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APVO

Aptevo TherapeuticsD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-14
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Investor releaseQuarter not tagged2026-08-14

Aptevo Provides 2Q26 Business Update and Reports Second Quarter Financial Results

ACCESS Newswire
Mipletamig Drives Clinical Momentum with Strong Frontline AML Data, Path Toward Phase 2 Chief Scientific Officer Appointment Strengthens Execution Across Advancing Oncology Pipeline Non-Dilutive Grant Funding Advances APVO451 and Validates Trispecific Solid Tumor Strategy Strategic Niowave Collaboration Opens a New Radiopharmaceutical Therapeutic Development Opportunity SEATTLE, WA / ACCESS Newswire / August 14, 2026 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today reported financial results for the quarter ended June 30, 2026 and provided a business update highlighting strong clinical progress for mipletamig, strengthened scientific leadership, non-dilutive funding to advance its solid tumor trispecific pipeline and expansion into radiopharmaceutical therapeutic development through a 50/50 collaboration with Niowave. "During the second quarter, we made important progress against the programs and initiatives we believe can create near- and long-term value for Aptevo," said Jeff Lamothe, President and Chief Executive Officer of Aptevo. "Mipletamig continues to lead our value creation strategy, with RAINIER generating compelling frontline acute myeloid leukemia data and moving toward completion of dose optimization by year end and Phase 2 regulatory interaction early in 2027. We also strengthened our scientific leadership, secured non-dilutive funding to advance trispecific candidate APVO451, and entered a 50/50 collaboration with Niowave that gives us a cost-effective path into radiopharmaceutical therapeutics and access to isotope supply in a constrained market. Together, these achievements put us in a stronger position to advance our pipeline and pursue multiple opportunities to create shareholder value." Mipletamig Drives Clinical Momentum with Strong Frontline AML Data and a Path Toward Phase 2 Mipletamig remained Aptevo's most advanced and central value driver during the quarter, with updated Phase 1b/2 RAINIER trial data continuing to show strong clinical activity in frontline acute myeloid leukemia (AML) when combined with venetoclax and azacitidine. Across 31 evaluable unfit frontline AML patients (through Cohort 5 plus four frontline patients from the completed dose expansion trial), mipletamig…Read full document

Mipletamig Drives Clinical Momentum with Strong Frontline AML Data, Path Toward Phase 2 Chief Scientific Officer Appointment Strengthens Execution Across Advancing Oncology Pipeline Non-Dilutive Grant Funding Advances APVO451 and Validates Trispecific Solid Tumor Strategy Strategic Niowave Collaboration Opens a New Radiopharmaceutical Therapeutic Development Opportunity SEATTLE, WA / ACCESS Newswire / August 14, 2026 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today reported financial results for the quarter ended June 30, 2026 and provided a business update highlighting strong clinical progress for mipletamig, strengthened scientific leadership, non-dilutive funding to advance its solid tumor trispecific pipeline and expansion into radiopharmaceutical therapeutic development through a 50/50 collaboration with Niowave. "During the second quarter, we made important progress against the programs and initiatives we believe can create near- and long-term value for Aptevo," said Jeff Lamothe, President and Chief Executive Officer of Aptevo. "Mipletamig continues to lead our value creation strategy, with RAINIER generating compelling frontline acute myeloid leukemia data and moving toward completion of dose optimization by year end and Phase 2 regulatory interaction early in 2027. We also strengthened our scientific leadership, secured non-dilutive funding to advance trispecific candidate APVO451, and entered a 50/50 collaboration with Niowave that gives us a cost-effective path into radiopharmaceutical therapeutics and access to isotope supply in a constrained market. Together, these achievements put us in a stronger position to advance our pipeline and pursue multiple opportunities to create shareholder value." Mipletamig Drives Clinical Momentum with Strong Frontline AML Data and a Path Toward Phase 2 Mipletamig remained Aptevo's most advanced and central value driver during the quarter, with updated Phase 1b/2 RAINIER trial data continuing to show strong clinical activity in frontline acute myeloid leukemia (AML) when combined with venetoclax and azacitidine. Across 31 evaluable unfit frontline AML patients (through Cohort 5 plus four frontline patients from the completed dose expansion trial), mipletamig demonstrated an 87% clinical benefit rate and an 81% remission rate, supporting its potential to improve standard-of-care outcomes for a patient population with significant unmet need. Safety data observed to date demonstrate mipletamig's combinability, safety and tolerability in combination with standard-of-care therapy. RAINIER has entered the final stage of dose optimization, positioning Aptevo to complete the Phase 1b RAINIER trial and select the recommended Phase 2 dose this year in anticipation of a Phase 2 regulatory interaction in 1Q27. Additional Outcomes of Note 55% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level (MRD neg), a result that is typically associated with stronger, more durable responses 36% of patients with remissions had the TP53 genetic mutation, a high-risk biomarker typically associated with poor prognosis in AML and for which most treatment options frequently fail 6 patients treated to date have proceeded to allogeneic stem cell transplant, which represents the best possible outcome in AML treatment and is rarely achieved in the older or unfit frontline patient population Mipletamig was designed for the way frontline AML is treated: as an added therapeutic component to standard-of-care venetoclax and azacitidine, with the goal of increasing efficacy without materially increasing toxicity burden. Its profile is supported by clinical experience across more than 120 treated patients, no cytokine release syndrome reported in frontline patients through Cohort 5 of the RAINIER trial, activity in a medically unfit frontline population and six patients bridged to transplant, the best possible outcome in the AML treatment landscape. Importantly, mipletamig is not limited to a single genetic alteration or narrow biomarker-defined subgroup, giving it potential applicability across a broader frontline AML population where tolerability, combinability and ease of integration with venetoclax and azacitidine are central to treatment decisions. Chief Scientific Officer Appointment Strengthens Execution Across an Advancing Oncology Pipeline Aptevo appointed Mary J. Janatpour, Ph.D., as Senior Vice President and Chief Scientific Officer, adding more than 25 years of oncology research and development leadership to support the Company's clinical priorities, preclinical strategy and next generation multispecific pipeline. Dr. Janatpour will lead research and preclinical development and play a key role in advancing Aptevo's expanding portfolio, including its radiopharmaceutical collaboration and trispecific solid tumor programs. Dr. Janatpour has held senior scientific leadership roles across both large biopharmaceutical organizations and emerging biotechnology companies, giving her a rare combination of deep oncology research expertise and hands-on experience building innovative programs in fast-moving development environments. Non-Dilutive Grant Funding Advances APVO451 and Validates Trispecific Solid Tumor Strategy Aptevo secured a $1.5 million non-dilutive research grant from the Andy Hill Cancer Research Endowment (CARE) Fund to support investigational new drug (IND)-enabling work for APVO451, a nectin-4-targeted trispecific immunotherapy candidate for solid tumors. The competitive, merit-reviewed award provides meaningful third-party validation for APVO451's tumor-directed trispecific design and underscores Aptevo's ability to advance innovative oncology programs through capital-efficient funding strategies. Together, the grant and planned development timeline position APVO451 as an emerging pipeline value driver, with development candidate selection targeted by year-end 2026 and IND-enabling studies planned for the first quarter of 2027. $1.5 million non-dilutive award to support APVO451 IND-enabling work Competitive, merit-reviewed grant provides third-party validation for APVO451's tumor-directed trispecific approach Development candidate selection targeted by year-end 2026, with IND-enabling studies planned for the first quarter of 2027 Strategic Niowave Collaboration Opens a New Radiopharmaceutical Development Opportunity Aptevo expanded its development strategy through a 50/50 collaboration with Niowave to develop up to three radiopharmaceutical oncology programs. With radiopharmaceutical therapeutics emerging as one of oncology's hottest investment areas, the collaboration gives Aptevo a capital-efficient way to enter a field attracting substantial big pharma interest while leveraging its own tumor-targeting expertise. The structure gives Aptevo a cost-efficient path into radiopharmaceutical therapeutics by sharing development costs, while pairing Aptevo's tumor-targeting expertise with Niowave's radioisotope production and supply capabilities. Importantly, the collaboration also provides access to isotope supply in a constrained market. Niowave also made an at-the-market equity investment in Aptevo at closing, creating additional alignment between the companies. 50/50 collaboration to develop up to three radiopharmaceutical oncology programs Strategic equity investment by Niowave at closing, representing an initial 7.9% ownership position, with the potential to build up to 19.99% Opportunity to extend Aptevo's tumor-targeting approach into radiopharmaceutical therapeutics for difficult-to-treat cancers Q2 2026 Financial Position Aptevo had cash and cash equivalents totaling $9.8 million as of June 30, 2026. During the second quarter of 2026, the company raised $0.6 million under the company's Standby Equity Purchase Agreements (SEPAs) with Yorkville. For additional APVO financial information and complete access to the company's filings, click here. About Aptevo Aptevo Therapeutics Inc. (Nasdaq: APVO) is a clinical-stage biotechnology company developing novel multispecific immunotherapies for the treatment of cancer. The Company's lead clinical candidate, mipletamig, is currently being evaluated in frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Aptevo's pipeline is generated from its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platforms and includes bispecific and trispecific candidates designed to create multiple oncology value drivers across hematologic malignancies and solid tumors. In preclinical development, Aptevo is advancing APVO451, a nectin-4-targeted trispecific immunotherapy candidate for solid tumors and is pursuing strategic opportunities in radiopharmaceutical therapeutics to extend its tumor-targeting expertise into additional cancer treatment approaches. For more information, visit www.aptevotherapeutics.com. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, let alone at a rate of 100%, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for ALG.APV-527, development and continued development of Aptevo's current and potential future molecules, including the Company's trispecific candidates and their future development and efficacy with respect to addressing multiple solid tumor types, whether pre-clinical studies of Aptevo's trispecific candidates will show the desired anti-tumor efficacy, mechanism of action and safety profile and whether Aptevo's trispecific candidates will function with new mechanisms of action compared to our previous candidates and synergistically induce a biological response, statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to access capital and funding runway, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises , geopolitical risks, including the current war between Russia and Ukraine, the war between United States and Iran and any other military event that could evolve out of any of the current conflicts, and macroeconomic conditions such as economic uncertainty, imposition of tariffs, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT:Miriam Weber MillerVP, Investor Relations & Corporate CommunicationsAptevo TherapeuticsEmail: [email protected] or [email protected]: 206-859-6628 SOURCE: Aptevo Therapeutics View the original press release on ACCESS Newswire

Investor releaseQuarter not tagged2025-11-06

Aptevo Therapeutics Reports 3Q25 Financial Results And Provides A Business Update

ACCESS Newswire
89% of evaluable mipletamig patients achieve remission in combination therapy for frontline AML across two trials Introduces first trispecific molecules, APVO451 and APVO452, advancing therapies designed to overcome immune suppression in certain solid tumors Both molecules leverage Aptevo's unique use of the CRIS-7-derived CD3 binding domain, associated with favorable safety outcomes in the clinic; CD3 T-cell engager portfolio expanded to five Company raises $18.7 million in the third quarter, $4.1 million since quarter end, extends cash runway into 4Q26 SEATTLE, WA / ACCESS Newswire / November 6, 2025 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology Company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies, today reported financial results for the quarter ended September 30, 2025, and provided a business update. Third Quarter Highlights 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). 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 Introduced the Company's first trispecific T-cell engagers - APVO451 and APVO452 - expanding the oncology portfolio to five CRIS-7-derived CD3-targeting molecules These candidates are designed to target tumors that suppress immune activity, a key barrier to durable responses in solid tumors 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 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 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 "We continue to make disciplined p…Read full document

89% of evaluable mipletamig patients achieve remission in combination therapy for frontline AML across two trials Introduces first trispecific molecules, APVO451 and APVO452, advancing therapies designed to overcome immune suppression in certain solid tumors Both molecules leverage Aptevo's unique use of the CRIS-7-derived CD3 binding domain, associated with favorable safety outcomes in the clinic; CD3 T-cell engager portfolio expanded to five Company raises $18.7 million in the third quarter, $4.1 million since quarter end, extends cash runway into 4Q26 SEATTLE, WA / ACCESS Newswire / November 6, 2025 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology Company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies, today reported financial results for the quarter ended September 30, 2025, and provided a business update. Third Quarter Highlights 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). 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 Introduced the Company's first trispecific T-cell engagers - APVO451 and APVO452 - expanding the oncology portfolio to five CRIS-7-derived CD3-targeting molecules These candidates are designed to target tumors that suppress immune activity, a key barrier to durable responses in solid tumors 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 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 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 "We continue to make disciplined progress across both our clinical and research programs," said Marvin White, President and Chief Executive Officer of Aptevo. "The Cohort 3 results reinforce mipletamig's potential to meaningfully improve outcomes for patients with frontline AML - a population that has had very limited treatment options. At the same time, the introduction of trispecific candidates, APVO451 and APVO452, reflects the continued strength of our platform strategy and our commitment to thoughtfully expanding the pipeline where we believe we can have real impact. Our approach remains focused, data-driven, and rooted in the belief that well-designed immunotherapies can be both powerful and tolerable for patients." "Aptevo raised $22.8 million since the end of the second quarter, extending our runway well into the fourth quarter of 2026 and ensuring we are well-capitalized for the important milestones ahead. We are pleased to have completed this financing in a cost-effective manner and without issuing new warrants, reflecting continued momentum in the business. This additional capital positions us to execute on our clinical and development plans while remaining focused on delivering value for patients and shareholders," said Daphne Taylor, SVP and Chief Financial Officer of Aptevo. Pipeline Expansion - APVO451 and APVO452 (Trispecific CD3 Portfolio) During the quarter, Aptevo introduced APVO451 (for multiple solid tumors) and APVO452 (for prostate cancer), two trispecific T-cell engagers designed to more effectively activate the immune system in solid tumors with highly suppressive tumor microenvironments. With these additions, the Company now has five CD3-engaging molecules, all built using Aptevo's unique application of the CRIS-7-derived CD3 binding domain, specifically engineered to deliver targeted, controlled T-cell activation. Mr. White commented, "Bispecifics already deliver selective T-cell activation and are clinically validated and commercially viable today. Trispecifics, APVO451 and APVO452, build on that foundation to more flexibly fight tumors that have evolved to create a suppressive tumor microenvironment. In these cases, trispecifics add a third coordinated signal to help overcome that suppression. We are excited about adding to the pipeline and expanding our potential to impact a broader range of tumor types." The design is intended to advance potent anti-tumor activity while reducing the risk of systemic cytokine release, a known challenge for traditional CD3-based therapies; these candidates extend Aptevo's platform to a broader range of tumor biology, while preserving the Company's core safety-first approach to immune activation via the CRIS-7-derived CD3 pathway. Mipletamig (CD123 x CD3) in Frontline AML Across two trials evaluating mipletamig in combination with venetoclax + azacitidine, 89% of newly diagnosed, evaluable AML patients unfit for intensive chemotherapy achieved remission. No cytokine release syndrome has been observed among frontline patients to date, supporting mipletamig's emerging profile of favorable safety and tolerability, combined with high response rates among evaluable patients. Q3 2025 Summary Financial Results Cash Position: Aptevo had cash and cash equivalents as of September 30, 2025, totaling $21.1 million. During the third quarter of 2025, the Company raised $18.7 million, net under the Company's Standy Equity Purchase Agreement (SEPA) with Yorkville and the Company's ATM agreement with Roth. An additional $4.1 million, net was raised under the ATM agreement in October, bringing the proforma cash and cash equivalents at September 30, 2025, to $25.2 million. The SEPA and ATM programs carry lower fees than traditional equity raises, are done at market prices and do not include warrants that could result in additional shareholder dilutions. As such, they enable the Company to raise capital on as-needed basis, providing liquidity to support our ongoing operations. The Company now has sufficient cash resources to meet our projected operating requirements for at least twelve months from the date of issuance of the financial statements. Research and Development Expenses: 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. The increase was primarily due to increased mipletamig and employee costs and was offset by lower costs on ALG.APV-527. General and Administrative Expenses: 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. The increase is primarily due to higher employee costs. Net Income (Loss): Aptevo had a net loss of $7.5 million or $2.23 per share for the three months ended September 30, 2025, compared to a net loss of $5.1 million or $357.86 per share for the corresponding period in 2024. Dividend Attributable to Down Round Feature of Warrants: This non-cash amount reflects the impact of reducing the exercise price of the Company's June 2025 warrants from the original $3.25 per share to $1.39 per share, the lowest price at which we sold common shares after issuance of such common warrants due to contractual requirements of the warrants. The $1.5 million recorded in three months ended September 30, 2025, reflects dividend deemed to common shareholders and it increases net loss attributable to common shareholders to $9.0 million for EPS purposes. Aptevo Therapeutics Inc. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts) Aptevo Therapeutics Inc. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) About Aptevo Therapeutics Aptevo Therapeutics Inc. (Nasdaq:APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and was most recently evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has six preclinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIRand ADAPTIR-FLEX. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for ALG.APV-527, development and continued development of Aptevo's current and potential future molecules, the anticipated timing of the initiation of preclinical studies of APVO451 and APVO452, APVO451's and APVO452's future development and efficacy with respect to addressing multiple solid tumor types, including prostate cancer, whether pre-clinical studies of Aptevo's trispecific candidates APVO451 and APVO452 will show the desired anti-tumor efficacy, mechanism of action and safety profile and whether APVO451 and APVO452 will function with new mechanisms of action compared to our previous candidates and synergistically induce a biological response, statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises, geopolitical risks, including the current war between Russia and Ukraine and any other military event that could evolve out of any of the current conflicts, and macroeconomic conditions such as economic uncertainty, imposition of tariffs, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT: Miriam Weber Miller Head, Investor Relations & Corporate Communications Aptevo Therapeutics Email: [email protected] or [email protected] Phone: 206-859-6628 SOURCE: Aptevo Therapeutics View the original press release on ACCESS Newswire

Investor releaseQuarter not tagged2025-10-08

Aptevo Presenting Scientific and Clinical Updates at SITC and ASH, also Participating in Leading Financial and Industry Conferences in the Fourth Quarter

ACCESS Newswire
SEATTLE, WASHINGTON / ACCESS Newswire / October 8, 2025 / Aptevo Therapeutics ("Aptevo" or the "Company") (Nasdaq:APVO), a clinical-stage biotechnology company developing novel bispecific and trispecific immuno-oncology therapeutics, today announced its participation in upcoming key financial, industry, scientific and medical conferences this fall, providing the opportunity to highlight continued momentum and recent developments among a broad range of stakeholder audiences. These conferences include: 4th Annual ROTH Healthcare Opportunities Conference October 9, 2025 - Metropolitan Club, New York City, New York Aptevo will participate in a panel on Acute Myeloid Leukemia titled "Novel AML Therapies Showing Clear Clinical Progress," discussing progress and recent trial outcomes of its lead asset, mipletamig, and sharing emerging evidence of its differentiated clinical profile in frontline AML-where strong safety, tolerability, and early efficacy continue to demonstrate meaningful potential for improved patient outcomes Biotechnology Innovation Organization (BIO)-Europe 2025 - 31st Annual International Partnering Conference November 3-5, 2025 (in-person); Digital Partnering Days: November 11-12, 2025 - Messe Wien Exhibition & Congress Center, Vienna, Austria The Business Development Team will be on-site and actively participating in meetings at the largest biotechnology meeting in Europe Society of Immunotherapy in Cancer (SITC) 2025 - 40th Anniversary Annual Meeting November 5-9, 2025 - Gaylord National Resort & Convention Center, National Harbor, Maryland Aptevo's R&D Team will present a poster highlighting a novel trispecific targeting Nectin-4, CD3 and CD40 to overcome the immunosuppressive the tumor microenvironment American Society of Hematology (ASH) 2025 - 67th American Society of Hematology Annual Meeting & Exposition December 6-9, 2025 - Orange County Convention Center, Orlando, Florida Interim results from the ongoing Phase 1b/2 RAINIER trial evaluating mipletamig in frontline combination therapy for the treatment of AML, will be presented in a poster session by the clinical team. To meet with onsite Company representatives at any of these meetings, we cordially invite you to contact: Miriam Weber Miller Aptevo Therapeutics [email protected] or [email protected] +1 (206) 859 6629 About Aptevo Therapeutics Aptevo Therapeutics Inc. (Nasdaq: APVO) is a clinic…Read full document

SEATTLE, WASHINGTON / ACCESS Newswire / October 8, 2025 / Aptevo Therapeutics ("Aptevo" or the "Company") (Nasdaq:APVO), a clinical-stage biotechnology company developing novel bispecific and trispecific immuno-oncology therapeutics, today announced its participation in upcoming key financial, industry, scientific and medical conferences this fall, providing the opportunity to highlight continued momentum and recent developments among a broad range of stakeholder audiences. These conferences include: 4th Annual ROTH Healthcare Opportunities Conference October 9, 2025 - Metropolitan Club, New York City, New York Aptevo will participate in a panel on Acute Myeloid Leukemia titled "Novel AML Therapies Showing Clear Clinical Progress," discussing progress and recent trial outcomes of its lead asset, mipletamig, and sharing emerging evidence of its differentiated clinical profile in frontline AML-where strong safety, tolerability, and early efficacy continue to demonstrate meaningful potential for improved patient outcomes Biotechnology Innovation Organization (BIO)-Europe 2025 - 31st Annual International Partnering Conference November 3-5, 2025 (in-person); Digital Partnering Days: November 11-12, 2025 - Messe Wien Exhibition & Congress Center, Vienna, Austria The Business Development Team will be on-site and actively participating in meetings at the largest biotechnology meeting in Europe Society of Immunotherapy in Cancer (SITC) 2025 - 40th Anniversary Annual Meeting November 5-9, 2025 - Gaylord National Resort & Convention Center, National Harbor, Maryland Aptevo's R&D Team will present a poster highlighting a novel trispecific targeting Nectin-4, CD3 and CD40 to overcome the immunosuppressive the tumor microenvironment American Society of Hematology (ASH) 2025 - 67th American Society of Hematology Annual Meeting & Exposition December 6-9, 2025 - Orange County Convention Center, Orlando, Florida Interim results from the ongoing Phase 1b/2 RAINIER trial evaluating mipletamig in frontline combination therapy for the treatment of AML, will be presented in a poster session by the clinical team. To meet with onsite Company representatives at any of these meetings, we cordially invite you to contact: Miriam Weber Miller Aptevo Therapeutics [email protected] or [email protected] +1 (206) 859 6629 About Aptevo Therapeutics Aptevo Therapeutics Inc. (Nasdaq: APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a Phase 1b/2 trial for the treatment of frontline AML in combination with standard of care venetoclax + azacitidine. Mipletamig has orphan status for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist that is only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. Aptevo has six pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIRÔand ADAPTIR-FLEXÔ. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b/2 dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final remission data or trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of future preliminary or interim data readouts for ALG.APV-527, statements related to the progress of and enthusiasm for Aptevo's clinical programs, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises, geopolitical risks, including the current wars between Russia and Ukraine, Israel and Hamas and any other military event that could evolve out of any of the current conflicts and macroeconomic conditions such as economic uncertainty, imposition of tariffs, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. SOURCE: Aptevo Therapeutics View the original press release on ACCESS Newswire

Investor releaseQuarter not tagged2025-08-11

Aptevo Therapeutics Reports 2Q25 Financial Results And Provides A Business Update

ACCESS Newswire
Mipletamig's 85% frontline AML remission rate and favorable safety profile drive APVO's differentiated CD3 portfolio expansion with APVO455, a Nectin-4 x CD3 bispecific for multiple solid tumor types CD3 bispecific portfolio now includes three candidates - mipletamig (AML), APVO442 (prostate cancer), and newly added APVO455 - advancing a targeted, tumor-specific strategy uniquely engineered for safety, tumor specificity and clinical impact Mipletamig, continues to outperform benchmarks, trial enrollment continues $15.9 million raised in 2Q25, extending cash runway into late 4Q25 SEATTLE, WASHINGTON / ACCESS Newswire / August 11, 2025 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology Company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies, today reported financial results for the quarter ended June 30, 2025, and provided a business update. Second Quarter Highlights 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 Mipletamig for acute myeloid leukemia (AML) - Achieved 85% remission* rate (11/13 patients) in frontline AML patients across two trials in combination therapy Increased Liquidity - Completed financings that raised a total of $15.9 million, extending cash runway into late 4Q25 Secured an equity line of credit for up to an additional $25 million in capital *Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered (CRi). "The second quarter marked a period of decisive progress for Aptevo across both clinical and corporate fronts," said Marvin White, President and CEO of Aptevo. We are energized by the expansion of our differentiated CD3 bispecific portfolio - anchored by mipletamig in AML and APVO442 in prostate cancer - with the introduction of APVO455, a Nectin-4 x CD3 bispecific designed to address a broad range of solid tumor types. Broadening our reach into solid tumors, beyond prostate cancer, with APVO455 underscores Aptevo's commitment to advancing differentiated, next-generation immunotherapies in areas of significant unmet need." Mr. White continued, "We're pleased to report that our lead asset, mipletamig, continu…Read full document

Mipletamig's 85% frontline AML remission rate and favorable safety profile drive APVO's differentiated CD3 portfolio expansion with APVO455, a Nectin-4 x CD3 bispecific for multiple solid tumor types CD3 bispecific portfolio now includes three candidates - mipletamig (AML), APVO442 (prostate cancer), and newly added APVO455 - advancing a targeted, tumor-specific strategy uniquely engineered for safety, tumor specificity and clinical impact Mipletamig, continues to outperform benchmarks, trial enrollment continues $15.9 million raised in 2Q25, extending cash runway into late 4Q25 SEATTLE, WASHINGTON / ACCESS Newswire / August 11, 2025 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology Company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies, today reported financial results for the quarter ended June 30, 2025, and provided a business update. Second Quarter Highlights 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 Mipletamig for acute myeloid leukemia (AML) - Achieved 85% remission* rate (11/13 patients) in frontline AML patients across two trials in combination therapy Increased Liquidity - Completed financings that raised a total of $15.9 million, extending cash runway into late 4Q25 Secured an equity line of credit for up to an additional $25 million in capital *Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered (CRi). "The second quarter marked a period of decisive progress for Aptevo across both clinical and corporate fronts," said Marvin White, President and CEO of Aptevo. We are energized by the expansion of our differentiated CD3 bispecific portfolio - anchored by mipletamig in AML and APVO442 in prostate cancer - with the introduction of APVO455, a Nectin-4 x CD3 bispecific designed to address a broad range of solid tumor types. Broadening our reach into solid tumors, beyond prostate cancer, with APVO455 underscores Aptevo's commitment to advancing differentiated, next-generation immunotherapies in areas of significant unmet need." Mr. White continued, "We're pleased to report that our lead asset, mipletamig, continues to perform as designed in the clinic. In frontline acute myeloid leukemia (AML), 85% of evaluable patients achieved remission when treated in combination with standard of care across two independent trials. These encouraging results validate mipletamig's differentiated mechanism of action and highlight its potential as a transformative therapy for AML, anchoring our CRIS-7-derived CD3 portfolio. Just as important, we strengthened our financial position with a $15.9 million raise, extending cash runway into late Q4 2025, and ensuring we are well-positioned to reach additional clinical and business milestones in the months ahead." APVO455: A New T-Cell Engager Targeting Solid Tumors APVO455 is a preclinical Nectin-4 x CD3 bispecific T-cell engager designed for tumors such as bladder, breast, NSCLC, and head and neck cancers, where nectin-4 is highly expressed. Unlike other approaches that restrict activity to acidic tumor environments or rely on activated T-cells, APVO455 is designed to avoid binding to or triggering T-cell activation in the periphery and do so only in the presence of nectin-4 positive tumor cells. This offers the potential for a broader therapeutic window, more consistent immune activation and the favorable safety and tolerability characteristics of Aptevo's clinical stage CD3 engager, mipletamig. CRIS-7-Derived CD3 Portfolio With this APVO455 addition to the pipeline, Aptevo now has a suite of three CD3-engaging molecules in development. All three molecules share the same CRIS-7-derived CD3 binding domain in the same orientation from within our ADAPTIR/ADAPTIR-FLEX platform that we believe drives the safety results, especially regarding our intention to reduce cytokine release syndrome, as is being delivered in the clinic by mipletamig. In addition, APVO455 and APVO442 contain CD3 binding domains that are optimized for localizing to solid tumors. All three molecules are designed to drive tumor-specific immune activation while limiting harmful side effects to the patient. The suite includes: Mipletamig, a CD123 x CD3 bispecific for frontline AML, currently in a Phase 1b/2 trial APVO442, a PSMA x CD3 bispecific targeting prostate cancer, currently in preclinical development And now APVO455, a Nectin-4 x CD3 bispecific developed to address multiple solid tumor types Additional Pipeline Candidates Aptevo continues to develop clinical candidate ALG.APV-527 ( 4-1BB x 5T4) and preclinical candidates APVO711, a checkpoint inhibitor with added functionality and APVO603, a 4-1BB x OX40 molecule. All targeting multiple solid tumor types. Mipletamig Data Highlights Results from the RAINIER trial, reported to date demonstrate mipletamig's increasingly impressive clinical profile, and highlight its potential as a differentiated, highly targeted immunotherapy with a compelling safety profile. As evidence grows, the Company believes that mipletamig is emerging as a strong candidate to reshape frontline AML treatment for unfit patients and potentially advance the standard of care. Efficacy Data Continues to Outperform Benchmarks To date, 85% frontline patients across two trials have achieved remission Of these remissions, multiple patients were considered to have poor prognosis at screening based on the genetic biomarkers of their disease and achieved CR, including one patient who was taken off study and successfully received a stem cell transplant. This is the most favorable outcome because transplant offers the best chance for a cure, although it is a rare occurrence in the unfit AML patient population Stand Out Safety and Tolerability Outcomes Continue No CRS has been reported in frontline patients treated to date Q2 2025 Financial Highlights Cash Position: Aptevo had cash and cash equivalents as of June 30, 2025, totaling $9.4 million. In Q2 2025, we raised $15.9M in gross proceeds from various equity offerings. Research and Development Expenses: 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. 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. General and Administrative Expenses: 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. The increase is primarily due to higher consulting costs. Net Loss: Aptevo had a net loss of $6.2 million or $8.40 per share for the three months ended June 30, 2025, compared to a net loss of $5.9 million or $1,236.96 per share for the corresponding period in 2024.   Aptevo Therapeutics Inc. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts, unaudited)   Aptevo Therapeutics Inc. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts, unaudited) *Adjusted retroactively to reflect reverse stock splits   About Aptevo Therapeutics Aptevo Therapeutics Inc. (Nasdaq:APVO) is a clinical-stage biotechnology Company focused on developing novel bispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has four pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR and ADAPTIR-FLEX. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, whether pre-clinical studies of APVO455 will show the desired anti-tumor efficacy, mechanism of action and safety profile and whether APVO455 will function with new mechanisms of action compared to our previous candidates and synergistically induce a biological response, whether APVO455 will demonstrate the ability to fight a range of solid malignancies, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for ALG.APV-527, statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises, geopolitical risks, including the current war between Russia and Ukraine, Israel and Hamas and Israel and Iran and any other military event that could evolve out of any of the current conflicts and macroeconomic conditions such as economic uncertainty, imposition of tariffs, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT: Miriam Weber Miller Head, Investor Relations & Corporate Communications Aptevo Therapeutics Email: [email protected] or [email protected] Phone: 206-859-6628 SOURCE: Aptevo Therapeutics View the original press release on ACCESS Newswire

Investor releaseQuarter not tagged2025-05-15

Aptevo Therapeutics Reports 1Q25 Financial Results And Provides an Update on Mipletamig

ACCESS Newswire
9 of 10 frontline AML patients achieve remission with mipletamig + standard of care across two trials Mipletamig triplet combination continues to outperform standard doublet benchmark No cytokine release syndrome observed in the ongoing RAINIER trial: favorable safety profile supports role in frontline AML Cohort 2 enrollment is complete, and Cohort 3 is now enrolling SEATTLE, WA / ACCESS Newswire / May 15, 2025 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology Company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies, today reported financial results for the quarter ended March 31, 2025, and provided an update on the ongoing mipletamig clinical trial. Business Update"The latest outcomes from the RAINIER trial-remissions that were achieved rapidly and with no reported cytokine release syndrome-underscore the strength of our approach and the potential of mipletamig to redefine frontline AML treatment. With each milestone, we are not only validating the safety and efficacy of our drug, but moving closer to changing the standard of care for patients who have long had limited options. We remain focused on advancing the trial and look forward to sharing further clinical updates in the months ahead. This is more than progress-it's momentum toward a new era in frontline AML care," said Marvin White, President and CEO of Aptevo. Mipletamig Data HighlightsEnrollment 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. Mipletamig has been evaluated in almost 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: Efficacy Results Reported on March 20, 2025 Data from Six frontline AML patients has been reported 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…Read full document

9 of 10 frontline AML patients achieve remission with mipletamig + standard of care across two trials Mipletamig triplet combination continues to outperform standard doublet benchmark No cytokine release syndrome observed in the ongoing RAINIER trial: favorable safety profile supports role in frontline AML Cohort 2 enrollment is complete, and Cohort 3 is now enrolling SEATTLE, WA / ACCESS Newswire / May 15, 2025 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology Company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies, today reported financial results for the quarter ended March 31, 2025, and provided an update on the ongoing mipletamig clinical trial. Business Update"The latest outcomes from the RAINIER trial-remissions that were achieved rapidly and with no reported cytokine release syndrome-underscore the strength of our approach and the potential of mipletamig to redefine frontline AML treatment. With each milestone, we are not only validating the safety and efficacy of our drug, but moving closer to changing the standard of care for patients who have long had limited options. We remain focused on advancing the trial and look forward to sharing further clinical updates in the months ahead. This is more than progress-it's momentum toward a new era in frontline AML care," said Marvin White, President and CEO of Aptevo. Mipletamig Data HighlightsEnrollment 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. Mipletamig has been evaluated in almost 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: Efficacy Results Reported on March 20, 2025 Data from Six frontline AML patients has been reported 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 One patient progressed after the first cycle and passed away due to reasons unrelated to the study drug 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* In total, 9 of 10 (90%) frontline patients across two trials have achieved remission with mipletamig in combination with standard of care therapy SafetyMipletamig continues to demonstrate a highly favorable safety profile, particularly with respect to cytokine release syndrome (CRS)-a common and often dose-limiting side effect seen in other T-cell engagers and bispecific antibodies. No CRS has been observed in the ongoing RAINIER trial to date This favorable profile is consistent with earlier trials, where CRS was generally minimal and manageable The company attributes this safety profile, a key differentiator, to the engineered CD3 binding domain (CRIS-7) and its ADAPTIR® format, which are designed to reduce cytokine release without compromising T-cell activation or anti-leukemic activity Additional Data RAINIER Cohort 1 data (included in the total patient outcomes above) in which 100% of patients achieved remission within the first 30 days One patient experienced complete remission with minimal residual disease (MRD)-negative status (100% elimination of cancer cells) 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 Phase 1b dose expansion combination therapy (included in the total patient outcomes above) trial in which 100% of frontline patients achieved remission Phase 1a dose escalation monotherapy trial in which 36% of evaluable patients who failed prior regimens experienced substantial leukemic blast reduction to a clinically 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 *Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered CRi. The Company anticipates providing multiple data readouts in 2025 and to present results at the American Society of Hematology meeting in the fourth quarter. About MipletamigMipletamig, a differentiated by design CD123xCD3 bispecific antibody built on Aptevo's ADAPTIR platform and driven by a unique CRIS-7-derived CD3 binding domain, is being investigated as frontline therapy in combination with venetoclax and azacitidine, the current standard of care for AML patients who are unfit for intensive chemotherapy. These latest results further reinforce mipletamig's potential as a transformative treatment, supported by impressive efficacy, safety, and tolerability data from two prior clinical trials involving almost 100 patients. 2025 Summary Financial Results Cash Position: Aptevo had cash and cash equivalents as of March 31, 2025, totaling $2.1 million. This excludes approximately $4.9 million raised by the Company in April and May 2025 through direct offerings and use of the Company's ATM facility. Research and Development Expenses: 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. General and Administrative Expenses: General and administrative expenses decreased by $0.6 million, from $3.2 million for the three months ended March 31, 2024, to $2.6 million for the three months ended March 31, 2025. The decrease is primarily due to lower stock-based compensation costs. Other Income, Net: 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. Net Income (Loss): Aptevo had a net loss of $6.3 million or $4.35 per share for the three months ended March 31, 2025, compared to a net loss of $6.8 million or $368.21 per share for the corresponding period in 2024. Aptevo Therapeutics Inc.CONSOLIDATED BALANCE SHEETS(in thousands, except share and per share amounts) Aptevo Therapeutics Inc.CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) About Aptevo TherapeuticsAptevo Therapeutics Inc. (Nasdaq:APVO) is a clinical-stage biotechnology Company focused on developing novel bispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIRand ADAPTIR-FLEX. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com. Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for ALG.APV-527, statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine and the war between Israel and Hamas, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT:Miriam Weber MillerHead, Investor Relations & Corporate CommunicationsAptevo TherapeuticsEmail: [email protected] or [email protected]: 206-859-6628 SOURCE: Aptevo Therapeutics View the original press release on ACCESS Newswire

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