On August 11, 2020 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported preliminary, unaudited revenue and net product sales for the second quarter of 2020 (Press release, Supernus, AUG 11, 2020, View Source [SID1234563431]).

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Preliminary second quarter 2020 revenue consisted of net product sales of $124.0 million and royalty revenue of $2.7 million. Preliminary second quarter 2020 net product sales of $124.0 million increased 21% compared to the same period in 2019 due to higher net product sales of Trokendi XR and Oxtellar XR and the addition of $10.6 million of net product sales from the acquisition of the CNS portfolio of US WorldMeds, which closed on June 9, 2020.

The second quarter 2020 revenue results included herein are preliminary and are therefore subject to change.

Conference Call Details

The Company expects to report full second quarter 2020 results after 5:00 p.m. ET on Tuesday, August 18, 2020. The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, August 19, 2020. Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 5175177
Conference Call Name: Supernus Pharmaceuticals Second Quarter 2020 Earnings Conference Call
Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".

On August 11, 2020 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, reported financial results for the three and six months ended June 30, 2020 and provided a business update (Press release, Aprea, AUG 11, 2020, View Source [SID1234563430]).

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"The full enrollment in June of our Phase 3 clinical trial evaluating eprenetapopt (APR-246) with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes (MDS) was a major milestone for Aprea and we look forward to top-line data by year-end 2020," said Christian S. Schade, President and Chief Executive Officer of Aprea. "In addition, we continue to advance the clinical development of eprenetapopt in different clinical settings and have recently enrolled the first patient in our solid tumor clinical trial program."

Business Operations Update:

The Company is conducting, supporting and planning multiple clinical trials of eprenetapopt (APR-246):

Pivotal Phase 3 MDS Trial—During the second quarter of 2020, the Company completed the full enrollment of 154 patients in its pivotal Phase 3 randomized, controlled trial evaluating eprenetapopt with azacitidine as frontline therapy in HMA-naïve TP53 mutant myelodysplastic syndromes (MDS) patients with a primary endpoint of complete remission (CR) rate. The Company remains confident it will have top-line data available by year-end 2020.

Phase 2 MDS/AML Post-Transplant Trial—The Company is currently enrolling its single-arm, open-label Phase 2 trial evaluating eprenetapopt with azacitidine as post-transplant maintenance therapy in TP53 mutant MDS and acute myeloid leukemia (AML) patients who have received an allogeneic stem cell transplant. Though the Company had initially observed a decrease in both patient screening and patient enrollment as a result of the COVID-19 pandemic, patient screening activity has returned to expected levels and the trial has currently enrolled 24 out of 31 patients with a number of additional patients in screening. The Company anticipates completing enrollment of this trial in the third quarter of 2020.

Phase 1 AML Trial—The Company is currently enrolling its Phase 1 trial evaluating the safety, tolerability, and preliminary efficacy of eprenetapopt therapy in TP53 mutant AML patients. The lead-in portion of the trial evaluated the tolerability of eprenetapopt with venetoclax, with or without azacitidine, and no dose-limiting toxicities were observed in patients receiving either regimen. Based on these results, the Company has expanded the trial to treat approximately 30 additional frontline TP53 mutant AML patients with the combination of eprenetapopt, venetoclax and azacitidine. The Company also plans to activate a separate cohort in the trial to evaluate the combination of eprenetapopt with azacitidine in approximately 30 frontline TP53 mutant AML patients.

Phase 1 NHL Trial—To further assess eprenetapopt in hematological malignancies, the Company has designed and plans to conduct a Phase 1 clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL) and mantle cell lymphoma (MCL) assessing eprenetapopt with venetoclax and rituximab, and eprenetapopt with ibrutinib. The Company is targeting the first patient to be enrolled in the second half of 2020.

Phase 1/2 Solid Tumor Trial—Based on in vivo data suggesting synergistic activity between eprenetapopt and immuno-therapy agents including anti-PD-1 antibody, the Company has designed and plans to conduct Phase 1/2 clinical trials in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy. The Company enrolled its first patient in August 2020.

APR-548 — The Company’s second product candidate, APR-548, is a pre-clinical, next-generation p53 reactivator with the potential for oral administration. APR-548 exhibits high oral bioavailability in preclinical testing and is being developed in an oral dosage form. The Company completed Investigational New Drug, or IND, enabling preclinical studies of APR-548 and filed an IND with the FDA. However, based on feedback from the FDA, the Company will not be able to initiate human clinical trials of APR-548 until it is able to provide additional information necessary to address questions raised by the FDA.
Second Quarter Financial Results

Cash and cash equivalents: As of June 30, 2020, the Company had $112.9 million of cash and cash equivalents compared to $130.1 million of cash and cash equivalents as of December 31, 2019. The Company expects cash burn for the full year 2020 to be between $35.0 million $40.0 million. The Company believes its cash and cash equivalents as of June 30, 2020 will be sufficient to meet its current projected operating requirements into 2023.

Research and Development (R&D) expenses: R&D expenses were $10.7 million for the quarter ended June 30, 2020, compared to $4.3 million for the comparable period in 2019. The increase in R&D expenses was primarily related to the advancement of the Company’s lead product candidate, eprenetapopt. In Q1 2019 the Company commenced a pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for frontline treatment of TP53 mutant MDS which completed enrollment in Q2 2020 and is supported by two ongoing Phase 1b/2 investigator initiated trials, one in the U.S. and one in France, testing eprenetapopt with azacitidine as frontline treatment in TP53 mutant MDS and AML patients. In addition, in Q1 2020, the Company continued enrolling patients in a Phase 2 post-transplant MDS/AML clinical trial began enrolling patients in a Phase 1 clinical trial in frontline and relapsed/refractory TP53 mutant AML assessing eprenetapopt with venetoclax with or without azacitidine.

General and Administrative (G&A) expenses: G&A expenses were $3.8 million for the quarter ended June 30, 2020, compared to $1.7 million for the comparable period in 2019. The increase in G&A expenses was primarily due to increased insurance expense, non-cash stock-based compensation, personnel related costs and commercial development expense.

Net loss: Net loss was $16.4 million, or $0.78 per share for the quarter ended June 30, 2020, compared to a net loss of $5.3 million, or $4.45 per share for the quarter ended June 30, 2019. The Company had 21,186,827 shares of common stock outstanding as of June 30, 2020.

On August 11, 2020 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, reported second-quarter 2020 financial results (Press release, Pliant Therapeutics, AUG 11, 2020, View Source [SID1234563429]).

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"2020 has been a productive year as we’ve made progress on multiple fronts, including the initiation of a 12-week Phase 2a clinical trial evaluating PLN-74809 in patients with idiopathic pulmonary fibrosis, as well as dosing initial cohorts in our first-in-human trial of our Novartis partnered program, PLN-1474, for the potential treatment of liver fibrosis," said Bernard Coulie, M.D., Ph.D., chief executive officer and president of Pliant Therapeutics. "Bolstered by a strong cash position from our Series C financing in February and our IPO in June, we continue to advance our robust pipeline. We’re now focused on executing our Phase 2a program for PLN-74809 and look forward to sharing further updates on all of our programs."

Recent Highlights

Completed an initial public offering (IPO) and concurrent private placement with Novartis. The IPO priced at $16.00 per share, generating gross proceeds of $165.6 million including shares sold to the underwriters pursuant to the full exercise of their overallotment option before deducting underwriting discounts, commissions and other offering expenses payable by Pliant. The company also received $10.0 million in additional proceeds from a concurrent private placement with Novartis Institutes for BioMedical Research, Inc. at the public offering price of $16.00 per share. The Company’s common stock commenced trading on the Nasdaq Global Select Market under the ticker symbol "PLRX" on June 3rd, 2020.
Phase 2a 12-week trials of PLN-74809 in idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) have resumed enrollment. Through close coordination with over 100 global trial sites, Pliant has continued to conduct site initiation activities throughout the COVID-19 pandemic. The Company is offering a hybrid approach to clinical trial participation with home-health solutions designed to minimize the requirements for visits to healthcare facilities, as well as a campaign to raise awareness of the IPF and PSC programs across patient communities and patient advocacy groups. Phase 2a clinical trial sites are currently enrolling patients in both the IPF and PSC trials.
Opened Investigational New Drug (IND) Application for PLN-74809 for treatment of acute respiratory distress syndrome (ARDS) associated with COVID-19. Pliant submitted the COVID-19 ARDS IND in June and the FDA has since issued a "safe to proceed" letter. The Company plans to initiate a Phase 2 trial evaluating safety, tolerability and pharmacokinetics (PK) of PLN-74809, as well as exploratory clinical outcome measures in patients hospitalized with severe and critical COVID-19 in the second half of 2020. This represents the fourth IND that Pliant has successfully opened since operations began in 2016.
Completed dosing of initial cohorts of a Phase 1 trial of PLN-1474. The Phase 1 trial is designed to evaluate safety and tolerability, as well as PK of PLN-1474 in approximately 100 healthy volunteers across a dose range compared to placebo. The Phase 1 trial site has experienced delays due to COVID-19; however, it is now open and expected to continue dosing the remaining cohorts with topline data expected in the first quarter of 2021, subject to further impact of the COVID-19 pandemic. PLN-1474 is partnered with Novartis.
COVID-19 Preparedness

Pliant has worked proactively to establish policies and procedures to enable the Company to operate safely and productively during the pandemic. The Company has experienced delays in clinical trial operations which will impact the expected timing of data readouts, but is working closely with clinical sites to continue site initiation activities in compliance with study protocols while observing government and institutional guidelines. The clinical site conducting Pliant’s Phase 2a PET trial of PLN-74809 in IPF remains closed to clinical research, but expects to resume trial activities in the third quarter. Pliant has made significant progress in opening trial sites for its Phase 2a 12-week IPF and PSC trials by offering a hybrid approach to clinical trial participation with home-health solutions designed to minimize the requirements for visits to healthcare facilities, as well as a campaign to raise awareness of the IPF and PSC programs across patient communities and patient advocacy groups. The Company intends to provide more specific guidance regarding clinical trial progress and the timing of data readouts as the impacts of the pandemic are better understood.

Second-Quarter 2020 Financial Results

Related party revenue was $3.6 million as compared to nil for the prior-year period.
Research and development expenses were $17.5 million, as compared to $13.1 million for the prior-year period. The increase was primarily related to higher external research and development expenses associated with the advancement of several programs and ongoing Phase 2 clinical trials.
General and administrative expenses were $3.0 million, as compared to $2.6 million for the same period in 2019. The increase was due to higher personnel-related and professional services expenses.
Net loss of $17.0 million as compared to a net loss of $15.5 million for the prior-year period.
As of June 30, 2020, Pliant had cash, cash equivalents and short-term investments of $312.5 million, compared to $102.8 million as of December 31, 2019. Pliant believes it has sufficient funds to meet its operating and capital requirements into 2023.

On August 11, 2020 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported its financial results for the quarter ended June 30, 2020 (Press release, HTG Molecular Diagnostics, AUG 11, 2020, sec.gov/Archives/edgar/data/1169987/000156459020039296/htgm-ex991_6.htm [SID1234563428]).

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Recent Accomplishments & Highlights:

Entered into a 10-year Commercialization and Distribution Agreement (Master Agreement) with QIAGEN Manchester Limited (QIAGEN), providing the foundation for HTG and QIAGEN to combine their technological and commercial strengths with the goal to offer pharmaceutical companies global development, distribution and commercialization capabilities for companion diagnostic assays developed on the HTG EdgeSeq platform.
Introduced three previously released research use only (RUO) assays for use with the Thermo Fisher Scientific Ion Torrent Ion S5 next-generation sequencing (NGS) platform. With the release of the HTG EdgeSeq Precision Immuno-Oncology Panel, the HTG EdgeSeq Mouse MRNA Tumor Response Panel and the HTG EdgeSeq Autoimmune Panel, HTG’s entire RUO profiling assay menu is now available on both the Illumina and Thermo Fisher Scientific NGS platforms.
Announced the launch of the new HTG EdgeSeq Pan B-Cell Lymphoma Panel, which is commercially available for purchase in kit form or as a service in HTG’s VERI/O laboratory. The HTG EdgeSeq Pan B-Cell Lymphoma Panel is an RUO panel designed to provide molecular characterization of aggressive lymphomas by allowing researchers to measure the expression of genes associated with the aggressive lymphoma transcriptome.
Signed three new European distributor agreements to promote HTG products and services in Nordic and Eastern European Countries with BioNordika (Denmark), Explorea (Czech Republic), and ELTA 90 (Bulgaria).
HTG’s EdgeSeq technology was highlighted in posters presented by partners at both the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 virtual meetings.
Secured a $10.0 million senior term loan from Silicon Valley Bank. Proceeds from the senior term loan were used to pay off the principal balances outstanding on HTG’s term loan with MidCap Financial and its subordinated convertible promissory note held by QIAGEN North American Holdings, Inc. The duration of the senior term loan is 42 months, with interest only payments through June 30, 2021 plus additional months under certain conditions.
"The COVID-19 pandemic continued to have a negative impact on our business and that of our customers in the second quarter of 2020 and we believe it will continue to have a negative impact likely through at least the remainder of 2020 as a number of our larger customers have communicated their intentions to remain operating at partial capacity or with limited external visitors through the end of the year," said John Lubniewski, President and CEO of HTG. "However, we have also been encouraged to see a number of our academic customers in Europe and the United States return to their laboratories, resume planned studies with HTG technologies and initiate new ones that we have been discussing and developing with them during the last several months of remote engagement. While we cannot be certain of the ultimate impact of the COVID-19 pandemic on us or our customers, this positive trend allows us to continue to be optimistic that demand for our products and services will increase in the future."

Mr. Lubniewski continued, "Our product development teams have made progress towards the key milestones during the quarter. Our California and Arizona development teams continue to implement our development strategy and we believe we are on track to deliver upcoming anticipated development milestones. While the pandemic has created some near-term uncertainty, we are very proud of how our employees have faced the challenges – with flexibility and a commitment to ensuring our long-term success. When our customers eventually return to a more normal work environment, we will be prepared to meet demand and for growth in our business."

Second Quarter 2020 Financial Highlights:

Total revenue for the quarter ended June 30, 2020 was $2.0 million, compared with $5.8 million for the same period in 2019. The decrease in revenue is a result of the impact of the COVID-19 pandemic requiring the closure of customer facilities around the globe for a large portion of the second quarter of 2020. These closures limited HTG’s ability to ship instruments and consumables to customer facilities and the ability of customers to prepare and ship samples to HTG’s VERI/O laboratory for processing.

Product and product-related services revenue was $1.7 million for the quarter ended June 30, 2020, compared with $4.4 million for the same period in 2019. In addition to the impacts of the COVID-19 pandemic, this decrease reflects a decline in lower margin subcontracted laboratory services revenue when compared with second quarter of 2019.

Collaborative development services revenue for the quarter ended June 30, 2020 was $0.2 million compared with $1.4 million for the same period in 2019, reflecting a decrease in activity as we continue to await additional activity based on customer decision points relating to our existing programs.

Net loss from operations for the quarter ended June 30, 2020 was $5.0 million, compared with $4.7 million for the second quarter of 2019. Net loss per share was $(0.09) for the second quarter of 2020 compared with $(0.17) for the second quarter of 2019.

Cash, cash equivalents and short-term available-for-sale securities totaled $32.9 million as of June 30, 2020, with current liabilities of approximately $4.9 million and non-current liabilities of $15.7 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

Date: Tuesday, August 11, 2020
Time: 4:30 p.m. Eastern Time
Toll Free: (877) 407-0789
International: (201) 689-8562
Conference ID: 13706480
Webcast: View Source

On August 11, 2020 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported corporate updates and financial results for the second quarter ended June 30, 2020 (Press release, Alector, AUG 11, 2020, View Source [SID1234563427]).

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"I am proud of the continued progress across our portfolio, most notably the initiation of our pivotal Phase 3 trial evaluating AL001 for the treatment of people with frontotemporal dementia," said Arnon Rosenthal, Ph.D., co-founder and chief executive officer of Alector. "We are encouraged by the findings from the Phase 2 study of AL001 and look forward to sharing additional data after longer-term treatment and follow up. Our novel immuno-neurology approach and commitment to delivering transformative new therapies to people living with devastating forms of degenerative brain diseases are at the core of what we do. We have taken significant steps to ensure that we will continue to be in a position to achieve our goals, and ultimately, deliver therapies to the people who need them."

Clinical Pipeline Highlights and Corporate Update

Progranulin Portfolio:

Announced dosing of first participant in pivotal Phase 3 trial evaluating AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). In July 2020, Alector announced that the first participant was dosed in INFRONT-3, a global, pivotal Phase 3 trial, evaluating the efficacy and safety of AL001 in pre-symptomatic and symptomatic participants with FTD-GRN. The trial will enroll up to 180 participants at approximately 50 centers globally.

Presented preliminary findings from AL001 Phase 1b and Phase 2 open label studies at the Alzheimer’s Association International Conference (AAIC). In July 2020, Alector presented promising preliminary data from the Phase 1b and Phase 2 open-label studies evaluating the long-term dosing of AL001 in patients with FTD-GRN at the virtual AAIC. The data demonstrated that AL001 was well-tolerated in both studies. Additionally, in the Phase 2 study, treatment with AL001 led to sustained restoration of plasma progranulin (PGRN) levels in all FTD-GRN participants back to the normal range. These preliminary findings also showed that the majority of symptomatic FTD-GRN participants (six out of the eight) experienced a decrease in neurofilament light chain levels (NfL), an exploratory biomarker of neurodegeneration, from baseline at the last measured time point. Alector plans to continue this 96-week open-label Phase 2 study and present additional data from study participants, including findings on safety, fluid and imaging biomarkers, and clinical outcomes assessments, at a later date.
Alzheimer’s Disease Portfolio:

Continued progress for multiple Alzheimer’s disease clinical programs:

In collaboration with its partner AbbVie, Alector plans to initiate a Phase 2 study evaluating AL002 in patients with Alzheimer’s disease in the second half of 2020.

Alector continues to advance the Phase 1b trial of AL003 in Alzheimer’s disease, also being developed in collaboration with AbbVie.

Alector plans to initiate Phase 1 development for AL014 in the first half of 2021. AL014 is the latest prioritized candidate that targets MS4A4A, a transmembrane receptor protein that is expressed selectively in microglia in the brain and is associated with control of microglia functionality and potential viability.
Notable Clinical and Early-Stage Research:

Published new findings from the AL002 program in leading research journal. In June 2020, Alector announced the publication of preclinical and Phase 1 data demonstrating the potential of AL002 as a treatment for Alzheimer’s disease in The Journal of Experimental Medicine.

Published research showing role of Trem2 in a multiple sclerosis disease model. In August 2020, Alector researchers and academic collaborators published findings highlighting the role of Trem2 as induced by AL002a (a murine specific Trem2 antibody) in promoting myelin debris clearance and remyelination in a cuprizone mouse model of multiple sclerosis in Acta Neuropathologica.
Ongoing COVID-19 Response Activities:

Alector continues to actively monitor the evolving impact of COVID-19 on its business and clinical operations, with a primary focus on the health and safety of clinical trial participants, clinical trial site teams and employees.

To help mitigate the potential effects of the ongoing COVID-19 pandemic on current participant recruitment activities, the Company has implemented a number of activities to enhance clinical trial continuation and patient recruitment including: increased remote support for clinical sites and study staff; evaluation of the availability of in-home dosing and monitoring services for trial participants; and concierge travel support for trial participants who prefer to visit clinical sites in person. A targeted disease education campaign is also planned to help drive awareness of FTD and the AL001 Phase 3 clinical trial.
Second Quarter 2020 Financial Results

Revenue. Collaboration revenue for the quarter ended June 30, 2020, was $3.2 million, compared to $6.9 million for the same period in 2019. Alector recognizes revenue from the upfront payments under an agreement with AbbVie over time as the services are provided. Revenues are recognized as the program costs are incurred by measuring actual costs incurred to date compared to the overall total expected costs to satisfy the performance obligation. Changes in estimates for revenue recognized over time are recognized on a cumulative basis.

R&D Expenses. Total research and development expenses for the quarter ended June 30, 2020, were $34.1 million, compared to $25.6 million for the same period in 2019. This increase was mainly driven by an increase in expenses to support the advancement of the clinical and pre-clinical programs across several therapeutic programs and an increase in personnel-related expenses.

G&A Expenses. Total general and administrative expenses for the quarter ended June 30, 2020, were $15.7 million, compared to $8.4 million for the same period in 2019. This increase was primarily due to an increase in personnel-related expenses due to increased headcount and an increase in legal costs associated with our ongoing arbitration proceedings for certain intellectual property matters.

Net Loss. For the quarter ended June 30, 2020, Alector reported a net loss of $45.3 million, compared to a net loss of $24.6 million for the same period in 2019.

Cash Position. Cash, cash equivalents, and marketable securities were $503.6 million as of June 30, 2020. The Company believes that its cash and investments as of June 30, 2020, will be sufficient to fund its anticipated operations through 2022.