Aptevo Therapeutics Inc

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 APVO436 is a CD3xCD123 T-cell engager currently being clinically evaluated 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 APVO436 is a CD123xCD3 T-cell engager currently being clinically evaluated 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.

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 molecules over monoclonal antibodies allow for the development of ADAPTIR 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 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.

Previous wording

Comparison of the three months ended March 31, 2024 and 2023

Current wording

Comparison of the three and six months ended June 30, 2024 and 2023

Previous wording

Our research and development expenses by program for the three months ended March 31, 2024 and 2023 are shown in the following table:

Current wording

Our research and development expenses by program for the three and six months ended June 30, 2024 and 2023 are shown in the following table:

Previous wording

Research and development expenses decreased by $0.4 million, from $4.2 million for the three months ended March 31, 2023 to $3.8 million for the three months ended March 31, 2024. The decrease was primarily due to lower spending on APVO436 clinical trial as we concluded the Phase 1b study and are preparing to initiate Phase 1b/2 study and lower spending on preclinical projects and employee costs. The decrease was partially offset by higher spending on ALG.APV-527 Phase 1 clinical trial costs.

Current wording

Research and development expenses decreased by $1.9 million, from $5.5 million for the three months ended June 30, 2023 to $3.6 million for the three months ended June 30, 2024. Research and development expenses decreased by $2.2 million, from $9.6 million for the six months ended June 30, 2023 to $7.4 million for the six months ended June 30, 2024. The decrease was primarily due to lower spending on APVO436 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 wording

General and administrative expenses decreased by $0.4 million, from $3.6 million for the three months ended March 31, 2023 to $3.2 million for the three months ended March 31, 2024. The decrease is primarily due to lower employee and consulting costs.

Current wording

General and administrative expenses decreased by $0.3 million, from $2.7 million for the three months ended June 30, 2023 to $2.4 million for the three months ended June 30, 2024. General and administrative expenses decreased by $0.7 million, from $6.3 million for the six months ended June 30, 2023 to $5.6 million for the six months ended June 30, 2024. The decrease is primarily due to lower employee and consulting costs.

Previous wording

Other income, net was $0.2 million and other expense, net was $0.1 million for the three months ended March 31, 2024 and 2023, respectively. The change in other income (expense), net is primarily due to the repayment of our MidCap term loan in the first quarter of 2023.

Current wording

Other income, net was $0.1 million and $0.3 million for the three and six months ended June 30, 2024, respectively. Other income, net was $0.2 million and $0.2 million for the three and six months ended June 30, 2023, respectively. The change in other income, net is primarily due to the repayment of our MidCap term loan in the first quarter of 2023 and the decrease in interest income from our money market accounts.

Previous wording

We recorded $9.7 million in other income for the three months ended March 31, 2023, due to the sale of the deferred payments and milestones to XOMA during the quarter (see Note 3).

Current wording

We recorded $9.7 million in other income for the six months ended June 30, 2023, due to the sale of the deferred payments and milestones to XOMA during the quarter (see Note 3).

Previous wording

We did not record income from discontinued operations for the three months ended March 31, 2024. For the three months ended March 31, 2023, we recorded $0.9 million of contingent gain consideration from previous discontinued operations.

Current wording

We did not record income from discontinued operations for the six months ended June 30, 2024. For the six months ended June 30, 2023, we recorded $0.9 million of contingent gain consideration from previous discontinued operations.

Previous wording

The following table provides information regarding our cash flows for the three months ended March 31, 2024 and 2023:

Current wording

The following table provides information regarding our cash flows for the six months ended June 30, 2024 and 2023:

Previous wording

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. Net cash provided by operating activities of $4.6 million for the three months ended March 31, 2023 was primarily due to our net income of $2.8 million for the period and changes in working capital accounts.

Current wording

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. Net cash used in operating activities of $0.2 million for the six months ended June 30, 2023 was primarily due to our net loss of $5.2 million for the period and changes in working capital accounts.

Previous wording

Net cash used in financing activities for the three months ended March 31, 2024 was $3 thousand. Net cash used in financing activities of $1.9 million for the three months ended March 31, 2023 was primarily due to the $3.5 million of repayments of the MidCap Financial term loan, which included the remaining outstanding principal balance and loan prepayment fees. This was offset by the $1.6 million proceeds received from issuance of common stock pursuant to our Equity Distribution Agreement with Piper Sandler.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2024 of $4.0 million was primarily due to the issuance of common stock. Net cash used in financing activities of $1.4 million for the six months ended June 30, 2023 was primarily due to the $3.5 million of repayments of the MidCap Financial term loan, which included the remaining outstanding principal balance and loan prepayment fees. This was offset by the $2.1 million proceeds received from issuance of common stock pursuant to our Equity Distribution Agreement with Piper Sandler and our 2022 Purchase Agreement with Lincoln Park.

Previous wording

On February 28, 2020, Aptevo entered into an LLC Purchase Agreement with Medexus, pursuant to which we sold all of the issued and outstanding limited liability company interests of Aptevo BioTherapeutics LLC, a wholly owned subsidiary of Aptevo (the "LLC Purchase Agreement"). On March 29, 2023, we entered into and closed a Purchase Agreement with XOMA pursuant to which we sold to XOMA our right, title, and interest to all future deferred payments from Medexus and a portion of potential milestones. As consideration, we received $9.6 million at closing from XOMA and an additional $0.05 million post-closing payment. Aptevo continues to be eligible to receive up to $5.8 million in milestone payments from Medexus upon achievement of certain regulatory and IXINITY net sales threshold. For the three months ended March 31, 2023, Aptevo received $0.5 million in deferred payments from Medexus related to IXINITY sales for the fourth quarter of 2022.

Current wording

On February 28, 2020, Aptevo entered into an LLC Purchase Agreement with Medexus, pursuant to which we sold all of the issued and outstanding limited liability company interests of Aptevo BioTherapeutics LLC, a wholly owned subsidiary of Aptevo. On March 29, 2023, we entered into and closed a Purchase Agreement with XOMA pursuant to which we sold to XOMA our right, title, and interest to all future deferred payments from Medexus and a portion of potential milestones. As consideration, we received $9.6 million at closing from XOMA and an additional $0.05 million post-closing payment. Aptevo continues to be eligible to receive up to $5.8 million in milestone payments from Medexus upon achievement of certain regulatory and IXINITY net sales threshold. For the six months ended June 30, 2023, Aptevo received $0.5 million in deferred payments from Medexus related to IXINITY sales for the fourth quarter of 2022.

Previous wording

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 have an exercise price of $27.28 per share, are exercisable immediately following the date of issuance and will expire on August 4, 2028 and February 4, 2025, respectively. As of March 31, 2024, we have 42,555 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. If the remaining August 2023 warrants are exercised, we will receive up to an additional $1.2 million in gross proceeds.

Current wording

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 June 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 as part of the Registered Direct Offering that was closed on July 1, 2024. If the remaining August 2023 warrants are exercised, we will receive up to an additional $0.1 million in gross proceeds.

Previous wording

On November 9, 2023, we entered into a warrant inducement agreement (the "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 March 31, 2024, we have 281,452 Series A and 363,930 Series B Common Warrants outstanding from our November 2023 warrant inducement with an exercise price of $10.25 per share. If the warrants are exercised, we will receive up to an additional $6.6 million in gross proceeds.

Current wording

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 June 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 and 263,928 Series A and 346,406 Series B common warrants with an amended exercise price of $0.515 as part of the Registered Direct Offering that was closed on July 1, 2024. If the warrants are exercised, we will receive up to an additional $0.7 million in gross proceeds.

Previous wording

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 have an exercise price of $1.35 per share, are exercisable immediately following the date of issuance and will expire in April 2029. If the warrants are exercised, we will receive up to an additional $9.2 million in proceeds.

Current wording

On July 1, 2024, we completed the 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 the date of issuance and will expire in August 2029. If the warrants are exercised, we will receive up to an additional $5.5 million in proceeds.

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 $10.3 million and an accumulated deficit of $230.3 million as of March 31, 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 $8.1 million and an accumulated deficit of $236.2 million as of June 30, 2024.

Previous wording

For the three months ended March 31, 2024, net cash used in our operating activities was $6.7 million.

Current wording

For the six months ended June 30, 2024, net cash used in our operating activities was $12.8 million.

Previous wording

We have an operating lease related to our office and laboratory space in Seattle, Washington. This lease was amended in March 2019 to extend the term of the amended lease is through April 2030 and provided two options to extend the lease term, each by five years, as well as a one-time option to terminate the lease in April 2023, with nine months’ notice, or by July 2022. On May 26, 2022, we further amended our office and laboratory lease to remove the one-time termination option in April 2023. In exchange for removing the termination option, we received six months of free rent. As a result, we recorded an additional $4.4 million of lease liability and right-of-use asset on the consolidated balance sheet in May 2022.

Current wording

We have an operating lease related to our office and laboratory space in Seattle, Washington. This lease was amended in March 2019 to extend the term of the amended lease through April 2030 and provided two options to extend the lease term, each by five years, as well as a one-time option to terminate the lease in April 2023, with nine months’ notice, or by July 2022. On May 26, 2022, we further amended our office and laboratory lease to remove the one-time termination option in April 2023. In exchange for removing the termination option, we received six months of free rent. As a result, we recorded an additional $4.4 million of lease liability and right-of-use asset on the consolidated balance sheet in May 2022.