Atara Biotherapeutics to Participate in the Canaccord Genuity 44th Annual Growth Conference

On August 7, 2024 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that Pascal Touchon, President and Chief Executive Officer and Cokey Nguyen, Ph.D., Executive Vice President, Chief Scientific & Technical Officer, will participate at the Canaccord Genuity 44th Annual Growth Conference on Wednesday, August 14, 2024 at 8:30 a.m. PDT / 11:30 a.m. EDT (Press release, Atara Biotherapeutics, AUG 7, 2024, View Source [SID1234645489]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available by visiting the Investors and Media section of atarabio.com. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation.

Applied Therapeutics Reports Second Quarter 2024 Financial Results

On August 7, 2024 Applied Therapeutics, Inc. (Nasdaq: APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the second quarter ended June 30, 2024 (Press release, Applied Therapeutics, AUG 7, 2024, View Source [SID1234645488]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Momentum continues with our steady regulatory progress in Classic Galactosemia and SORD Deficiency," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "We are incredibly pleased to share our alignment with the Neurology Division of the FDA regarding a potential second NDA submission for govorestat for the treatment of SORD Deficiency. Both Galactosemia and SORD Deficiency are rare neurological diseases with no currently approved treatment options. At Applied, we are dedicated to creating transformative treatments for rare diseases, and we continue to work closely with regulatory agencies and patient advocacy groups to ensure that treatments become available for patients with these debilitating diseases."

Recent Highlights

· Govorestat PDUFA Target Action Date of November 28, 2024; MAA under CHMP Review by EMA; Updated Cognition Data Included in Review. In the process of preparing for the United States Food and Drug Administration (FDA) inspection, it was discovered that the vendor hired to compile NIH Toolbox data for the Company used an adult formula for calculation of about one third of composite cognition and motor skills scores. Adjusting the formula to the pediatric formula resulted in significantly improved data for cognition as compared to the prior data, demonstrating improvement in the govorestat (AT-007) treated group of approximately 8 points on a standard scale, which was statistically significant compared to placebo (p=0.032). This also resulted in a statistically significant effect on the primary endpoint sensitivity analysis which included cognition (p=0.034). The motor skills data did not change substantially. These updates were disclosed and discussed with the FDA and European Medicines Agency (EMA) and will be used in the ongoing evaluation of the New Drug Application (NDA) and Marketing Authorization Application (MAA). As previously announced, the FDA Prescription Drug User Fee Act (PDUFA) target action date is November 28, 2024. Govorestat was previously granted Pediatric Rare Disease designation and will qualify for a Priority Review Voucher (PRV) upon approval. The Company has also submitted a MAA for govorestat for the treatment of Classic Galactosemia to the EMA, which was validated in December 2023 and is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). As previously announced, in April 2024, the EMA granted a 3-month extension to the Day 120 clock stop period to allow sufficient time for responses to the CHMP’s Day 120 list of questions. The Company expects a decision by the EMA early in the first quarter of 2025. The NDA and MAA submission packages are supported by rapid and sustained reduction in galactitol, which resulted in a meaningful benefit on clinical outcomes across pediatric patients, alongside a favorable safety profile. The submission packages include clinical outcomes data from the Phase 3 registrational ACTION-Galactosemia Kids study in children aged 2-17 with Galactosemia, the Phase 1/2 ACTION-Galactosemia study in adult patients with Galactosemia, and preclinical data. If approved, govorestat would be the first medication indicated for the treatment of Galactosemia and would be Applied Therapeutics’ first commercial product.

· FDA Advisory Committee Meeting to Review Govorestat NDA for the Treatment of Classic Galactosemia Tentatively Scheduled for October 9, 2024. The FDA notified the Company of their tentative plans to convene the Genetic Metabolic Diseases Advisory Committee (GeMDAC) on October 9, 2024, to discuss the Company’s NDA for govorestat for the treatment of Classic Galactosemia. The date is tentative and has not yet been confirmed in the federal register. The newly formed GeMDAC will consist of experts in the fields of medical genetics, inborn errors of metabolism, epidemiology, and other related specialties.

· Company Aligned with the Neurology I Division of the FDA on Potential Submission of an NDA for Govorestat for the Treatment of SORD Deficiency Under Accelerated Approval. In July 2024, the Company held a Type C meeting with the FDA to align on the regulatory path forward for govorestat for the treatment of SORD Deficiency. The Neurology I Division confirmed that the data generated to-date was appropriate for a potential NDA submission under the FDA’s Accelerated Approval Program, and discussed the design of a new confirmatory study to be completed as a post-marketing requirement. The Company plans to hold a pre-NDA meeting to discuss administrative aspects of the submission in the second half of this year, and expects to submit an NDA early in the first quarter of 2025. If govorestat is approved for the treatment of Classic Galactosemia, the regulatory submission for the treatment of SORD will be submitted as a supplementary New Drug Application (sNDA). Patients in the INSPIRE study will be offered open-label govorestat treatment and will be followed for additional safety data generation. The review and potential approval of govorestat for SORD is independent of the ongoing review of govorestat for Classic Galactosemia.

· APLT Added to Russell 3000 Index. In June 2024, as part of the Russell indexes annual reconstitution, the Company was added to the Russell 3000 Index, a market capitalization-weighted equity index that tracks the performance of the largest 3,000 U.S. stocks. Membership of the Russell indexes is primarily determined by objective, market-capitalization rankings and style attributes. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.

· Participated in Multiple Medical and Patient Advocacy Group Focused Conferences. In the second and third quarters of 2024, the Company deepened its relationships and partnership with the patient community, presenting data and giving keynote addresses at the following medical meetings and patient advocacy group conferences:

o Hereditary Neuropathy Foundation (HNF) Charcot-Marie Tooth Syndrome (CMT) Summit, June 7-8 in San Diego, California;
o Charcot-Marie-Tooth Associate (CMTA) Strategy to Accelerate Research (STAR) Advisory Board meeting held June 21 in Montreal, Canada;
o Peripheral Nerve Society (PNS) 2024 Annual Meeting, held June 22-25 in Montreal, Canada;
o Sponsored and presented at the 2024 Galactosemia Foundation Conference, held July 18-20 in Concord, North Carolina.

Financial Results

· Cash and cash equivalents and short-term investments totaled $122.2 million as of June 30, 2024, compared with $49.9 million at December 31, 2023.

· Research and development expenses for the three months ended June 30, 2024, were $10.0 million, compared to $11.9 million for the three months ended June 30, 2023. The decrease of approximately $1.9 million was primarily related to decreased expenses associated with clinical and pre-clinical expenses for the near completion of AT-001 and AT-007 and drug manufacturing and formulation costs, partially offset by an increase in regulatory and personnel expenses.

· General and administrative expenses were $10.6 million for the three months ended June 30, 2024, compared to $5.3 million for the three months ended June 30, 2023. The increase of approximately $5.3 million was primarily related to an increase in legal and professional fees of $1.3 million, an increase in commercial expenses to support planned commercialization of govorestat of $3.5 million, and an increase in personnel expenses of $1.1 million due to increased headcount and salary increases, offset by a decrease in stock-based compensation, insurance expenses and other miscellaneous expense.

·
Net income for the second quarter of 2024 was $2.9 million, or $0.02 per basic common share and a net loss of $0.13 per diluted common share, compared to a net loss of $29.6 million, or $0.37 per basic and diluted common share, for the second quarter of 2023.

· Cash runway: The Company expects that its cash and cash equivalents will fund the business into 2026. Additionally, the Company expects that the sale of the priority review voucher (PRV), which would be granted upon a potential NDA approval of govorestat for the treatment of Galactosemia, could substantially extend the Company’s cash runway.

Allogene Therapeutics Reports Second Quarter 2024 Financial Results and Business Update

On August 7, 2024 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter ended June 30, 2024 (Press release, Allogene, AUG 7, 2024, View Source [SID1234645487]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter has been an excellent example of the power of momentum, particularly as we bring into the fold community cancer centers who are eager to be a part of our pivotal Phase 2 ALPHA3 trial and we are now manufacturing all of our CAR T investigational products in-house," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Beyond the progress we’ve seen across our four core programs with cema-cel in blood cancers, ALLO-329 in autoimmune disease, and ALLO-316 in relapsed and refractory renal cell carcinoma, there is renewed energy from investigators, clinical trial sites, and top-tier investors as it becomes increasingly apparent that we have the potential to reshape the future of CAR T therapies."

Program Updates

Cema-Cel: Pivotal ALPHA3 1L Consolidation Trial in Large B Cell Lymphoma (LBCL)
The pivotal Phase 2 ALPHA3 trial was initiated in June 2024 and site activation is ahead of schedule with ten community cancer and academic centers opened in less than two months. Patient screening for minimal residual disease (MRD) and enrollment are proceeding as planned.

This groundbreaking study is evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) treatment regimen for patients with LBCL who are likely to relapse after standard 1L treatment. ALPHA3 is the first pivotal trial to offer CAR T as part of 1L treatment consolidation.

This innovative ALPHA3 trial will identify patients at high risk for relapse after 1L treatment by utilizing the Foresight CLARITY Investigational Use Only (IUO) MRD test, powered by PhasED-Seq. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation). ALPHA3 is expected to complete enrollment in 1H 2026. Efficacy analyses are expected to occur in 2026 and will include an interim EFS analysis monitored by the independent Data Safety Monitoring Board (DSMB) in 1H 2026 and the data readout of the primary EFS analysis YE 2026. A potential biologics license application (BLA) submission is targeted for 2027.

Cema-Cel: Phase 1 Trial in Chronic Lymphocytic Leukemia (CLL)
Enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel. Initial data readout from the CLL cohort is projected by early 2025.

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in Autoimmune Disease (AID)
ALLO-329, the Company’s first CRISPR-based AlloCAR T investigational product for AID, incorporates the Dagger technology, which is intended to reduce or eliminate the need for lymphodepletion while targeting CD19+ B-cells and CD70+ activated T-cells, both of which are likely to play a role in AID. The Company plans to file an investigational new drug (IND) application in Q1 2025 and expects to have proof-of-concept by YE 2025.

ALLO-316: TRAVERSE Trial in Renal Cell Carcinoma (RCC)
A Phase 1 data update from approximately 20 patients with CD70 positive RCC, which will include details on the diagnostic and treatment algorithm used to mitigate treatment-associated hyperinflammatory response seen in some patients, is planned by YE 2024. In April 2024, the Company announced a $15 million award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.

2024 Second Quarter Financial Results
•Research and development expenses were $50.4 million for the second quarter of 2024, which includes $5.3 million of non-cash stock-based compensation expense.
•General and administrative expenses were $16.1 million for the second quarter of 2024, which includes $8.2 million of non-cash stock-based compensation expense.
•Net loss for the second quarter of 2024 was $66.4 million, or $0.35 per share, including non-cash stock-based compensation expense of $13.6 million and $5.0 million in non-cash impairment of long-lived asset expense.
•The Company had $444.6 million in cash, cash equivalents, and investments as of June 30, 2024.

Based on the cash runway as of June 30, 2024, the Company continues to expect its cash runway to fund operations into the second half of 2026. Guidance remains unchanged from the most recent update with an expectation of a decrease in cash, cash equivalents, and investments of approximately $200 million in 2024. GAAP Operating Expenses are expected to be approximately $300 million, including estimated non-cash stock-based compensation expense of approximately $60 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 PM PT/5:00 PM ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

Allakos Provides Business Update and Reports Second Quarter 2024 Financial Results

On August 7, 2024 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, reported a business update and announced financial results for the second quarter ended June 30, 2024 (Press release, Allakos, AUG 7, 2024, View Source [SID1234645486]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Allakos Events


Initiated the randomized, double-blind, placebo-controlled Phase 1 trial of intravenous (IV) AK006 in patients with chronic spontaneous urticaria.

Completed dosing in the randomized, double-blind, placebo-controlled subcutaneous (SC) AK006 cohort in healthy volunteers.

Reported safety, pharmacokinetics (PK), and pharmacodynamic (PD) results from the Phase 1 trial of IV AK006 in healthy volunteers.

Presented preclinical data at the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress on mast cell inhibition with AK006.

Upcoming Allakos Anticipated Milestones


Report safety, PK, and PD results from the Phase 1 trial of SC AK006 in healthy volunteers in Q3 2024.

Report randomized double-blind, placebo-controlled data from the Phase 1 trial of AK006 in patients with CSU at year end 2024.

Cash Guidance

Allakos ended the second quarter of 2024 with $123.1 million in cash, cash equivalents and investments. Allakos’ financial outlook, restructuring activities and estimated cash runway as reported by the Company in January 2024 remain unchanged. The Company reiterates that the restructuring activities will extend the cash runway into mid-2026 and continues to expect to end 2024 with total cash, cash equivalents and investments in the range of $81 to $86 million. The Company reiterates that an estimated $30 million of closeout, severance and other costs will be paid in 2024 in connection with exiting the lirentelimab development program, of which we have spent $13 million to date in the first six months of 2024. Approximately $1 million of these payments were made in the second quarter of 2024.

Second Quarter 2024 Financial Results

Allakos ended the second quarter of 2024 with $123.1 million in cash, cash equivalents and investments resulting in a net decrease in cash, cash equivalents and investments of $16.2 million during the second quarter of 2024.

Research and development expenses were $19.4 million in the second quarter of 2024 compared to $27.3 million in the second quarter of 2023, a decrease of $7.9 million. This quarter over quarter decrease is attributed to $2.5 million of lower contract research and development costs, primarily due to halting lirentelimab development, $2.5 million of decreased compensation costs and a $2.9 million decrease in other research and development expenses.

General and administrative expenses were $9.2 million for the second quarter of 2024 compared to $10.5 million for the second quarter of 2023, a decrease of $1.3 million. The quarter over quarter change included $0.7 million of decreased compensation costs and $0.6 million of decreased other general and administrative expenses.

Allakos reported a net loss of $26.7 million in the second quarter of 2024 compared to $35.1 million in the second quarter of 2023. Net loss per basic and diluted share was $0.30 for the second quarter of 2024 compared to $0.41 in the second quarter of 2023.

Alector Reports Second Quarter 2024 Financial Results and Provides Business Update

On August 7, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported second quarter 2024 financial results and recent portfolio and business updates (Press release, Alector, AUG 7, 2024, View Source [SID1234645485]). As of June 30, 2024, Alector’s cash, cash equivalents and investments totaled $503.3 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Alector’s significant progress in recent months has set the stage for a transformative period ahead, as we approach key clinical catalysts for our maturing, potential first-in-class immuno-neurology programs," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "We remain on track to report data from INVOKE-2, our Phase 2 clinical trial in early Alzheimer’s disease for AL002, in the fourth quarter, and we are encouraged that the recently reported patient baseline characteristics reflect a study population appropriate for the clinical evaluation of a TREM2 agonist in this indication."

Dr. Rosenthal continued, "In addition, the recent Breakthrough Therapy Designation for latozinemab in frontotemporal dementia with a progranulin gene mutation has provided the opportunity for increased interactions with the FDA about this program, and we now have additional clarity on how key biomarkers may support our path to a potential regulatory submission. In parallel, we are continuing to enroll patients in the PROGRESS-AD Phase 2 trial of AL101/GSK4527226. With a cash runway that extends through 2026, we are in a strong financial position as we approach these key milestones."

Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector added, "In June, Alector hosted a virtual research and development event focused on the Alector Brain Carrier (ABC), our proprietary, versatile blood-brain barrier technology. We believe our ABC technology platform has the potential to deliver novel drugs safely into the CNS, enabling potential best-in-class therapeutics for patients suffering from neurological disorders. We look forward to providing updates on our progress in the future."

Recent Clinical Updates

Immuno-Neurology Portfolio
Progranulin Programs (latozinemab (AL001) and AL101/GSK4527226) Being Developed in Collaboration with GSK

In a recent Type B interaction with the U.S. Food and Drug Administration (FDA), Alector and GSK received feedback on the potential future Biologics License Application (BLA) for latozinemab targeting frontotemporal dementia with a progranulin gene mutation (FTD-GRN). The FDA has indicated that it would consider the effects of latozinemab on plasma and cerebrospinal fluid concentrations of progranulin (PGRN) as confirmatory evidence, supplementing the potential clinical effects of latozinemab in FTD-GRN, pending BLA review. The companies also aligned with the agency on disease-relevant fluid and imaging biomarkers that may be considered as supportive evidence of clinical efficacy, subject to BLA review. These include biomarkers of astrocyte function, neurodegeneration, and brain atrophy. Based on the FDA feedback, Alector and GSK remain confident that the totality of evidence, including the primary clinical endpoint and biomarkers, could provide a path to potential approval for latozinemab. The Type B interaction occurred after the FDA granted Breakthrough Therapy Designation to latozinemab for the potential treatment of FTD-GRN earlier this year.
The pivotal, randomized, double-blind, placebo-controlled INFRONT-3 Phase 3 clinical trial of latozinemab in FTD-GRN is ongoing. Enrollment was completed in October 2023, and the treatment duration is 96 weeks. INFRONT-3 is evaluating the safety and efficacy of latozinemab in slowing disease progression in individuals with FTD-GRN. The primary endpoint in INFRONT-3 is disease progression as measured by the Clinical Dementia Rating scale plus National Alzheimer’s Disease Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR plus NACC FTLD-SB). The trial also employs other clinical and functional outcome assessments.
Alector plans to present the poster "Baseline characteristics for INFRONT-3: A Phase 3, double-blind, placebo-controlled 96-week study evaluating latozinemab in FTD-GRN" at the International Society for Frontotemporal Dementias (ISFTD) in Amsterdam from September 19-22, 2024.
Enrollment is ongoing in the PROGRESS-AD global Phase 2 clinical trial of AL101/GSK4527226 in early Alzheimer’s disease (AD). Alector and GSK are co-developing AL101 for the potential treatment of more prevalent neurodegenerative diseases, including AD and Parkinson’s disease.
In July 2024, Alector and GSK presented posters highlighting PGRN and AL101 at the Alzheimer’s Association International Conference 2024 (AAIC). The presentations included data supporting the therapeutic hypothesis of increasing PGRN levels for the potential treatment of AD and the design of the ongoing PROGRESS-AD Phase 2 clinical trial.
TREM2 Program (AL002) Being Developed in Collaboration with AbbVie

The INVOKE-2 Phase 2 clinical trial of AL002 is fully enrolled, and data from the trial are anticipated in the fourth quarter of 2024. INVOKE-2, a randomized, double-blind, placebo-controlled, dose-ranging study, is designed to evaluate the efficacy and safety of AL002 in slowing disease progression in individuals with early AD. AL002 is a novel investigational humanized monoclonal antibody that binds to TREM2 to increase TREM2 signaling and, thereby, is hypothesized to improve the functionality of microglia. It is the most advanced TREM2-activating product candidate in clinical development worldwide.
At AAIC in July 2024, Alector presented data highlighting the patient baseline characteristics for the INVOKE-2 study. The data confirm the intended study population for testing the effects of AL002, a novel TREM2 agonist, in early AD. Of note, for those participants with amyloid PET assessed at baseline, the mean (standard deviation) in centiloids was 100.1 (38.9), consistent with expectations for an early AD population in INVOKE-2. In a separate poster, Alector also presented data supporting the use of a blood-based amyloid test for screening AD patients eligible for participation in the INVOKE-2 trial.
AbbVie has an exclusive option to globally develop and commercialize AL002, upon receipt and evaluation of the INVOKE-2 data. AbbVie’s exercise of that option would prompt a $250 million payment to Alector.
Early Research Pipeline

Alector is actively progressing its Alector Brain Carrier (ABC), a proprietary, versatile blood-brain barrier (BBB) technology platform, which is being applied selectively to the company’s next-generation product candidates and research pipeline. Initial work has focused on transferrin receptor (TfR) and CD98hc targets, which have distinct expression profiles and cellular trafficking pathways but have both been shown to be highly expressed at the BBB and able to drive brain uptake when utilized as transcytosis receptors.
In June 2024, Alector hosted a virtual research and development event discussing the company’s ABC technology platform in detail. The event included a presentation from Dr. Zhiqiang An, Ph.D., Professor & Robert A. Welch Distinguished University Chair in Chemistry and Director of the Texas Therapeutics Institute at UTHealth Houston, who provided insights into emerging technologies for BBB modulation and discussed future directions and opportunities in the field.
Second Quarter 2024 Financial Results

Revenue. Collaboration revenue for the quarter ended June 30, 2024, was $15.1 million, compared to $56.2 million for the same period in 2023. The decrease was mainly due to a $35.7 million decrease in revenue recognized for the AL101 programs, including a cumulative non-cash revenue adjustment due to a contract modification in the second quarter of 2023 to have GSK operationalize the AL101 Phase 2 study. The decrease is partially due to a $15.2 million decrease in revenue recognized for the AL002 program due to the addition of AL002 LTE and patient replacement revenue in 2023. This was offset by a $9.8 million increase in revenue recognized for the latozinemab programs.

R&D Expenses. Total research and development expenses for the quarter ended June 30, 2024, were $46.3 million, compared to $46.2 million for the quarter ended June 30, 2023. The increase was mainly driven by the Company’s prioritization on selected late-stage programs.

G&A Expenses. Total general and administrative expenses for the quarter ended June 30, 2024, were $14.4 million, compared to $13.6 million for the quarter ended June 30, 2023.

Net Income (Loss). For the quarter ended June 30, 2024, Alector reported a net loss of $38.7 million, or $0.40 per share, compared to a net income of $1.4 million, or $0.02 net income per share, for the same period in 2023.

Cash Position. Cash, cash equivalents, and investments were $503.3 million as of June 30, 2024. Management expects that this will be sufficient to fund current operations through 2026.

2024 Guidance. The Company continues to anticipate collaboration revenue to be between $60 million and $70 million. Management has updated its total research and development expenses to be between $210 million and $220 million and reiterated total general and administrative expenses to be between $60 million and $70 million.

Second Quarter 2024 Conference Call

Alector’s management team will host a conference call discussing Alector’s results for the second quarter of 2024 and provide a business update. The conference call will be webcast and accessible via the investor relations section of Alector’s website at www.alector.com.

To access the call, please use the following information:

Date: Wednesday, August 7, 2024
Time: 4:30 p.m. ET, 1:30 p.m. PT

The event will be webcast live under the investor relations section of Alector’s website at View Source, and following the event, a replay will be archived there for 30 days. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone.