공시 • Mar 14
Aptevo Therapeutics Inc Announces New Interim Data For Mipletamig In Combination With Venetoclax And Azacitidine Aptevo Therapeutics Inc. announced new interim data for mipletamig in combination with venetoclax and azacitidine in newly diagnosed acute myeloid leukemia (AML) patients who are either elderly or unfit for intensive chemotherapy. In data from two trials, the combination has demonstrated robust clinical activity, delivering an 86% clinical benefit rate (CR/CRi/PR*) with zero patients experiencing the common symptom of cytokine release syndrome (CRS). These data support an emerging efficacy profile coupled with differentiated patient safety and tolerability that is additive to the current AML standard-of-care therapy. Among the evaluable frontline patient population treated to date (N=28), including 24 patients from the RAINIER trial and 4 patients from the completed dose expansion trial, mipletamig in combination with venetoclax and azacitidine has demonstrated: 100% of frontline patients have remained free of cytokine release syndrome (CRS), 86% clinical benefit rate, 79% achieved CR or CRi, 61% achieved CR, 55% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level, a result that is typically associated with stronger, more durable responses, 35% of patients with remissions had the TP53 genetic mutation, a high-risk biomarker typically associated with poor prognosis in AML and for which most treatment options frequently fail. Collectively, these data demonstrate mipletamigs potential to meaningfully enhance frontline AML treatment in older and/or unfit patients, by improving efficacy outcomes without materially increasing toxicity. RAINIER, a frontline AML study, is a Phase 1b/2 dose optimization, multi-center, multi-cohort, open label study. Subjects are adults aged 18 or older, newly diagnosed with AML who are not eligible for intensive induction chemotherapy. RAINIER will be conducted in two parts. First, a Phase 1b dose optimization study in frontline AML patients followed by a Phase 2 study. The Phase 1b trial consists of 28-day cycles of treatment across multiple, sequential cohorts. Aptevo's wholly owned lead proprietary drug candidate, mipletamig, being evaluated for the treatment of AML, 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. Mipletamig is purposefully designed to reduce the likelihood and severity of CRS by use of the CRIS-7-derived CD3 binding pathway, an approach that differentiates Aptevo from competitors. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. Orphan drug designation provides key advantagesincluding the opportunity to seek U.S. market exclusivity for a specific period of time upon approval, FDA fee reductions, and access to development and tax credits. Mipletamig has been evaluated in more than 120 patients over three trials to date. In frontline patients treated to date, no cytokine release syndrome (CRS) has been observed. Together with strong efficacy outcomes, this outcome underscores mipletamigs safety and combinability, potentially offering a superior treatment in the future. This safety profile is particularly important in frontline AML, where tolerability and combinability are essential for treating older patients and/or those with comorbidities. New Risk • Mar 10
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Shareholders have been substantially diluted in the past year (over 245x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$6.72m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$29m net loss in 3 years). New Risk • Dec 31
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.27m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (over 672x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.27m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$29m net loss in 3 years). Share price has been volatile over the past 3 months (16% average weekly change). New Risk • Nov 28
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (over 672x increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$29m net loss in 3 years). Market cap is less than US$100m (US$21.6m market cap). 공시 • Nov 08
Aptevo Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $11.802524 million. Aptevo Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $11.802524 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 15,292
Price\Range: $11.891708
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 384,160
Price\Range: $8.244627
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 82,377
Price\Range: $5.050427
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,318,171
Price\Range: $1.685319
Transaction Features: At the Market Offering 
