RBC Capital Markets Global Healthcare Conference on Wednesday, May 22, 2019, and will present at 2:05 p.m. ET.
A live webcast of the RBC presentation can be accessed on the "Events & Presentations" page in the Investors section of the Company’s website, View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On May 8, 2019 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended March 31, 2019, and provided an update on recent clinical developments (Press release, Scynexis, MAY 8, 2019, View Source [SID1234535964]).

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"We are encouraged by the positive interim results and patient cases from our ongoing studies evaluating oral ibrexafungerp in severe and difficult-to-treat fungal infections," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We also continue to advance oral ibrexafungerp in our ongoing Phase 3 VANISH study in patients with VVC, with the goal of sharing top-line data in the first half of 2020. In parallel, with the positive results seen in our complete reproductive and developmental toxicology package, we are moving closer to a potential New Drug Application (NDA) submission for VVC in the second half of 2020."

Ibrexafungerp (formerly SCY-078), the first representative of a novel family of compounds referred to as triterpenoids, is being developed for oral and intravenous administration and is in clinical development for the treatment of several serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, ibrexafungerp would be the only oral alternative to azoles for the treatment of VVC and prevention of recurrent VVC.

Ibrexafungerp Update

Data presented at the 2019 American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting (ACOG) support a future NDA submission of oral ibrexafungerp for the treatment of VVC and highlight potential differentiation versus VVC standard-of-care.
Pre-clinical studies, conducted as part of a full reproductive and developmental toxicity package, showed that ibrexafungerp did not cause reproductive harm to adult animals or developmental harm to offspring. These findings are extremely meaningful for women with VVC, often of child-bearing age, and can differentiate oral ibrexafungerp against fluconazole, which has a warning for potential risks of spontaneous abortion and congenital abnormalities in its prescribing information.
Additional data presented further support the utility of ibrexafungerp as a treatment for VVC, including clinical results from a prior Phase 2b dose-finding study of oral ibrexafungerp in patients with VVC and preclinical data demonstrating in vitro activity against fluconazole-resistant Candida spp.
All ACOG 2019 posters and presentations can be found on the SCYNEXIS website.

SCYNEXIS is currently enrolling patients in the VANISH Phase 3 registration program evaluating the safety and efficacy of oral ibrexafungerp in patients with acute VVC and is on track to initiate a planned Phase 3 trial for the prevention of recurrent VVC (the CANDLE study) in the second quarter of 2019.

New data from six presentations at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) shows favorable clinical activity in difficult-to-treat fungal infections, including Candida auris.
An oral presentation showcased results from the first interim analysis of 20 patients with various Candida infections from the FURI study, an open-label trial of oral ibrexafungerp in patients with refractory fungal infections. Oral ibrexafungerp demonstrated a clinical benefit in 17 of the 20 patients, with 11 patients achieving a complete or partial response and six patients achieving a stable disease response. Enrollment in the study continues to progress in the U.S. and Europe.
A poster presentation highlighted clinical findings for two patients with Candida auris candidemia enrolled in the CARES study, who were successfully treated with oral ibrexafungerp. Candida auris is a pathogen defined by the Centers for Disease Control and Prevention (CDC) as "an emerging fungus that presents a serious global health threat."
Preliminary results from the FURI and CARES studies build toward a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).
All ECCMID 2019 posters and presentations can be found on the SCYNEXIS website.
First Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $39.1 million as of March 31, 2019, with net working capital of $35.4 million.

Research and development expenses increased to $9.7 million for the quarter ended March 31, 2019, compared to $5.3 million in the first quarter of 2018. The increase of $4.4 million, or 82%, was primarily driven by a milestone payment made during the quarter upon initiation of the Phase 3 VVC registration study, an increase of $1.1 million in clinical development, and a net increase of $0.5 million in other research and development expenses, offset in part by a decrease of $0.5 million in chemistry, manufacturing, and controls (CMC) and a decrease of $0.7 million in preclinical development expense.

Selling, general and administrative expenses in the first quarter of 2019 increased to $2.2 million, compared with $2.0 million in the first quarter of 2018.

Total other expense was $11.0 million in the first quarter of 2019, compared to total other income of $3.2 million in the first quarter of 2018. The increase in other expense is attributable to the non-cash losses recognized during the first quarter of 2019 of $6.5 million and $3.4 million associated with the fair value adjustments for warrant liabilities and derivative liability, respectively. Additionally, during the first quarter of 2019, we recognized a loss on extinguishment of debt of $0.8 million.

Net loss for the first quarter of 2019 was $22.9 million, or $0.46 per share. This compares with a net loss for the first quarter of 2018 of $4.0 million, or $0.12 per share.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel family of compounds referred to as "fungerps" (antifungal triterpenoids). This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous formulations. Ibrexafungerp has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species, and is being evaluated in multiple clinical programs: the VANISH registration program for the treatment of VVC is enrolling, the Phase 3 trial for the prevention of recurrent VVC is being initiated in the second quarter of 2019, the SCYNERGIA Phase 2 trial for invasive aspergillosis (IA) and the FURI and CARES Phase 3 trials for the treatment of patients with refractory infections are ongoing. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), IA and VVC, and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On May 8, 2019 MaxCyte, the global clinical-stage cell-based therapies and life sciences company, reported that it has initiated dosing for the second cohort of patients in its US Phase I clinical trial with MCY-M11, the lead, wholly-owned, non-viral mRNA-based cell therapy candidate from its CARMA platform (Press release, MaxCyte, MAY 8, 2019, View Source [SID1234537620]). MCY-M11 is a mesothelin-targeting chimeric antigen receptor (CAR) therapy being tested in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma.

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The dose escalation trial is evaluating the safety and tolerability of MCY-M11 in approximately 15 patients across a series of cohorts.

"Successfully completing patient dosing in our first cohort and initiating dosing in a second higher-dose cohort are important milestones for MaxCyte, representing tangible progress for our lead CAR therapeutic and our proprietary CARMA autologous cell therapy platform," said Claudio Dansky Ullmann, MD, Chief Medical Officer. "We are very excited about the potential of MCY-M11 as a new, effective therapeutic in solid tumors where the majority of patients still have very limited treatment options."

The manufacturing process for MCY-M11 utilizes MaxCyte’s proprietary Flow Electroporation technology to transfect mRNA into fresh (i.e., unexpanded) peripheral blood mononuclear cells (PBMCs). This streamlined, faster manufacturing process for an autologous cell therapy is an important differentiator from other CAR technologies. In addition, the CARMA platform’s utilization of Flow Electroporation rather than viral vectors enables repeat dosing of patients, a feature that may be key for the successful treatment of solid tumors with a cell therapy. Another distinguishing feature of MaxCyte’s CARMA platform is the insertion of the CAR as mRNA into cells rather than as DNA. The transient nature of mRNA could help alleviate some of the safety limitations of other CAR treatment approaches.

About the Phase I Clinical Trial
The multi-center, non-randomized, open label, dose-escalation Phase I clinical trial is evaluating the safety and effectiveness of intraperitoneal infusions of MCY-M11 in individuals with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube, or individuals with advanced peritoneal mesothelioma with recurrence after prior chemotherapy. MaxCyte anticipates approximately 15 study participants will be enrolled across the two clinical sites participating in the study (the National Cancer Institute at the National Institutes of Health (NIH) and Washington University at St. Louis). More information about the study can be found at ClinicalTrials.gov.

About the CARMA Platform
CARMA is the autologous, mRNA-based CAR therapeutic platform developed by MaxCyte, Inc. that can be applied toward a broad range of diseases, including solid tumors. Utilizing a streamlined manufacturing process, CARMA allows for a faster turnaround of cell therapy to patients compared to traditional CAR therapies and works to trigger a patient’s own immune system to fight disease. MaxCyte’s first CARMA drug candidate, MCY-M11, is currently in a Phase I clinical trial in individuals with advanced ovarian cancer and peritoneal mesothelioma. More information on MaxCyte’s CARMA platform and pipeline is available at www.maxcyte.com/car/

On May 8, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca reported positive topline results for the pivotal phase 2 DESTINY-Breast01 trial of [fam-] trastuzumab deruxtecan (DS-8201) (Press release, Daiichi Sankyo, MAY 8, 2019, View Source [SID1234535903]). The HER2 targeting antibody drug conjugate (ADC) was evaluated in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine (T-DM1).

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The response rate in DESTINY-Breast01, as assessed by an independent review committee, confirms in a heavily-pretreated global patient population the unprecedented clinical activity in the recently published phase 1 trial. The safety and tolerability profile of [fam-] trastuzumab deruxtecan was also consistent with previous experience. These results are expected to support planned global regulatory submissions, including the Biologics License Application with the U.S. Food and Drug Administration (FDA) anticipated in the first half of fiscal year 2019.

DESTINY-Breast01 is a pivotal phase 2, open-label, global, multicenter, two-part trial of [fam-] trastuzumab deruxtecan. The optimal dose of 5.4 mg/kg was previously identified in part one of the trial. Today’s results from part two evaluated the efficacy and safety of that dose in patients who have failed or discontinued previous treatment with T-DM1.

"These results confirm our commitment to pursue accelerated regulatory pathways in HER2 positive metastatic breast cancer with [fam-] trastuzumab deruxtecan," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "We are more dedicated than ever to our comprehensive and ambitious development strategy evaluating the potential across a spectrum of HER2expressing cancers including breast, gastric, lung and colorectal."

"We are encouraged to see positive data from [fam-] trastuzumab deruxtecan, with the DESTINY-Breast01 trial now reinforcing what earlier data have shown," said José Baselga, Executive Vice President and President R&D Oncology, AstraZeneca. "We believe this antibody drug conjugate has the potential to redefine the treatment of patients with HER2 expressing cancers, and we are eager to bring it as quickly as possible to patients with refractory HER2 positive breast cancer who continue to have high unmet medical need."

[Fam-] trastuzumab deruxtecan has been granted U.S. FDA Breakthrough Therapy Designation and Fast Track Designation for HER2 positive patients in the advanced or refractory breast cancer setting. A recent publication in The Lancet Oncology reported long-term phase 1 safety and preliminary efficacy results in HER2 positive metastatic breast cancer. This investigational agent is currently in development for the treatment of multiple HER2 expressing cancers, including in patients with HER2 low expression.

Daiichi Sankyo and AstraZeneca plan to present the data from DESTINY-Breast01 at an upcoming medical meeting.

About HER2

HER2 is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells that is associated with aggressive disease and poorer prognosis in breast cancer patients.[1] To be considered HER2 positive, tumor cancer cells are usually tested by one of two methods: immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH).IHC test results are reported as: 0, IHC 1+, IHC 2+, or IHC 3+.1 A finding of IHC 3+ and/or FISH amplification is considered positive.1There are currently no targeted therapies for HER2 FISH negative, IHC 2+ or IHC 1+ tumors.

Unmet Need in HER2 Positive Breast Cancer

Approximately one in five breast cancers are HER2 positive.[2]Several unmet treatment needs remain today in HER2 positive metastatic breast cancer. Many HER2 positive breast cancers eventually advance to the point where no currently approved HER2 targeting medicine continues to control the disease;[3] after treatment with trastuzumab, pertuzumab, and T-DM1, optimal treatment is less clearly defined, and choices may be limited.[4]

About DESTINY-Breast01

DESTINY-Breast01 is a pivotal phase 2, open-label, global, multicenter, two-part trial evaluating the safety and efficacy of [fam-] trastuzumab deruxtecan in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with T-DM1. The primary endpoint of the trial is objective response rate. Secondary objectives include duration of response, disease control rate, clinical benefit rate, progression-free survival and overall survival.

The first part of the trial includes a pharmacokinetic stage and a dose-finding stage to identify the recommended dose of [fam-] trastuzumab deruxtecan to be evaluated in the second part of the trial. The second part enrolled patients into one of two cohorts: patients resistant or refractory to T-DM1 (part 2a) and patients who discontinued treatment with T-DM1 for reasons other than resistant or refractory disease (part 2b). Enrollment into DESTINY-Breast01 was completed in September 2018 with 253 patients at more than 100 sites across North America, Europe, Japan and other countries in Asia.

The safety and tolerability profile of [fam-] trastuzumab deruxtecan in DESTINY-Breast01 was consistent with the recently published phase 1 trial, in which the most common adverse events (≥30 percent, any grade) included nausea, decreased appetite, vomiting, alopecia, fatigue, anemia, diarrhea, and constipation. Cases of drug-related pneumonitis, including grade 5 events, have also been reported in the clinical development program.

About [Fam-] Trastuzumab Deruxtecan

[Fam-] trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in U.S. only; trastuzumab deruxtecan in other regions of world) is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise and the most advanced program in AstraZeneca’s ADC Scientific platform. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.

Designed using Daiichi Sankyo’s proprietary DXd ADC technology, [fam-] trastuzumab deruxtecan is comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

A broad and comprehensive development program with [fam-] trastuzumab deruxtecan is underway in North America, Europe and Asia, including five pivotal trials in HER2 expressing breast and gastric cancers, including in breast cancer patients with HER2 low expression. [Fam-] trastuzumab deruxtecan is also in phase 2 development for HER2 expressing advanced colorectal cancer and metastatic non-squamous HER2 overexpressing or HER2 mutated NSCLC, and phase 1 development in combination with nivolumab for HER2 expressing metastatic breast and bladder cancers.

[Fam-] trastuzumab deruxtecan was granted Breakthrough Therapy Designation in 2017 by the U.S. FDA for the treatment of patients with HER2 positive, locally-advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after T-DM1. Fast Track Designation was also granted in the U.S. for the treatment of HER2 positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2 targeted medicines, including T-DM1. Trastuzumab deruxtecan has received SAKIGAKE designation for the treatment of HER2 positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare.

[Fam-] trastuzumab deruxtecan is an investigational agent that has not been approved for any indication

in any country. Safety and efficacy have not been established.

About the Collaboration between Daiichi Sankyo and AstraZeneca

In March 2019, Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize [fam-] trastuzumab deruxtecan as a medicine worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: [fam-] trastuzumab deruxtecan, an antibody drug conjugate (ADC) for HER2 expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory FLT3-ITD acute myeloid leukemia (AML); and pexidartinib, an oral CSF1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.

On May 8, 2019 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS),reported its financial and operating results for the first quarter ended March 31, 2019 and provided a business update (Press release, Radius, MAY 8, 2019, View Source [SID1234535931]).

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"I am very pleased to see continued strong market share gains by TYMLOS, which we believe is poised to achieve anabolic leadership of new patient starts in the second half of 2019. Our first quarter sales set the stage for continued growth throughout the year as key new account wins come online and temporary Medicare Part D coverage gaps are satisfied," said Jesper Hoeiland, President and Chief Executive Officer of Radius. "We are confident in our ability to deliver on our full-year financial guidance and attain our goal of leadership in the anabolic market."

TYMLOS (abaloparatide) injection

First quarter 2019 U.S. net sales of TYMLOS were $29.8 million, a 105% increase from the first quarter of 2018. The anabolic market grew 6% in the first quarter of 2019 as compared to the first quarter of 2018.

First quarter 2019 TYMLOS U.S. net sales were impacted by anabolic market seasonality that showed lower volumes versus the fourth quarter of 2018, higher gross-to-net expenses due to the impact of the Medicare Part D coverage gap on manufacturers and increased support for commercial patient deductibles.

In the first quarter of 2019, TYMLOS continued to increase its market share and captured, on average, 30% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT) and 42% of new anabolic patient starts (NBRx). TYMLOS continued to increase its market share in April capturing a 34% share of the U.S. anabolic osteoporosis market and over 44% of new anabolic patient starts. During the second half of 2019, Radius expects TYMLOS to become the NBRx anabolic market leader by reaching over 50% of new patient starts. If achieved, the Company further expects this performance would translate to total TRx market leadership for TYMLOS during 2020.

At the end of the first quarter of 2019, TYMLOS was covered for approximately 283 million U.S. insured lives, representing approximately 99% of U.S. commercial, 67% of Medicare and 97% Medicaid/Other insured lives. After the decisions of SilverScript Insurance Company (CVS), WellCare Health Plans, Inc., and Prime Therapeutics to cover TYMLOS for their Medicare Part D beneficiaries in 2019, TYMLOS volume in new scripts from Medicare Part D business increased by 22% in the first quarter of 2019 as compared to the fourth quarter of 2018. Growth of TYMLOS volume in new scripts in the commercial business was also strong with a 17% increase in the first quarter of 2019 over the fourth quarter of 2018.

As of its second anniversary since commercial launch, more than 20,000 patients have received TYMLOS. In three separate network meta-analyses1 of approved osteoporosis treatments published in the first quarter 2019, TYMLOS showed strong efficacy results in vertebral and non-vertebral fracture risk reduction.

Radius presented a post-hoc subset analysis on postmenopausal osteoporosis patients with Type 2 diabetes from the Phase 3 ACTIVExtend Study at the American Association of Clinical Endocrinologists conference in April 2019. Among this subgroup of patients, abaloparatide for subcutaneous injection (abaloparatide-SC) treatment for 18 months followed by 25 months of alendronate therapy showed numerical reductions in the risk of vertebral, nonvertebral, clinical and major osteoporotic fractures and significant improvements in bone mineral density versus placebo followed by alendronate. Previously, in the ACTIVE Study cohort that included patients with Type 2 Diabetes, use of abaloparatide-SC for 18 months led to significant improvement in lumbar spine TBS (trabecular bone score), suggesting that abaloparatide-SC improved bone microarchitecture. As the incidence of both Type 2 diabetes and osteoporosis increase with age, they frequently coexist and represent a high unmet medical need population with a lower diagnosis rate for osteoporosis, compromised bone quality and higher fracture risk.

Moreno PB, Kapoor Asi N, et al. Efficacy of pharmacological therapies for the prevention of fractures in postmenopausal women; a network meta-analysis; J Clin Endocrinol Metab. 2019; 104(5)

Abaloparatide for risk reduction of nonvertebral and vertebral fractures in postmenopausal women with osteoporosis: a network meta-analysis Reginster et Al;Osteoporosis International 2019

Drug efficacies on bone mineral density and fracture rate for the treatment of postmenopausal osteoporosis: a network meta-analysis. Yang et Al; Review for Medical and Pharmacological Sciences 2019

Financial Guidance

Radius tightens its full-year 2019 financial guidance for TYMLOS U.S. net sales from $155 to $175 million to $160 to $175 million and increases guidance for its year-end cash, cash equivalents and investments balance from over $100 million to over $110 million.

Pipeline Highlights

Abaloparatide-Transdermal Patch (abaloparatide-patch)

In the first quarter of 2019, Radius made continued progress in its readiness for clinical supplies for its planned Phase 3 study, reaching targeted scale-up of production and completing analytical method validations. Clinical supplies are planned to be manufactured in the second quarter of 2019 for the Phase 3 study, which the Company expects to initiate in August 2019.

Anticipated Milestones in 2019

Abaloparatide-patch

Initiate Phase 3 study in August 2019

Elacestrant

Advance recruitment in Phase 3 EMERALD monotherapy study

Global co-development/co-commercialization partnership for elacestrant

Initiate a combination trial for elacestrant in conjunction with a partner

TYMLOS/Financial

Grow full-year TYMLOS U.S. net sales to between $160M to $175M

Deliver a strong balance sheet with greater than $110M cash, cash equivalents and investments balance at year-end

Expected Radius Presentations at Upcoming Conferences in Q2 2019

On May 16, 2019, the Company will present and host one-on-one meetings at the Bank of America Merrill Lynch 2019 Health Care Conference in Las Vegas.

On June 11-13, 2019, the Company will host one-on-one meetings at the Goldman Sachs 40th Annual Global Healthcare Conference in Palos Verdes, CA.

First Quarter 2019 Financial Results

Three Months Ended March 31, 2019

For the three months ended March 31, 2019, Radius reported a net loss of $42.8 million, or $0.94 per share, compared to a net loss of $61.6 million, or $1.37 per share, for the three months ended March 31, 2018.

For the three months ended March 31, 2019, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $31.8 million, or $0.70 per share, compared to non-GAAP adjusted net loss of $50.1 million, or $1.11 per share, for the three months ended March 31, 2018.

For the three months ended March 31, 2019, TYMLOS net product revenues were $29.8 million compared to approximately $14.5 million for the three months ended March 31, 2018.

Research and development expense for the three months ended March 31, 2019 was $23.3 million compared to $22.9 million for the three months ended March 31, 2018, an increase of $0.4 million, or 2%. This increase was primarily driven by a $3.1 million increase in elacestrant project costs, a $1.8 million increase in abaloparatide-patch project costs, and a $0.4 million increase in abaloparatide-SC project costs. These increases were partially offset by a $1.2 million decrease in other project related spending, a $0.5 million decrease in occupancy and depreciation costs, a $0.1 million decrease in other operating and support costs, and a $3.1 million decrease in personnel related spending attributed to a decrease in headcount from 131 research and development employees as of March 31, 2018 to 95 research and development employees as of March 31, 2019.

For the three months ended March 31, 2019, selling, general and administrative expense was $41.2 million compared to $48.0 million for the three months ended March 31, 2018, a decrease of $6.8 million, or 14%. This decrease was primarily the result of a $4.6 million decrease in compensation related expenses attributed to a decrease in headcount from 405 selling, general, and administrative employees as of March 31, 2018 to 284 selling, general, and administrative employees as of March 31, 2019, a $2.5 million decrease in travel and expense related costs, and a $0.3 million decrease in other operating costs. These decreases were partially offset by a $0.4 million increase in occupancy and depreciation expenses and a $0.2 million increase in professional fees and support costs.

As of March 31, 2019, Radius had $204.7 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of March 31, 2019, 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 at least twelve months from the date of this press release.

Webcast and Conference Call

In connection with today’s reporting of First Quarter 2019 Financial Results, Radius will host a conference call and live audio webcast at 8:00 a.m. ET today, May 8, 2019, to discuss the commercial outlook for TYMLOS, review the financial results and provide a Company update.

Conference Call Information:

Date: May 8, 2019

Time: 8:00 a.m. ET

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

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

Conference ID: 5856126

Live webcast:
View Source

For those unable to participate in the conference call or webcast, a replay will be available on Wednesday, May 8, 2019 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 5856126.

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 in this press release: 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 and period-over-period comparability with respect to Radius’ operating performance and can enhance investors’ ability to identify operating trends in our business. 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 months ended March 31, 2018 and 2019 are

included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.