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, ...

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 March 31, 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 1Q 2024 FINANCIAL RESULTS AND PROVIDES A BUSINESS UPDATE Heavily pre-treated breast cancer patient who achieved stable disease on study, remains on treatment for more than eleven months after entering the ALG.APV-527 Phase 1 trial with progressive disease and transitioning to higher dose with potential for greater clinical benefit, experienced no new adverse events since the transition to the higher dose level APVO436 Phase 1b/2 dose optimization trial initiation of ...

Aptevo Therapeutics (APVO) is a clinical-stage pharmaceutical company focused on developing novel therapies targeting cancer indications.In the past week, the company’s stock lost 79.0%. This downside came after management came out with a secondary issue of 3.4 million shares of its common stock to the public at an issue price of $1.35 per share, amounting to $4.6 million in gross proceeds. The issue was closed on Apr 15.Per the public offer’s terms, each common stock will be accompanied by two warrants. Ea ...

Aptevo Therapeutics (NASDAQ:APVO) stock is falling on Thursday after the clinical-stage biotechnology company priced a public offering for its shares.That public offering has Aptevo Therapeutics selling 3.4 million shares of APVO stock at a price of $1.35 each. The shares also come with warrants to purchase another 6.8 million shares of the company’s stock.Aptevo Therapeutics notes that the exercise price for the warrants in this offer is also $1.35 per share. The warrants are exercisable immediately and ex ...

Exhibit 99.1 APTEVO THERAPEUTICS REPORTS 2023 FINANCIAL RESULTS AND PROVIDES A BUSINESS UPDATE Announces 1H24 Plan for Development of Lead Candidate APVO436 for the Treatment of Frontline Acute Myeloid Leukemia, Interim Results Expected Late 2H24 ALG.APV-527 Phase 1 Trial for the Treatment of Multiple Solid Tumors Continues Enrollment, Interim Results Expected 1H24 SEATTLE, WA – March 5, 2024 – Aptevo Therapeutics Inc. (Nasdaq: APVO), a clinical-stage biotechnology company focused on developing novel immune ...