Aptevo Therapeutics Reports 3Q25 Financial Results And Provides A Business Update
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
Third Quarter Highlights
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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).
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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
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Introduced the Company's first trispecific T-cell engagers - APVO451 and APVO452 - expanding the oncology portfolio to five CRIS-7-derived CD3-targeting molecules
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These candidates are designed to target tumors that suppress immune activity, a key barrier to durable responses in solid tumors
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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
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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
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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
"Aptevo raised
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.
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
Research and Development Expenses: Research and development expenses increased by
General and Administrative Expenses: General and administrative expenses increased by
Net Income (Loss): Aptevo had a net loss of
Dividend Attributable to Down Round Feature of Warrants: This non-cash amount reflects the impact of reducing the exercise price of the Company's
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$ |
21,061 |
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$ |
8,714 |
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Prepaid expenses
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1,511 |
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1,689 |
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Other current assets
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77 |
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256 |
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Total current assets
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22,649 |
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10,659 |
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Property and equipment, net
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384 |
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543 |
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Operating lease right-of-use asset
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3,963 |
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4,389 |
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Total assets
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$ |
26,996 |
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$ |
15,591 |
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LIABILITIES AND STOCKHOLDERS' EQUITY
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Current liabilities:
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Accounts payable and other accrued liabilities
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$ |
2,219 |
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$ |
3,053 |
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Accrued compensation
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1,901 |
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1,856 |
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Other current liabilities
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1,494 |
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1,298 |
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Total current liabilities
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5,614 |
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6,207 |
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Operating lease liability
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3,990 |
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4,629 |
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Total liabilities
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9,604 |
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10,836 |
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Stockholders' equity:
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Preferred stock:
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- |
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- |
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Common stock:
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110 |
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84 |
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Additional paid-in capital
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286,499 |
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252,248 |
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Accumulated deficit
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(269,217 |
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(247,577 |
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Total stockholders' equity
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17,392 |
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4,755 |
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Total liabilities and stockholders' equity
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$ |
26,996 |
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$ |
15,591 |
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CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
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For the Three Months Ended |
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For the Nine Months Ended |
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2025 |
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2024 |
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2025 |
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2024 |
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Operating expenses:
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Research and development
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$ |
(4,044 |
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$ |
(3,103 |
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$ |
(11,005 |
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$ |
(10,498 |
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General and administrative
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(3,566 |
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(2,110 |
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(9,311 |
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(7,722 |
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Loss from operations
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(7,610 |
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(5,213 |
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(20,316 |
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(18,220 |
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Other income:
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Other income, net
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61 |
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112 |
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155 |
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402 |
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Net loss
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$ |
(7,549 |
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$ |
(5,101 |
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$ |
(20,161 |
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$ |
(17,818 |
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Dividend attributable to down round feature of warrants
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(1,479 |
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- |
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(1,479 |
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- |
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Net loss attributable to common stockholders
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$ |
(9,028 |
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$ |
(5,101 |
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$ |
(21,640 |
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$ |
(17,818 |
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Basic and diluted net loss per share:
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$ |
(2.23 |
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$ |
(357.86 |
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$ |
(11.42 |
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$ |
(3,709.76 |
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Shares used in calculation:
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4,049,046 |
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14,254 |
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1,895,494 |
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4,803 |
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About
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
CONTACT:
Head, Investor Relations & Corporate Communications
Email: IR@apvo.com or Millerm@apvo.com
Phone: 206-859-6628
SOURCE:
press release
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