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Aptevo Therapeutics Reports 3Q 2024 Financial Results and Provides a Business Update

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Aptevo Therapeutics (NASDAQ:APVO) reported Q3 2024 financial results and clinical progress. The company initiated the mipletamig Phase 1b/2 'RAINIER' trial for frontline AML treatment and presented positive interim data for ALG.APV-527 in solid tumors, showing 60% of evaluable patients achieving stable disease. Financial results showed cash position of $7.8 million, reduced R&D expenses to $3.1 million (down from $3.9 million), and decreased G&A expenses to $2.1 million (down from $2.7 million). The company reported a net loss of $5.1 million ($0.48 per share) and raised $5.75 million through financings during the quarter.

Aptevo Therapeutics (NASDAQ:APVO) ha riportato i risultati finanziari del terzo trimestre 2024 e progressi clinici. L'azienda ha avviato il trial di Fase 1b/2 'RAINIER' per il trattamento dell'AML di prima linea e ha presentato dati interini positivi per l'ALG.APV-527 in tumori solidi, mostrando che il 60% dei pazienti valutabili ha raggiunto una malattia stabile. I risultati finanziari hanno rivelato una posizione di cassa di $7,8 milioni, riducendo le spese per R&S a $3,1 milioni (in calo da $3,9 milioni) e abbassando le spese generali e amministrative a $2,1 milioni (in calo da $2,7 milioni). L'azienda ha riportato una perdita netta di $5,1 milioni ($0,48 per azione) e ha raccolto $5,75 milioni tramite finanziamenti durante il trimestre.

Aptevo Therapeutics (NASDAQ:APVO) reportó los resultados financieros del tercer trimestre de 2024 y avances clínicos. La compañía inició el ensayo de fase 1b/2 'RAINIER' para el tratamiento de la LMA de primera línea y presentó datos interinos positivos para el ALG.APV-527 en tumores sólidos, mostrando que el 60% de los pacientes evaluables alcanzaron enfermedad estable. Los resultados financieros mostraron una posición de caja de $7.8 millones, reduciendo los gastos en I+D a $3.1 millones (bajando de $3.9 millones) y disminuyendo los gastos generales y administrativos a $2.1 millones (bajando de $2.7 millones). La compañía reportó una pérdida neta de $5.1 millones ($0.48 por acción) y recaudó $5.75 millones a través de financiamientos durante el trimestre.

Aptevo Therapeutics (NASDAQ:APVO)는 2024년 3분기 재무 결과와 임상 진행 상황을 보고했습니다. 이 회사는 1차 AML 치료를 위한 mipletamig 1b/2 'RAINIER' 시험을 시작했으며, 고형 종양에서 ALG.APV-527의 긍정적인 중간 데이터를 발표하여 평가 가능한 환자의 60%가 안정적인 질병을 달성했음을 보여주었습니다. 재무 결과에 따르면 현금 보유고는 $7.8백만이며, 연구개발 비용은 $3.1백만으로 감소(이전 $3.9백만에서 감소)했고, 관리 비용은 $2.1백만으로 줄었습니다(이전 $2.7백만에서 감소). 이 회사는 $5.1백만($0.48 주당)의 순손실을 기록했으며, 분기 동안 자금 조달을 통해 $5.75백만을 모금했습니다.

Aptevo Therapeutics (NASDAQ:APVO) a annoncé les résultats financiers du troisième trimestre 2024 et les progrès cliniques. La société a lancé l'essai de phase 1b/2 'RAINIER' pour le traitement de la LMA en première ligne et a présenté des données intermédiaires positives pour l'ALG.APV-527 dans les tumeurs solides, montrant que 60 % des patients évaluables ont atteint une maladie stable. Les résultats financiers ont révélé une position de trésorerie de $7,8 millions, une réduction des dépenses de R&D à $3,1 millions (contre $3,9 millions auparavant), et une baisse des dépenses générales et administratives à $2,1 millions (contre $2,7 millions). La société a déclaré une perte nette de $5,1 millions ($0,48 par action) et a levé $5,75 millions grâce à des financements au cours du trimestre.

Aptevo Therapeutics (NASDAQ:APVO) hat die Finanzzahlen für das dritte Quartal 2024 und klinische Fortschritte berichtet. Das Unternehmen hat die Phase 1b/2-Studie 'RAINIER' zur vordergründigen Behandlung von AML gestartet und positive vorläufige Daten zu ALG.APV-527 bei soliden Tumoren präsentiert, wobei 60% der bewertbaren Patienten stabile Erkrankungen erreichten. Die Finanzzahlen zeigten einen Kassenbestand von $7,8 Millionen, reduzierten die F&E-Ausgaben auf $3,1 Millionen (gegenüber $3,9 Millionen) und senkten die allgemeinen und Verwaltungskosten auf $2,1 Millionen (von $2,7 Millionen). Das Unternehmen berichtete von einem Nettoverlust von $5,1 Millionen ($0,48 pro Aktie) und erhöhte im Quartal durch Finanzierungen $5,75 Millionen.

Positive
  • Raised $5.75 million through financings in Q3
  • 60% of evaluable patients achieved stable disease in ALG.APV-527 trial
  • Reduced R&D expenses by $0.8 million year-over-year
  • Decreased G&A expenses by $0.6 million year-over-year
Negative
  • Net loss of $5.1 million in Q3 2024
  • Cash position decreased to $7.8 million from $16.9 million at end of 2023
  • Accumulated deficit increased to $241.3 million

Insights

The Q3 results reveal concerning financial metrics. Cash position declined to $7.8 million from $16.9 million at year-end 2023, despite raising $5.75 million in the quarter. The quarterly net loss of $5.1 million suggests a cash runway of approximately 4-5 months at current burn rates. While R&D and G&A expenses decreased by $0.8 million and $0.6 million respectively year-over-year, the company's financial position remains precarious given its market cap of just $3.6 million. Additional financing will likely be needed in early 2025, risking significant dilution for current shareholders.

The clinical progress shows promise despite financial constraints. The RAINIER trial advancement for mipletamig in frontline AML and ALG.APV-527's 60% stable disease rate in solid tumors demonstrate potential therapeutic value. The durability of response in breast cancer patients (>11 months) and clean safety profile are particularly encouraging. However, while stable disease is positive, the absence of partial or complete responses in the solid tumor program warrants cautious interpretation. The combination strategy with venetoclax in AML appears strategically sound given existing treatment paradigms.

Company Achieves Milestones in Both Clinical Programs

Initiates Mipletamig Phase 1b/2 Clinical Trial, "RAINIER," in Frontline Acute Myeloid Leukemia, Informed by Positive Dose Escalation Trial Results

Presented Interim Data from ALG.APV-527 Phase 1 Trial in Multiple Solid Tumors at the European Society for Medical Oncology Congress

Additional Favorable Data to be Presented at the Society for Immunotherapy of Cancer Conference on November 9th

Raises $5.75 Million in the Quarter

SEATTLE, WA / ACCESSWIRE / November 7, 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 ending September 30, 2024 and provided a business update.

Business Highlights
Aptevo met multiple clinical milestones in the third quarter, including:

  • Based on positive safety, tolerability efficacy and durability data in its completed dose escalation trial, Aptevo Initiated the mipletamig Phase 1b/2 dose optimization trial, "RAINIER," as part of its ongoing program to evaluate the compound in combination with standard of care venetoclax + azacitidine in frontline patients with acute myeloid leukemia (AML). RAINIER will be conducted in two parts. First, a Phase 1b frontline AML dose optimization study followed by a Phase 2 study

  • Presented positive interim data from their Phase 1 trial evaluating ALG.APV-527 as monotherapy for the treatment of solid tumors likely to express the tumor antigen 5T4 at the European Society of Medical Oncology (ESMO) Congress in September. Additional positive trial data will be presented at the Society for Immunotherapy of Cancer conference on November 9th.

  • Highlights from the ESMO presentation include:

    • Clinical Activity/Efficacy: To date,nine of 15 efficacy evaluable patients (60%) have a best overall response of stable disease (SD). The longest SD duration was in a breast cancer patient who entered the study with progressive disease, achieved stable disease and remained on study for >11 months. This patient successfully transitioned to a higher dose level twice.

    • Safety and Tolerability: ALG.APV-527 demonstrated a well-tolerated safety profile across all dose-level cohorts dosed to date.

    • Evidence of biological activity: ALG.APV-527 could be measured in all patients with serum concentration of ALG.APV-527 consistent with the administered dose and preclinical predictions. Biomarker analyses confirm biological activity of ALG.APV-527

  • Closed two financings for total proceeds of $5.75 million during the quarter

"Aptevo achieved significant clinical progress in both programs this quarter, marking important progress toward our mission and goals. We were thrilled to initiate the next phase of our mipletamig development program-a robust Phase 1b/2 trial for frontline AML patients, combining mipletamig with the established standard of care, venetoclax and azacitidine. This trial structure is informed by the encouraging results from our dose expansion trial, reinforcing our belief in mipletamig's transformative potential for AML patients," stated Marvin White, President and CEO of Aptevo. "We also released positive interim data on our solid tumor drug, ALG.APV-527, at the European Society of Medical Oncology conference in September that further underscores the impact of our innovation. In early clinical evaluation, our solid tumor targeting bispecific demonstrated safety, tolerability, and compelling activity, with 60% of evaluable patients achieving stable disease in monotherapy across challenging tumor types, including breast and colon cancer. The progress we're witnessing, combined with nearly $6 million in capital secured in the quarter, sets a promising stage for the fourth quarter and lays the groundwork for continued successes into 2025."

3Q Summary Financial Results

Cash Position: Aptevo had cash and cash equivalents totaling $7.8 million as of September 30, 2024.

Research and Development Expenses: Research and development expenses decreased by $0.8 million, from $3.9 million for the three months ended September 30, 2023, to $3.1 million for the three months ended September 30, 2024. The decrease was primarily due to lower spending on preclinical projects and employee costs.

General and Administrative Expenses: General and administrative expenses decreased by $0.6 million, from $2.7 million for the three months ended September 30, 2023, to $2.1 million for the three months ended September 30, 2024. The decrease is primarily due to lower employee and consulting costs.

Other Income (Expense), Net:
Other Income (Expense) from Continuing Operations, Net consists of other income, net of $0.1 million and $0.2 million for the three months ended September 30, 2024, and 2023, respectively. The change in other income, net is primarily due to the decrease of interest income from our money market accounts.

Net Income (Loss): Aptevo had a net loss of $5.1 million or $0.48 per share for the three months ended September 30, 2024, compared to a net loss of $6.3 million or $22.16 per share for the corresponding period in 2023.

Aptevo Therapeutics Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts, unaudited)

September 30, 2024

December 31, 2023

ASSETS

Current assets:

Cash and cash equivalents

$

7,753

$

16,904

Prepaid expenses

1,635

1,473

Other current assets

624

689

Total current assets

10,012

19,066

Property and equipment, net

614

895

Operating lease right-of-use asset

4,520

4,881

Total assets

$

15,146

$

24,842

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable and other accrued liabilities

$

3,532

$

3,984

Accrued compensation

922

2,098

Other current liabilities

1,428

1,142

Total current liabilities

5,882

7,224

Other long-term liabilities

14

-

Operating lease liability

4,830

5,397

Total liabilities

10,726

12,621

Stockholders' equity:

Preferred stock: $0.001 par value; 15,000,000 shares authorized, zero
shares issued or outstanding

-

-

Common stock: $0.001 par value; 500,000,000 shares authorized;
17,050,536 and 442,458 shares issued and outstanding at
September 30, 2024 and December 31, 2023, respectively

82

61

Additional paid-in capital

245,603

235,607

Accumulated deficit

(241,265

)

(223,447

)

Total stockholders' equity

4,420

12,221

Total liabilities and stockholders' equity

$

15,146

$

24,842

Aptevo Therapeutics Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts, unaudited)

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

2024

2023

2024

2023

Operating expenses:

Research and development

$

(3,103

)

$

(3,887

)

(10,498

)

(13,516

)

General and administrative

(2,110

)

(2,674

)

(7,722

)

(8,978

)

Loss from operations

(5,213

)

(6,561

)

(18,220

)

(22,494

)

Other income:

Other income from continuing operations, net

112

227

402

390

Gain related to sale of non-financial asset

-

-

-

9,650

Net loss from continuing operations

$

(5,101

)

$

(6,334

)

$

(17,818

)

$

(12,454

)

Discontinued operations:

Income from discontinued operations

$

-

$

-

$

-

$

946

Net loss

$

(5,101

)

$

(6,334

)

$

(17,818

)

$

(11,508

)

Basic and diluted net loss per share from
continuing operations:

Basic

$

(0.48

)

$

(22.16

)

$

(5.01

)

$

(60.84

)

Diluted

$

(0.48

)

$

(22.16

)

$

(5.01

)

$

(60.84

)

Basic and diluted net loss per share:

Basic

$

(0.48

)

$

(22.16

)

$

(5.01

)

$

(56.22

)

Diluted

$

(0.48

)

$

(22.16

)

$

(5.01

)

$

(56.22

)

Shares used in calculation:

Basic

10,548,470

285,886

3,554,796

204,694

Diluted

10,548,470

285,886

3,554,796

204,694

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.

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 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 future preliminary or interim data readouts for ALG.APV-527, whether Aptevo's final trial results will vary from its preliminary or interim assessments, 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 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, war between Israel and Hamas, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, continued market volatility and decreased consumer confidence and uncertainty in the impact of the results of the United States presidential election and congressional election. 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 (APVO) Q3 2024 financial results?

Aptevo reported a net loss of $5.1 million ($0.48 per share), with cash position of $7.8 million, R&D expenses of $3.1 million, and G&A expenses of $2.1 million.

What clinical progress did APVO report in Q3 2024?

APVO initiated the mipletamig Phase 1b/2 'RAINIER' trial for frontline AML and presented positive interim data for ALG.APV-527, showing 60% of patients achieving stable disease in solid tumors.

How much funding did APVO raise in Q3 2024?

Aptevo raised $5.75 million through two financing rounds during the third quarter of 2024.

Aptevo Therapeutics Inc

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