PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements reveal a significant decrease in cash, a net loss for the quarter, and a shift to a stockholders' deficit, raising substantial doubt about the company's ability to continue as a going concern [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $8.3 million from $15.6 million, driven by a drop in cash, shifting the company from stockholders' equity to a deficit of $1.5 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,139 | $8,714 | | Total current assets | $3,607 | $10,659 | | Total assets | $8,342 | $15,591 | | **Liabilities & Equity** | | | | Total current liabilities | $5,393 | $6,207 | | Total liabilities | $9,815 | $10,836 | | Total stockholders' (deficit) equity | $(1,473) | $4,755 | | Total liabilities and stockholders' (deficit) equity | $8,342 | $15,591 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, the company reported a net loss of $6.4 million, a slight improvement from the $6.8 million loss in Q1 2024 due to lower operating expenses and a significant change in per-share loss after reverse stock splits Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $(3,633) | $(3,752) | | General and administrative | $(2,847) | $(3,231) | | Loss from operations | $(6,480) | $(6,983) | | Net loss | $(6,408) | $(6,834) | | Basic and diluted net loss per share | $(4.39) | $(368.21) | | Weighted average shares outstanding | 1,458,458 | 18,560 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $6.6 million for Q1 2025, leading to a decrease in cash and cash equivalents to $2.1 million by the end of the period Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(6,575) | $(6,651) | | Net cash from investing activities | — | — | | Net cash used in financing activities | — | $(3) | | **Decrease in cash and cash equivalents** | **$(6,575)** | **$(6,654)** | | Cash and cash equivalents at end of period | $2,139 | $10,250 | [Condensed Consolidated Statements of Changes in Stockholders' (Deficit) Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20(Deficit)%20Equity) Stockholders' equity decreased from $4.8 million to a deficit of $1.5 million in Q1 2025, primarily driven by the period's net loss of $6.4 million - The company's equity position deteriorated from a positive **$4.76 million** at the end of 2024 to a **deficit of $1.47 million** by March 31, 2025, mainly due to the **$6.41 million net loss** incurred during the quarter[20](index=20&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's clinical-stage status and highlight substantial doubt about its going concern status due to recurring losses, also covering reverse stock splits and financing activities - The company has suffered recurring losses, with a **net loss of $6.4 million for Q1 2025** and an **accumulated deficit of $254.0 million**, raising substantial doubt about its ability to continue as a going concern[24](index=24&type=chunk) - The company will need to raise additional funds to support operations, as existing cash and potential milestone payments are insufficient; without new funding, it may be forced to delay or scale back R&D[24](index=24&type=chunk)[25](index=25&type=chunk) - In 2024, the company executed two reverse stock splits: a **1-for-44 split** and a **1-for-37 split**, with all share and per-share amounts retroactively adjusted[44](index=44&type=chunk) - In April 2025, the company completed two offerings and a private placement, raising **$3.7 million** after expenses, and entered an ATM offering agreement for up to **$50 million**[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its focus on cancer immunotherapies, recent financing, positive clinical updates for mipletamig, and the critical liquidity situation reinforcing the going concern risk [Recent Developments](index=22&type=section&id=Recent%20Developments) The company secured $4.1 million in financing in April 2025 and reports promising clinical data for its mipletamig RAINIER trial, with no observed cytokine release syndrome - In April 2025, Aptevo secured **$4.1 million in gross proceeds** from two registered direct offerings and entered an 'At The Market' agreement to sell up to **$50 million** in common stock[86](index=86&type=chunk) - The RAINIER Phase 1b/2 trial for mipletamig in frontline AML is advancing, with **9 out of 10 (90%) frontline patients** treated in combination with standard of care achieving remission[86](index=86&type=chunk) - Mipletamig has demonstrated a favorable safety profile, with **no cytokine release syndrome (CRS)** observed in the ongoing RAINIER trial, a key differentiator[86](index=86&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Total operating expenses for Q1 2025 decreased to $6.48 million from $6.98 million in Q1 2024, driven by lower research and development and general and administrative spending Research and Development Expenses by Program (in thousands) | Program | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Mipletamig | $1,622 | $684 | | ALG.APV-527 | $178 | $827 | | **Total clinical programs** | **$1,800** | **$1,511** | | Preclinical & general research | $1,833 | $2,241 | | **Total R&D** | **$3,633** | **$3,752** | - The decrease in R&D spending was primarily due to the ALG.APV-527 escalation phase ramping down and lower preclinical costs, offset by increased patient enrollment costs for the mipletamig trial[91](index=91&type=chunk) - General and administrative expenses **decreased by $0.4 million** year-over-year, from $3.2 million to $2.8 million, mainly due to reduced stock-based compensation costs[94](index=94&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is critical with only $2.1 million in cash, an accumulated deficit of $254.0 million, and a dependency on raising additional capital to continue operations - As of March 31, 2025, the company had **cash and cash equivalents of $2.1 million** and an **accumulated deficit of $254.0 million**[104](index=104&type=chunk) - The company has an 'At The Market' (ATM) sales agreement to sell up to **$50 million** in common stock, though sales are currently limited by SEC rules; as of May 14, 2025, it had sold approximately **$1.2 million**[100](index=100&type=chunk)[102](index=102&type=chunk) - The company has **5.2 million common warrants outstanding**, which, if exercised, could provide up to an additional **$6.8 million** in gross proceeds[103](index=103&type=chunk) - A significant contractual obligation is a potential **$2.0 million milestone payment** to OMT upon dosing the first patient in a Phase 2 clinical trial of mipletamig[113](index=113&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes to its market risk disclosures since its Annual Report on Form 10-K for the year ended December 31, 2024 - There were no material changes to the information regarding market risk as of March 31, 2025, compared to what was disclosed in the 2024 Annual Report on Form 10-K[116](index=116&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the CEO and CFO concluded that the company's **disclosure controls and procedures were effective**[117](index=117&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter ended March 31, 2025, that have materially affected or are likely to materially affect internal controls[118](index=118&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any legal claims or actions that its management believes would have a material adverse effect on its financial condition or operations - Management believes there are **currently no pending legal claims** or actions against the company that would have a material adverse effect on its business[121](index=121&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including precarious financial condition, dependence on clinical success, reliance on third parties, intense competition, and common stock volatility [Financial Risks](index=34&type=section&id=Financial%20Risks) The company faces severe financial risks, including a history of significant operating losses, a $254.0 million accumulated deficit, and substantial doubt about its ability to continue as a going concern - The company has a history of significant losses, with a **net loss of $6.4 million for Q1 2025** and an **accumulated deficit of $254.0 million** as of March 31, 2025[124](index=124&type=chunk) - Management has concluded that **substantial doubt exists about the company's ability to continue as a going concern**, which may adversely affect its stock price and ability to raise capital[125](index=125&type=chunk) - The company requires additional funding to continue operations; **failure to secure funding** may force reductions in spending, suspension of programs, or unfavorable licensing deals[126](index=126&type=chunk) [Product Development and Commercialization Risks](index=50&type=section&id=Product%20Development%20and%20Commercialization%20Risks) The company's success hinges on its ability to develop and commercialize its product candidates, a process fraught with risk, reliance on its ADAPTIR platforms, and substantial competition - **Success in early preclinical and clinical trials does not guarantee success** in later-stage trials, as product candidates may fail to demonstrate sufficient safety and efficacy[182](index=182&type=chunk) - The company's **open-label clinical trial for mipletamig is subject to potential patient and investigator bias**, and results may not be predictive of future trial outcomes[184](index=184&type=chunk) - The company faces **substantial competition** from numerous well-established pharmaceutical and biotechnology companies with greater resources, including AbbVie, Amgen, and Johnson & Johnson[236](index=236&type=chunk) - The company's long-term success depends on its ability to successfully use and develop its **ADAPTIR and ADAPTIR-FLEX platforms**, which is not guaranteed[234](index=234&type=chunk) [Regulatory, Compliance, and Manufacturing Risks](index=57&type=section&id=Regulatory%2C%20Compliance%2C%20and%20Manufacturing%20Risks) The company is subject to extensive regulations, depends entirely on third-party manufacturers, and must comply with stringent healthcare laws, with violations carrying substantial penalties - The company **depends on third parties (CROs, investigators) to conduct its clinical trials** and does not have day-to-day control over their activities[198](index=198&type=chunk)[199](index=199&type=chunk) - The company **has no manufacturing capabilities** and relies on a limited number of third-party suppliers, where production problems could halt development[205](index=205&type=chunk) - The company is subject to numerous healthcare laws, including the Anti-Kickback Statute and False Claims Act; **violations can lead to significant penalties** and exclusion from federal programs[265](index=265&type=chunk)[266](index=266&type=chunk)[270](index=270&type=chunk) - The company's information technology systems are **vulnerable to cybersecurity breaches**, which could lead to the loss of trade secrets and significant legal and financial liability[276](index=276&type=chunk)[280](index=280&type=chunk)[281](index=281&type=chunk) [Risks Related to Our Common Stock and General Risks](index=43&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock%20and%20General%20Risks) Ownership of the company's common stock involves significant risk due to extreme price volatility and a substantial risk of delisting from Nasdaq for failing to meet the minimum bid price - The company's common stock is at **risk for delisting from Nasdaq** if it fails to maintain a minimum closing bid price of $1.00 per share[166](index=166&type=chunk) - The **stock price is highly volatile**, having fluctuated between $1.12 and $182,290.42 per share (split-adjusted) since 2016[157](index=157&type=chunk) - Future equity issuances for capital raising or other purposes will result in the **dilution of existing stockholders' ownership** percentage[170](index=170&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=88&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[309](index=309&type=chunk) [Defaults Upon Senior Securities](index=88&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable for the reporting period - Not applicable[310](index=310&type=chunk) [Mine Safety Disclosures](index=88&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable for the reporting period - Not applicable[311](index=311&type=chunk) [Other Information](index=88&type=section&id=Item%205.%20Other%20Information) Stockholders approved proposals for a stock issuance, a potential reverse stock split, and meeting adjournment at the Special Meeting of Stockholders held on May 14, 2025 Proposal 1: Approval of Stock Issuance and Warrant Proposal | FOR | AGAINST | ABSTAIN | BROKER NON-VOTES | | :--- | :--- | :--- | :--- | | 174,107 | 120,876 | 20,950 | 826,918 | Proposal 2: Approval of Reverse Stock Split | FOR | AGAINST | ABSTAIN | BROKER NON-VOTES | | :--- | :--- | :--- | :--- | | 804,924 | 311,563 | 26,364 | 0 | Proposal 3: Authorization to Adjourn the Special Meeting | FOR | AGAINST | ABSTAIN | BROKER NON-VOTES | | :--- | :--- | :--- | :--- | | 791,430 | 299,950 | 51,471 | 0 | [Exhibits](index=91&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications pursuant to the Sarbanes-Oxley Act and Inline XBRL data files - The exhibits include **certifications from the Principal Executive Officer and Principal Financial Officer** as required by the Sarbanes-Oxley Act, as well as XBRL data files[320](index=320&type=chunk)

[At The Market Offering Agreement](index=1&type=section&id=AT%20THE%20MARKET%20OFFERING%20AGREEMENT) This agreement outlines the terms for Aptevo Therapeutics Inc. to sell common stock through Roth Capital Partners, LLC via an at-the-market offering [Agreement Overview](index=1&type=section&id=Agreement%20Overview) This section introduces the At The Market Offering Agreement between Aptevo Therapeutics Inc. and Roth Capital Partners, detailing terms for common stock sales - Parties to the agreement are **Aptevo Therapeutics Inc.** and **Roth Capital Partners, LLC**[1](index=1&type=chunk) - The agreement was executed on **April 28, 2025**[1](index=1&type=chunk) [Definitions](index=1&type=section&id=1.%20Definitions) This section defines key terms like "Act," "Commission," and "Common Stock" to ensure consistent interpretation throughout the agreement [Sale and Delivery of Shares](index=4&type=section&id=2.%20Sale%20and%20Delivery%20of%20Shares) This section outlines the mechanics of the at-the-market offering, including maximum size, sales process, Manager's compensation, and settlement procedures Offering Details | Parameter | Detail | | :--- | :--- | | **Maximum Offering Size** | Up to **$50,000,000** aggregate gross offering price | | **Security** | Common Stock, **$0.0001** par value per share | | **Manager's Compensation** | A placement fee of **3.0%** of the gross sales price ("Broker Fee") | | **Trading Market** | The Nasdaq Capital Market | - Roth Capital Partners is appointed as the Company's exclusive agent for share sales on a commercially reasonable efforts basis[22](index=22&type=chunk) - Sales are initiated by the Company through a "Sales Notice" specifying maximum shares and minimum acceptable price[24](index=24&type=chunk) - Settlement for sales will occur on the first Trading Day (T+1) following the sale date[30](index=30&type=chunk) [Representations and Warranties](index=7&type=section&id=3.%20Representations%20and%20Warranties) The Company provides extensive representations and warranties to the Manager regarding its corporate structure, financial reporting, legal compliance, and intellectual property - The Company confirms compliance with Form S-3 requirements and the effectiveness of its Registration Statement[47](index=47&type=chunk) - All SEC reports are affirmed as accurate, complete, and Exchange Act compliant, with financial statements prepared under GAAP[53](index=53&type=chunk)[54](index=54&type=chunk) - The Company represents no undisclosed material litigation and compliance with Sarbanes-Oxley, FDA, environmental, and anti-corruption laws[56](index=56&type=chunk)[68](index=68&type=chunk)[82](index=82&type=chunk) - The Company confirms no other at-the-market sales agency agreements have been executed[70](index=70&type=chunk) [Agreements (Covenants)](index=23&type=section&id=4.%20Agreements) This section outlines the Company's ongoing obligations, including maintaining an effective registration statement, providing timely disclosures, and facilitating due diligence - The Company must notify the Manager and amend the Prospectus for any material misstatement or omission[94](index=94&type=chunk)[97](index=97&type=chunk) - The Company will provide officer's certificates, legal opinions, and auditor comfort letters at the offering's start and on Representation Dates[104](index=104&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - The Company will disclose shares sold, net proceeds, and commissions in its quarterly and annual reports[111](index=111&type=chunk) - The Company agrees to conduct due diligence sessions with management, counsel, and accountants upon Manager's request at commencement and each Representation Date[109](index=109&type=chunk) [Payment of Expenses](index=31&type=section&id=5.%20Payment%20of%20Expenses) This section stipulates the Company's responsibility for all offering-related expenses, including filing fees, printing, and legal and accounting costs, regardless of transaction completion - The Company agrees to pay all offering expenses, including SEC and FINRA filing fees, printing, and legal/accounting fees[120](index=120&type=chunk)[121](index=121&type=chunk) - The Company will reimburse Manager's counsel fees up to **$50,000**, plus additional fees for periodic due diligence[121](index=121&type=chunk)[109](index=109&type=chunk) [Conditions to the Obligations of the Manager](index=32&type=section&id=6.%20Conditions%20to%20the%20Obligations%20of%20the%20Manager) This section outlines conditions precedent for the Manager's obligation to sell shares, serving as a protective measure against unmet requirements or adverse events - The Manager's obligation to sell shares is conditional upon the continued accuracy of the Company's representations and warranties[121](index=121&type=chunk) - The Company must deliver required documents, including legal opinions, officer's certificates, and auditor comfort letters[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) - No stop order from the SEC must be in effect suspending the Registration Statement's effectiveness[121](index=121&type=chunk) - The Manager can cancel obligations if a Material Adverse Effect impacts the Company's business or financial condition[123](index=123&type=chunk)[126](index=126&type=chunk) [Indemnification and Contribution](index=35&type=section&id=7.%20Indemnification%20and%20Contribution) This section defines each party's legal and financial responsibilities for losses or claims arising from misstatements or omissions in offering documents, with the Company providing broad indemnification - The Company agrees to indemnify the Manager from losses arising from material misstatements or omissions in offering documents[132](index=132&type=chunk) - The Manager's indemnification is limited to losses from Manager-furnished written information, capped at total broker fees paid[133](index=133&type=chunk)[134](index=134&type=chunk) - If indemnification is unavailable, parties will contribute to losses based on relative benefits and fault[137](index=137&type=chunk) [Termination](index=37&type=section&id=8.%20Termination) This section defines termination rights for both the Company and Manager, specifying notice periods and outlining surviving obligations like expenses and indemnification - The Company may terminate the agreement with **ten (10) business days'** prior written notice[138](index=138&type=chunk) - The Manager may terminate the agreement at any time by giving written notice[140](index=140&type=chunk) - Key provisions, including payment of expenses (Section 5), indemnification (Section 7), and governing law (Section 15), survive termination[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) [Miscellaneous Provisions](index=38&type=section&id=9-18.%20Miscellaneous%20Provisions) This section includes standard boilerplate clauses governing the contract, such as survival of representations, notice procedures, governing law, and waiver of jury trial - The agreement explicitly states the Manager acts as an independent contractor, not a fiduciary, to the Company[146](index=146&type=chunk)[147](index=147&type=chunk) - The agreement is governed by New York State laws, with legal proceedings instituted in New York courts[150](index=150&type=chunk) - Both parties irrevocably waive their right to a jury trial for any related legal proceeding[152](index=152&type=chunk)

Clinical Development and Trials - Clinical candidate mipletamig shows a 100% complete remission (CR) rate in the first cohort of the RAINIER trial for frontline acute myelogenous leukemia (AML) patients [19]. - In the Phase 1b dose expansion trial, mipletamig demonstrated an 82% composite clinical remission rate and a 73% complete remission rate in venetoclax naïve patients [33]. - The current product candidate pipeline includes mipletamig in Phase 1b/2, ALG.APV-527 in Phase 1, and APVO711 in preclinical studies [25]. - Mipletamig is designed to engage CD3 and CD123, redirecting T cells to destroy leukemia cells, with a focus on reducing the likelihood of cytokine release syndrome (CRS) [27][38]. - In the RAINIER frontline AML Phase 1b trial, 100% of patients achieved remission within 30 days, including one patient with complete remission and MRD-negative status [42]. - ALG.APV-527 demonstrated positive safety and tolerability across all cohorts, with no serious liver toxicity observed, and a maximum tolerated dose has not been identified [49]. - The ALG.APV-527 Phase 1 dose escalation trial is currently assessing safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity [47]. - The company completed its Phase 1b dose expansion clinical trial with mipletamig in 2023 and initiated a dose optimization Phase 1b/2 study in August 2024 [191]. - Clinical trials may produce inconsistent or negative results, and success in early trials does not guarantee success in later-stage trials [192]. - Serious adverse events or undesirable side effects may arise during clinical trials, potentially leading to regulatory delays or the abandonment of product candidates [201]. Product Pipeline and Technology - The company has two clinical candidates and three preclinical candidates currently in development, utilizing its proprietary ADAPTIR and ADAPTIR-FLEX platforms [15][16]. - The ADAPTIR platform allows for the generation of bispecific and multi-specific antibody candidates, with 16 new bispecific agents approved by the FDA in the last three years [22]. - The ADAPTIR and ADAPTIR-FLEX platform technologies allow for the development of monospecific, bispecific, and multi-specific immunotherapeutic proteins targeting various tumor cells [56]. - The ADAPTIR platform technology enables the design of both monospecific and bispecific bi-valent protein therapeutics, enhancing the potential for innovative cancer treatments [62]. - APVO603, a preclinical dual agonist bispecific candidate, is designed to target both 4-1BB and OX40, potentially amplifying anti-tumor responses [49]. Competitive Landscape - The company anticipates significant competition in the oncology market from various producers, including Affimed, AstraZeneca, and Bristol Myers Squibb, among others [72]. - Mipletamig is expected to compete with other agents targeting CD123 and non-CD123 for AML treatment, with competitors including Affimed and ImmunoGen [70]. - ALG.APV-527 targets 4-1BB and is anticipated to compete with bispecifics currently in preclinical development, such as those by Crescendo Biologics [71]. Intellectual Property and Collaboration - The company has a collaboration agreement with Alligator Bioscience for the development of ALG.APV-527, with joint ownership of intellectual property generated [74]. - The collaboration agreement includes revenue sharing from commercialization partners, with terms based on development costs borne by each party [75]. - The company relies on a combination of patents, trademarks, and trade secrets to protect its intellectual property, particularly for the ADAPTIR-FLEX platform [79]. - The ADAPTIR platform technology is protected through patents and trade secrets, with pending applications in various countries, including the United States and China [88]. - The company has nationalized its core patent family for mipletamig in multiple countries, including the United States and Australia [90]. - The company co-owns a patent family for ALG.APV-527 with Alligator, which has been nationalized in various countries [91]. - The company routinely files provisional patent applications for its preclinical therapeutic candidates, including APVO603, APVO442, and APVO711 [93]. Regulatory Environment - The FDA requires two Phase 3 clinical trials for product approval, although under certain circumstances, a single trial may suffice [105]. - The Prescription Drug User Fee Act (PDUFA) establishes a six-month review goal for Priority Review applications, compared to ten months for Standard Review [114]. - The FDA may issue a Complete Response Letter (CRL) if an application does not meet approval standards, detailing specific deficiencies [117]. - The FDA may impose conditions on approval, such as requiring a Risk Evaluation and Mitigation Strategy (REMS) to ensure product safety [118]. - The FDA has a two-month timeframe to review applications for acceptability for filing [113]. - The FDA may require post-marketing studies to confirm product effectiveness and safety after approval [105]. - The FDA's review process may be extended if substantial additional information is provided by the sponsor [114]. - Biologics License Applications (BLAs) are subject to substantial user fees, which must be paid upon initial submission [111]. - The FDA may refer applications to an advisory committee for expert evaluation before approval [115]. - The FDA conducts Pre-Approval Inspections to ensure compliance with manufacturing standards before granting approval [116]. - The company is eligible for designated platform technology status under the Food and Drug Omnibus Reform Act of 2022, which may expedite the development and review of subsequent original BLAs [122]. - The FDA can designate a product as a breakthrough therapy if it shows substantial improvement over existing therapies, with a determination required within 60 days of the request [123]. - Orphan drug designation can be requested for products intended to treat rare diseases affecting fewer than 200,000 people in the U.S., providing benefits such as seven years of market exclusivity after approval [124]. - The first applicant to receive orphan drug approval is granted exclusivity, preventing FDA approval of similar applications unless certain conditions are met [125]. - Post-approval, biologics are subject to ongoing FDA regulation, including record-keeping and reporting of adverse experiences [127]. - Facilities involved in manufacturing approved products must register with the FDA and comply with cGMP, facing inspections and potential penalties for non-compliance [128]. - The FDA monitors advertising and promotional materials for compliance, with significant penalties for off-label promotion violations [129]. - The Biologics Price Competition and Innovation Act allows for an abbreviated approval pathway for biosimilars, requiring high similarity to reference products [130]. - Reference biologics receive 12 years of exclusivity from the first licensure, with no biosimilar applications allowed for four years [131]. Financial Performance and Funding - For the year ended December 31, 2024, the company reported a net loss of $24.1 million, an increase from a net loss of $17.4 million for the same period in 2023 [160]. - As of December 31, 2024, the company had an accumulated deficit of $247.6 million [160]. - The company had cash and cash equivalents amounting to $8.7 million as of December 31, 2024, indicating a need for additional funding to support ongoing clinical development and operations [162]. - The company has a history of operating losses and may not achieve profitability in the future, which raises substantial doubt about its ability to continue as a going concern [161]. - The company is focused on developing immunotherapeutic candidates and will require substantial resources for commercialization efforts [160]. - The company completed a public offering on August 4, 2023, issuing 4,959 shares and receiving net proceeds of $4.3 million [165]. - On November 9, 2023, the company entered into a warrant inducement agreement, receiving net proceeds of $3.0 million from the exercise of 8,725 existing common warrants [165]. - The company raised $4.0 million in net proceeds from a public offering of 91,891 shares on April 15, 2024 [165]. - A registered direct offering on July 1, 2024, resulted in net proceeds of $2.3 million from the sale of 144,318 shares [165]. - The company received $2.5 million in net proceeds from a registered direct offering on September 18, 2024, involving 245,699 shares [165]. - On December 12, 2024, the company entered into a warrant inducement agreement, generating net proceeds of $5.6 million from the exercise of 823,544 common warrants [165]. - Future issuances of common stock could result in gross proceeds of $16.5 million from outstanding warrants [165]. - The company is susceptible to macroeconomic conditions, including inflation and interest rate fluctuations, which could adversely affect its capital raising ability [168]. - The company faces potential product liability exposure, which could lead to substantial liabilities and negatively impact its financial condition [178]. Workforce and Diversity - As of December 31, 2024, 49% of the workforce and 46% of leadership positions were held by females, while 38% of both the workforce and leadership were racially or ethnically diverse [146]. - The company emphasizes the importance of diversity, equity, and inclusion (DEI) in its operations, believing it drives innovation and business growth [146]. - The company maintains a hybrid working environment, with essential employees working onsite and non-essential employees working remotely or in a hybrid model [149]. - The company has implemented an unlimited paid time off policy to provide employees with flexibility in scheduling time away from work [148]. - The ability to attract and retain key personnel is critical for the company's success, as competition for qualified employees is intense in the biotechnology sector [180]. Risks and Challenges - The company faces significant risks, including potential delisting from the Nasdaq Capital Market and challenges in attracting and retaining key personnel [158]. - The company may experience ownership changes in the future due to shifts in stock ownership, which could limit the use of net operating loss carryforwards and other tax attributes [188]. - The realization of deferred income tax assets, including net operating loss carryforwards, depends on generating future income during statutory carryforward periods [186]. - The company is subject to market and credit risks that could adversely impact its financial condition and results of operations, especially during periods of extreme volatility [190]. - The company relies on third-party service providers for clinical trials, and any failure in their performance could significantly harm the company's ability to obtain regulatory approval [205]. - Manufacturing of product candidates is complex and dependent on third-party suppliers, with potential risks of product shortages or delays in clinical development [213]. - Regulatory authorities may require additional clinical trials or impose restrictions based on adverse events, which could increase commercialization costs and delay revenue generation [204]. - The company may face challenges in maintaining agreements with third-party providers, which could lead to delays in product development activities [212]. - Changes in regulatory requirements during the development period could render existing data insufficient for marketing approval [200].

[Business Update](index=1&type=section&id=Business%20Update) [Mipletamig AML Bispecific Highlights](index=1&type=section&id=Mipletamig%20AML%20bispecific%20highlights) 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](index=3&type=chunk) - One patient in Cohort 1 achieved **complete remission with minimal residual disease (MRD)-negative status**, indicating 100% elimination of cancer cells[3](index=3&type=chunk) - Mipletamig showed a **favorable safety profile** with limited incidences of cytokine release syndrome (CRS), a common side effect in similar therapies[3](index=3&type=chunk) - 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](index=6&type=chunk) [ALG.APV-527 Solid Tumor Bispecific Highlights](index=2&type=section&id=ALG.APV-527%20solid%20tumor%20bispecific%20highlights) 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](index=7&type=chunk)[6](index=6&type=chunk) - 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](index=7&type=chunk) [About Mipletamig and RAINIER Trial](index=3&type=section&id=About%20Mipletamig%20and%20RAINIER) 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](index=8&type=chunk) - It is designed to **reduce the likelihood and severity of Cytokine Release Syndrome (CRS)** by using a unique CD3 binding domain[8](index=8&type=chunk) - 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](index=9&type=chunk) [About ALG.APV-527 and The Phase 1 Trial](index=3&type=section&id=About%20ALG.APV-527%20and%20The%20Phase%201%20Dose%20Escalation%20Trial) 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](index=10&type=chunk) - The **5T4 antigen is overexpressed** on numerous solid tumors, including non-small-cell lung, breast, head and neck, and colorectal cancer[10](index=10&type=chunk) - The Phase 1 trial was a multi-center, open-label, dose-escalation study to assess **safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity**[11](index=11&type=chunk) [Financial Results and Statements](index=4&type=section&id=Financial%20Results%20and%20Statements) [2024 Summary Financial Results](index=4&type=section&id=2024%20Summary%20Financial%20Results) 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](index=14&type=chunk) - 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](index=17&type=chunk) [Consolidated Balance Sheets](index=5&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) 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](index=6&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) 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](index=7&type=section&id=Corporate%20Information%20and%20Forward-Looking%20Statements) [About Aptevo Therapeutics](index=7&type=section&id=About%20Aptevo%20Therapeutics) 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](index=25&type=chunk) - Its lead clinical candidates are **Mipletamig for frontline acute myeloid leukemia (AML)** and **ALG.APV-527 for multiple solid tumor types**[25](index=25&type=chunk) - All pipeline candidates are created from the company's proprietary **ADAPTIR® and ADAPTIR-FLEX® platforms**[25](index=25&type=chunk) [Safe Harbor Statement](index=7&type=section&id=Safe%20Harbor%20Statement) 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](index=26&type=chunk) - 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](index=26&type=chunk) - Key risks include **deterioration in business prospects, adverse clinical development events, regulatory changes, competitive products, and macroeconomic conditions**[27](index=27&type=chunk)[28](index=28&type=chunk)

Company Overview - Aptevo Therapeutics Inc. (APVO) is part of the Medical group, which is currently ranked 1 within the Zacks Sector Rank, encompassing 1011 companies [2] - The company has a Zacks Rank of 2 (Buy), indicating a favorable outlook based on earnings estimates and revisions [3] Performance Metrics - Year-to-date, Aptevo Therapeutics Inc. has gained approximately 15.6%, while the average loss in the Medical group is about 3.9%, demonstrating strong relative performance [4] - The Zacks Consensus Estimate for APVO's full-year earnings has increased by 65.1% over the past three months, reflecting improved analyst sentiment [3] Industry Context - Aptevo Therapeutics Inc. operates within the Medical - Biomedical and Genetics industry, which includes 513 companies and is currently ranked 63 in the Zacks Industry Rank [5] - The Medical - Biomedical and Genetics industry has experienced an average loss of 12.6% this year, further highlighting APVO's superior performance [5] Comparison with Peers - Another outperforming stock in the Medical sector is Accuray (ARAY), which has increased by 7.6% year-to-date and also holds a Zacks Rank of 2 (Buy) [4][6] - Accuray's EPS consensus estimate has surged by 200% over the past three months, indicating strong growth potential [5]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements show a significant decrease in assets and a rising net loss, which, combined with an accumulated deficit and increased cash burn, raise substantial doubt about the company's ability to continue as a going concern [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased significantly to $15.1 million due to a reduction in cash, while stockholders' equity fell sharply from $12.2 million to $4.4 million Condensed Consolidated Balance Sheet Data (in thousands) | Balance Sheet Items | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,753 | $16,904 | | Total current assets | $10,012 | $19,066 | | Total assets | $15,146 | $24,842 | | **Liabilities & Equity** | | | | Total current liabilities | $5,882 | $7,224 | | Total liabilities | $10,726 | $12,621 | | Total stockholders' equity | $4,420 | $12,221 | | Total liabilities and stockholders' equity | $15,146 | $24,842 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company's net loss widened to $17.8 million for the nine-month period, despite an improved quarterly loss, influenced by the absence of a significant prior-year gain on an asset sale Condensed Consolidated Statements of Operations (in thousands) | Metric | Q3 2024 | Q3 2023 | 9 Months 2024 | 9 Months 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $(3,103) | $(3,887) | $(10,498) | $(13,516) | | General and administrative | $(2,110) | $(2,674) | $(7,722) | $(8,978) | | Loss from operations | $(5,213) | $(6,561) | $(18,220) | $(22,494) | | Gain related to sale of non-financial asset | — | — | — | $9,650 | | Net loss from continuing operations | $(5,101) | $(6,334) | $(17,818) | $(12,454) | | Net loss | $(5,101) | $(6,334) | $(17,818) | $(11,508) | Net Loss Per Share (Basic and Diluted) | Period | 2024 | 2023 | | :--- | :--- | :--- | | **Three Months Ended Sep 30** | $(0.48) | $(22.16) | | **Nine Months Ended Sep 30** | **$(5.01)** | **$(56.22)** | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased substantially to $18.0 million, while financing activities provided $8.9 million, resulting in a net cash decrease of $9.2 million Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(18,026) | $(6,477) | | Net cash provided by financing activities | $8,875 | $2,952 | | **Decrease in cash and cash equivalents** | **$(9,151)** | **$(3,525)** | | Cash and cash equivalents at end of period | $7,753 | $19,110 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's clinical-stage focus, significant financing activities including a reverse stock split, and the substantial doubt about its ability to continue as a going concern - The company is a clinical-stage biotechnology firm focused on novel immuno-oncology candidates, using its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platforms[16](index=16&type=chunk) - Due to recurring losses, a net loss of **$17.8 million** and negative operating cash flow of **$18.0 million** for the nine months ended September 30, 2024, there is **substantial doubt about the company's ability to continue as a going concern**[16](index=16&type=chunk) - On March 5, 2024, the company effected a **1-for-44 reverse stock split** of its common stock, and all share and per-share amounts have been retroactively adjusted[30](index=30&type=chunk) - Subsequent to the reporting period, remaining pre-funded warrants were exercised, bringing the total shares of common stock outstanding to **18,512,084** as of November 7, 2024[59](index=59&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses decreased operating expenses, a critical liquidity position with $7.8 million in cash, and the urgent need for substantial additional funding to continue operations and advance clinical programs [Overview](index=19&type=section&id=Overview) Aptevo is a clinical-stage biotechnology company developing novel cancer immunotherapies using its versatile ADAPTIR and ADAPTIR-FLEX protein technology platforms - The company is focused on developing novel immunotherapy candidates for cancer treatment[63](index=63&type=chunk) - Key assets include two proprietary technology platforms, **ADAPTIR and ADAPTIR-FLEX**, used to design multi-specific antibody candidates[65](index=65&type=chunk) - The clinical pipeline includes **mipletamig (APVO436)** for acute myelogenous leukemia (AML) and **ALG.APV-527** for multiple solid tumor types[63](index=63&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Operating expenses decreased in 2024 due to lower spending on the mipletamig clinical trial and reduced G&A costs, while the prior year's results included a significant one-time gain Research and Development Expenses by Program (in thousands) | Program | 9 Months 2024 | 9 Months 2023 | | :--- | :--- | :--- | | Mipletamig | $2,544 | $4,300 | | ALG.APV-527 | $2,004 | $2,264 | | Preclinical, research & discovery | $5,950 | $6,952 | | **Total** | **$10,498** | **$13,516** | - The decrease in R&D expenses was primarily due to lower spending on the **mipletamig clinical trial** as the Phase 1b dose expansion study concluded[70](index=70&type=chunk) - General and administrative expenses decreased by **$1.3 million** for the nine months ended September 30, 2024, compared to the prior year, mainly due to lower employee and consulting costs[71](index=71&type=chunk) - In 2023, the company recorded a **$9.7 million gain** from the sale of nonfinancial assets to XOMA, which was not present in 2024[72](index=72&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is a significant concern, with cash of $7.8 million and an accumulated deficit of $241.3 million, necessitating substantial additional funds to continue development - As of September 30, 2024, the company had cash and cash equivalents of **$7.8 million** and an accumulated deficit of **$241.3 million**[83](index=83&type=chunk) - The company **does not have sufficient cash** to complete the clinical development of any of its product candidates and will require substantial additional funds to continue its development programs[83](index=83&type=chunk) - If unable to raise additional capital, the company may be required to **delay, limit, reduce, or terminate** its clinical trials and other development activities[84](index=84&type=chunk) Financing Activities (Gross Proceeds) | Offering | Date | Gross Proceeds | | :--- | :--- | :--- | | Public Offering | August 2023 | $4.3M (net) | | Warrant Inducement | November 2023 | $3.3M | | Public Offering | April 2024 | $4.6M | | Registered Direct Offering | July 2024 | $2.7M | | Registered Direct Offering | September 2024 | $3.0M | [Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states there have been no material changes to the information regarding market risk since its 2023 Annual Report on Form 10-K - There were **no material changes** to the disclosures about market risk as of September 30, 2024, compared to those in the 2023 Annual Report on Form 10-K[86](index=86&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the company's disclosure controls and procedures and concluded they were effective, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that as of September 30, 2024, the company's disclosure controls and procedures were **effective**[87](index=87&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter ended September 30, 2024, that have materially affected or are likely to materially affect internal controls[88](index=88&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal claims or actions that management believes would have a material adverse effect on its financial condition or operations - Management believes there are currently **no pending legal claims or actions** that could have a material adverse effect on the company's results, financial condition, or cash flows[90](index=90&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, operational, and regulatory risks, including a history of losses, going concern uncertainty, reliance on clinical trial success, and potential delisting from Nasdaq - The company's common stock is at **risk of delisting from Nasdaq** for failing to maintain the minimum $1.00 bid price requirement[92](index=92&type=chunk)[169](index=169&type=chunk) - The company has a history of losses, an accumulated deficit of **$241.3 million**, and its ability to continue as a **going concern is in substantial doubt**[92](index=92&type=chunk)[94](index=94&type=chunk) - Success is highly dependent on the ability to develop, receive regulatory approval for, and commercialize product candidates, a process which is **long, costly, and uncertain**[92](index=92&type=chunk)[134](index=134&type=chunk) - The business is affected by macroeconomic conditions, including **inflation, interest rates, and market volatility**, which could impact operations and the ability to raise capital[92](index=92&type=chunk)[97](index=97&type=chunk) [Other Information](index=58&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted, terminated, or materially modified a Rule 10b5-1 trading plan or other non-Rule 10b5-1 trading arrangement during the third quarter of 2024 - In Q3 2024, **no directors or executive officers** adopted, terminated, or modified a Rule 10b5-1 trading plan or other non-Rule 10b5-1 trading arrangement[179](index=179&type=chunk) [Exhibits](index=58&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including financing agreements, an amendment to the stockholder Rights Agreement, and officer certifications - Exhibits filed include agreements from the **September 2024 registered direct offering**, such as the Securities Purchase Agreement and forms of Common and Pre-Funded Warrants[181](index=181&type=chunk) - An amendment to the **Rights Agreement** with Broadridge Corporate Issuer Solutions, Inc., dated November 1, 2024, was filed[181](index=181&type=chunk) - **Certifications by the Principal Executive Officer and Principal Financial Officer** pursuant to Sarbanes-Oxley Sections 302 and 906 are included as exhibits[181](index=181&type=chunk)

Aptevo Therapeutics 3Q 2024 Financial Results and Business Update [Business Highlights](index=1&type=section&id=Business%20Highlights) Aptevo Therapeutics achieved significant clinical milestones in Q3 2024, advancing key trials and successfully raising $5.75 million - Initiated the mipletamig Phase 1b/2 dose optimization trial, "RAINIER," for frontline Acute Myeloid Leukemia (AML) patients, combining it with standard of care venetox and azacitidine[1](index=1&type=chunk)[2](index=2&type=chunk) - Presented positive interim data from the ALG.APV-527 Phase 1 trial at the ESMO Congress, with **9 out of 15 (60%) efficacy evaluable patients achieving a best overall response of stable disease (SD)**[2](index=2&type=chunk) - The ALG.APV-527 trial demonstrated a well-tolerated safety profile and confirmed biological activity through biomarker analyses[3](index=3&type=chunk) - Raised a total of **$5.75 million** through two financing deals during the third quarter[1](index=1&type=chunk)[3](index=3&type=chunk) [3Q 2024 Summary Financial Results](index=2&type=section&id=3Q%20Summary%20Financial%20Results) Aptevo reported a Q3 2024 net loss of $5.1 million, reduced from the prior year, with $7.8 million cash and lower operating expenses Q3 2024 Financial Highlights (vs. Q3 2023) | Financial Metric | Q3 2024 | Q3 2023 | Change | | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | $7.8 million | N/A | - | | Research & Development Expenses | $3.1 million | $3.9 million | -$0.8 million | | General & Administrative Expenses | $2.1 million | $2.7 million | -$0.6 million | | Net Loss | $5.1 million | $6.3 million | -$1.2 million | | Net Loss Per Share | $0.48 | $22.16 | - | - The decrease in R&D expenses was primarily due to lower spending on preclinical projects and employee costs[4](index=4&type=chunk) - The decrease in G&A expenses was mainly attributed to lower employee and consulting costs[5](index=5&type=chunk) Financial Statements [Condensed Consolidated Balance Sheets](index=3&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of September 30, 2024, Aptevo's total assets were $15.1 million, with liabilities at $10.7 million and equity at $4.4 million Balance Sheet Summary (in thousands) | Account | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,753 | $16,904 | | Total current assets | $10,012 | $19,066 | | **Total assets** | **$15,146** | **$24,842** | | **Liabilities & Equity** | | | | Total current liabilities | $5,882 | $7,224 | | **Total liabilities** | **$10,726** | **$12,621** | | **Total stockholders' equity** | **$4,420** | **$12,221** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Aptevo reported a Q3 2024 net loss of $5.1 million ($0.48 per share) and a nine-month net loss of $17.8 million Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $(3,103) | $(3,887) | $(10,498) | $(13,516) | | General and administrative | $(2,110) | $(2,674) | $(7,722) | $(8,978) | | Loss from operations | $(5,213) | $(6,561) | $(18,220) | $(22,494) | | Net loss from continuing operations | $(5,101) | $(6,334) | $(17,818) | $(12,454) | | Net loss | $(5,101) | $(6,334) | $(17,818) | $(11,508) | | Basic and diluted net loss per share | $(0.48) | $(22.16) | $(5.01) | $(56.22) | Company Information and Forward-Looking Statements [About Aptevo Therapeutics Inc.](index=5&type=section&id=About%20Aptevo%20Therapeutics%20Inc.) Aptevo Therapeutics Inc. is a clinical-stage biotechnology company developing novel immuno-oncology therapies for cancer treatment - Aptevo is a clinical-stage biotechnology company focused on developing novel immuno-oncology therapies to treat cancer[13](index=13&type=chunk) [Safe Harbor Statement](index=5&type=section&id=Safe%20Harbor%20Statement) This section outlines forward-looking statements, cautioning that actual results may differ due to clinical, regulatory, and macroeconomic risks - The press release includes forward-looking statements concerning the efficacy, safety, and potential of its therapeutic candidates, progress of clinical programs, and financial position[14](index=14&type=chunk) - Warns that actual results may differ materially due to risks such as adverse clinical trial outcomes, regulatory hurdles, competitive products, and macroeconomic factors like inflation and geopolitical risks[15](index=15&type=chunk)[17](index=17&type=chunk) - Investors are directed to the company's SEC filings, including the Annual Report on Form 10-K, for a more comprehensive discussion of risks and uncertainties[17](index=17&type=chunk)

Aptevo Therapeutics Inc. (APVO) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37746 | --- | --- | --- | --- | |------------------------------------------|-----------------------------------|------------------ ...

Exhibit 99.1 APTEVO THERAPEUTICS REPORTS 2Q 2024 FINANCIAL RESULTS AND PROVIDES A BUSINESS UPDATE SEATTLE, WA – August 8, 2024 – Aptevo Therapeutics Inc. (Nasdaq: APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today reported financial results for the quarter ended March 31, 2024 and provided a business update. "After the successful completion of our APVO436 dose expansion trial, ...