On May 8, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported results from the first quarter 2024 and business highlights (Press release, BeiGene, MAY 8, 2024, View Source [SID1234642865]).

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"We are pleased to present another quarter of strong financial results. Supported by our tremendous global growth in revenue, we have now ascended into the top 15 of global oncology innovators based on total oncology sales. We also continue to make significant improvement in our operating leverage as we progress to sustainable profitability," said John V. Oyler, Co-Founder, Chairman and CEO at BeiGene. "We strengthened our hematology leadership with BRUKINSA, now the BTK inhibitor with the broadest label in the class, as we advance our innovative pipeline of therapies for hematologic malignancies. With TEVIMBRA now approved for use in the U.S. and Europe, we look forward to rapidly advancing our deep pipeline of solid tumor therapies to match our leadership in hematology and continue to solidify our reputation as a global oncology innovator."

Financial Highlights

(Amounts in thousands of U.S. dollars)

Three Months Ended March 31,

(in thousands, except percentages)

2024

2023

% Change

Net product revenues

$

746,918

$

410,291

82

%

Net revenue from collaborations

$

4,734

$

37,510

(87

)%

Total Revenue

$

751,652

$

447,801

68

%

GAAP loss from operations

$

(261,348

)

$

(371,258

)

(30

)%

Adjusted loss from operations*

$

(147,341

)

$

(275,859

)

(47

)%

* For an explanation of our use of non-GAAP financial measures refer to the "Use of Non-GAAP Financial Measures" section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.

Key Business Updates

BRUKINSA (zanubrutinib)

U.S. sales of BRUKINSA totaled $351 million in the first quarter of 2024, representing growth of 153% over the prior-year period, as BRUKINSA gained share in treatment-naïve (TN) chronic lymphocytic leukemia (CLL), and emerged as the BTKi class leader in new-patient share in relapsed or refractory (R/R) CLL; BRUKINSA sales in Europe totaled $67 million in the first quarter of 2024, representing growth of 243%, driven by continued gains in market share and additional reimbursements including France, which implemented reimbursement for BRUKINSA within CLL, Waldenström’s macroglobulinemia (WM) and marginal zone lymphoma for the first time;
Presented a new matching adjusted indirect comparison of the efficacy of BRUKINSA versus acalabrutinib in R/R CLL based on data from the Phase 3 ALPINE and Phase 3 ASCEND trials demonstrating a progression-free survival and Complete Response (CR) advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival; and
Received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with R/R follicular lymphoma, in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy.
TEVIMBRA (tislelizumab)

Sales of tislelizumab totaled $145 million in the first quarter of 2024, representing growth of 26% compared to the prior-year period;
Announced European Commission approval as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use;
Received FDA approval for the treatment of second-line esophageal squamous cell carcinoma (ESCC) after prior chemotherapy;
Received FDA acceptance of BLA for the treatment of first-line gastric or gastroesophageal junction cancers; and
The pending FDA approval for tislelizumab in first-line unresectable, recurrent, locally advanced, or metastatic ESCC with a target PDUFA action date of July 2024 may be deferred on account of a potential delay in scheduling clinical site inspections.
Key Pipeline Highlights

Hematology

Sonrotoclax (BCL2 inhibitor)

Received FDA fast track designation for R/R mantle cell lymphoma (MCL); and
Continued enrollment in R/R MCL and WM with registrational intent as well as Phase 3 in TN CLL in combination with BRUKINSA; more than 850 patients enrolled to date across the program.
BGB-16673 (BTK CDAC)

Initiated expansion cohorts in R/R MCL (potential registrational intent) and R/R CLL; more than 220 patients enrolled to date across the program; and
Expect to initiate Phase 3 clinical trial in R/R CLL by the end of 2024.
Solid Tumors

Lung Cancer

Enrolled last subject in a Phase 3 clinical trial for ociperlimab (anti-TIGIT) for first-line PD-L1 high NSCLC;
Multiple tislelizumab lung cancer combination cohorts with BGB-A445 (anti-OX40), LBL-007 (anti-LAG3) and BGB-15025 (HPK1 inhibitor) expected to read out in 2024; and
Pan-KRAS and MTA-cooperative PRMT5 inhibitors and EGFR CDAC on track to enter the clinic in the second half of 2024.
Breast Cancer

BGB-43395 (CDK4 inhibitor): Initiated fourth dose level of monotherapy, which is in the efficacious dose range with no dose limiting toxicities observed; and initiated dosing of combination with fulvestrant just over four months from first monotherapy dose.
BG-68501 (CDK2 inhibitor): Initiated second dose level of monotherapy in first-in-human study, with clinical pharmacokinetics as expected and no dose limiting toxicities observed.
BG-C9074 (B7H4 ADC): First patient dosed in Australia in global first-in-human Phase 1 study.
Gastrointestinal Cancers

Multiple tislelizumab combination cohorts with LBL-007 (anti-LAG3) and BGB-A445 (anti-OX40) reading out in 2024;
Plan to submit a BLA with the NMPA for zanidatamab for the treatment of second-line biliary tract cancer; and
CEA-ADC and FGFR2b-ADC on track to enter the clinic in the second half of 2024.
Other Business Highlights

The U.S. Patent and Trademark Office (USPTO) granted the Company’s petition for post-grant review of the Pharmacyclics’ patent asserted against the Company in a patent infringement suit, stating that the Company has shown that it is more likely than not that the patent is invalid; The USPTO is expected to issue a final decision on the validity of the patent within 12 months;
Published the 2023 Responsible Business & Sustainability Report which details the Company’s commitment to providing equitable benefit to patients, business and society; and
Anticipate opening of state-of-the-art biologics manufacturing facility and clinical R&D center at the Princeton West Innovation Campus in Hopewell, New Jersey, in July.
First Quarter 2024 Financial Highlights

Revenue for the three months ended March 31, 2024, was $752 million, compared to $448 million in the same period of 2023, driven primarily by growth in BRUKINSA product sales in the U.S. and Europe of 153% and 243% respectively.

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%. The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab. For the three months ended March 31, 2024, the U.S. was the Company’s largest market, with product revenue of $351 million, compared to $139 million in the prior year period.

Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period. The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.

Operating Expenses

GAAP

Non-GAAP

(in thousands, except percentages)

Q1 2024

Q1 2023

% Change

Q1 2024

Q1 2023

% Change

Research and development

$

460,638

$

408,584

13

%

$

405,440

$

361,696

12

%

Selling, general and administrative

$

427,427

$

328,499

30

%

$

372,146

$

283,154

31

%

Amortization

$

—

$

187

(100

)%

$

—

$

—

NM

Total operating expenses

$

888,065

$

737,270

20

%

$

777,586

$

644,850

21

%

Research and Development (R&D) Expenses increased for the first quarter of 2024 compared to the prior-year period on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $35 million in the first quarter of 2024, compared to nil in the prior-year period.

Selling, General and Administrative (SG&A) Expenses increased for the first quarter of 2024 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in the global commercial launch of BRUKINSA, primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 57% for the first quarter of 2024 compared to 80% in the prior year period.

Loss from Operations in the first quarter of 2024 decreased 30% on a GAAP basis and 47% on an adjusted basis compared to the prior-year period. The decrease is driven by significantly improved operating leverage associated with substantial revenue growth and expense discipline as we make significant progress on the path to sustainable profitability.

GAAP Net Loss improved for the quarter ended March 31, 2024, compared to the prior-year period, as our product revenue growth and management of expenses is driving increased operating leverage.

For the quarter ended March 31, 2024, net loss per share was $(0.19) and $(2.41) per American Depositary Share (ADS), compared to $(0.26) per share and $(3.34) per ADS in the prior year period.

Cash Used in Operations for the quarter ended March 31, 2024, totaled $309 million compared to $564 million in the prior-year period, driven by improved operating leverage.

For further details on BeiGene’s First Quarter 2024 Financial Statements, please see BeiGene’s Quarterly Report on Form 10-Q for the first quarter of 2024 filed with the U.S. Securities and Exchange Commission.

On May 8, 2024 ArriVent BioPharma, Inc. ("Company" or "ArriVent") (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the first quarter ended March 31, 2024, and highlighted recent Company progress (Press release, ArriVent Biopharma, MAY 8, 2024, View Source [SID1234642864]).

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"In the first quarter of this year, we continued our strong progress as we fully enrolled our NSCLC EGFR PACC mutation Phase 1b cohort in our FURTHER study and initiated a Phase 1b combination study of firmonertinib and ICP-189, a SHP2 inhibitor, in NSCLC patients with EGFR classical mutations. This underscores our comprehensive development plan to maximize the potential of firmonertinib across EGFR mutant NSCLC," said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "We were also proud to present data at the AACR (Free AACR Whitepaper) annual meeting, which further demonstrated that firmonertinib was observed to be broadly active preclinically across a wide range of EGFR uncommon mutations in NSCLC, including PACC and exon 20 insertion mutations. We look forward to continuing building upon these milestones as we work to give cancer patients important new treatment options."

First Quarter 2024 and Recent Highlights

Firmonertinib

● Presentation of preclinical data for firmonertinib at the 2024 AACR (Free AACR Whitepaper) Annual Meeting. ArriVent presented preclinical data evaluating firmonertinib in NSCLC with EGFR exon 20 insertion mutations and P-loop and alpha-c helix compressing ("PACC") mutations at the AACR (Free AACR Whitepaper) Annual Meeting in April 2024. In the preclinical study firmonertinib, a highly brain penetrant mutant-selective EGFR inhibitor, was observed to be broadly active across a wide range of uncommon mutations including PACC and exon 20 insertion mutations.

● Initiation of the Phase 1b combination study with firmonertinib and ICP-189, a novel Src Homology 2 domain containing protein tyrosine phosphatase ("SHP2") allosteric inhibitor. ArriVent, in partnership with InnoCare Pharma, dosed its first patient in the Phase 1b clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in March 2024.
Graphic

Upcoming Milestones

● Proof-of-concept data expected in 2024. Firmonertinib is currently being studied in the Phase 1b clinical trial, the FURTHER trial (NCT05364073), in patients with NSCLC EGFR PACC mutations, which has been fully enrolled, with proof-of-concept data expected in 2024.

● Selection of next-generation antibody drug conjugate ("ADC") development candidate. ArriVent and its partner, Aarvik Therapeutics, Inc., continue to make progress on selecting a multitarget multivalent ADC development candidate, and expect to complete selection in late 2024 or early 2025.
Corporate Updates

● Strengthened board leadership. In April 2024, ArriVent appointed Kristine Peterson to its Board of Directors. Ms. Peterson has served on the boards of multiple public biopharmaceutical companies, including Immunocore and ImmunoGen (recently acquired by Abbvie), and brings over 30 years of industry leadership experience having previously served as Chief Executive Officer of Valeritas and Company Group Chair of Johnson and Johnson for their worldwide biotech and oncology groups.
First Quarter 2024 Financial Results

● As of March 31, 2024, the Company had cash and cash equivalents of $317.4 million, which is expected to fund operations into 2026. Net cash used in operations was $18.6 million and $16.9 million for the quarters ended March 31, 2024 and 2023, respectively.

● Research and development expenses were $17.0 million and $10.2 million for the quarters ended March 31, 2024 and 2023, respectively. The increase in expense was primarily due to increased headcount and clinical expense related to firmonertinib.

● General and administrative expenses were $3.7 million and $1.9 million for the quarters ended March 31, 2024 and 2023, respectively. The increase in expense was primarily due to expenses related to expanding the infrastructure necessary for operating as a public company.

● Net loss was $17.4 million and $12.2 million for the quarters ended March 31, 2024 and 2023, respectively.

On May 8, 2024 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported financial results for the first quarter ended March 31, 2024, and provided a pipeline update on its clinical-stage investigational molecules – targeting TIGIT, the adenosine axis (CD73 and A2a/A2b receptors), HIF-2a, AXL and PD-1 – across multiple common cancers (Press release, Arcus Biosciences, MAY 8, 2024, View Source [SID1234642863]).

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"Arcus has evolved to become a late-stage oncology company with multiple programs targeting lung, gastrointestinal and kidney cancers that address extremely large patient populations with high unmet need," said Terry Rosen, Ph.D., chief executive officer of Arcus. "With two oral presentations at ASCO (Free ASCO Whitepaper) in GI cancers and a third dataset for our HIF-2a inhibitor expected later this year, we have several near-term catalysts that will further validate our deep pipeline of potentially first- and best-in-class molecules, which will be in at least 5 different Phase 3 studies by the first half of 2025."

Domvanalimab (Fc-silent anti-TIGIT monoclonal antibody) plus Zimberelimab (anti-PD-1 antibody)
•Results from Arm A1 of the Phase 2 EDGE-Gastric trial evaluating domvanalimab plus zimberelimab and chemotherapy in first-line upper GI cancers, including objective response rate (ORR), median progression-free survival (PFS) and duration of response, will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2024. This study is evaluating the same regimen in the same setting as the STAR-221 Phase 3 study.
•Two Phase 3 studies are expected to complete enrollment this year:
◦STAR-221 evaluating domvanalimab plus zimberelimab and chemotherapy in PD-L1 all-comer first-line metastatic upper GI cancers is expected to complete enrollment by mid-year.
◦STAR-121 evaluating domvanalimab plus zimberelimab and chemotherapy in PD-L1 all-comer first-line metastatic non-small cell lung cancer (NSCLC) is expected to complete enrollment by the second half of 2024.
Casdatifan (HIF-2a inhibitor)
•Multiple expansion cohorts evaluating casdatifan in clear cell renal cell carcinoma (ccRCC) are underway, with several data presentations expected over the next 18 months:
◦ARC-20: Phase 1/1b study evaluating casdatifan as a monotherapy and in combination with other agents:
▪100 mg daily expansion cohort in 2L+ ccRCC (n=30): ORR data with minimum follow-up of at least 7 months are expected to be presented in the second half of 2024.
▪50 mg and 150mg expansion cohorts in 2L+ ccRCC (n=30 each): Enrollment has been completed for the 50mg cohort, and enrollment in the 150mg cohort was just initiated. Data from these cohorts are expected to be presented over the next 18 months.

◦STELLAR-009, a Phase 1b/2 trial evaluating casdatifan plus zanzalintinib in ccRCC, is currently enrolling.
•Arcus intends to initiate its first Phase 3 study evaluating casdatifan in combination with a TKI in ccRCC in the first half of 2025.
CD-73-Adenosine Axis: Etrumadenant (A2a/A2b receptor antagonist) and Quemliclustat (small-molecule CD73 inhibitor)
•Data from ARC-9, a randomized Phase 1b/2 study evaluating etrumadenant plus zimberelimab, bevacizumab and chemotherapy versus regorafenib in third-line metastatic colorectal cancer (mCRC), will be presented at ASCO (Free ASCO Whitepaper) in June.
•Data from MORPHEUS-PDAC, a randomized Phase 2 study operationalized by Roche, evaluating etrumadenant plus atezolizumab plus chemotherapy versus chemotherapy in first-line metastatic pancreatic ductal adenocarcinoma (PDAC), were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2024.
◦Median PFS of 8.2 months for the etrumadenant-containing regimen versus 6.8 months (HR = 0.67) for the chemotherapy arm.
◦Median OS of 16.5 months for the etrumadenant-containing regimen versus 12.1 months for the chemotherapy arm.
•These data further validate the results observed for quemliclustat in the Phase 1/1b ARC-8 trial, which showed a 15.7-month median OS (pooled analysis) when combined with chemotherapy in 1L pancreatic cancer, well above historical benchmark data for chemotherapy alone.
◦Initiation of a Phase 3 trial of quemliclustat combined with chemotherapy in pancreatic cancer is expected to begin by early 2025.
Early Clinical Programs
•Dose escalation for AB801, a potent and highly selective small-molecule AXL inhibitor, continues. Arcus anticipates advancing this molecule into expansion cohorts in NSCLC in early 2025.
Financial Results for First Quarter 2024:
•Cash, Cash Equivalents and Marketable Securities were $1.1 billion as of March 31, 2024, compared to $866 million as of December 31, 2023. The increase during the period is primarily due to the receipt of $320 million in cash from Gilead for their January 2024 equity investment, partially offset by the use of cash in research and development activities. We believe our cash, cash equivalents and marketable securities on-hand will be sufficient to fund operations into 2027. Cash, cash equivalents and marketable securities are expected to be between $870 million and $920 million at the end of 2024.
•Revenues were $145 million for the first quarter 2024, compared to $25 million for the same period in 2023. In the first quarter 2024, Arcus recognized $135 million in license and development services revenue related to the advancement of programs, primarily driven by a cumulative catch-up to revenue of $107 million relating to the Gilead collaboration amendments we executed in January 2024, as well as $10 million in other collaboration revenue primarily related to Gilead’s ongoing rights to access Arcus’s research and development pipeline in accordance with the Gilead collaboration agreement.
•Research and Development (R&D) Expenses were $109 million for the first quarter 2024, compared to $81 million for the same period in 2023. The net increase of $28 million was primarily driven by higher clinical manufacturing, clinical trial and headcount-related costs associated with our late-stage development program activities. Non-cash stock-based compensation expense was $10 million for the first quarter 2024, compared to $9 million for the same period in 2023. For the first quarter 2024 and 2023, Arcus recognized gross reimbursements of $37 million and $42 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration. R&D expense by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.
•General and Administrative (G&A) Expenses were $32 million for the first quarter 2024, compared to $30 million for the same period in 2023. The increase was primarily driven by compensation related to higher headcount and our 2024 stock awards, and costs incurred to obtain the Third Gilead Agreement Amendment. Non-cash stock-based compensation expense was $10 million for each of the first quarters 2024 and 2023.
•Impairment of Long-lived Assets was $20 million for the first quarter 2024, without similar expense for the same period in 2023. In the first quarter, we evaluated our needs for office space under our lease agreements. As a result, we now plan to sublease a portion of our facilities, resulting in a $20 million non-cash impairment charge.
•Net Loss was $4 million for the first quarter 2024, compared to $80 million for the same period in 2023.

Conference Call Information:
Arcus will host a conference call and webcast today, May 8, at 1:30 PM PT / 4:30 PM ET to discuss its first-quarter 2024 financial results and pipeline updates. To access the call, please dial (404) 975-4839 (local) or (833) 470-1428 (toll-free), using Access Code: 034427. To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event.
Arcus Ongoing and Announced Clinical Studies:
Trial Name Arms Setting Status NCT No.
Lung Cancer
STAR-121
dom + zim + chemo vs. pembro + chemo 1L NSCLC (PD-L1 all-comers) Ongoing Registrational Phase 3 NCT05502237
PACIFIC-8
dom + durva vs. durva Unresectable Stage 3 NSCLC Ongoing Registrational Phase 3 NCT05211895
STAR-131 dom + zim + chemo; dom + zim Perioperative NSCLC Registrational Phase 3 In Planning TBD
ARC-7 zim vs. dom + zim vs. etruma + dom + zim 1L NSCLC (PD-L1 ≥ 50%) Ongoing Randomized Phase 2 NCT04262856
EDGE-Lung dom +/- zim +/- quemli +/- chemo 1L/2L NSCLC (lung cancer platform study) Ongoing Randomized Phase 2 NCT05676931
VELOCITY-Lung
dom +/- zim +/- etruma +/- sacituzumab govitecan-hziy or other combos 1L/2L NSCLC (lung cancer platform study) Ongoing Randomized Phase 2 NCT05633667
Upper Gastrointestinal Cancers
STAR-221 dom + zim + chemo vs. nivo + chemo 1L Gastric, GEJ and EAC Ongoing Registrational Phase 3 NCT05568095
EDGE-Gastric (ARC-21) dom +/- zim +/- quemli +/- chemo 1L/2L Upper GI Malignancies
Ongoing
Randomized Phase 2
NCT05329766
Colorectal Cancer
ARC-9 etruma + zim + mFOLFOX vs. SOC 2L/3L/3L+ CRC Ongoing
Randomized Phase 2
NCT04660812
Pancreatic Cancer
PRISM-1 quemli + gem/nab-pac vs. gem/nab-pac 1L PDAC Planned Phase 3 TBD
ARC-8 quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac 1L, 2L PDAC Ongoing Randomized Phase 1/1b NCT04104672
Kidney Cancer
STELLAR-009 cas + zanza ccRCC Ongoing Phase 1b/2 NCT06191796
ARC-20 cas, cas + cabo Cancer Patients / ccRCC Ongoing Phase 1/1b NCT05536141
Other
ARC-25 AB598 Advanced Malignancies Ongoing NCT05891171
ARC-27 AB801 Advanced Malignancies Ongoing NCT06120075

cabo: cabozantinib; cas: casdatifan; dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard of care; zanza: zanzalintinib; zim: zimberelimab; ccRCC: clear-cell renal cell carcinoma; CRC: colorectal cancer; EAC: esophageal adenocarcinoma; GEJ: gastroesophageal junction; GI: gastrointestinal; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma

On May 8, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, reported that it has entered into a joint development agreement with Cleveland Clinic to develop novel vaccines for various cancer types (Press release, Anixa Biosciences, MAY 8, 2024, View Source [SID1234642862]). Cleveland Clinic is currently conducting a Phase 1 clinical trial targeting triple negative breast cancer (TNBC), the most aggressive and lethal form of breast cancer, and an ovarian cancer vaccine is in pre-clinical development in collaboration with the National Cancer Institute.

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The vaccines focus on a novel scientific mechanism never used before in a cancer vaccine. By developing vaccines that immunize against "retired" proteins found to be expressed in specific forms of cancer, the researchers are investigating if certain cancer cells can be destroyed as they arise, and ultimately prevent tumors from forming. The vaccines were developed at Cleveland Clinic and licensed to Anixa Biosciences. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company.

The research under this new JDA will be led at Cleveland Clinic by Thaddeus Stappenbeck, MD, PhD, Department Chair of Inflammation and Immunity, and will include Justin Johnson, PhD, one of the co-inventors of the breast and ovarian cancer vaccines along with the late Vincent Tuohy, PhD.

Anixa Chairman and CEO Dr. Amit Kumar stated, "Cleveland Clinic is a valued partner to Anixa in the development of both breast and ovarian cancer vaccines. The progress we’ve made to date in the breast cancer vaccine program, including promising preliminary data, drives our confidence in pursuing research and development for additional vaccines and cancer types using the same technology platform. Assuming the breast cancer clinical studies continue to exhibit positive results, we believe the search for ‘retired’ protein antigens will be pursued by many cancer researchers. We are seeking to maintain our lead in this potentially game-changing arena of cancer research."

"We look forward to expanding our relationship with Anixa in this endeavor," said Dr. Stappenbeck. "As we begin the discovery effort to evaluate which cancer types will be best for targeting, we hope to address many intractable cancers, including high incidence malignancies in the lung, colon, and prostate."

Company Presentation

Dr. Kumar will be presenting an overview of the Company, its clinical programs, and more information on the expansion of its cancer vaccine program with Cleveland Clinic at the Sidoti Micro-Cap Virtual Conference on May 9, 2024. All interested parties are invited to attend the conference.

Conference details:

Presentation: Thursday, May 9, 2024, at 11:30 am ET*
Presentation link: Click here to register; available via Zoom
Conference registration: Available on the conference website

The presentation will be available here on the Company’s website after the conference.

*The presentation date and time are subject to change. Participants should refer to the final program agenda for up-to-date information.

On May 8, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported first quarter 2024 financial results and recent portfolio and business updates. As of March 31, 2024, Alector’s cash, cash equivalents and investments totaled $562.1 million (Press release, Alector, MAY 8, 2024, View Source [SID1234642861]).

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"Continuing the momentum built through the first quarter, Alector is well positioned to have an impactful year, supported by an extended cash runway that carries the company through 2026," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "We are advancing our maturing pipeline, including our pivotal Phase 3 trial of latozinemab in FTD-GRN. In early Alzheimer’s disease, we are now investigating two clinical candidates. The data readout from the INVOKE-2 Phase 2 clinical trial of AL002 is expected in the fourth quarter, while enrollment continues in the PROGRESS-AD Phase 2 trial of AL101/GSK4527226. Additionally, the potential of our versatile blood-brain barrier technology, Alector Brain Carrier, to enhance brain penetrance of selected product candidates is exciting and provides opportunities to further expand our clinical pipeline for the long term. With the most advanced TREM2-activating and PGRN-modulating product candidates in clinical trials and a robust early-stage pipeline, we remain dedicated to developing medicines for individuals suffering from brain disorders."

Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, "In addition to these encouraging research and development updates, Alector continues to strengthen its leadership team with executive and Board appointments. We are excited to recognize the addition of Neil Berkley to our executive team as our Chief Business Officer. Neil has over 20 years of corporate development, business development and strategic planning experience, spanning large pharma to small biotechs. Additionally, we are pleased to welcome Dr. Errol De Souza and Mark Altmeyer to our Board of Directors. As our late-stage clinical assets progress closer toward potential FDA approval and commercialization, we look forward to leveraging their collective experience."

Recent Clinical Updates

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

The pivotal, randomized, double-blind, placebo-controlled INFRONT-3 Phase 3 clinical trial of latozinemab in frontotemporal dementia with a progranulin gene mutation (FTD-GRN) is ongoing after reaching full enrollment in October 2023. The trial has a treatment duration of 96 weeks.
Enrollment is ongoing in the PROGRESS-AD global Phase 2 clinical trial of AL101/GSK4527226 in early Alzheimer’s disease (AD), with dosing initiated in February 2024. AL101 is an investigational human monoclonal antibody (mAb) designed to block and downregulate the sortilin receptor to elevate the level of progranulin (PGRN) in the brain in a manner that is similar to latozinemab but with different pharmacokinetic (PK) and pharmacodynamic (PD) properties. Alector and GSK are co-developing AL101 for the potential treatment of more prevalent neurodegenerative diseases, including AD and Parkinson’s disease.
Alector and GSK plan to present a poster on the design of the AL101 Phase 2 trial at the Alzheimer’s Association International Conference 2024 (AAIC) in Philadelphia from July 28 to August 1, 2024. The poster is entitled, "PROGRESS-AD: a Phase 2 study to evaluate efficacy and safety of GSK4527226 (AL101), an anti-sortilin monoclonal antibody, in patients with early Alzheimer’s disease."
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 mAb 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.
The company expects to report baseline characteristics data from the Phase 2 trial of AL002 at a medical conference later this year, providing insights into the early AD patient population enrolled, including key baseline health metrics and disease characteristics.
AbbVie has an exclusive option to globally develop and commercialize AL002. AbbVie’s exercise of that option would prompt a $250 million payment to Alector.
Early Research Pipeline

Alector continues to advance 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.
Alector will host a virtual research and development event on June 18, 2024, to discuss the company’s ABC technology platform. The event will include a presentation from a leading scientific expert, offering insights into emerging technologies for BBB modulation and discussing future directions and opportunities in the field. The event will be webcast live on the Investor section of the company’s website at View Source
Details of the event are as follows:

Crossing the Blood-Brain Barrier: Advancing the Next Generation of Alector Neurodegenerative Therapies ​
June 18, 2024, at 12 pm Pacific Daylight Time / 3 pm Eastern Daylight Time
Corporate

In March 2024, Alector expanded its executive leadership team with the appointment of Neil Berkley, M.S., M.B.A., as Chief Business Officer. Mr. Berkley is responsible for driving strategic growth and maximizing partnership opportunities at the company. He brings over 20 years of extensive experience in corporate development, business development and strategic planning across a spectrum of biopharmaceutical companies.
In March 2024, Alector strengthened its Board of Directors with the appointments of Errol De Souza, Ph.D., and Mark Altmeyer, M.B.A.
Dr. De Souza is an esteemed leader in research and development, as well as a seasoned business executive, whose expertise is focused on the discovery and development of therapeutics targeting central nervous system (CNS) disorders.
Mr. Altmeyer has more than 35 years of experience leading successful drug development and commercialization efforts as a biopharmaceutical executive, with a focus on CNS disorders and oncology.
First Quarter 2024 Financial Results

Revenue. Collaboration revenue for the quarter ended March 31, 2024, was $15.9 million, compared to $16.5 million for the same period in 2023. The decrease was primarily due to a decrease in collaboration revenue recognized for the AL001 program.

R&D Expenses. Total research and development expenses for the quarter ended March 31, 2024, were $45.2 million, compared to $51.9 million for the quarter ended March 31, 2023. The decrease was mainly driven by the Company’s prioritization on selected late-stage programs and a decrease in personnel-related costs.

G&A Expenses. Total general and administrative expenses for the quarter ended March 31, 2024, were $14.4 million, compared to $14.8 million for the quarter ended March 31, 2023.

Net Loss. For the quarter ended March 31, 2024, Alector reported a net loss of $36.1 million, or $0.38 per share, compared to a net loss of $45.9 million, or $0.55 net loss per share, for the same period in 2023.

Cash Position. Cash, cash equivalents, and investments were $562.1 million as of March 31, 2024. In January 2024, Alector further strengthened its balance sheet with the completion of a follow-on financing issuing 10,869,566 shares of its common stock for total gross proceeds of $75 million before deducting underwriting discounts and commissions and estimated offering expenses. Management expects that this will be sufficient to fund current operations through 2026.

2024 Guidance. Management is reiterating its guidance for the year ending 2024. The company continues to anticipate collaboration revenue to be between $60 million and $70 million, total research and development expenses to be between $210 million and $230 million, and total general and administrative expenses to be between $60 million and $70 million.