Ramucirumab

SOUTH SAN FRANCISCO, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer in new ways and extend patients’ lives, today reported financial results for the third quarter ended September 30, 2024, and provided a corporate update. “We made substantial clinical progress during the third quarter, most notably announcing topline data from our ASPEN-06 Phase 2 trial in which our lead candidate evorpacept became the first and only CD47-blocking agent to show a durable clinical benefit and a well-tolerated safety profile in a prospective randomized clinical trial,” said Jason Lettmann, Chief Executive Officer of ALX Oncology. “These results provided further validation for evorpacept’s novel mechanism of action and our robust evorpacept clinical program. We anticipate achieving several additional clinical milestones in the near-term that could advance evorpacept towards being a best-in-class, combinable therapeutic across a wide range of cancer types.” Third Quarter 2024 Highlights and Recent Developments Reported topline data results in July from the multi-center, international ASPEN-06 Phase 2 clinical trial (NCT05002127) evaluating evorpacept in combination with HERCEPTIN® (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. 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.Evo-TRP achieved a confirmed overall response rate (ORR) of 40.3% compared to 26.6% for the TRP control arm and demonstrated a median duration of response 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% 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 September, commenced patient dosing to investigate evorpacept plus SARCLISA® (isatuximab-irfc) and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) in the Sanofi-partnered arm of the randomized UMBRELLA phase 1/2 clinical study. Sanofi is conducting the two-part multicenter, randomized, open-label, controlled, parallel-group study (NCT04643002) to evaluate the safety, efficacy, pharmacokinetics and biomarker data of evorpacept in combination with SARCLISA and dexamethasone in patients with RRMM.Part 1 is evaluating the dosing of evorpacept in combination with standard doses of SARCLISA and dexamethasone to identify a recommended evorpacept dose.Part 2 is investigating the efficacy and safety of this three-drug combination in an expanded population of patients with RRMM. In August, enhanced the leadership team by appointing Alan Sandler, M.D. to Board of Directors, a distinguished leader in oncology and drug development with over 30 years of experience across industry and academia. Dr. Sandler’s industry background includes serving as Executive Vice President, Chief Medical Officer at Mirati Therapeutics, prior to its acquisition by Bristol Myers Squibb. Before joining Mirati, he served as President, Global Head of Development in Oncology at Zai Lab, and prior to that, he was the Senior Vice President and Global Head, Product Development of Oncology Solid Tumors at Genentech, a member of the Roche Group. Presented at the 2024 Cantor Fitzgerald Global Healthcare Conference in New York City in September. Participated in fireside chat with Analyst, Li Watsek and conducted investor meetings. Upcoming Clinical Milestones for Evorpacept’s Development Pipeline Breast Cancer – Results from a Phase 1b/2 combination trial evaluating evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab in HER2-positive and HER2-low metastatic breast cancer will be presented at a poster spotlight presentation at the San Antonio Breast Cancer Symposium on December 12, 2024Gastric/GEJ Cancer – Updated results of ASPEN-06 Phase 2 clinical trial (1H 2025)Head and Neck Squamous Cell Carcinoma – Topline results from a Phase 2 randomized clinical trial of ASPEN-03 with KEYTRUDA® (pembrolizumab) (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)Urothelial Cancer – Updated results from a Phase 1 clinical trial of ASPEN-07 in combination with PADCEV® (enfortumab vedotin) (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) Third Quarter 2024 Financial Results: Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of September 30, 2024, were $162.6 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 September 30, 2024, were $26.5 million, compared to $45.8 million for the prior-year period. R&D expenses decreased by $19.3 million during the three months ended September 30, 2024, compared to the three months ended September 30, 2023. Lower expense was primarily attributable to a decrease of $22.2 million in clinical and development costs primarily due to manufacturing of clinical trial materials to support active clinical trials for our lead product candidate, evorpacept, slightly offset by increased preclinical costs for development of new targets, an increase in personnel and related costs, and an increase 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, 2024, were $6.1 million, compared to $7.5 million for the prior year period. G&A expenses decreased by $1.4 million during the three months ended September 30, 2024, compared to the three months ended September 30, 2023. The decrease was primarily attributable to lower stock-based compensation expense and lower accounting consulting costs.Net loss: GAAP net loss was $30.7 million for the three months ended September 30, 2024, or ($0.58) per basic and diluted share, as compared to a GAAP net loss of $51.0 million for the three months ended September 30, 2023, or ($1.24) per basic and diluted share. Non-GAAP net loss was $23.7 million for the three months ended September 30, 2024, as compared to a non-GAAP net loss of $44.0 million for the three months ended September 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 (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer in new ways and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. 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 Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Operating expenses: Research and development$26,471 $45,766 $92,841 $100,011 General and administrative 6,096 7,509 19,013 22,244 Total operating expenses 32,567 53,275 111,854 122,255 Loss from operations (32,567) (53,275) (111,854) (122,255)Interest income 2,303 2,677 7,488 7,654 Interest expense (446) (391) (1,302) (1,150)Other (expense) income, net 3 (1) (19) 418 Net loss$(30,707) $(50,990) $(105,687) $(115,333)Net loss per share, basic and diluted$(0.58) $(1.24) $(2.05) $(2.82)Weighted-average shares of common stock used to compute net loss per shares, basic and diluted 52,693,878 41,147,938 51,544,501 40,963,015 Condensed Consolidated Balance Sheet Data(in thousands) September 30, December 31, 2024 2023 Cash, cash equivalents and investments$162,610 $218,147 Total assets$185,715 $242,553 Total liabilities$48,908 $52,841 Accumulated deficit$(591,959) $(486,272)Total stockholders’ equity$136,807 $189,712 GAAP to Non-GAAP Reconciliation(unaudited)(in thousands) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 GAAP net loss, as reported$(30,707) $(50,990) $(105,687) $(115,333)Adjustments: Stock-based compensation expense 6,952 6,964 21,235 19,552 Accretion of term loan discount and issuance costs 66 63 196 186 Total adjustments 7,018 7,027 21,431 19,738 Non-GAAP net loss$(23,689) $(43,963) $(84,256) $(95,595) 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.

-- Promising initial Phase 1 data of EO-3021 reported in August highlighting 42.8% confirmed ORR observed in Claudin 18.2-enriched subset of gastric and GEJ cancer, with differentiated safety profile -- -- Progressed into dose expansion portion of Phase 1 trial; additional monotherapy data expected in 1H 2025 -- -- Expect to present preclinical data on the combination potential of EO-3021 with VEGFR2 or PD-1 inhibitors at ESMO Immuno-Oncology Annual Congress 2024 (ESMO-IO 2024) -- -- Expect to initiate dosing in combination portion of the Phase 1 trial of EO-3021 in 4Q 2024 -- -- On-track to nominate development candidate for HER3-ADC program in 4Q 2024 -- BOSTON, Nov. 6, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced financial results for the third quarter ended September 30, 2024, and highlighted recent business achievements. "We continue to make significant progress with EO-3021, our potentially best-in-class Claudin 18.2 antibody-drug conjugate (ADC). Based on the favorable initial clinical data reported in August, we are advancing EO-3021 in both the monotherapy and combination settings across early and later lines of therapy for patients with Claudin 18.2-expressing gastric or GEJ cancer," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "In the past quarter, we initiated the dose expansion portion of the Phase 1 trial of monotherapy EO-3021 and we look forward to reporting additional data in the first half of 2025." Mr. Ferra continued, "We are encouraged by the promising preliminary efficacy and differentiated safety profile seen in the dose escalation portion of our Phase 1 trial. The favorable initial data highlights EO-3021's unique potential as a more combinable Claudin 18.2 ADC with competitive anti-tumor activity. We are well-positioned to explore the full promise of EO-3021 including its better combinability, and are initiating the combination portion of our Phase 1 trial in Q4 2024. Additionally, we look forward to sharing preclinical data at ESMO-IO 2024 in December that further reinforce our combination strategy with VEGFR2 or PD-1 inhibitors. Together with our ongoing monotherapy efforts, this reflects a robust, broad clinical development plan that will allow us to evaluate EO-3021 across the first, second and later lines of therapy. We remain focused on generating meaningful data and executing toward our goal of bringing important treatment options to patients with significant unmet medical needs." Recent Business Achievements In September 2024, Elevation Oncology announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation (FTD) to EO-3021 for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy. Fast Track is a process designed by the FDA to facilitate the development and expedite the review of therapeutic candidates intended to treat serious or life-threatening conditions, for which nonclinical or clinical data demonstrate the potential to address unmet medical needs. Therapeutic candidates that receive FTD may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan. Therapeutic candidates with FTD may also be eligible for priority review and accelerated approval if supported by clinical data. In August 2024, Elevation Oncology announced promising initial clinical data from the dose escalation portion of the ongoing Phase 1 clinical trial of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, GEJ, pancreatic or esophageal cancers. As of the data cutoff date of June 10, 2024: In seven patients with Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+: Objective response rate (ORR) was 42.8% (three confirmed partial responses, one of which was confirmed following the June 10, 2024 data cutoff). Disease control rate (DCR) was 71.4%, including two patients with stable disease. EO-3021 was observed to be generally well-tolerated: Minimal hematological toxicity or hepatotoxicity, and no peripheral neuropathy/hypoesthesia was observed in the safety population of 32 patients treated with EO-3021. Initial safety data suggests minimal payload-associated toxicity and limited overlapping toxicity with standard-of-care agents including PD-1 inhibitors and chemotherapies. Expected Upcoming Milestones EO-3021: Present preclinical data on the combination potential of EO-3021 with VEGFR2 or PD-1 inhibitors at ESMO-IO 2024 in December 2024. Initiate dosing in combination portion of the ongoing Phase 1 clinical trial of EO-3021 in the fourth quarter of 2024; combination cohorts will explore EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in the second-line setting and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting. Report additional data from the ongoing Phase 1 clinical trial of monotherapy EO-3021, including from the dose expansion cohort, in the first half of 2025. HER3-ADC: Nominate development candidate for HER3-ADC program in the fourth quarter of 2024. Third Quarter 2024 Financial Results As of September 30, 2024, Elevation Oncology had cash, cash equivalents and marketable securities totaling $103.1 million, compared to $83.1 million as of December 31, 2023. The increase in cash reflects net proceeds of $44.2 million, which Elevation Oncology raised through its at-the-market (ATM) facility in the first half of 2024, partially offset by cash used to fund operating activities. Research and development (R&D) expenses for the third quarter of 2024 were $9.4 million, compared to $7.4 million for the third quarter of 2023. The increase in R&D expenses was driven by continuous investment in the Company's lead and pipeline programs. General and administrative (G&A) expenses for the third quarter of 2024 were $3.8 million, compared to $3.5 million for the third quarter of 2023. The increase in G&A expenses in the third quarter of 2024 was primarily due to increased personnel costs, including stock-based compensation. Net loss for the third quarter of 2024 was $12.9 million, compared to $10.6 million for the third quarter of 2023. Financial Outlook Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of September 30, 2024 to be sufficient to fund its current operations into 2026. About EO-3021 EO-3021 is a differentiated, clinical-stage, potentially best-in-class, antibody-drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and a monomethyl auristatin E (MMAE) payload with a cleavable linker that is site-specifically conjugated to Glutamine 295 providing a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in the dose expansion portion of a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2. Following recently signed clinical supply agreements with Lilly and GSK, respectively, Elevation Oncology will evaluate EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in second-line patients and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting. In September 2024, EO-3021 was granted Fast Track designation by the FDA for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy. EO-3021 was granted orphan drug designation by the FDA for the treatment of gastric cancer (including cancer of gastroesophageal junction) in November 2020 and for the treatment of pancreatic cancer in May 2021. Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside Greater China. About Elevation Oncology, Inc. Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our ADC expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class, Claudin 18.2 ADC and is currently being evaluated in the dose expansion portion of a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2. Additionally, we expect to nominate a development candidate for our second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3, in 2024. For more information, visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical and preclinical development activities, expected timing of announcements of clinical and preclinical results, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates, the ability of Elevation Oncology's product candidates to treat their targeted indications and Elevation Oncology's expectations about its cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Elevation Oncology Investor and Media Contact Gracie Tong Senior Director, Investor Relations and Corporate Communications [email protected] SOURCE Elevation Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED