ALX Oncology Holdings (ALXO) 2025 Conference June 05, 2025 01:25 PM ET Speaker0 People here with us. And I would love to give the opportunity for, perhaps Jason, to make some opening comments about, where ALX is at now. They obviously are interrogating an anti CD47 antibody. There was gastric results. They talked with FDA about it. But there's no doubt they continue to have a lot of promise on that with other modalities, ADCs, etcetera. Should talk a little bit about that and where you are with that program ...

SOUTH SAN FRANCISCO, Calif., May 30, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that management will participate in the Jefferies 2025 Global Healthcare Conference. Details are as follows: Format: Fireside Chat Date: Thursday, June 5, 2025Time: 1:25 PM ETLocation: New York, NYWebcast link: Available her ...

ALX2004 Potential First- and Best-In-Class EGFR-targeted ADC May 2025 NASDAQ GS ALXO © ALX Oncology Inc. All rights reserved. Forward-Looking Statements Certain information set forth in this presentation contains "forward-looking information", under applicable laws collectively referred to herein as forward-looking statements. Except for statements of historical fact, information contained herein constitutes forward-looking statements and includes, but is not limited to the (i) results and cost and timing o ...

Summary of ALX Oncology Holdings (ALXO) Conference Call Company Overview - **Company**: ALX Oncology Holdings (ALXO) - **Focus**: Development of ALX2004, a differentiated antibody-drug conjugate (ADC) targeting EGFR Key Points and Arguments Industry and Product Development - **ADC Focus**: ALX2004 is designed to maximize therapeutic window and overcome historical toxicity challenges associated with EGFR-targeted ADCs [5][6][10] - **Clinical Pipeline**: The company is advancing its ADC in combination with anti-cancer antibodies, specifically targeting breast and colorectal cancers [4][5] - **IND Clearance**: ALX2004 has received Investigational New Drug (IND) clearance, with plans to launch a Phase I trial in mid-2025 [5][7] Scientific Rationale - **Payload and Linker Design**: ALX2004 utilizes a proprietary topoisomerase one inhibitor payload, designed to minimize off-target toxicity while maximizing tumor cell killing [17][20] - **Immunogenic Cell Death**: The payload triggers immunogenic cell death, potentially enhancing long-term tumor control through adaptive immune response [18][28] - **Optimized Antibody**: The antibody component is designed to block EGFR signaling and bind to a unique epitope, potentially overcoming resistance to existing therapies [30][32] Clinical Development Plans - **Phase I Study**: The study will focus on four tumor types: head and neck squamous cell carcinoma, colorectal cancer, non-small cell lung cancer, and esophageal squamous cell carcinoma, targeting patients with relapsed or refractory disease [40][41] - **Safety and Efficacy Goals**: Initial safety data is expected in the first half of 2026, with an emphasis on establishing a recommended dosing schema [42][43] Competitive Landscape - **Market Positioning**: ALX Oncology aims to be a leader in the ADC space targeting EGFR, which currently lacks an approved drug [43][85] - **Comparison with Competitors**: The company is aware of other ADCs in development, such as MRG003, but believes its optimized design gives it a competitive edge [85] Additional Important Insights - **Preclinical Data**: Robust preclinical data supports the efficacy and safety profile of ALX2004, with encouraging results in various tumor models [14][34] - **Toxicity Management**: The design aims to avoid common toxicities seen in previous EGFR-targeted ADCs, such as skin toxicity and interstitial lung disease [14][72] - **Funding and Capital Allocation**: The company has sufficient cash to fund its ongoing studies into 2024, with plans to explore additional capital options as needed [51][52] This summary encapsulates the critical aspects of ALX Oncology's conference call, highlighting the company's strategic focus on developing ALX2004 and its potential impact on the oncology market.

Core Insights - ALX Oncology is advancing ALX2004, a potential best- and first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, designed to maximize therapeutic efficacy while minimizing toxicity [1][2] - The U.S. FDA has cleared the IND application for ALX2004, with clinical studies set to begin in mid-2025 and initial safety data expected in the first half of 2026 [1][6] - The company plans to initiate trials for its lead therapy, evorpacept, in breast and colorectal cancers around the same time, with significant milestones anticipated in 2026 [1] ALX2004 Development Overview - ALX2004 is developed using a proprietary linker-payload platform, featuring an affinity-tuned EGFR antibody and a stable linker-Top1i payload, aimed at enhancing anti-tumor activity and reducing toxicity [3][4] - Preclinical data indicates that ALX2004 has superior stability and a favorable safety profile compared to other ADCs, showing dose-dependent activity across various tumors and EGFR expression levels [5] Clinical Trial Plans - The Phase 1 clinical trial for ALX2004 will target EGFR-expressing solid tumors, including non-small cell lung cancer and colorectal cancer, focusing on patients with relapsed or refractory cancers [6] - The trial is expected to begin in mid-2025, with initial safety data anticipated in the first half of 2026 [1][6]

Financial Performance - Net loss for the three months ended March 31, 2025, was $30,754,000, compared to a net loss of $35,581,000 for the same period in 2024, representing a reduction of about 13.5%[18]. - The company reported a total comprehensive loss of $30,911,000 for the three months ended March 31, 2025, compared to $35,809,000 for the same period in 2024, a reduction of approximately 13.5%[21]. - The net loss for the three months ended March 31, 2025, was $30.8 million, compared to a net loss of $35.6 million for the same period in 2024, reflecting a 13.5% improvement[44]. - For the three months ended March 31, 2025, the net loss was $30.8 million, a decrease of 14% compared to a net loss of $35.6 million for the same period in 2024[113]. - The accumulated deficit reached $651.9 million as of March 31, 2025, with expectations of continued net losses in the foreseeable future[139]. Assets and Liabilities - Total current assets decreased from $134,352,000 as of December 31, 2024, to $102,532,000 as of March 31, 2025, a decline of approximately 23.7%[16]. - Total liabilities decreased from $34,157,000 as of December 31, 2024, to $32,605,000 as of March 31, 2025, a decrease of approximately 4.5%[16]. - Total stockholders' equity decreased from $113,618,000 as of December 31, 2024, to $88,295,000 as of March 31, 2025, a decline of approximately 22.3%[16]. - As of March 31, 2025, the company's cash, cash equivalents, and investments totaled $107.0 million, down from $131.3 million as of December 31, 2024[42]. - The fair value of cash equivalents and available-for-sale investments decreased to $105.3 million as of March 31, 2025, from $129.2 million as of December 31, 2024[48]. Research and Development - Research and development expenses decreased from $31,717,000 in Q1 2024 to $23,888,000 in Q1 2025, a decrease of approximately 24.7%[18]. - Total research and development expenses for the three months ended March 31, 2025, were $23.9 million, a decrease of 24.8% compared to $31.7 million for the same period in 2024[44]. - Clinical and development costs decreased by $7.0 million to $10.5 million, primarily due to the completion of manufacturing clinical trial materials for evorpacept[133]. - The company expects to incur significant expenses and increasing operating losses in the foreseeable future due to ongoing research and development activities[114]. - The company is developing ALX2004, a novel EGFR-targeted antibody-drug conjugate (ADC), which is designed to overcome limitations of earlier-generation EGFR-targeted ADCs[97]. Stock and Financing - The weighted-average shares of common stock used to compute net loss per share increased from 50,120,758 in Q1 2024 to 53,359,338 in Q1 2025, an increase of about 6.0%[18]. - The Company raised approximately $30 million through the sale of 2,404,855 shares under its at-the-market equity offering program as of March 31, 2025[65]. - The company completed a follow-on public offering in October 2023, raising approximately $58.9 million in net proceeds[147]. - The company expects to finance operations through equity offerings, debt financings, and collaborations, with a focus on raising additional capital[140]. - The company has a secured term loan facility of up to $100 million, with an initial draw of $10 million and future maturities totaling $10,600,000 as of March 31, 2025[60][62]. Clinical Trials and Product Development - The lead product candidate, evorpacept, demonstrated an overall response rate (ORR) of 41.3% in the intent-to-treat population in the ASPEN-06 Phase 2 clinical trial, compared to 30% for the historical control[94]. - In the same trial, evorpacept showed a median duration of response (mDOR) of 15.7 months and a median progression-free survival (mPFS) of 7.5 months, outperforming the control group[94]. - Evorpacept demonstrated a confirmed overall response rate (ORR) of 52% in the Evo-TRP treatment arm compared to 22% for the TRP control arm in the interim Phase 2 clinical data from the ASPEN-06 trial[99]. - The ASPEN-07 trial reported an unconfirmed ORR of 59% for evorpacept plus enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer[106]. - The company filed an IND application for ALX2004 in March 2025, which was cleared by the FDA in April 2025 for a Phase 1 clinical trial[112]. Operational Challenges - The company has not generated any revenue from product sales, licenses, or collaborations to date, and is heavily reliant on the success of its lead product candidate, evorpacept[176]. - The company has encountered setbacks in clinical trials, including the failure to meet primary endpoints in recent trials, which may impact future development[196]. - The company anticipates ongoing challenges in clinical trial enrollment due to factors such as COVID-19 and competition for eligible subjects[202]. - The company must navigate various regulatory requirements and potential delays in clinical trials, which could hinder the commercialization of its product candidates[194]. - The company has faced delays in clinical trial enrollment and retention, which could impact regulatory submissions and marketing approvals[201]. Compliance and Regulatory Issues - The company received a compliance notice from Nasdaq on April 23, 2025, regarding its common stock closing below the minimum bid price requirement of $1.00 per share for 30 consecutive business days, with a compliance period until October 20, 2025[88]. - The company has not identified any material changes to its critical accounting policies and estimates from the previous year[160]. - The company has no off-balance sheet arrangements as defined by SEC rules[158]. - The company is exposed to interest rate risk, with borrowings of $10.0 million under a Loan Agreement, which bears interest at a floating rate[164]. - The company has not experienced any realized losses on its deposits of cash, cash equivalents, or investments during the periods presented[166].

Core Insights - ALX Oncology will not pursue a U.S. registrational path for evorpacept in gastric cancer due to FDA feedback indicating that the accelerated approval pathway is not feasible based on ASPEN-06 data, as the standard-of-care has evolved to ENHERTU® [1][11] - The company has extended its cash runway into Q4 2026, allowing for continued development of its clinical programs [2][4] - Data milestones are expected across three clinical programs in 2026, focusing on evorpacept in combination with anti-cancer antibodies and the new ADC candidate ALX2004 [4][9] Financial Performance - For Q1 2025, ALX Oncology reported a GAAP net loss of $30.8 million, or $0.58 per share, compared to a net loss of $35.6 million, or $0.71 per share, in Q1 2024 [12][17] - Research and Development (R&D) expenses decreased to $23.9 million from $31.7 million year-over-year, primarily due to reduced clinical trial material manufacturing [12][16] - General and Administrative (G&A) expenses increased to $7.9 million from $6.0 million, attributed to higher personnel-related costs [12][16] Clinical Development Updates - The company is set to initiate Phase 2 ASPEN-Breast and Phase 1 ASPEN-CRC studies in mid-2025, focusing on evorpacept in combination with HERCEPTIN® and ERBITUX® respectively [6][11] - ALX2004, a novel EGFR-targeted ADC, received IND clearance from the FDA and is expected to begin clinical trials in mid-2025 [7][11] - Encouraging results were reported from a Phase 1 trial of evorpacept in combination with RITUXAN® and lenalidomide for B-cell non-Hodgkin lymphoma, showing a complete response rate of 83% [8][11] Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $107.0 million, sufficient to fund operations into Q4 2026 [12][19] - The total assets were reported at $120.9 million, with total liabilities of $32.6 million and an accumulated deficit of $651.9 million [19]

Core Insights - The combination of ALX Oncology's evorpacept with rituximab and lenalidomide (R2) shows promising anti-tumor activity and was well-tolerated in patients with indolent relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) [1][2][4] - The trial reported a complete response (CR) rate of 83% in patients with indolent NHL, significantly higher than the historical CR rate of 34% for R2 alone [1][3] - The ongoing Phase 2 trial in previously untreated indolent NHL has completed enrollment, indicating continued evaluation of evorpacept's efficacy [1][4] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as its lead candidate [7] - The company aims to address unmet needs in cancer treatment by enhancing the effectiveness of existing therapies [4][7] Clinical Trial Details - The Phase 1/2 trial included 20 patients, with 18 having indolent and 2 having aggressive R/R B-NHL, all of whom had previously received anti-CD20 monoclonal antibodies [2] - The trial demonstrated a two-year progression-free survival (PFS) rate of 69% and an overall survival (OS) rate of 84% after a median follow-up of 28 months [3] - The trial's results will be presented at the AACR 2025 Annual Meeting, highlighting the significance of evorpacept in cancer therapy [5][6]

Core Insights - The combination of ALX Oncology's investigational CD47-blocker, evorpacept, with rituximab and lenalidomide has shown promising anti-tumor activity and was well-tolerated in patients with indolent relapsed or refractory B-cell non-Hodgkin lymphoma [1][4] - The trial reported a complete response (CR) rate of 83% in patients with indolent NHL, significantly higher than the historical CR rate of 34% with rituximab alone [1][3] - The ongoing Phase 2 trial in previously untreated indolent NHL has completed enrollment, indicating continued evaluation of evorpacept's efficacy [1][4] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as its lead candidate [7] - The company aims to address significant unmet needs in cancer treatment by enhancing the therapeutic benefits of existing anti-cancer antibodies [4][7] Clinical Trial Details - The Phase 1/2 trial enrolled 20 patients, with 18 having indolent and 2 having aggressive R/R B-NHL, all of whom had previously received anti-CD20 monoclonal antibodies [2] - Evorpacept was administered at two dose levels, and the treatment was well-tolerated with no dose-limiting toxicities reported [2] - After a median follow-up of 28 months, the two-year progression-free survival (PFS) rate was 69% and the overall survival (OS) rate was 84% [3] Upcoming Presentation - Final results from the Phase 1 trial will be presented at the AACR 2025 Annual Meeting on April 29, 2025, highlighting the clinical research findings [5][6]

Core Insights - ALX Oncology announced topline data from Phase 2 ASPEN-03 and ASPEN-04 clinical trials, revealing that the investigational CD47-blocker evorpacept did not meet primary endpoints for improved objective response rates when combined with Merck's KEYTRUDA® in advanced head and neck squamous cell carcinoma [1][6] - Despite the trial outcomes, the company remains committed to advancing evorpacept in combination with other anti-cancer antibodies based on previous positive clinical data [4][6] Group 1: Clinical Trial Results - The ASPEN-03 and ASPEN-04 trials evaluated evorpacept combined with KEYTRUDA® with or without chemotherapy in patients with advanced head and neck squamous cell carcinoma [7] - The primary endpoints for both trials were objective response rates compared to historical controls, with key secondary endpoints including safety, duration of response, progression-free survival, and overall survival [7] - The combination demonstrated a manageable safety profile consistent with previous reports for pembrolizumab and chemotherapy [1][4] Group 2: Mechanism of Action - Evorpacept functions by blocking the 'don't eat me' signal from CD47 on cancer cells, allowing macrophages to target cancer cells selectively [2][9] - The drug is designed to enhance T-cell priming and stimulate the adaptive immune system, although the trials did not support advancing this combination into registrational studies [3][6] Group 3: Future Directions - The company will continue to explore evorpacept in combination with various anti-cancer antibodies in other cancer types, including colorectal cancer, breast cancer, non-Hodgkin lymphoma, and multiple myeloma [2][4] - ALX Oncology is prioritizing its established anti-cancer antibody combination program, which has shown positive results in other studies [4][6] - Evorpacept has received Fast Track designation from the FDA for second-line treatment of HER2-positive gastric or GEJ carcinoma, indicating its potential in the oncology pipeline [9][10]