On August 7, 2019 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer, reported its second quarter 2019 financial results and corporate highlights (Press release, Kezar Life Sciences, AUG 7, 2019, View Source [SID1234538299]).

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"I’m proud of the tremendous progress made by the team over the quarter, culminating with the first-in-patient data reported with KZR-616," said John Fowler, Chief Executive Officer. "The broad therapeutic potential demonstrated thus far by KZR-616 reinforces our view that selective immunoproteasome inhibition can target multiple autoimmune diseases. To that end, in addition to having initiated the Phase 2 portion of the MISSION study in lupus nephritis patients, we are pleased to announce that the Phase 2 PRESIDIO and MARINA trials have commenced in four additional autoimmune indications—dermatomyositis, polymyositis, autoimmune hemolytic anemia, and immune thrombocytopenia. Furthermore, we remain on-track to nominate the first oncology clinical candidate from our novel protein secretion program before the end of the year."

Recent Clinical and Business Highlights

KZR-616 (Selective Immunoproteasome Inhibitor)

MISSION Study

The Phase 1b/2 MISSION study in systemic lupus erythematosus (SLE) patients with and without nephritis is currently ongoing.

We reported promising data with KZR-616 in patients with SLE at the European League Against Rheumatism (EULAR) 2019 Annual Meeting. Initial data were reported from 3 cohorts of the open-label dose escalation portion of the trial (Phase 1b). The study met its objectives by establishing the safety and tolerability of KZR-616 and identifying doses to advance into our Phase 2 clinical trials.

Enrollment to the Phase 1b portion of the MISSION study is ongoing and updated data from cohorts testing step-up dosing to a 60 mg dose are expected in Q4 2019.

The Phase 2 portion of the MISSION study, which is evaluating KZR-616 for the treatment of lupus nephritis (LN), was initiated.

PRESIDIO Study

We recently initiated the PRESIDIO study (NCT04033926). This is a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, PK and PD of treatment with KZR-616 in patients with active dermatomyositis (DM) or polymyositis (PM). The trial is expected to enroll 24 patients with either DM or PM.

MARINA Study

We recently initiated the MARINA study (NCT04039477). MARINA is a Phase 2 randomized, dose-blind, multicenter study to evaluate the safety and efficacy of KZR-616 in the treatment of patients with autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). The trial is expected to enroll 40 patients with either AIHA or ITP.

Protein Secretion Program (Sec61 translocon modulation)

Our research and discovery efforts targeting the protein secretion pathway as a potential therapy for oncology indications is progressing well, and we remain on track to nominate a first clinical candidate before the end of the year.

Management Update

Kezar announced today that Niti Goel, MD, Chief Medical Officer, will be departing the company following a transition period ending October 1, 2019.

"On behalf of the Executive Team and Board of Directors, I would like to sincerely thank Niti for her contributions during her tenure at Kezar," said John Fowler, Chief Executive Officer. "Niti’s exceptional skill designing innovative clinical trials and her unwavering commitment to patients has positioned KZR-616 for success in our Phase 2 studies and will be missed."

Financial Results

Cash, cash equivalents and marketable securities totaled $93.4 million as of June 30, 2019, compared to $107.4 million as of December 31, 2018. The decrease in cash, cash equivalents and marketable securities was primarily attributable to cash used by the company in operations to advance its clinical stage programs as well as preclinical research and development.

Research and development expenses for the second quarter of 2019 increased by $1.7 million to $6.9 million from $5.2 million in the second quarter of 2018. This increase was primarily related to advancing both the KZR-616 clinical program across indications and the protein secretion preclinical program.

General and administrative expenses for the second quarter of 2019 increased by $0.7 million to $2.4 million from $1.7 million in the second quarter of 2018. The increase was primarily due to an increase in personnel expenses and costs related to operating as a public company.

Net loss for the second quarter of 2019 was $8.7 million, or $0.46 per basic and diluted common share, compared to a net loss of $6.8 million, or $3.31 per basic and diluted common share, for the second quarter of 2018.

Total shares outstanding were 19.1 million as of June 30, 2019. Additionally, there were outstanding options to purchase 2.9 million shares of common stock at a $8.02 weighted average exercise price as of June 30, 2019.

About KZR-616

KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Nonclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Phase 1a clinical trial results in healthy volunteers provide evidence that KZR-616 potentially avoids adverse effects caused by currently marketed non-selective proteasome inhibitors, which we believe prevent them from being utilized as a chronic treatment in autoimmune disorders. Phase 2 trials have commenced for the treatment of lupus nephritis (MISSION study), dermatomyositis and polymyositis (PRESIDIO study), and autoimmune hemolytic anemia and immune thrombocytopenia (MARINA study).

About Protein Secretion

We are conducting research and discovery efforts targeting protein secretion pathways as potential therapies for oncology and immuno-oncology indications. In mammalian cells, the secretion of proteins such as cytokines and the expression of cell surface transmembrane proteins such as cytokine receptors involve a process called cotranslational translocation. For most proteins, this process occurs via the Sec61 translocon, a highly conserved multi-subunit protein complex found in the membrane of the endoplasmic reticulum of all cells. Inhibition of the Sec61 translocon with small molecules blocks the secretion of some or all proteins, which can result in several physiologic outcomes, including altered cellular function, inhibition of cytokine release and/or cell death. We believe this platform has the potential to yield oral small molecule alternatives to currently marketed biologic therapeutics, to act as cytotoxic anti-cancer agents or to block the secretion of novel targets of interest in immuno-oncology or inflammation.

On August 7, 2019 Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the second quarter ended June 30, 2019 (Press release, Syndax, AUG 7, 2019, View Source [SID1234538298]). In addition, the Company provided a clinical and business update. As of June 30, 2019, Syndax had $80.5 million in cash, cash equivalents and short-term investments.

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"The FDA’s recent clearance of our IND application for SNDX-5613, a potent, highly selective, oral Menin inhibitor, marks an important milestone not only for Syndax, but also for patients suffering with acute leukemias," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "The Menin-MLL interaction has been strongly implicated in the development of MLL-r and NPM1 mutant leukemias. We look forward to initiating the clinical program and anticipate establishing a safe dose that provides appropriate target coverage in patients."

Dr. Morrison added, "We look forward to the near-term completion of E2112, the Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we anticipate will occur either in the fourth quarter of 2019 or the first half of 2020. A positive survival benefit at either assessment will enable us to file an NDA with the FDA and take us one step closer to improving outcomes for patients with this difficult to treat disease."

Pipeline Updates

Entinostat

In May 2019, Syndax announced that the E2112 trial passed its fourth interim overall survival (OS) analysis and will continue as planned until either an OS benefit is observed, or the final target number of events occur. E2112 is Syndax’s NCI-sponsored, ECOG-ACRIN led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer.

The Company continues to anticipate the final E2112 interim OS analysis in 4Q19. If necessary, the final OS assessment, which will be triggered when the trial reaches a total of 410 death events, is expected to be conducted in 2Q20. A positive OS assessment at any point would enable the Company to file for full regulatory approval. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+, HER2- breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a strong OS benefit.

SNDX-5613

In July 2019, Syndax announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application to begin a Phase 1/2 trial for SNDX-5613, a highly selective Menin inhibitor. The Company will refer to the clinical development of SNDX-5613 as the AUGMENT Program. The Phase 1/2 open-label trial will assess orally administered SNDX-5613 in adults with relapsed/refractory (R/R) acute leukemias. The Phase 1 dose escalation portion of the study will evaluate the safety, tolerability and pharmacokinetics of SNDX-5613, and will seek to establish a recommended Phase 2 dose. The Phase 2 portion will evaluate efficacy, as defined by Complete Response rate (per International Working Group response criteria), across three expansion cohorts: MLL-rearranged (MLL-r) acute lymphoblastic leukemia (ALL), MLL-r acute myeloid leukemia (AML), and NPM1 mutant AML. The Company expects to report initial clinical data from the trial in 2020.

SNDX-6352

Enrollment continues in the Phase 1 dose escalation trial of SNDX-6352, Syndax’s anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD). The Company now anticipates results from this trial in the second half of 2020. The objectives of this trial are to evaluate the safety and preliminary efficacy of SNDX-6352 in cGVHD and to identify a recommended Phase 2 dose and schedule.

Corporate Updates

Syndax announced the appointment of Michael A. Metzger to its Board of Directors. Mr. Metzger has served as Syndax’s President and Chief Operating Officer since May 2015.

Second Quarter 2019 Financial Results

As of June 30, 2019, Syndax had cash, cash equivalents and short-term investments of $80.5 million and 31.6 million shares and share equivalents issued and outstanding.

Second quarter 2019 research and development expenses decreased to $12.3 million from $14.9 million. The second quarter decrease was primarily due to decreased development activities primarily in the ENCORE programs, and decreased CMC activities associated with SNDX-6352, partially offset by accrued milestone expenses associated with the development of SNDX-5613.

General and administrative expenses for the second quarter 2019 decreased to $3.5 million from $4.5 million. The decrease was primarily due to decreased professional fees and employee compensation expenses.

For the three months ended June 30, 2019, Syndax reported a net loss attributable to common stockholders of $14.9 million or $0.47 per share compared to $18.4 million or $0.74 per share for the prior year period.

Financial Guidance

Today the Company provided operating expense guidance for the third quarter and full year 2019. For the third quarter and full year 2019, research and development expenses are expected to be $11 to $12 million and $45 to $46 million, respectively, and total operating expenses are expected to be $15 to $16 million and $60 to $63 million, respectively.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Wednesday, August 7, 2019.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 8959885
Domestic Dial-in Number: 855-251-6663
International Dial-in Number: 281-542-4259
Live Webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

On August 7, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held, Friday, August 9, 2019 at 8:30 AM ET to discuss results for the second quarter of 2019 and provide a business outlook for the remainder of the year (Press release, TG Therapeutics, AUG 7, 2019, http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-second-quarter-2019 [SID1234538297]). Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer will host the call.

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Second Quarter 2019 Business Update Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for replay on the Company’s website, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

On August 7, 2019 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its second-quarter and six-month 2019 financial results (Press release, Constellation Pharmaceuticals, AUG 7, 2019, View Source [SID1234538296]).

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"2019 is a year of data for Constellation," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "We made multiple important data presentations in the second quarter that help to advance our vision of becoming a late-stage oncology development company, with an exciting pipeline of development and discovery programs.

"We look forward to providing further data updates in the second half of 2019 across our pipeline," Mr. Raythatha continued. "We remain deeply committed to delivering important new medicines to cancer patients around the world in order to reduce their suffering and improve their lives."

Program Updates

CPI-0610

Data presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) from the MANIFEST study suggest that CPI-0610 may have disease-modifying effects.

In addition to improvements in spleen volume and constitutional symptoms, the interim data suggest improvements in anemia, transfusion dependence, and bone marrow fibrosis.

Our vision for CPI-0610 is to create a differentiated treatment for MF in ruxolitinib-resistant patients and to transform standard of care as a first-line therapy. We have begun planning for pivotal trials.
EZH2 Franchise

Enrollment for the ProSTAR clinical trial for CPI-1205 continues on track.

We are enrolling patients in three cohorts:
— CPI-1205 + abiraterone in second-line mCRPC;
— CPI-1205 + enzalutamide in second-line mCRPC, randomized against enzalutamide alone; and
— CPI-1205 + enzalutamide in heavily pre-treated patients who have progressed after treatment with each of enzalutamide, abiraterone, and chemotherapy.

We plan to provide an update for ProSTAR in the fourth quarter and additional data in early 2020.

The IND for CPI-0209, our second-generation and potentially best-in-class EZH2 inhibitor, was filed and cleared by the FDA.

CPI-0209 could address additional patient populations beyond those targeted by first-generation EZH2 inhibitors.
Milestones

The Company anticipates achieving the following milestones during the second half of 2019:

CPI-0610 MANIFEST Study

Update spleen volume, symptom, and anemia data from about 40 ruxolitinib-resistant patients and bone-marrow-fibrosis changes from a subset of patients.

Update status of conversion from transfusion dependence to transfusion independence from about 16 ruxolitinib-resistant patients.

Disclose spleen volume and symptom data for 10-15 JAK-inhibitor-naïve (first-line) patients.
EZH2 Franchise

Dose the first patients in a Phase 1 clinical trial of CPI-0209.

Provide an update from the ProSTAR clinical trial of CPI-1205 across various patient contexts.
Second Quarter 2019 Financial Results

Cash, cash equivalents, and marketable securities as of June 30, 2019, were $98.1 million, a decline of 14.4% compared to December 31, 2018, primarily due to operating expenses.

Research and development (R&D) expenses increased 67.3% year over year to $16.0 million in the second quarter of 2019 mainly due to increased clinical trial expenses.

General and administrative (G&A) expenses grew 96.5% year over year to $4.9 million in the second quarter of 2019, primarily due to building out the organization of the company.

The net loss increased 73.9% year over year to $20.8 million for the second quarter of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 92.0% to $0.80 per share due to an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
First Half 2019 Financial Results

Research and development (R&D) expenses increased 63.0% year over year to $31.6 million in the first half of 2019, mainly due to increased clinical trial expenses.

General and administrative (G&A) expenses grew 94.5% year over year to $9.3 million in the first half of 2019, primarily due to building out the organization of the company.

The net loss increased 67.2% year over year to $40.2 million for the first half of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 92.9% to $1.56 per share due to an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
Financial Guidance

Constellation expects that cash, cash equivalents, and marketable securities as of June 30, 2019, will enable the Company to fund planned operating expenses and capital expenditure requirements until late third-quarter 2020.

On August 7, 2019 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the second quarter ended June 30, 2019 and provided a business update (Press release, Radius, AUG 7, 2019, View Source [SID1234538295]).

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"I am delighted to see continued market share growth of TYMLOS, which puts us on track to attain our goal of anabolic leadership of new patient starts in the second half of 2019," said Jesper Hoeiland, President and Chief Executive Officer of Radius. "Initiation of the Company’s Phase 3 abaloparatide-patch study has been a major milestone toward our mission of addressing the needs of osteoporosis patients."

TYMLOS (abaloparatide) injection

Second quarter 2019 U.S. net sales of TYMLOS were $41.0 million, an 81% increase from the second quarter of 2018. The anabolic market grew 4% in the first half of 2019 as compared to the first half of 2018.

In the second quarter of 2019, TYMLOS continued to increase its market share and captured, on average, 35% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT) and 46% of new anabolic patient starts (NBRx).

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.

Financial Guidance

Radius tightens its full-year 2019 financial guidance for TYMLOS U.S. net sales to $165 to $170 million and increases guidance for its year-end cash, cash equivalents and investments balance to over $120 million.

Pipeline Highlights

Abaloparatide-Patch

In July 2019, Radius obtained preliminary results from the abaloparatide-transdermal patch (abaloparatide-patch) patient assessment study which evaluated self-administration of abaloparatide-patch over 29 days in 22 postmenopausal women with low bone density. The patients were observed at a study site on the first, 15th and 29th day of the study. Top-line study results showed that patients were able to follow the instructions for use (IFU) and applied the patches with a 99.7% success rate. The data also measured patient acceptability and indicated changes in patient PINP (procollagen type I propeptide) levels. The mean subject acceptability score on a 5-point scale was ≥ 4.5 at each site visit. An exploratory assessment of PINP levels, a biomarker that indicates bone formation, compared the PINP results at one month in this study with the one-month results in the Phase 3 ACTIVE study of TYMLOS (abaloparatide injection). The PINP levels and baseline increase at one month in this study were consistent with those values seen with abaloparatide injection at one month in the ACTIVE trial. At baseline, the median PINP level was 50.5 ng/ml, increasing to a median value of 100.1 ng/ml at day 29. The median PINP values observed with abaloparatide injection in the ACTIVE study were 50.6 ng/ml at baseline and 100.5 ng/ml at one month.

On August 5, 2019, the first patient was randomized in the Phase 3 wearABLe clinical trial studying the safety and efficacy of abaloparatide-patch in the treatment of postmenopausal patients with osteoporosis at high risk for fracture.

Prior to initiating the study, the Company achieved a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the acceptability of the overall protocol design. An SPA agreement provides a concurrence with the FDA that the study can be considered adequate and well-controlled in support of a marketing application.

The wearABLe Phase 3 study is a pivotal, randomized, open label, active-controlled, bone mineral density ("BMD") non-inferiority bridging study that will evaluate the efficacy and safety of abaloparatide-patch versus TYMLOS (abaloparatide injection) in approximately 470 patients with postmenopausal osteoporosis at high risk of fracture. The primary endpoint of the study is the percentage of change in lumbar spine BMD at 12 months. Non-inferiority of abaloparatide-patch to abaloparatide injection will be concluded if the lower bound of the 2-sided 95% confidence interval for the estimated treatment difference (abaloparatide-patch minus abaloparatide injection) in the percentage change from baseline in lumbar spine BMD at 12 months is above -2.0%. A non-inferiority margin of 2% preserves ~77% of the historical effect of TYMLOS based on the data from the Phase 3 ACTIVE Study which showed placebo-adjusted increase in lumbar spine BMD of 9.1% (95% CI: 8.6%, 9.6%) at 12 months.

The wearABLe Phase 3 study is currently open for enrollment at multiple clinical sites. Radius plans to complete patient recruitment in this study by the end of 2019.

Anticipated Milestones in 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 $165M to $170M

Deliver greater than $120M cash, cash equivalents and investments balance at year-end

Expected Radius Presentations at Upcoming Conferences in Q2 2019

On September 5, 2019, the Company will host one-on-one meetings at the Citi’s 14th Annual Biotech Conference in Boston, MA.

On September 11, 2019, the Company will present and host one-on-one meetings at the Morgan Stanley 17th Annual Global Healthcare Conference in New York City, NY.

Second Quarter 2019 Financial Results

Three Months Ended June 30, 2019

For the three months ended June 30, 2019, Radius reported a net loss of $35.5 million, or $0.77 per share, compared to a net loss of $68.9 million, or $1.52 per share, for the three months ended June 30, 2018.

For the three months ended June 30, 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 $25.4 million, or $0.55 per share, compared to non-GAAP adjusted net loss of $44.6 million, or $0.98 per share, for the three months ended June 30, 2018.

For the three months ended June 30, 2019, TYMLOS net product revenues were $41.0 million compared to approximately $22.6 million for the three months ended June 30, 2018.

For the three months ended June 30, 2019, research and development expense was $27.2 million compared to $26.3 million for the three months ended June 30, 2018, an increase of $0.9 million, or 3%. This increase was primarily driven by a $5.0 million increase in abaloparatide-patch project costs, and a $0.5 million increase in abaloparatide-SC project costs. These increases were partially offset by a $0.7 million decrease in project costs for elacestrant, a $0.3 million decrease in professional costs, and a $3.6 million decrease in compensation expenses.

For the three months ended June 30, 2019, selling, general and administrative expense was $40.1 million compared to $48.6 million for the three months ended June 30, 2018, a decrease of $8.5 million, or 17%. This decrease was primarily the result of a $6.2 million decrease in compensation related expenses attributed to a decrease in headcount from 338 selling, general, and administrative employees as of June 30, 2018 to 289 selling, general, and administrative employees as of June 30, 2019, a $1.2 million decrease in professional costs, a $0.3 million decrease in travel and expense related costs, and a $0.8 million decrease in occupancy, depreciation, and other operating costs.

Six Months Ended June 30, 2019

For the six months ended June 30, 2019, Radius reported a net loss of $78.2 million, or $1.70 per share, compared to a net loss of $130.4 million, or $2.89 per share, for the six months ended June 30, 2018.

For the six months ended June 30, 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 $57.2 million, or $1.25 per share, compared to non-GAAP adjusted net loss of $94.7 million, or $2.10 per share, for the six months ended June 30, 2018.

For the six months ended June 30, 2019, TYMLOS net product revenues were $70.9 million compared to approximately $37.2 million for the six months ended June 30, 2018.

For the six months ended June 30, 2019, research and development expense was $50.4 million compared to $49.2 million for the six months ended June 30, 2018, an increase of $1.3 million, or 3%. This increase was primarily driven by a $6.8 million increase in abaloparatide-patch project costs, a $2.4 million increase in project costs for elacestrant, and a $0.9 million increase in abaloparatide-SC project costs. These increases were partially offset by a $1.2 million decrease in RAD140 project costs, a $0.5 million decrease in occupancy and depreciation costs, a $0.4 million decrease in other operating and support costs, and a $6.7 million decrease in compensation expenses.

For the six months ended June 30, 2019, selling, general and administrative expense was $81.3 million compared to $96.6 million for the six months ended June 30, 2018, a decrease of $15.3 million, or 16%. This decrease was primarily the result of a $10.8 million decrease in compensation related expenses attributed to a decrease in headcount from 338 selling, general, and administrative employees as of June 30, 2018 to 289 selling, general, and administrative employees as of June 30, 2019, a $2.8 million decrease in travel and expense related costs, a $1.0 decrease in professional fees, and a $1.0 million decrease in other operating costs. These decreases were partially offset by a $0.3 million increase in occupancy and depreciation expenses.

As of June 30, 2019, Radius had $189.0 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of June 30, 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.