Aptevo Therapeutics(APVO)
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Aptevo Therapeutics(APVO) - 2024 Q4 - Annual Results
2025-02-14 13:50
[Business Update](index=1&type=section&id=Business%20Update) [Mipletamig AML Bispecific Highlights](index=1&type=section&id=Mipletamig%20AML%20bispecific%20highlights) The Mipletamig drug candidate showed high remission rates and a favorable safety profile in its RAINIER trial for Acute Myeloid Leukemia (AML) - In the frontline AML RAINIER trial, **100% of patients in Cohort 1 achieved remission** within 30 days[3](index=3&type=chunk) - One patient in Cohort 1 achieved **complete remission with minimal residual disease (MRD)-negative status**, indicating 100% elimination of cancer cells[3](index=3&type=chunk) - Mipletamig showed a **favorable safety profile** with limited incidences of cytokine release syndrome (CRS), a common side effect in similar therapies[3](index=3&type=chunk) - Previous trial results supporting the current findings include a Phase 1b trial where **100% of frontline patients achieved remission** and a Phase 1a monotherapy trial where **36% of patients showed substantial leukemic blast reduction**[6](index=6&type=chunk) [ALG.APV-527 Solid Tumor Bispecific Highlights](index=2&type=section&id=ALG.APV-527%20solid%20tumor%20bispecific%20highlights) The ALG.APV-527 trial for solid tumors demonstrated a 59% stable disease rate and a favorable safety profile without serious liver toxicities | Metric | Result | | :--- | :--- | | Stable Disease Rate | 10 of 17 efficacy evaluable patients (59%) achieved stable disease | | Longest Duration of Stable Disease | A breast cancer patient remained on study for >12 months | | Other Stable Disease Durations | A colon cancer patient for >6 months; a prostate cancer patient for >4 months | - ALG.APV-527 demonstrated a **favorable safety profile** with limited incidence and no severe cases of liver toxicity, a common dose-limiting side effect in similar treatments[7](index=7&type=chunk)[6](index=6&type=chunk) - The data was presented at the **European Society for Medical Oncology (ESMO) Congress** and the **Society for Immunotherapy of Cancer (SITC) Conference** in 2024[7](index=7&type=chunk) [About Mipletamig and RAINIER Trial](index=3&type=section&id=About%20Mipletamig%20and%20RAINIER) Mipletamig is a bispecific antibody targeting CD123 for AML, evaluated in the Phase 1b/2 RAINIER combination therapy trial - Mipletamig is an antibody-like recombinant protein that targets the **CD123 antigen**, which is overexpressed on leukemic stem cells and AML blasts[8](index=8&type=chunk) - It is designed to **reduce the likelihood and severity of Cytokine Release Syndrome (CRS)** by using a unique CD3 binding domain[8](index=8&type=chunk) - The RAINIER trial is a two-part **Phase 1b/2 study**, with part one being a dose optimization study for up to 39 adult patients[9](index=9&type=chunk) [About ALG.APV-527 and The Phase 1 Trial](index=3&type=section&id=About%20ALG.APV-527%20and%20The%20Phase%201%20Dose%20Escalation%20Trial) ALG.APV-527 is a conditional 4-1BB agonist targeting the 5T4 tumor antigen, assessed for safety and efficacy in a Phase 1 trial - ALG.APV-527 is a bispecific conditional **4-1BB agonist**, designed to be active only upon simultaneous binding to 4-1BB and the tumor antigen 5T4[10](index=10&type=chunk) - The **5T4 antigen is overexpressed** on numerous solid tumors, including non-small-cell lung, breast, head and neck, and colorectal cancer[10](index=10&type=chunk) - The Phase 1 trial was a multi-center, open-label, dose-escalation study to assess **safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity**[11](index=11&type=chunk) [Financial Results and Statements](index=4&type=section&id=Financial%20Results%20and%20Statements) [2024 Summary Financial Results](index=4&type=section&id=2024%20Summary%20Financial%20Results) The company's 2024 net loss increased to $24.1 million, despite lower operating expenses, due to the absence of a prior-year one-time gain | Financial Metric | 2024 | 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $8.7 million | $16.9 million | | Research and Development Expenses | $14.4 million | $17.1 million | | General and Administrative Expenses | $10.2 million | $11.8 million | | Net Loss | $24.1 million | $17.4 million | | Net Loss Per Share | $87.38 | $2,316.83 | - The decrease in R&D expenses was mainly due to lower preclinical spending and **reduced costs for the mipletamig trial** as it transitioned between phases[14](index=14&type=chunk) - The 2023 financials included a **$9.7 million gain** from the sale of a non-financial asset to XOMA, which was not repeated in 2024[17](index=17&type=chunk) [Consolidated Balance Sheets](index=5&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) Total assets decreased to $15.6 million from $24.8 million, driven by a reduction in cash, while total equity fell to $4.8 million | (in thousands) | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $8,714 | $16,904 | | Total current assets | $10,659 | $19,066 | | **Total assets** | **$15,591** | **$24,842** | | **LIABILITIES & EQUITY** | | | | Total current liabilities | $6,207 | $7,224 | | **Total liabilities** | **$10,836** | **$12,621** | | **Total stockholders' equity** | **$4,755** | **$12,221** | | **Total liabilities and stockholders' equity** | **$15,591** | **$24,842** | [Consolidated Statements of Operations](index=6&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Loss from operations improved to $24.6 million, but the net loss widened to $24.1 million due to non-recurring income in the prior year | (in thousands, except per share amounts) | For the Year Ended Dec 31, 2024 | For the Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Research and development | $(14,378) | $(17,107) | | General and administrative | $(10,224) | $(11,771) | | **Loss from operations** | **$(24,602)** | **$(28,878)** | | Gain related to sale of non-financial asset | — | $9,650 | | Net loss from continuing operations | $(24,130) | $(18,650) | | Income from discontinued operations | — | $1,239 | | **Net loss** | **$(24,130)** | **$(17,411)** | | **Basic and diluted net loss per share** | **$(87.38)** | **$(2,316.83)** | [Corporate Information and Forward-Looking Statements](index=7&type=section&id=Corporate%20Information%20and%20Forward-Looking%20Statements) [About Aptevo Therapeutics](index=7&type=section&id=About%20Aptevo%20Therapeutics) Aptevo Therapeutics is a clinical-stage biotech company developing novel bispecific immunotherapies for cancer using its proprietary platforms - Aptevo is a clinical-stage biotechnology company (Nasdaq: APVO) developing **novel bispecific immunotherapies** for cancer[25](index=25&type=chunk) - Its lead clinical candidates are **Mipletamig for frontline acute myeloid leukemia (AML)** and **ALG.APV-527 for multiple solid tumor types**[25](index=25&type=chunk) - All pipeline candidates are created from the company's proprietary **ADAPTIR® and ADAPTIR-FLEX® platforms**[25](index=25&type=chunk) [Safe Harbor Statement](index=7&type=section&id=Safe%20Harbor%20Statement) This section cautions that forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ - The press release contains **forward-looking statements** regarding the efficacy, safety, and potential of its therapeutic candidates, clinical milestones, and financial position[26](index=26&type=chunk) - Investors are cautioned **not to place undue reliance on these statements** as actual results could differ materially if underlying assumptions prove inaccurate or risks materialize[26](index=26&type=chunk) - Key risks include **deterioration in business prospects, adverse clinical development events, regulatory changes, competitive products, and macroeconomic conditions**[27](index=27&type=chunk)[28](index=28&type=chunk)
Are Medical Stocks Lagging Aptevo Therapeutics (APVO) This Year?
ZACKS· 2025-01-10 16:02
Company Overview - Aptevo Therapeutics Inc. (APVO) is part of the Medical group, which is currently ranked 1 within the Zacks Sector Rank, encompassing 1011 companies [2] - The company has a Zacks Rank of 2 (Buy), indicating a favorable outlook based on earnings estimates and revisions [3] Performance Metrics - Year-to-date, Aptevo Therapeutics Inc. has gained approximately 15.6%, while the average loss in the Medical group is about 3.9%, demonstrating strong relative performance [4] - The Zacks Consensus Estimate for APVO's full-year earnings has increased by 65.1% over the past three months, reflecting improved analyst sentiment [3] Industry Context - Aptevo Therapeutics Inc. operates within the Medical - Biomedical and Genetics industry, which includes 513 companies and is currently ranked 63 in the Zacks Industry Rank [5] - The Medical - Biomedical and Genetics industry has experienced an average loss of 12.6% this year, further highlighting APVO's superior performance [5] Comparison with Peers - Another outperforming stock in the Medical sector is Accuray (ARAY), which has increased by 7.6% year-to-date and also holds a Zacks Rank of 2 (Buy) [4][6] - Accuray's EPS consensus estimate has surged by 200% over the past three months, indicating strong growth potential [5]
Aptevo Therapeutics(APVO) - 2024 Q3 - Quarterly Report
2024-11-07 13:30
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements show a significant decrease in assets and a rising net loss, which, combined with an accumulated deficit and increased cash burn, raise substantial doubt about the company's ability to continue as a going concern [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased significantly to $15.1 million due to a reduction in cash, while stockholders' equity fell sharply from $12.2 million to $4.4 million Condensed Consolidated Balance Sheet Data (in thousands) | Balance Sheet Items | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,753 | $16,904 | | Total current assets | $10,012 | $19,066 | | Total assets | $15,146 | $24,842 | | **Liabilities & Equity** | | | | Total current liabilities | $5,882 | $7,224 | | Total liabilities | $10,726 | $12,621 | | Total stockholders' equity | $4,420 | $12,221 | | Total liabilities and stockholders' equity | $15,146 | $24,842 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company's net loss widened to $17.8 million for the nine-month period, despite an improved quarterly loss, influenced by the absence of a significant prior-year gain on an asset sale Condensed Consolidated Statements of Operations (in thousands) | Metric | Q3 2024 | Q3 2023 | 9 Months 2024 | 9 Months 2023 | | :--- | :--- | :--- | :--- | :--- | | 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) | | Gain related to sale of non-financial asset | — | — | — | $9,650 | | Net loss from continuing operations | $(5,101) | $(6,334) | $(17,818) | $(12,454) | | Net loss | $(5,101) | $(6,334) | $(17,818) | $(11,508) | Net Loss Per Share (Basic and Diluted) | Period | 2024 | 2023 | | :--- | :--- | :--- | | **Three Months Ended Sep 30** | $(0.48) | $(22.16) | | **Nine Months Ended Sep 30** | **$(5.01)** | **$(56.22)** | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased substantially to $18.0 million, while financing activities provided $8.9 million, resulting in a net cash decrease of $9.2 million Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(18,026) | $(6,477) | | Net cash provided by financing activities | $8,875 | $2,952 | | **Decrease in cash and cash equivalents** | **$(9,151)** | **$(3,525)** | | Cash and cash equivalents at end of period | $7,753 | $19,110 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's clinical-stage focus, significant financing activities including a reverse stock split, and the substantial doubt about its ability to continue as a going concern - The company is a clinical-stage biotechnology firm focused on novel immuno-oncology candidates, using its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platforms[16](index=16&type=chunk) - Due to recurring losses, a net loss of **$17.8 million** and negative operating cash flow of **$18.0 million** for the nine months ended September 30, 2024, there is **substantial doubt about the company's ability to continue as a going concern**[16](index=16&type=chunk) - On March 5, 2024, the company effected a **1-for-44 reverse stock split** of its common stock, and all share and per-share amounts have been retroactively adjusted[30](index=30&type=chunk) - Subsequent to the reporting period, remaining pre-funded warrants were exercised, bringing the total shares of common stock outstanding to **18,512,084** as of November 7, 2024[59](index=59&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses decreased operating expenses, a critical liquidity position with $7.8 million in cash, and the urgent need for substantial additional funding to continue operations and advance clinical programs [Overview](index=19&type=section&id=Overview) Aptevo is a clinical-stage biotechnology company developing novel cancer immunotherapies using its versatile ADAPTIR and ADAPTIR-FLEX protein technology platforms - The company is focused on developing novel immunotherapy candidates for cancer treatment[63](index=63&type=chunk) - Key assets include two proprietary technology platforms, **ADAPTIR and ADAPTIR-FLEX**, used to design multi-specific antibody candidates[65](index=65&type=chunk) - The clinical pipeline includes **mipletamig (APVO436)** for acute myelogenous leukemia (AML) and **ALG.APV-527** for multiple solid tumor types[63](index=63&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Operating expenses decreased in 2024 due to lower spending on the mipletamig clinical trial and reduced G&A costs, while the prior year's results included a significant one-time gain Research and Development Expenses by Program (in thousands) | Program | 9 Months 2024 | 9 Months 2023 | | :--- | :--- | :--- | | Mipletamig | $2,544 | $4,300 | | ALG.APV-527 | $2,004 | $2,264 | | Preclinical, research & discovery | $5,950 | $6,952 | | **Total** | **$10,498** | **$13,516** | - The decrease in R&D expenses was primarily due to lower spending on the **mipletamig clinical trial** as the Phase 1b dose expansion study concluded[70](index=70&type=chunk) - General and administrative expenses decreased by **$1.3 million** for the nine months ended September 30, 2024, compared to the prior year, mainly due to lower employee and consulting costs[71](index=71&type=chunk) - In 2023, the company recorded a **$9.7 million gain** from the sale of nonfinancial assets to XOMA, which was not present in 2024[72](index=72&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is a significant concern, with cash of $7.8 million and an accumulated deficit of $241.3 million, necessitating substantial additional funds to continue development - As of September 30, 2024, the company had cash and cash equivalents of **$7.8 million** and an accumulated deficit of **$241.3 million**[83](index=83&type=chunk) - The company **does not have sufficient cash** to complete the clinical development of any of its product candidates and will require substantial additional funds to continue its development programs[83](index=83&type=chunk) - If unable to raise additional capital, the company may be required to **delay, limit, reduce, or terminate** its clinical trials and other development activities[84](index=84&type=chunk) Financing Activities (Gross Proceeds) | Offering | Date | Gross Proceeds | | :--- | :--- | :--- | | Public Offering | August 2023 | $4.3M (net) | | Warrant Inducement | November 2023 | $3.3M | | Public Offering | April 2024 | $4.6M | | Registered Direct Offering | July 2024 | $2.7M | | Registered Direct Offering | September 2024 | $3.0M | [Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states there have been no material changes to the information regarding market risk since its 2023 Annual Report on Form 10-K - There were **no material changes** to the disclosures about market risk as of September 30, 2024, compared to those in the 2023 Annual Report on Form 10-K[86](index=86&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the company's disclosure controls and procedures and concluded they were effective, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that as of September 30, 2024, the company's disclosure controls and procedures were **effective**[87](index=87&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter ended September 30, 2024, that have materially affected or are likely to materially affect internal controls[88](index=88&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal claims or actions that management believes would have a material adverse effect on its financial condition or operations - Management believes there are currently **no pending legal claims or actions** that could have a material adverse effect on the company's results, financial condition, or cash flows[90](index=90&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, operational, and regulatory risks, including a history of losses, going concern uncertainty, reliance on clinical trial success, and potential delisting from Nasdaq - The company's common stock is at **risk of delisting from Nasdaq** for failing to maintain the minimum $1.00 bid price requirement[92](index=92&type=chunk)[169](index=169&type=chunk) - The company has a history of losses, an accumulated deficit of **$241.3 million**, and its ability to continue as a **going concern is in substantial doubt**[92](index=92&type=chunk)[94](index=94&type=chunk) - Success is highly dependent on the ability to develop, receive regulatory approval for, and commercialize product candidates, a process which is **long, costly, and uncertain**[92](index=92&type=chunk)[134](index=134&type=chunk) - The business is affected by macroeconomic conditions, including **inflation, interest rates, and market volatility**, which could impact operations and the ability to raise capital[92](index=92&type=chunk)[97](index=97&type=chunk) [Other Information](index=58&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted, terminated, or materially modified a Rule 10b5-1 trading plan or other non-Rule 10b5-1 trading arrangement during the third quarter of 2024 - In Q3 2024, **no directors or executive officers** adopted, terminated, or modified a Rule 10b5-1 trading plan or other non-Rule 10b5-1 trading arrangement[179](index=179&type=chunk) [Exhibits](index=58&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including financing agreements, an amendment to the stockholder Rights Agreement, and officer certifications - Exhibits filed include agreements from the **September 2024 registered direct offering**, such as the Securities Purchase Agreement and forms of Common and Pre-Funded Warrants[181](index=181&type=chunk) - An amendment to the **Rights Agreement** with Broadridge Corporate Issuer Solutions, Inc., dated November 1, 2024, was filed[181](index=181&type=chunk) - **Certifications by the Principal Executive Officer and Principal Financial Officer** pursuant to Sarbanes-Oxley Sections 302 and 906 are included as exhibits[181](index=181&type=chunk)
Aptevo Therapeutics(APVO) - 2024 Q3 - Quarterly Results
2024-11-07 13:15
Aptevo Therapeutics 3Q 2024 Financial Results and Business Update [Business Highlights](index=1&type=section&id=Business%20Highlights) Aptevo Therapeutics achieved significant clinical milestones in Q3 2024, advancing key trials and successfully raising $5.75 million - Initiated the mipletamig Phase 1b/2 dose optimization trial, "RAINIER," for frontline Acute Myeloid Leukemia (AML) patients, combining it with standard of care venetox and azacitidine[1](index=1&type=chunk)[2](index=2&type=chunk) - Presented positive interim data from the ALG.APV-527 Phase 1 trial at the ESMO Congress, with **9 out of 15 (60%) efficacy evaluable patients achieving a best overall response of stable disease (SD)**[2](index=2&type=chunk) - The ALG.APV-527 trial demonstrated a well-tolerated safety profile and confirmed biological activity through biomarker analyses[3](index=3&type=chunk) - Raised a total of **$5.75 million** through two financing deals during the third quarter[1](index=1&type=chunk)[3](index=3&type=chunk) [3Q 2024 Summary Financial Results](index=2&type=section&id=3Q%20Summary%20Financial%20Results) Aptevo reported a Q3 2024 net loss of $5.1 million, reduced from the prior year, with $7.8 million cash and lower operating expenses Q3 2024 Financial Highlights (vs. Q3 2023) | Financial Metric | Q3 2024 | Q3 2023 | Change | | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | $7.8 million | N/A | - | | Research & Development Expenses | $3.1 million | $3.9 million | -$0.8 million | | General & Administrative Expenses | $2.1 million | $2.7 million | -$0.6 million | | Net Loss | $5.1 million | $6.3 million | -$1.2 million | | Net Loss Per Share | $0.48 | $22.16 | - | - The decrease in R&D expenses was primarily due to lower spending on preclinical projects and employee costs[4](index=4&type=chunk) - The decrease in G&A expenses was mainly attributed to lower employee and consulting costs[5](index=5&type=chunk) Financial Statements [Condensed Consolidated Balance Sheets](index=3&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of September 30, 2024, Aptevo's total assets were $15.1 million, with liabilities at $10.7 million and equity at $4.4 million Balance Sheet Summary (in thousands) | Account | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,753 | $16,904 | | Total current assets | $10,012 | $19,066 | | **Total assets** | **$15,146** | **$24,842** | | **Liabilities & Equity** | | | | Total current liabilities | $5,882 | $7,224 | | **Total liabilities** | **$10,726** | **$12,621** | | **Total stockholders' equity** | **$4,420** | **$12,221** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Aptevo reported a Q3 2024 net loss of $5.1 million ($0.48 per share) and a nine-month net loss of $17.8 million Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | 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) | | Net loss from continuing operations | $(5,101) | $(6,334) | $(17,818) | $(12,454) | | Net loss | $(5,101) | $(6,334) | $(17,818) | $(11,508) | | Basic and diluted net loss per share | $(0.48) | $(22.16) | $(5.01) | $(56.22) | Company Information and Forward-Looking Statements [About Aptevo Therapeutics Inc.](index=5&type=section&id=About%20Aptevo%20Therapeutics%20Inc.) Aptevo Therapeutics Inc. is a clinical-stage biotechnology company developing novel immuno-oncology therapies for cancer treatment - Aptevo is a clinical-stage biotechnology company focused on developing novel immuno-oncology therapies to treat cancer[13](index=13&type=chunk) [Safe Harbor Statement](index=5&type=section&id=Safe%20Harbor%20Statement) This section outlines forward-looking statements, cautioning that actual results may differ due to clinical, regulatory, and macroeconomic risks - The press release includes forward-looking statements concerning the efficacy, safety, and potential of its therapeutic candidates, progress of clinical programs, and financial position[14](index=14&type=chunk) - Warns that actual results may differ materially due to risks such as adverse clinical trial outcomes, regulatory hurdles, competitive products, and macroeconomic factors like inflation and geopolitical risks[15](index=15&type=chunk)[17](index=17&type=chunk) - Investors are directed to the company's SEC filings, including the Annual Report on Form 10-K, for a more comprehensive discussion of risks and uncertainties[17](index=17&type=chunk)
Aptevo Therapeutics (APVO) Upgraded to Buy: Here's What You Should Know
ZACKS· 2024-08-15 17:06
Aptevo Therapeutics Inc. (APVO) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the ...
Aptevo Therapeutics(APVO) - 2024 Q2 - Quarterly Report
2024-08-08 12:30
Financial Performance - Net cash used in operating activities was $12.8 million for the six months ended June 30, 2024, compared to $0.2 million for the same period in 2023, driven by a net loss of $12.7 million[85]. - As of June 30, 2024, the company had cash and cash equivalents of $8.1 million and an accumulated deficit of $236.2 million[91]. - For the six months ended June 30, 2024, net cash used in operating activities was $12.8 million[91]. - The company anticipates significant operating losses for the next several years as it continues to develop its product candidates[92]. - The company requires substantial additional funds to continue its development programs and fulfill planned operating goals[92]. Research and Development - Research and development expenses decreased by $1.9 million, from $5.5 million for Q2 2023 to $3.6 million for Q2 2024, primarily due to lower spending on the APVO436 clinical trial[78]. - Total research and development expenses for the six months ended June 30, 2024, were $7.4 million, down from $9.6 million in the same period of 2023, reflecting reduced costs in clinical trials and preclinical projects[78]. - Clinical candidate APVO436 is currently being evaluated for the treatment of acute myelogenous leukemia (AML)[71]. - Clinical candidate ALG.APV-527 is designed to reactivate antigen-primed T-cells to specifically kill tumor cells and is under evaluation for multiple solid tumor types[71]. - The company has a milestone payment obligation of $2.0 million upon dosing the first patient in a Phase 2 clinical trial of product candidate APVO436[94]. Financing Activities - Net cash provided by financing activities for the six months ended June 30, 2024, was $4.0 million, primarily from the issuance of common stock[85]. - The company completed a public offering on April 10, 2024, issuing 3,400,000 shares at $1.35 per share, generating gross proceeds of $4.6 million and net proceeds of $4.0 million after fees[89]. - On July 1, 2024, the company completed a Registered Direct Offering of 5,339,806 shares at $0.515 per share, resulting in gross proceeds of $2.7 million and net proceeds of $2.3 million after fees[90]. - The company has issued common warrants to purchase up to 6,800,000 shares at an exercise price of $1.35 and 10,679,612 shares at $0.515, which could generate additional proceeds of up to $9.1 million if exercised[89][90]. General and Administrative Expenses - General and administrative expenses decreased by $0.3 million, from $2.7 million for Q2 2023 to $2.4 million for Q2 2024, mainly due to lower employee and consulting costs[80]. Risks and Obligations - The company faces risks related to macroeconomic conditions, which may impact its ability to partner product candidates and complete clinical trials[92][93]. - The company has an operating lease obligation extending through April 2030, with a recorded lease liability of $4.4 million[94]. - The company is eligible to receive up to $5.8 million in milestone payments from Medexus upon achievement of certain regulatory and IXINITY net sales thresholds[86]. - As of June 30, 2024, the company had 1,316 Series A and 1,316 Series B common warrants outstanding from the August 2023 public offering, with an exercise price of $27.28 per share[87].
Aptevo Therapeutics(APVO) - 2024 Q2 - Quarterly Results
2024-08-08 12:15
Exhibit 99.1 APTEVO THERAPEUTICS REPORTS 2Q 2024 FINANCIAL RESULTS AND PROVIDES A BUSINESS UPDATE SEATTLE, WA – August 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. "After the successful completion of our APVO436 dose expansion trial, ...
Aptevo Therapeutics(APVO) - Prospectus(update)
2024-06-26 12:30
As filed with the Securities and Exchange Commission on June 26, 2024. Registration No. 333-280226 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO.1 TO FORM S-1 Delaware 2834 81-1567056 (I.R.S. Employer Identification Number) 2401 4th Avenue, Suite 1050 Seattle, Washington, 98121 (206) 838-0500 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 APTEVO THERAPEUTICS INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporati ...
Aptevo Therapeutics(APVO) - Prospectus
2024-06-14 20:30
As filed with the Securities and Exchange Commission on June 14, 2024. THE SECURITIES ACT OF 1933 APTEVO THERAPEUTICS INC. (Exact Name of Registrant as Specified in Its Charter) Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial (Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service) Copies to ...
Aptevo Therapeutics(APVO) - 2024 Q1 - Quarterly Report
2024-05-08 12:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37746 | --- | --- | --- | --- | |------------------------------------------|-----------------------------------|----------------- ...