On August 7, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the second quarter ended June 30, 2019 (Press release, G1 Therapeutics, AUG 7, 2019, View Source [SID1234538364]).

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"Our most advanced investigational therapy, trilaciclib, has demonstrated significant benefits for people being treated with chemotherapy for small cell lung cancer and triple-negative breast cancer. We are pleased that the FDA has granted Breakthrough Therapy Designation based on myelopreservation data in small cell lung cancer, an important step toward making trilaciclib available to these patients. We look forward to working with the FDA during our pre-NDA meeting next month. We have also initiated parallel discussions with the FDA regarding promising data in metastatic triple-negative breast cancer, which showed improved overall survival," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "In addition, we continue to make rapid progress across our pipeline, with emerging data suggesting that all three investigational therapies – trilaciclib, lerociclib and G1T48 – have the potential to improve outcomes for women with breast cancer and be used in early stages of their disease."

Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D, added, "We will present new data on trilaciclib, lerociclib and G1T48 at the upcoming ESMO (Free ESMO Whitepaper) congress. Of note, we will report the first clinical data from approximately 25 patients in a Phase 1 trial of G1T48, our oral selective estrogen receptor degrader. Based on data from this trial, we are planning to initiate a pivotal trial in 2020 with G1T48 for the treatment of ER+, HER2- breast cancer in combination with a CDK4/6 inhibitor."

Clinical, Regulatory and Corporate Updates

Breakthrough Therapy Designation (BTD) granted for trilaciclib based on myelopreservation data in small cell lung cancer (SCLC) patients; U.S. and European regulatory filings on track for 2020: The company has received BTD from the U.S. Food and Drug Administration (FDA) based on positive myelopreservation data in small cell lung cancer patients from three randomized Phase 2 clinical trials. The BTD program is designed to expedite development and review of drugs intended for serious or life-threatening conditions. The company expects to submit marketing applications in the U.S. and Europe in 2020.

Preliminary overall survival (OS) results from randomized Phase 2 trial demonstrated women with metastatic triple-negative breast cancer (mTNBC) lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone: Myelopreservation results, objective response rate (ORR), progression-free survival (PFS) and safety data from this trial were presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) (press release here). In June 2019, the company reported updated anti-tumor efficacy results that showed women receiving trilaciclib and a chemotherapy regimen of gemcitabine/carboplatin had a statistically significant improvement in OS compared with those receiving gemcitabine/carboplatin alone (press release here). Detailed data from this trial will be presented at a medical meeting later this year.

Data on all three clinical-stage programs accepted for presentation at ESMO (Free ESMO Whitepaper) 2019 Congress: New clinical data on trilaciclib, lerociclib and G1T48 have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, being held Sept. 27-Oct. 1. Presentations include the first clinical data on G1T48, an oral selective estrogen receptor degrader (SERD), myelopreservation and efficacy data from the Phase 2 trilaciclib + chemotherapy + Tecentriq (atezolizumab) small cell lung cancer trial, and safety and tolerability data from the Phase 1b/2a lerociclib + Tagrisso (osimertinib) non-small cell lung cancer trial. The company will host a webcast on Sunday, Sept. 29 to review the data and provide an overview of development and commercial plans across the pipeline.

Additional data on trilaciclib reported at ASCO (Free ASCO Whitepaper) and MASCC/ISOO annual meetings: The company reported additional data from trilaciclib SCLC clinical trials at both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) 2019 annual meetings. Pooled myelopreservation and patient-reported outcomes (PRO) data from all three trilaciclib SCLC trials presented at MASCC 2019 showed significant multilineage benefits across neutrophils, red blood cells and platelets, and significantly improved symptoms and function across multiple parameters over time compared to placebo.

Executive team update: In July, the company announced the appointment of Mark Avagliano as Chief Business Officer. Prior to joining G1, Mr. Avagliano was Vice President, Corporate Development at Pfizer Inc., where he was responsible for the evaluation, planning and execution of significant corporate level transactions and oversaw the Mergers and Acquisitions, Transactions and Valuations, and Out-licensing groups (press release here).

Board of Directors update: In June, current board member Garry Nicholson was named board chair, succeeding former chair Seth Rudnick, M.D. Additionally, Dr. Rudnick, Sir Andrew Witty and Fredric Eshelman, Pharm.D. were re-elected to the company’s Board of Directors.

Second Quarter 2019 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $324.9 million as of June 30, 2019, compared to $369.3 million as of December 31, 2018.

Operating Expenses: Operating expenses were $32.6 million for the second quarter of 2019, compared to $21.7 million for the second quarter of 2018. GAAP operating expenses include stock-based compensation expense of $3.7 million for the second quarter of 2019, compared to $2.1 million for the second quarter of 2018.

Research and Development Expenses: Research and development (R&D) expenses for the second quarter of 2019 were $23.5 million, compared to $18.4 million for the second quarter of 2018. The increase in R&D expense was primarily due to an increase in clinical program costs and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the second quarter of 2019 were $9.1 million, compared to $3.3 million for the second quarter of 2018. The increase in G&A expense was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, and an increase in professional fees and other administrative costs necessary to support our operations as a public company.

Net Loss: G1 reported a net loss of $30.7 million for the second quarter of 2019, compared to $20.9 million for the second quarter of 2018.

2019 Guidance: the company expects to end the year with $260-$270 million in cash and cash equivalents.

Anticipated Milestones for 2H 2019

Present new clinical results for trilaciclib, lerociclib and G1T48 at the ESMO (Free ESMO Whitepaper) 2019 Congress, being held Sept. 27-Oct. 1. The company will host an onsite event/webcast on Sunday, Sept. 29 to review the data.

Complete meetings with the FDA and provide regulatory update for trilaciclib, including NDA filing timeline.

Present preliminary OS findings from trilaciclib mTNBC trial at a medical meeting in 2H19

Present additional data from the Phase 1b/2a clinical trial of lerociclib + Faslodex (fulvestrant) in ER+, HER2- breast cancer in 4Q19.

In 4Q19, identify dose and schedule of lerociclib and G1T48 for pivotal trials in breast cancer in 2020.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the second quarter 2019 ended June 30, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 7989125. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On August 7, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the second quarter of 2019 (Press release, Surface Oncology, AUG 7, 2019, View Source [SID1234538265]).

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"We are pressing forward at Surface on our mission to Break Through for patients with cancer, and we are excited to be entering the second half of 2019 where you will begin to see some of the results of our hard work. SRF617 and SRF388 remain on track for IND filings later this year. Furthermore, we anticipate multiple poster presentations at SITC (Free SITC Whitepaper) highlighting a number of our pipeline programs, as well as hosting our first ever research and development day in November where executives from Surface, as well as key opinion leaders, will discuss our programs," said Jeff Goater, chief executive officer of Surface Oncology.

Recent & Upcoming Corporate Highlights:

Presented preclinical data further supporting the anti-tumor mechanisms for SRF617 (targeting CD39; currently in IND-enabling studies) and NZV930 (targeting CD73; currently in phase 1) at the Brisbane Immunotherapy 2019 Conference in May.

The ongoing phase 1b study of NZV930 (CD73), licensed to Novartis, is continuing to enroll and is evaluating combinations of NZV930 with PDR001 (anti PD-1), NIR178 (A2aR inhibitor), as well as a triplet combination of all three therapies. Novartis is paying for all development costs associated with NZV930. Surface Oncology is currently entitled to cumulative potential milestones in excess of $500 million, as well as tiered royalties on annual net sales by Novartis ranging from high single-digit to mid-teens percentages upon the successful commercialization of NZV930.

Submitted multiple abstracts for presentation at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference discussing data from the SRF617, SRF388 and SRF231 programs.

Announced the inaugural Surface Oncology Research and Development Day in New York City on Monday, November 18th, 2019, at the Nasdaq MarketSite in Times Square. Presenters will include members of Surface’s executive management, as well as key opinion leaders in the field of immuno-oncology. Topics will include deep dives into both SRF617 and SRF388, presentation of data and clinical trial designs, as well as the introduction of a newly nominated pipeline program.

Continued preparation to file Investigational New Drug applications for both SRF617 and SRF388 in Q4 of 2019. These filings will be staggered, with the IND for SRF617 to be filed first.

Financial Results:

As of June 30, 2019, cash, cash equivalents and marketable securities were $126.3 million, compared to $140.2 million on March 31, 2019.

Research and development (R&D) expenses were $13.2 million for the second quarter ended June 30, 2019, compared to $15.1 million for the same period in 2018. The decrease in expenditures was primarily driven by a reduction of CMC related spend on SRF231 (CD47) program, which was partially offset by increased spend on SRF617. R&D expenses included $0.6 million in stock-based compensation expense for the second quarter of 2019.

General and administrative (G&A) expenses were $5.4 million for the second quarter ended June 30, 2019, compared to $3.9 million for the same period in 2018. The increase in G&A expenses is primarily due to increased personnel costs and professional fees associated with the growth of the Company and operating as a public company. G&A expenses included $0.9 million in stock-based compensation expense for the second quarter of 2019.

For the second quarter ended June 30, 2019, net loss was $17.8 million, or basic and diluted net loss per share attributable to common stockholders of $0.64. Net loss was $15.9 million for the same period in 2018 or diluted net income per share attributable to common stockholders of $0.73.

Financial Outlook:

Based upon its current operating plan, which includes anticipated milestones from Novartis, Surface continues to have a projected cash runway through 2021.

On August 7, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported financial results and a corporate update for the quarter ended June 30, 2019 (Press release, CymaBay Therapeutics, AUG 7, 2019, View Source [SID1234538302]).

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"In the second quarter of 2019, we made significant progress advancing the development of seladelpar for PBC and NASH and began activities to further diversify development into PSC," said Sujal Shah, President and CEO of CymaBay. "Enrollment in our ENHANCE Phase 3 registration study in PBC, expected to be completed by year-end, continued on track during the quarter. Topline 12-week results from our 52-week, dose-ranging Phase 2b study in NASH showed clinically meaningful reductions in multiple biomarkers of inflammation and liver injury despite minimal reductions in total liver fat. At two of the three doses being tested, mean reductions in alanine aminotransferase exceed thresholds that have been correlated to histologic improvement in NASH. In this ongoing study, the effects of seladelpar on the two key histologic endpoints, NASH resolution and fibrosis, will be assessed from a liver biopsy taken at 52 weeks. We expect to share these data in the second quarter of 2020. In June, we announced plans to initiate a Phase 2, dose-ranging study of seladelpar in patients with PSC in the third quarter of 2019."

Second Quarter and Recent Business Highlights

Janet Dorling joined the CymaBay executive team as Chief Commercial Officer
Ms. Dorling is a seasoned commercial leader with over 15 years of experience in pharmaceutical sales and marketing at Achaogen, Roche and Genentech.
Continued enrollment of ENHANCE, a global, Phase 3 registration study of seladelpar for the treatment of primary biliary cholangitis (PBC).
ENHANCE is intended to establish the efficacy and safety of seladelpar for the treatment of PBC to support the submission of a global registration dossier with health authorities to obtain approval.
The study is expected to be fully enrolled by the end of 2019 with the 52-week treatment period targeted for completion by the end of 2020 and topline data in 2021.
Topline data from our Phase 2b dose-ranging, paired liver biopsy study of seladelpar for the treatment of nonalcoholic steatohepatitis (NASH) was released in June 2019.
Treatment with seladelpar resulted in robust and clinically meaningful reductions in markers associated with liver injury.
Treatment with seladelpar resulted in minimal reductions in liver fat that were not significant when compared to placebo.
Seladelpar demonstrated a favorable safety and tolerability profile at all doses evaluated in this study.
Announced FDA acceptance of an IND to initiate a Phase 2 clinical study of seladelpar in primary sclerosing cholangitis (PSC).
PSC is a rare, chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts for which there are no FDA-approved treatments.
The Phase 2 study is expected to be initiated in the third quarter of 2019 and will be a randomized, placebo-controlled, dose-ranging study that will enroll approximately 100 patients at 60 sites globally.
Second Quarter Financial Highlights & Results

Held $241.2 million in cash, cash equivalents and marketable securities at June 30, 2019. Existing cash is expected to fund the current operating plan into 2021.
Research and development expenses were $21.1 million in the second quarter of 2019 as compared to $14.4 million in the same period of 2018. The increase was primarily driven by increases in seladelpar-related clinical trial expenses including:
start-up and enrollment activities related to our ENHANCE PBC Phase 3 clinical study
continued treatment of patients in our PBC Phase 2 clinical study
start-up activities related to our PSC Phase 2 clinical study
execution of other NDA-enabling studies
General and administrative expenses were $4.5 million in the second quarter of 2019 as compared to $3.6 million in the same period of 2018. The increase was driven primarily by higher employee compensation and other administrative expenses as we hired additional personnel to support our expanding operations.
Net loss was $24.0 million, or ($0.35) per diluted share in the second quarter of 2019, as compared to $17.5 million, or ($0.30) per diluted share, in the same period of 2018. Net loss was higher primarily due to increased research and development expenses.
First Half Financial Highlights & Results

Raised $107.7 million in net proceeds through our March public offering of common stock.
Research and development expenses were $39.7 million in the first half of 2019 as compared to $23.9 million in the same period of 2018. The increase was primarily driven by increases in seladelpar-related clinical trial expenses including:
start-up and enrollment activities related to our ENHANCE PBC Phase 3 clinical study
final enrollment activities and ongoing treatment of patients in our NASH Phase 2b clinical study
continued treatment of patients in our PBC Phase 2 clinical study
start-up activities related to our PSC Phase 2 clinical study
execution of other NDA-enabling studies
General and administrative expenses were $10.2 million in the first half of 2019 as compared to $6.9 million in the same period of 2018. The increase was driven primarily by higher employee compensation and other administrative expenses as we hired additional personnel to support our expanding operations.
Net loss was $47.1 million, or ($0.72) per diluted share in the first quarter of 2019, as compared to $34.5 million, or ($0.61) per diluted share, in the same period of 2018. Net loss was higher primarily due to increased research and development expenses.
Conference Call Details

CymaBay management will host a conference call today at 4:30 p.m. ET to discuss second quarter 2019 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13692706. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On August 7, 2019 Vor Biopharma, an oncology company pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of hematological cancers, reported the appointment of Robert Ang, MBBS, MBA as its President and Chief Executive Officer (Press release, Vor BioPharma, AUG 7, 2019, View Source [SID1234538336]). Vor also announced a move into new integrated headquarters in Cambridge, Mass. This expansion follows a recent $42 million Series A financing directed at advancing the Company’s lead eHSC-based candidate for the treatment of acute myeloid leukemia towards the clinic and further building the pipeline.

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Dr. Ang is the former Chief Business Officer of Neon Therapeutics, part of the early team establishing the company prior to its Series A investment and through its initial public offering. Prior to Neon, he served as Senior Vice President of Business Development at Bavarian Nordic, where he was primarily responsible for conducting a $975 million transaction between the company and Bristol-Myers Squibb for PROSTVAC, a Phase 3 immuno-oncology asset. Before joining Bavarian Nordic, Dr. Ang served as Head of both Business Development and Medical Affairs for Cadence Pharmaceuticals (now Mallinckrodt) and worked at Frazier Healthcare Ventures, a leading life sciences venture capital firm. At Frazier, he was involved in several pharmaceutical and biotechnology investments including Cadence Pharmaceuticals, Incline Therapeutics (now The Medicines Company), Alnara Pharmaceuticals (now Eli Lilly) and Collegium Pharmaceuticals. Dr. Ang also has experience in strategy consulting at the Boston Consulting Group and has general surgical training. He holds an MBBS (Doctor of Medicine) from the University of Western Australia and an MBA with honors from Columbia Business School.

"I am privileged to join Vor Biopharma, a company already equipped with leading science from Dr. Siddhartha Mukherjee’s lab at Columbia University and strong financial backing from eminent life science investors. Vor’s unique and scientifically elegant eHSC approach places it among the most exciting opportunities in oncology, with the potential to change the treatment paradigm of liquid tumors," said Dr. Ang. "An excellent team has already been established in Cambridge, Mass., and new headquarters in Kendall Square will catalyze our research and development in gene editing, hematopoietic stem cell biology, process development and translational medicine."

"Robert has a deep understanding of the oncology landscape and a proven track record in strategic planning and business development," said Kush Parmar, MD, PhD, Managing Partner at 5AM Ventures and Chairman of Vor’s Board of Directors. "We are thrilled to welcome Robert to Vor at this pivotal moment as we bring the company to a new stage of growth and development while advancing our lead candidate, VOR33, toward the clinic."

About VOR33
Vor’s lead engineered hematopoietic stem cell (eHSC) product candidate, VOR33, is in development for acute myeloid leukemia (AML). VOR33 is designed to produce healthy blood cells that lack the receptor CD33, thus enabling the targeting of AML cells through the CD33 antigen while avoiding toxicity to the blood and bone marrow. Currently, treating AML with therapy that targets CD33 can be effective but may be limited in dose and duration due to toxicity to the blood and bone marrow. By rendering healthy blood and bone marrow cells ‘invisible’ to CD33-targeted therapies, VOR33 aims to significantly improve the therapeutic window and effectiveness of these AML therapies with potential to broaden clinical benefit to different patient populations.

On August 7, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three months ended June 30, 2019 (Press release, Opko Health, AUG 7, 2019, View Source [SID1234538365]).

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Business Highlights

RAYALDEE total prescriptions reported by IQVIA increased 92% in 2Q 2019 compared with 2Q 2018: Total prescriptions for the three months ended June 30, 2019 increased to approximately 12,700, compared with approximately 6,600 (as adjusted by IQVIA) during the comparable period of 2018.

4Kscore receives a new proposed local coverage determination from Novitas Solutions and utilization remained strong during 2Q 2019 with approximately 18,800 tests performed: Novitas Solutions, Inc. has issued a new proposed local coverage determination (LCD) for the 4Kscore test, with defined coverage criteria. Under the LCD, Medicare proposes reimbursing the test for patients who meet the defined criteria. The LCD is subject to a comment period ending August 11, 2019.

OPKO Plans to Refile 4Kscore De Novo Submission as PreMarket Approval Application (PMA): The Company plans to refile its 4Kscore test submission as a PMA application based on FDA feedback to the Company’s de novo request for this test, which has now been withdrawn. The FDA did not request any additional clinical data or any additional clinical trials in connection with a PMA submission. The Company currently anticipates submitting the PMA application in August 2019.

BioReference Laboratories formed a strategic collaboration with SOMOS, New York City’s largest multi-cultural physician led network: BioReference is now SOMOS’ preferred provider of diagnostic testing and will assist with data analytics for its patients. This collaboration is designed to streamline patient care and offer communication efficiencies between BioReference and the SOMOS network. SOMOS will leverage its relationship with BioReference to improve patient outcomes among its participants while decreasing the overall cost of care.

BioReference and its GeneDx subsidiary expand access to commercially insured lives: BioReference and GeneDx have been selected for inclusion in the UnitedHealthcare Preferred Lab Network beginning July 1, 2019. This was a comprehensive process that evaluated service

standards, turnaround time, quality and accreditation. More than 300 laboratories were invited to apply; only 100 submitted applications due to the complexity of the requirements, and BioReference and GeneDx, along with five other laboratories, earned a place in the Preferred Lab Network. In addition, effective April 1, 2019, BioReference and GeneDx are now in-network providers with Humana, which provides access to 11 million additional lives.

Pharmaceutical pipeline continues to progress. Last patient, last visit for our pivotal global Phase 3 clinical trial for hGH-CTP in growth hormone deficient children is expected this month. Topline data from the trial are expected to be announced by the end of 2019. The ongoing open-label phase 2 trial for RAYALDEE in hemodialysis patients is progressing well and initial data are expected by the end of 2019.

RAYALDEE Marketing Authorization Application filed by Vifor Fresenius in Switzerland. With several Marketing Authorization Applications already accepted and under review in other European countries, Vifor expects to receive approvals in several European countries to market RAYALDEE for the treatment of secondary hyperparathyroidism in adult non-dialysis patients with chronic kidney disease during 2020.

Financial Highlights

Consolidated revenues for the second quarter of 2019 were $226.4 million, compared with $263.7 million for the comparable period of 2018. During the 2019 quarter, revenue from services was $178.5 million, revenue from products was $28.7 million, including RAYALDEE net revenue of $5.7 million, and revenue from licensing and intellectual property was $19.2 million.

Operating expenses for the second quarter of 2019 were $273.6 million. This included continued investment in the company’s pharmaceutical pipeline, with R&D expense of $28.3 million, principally for pediatric trials with the hGH-CTP long-acting human growth hormone product.

The net loss for the three months ended June 30, 2019 was $59.8 million, compared with a net loss of $6.2 million for the comparable period of 2018 principally as a result in the decrease in revenue from services as wells as the comparable period of 2018 including a $15.4 million reversal of contingent consideration expense compared to $3.8 million for the 2019 period.

Cash, cash equivalents and marketable securities were $111.1 million as of June 30, 2019, which includes the repayment of a line of credit during the second quarter of approximately $40 million.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
PASSCODE: 7984069
WEBCAST: OPKO 2Q19 Results Conference Call

For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 7984069. The replay can be accessed for a period of time on OPKO’s website at OPKO 2Q19 Results Conference Call.