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Aptevo Therapeutics Reports 2Q 2024 Financial Results and Provides a Business Update
"After the successful completion of our APVO436 dose expansion trial, where we saw a 91% clinical benefit rate and an excellent safety, tolerability and duration of remission profile, we worked in the second quarter to finalize plans for the launch of the first part of our Phase 1b/2 trial, a dose optimization study, continuing evaluation of APVO436 in combination with venetoclax and azacitidine for the treatment of Acute Myeloid Leukemia (AML) in frontline patients. This trial represents a crucial step in our mission to develop a new therapeutic regimen for patients fighting this challenging cancer. Dosing continues in our ongoing Phase 1 trial to evaluate ALG.APV-527 for the treatment of multiple solid tumor types likely to express 5T4 and we look forward to announcing additional data from that trial in the third quarter," said
Aptevo's Clinical Programs
APVO436
Aptevo's wholly owned lead proprietary drug candidate, APVO436 is targeting AML and is differentiated by design to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts. This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. APVO436 is purposefully designed to reduce the likelihood and severity of CRS by use of a unique CD3 binding domain derived from CRIS-7 vs. the CD3 used by other competitors. APVO436 has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act.
Results from the Phase 1b dose expansion trial showed a 91% clinical benefit rate in combination with venetoclax + azacitidine in venetoclax naïve patients, a 27% incidence of CRS across all trial cohorts (the majority were grades 1 & 2) and meaningful duration of remission, including three patients who transitioned to transplant after receiving therapy, the best possible outcome for AML patients.
The Company is planning to initiate the first part of the Phase 1b/2 dose optimization program in this quarter.
ALG.APV-527
ALG.APV-527 is a conditional 4-1BB agonist bispecific that is designed for activation only upon simultaneous binding to 4-1BB and 5T4. It is designed to target cancer cells by activating both T cells and natural killer cells and is intended to bind to tumor-specific antigens while sparing healthy cells and maximizing immune response. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. The compound is currently being evaluated for multiple solid tumor types in a multi-center, dose escalation trial that is more than 90% enrolled.
Additional promising preliminary data includes:
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A heavily pretreated breast cancer patient, entered the trial and improved from progressive disease to long-lasting stable disease (SD) while on therapy. The patient remained on study for more than a year and successfully transitioned to a higher dose level twice
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A second heavily pretreated breast cancer patient who was also progressing prior to enrolling in the trial has sustained long lasting stable disease and remained on study drug for seven months. Analysis demonstrated measurable levels of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active
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Treatment to date has been overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing and the Company is dosing cohort five
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ALG.APV-527 has been measurable in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose
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Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527
2024 2Q Summary Financial Results
Cash Position: Aptevo had cash and cash equivalents as of
Research and Development Expenses: Research and development expenses decreased by
General and Administrative Expenses: General and administrative expenses decreased by
Other Income (Expense), Net:
Other Income (Expense) from Continuing Operations, Net consists of other income, net of
Net Income (Loss): Aptevo had a net loss of
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts, unaudited)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$ |
8,066 |
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$ |
16,904 |
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Prepaid expenses
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798 |
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1,473 |
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Other current assets
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715 |
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689 |
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Total current assets
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9,579 |
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19,066 |
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Property and equipment, net
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697 |
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895 |
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Operating lease right-of-use asset
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4,645 |
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4,881 |
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Total assets
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$ |
14,921 |
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$ |
24,842 |
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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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$ |
3,736 |
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$ |
3,984 |
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Accrued compensation
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892 |
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2,098 |
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Other current liabilities
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791 |
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1,142 |
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Total current liabilities
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5,419 |
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7,224 |
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Other long-term liabilities
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14 |
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- |
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Operating lease liability
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5,025 |
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5,397 |
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Total liabilities
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10,458 |
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12,621 |
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Stockholders' equity:
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Preferred stock:
zero shares issued or outstanding
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- |
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- |
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Common stock:
4,080,665 and 442,458 shares issued and outstanding at
2024 and
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69 |
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61 |
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Additional paid-in capital
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240,558 |
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235,607 |
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Accumulated deficit
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(236,164 |
) |
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(223,447 |
) |
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Total stockholders' equity
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4,463 |
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12,221 |
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Total liabilities and stockholders' equity
|
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$ |
14,921 |
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$ |
24,842 |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts, unaudited)
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For the Three Months Ended |
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For the Six Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses:
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Research and development
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$ |
(3,643 |
) |
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$ |
(5,462 |
) |
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(7,395 |
) |
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(9,630 |
) |
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General and administrative
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(2,381 |
) |
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(2,716 |
) |
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(5,612 |
) |
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(6,304 |
) |
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Loss from operations
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(6,024 |
) |
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(8,178 |
) |
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(13,007 |
) |
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(15,934 |
) |
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Other income:
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Other income from continuing operations, net
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141 |
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230 |
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290 |
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|
163 |
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Gain related to sale of non-financial asset
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- |
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- |
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- |
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9,650 |
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Net loss from continuing operations
|
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$ |
(5,883 |
) |
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$ |
(7,948 |
) |
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$ |
(12,717 |
) |
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$ |
(6,121 |
) |
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Discontinued operations:
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Income from discontinued operations
|
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$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
946 |
|
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Net loss
|
|
$ |
(5,883 |
) |
|
$ |
(7,948 |
) |
|
$ |
(12,717 |
) |
|
$ |
(5,175 |
) |
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Basic and diluted net loss per share from continuing operations:
|
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Basic
|
|
$ |
(1.67 |
) |
|
$ |
(53.95 |
) |
|
$ |
(6.02 |
) |
|
$ |
(37.45 |
) |
|
Diluted
|
|
$ |
(1.67 |
) |
|
$ |
(53.95 |
) |
|
$ |
(6.02 |
) |
|
$ |
(37.45 |
) |
|
Basic and diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(1.67 |
) |
|
$ |
(53.95 |
) |
|
$ |
(6.02 |
) |
|
$ |
(31.67 |
) |
|
Diluted
|
|
$ |
(1.67 |
) |
|
$ |
(53.95 |
) |
|
$ |
(6.02 |
) |
|
$ |
(31.67 |
) |
|
Shares used in calculation:
|
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|
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|
|
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Basic
|
|
|
3,519,875 |
|
|
|
147,321 |
|
|
|
2,111,131 |
|
|
|
163,425 |
|
|
Diluted
|
|
|
3,519,875 |
|
|
|
147,321 |
|
|
|
2,111,131 |
|
|
|
163,425 |
|
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 such as Phase 1b/2 trial initiation for APVO436 in frontline, venetoclax naïve AML patients, whether further study of APVO436 in a Phase 1b dose optimization trial focusing on multiple doses of APVO436 in combination with venetoclax + azacitidine on a targeted patient population will continue to show clinical benefit, whether Aptevo's final trial results will vary from its earlier assessment, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, whether higher dose ranges for ALG.APV-527 will result in increased signs of clinical activity, whether biomarker analyses will continue to confirm biological activity of ALG.APV-527, the possibility and timing of interim data readouts for ALG.APV-527, whether Aptevo's final trial results will vary from its preliminary or interim assessments, the possibility and timing of 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 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 APVO436, 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
CONTACT:
Head, Investor Relations & Corporate Communications
Email: IR@apvo.com or Millerm@apvo.com
Phone: 206-859-6628
SOURCE:
press releaseaccesswire.com