Aptevo Therapeutics(APVO) - 2024 Q4 - Annual Results

Business Update Mipletamig AML Bispecific Highlights The Mipletamig drug candidate showed high remission rates and a favorable safety profile in its RAINIER trial for Acute Myeloid Leukemia (AML) - In the frontline AML RAINIER trial, 100% of patients in Cohort 1 achieved remission within 30 days[3] - One patient in Cohort 1 achieved complete remission with minimal residual disease (MRD)-negative status, indicating 100% elimination of cancer cells[3] - Mipletamig showed a favorable safety profile with limited incidences of cytokine release syndrome (CRS), a common side effect in similar therapies[3] - Previous trial results supporting the current findings include a Phase 1b trial where 100% of frontline patients achieved remission and a Phase 1a monotherapy trial where 36% of patients showed substantial leukemic blast reduction[6] ALG.APV-527 Solid Tumor Bispecific Highlights The ALG.APV-527 trial for solid tumors demonstrated a 59% stable disease rate and a favorable safety profile without serious liver toxicities | Metric | Result | | :--- | :--- | | Stable Disease Rate | 10 of 17 efficacy evaluable patients (59%) achieved stable disease | | Longest Duration of Stable Disease | A breast cancer patient remained on study for >12 months | | Other Stable Disease Durations | A colon cancer patient for >6 months; a prostate cancer patient for >4 months | - ALG.APV-527 demonstrated a favorable safety profile with limited incidence and no severe cases of liver toxicity, a common dose-limiting side effect in similar treatments[7][6] - The data was presented at the European Society for Medical Oncology (ESMO) Congress and the Society for Immunotherapy of Cancer (SITC) Conference in 2024[7] About Mipletamig and RAINIER Trial Mipletamig is a bispecific antibody targeting CD123 for AML, evaluated in the Phase 1b/2 RAINIER combination therapy trial - Mipletamig is an antibody-like recombinant protein that targets the CD123 antigen, which is overexpressed on leukemic stem cells and AML blasts[8] - It is designed to reduce the likelihood and severity of Cytokine Release Syndrome (CRS) by using a unique CD3 binding domain[8] - The RAINIER trial is a two-part Phase 1b/2 study, with part one being a dose optimization study for up to 39 adult patients[9] About ALG.APV-527 and The Phase 1 Trial ALG.APV-527 is a conditional 4-1BB agonist targeting the 5T4 tumor antigen, assessed for safety and efficacy in a Phase 1 trial - ALG.APV-527 is a bispecific conditional 4-1BB agonist, designed to be active only upon simultaneous binding to 4-1BB and the tumor antigen 5T4[10] - The 5T4 antigen is overexpressed on numerous solid tumors, including non-small-cell lung, breast, head and neck, and colorectal cancer[10] - The Phase 1 trial was a multi-center, open-label, dose-escalation study to assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity[11] Financial Results and Statements 2024 Summary Financial Results The company's 2024 net loss increased to $24.1 million, despite lower operating expenses, due to the absence of a prior-year one-time gain | Financial Metric | 2024 | 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $8.7 million | $16.9 million | | Research and Development Expenses | $14.4 million | $17.1 million | | General and Administrative Expenses | $10.2 million | $11.8 million | | Net Loss | $24.1 million | $17.4 million | | Net Loss Per Share | $87.38 | $2,316.83 | - The decrease in R&D expenses was mainly due to lower preclinical spending and reduced costs for the mipletamig trial as it transitioned between phases[14] - The 2023 financials included a $9.7 million gain from the sale of a non-financial asset to XOMA, which was not repeated in 2024[17] Consolidated Balance Sheets Total assets decreased to $15.6 million from $24.8 million, driven by a reduction in cash, while total equity fell to $4.8 million | (in thousands) | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | ASSETS | | | | Cash and cash equivalents | $8,714 | $16,904 | | Total current assets | $10,659 | $19,066 | | Total assets | $15,591 | $24,842 | | LIABILITIES & EQUITY | | | | Total current liabilities | $6,207 | $7,224 | | Total liabilities | $10,836 | $12,621 | | Total stockholders' equity | $4,755 | $12,221 | | Total liabilities and stockholders' equity | $15,591 | $24,842 | Consolidated Statements of Operations Loss from operations improved to $24.6 million, but the net loss widened to $24.1 million due to non-recurring income in the prior year | (in thousands, except per share amounts) | For the Year Ended Dec 31, 2024 | For the Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Research and development | $(14,378) | $(17,107) | | General and administrative | $(10,224) | $(11,771) | | Loss from operations | $(24,602) | $(28,878) | | Gain related to sale of non-financial asset | — | $9,650 | | Net loss from continuing operations | $(24,130) | $(18,650) | | Income from discontinued operations | — | $1,239 | | Net loss | $(24,130) | $(17,411) | | Basic and diluted net loss per share | $(87.38) | $(2,316.83) | Corporate Information and Forward-Looking Statements About Aptevo Therapeutics Aptevo Therapeutics is a clinical-stage biotech company developing novel bispecific immunotherapies for cancer using its proprietary platforms - Aptevo is a clinical-stage biotechnology company (Nasdaq: APVO) developing novel bispecific immunotherapies for cancer[25] - Its lead clinical candidates are Mipletamig for frontline acute myeloid leukemia (AML) and ALG.APV-527 for multiple solid tumor types[25] - All pipeline candidates are created from the company's proprietary ADAPTIR® and ADAPTIR-FLEX® platforms[25] Safe Harbor Statement This section cautions that forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ - The press release contains forward-looking statements regarding the efficacy, safety, and potential of its therapeutic candidates, clinical milestones, and financial position[26] - Investors are cautioned not to place undue reliance on these statements as actual results could differ materially if underlying assumptions prove inaccurate or risks materialize[26] - Key risks include deterioration in business prospects, adverse clinical development events, regulatory changes, competitive products, and macroeconomic conditions[27][28]