Aptevo Therapeutics(APVO) - 2025 Q2 - Quarterly Results

Executive Summary & Q2 2025 Business Update Aptevo Therapeutics achieved significant clinical and financial milestones in Q2 2025, including a new bispecific drug launch, high AML response rates, and increased liquidity Second Quarter Highlights Aptevo Therapeutics made significant progress in Q2 2025, launching APVO455, achieving an 85% AML response rate with mipletamig, and securing $15.9 million in financing - Company pipeline expanded, introducing APVO455, a Nectin-4 x CD3 bispecific for solid tumors[5] - Mipletamig achieved an 85% response rate in frontline AML patients (11 out of 13) across two combination trials[5] - Raised $15.9 million through financing, extending cash runway to Q4 2025, and secured an additional $25 million equity credit line[5] CEO Commentary CEO Marvin White highlighted decisive Q2 progress, emphasizing the expanded CD3 bispecific portfolio, mipletamig's strong AML performance, and improved financial health - CEO emphasized the company expanded its differentiated CD3 bispecific portfolio by introducing APVO455 (a Nectin-4 x CD3 bispecific) to address a broad range of solid tumor types[4] - Mipletamig showed outstanding performance in frontline Acute Myeloid Leukemia (AML) patients, with 85% of evaluable patients achieving remission in two independent trials, validating its differentiated mechanism of action[4][6] - Company strengthened its financial position by raising $15.9 million, extending the cash runway to the end of Q4 2025 to support future clinical and business milestones[6] Pipeline and Clinical Development Aptevo's pipeline features novel bispecific immunotherapies, including the new APVO455 for solid tumors and mipletamig, showing strong efficacy in AML APVO455: A Novel T-Cell Engager for Solid Tumors APVO455 is a preclinical Nectin-4 x CD3 bispecific T-cell engager designed for Nectin-4 high-expressing solid tumors, aiming for a wide therapeutic window and favorable safety - APVO455 is a preclinical Nectin-4 x CD3 bispecific T-cell engager, targeting Nectin-4 high-expressing solid tumors such as bladder, breast, NSCLC, and head and neck cancers[7] - The drug is designed to avoid peripheral binding or T-cell activation, activating only in the presence of Nectin-4 positive tumor cells, aiming for a wider therapeutic window, more consistent immune activation, and favorable safety[7] CRIS-7-Derived CD3 Portfolio Aptevo's CRIS-7 derived CD3 portfolio includes mipletamig, APVO442, and APVO455, all sharing a common CD3 binding domain for enhanced safety and tumor-specific activation - The CD3 portfolio includes mipletamig (CD123 x CD3, for frontline AML, in Phase 1b/2 clinical trials), APVO442 (PSMA x CD3, targeting prostate cancer, in preclinical development), and APVO455 (Nectin-4 x CD3, for various solid tumor types)[8][12] - All three molecules share the same CRIS-7-derived CD3 binding domain, designed to drive tumor-specific immune activation while limiting harmful side effects for patients, particularly reducing cytokine release syndrome[8] Additional Pipeline Candidates Beyond the CD3 portfolio, Aptevo is developing ALG.APV-527 and preclinical candidates APVO711 and APVO603 for various solid tumor types - Aptevo continues to develop the clinical candidate ALG.APV-527 (4-1BB x 5T4)[9] - Preclinical candidates include APVO711 (checkpoint inhibitor with additional features) and APVO603 (4-1BB x OX40), both targeting various solid tumor types[9] Mipletamig Data Highlights Mipletamig continues to demonstrate impressive clinical performance and a compelling safety profile, positioning it to potentially redefine frontline AML treatment - Mipletamig's clinical data remains impressive, positioning it as a strong candidate to reshape frontline AML treatment and potentially elevate the standard of care[10] Efficacy Data Continues to Outperform Benchmarks Mipletamig's efficacy data consistently surpasses benchmarks, with 85% of frontline patients achieving remission, including those with poor prognoses - To date, 85% of frontline patients in two trials have achieved remission[11] - Among these responding patients, several with poor prognoses at screening achieved complete remission (CR), including one successfully undergoing stem cell transplant, a rare favorable outcome in the unfit AML patient population[13] Stand Out Safety and Tolerability Outcomes Continue Mipletamig continues to show excellent safety and tolerability, with no cytokine release syndrome reported in frontline treated patients - To date, no cytokine release syndrome (CRS) has been reported in frontline treated patients[14] Financial Results Aptevo's Q2 2025 financial results show $9.4 million in cash, $15.9 million raised, and a net loss of $6.2 million, with shifts in R&D and G&A expenses Q2 2025 Financial Highlights As of June 30, 2025, Aptevo reported $9.4 million in cash, raised $15.9 million, and recorded a net loss of $6.2 million, with R&D decreasing and G&A increasing year-over-year Q2 2025 Financial Highlights (Units: Million USD) | Metric | Q2 2025 (Million USD) | Q2 2024 (Million USD) | Change (YoY) | | :------------------------- | :----------------------- | :----------------------- | :---------- | | Cash and Cash Equivalents (as of June 30) | 9.4 | N/A | N/A | | Gross Proceeds from Equity Offering (Q2) | 15.9 | N/A | N/A | | Research and Development Expenses | 3.3 | 3.6 | Decrease of 0.3 | | General and Administrative Expenses | 2.9 | 2.4 | Increase of 0.5 | | Net Loss | 6.2 | 5.9 | Increase of 0.3 | | Net Loss Per Share | 8.40 | 1,236.96 | Decrease of 1,228.56 | - The decrease in R&D expenses was primarily due to reduced preclinical and ALG.APV-527 expenditures, partially offset by increased mipletamig trial costs[16] - The increase in G&A expenses was primarily due to higher consulting costs[17] CONSOLIDATED BALANCE SHEETS As of June 30, 2025, Aptevo's total assets were $15.624 million, with cash at $9.41 million, total liabilities at $9.1 million, and total stockholders' equity increasing to $6.524 million Key Consolidated Balance Sheet Data (Units: Thousand USD) | Item | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and Cash Equivalents | $9,410 | $8,714 | | Total Current Assets | $11,081 | $10,659 | | Total Assets | $15,624 | $15,591 | | Total Current Liabilities | $4,891 | $6,207 | | Total Liabilities | $9,100 | $10,836 | | Total Stockholders' Equity | $6,524 | $4,755 | - Total stockholders' equity increased from $4.755 million as of December 31, 2024, to $6.524 million as of June 30, 2025[20] CONSOLIDATED STATEMENTS OF OPERATIONS For the three months ended June 30, 2025, Aptevo reported a net loss of $6.204 million and a net loss per share of $8.40, with R&D at $3.328 million and G&A at $2.898 million Key Consolidated Statements of Operations Data (Units: Thousand USD) | Operating Expenses | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :----------------------- | :------------- | :------------- | :----------- | :----------- | | Research and Development Expenses | $(3,328) | $(3,643) | $(6,961) | $(7,395) | | General and Administrative Expenses | $(2,898) | $(2,381) | $(5,745) | $(5,612) | | Operating Loss | $(6,226) | $(6,024) | $(12,706) | $(13,007) | | Other Income, Net | $22 | $141 | $94 | $290 | | Net Loss | $(6,204) | $(5,883) | $(12,612) | $(12,717) | | Net Loss Per Share, Basic and Diluted | $(8.40) | $(1,236.96) | $(30.84) | $(4,458.98) | | Shares Used in Per Share Calculation | 738,149 | 4,756 | 408,985 | 2,852 | - Net loss per share significantly decreased from ($1,236.96) in Q2 2024 to ($8.40) in Q2 2025, primarily due to a substantial increase in outstanding shares[22] Corporate Information This section provides an overview of Aptevo Therapeutics, its proprietary platform technologies, mission, forward-looking statement disclaimers, and contact details About Aptevo Therapeutics Aptevo Therapeutics Inc. is a clinical-stage biotech company leveraging its ADAPTIR® and ADAPTIR-FLEX® platforms to develop novel bispecific immunotherapies for cancer patients - Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for cancer treatment[23] - The company has two clinical candidates (Mipletamig and ALG.APV-527) and four preclinical candidates, all based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies[23] - Aptevo's mission is to improve treatment outcomes and transform the lives of cancer patients[23] Safe Harbor Statement The Safe Harbor Statement clarifies that the press release contains forward-looking statements based on current expectations, but actual results may differ due to inherent risks and uncertainties - This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, regarding the activity, efficacy, safety, tolerability, and potential uses of therapeutic candidates, as well as clinical program progress and financial condition[24] - Investors should recognize that actual results may differ materially from Aptevo's expectations if underlying assumptions prove inaccurate or unknown risks or uncertainties emerge, and thus should not place undue reliance on any forward-looking statements[25] - Important factors that could cause actual results to differ materially from forward-looking statements include further evaluation of preliminary or interim data, adverse events in clinical development, changes in regulatory, social, macroeconomic, and political conditions, the impact of competing products, and the company's ability to raise capital[26] CONTACT This section provides contact information for Aptevo Therapeutics' Investor Relations and Corporate Communications, including the name, email, and phone number of the lead - The head of Investor Relations and Corporate Communications is Miriam Weber Miller[27] - Contact email: IR@apvo.com or Millerm@apvo.com, phone: 206-859-6628[27]