New Risk • Jun 26
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 5.1% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (152% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$97m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Announcement • May 09
ALX Oncology Holdings Inc.'s Evorpacept in Combination with Zanidatamab Generates Promising, Durable Response in Patients with Advanced HER2-Positive Breast Cancer and High CD47 Expression ALX Oncology Holdings Inc. announced that data from exploratory analyses in the Phase 1b/2 clinical trial evaluating the company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab (ZIIHERA®) in patients with heavily pre-treated HER2-positive metastatic breast cancer (mBC) were presented for the first time in a poster session at the ESMO Breast Cancer 2026 congress. The findings show that patients with centrally confirmed HER2-positive (ccHER2-positive) mBC and high CD47 expression experienced a promising, durable response. Specifically, patients in the trial with ccHER2-positive disease and high CD47 expression (defined as total membrane staining of >20%) had a confirmed objective response rate (cORR) of 100% (n=5/5), while the cORR was 25% (n=1/4) among those with lower CD47 expression. Patients with ccHER2-positive disease (n=10) had higher response rates, with a cORR of 60% and mPFS of 8.3 months. All of the patients (n=5/5) with ccHER2-positive disease and high CD47 expression (defined as total membrane staining of >20%) responded (including one complete response and four partial responses), with an mDOR of 20.2 months and mPFS of 22.1 months. In comparison, among the patients with ccHER2-positive disease and low CD47 expression (defined as total membrane staining of. ALX Oncology management will host a webcast to provide an overview of First Quarter 2026 financial results. A live audio webcast of the call, along with the ALX Oncology corporate presentation, will be available under "Events & Presentations" in the Investor section of the Company's website. An archived webcast will be available on the Company's website after the event. Announcement • May 02
ALX Oncology Holdings Inc Announces CD47 Biomarker Data from Clinical Trial Evaluating Evorpacept and Zanidatamab Combination in Advanced Breast Cancer ALX Oncology Holdings Inc. had announced that new data from the Phase 1b/2 clinical trial evaluating the company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab (ZIIHERA®) in heavily pretreated patients with HER2-positive metastatic breast cancer will be presented at the ESMO Breast Cancer 2026 Congress in Berlin on May 7. The ESMO Breast Cancer poster presentation will highlight data from exploratory analyses conducted to identify biomarkers predictive of response to the evorpacept and zanidatamab regimen. The ESMO Breast Cancer presentation will feature data from an exploratory biomarker analysis of patients with HER2-positive metastatic breast cancer in the evorpacept and zanidatamab Phase 1b/2 trial. Topline data from this analysis, which ALX Oncology announced in January 2026, indicate that the responses were largely restricted to patients with higher CD47 expression. These results reinforce data from the ASPEN-06 clinical trial, which previously demonstrated that CD47 expression could potentially serve as an important predictive biomarker for response and durable benefit in patients with advanced gastric cancer who retained HER2 expression. Title: Exploratory biomarker analysis from a phase 1b/2 trial of zanidatamab and evorpacept in patients with HER2-positive metastatic breast cancer. Date & Time: Thursday, May 7, 2026, 7:15 am ET /13:15 CEST. Abstract Number: 561. Poster Number: 72P. Presenter: Funda Meric-Bernstam, MD, Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1 dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. Announcement • Apr 30
ALX Oncology Holdings Inc. to Report Q1, 2026 Results on May 08, 2026 ALX Oncology Holdings Inc. announced that they will report Q1, 2026 results Pre-Market on May 08, 2026 Announcement • Apr 22
ALX Oncology Holdings Inc., Annual General Meeting, Jun 10, 2026 ALX Oncology Holdings Inc., Annual General Meeting, Jun 10, 2026. Location: alx oncology holdings, United States Announcement • Apr 15
ALX Oncology Holdings Inc. Appoints Jeff Knight As Chief Development And Operating Officer, Effective April 13, 2026 ALX Oncology Holdings Inc. announced the appointment of Jeff Knight, M.P.H., as Chief Development and Operating Officer, effective April 13, 2026. Mr. Jeff Knight, age 55, served as the Chief Development and Operating Officer at Crinetics Pharmaceuticals Inc., a global biopharmaceutical company, from September 2021 to April 2026. From October 2018 to August 2021, Mr. Knight served as Senior Vice President, Portfolio Management and Corporate Operations at Poseida Therapeutics Inc., where he was responsible for portfolio management and strategy, alliance management, quality and compliance, and corporate operations. From March 2017 until October 2018, he was Vice President, Development Operations and Project and Portfolio Management at Halozyme Therapeutics Inc. From July 2015 until March 2017, he served as Executive Director, Global Development Operations at Amgen Inc. and from January 2012 until July 2015, Mr. Knight served in various program and portfolio management and development operations roles at Onyx Pharmaceuticals. Prior to that, he held several leadership roles of increasing responsibility in clinical operations, regulatory affairs, and project management at Genentech, PRA International, and Hoechst Marion Roussel (now Sanofi). Mr. Knight earned a Master’s of Public Health in biostatistics and epidemiology from the University of Oklahoma Health Sciences Center and a B.A. in psychology from the University of Oklahoma. He also earned a B.S. in nursing from the University of Kansas. New Risk • Mar 02
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.4% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 1.4% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (149% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$81m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Announcement • Feb 19
ALX Oncology Holdings Inc. to Report Q4, 2025 Results on Feb 27, 2026 ALX Oncology Holdings Inc. announced that they will report Q4, 2025 results Pre-Market on Feb 27, 2026 New Risk • Feb 17
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 149% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (149% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$78m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Announcement • Jan 31
ALX Oncology Holdings Inc. has completed a Follow-on Equity Offering in the amount of $150 million. ALX Oncology Holdings Inc. has completed a Follow-on Equity Offering in the amount of $150 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 76,979,112
Price\Range: $1.57
Discount Per Security: $0.0942
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 18,574,120
Price\Range: $1.569
Discount Per Security: $0.09414 Announcement • Jan 30
ALX Oncology Holdings Inc. Announces New Data from a Phase 1b/2 Clinical Trial Evaluating the Company's Investigational CD47-Inhibitor Evorpacept in Combination with Jazz Pharmaceuticals' ZIIHERTU ALX Oncology Holdings Inc. announced new data from a Phase 1b/2 clinical trial evaluating the company's investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals' ZIIHERA (zanidatamab-hrii) in heavily pretreated patients with metastatic breast cancer (mBC). The topline findings, from an exploratory analysis in this trial, indicate that among patients with confirmed HER2-positive mBC, CD47 expression is predictive of evorpacept activity. The Phase 1b/2 open-label, multi-center clinical trial (NCT05027139) evaluated the potential of evorpacept in combined with zanidatamab as a novel treatment for patients with previously treated, inoperable, locally advanced, or metastatic HER2-expressing breast cancer and other cancers. The primary trial results, presented at the 2024 San Antonio Breast Cancer Symposium (SABCS), demonstrated that the investigational combination generated promising anti-tumor activity and a manageable safety profile in patients with heavily pretreated HER2-positive breast cancer (median of six prior therapies), including treatment with ENHERTU. Researchers previously reported a 56% (5/9) confirmed objective response rate (cORR) and a median progression-free survival (mPFS) of 7.4 months in the nine patients with centrally confirmed HER2-positive breast cancer who received the investigational combination. The additional exploratory analysis, conducted to identify biomarkers of response to the evorpacept/zanidatamab combination, shows that responses in this trial were largely restricted to patients with higher CD47 expression. This finding reinforces results from the ASPEN-06 clinical trial, which demonstrated that CD47 expression is a predictive biomarker for response and durable benefit from evorpacept among patients with advanced gastric cancer that has retained HER2 expression. The full biomarker analysis from the Phase 1b/2 clinical trials has been submitted to an upcoming scientific congress for presentation. Announcement • Jan 08
ALX Oncology Holdings Inc. Advances Separate Clinical Trials Evaluating Investigational CD47-Inhibitor Evorpacept and Novel EGFR-Targeted Antibody-Drug Conjugate ALX2004 ALX Oncology Holdings Inc. announced that the first patient has been dosed in the Company's Phase 2 ASPEN-09-Breast trial evaluating its investigational CD47-inhibitor evorpacept. This trial will evaluate the combination of evorpacept with trastuzumab and physicians' choice of chemotherapy in patients with HER2-positive metastatic breast cancer whose disease has progressed after ENHERTU (T-DXd). Additionally, after successfully clearing the second dose cohort, the Phase 1 trial evaluating the Company's epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC) ALX2004 for the treatment of EGFR-expressing solid tumors has begun enrolling patients in the third dose cohort at 4mg/kg. No dose-limiting toxicities were observed in the prior two dose cohorts. Evorpacept is the first CD47 inhibitor to show substantial tumor response and a well-tolerated safety profile in a randomized trial. Data from this prior gastric cancer trial, ASPEN-06, show that evorpacept demonstrated benefit across all efficacy parameters in patients with HER2- positive disease and high CD47 expression levels. Research has demonstrated that increased CD47 expression is correlated with poor patient outcomes in many tumor types, including breast cancer. The Phase 2 ASPEN- 09-Breast clinical trial (NCT07007559) is a single-arm, open-label, multicenter study evaluating evorpacept plus trastuzumab and physician' choice of chemotherapy in 80 patients with HER2-positive breast cancer previously treated with ENHERTU ("fam-trastuzumab deruxtecan-nxki), which was recently approved as first-line therapy. The trial will utilize participants' CD47 expression levels as a biomarker to assess responses. The primary endpoint of the trial is overall response rate (ORR) in patients who are confirmed HER2 positive by circulating tumor DNA (ctDNA). ORR in the HER2 ctDNA-negative subpopulation is an exploratory endpoint. ALX Oncology anticipates sharing interim data from the trial in third quarter 2026. The ALX2004 Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label, multic enter trial evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumor. The study consists of a Phase 1a dose escalation portion followed by optional dose exploration, and a Phase 1b dose expansion. ALX Oncology's lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology' second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjUGate with a differentiated mechanism of action. Announcement • Dec 09
Alx Oncology Holdings Inc. Announces Positive Results from Ongoing Investigator-Sponsored Phase 2 Trial Evaluating Evorpacept in Combination with Standard-Of-Care Treatment in Patients with Indolent B-Cell Non-Hodgkin Lymphoma, At Ashodgkinlymphoma ALX Oncology Holdings Inc. announced that positive data from a Phase 2 investigator-sponsored trial (IST) of evorpacept, in combination with standard-of-care rituximab and lenalidomide, for patients with indolent B-cell non-Hodgkin lymphoma (iNHL) is being presented Sunday, December 7 during a poster presentation at the American Society of Hematology (ASH) Annual Meeting 2025 in Orlando, Florida. The clinical trial conducted by Dr. Paolo Strati, the trial's lead investigator and Associate Professor of Lymphoma-Myeloma at The University of Texas MD Anderson Cancer Center, along with his colleagues enrolled a total of 24 patients with previously untreated iNHL, 14 patients with follicular lymphoma and 10 patients with margins zone lymphoma. The primary objective of best CR rate above 80% was met with evorpacept added to R2 in the context of a historical R2 CR rate of 50%. The investigators found the addition of evorpacept to R2 to be a well-tolerated frontline non-chemotherapy regimen for patients with iNHL, resulting in a high CR rate. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II Location/Room: OCCC - West Halls B3-B4. Price Target Changed • Nov 13
Price target increased by 12% to US$3.00 Up from US$2.67, the current price target is an average from 3 analysts. New target price is 146% above last closing price of US$1.22. Stock is down 8.3% over the past year. The company is forecast to post a net loss per share of US$1.82 next year compared to a net loss per share of US$2.58 last year. Announcement • Oct 30
ALX Oncology Holdings Inc. to Report Q3, 2025 Results on Nov 07, 2025 ALX Oncology Holdings Inc. announced that they will report Q3, 2025 results Pre-Market on Nov 07, 2025 Announcement • Oct 23
ALX Oncology Holdings Inc. Announces Preclinical Data and Phase 1 Trial-In-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, At 2025 AACR-NCI-EORTC Conference ALX Oncology Holdings Inc. presented preclinical data and the trial design for the ongoing Phase 1 clinical trial for its ADC candidate, ALX2004, in two poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22 - 26, 2025 in Boston, Massachusetts. ALX2004-01 is a first-in-human study to evaluate the safety, tolerability, and preliminary efficacy of ALX2004 in patients with advanced or metastatic solid tumors that are known to express EGFR. Enrollment in this trial began in August and continues to be on track to allow to deliver initial safety data in the first half of next year. The Company's first ADC, ALX2004, is the result of a rigorous internal drug design process. Developed in house by ALX Oncology's protein engineers utilizing the Company's proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is designed to optimize all mechanisms of ADC cancer killing while maximizing the therapeutic window. ALX2004 uses a matuzumab-derived EGFR antibody selected to minimize off tumor skin toxicity and maximize therapeutic window, with a binding epitope distinct from U.S. Food and Drug Administration approved EGFR antibodies. Additionally, ALX2004 has a proprietary linker-payload and Top1i payload engineered to offer improved linker stability for on-target delivery of payload and enhanced bystander effect. ALX2004 is currently being evaluated in a first-in-human, open-label multicenter study in participants with advanced or metastatic select EGFR-expressing solid tumors. The design of this Phase 1 clinical trial (NCT07085091) will also be presented at the meeting. Details for ALX Oncology's poster presentations are as follows: Title: ALX2004, A Novel Anti-EGFR Topoisomerase I Inhibitor Antibody-Drug Conjugate for the Treatment of EGFR-Expressing Solid Tumors. Presenter: Marja Vrljic, Ph.D., Vice President, Antibody Technologies, ALX Oncology is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients' lives. Evorpaceptptptptets is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. Announcement • Oct 03
ALX Oncology Holdings Inc. to Present Updated Data from Phase 2 ASPEN-06 Trial ALX Oncology Holdings Inc. announced updated data from its Phase 2 ASPEN-06 (NCT05002127) trial will be presented during a poster session at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting taking place November 5-9, 2025, in National Harbor, Maryland. The Phase 2 trial evaluated evorpacept, the Company's lead therapeutic candidate, in combination with HERCEPTIN®? (trastuzumab), CYRAMZA®? (ramucirumab) and paclitaxel, for patients with previously treated HER2-positive advanced gastric cancer (GC) and gastroesophageal junction (GEJ) cancer. Details for the poster presentation at SITC 2025 are as follows: Title: CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer from the Phase 2 randomized ASPEN-06 trial. First Author: Zev A. Wainberg, M.D., Professor of Medicine and Co-Director of GI Oncology Program, University of California, Los Angeles. Abstract: 496 Date and Time: Saturday, November 8, 2025, 10:00 a.m. - 6:35 p.m. ET. Location: Poster Hall (Exhibit Halls AB) About ASPEN-06:ASPEN-06 is a randomized Phase 2 (open-label)/3 (blinded), international, multi-center study, evaluating evorpacept in combination with HERCEPTIN™? (trastuzum AB), CYRAMZA®? ("ramucirumab") and pac litaxel, for patients with metastatic second- or third-line HER2 overexpressing gastric/GEJ adenocarcinoma that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy and are suitable for chemotherapy. One hundred twenty-seven adult patients were enrolled in the Phase 2 portion of the study. Recent Insider Transactions • Sep 21
CEO & Director recently bought US$99k worth of stock On the 17th of September, Jason Lettmann bought around 92k shares on-market at roughly US$1.08 per share. This transaction amounted to 69% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Jason has been a buyer over the last 12 months, purchasing a net total of US$95k worth in shares. Announcement • Sep 12
ALX Oncology Holdings Inc. Announces Management and Committee Changes ALX Oncology Holdings Inc. announced the appointment of Dr. Barbara Klencke to the role of Interim Chief Medical Officer (CMO) on a full-time basis and will step down from the Board. Dr. Alan Sandler is departing from the role of CMO and will return to his former position on the ALX Oncology Board of Directors (BOD), where he previously served. An ALX Board member since January 2025, Dr. Klencke has more than 30 years of experience in patient care, academic and scientific research, and clinical drug development in hematology and oncology. She has deep R&D expertise and has made significant contributions to the development, approval and commercialization of numerous oncology products through various executive leadership roles at a range of small, mid-sized and large biotech companies including Sierra Oncology (acquired by GSK), Onyx Pharmaceuticals (acquired by Amgen) and Genentech, a member of the Roche Group. Prior to entering the biotechnology industry, Dr. Klencke served as an Assistant Clinical Professor of Medicine, Division of Hematology and Oncology, at the University of California, San Francisco, where she previously completed her training in hematology, oncology and internal medicine. She holds a Bachelor of Science degree from Indiana University and an M.D. from the University of California, Davis. In addition to ALX Oncology, Dr. Klencke is an independent board director of Xencor and TScan Therapeutics. In connection with the Board and management changes referenced above, the Board approved the following composition of committees of the Board: Audit Committee: Rekha Hemrajani, Chair; Daniel Curran, M.D.; and Scott Garland; Compensation Committee: Corey Goodman, Ph.D., Chair; Scott Garland; and Chris Takimoto, M.D., Ph.D., F.A.C.P.; Corporate Governance and Nominating Committee: Scott Garland, Chair; Daniel Curran, M.D.; and Rekha Hemrajani. Recent Insider Transactions • Aug 21
Chief Financial Officer recently bought US$58k worth of stock On the 18th of August, Harish Shantharam bought around 75k shares on-market at roughly US$0.78 per share. This trade did not impact their existing holding. This was the largest purchase by an insider in the last 3 months. This was Harish's only on-market trade for the last 12 months. Announcement • Aug 20
Alx Oncology Holdings Inc. Doses First Patient in Phase 1 Dose Escalation Trial Evaluating Adc Alx2004 for the Treatment of Egfr-Expressing Solid Tumors ALX Oncology Holdings Inc. announced that the first patient has been dosed in the Company's Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, e
pidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors. The Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumor. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial. Developed by ALX Oncology's protein engineers utilizing the Company's proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile. New Risk • Aug 18
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 20% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$106m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$97m net loss in 3 years). Market cap is less than US$100m (US$34.5m market cap). Announcement • Aug 05
ALX Oncology Holdings Inc. to Report Q2, 2025 Results on Aug 12, 2025 ALX Oncology Holdings Inc. announced that they will report Q2, 2025 results After-Market on Aug 12, 2025 New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$109m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$109m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$98m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (US$22.2m market cap). Announcement • May 20
ALX Oncology Holdings Inc. Highlights Differentiated Design, Preclinical Data and Development Plans for EGFR-Targeted ADC, ALX2004, in R&D Webcast Event ALX Oncology Holdings Inc. provided an overview of the clinical development program for its highly-differentiated antibody-drug conjugate (ADC), ALX2004, at the Company's R&D webcast event today. ALX Oncology leadership will discuss the unique design profile, preclinical data and clinical development plans for ALX2004, a potential best- and first-in-class ADC for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, that is planned to enter Phase 1 studies in mid-year 2025. The Company's ALX2004 Unique Design: Optimized for Anti-Tumor Activity and Improved Outcomes: Developed by ALX Oncology's protein engineers utilizing the Company's proprietary topoisomerase I inhibitor payload and linker-payload platform, ALX2004 has been rigorously designed to maximize the therapeutic window and overcome toxicity challenges observed in this class. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potential activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile. The U.S. Food and Drug Administration (FDA) cleared ALX Oncology's Investigational New Drug (IND) application for ALX2004 in April 2025. ALX Oncology will provide an overview of its Phase 1 clinical trial design for ALX2004 planned to initiate mid-2025. The Company anticipates initiating a Phase 1 dose escalation trial in EGFR-expressing solid tumors, including non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma and esophageal squamous cell carcinoma, targeting patients with relapsed/refractory cancers. The Company anticipates initial safety data in the first half of 2026. Date & Time: Tuesday, May 20, 2025, 8:00 a.m. PT/11:00 a.m. ET. Announcement • May 02
ALX Oncology Holdings Inc. to Report Q1, 2025 Results on May 08, 2025 ALX Oncology Holdings Inc. announced that they will report Q1, 2025 results Pre-Market on May 08, 2025 Announcement • Apr 27
ALX Oncology Holdings Receives A Written Notice from the Listing Qualifications Staff of the Nasdaq Stock Market On April 23, 2025, ALX Oncology Holdings Inc. received a written notice from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it has not been in compliance with the minimum bid price requirement for continued listing on the Nasdaq Global Select Market set in Nasdaq Listing Rule 5450(a)(1) for a period of 30 consecutive business days (the “Notice”). The Notice has no immediate effect on the listing of the Company’s stock on the Nasdaq Global Select Market, subject to the Company’s compliance with the other listing requirements of Nasdaq. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company is provided a compliance period of 180 calendar days from the date of the Notice, or until October 20, 2025, to regain compliance with the minimum bid price requirement. To regain compliance with Nasdaq’s minimum bid price requirement, the closing price per share of the Company’s common stock, must be at least $1.00 per share for a minimum of ten consecutive business days during the 180-calendar day compliance period, unless the Staff exercises its discretion to extend this ten-business day period. If the Company does not regain compliance during the 180-calendar day compliance period, the Company may be afforded a second 180-calendar day compliance period to regain compliance if it elects to transfer to the Nasdaq Capital Market. To qualify, the Company must meet the continued listing requirement for market value of publicly-held shares and all other initial listing standards for the Nasdaq Capital Market (with the exception of the minimum bid price requirement) and notify Nasdaq of its intent to cure the deficiency. If the Company does not regain compliance within the allotted compliance periods, including any extensions that may be granted by Nasdaq, the Company’s stock will be subject to delisting. There can be no assurance that the Company will be eligible for the second compliance period, if applicable, or that the Staff would grant the Company’s request for continued listing subsequent to any delisting notification. The Company intends to actively monitor the closing bid price of its common stock and assess potential actions to regain compliance during the 180-calendar day compliance period, including effecting a reverse stock split, if necessary. While the Company is exercising diligent efforts to maintain the listing of its common stock on the Nasdaq Global Select Market, there can be no assurance that the Company will be able to regain or maintain compliance with the minimum bid price requirement or any other Nasdaq listing requirements. Announcement • Apr 26
ALX Oncology Holdings Inc. Announces Encouraging Final Results from Phase 1 Trial Evaluating Evorpacept in Combination with Standard-Of-Care Treatment in Patients with B-Cell Non-Hodgkin Lymphoma ALX Oncology Holdings Inc. announced encouraging data from an ongoing Phase 1/2 investigator-sponsored trial (IST) of the company's lead clinical candidate, evorpacept, in combination with standard-of-care rituximab and lenalidomide (R2) in patients with indolent and aggressive relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). Final results from the Phase 1 portion of the trial will be presented Tuesday, April 29, during a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, Illinois. The clinical trial conducted by Dr. Strati and colleagues at MD Anderson enrolled a total of 20 patients with indolent (n=18) and aggressive (n=2) R/R B-NHL; all 20 had previously received an anti-CD20 monoclonal antibody (rituximab), 72% had received prior chemoimmunotherapy and 80% had progressed within 24 months from frontline therapy. Patients with indolent NHL had received at least one prior line of systemic therapy. During treatment, a significant increase in T cells and anti-tumoral macrophages was observed. Announcement • Apr 25
ALX Oncology Holdings Inc. Reports Aspen-03 and Aspen-04 Phase 2 Trials Evaluating Evorpacept with A Checkpoint Inhibitor for the Treatment of Head and Neck Cancers Did Not Meet Primary Endpoints ALX Oncology Holdings Inc. announced topline data from its Phase 2 ASPEN-03 and ASPEN-04 clinical trials. The company's investigational CD47-blocker evorpacept, when added to Merck's (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA®? (pembrolizumab) with or without chemotherapy, did not meet the primary endpoints in the ASPEN-03 and ASPen-04 trials of improved objective response rates (ORR) as compared to historical controls of pembrolizumab alone and pembrolizumab with chemotherapy, respectively, as a first-line treatment in patients with advanced head and neck squamous cell carcinoma (HNSCC). The combination of evorpacept and pembrolizum ab with or without chemotherapy in ASPEN-03 and ASP EN-04 demonstrated a manageable safety profile and was consistent with what has been previously reported for pembrolizumab and chemotherapy in this setting. Although the company will no longer pursue evorpacept in combination with pembrolizumab in HNSCC, multiple clinical trials of evorpacept in combination With anti-cancer antibodies will continue based on established proof-of-concept. Evorpacept blocks the 'don't eat me' signal transmitted by CD47 on the surface of cancer cells that these cells use to evade detection by the immune system. As its primary mechanism of action, evorpacept is uniquely designed to stimulate macrophages to selectively attack cancer cells and not healthy cells, when combined with active anti-cancer antibodies. This mechanism has translated into durable clinical responses and a well-tolerated safety profile in HER2-positive gastric and HER2-positive breast cancer clinical trials. To further explore the benefit in this setting, evorpacept is currently being evaluated in combination with various anti-cancer antibodies in colorectal cancer, breast cancer, non-Hodgkin lymphoma and multiple myeloma. In the ASPEN-03 andASPEN-04 clinical trials, evorpacept was combined with pembrolizum AB with or without chemotherapy to investigate a second and distinct mechanism of action. This discrete approach explored the concept that evorpacept may enhance T-cell priming by activating dendritic cells and stimulating the adaptive immune system. Announcement • Apr 22
ALX Oncology Holdings Inc., Annual General Meeting, Jun 11, 2025 ALX Oncology Holdings Inc., Annual General Meeting, Jun 11, 2025. Announcement • Apr 08
Alx Oncology Holdings Inc. Receives Ind Clearance from U.S. Fda for Alx2004, A Novel Egfr-Targeted Antibody-Drug Conjugate ALX Oncology Holdings Inc. announced receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company's potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR) -expressing solid tumors. Based on this clearance, ALX Oncology will initiate a single-agent dose-escalation and expansion Phase 1 clinical trial for ALX2004 in mid-2025. EGFR is a transmembrane protein located on the surface of cells that regulates cell growth; overexpression occurs across various tumor types, including breast cancer, colorectal carcinoma, head and neck squamous cell carcinoma and non-small cell lung cancer. EGFR is clinically validated as a therapeutic target with several FDA-approved targeted antibodies and small molecules. However, there are currently no approved EGFR-targeted ADCs. Early-generation attempts to develop EGFR-targeted ADC were limited by drug design, on-target off-tumor toxicities and toxicity of older generation payloads. Utilizing the company's proprietary, highly differentiated topoisomerase I inhibitor payload platform, ALX Oncology scientists designed ALX2004 to optimize ADC-based mechanisms of anti-tumor activity and improve outcomes in patients with EGFR-expressing tumors. The ALX2004 molecule, created entirely in ALX Oncology labs, comprises an antibody backbone engineered to optimize anti-EGFR activity, a linker with enhanced stability and a proprietary topoisomerase I payload that can generate an enhanced bystander effect. ALX Oncology plans to conduct an R&D call focused on ALX2004 in second quarter 2025 and to initiate a Phase 1 clinical trial of the investigational therapy in mid-2025. New Risk • Mar 07
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$142m net loss in 3 years). Market cap is less than US$100m (US$69.9m market cap). Announcement • Mar 06
ALX Oncology Holdings Inc. Highlights Focused Evorpacept Development Plan, Clinical Progress ALX Oncology Holdings Inc. will highlight progress across its clinical pipeline, including continued advancement of investigational CD47-blocker evorpacept and planned entry into the clinic of its novel EGFR-directed ADC clinical candidate ALX2004, and provide key business and financial updates in an R&D Day webcast event today. ALX Oncology leadership will be joined by external key opinion leaders in the oncology field, Paula R. Pohlmann, M.D., M.S., Ph.D., Chief, Clinical Research, Department of Breast Oncology, and Associate Professor, Department of Breast Medical Oncology and Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center, and Eric Van Cutsem, M.D., Ph.D., Professor of Gastroenterology and Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven in Leuven, Belgium. Evorpacept Clinical Program Updates: During the R&D Day event, ALX oncology leadership will discuss the mechanistic rationale and clinical data that support further development of evorpacept with anti-cancer antibodies. In addition to updates on ongoing trials leveraging this combination approach, new plans will be introduced around the initiation of studies evaluating evorpacept in combination with trastuzumab in HER2-positive breast cancer and in combination with cetuximab in colorectal cancer (CRC). Announcement • Feb 27
ALX Oncology Holdings Inc. to Report Q4, 2024 Results on Mar 06, 2025 ALX Oncology Holdings Inc. announced that they will report Q4, 2024 results Pre-Market on Mar 06, 2025 Announcement • Jan 23
ALX Oncology Holdings Inc. Presents Positive Updated Data from ASPEN-06 Phase 2 Trial Demonstrating Evorpacept Generates Strong Response and Durable Clinical Benefit in Patients with HER2-Positive Gastric Cancer ALX Oncology Holdings Inc. announced positive updated data from the ASPEN-06 Phase 2 clinical trial demonstrating that the company's investigational CD47-blocker evorpacept generates a durable clinical response with a well-tolerated safety profile among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. The updated results, which build upon previously announced topline results, will be shared in an oral presentation (Abstract #332) at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco. These findings suggested that patients with heavily pretreated HER2-positive advanced breast cancer had anti-tumor activity from CD47 inhibition with evorpacept when it is combined with a HER2-targeted agent. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Additionally, both the FDA and European Commission have granted Orphan Drug Designation for this indication. Company Conference Call and Webcast on January 23 at 1:00 PM PT/4:00 PM ET to review the updatedASPEN-06 data. Price Target Changed • Dec 20
Price target decreased by 18% to US$7.67 Down from US$9.33, the current price target is an average from 6 analysts. New target price is 373% above last closing price of US$1.62. Stock is down 89% over the past year. The company is forecast to post a net loss per share of US$2.70 next year compared to a net loss per share of US$3.74 last year. Announcement • Dec 11
Alx Oncology Announces New Data Demonstrating Evorpacept in Combination with Zanidatamab Generates Promising Antitumor Activity in Advanced Breast Cancer ALX Oncology Holdings Inc. announced results from a Phase 1b/2 clinical trial demonstrating the company’s investigational CD47-blocker evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab generates promising anti-tumor activity in patients with both HER2-positive and HER2-low advanced breast cancer. The findings, which are the first from a clinical trial evaluating the safety and efficacy of evorpacept and zanidatamab in heavily pretreated patients with metastatic breast cancer (mBC), will be presented on Thursday, December 12 in a poster spotlight presentation (#PS8-09) at the 2024 San Antonio Breast Cancer Symposium (SABCS). The Phase 1b/2 open-label, multi-center clinical trial (NCT05027139) evaluated the potential of evorpacept, a highly differentiated, investigational CD47 blocker, in combination with zanidatamab, a dual HER2-targeted bispecific antibody, as a novel treatment for patients with previously treated inoperable, locally advanced, or metastatic HER2-expressing breast cancer and other cancers. Part one of the trial evaluated the safety and recommended doses for the combination; part two assessed the anti-tumor activity of the resulting combination. The SABCS poster presentation will include efficacy findings from all three of the part-two trial cohorts: Cohort 1 (n=21) consisted of patients with HER2-positive breast cancer who had received a median of six prior systemic therapies in the metastatic setting. Notably, all patients in Cohort 1 had received prior fam-trastuzumab deruxtecan-nxki (ENHERTU). Patients were enrolled based on local assessment of tumor samples or central assessment. Of the 21 patients enrolled in Cohort 1, nine were found to be HER2-positive based on central assessment. Cohort 2 (n=15) consisted of patients with HER2-low breast cancer who had received a median of five prior systemic therapies. Cohort 3 (n=8) consisted of patients with other HER2-expressing cancers. Key trial results to be shared at SABCS 2024 include: HER2-positive by central assessment mBC: Patients in Cohort 1 who were HER2-positive by central assessment (n=9) showed the greatest anti-tumor activity with a confirmed objective response rate (cORR) of 55.6% and a median progression free survival (mPFS) of 7.4 months. HER2-positive mBC: Overall, patients in Cohort 1 (n=21) had a confirmed cORR and mPFS of 33.3% and 3.6 months, respectively. HER2-low mBC: Responses were also observed in Cohort 2 (cORR: 20.0%; mPFS: 1.9 months). As of the August 2024 data cutoff, median follow-up was 9.6 months, with six patients still on treatment. The median duration of response was not reached for Cohort 1 patients (range: 3.6-25.9 months) and was 5.5 months for Cohort 2 patients (range: 3.6-11.0 months), with responses ongoing, including the longest observed response, in each cohort. Most treatment-related adverse events were grade 1 or 2. The most frequent adverse events due to any cause were fatigue, nausea, diarrhea, and infusion-related reactions. There were no treatment-related deaths in the study and no non-infectious pulmonary toxicities. These safety findings are consistent with those observed in the >700 patients treated with evorpacept to date. New Risk • Nov 14
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.4% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 5.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$200m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (5.9% increase in shares outstanding). Market cap is less than US$100m (US$70.7m market cap). Announcement • Nov 14
ALX Oncology Holdings Inc. Appoints Alan Sandler as Chief Medical Officer ALX Oncology Holdings Inc. announced the appointment of Alan Sandler, M.D., as Chief Medical Officer. Dr. Sandler brings more than 30 years of experience as a distinguished leader in oncology and drug development. Dr. Sandler’s expertise spans clinical development and operations, regulatory affairs, drug safety and development strategies. He previously held the position of Executive Vice President, Chief Medical Officer at Mirati Therapeutics, prior to its acquisition by Bristol Myers Squibb in early 2024. Before joining Mirati, Dr. Sandler was the President, Global Head of Development in Oncology at Zai Lab. Prior to that, he held roles of increasing responsibility at Genentech, a member of the Roche Group, where he ultimately served as Senior Vice President and Global Head, Product Development of Oncology Solid Tumors. Dr. Sandler’s academic positions include roles at Oregon Health and Science University, where he served as Professor of Medicine and Head of the Division of Hematology/Medical Oncology and Medical Lead of the Thoracic Oncology Program; Vanderbilt University as an Associate Professor of Medicine and Indiana University as Assistant Professor of Medicine. Dr. Sandler earned his M.D. from Rush Medical College and completed his training in internal medicine and fellowship in medical oncology at Yale-New Haven Medical Center. He has co-authored over 300 publications, including peer-reviewed articles, reviews, abstracts, and book chapters. Announcement • Oct 04
ALX Oncology Holdings Inc. Announces Resignation of Sophia Randolph as Chief Medical Officer, Effective October 11, 2024 On September 30, 2024, Sophia Randolph, M.D., Ph.D., Chief Medical Officer of ALX Oncology Holdings Inc. informed the Company of her resignation from her position effective October 11, 2024, to pursue other professional opportunities. Dr. Randolph’s resignation is not the result of any disagreement with the Company related to its operations, policies, or practices. The Company plans to commence a search for a new Chief Medical Officer. The Company thanks Dr. Randolph for her dedication over many years of service to the Company in pursuing its mission of helping patients fight cancer. New Risk • Sep 26
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$95.3m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$182m net loss in 3 years). Shareholders have been diluted in the past year (28% increase in shares outstanding). Significant insider selling over the past 3 months (US$110k sold). Market cap is less than US$100m (US$95.3m market cap). Announcement • Sep 04
ALX Oncology Holdings Inc. Announces First Patients Dosed with Evorpacept and Sarclisa as Part of Randomized Phase 1/2 UMBRELLA Study with Sanofi ALX Oncology Holdings Inc. announced the first patients have been dosed in an arm of the randomized UMBRELLA phase 1/2 clinical study partnered with Sanofi that is evaluating evorpacept in combination with SARCLISA (isatuximab-irfc). Evorpacept is ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated Fc domain and SARCLISA is Sanofi’s approved CD38 monoclonal antibody in patients with relapsed or refractory multiple myeloma (RRMM). SARCLISA binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells, inducing distinct antitumor activity. CD38 is highly and uniformly expressed on the surface of MM cells and after first-line treatment, some relapsed or recurred patients have shown resistance to CD38 agents. CD47 expression increases as multiple myeloma progresses, suggesting that evorpacept may have the potential to re-sensitize tumors to CD38 treatment or overcome anti-CD38 resistance. This novel therapeutic combination has demonstrated synergistic anti-tumor activity in preclinical models. Under the terms of the agreement, Sanofi will conduct the multicenter, randomized, open-label, controlled, parallel-group UMBRELLA phase 1/2 clinical study (NCT04643002) to evaluate the safety, efficacy, pharmacokinetics and biomarker data of evorpacept in combination with SARCLISA and dexamethasone in patients with RRMM. Part 1 of the study is designed to evaluate the dosing of evorpacept in combination with standard doses of SARCLISA and dexamethasone to identify a recommended evorpacept dose. Part 2 is designed to investigate the efficacy and safety of this three-drug combination in an expanded population of patients with RRMM. ALX Oncology will supply evorpacept and Sanofi will conduct the clinical trial. ALX Oncology owns worldwide commercial rights to evorpacept. Multiple myeloma (MM) is the second most common hematologic malignancy, with more than 185,000 new diagnoses of MM worldwide annually (Globocan) and over 35,000 new diagnoses in the United States each year (American Cancer Society). Despite available treatments, MM remains an incurable malignancy and is associated with significant patient burden. Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy. Price Target Changed • Aug 16
Price target decreased by 30% to US$9.27 Down from US$13.17, the current price target is an average from 6 analysts. New target price is 265% above last closing price of US$2.54. Stock is down 46% over the past year. The company is forecast to post a net loss per share of US$2.96 next year compared to a net loss per share of US$3.74 last year. Announcement • Aug 07
ALX Oncology Holdings Inc. Announces Board Changes ALX Oncology Holdings Inc. announced the appointment of Alan Sandler, M.D., to its Board of Directors effective August 5, 2024. Dr. Sandler is a distinguished leader in oncology and drug development with over 30 years of experience across industry and academia. Dr. Sandler’s expertise spans clinical development and operations, regulatory affairs, drug safety and development strategies. He previously held the position of Executive Vice President, Chief Medical Officer at Mirati Therapeutics, prior to its acquisition by Bristol Myers Squibb. Before joining Mirati, Dr. Sandler was the President, Global Head of Development in Oncology at Zai Lab. Prior to that, he held roles of progressive responsibility at Genentech, a member of the Roche Group, where he ultimately served as Senior Vice President and Global Head, Product Development of Oncology Solid Tumors. Dr. Sandler’s academic positions include roles at Oregon Health and Science University, where he served as Professor of Medicine and Head of the Division of Hematology/Medical Oncology and Medical Lead of the Thoracic Oncology Program, and at Vanderbilt University as an Associate Professor of Medicine and Indiana University as Assistant Professor of Medicine. Dr. Sandler earned his M.D. from Rush Medical College and completed his training in internal medicine and fellowship in medical oncology at Yale-New Haven Medical Center. An active contributor to the medical field, he has co-authored over 300 publications, including peer-reviewed articles, reviews, abstracts, and book chapters. ALX also announced that Jaume Pons, Ph.D., and Sophia Randolph, M.D., Ph.D., have resigned as members of the Company’s Board of Directors to focus on their ALX Oncology senior leadership responsibilities as the Company’s clinical program advances. Drs. Pons and Randolph will continue in their current roles as President and Chief Scientific Officer and Chief Medical Officer, respectively. Price Target Changed • Aug 02
Price target decreased by 7.9% to US$19.33 Down from US$21.00, the current price target is an average from 6 analysts. New target price is 590% above last closing price of US$2.80. Stock is down 50% over the past year. The company is forecast to post a net loss per share of US$2.92 next year compared to a net loss per share of US$3.74 last year. New Risk • Aug 01
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$184m net loss in 3 years). Shareholders have been diluted in the past year (27% increase in shares outstanding). Significant insider selling over the past 3 months (US$100k sold). Announcement • Aug 01
ALX Oncology Holdings Inc. Reports Topline Data from ASPEN-06 Phase 2 Trial Demonstrating Evorpacept Improves Tumor Response in Patients with HER2-Positive Gastric Cancer ALX Oncology Holdings Inc. announced topline data from its Phase 2 ASPEN-06 clinical trial. The trial demonstrated clinically meaningful improvements in overall response rate and duration of response among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. ASPEN-06 is a randomized, multi-center, international trial evaluating evorpacept, ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated proprietary Fc domain, in combination with trastuzumab, CYRAMZA® (ramucirumab) and paclitaxel (collectively, TRP) against TRP alone for the treatment of patients with HER2-positive gastric/GEJ cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. Patients in the trial (N=127) were generally well-balanced across arms based on pre-specified stratification factors including line of therapy, prior ENHERTU® (fam-trastuzumab deruxtecan-nxki) use, Asia region, tumor location (GC or GEJ), HER2 expression level (IHC3+ or IHC2+/ISH+) and HER2-positive biopsy (fresh or archival). The trial’s primary endpoint is overall response rate (ORR). Key secondary endpoints are safety, median duration of response (mDOR), progression-free survival (PFS) and overall survival (OS). Key Phase 2 ASPEN-06 Clinical Trial Topline Results: In the full intent-to-treat population (N=127), the addition of evorpacept to TRP demonstrated an ORR of 40.3% compared to the TRP control ORR of 26.6%; In patients with fresh HER2-positive biopsies (n=48), evorpacept plus TRP demonstrated an ORR of 54.8% compared to 23.1% for the TRP control; Median duration of response (DOR) in the evorpacept arm was 15.7 months [95% CI: 11.0; NE] compared to the TRP control of 7.6 months [95% CI: 6.3; NE] in the full intent-to-treat population; Secondary endpoints of PFS and OS were immature at the time of analysis and Evorpacept in combination with TRP was generally well tolerated and consistent with TRP control. The ASPEN-06 full data set will be submitted for presentation at an upcoming medical conference. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Additionally, both the FDA and European Commission have granted Orphan Drug Designation for this indication. ASPEN-06 is a randomized Phase 2 (open-label) /Phase 3 (double-blinded), multi-center, international trial of patients with second- or third-line metastatic HER2-overexpressing gastric/GEJ adenocarcinoma that progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy (NCT05002127). HER2 status was determined by an FDA-approved test in the most recent gastric/GEJ cancer tissue sample. The primary analysis of the full intent-to-treat population included all randomized patients whose HER2 status was based on a tissue sample obtained at any time. An additional primary analysis was conducted on patients who had a recent HER2-positive tissue sample after prior anti-HER2 therapy (“fresh biopsy”). While trastuzumab is currently approved in combination with cisplatin and capecitabine/5-FU for HER2-positive gastric/GEJ cancers, it is not approved in combination with standard-of-care CYRAMZA + paclitaxel. The Phase 2 portion of the ASPEN-06 trial enrolled 127 patients. To determine the activity of evorpacept + trastuzumab + CYRAMZA + paclitaxel, in the Phase 2 portion of ASPEN-06, patients were randomized to receive either a four-drug combination regimen (evorpacept + trastuzumab + CYRAMZA + paclitaxel) or a three-drug combination regimen (trastuzumab + CYRAMZA + paclitaxel). This design enabled the assessment of evorpacept’s contribution to the standard of care plus trastuzumab and to global standard of care, CYRAMZA + paclitaxel. Recent Insider Transactions Derivative • Jul 14
Founder notifies of intention to sell stock Jaume Pons intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of July. If the sale is conducted around the recent share price of US$6.76, it would amount to US$135k. Since September 2023, Jaume's direct individual holding has decreased from 481.04k shares to 459.70k. Company insiders have collectively sold US$981k more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • Jul 07
Founder recently sold US$63k worth of stock On the 1st of July, Jaume Pons sold around 11k shares on-market at roughly US$5.82 per share. This transaction amounted to 2.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Jaume has been a net seller over the last 12 months, reducing personal holdings by US$171k. Recent Insider Transactions • Jun 18
Chief Financial Officer recently bought US$102k worth of stock On the 13th of June, Peter Garcia bought around 12k shares on-market at roughly US$8.53 per share. This transaction amounted to 31% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Peter has been a buyer over the last 12 months, purchasing a net total of US$67k worth in shares. Recent Insider Transactions Derivative • Jun 08
Founder notifies of intention to sell stock Jaume Pons intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 4th of June. If the sale is conducted around the recent share price of US$8.96, it would amount to US$179k. Since June 2023, Jaume's direct individual holding has decreased from 481.04k shares to 450.08k. Company insiders have collectively sold US$1.0m more than they bought, via options and on-market transactions in the last 12 months. Announcement • Jun 05
ALX Oncology Holdings Inc. Presents First Evorpacept Combination Data with an Antibody-Drug Conjugate from Phase 1 Aspen-07 Clinical Trial in Patients with Advanced Bladder Cancer ALX Oncology Holdings Inc. presented data from its Phase 1 ASPEN-07 clinical trial in a poster presentation (abstract #4575) at the 2024 American Society of Cancer Oncology ("ASCO") Annual Meeting being held in Chicago from May 31-June 4, 2024. These findings represent the first evorpacept combination data with an ADC from ASPEN-07's ongoing, open-label, single-arm, clinical trial of evorpacept in combination with PADCEV (enfortumabvedotin or "EV") in patients with locally advanced or metastatic urothelial cancer ("la/m UC"). Evorpacept is a CD47 blocker with an inactivated Fc effector domain that is designed to minimize associated toxicity. The event will feature leading ASPEN-07 principal investigator and bladder cancer expect, Samuel A. Funt, M.D., from Memorial Sloan Kettering Cancer Center, along with the management team of ALX Oncology. The discussion will cover details of the first promising initial dose escalation data from the Phase 1 ASPen-07 clinical trial of evorpacePT in combination with EV in patients with la/m UC, and how ASPEN-07 could fit into the treatment paradigm of this indication. Samuel A. Funt,M.D., is a genitourinary oncologist at Memorial Sloan Kettering Cancer Center in New York, NY, where he is also Director of the Inpatient Genitourinary Oncology Service, Director of Bladder Cancer Clinical Trials Operations, and member of the Data Safety Monitoring Committee. Dr. Funt has practiced medicine and been involved in clinical trials for over 10 years. His top areas of clinical expertise are Bladder and Testicular Cancers. An archived webcast will be available following the event. The Phase 1 clinical trial is an ongoing, open-label, Single arm is designed to evaluate the safety, tolerability, and efficacy of evorpacept in collaboration with EV in patients with la-m UC (NCT05524545). This dose escalation clinical trial has enrolled cohorts receiving 20 mg/kg Q2W or 30 mg/kg Q2W evorpacept plus standard EV treatment. The study is sponsored and conducted by ALX Oncology and the Company's Phase 1 ASPEN-07 Phase 1 clinical trial is a Phase 1 ASPEN-07 patients with la/m UC (NCT055 24545). The Phase 1 clinical trial has enrolled cohort receiving 20 mg/kg Q 2W or 30 mg/kg Second QuarterW evorpacept plus EV treatment. New Risk • May 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.4% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 2.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$197m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Recent Insider Transactions Derivative • May 08
Founder notifies of intention to sell stock Jaume Pons intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 6th of May. If the sale is conducted around the recent share price of US$15.36, it would amount to US$307k. Since June 2023, Jaume's direct individual holding has decreased from 481.04k shares to 450.08k. Company insiders have collectively sold US$582k more than they bought, via options and on-market transactions in the last 12 months. Announcement • May 08
ALX Oncology Appoints Allison Dillon as Chief Business Officer ALX Oncology Holdings Inc. announced the appointment of Allison Dillon, Ph.D., as Chief Business Officer. Dr. Dillon joined ALX Oncology from Calithera Biosciences, where she most recently served as Senior Vice President of Commercial and Portfolio Strategy until 2023. During her time at Calithera, Dr. Dillon spearheaded commercial planning across a pipeline of hematology, solid tumors, and cystic fibrosis molecules. As Senior Vice President, Dr. Dillon also led corporate communications, including public and investor relations functions. Dr. Dillon helped oversee successful fundraising activities and acquisition of drugs such as mivavotinib and sapansertib from Takeda. Prior to joining Calithera in 2017, Dr. Dillon’s expertise on pre- and post-launch commercialization strategy grew during her time at Genentech. Dr. Dillon drove the commercial launch plan for the initial launch of TECENTRIQ (atezolizumab) in the US, and multiple subsequent launches, later serving as the Marketing Lead for GU indications. Additionally, she was the U.S. commercial representative on various Roche global business teams that informed investments. She served in marketing and sales roles for AVASTIN® (bevacizumab), TARCEVA (erlotinib), ZELBORAF (vemurafenib), and TECENTRIQ. Prior to Genentech, Dr. Dillon was a Senior Consultant at the management consulting firm Campbell Alliance, working across pharma and biotech clients. Prior to consulting, she was a Postdoctoral Fellow at the University of California San Francisco, Howard Hughes Medical Institute studying genetic pathways involved in medulloblastoma. Dr. Dillon holds a Ph.D. and M.S. in Neuroscience from Albert Einstein College of Medicine and a B.A. in Psychology from the University of Richmond. Announcement • Apr 30
ALX Oncology Holdings Inc. Announces Initiation of Phase 2 Investigator-Sponsored Trial of Neoadjuvant Radiation and Evorpacept in Combination with Pembrolizumab in Patients with Untreated HPV-Mediated Oropharyngeal Cancer ALX Oncology Holdings Inc. announced the initiation of a Phase 2 investigator-sponsored trial ("IST") of neoadjuvant radiation and evorpacept, a next-generation CD47 blocker, in combination KEYTRUDA®? (pembrolizumab) in patients with previously untreated and early-stage locally advanced, resectable, humanapillomavirus-mediated oropharyngeal cancer ("HPVOC"). This multi-center, single-arm, open-label Phase 2 IST is being led by Joseph A. Califano III, M.D., Director of the Hanna and Mark Gleiberman Head and Neck Cancer Center at the University of California, San Diego (NCT05787639). Radadiotherapy induces the release of tumor-associated antigens and upregulates PD-L1 expression by tumor cells. Blocking the CD47/SIRPa axis may yield a synergistic anti-tumor effect when combined with radiotherapy and immunotherapy. The Company's pipeline of therapeutic candidates with standard-of-care agents include: Anti-cancer antibodies (the "don't eat me" signal): evorpacept enables Fc-mediated antibody-dependent phagocytosis by macrophages in combination with anti-cancer antibodies (e.g., Herceptin®?) with an active Fc domain, which is otherwise impaired by CD47 expression on cancer cells binding to SIRP alpha on macrophages. This same mechanism of action applies to ADCs. PD-1/PD-L1 immune checkpoint inhibitors (the "don't activate T-cells" signal): evor pacept enables T-cell activation by dendritic cells that are constitutively inhibited by CD47 expression on cancer cell binding to SIRP alpha On dendritic cells. Activated dendritic cells present neoantigens to T-cells that once activated will kill cancer cells when the PD-1/PD- L1 inhibitory interaction is blocked by T-cell checkpoint inhibitors. Board Change • Apr 30
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was an independent director. The company's board is composed of: 1 new director. 7 experienced directors. 2 highly experienced directors. 3 independent directors (4 non-independent directors). Independent Director Scott Garland was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Announcement • Apr 23
ALX Oncology Holdings Inc., Annual General Meeting, Jun 12, 2024 ALX Oncology Holdings Inc., Annual General Meeting, Jun 12, 2024, at 13:00 Pacific Standard Time. Agenda: To consider to elect three Class I directors to serve until the 2027 annual meeting of stockholders or until their successors are duly elected and qualified; to conduct an advisory vote to approve the compensation of named executive officers (NEOs); to ratify the appointment of KPMG LLP as independent registered public accounting firm for our fiscal year ending December 31, 2024; and to consider to transact such other business as may properly come before the Annual Meeting or any adjournments or postponements thereof. Recent Insider Transactions Derivative • Apr 18
Founder notifies of intention to sell stock Jaume Pons intends to sell 50k shares in the next 90 days after lodging an Intent To Sell Form on the 16th of April. If the sale is conducted around the recent share price of US$12.89, it would amount to US$645k. Since June 2023, Jaume's direct individual holding has decreased from 481.04k shares to 474.23k. Company insiders have collectively sold US$240k more than they bought, via options and on-market transactions in the last 12 months. Announcement • Apr 10
ALX Oncology Holdings Inc. Reports Encouraging Clinical Data of Evorpacept in Combination with Standard-of-Care in an Ongoing Phase 1/2 Clinical Trial in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (“R/R B-NHL”) ALX Oncology Holdings Inc. reported encouraging clinical data from the ongoing Phase 1/2 investigator-sponsored trial (“IST”) of evorpacept in combination with R2 in patients with indolent and aggressive R/R B-NHL. The new data were presented in an oral presentation at the 2024 American Association for Cancer Research (“AACR”) Annual Meeting. The clinical trial enrolled a total of 20 patients with indolent (n=18) and aggressive (n=2) R/R B-NHL where all patients had received prior rituximab and 72% had received prior chemoimmunotherapy. Patients received evorpacept 30 mg/kg Q2W (n=3) or 60 mg/kg Q4W (n=17) in combination with standard R2 treatment. The regimen was well tolerated, and there were no dose-limiting toxicities. The maximum administered dose for evorpacept was 60 mg/kg Q4W. The most common adverse events due to any cause were fatigue, ALT increase, anemia, and AST increase, all of which were mostly low grade. There were no reported treatment-related deaths on study. Patients with indolent R/R B-NHL (n=18) had a best ORR of 94% and a CRR of 83%. The median duration of response was not reached. The AUGMENT Phase 3 clinical trial1, a benchmark study in a similar patient population, reported an ORR of 78% and a CRR of 34% with R2 alone. The Phase 1/2 IST is an ongoing, open-label, single arm clinical trial designed to evaluate the safety, tolerability, and efficacy of evorpacept, otherwise known as ALX148, in combination with R2 in patients with R/R B-cell NHL (both indolent and aggressive) histology. Patient enrollment is currently open to the Phase 2 portion of the study evaluating patients with previously untreated indolent B-NHL (NCT05025800). The study is sponsored and conducted by MD Anderson Cancer Center. Recent Insider Transactions Derivative • Apr 07
Founder notifies of intention to sell stock Jaume Pons intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 4th of April. If the sale is conducted around the recent share price of US$10.80, it would amount to US$216k. Since June 2023, Jaume's direct individual holding has increased from 481.04k shares to 494.23k. Company insiders have collectively sold US$240k more than they bought, via options and on-market transactions in the last 12 months. Price Target Changed • Mar 08
Price target increased by 17% to US$20.07 Up from US$17.21, the current price target is an average from 6 analysts. New target price is 32% above last closing price of US$15.21. Stock is up 182% over the past year. The company is forecast to post a net loss per share of US$3.42 next year compared to a net loss per share of US$3.74 last year. Recent Insider Transactions • Jan 07
Founder recently sold US$108k worth of stock On the 29th of December, Jaume Pons sold around 7k shares on-market at roughly US$15.04 per share. This transaction amounted to 1.4% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Jaume has been a net seller over the last 12 months, reducing personal holdings by US$132k. Announcement • Oct 07
ALX Oncology Holdings Inc. has completed a Follow-on Equity Offering in the amount of $54.998752 million. ALX Oncology Holdings Inc. has completed a Follow-on Equity Offering in the amount of $54.998752 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 7,370,690
Price\Range: $6.38
Discount Per Security: $0.3828
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,250,000
Price\Range: $6.379
Discount Per Security: $0.3827 Announcement • Oct 06
ALX Oncology Holdings Inc. has completed a Follow-on Equity Offering in the amount of $54.998752 million. ALX Oncology Holdings Inc. has completed a Follow-on Equity Offering in the amount of $54.998752 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 7,370,690
Price\Range: $6.38
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,250,000
Price\Range: $6.379 New Risk • Oct 06
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 19% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings are forecast to decline by an average of 7.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$206m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Announcement • Oct 05
ALX Oncology Holdings Inc. Reports Positive Interim Phase 2 ASPEN-06 Clinical Trial Results of Evorpacept for the Treatment of Advanced HER2-Positive Gastric Cancer ALX Oncology Holdings Inc. announced positive prespecified interim Phase 2 data from its ASPEN-06 clinical trial, a randomized multi-center international study evaluating evorpacept, the Company’s CD47 blocking therapeutic, in combination with trastuzumab, CYRAMZA® (ramucirumab) and paclitaxel for the treatment of patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer. This prespecified interim analysis represents results from 54 randomized patients with second and third line gastric/GEJ cancer, including a meaningful number of patients previously treated with ENHERTU® (trastuzumab deruxtecan) and checkpoint inhibitors. Patients were treated with evorpacept at 30 mg/kg every two weeks, mirroring the treatment cycle of trastuzumab, CYRAMZA and paclitaxel. Phase 2 ASPEN-06 Interim Analysis Results: A confirmed overall response rate (“ORR”) of 52% was demonstrated for evorpacept in combination with trastuzumab + CYRAMZA + paclitaxel compared to 22% for the control group of trastuzumab + CYRAMZA + paclitaxel; Median duration of response (“mDOR”) was not reached for the evorpacept combination treatment arm compared to 7.4 months for the control group; The safety profile of evorpacept was consistent with previous clinical trials and was well-tolerated; These interim results compare favorably to the efficacy reported for CYRAMZA + paclitaxel in the RAINBOW study (ORR of 28% and mDOR of 4.4 months), which is the regulatory benchmark and global standard of care for second line gastric/GEJ cancer. New Risk • Aug 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 7.9% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 7.9% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$206m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Significant insider selling over the past 3 months (US$93k sold). Announcement • Feb 17
ALX Oncology Announces First Patient Dosed in ASPEN-07, a Phase 1 Study of Evorpacept for the Treatment of Patients with Urothelial Cancer ALX Oncology Holdings Inc. announced the first patient has been dosed in the ASPEN-07 study evaluating evorpacept, a next generation CD47 blocker, in combination with PADCEV® (enfortumab vedotin-ejfv), an antibody drug conjugate (“ADC”), in patients with urothelial cancer (“UC”). ASPEN-07 is a phase 1, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of evorpacept in combination with enfortumab vedotin-ejfv in subjects with unresectable locally advanced or metastatic UC (NCT05524545). Recent Insider Transactions Derivative • Dec 22
Chief Medical Officer & Director exercised options to buy US$479k worth of stock. On the 16th of December, Sophia Randolph exercised options to buy 46k shares at a strike price of around US$4.09, costing a total of US$190k. This transaction amounted to 25% of their direct individual holding at the time of the trade. Since March 2022, Sophia has owned 188.40k shares directly. Company insiders have collectively bought US$292k more than they sold, via options and on-market transactions, in the last 12 months. Announcement • Dec 14
Alx Oncology Announces Initial Data from Aspen-05 Study of Evorpacept in Combination with Azacitidine and Venetoclax, Demonstrating Tolerability and Preliminary Activity in Patients with Acute Myeloid Leukemia ALX Oncology Holdings Inc. announced the presentation of clinical data from the Phase 1a dose escalation part of the ASPEN-05 trial evaluating evorpacept in combination with azacitidine and venetoclax for the treatment of patients with relapsed or refractory ("r/r") or newly diagnosed ("ND") acute myeloid leukemia ("AML"). The new results, shared in a poster at the 64(th) American Society of Hematology ("ASH") Annual Meeting [Abstract #4076], show that the combination of evorpacept with azacitidine and venetoclax is active and generally well tolerated. As of October 3, 2022, 14 patients with either r/r or ND AML have been treated with evorpacept in the Phase 1 dose escalation part of the study, administered at 20 mg/kg or 30 mg/kg once every 2 weeks ("Q2W") or 60 mg/kg once every 4 weeks ("Q4W") together with standard dosing of azacitidine and venetoclax. Evoacepept in combination with azacitidine and venetoclax was generly well tolerated (N=14) with no maximumum tolerated dose identified and a maximum administered dose of 60 mg/kg Q4W. In 10 relapsed or refractory AML response-evaluable patients, including 8 that had progressed after prior venetoclax treatment, all experienced a reduction in bone marrow blasts, and 4 achieved a response. In 3 newly diagnosed AML response-evaluable patients, all 3 achieved a response, including 1 complete response ("CR"), 1 CR with incomplete hematologic recovery ("CRi"), and 1 morphologic leukemia free state ("MLFS"). Announcement • Nov 30
ALX Oncology Holdings Inc. Appoints Scott Garland to Its Board of Directors ALX Oncology Holdings Inc. announced the appointment of Scott Garland to its board of directors, effective November 29, 2022. With more than 30 years of biopharmaceutical industry knowledge, Mr. Garland brings deep commercial and executive leadership experience. Mr. Garland is the Chief Executive Officer of PACT Pharma, an immuno-oncology company focused on developing neoantigen targeted T-cell therapies for solid tumors. He was formerly the Chief Executive Officer of Portola Pharmaceuticals, which was acquired by Alexion in 2020. At Portola, he led the company through the commercial launch of Andrexxa®, a novel reversal agent for factor Xa inhibitors. Before joining Portola, Mr. Garland held leadership roles at multiple pharmaceutical and biotechnology companies. At Relypsa, he served first as Chief Commercial Officer, then as president overseeing the U.S. commercial launch of Veltassa® for the treatment of hyperkalemia. Prior to Relypsa, Mr. Garland spent three years as Chief Commercial Officer at Exelixis where he built the commercial organization for the company's launch of cabozantinib in medullary thyroid cancer. He also spent nine years at Genentech, where he led the commercial franchises for two multi-billion-dollar cancer therapies – Avastin® and Rituxan®. Mr. Garland sits on the Board for Day One Biopharmaceuticals and Calithera Biosciences, and formerly sat on the Board of Karyopharm Therapeutics. Mr. Garland received a Bachelor of Science degree from California Polytechnic State University-San Luis Obispo and a master's degree in business administration from the Fuqua School of Business at Duke University. Price Target Changed • Nov 16
Price target decreased to US$35.00 Down from US$38.13, the current price target is an average from 8 analysts. New target price is 202% above last closing price of US$11.60. Stock is down 74% over the past year. The company is forecast to post a net loss per share of US$3.18 next year compared to a net loss per share of US$2.07 last year. Board Change • Nov 16
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 2 experienced directors. No highly experienced directors. Independent Executive Chairman Corey Goodman is the most experienced director on the board, commencing their role in 2015. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Price Target Changed • Nov 10
Price target decreased to US$35.00 Down from US$38.13, the current price target is an average from 8 analysts. New target price is 182% above last closing price of US$12.42. Stock is down 72% over the past year. The company is forecast to post a net loss per share of US$3.18 next year compared to a net loss per share of US$2.07 last year. Price Target Changed • Aug 15
Price target decreased to US$38.88 Down from US$43.25, the current price target is an average from 5 analysts. New target price is 157% above last closing price of US$15.14. Stock is down 77% over the past year. The company is forecast to post a net loss per share of US$3.07 next year compared to a net loss per share of US$2.07 last year. Announcement • Aug 12
ALX Oncology Holdings Inc. Announces First Patient Dosed in Phase 2 Investigator-Sponsored Trial of Evorpacept in Combination with Cetuximab and Pembrolizumab in Patients with Advanced Colorectal Cancer ALX Oncology Holdings Inc. announced the initiation of a Phase 2 investigator-sponsored study of evorpacept, a next generation CD47 blocker, in combination with ERBITUX® (cetuximab) and KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with refractory microsatellite stable metastatic colorectal cancer (“mCRC”) who have progressed on at least two lines of systemic therapy. This is an open-label, multi-center, single-arm phase 2 clinical trial (NCT05167409). Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, will respectively provide ERBITUX and KEYTRUDA to support this study. This trial is being co-led by Wells Messersmith, M.D., Professor and Head of Medical Oncology at the University of Colorado Cancer Center and Director of the Academic GI Cancer Consortium (“AGICC”), and Robert Lentz, M.D., Assistant Professor of Medical Oncology at the University of Colorado Cancer Center. AGICC brings together a world class team of institutions and investigators to design and rapidly complete clinical trials in gastrointestinal cancers. The study is being managed by Criterium Inc., a full-service contract research organization dedicated to providing efficiency and expertise in clinical trial services. Price Target Changed • Aug 09
Price target decreased to US$38.88 Down from US$43.25, the current price target is an average from 6 analysts. New target price is 230% above last closing price of US$11.77. Stock is down 82% over the past year. The company is forecast to post a net loss per share of US$2.89 next year compared to a net loss per share of US$2.07 last year. Announcement • Aug 02
ALX Oncology's Evorpacept Receives Fast Track Designation from FDA as First-Line Treatment for Head and Neck Squamous Cell Carcinoma ALX Oncology Holdings Inc. announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to evorpacept, a next generation CD47 blocker, in combination with KEYTRUDA(R) (pembrolizumab), Merck's anti-PD-1 therapy, for the first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell carcinoma ("HNSCC"). The FDA's decision is informed by the results of ALX Oncology's phase 1 clinical trial, ASPEN-01, that showed preliminary antitumor activity and a favorable safety profile in checkpoint inhibitor-naïve patients with second-line or greater advanced HNSCC treated with evorpacept and pembrolizumab (n=10). The preliminary objective response rate of 40% in this limited population represents an improvement over historical anti-PD-1 monotherapy activity in a similar population and supported the initiation of the ASPEN-03 (NCT04675294) study in May 2021 in collaboration with Merck (known as MSD outside the US and Canada). ASPEN-03 is a randomized phase 2 multi-center study to investigate the anti-tumor efficacy of evorpacept plus pembrolizumab in patients with first-line metastatic or unresectable, recurrent PD-L1 positive HNSCC. Announcement • Jun 26
ALX Oncology Holdings Inc.(NasdaqGS:ALXO) dropped from Russell 2000 Growth Index ALX Oncology Holdings Inc.(NasdaqGS:ALXO) dropped from Russell 2000 Growth Index Price Target Changed • Jun 06
Price target decreased to US$43.25 Down from US$48.38, the current price target is an average from 6 analysts. New target price is 505% above last closing price of US$7.15. Stock is down 88% over the past year. The company is forecast to post a net loss per share of US$2.70 next year compared to a net loss per share of US$2.07 last year. Announcement • Jun 04
ALX Oncology Holdings Inc Announces Evorpacept Clinical Program Updates ALX Oncology Holdings Inc. announced clinical program updates for its lead program, evorpacept, a next generation CD47 blocker. Introducing ASPEN-07, a Phase 1 Trial of Evorpacept for the Treatment of Patients with Urothelial Carcinoma ALX Oncology will initiate a new clinical study, ASPEN-07, to investigate evorpacept in combination with an antibody-drug conjugate, PADCEV® (enfortumab vedotin-ejfv), for the treatment of patients with urothelial carcinoma in the fourth quarter of 2022. Enfortumab vedotin-ejfv is an ADC directed to Nectin-4, a protein located on the surface of cells that is highly expressed in UC. In April 2022, ALX Oncology successfully completed a pre-IND consultation with the U.S. Food and Drug Administration for a Phase 1 study of evorpacept in combination with enfortumab vedotin-ejfv in patients with previously treated locally advanced or metastatic UC. The IND application for ASPEN-07 was submitted to the FDA in May 2022. Update of ASPEN-05, a Phase 1 /2 Clinical Trial of Evorpacept in Combination with Venetoclax and Azacitidine in Acute Myeloid Leukemia (“AML”), and ASPEN-02, a Phase 1/2 Study of Evorpacept in Combination with Azacitidine in Myelodysplastic Syndrome The Phase 1 dose escalation portion of ASPEN-05 has successfully completed enrollment with no safety concerns to date up to the highest protocol defined dose level of 60 mg/kg evorpacept once every four weeks. This portion of the study is designed to characterize the initial safety of evorpacept in combination with venetoclax and azacitidine for the treatment of patients with relapsed/refractory AML and previously untreated AML who are not candidates for intensive induction therapy. Patient enrollment will be paused before proceeding into the Phase 1 dose optimization portion of ASPEN-05 pending completion of the Phase 1 portion of ASPEN-02, a Phase 1/2 study of evorpacept in combination with azacitidine in patients with MDS. Data from ASPEN-02 will be used to inform the optimal dose(s) of evorpacept to be studied in the ASPEN-05 study in combination with venetoclax and azacitidine. Ongoing patients in ASPEN-05 will continue to be treated and followed per protocol. Update of ASPEN-03 and ASPEN-04, which are two distinct randomized Phase 2 studies for the treatment of patients with advanced head and neck squamous cell carcinoma ALX Oncology continues to advance evorpacept in two randomized Phase 2 studies in patients with HNSCC in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, with or without chemotherapy. Both studies are being conducted in collaboration with Merck, known as MSD outside the United States and Canada. The first study, ASPEN-03, is evaluating the efficacy of evorpacept in combination with pembrolizumab for the first-line (“1L”) treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC with a Combined Positive Score (“CPS”) = 1. The second study, ASPEN-04, is investigating evorpacept in combination with pembrolizumab and standard chemotherapy for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC (any CPS value). Patient enrollment for ASPEN-03 and ASPEN-04 continues as planned with results expected to be presented by mid-2024. Update of ASPEN-06, a Phase 2/3 Study of Evorpacept for the Treatment of Patients with Advanced Gastric or Gastroesophageal Junction Cancer ASPEN-06 is a randomized Phase 2 (open-label) /Phase 3 (double-blind), international, multi-center study to evaluate the efficacy of evorpacept and CYRAMZA® (ramucirumab) added to trastuzumab and paclitaxel for the treatment of patients with HER-positive gastric/GEJ cancer whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. ASPEN-06 is being conducted in collaboration with Eli Lilly and Company. In March 2022, the first patient was dosed in the Phase 2/3 ASPEN-06 study. Patient enrollment continues to progress and results from the Phase 2 portion of ASPEN-06 are expected to be presented in 2023. Price Target Changed • May 19
Price target decreased to US$45.63 Down from US$49.38, the current price target is an average from 6 analysts. New target price is 421% above last closing price of US$8.76. Stock is down 85% over the past year. The company is forecast to post a net loss per share of US$2.73 next year compared to a net loss per share of US$2.07 last year. 