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Avidity Biosciences Reports Third Quarter 2020 Financial Results and Recent Highlights

On November 10, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported financial results for the quarter ended September 30, 2020 and highlighted recent corporate progress (Press release, Avidity Biosciences, NOV 10, 2020, View Source [SID1234570442]).

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"During the third quarter, we continued to invest in all aspects of our business and advanced our muscle-disease programs toward the clinic," said Sarah Boyce, President and Chief Executive Officer. "In the near term, we are focused on preparing for the initiation of our first clinical study with AOC 1001 in adults with myotonic dystrophy type 1. We are also advancing our research efforts in new tissues and cell types beyond muscle that we believe we can effectively target with AOCs to create new therapies designed to improve the lives of patients with serious diseases."

"As we prepare for clinical development with AOC 1001, we maintain a strong financial position with $341 million in cash at quarter-end," said Mike MacLean, Chief Financial Officer. "With our current financial resources, we are well-positioned to meet our goals and advance multiple AOC programs into the clinic in the next two years."

Third Quarter 2020 and Recent Corporate Highlights

Presented at Key Scientific Meetings. Avidity presented at several key virtual scientific meetings, including TIDES USA 2020, the 16th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) 2020, the Next Generation Protein Therapeutics and Bioconjugates Summit 2020, and TIDES Europe 2020. In early December 2020, the company plans to present an overview of its AOC technology and preclinical data at the 3rd Annual Neuromuscular Drug Development Summit.
Entered into Collaboration to Study the Natural History of DM1 to Support Lead Program AOC 1001. Avidity entered into a collaboration supporting END-DM1 (Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1), a natural history study to advance the understanding of disease progression in patients with myotonic dystrophy type 1 (DM1). This new collaboration supports Avidity’s lead program, AOC 1001, in development for the treatment of DM1. END-DM1 is a non-interventional study designed and run by the Myotonic Dystrophy Clinical Research Network (DMCRN), a network of medical centers. DMCRNaims to support future clinical trials of potential therapies for DM1 through the generation of evidence around endpoint measures and testing methods.
Appointed Key New Hires to Leadership Positions. Avidity welcomed three new team members into leadership positions: Teresa McCarthy, Chief Human Resources Officer, Kelly DiTrapani, Vice President of Medical Affairs, and Monica Zepeda, Vice President of Program and Alliance Management. Avidity strives to achieve a strong diversity climate and celebrates its newest female executives.
Financial Results

Cash and Cash Equivalents: Cash and cash equivalents totaled $341.1 million as of September 30, 2020, which includes net proceeds of $274.1 million from the company’s IPO in June 2020, compared to cash and cash equivalents of $94.6 million as of December 31, 2019.
Collaboration Revenue: Collaboration revenue, including reimbursable expenses, was $1.7 million for the third quarter of 2020 compared with $0.7 million for the third quarter of 2019, and $4.6 million for the first nine months of 2020 compared with $0.9 million for the first nine months of 2019.
Research and Development (R&D) Expenses: R&D expenses, including external and internal costs associated with research activities, primarily relate to the progression of the company’s research on AOC 1001 and other programs. These expenses were $9.5 million for the third quarter of 2020 compared with $5.1 million for the third quarter of 2019, and $24.0 million for the first nine months of 2020 compared with $8.9 million for the first nine months of 2019. The increases were primarily driven by the advancement of AOC 1001, as well as other programs.
General and Administrative (G&A) Expenses: G&A expenses primarily consist of employee-related expenses, professional fees, insurance costs, and patent filing and maintenance fees. These expenses were $3.8 million for the third quarter of 2020 compared with $0.8 million for the third quarter of 2019, and $8.6 million for the first nine months of 2020 compared with $3.3 million for the first nine months of 2019. The increases were primarily due to higher personnel costs (including noncash stock-based compensation), professional fees and insurance costs related to being a public company, as well as higher patent filing fees.

Aura Biosciences Announces AU-011 Data from Phase 1b/2 Clinical Trial Selected for Late Breaking Presentation at the Upcoming American Academy of Ophthalmology 2020 Virtual Annual Meeting

On November 10, 2020 Aura Biosciences, a clinical-stage biopharmaceutical company developing a novel class of tumor targeted therapies for initial application in primary tumors such as choroidal melanoma, reported that an abstract has been selected as a late breaking presentation as part of the Retina Subspecialty Day at the upcoming American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting, taking place November 14-17, 2020 (Press release, Aura Biosciences, NOV 10, 2020, View Source [SID1234570440]). The abstract details results from the ongoing intravitreal administration Phase 1b/2 clinical study and suprachoroidal administration Phase 2 clinical study evaluating AU-011 in patients with choroidal melanoma.

This late-breaking presentation will be given by Carol L. Shields, M.D., Director, Ocular Oncology Service at Wills Eye Hospital, and Professor of Ophthalmology at Thomas Jefferson University. Other key presentations will be given by Brian P. Marr, M.D., Director, Division of Ophthalmic Oncology, New York-Presbyterian/Columbia Medical Center and Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, and Associate Professor of Ophthalmology, Harvard Medical School, and will also highlight updated clinical data from Aura’s ongoing Phase 1b/2 AU-011 clinical trial, and the overall development plan including the ongoing Phase 2 study evaluating suprachoroidal administration of AU-011, also in patients with primary choroidal melanoma.

Details for the AAO 2020 presentations are as follows:

Late breaker title: AU-011, a Targeted Therapy for Primary Treatment of Choroidal Melanoma (CM) via Intravitreal (IVT) and Suprachoroidal (SC) Administration

Presenter: Carol S. Shields, MD, Wills Eye Hospital

Session: RET10V

Date and time: Friday, November 13, 2020 from 3:15 – 3:20 PM PT

Location: Virtual Live Meeting Broadcast

Title: AU-011 for Choroidal Melanoma: Trial Update

Presenter: Brian P. Marr, MD, New York-Presbyterian/Columbia medical Center

Session: PTH05V

Date and time: Friday, November 13, 2020 from 4:02 – 4:07 PM PT

Location: Virtual Live Meeting Broadcast

Title: Update from an Ongoing Phase 1b/2 Open-label Trial with Intravitreal (IVT) AU-011 for Choroidal Melanoma (CM) and Further Development Plan

Presenter: Ivana K. Kim, MD, Massachusetts Eye and Ear

Session: PA034

Date and time: Available on demand Nov 14-15, 2020

Location: Virtual Meeting Live Broadcast

About Choroidal Melanoma

Choroidal melanoma is a rare and life-threatening type of eye cancer. It is the most common primary intraocular cancer in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts, and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of patients with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About AU-011 (belzupacap sarotalocan)

AU-011 is a first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of malignant tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

About Suprachoroidal Administration

In addition to intravitreal administration, Aura is also investigating AU-011 using the suprachoroidal (SC) route of administration. Aura believes that delivering AU-011 into the suprachoroidal space (SCS) within the eye, has the potential to offer certain advantages over intravitreal injection, including higher bioavailability at the tumor site and reduced exposure of non-targeted tissues, which may lead to an improved therapeutic index for AU-011. Collectively, these features could allow for the treatment of a wider range of tumor sizes, and, therefore, a larger number of patients. The Company is partnered with Clearside Biomedical for use of Clearside’s SCS Microinjector for administration of AU-011 into the SCS. In preclinical research presented as part of the ARVO 2020 virtual program, AU-011 showed excellent distribution in the SCS, complete necrosis of tumors following laser activation in an animal model of choroidal melanoma and no clinical signs of anterior segment or posterior segment inflammation.

Aptose Reports Results for the Third Quarter 2020

On November 10, 2020 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, reported financial results and a corporate update for the three months ended September 30, 2020 (Press release, Aptose Biosciences, NOV 10, 2020, View Source [SID1234570439]).

The net loss for the quarter ended September 30, 2020 was $13.3 million ($0.15 per share) compared with $6.8 million ($0.12 per share) for the quarter ended September 30, 2019. Total cash and cash equivalents and investments as of September 30, 2020 were $132.7 million. Based on current operations, we expect that cash on hand provides the Company with sufficient resources to fund all planned operations including research and development into 2023.

"With our recently initiated Phase 1 a/b trial of CG-806 in patients with relapsed or refractory (R/R) acute myeloid leukemia, we now have three clinical trials under way – two studies with our FLT3 and BTK kinase inhibitor CG-806 and one with our MYC inhibitor APTO-253," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "Enrollment of AML patients has been brisk at the 450mg BID dose level and clinical site investigators are hopeful about the potential for CG-806 as a therapeutic option in relapsed or refractory AML. In our B-cell malignancy clinical trial, we are beginning to observe nodal reductions in the deep R/R-CLL and SLL patients and are treating patients at dose level 5 (750 mg BID), which gives us optimism that clinical responses may emerge over time. We look forward to sharing more details from our CG-806 and APTO-253 programs with you at a corporate update just a few weeks from now during ASH (Free ASH Whitepaper)."

Key Corporate Highlights

CG-806 Phase 1 a/b Clinical Study in AML – In October, Aptose announced dosing of the first patient with R/R acute myeloid leukemia (AML) in a Phase 1 a/b clinical study with CG-806, the Company’s oral kinase inhibitor that potently inhibits the wildtype and mutant forms of FLT3 and BTK, and suppresses select clusters of kinases that drive oncogenic signaling pathways. The Phase 1 a/b trial is a multicenter open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML. The investigational drug is the only known clinical agent that potently inhibits both FLT3 and BTK, giving it broad therapeutic potential across the spectrum of lymphoid and myeloid hematologic malignancies. Currently, 5 U.S. sites are open for screening and enrolling patients for the study, and more information is available at www.clinicaltrials.gov (NCT04477291).

CG-806 Phase 1 a/b B-cell Malignancy Clinical Study – Separate from the AML trial, Aptose is treating patients at the fifth dose level of 750 mg BID in its Phase 1 a/b dose escalation study with CG-806 in patients with R/R B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to current therapies. At the 750mg dose Aptose is focusing exclusively on enrolling CLL patients, where on-target activity has been observed, including inhibition of multiple oncogenic driver kinases, lymphocytosis, classically ascribed as a consequence of inhibiting BTK, as well as nodal reductions. Currently, 29 U.S. sites are open for screening and enrolling patients for the study, and more information is available at www.clinicaltrials.gov (NCT03893682).

APTO-253 Phase 1b Clinical Study in R/R AML and MDS – Aptose has completed the 28-day dosing in the first four dose cohorts of the Phase 1b clinical study of APTO-253 in patients with relapsed or refractory AML or high-risk MDS. The Company has enrolled three patients at dose level five (150 mg/m2), which represents a 50% increase over dose level four. APTO-253 is the only known clinical-stage molecule that can directly target and inhibit expression of the MYC oncogene, shown to reprogram survival signaling pathways and contribute to drug resistance in many malignancies, including AML and B cell malignancies. In the ongoing Phase 1b trial, 253 continues to be well tolerated with no evidence of drug-related adverse events, including no observed myelosuppression. More information is available at www.clinicaltrials.gov (NCT02267863).

Upcoming Presentations at ASH (Free ASH Whitepaper) – Last week, Aptose announced that early clinical data, along with certain preclinical data, for CG-806, an oral, first-in-class FLT3 and BTK cluster selective kinase inhibitor, and early clinical data for APTO-253, a first-in-class small molecule MYC inhibitor, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held virtually Saturday, December 5 – Monday, December 7, 2020. The abstracts accepted for presentation can be viewed online at the ASH (Free ASH Whitepaper) conference website. Note that the poster presentations will include additional data not found in the abstracts.

In addition, Aptose is planning to hold a corporate update during ASH (Free ASH Whitepaper) to review the most current clinical data for each of the ongoing trials. More details to follow.

RESULTS OF OPERATIONS

A summary of the results of operations for the three-month and nine-month periods ended September 30, 2020 and 2019 is presented below:

The net loss for the three-month period ended September 30, 2020 increased by $6.4 million to $13.2 million as compared with $6.8 million for the comparable period in 2019, primarily as a result of an increase of $4.4 million in stock-based compensation in the current period, a combined increase in costs for our CG-806 development program and related labor costs of approximately $2.5 million and offset by lower costs of approximately $721 thousand on our APTO-253 program. There was also an increase in cash-based general and administrative expenses of $108 thousand and a decrease in net finance income of $138 thousand in the current period compared to the comparative period, mostly as a result of lower yields on investments held during the three-month period ended September 30, 2020.

The net loss for the nine-month period ended September 30, 2020 increased by $22.0 million to $40.5 million as compared with $18.6 million for the comparable period in 2019, primarily as a result of an increase of $15.3 million in stock-based compensation in the current period, a combined increase in program costs and related labor costs of approximately $7.1 million on our CG-806 development program and higher cash-based general and administrative expenses of approximately $492 thousand. These expenses were partially offset by lower costs of $836 thousand on our APTO-253 development programs.

Research and Development
The research and development expenses for the three-month and nine-month periods ended September 30, 2020 and 2019 were as follows:

Research and development expenses increased by $2.8 million to $7.5 million for the three-month period ended September 30, 2020 as compared with $4.8 million for the comparative period in 2019. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for CG-806 increased by approximately $2.1 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation, higher costs associated with the CG-806 Phase 1a/b trial and the costs associated the CG-806 AML trial.

Program costs for APTO-253 decreased by approximately $721 thousand, mostly as a result of lower manufacturing costs and lower clinical trial costs related to the APTO-253 Phase 1b trial.

Personnel-related expenses increased by $398 thousand, mostly related to new positions hired since the second quarter of 2019 to support the CG-806 Phase 1a/b and APTO-253 Phase 1b clinical trials and the CG-806 AML Phase 1 clinical trial.

Stock-based compensation increased by approximately $1.0 million in the three months ended September 30, 2020, compared with the three months ended September 30, 2019, mostly related to an increase in the number of options granted during the nine months ended September 30, 2020 and a higher grant date fair value of options as compared with the nine months ended September 30, 2019, and a higher rate of forfeitures in the comparative period.
Research and development expenses increased by $8.7 million to $20.3 million for the nine-month period ended September 30, 2020 as compared with $11.6 million for the comparative period in 2019 for the same reasons as described above for the three-month period ended September 30, 2020.

Program costs for CG-806 increased by approximately $5.7 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation, higher costs associated with the CG-806 Phase 1a/b trial and the costs associated with the CG-806 AML trial.

Program costs for APTO-253 decreased by approximately $836 thousand, mostly as a result of lower manufacturing costs and lower clinical trial costs related to the APTO-253 Phase 1b trial.

Personnel-related expenses increased by $1.4 million, mostly related to new positions hired since the second quarter of 2019 to support the CG-806 Phase 1a/b and APTO-253 Phase 1b clinical trials and the CG-806 AML Phase 1 clinical trial.

Stock-based compensation increased by approximately $2.5 million in the three months ended September 30, 2020, compared with the three months ended September 30, 2019, mostly related to an increase in the number of options granted during the nine months ended September 30, 2020 and a higher grant date fair value of options as compared with the nine months ended September 30, 2019, and a higher rate of forfeitures in the comparative period in 2019.
General and Administrative
The general and administrative expenses for the three-month and nine-month periods ending September 30, 2020 and 2019 were as follows:

General and administrative expenses for the three-month period ended September 30, 2020 were $5.8 million as compared with $2.3 million for the comparative period in 2019, an increase of approximately $3.5 million. The increase was primarily as a result of the following:

General and administrative expenses, other than share-based compensation and depreciation of equipment, increased by approximately $108 thousand in the three months ended September 30, 2020, primarily as a result of higher personnel related costs, higher insurance costs and higher office administrative costs offset by lower professional fees and lower travel expenses.

Stock-based compensation increased by approximately $3.4 million in the three months ended September 30, 2020, compared with the three months ended September 30, 2019, mostly related to an increase in the number of options granted during the nine-month period ended September 30, 2020, and a higher grant date fair value of options as compared with September 30, 2019.
General and administrative expenses for the nine-month period ended September 30, 2020 were $20.7 million as compared with $7.4 million for the comparative period in 2019, an increase of approximately $13.3 million. The increase was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, increased by approximately $492 thousand in the nine months ended September 30, 2020 primarily as a result of higher personnel related costs, higher insurance costs and higher office administrative costs and offset by lower financing costs and lower travel expenses.

Stock-based compensation increased by approximately $12.8 million in the nine months ended September 30, 2020, compared with the nine months ended September 30, 2019 mostly related to an increase in the number of restricted share units and options granted during the nine-month period ended September 30, 2020, and a higher grant date fair value of options as compared with September 30, 2019.
COVID-19 did not have a significant impact on our results of operations for the quarter ended September 30, 2020. We have not experienced and do not foresee material delays to the enrollment of patients or timelines for the CG-806 Phase 1a/b trial due to the variety of clinical sites that we have actively recruited for this trial. Similarly, we do not expect our enrollment of the CG-806 AML trial to be negatively impacted by COVID-19 as we plan to use a variety of clinical sites for this trial as well. APTO-253, which is administered intravenously, requires the need for hospital / clinical site resources to assist and monitor patients during each infusion and, based on the current conditions caused by COVID-19, future enrollment of patients on this trial is likely to be negatively impacted. As of the date of this report, we have not experienced material delays in the manufacturing of CG-806 or APTO-253 related to COVID-19. Should our manufacturers be required to shut down their facilities due to COVID-19 for an extended period of time, our trials may be negatively impacted.

Conference Call and Webcast

Aptose will host a conference call to discuss results for the quarter ended September 30, 2020 today, Tuesday, November 10, 2020 at 5:00 PM ET. Participants can access the conference call by dialing 1-844-882-7834 (North American toll-free number) and 1-574-990-9707 (international/toll number) and using conference ID #5539639. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days. An audio replay of the webcast will be available approximately two hours after the conclusion of the call for seven days by dialing 1-855-859-2056 (toll free number) and 1-404-537-3406 (international/toll number), using the conference ID # 5539639.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended September 30, 2020 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

Alexion to Present at Upcoming Virtual Investor Conferences

On November 10, 2020 Alexion Pharmaceuticals (Nasdaq:ALXN) reported that management will present at the following upcoming investor conferences (Press release, Alexion, NOV 10, 2020, View Source [SID1234570438]):

Stifel 2020 Virtual Healthcare Conference, taking place on Tuesday, November 17th, 2020 from 10:00-10:30 a.m. ET.
3rd Annual Evercore ISI HealthCONx Conference, taking place virtually on Tuesday, December 1st, 2020 from 8:50-9:35 a.m. ET.
Audio webcasts of the presentations will be available live at: View Source Archived versions of the remarks will also be available through the Company’s website for a limited time following the conferences.

Alector Reports Third Quarter 2020 Financial Results and Provides Corporate Update

On November 10, 2020 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported corporate updates and financial results for the third quarter ended September 30, 2020 (Press release, Alector, NOV 10, 2020, View Source [SID1234570437]).

"We continued to make progress across our portfolio during the third quarter, notably advancing AL001 into our first Phase 3 pivotal trial in people living with frontotemporal dementia," said Arnon Rosenthal, Ph.D., co-founder and chief executive officer of Alector. "As we approach the end of 2020, we remain focused on initiating a Phase 2 study evaluating AL002 in people with Alzheimer’s disease, and as we look ahead to 2021, we look forward to sharing updated findings from our clinical programs, including AL001, AL101 and AL003."

Recent Clinical Pipeline Highlights and Corporate Update

Progranulin Portfolio:

Initiated Phase 3 AL001 trial in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). In July 2020, Alector initiated its pivotal, global Phase 3 trial, INFRONT-3, evaluating AL001 for the treatment of FTD-GRN and is continuing to enroll participants. The trial is evaluating the efficacy and safety of AL001 in pre-symptomatic and symptomatic participants with FTD-GRN. Participants in the trial will be randomized to receive AL001 or placebo intravenously and will be given the option to continue receiving treatment in an open-lacabel extension study. FTD-GRN affects approximately 15,000 people in the United States and Europe and up to approximately 60,000 people in the U.S. that are pre-symptomatic carriers of the GRN mutation.

AL001 Phase 2 open label study continues to progress. Alector plans to present additional data from the Phase 2 trial of AL001 in pre-symptomatic and symptomatic FTD-GRN participants and an additional cohort of FTD-C9orf72 patients in 2021. The data will include findings on safety, fluid and imaging biomarkers and clinical outcomes assessments, providing additional insights to the mechanism of action and safety of AL001 in this population with great unmet medical need.

AL101 Phase 1a study continues to advance. The company anticipates reporting preliminary findings from the Phase 1a study of AL101 in healthy volunteers in 2021. The Company continues to develop a subcutaneous formulation for the investigational product that will be pursued in additional neurological diseases.
Alzheimer’s Disease Portfolio:

In collaboration with its partner AbbVie, the Company expects to initiate a Phase 2 trial evaluating AL002 in patients with Alzheimer’s disease in 2020. Alector continues to work on clinical site activation and patient screening activities in anticipation of dosing the first study participant.

A Phase 1b trial of AL003 in Alzheimer’s disease, also being developed in collaboration with AbbVie, continues to progress, with data expected in 2021.

Alector plans to initiate Phase 1 development for its latest prioritized product candidate in its development program that targets MS4A4A, a major risk gene for Alzheimer’s disease that encodes a transmembrane receptor protein that is expressed selectively in microglia in the brain and is associated with control of microglia functionality and potential viability, in the next 12-18 months.
Immuno-oncology Portfolio:

Alector scientists provided an overview of two different investigational product candidates at two recent scientific conferences. The first is AL008, a novel, investigational, antibody product candidate that combines inhibition of the CD47-SIRP-alpha (SIRPα) pathway, a potent immune checkpoint pathway co-opted by tumors to evade the immune system, with stimulation of activating Fc receptors to yield a potential best-in-class product. The second is the Company’s latest prioritized investigational product candidate within its ADP009 development program, which is a first-in-class multi Siglec inhibitor that works to enhance the innate and adaptive immune system response by blocking a critical glycan checkpoint pathway that drives immune inhibition. This product candidate is being developed in oncology and the Company believes it could also have potential therapeutic application to neurodegenerative disorders.
Ongoing COVID-19 Response Activities:

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

Although most clinical trial activities have resumed, the Company has experienced delays in enrollment and ongoing site visits as a result of the COVID-19 pandemic during previous quarters. The Company remains optimistic that future enrollment and follow up will continue for its clinical programs at an expected pace, and Alector is prepared for any future disruptions that might adversely impact currently scheduled timelines and patient follow-up and care.
Resolution of Arbitration in Alector’s Favor:

On November 2, 2020, Alector provided an update on its confidential arbitration proceedings against Dr. Asa Abeliovich, co-founder and CEO of Prevail Therapeutics. An independent arbitrator issued a confidential decision in favor of Alector, finding Dr. Abeliovich liable for breach of his confidentiality agreement and for spoliation based on his destruction of documents relevant to the proceeding. The arbitrator awarded damages for breach of the agreement and sanctions for the spoliation, as well as violation of orders during the proceeding. Monetary damages will be determined in further proceedings.
Third Quarter 2020 Financial Results

Revenue. Collaboration revenue for the quarter ended September 30, 2020, was $5.9 million, compared to $2.7 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 September 30, 2020, were $43.8 million, compared to $28.5 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 September 30, 2020, were $15.8 million, compared to $8.3 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 arbitration proceedings.

Net Loss. For the quarter ended September 30, 2020, Alector reported a net loss of $52.7 million, compared to a net loss of $31.7 million for the same period in 2019.

Cash Position. Cash, cash equivalents, and marketable securities were $461.7 million as of September 30, 2020. The Company believes that its cash and investments as of September 30, 2020, will be sufficient to fund its anticipated operations through 2022.