1. BURLINGAME, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the initiation of a Phase 1/2 investigator-sponsored trial of evorpacept (also known as ALX148), a next generation CD47 blocker, in combination with rituximab and lenalidomide for the treatment of patients with indolent and aggressive non-Hodgkin lymphoma ("NHL"). This study is being led by Dr. Paolo Strati at The University of Texas M.D. Anderson Cancer Center ("MDACC"), one of the largest multidisciplinary programs in the U.S. for treating NHL.

    "We are excited to launch this study that builds upon the promising…

    BURLINGAME, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the initiation of a Phase 1/2 investigator-sponsored trial of evorpacept (also known as ALX148), a next generation CD47 blocker, in combination with rituximab and lenalidomide for the treatment of patients with indolent and aggressive non-Hodgkin lymphoma ("NHL"). This study is being led by Dr. Paolo Strati at The University of Texas M.D. Anderson Cancer Center ("MDACC"), one of the largest multidisciplinary programs in the U.S. for treating NHL.

    "We are excited to launch this study that builds upon the promising anti-tumor activity and tolerability observed from ASPEN-01, ALX Oncology's Phase 1b study to investigate the combination of evorpacept and rituximab in patients with advanced relapsed and refractory NHL," said Paolo Strati, M.D., Assistant Professor, Department of Lymphoma-Myeloma and Department of Translational Molecular Pathology, MDACC. "NHL remains a difficult-to-treat cancer and patients are in desperate need for more therapeutic options to help improve disease outcomes. From a mechanistic perspective, the combination of a CD47 blocker and rituximab, as well as the combination of lenalidomide and rituximab, have demonstrated clinical activity against NHL. As these doublet combinations act through different but synergistic mechanisms, and have non-overlapping individual toxicity profiles, we anticipate the triplet combination of evorpacept, rituximab and lenalidomide will positively impact efficacy without increasing toxicity."

    About Non-Hodgkin Lymphoma

    Approximately 500,000 people worldwide are diagnosed with NHL each year. In the U.S., NHL is the seventh most common type of cancer, and over 80,000 newly diagnosed cases of NHL are estimated in 2021. Treatment options are currently limited and resistance to existing therapies or relapse following treatment is common. The most prevalent form of NHL, accounting for about 40% of newly diagnosed NHL cases, is an aggressive form called diffuse large B-cell lymphoma ("DLBCL"). Patients with relapsed or refractory DLBCL have an extremely poor prognosis with a median survival of approximately 6 months. Indolent lymphomas comprise another common form of NHL, especially among elderly individuals, where safe and effective chemotherapy-free options for these patients are urgently needed.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of evorpacept for the treatment of multiple solid tumor indications and hematologic malignancies, including acute myeloid leukemia and myelodysplastic syndromes.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  2. MENLO PARK, Calif. and BOSTON, Sept. 14, 2021 /PRNewswire/ -- Lightstone Ventures today announced the closing of Lightstone Ventures III with $375 million in capital commitments, to invest in early-stage companies developing high impact therapeutics and technologies that have the potential to change patients' lives. The new fund was oversubscribed, exceeding the firm's targeted raise, and included strong support from both new and existing limited partners. With the closing of Fund III, Lightstone Ventures also announced the appointments of Christina Isacson, Ph.D., as Partner and Young Kwon, Ph.D., as Operating Partner.

    "We are very excited for the future of Lightstone and the important work that this new fund will enable," said Mike Carusi

    MENLO PARK, Calif. and BOSTON, Sept. 14, 2021 /PRNewswire/ -- Lightstone Ventures today announced the closing of Lightstone Ventures III with $375 million in capital commitments, to invest in early-stage companies developing high impact therapeutics and technologies that have the potential to change patients' lives. The new fund was oversubscribed, exceeding the firm's targeted raise, and included strong support from both new and existing limited partners. With the closing of Fund III, Lightstone Ventures also announced the appointments of Christina Isacson, Ph.D., as Partner and Young Kwon, Ph.D., as Operating Partner.

    "We are very excited for the future of Lightstone and the important work that this new fund will enable," said Mike Carusi, General Partner at Lightstone. "Our investment philosophy is guided by a commitment not just to exciting ideas but to the people leading them forward. This is an important moment for the firm that builds upon the successes we have had with our previous two funds and the companies we have invested in that are already making an impact on patients. We look forward to continuing our partnership with driven entrepreneurs developing therapies and technologies that have the potential to be industry-leading products."

    Since its inception in 2012, Lightstone has invested in more than 30 companies, all of which share a commitment to translating scientific breakthroughs into clinically and commercially meaningful therapies and technologies. In addition to venture capital experience, Lightstone's senior investment team brings significant operational leadership experience, enabling the firm to collaborate with founders to establish strategies that transform their visions into commercially viable products. Lightstone has a global presence, with offices in Menlo Park, Calif., Boston, Mass., Singapore, and Dublin, Ireland. The team includes:

    • Mike Carusi, General Partner
    • Jean George, General Partner
    • Jason Lettmann, General Partner
    • Hanson S. Gifford, III, Partner
    • Christina Isacson, Ph.D., Partner
    • Caroline Gaynor, Principal
    • Hank Plain, Special Partner
    • Mark Deem, Operating Partner
    • Young Kwon, Ph.D., Operating Partner
    • Stacy Enxing Seng, Operating Partner
    • Kenneth D. Noonan, Ph.D., CEO, Lightstone Singapore PTE. LTD.
    • Travis Boettner, CFO & CCO

    The Lightstone team has raised over $850 million since inception and has invested in companies such as Alchemab Therapeutics, ALX Oncology (NASDAQ:ALXO), Catamaran Bio, Cyteir Therapeutics (NASDAQ:CYT), Claret Medical (Acquired by Boston Scientific), Disarm Therapeutics (Acquired by Eli Lilly and Co.), Gemini Therapeutics (NASDAQ:GMTX), LocanaBio, Nimbus, Ra Pharma (Acquired by UCB), Tizona (Acquired by Gilead Sciences), and Willow.  

    "With Lightstone Ventures III, we look forward to empowering visionary entrepreneurs who are changing medicine, providing the same high-touch collaboration that founders have come to expect from our team along with increased financial resources," said Jason Lettmann, General Partner at Lightstone Ventures. "In addition, we are delighted to welcome Christina and Young to the team. One of Lightstone's key differentiators is our ability to leverage our team's leadership experience to provide hands-on guidance to the founders and teams we support. Both Christina and Young have held multiple C-suite level leadership roles, and they bring significant operational experience that will prove incredibly valuable to our portfolio companies."

    Dr. Isacson has spent over 16 years in the biotechnology industry and brings experience creating, launching, building and operating public and private biotech companies. Prior to joining Lightstone, she was a member of the founding team and Chief Business Officer at Magenta Therapeutics, and a part of the founding team at Decibel Therapeutics. She also has extensive experience in venture capital, most recently with Third Rock Ventures. Dr. Isacson holds a Ph.D. in Neuroscience from Tufts University School of Medicine, Graduate School of Biomedical Sciences, as well as a B.Sc. in Biology from McGill University.

    Dr. Kwon is a proven executive with significant operating and venture capital experience, and specializes in deal sourcing, due diligence, and portfolio company management. He has held a variety of leadership roles with over ten years as a C-suite executive at Momenta Pharmaceuticals, a public biotech company, prior to its sale to Johnson & Johnson for $6.5 billion. He holds a Ph.D. in Biological Chemistry and Molecular Pharmacology from Harvard University, as well as a B.S. in Biology from the Massachusetts Institute of Technology.

    About Lightstone Ventures

    Lightstone Ventures is a global venture capital firm investing in biotech and medtech companies pioneering big ideas poised to transform patient outcomes. We were founded in 2012 to empower visionary entrepreneurs with the resources and operational guidance necessary to bring their innovative therapeutics and technologies to the patients who need them most. Our investment team has led deals resulting in 19 acquisitions and 20 initial public offerings over the last two decades. The firm has offices in Boston, Mass., Menlo Park, Calif., Dublin, Ireland and Singapore.

    For more information, please visit www.lightstonevc.com

    Cision View original content:https://www.prnewswire.com/news-releases/lightstone-ventures-raises-375-million-fund-301375755.html

    SOURCE Lightstone Ventures

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  3. BURLINGAME, Calif., Sept. 07, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in two upcoming virtual investor conferences.

    H.C. Wainwright 23rd Annual Global Investment Conference
    Format: Fireside chat with analyst, Swayampakula Ramakanth
    Date: Monday, September 13
    Time: 7:00 AM Eastern Time
    Webcast link: Available here

    Cantor Virtual Global Healthcare Conference
    Format: Fireside chat with analyst, Alethia Young
    Date: Tuesday, September 28
    Time: 11:50 AM Eastern Time
    Webcast link…

    BURLINGAME, Calif., Sept. 07, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in two upcoming virtual investor conferences.

    H.C. Wainwright 23rd Annual Global Investment Conference

    Format: Fireside chat with analyst, Swayampakula Ramakanth

    Date: Monday, September 13

    Time: 7:00 AM Eastern Time

    Webcast link: Available here

    Cantor Virtual Global Healthcare Conference

    Format: Fireside chat with analyst, Alethia Young

    Date: Tuesday, September 28

    Time: 11:50 AM Eastern Time

    Webcast link: Available here

    A live webcast of the fireside chats can be accessed by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcasts will be archived for up to 90 days following the fireside chat dates.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, evorpacept (also known as ALX148), is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of evorpacept for the treatment of multiple solid tumor indications and hematologic malignances, including acute myeloid leukemia and myelodysplastic syndromes.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

    Primary Logo

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  4. BURLINGAME, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the second quarter ended June 30, 2021 and provided clinical development and operational highlights.

    "We are pleased to report on the substantial progress we made since the prior quarter with our lead product candidate, ALX148, and that the United States Adopted Names (USAN) Council has approved ‘evorpacept' as the nonproprietary (generic) name for ALX148," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Our highlights include the presentation of…

    BURLINGAME, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the second quarter ended June 30, 2021 and provided clinical development and operational highlights.

    "We are pleased to report on the substantial progress we made since the prior quarter with our lead product candidate, ALX148, and that the United States Adopted Names (USAN) Council has approved ‘evorpacept' as the nonproprietary (generic) name for ALX148," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Our highlights include the presentation of additional positive Phase 1b data in second-line or greater HER2 positive gastric or gastroesophageal junction cancer from our ASPEN-01 trial during an oral session at the ESMO World Congress on Gastrointestinal Cancer; these results provide the basis for initiating a randomized Phase 2/3 trial in the same setting (ASPEN-06) scheduled to start in the second half of this year."

    "We recently dosed the first patient in our Phase 2 ASPEN-04 trial in first line metastatic or unresectable recurrent head and neck squamous cell carcinoma in combination with KEYTRUDA® and chemotherapy, are continuing enrollment in our Phase 2 ASPEN-03 trial in first line metastatic or unresectable, PD-L1 positive recurrent head and neck cancer in combination with KEYTRUDA, and plan to present full results of the Phase 1b study (ASPEN-01) in the fourth quarter of this year. In addition, we plan to present results from our Phase 1 study in myelodysplastic syndromes, to initiate a Phase 2 study in the same setting (ASPEN-02), as well as to initiate a Phase 1 study in acute myeloid leukemia (ASPEN-05)," Dr. Pons continued.

    Recent Clinical Developments for Evorpacept (Also known as ALX148)

    • First Patient Dosed in Phase 2 ASPEN-04 Study
      • In July 2021, dosed first patient in the Phase 2 ASPEN-04 study evaluating the combination of evorpacept, a next generation CD47 blocker, with KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, and standard 5-fluorouracil and platinum chemotherapy for the first line ("1L") treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma ("HNSCC"). In June 2021, the U.S. Food and Drug Administration ("FDA") informed ALX Oncology that it reviewed its standard non-clinical safety study and has lifted the previously set partial clinical hold and cap on patient enrollment.
    • First Patient Dosed in Phase 2 ASPEN-03 Study

      • In May 2021, dosed first patient in the Phase 2 ASPEN-03 study, which is also evaluating the efficacy of evorpacept in combination with KEYTRUDA (pembrolizumab) for the 1L treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC with a combined positive score ("CPS") ≥ 1. In June 2021, the FDA informed ALX Oncology that it reviewed its standard non-clinical safety study and has lifted the previously set partial clinical hold and cap on patient enrollment.

    • Data for Phase 1b ASPEN-01 Study Presented at 23rd ESMO World Congress on Gastrointestinal Cancer
      • In July 2021, updated clinical data from the Phase 1b ASPEN-01 trial evaluating evorpacept in combination with trastuzumab and CYRAMZA® (ramucirumab) for the treatment of gastric or gastroesophageal junction cancer ("G/GEJ") were shared in an oral presentation at the 23rd ESMO World Congress on Gastrointestinal Cancer. Data showed that evorpacept in combination with trastuzumab and ramucirumab is highly active and well-tolerated in patients with second line ("≥2L") or greater HER2 positive G/GEJ cancer.
    • Collaboration and Supply Agreement Entered with Eli Lilly
      • In June 2021, ALX Oncology entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company to evaluate the combination of evorpacept with CYRAMZA (ramucirumab), Lilly's anti-VEGFR2 antibody, for the treatment of patients with HER2 positive G/GEJ. Under the terms of the agreement, ALX Oncology will conduct a Phase 2/3 study to evaluate the efficacy of evorpacept in combination with ramucirumab, trastuzumab, and paclitaxel for the treatment of patients whose tumors have progressed following treatment of HER2 targeted therapy and chemotherapy. Lilly will supply ramucirumab for this trial.

    Anticipated Key Milestones for Remainder of 2021

    • Full results of a Phase 1b study of evorpacept in combination with Merck's KEYTRUDA (pembrolizumab) and chemotherapy for the treatment of patients with HNSCC (ASPEN-01) are planned to be presented in the fourth quarter of 2021.
    • Initiation of a Phase 1b clinical trial with evorpacept in combination with Zymeworks' zanidatamab in patients with advanced HER2-expressing breast cancer and other solid tumors is expected in the second half of 2021.
    • Initiation of a Phase 1 clinical trial evaluating evorpacept in combination with azacitidine and venetoclax in patients with acute myeloid leukemia ("AML") (ASPEN-05) is planned in the second half of 2021.
    • Initiation of a randomized Phase 2 trial of evorpacept in combination with Herceptin (trastuzumab), CYRAMZA (ramucirumab) and paclitaxel in second- or third-line treatment of patients with HER2-positive G/GEJ cancer (ASPEN-06) is expected in the second half of 2021.
    • Results of a Phase 1 clinical trial of evorpacept in combination with azacitidine in patients with myelodysplastic syndromes ("MDS") and the initiation of the Phase 2 clinical trial in MDS (ASPEN-02) are expected in the fourth quarter of 2021.

    Second Quarter 2021 Financial Results:

    • Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2021, were $410.0 million. ALX Oncology continues to believe its cash and cash equivalents is sufficient to fund planned operations through 2024.
    • Net Loss: Generally accepted accounting principles (GAAP) net loss attributable to common stockholders was $16.3 million, or $0.40 per basic and diluted share and $14.0 million, or $4.41 per basic and diluted share for the three months ended June 30, 2021 and 2020, respectively. Non-GAAP net loss attributable to common stockholders was $14.0 million for the three months ended June 30, 2021, as compared to $10.7 million for the three months ended June 30, 2020. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.
    • Related-party Revenue: Related-party revenue for the three months ended June 30, 2021 was nil compared to $0.5 million for the prior-year period. The decrease in related-party revenue relates to the termination of the Tollnine Agreement as of July 1, 2020.
    • Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of evorpacept. These expenses for the three months ended June 30, 2021 were $11.2 million, compared to $7.7 million for the prior-year period. The increase of $3.5 million was primarily attributable to an increase of $3.7 million in clinical and development costs due to higher expenses associated with increased pre-clinical, clinical and other research costs in advancement of our current lead product candidate, evorpacept, an increased personnel-related costs of $1.1 million primarily due to headcount growth, and an increase of $0.3 million other research and development costs primarily driven by milestone payments triggered by the initiation of our Phase 2 trials, offset by a decrease of $1.6 million in stock-based compensation expense primarily resulting from the modification of stock options in the second quarter of 2020 whereas there was no such modification in 2021.
    • General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended June 30, 2021 were $5.1 million, compared to $3.2 million for the prior-year period. This increase of $1.9 million was primarily attributable to an increase in stock-based compensation expense of $1.0 million primarily resulting from additional stock option award grants at higher fair values, an increase in personnel-related costs of $0.5 million due to headcount growth, and a $0.4 million increase in other general and administrative costs related to being a public company, including directors and officers liability insurance premiums.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, evorpacept (also known as ALX148), is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of evorpacept for the treatment of multiple solid tumor indications and hematologic malignances, including AML and myelodysplastic syndromes.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include, but are not limited to, statements regarding ALX Oncology's financial condition, results of operations and sufficiency of its cash and cash equivalents to fund its planned operations as well as statements about ALX Oncology's clinical pipeline, including the timing of clinical trial initiations and data releases, and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of evorpacept. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Report on Form 10-K, filed with the SEC on March 18, 2021, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    ALX ONCOLOGY HOLDINGS INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (unaudited)

    (in thousands, except share and per share amounts)

      Three Months Ended  Six Months Ended 
      June 30,  June 30, 
      2021  2020  2021  2020 
    Related-party revenue $  $527  $  $1,182 
    Operating expenses:                
    Research and development  11,213   7,663   21,062   11,491 
    General and administrative  5,086   3,172   9,445   4,645 
    Cost of services for related-party revenue     479      1,075 
    Total operating expenses  16,299   11,314   30,507   17,211 
    Loss from operations  (16,299)  (10,787)  (30,507)  (16,029)
    Interest expense  (3)  (219)  (6)  (434)
    Other income (expense), net  28   (305)  54   (298)
    Loss before income taxes  (16,274)  (11,311)  (30,459)  (16,761)
    Income tax provision     (20)     (24)
    Net loss and comprehensive loss  (16,274)  (11,331)  (30,459)  (16,785)
    Cumulative dividends allocated to preferred stockholders     (2,641)     (4,624)
    Net loss attributable to common stockholders $(16,274) $(13,972) $(30,459) $(21,409)
    Net loss per share attributable to common stockholders, basic and diluted $(0.40) $(4.41) $(0.76) $(6.78)
    Weighted-average shares of common stock used to compute net loss per share attributable to common stockholders, basic and diluted  40,247,110   3,164,707   40,151,802   3,157,387 
                     



    Condensed Consolidated Balance Sheet Data


    (unaudited)

    (in thousands)

      June 30,

    2021
      December 31,

    2020
     
    Cash and cash equivalents $409,964  $434,219 
    Total assets $421,289  $436,054 
    Total liabilities $16,275  $6,209 
    Total stockholders' equity $405,014  $429,845 



    GAAP to Non-GAAP Reconciliation


    (unaudited)

    (in thousands)

      Three Months Ended  Six Months Ended 
      June 30,  June 30, 
      2021  2020  2021  2020 
    GAAP net loss attributable to common stockholders, as reported $(16,274) $(13,972) $(30,459) $(21,409)
    Adjustments:                
    Stock-based compensation expense  2,237   2,853   4,037   3,004 
    Accretion of term loan     113      221 
    Mark-to-market adjustment on financial instruments     308      408 
    Total adjustments  2,237   3,274   4,037   3,633 
    Non-GAAP net loss attributable to common stockholders $(14,037) $(10,698) $(26,422) $(17,776)
                     

    Use of Non-GAAP Financial Measures

    We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

    "Non-GAAP net loss attributable to common stockholders" is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) accretion of term loan (interest expense related to ALX Oncology's amortization of debt discount) and (3) mark-to-market adjustment on financial instruments (which include preferred stock warrants and derivatives). Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

    Primary Logo

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  5. BURLINGAME, Calif., July 28, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, in partnership with Merck, known as MSD outside the United States and Canada, today announced the first patient has been dosed in the Phase 2 ASPEN-04 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, and standard chemotherapy for the treatment of patients with advanced head and neck squamous cell carcinoma ("HNSCC").

    ASPEN-04 (NCT04675333) is an open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 in combination…

    BURLINGAME, Calif., July 28, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, in partnership with Merck, known as MSD outside the United States and Canada, today announced the first patient has been dosed in the Phase 2 ASPEN-04 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, and standard chemotherapy for the treatment of patients with advanced head and neck squamous cell carcinoma ("HNSCC").

    ASPEN-04 (NCT04675333) is an open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 in combination with pembrolizumab and standard chemotherapy in patients with first line metastatic or unresectable, recurrent HNSCC who have not received prior systemic therapy for their advanced disease. This study will enroll patients regardless of PD-L1 expression status. The study is being conducted in collaboration with Merck and is based on promising clinical data reported from the ASPEN-01 Phase 1 study (NCT03013218), which provided the basis for ALX148's Fast Track Approval in HNSCC granted by the U.S. Food and Drug Administration.

    "We are excited to expand the ALX148 clinical program with the initiation of a second Phase 2 trial, that has the potential to integrate ALX148 into current standard-of-care therapies for patients with PD-L1-unselected, treatment naive HNSCC," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "The demonstrated tolerability of ALX148 with chemotherapy agents, when both myeloid and T cell checkpoints are inhibited, maximizes the potential anti-cancer immune response to novel tumor antigens. ASPEN-04 builds upon the promising combination activity we have already observed in patients with HNSCC, and provides an opportunity for more optimized anti-cancer activity."

    About Head and Neck Cancers

    Cancers that are known collectively as head and neck cancers usually begin in the squamous cells. These cells line the moist, mucosal surfaces inside head and neck structures like the mouth, the nose, and the throat. These squamous cell cancers are often referred to as squamous cell carcinomas of the head and neck. It is estimated that there are over 50,000 newly diagnosed cases of HNSCC at all stages in the U.S. each year. The 5-year survival is only 40% for those patients diagnosed with metastatic disease.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of multiple solid tumor indications and hematologic malignancies, including AML and myelodysplastic syndromes.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  6. -- ORR of 72% Observed in Patients with >2L HER2 Positive Gastric or Gastroesophageal Junction Cancer 
    -- Estimated OS at 12 months of 76% 
    -- ALX Oncology to Host Conference Call on July 6th at 8:30 a.m. ET

    BURLINGAME, Calif., July 03, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced the presentation of updated clinical data from its ongoing ASPEN-01 trial evaluating ALX148 in combination with trastuzumab and chemotherapy for the treatment of gastric or gastroesophageal junction cancer ("GC"). The new results, shared in an oral presentation at the 23rd World Congress on Gastrointestinal…

    -- ORR of 72% Observed in Patients with >2L HER2 Positive Gastric or Gastroesophageal Junction Cancer 

    -- Estimated OS at 12 months of 76% 

    -- ALX Oncology to Host Conference Call on July 6th at 8:30 a.m. ET

    BURLINGAME, Calif., July 03, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced the presentation of updated clinical data from its ongoing ASPEN-01 trial evaluating ALX148 in combination with trastuzumab and chemotherapy for the treatment of gastric or gastroesophageal junction cancer ("GC"). The new results, shared in an oral presentation at the 23rd World Congress on Gastrointestinal Cancer, show that ALX148 in combination with trastuzumab and chemotherapy is highly active and well-tolerated in patients with second-line or greater (">2L") HER2 positive GC [abstract SO-31].

    "The data that continue to emerge from this clinical trial are tremendously encouraging, suggesting that the combination of ALX148 with trastuzumab, ramucirumab and paclitaxel may offer an important advancement for patients who have progressed on or after prior trastuzumab and chemotherapy," said Hyun Cheol Chung, M.D., Yonsei Cancer Center, South Korea, an investigator for ASPEN-01. "Importantly, these results also support ALX148's tolerability profile, further differentiating it as a unique CD47 blocker that may be used in combination with an array of anti-cancer drugs, including chemotherapy."

    As of the data cut-off of May 3, 2021, 18 patients had been treated with either 10 mg/kg or 15 mg/kg of ALX148 once weekly with standard dosing regimens of trastuzumab, ramucirumab, and paclitaxel.

    • In patients with >2L HER2 positive GC, whose tumors have progressed upon prior trastuzumab therapy, ALX148 demonstrates a promising initial confirmed objective response rate ("ORR") of 72% and estimated overall survival ("OS") at 12 months of 76%.

    • These results compare favorably to randomized historical control studies; RAINBOW reported an ORR of 28% and OS at 12 months of 40%, and DESTINY-01 reported an ORR of 41% and OS at 12 months of 52%.

    • Preliminary data suggest that ALX148 can be combined with trastuzumab, ramucirumab and paclitaxel with no maximum tolerated dose reached. The maximum administered dose of ALX148 in combination was 15 mg/kg once weekly.

    Conference Call on July 6th at 8:30 a.m. ET

    ALX Oncology will host a conference call on Tuesday, July 6, 2021 at 8:30 a.m. ET to further discuss the new GC data from ASPEN-01, the Phase 1b study of ALX148 that was presented at the ESMO 23rd World Congress on Gastrointestinal Cancer.

    To access the conference call, please dial (844) 467-7655 (local) or (409) 983-9840 (international) at least 10 minutes prior to the start time and refer to conference ID 4117088. Presentation slides will be available to download under "News & Events" (see "Events") in the Investors section of the ALX Oncology website at www.alxoncology.com.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of multiple solid tumor indications and hematologic malignances, including AML and myelodysplastic syndromes.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends.  Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alx@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  7. --Interim report completed by ALX for a standard ongoing non-clinical safety study 

    --Based on the safety study results, the FDA has lifted a previously set partial clinical hold and cap on patient enrollment in ASPEN-03 and ASPEN-04

    --The first of two distinct randomized Phase 2 head and neck cancer studies in collaboration with Merck has been initiated; enrollment in ASPEN-03 is ongoing

    BURLINGAME, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced updates on its ALX148 Phase 2 studies in patients with advanced head and neck squamous cell carcinoma ("HNSCC"). The U.S…

    --Interim report completed by ALX for a standard ongoing non-clinical safety study 

    --Based on the safety study results, the FDA has lifted a previously set partial clinical hold and cap on patient enrollment in ASPEN-03 and ASPEN-04

    --The first of two distinct randomized Phase 2 head and neck cancer studies in collaboration with Merck has been initiated; enrollment in ASPEN-03 is ongoing

    BURLINGAME, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced updates on its ALX148 Phase 2 studies in patients with advanced head and neck squamous cell carcinoma ("HNSCC"). The U.S. Food and Drug Administration ("FDA") informed ALX Oncology that it reviewed its standard non-clinical safety study and has lifted the previously set partial clinical hold and cap on patient enrollment. The two randomized Phase 2 studies, ASPEN-03 and ASPEN-04, are potentially registrational with patient enrollment unimpacted in either study. ASPEN-03 has initiated with enrollment ongoing.

    ALX Oncology is advancing ALX148 into two randomized Phase 2 studies in subjects with HNSCC in combination with pembrolizumab, marketed as KEYTRUDA®, the market leading anti-programmed cell death protein-1, or PD-1, checkpoint inhibitor, with or without chemotherapy. Both studies are being conducted in collaboration with Merck. The first study, ASPEN-03, is evaluating the efficacy of ALX148 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 evaluating ALX148 in combination with pembrolizumab and standard chemotherapy for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC (any CPS value). Further details can be found here.

    "We are very pleased that the FDA has reviewed our standard non-clinical safety study and has removed the partial clinical hold and patient cap on our two Phase 2 studies of ALX148 in patients with HNSCC," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "Patients with advanced HNSCC are in need of novel therapeutic options, and we look forward to expediting the global enrollment of patients into ASPEN-03 and ASPEN-04 in the coming months and evaluating ALX148's contribution to standard pembrolizumab-based therapy."

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of multiple solid tumor indications and hematologic malignances, including AML and myelodysplastic syndromes (MDS).

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends.  Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Peter Garcia

    Chief Financial Officer, ALX Oncology

    (650) 466-7125 Ext. 113

    peter@alxoncology.com

    Argot Partners

    (212)-600-1902

    alxoncology@argotpartners.com

    Media Contact:



    Karen Sharma

    MacDougall

    (781) 235-3060

    alx@macbiocom.com



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  8. BURLINGAME, Calif., June 10, 2021 (GLOBE NEWSWIRE) -- ALX Oncology (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced it has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company to evaluate the combination of ALX148, a next generation CD47 blocker, and CYRAMZA® (ramucirumab), Lilly's anti-VEGFR2 antibody, for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction cancer.

    Under the terms of the agreement, ALX Oncology will conduct a randomized Phase 2/3 study to evaluate the efficacy of ALX148 in combination with ramucirumab, trastuzumab, and paclitaxel for the treatment of patients…

    BURLINGAME, Calif., June 10, 2021 (GLOBE NEWSWIRE) -- ALX Oncology (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced it has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company to evaluate the combination of ALX148, a next generation CD47 blocker, and CYRAMZA® (ramucirumab), Lilly's anti-VEGFR2 antibody, for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction cancer.

    Under the terms of the agreement, ALX Oncology will conduct a randomized Phase 2/3 study to evaluate the efficacy of ALX148 in combination with ramucirumab, trastuzumab, and paclitaxel for the treatment of patients whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. Lilly will supply ramucirumab for this trial. Financial details of the collaboration agreement are undisclosed.

    This clinical collaboration is based on compelling data from the ongoing ASPEN-01 Phase 1b trial in patients with HER2-positive gastric or gastroesophageal junction cancer who had progressed on one or more lines of trastuzumab therapy, which was presented at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting in November 2020. ALX148 demonstrated a promising initial objective response rate of 64 percent with the combination with ramucirumab, trastuzumab and paclitaxel in patients who historically have low response rates and poor outcomes in this clinical setting. Updated data from the ASPEN-01 Phase 1b trial will be presented at the ESMO 23rd World Congress on Gastrointestinal Cancer on July 3, 2021.

    "We are thrilled to enter this collaboration with Lilly that aims to provide a CD47-targeted combination regimen for gastric or gastroesophageal junction cancer patients in need of novel effective treatment options," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Our team has worked tirelessly to advance the clinical development of ALX148 in the fight against cancer, and we believe that ALX148 has the potential to be best-in-class as a new foundational immunotherapy in both hematologic and solid tumors."

    ALX Oncology owns worldwide commercial rights to ALX148.

    About Gastric Cancer

    Gastric cancer begins in the cells lining the inner wall of the stomach and spreads through the outer layers and eventually the body as it grows. It is estimated that there will be over 26,000 newly diagnosed cases of gastric cancer at all stages in the U.S. in 2021, and approximately 17 percent of all gastric cancer patients have HER2-positive disease. The five-year survival rate is only 5.5 percent for those patients diagnosed with metastatic disease. Gastric cancer is much more common in East Asian countries, with incidence rates 4 to 10 times higher than in the U.S.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of multiple solid tumor indications and hematologic malignances, including AML and myelodysplastic syndrome.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends.  Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    CYRAMZA ® is a registered trademark of Eli Lilly and Company.



    Investor Contact:
    
    Peter Garcia
    CFO, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212) 600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  9. - venBio promoted Richard Gaster M.D., Ph.D. to Managing Partner

    venBio today announced the closing of venBio Global Strategic Fund IV, LP ("venBio Fund IV"), its fourth life sciences venture capital fund, exceeding its target and closing on approximately $550 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising corporate pensions, financial institutions, university endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., Aaron Royston, M.D., and Richard Gaster, M.D., Ph.D., venBio Fund IV will continue to invest primarily in therapeutics…

    - venBio promoted Richard Gaster M.D., Ph.D. to Managing Partner

    venBio today announced the closing of venBio Global Strategic Fund IV, LP ("venBio Fund IV"), its fourth life sciences venture capital fund, exceeding its target and closing on approximately $550 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising corporate pensions, financial institutions, university endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., Aaron Royston, M.D., and Richard Gaster, M.D., Ph.D., venBio Fund IV will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs. The venBio team takes an active role with each of their portfolio companies, providing strategic guidance on a range of business activities including intellectual property, chemistry, manufacturing and controls (CMC), as well as assisting with clinical trials: from trial design to endpoints to regulatory deliberations.

    "We remain committed to our unique approach and strategy and hope the results speak for themselves – our portfolio companies have delivered four drugs to market for six clinical indications, and another seven drug candidates are demonstrating promising late-stage efficacy," said Dr. Adelman.

    "Our portfolio is directly impacting patient lives and we could not have accomplished that without the ongoing commitment from our limited partners, and we are grateful for their continued support for Fund IV," said Dr. Goodman. "With Fund IV we intend to continue our proven approach of helping to build 12-15 companies per fund while doubling down on winners by providing stronger support for our portfolio companies in crossover rounds and at IPO."

    "We are delighted to announce with the closing of Fund IV, the promotion of Dr. Rich Gaster to Managing Partner," said Dr. Royston. "Our core investment team and investment strategy remain the same as we launch our new fund."

    "Our strategy at venBio has always been to turn exceptional science into impactful medicine," said Dr. Gaster. "Every member of our team is involved in every investment that we make, and we believe this collaborative approach is what helps drive our success."

    Sidley Austin LLP served as legal adviser to venBio.

    About venBio

    Established in 2011, venBio is a life science venture capital firm that focuses on novel therapeutics for unmet medical needs. Since inception in 2011, venBio has raised nearly $1.5 billion in capital commitments and led investment rounds in 34 companies, including: venBio-founded Labrys Biologics (acquired by Teva) and ALX Oncology (NASDAQ:ALXO); Aragon Pharmaceuticals (acquired by Johnson & Johnson); Seragon Pharmaceuticals (acquired by Roche); Aurinia Pharmaceuticals (NASDAQ:AUPH); Apellis Pharmaceuticals (NASDAQ:APLS); Turning Point Therapeutics (NASDAQ:TPTX); Precision Biosciences (NASDAQ:DTIL); Akero Therapeutics (NASDAQ:AKRO); Harmony Biosciences (NASDAQ:HRMY); and Pharvaris (NASDAQ:PHVS). For more information, please visit www.venbio.com.

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  10. BURLINGAME, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in two upcoming virtual investor conferences.

    UBS 2021 Global Healthcare Virtual Conference
    Format: Podium presentation
    Date: Monday, May 24
    Time: 4:00 PM Eastern Time
    Webcast link: Available here

    Jefferies 2021 Virtual Healthcare Conference
    Format: Fireside chat with analyst, Michael Yee
    Date: Wednesday, June 2
    Time: 1:30 PM Eastern Time
    Webcast link: Available here

    A live webcast of the UBS podium presentation…

    BURLINGAME, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in two upcoming virtual investor conferences.

    UBS 2021 Global Healthcare Virtual Conference

    Format: Podium presentation

    Date: Monday, May 24

    Time: 4:00 PM Eastern Time

    Webcast link: Available here

    Jefferies 2021 Virtual Healthcare Conference

    Format: Fireside chat with analyst, Michael Yee

    Date: Wednesday, June 2

    Time: 1:30 PM Eastern Time

    Webcast link: Available here

    A live webcast of the UBS podium presentation and Jefferies fireside chat can be accessed by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcasts will be archived for up to 90 days following the presentation dates.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  11. BURLINGAME, Calif., May 17, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the first quarter ended March 31, 2021 and provided recent clinical development and operational highlights.

    "Having achieved important milestones in the first quarter of 2021, we look forward to what we expect will be another exciting year of substantial progress for our lead candidate, ALX148, as we prepare to initiate several clinical trials in combination with other agents in a variety of indications, as well as multiple anticipated data readouts during the year," said Jaume Pons, Ph.D., Founder…

    BURLINGAME, Calif., May 17, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the first quarter ended March 31, 2021 and provided recent clinical development and operational highlights.

    "Having achieved important milestones in the first quarter of 2021, we look forward to what we expect will be another exciting year of substantial progress for our lead candidate, ALX148, as we prepare to initiate several clinical trials in combination with other agents in a variety of indications, as well as multiple anticipated data readouts during the year," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology.

    "We recently dosed the first patient in our Phase 2 study (ASPEN-03) to evaluate ALX148 in combination with KEYTRUDA® in first line treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent head and neck squamous cell carcinoma ("HNSCC") and we are preparing to initiate a second Phase 2 study (ASPEN-04) in the coming weeks with ALX148 in combination with KEYTRUDA and standard chemotherapy in a similar patient population but regardless of PD-L1 expression status. We also look forward to presenting additional results from a Phase 1b study (ASPEN-01) of ALX148 in combination with trastuzumab, ramucirumab and paclitaxel in patients with HER2-positive gastric/gastroesophageal junction cancer ("G/GEJ") at the upcoming ESMO 23rd World Congress on Gastrointestinal Cancer in July," Dr. Pons continued.

    Recent Clinical Developments for ALX148:

    • Phase 2 ASPEN-03 study



      In May 2021, dosed first patient in the Phase 2 ASPEN-03 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of patients with HNSCC.
    • Strengthened IP Portfolio Covering ALX148



      In April 2021, ALX Oncology announced that the post-grant review period for granted U.S. Patent No. 10,696,730 ended on March 30, 2021. This patent covers the lead product candidate ALX148, a next generation CD47-blocking therapeutic that combines a high-affinity signal regulatory protein-alpha ("SIRPα") CD47-binding domain fused with an inactivated, proprietary Fc domain. The U.S. patent is not expected to expire before August 5, 2036, excluding patent term adjustments or extensions.

    Recent Operational Highlights:

    • In May 2021, reported the appointment of Shelly Pinto as VP Finance and Chief Accounting Officer. Ms. Pinto was most recently VP of Finance and Operations at Tizona Therapeutics and is a Certified Public Accountant.

    First Quarter 2021 Financial Results:

    • Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2021 were $429.9 million. ALX Oncology believes its cash and cash equivalents is sufficient to fund planned operations through 2024.
    • Net loss: Generally accepted accounting principles (GAAP) net loss attributable to common stockholders was $14.2 million, or $0.35 per basic and diluted share and $7.4 million, or $2.37 per basic and diluted share for the three months ended March 31, 2021, and 2020, respectively. Non-GAAP net loss attributable to common stockholders was $12.4 million for the three months ended March 31, 2021, as compared to $7.1 million for the three months ended March 31, 2020. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.
    • Related-party Revenue: There was no related-party revenue for the three months ended March 31, 2021, compared to $0.7 million for the same prior-year period. The decrease in related-party revenue relates to the termination of the research and development agreement with Tallac Therapeutics, Inc. in July 2020.
    • Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of ALX148. These expenses for the three months ended March 31, 2021, were $9.8 million, compared to $3.8 million for the same prior-year period. The increase of $6.0 million was primarily attributable to an increase of $5.1 million in clinical and development costs due to higher expenses associated with increased pre-clinical, clinical and other research costs in advancement of our current lead product candidate, ALX148, as well as an increase of $0.5 million in stock-based compensation expense primarily resulting from additional stock option award grants at higher fair values. In addition, we incurred increased personnel-related costs of $0.4 million due to headcount growth.
    • General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended March 31, 2021, were $4.4 million, compared to $1.5 million for the same prior-year period. The increase of $2.9 million was primarily due to a $1.2 million increase in stock-based compensation expense primarily resulting from additional stock option award grants at higher fair values, an increase of $0.7 million in personnel-related costs due to headcount growth, an increase of $0.5 million of directors and officers liability insurance premium, and an increase of $0.3 million in professional service fees associated with increased accounting and compliance activities.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as myelodysplastic syndromes ("MDS") and acute myeloid leukemia ("AML"). For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include, but are not limited to, statements regarding ALX Oncology's financial condition, results of operations and sufficiency of its cash and cash equivalents to fund its planned operations as well as statements about ALX Oncology's clinical pipeline, including the timing of clinical trial initiations and data releases, and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Report on Form 10-K, filed with the SEC on March 18, 2021, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    ALX ONCOLOGY HOLDINGS INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (unaudited)

    (in thousands, except share and per share amounts)

      Three Months Ended 
      March 31, 
      2021  2020 
    Related-party revenue $  $655 
    Operating expenses:        
    Research and development  9,849   3,828 
    General and administrative  4,359   1,473 
    Cost of services for related-party revenue     596 
    Total operating expenses  14,208   5,897 
    Loss from operations  (14,208)  (5,242)
    Interest expense  (3)  (215)
    Other income, net  26   7 
    Loss before income taxes  (14,185)  (5,450)
    Income tax provision     (4)
    Net loss and comprehensive loss  (14,185)  (5,454)
    Cumulative dividends allocated to preferred stockholders     (1,983)
    Net loss attributable to common stockholders $(14,185) $(7,437)
    Net loss per share attributable to common stockholders, basic and diluted $(0.35) $(2.37)
    Weighted-average shares of common stock used to compute net loss per share attributable to common stockholders, basic and diluted  40,055,435   3,143,159 



    Condensed Consolidated Balance Sheet Data

    (unaudited)

    (in thousands)

      March 31,

    2021
      December 31,

    2020
     
    Cash and cash equivalents $429,855  $434,219 
    Total assets $432,910  $436,054 
    Total liabilities $14,426  $6,209 
    Total stockholders' equity $418,484  $429,845 



    GAAP to Non-GAAP Reconciliation

    (unaudited)

    (in thousands)

      Three Months Ended 
      March 31, 
      2021  2020 
    GAAP net loss attributable to common stockholders, as reported $(14,185) $(7,437)
    Adjustments:        
    Stock-based compensation expense  1,800   151 
    Accretion of term loan     108 
    Mark-to-market adjustment on financial instruments     100 
    Total adjustments  1,800   359 
    Non-GAAP net loss attributable to common stockholders $(12,385) $(7,078)



    Use of Non-GAAP Financial Measures

    We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

    "Non-GAAP net loss attributable to common stockholders" is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) accretion of term loan (interest expense related to ALX Oncology's amortization of debt discount) and (3) mark-to-market adjustment on financial instruments (which include preferred stock warrants and derivatives). Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  12. - The first of two distinct randomized Phase 2 studies in collaboration with Merck has been initiated

    BURLINGAME, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, in partnership with Merck, known as MSD outside the United States and Canada, today announced the first patient has been dosed in the Phase 2 ASPEN-03 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of patients with advanced head and neck squamous cell carcinoma ("HNSCC").

    ASPEN-03 (NCT04675294) is an open-label, randomized…

    - The first of two distinct randomized Phase 2 studies in collaboration with Merck has been initiated

    BURLINGAME, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, in partnership with Merck, known as MSD outside the United States and Canada, today announced the first patient has been dosed in the Phase 2 ASPEN-03 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of patients with advanced head and neck squamous cell carcinoma ("HNSCC").

    ASPEN-03 (NCT04675294) is an open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 plus pembrolizumab in patients with first line metastatic or unresectable, recurrent PD-L1 positive HNSCC. This study is being conducted in collaboration with Merck and is based upon promising clinical data reported from the ASPEN-01 Phase 1 study (NCT03013218), which provided the basis for ALX148's Fast Track designation in HNSCC granted by the U.S. Food and Drug Administration.

    "We are excited to have achieved this latest milestone of initiating the first Phase 2 trial in the ALX148 clinical program. We believe the combination of ALX148 and pembrolizumab exemplifies the broad therapeutic potential of inhibiting both myeloid and T cell checkpoints across a wide range of solid tumor cancers including HNSCC," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "ASPEN-03 builds upon the promising combination activity already observed in patients with HNSCC, and our team intends to continue to accelerate ALX148 development in both this and additional solid and hematological indications this year."

    About Head and Neck Cancers

    Cancers that are known collectively as head and neck cancers usually begin in squamous cells. These cells line the moist, mucosal surfaces in head and neck structures such as the mouth, nose, and throat. These squamous cell cancers are often referred to as squamous cell carcinomas of the head and neck. It is estimated that there are over 50,000 newly diagnosed cases of HNSCC at all stages in the U.S. each year. The 5-year survival is only 40% for those patients diagnosed with metastatic disease.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Report on Form 10-K, filed with the SEC on March 18, 2021, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  13. BURLINGAME, Calif., April 21, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that our Phase 1b study of ALX148 in patients with advanced gastric or gastroesophageal junction cancer has been selected for a short oral presentation at the ESMO 23rd World Congress on Gastrointestinal Cancer to be held virtually from June 30 – July 3, 2021.

    Oral Presentation Information

    Title: ASPEN-01: A phase 1 study of ALX148, a CD47 blocker, in combination with trastuzumab, ramucirumab and paclitaxel in patients with 2nd line HER2-positive advanced gastric or gastroesophageal junction (G/GEJ) cancer…

    BURLINGAME, Calif., April 21, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that our Phase 1b study of ALX148 in patients with advanced gastric or gastroesophageal junction cancer has been selected for a short oral presentation at the ESMO 23rd World Congress on Gastrointestinal Cancer to be held virtually from June 30 – July 3, 2021.

    Oral Presentation Information

    Title: ASPEN-01: A phase 1 study of ALX148, a CD47 blocker, in combination with trastuzumab, ramucirumab and paclitaxel in patients with 2nd line HER2-positive advanced gastric or gastroesophageal junction (G/GEJ) cancer

    Abstract Number: SO-31

    Session Name: Session X: Esophageal and Gastric Cancers

    Date and Time: Saturday, July 3, 2021, 15:01 – 15:08 CEST

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Report on Form 10-K, filed with the SEC on March 18, 2021, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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    • The post-grant review period for U.S. Patent 10,696,730 covering the composition of matter of ALX148 ended on March 30, 2021.
    • This patent provides coverage of ALX148 until at least 2036, not including term adjustments or extensions.

    BURLINGAME, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, announces that the post-grant review period for granted U.S. Patent No. 10,696,730 ended on March 30, 2021. This patent covers the lead product candidate ALX148, a next generation CD47-blocking therapeutic that combines a high-affinity signal regulatory protein-alpha ("SIRP") CD47-binding domain fused…

    • The post-grant review period for U.S. Patent 10,696,730 covering the composition of matter of ALX148 ended on March 30, 2021.
    • This patent provides coverage of ALX148 until at least 2036, not including term adjustments or extensions.

    BURLINGAME, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, announces that the post-grant review period for granted U.S. Patent No. 10,696,730 ended on March 30, 2021. This patent covers the lead product candidate ALX148, a next generation CD47-blocking therapeutic that combines a high-affinity signal regulatory protein-alpha ("SIRP") CD47-binding domain fused with an inactivated, proprietary Fc domain. The U.S. patent is not expected to expire before August 5, 2036, excluding patent term adjustments or extensions.

    ALX Oncology's engineered fusion protein ALX148 is designed to enhance the activity of a wide range of leading anti-cancer agents and has shown promising clinical activity in both solid tumors and hematologic malignancies. ALX148's proprietary inactive Fc domain maintains antibody-like pharmacokinetics, while improving tolerability when compared to other CD47 blocking approaches and their associated cytopenias.

    ALX148 has a lower molecular weight compared to a typical antibody, which enables it to deliver the molar equivalent of an antibody at one half the dose. This may facilitate increased solid tumor penetration and, coupled with ALX148's very high affinity for CD47, may provide greater potency within the tumor microenvironment.

    The U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent No. 10,696,730 on June 30, 2020, which is part of a portfolio covering ALX148 that includes U.S. Patent No. 10,259,859 granted on April 16, 2019. The latter patent covers sequences for a wide variety of high-affinity SIRP domains fused to inactivated Fc domains.

    Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology commented, "We are excited about the grant of the ‘730 patent and the expiration of the post-grant review period as we prepare to initiate randomized Phase 2 studies in myelodysplastic syndromes, gastric/gastroesophageal junction cancer, and head and neck squamous cell carcinoma. The USPTO's issuance of this patent reinforces the strength of our intellectual property portfolio, and further supports our ongoing and planned clinical trials in treating patients with cancer."

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Report on Form 10-K, filed with the SEC on March 18, 2021, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

    Primary Logo

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  14. BURLINGAME, Calif., March 18, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided clinical development and operational highlights.

    "ALX made substantial progress in 2020 towards advancing our lead development candidate, ALX148, marked by a growing body of positive data reported in solid tumors, including encouraging Phase 1b clinical data in combination with antibodies and standard chemotherapy in patients with gastric/gastroesophageal junction ("G/GEJ") cancer and head and neck squamous cell carcinoma ("HNSCC…

    BURLINGAME, Calif., March 18, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided clinical development and operational highlights.

    "ALX made substantial progress in 2020 towards advancing our lead development candidate, ALX148, marked by a growing body of positive data reported in solid tumors, including encouraging Phase 1b clinical data in combination with antibodies and standard chemotherapy in patients with gastric/gastroesophageal junction ("G/GEJ") cancer and head and neck squamous cell carcinoma ("HNSCC")," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology.

    "In 2021, we are focused on reporting our Phase 1b full clinical results and initiating several clinical trials, including two randomized Phase 2 studies of ALX148 in combination with KEYTRUDA® (pembrolizumab) in patients with HNSCC, and the start of a Phase 1b clinical trial with ALX148 in combination with Zymeworks' zanidatamab in patients with advanced HER2-expressing breast cancer and other solid tumors in the first half of the year. In addition, randomized Phase 2 studies in myelodysplastic syndromes ("MDS") and G/GEJ cancer will initiate in the second half of a very exciting year," Dr. Pons continued.

    Anticipated Key Clinical Milestones for 2021

    • Full results of a Phase 1b clinical trial with ALX148 in combination with Herceptin® (trastuzumab), Cyramza® (ramucirumab) and paclitaxel in patients with second line or greater ("≥2L") G/GEJ cancer (ASPEN-01) is planned to be presented in mid-2021.



    • Initiation of two randomized Phase 2 studies with ALX148 in combination with KEYTRUDA in patients with HNSCC are planned in the first half of 2021. The first study (ASPEN-03) will evaluate the efficacy of ALX148 in combination with KEYTRUDA for the first line ("1L") treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study (ASPEN-04) will evaluate ALX148 in combination with KEYTRUDA and standard 5-fluorouracil and platinum chemotherapy for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC.



    • Initiation of a Phase 1b clinical trial with ALX148 in combination with Zymeworks' zanidatamab in patients with advanced HER2-expressing breast cancer and other solid tumors in the first half of 2021.



    • Full results of a Phase 1b study of ALX148 in combination with Merck's KEYTRUDA (pembrolizumab) and chemotherapy for the treatment of patients with HNSCC (ASPEN-01) is planned to be presented in the second half of 2021.



    • Initiation of a Phase 1 clinical trial evaluating ALX148 in combination with azacitidine and venetoclax in patients with acute myeloid leukemia ("AML") (ASPEN-05) in the second half of 2021.



    • Initiation of a randomized Phase 2 trial of ALX148 in combination with Herceptin (trastuzumab), Cyramza (ramucirumab) and paclitaxel in second- or third-line ("2L or 3L") treatment of patients with G/GEJ cancer (ASPEN-06) is expected in the second half of 2021.



    • Results of a Phase 1 clinical trial of ALX148 in combination with azacitidine in patients with MDS and the initiation of the Phase 2 clinical trial in MDS (ASPEN-02) are expected in the fourth quarter 2021.

    Recent Clinical Developments for ALX148

    • Announced Collaboration with Tallac Therapeutics on Novel Class of Cancer Immunotherapeutics
      • In March 2021, ALX Oncology and Tallac Therapeutics ("Tallac"), a privately held biopharmaceutical company, announced a collaboration to jointly develop, manufacture, and commercialize a novel class of cancer immunotherapeutics. The collaboration builds on ALX Oncology's expertise in developing therapies that block the CD47 checkpoint pathway and expands its immuno-oncology pipeline with Tallac's pipeline of next generation immunotherapies derived from its novel Toll-like Receptor Agonist Antibody Conjugate ("TRAAC") platform. ALX Oncology and Tallac expect to submit an Investigational New Drug application by the end of 2022.
    • Presented Updated Data at the 62nd American Society of Hematology Annual Meeting from the ASPEN-01 Phase 1b Study of ALX148 in Combination with Rituximab in Patients with Advanced Relapsed/Refractory ("r/r") non-Hodgkin lymphoma ("NHL")
      • In December 2020, ALX Oncology reported updated clinical data from its ongoing trial evaluating ALX148 in combination with rituximab for the treatment of advanced r/r NHL. ALX148 in combination with rituximab was well tolerated with no dose limiting toxicities observed.
      • As of the data cutoff of October 1, 2020, 33 subjects had been treated with ALX148 administered at 10 or 15 mg/kg once weekly ("QW") with standard regimens of rituximab. In response-evaluable subjects (n=10) who received ALX148 at 15 mg/kg QW, the objective response rate ("ORR") was 70.0%. In response-evaluable subjects (n=22) who received ALX148 at 10 mg/kg QW, the ORR was 40.9%. A statistically significant improvement in clinical response was demonstrated with increased ALX148 exposure across the doses evaluated (p=0.023).
    • Announced Collaboration with Zymeworks Inc. to Conduct Phase 1b Study to Evaluate Zanidatamab with ALX148 in Patients with HER2 Expressing Breast Cancer
      • In November 2020, ALX Oncology announced a collaboration with Zymeworks to jointly run a clinical trial to evaluate the combination of Zymeworks' zanidatamab, a HER2-targeted bispecific antibody, and ALX148, a next-generation CD47 blocker, for the treatment of patients with advanced HER2-expressing breast cancer and other solid tumors. Under the collaboration, Zymeworks will conduct an open label, multi-center Phase 1b study to assess the safety and efficacy of the combination of zanidatamab and ALX148 in subjects with HER2-positive breast cancer, HER2-low breast cancer, and non-breast HER2-expressing solid tumors.  
    • Presented New Data at the SITC 35th Anniversary Annual Meeting from ASPEN-01 Phase 1b Study of ALX148 in Combination with Standard Chemotherapy and Antibody Regimens in Patients with G/GEJ Cancer and HNSCC.
      • In November 2020, ALX Oncology reported preliminary data from the G/GEJ cancer patient cohort receiving ALX148 plus trastuzumab plus chemotherapy. In patients with ≥2L HER2 positive G/GEJ cancer (n=14), whose tumors have progressed upon prior trastuzumab therapy, ALX148 in combination with trastuzumab plus ramucirumab and paclitaxel demonstrated an initial ORR of 64.3% that compares favorably with historical data. In addition, updated data from patients with ≥2L HER2 positive G/GEJ cancer receiving ALX148 plus trastuzumab suggested promising clinical activity after their tumors have progressed upon prior trastuzumab therapy.
      • ALX Oncology also reported preliminary data from a HNSCC patient cohort receiving ALX148 plus pembrolizumab plus chemotherapy. In patients with first line HNSCC who have not received prior treatment for advanced disease (n=4), ALX148 demonstrated an initial ORR of 75.0%, including a complete response, in combination with pembrolizumab plus 5-fluorouracil and platinum. In addition, updated data from subjects who were treatment naïve to a PD-1/PD-L1 inhibitor for their ≥2L HNSCC and who received ALX148 plus pembrolizumab suggested greater clinical activity than with pembrolizumab as a monotherapy.

    Recent Operational Highlights:

    • Appointed New Member to the Board of Directors. In March 2021, ALX Oncology appointed Sophia Randolph, M.D., Ph.D. to its Board of Directors. Dr. Randolph has served as Chief Medical Officer of ALX Oncology since June 2016 and will continue in this role.
    • Added to the NASDAQ Biotechnology Index®. In December 2020, ALX Oncology was added to the NASDAQ Biotechnology Index® (NASDAQ:NBI) effective Monday, December 21, 2020.                            
    • Raised Gross Proceeds of $208 Million in Oversubscribed Follow-on Public Offering. In December 2020, ALX Oncology announced the closing of an oversubscribed underwritten follow-on public offering yielding aggregate gross proceeds of approximately $208.0 million. All of the shares in the offering were offered by ALX Oncology.



    Full Year and Fourth Quarter 2020 Financial Results:

    • Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2020 were $434.2 million. ALX Oncology believes its current cash and cash equivalents are sufficient to fund planned operations through 2024.
    • Related-party Revenue: There was no related-party revenue for the three months ended December 31, 2020, compared to $1.2 million for the prior-year period. There was $1.2 million related-party revenue for the year ended December 31, 2020, compared to $4.8 million for the prior-year period. The decrease in related-party revenue relates to the termination of the research and development agreement with Tallac in July 2020.
    • Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of ALX148. These expenses for the three months ended December 31, 2020, were $12.1 million, compared to $6.7 million for the prior-year period. These expenses for the year ended December 31, 2020, were $29.0 million, compared to $16.3 million for the prior-year period.
    • General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended December 31, 2020, were $5.7 million, compared to $1.1 million for the prior-year period. These expenses for the year ended December 31, 2020, were $14.8 million, compared to $3.3 million for the prior-year period.
    • Net Loss: GAAP net loss attributable to common stockholders was $18.8 million for the fourth quarter ended December 31, 2020, or $0.50 per basic and diluted share, as compared to a net loss of $8.8 million for the fourth quarter ended December 31, 2019, or $2.83 per basic and diluted share. GAAP net loss for the year ended December 31, 2020 was $50.9 million, or $2.76 per basic and diluted share, as compared to $23.3 million, or $7.56 per basic and diluted share, for the year ended December 31, 2019.  Non-GAAP net loss was $16.3 million for the fourth quarter ended December 31, 2020, as compared to a net loss of $8.7 million for the fourth quarter ended December 31, 2019. Non-GAAP net loss for the year ended December 31, 2020 was $43.8 million, as compared to $23.0 million for the year ended December 31, 2019.   A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include, but are not limited to, statements regarding ALX Oncology's financial condition, results of operations and sufficiency of its cash and cash equivalents to fund its planned operations as well as statements about ALX Oncology's clinical pipeline, including the timing of clinical trial initiations and data releases, and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Report on Form 10-K, filed with the SEC on March 18, 2021, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    ALX ONCOLOGY HOLDINGS INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (unaudited)

    (in thousands, except share and per share amounts)

      Three Months Ended  Year Ended 
      December 31,  December 31, 
      2020  2019  2020  2019 
    Related-party revenue $  $1,213  $1,182  $4,796 
    Operating expenses:                
    Research and development  12,142   6,735   28,961   16,306 
    General and administrative  5,683   1,108   14,809   3,313 
    Cost of services for related-party revenue     1,103   1,075   4,360 
    Total operating expenses  17,825   8,946   44,845   23,979 
    Loss from operations  (17,825)  (7,733)  (43,663)  (19,183)
    Interest expense  (151)  (21)  (811)  (21)
    Other expense, net  5   (1)  (404)  (5)
    Loss on early debt extinguishment  (621)     (621)   
    Loss before income taxes  (18,592)  (7,755)  (45,499)  (19,209)
    Income tax provision  (182)  (9)  (241)  (34)
    Net loss and comprehensive loss  (18,774)  (7,764)  (45,740)  (19,243)
    Cumulative dividends allocated to preferred stockholders     (1,071)  (5,202)  (4,028)
    Net loss attributable to common stockholders $(18,774) $(8,835) $(50,942) $(23,271)
    Net loss per share attributable to common stockholders, basic and diluted $(0.50) $(2.83) $(2.76) $(7.56)
    Weighted-average shares of common stock used to compute net loss per share attributable to common stockholders, basic and diluted  37,642,897   3,122,204   18,485,343  3,076,461 
                    

    Condensed Consolidated Balance Sheet Data

    (unaudited)

    (in thousands)

     December 31, 2020  December 31, 2019 
    Cash and cash equivalents$434,219  $9,017 
    Total assets$436,054  $10,676 
    Total liabilities$6,209  $10,952 
    Convertible preferred stock$  $70,363 
    Total stockholders' equity (deficit)$429,845  $(70,639)

    GAAP to Non-GAAP Reconciliation

    (unaudited)

    (in thousands)

      Three Months Ended  Year Ended 
      December 31,  December 31, 
      2020  2019  2020  2019 
    GAAP net loss attributable to common stockholders, as reported $(18,774) $(8,835) $(50,942) $(23,271)
    Adjustments:                
    Stock-based compensation expense  1,743   75   5,436   297 
    Accretion of term loan  82   11   421   11 
    Mark-to-market adjustment on financial

    instruments
            650    
    Loss on early debt extinguishment  621      621    
    Total adjustments  2,446   86   7,128   308 
    Non-GAAP net loss attributable to common stockholders $(16,328) $(8,749) $(43,814) $(22,963)

    Use of Non-GAAP Financial Measures

    We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

    "Non-GAAP net loss attributable to common stockholders" is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) accretion of term loan (interest expense related to ALX Oncology's amortization of debt discount), (3) mark-to market adjustment on financial instruments (which include preferred stock warrants and derivatives) and (4) loss on early debt extinguishment within our reconciliation of our GAAP to Non-GAAP net loss. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

    Investor Contact:

    Peter Garcia

    Chief Financial Officer, ALX Oncology

    (650) 466-7125 Ext. 113

    peter@alxoncology.com

    Argot Partners

    (212)-600-1902

    alxoncology@argotpartners.com

    Media Contact:

    Karen Sharma

    MacDougall

    (781) 235-3060

    alx@macbiocom.com



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  15. BURLINGAME, Calif., March 15, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the appointment of Sophia Randolph, M.D., Ph.D., to its Board of Directors. Dr. Randolph brings over fifteen years of biopharmaceutical industry experience and serves as Chief Medical Officer of ALX Oncology and will continue in this role.

    "Dr. Randolph brings significant pharmaceutical research and development expertise to ALX Oncology and has been a crucial member of our management team over the last five years," said Corey Goodman, Ph.D., Executive Chairman of ALX Oncology. "This appointment represents another…

    BURLINGAME, Calif., March 15, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the appointment of Sophia Randolph, M.D., Ph.D., to its Board of Directors. Dr. Randolph brings over fifteen years of biopharmaceutical industry experience and serves as Chief Medical Officer of ALX Oncology and will continue in this role.

    "Dr. Randolph brings significant pharmaceutical research and development expertise to ALX Oncology and has been a crucial member of our management team over the last five years," said Corey Goodman, Ph.D., Executive Chairman of ALX Oncology. "This appointment represents another strong addition to our Board of Directors and complements the expertise of the current board members, as well as adding a valuable new perspective, and positions us well for continued clinical development and growth."

    "It is a privilege to be joining ALX Oncology's Board of Directors and contribute to corporate strategy as ALX prepares to initiate numerous clinical trials this year," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer of ALX Oncology. "I look forward to working closely with the Board and continuing my role as Chief Medical Officer through what I believe will be a momentous time for the Company, while making a positive impact on people living with cancer."

    Dr. Randolph has served as the Chief Medical Officer of ALX Oncology since June 2016. Prior to joining us, she was with Pfizer Oncology Early and Late Development Groups, where she served most recently as Executive Director, Oncology and was the global clinical franchise lead for Ibrance® (palbociclib) at Pfizer, where she oversaw the program from first-in-human trials to regulatory approval. Previously, Dr. Randolph was Director, Clinical Sciences, Oncology at Merck & Co., Inc. She holds an A.B. in Biochemistry from Harvard University and an M.D. and a Ph.D. in Cellular and Molecular Biology from the University of Michigan. Dr. Randolph completed her oncology fellowship training at Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding ALX Oncology's clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148 in addition to key milestones such as anticipated clinical trial data readouts and cash and other financial expectations. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.





    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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    • Companies will combine their unique scientific and technical expertise to develop a first-in-class anti-SIRPα antibody conjugated to TLR9 agonist ("SIRPα TRAAC") that delivers targeted immune activation

    • ALX expands anti-cancer therapeutics pipeline targeting the CD47 checkpoint pathway

    • Collaboration extends Tallac's pipeline of next generation immunotherapies derived from its Toll-like Receptor Agonist Antibody Conjugate ("TRAAC") platform

    • ALX Oncology to Host Conference Call on March 5 at 8:30 a.m. EST

    BURLINGAME, Calif., March 04, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Tallac Therapeutics, Inc…

    • Companies will combine their unique scientific and technical expertise to develop a first-in-class anti-SIRPα antibody conjugated to TLR9 agonist ("SIRPα TRAAC") that delivers targeted immune activation



    • ALX expands anti-cancer therapeutics pipeline targeting the CD47 checkpoint pathway



    • Collaboration extends Tallac's pipeline of next generation immunotherapies derived from its Toll-like Receptor Agonist Antibody Conjugate ("TRAAC") platform



    • ALX Oncology to Host Conference Call on March 5 at 8:30 a.m. EST

    BURLINGAME, Calif., March 04, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Tallac Therapeutics, Inc. ("Tallac"), a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, today announced a collaboration to jointly develop, manufacture, and commercialize a novel class of cancer immunotherapeutics. Under the terms of the agreement, ALX Oncology and Tallac will share equally in the cost of research and development and any profits or losses incurred.

    The collaboration builds on ALX Oncology's expertise in developing therapies that block the CD47 checkpoint pathway and expands its immuno-oncology pipeline. The collaboration also extends Tallac's pipeline of next generation immunotherapies derived from its novel Toll-like Receptor Agonist Antibody Conjugate ("TRAAC") platform. The companies will leverage their respective scientific and technical expertise to advance an anti-SIRPα antibody conjugated to a Toll-like receptor 9 ("TLR9") agonist for targeted activation of both the innate and adaptive immune systems.

    "We are excited to partner with ALX Oncology in the development of next-generation breakthrough cancer immunotherapies," said Hong I. Wan, Ph.D., President, Chief Executive Officer and co-founder of Tallac. "TLR9 agonists are a class of immunotherapy that generate both innate and adaptive immune responses which may produce robust and durable anti-cancer immunity for patients with advanced-stage cancers. While intratumoral TLR9 agonists have clinically validated this pathway, systemic administration has been unsuccessful, limiting clinical utility in broader patient populations. With Tallac's TRAAC technology, we now have a way to target this pathway systemically, which could expand the clinical benefit to a much broader patient population. To date, we have generated promising preclinical data with multiple TRAAC molecules that demonstrates the potential of this pathway. The goal of our collaboration with ALX Oncology is to advance SIRPα TRAAC, a systemically delivered TLR9 agonist targeting dendritic cells via SIRPα receptors, enabling a powerful innate and adaptive anti-tumor immune response."

    "Collaborating with Tallac and their novel TRAAC platform broadens ALX Oncology's therapeutic strategies to activate the innate immune system and SIRPα TRAAC complements our lead product candidate, ALX148," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "While ALX148 is an antagonistic molecule designed to maximize the activity of a wide array of anticancer agents by the blockade of the CD47 myeloid checkpoint, SIRPα TRAAC is an agonistic molecule that directly activates dendritic cells and enables a coordinated innate and adaptive immune response against cancer. Since SIRPα is expressed on both dendritic cells and a range of tumor types, SIRPα TRAAC may enable an effective immune activation response in advanced cancer settings. We are excited about this potentially transformative approach and the possible benefits to patients that are in need of new treatment options."



    Conference Call on March 5 at 8:30 a.m. EST

    ALX Oncology and Tallac will host a conference call on Friday, March 5, 2021 at 8:30 a.m. EST to further discuss the collaboration.

    To access the conference call, please dial (844) 467-7655 (local) or (409) 983-9840 (international) at least 10 minutes prior to the start time and refer to conference ID 4117088. Presentation slides will be available to download under "News & Events" (see "Events") in the investors section of the ALX Oncology website at www.alxoncology.com.  



    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit www.alxoncology.com.

    About Tallac

    Tallac Therapeutics is a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer. Tallac's pipeline of immunotherapy candidates are derived from the company's novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform to deliver a potent Toll-like receptor (TLR9) agonist (T-CpG) for targeted immune activation via systemic administration. Several TRAAC molecules are in various stages of discovery and preclinical development. For more information, please visit www.tallactherapeutics.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding the expectations of the collaboration with Tallac and the beneficial characteristics and potential therapeutic effects of SIRPα TRAAC. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    ALX Oncology
    
    Investor Contact:
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212) 600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com
    
    Tallac Therapeutics
    
    Media Contact:
    Tara Cooper
    The Grace Communication Group
    (650) 303-7306
    tara@gracegroup.us

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  16. BURLINGAME, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in a fireside chat at H.C. Wainwright's Global Life Sciences Conference, being held virtually on March 9-10, 2021.

    The prerecorded fireside chat will be available on Tuesday, March 9, 2021 at 7:00 a.m. Eastern Time here and can be accessed by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcast…

    BURLINGAME, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in a fireside chat at H.C. Wainwright's Global Life Sciences Conference, being held virtually on March 9-10, 2021.

    The prerecorded fireside chat will be available on Tuesday, March 9, 2021 at 7:00 a.m. Eastern Time here and can be accessed by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcast will be archived for up to 30 days following the presentation date.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212) 600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  17. BURLINGAME, Calif., Jan. 11, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today provided a corporate update and highlighted key milestones anticipated in 2021.

    "2020 was a year of numerous corporate and clinical accomplishments. Following our successful IPO in July and upsized secondary offering last month, we secured gross proceeds of approximately $394 million which provides the cash to fund our clinical development plans through 2024. During the year, we initiated several clinical trials evaluating our lead candidate, ALX148, in both hematologic and solid tumors and were highly encouraged by the…

    BURLINGAME, Calif., Jan. 11, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today provided a corporate update and highlighted key milestones anticipated in 2021.

    "2020 was a year of numerous corporate and clinical accomplishments. Following our successful IPO in July and upsized secondary offering last month, we secured gross proceeds of approximately $394 million which provides the cash to fund our clinical development plans through 2024. During the year, we initiated several clinical trials evaluating our lead candidate, ALX148, in both hematologic and solid tumors and were highly encouraged by the multiple data readouts in patients with HER2 positive gastric/gastroesophageal junction cancer and head and neck cancer that were recently reported at 35th Annual SITC meeting," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology.

    "2021 is expected to be another exciting and productive year with additional clinical trial initiations and data readouts that we expect to further validate and distinguish ALX148 from other CD47 targeted approaches. We also look forward to initiating our collaboration with Zymeworks to evaluate ALX148 in combination with zanidatamab and providing additional updates on our development programs during the year," Dr. Pons stated.

    Anticipated Key Milestones for 2021

    • Phase 1b full data read out for ALX148 in combination with Merck's Keytruda® (pembrolizumab) and chemotherapy for the treatment of patients with head and neck squamous cell carcinoma (HNSCC) is planned in the first half of 2021.

    • Initiation of two randomized Phase 2 studies for ALX 148 in combination with Keytruda in patients with HNSCC are planned in the first half of 2021. The first study (ASPEN-03) will evaluate the efficacy of ALX148 in combination with KEYTRUDA for the first line treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study (ASPEN-04) will evaluate ALX148 in combination with KEYTRUDA and standard chemotherapy for the first line treatment of patients with metastatic or unresectable, recurrent HNSCC.

    • Initiation of a Phase 1b clinical trial in the first half of 2021 with ALX148 in combination with Zymeworks' zanidatamab in patients with advanced HER2-expressing breast cancer and other solid tumors.

    • Initiation of a Phase 1 clinical trial evaluating ALX148 in combination with azacitidine and venetoclax in acute myeloid leukemia (AML) (ASPEN-05) patients in the second half of 2021.

    • Initiation of a randomized Phase 2 trial of ALX148 in combination with Herceptin® (trastuzumab), Cyramza® (ramucirumab) and paclitaxel in patients with 2nd line or greater gastric/gastroesophageal junction cancer (ASPEN-06) is expected in the second half of 2021.

    • Results of a Phase 1 clinical trial of ALX 148 in combination with azacitidine in patients with myelodysplastic syndromes (MDS) and the initiation of the Phase 2 clinical trial in MDS (ASPEN-02) are expected in the fourth quarter 2021.

    • Announcements of potential initiation of additional clinical trials and investigator sponsored trials in additional solid tumor indications are expected during 2021.

    Cash Position and Financial Guidance

    ALX Oncology ended the third quarter of 2020 with approximately $259.5 million in cash, cash equivalents. In December, ALX Oncology completed an upsized public offering of common stock which raised gross proceeds of $208 million including the exercise of the underwriters' option to purchase additional shares. The Company expects that its cash and cash equivalents will be sufficient to fund its planned operations through 2024.

    Upcoming Presentation at 39th Annual J.P. Morgan Healthcare Conference

    ALX Oncology will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 10:50 AM Eastern Time. A live webcast of the presentation can be accessed here or by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcast will be archived for up to 90 days following the presentation dates.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding ALX Oncology's clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148 in addition to key milestones such as anticipated clinical trial data readouts and cash and other financial expectations. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

     



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  18. BURLINGAME, Calif., Jan. 05, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer, will present a company overview at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12 at 10:50 am ET.

    A live webcast of the presentation is available here and can be accessed by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcast will be archived for up to 30 days following the presentation date.

    About ALX Oncology

    BURLINGAME, Calif., Jan. 05, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer, will present a company overview at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12 at 10:50 am ET.

    A live webcast of the presentation is available here and can be accessed by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcast will be archived for up to 30 days following the presentation date.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  19. BURLINGAME, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that it has been selected for addition to the NASDAQ Biotechnology Index® (NASDAQ:NBI). ALX's addition to the NBI will become effective prior to market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The NASDAQ Stock Market® (NASDAQ®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted…

    BURLINGAME, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that it has been selected for addition to the NASDAQ Biotechnology Index® (NASDAQ:NBI). ALX's addition to the NBI will become effective prior to market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The NASDAQ Stock Market® (NASDAQ®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted methodology and ranked on an annual basis. All securities in the NASDAQ Biotechnology Index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market and meet minimum market value and share volume requirements, among other criteria.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Peter Garcia

    Chief Financial Officer, ALX Oncology

    (650) 466-7125 Ext. 113

    peter@alxoncology.com

    Argot Partners

    (212)-600-1902

    alxoncology@argotpartners.com

    Media Contact:



    Karen Sharma

    MacDougall

    (781) 235-3060

    alx@macbiocom.com



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  20. BURLINGAME, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced the closing of its previously announced underwritten public offering of 2,737,000 shares of its common stock, which includes the exercise in full of the underwriters' option to purchase 357,000 additional shares of its common stock, at a price to the public of $76.00 per share. The aggregate gross proceeds to ALX Oncology from the offering were approximately $208.0 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by ALX Oncology…

    BURLINGAME, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced the closing of its previously announced underwritten public offering of 2,737,000 shares of its common stock, which includes the exercise in full of the underwriters' option to purchase 357,000 additional shares of its common stock, at a price to the public of $76.00 per share. The aggregate gross proceeds to ALX Oncology from the offering were approximately $208.0 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by ALX Oncology. 

    Jefferies, Credit Suisse, and Piper Sandler acted as joint book-running managers for the offering. Cantor and UBS Investment Bank also acted as book-running managers for the offering. LifeSci Capital acted as lead manager for the offering.

    Registration statements relating to these securities became effective on December 9, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at prospectus@psc.com; Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor New York, NY 10022, or by email at prospectus@cantor.com; or UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275, or by email at ol-prospectus-request@ubs.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML.

    Investor Contact:

    Peter Garcia

    Chief Financial Officer, ALX Oncology

    (650) 466-7125 Ext. 113

    peter@alxoncology.com

    Argot Partners

    (212)-600-1902

    alx@argotpartners.com

    Media Contact:

    Karen Sharma

    MacDougall

    (781) 235-3060

    alx@macbiocom.com



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  21. BURLINGAME, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced the pricing of an upsized underwritten public offering of 2,380,000 shares of its common stock at a price of $76.00 per share. All of the shares of common stock are being offered by ALX Oncology. The gross proceeds to ALX Oncology from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by ALX Oncology, are expected to be approximately $180.9 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close…

    BURLINGAME, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced the pricing of an upsized underwritten public offering of 2,380,000 shares of its common stock at a price of $76.00 per share. All of the shares of common stock are being offered by ALX Oncology. The gross proceeds to ALX Oncology from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by ALX Oncology, are expected to be approximately $180.9 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on December 14, 2020, subject to the satisfaction of customary closing conditions. In addition, ALX Oncology has granted the underwriters a 30-day option to purchase up to an additional 357,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

    Jefferies, Credit Suisse, and Piper Sandler are acting as joint book-running managers for the offering. Cantor and UBS Investment Bank are also acting as book-running managers for the offering. LifeSci Capital is acting as lead manager for the offering.

    Registration statements relating to these securities became effective on December 9, 2020. The offering is made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at prospectus@psc.com; Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor New York, NY 10022, or by email at prospectus@cantor.com; or UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275, or by email at ol-prospectus-request@ubs.com. Copies of the final prospectus, when available, related to the offering will be available at www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Such forward-looking statements include, among other things, statements regarding the timing, size and completion of the public offering of common stock.  The forward-looking statements contained herein are based upon ALX Oncology's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the offering, and other risks. These and other risks are described more fully in ALX Oncology's registration statement on Form S-1 filed with the U.S. Securities and Exchange Commission ("SEC") on December 7, 2020 and the prospectus included therein, as well as ALX Oncology's other filings with the SEC from time to time, including its Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Peter Garcia

    Chief Financial Officer, ALX Oncology

    (650) 466-7125 Ext. 113

    peter@alxoncology.com

    Argot Partners

    (212)-600-1902

    alx@argotpartners.com

    Media Contact:

    Karen Sharma

    MacDougall

    (781) 235-3060

    alx@macbiocom.com



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  22. BURLINGAME, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced that it has commenced an underwritten public offering of 2,000,000 shares of its common stock. All of the shares in the proposed offering will be sold by ALX Oncology. In addition, ALX Oncology expects to grant the underwriters a 30-day option to purchase up to an additional 300,000 shares of its common stock in the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of…

    BURLINGAME, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced that it has commenced an underwritten public offering of 2,000,000 shares of its common stock. All of the shares in the proposed offering will be sold by ALX Oncology. In addition, ALX Oncology expects to grant the underwriters a 30-day option to purchase up to an additional 300,000 shares of its common stock in the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering.

    Jefferies, Credit Suisse, and Piper Sandler are acting as joint book-running managers for the proposed offering. Cantor and UBS Investment Bank are also acting as book-running managers for the proposed offering. LifeSci Capital is acting as lead manager for the proposed offering.

    The offering will be made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com; Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at prospectus@psc.com; Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com; or UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275 or by email at ol-prospectus-request@ubs.com. Copies of the final prospectus, when available, related to the offering will be available at www.sec.gov.

    A registration statement relating to the securities has been filed with the Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Such forward-looking statements include, among other things, statements regarding the timing, size and completion of the proposed public offering of common stock and granting the underwriters a 30-day option to purchase additional shares.  The forward-looking statements contained herein are based upon ALX Oncology's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the proposed offering, and other risks. These and other risks are described more fully in ALX Oncology's registration statement on Form S-1 filed with the SEC on December 7, 2020 and the prospectus included therein, as well as ALX Oncology's other filings with the SEC from time to time, including its Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor Contact:
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alx@argotpartners.com
    
    Media Contact:
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  23. -- ORR of 70.0% Observed in Patients with NHL Treated with Higher Doses of ALX148 with Median Duration of Response Not Yet Reached

    -- Significant Improvement in Clinical Response Demonstrated with Increased ALX148 Exposure

    BURLINGAME, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced the presentation of updated clinical data from its ongoing trial evaluating ALX148 in combination with rituximab for the treatment of patients with advanced relapsed and refractory ("r/r") non-Hodgkin lymphoma ("NHL"). The new results, shared in a poster at the 62nd American Society of Hematology…

    -- ORR of 70.0% Observed in Patients with NHL Treated with Higher Doses of ALX148 with Median Duration of Response Not Yet Reached

    -- Significant Improvement in Clinical Response Demonstrated with Increased ALX148 Exposure

    BURLINGAME, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced the presentation of updated clinical data from its ongoing trial evaluating ALX148 in combination with rituximab for the treatment of patients with advanced relapsed and refractory ("r/r") non-Hodgkin lymphoma ("NHL"). The new results, shared in a poster at the 62nd American Society of Hematology ("ASH") Annual Meeting, show that the combination of ALX148 and rituximab is highly active and well tolerated in patients with r/r NHL [abstract 3016]. As of the data cutoff of October 1, 2020, 33 patients have been treated with ALX148 administered at 15 or 10 mg/kg once weekly ("QW") with standard regimens of rituximab.

    • In response-evaluable patients (n=10) who received ALX148 at 15 mg/kg QW, the objective response rate ("ORR") was 70.0%.



      • The ORR was 50.0% in patients (n=6) with aggressive lymphoma (r/r Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma) and 100% in patients (n=4) with indolent lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma).



    • In response-evaluable patients (n=22) who received ALX148 at 10 mg/kg QW, the ORR was 40.9%.



      • The ORR was 33.3% in patients (n=15) with aggressive lymphoma and 57.1% in patients (n=7) with indolent lymphoma.



    • ALX148 in combination with rituximab was well tolerated with no dose limiting toxicities observed. A significant improvement in clinical response was demonstrated with increased ALX148 exposure across the doses evaluated (p=0.023).

    "It is notable that higher ALX148 exposure is associated with greater objective response in this patient population," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "ALX148's favorable tolerability profile permits the use of higher doses that may drive further improvements in clinical activity. We are excited to investigate higher doses of ALX148 in our planned Phase 2 program that includes patients with myelodysplastic syndromes ("MDS"), acute myeloid lymphoma ("AML"), head and neck cancer, gastric cancer, and breast cancer."

    "Furthermore, we believe there is a strong and compelling scientific rationale for using ALX148 in combination with different anti-cancer therapies. Thus, we are pleased to present preclinical data at the 62nd ASH Annual Meeting [abstract 1965] demonstrating superior tumor control and significant prolongation of survival in aggressive murine models of AML with ALX148 in combination with venetoclax and azacitidine. We believe these preclinical data further support our combination strategy and expand upon ASPEN-01's encouraging clinical findings as we plan a robust Phase 2 program."

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.



    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding ALX Oncology's clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alx@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  24. --  Due to the registration potential of two planned Phase 2 head and neck cancer studies, FDA has requested completion of a standard ongoing non-clinical safety study

    --  Initiation of planned Phase 2 studies is allowed with enrollment of up to 50 total ALX148 treated subjects with full accrual proceeding upon non-clinical report acceptance by FDA

    --  Cap on patient enrollment is defined as partial clinical hold and no delays in the clinical program are anticipated

    --  FDA request is not in response to any adverse event from ALX148 clinical studies

    BURLINGAME, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or "Company") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies…

    --  Due to the registration potential of two planned Phase 2 head and neck cancer studies, FDA has requested completion of a standard ongoing non-clinical safety study

    --  Initiation of planned Phase 2 studies is allowed with enrollment of up to 50 total ALX148 treated subjects with full accrual proceeding upon non-clinical report acceptance by FDA

    --  Cap on patient enrollment is defined as partial clinical hold and no delays in the clinical program are anticipated

    --  FDA request is not in response to any adverse event from ALX148 clinical studies

    BURLINGAME, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or "Company") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced updates on its planned ALX148 Phase 2 studies in patients with advanced head and neck squamous cell carcinoma ("HNSCC"). The U.S. Food and Drug Administration ("FDA") verbally informed the Company that given its planned initiation of two Phase 2 HNSCC studies that could be potentially registrational, they require completion of a routine non-clinical safety study that the Company currently has in process. The FDA noted that for any drug development program moving swiftly through development, this non-clinical study is still required prior to the initiation of a clinical trial that could be considered pivotal. ALX Oncology is allowed to initiate both Phase 2 HNSCC studies with the enrollment capped at a total of 50 subjects treated with ALX148 across both studies (excluding safety lead-in cohorts) pending acceptance of the non-clinical safety study report. The Company expects to provide the required report to the FDA prior to reaching the 50-patient enrollment cap. While this cap on enrollment is defined as a partial clinical hold, no delays are anticipated in the Company's current clinical study timelines.

    ALX Oncology plans to advance ALX148 into two Phase 2 studies in subjects with HNSCC in combination with pembrolizumab, marketed as KEYTRUDA®, the market leading anti-programmed cell death protein-1, or PD-1, checkpoint inhibitor, with or without chemotherapy, in the first half of 2021. Both studies will be conducted in collaboration with Merck. The first study will evaluate the efficacy of ALX148 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 will evaluate ALX148 in combination with pembrolizumab and standard chemotherapy for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC (any CPS value).

    "We are pleased that the FDA is allowing us to initiate our two planned Phase 2 studies of ALX148 in patients with HNSCC and we are on track to complete the standard ongoing non-clinical safety study. We do not anticipate any delays in our planned clinical study timelines," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "Importantly, this recent FDA communication is not in response to any adverse events seen in ALX Oncology's ongoing clinical studies of ALX148. We are excited to have demonstrated encouraging anti-tumor activity with ALX148 in combination treatment in patients with HNSCC as well as HER2-positive gastric and gastroesophageal junction cancer. We believe these indications, in addition to our myelodysplastic syndromes ("MDS") program (ASPEN-02), offer potential registration pathways in combination with existing approved therapies and we intend to accelerate ALX148 development in solid and hematological indications in 2021."

    ALX Oncology recently announced that ALX148 in combination with pembrolizumab, 5-fluoropyrimidine and platinum achieved a 75.0% (n=4) overall response rate ("ORR"), including a complete response, in the Company's Phase 1b expansion cohort (ASPEN-01) for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC who have not received prior treatment for their advanced disease. The Company also reported recent ASPEN-01 data that ALX148 in combination with pembrolizumab achieved a 40.0% ORR (n=10) in patients with 2L HNSCC who had never received a checkpoint inhibitor for their advanced disease. ALX Oncology intends to pursue a strategy that will leverage the data generated from its planned Phase 2 randomized studies of ALX148 and pembrolizumab with and without chemotherapy to request from the FDA that ALX148 be a candidate for accelerated approval in the 1L treatment of HNSCC.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and acute myeloid leukemia. For more information, please visit ALX Oncology's website at www.alxoncology.com.



    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding ALX Oncology's clinical pipeline and timeline, strategy, the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148, and the statements made by ALX Oncology's Chief Medical Officer. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Peter Garcia

    Chief Financial Officer, ALX Oncology

    (650) 466-7125 Ext. 113

    peter@alxoncology.com

    Argot Partners

    (212)-600-1902

    alx@argotpartners.com

    Media Contact:

    Karen Sharma

    MacDougall

    (781) 235-3060

    alx@macbiocom.com

     



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  25. BURLINGAME, Calif., Nov. 24, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in two virtual investor conferences in December.

    Piper Sandler 32nd Annual Virtual Healthcare Conference
    Format: Fireside chat with covering analyst, Chris Raymond
    Date: November 30 – December 3
    Webcast link: Available here

    3rd Annual Evercore ISI HealthCONx Conference
    Format: Fireside chat with analyst, Umer Raffat
    Date: Thursday, December 3
    Time: 10:30 AM Eastern Time
    Webcast link: Available here

    A live…

    BURLINGAME, Calif., Nov. 24, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in two virtual investor conferences in December.

    Piper Sandler 32nd Annual Virtual Healthcare Conference

    Format: Fireside chat with covering analyst, Chris Raymond

    Date: November 30 – December 3

    Webcast link: Available here

    3rd Annual Evercore ISI HealthCONx Conference

    Format: Fireside chat with analyst, Umer Raffat

    Date: Thursday, December 3

    Time: 10:30 AM Eastern Time

    Webcast link: Available here

    A live webcast of the Evercore fireside chat and a recording of the Piper Sandler fireside chat can be accessed by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcasts will be archived for up to 90 days following the presentation dates.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as myelodysplastic syndromes and acute myeloid lymphoma. For more information, please visit ALX Oncology's website at www.alxoncology.com. 

     



    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  26. Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, and ALX Oncology Holdings Inc. (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced they have entered into a clinical collaboration to evaluate the combination of Zymeworks' zanidatamab (formerly ZW25), a HER2-targeted bispecific antibody, and ALX148, a next-generation CD47 blocker, for the treatment of patients with advanced HER2-expressing breast cancer and other solid tumors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201116005959/en/

    Under the terms of the agreement, Zymeworks will…

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, and ALX Oncology Holdings Inc. (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced they have entered into a clinical collaboration to evaluate the combination of Zymeworks' zanidatamab (formerly ZW25), a HER2-targeted bispecific antibody, and ALX148, a next-generation CD47 blocker, for the treatment of patients with advanced HER2-expressing breast cancer and other solid tumors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201116005959/en/

    Under the terms of the agreement, Zymeworks will conduct an open label, multi-center Phase 1b study to assess the safety and efficacy of the combination of zanidatamab and ALX148 in a two-part study. The first part of the trial will evaluate the safety of the combination treatment. The second part of the trial will evaluate the safety, tolerability and anti-tumor activity of the combination in separate cohorts of subjects with HER2-positive breast cancer, HER2-low breast cancer, and non-breast HER2-expressing solid tumors.

    "In addition to broad anti-tumor activity, zanidatamab's safety profile supports combination approaches with other therapeutics," said Diana Hausman, M.D., Chief Medical Officer at Zymeworks. "Our collaboration with ALX Oncology and their CD47 blocker, ALX148, has the potential to further expand the opportunity for zanidatamab to provide benefit to a broader population of patients, including those with advanced HER2‑expressing breast cancer."

    Zanidatamab is designed to have multiple mechanisms of action, including immune clearance of HER2-expressing tumor cells by macrophages through antibody-dependent cellular phagocytosis (ADCP). CD47 is a "don't eat me" signal that acts as a checkpoint inhibitor to macrophages. Cancer cells that express CD47 are resistant to immune clearance even when targeted with therapeutic antibodies. Treatment with zanidatamab plus ALX148 has the potential to increase the immune clearance of HER2-expressing cancer cells by combining a biparatopic antibody capable of binding at higher density than monospecific antibodies with a molecule that blocks CD47 on the same targeted cancer cells.

    "We are excited about this collaboration with Zymeworks that combines two promising next-generation anti-cancer agents, a HER2-targeted bispecific antibody with a CD47 blocker, to enhance their potential activity in treating patients with advanced breast cancer," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "ALX148 was designed for safe use in combination to maximize clinical activity with a range of anti-cancer agents. This collaboration builds on the promising anti-tumor activity observed in clinical trials of ALX148 combined with a HER2-targeted therapy in patients with advanced HER2-positive gastric and gastroesophageal cancer."

    Zanidatamab is in advanced clinical development, actively enrolling a pivotal study in patients with previously-treated HER2 gene-amplified biliary tract cancer. In addition, five active Phase 2 programs are underway, and Zymeworks plans to initiate a second pivotal study for zanidatamab as first-line treatment for advanced HER2‑positive gastroesophageal adenocarcinomas.

    Phase 1 studies of ALX148 have been conducted in combination with tumor antigen targeted antibodies, a checkpoint inhibitor and chemotherapy. Preliminary results from ASPEN-01, the ALX148 Phase 1b study, were presented at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting [abstract 404]. ALX148 displayed promising initial clinical activity in patients with solid tumors, including advanced HER2-positive gastric and gastroesophageal cancer where ALX148 was well tolerated in combination with an anti-HER2 specific antibody and chemotherapy with no maximum tolerated dose reached. ALX Oncology plans to continue the advancement of ALX148 as a potential treatment for a range of solid tumor indications and is currently also in development in patients with higher risk myelodysplastic syndromes (ASPEN-02).

    About Zymeworks Inc.

    Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks' suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks' lead clinical candidate, zanidatamab (ZW25), is a novel Azymetric™ bispecific antibody currently in a registration-enabling clinical trial for refractory HER2+ biliary tract cancer as well as several Phase 2 clinical trials for HER2+ gastroesophageal and breast cancers. Zymeworks' second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks' proprietary ZymeLink™ linker-cytotoxin. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies. For more information, visit www.zymeworks.com.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications and myelodysplastic syndromes. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Zymeworks Cautionary Note Regarding Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks' expectations regarding the beneficial characteristics, safety, and therapeutic effects of zanidatamab, its planned trials combining zanidatamab and ALX148, the potential benefits of that combination, and other information that is not historical information. When used herein, words such as "will", "may", "plan", "potential", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks' current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under "Risk Factors" in Zymeworks' Quarterly Report on Form 10-Q for its quarter ended September 30, 2020 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks' current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

    ALX Oncology Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause its actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding ALX Oncology's clinical pipeline and expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents that ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  27. BURLINGAME, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the third quarter ended September 30, 2020, and clinical development and operational highlights.

    "We are very pleased to report that during the third quarter we continued to make substantial progress in advancing our next generation anti-CD47 therapeutic, ALX148, in clinical trials in advanced gastric/gastroesophageal junction cancer and head and neck squamous cell cancers, as well as securing a clinical trial collaboration with Merck to study the combination of ALX148 with KEYTRUDA® in the…

    BURLINGAME, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the third quarter ended September 30, 2020, and clinical development and operational highlights.

    "We are very pleased to report that during the third quarter we continued to make substantial progress in advancing our next generation anti-CD47 therapeutic, ALX148, in clinical trials in advanced gastric/gastroesophageal junction cancer and head and neck squamous cell cancers, as well as securing a clinical trial collaboration with Merck to study the combination of ALX148 with KEYTRUDA® in the setting of first line, metastatic or unresectable, recurrent head and neck squamous cell cancer," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "In addition, subsequent to the third quarter, we announced the first patient has been dosed in the Phase 1/2 ASPEN-02 study evaluating the combination of ALX148 with azacitidine for the treatment of patients with higher-risk myelodysplastic syndromes. We also recently presented further encouraging data for ALX148 from the ASPEN-01 Phase 1b Study at the 35th Annual SITC meeting, including a 64% ORR in advanced gastric cancer patients treated with ALX148 in combination with trastuzumab and the current chemotherapeutic standard of care. We look forward to providing further updates as we continue to advance ALX148 as a potential treatment for a range of solid tumor indications and hematologic malignancies."

    Recent Clinical Developments for ALX148

    • Presented New Data from the ASPEN-01 Phase 1b Study of ALX148 in Combination with Standard Chemotherapy and Antibody Regimens in Patients with Gastric/Gastroesophageal Junction Cancer ("GC") and Head and Neck Squamous Cell Carcinoma ("HNSCC") at the SITC 35th Anniversary Annual Meeting [Abstract #404].
      • In November 2020, ALX Oncology reported new preliminary data from the GC patient cohort receiving ALX148 plus trastuzumab plus chemotherapy. In patients with >2L HER2 positive GC (n=14), whose tumors have progressed upon prior trastuzumab therapy, ALX148 demonstrated an initial objective response rate ("ORR") of 64% in combination with trastuzumab plus ramucirumab and paclitaxel that compares favorably with historical data. In addition, updated data from patients with >2L HER2 positive GC receiving ALX148 plus trastuzumab suggested promising clinical activity after their tumors have progressed upon prior trastuzumab therapy.
      • ALX Oncology also reported new preliminary data from the HNSCC patient cohort receiving ALX148 plus pembrolizumab plus chemotherapy. In initial patients with 1L HNSCC who have not received prior treatment for their advanced disease (n=4), ALX148 demonstrated an initial ORR of 75%, including a complete response, in combination with pembrolizumab plus 5-fluorouracil and platinum. In addition, updated data from patients who have never been treated with a PD-1/PD-L1 inhibitor for their >2L HNSCC and who received ALX148 plus pembrolizumab suggested clinical activity beyond that expected from pembrolizumab monotherapy.



    • Collaboration Initiated with Merck on Phase 2 Immuno-Oncology Studies Evaluating ALX148, Targeting CD47, in Combination with KEYTRUDA® (pembrolizumab) in Patients with Head & Neck Cancer. In September 2020, ALX Oncology entered into a clinical trial collaboration with Merck to evaluate the combination of ALX148 and KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of patients with HNSCC. ALX Oncology will conduct a Phase 2 program comprising two separate Phase 2 studies. The first study will evaluate the efficacy of ALX148 in combination with KEYTRUDA for the first line treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study will evaluate ALX148 in combination with KEYTRUDA and standard chemotherapy for the first line treatment of patients with metastatic or unresectable, recurrent HNSCC.
    • Announced the first patient has been dosed in the Phase 1/2 ASPEN-02 study evaluating the combination of ALX148 with azacitidine for the treatment of patients with higher-risk myelodysplastic syndromes ("MDS"). With the first patient dosed in October 2020, the Phase 1 part of the study is expected to characterize the safety of ALX148 in combination with azacitidine in patients with relapsed/refractory or previously untreated higher-risk MDS. Upon completion of the Phase 1, the Phase 2 component of the study will be initiated to evaluate the efficacy of the combination in patients with previously untreated higher-risk MDS.

    Operational Highlights:

    • Named Leading Oncology Experts to Scientific Advisory Board. In October 2020, ALX Oncology announced the formation of the Company's Scientific Advisory Board ("SAB") with three leading oncology experts. The members of the ALX Oncology SAB include Keith Flaherty, M.D. (Chair), Charles M. Baum, M.D., Ph.D. and Kipp Weiskopf, M.D., Ph.D.
    • Added to Russell 2000® and 3000® Indexes. In September 2020, ALX Oncology was added as a member of the Russell 2000® and 3000® Indexes effective as of September 18, 2020, as part of Russell's quarterly additions of select initial public offering ("IPO") companies.

    Conference Call on November 16th at 5:00 p.m. EST

    New ALX148 Data from the Phase 1b GC Expansion Cohort in ASPEN-01

    ALX Oncology will host a conference call on Monday, November 16, 2020 at 5:00 p.m. EST to discuss the updated results from the GC expansion cohort in ASPEN-01, the ALX148 Phase 1b study, which was presented at the SITC 35th Anniversary Annual Meeting. In addition to ALX Oncology's executive management team, Dr. Yung-Jue Bang, Professor Emeritus and former Director of Cancer Research Institute, Seoul National University College of Medicine and Hospital, South Korea, will be featured on the call to discuss the latest ALX148 clinical data in patients with GC.

    To access the conference call, please dial (844) 467-7655 (local) or (409) 983-9840 (international) at least 10 minutes prior to the start time and refer to conference ID 4766826. Presentation slides will be available to download under "News & Events" (see "Events") in the Investors section of the ALX Oncology website at www.alxoncology.com.

    Third Quarter 2020 Financial Results:

    • Cash and Cash Equivalents: Cash and cash equivalents as of September 30, 2020 were $259.5 million. ALX Oncology believes its cash and cash equivalents is sufficient to fund planned operations through 2023.
    • Related-party Revenue: There was no related-party revenue for the quarter ended September 30, 2020, compared to $1.3 million for the corresponding period in 2019. The decrease in related-party revenue relates to the termination of the research and development agreement with Tallac Therapeutics, Inc. in July 2020.
    • Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of ALX148. These expenses for the three months ended September 30, 2020, were $5.3 million, compared to $2.2 million for the three months ended September 30, 2019. The increase of $3.1 million was primarily due to an increase of $2.9 million in clinical and development costs due to higher expenses associated with increased pre-clinical, clinical and other research costs in advancement of our current lead product candidate, ALX148 and an increase of $0.6 million in personnel-related costs, partially offset by a decrease of $0.4 million in stock-based compensation expense.
    • General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended September 30, 2020, were $4.5 million, compared to $0.9 million for the prior-year period. This increase of $3.5 million was primarily due to an increase in stock-based compensation expense of $1.0 million, an increase in professional service costs of $0.6 million, additional $0.4 million in directors and officers liability insurance premium, increased personnel-related costs of $1.2 million due to higher headcount and additional other G&A costs of $0.3 million.
    • Net loss: Net loss attributable to common stockholders was $10.8 million and $4.1 million for the three months ended September 30, 2020, and 2019, respectively. Included in the $10.8 million loss for the three months ended September 30, 2020, was $0.6 million related to cumulative dividends allocated to preferred shareholders, which, along with prior cumulative dividends, were converted into 2.6 million shares of common stock at the IPO. Non-GAAP net loss was $9.1 million and $3.0 million for the three months ended September 30, 2020, and 2019, respectively. A reconciliation of GAAP to non-GAAP financial results can be found in a table at the end of this press release.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications and myelodysplastic syndromes. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include, but are not limited to, statements regarding ALX Oncology's financial condition, results of operations and sufficiency of its cash and cash equivalents to fund its planned operations as well as statements about ALX Oncology's clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    ALX ONCOLOGY HOLDINGS INC.


    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (unaudited)

    (in thousands)

     Three Months Ended Nine Months Ended 
     September 30, September 30, 
     2020 2019 2020 2019 
    Related-party revenue$ $1,256 $1,182 $3,583 
    Operating expenses:            
    Research and development 5,328  2,210  16,819  9,571 
    General and administrative 4,481  938  9,126  2,205 
    Cost of services for related-party revenue   1,142  1,075  3,257 
    Total operating expenses 9,809  4,290  27,020  15,033 
    Loss from operations (9,809) (3,034) (25,838) (11,450)
    Interest expense (226)   (660)  
    Other expense, net (111) (2) (409) (4)
    Loss before income taxes (10,146) (3,036) (26,907) (11,454)
    Income tax provision (35) (8) (59) (25)
    Net loss and comprehensive loss (10,181) (3,044) (26,966) (11,479)
    Cumulative dividends allocated to preferred stockholders (578) (1,071) (5,202) (2,957)
    Net loss attributable to common stockholders$(10,759)$(4,115)$(32,168)$(14,436)



    Condensed Consolidated Balance Sheet Data


    (unaudited)

    (in thousands)

      September 30,

    2020
      December 31,

    2019
     
    Cash and cash equivalents$259,484 $9,017 
    Total assets$262,449 $10,676 
    Total liabilities$10,433 $10,952 
    Convertible preferred stock$ $70,363 
    Total stockholders' equity/(deficit)$252,016 $(70,639)



    GAAP to Non-GAAP Reconciliation


    (unaudited)

    (in thousands)

     Three Months Ended Nine Months Ended 
     September 30, September 30, 
     2020 2019 2020 2019 
    GAAP net loss, as reported$(10,181)$(3,044)$(26,966)$(11,479)
    Adjustments:            
    Stock-based compensation expense 689  86  3,693  222 
    Accretion of term loan 118    339   
    Mark-to-market adjustment on financial instruments 242    650   
    Total adjustments 1,049  86  4,682  222 
    Non-GAAP net loss$(9,132)$(2,958)$(22,284)$(11,257)

    Use of Non-GAAP Financial Measures

    We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

    "Non-GAAP net loss" is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) debt offering costs (interest expense related to ALX Oncology's term loan offering costs) and (3) mark-to market adjustment on financial instruments (which include preferred stock warrants and derivatives) within our reconciliation of our GAAP to Non-GAAP net loss. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

    Investor Contact:

    Peter Garcia

    Chief Financial Officer, ALX Oncology

    (650) 466-7125 Ext. 113

    peter@alxoncology.com

    Argot Partners

    (212)-600-1902

    alxoncology@argotpartners.com

    Media Contact:

    Karen Sharma

    MacDougall

    (781) 235-3060

    alx@macbiocom.com

    Primary Logo

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  28. -- ORR of 64% Observed in Patients with >2L HER2 Positive Gastric/Gastroesophageal Junction Cancer 

    -- ORR of 75% and One Complete Response Observed in Patients with 1L Head and Neck Cancer

    -- ALX Oncology to Host Conference Call on November 16 at 5:00pm EST

    BURLINGAME, Calif., Nov. 09, 2020 (GLOBE NEWSWIRE) --  ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced new results from ASPEN-01, the ALX148 Phase 1b study, evaluating patients with solid tumor malignancies at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting [abstract 404].

    ALX Oncology reports new preliminary data from the gastric/gastroesophageal…

    -- ORR of 64% Observed in Patients with >2L HER2 Positive Gastric/Gastroesophageal Junction Cancer 

    -- ORR of 75% and One Complete Response Observed in Patients with 1L Head and Neck Cancer

    -- ALX Oncology to Host Conference Call on November 16 at 5:00pm EST

    BURLINGAME, Calif., Nov. 09, 2020 (GLOBE NEWSWIRE) --  ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced new results from ASPEN-01, the ALX148 Phase 1b study, evaluating patients with solid tumor malignancies at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting [abstract 404].

    ALX Oncology reports new preliminary data from the gastric/gastroesophageal junction cancer ("GC") patient cohort receiving ALX148 plus trastuzumab plus chemotherapy, and from the head and neck squamous cell carcinoma ("HNSCC") patient cohort receiving ALX148 plus pembrolizumab plus chemotherapy. In addition, updated data are presented from the GC patient cohort receiving ALX148 plus trastuzumab, and from the HNSCC patient cohort receiving ALX148 plus pembrolizumab. All data reflect response evaluable patients as of October 1, 2020.

    • In patients with >2L HER2 positive GC (n=14), whose tumors have progressed upon prior trastuzumab therapy, ALX148 demonstrates a promising initial objective response rate (ORR) of 64% in combination with trastuzumab plus ramucirumab and paclitaxel that compares favorably with historical data.



    • In initial patients with 1L HNSCC who have not received prior treatment for their advanced disease (n=4), ALX148 demonstrates a promising initial ORR of 75%, including a complete response, in combination with pembrolizumab plus 5-fluorouracil and platinum.



    • Updated data from patients with >2L HER2 positive GC receiving ALX148 plus trastuzumab suggests promising clinical activity after their tumors have progressed upon prior trastuzumab therapy.

    • Updated data from patients who have never been treated with a PD-1/PD-L1 inhibitor for their >2L HNSCC and who received ALX148 plus pembrolizumab suggests clinical activity beyond that expected from pembrolizumab monotherapy.



    • Preliminary data suggests that ALX148 can be safely combined with multi-agent chemotherapy regimens studied with no maximum tolerated dose reached. The maximum administered dose of ALX148 in combination was 15 mg/kg once per week.

    "This remarkable emerging data suggest that ALX148 in combination with the standard chemotherapy based regimens studied may induce meaningful clinical benefit in patients with advanced HER2 positive gastric as well as head and neck cancers," said Dr Keun-Wook Lee, Professor of Internal Medicine at Seoul National University College of Medicine, and Chief of The Clinical Trials Center at Seoul National University Bundang Hospital, South Korea.

    "To our knowledge, these data are the first to support this degree of clinical activity in patients with solid tumors by a CD47 targeted agent," said Dr. Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "Importantly, these results and ALX148's favorable tolerability profile further differentiate it from other CD47 targeted approaches, and we look forward to continuing its clinical development in our robust phase 2 program."

    Conference Call on November 16th at 5:00pm EST

    ALX Oncology will host a conference call on Monday, November 16, 2020 at 5:00 p.m. EST to further discuss the new GC data from ASPEN-01, the Phase 1b study of ALX148 that was presented at the SITC 35th Anniversary Annual Meeting. In addition to ALX Oncology's executive management team, Dr. Yung-Jue Bang, Professor Emeritus and former Director of Cancer Research Institute, Seoul National University College of Medicine and Hospital, South Korea, will be featured on the call to discuss the latest ALX148 clinical data in patients with GC.

    To access the conference call, please dial (844) 467-7655 (local) or (409) 983-9840 (international) at least 10 minutes prior to the start time and refer to conference ID 4766826. Presentation slides will be available to download under "News & Events" (see "Events") in the Investors section of the ALX Oncology website at www.alxoncology.com.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications and myelodysplastic syndromes. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding ALX Oncology's clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on August 27, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alx@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

    Primary Logo

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  29. BURLINGAME, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced that both ALX148 clinical and preclinical results have been selected for presentation at the 62nd ASH Annual Meeting & Exposition, December 5-8, 2020.

    "This year's ASH meeting will be an opportunity to provide important clinical updates on our ALX148 program in patients with hematologic malignancies," said Sophia Randolph M.D., Ph.D., Chief Medical Officer of ALX Oncology. "We are excited to share new clinical efficacy data that investigates the combination of ALX148 with rituximab in patients with relapsed/refractory…

    BURLINGAME, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced that both ALX148 clinical and preclinical results have been selected for presentation at the 62nd ASH Annual Meeting & Exposition, December 5-8, 2020.

    "This year's ASH meeting will be an opportunity to provide important clinical updates on our ALX148 program in patients with hematologic malignancies," said Sophia Randolph M.D., Ph.D., Chief Medical Officer of ALX Oncology. "We are excited to share new clinical efficacy data that investigates the combination of ALX148 with rituximab in patients with relapsed/refractory NHL. We are committed to further development of ALX148 to transform standards of care for patients with cancer."

    Poster Presentation Details

    Title:   ALX148, a CD47 Blocker, in Combination with Rituximab in Patients with Non-Hodgkin Lymphoma

    Session Name: 626. Aggressive Lymphoma – Results from Prospective Clinical Trials: Poster III

    Presentation Date and Location: December 7, 7:00am – 3:30pm PT, Virtual Poster Hall

    Publication Number: 3016

    Abstract Link: https://ash.confex.com/ash/2020/webprogram/Paper135941.html



    Title:   ALX148 Enhances the Depth and Durability of Response to Multiple AML Therapies

    Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II

    Presentation Date and Location: December 6, 7:00am – 3:30pm PT, Virtual Poster Hall

    Publication Number: 1965

    Abstract Link: https://ash.confex.com/ash/2020/webprogram/Paper137112.html



    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications and myelodysplastic syndromes. For more information, please visit ALX Oncology's website at www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding ALX Oncology's clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on August 27, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alx@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

    Primary Logo

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  30. BURLINGAME, Calif., Nov. 02, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in two virtual investor conferences in November.

    29th Annual Credit Suisse Virtual Healthcare Conference
    Format: Fireside chat with covering analyst, Martin Auster, M.D.
    Date: Monday, November 9
    Time: 11:45 AM Eastern Time
    Webcast link: Available here

    Jefferies Virtual London Healthcare Conference
    Format: Fireside chat with covering analyst, Michael Yee
    Date: Thursday, November 19
    Time: 1:10 PM Eastern…

    BURLINGAME, Calif., Nov. 02, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in two virtual investor conferences in November.

    29th Annual Credit Suisse Virtual Healthcare Conference

    Format: Fireside chat with covering analyst, Martin Auster, M.D.

    Date: Monday, November 9

    Time: 11:45 AM Eastern Time

    Webcast link: Available here

    Jefferies Virtual London Healthcare Conference

    Format: Fireside chat with covering analyst, Michael Yee

    Date: Thursday, November 19

    Time: 1:10 PM Eastern Time

    Webcast link: Available here

    A live webcast of the fireside chats can be accessed by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting the Investor Calendar under the News and Events tab. A replay of the webcasts will be archived for up to 90 days following the presentation dates.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications and myelodysplastic syndromes. For more information, please visit ALX Oncology's website at https://www.alxoncology.com.

     

    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

    Primary Logo

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  31. BURLINGAME, Calif., Oct. 28, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the first patient has been dosed in the Phase 1/2 ASPEN-02 study evaluating the combination of ALX148, a next-generation CD47 blocker, with azacitidine for the treatment of patients with higher-risk myelodysplastic syndrome ("MDS").

    The Phase 1 part of the study is expected to characterize the safety of ALX148 in combination with azacitidine in patients with relapsed/refractory or previously untreated higher-risk MDS. Upon completion of the Phase 1, the Phase 2 component of the study will be initiated to evaluate…

    BURLINGAME, Calif., Oct. 28, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the first patient has been dosed in the Phase 1/2 ASPEN-02 study evaluating the combination of ALX148, a next-generation CD47 blocker, with azacitidine for the treatment of patients with higher-risk myelodysplastic syndrome ("MDS").

    The Phase 1 part of the study is expected to characterize the safety of ALX148 in combination with azacitidine in patients with relapsed/refractory or previously untreated higher-risk MDS. Upon completion of the Phase 1, the Phase 2 component of the study will be initiated to evaluate the efficacy of the combination in patients with previously untreated higher-risk MDS.

    This study has been initiated based on promising preclinical data of ALX148 in combination with azacitidine in myeloid leukemia models, and clinical data generated by ALX Oncology in an ongoing Phase 1 trial (NCT03013218) evaluating ALX148 in combination with other anti-cancer agents in over 150 patients with various malignancies, including non-Hodgkins lymphoma, gastric/gastroesophageal junction cancer ("GC"), and head and neck squamous cell carcinoma ("HNSCC"). Data from the Phase 1 study provides the basis for ALX148's Fast Track Approvals in GC and HNSCC granted by the U.S. Food and Drug Administration.

    "We are looking forward to evaluating the addition of ALX148 to azacitidine in patients with advanced MDS who are in need of effective new therapies," said Guillermo Garcia-Manero, M.D., Professor and Chief of Section of Myelodysplastic Syndromes, Department of Leukemia at MD Anderson Cancer Center. "ALX148 was designed for use in combination with a range of agents to maximize anti-cancer activity while minimizing associated toxicity."

    "Through blockade of the CD47 myeloid checkpoint pathway, ALX148 bridges the innate and adaptive immune responses to cancer. This study builds upon the compelling combination activity observed in patients with ALX148 and multiple other anti-cancer agents," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer of ALX Oncology. "Our goal is to transform treatment options for patients with cancer by developing ALX148 as a foundational checkpoint immunotherapy."

    The ASPEN-02 trial is registered under NCT04417517. ALX Oncology owns worldwide commercial rights to ALX148.

    About Myelodysplastic Syndrome ("MDS")

    MDS represents a group of blood cancers characterized by ineffective production of healthy red blood cells, white blood cells, and platelets. This can lead to anemia with a potential need for frequent transfusions, infections, and a risk for transformation into leukemia. Over 10,000 people are estimated to be diagnosed with MDS in the U.S. each year. The average survival rate for those with higher-risk MDS is approximately 18 months.

    About ALX Oncology

    ALX Oncology is a publicly-traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to advance ALX148 into clinical development for the treatment of hematologic malignancies, including MDS and acute myeloid leukemia, and to continue clinical development in multiple solid tumor indications.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding ALX Oncology's clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on August 27, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212) 600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma 
    MacDougall 
    (781) 235-3060
    alx@macbiocom.com

    Primary Logo

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  32. BURLINGAME, Calif., Oct. 14, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced that ALX148 clinical results have been selected for presentation at the SITC 35th Anniversary Annual Meeting, November 9 –14, 2020.

    The abstract for our presentation appeared briefly and in error on the SITC website this morning, prior to its intended release on November 9th 2020, and as a result the abstract is provided in full below.

    Poster Presentation Details

    Title:   ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction…

    BURLINGAME, Calif., Oct. 14, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced that ALX148 clinical results have been selected for presentation at the SITC 35th Anniversary Annual Meeting, November 9 –14, 2020.

    The abstract for our presentation appeared briefly and in error on the SITC website this morning, prior to its intended release on November 9th 2020, and as a result the abstract is provided in full below.

    Poster Presentation Details

    Title:   ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction (GC) cancer and head and neck squamous cell carcinoma (HNSCC) (Abstract 404)

    Presentation Time: November 11 – 14, 2020, 9:00am – 5:00pm ET

    Location: Virtual Poster Hall

    Abstract authors: Keun-Wook Lee,1 Hyun Cheol Chung,2 Won Seog Kim,3 Laura QM Chow,4* Nehal Lakhani,5 Wells Messersmith,6 Yung-Jue Bang,7 Patricia LoRusso,8 Philip Fanning,9 Pierre Squifflet,10 Feng Jin,9 Allison Forgie,9 Hong Wan,9 Jaume Pons,9 Sophia Randolph,9 Justin Gainor,11

    1Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea; 2Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea; 3Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea; 4University of Washington, Seattle, WA; 5START Midwest, Grand Rapids, MI; 6University of Colorado Cancer Center, Aurora, CO; 7Seoul National University College of Medicine, Seoul, Korea; 8Yale Cancer Center, New Haven, CT; 9ALX Oncology, Burlingame, CA, USA, 10International Drug Development Institute, Brussels, Belgium, 11Massachusetts General Hospital Cancer Center, Boston, MA

    Full Abstract

    Background: CD47 is a myeloid checkpoint up-regulated by tumors to evade the anticancer immune response. ALX148 is a high affinity CD47-blocking fusion protein with an inactive Fc region designed to safely enhance anticancer therapeutics [1,2]. ALX148 in combination with standard chemotherapy and antibody regimens was evaluated in patients (pts) with advanced HER2-positive GC or HNSCC.

    Methods: Pts with previously treated advanced HER2-positive GC or untreated advanced HNSCC received ALX148 (A) 10 mg/kg QW or 15 mg/kg QW in combination with trastuzumab (T) + ramucirumab (ram) + paclitaxel (pac) as 2nd or later-line treatment or pembrolizumab (P) + 5FU + platinum (cisplatin or carboplatin) as 1st line therapy, respectively. The primary endpoint was dose limiting toxicity (DLT). Tumor response, pharmacokinetic (PK), and pharmacodynamic (PD) markers were assessed in all pts. Preliminary data from enrolling cohorts, and follow-up data from pts with GC administered A+T, and with HNSCC administered A+P are also reported as of 30June2020.

    Results: Fifty-five pts enrolled into this portion of the study. Twelve patients with ≥2L GC received A+T+ram+pac and were evaluated for safety. No DLTs, were reported, and the ALX148 maximum administered dose was 15 mg/kg QW. Out of the 9 pts who experienced any adverse event, 7 pts reported treatment-related adverse events (TRAE). The most common TRAEs were low grade diarrhea, fatigue, pruritus and rash (each n=2,17%). Nine of the 12 patients were response-evaluable and reported a 66% ORR with 6PR and 3SD (including one ongoing near PR, ↓29.6%). Three patients with 1L HNSCC were administered A+P+5FU+platinum. No DLTs were reported and accrual to 15 mg/kg QW continues. Three pts experienced any AE, none were treatment-related. Of 3 evaluable patients with HNSCC, 2PR and 1SD were reported. Initial ALX148 combination PK and CD47 target occupancy are similar to that of single agent administration. Response duration and survival follow-up of 19 pts with HER2-positive GC administered A+T (2nd or later-line; 21% ORR) and of 10 pts with checkpoint inhibitor naïve HNSCC administered A+P (2nd or later-line; 40% ORR) will be reported. Results of all cohorts will be updated at time of presentation.

    Conclusions: Initial data suggests the myeloid checkpoint inhibitor, ALX148, is well tolerated in combination with the above anticancer antibodies, T-cell checkpoint inhibitor, and cytotoxic chemotherapy regimens with early anticancer signals in GC and HNSCC that compare favorably with historic controls. No MTD has been reached in any combination to date and accrual to chemotherapy combination regimens is ongoing. ClinicalTrials.gov identifier NCT03013218.

    References:

    1. Kauder S, Kuo T, Harrabi O, Chen A, Sangalang E, et al. ALX148 blocks CD47 and enhances innate and adaptive antitumor immunity with a favorable safety profile. PLoS ONE. 2018;13(8).

    2. Chow L, Gainor J, Lakhani N, et al. A phase I study of ALX148, a CD47 blocker, in combination with standard anticancer antibodies and chemotherapy regimens in patients with advanced malignancy. Journal of Clinical Oncology 2020; 38:15_suppl, 3056-3056.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to advance ALX148 into clinical development for the treatment of myelodysplastic syndromes and to continue clinical development for the treatment of a range of solid tumor indications. For more information, please visit ALX Oncology's website at https://www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding ALX Oncology's clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on August 27, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alx@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  33. BURLINGAME, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the formation of the Company's Scientific Advisory Board ("SAB") with three leading oncology experts. The SAB will provide valuable strategic and scientific counsel to ALX Oncology's clinical programs related to its lead product candidate, ALX148.

    "We are honored to welcome these acclaimed experts in oncology to our scientific advisory board," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "These advisors will work closely with our leadership team and will…

    BURLINGAME, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the formation of the Company's Scientific Advisory Board ("SAB") with three leading oncology experts. The SAB will provide valuable strategic and scientific counsel to ALX Oncology's clinical programs related to its lead product candidate, ALX148.

    "We are honored to welcome these acclaimed experts in oncology to our scientific advisory board," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "These advisors will work closely with our leadership team and will be integral in helping to advance our clinical pipeline for ALX148 across multiple oncology indications."

    "It is a privilege to work with a talented group of renowned oncology experts to assist ALX Oncology in developing ALX148, which has emerged as a next-generation checkpoint inhibitor designed to have high affinity for CD47 and to overcome the hematologic toxicity associated with other CD47 blocking approaches," said Keith Flaherty, M.D., chair of ALX Oncology's SAB. "ALX148 has the potential to make a significant impact on people who are fighting cancer."

    The members of the ALX Oncology SAB include:

    • Keith Flaherty, M.D. (Chair) - Dr. Flaherty is a Professor of Medicine at Harvard Medical School and Director of Clinical Research, at the Massachusetts General Hospital Cancer Center. He co-founded and served on the Board of Directors of Loxo Oncology until its acquisition by Eli Lilly and Company. He currently serves on the Board of Directors of Clovis Oncology and Checkmate Pharmaceuticals. Dr. Flaherty has been awarded numerous grants from the National Cancer Institute, including K23, RO1 and PO1 grants. He is an author of many research articles, abstracts and reviews in the peer-reviewed literature, including three first-author and three senior author New England Journal of Medicine papers. He serves as Editor-in-Chief for Clinical Cancer Research and on the Board of Directors of the American Association for Cancer Research. Dr. Flaherty holds a B.S. from Yale University and an M.D. from Johns Hopkins University. Dr. Flaherty trained in internal medicine at Brigham and Women's Hospital and completed a medical oncology fellowship at the University of Pennsylvania.
    • Charles M. Baum, M.D., Ph.D. - Dr. Baum has been President and Chief Executive Officer and Board Member of Mirati Therapeutics for the last eight years. Under his leadership, he transformed Mirati into a world class precision oncology company focused on translating drug discovery and research into novel therapeutics that target the genetic and immunologic drivers of various cancers. Prior to joining Mirati, Dr. Baum was Senior Vice President for Biotherapeutic Clinical Research within Pfizer's Worldwide Research & Development division and held multiple roles including Vice President and Head of Oncology Development and as Chief Medical Officer for Pfizer's Biotherapeutics and Bioinnovation Center. He was responsible for the development of Pfizer's oncology portfolio, including axitinib (Inlyta®), crizotinib (Xalkori®) and the approval of sunitinib (Sutent®). Prior to joining Pfizer, Dr. Baum oversaw the Phase I-IV development of several oncology compounds at Schering-Plough, including temozolomide (Temodar®) for the treatment of patients with advanced brain tumors. Dr. Baum has received research support from the National Institutes of Health and the American Cancer Society, published more than 50 peer-reviewed manuscripts, and holds a number of patents and patent applications. Dr. Baum currently serves on the board of directors of Immunomedics and BCTG Acquisition Corp. Dr. Baum holds an M.D. and a Ph.D. from Washington University School of Medicine and completed his post-graduate training at Stanford University.
    • Kipp Weiskopf, M.D., Ph.D. - Dr. Weiskopf is a co-founder of ALX Oncology and a Whitehead Fellow at the Whitehead Institute for Biomedical Research. He is a leader in the field of macrophage-directed therapies and he oversees a research laboratory that studies novel macrophage and myeloid immune checkpoints. Dr. Weiskopf is concurrently appointed as a Hematology and Oncology fellow at the Dana-Farber Cancer Institute. Dr. Weiskopf is an inventor on 12 U.S. patents and patent applications pertaining to macrophage-directed therapies, including the engineered SIRP variants that underlie the development of ALX148. He is also the recipient of the Churchill Scholarship, the National Cancer Institute Ruth L. Kirschstein National Research Service Award and the Harold M. Weintraub Graduate Student Award and received first place in the Collegiate Inventors Competition. Dr. Weiskopf holds a B.A. from Amherst College, an M.Phil. from University of Cambridge, and an M.D. and Ph.D. from Stanford University. Dr. Weiskopf trained in internal medicine at Brigham and Women's Hospital.

    About ALX Oncology

    ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to advance ALX148 into clinical development for the treatment of myelodysplastic syndromes and to continue clinical development for the treatment of a range of solid tumor indications. For more information, please visit ALX Oncology's website at https://www.alxoncology.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding the Company's clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on August 27, 2020, and other documents that ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alx@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  34. BURLINGAME, Calif., Sept. 22, 2020 (GLOBE NEWSWIRE) -- ALX Oncology (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced it has entered into a clinical trial collaboration with Merck, known as MSD outside the United States and Canada, to evaluate the combination of ALX148, an investigational next generation CD47 blocker, and KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of patients with Head & Neck Squamous Cell Carcinoma (HNSCC).

    Under the terms of the agreement, ALX Oncology will conduct a Phase 2 program comprising two separate Phase 2 studies. The first study will evaluate the efficacy of ALX148 in combination with KEYTRUDA for the…

    BURLINGAME, Calif., Sept. 22, 2020 (GLOBE NEWSWIRE) -- ALX Oncology (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced it has entered into a clinical trial collaboration with Merck, known as MSD outside the United States and Canada, to evaluate the combination of ALX148, an investigational next generation CD47 blocker, and KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of patients with Head & Neck Squamous Cell Carcinoma (HNSCC).

    Under the terms of the agreement, ALX Oncology will conduct a Phase 2 program comprising two separate Phase 2 studies. The first study will evaluate the efficacy of ALX148 in combination with KEYTRUDA for the first line treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study will evaluate ALX148 in combination with KEYTRUDA and standard chemotherapy for the first line treatment of patients with metastatic or unresectable, recurrent HNSCC.

    These new studies will be initiated based on promising data from ALX148 in combination with pembrolizumab generated by ALX Oncology in a Phase 1b trial evaluating patients with HNSCC that was the basis for ALX148's Fast Track Approval granted by the U.S. Food and Drug Administration. Phase 1b trial results presented at ASCO 2020 showed that patients with HNSCC who had progressed on prior platinum therapy and who had never received a checkpoint inhibitor treated with ALX148 in combination with pembrolizumab demonstrated a 40% objective response rate (ORR), a median progression-free survival (PFS) of 4.6 months with a median overall survival (OS) that was not reached.

    "ALX148 was designed for use in combination to maximize clinical activity with a range of anti-cancer agents. We believe that blocking the CD47 myeloid checkpoint pathway bridges the innate and adaptive immune response against cancer to enhance efficacy. This collaboration builds upon the compelling combination activity observed in patients with ALX148 and KEYTRUDA," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Our goal is to transform treatment options for patients with cancer by developing ALX148 as a foundational checkpoint immunotherapy."

    ALX Oncology owns worldwide commercial rights to ALX148.

    KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

    About ALX Oncology

    ALX Oncology is a publicly-traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to advance ALX148 into clinical development for the treatment of myelodysplastic syndromes and to continue clinical development for the treatment of a range of solid tumor indications.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology Holdings Inc.'s (the "Company") beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding the Company's continued reliance on third parties to conduct clinical trials of ALX148, the Company's expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148, the design, progress and timing of clinical trials for ALX148, including enrollment and its regulatory plans, and the ability of the Company's clinical trials to demonstrate the safety and efficacy of ALX148. These and other risks are described more fully in the Company's filings with the Securities and Exchange Commission ("SEC"), including the Company's Quarterly Report on Form 10-Q, filed with the SEC on August 27, 2020, and other documents the Company subsequently files with the SEC from time to time. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:
    
    Peter Garcia
    CFO, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212) 600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  35. BURLINGAME, Calif., Sept. 17, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that it will be added as a member of the Russell 2000® and 3000® Indexes, effective after the U.S. market opens tomorrow, September 18, 2020, as a part of Russell's quarterly additions of select initial public offering ("IPO") companies.

    "We are pleased to join the Russell Indexes within just two months of our IPO," said Peter Garcia, Chief Financial Officer of ALX Oncology. "Our inclusion validates the potential we believe investors see in ALX Oncology and will further increase the overall awareness and visibility…

    BURLINGAME, Calif., Sept. 17, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that it will be added as a member of the Russell 2000® and 3000® Indexes, effective after the U.S. market opens tomorrow, September 18, 2020, as a part of Russell's quarterly additions of select initial public offering ("IPO") companies.

    "We are pleased to join the Russell Indexes within just two months of our IPO," said Peter Garcia, Chief Financial Officer of ALX Oncology. "Our inclusion validates the potential we believe investors see in ALX Oncology and will further increase the overall awareness and visibility of our stock within the investment community."

    The Russell U.S. indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider. 

    About ALX Oncology

    ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to advance ALX148 into clinical development for the treatment of myelodysplastic syndromes and to continue clinical development for the treatment of a range of solid tumor indications. For more information, please visit ALX Oncology's website at https://www.alxoncology.com/.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding investor awareness of ALX Oncology's stock. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on August 27, 2020, and other documents that ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alx@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com 

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  36. BURLINGAME, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., President and Chief Executive Officer and other senior executives, will participate in two upcoming virtual investor conferences in September:

    Cantor Virtual Healthcare Conference
    Format: Fireside chat with Alethia Young, Director of Research
    Date: Tuesday, September 15, 2020
    Time: 1:20 PM Eastern Time
    Webcast link:  Available here

    H.C. Wainwright 22nd Annual Global Investment Conference
    Format: Corporate Presentation
    Date: Wednesday, September 16, 2020
    Time: 2:30 PM Eastern Time
    Webcast link…

    BURLINGAME, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., President and Chief Executive Officer and other senior executives, will participate in two upcoming virtual investor conferences in September:

    Cantor Virtual Healthcare Conference

    Format: Fireside chat with Alethia Young, Director of Research

    Date: Tuesday, September 15, 2020

    Time: 1:20 PM Eastern Time

    Webcast link:  Available here

    H.C. Wainwright 22nd Annual Global Investment Conference

    Format: Corporate Presentation

    Date: Wednesday, September 16, 2020

    Time: 2:30 PM Eastern Time

    Webcast link:  Available here

    Company management will also be participating in one-on-one investor meetings at both conferences.

    A live webcast of the events can also be accessed by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting the Investor Calendar under the "News & Events" tab. A replay of the webcasts will be archived for up to 90 days following the presentation dates.

    About ALX Oncology

    ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to advance ALX148 into clinical development for the treatment of myelodysplastic syndromes and to continue clinical development for the treatment of a range of solid tumor indications.

    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  37. Completed initial public offering of common stock on July 21, 2020, raising gross proceeds of $185.7 million

    Strengthened leadership team and expanded board of directors to support growth

    IND open for ALX148 in combination with azacitidine for first-line treatment of patients with higher risk myelodysplastic syndromes (MDS)

    BURLINGAME, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the second quarter ended June 30, 2020, and operational and clinical development highlights.

    "Our mission is to leverage the unique profile of ALX148…

    Completed initial public offering of common stock on July 21, 2020, raising gross proceeds of $185.7 million

    Strengthened leadership team and expanded board of directors to support growth

    IND open for ALX148 in combination with azacitidine for first-line treatment of patients with higher risk myelodysplastic syndromes (MDS)

    BURLINGAME, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the second quarter ended June 30, 2020, and operational and clinical development highlights.

    "Our mission is to leverage the unique profile of ALX148 to transform the lives of patients with cancer," said Jaume Pons, Ph.D., President and Chief Executive Officer of ALX Oncology. "We believe ALX148, our lead development candidate, is emerging as a next-generation checkpoint inhibitor designed to have high affinity for CD47 and to overcome hematologic toxicity limitations associated with other CD47 blocking approaches in the clinic. With the successful completion of our initial public offering in July, we have a strong cash position to advance ALX148 in multiple clinical trials for hematologic and solid tumor malignancies in combination with a number of leading anti-cancer agents. We are focused on executing our clinical development plans and look forward to providing more updates in the future."

    Operational Highlights:

    • Completed initial public offering ("IPO"). In July 2020, ALX Oncology closed an upsized IPO of 9,775,000 of its common stock, including the exercise in full of the underwriters' option, at a public offering price of $19.00 per share. The aggregate gross proceeds to ALX Oncology from the IPO were approximately $185.7 million, before deducting underwriting discounts and commissions and other offering expenses. The Company's common stock commenced trading on the Nasdaq Global Select Market under the ticker symbol "ALXO" on July 17, 2020.

       
    • Appointed Jeanne Jew as Chief Business Officer. In August 2020, Jeanne Jew was appointed Chief Business Officer of ALX Oncology. Ms. Jew brings to ALX Oncology over 25 years of business development and commercial planning experience in the biopharmaceutical industry, most recently serving as Senior Vice President of Business Development of Paratek Pharmaceuticals. 

       
    • Appointed New Director. In April 2020, Rekha Hemrajani, was appointed to the Company's Board of Directors, and serves as the Audit Committee chair and as a member of the Corporate Governance and Nominating Committee. Ms. Hemrajani has over 20 years of business development and financial expertise in the biotechnology industry, and most recently served as President and Chief Executive Officer at Aravive.

    Recent Clinical Developments for ALX148

    ALX148 is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. 

    • Opened Investigational New Drug ("IND") Application for ALX148 in combination with azacitidine for first-line treatment of patients with higher risk myelodysplastic syndromes (MDS): ALX Oncology submitted the IND in June 2020, and the FDA issued a "Study May Proceed" letter in July 2020. The Company expects patient enrollment to begin in the fourth quarter of 2020.
    • Presented Preliminary Phase 1 Study Results of ALX148 in Combination with Rituximab in Patients with Refractory Non-Hodgkin Lymphoma. In June 2020, ALX Oncology presented preliminary results from the fully enrolled ALX148 plus rituximab combination cohort of the Phase 1 clinical program at the 25th Annual Congress of European Hematology Association [abstract #EP1247]. Thirty-three patients with relapsed or refractory non-Hodgkin Lymphoma (NHL) were administered ALX148 at 10 or 15 mg/kg once per week in combination with standard rituximab regimen. No exposure-dependent cytopenias were observed, and a greater response rate was observed in the higher dosing cohort of heavily pre-treated subjects with NHL.

       
    • Presented Phase 1 Study Results of ALX148 in Combination with Standard Anti-Cancer Antibodies and Chemotherapy Regimens in Patients with Advanced Solid Tumors. In May 2020, ALX Oncology announced final results from the fully enrolled ALX148 plus pembrolizumab and ALX148 plus trastuzumab portions of the Phase 1 clinical trial at the 2020 American Society of Clinical Oncology Annual Meeting [Abstract #3056]. Eighty-nine patients with advanced solid tumors were administered ALX148 in combination with standard regimens of: 1) pembrolizumab, 2) trastuzumab, 3) pembrolizumab plus 5-fluorouracil plus platinum, or 4) trastuzumab plus ramucirumab plus paclitaxel. Expansion cohorts were comprised of patients with previously treated advanced head and neck squamous cell carcinoma (HNSCC) and advanced gastric/gastroesophageal junction cancer (G/GEJ) demonstrated objective responses. ALX148 displayed a favorable tolerability profile with no exposure-dependent cytopenia observed across the dose range evaluated. Preliminary data suggest that ALX148 can be combined with chemotherapy-containing regimens with objective responses observed in patients with HNSCC and G/GEJ disease. Future clinical development will focus upon evaluating these combinations in patients with previously untreated disease as well as later line disease.

    Second Quarter 2020 Financial Results:

    • Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2020, were $98.1 million. Including the net proceeds from the Company's IPO of $172.7 million, after deducting underwriting discounts and commissions, the Company believes its cash balance is sufficient to fund planned operations through 2023.

       
    • Related-party Revenue: Related-party revenue for the quarter ended June 30, 2020, was $0.5 million compared to $1.3 million for the corresponding period in 2019. The decrease in related-party revenue relates to decreased fee-for-service hours provided to Tallac Therapeutics ("Tallac") as a result of winding down the research and development agreement, which terminated in July 2020. Due to the changes in the arrangement with Tallac, the Company will no longer recognize any related-party revenue beginning with the third quarter of 2020.  

       
    • Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of ALX148.  These expenses for the three months ended June 30, 2020, were $7.7 million, compared to $3.6 million for the three months ended June 30, 2019. The increase of $4.0 million was primarily attributable to an increase of $2.3 million in non-cash stock-based compensation expense, mainly resulting from modification of awards for former employees that transferred to Tallac, as well as increased clinical supply manufacturing costs of $1.4 million and increased clinical development personnel costs of $0.3 million.

       
    • General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended June 30, 2020, were $3.2 million, compared to $0.7 million for the prior-year period. This increase of $2.5 million was primarily due to increased headcount, and increased accounting, legal and other professional fees of $1.4 million to support the transition to a public company, and $0.6 million related to non-cash stock-based compensation expense from the modification of awards for a former employee that transferred to Tallac and additional stock option awards granted during the second quarter.

       
    • Net loss: Net loss attributable to common stockholders was $14.0 million and $5.2 million for the three months ended June 30, 2020, and 2019, respectively. Included in the $14.0 million loss for the three months ended June 30, 2020, was $2.6 million related to cumulative dividends allocated to preferred shareholders, which, along with prior cumulative dividends, were converted into common shares at the IPO. Non-GAAP net loss was $8.1 million and $4.1 million for the three months ended June 30, 2020, and 2019, respectively.  A reconciliation of GAAP to non-GAAP financial results can be found in a table at the end of this news release.

    About ALX Oncology

    ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to advance ALX148 into clinical development for the treatment of myelodysplastic syndromes and to continue clinical development for the treatment of a range of solid tumor indications.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on the Company's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include, but are not limited to, statements regarding the Company's financial condition, results of operations and sufficiency of its cash and cash equivalents to fund its planned operations as well as statements about the Company's expectations regarding its progress and timing of clinical trials for ALX148, including enrollment and its regulatory plans. These and other risks are described more fully in the Company's filings with the Securities and Exchange Commission ("SEC"), including the Company's Quarterly Report on Form 10-Q, filed with the SEC on August 27, 2020, and other documents the Company subsequently files with the SEC from time to time. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    ALX Oncology Holdings Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (unaudited)

    (in thousands, except share and per share amounts)

      THREE MONTHS ENDED  SIX MONTHS ENDED 
      JUNE 30,  JUNE 30, 
      2020  2019  2020  2019 
    Related-party revenue $ 527  $ 1,295  $ 1,182  $ 2,327 
    Operating expenses:                    
    Research and development   7,663    3,628    11,491    7,361 
    General and administrative   3,172    679    4,645    1,267 
    Cost of services for related-party revenue   479    1,177    1,075    2,115 
    Total operating expenses   11,314    5,484    17,211    10,743 
    Loss from operations   (10,787)   (4,189)   (16,029)   (8,416)
    Interest expense   (219)   -    (434)   - 
    Other expense, net   (305)   -    (298)   (2)
    Loss before income taxes   (11,311)   (4,189)   (16,761)   (8,418)
    Income tax provision   (20)   (8)   (24)   (17)
    Net loss and comprehensive loss   (11,331)   (4,197)   (16,785)   (8,435)
    Cumulative dividends allocated to preferred

       stockholders
       (2,641)   (981)   (4,624)   (1,886)
    Net loss attributable to common stockholders $ (13,972) $ (5,178) $ (21,409) $ (10,321)

    Condensed Consolidated Balance Sheet Data

    (unaudited)

    (Amount in thousands)

      June 30,

    2020
      December 31,

    2019
     
    Assets        
    Cash and cash equivalents $98,103  $9,017 
    Total assets $103,112  $10,676 
    Total liabilities $12,467  $10,952 
    Convertible preferred stock $175,043  $70,363 
    Total stockholders' deficit $(84,398) $(70,639)

    GAAP to Non-GAAP Reconciliation

    (unaudited)

    (in thousands)

      Three months ended  Six months ended 
      June 30,  June 30, 
      2020  2019  2020  2019 
    GAAP net loss, as reported $(11,331) $(4,197) $(16,785) $(8,435)
    Adjustments:                
    Stock-based compensation  2,853   60   3,004   136 
    Accretion of term loan  113   -   221   - 
    Mark-to-market adjustment on financial instruments  308   -   408   - 
    Total adjustments  3,274   60   3,633   136 
    Non-GAAP net loss $(8,057) $(4,137) $(13,152) $(8,299)

    Use of Non-GAAP Financial Measures

    We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and diluted earnings per share, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

    "Non-GAAP net loss" is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) accretion on term loan and (3) mark-to market adjustment on financial instruments (which include preferred stock warrants and derivatives) within our reconciliation of our GAAP to Non-GAAP net loss. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

    Investor Contact:
    
    Peter Garcia
    Chief Financial Officer, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com
    
    Argot Partners
    (212)-600-1902
    alxoncology@argotpartners.com
    
    Media Contact:
    
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com

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  38. BURLINGAME, Calif., July 21, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the closing of its initial public offering of 9,775,000 shares of common stock, including the full exercise of the underwriters' option to purchase up to 1,275,000 additional shares of common stock, at a public offering price of $19.00 per share. The aggregate gross proceeds to ALX Oncology from the offering were approximately $185.7 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by ALX Oncology. 

    ALX Oncology's common stock began trading…

    BURLINGAME, Calif., July 21, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the closing of its initial public offering of 9,775,000 shares of common stock, including the full exercise of the underwriters' option to purchase up to 1,275,000 additional shares of common stock, at a public offering price of $19.00 per share. The aggregate gross proceeds to ALX Oncology from the offering were approximately $185.7 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by ALX Oncology. 

    ALX Oncology's common stock began trading on The Nasdaq Global Select Market on July 17, 2020 under the ticker symbol "ALXO."

    Jefferies, Credit Suisse, Piper Sandler and Cantor acted as joint book-running managers for the offering. LifeSci Capital acted as lead manager for the offering.

    Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on July 16, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com; Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at prospectus@psc.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor New York, New York 10022, or by email at prospectus@cantor.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About ALX Oncology

    ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to advance ALX148 into clinical development for the treatment of myelodysplastic syndromes and to continue clinical development for the treatment of a range of solid tumor indications.

    Media Contact
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com
    
    Investor Contact
    Peter Garcia
    CFO, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com

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  39. BURLINGAME, Calif., July 16, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the pricing of its initial public offering of 8,500,000 shares of its common stock at a public offering price of $19.00 per share. All of the shares are being offered by ALX Oncology. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by ALX Oncology, are expected to be $161.5 million. The shares are expected to begin trading on the Nasdaq Global Market on July 17, 2020, under the ticker symbol "ALXO." The offering is expected to close on July 21, 2020…

    BURLINGAME, Calif., July 16, 2020 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the pricing of its initial public offering of 8,500,000 shares of its common stock at a public offering price of $19.00 per share. All of the shares are being offered by ALX Oncology. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by ALX Oncology, are expected to be $161.5 million. The shares are expected to begin trading on the Nasdaq Global Market on July 17, 2020, under the ticker symbol "ALXO." The offering is expected to close on July 21, 2020, subject to the satisfaction of customary closing conditions. In addition, ALX Oncology has granted the underwriters a 30-day option to purchase up to an additional 1,275,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. 

    Jefferies, Credit Suisse, Piper Sandler and Cantor are acting as joint book-running managers for the offering. LifeSci Capital is acting as lead manager for the offering.

    Registration statements relating to these securities became effective on July 16, 2020. The offering will be made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com; Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at prospectus@psc.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor New York, New York 10022, or by email at prospectus@cantor.com. Copies of the final prospectus, when available, related to the offering will be available at www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About ALX Oncology

    ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to advance ALX148 into clinical development for the treatment of myelodysplastic syndromes and to continue clinical development for the treatment of a range of solid tumor indications. 

    Media Contact
    Karen Sharma
    MacDougall
    (781) 235-3060
    alx@macbiocom.com
    
    Investor Contact
    Peter Garcia
    CFO, ALX Oncology
    (650) 466-7125 Ext. 113
    peter@alxoncology.com

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