On August 7, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), reported that the Company will release its second quarter financial results on August 14, 2019, before the market opens (Press release, Onconova, AUG 7, 2019, View Source [SID1234538327]). The Company will host a conference call on August 14, 2019, at 9 a.m. Eastern Time to discuss these results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S. or (210) 229-8823 internationally and using conference ID 9150777. The call will also be webcast live. Please click here to access the webcast on the Investor Relations page of the Company’s website. A replay will be available for 90 days.

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About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia.

On August 7, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the three months ended June 30, 2019, and provided a corporate update (Press release, Portola Pharmaceuticals, AUG 7, 2019, View Source [SID1234538344]).

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"This is our fifth consecutive quarter of strong revenue growth reflecting our exceptional launch execution and continued demand for Andexxa. Support for this novel therapy continues to grow with CMS’ decision to increase our NTAP reimbursement and two recent updates from the Joint Commission which recommend specific reversal agents for Factor Xa inhibitors. In Europe, the team exceeded expectations on timing for the first sale of Ondexxya, and we are positioned well to continue our launch in key European countries," said Scott Garland, Portola’s president and chief executive officer. "We look forward to building upon our momentum backed by a rapidly growing Factor Xa inhibitor market and increasing global demand for Andexxa. Beyond Andexxa, we plan to initiate a registrational trial for cerdulatinib."

Quarter Ending June 30, 2019

Total revenues for the second quarter of 2019 were $28.4 million, compared with $4.0 million for the second quarter of 2018. This includes $27.1 million in net product revenues from sales of Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], $74 thousand in revenues from Bevyxxa (betrixaban) sales and $1.3 million in collaboration and license revenues.

Net loss attributable to Portola, according to generally accepted accounting principles in the U.S. (GAAP), was $66.2 million, or $0.97 net loss per share for the second quarter of 2019, compared with a net loss of $106.2 million, or $1.61 net loss per share, for the same period in 2018. This includes the effect of a $3.1 million impairment charge taken in the second quarter related to the discontinuation of our SRX program.

Cash, cash equivalents and investments at June 30, 2019, totaled $273.9 million, compared with $317.0 million as of December 31, 2018.

Total GAAP operating expenses for the second quarter of 2019 were $92.4 million, compared with $107.7 million for the same period in 2018. This decrease was driven primarily by manufacturing costs for Andexxa Gen 2 being capitalized and no longer flowing through R&D.

Stock-based compensation expense for the second quarter of 2019 was $12.3 million, compared with $13.2 million for the same period in 2018.

Cost of Sales (COS) for the second quarter of 2019 was $5.0 million, compared to $1.1 million for the same period in 2018. The increase was driven by the launch of Andexxa.

Research and development (R&D) expenses were $33.5 million for the second quarter of 2019, which includes the impairment charge, compared with $66.4 million for the second quarter of 2018. The decrease was driven primarily by the manufacturing costs for Andexxa Gen 2 being capitalized and no longer flowing through R&D and partially offset by the SRX program impairment charge.

Non-GAAP research and development expenses, which excludes the SRX program impairment charge, were $30.4 million for the second quarter of 2019. Please see the reconciliation of GAAP to non-GAAP financial measures table at the end of this release for more details.

Selling, general and administrative (SG&A) expenses for the second quarter of 2019 were $53.9 million, compared with $40.2 million for the same period in 2018. The increase was driven by the expansion of the Company’s field force, commercial activities to support the launch of Andexxa and launch preparations in Europe.
Recent Achievements and Events

Launched Ondexxya with first orders in Europe.
CMS increased maximum NTAP reimbursement for Andexxa from 50 to 65 percent effective on October 1, 2019.
Presented new Andexxa data from a subset of patients from the ANNEXA-4 study with spontaneous (non-traumatic) intracranial hemorrhage, which demonstrated excellent or good hemostasis achieved in 79% of evaluable patients.
Presented in vitro data demonstrating that four-factor prothrombin complex concentrate (4F-PCC) does not appear to have an effect on the inhibition of thrombin generation by apixaban or rivaroxaban unless the Factor Xa inhibitor concentration was less than 75 ng/mL. In contrast, data from the same thrombin generation assay demonstrated that Andexxa fully corrected the inhibition of thrombin generation by apixaban and rivaroxaban across a broad range of inhibitor concentrations.
Presented new interim results from the cerdulatinib Phase 2a study demonstrating favorable safety and efficacy profiles in patients with relapsed/refractory follicular lymphoma (FL) receiving cerdulatinib alone (45% objective response rate) or in combination with rituximab (62% objective response rate).
Planned Upcoming Milestones

Continue launch of Ondexxya in a select group of high-potential European countries where Factor Xa inhibitor use is among the highest.
Plan to initiate surgical study for Andexxa label expansion by year end or beginning of 2020.
Launch a cerdulatinib registrational study in peripheral T-cell lymphoma (PTCL) by the end of the year.
Present new data from additional subsets of the ANNEXA-4 study.
Conference Call Details
Portola will host a conference call today, Wednesday, August 7, 2019, at 4:30 p.m. ET, during which time management will discuss the second quarter 2019 financial results, updates on the U.S. launch of Andexxa, and other matters. The live call can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 8046269. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

On August 7, 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 June 30, 2019, and provided an update on recent clinical developments (Press release, Scynexis, AUG 7, 2019, View Source [SID1234538449]).

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"We are pleased with the rapid enrollment observed in our Phase 3 VANISH program for vulvovaginal candidiasis (VVC), which underscores the significant unmet need in this patient population," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We look forward to sharing top-line data from the U.S. study in the first quarter of 2020, and from the global study in the second quarter of 2020. We are making great progress toward our goal of a planned New Drug Application (NDA) submission for VVC in the second half of 2020."

Dr. Taglietti continued, "We are committed to maximizing the full value of ibrexafungerp in multiple settings. As we approach important milestones for our VVC registration program, we are also excited by the promising data supporting the potential role of oral ibrexafungerp as a treatment for a broad range of life-threatening, hospital-based, fungal infections, including Candida auris and other multidrug-resistant pathogens for which few existing treatment options are available."

Ibrexafungerp (formerly SCY-078), the first representative of a novel family of antifungal compounds referred to as triterpenoids, is being developed for oral and intravenous (IV) administration and is in clinical development for the treatment of both serious outpatient fungal infections, including VVC, and hospital-based life-threatening fungal infections, including invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, ibrexafungerp could potentially address significant unmet medical needs as the only oral non-azole antifungal therapy.

Ibrexafungerp Update

Significant progress made in Phase 3 VANISH program evaluating the safety and efficacy of oral ibrexafungerp (300mg BID for one day) versus placebo for the treatment of VVC
The VANISH Phase 3 program is comprised of two Phase 3, randomized, double-blind, placebo-controlled, multicenter studies:
The VANISH 303 study is being conducted in U.S. centers and is expected to enroll approximately 350 patients; enrollment in the study is exceeding expectations and SCYNEXIS anticipates top-line data in the first quarter of 2020. More information about this study can be found at: View Source
The global VANISH 306 study is being conducted in U.S. and European centers and is expected to enroll approximately 350 patients; enrollment is progressing as planned, and the Company anticipates top-line data in the second quarter of 2020. More information about this study can be found at: View Source
All NDA preparatory activities remain on track to support a planned NDA submission in the second half of 2020.
Phase 3 CANDLE study evaluating the safety and efficacy of oral ibrexafungerp versus placebo for the prevention of recurrent VVC is on track to start enrollment this quarter following the Special Protocol Assessment (SPA) agreement received from the U.S. Food and Drug Administration (FDA) in July 2019
The Company recently announced an agreement with the FDA under a SPA, on the design, trial population, endpoints and statistical analysis of the CANDLE study, a pivotal Phase 3 clinical trial of oral ibrexafungerp for the prevention of recurrent VVC. This SPA provides agreement with the FDA that the Phase 3 protocol design adequately addresses efficacy objectives that, if met, would form the primary basis of a regulatory submission for approval of oral ibrexafungerp for the prevention of recurrent VVC, an indication with no FDA-approved therapies.
The CANDLE study is a global Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of oral ibrexafungerp (300mg BID for one day, given once per month for a total of six treatment days) compared to placebo in female patients with recurrent VVC (defined as three or more episodes of VVC in the past 12 months, including the episode at screening). The study is being conducted at approximately 50 sites and is expected to enroll approximately 320 patients. Enrollment is expected to commence this quarter with an expected supplemental NDA submission in 2021.
More information about the CANDLE study can be found at: View Source
An open-label sub-study within CANDLE will evaluate the efficacy of oral ibrexafungerp in fluconazole-failure VVC patients
All patients in the CANDLE study will initially receive three doses of oral fluconazole to treat their acute episode of VVC present at screening before progressing to the prevention phase of the study.
Patients who fail to sufficiently respond to fluconazole treatment for their acute episode will be included in the sub-study, in which they will be offered one day of oral ibrexafungerp treatment (300mg BID) for their unresolved acute episode.
More information about the sub-study within the CANDLE study can be found at: View Source
Continued advancement of oral ibrexafungerp for hospital-based invasive fungal infections with two Phase 3 studies (FURI in refractory infections and CARES in Candida auris infections) and one Phase 2 study in invasive aspergillosis (SCYNERGIA)
Enrollment is ongoing in the Company’s refractory invasive fungal infection (rIFI) program, which comprises two open-label Phase 3 studies (FURI and CARES) designed to support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). Positive clinical findings from these studies have so far reinforced the potential role of oral ibrexafungerp as a novel therapy to combat severe and difficult-to-treat fungal infections, including multidrug-resistant Candida auris. More information about these studies can be found at:
View Source
View Source
Enrollment continues in the Phase 2 SCYNERGIA study, a randomized, double-blind clinical trial assessing the safety and efficacy of oral ibrexafungerp in combination with voriconazole, compared to voriconazole alone. More information about this study can be found at: View Source
Data presented at the American Society for Microbiology (ASM) Microbe 2019 Meeting demonstrates broad potential utility of ibrexafungerp for the treatment and prevention of multiple severe fungal infections
A total of nine presentations revealed data further demonstrating the potential of ibrexafungerp as a treatment for invasive fungal infections (visit scynexis.com/science to view the presentations). The data presented highlighted the potent activity of ibrexafungerp against difficult-to-treat and/or multidrug-resistant pathogens, including Candida auris, Candida glabrata, and Pneumocystis pneumonia. The activity of ibrexafungerp was tested against many Candida strains resistant to echinocandins, the current standard of care for these infections, and potent activity of ibrexafungerp was observed.
In vivo chronic toxicology studies further support the safety profile of ibrexafungerp, allowing for patients suffering from invasive fungal infections to use oral ibrexafungerp for an extended period of time and enabling its potential development as a prophylactic agent and as a treatment for chronic fungal infections.
Corporate Highlight

Management Team strengthened with appointment of Dr. Nkechi Azie as Vice President of Clinical Development.
SCYNEXIS announced the appointment of Nkechi Azie, MD, MBA, FIDSA, as Vice President of Clinical Development. Dr. Azie will lead clinical development activities and strengthen medical affairs efforts in anticipation of ibrexafungerp’s potential approval and commercial launch. She joins SCYNEXIS with over 25 years of experience in drug development and medical affairs, having worked in therapeutic areas including infectious disease, women’s health and immunology.
Second Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $35.2 million as of June 30, 2019, with net working capital of $28.9 million. Based upon its existing operating plan, SCYNEXIS believes its existing cash, cash equivalents, short-term investments, and the sale of a portion of its New Jersey net operating losses (NOLs), will be sufficient to fund operations beyond the planned NDA submission for acute VVC in the second half of 2020.

Research and development expenses increased to $8.5 million for the quarter ended June 30, 2019, compared to $5.6 million in the second quarter of 2018. The increase of $2.9 million, or 51%, was primarily driven by an increase of $3.2 million in clinical development costs, an increase of $0.4 million in chemistry, manufacturing, and controls (CMC) costs, a net increase in other research and development costs of $0.6 million, offset in part by a decrease of $1.3 million in preclinical development expense.

Selling, general and administrative expenses in the second quarter of 2019 increased to $2.8 million, compared with $2.1 million in the second quarter of 2018. The increase of $0.7 million, or 31%, was primarily driven by a $0.4 million increase in business development costs.

Total other income increased to $2.8 million in the second quarter of 2019, compared to a $3.1 million loss in the second quarter of 2018. The increase in other income is attributable to the non-cash gains recognized during the second quarter of 2019 of $2.0 million and $1.3 million associated with the fair value adjustments for warrant liabilities and derivative liability, respectively.

Net loss for the second quarter of 2019 was $8.4 million, or $0.16 per share. This compares with a net loss for the second quarter of 2018 of $10.8 million, or $0.23 per share.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. 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), invasive aspergillosis (IA) and VVC (including prevention of recurrent VVC), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On August 7, 2019 Helix BioPharma Corp. (TSX: HBP), ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it has received approval from the U.S. Food and Drug Administration ("FDA"), to initiate a Phase Ib/II study of L-DOS47 and doxorubicin in advanced metastatic pancreatic cancer (Press release, Helix BioPharma, AUG 7, 2019, View Source [SID1234538499]).

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This is an open label, non-randomized study designed to evaluate the safety, tolerability and preliminary activity of L-DOS47 in combination with doxorubicin in patients with metastatic pancreatic cancer who have progressed on at least two prior treatment regimens.

Phase Ib will involve a dose escalation safety run-in to determine the appropriate dose to be used in combination with doxorubicin for Phase II. Phase II will evaluate preliminary anti-tumor activity and safety of the Maximum Tolerated Dose of L-DOS47 given in combination with doxorubicin.

"We are very pleased to gain this approval from the FDA," said Dr. Herman Chao, Helix’s Chief Executive Officer. "This represents an expansion of the L-DOS47 application from treating lung cancer to potentially benefiting pancreatic patients. The team is already hard at work to begin all the necessary preparatory activities to move the trial forward. We look forward to be ready to dose patients at the earliest opportunity."

On August 7, 2019 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the second quarter of 2019 (Press release, Immunomedics, AUG 7, 2019, View Source [SID1234538294]). Please refer to the Company’s Quarterly Report on Form 10-Q for more details on the Company’s financial results.

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"We continued to execute well against our key strategic priorities for sacituzumab govitecan this quarter. In particular, we are very pleased to have reached target enrollment in the ASCENT study in less than twenty months. We believe this rapid pace is testament to the unmet need in late-stage metastatic triple-negative breast cancer (mTNBC) and the confidence of our investigators in the safety and efficacy of our ADC to provide a meaningful clinical benefit to patients," commented Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics.

Based on current projections, the Company anticipates reporting top-line data from ASCENT in mid-2020. "We are grateful to the patients, their families and caregivers who have participated in our studies. We look forward to the data readout as we continue to work on delivering this important, potential new treatment paradigm to mTNBC patients," added Dr. Aghazadeh.

"The Company’s preparation of the Biologics License Application (BLA) for sacituzumab govitecan in mTNBC is progressing according to plan," said Scott Canute, Executive Director of Immunomedics. "Our goal is to have a high-quality resubmission and a successful reinspection. To that end, we have made steady progress in both areas and we remain confident that we will meet our guided resubmission timeline of early fourth quarter 2019."

Building on the ASCENT momentum and leveraging the existing relationships with breast cancer specialists, the Company has launched the registrational Phase 3 TROPICS-02 in hormonal receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC).

"Given our experience treating patients with sacituzumab govitecan in ASCENT, we are excited to be a participant in the TROPICS-02 study," stated Principal Investigator Hope S. Rugo, M.D., FACP, Professor of Medicine; and Director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA. "We are very encouraged about sacituzumab govitecan’s efficacy and look forward to utilizing the ADC for patients with mTNBC. Additional effective treatment options for those with both mTNBC and HR+ disease are critical for our patients."

The randomized global TROPICS-02 study has dosed the first patients with HR+/HER2– mBC who have failed at least two prior chemotherapy regimens for metastatic disease. With progression-free survival (PFS) and overall response rate (ORR) serving as co-primary endpoints, the study allows for an analysis of ORR on a pre-specified number of patients as a basis of a potential accelerated approval submission.

"Targeting HR+/HER2– mBC, which accounts for 70% of all breast cancers, signifies our intention to establish sacituzumab govitecan as a foundational therapy for mBC," continued Dr. Aghazadeh. "To further unlock the full potential of sacituzumab govitecan, we have initiated, for the first time, a Trop-2-enriched study in various difficult-to-treat cancers, beginning with non-small cell lung cancer (NSCLC). Finally, the combination study with sacituzumab govitecan and rucaparib in second-line mTNBC and other cancers, in collaboration with Clovis, is now open for patient enrollment."

Recent Company Highlights

The Phase 3 confirmatory ASCENT study (NCT02574455) has reached its target enrollment for mTNBC patients previously treated with at least two systemic chemotherapy regimens. Top-line data is expected to be available in mid-2020 based on projected event trajectory and timelines associated with central review, database lock and analysis.

The global randomized, open-label, Phase 3 registrational TROPICS-02 study (NCT03901339) has dosed the first patients with HR+/HER2– mBC. This study includes an ORR analysis on a pre-specified number of patients for a potential accelerated approval submission. Enrollment of 400 patients is expected to take approximately eighteen months to complete.

The Company launched TROPICS-03 (NCT03964727), an open-label, Trop-2-enriched multi-cohort Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in patients with metastatic solid tumors, including NSCLC, small cell lung cancer, head and neck cancer, and endometrial cancer. Dosing of the first NSCLC patient is expected in the third quarter of 2019.

The open-label Phase 1b/2 SEASTAR study (NCT03992131) of sacituzumab govitecan in combination with Clovis’ PARP inhibitor, rucaparib, in mTNBC, mUC, and platinum resistant ovarian cancer is recruiting patients with at least one prior line of standard therapy for advanced disease.

Initiated by Dr. Aditya Bardia, Massachusetts General Hospital is sponsoring a Phase 1b/2 study (NCT04039230) evaluating sacituzumab govitecan in combination with Pfizer’s PARP inhibitor, talazoparib, in patients with mTNBC previously treated with no more than one prior therapeutic regimens for metastatic disease.
Second Quarter and Six Months 2019 Financial Results
The Company had no revenues for the quarter and six months ended June 30, 2019, due primarily to the discontinued sale of LeukoScan in February 2018 in order for the Company to focus on its ADC business. Revenues in the comparable quarter and six months ended June 30, 2018 were $0.4 million and $0.9 million, respectively.

Total costs and expenses were $67.2 million for the quarter and $146.8 million for the six months ended June 30, 2019, compared to $52.8 million for the comparable quarter and $90.9 million for the six months ended June 30, 2018. The increases were due primarily to increased expenses in research and development and sales and marketing, partially offset by decreases in general and administrative expenses. The increases in research and development costs were mostly attributable to activities related to preparations for the approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for metastatic TNBC in the United States and expanded clinical development of sacituzumab govitecan into other indications.

The Company had no non-cash warrant-related income or expense for the quarter and six months ended June 30, 2019, compared to non-cash warrant-related expenses of $58.9 million for the comparable quarter and $49.0 million for the six months ended June 30, 2018, due to the net appreciation in the fair value of then outstanding warrants. There were no warrants outstanding as of June 30, 2019.

Interest expense was $10.6 million for the quarter and $20.6 million for the six months ended June 30, 2019, compared to $9.4 million for the comparable quarter and $20.3 million for the six months ended June 30, 2018. The increases were due primarily to the net appreciation in the fair value of our debt balances as a result of the agreement with RPI Finance Trust.

Net loss attributable to stockholders was $76.0 million, or $0.40 per share, for the quarter ended June 30, 2019, compared to $117.0 million, or $0.68 per share, for the comparable quarter ended June 30, 2018. Net loss attributable to stockholders was $163.3 million, or $0.85 per share, for the six months ended June 30, 2019, compared to $152.6 million, or $0.91 per share, for the six months ended June 30, 2018.

As of June 30, 2019, the Company had $432.7 million in cash, cash equivalents, and marketable securities, including the $65 million upfront payment received from the licensing agreement with Everest Medicines for sacituzumab govitecan for Greater China. The Company believes this amount is adequate to support its clinical development plan for sacituzumab govitecan, further build its clinical and manufacturing infrastructure and fund its operations through 2020.

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss second quarter 2019 financial results and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 2069775. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.