Aptevo Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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, 2024 · Filed Nov 7, 2024
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 2024-06-30; filed 2024-08-08.
0000950170-24-093366
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 78 previous paragraphs and 86 current paragraphs.
59 unchanged; 19 reworded; 7 added; 0 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 2 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 (7)
Current report
Recent Developments
Current report
APVO436 received its generic name, mipletamig (mih-ple'-tah-mig), and the lead candidate will be referred to by this name moving forward.
Current 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).
Current 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.
Current 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.
Current report
Common Warrants - September 2024
Current report
Our common stock may be at risk for delisting from the Nasdaq Capital Market in the future if we do not maintain compliance with Nasdaq’s continued listing requirements. Delisting could adversely affect the liquidity of our common stock and the market price of our common stock could decrease;
Reworded paragraphs (19)
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 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.
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 (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.
Previous wording
Comparison of the three and six months ended June 30, 2024 and 2023
Current wording
Comparison of the three and nine months ended September 30, 2024 and 2023
Previous 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:
Current 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:
Previous 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.
Current wording
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 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.
Current 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.
Previous 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.
Current wording
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 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).
Current wording
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 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.
Current wording
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 wording
The following table provides information regarding our cash flows for the six months ended June 30, 2024 and 2023:
Current wording
The following table provides information regarding our cash flows for the nine months ended September 30, 2024 and 2023:
Previous 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.
Current 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.
Previous 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.
Current wording
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 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.
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 nine months ended September 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 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.
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 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 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.
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 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 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 are exercisable immediately following the date of issuance and will expire in April 2029. As of June 30, 2024, we have 133,332 common warrants outstanding from our April public offering with an exercise price of $1.35 per share and 6,666,668 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 warrants are exercised, we will receive up to an additional $3.6 million in proceeds.
Current 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 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 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.
Current wording
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.
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 $8.1 million and an accumulated deficit of $236.2 million as of June 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 $7.8 million and an accumulated deficit of $241.3 million as of September 30, 2024.
Previous wording
For the six months ended June 30, 2024, net cash used in our operating activities was $12.8 million.
Current wording
For the nine months ended September 30, 2024, net cash used in our operating activities was $18.0 million.
Previous wording
We have a non-exclusive Commercial Platform License Agreement with OMT ("OMT License Agreement") for certain transgenic rodents of OMT's OmniAb platform. Our OMT License Agreement obligates us to make milestone and royalty payments upon achievement of certain regulatory approvals and commercialization of our product candidates. APVO436 and APVO603 are the product candidates currently subject to this agreement. Pursuant to our agreement, we are required to make a $2.0 million milestone payment upon dosing the first patient in a Phase 2 clinical trial of APVO436.
Current wording
We have a non-exclusive Commercial Platform License Agreement with OMT ("OMT License Agreement") for certain transgenic rodents of OMT's OmniAb platform. Our OMT License Agreement obligates us to make milestone and royalty payments upon achievement of certain regulatory approvals and commercialization of our product candidates. Mipletamig and APVO603 are the product candidates currently subject to this agreement. Pursuant to our agreement, we are required to make a $2.0 million milestone payment upon dosing the first patient in a Phase 2 clinical trial of mipletamig.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.