Aptevo Therapeutics Reports 1Q 2024 Financial Results and Provides a Business Update
Aptevo Therapeutics Inc. reported positive outcomes from its clinical trials, with a breast cancer patient showing stable disease for over eleven months on a higher dose level. The company is set to start a dose optimization trial for APVO436 in 2Q 2024. Financially, Aptevo's cash position was $10.3 million as of March 31, 2024, with reduced research and development expenses and general administrative expenses. However, the company reported a net loss of $6.8 million for the quarter.
Aptevo's ALG.APV-527 Phase 1 trial showed promising results with a breast cancer patient on higher dose level exhibiting stable disease for over eleven months.
The company is planning to initiate a dose optimization trial for APVO436 in frontline AML patients in 2Q 2024.
Aptevo's cash position stood at $10.3 million as of March 31, 2024, with total cash and cash equivalents of $14.3 million including proceeds from an equity raise.
Aptevo reported a net loss of $6.8 million for the quarter, compared to a net income of $2.8 million for the same period last year.
The company's research and development expenses decreased by $0.4 million, primarily due to lower spending on clinical trials and preclinical projects.
Insights
The cash position of Aptevo Therapeutics, as reported, draws interest due to its potential implications on their ability to sustain operations and fund critical research. The update indicates a proforma cash balance, including recent equity raise proceeds, which is a key indicator of near-term liquidity. The reduction in R&D expenses could indicate either improved efficiency in operations or a potential scaling back in research scope. Notably, the company's transition from Phase 1b to upcoming Phase 1b/2 clinical trials may attract investor attention due to the potential impact on future profitability and market position, assuming successful trial outcomes.
In the highly regulated and competitive field of oncology drug development, the prolonged stable disease status of a breast cancer patient in the ALG.APV-527 trial is a positive signal. The transition to a higher dosing regimen without adverse events suggests a favorable safety profile, an essential factor in gaining regulatory approval. Investors should monitor the patient outcomes and enrollment rates, as these can be harbingers of clinical success and may affect drug development timelines and market entry.
For investors, the advancement of the APVO436 trial in frontline AML in combination with venetoclax + azacitidine could represent a significant market opportunity. Aptevo's collaboration with a premier CRO might enhance trial execution, which is often a critical hurdle in drug development. Market sentiment may be swayed by Aptevo's strategic moves, including trial collaborations and pipeline progress, as these factors are tightly linked to the firm's long-term value creation in the competitive biotech industry.
Heavily pre-treated breast cancer patient who achieved stable disease on study, remains on treatment for more than eleven months after entering the ALG.APV-527 Phase 1 trial with progressive disease and transitioning to higher dose with potential for greater clinical benefit, experienced no new adverse events since the transition to the higher dose level
APVO436 Phase 1b/2 dose optimization trial initiation of APVO436 for frontline AML in combination with venetoclax + azacitidine in venetoclax naïve patients expected 2Q 2024
SEATTLE, WA / ACCESSWIRE / May 8, 2024 / 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, 2024 and provided a business update.
- A heavily pretreated breast cancer patient, enrolled in the ALG.APV-527 Phase 1 open-label, multi-center, multi-cohort trial for the treatment of multiple solid tumor types, entered the trial with progressive disease and improved to long-lasting stable disease (SD) while on therapy. The patient has remained on study for more than eleven months, having been successfully transitioned to a higher dose level and has experienced no new adverse events since the transition. The higher dose may allow for increased clinical benefit. The trial is more than
50% enrolled and we are dosing cohort 5. Additional information about the Company's ALG.APV-527 clinical program appears below. - The Company is on track to initiate its upcoming dose optimization trial in 2Q 2024to further evaluate APVO436 for the treatment of frontline acute myeloid leukemia (AML). Aptevo has partnered with premier CRO, Prometrika, for the upcoming study. The first part of the Phase 1b/2 study is a dose optimization trial evaluating standard of care venetoclax + azacitidine along with APVO436 as a frontline treatment for AML patients. It is planned as an open-label, multi-center, multi-cohort study. The trial will evaluate safety/tolerability and efficacy of the triplet combination at multiple dose levels. Additional information about the Company's APVO436 clinical program appears below.
"Aptevo has had an exciting first quarter, making progress in both clinical programs. We are particularly enthusiastic about one breast cancer patient in our ALG.APV-527 trial who has remained on study with stable disease for more than eleven months, in addition, to being safely and successfully transitioned to a higher dose level within the study. This rarely happens in an early-stage trial, and we believe it underscores the potential of our bispecific solid tumor candidate," said Marvin White, President & CEO of Aptevo. "Additionally, we plan to initiate our APVO436 dose optimization trial in frontline AML patients this quarter. Overall, we are excitingly seeing in the clinic that our molecules are performing as they were engineered to perform."
2024 Q1 Summary Financial Results
Cash Position: Aptevo had cash and cash equivalents as of March 31, 2024, totaling
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
Gain Related to Sale of Non-Financial Asset consists of a
Discontinued Operations: We did not record income from discontinued operations for the three months ended March 31, 2024. For the three months ended March 31, 2023, we recorded
Net Income (Loss): Aptevo had a net loss of
Aptevo Therapeutics Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts, unaudited)
| March 31, 2024 | December 31, 2023 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 10,250 | $ | 16,904 | ||||
Prepaid expenses | 1,133 | 1,473 | ||||||
Other current assets | 691 | 689 | ||||||
Total current assets | 12,074 | 19,066 | ||||||
Property and equipment, net | 789 | 895 | ||||||
Operating lease right-of-use asset | 4,766 | 4,881 | ||||||
Total assets | $ | 17,629 | $ | 24,842 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable and other accrued liabilities | $ | 3,720 | $ | 3,984 | ||||
Accrued compensation | 1,610 | 2,098 | ||||||
Other current liabilities | 968 | 1,142 | ||||||
Total current liabilities | 6,298 | 7,224 | ||||||
Other long-term liabilities | 14 | - | ||||||
Operating lease liability | 5,214 | 5,397 | ||||||
Total liabilities | 11,526 | 12,621 | ||||||
Stockholders' equity: | ||||||||
Preferred stock: issued or outstanding | - | - | ||||||
Common stock: 442,458 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 66 | 61 | ||||||
Additional paid-in capital | 236,318 | 235,607 | ||||||
Accumulated deficit | (230,281 | ) | (223,447 | ) | ||||
Total stockholders' equity | 6,103 | 12,221 | ||||||
Total liabilities and stockholders' equity | $ | 17,629 | $ | 24,842 | ||||
Aptevo Therapeutics Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts, unaudited)
| For the Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
Operating expenses: | ||||||||
Research and development | $ | (3,752 | ) | $ | (4,168 | ) | ||
General and administrative | (3,231 | ) | (3,588 | ) | ||||
Loss from operations | (6,983 | ) | (7,756 | ) | ||||
Other income (expense): | ||||||||
Other income (expense) from continuing operations, net | 149 | (67 | ) | |||||
Gain related to sale of non-financial asset | - | 9,650 | ||||||
Net (loss) income from continuing operations | $ | (6,834 | ) | $ | 1,827 | |||
Discontinued operations: | ||||||||
Income from discontinued operations | $ | - | $ | 946 | ||||
Net (loss) income | $ | (6,834 | ) | $ | 2,773 | |||
Basic and diluted net (loss) income per share from continuing operations: | ||||||||
Basic | $ | (9.95 | ) | $ | 11.45 | |||
Diluted | $ | (9.95 | ) | $ | 11.45 | |||
Basic and diluted net (loss) income per share: | ||||||||
Basic | $ | (9.95 | ) | $ | 17.38 | |||
Diluted | $ | (9.95 | ) | $ | 17.38 | |||
Shares used in calculation: | ||||||||
Basic | 686,735 | 159,597 | ||||||
Diluted | 686,735 | 159,597 | ||||||
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immuno-oncology therapies for the treatment of cancer. Aptevo is seeking to improve treatment outcomes for cancer patients. For more information, please visit www.aptevotherapeutics.com.
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
Additional promising preliminary data includes:
- In addition to the patient described above, a second heavily pretreated breast cancer patient who was progressing prior to enrolling in the trial has sustained long lasting stable disease and remained on study drug for seven months. Analysis demonstrated measurable level of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active
- 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 (of six)
- ALG.APV-527 has been measurable in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose
- Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527
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 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.
The Phase 1b dose escalation trial results showed a
The Company is planning to initiate the first part of the Phase 1b/2 dose optimization program in this quarter.
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 a cross section of 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 Russia and Ukraine and the rising conflict in the Middle East, 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, 2023, 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: IR@apvo.com or Millerm@apvo.com
Phone: 206-859-6628
SOURCE: Aptevo Therapeutics
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FAQ
What were Aptevo Therapeutics' cash and cash equivalents as of March 31, 2024?
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