HPV16 positive Oropharyngeal Cancer

PRESS RELEASE EnnoDC unveils the next generation of dendritic cell-targeting immunotherapies supported by new leadership and an evolved strategy Versatile new technology featuring an antibody fused with an antigen, harnesses the power of immunotherapy and vaccines by stimulating dendritic cells through CD40 to deliver a targeted and effective immune response for cancer and infectious diseasesNew approach aims to reduce harmful side effects and optimize the immune system's ability to detect, combat, and prevent cancer and infectious diseases Dr. Jean-Paul Kress, former Chief Executive Officer of MorphoSys, joins as Board Chairman; Christophe Hubert, industry veteran and entrepreneur joins as Chief Executive Officer; with co-founder Prof. Yves Levy, as Chief Medical and Scientific Officer and Dr. Hatem Azim joining as Chief Medical Officer Oncology Paris, France, 26 September 2024 – EnnoDC (or “the Company”), a clinical-stage biotech company pioneering the development of first-in-class dendritic cell-targeting immunotherapies, unveils today its promising pipeline of preclinical and clinical-stage programs for cancer and infectious diseases. EnnoDC’s technology, developed by the Vaccine Research Institute (VRI) of Inserm (French National Institute for health and Medical Research) and its spin-off LinKinVax, combines an antibody fused with an antigen to stimulate Dendritic Cells (DCs) through CD40 and deliver a targeted and effective immune response. The technology has already entered clinical development in the field of infectious diseases. EnnoDC is now extending the use of its technology to expand its portfolio of immunotherapies to fight cancers. EnnoDC is one of the innovative projects selected and supported by the Paris Saclay Cancer Cluster, whose mission is to accelerate the development of innovation in oncology. Immunotherapies, which enable a patient’s immune system to recognize and target cancer cells, have made a significant difference to cancer patients over the last decade. However, many patients fail to mount a robust and durable immune response, resistance can develop, and immune-related adverse events and systemic toxicity can be severe. DCs are crucial for the development of immune memory to identify and eliminate threats such as viruses and cancer. They form the basis of EnnoDC’s first-in-class immunotherapy platform by directly targeting DCs through a unique anti-CD40 antibody fused with tumor-specific or a pathogenic antigen, driving a highly specific immune response. EnnoDC’s evolution is accompanied by a change of leadership with the appointment of Christophe Hubert as the new Chief Executive Officer. Christophe is an international business executive and biotech entrepreneur, with over 25 years’ experience in the pharmaceutical and biotech industry. He previously served as SVP of Asia Merck and was the founder of three biotech companies. Christophe Hubert, Chief Executive Officer of EnnoDC, commented: “I am honored to lead the team at EnnoDC as it pioneers the development of the next generation of immunotherapies for cancer and infectious diseases. This is a fantastic opportunity to translate some of the best research within the immunotherapy space into meaningful change for patients.” Dr Jean-Paul Kress has joined EnnoDC as its Chairman of the Board and brings over 25 years of experience driving transformative change in the biotech and pharmaceutical industries. As the former CEO of MorphyoSys, he has completed two significant transactions: the acquisition of Constellation Pharmaceuticals in 2021 and the acquisition of MorphoSys by Novartis in 2024. Dr. Jean-Paul Kress, Chairman of EnnoDC added: “My time at MorphoSys has given me a deep appreciation of the complexities and challenges of developing effective treatments for cancer. EnnoDC’s new technology at the forefront of medicine drew me to the role of Chairman as I see great promise in the scientific approach which has already shown promise in the clinic. I look forward to working with the Board and management.” Dr Hatem Azim has also joined EnnoDC as the Chief Medical Officer Oncology and is an expert in cancer and drug development. His previous research focused on breast cancer and early drug development, with his contributions shaping international guidelines. This new clinical oncology expertise will be particularly useful with EnnoDC’s additional focus on developing immunotherapies for cancer. Pr. Yves Lévy, co-founder, Chief Medical and Scientific Officer at EnnoDC concluded: “Clinical progress and technological development over the last ten years in the fields of infectious diseases and cancer in an academic laboratory like the Vaccine Research Institute (VRI), supported by its supervisory authorities, is a source of great pride for all researchers. However, challenges remain immense and we are aware of this. The environment and resources provided by EnnoDC will be essential to succeed for the benefit of patients.” EnnoDC has an extensive pipeline of clinical and preclinical stage assets in HPV-induced cancers, prostate cancer and in infectious diseases. A Phase I/II clinical trial with CD40.HVac is currently running in 24 HPV16+ oropharyngeal cancer patients at Gustave Roussy Cancer Campus and Curie Institute in France. EnnoDC is planning to initiate in Q2 2025 a Phase IIb in HPV16+ oropharyngeal cancer patients and is planning a pre-IND filing for a Phase I/IIa trial in prostate cancer early 2027. A Phase I/IIa clinical trial for a prophylactic COVID-19 vaccine is ongoing and a Phase I clinical trial with a HIV vaccine has been completed. * EnnoDC is the trading name of LinKinVax Europe SAS. -Ends- For more information please contact: EnnoDC Christophe Hubert, CEOinfo@EnnoDC.com ICR Consilium Ashley Tapp / Jonathan Edwards / Kumail Waljee EnnoDC@consilium-comms.comTel: +44 (0) 20 3709 5700 About EnnoDC EnnoDC, the trading name of LinKinVax, is a clinical-stage biotech company pioneering the development of first-in-class Dendritic Cell (DC)-targeting immunotherapies. Through our versatile DC-targeting immunotherapy platform we are developing CD40-specific monoclonal antibodies fused with pathogenic antigens to induce a highly specific, safe, broad, and long-lasting immune response to combat diseases like cancer and infectious diseases. The Company currently has three active clinical trials in various stages of clinical development, addressing oncology and infectious disease indications. Its lead asset, CD40HVac is currently in a Phase I/IIa clinical trial for HPV16+ oropharyngeal cancer patients. EnnoDC is a spin out from the Vaccine Research Institute (VRI), an institute of INSERM (the French National Institute of Health and Medical Research) and is supported by longstanding investors and internationally renowned key opinion leaders who contribute their expertise in the clinical development of EnnoDC’s assets and help explore the expansive therapeutic potential of its innovative platform. Find out more online at: http://www.EnnoDC.com Follow us on X and LinkedIn

New Leadership Appointments; Positive Clinical and Regulatory Reports for the Lead Product Candidate, HB-200 (eseba-vec); On track to initiate the Phase 2/3 “AVALON-1” study with eseba-vec in Q4 2024 ASCO 2024 Presentation: Reported best-in-class Phase 2 data for first-line HPV16+ head and neck cancer patients treated with eseba-vec (formerly HB-200) in combination with pembrolizumab during oral presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual MeetingRegulatory Progress: Announced alignment with U.S. Food and Drug Administration (FDA) for the AVALON-1 Phase 2/3 pivotal trial design and protocol for eseba-vec, in combination with pembrolizumab for the first-line treatment of patients with HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC)PRIME Designation: Announced that EMA has granted PRIME designation for the investigational product eseba-vec for the treatment of patients with HPV16+ recurrent or metastatic PD-L1 CPS ≥ 20 OPSCC in the first line setting.New IND Clearance in Oncology: Received FDA clearance for Investigational New Drug (IND) application for HB-700 for the treatment of KRAS mutated cancers Initiation of HIV Study with Partner, Gilead: Dosed first person in Phase 1b clinical trial of HB-500 for the treatment of human immunodeficiency virus (HIV); achieved $5 million milestone payment under collaboration and license agreement with Gilead Sciences, Inc. (Gilead) NEW YORK and VIENNA, Aug. 08, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today reported financial results and recent business highlights for the second quarter of 2024. “It is an honor to be appointed CEO of HOOKIPA at such an important time for the Company. I am optimistic about the Company’s prospects, based on the strength of the pipeline, early clinical data, and the experience and dedication of the accomplished team we have in place,” said Malte Peters, Chief Executive Officer of HOOKIPA. “Our best-in-class Phase 2 data that were presented at ASCO has generated significant momentum among investigators and this has enhanced the pace of enrollment in our ongoing Phase 2 study. In the meantime, preparations are well underway for our AVALON-1 pivotal adaptive Phase 2/3 trial of eseba-vec, expected to be initiated in the fourth quarter of this year.” “We have important work ahead of us in the second half of this year,” added Terry Coelho, Executive Vice President and Chief Financial Officer of HOOKIPA. “We are keenly focused on clinical execution and operational excellence, and I look forward to working closely with Malte to explore opportunities to ensure that we are sufficiently capitalized to reach these goals.” Anticipated Catalysts Oncology Eseba-vec (HPV16+ OPSCC): AVALON-1 pivotal study start (Q4 2024)HB-700 (KRAS): Partnering and collaborations under evaluation Infectious Disease: Partnered with Gilead HB-400 (HBV): Complete Phase 1b enrollment and initiate Phase 2 study (timing to be determined by Gilead)HBV-500 (HIV): Actively enrolling Phase 1b trial Business Highlights and Recent Developments Oncology Eseba-vec: HOOKIPA is on track to start a seamless pivotal Phase 2/3 trial of eseba-vec in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive (HPV16+) recurrent/metastatic PD-L1 CPS ≥ 20 OPSCC in the first line setting. The AVALON-1 Phase 2/3 trial design and protocol has been aligned with the FDA with a path to potential accelerated approval.The Company anticipates the trial will start in the fourth quarter of 2024.Updated data from a Phase 2 trial of eseba-vec in combination with pembrolizumab were reported at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting. The data strongly validate the Company’s clinical development plan. HB-700: The HB-700 program is a novel arenaviral immunotherapy for KRAS-mutated cancers, including the five mutations that are the primary causes of lung, pancreatic and colon cancers. The Company received clearance from the FDA for its IND application for HB-700 for the treatment of KRAS-mutated cancers. Effective April 25, 2024, HOOKIPA regained full control of the associated intellectual property portfolio and has full collaboration and licensing rights for this program. Preclinical data published at the ASCO 2024 Annual Meeting demonstrated that HB-700 was well tolerated and induced KRAS mutation specific T cell responses in HLA transgenic mice. Infectious Disease HB-400: HB-400 is an investigational therapeutic vaccine for the treatment of chronic hepatitis B (HBV) and is currently being evaluated in a Phase 1 trial. HB-400 is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead. Gilead is solely responsible for further development and commercialization of the HBV product candidate.HB-500: HB-500 is an investigational therapeutic vaccine for the treatment of HIV, also partnered with Gilead. On July 1, 2024, HOOKIPA dosed the first eligible person living with HIV in the Phase 1b clinical trial of HB-500. Under the collaboration agreement with Gilead, HOOKIPA received a $5 million milestone payment associated with the first dosing for this trial.HOOKIPA and Gilead also published two peer-reviewed preclinical research papers on HB-500 during the quarter: In articles published in the Journal of Virology, and Vaccines, research demonstrated robust immunogenicity in non-human primates driven by administration of HB-500. The research also demonstrated the potential of immunogenicity of HB-500 to be enhanced when combined with a Flt3L-Fc fusion protein.These findings show the potential that HB-500 can be a critical component of a curative treatment for HIV. Corporate and Financial Updates Corporate Highlights Reverse Split: On July 9, 2024, the Company effected a reverse stock split of the outstanding shares of its common stock on a one-for-ten (1:10) basis. The reverse stock split is part of the Company’s plan to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.New Leadership Team: On July 22, 2024, the Board of Directors appointed Malte Peters, M.D., as Chief Executive Officer and Terry Coelho as Executive Vice President and Chief Financial Officer to lead the Company through its next phase of development and realize the significant opportunity eseba-vec represents.Board Appointment: Sean A. Cassidy was appointed to the Board of Directors on July 22, 2024, and will serve as the chair of the Audit Committee and member of the Compensation Committee. Financial Highlights Roche: In April, HOOKIPA received a final $10.0 million milestone payment under its now-terminated HB-700 collaboration agreement with Roche. The success-based milestone payment was achieved in connection with HOOKIPA’s submission of an IND application for HB-700 for the treatment of KRAS mutated tumors.Gilead: In July, HOOKIPA received a $5.0 million milestone payment under its collaboration and license agreement with Gilead. The success-based milestone payment was achieved in connection with the dosing of the first person in a Phase 1b clinical trial of HB-500 for the treatment of HIV. Second Quarter 2024 Financial Results Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of June 30, 2024 was $77.4 million compared to $117.5 million as of December 31, 2023. The decrease was primarily attributable to cash used in operating activities. Revenue: Revenue was $1.3 million for the three months ended June 30, 2024, compared to $2.7 million for the same period in 2023. The decrease was primarily due to lower partial recognition of the upfront and milestone payments under the Roche collaboration as a result of the termination of the collaboration agreement with Roche. Research and Development Expenses: HOOKIPA’s research and development expenses were $19.7 million for the three months ended June 30, 2024, and June 30, 2023, respectively. The primary changes in research and development expenses were lower personnel-related and laboratory-related expenses as well as lower manufacturing expenses, offset by higher clinical study expenses for the eseba-vec program. General and Administrative Expenses: General and administrative expenses amounted to $3.9 million for the three months ended June 30, 2024, compared to $4.4 million for the same period in 2023. The primary driver of the decrease in general and administrative expenses was a decrease in personnel-related expenses and in professional and consulting fees. Restructuring Expenses: Restructuring expenses amounted to $0.1 million for the three months ended June 30, 2024, and resulted from severance and other personnel costs as well as consulting costs associated with the Company’s restructuring plan announced in January 2024. The restructuring plan was completed as of June 30, 2024. Net Loss: HOOKIPA’s net loss was $19.1 million for the three months ended June 30, 2024, compared to a net loss of $18.0 million for the same period in 2023. This increase was primarily due to lower revenues resulting from lower partial recognition of the upfront and milestone payments under the terminated Roche Collaboration. HOOKIPA Pharma Inc.Consolidated Statements of Operations (Unaudited)(In thousands, except share and per share data) Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023Revenue from collaboration and licensing $1,290 $2,679 $37,889 $5,855 Operating expenses: Research and development (19,749) (19,706) (39,917) (40,637)General and administrative (3,945) (4,445) (8,001) (9,347)Restructuring (54) — (1,323) — Total operating expenses (23,748) (24,151) (49,241) (49,984)Loss from operations (22,458) (21,472) (11,352) (44,129)Total interest, other income and taxes, net 3,363 3,456 6,640 6,433 Net loss $(19,095) $(18,016) $(4,712) $(37,696)Net loss per share — basic and diluted (1.52) (2.18) (0.38) (4.86) Condensed Balance Sheets (Unaudited)(In thousands) As of As of June 30, December 31, 2024 2023Cash, cash equivalents and restricted cash $77,353 $117,521 Total assets 125,046 161,337 Total liabilities 38,982 71,480 Total stockholders’ equity 86,064 89,857 About HOOKIPAHOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, KRAS-mutated cancers, and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead. Find out more about HOOKIPA online at www.hookipapharma.com. Forward Looking StatementsCertain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “anticipates”, “believes,” “expects,” “plans,” “potential,” “will,” “would” or similar expressions and the negative of those terms. Forward-looking statements in this press release include HOOKIPA’s statements regarding the potential of its product candidates to positively impact quality of life and alter the course of disease in the patients it seeks to treat, HOOKIPA’s plans, strategies, expectations and anticipated milestones for its preclinical and clinical programs, including the timing of initiating clinical trials (including the Phase 2/3 trial of eseba-vec) and patient enrollment, the availability and timing of results from preclinical studies and clinical trials, the timing of regulatory filings, the expected safety profile of HOOKIPA’s product candidates, and the probability of successfully developing and receiving regulatory approval for its product candidates. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including HOOKIPA’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs, the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including those for eseba-vec, HB-700, HB-400 and HB-500, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, HOOKIPA’s ability to successfully establish, protect and defend its intellectual property, HOOKIPA’s ability to effectively transition the recent senior executive leadership changes and HOOKIPA’s ability to continue as a going concern and other matters that could affect the sufficiency of existing cash to fund operations. HOOKIPA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see HOOKIPA’s Annual Report on Form 10-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in HOOKIPA’s subsequent filings with the Securities and Exchange Commission, which are available on the SEC’s website at https://sec.gov and HOOKIPA’s website at www.hookipapharma.com. All information in this press release is as of the date of the release, and HOOKIPA undertakes no duty to update this information unless required by law. Availability of Other Information About HOOKIPAInvestors and others should note that we announce material financial information to our investors using our investor relations website, www.ir.hookipapharma.com, SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our investors and the public about our company, our services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the social media channels listed on our investor relations website. For further information, please contact: Investors & MediaMichael Kaisermichael.kaiser@hookipapharma.com +1 (917) 984 7537

SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported financial results for the second quarter ended June 30, 2024, and provided a corporate update. “Our team continues to make significant progress in the advancement of our evorpacept development pipeline across multiple oncology indications,” said Jason Lettmann, Chief Executive Officer of ALX Oncology. “Data readouts across our Phase 1 and 2 clinical trials highlight the potential of evorpacept as a disruptive therapy in combination with anti-cancer antibodies and ADCs. In particular, the recent ASPEN-06 Phase 2 clinical trial readout in patients with previously treated HER2-positive advanced gastric cancer is a significant growth milestone for the Company. We are well positioned to build on our second quarter achievements and continue to advance toward our anticipated milestones in the months ahead.” Second Quarter 2024 Highlights and Recent Developments Evorpacept Clinical Development Program On July 31, ALX Oncology reported topline data from the multi-center, international ASPEN-06 Phase 2 clinical trial evaluating evorpacept in combination with trastuzumab, CYRAMZA® (ramucirumab) and paclitaxel (“Evo-TRP”) against trastuzumab, CYRAMZA (ramucirumab) and paclitaxel (“TRP”) for the treatment of patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer, where all patients had received an anti-HER2 agent in prior lines of therapy (NCT05002127). Results demonstrated that evorpacept improved tumor response in patients with HER2-positive gastric/GEJ cancer, becoming the first CD47 blocker to show promising and durable response with a well-tolerated safety profile in a prospective randomized study.The primary endpoint was confirmed overall response rate (“ORR”) with key secondary endpoints being safety, median duration of response (“mDOR”), progression-free survival (“PFS”) and overall survival (“OS”). Primary study objectives were to compare confirmed ORR of Evo-TRP to an assumed ORR of 30% for CYRAMZA (ramucirumab) and paclitaxel (“RP”) with one-sided alpha error of 0.025, and to identify a clinically meaningful contribution of Evo to TRP in ORR (delta >10%).Evo-TRP achieved a confirmed ORR of 40.3% compared to 26.6% for the TRP control arm and demonstrated a mDOR of 15.7 months compared to 7.6 months in the intent to treat population (“ITT”) (N=127). The primary analysis of the ITT compared Evo-TRP to an assumed RP control ORR of 30% (p=0.095). When a comparison of Evo-TRP to the observed TRP control arm ORR of 26.6% was explored using a similar testing procedure, a p-value of p=0.027 was observed. Secondary endpoints of PFS and OS were immature at the time of analysis.Evo-TRP combination showed the greatest response with an ORR of 54.8% compared to 23.1% in the TRP control arm in a pre-specified population of patients with fresh HER2-positive biopsies (n=48). In this population, Evo-TRP compared to an assumed RP control ORR of 30% yielded a p-value of p=0.030 . When Evo-TRP compared to the observed TRP ORR of 23.1% was explored using a similar testing procedure, a p-value of p=0.0038 was observed, suggesting HER2-expression strongly correlates with evorpacept efficacy and validating its mechanism of action. In June, ALX Oncology presented the first evorpacept combination data with an antibody-drug conjugate (“ADC”) from the Phase 1 ASPEN-07 clinical trial in patients with advanced urothelial cancer at the 2024 American Society of Cancer Oncology (“ASCO”) Annual Meeting. This open-label, single-arm, clinical trial of evorpacept in combination with an approved ADC, PADCEV® (enfortumab vedotin), demonstrated promising activity and was generally well tolerated in patients with locally advanced or metastatic urothelial cancer (NCT05524545). In April, ALX Oncology reported positive data from the ongoing Phase 1/2 investigator-sponsored clinical trial of evorpacept in combination with standard-of-care in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NCT05025800). The combination achieved promising initial activity with a best ORR of 94% and a complete response rate ("CRR") of 83% in patients with indolent R/R B-NHL (compared to rituximab and lenalidomide historical CRR benchmark of 34%). In April, ALX Oncology announced the initiation of a Phase 2 investigator-sponsored trial of neoadjuvant radiation and evorpacept in combination with KEYTRUDA® (pembrolizumab) in patients with previously untreated and early-stage locally advanced, resectable, human papillomavirus-mediated oropharyngeal cancer (NCT05787639). Conference Presentations At the 2024 ASCO Annual Meeting, ALX Oncology presented the first evorpacept combination data with an ADC from the Phase 1 ASPEN-07 clinical trial in patients with locally advanced or metastatic urothelial cancer. In the open-label, single-arm, clinical trial of evorpacept in combination with an approved ADC, PADCEV® (enfortumab vedotin), demonstrated promising activity and was generally well tolerated in patients. The Company also presented results of an investigator-sponsored, Phase 2 study of evorpacept, cetuximab and pembrolizumab in patients with refractory microsatellite stable metastatic colorectal cancer. At the 2024 American Association of Cancer Research Annual Meeting, ALX Oncology presented two evorpacept clinical abstracts including: Phase 1 investigator-initiated trial of evorpacept, lenalidomide and rituximab for patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Phase 1 study of azacitidine in combination with evorpacept for higher-risk myelodysplastic syndrome (MDS) Board and Executive Appointments ALX Oncology strengthened the Company’s board and leadership team with the appointment of Alan Sandler, M.D., to its Board of Directors, and the addition of Allison Dillon, Ph.D., to its executive leadership team as Chief Business Officer. Upcoming Clinical Milestones for Evorpacept’s Development Pipeline ALX Oncology is well-positioned to achieve numerous milestones across multiple oncology indications in its evorpacept clinical development program: Head and Neck Squamous Cell Carcinoma – Topline results from a Phase 2 randomized clinical trial of ASPEN-03 with KEYTRUDA (1H 2025)Head and Neck Squamous Cell Carcinoma – Topline results from a Phase 2 randomized clinical trial of ASPEN-04 with KEYTRUDA and chemotherapy (1H 2025)Gastric/GEJ Cancer – Updated results of ASPEN-06 Phase 2 clinical trial (1H 2025)Urothelial Cancer – Updated results from a Phase 1 clinical trial of ASPEN-07 in combination with PADCEV (1H 2025)Gastric/GEJ Cancer – Initiation of Phase 3 registrational randomized clinical trial for evorpacept (mid-2025) Breast Cancer – Topline results from a Phase 1b I-SPY TRIAL with ENHERTU® (fam-trastuzumab deruxtecan-nxki) (2H 2025) Second Quarter 2024 Financial Results: Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of June 30, 2024, were $186.2 million. The Company believes its cash, cash equivalents and investments, which includes the proceeds from sales under its at-the-market (“ATM”) offering in the first half of 2024 are sufficient to fund planned operations well into Q1 2026. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended June 30, 2024, were $34.7 million, compared to $29.5 million for the prior-year period. R&D expenses increased by $5.2 million during the three months ended June 30, 2024, compared to the three months ended June 30, 2023. The increase was primarily attributable to an increase of $1.7 million in preclinical costs for development of new targets, an increase of $1.2 million in personnel and related costs primarily driven by headcount growth, an increase of $1.8 million in stock-based compensation expense and an increase of $0.7 million in other research costs primarily due to absence of VAT refunds in the current quarter compared to prior year quarter.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, 2024, were $6.9 million, compared to $7.3 million for the prior year period. G&A expenses decreased by $0.4 million during the three months ended June 30, 2024, compared to the three months ended June 30, 2023. The decrease was primarily attributable to a decrease of $0.8 million in stock-based compensation expense primarily due to a change in classification from the comparative periods of stock-based compensation from G&A to R&D as described above under R&D expenses, offset by an increase of $0.3 million in other G&A costs from accounting consulting and personnel costs driven by headcount growth.Net loss: GAAP net loss was $39.4 million for the three months ended June 30, 2024, or ($0.76) per basic and diluted share, as compared to a GAAP net loss of $34.2 million for the three months ended June 30, 2023, or ($0.84) per basic and diluted share. Non-GAAP net loss was $32.1 million for the three months ended June 30, 2024, as compared to a non-GAAP net loss of $27.9 million for the three months ended June 30, 2023. 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 immune checkpoint inhibitor and bridge the innate and adaptive immune system. ALX Oncology’s lead product candidate, evorpacept, is a CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. To date, evorpacept has been dosed in over 500 subjects and has demonstrated promising activity and favorable tolerability profile across a range of hematologic and solid malignancies in combination with various leading anti-cancer antibodies. ALX Oncology is currently focusing on combining evorpacept with anti-cancer antibodies, ADCs, and PD-1/PD-L1 immune checkpoint inhibitors. 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. ALX ONCOLOGY HOLDINGS INC.Condensed Consolidated Statements of Operations(unaudited)(in thousands, except share and per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Operating expenses: Research and development$34,653 $29,482 $66,370 $54,245 General and administrative 6,872 7,295 12,917 14,735 Total operating expenses 41,525 36,777 79,287 68,980 Loss from operations (41,525) (36,777) (79,287) (68,980)Interest income 2,563 2,666 5,185 4,977 Interest expense (429) (372) (856) (759)Other (expense) income, net (8) 324 (22) 419 Net loss$(39,399) $(34,159) $(74,980) $(64,343)Net loss per share, basic and diluted$(0.76) $(0.84) $(1.47) $(1.57)Weighted-average shares of common stock used to compute net loss per shares, basic and diluted 51,831,157 40,875,457 50,969,089 40,869,021 Condensed Consolidated Balance Sheet Data(in thousands) June 30, December 31, 2024 2023 Cash, cash equivalents and investments$186,198 $218,147 Total assets$214,618 $242,553 Total liabilities$55,301 $52,841 Accumulated deficit$(561,252) $(486,272)Total stockholders’ equity$159,317 $189,712 GAAP to Non-GAAP Reconciliation (unaudited) (in thousands) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 GAAP net loss, as reported$(39,399) $(34,159) $(74,980) $(64,343)Adjustments: Stock-based compensation expense 7,252 6,237 14,283 12,588 Accretion of term loan discount and issuance costs 66 62 130 123 Total adjustments 7,318 6,299 14,413 12,711 Non-GAAP net loss$(32,081) $(27,860) $(60,567) $(51,632) 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 SEC 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 represents GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs. 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.