Aptevo Therapeutics Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 6, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-11.
0000950170-25-106247
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001193125-25-269598
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 92 previous paragraphs and 88 current paragraphs.
57 unchanged; 22 reworded; 8 added; 13 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
No cytokine release syndrome (CRS) observed among evaluable frontline patients to date — a meaningful distinction in a category where CRS is a common and often dose-limiting toxicity
Current report
Introduced the Company’s first trispecific T-cell engagers — APVO451 and APVO452 — expanding the oncology portfolio to five CRIS-7-derived CD3-targeting molecules
Current report
These candidates are designed to target tumors that suppress immune activity, a key barrier to durable responses in solid tumors
Current report
Both trispecifics leverage Aptevo’s unique use of the CRIS-7–derived CD3 binding domain, a clinically validated T-cell activation approach that has demonstrated favorable safety and tolerability in clinical trials with mipletamig
Current report
Continued expansion of the portfolio reflects Aptevo’s intentional platform strategy: purpose-built immune-modulating therapies that aim to be both powerful and clinically manageable for patients
Current report
Raised $18.7 million, net in the third quarter and $4.1 million, net since quarter end, extending cash runway well into 4Q26 and enabling the Company to reach important clinical milestones next year
Current report
Research and development expenses increased by $0.9 million, from $3.1 million for the three months ended September 30, 2024 to $4.0 million for the three months ended September 30, 2025. Research and development expenses increased by $0.5 million, from $10.5 million for the nine months ended September 30, 2024 to $11.0 million for the nine months ended September 30, 2025. The increase was primarily due to increased Mipletamig and employee costs and was offset by lower costs on ALG.APV- 527 as we wrapped up the dose escalation trial. As of September 30, 2025 and December 31, 2024, we had $1.1 million and $1.4 million in accounts payable and other accrued liabilities related to accrued clinical expenses.
Current report
For the nine months ended September 30, 2025, we issued 8.3 million shares of common stock to Yorkville at an average price of $1.82 per share under the SEPA for aggregate gross proceeds of $15 million. The remaining availability under the SEPA is $10.0 million.
Removed paragraphs (13)
Previous report
Pipeline Expansion — Introduced APVO455, a Nectin-4 x CD3 bispecific for solid tumors, expanding the Company’s suite of differentiated CRIS-7–derived CD3-engaging molecules in development, including lead candidate, mipletamig.
Previous report
Mipletamig for acute myeloid leukemia (AML) — Achieved 85% remission*rate (11/13 patients) in frontline AML patients across two trials in combination therapy.
Previous report
Increased Liquidity — Completed financings that raised a total of $15.9 million, extending cash runway into late 4Q25.
Previous report
Secured an equity line of credit for up to an additional $25 million in capital.
Previous report
Research and development expenses decreased by $0.3 million, from $3.6 million for the three months ended June 30, 2024 to $3.3 million for the three months ended June 30, 2025. Research and development expenses decreased by $0.4 million, from $7.4 million for the six months ended June 30, 2024 to $7.0 million for the six months ended June 30, 2025. The decrease was primarily due to lower preclinical and ALG.APV-527 spending due to escalation phase ramping down and was offset by higher mipletamig trial costs from clinical trial patient enrollment.
Previous report
Supplemental Cash Payments
Previous report
On August 6, 2025, the Compensation Committee of the Board (the “Compensation Committee”) approved a one-time supplemental cash payment, minus applicable deductions and withholdings, to each of its executive officers in the aggregate amount of $1.2 million allocated as set forth below to narrow the gap between target long-term incentives and market competitive equity values due to the volatility in the Company’s stock price and share constraints. The one-time supplemental cash payments will be paid in accordance with the Company’s regular pay schedule.
Previous report
Base Compensation Changes
Previous report
In approving the compensation changes for the executive officers, the Compensation Committee considered, among other factors, the compensation practices, trends and data from comparable companies as identified by the Compensation Committee and an independent compensation consultant engaged by the Compensation Committee and adjusted the executive officer compensation to target the 75th percentile of public company peers.
Previous report
Salary Increases
Previous report
The Compensation Committee approved the following salary increases to each of the Company’s executive officers:
Previous report
Bonus Target Increases
Previous report
The Compensation Committee approved the following target cash bonuses for 2025 based on the above salary increases. The total 2025 Target Bonus amount increased by $352,000 in the aggregate.
Reworded paragraphs (22)
Previous wording
We are a clinical-stage, research and development biotechnology company focused on developing novel immunotherapy candidates for the treatment of different forms of cancer. We have developed two versatile and enabling platform technologies for rational design of precision immune modulatory drugs and have two clinical candidates and four preclinical candidates currently in development. Clinical candidate mipletamig is a CD123xCD3 T cell engager that is currently being evaluated in the RAINIER study, a Phase 1b/2 program evaluating mipletamig in combination with standard of care venetoclax + azacitidine for the treatment of frontline acute myelogenous leukemia (AML) patients who are unfit for intensive chemotherapy. The ongoing Phase 1b trial was initiated in August 2024. Results from cohorts 1 and 2 to date were highly favorable for both safety and efficacy. Clinical candidate ALG.APV-527 targets 4-1BB (co-stimulatory receptor) and 5T4 (tumor antigen). The compound is designed to reactivate antigen-primed T cells to specifically kill tumor cells and is currently being evaluated for the treatment of multiple solid tumor types in a dose escalation trial.
Current wording
We are a clinical-stage, research and development biotechnology company focused on developing novel immunotherapy candidates for the treatment of different forms of cancer. We have developed two versatile and enabling platform technologies for rational design of precision immune modulatory drugs and have two clinical candidates and six preclinical candidates currently in development. Clinical candidate mipletamig is a CD123xCD3 T cell engager that is currently being evaluated in the RAINIER study, a Phase 1b/2 program evaluating mipletamig in combination with standard of care venetoclax + azacitidine for the treatment of frontline acute myelogenous leukemia (AML) patients who are unfit for intensive chemotherapy. The ongoing Phase 1b trial was initiated in August 2024. Results from cohorts 1, 2 and 3 to date were highly favorable for both safety and efficacy. Clinical candidate ALG.APV-527 targets 4-1BB (co-stimulatory receptor) and 5T4 (tumor antigen). The compound is designed to reactivate antigen-primed T cells to specifically kill tumor cells and is currently being evaluated for the treatment of multiple solid tumor types in a dose escalation trial.
Previous wording
Preclinical candidates, APVO603, a dual agonist bispecific designed to simultaneously target 4-1BB (CD137) and OX40 (CD134), and APVO711, a bispecific checkpoint inhibitor with added functionality that targets PD-L1 and CD40, were also developed using our ADAPTIR modular protein technology platform. Our preclinical candidate APVO442 was developed using our ADAPTIR-FLEX heterodimer protein technology platform and is engineered to address treatment challenges associated with later stage and castration resistant prostate cancer with its unique design that enables precise tumor targeting while activating the immune system in a controlled manner. We wholly own both platforms which enable us to efficiently design and create new molecules, supporting our pipeline growth. Our recently announced preclinical candidate, APVO455, is a Nectin-4 x CD3 bispecific developed to address multiple solid tumor types. With the addition of APVO455 to the pipeline, Aptevo now has a suite of three CD3-engaging molecules in development. The portfolio includes mipletamig for AML, APVO442 for prostate cancer and APVO455 for multiple solid tumor types. All three molecules share the same CRIS-7 derived binding domain with a low cytokine release profile. In addition, APVO455 and APVO442 contain CD3 binding domains that are optimized for targeting solid tumors. All three molecules are designed to drive tumor-specific immune activation while limiting systemic toxicity.
Current wording
Preclinical candidates, APVO603, a dual agonist bispecific designed to simultaneously target 4-1BB (CD137) and OX40 (CD134), and APVO711, a bispecific checkpoint inhibitor with added functionality that targets PD-L1 and CD40, were also developed using our ADAPTIR modular protein technology platform. Our preclinical candidate APVO442 was developed using our ADAPTIR-FLEX heterodimer protein technology platform and is engineered to address treatment challenges associated with later stage and castration resistant prostate cancer with its unique design that enables precise tumor targeting while activating the immune system in a controlled manner. We wholly own both platforms which enable us to efficiently design and create new molecules, supporting our pipeline growth. We recently announced two new trispecific assets. APVO452 targeting PSMA, CD3, and CD40, is designed to address prostate cancers via PSMA targeting. APVO451 similarly incorporates trispecific design principles, targeting Nectin-4, CD3, and CD40, and is intended for a broad range of solid tumors. With the addition of APVO451 and APVO452 to the pipeline, Aptevo now has a suite of five CD3-engaging molecules in development. The portfolio also includes mipletamig for AML, APVO442 for prostate cancer and APVO455 for multiple solid tumor types. All five molecules share the same CRIS-7 derived binding domain with a low cytokine release profile. All molecules are designed to drive tumor-specific immune activation while limiting systemic toxicity.
Previous wording
*Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered (CRi).
Current wording
89% remission* reported among evaluable frontline AML patients across two trials treated with mipletamig in combination therapy, including 100% remission in Cohort 3 in the ongoing RAINIER trial (*Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered (CRi).
Previous wording
Comparison of the three and six months ended June 30, 2025 and 2024
Current wording
Comparison of the three and nine months ended September 30, 2025 and 2024
Previous wording
Our research and development expenses by program for the three and six months ended June 30, 2025 and 2024 are shown in the following table:
Current wording
Our research and development expenses by program for the three and nine months ended September 30, 2025 and 2024 are shown in the following table:
Previous wording
General and administrative expenses increased by $0.5 million, from $2.4 million for the three months ended June 30, 2024 to $2.9 million for the three months ended June 30, 2025. General and administrative expenses increased by $0.1 million, from $5.6 million for the six months ended June 30, 2024 to $5.7 million for the six months ended June 30, 2025. The increase is primarily due to higher consulting costs.
Current wording
General and administrative expenses increased by $1.5 million, from $2.1 million for the three months ended September 30, 2024 to $3.6 million for the three months ended September 30, 2025. General and administrative expenses increased by $1.6 million, from $7.7 million for the nine months ended September 30, 2024 to $9.3 million for the nine months ended September 30, 2025. The increase is primarily due to higher employee costs.
Previous wording
Other income, net consists primarily of interest income from our cash equivalents and short term rental income. Other income, net was $0.02 million and $0.1 million for the three and six months ended June 30, 2025, respectively. Other income, net was $0.1 million and $0.3 million for the three and six months ended June 30, 2024, respectively. The change in other income, net is primarily due to lower interest income from our money market accounts.
Current wording
Other income, net consists primarily of interest income from our cash equivalents and short term rental income. Other income, net was $0.06 million and $0.1 million for the three and nine months ended September 30, 2025, respectively. Other income, net was $0.1 million and $0.4 million for the three and nine months ended September 30, 2024, respectively. The change in other income, net is primarily due to lower interest income from our money market accounts.
Previous wording
The following table provides information regarding our cash flows for the six months ended June 30, 2025 and 2024:
Current wording
The following table provides information regarding our cash flows for the nine months ended September 30, 2025 and 2024:
Previous wording
Net cash used in operating activities of $13.7 million for the six months ended June 30, 2025 was primarily due to our net loss of $12.6 million for the period and changes in working capital accounts. Net cash used in operating activities of $12.8 million for the six months ended June 30, 2024 was primarily due to our net loss of $12.7 million for the period and changes in working capital accounts.
Current wording
Net cash used in operating activities of $20.4 million for the nine months ended September 30, 2025 was primarily due to our net loss of $20.2 million for the period and changes in working capital accounts. Net cash used in operating activities of $18.0 million for the nine months ended September 30, 2024 was primarily due to our net loss of $17.8 million for the period and changes in working capital accounts.
Previous wording
Net cash provided by financing activities of $14.4 million and $4.0 million for the three and six months ended June 30, 2025 and 2024, respectively, were primarily due to issuance of common stock.
Current wording
Net cash provided by financing activities of $32.7 million and $8.9 million for the three and nine months ended September 30, 2025 and 2024, respectively, were primarily due to exercise of warrants and issuance of common stock, including common stock issued pursuant to the SEPA (as defined below) and the ATM Agreement (as defined below).
Previous wording
On June 16, 2025, we entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, LTD., a Cayman Islands exempt limited company (“Yorkville”). Pursuant to the SEPA, the Company has the right, but not the obligation, to issue and sell to Yorkville from time to time up to $25.0 million (the “Commitment Amount”) of the Company’s common stock during the 36 months following the execution of the SEPA, subject to the restrictions and satisfaction of the conditions in the SEPA. As consideration for Yorkville’s irrevocable commitment to purchase the shares of common stock up to the Commitment Amount, the Company paid a structuring fee in the amount of $25,000 to Yorkville, and the Company has agreed to pay a commitment fee to Yorkville in an amount equal to 2.00% of the Commitment Amount in five equal installments. Pursuant to the SEPA, we will not sell shares of our common stock to Yorkville that would result in the beneficial ownership of Yorkville and its affiliates (on an aggregated basis) exceeding 9.99% of our then outstanding common stock. We did not issue any shares under the SEPA in the six months ended June 30, 2025 and 2024.
Current wording
On June 16, 2025, we entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, LTD., a Cayman Islands exempt limited company (“Yorkville”). Pursuant to the SEPA, the Company has the right, but not the obligation, to issue and sell to Yorkville from time to time up to $25.0 million (the “Commitment Amount”) of the Company’s common stock during the 36 months following the execution of the SEPA, subject to the restrictions and satisfaction of the conditions in the SEPA. As consideration for Yorkville’s irrevocable commitment to purchase the shares of common stock up to the Commitment Amount, the Company paid a structuring fee in the amount of $25,000 to Yorkville, and the Company has agreed to pay a commitment fee to Yorkville in an amount equal to 2.00% of the Commitment Amount in five equal installments. Pursuant to the SEPA, we will not sell shares of our common stock to Yorkville that would result in the beneficial ownership of Yorkville and its affiliates (on an aggregated basis) exceeding 9.99% of our then outstanding common stock. For the nine months ended September 30, 2025, the Company issued 8.3 million shares of common stock to Yorkville under the SEPA for aggregate gross proceeds of $15.0 million. As of September 30, 2025, the remaining availability under the SEPA is $10.0 million. We filed Form S-1 for 6.9 million shares under the SEPA on October 1, 2025. The filing is currently pending SEC review and approval, which has been delayed due to the U.S. federal government shutdown. We believe that our existing cash resources will be sufficient to meet our projected operating requirements for at least twelve months from the date of issuance of these financial statements.
Previous wording
On April 28, 2025, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with Roth Capital Partners, LLC, as sales agent (“Roth”) for an aggregate offering price of $50 million, pursuant to which the Company may offer and sell shares of its common stock from time to time through Roth. The compensation to Roth for the shares sold pursuant to the ATM Agreement will be an amount equal to 3.0% of the gross sales price of the shares sold under the ATM Agreement. The sale of such shares of common stock by Roth will be effected under the Company’s existing shelf Registration Statement on Form S-3, which was declared effective on February 26, 2025 (the “Registration Statement”). For the six months ended June 30, 2025, we issued 481,829 shares of our common stock at an average price of $7.81 per share under the ATM Agreement. We received $3.8 million in proceeds from the issuance of these shares.
Current wording
On April 28, 2025, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with Roth Capital Partners, LLC, as sales agent (“Roth”) for an aggregate offering price of $50 million, pursuant to which the Company may offer and sell shares of its common stock from time to time through Roth. The compensation to Roth for the shares sold pursuant to the ATM Agreement will be an amount equal to 3.0% of the gross sales price of the shares sold under the ATM Agreement. The sale of such shares of common stock by Roth will be effected under the Company’s existing shelf Registration Statement on Form S-3, which was declared effective on February 26, 2025 (the “Registration Statement”). For the nine months ended September 30, 2025, we issued 2.8 million shares of our common stock at an average price of $2.74 per share under the ATM Agreement. We received $7.6 million less issuance costs of $0.23 million in proceeds from the issuance of these shares. In addition, $4.1 million in net proceeds was raised during the subsequent events period. There is currently no remaining availability under the ATM Agreement due to the limitations of General Instruction I.B.6.
Previous wording
On February 14, 2025, we filed a Registration Statement on Form S-3 covering the offering, issuance, and sale up to $100 million in common stock, preferred stock, and various series of debt securities and/or warrants to purchase any of such securities, which included the unsold securities from the prior registration statement. On June 20, 2025, we filed the latest amendment to the prospectus supplement to the Registration Statement on Form S-3 filed on February 14, 2025 pursuant to General Instruction I.B.6 of Form S-3 (General Instruction I.B.6), which updates the amount of shares that we are eligible to sell under the ATM Agreement to $8.0 million. So long as the aggregate market value of our common stock held by non-affiliates is less than $75 million, we will not sell shares under the ATM Agreement with a value of more than one-third of the aggregate market value of our common stock held by non-affiliates in any 12-month period due to the limitations of General Instruction I.B.6 of Form S-3 and the current public float of our common stock. If our public float increases such that we may sell additional amounts under the ATM Agreement and the prospectus, we will file another amendment to the prospectus supplement prior to making additional sales. The limitations of General Instruction I.B.6 do not apply to sales of our shares under our SEPA with Yorkville as the sales of such shares were registered under a separate registration statement on Form S-1.
Current wording
On February 14, 2025, we filed a Registration Statement on Form S-3 covering the offering, issuance, and sale up to $100 million in common stock, preferred stock, and various series of debt securities and/or warrants to purchase any of such securities, which included the unsold securities from the prior registration statement. On June 20, 2025, we filed the latest amendment to the prospectus supplement to the Registration Statement on Form S-3 filed on February 14, 2025 pursuant to General Instruction I.B.6 of Form S-3 (General Instruction I.B.6), which updates the amount of shares that we are eligible to sell under the ATM Agreement to $8.0 million. So long as the aggregate market value of our common stock held by non-affiliates is less than $75 million, we will not sell shares under the ATM
Previous wording
We have an aggregate of 12,585,033 common warrants outstanding for which we may receive up to an additional $46.9 million in gross proceeds if exercised. The following is a summary of our currently outstanding common warrants:
Current wording
We have an aggregate of 12,535,033 common warrants outstanding for which we may receive up to an additional $23.9 million in gross proceeds if exercised. For additional information on our currently outstanding warrants, see Note 8 to the unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
Previous wording
We have financed our operations to date primarily through royalty and purchase agreements with various partners, sale of business products and segments, public offerings of our common stock, loan proceeds, milestone payments, research and development funding from strategic partners, revenue generated from our previously owned commercial products, and funds received at the date of our spin-off from Emergent. We had cash and cash equivalents of $9.4 million and an accumulated deficit of $260.2 million as of June 30, 2025.
Current wording
We have financed our operations to date primarily through royalty and purchase agreements with various partners, sale of business products and segments, public offerings of our common stock, loan proceeds, milestone payments, research and development funding from strategic partners, revenue generated from our previously owned commercial products, and funds received at the date of our spin-off from Emergent. We had cash and cash equivalents of $21.1 million and an accumulated deficit of $269.2 million as of September 30, 2025.
Previous wording
For the six months ended June 30, 2025, net cash used in our operating activities was $13.7 million.
Current wording
For the nine months ended September 30, 2025, net cash used in our operating activities was $20.4 million.
Previous wording
For the six months ended June 30, 2025, we received $15.9 million in proceeds through various equity offerings as follows:
Current wording
For the nine months ended September 30, 2025, we received $32.7 million in proceeds through various equity offerings as follows:
Previous wording
Additionally, on June 20, 2025, we completed an offering priced at-the-market with certain institutional investors, in which we received gross proceeds of $8.0 million, which included 2,465,000 shares of common stock (or pre-funded warrants in lieu thereof, all of which have been exercised as of June 30, 2025) and accompanying common warrants to purchase up to 12,325,000 shares of common stock at an exercise price of $3.25 per share for a combined purchase price of $3.25 per share and accompanying common warrants.
Current wording
Additionally, on June 20, 2025, we completed an offering priced at-the-market with certain institutional investors, in which we received gross proceeds of $8.0 million, which included 2,465,000 shares of common stock (or pre-funded warrants in lieu thereof, all of which have been exercised as of June 30, 2025) and accompanying common warrants to purchase up to 12,325,000 shares of common stock at an exercise price of $3.25 per share for a combined purchase price of $3.25 per share and accompanying common warrants. On September 16, 2025, the exercise price of such common warrants was lowered to $1.39 per share upon the trigger of the down round provision of the common warrants.
Previous wording
For the six months ended June 30, 2025, we issued 481,829 shares of our common stock at an average price of $7.81 per share under the ATM Agreement and received $3.8 million in proceeds from the issuance of such shares.
Current wording
For the nine months ended September 30, 2025, we issued 3.2 million shares of our common stock at an average price of $2.57 per share under the ATM Agreement and received $8.2 million in proceeds from the issuance of such shares.
Previous wording
the effects of macroeconomic conditions, including rising and fluctuating inflation and supply chain constraints;
Current wording
the effects of macroeconomic conditions, including rising and fluctuating inflation and supply chain constraints as well as political events such as the U.S. federal government shutdown and evolving healthcare policies;
Previous wording
the cost of commercialization activities if any of our product candidates are approved for sale, including marketing, sales, and distribution costs;
Current wording
the cost of commercialization activities if any of our product candidates are approved for sale, including marketing, sales, and distribution costs; and
Previous wording
our ability to continue as a going concern.
Current wording
our future ability to continue as a going concern.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Agreement with a value of more than one-third of the aggregate market value of our common stock held by non-affiliates in any 12-month period due to the limitations of General Instruction I.B.6 of Form S-3 and the current public float of our common stock. If our public float increases such that we may sell additional amounts under the ATM Agreement and the prospectus, we will file another amendment to the prospectus supplement prior to making additional sales. The limitations of General Instruction I.B.6 do not apply to sales of our shares under our SEPA with Yorkville as the sales of such shares were registered under a separate registration statement on Form S-1.