UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8‑K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
December 13, 2019
Alector, Inc.
(Exact name of registrant as specified in its charter)
|
Delaware |
|
001-38792 |
|
82-2933343 |
|
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer |
131 Oyster Point Blvd. Suite 600
South San Francisco, California 94080
(Address of principal executive offices, including zip code)
(415) 231-5660
(Registrant’s telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
|
Common Stock |
ALEC |
The NASDAQ Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 7.01 Regulation FD Disclosure.
On December 13, 2019, Alector, Inc. (the “Company”) issued a press release regarding updates in the Company’s clinical and research programs to be shared at its R&D Day on December 13, 2019 and a separate press release announcing the appointment of Dr. Richard Scheller and Dr. Thomas Südhof as co-chairs of the Company’s Strategic Portfolio Advice and Review Committee (SPARC). A copy of the press releases are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are hereby incorporated by reference into this Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liabilities of that section, nor shall such information and exhibit be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
In connection with Dr. Scheller’s service and engagement as a co-chair of SPARC, the Board determined that Dr. Scheller is no longer considered “independent” under the rules of NASDAQ and the Securities and Exchange Commission. On December 6, 2019, the Board re-established the Compensation Committee and Nominating and Corporate Governance Committee as follows:
Compensation Committee
Mr. David Wehner (Chairperson)
Mr. Louis J. Lavigne, Jr.
Nominating and Corporate Governance Committee
Mr. Terry McGuire (Chairperson)
Dr. Kristine Yaffe
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
Exhibit No. |
Description |
|
99.1 |
|
|
99.2 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
ALECTOR, INC. |
|
|
|
|
|
|
|
Date: December 13, 2019 |
|
By: |
/s/ Arnon Rosenthal |
|
|
|
|
Arnon Rosenthal, Ph.D. |
|
|
|
|
Co-Founder and Chief Executive Officer
|
Exhibit 99.1
Alector Showcases Progress in Immuno-Neurology Clinical Programs and Research Portfolio at R&D Day
|
|
- |
Reported results from analysis of the Phase 1b study of AL001 in patients with symptomatic FTD-GRN showing a statistically significant normalization in a number of disease-associated proteins and an initial trend of a decrease compared to baseline levels in plasma Neurofilament (NfL) |
|
|
- |
Phase 1 study of AL002 demonstrated target engagement and indicated proof-of-mechanism in healthy volunteers |
|
|
- |
Phase 1 study of AL003 demonstrated a dose dependent and long-lasting target engagement in healthy volunteers |
|
|
- |
Progressed new product candidate targeting Alzheimer’s disease, AL014, from research to IND-enabling nonclinical studies |
SOUTH SAN FRANCISCO, Calif., Dec. 13, 2019 -- Alector, Inc. (Nasdaq: ALEC), a clinical stage biotechnology company pioneering immuno-neurology, today announced that it will provide updates related to its lead product candidates during a previously announced R&D day being held today at 8:00 a.m. ET in New York, NY. During today’s session, Alector will outline key activities underway for AL001, AL002, AL003, AL101, and AL014, and will feature presentations from leading key opinion leaders focused on the human genetics of neurodegeneration. Today’s presentations will be webcasted beginning at 8:00 a.m. ET and are available for viewing at the Investors section of www.alector.com.
“At Alector, we are pursuing a meaningful and ambitious goal: to cure neurodegenerative diseases and make them illnesses of the past. By incorporating human genetics, immunology and neuroscience, our immuno-neurology therapeutic approach aims to change the lives of patients and their families,” said Arnon Rosenthal, chief executive officer of Alector. “We continue to innovate, discover and develop medicines in pursuit of this goal, and we have recently made substantial advances with our programs. In FTD, we have moved our AL001 program from pre-clinical to Phase 2 clinical studies in under two years, with clinical data from the Phase 1b study showing a trend towards normalization of disease-associated biomarkers. Moreover, we continue to be encouraged by target engagement results in healthy volunteers from our two Alzheimer’s disease programs, AL002 and AL003, and are excited to advance our third program in Alzheimer’s disease, AL014, from research to IND-enabling nonclinical studies. We continue to be fully committed to improving outcomes for patients with neurodegenerative diseases in 2020 and beyond.”
Key highlights from the event included:
AL001
Alector’s AL001 program is initially aimed at treating patients with frontotemporal dementia (FTD) who have a known genetic mutation that causes a deficiency in progranulin (PGRN), which is called FTD-GRN. AL001 is designed to function by shutting down Sortilin (SORT1) degradation mechanism for PGRN and increasing the circulating half-life of the functional PGRN in the brain.
|
|
• |
The company has completed the Phase 1b portion of the study, in which treatment with AL001 demonstrated proof-of-mechanism in FTD-GRN patients by restoring PGRN levels in plasma and cerebrospinal fluid back to the normal range. |
|
|
• |
Today, the company also reported additional results from the Phase 1b study with AL001. A global proteomics profiling from the CSF of FTD-GRN patients two months post-dosing with AL001 showed that AL001 elicited a statistically significant normalization in a number of disease-associated proteins, including inflammatory and lysosomal biomarkers (R= -0.36; P= 3E-43). Preliminary data also indicated an initial trend of an approximate 14% decrease compared to baseline levels in plasma Neurofilament (NfL) in five (5) FTD-GRN patients for which blood samples were available three months after the first dose. |
|
|
• |
In the third quarter of 2019, Alector advanced AL001 into a Phase 2 study in FTG-GRN patients with proof-of-concept data expected in the first half of 2020. |
|
|
• |
In addition, in consultation with the U.S. Food and Drug Administration (FDA), the company plans to advance AL001 into a Phase 3 study in FTD-GRN patients in 2020. |
AL002
Alector’s AL002 program is aimed at treating patients with Alzheimer’s disease by targeting a triggering receptor expressed on myeloid cells 2 (TREM2) with strong genetic links to Alzheimer’s disease and other neurodegenerative disorders.
|
|
• |
First-in-human data in healthy volunteers for the AL002 program shows that the TREM2 activating antibody engages its target and elicits downstream activity in the CNS. |
|
|
• |
In the 56-healthy-volunteer single ascending dose portion of the Phase 1 study, AL002 was generally safe and well-tolerated. |
|
|
• |
AL002 demonstrated target engagement as measured by reduced CSF soluble TREM2 (sTREM2) in a dose-dependent manner in healthy volunteers. |
|
|
• |
Additionally, AL002 elevated a biomarker for microglia activity in the CSF, indicating proof-of-mechanism in healthy volunteers. |
|
|
• |
Proof-of-mechanism data from the ongoing Phase 1b portion of the study in Alzheimer’s disease patients is expected in 2020. |
|
|
• |
The Company also expects to initiate a Phase 2 study in 2020. |
The AL003 program is initially being evaluated for the treatment of people with Alzheimer’s disease and aims to block the function of sialic acid binding Ig-like lectin 3 (SIGLEC 3) to increase the activity of beneficial microglia and elicit a therapeutic benefit.
|
|
• |
In the 38-healthy-volunteer Phase 1 study initiated earlier this year, single dose AL003 demonstrated dose dependent and long-lasting change in SIGLEC 3 in the blood, indicating target engagement. |
|
|
• |
The Company is progressing the Phase 1b portion of the study in Alzheimer’s disease patients and is planning to announce proof-of-mechanism data in 2020. |
AL014
Today, Alector unveiled its newest prioritized product candidate, AL014, for Alzheimer’s disease.
|
|
• |
AL014 targets the MS4A4A protein and is designed to mimic and exceed the beneficial activities of the protective MS4A4A gene variant in Alzheimer’s disease. |
|
|
• |
MS4A4A is a transmembrane receptor protein that is expressed selectively in microglia in the brain and is associated with control of microglia functionality and/or viability. |
|
|
• |
MS4A4A is among the most prominent genetic risk clusters known for late onset Alzheimer’s disease. |
|
|
• |
Risk variants of MS4A4A were shown to increase the prevalence of Alzheimer’s disease, decrease the age of onset and increase the conversion rate from mild cognitive deficit to Alzheimer’s disease. |
|
|
• |
Alector aims to initiate IND-enabling studies in 2020. |
The live webcast of the event is available on the “Events & Presentations” page within the Investors section of the Alector website at http://investors.alector.com. A replay will be available on the Alector website for 90 days.
For further information, please contact alector@argotpartners.com
About Alector
Alector is a clinical-stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. Alector is developing a broad portfolio of programs designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. The Company’s product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer’s disease. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on our beliefs and assumptions and on information currently available to us on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding the Company’s plans for and anticipated benefits and mechanism of the Company’s product candidates, the timing and objectives of the clinical studies and anticipated regulatory and development milestones. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Important factors that could cause our actual results to differ materially are detailed from time to time in the reports Alector files with the Securities and Exchange Commission, including in our quarterly report on Form 10-Q that is filed with the Securities and Exchange Commission (“SEC”). Copies of reports filed with the SEC are posted on Alector’s website and are available from Alector without charge.
Contacts
Media:
1AB
Dan Budwick, 973-271-6085
dan@1abmedia.com
Investors:
Alector, Inc.
ir@alector.com
Exhibit 99.2
Alector Appoints Dr. Richard Scheller, Lasker Prize Awarded Scientist, and Dr. Thomas Südhof, Nobel Laureate as Co-Chairs of its Strategic Portfolio Advice and Review Committee
|
|
- |
During its R&D day, company announced that Drs. Scheller and Südhof will support its mission to pioneer the discovery and development of transformative immune therapies for neurodegeneration |
SOUTH SAN FRANCISCO, Calif. – Dec. 13, 2019 -- Alector, Inc. (Nasdaq: ALEC), a clinical stage biotechnology company pioneering immuno-neurology, today announced the appointment of Richard Scheller, Ph.D. and Thomas Südhof, M.D. as co-chairs of the Company’s Strategic Portfolio Advice and Review Committee (SPARC).
As co-chairs of SPARC, Drs. Scheller and Südhof will serve as key R&D leaders supporting the advancement of Alector’s research pipeline and proprietary drug discovery platform. The appointment of Drs. Scheller and Südhof, both world-renowned neuroscientists, reflects Alector’s commitment to pioneering the discovery and development of transformative immune therapies for neurodegeneration and to building a leading biotechnology organization.
In addition to his strong track-record of developing new medicines and leading multiple R&D organizations, Dr. Scheller is the 2013 recipient of the Lasker Award for discoveries about the mechanism of neurotransmitters. He is currently the Chairman of Research and Development at BridgeBio, and previously held executive leadership positions at 23andMe and Genentech. Dr. Südhof is the Avram Goldstein Professor in the School of Medicine at Stanford University, who won the Nobel Prize in Physiology or Medicine in 2013 for the discovery of a major transport system in cells.
“Scientific innovation is at the heart of Alector, and we are proud to have two of the world’s leading neuroscientists join us in our mission to find cures for neurodegenerative diseases. We believe that Drs Südhof and Scheller’s invaluable insights and experiences will support our vision to build the leading research engine and discovery platform in immuno-neurology by working one-on-one with our teams here at Alector,” said Arnon Rosenthal, Ph.D., chief executive officer of Alector. “I have known Dr. Südhof and Dr. Scheller for many years, and I have tremendous respect for their capabilities and long-standing dedication to advancing the field of neuroscience.”
“Addressing the burden of neurodegenerative disorders has been a long-fought challenge for the pharmaceutical industry, and despite some advances, many people still suffer the devastating consequences of these diseases,” said Dr. Südhof. “Alector’s focus of addressing neurodegeneration through the completely novel approach of immuno-neurology represents a turning point in the development of treatments for neurodegeneration. I have been inspired by the science and the data we have seen, while early, is compelling, and I look forward to helping them further advance their pipeline.”
“As an industry, we have a responsibility to think outside the box and find solutions that will make a difference for patients no matter how hard the work is or what challenges we face,” said Dr. Scheller. “I believe strongly in Alector’s vision to do something different to address neurodegeneration. In a short time, Alector has made tremendous progress with several
programs in the clinic, and many more to follow shortly behind. Alector has an opportunity to reshape the way we think about and treat neurodegenerative disorders, and I am honored to join them in that effort.”
About Richard Scheller, PhD
Dr. Scheller is the 2013 recipient of the Albert Lasker Basic Medical Research Award for discoveries concerning the molecular machinery and regulatory mechanism that underlie the rapid release of neurotransmitters. He is currently the Chairman of Research and Development at BridgeBio. He was previously the head of therapeutics and chief scientific officer at 23andMe from 2015 to 2019. Prior to his role there, Dr. Scheller spent 14 years at Genentech where he was executive vice president of research and early development. He served on the executive committees of Roche and Genentech focusing on research strategy, drug discovery, business development and early drug development activities. From 1982 to 2001, Dr. Scheller served on the faculty of Stanford University as a professor in the Department of Biological Sciences and the Department of Molecular and Cellular Physiology and was an investigator at the Howard Hughes Medical Institute of Stanford University Medical Center. Since 2004, Dr. Scheller has served as an adjunct professor in the Department of Biochemistry and Biophysics at the University of California, San Francisco. He has published more than 200 primary research papers during his career. Dr. Scheller holds a B.S. in biochemistry from the University of Wisconsin-Madison and a Ph.D. in chemistry from California Institute of Technology (Caltech).
About Thomas Südhof, M.D.
Dr. Südhof won the Nobel Prize in Physiology or Medicine in 2013 for discoveries that advanced our understanding of how nerve cells communicate by synaptic transmission. He has been the Avram Goldstein Professor in the School of Medicine at Stanford University since 2008 and is currently studying how synapses are formed and maintained, processes that are essential for understanding the mechanisms causing neurodegenerative and neuropsychiatric disorders. Prior to Stanford University, Dr. Südhof spent 25 years at the University of Texas, Southwestern, where he acted as founding chairman of the department of neuroscience. Most of his research at that time focused on the mechanisms of synaptic transmission, whereas his current work focuses on the specificity of synaptic connections which has profound implications for the treatment of neurodegenerative and neuropsychiatric diseases. In addition, Dr. Südhof has been an investigator of the Howard Hughes Medical Institute since 1986. He holds an M.D. and a doctoral degree from the University of Göttingen, where he described the structure and function of chromaffin granules, at the Max Planck Institute for Biophysical Chemistry in the lab of Victor P. Whittaker.
About Alector
Alector is a clinical-stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. Alector is developing a broad portfolio of programs designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. The Company’s product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer’s disease. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.
Contacts
Investors:
Alector, Inc.
ir@alector.com
Media:
1AB
Dan Budwick, 973-271-6085
dan@1abmedia.com