Aptevo Therapeutics Inc.
For the period ended Mar 31, 2025. Filed May 15, 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.
Mar 31, 2025 · Filed May 15, 2025
APVO$1.24-2.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0000950170-24-122837
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0000950170-25-072622
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 86 previous paragraphs and 94 current paragraphs.
50 unchanged; 12 reworded; 32 added; 22 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 3 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 (32)
Current report
On April 4, 2025, Aptevo closed a registered direct offering with certain institutional investors for 1,764,710 shares of our common stock, and in a concurrent private placement we also sold common warrants to purchase up to 3,529,420 shares of common stock for a combined purchase price of $1.19 per share and accompanying common warrants. We received $2.1 million in gross proceeds from the offering, less $0.2 million in issuance costs that included placement agent, legal and other fees.
Current report
On April 22, 2025, Aptevo closed a registered direct offering with certain institutional investors for 2,324,000 shares of our common stock for a purchase price of $0.862 per shares. We received $2.0 million in gross proceeds from the offering, less $0.2 million in issuance costs that included placement agent, legal and other fees.
Current report
On April 28, 2025, Aptevo entered into an At The Market Offering Agreement (the "Sales Agreement") to offer and sell shares of our common stock, having an aggregate offering price of up to $50,000,000 from time to time through Roth Capital Partners ("Roth"), as sales agent. As a result of the limitations of General Instruction I.B.6 of Form S-3, and in accordance with the terms of the Sales Agreement, we may currently offer and sell shares of our common stock having an aggregate offering price of up to $2,141,945 from time to time through Roth as sales agent.
Current report
Enrollment continues in the RAINIER dose optimization trial. This is a Phase 1b/2 study evaluating mipletamig in combination with venetoclax and azacitidine, the standard of care for frontline acute myeloid leukemia (AML) patients who are unfit to receive intensive high dose chemotherapy. Cohort 2 enrollment is now complete, and Cohort 3 is now open and enrolling.
Current report
Mipletamig has been evaluated in more than 100 patients across three clinical studies, thus far, in both combination and monotherapy settings. Outcomes have consistently demonstrated a growing body of evidence that supports its potential role in the treatment of frontline AML. Data highlights include:
Current report
Efficacy
Current report
To date, six frontline AML patients have been reported on in the ongoing RAINIER Phase 1b/2 trial evaluating mipletamig in combination with venetoclax and azacitidine. Of these, five of six (5/6) patients have achieved remission within 30 days of being dosed.
Current report
One patient progressed after the first cycle and passed away due to reasons unrelated to the study drugs.
Current report
These results build on data from a prior expansion study, in which four additional frontline patients treated with the same triplet combination also achieved remission (complete remission ("CR"), and complete remission with blood markers that have not yet recovered ("CRi")).
Current report
In total, 9 of 10 (90%) frontline patients across two trials have achieved remission with mipletamig in combination with standard of care therapy.
Current report
Safety
Current report
No cytokine release syndrome ("CRS") has been observed in the ongoing RAINIER trial to date.
Current report
This favorable profile is consistent with earlier trials, where CRS was generally minimal and manageable.
Current report
The company attributes this safety profile, a key differentiator, to the engineered CD3 domain (Cris7) and its ADAPTIR™ format, which are designed to reduce cytokine release without compromising T-cell activation or anti-leukemic activity.
Current report
Additional details
Current report
RAINIER Cohort 1 data (included in the total patient outcomes above) in which 100% of patients achieved remission within the first 30 days.
Current report
One patient experienced complete remission with minimal residual disease ("MRD")-negative status (100% elimination of cancer cells).
Current report
MRD-negative status is a critical outcome indicating that even the most sensitive diagnostic methods detect no remaining cancer cells. This result is strongly associated with longer-lasting remissions and improved survival rates.
Current report
Phase 1b dose expansion combination therapy (included in the total patient outcomes above) trial in which 100% of frontline patients achieved remission.
Current report
Phase 1a dose escalation monotherapy trial in which 36% of evaluable patients who failed prior regimens experienced substantial leukemic blast reduction to a clinical meaningful degree compared to baseline (range of 17% to 88% reduction), providing evidence of the pharmacodynamic effect of the drug – and efficacy contribution to the triplet combination.
Current report
The total ALG.APV-527 project costs of $0.2 million are presented in the table above net of $0.1 million expense reimbursement pursuant to the collaboration agreement detailed in Note 2 - Collaboration Agreements.
Current report
Research and development expenses decreased by $0.2 million, from $3.8 million for the three months ended March 31, 2024 to $3.6 million for the three months ended March 31, 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.
Current report
Other Income, Net
Current report
Other Income, Net
Current report
We did not use cash in financing activities for the three months ended March 31, 2025. Net cash used in financing activities of $3 thousand for the three months ended March 31, 2024 was primarily due to payments in lieu of fractional shares.
Current report
Sales Agreement
Current report
On April 28, 2025, we entered into the Sales Agreement with Roth. The Sales Agreement provides that, upon the terms and subject to the conditions set forth therein, we may issue and sell through Roth, acting as sales agent, shares of our common stock having an aggregate offering price of up to $50 million. We have no obligation to sell any such shares under the Sales Agreement. The sale of the shares of our common stock by Roth will be effected pursuant to a Registration Statement on Form S-3 which we filed on February 14, 2025, and subsequently amended and supplemented on April 28 and April 29, 2025. As of May 14, 2025, we had issued and sold 2,749,351 shares of our common stock at an aggregate gross offering price of $0.4392 pursuant to the Sales Agreement and the Registration Statement and Accompanying prospectus for aggregate gross sale proceeds of approximately $1.2 million. In accordance with the terms of the Sales Agreement, we may currently offer and sell shares of our common stock having an aggregate offering price of up to $2,141,945 from time to time through Roth as sales agent.
Current report
Common Warrants
Current report
We have an aggregate of 5,200,561 common warrants outstanding for which we may receive up to an additional $6.8 million in gross proceeds if exercised. The following is a summary of our currently outstanding common warrants:
Current report
At a special meeting of the stockholders on May 14, 2025, stockholders approved a proposal in which the exercise price of December 2024 Common Warrants was amended to $1.19 per share.
Current report
On April 4, 2025, we completed a registered direct offering with certain institutional investors (the "Investors") for 1,764,710 shares of our common stock, and in a concurrent private placement we also sold to Investors common warrants to purchase up to 3,529,420 shares of common stock for a combined purchase price of $1.19 for one share of our common stock and accompanying common warrants. On April 22, 2025, we completed a registered direct offering with certain investors for 2,324,000 shares of our common stock for a purchase price of $0.862 per share.
Current report
Collectively, we received $3.7 million in proceeds from the offerings after deducting placement agent expenses payable by us. The common warrants have an exercise price of $1.19 per share and are exercisable upon and will expire five years after obtaining stockholder approval. If the common warrants are exercised, we may receive up to an additional $4.2 million in proceeds. In the event that we are unable to obtain such stockholder approval, the Common Warrants will not be exercisable and therefore have no value.
Removed paragraphs (22)
Previous report
APVO436 received its generic name, mipletamig (mih-ple'-tah-mig), and the lead candidate will be referred to by this name moving forward.
Previous report
The Company initiated mipletamig Phase 1b/2 dose optimization trial, "RAINIER," as part of its ongoing program to evaluate the compound in combination with standard of care for frontline patients with acute myeloid leukemia (AML).
Previous report
On September 16, 2024, the Company announced data from the Phase 1 ALG.APV-527 monotherapy trial showing 60% of evaluable patients achieved stable disease in solid tumor study.
Previous report
Research and development expenses decreased by $0.8 million, from $3.9 million for the three months ended September 30, 2023 to $3.1 million for the three months ended September 30, 2024. Research and development expenses decreased by $3.0 million, from $13.5 million for the nine months ended September 30, 2023 to $10.5 million for the nine months ended September 30, 2024. The decrease was primarily due to lower spending on mipletamig clinical trial as we concluded the Phase 1b dose expansion study while preparing to initiate a Phase 1b/2 dose optimization study and lower spending on preclinical projects and employee costs.
Previous report
Other Income (Expense), Net
Previous report
Other Income (Expense), Net
Previous report
Other income, net was $0.1 million and $0.4 million for the three and nine months ended September 30, 2024, respectively. Other income, net was $0.2 million and $0.4 million for the three and nine months ended September 30, 2023, respectively. The change in other income, net is primarily due to the decrease in interest income from our money market accounts.
Previous report
Gain Related to Sale of Nonfinancial Asset
Previous report
We recorded $9.7 million in other income for the nine months ended September 30, 2023, due to the sale of the deferred payments and milestones to XOMA during the quarter (see Note 3).
Previous report
Discontinued Operations
Previous report
We did not record income from discontinued operations for the nine months ended September 30, 2024. For the nine months ended September 30, 2023, we recorded $0.9 million of contingent gain consideration from previous discontinued operations.
Previous report
Net cash provided by financing activities for the nine months ended September 30, 2024 of $8.9 million was primarily due to the issuance of common stock. Net cash provided by financing activities of $3.0 million for the nine months ended September 30, 2023 was primarily due to $6.4 million proceeds received from issuance of common stock and pre-funded warrants. This was offset by $3.5 million of repayments of the MidCap term loan, which included the remaining outstanding principal balance and loan prepayment fees.
Previous report
Series A and Series B Common Warrants - August 2023
Previous report
On August 4, 2023, in connection with the completion of a public offering, we issued Series A common warrants to purchase up to an aggregate of 183,281 shares of common stock and Series B common warrants to purchase up to an aggregate of 183,281 shares of common stock. The Series A and Series B common warrants are exercisable immediately following the date of issuance and will expire on August 4, 2028 and February 4, 2025, respectively. As of September 30, 2024, we have 1,316 Series A and 1,316 Series B common warrants outstanding from our August 2023 public offering with an exercise price of $27.28 per share and 41,239 Series A common warrants outstanding with an amended exercise price of $0.515 per share as part of the July Registered Direct Offering. If the remaining August 2023 warrants are exercised at their current exercise price, we will receive up to an additional $0.1 million in gross proceeds.
Previous report
Series A and Series B Common Warrants – November 2023
Previous report
On November 9, 2023, we entered into an Inducement Agreement with certain holders of our Series A and Series B common warrants issued in connection with our August 2023 public offering to exercise for cash 140,726 Series A and 181,965 Series B common warrants at a reduced exercise price of $10.25. We received $3.3 million in gross proceeds from the exercise of these warrants and issued an aggregate of 645,382 new Series A and new Series B warrants. As of September 30, 2024, we have 17,524 Series A and 17,524 Series B common warrants outstanding from our November 2023 warrant inducement with an exercise price of $10.25 per share, 82,478 Series A and 164,956 Series B common warrants with an amended exercise price of $0.515 per share as part of the July Registered Direct Offering and 181,450 Series A and 181,450 Series B common warrants with an amended exercise price of $0.33 per share as part of the September Registered Direct Offering. If the warrants are exercised at their current exercise price, we will receive up to an additional $0.6 million in gross proceeds.
Previous report
Common Warrants - April 2024
Previous report
On April 10, 2024, we completed a public offering related to the issuance and sale of 3,400,000 shares of our common stock (or pre-funded warrants in lieu thereof) at a purchase price of $1.35 per share. We received $4.6 million in gross proceeds from the issuance of these shares. Our net proceeds from the offering amounted to $4.0 million after placement agent and other fees. Additionally, we issued common warrants to purchase up to an aggregate of 6,800,000 shares of common stock. The common warrants are exercisable immediately following the date of issuance and will expire in April 2029. As of September 30, 2024, we have 133,332 common warrants outstanding from our April public offering with an exercise price of $1.35 per share, 2,222,222 common warrants outstanding with an amended exercise price of $0.515 per share as part of the July Registered Direct Offering and 4,444,446 common warrants outstanding with an amended exercise price of $0.33 per share as part of the September Registered Direct Offering. If the warrants are exercised at their current exercise price, we will receive up to an additional $2.8 million in proceeds.
Previous report
Common Warrants - July 2024
Previous report
On July 1, 2024, we completed the July Registered Direct Offering related to the issuance and sale of 5,339,806 shares of our common stock (or pre-funded warrants in lieu thereof) at a purchase price of $0.515 per share. We received $2.7 million in gross proceeds from the issuance of these shares. Our net proceeds from the offering amounted to $2.3 million after placement agent and other fees. Additionally, we issued common warrants to purchase up to an aggregate of 10,679,612 shares of common stock. The common warrants have an exercise price of $0.515 per share, are exercisable immediately following stockholder approval on August 6, 2024, and will expire in August 2029. The July Registered Direct Offering also amended 7,318,241 existing common warrants to lower the exercise price to $0.515 per share. The amended warrants became exercisable immediately following stockholder approval on August 6, 2024. As of September 30, 2024, we have 3,664,184 common warrants outstanding from the July Registered Direct Offering with an exercise price of $0.515 per share and 7,015,428 common warrants outstanding with an amended exercise price of $0.33 per share as part of the September Registered Direct Offering. If the warrants are exercised at their current exercise price, we will receive up to an additional $4.2 million in proceeds.
Previous report
Common Warrants - September 2024
Previous report
On September 16, 2024, we completed a public offering related to the issuance and sale of 9,090,910 shares of our common stock (or pre-funded warrants in lieu thereof) at a purchase price of $0.33 per share. We received $3.0 million in gross proceeds from the issuance of these shares. Our net proceeds from the offering amounted to $2.5 million after placement agent and other fees. Additionally, we issued common warrants to purchase up to an aggregate of 18,181,820 shares of common stock. The common warrants have an exercise price of $0.33 per share, are exercisable immediately following stockholder approval on October 25, 2024, and will expire in October 2029. The September Registered Direct Offering also amended 11,822,774 existing common warrants to lower the exercise price to $0.33 per share. The amended warrants became exercisable immediately following stockholder approval on October 25, 2024. As of September 30, 2024, we have 18,181,820 common warrants as part of the September Registered Direct Offering. If the warrants are exercised at their current exercise price, we will receive up to an additional $6.0 million in proceeds.
Reworded paragraphs (12)
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 three preclinical candidates currently in development. Clinical candidate mipletamig (formerly APVO436) is a CD3xCD123 T-cell engager currently being clinically evaluated in the RAINIER trail, part one of a Phase 1b/2 program initiated in August 2024 for the treatment of acute myelogenous leukemia (AML). 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.
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 three preclinical candidates currently in development. Clinical candidate mipletamig is a CD123xCD3 T cell engager currently being evaluated in the RAINIER clinical trial, part one of a Phase 1b/2 program initiated in August 2024 for the treatment of frontline acute myelogenous leukemia (AML) in combination with standard of care venetoclax + azacitidine. 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 and APVO711, were also developed using our ADAPTIR™ modular protein technology platform. Our preclinical candidate APVO442 was developed using our ADAPTIR-FLEX™ modular protein technology platform.
Current wording
Preclinical candidates, APVO603 and APVO711, were also developed using our ADAPTIR modular protein technology platform. Our preclinical candidate APVO442 was developed using our ADAPTIR-FLEX heterodimer protein technology platform. We wholly own both platforms which enable us to efficiently design and create new molecules, supporting our pipeline growth.
Previous wording
Our ADAPTIR and ADAPTIR-FLEX platforms are designed to generate monospecific, bispecific, and multi-specific antibody candidates capable of enhancing the human immune system against cancer cells. ADAPTIR and ADAPTIR-FLEX are both modular platforms, which gives us the flexibility to potentially generate immunotherapeutic candidates with a variety of mechanisms of action. This flexibility in design allows us to generate novel therapeutic candidates that may provide effective strategies against difficult to treat, as well as advanced forms of cancer. We have successfully designed and constructed numerous investigational-stage product candidates based on our ADAPTIR platform. The ADAPTIR platform technology is designed to generate monospecific and bispecific immunotherapeutic proteins that specifically bind to one or more targets, for example, bispecific therapeutic molecules, which may have structural and functional advantages over monoclonal antibodies. The structural differences of ADAPTIR and ADAPTIR FLEX molecules over monoclonal antibodies allow for the development of immunotherapies that are designed to engage immune effector cells and disease targets to produce signaling responses that modulate the immune system to kill tumor cells.
Current wording
Our ADAPTIR and ADAPTIR-FLEX platforms are designed to generate monospecific, bispecific, and multi-specific antibody candidates capable of enhancing the human immune system against cancer cells. ADAPTIR and ADAPTIR-FLEX are both heterodimer platforms, which gives us the flexibility to potentially generate immunotherapeutic candidates with a variety of mechanisms of action. This flexibility in design allows us to generate novel therapeutic candidates that may provide effective strategies against difficult to treat, as well as advanced forms of cancer. We have successfully designed and constructed numerous investigational-stage product candidates based on our ADAPTIR platform. The ADAPTIR platform technology is designed to generate monospecific and bispecific immunotherapeutic proteins that specifically bind to one or more targets, for example, bispecific therapeutic molecules, which may have structural and functional advantages over monoclonal antibodies. We have also developed a preclinical candidate based on the ADAPTIR-FLEX platform which is advancing in our pipeline. The structural differences of ADAPTIR and ADAPTIR FLEX molecules over monoclonal antibodies allow for the development of immunotherapies that are designed to engage immune effector cells and disease targets to produce signaling responses that modulate the immune system to kill tumor cells. We believe we are skilled at candidate generation, validation, and subsequent preclinical and clinical development.
Previous wording
Comparison of the three and nine months ended September 30, 2024 and 2023
Current wording
Comparison of the three months ended March 31, 2025 and 2024
Previous wording
Our research and development expenses by program for the three and nine months ended September 30, 2024 and 2023 are shown in the following table:
Current wording
Our research and development expenses by program for the three months ended March 31, 2025 and 2024 are shown in the following table:
Previous wording
General and administrative expenses decreased by $0.6 million, from $2.7 million for the three months ended September 30, 2023 to $2.1 million for the three months ended September 30, 2024. General and administrative expenses decreased by $1.3 million, from $9.0 million for the nine months ended September 30, 2023 to $7.7 million for the nine months ended September 30, 2024. The decrease is primarily due to lower employee and consulting costs.
Current wording
General and administrative expenses decreased by $0.4 million, from $3.2 million for the three months ended March 31, 2024 to $2.8 million for the three months ended March 31, 2025. The decrease is primarily due to lower stock-based compensation costs.
Previous wording
Other income (expense), net consists primarily of interest income from our cash equivalents and interest expense related to debt financing, which was paid off in Q1 2023.
Current wording
Other income, net consists primarily of interest income from our cash equivalents and short term rental income. Other income, net was $0.1 million for the three months ended March 31, 2025 and 2024.
Previous wording
The following table provides information regarding our cash flows for the nine months ended September 30, 2024 and 2023:
Current wording
The following table provides information regarding our cash flows for the three months ended March 31, 2025 and 2024:
Previous wording
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. Net cash used in operating activities of $6.5 million for the nine months ended September 30, 2023 was primarily due to our net loss of $11.5 million for the period and changes in working capital accounts.
Current wording
Net cash used in operating activities of $6.6 million for the three months ended March 31, 2025 was primarily due to our net loss of $6.4 million for the period and changes in working capital accounts. Net cash used in operating activities of $6.7 million for the three months ended March 31, 2024 was primarily due to our net loss of $6.8 million for the period and changes in working capital accounts
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 $7.8 million and an accumulated deficit of $241.3 million as of September 30, 2024.
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 $2.1 million and an accumulated deficit of $254.0 million as of March 31, 2025.
Previous wording
For the nine months ended September 30, 2024, net cash used in our operating activities was $18.0 million.
Current wording
For the three months ended March 31, 2025, net cash used in our operating activities was $6.6 million.
Previous wording
the effects of macroeconomic conditions, including rising and fluctuating inflation, interest rates and supply chain constraints;
Current wording
the effects of macroeconomic conditions, including rising and fluctuating inflation and supply chain constraints;
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Previous report — wording carried elsewhere
We believe we are skilled at candidate generation, validation, and subsequent preclinical and clinical development using the ADAPTIR platform and the ADAPTIR-FLEX platform to generate bispecific and multi-specific candidates or other candidates to our platform capabilities. We have developed a preclinical candidate based on the ADAPTIR-FLEX platform which is advancing in our pipeline. We are developing our ADAPTIR and ADAPTIR-FLEX molecules using our protein engineering, preclinical development, process development, and clinical development capabilities.