Aankondiging • 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). Aankondiging • 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 New Risk • Aug 03
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.93m 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 Share price has been highly volatile over the past 3 months (29% average weekly change). Negative equity (-US$1.5m). Shareholders have been substantially diluted in the past year (over 290x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.93m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Aankondiging • Jun 24
Aptevo Therapeutics Inc., Annual General Meeting, Jul 24, 2025 Aptevo Therapeutics Inc., Annual General Meeting, Jul 24, 2025. Aankondiging • Jun 17
Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering. Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,709,401
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,709,401
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 8,547,005 Aankondiging • May 23
Aptevo Therapeutics Receives Non-Compliance Letter from Nasdaq Regarding Stockholders' Equity Requirement On May 22, 2025, Aptevo Therapeutics Inc. (the Company") received a letter from The Nasdaq Stock Market LLC (Nasdaq") indicating that it is not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires companies listed on The Nasdaq Capital Market to maintain a minimum of $2,500,000 in stockholders' equity for continued listing. On its Quarterly Report for the quarterly period ended March 31, 2025, the Company reported stockholders' deficit of $1,473,000, and, as a result, does not currently satisfy Nasdaq Listing Rule 5550(b)(1). Nasdaq's letter has no immediate impact on the listing of the Company's common stock, which will continue to be listed and traded on Nasdaq, subject to the Company's compliance with the other continued listing requirements. Nasdaq's letter provides the Company 45 calendar days, or until July 7, 2025, to submit a plan to regain compliance. If the plan is accepted, the Company can be granted up to 180 calendar days from May 22, 2025 (or until November 18, 2025), to evidence compliance. There can be no assurance that the Company will be able to regain compliance with all applicable continued listing requirements or that its plan will be accepted by the Nasdaq staff. In the event the plan is not accepted by the Nasdaq staff, or in the event the plan is accepted but the Company fails to regain compliance within the plan period, the Company would have the right to a hearing before an independent panel pursuant to the procedures set in the applicable Nasdaq Listing Rules. However, there can be no assurance that, if the Company does appeal any delisting determination by Nasdaq to a panel, that such appeal would be successful. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. The Company is currently evaluating its available options to resolve the deficiency and regain compliance with the Nasdaq minimum stockholders' equity requirement. The Company intends to submit the compliance plan by the Nasdaq deadline. However, there can be no assurance that the Company's compliance plan will be accepted by Nasdaq, that it be able to regain compliance with Nasdaq Listing Rule 5550(b)(1), maintain compliance with the other Nasdaq listing requirements or be successful in appealing any delisting determination. New Risk • May 17
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$1.5m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (26% average weekly change). Negative equity (-US$1.5m). Shareholders have been substantially diluted in the past year (over 55x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.07m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Aankondiging • May 13
Aptevo Therapeutics Inc. has withdrawn its Follow-on Equity Offering in the amount of $17.5 million. Aptevo Therapeutics Inc. has withdrawn its Follow-on Equity Offering in the amount of $17.5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 15,086,207
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 15,086,207
Security Name: Series A Warrants
Security Type: Equity Warrant
Securities Offered: 15,086,207
Security Name: Series B Warrants
Security Type: Equity Warrant
Securities Offered: 15,086,207 Aankondiging • Apr 28
Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $2.959952 million. Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $2.959952 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Aankondiging • Apr 23
Aptevo Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $2.003288 million. Aptevo Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $2.003288 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,324,000
Price\Range: $0.862
Discount Per Security: $0.06034
Transaction Features: Registered Direct Offering Aankondiging • Apr 22
Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $1.99864 million. Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $1.99864 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,324,000
Price\Range: $0.86
Discount Per Security: $0.0602
Transaction Features: Registered Direct Offering Aankondiging • Apr 04
Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $2.100005 million. Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $2.100005 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,764,710
Price\Range: $1.19
Discount Per Security: $0.08
Transaction Features: Registered Direct Offering New Risk • Dec 19
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$24m Forecast net loss in 3 years: US$16m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$23m free cash flow). Share price has been highly volatile over the past 3 months (30% average weekly change). Shareholders have been substantially diluted in the past year (over 45x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.15m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$16m net loss in 3 years). Aankondiging • Dec 13
Aptevo Therapeutics Inc. Announces 100% of Patients Achieve Remission Within 30 Days in Cohort 1 of Bispecific Mipletamig Frontline Aml Trial Aptevo Therapeutics Inc. announced 100% of patients achieved remission within 30 days, in Cohort 1 of the RAINIER frontline acute myeloid leukemia (AML) Phase 1b trial, including two patients who experienced complete remission with minimal residual disease (MRD)-negative status (100% elimination of cancer cells). The results build on data from the prior trial, in which 100% of frontline patients also achieved remission. (Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered (CRi). Mipletamig, a CD3 x CD123 bispecific antibody, is being investigated as frontline therapy in combination withvenetoclax and azacitidine, a current standard of care for AML. These latest results further reinforce mipletamig's potential as a transformative treatment, supported by impressive efficacy, safety, and tolerability data from two prior clinical trials involving 90 patients. "Achieving remission in all three Cohort 1 patients is highly encouraging, particularly when viewed alongside prior trial results. RAINIER, Aptevo's Phase 1b/2 frontline AML program, was initiated in third quarter24. Aankondiging • Dec 05
Aptevo Therapeutics Inc. Announces Bispecific Antibody, Apvo442, Differentiated to Treat Prostate Cancer with Precision Tumor Targeting and Reduced Risk of Side Effects Aptevo Therapeutics Inc. announced additional details about the Company's preclinical bispecific antibody, APVO442, differentiated to target prostate cancer with enhanced precision and minimized safety risk. APVO442 is the first molecule developed using Aptevo's cutting-edge ADAPTIR-FLEX platform, which is driving innovation in antibody engineering for complex disease management. While early diagnosis and treatment have significantly improved prostate cancer survival rates, it remains challenging to treat effectively in late-stage, advanced forms like castration-resistant prostate cancer (CRPC). Prostate cancer is the second most common cancer in men and according to the American Cancer Society approximately 300,000 new cases are diagnosed in the United States annually. The therapeutic treatment market is approximately $14 billion and is expected to grow to more than $24 billion over the next ten years.APVO442 is engineered to address treatment challenges associated with later stage diagnosis with its unique design that enables precise tumor targeting while activating the immune system in a controlled manner. The molecule binds to Prostate-Specific Membrane Antigen (PSMA) on prostate cancer cells where it activates T cells within the tumor and enhances targeted tumor cell killing. This is notable because the approach reduces the risk of harm to healthy cells. Preclinical studies have shown that the molecule readily localizes to solid tumors by avoiding unwanted binding to immune cells circulating in the bloodstream. This approach helps the treatment focus on fighting the tumor itself while reducing the risk of widespread side effects, making it both safer and more effective. Aankondiging • Dec 02
Aptevo Therapeutics Announces 1-for 37 Reverse Stock Split as Part of Nasdaq Compliance Plan Aptevo Therapeutics Inc. (‘Aptevo’ or the ‘Company’) announced that it will conduct a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-37 (the ‘Reverse Stock Split’). The Reverse Stock Split is expected to become effective on December 3, 2024 at 5:01 p.m. Eastern Time (the ‘Effective Time’), with shares expected to begin trading on the Nasdaq Capital Market, on a split-adjusted, at market open on December 4, 2024. In connection with the Reverse Stock Split, every 37 shares of the Company's common stock issued and outstanding as of the Effective Time will be automatically converted into one share of the Company's common stock. No change will be made to the trading symbol for the Company's shares of common stock, ‘APVO’, in connection with the reverse split. The Reverse Stock Split is part of the Company's plan to regain compliance with the minimum bid price requirement of $1.00 per share required to maintain continued listing on The Nasdaq Capital Market, among other benefits. The Reverse Stock Split was approved by the Company's stockholders at the Company's Special Meeting of Stockholders held on October 25, 2024 (the ‘Special Meeting’) to be effected in the Board's discretion within approved parameters. Following the Special Meeting, the final ratio was approved by the Company's Board on October 25, 2024. Aankondiging • Nov 21
Aptevo Therapeutics Expands on the Potential of Mipletamig Aptevo Therapeutics expanded on the potential of mipletamig, currently being evaluated as frontline therapy for the treatment of Acute Myeloid Leukemia (AML), in combination with standard of care venetoclax and azacitidine, noting the first patient dosed in the ongoing RAINIER trial achieved a 90% reduction in leukemic blasts within the first 30 days of treatment, continuing the overall efficacy trend seen in prior studies. The Company's move to evaluate mipletamig as frontline combination therapy is informed by favorable data from earlier trials, which demonstrated strong safety, efficacy, and tolerability profiles, alongside evidence of durable remission. These early findings have fueled excitement around RAINIER among the group of investigators at premier cancer treatment institutions who have been working with the drug and members of the biotechnology industry who have been following its progress.RAINIER seeks to further demonstrate the impact of mipletamig's unique, dual targeted mechanism of action by combining it with standard of care therapies venetoclax and azacitidine. The triplet combination targets AML from multiple angles and has the potential to improve patient outcomes, especially among the elderly who have few treatment options available. Aankondiging • Nov 12
Aptevo Therapeutics (Aptevo) and Alligator Bioscience AB Announce Preliminary Data from Its Phase 1 Trial Evaluating the First-In-Class Bispecific Antibody, ALG.APV-527 Aptevo Therapeutics (Aptevo) and Alligator Bioscience AB (Alligator) (ATORX) announced preliminary data from the companies' Phase 1 trial evaluating the first-in-class bispecific antibody, ALG.APV-527, as monotherapy for the treatment of multiple solid tumor types likely to express tumor antigen 5T4. These data indicate that trial endpoints of adequate exposure, safety, tolerability and biological activity were met. Outcomes were presented at a poster session on Friday November 8, 2024, at the Society for Immunotherapy of Cancer Conference in Houston, Texas. Clinical Highlights: Safety and Tolerability: ALG.APV-527 demonstrated positive safety and tolerability across all cohorts; No serious liver toxicity, a common side effect of other 4-1BB targeting treatments that can cause patients to discontinue dosing, was observed; A maximum tolerated dose has not been identified, highlighting the tolerability of the drug at high dose levels. Clinical Activity/Efficacy: Nine of 16 efficacy evaluable patients (56%) achieved stable disease (SD); One colon cancer patient achieved SD for more than six months; 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. Evidence of biological activity of ALG.APV-527: ALG.APV-527 could be measured in all patients. Serum concentrations of ALG.APV-527 were proportional to the administered dose; Analysis of biomarkers in the serum of treated patients including soluble 4-1BB (surface protein found on certain immune cells) confirm biological activity of ALG.APV-527; Analysis of biomarkers in biopsies (including the 5T4 target cells and CD8 T cancer killer cells are consistent with immune activation in the tumor microenvironment). This observation consistent with ALG.APV-527 expected MOA. Aankondiging • Sep 19
Aptevo Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $2.999493 million. Aptevo Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $2.999493 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 4,020,000
Price\Range: $0.33
Discount Per Security: $0.0231
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 5,070,910
Price\Range: $0.3299
Discount Per Security: $0.0231
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 18,181,820 Aankondiging • Sep 16
Alligator Bioscience and Aptevo Therapeutics Announce Data from Phase 1 ALG.APV-527 Monotherapy Trial Showing 60% of Evaluable Patients Achieved Stable Disease in Solid Tumor Study Alligator Bioscience and Aptevo Therapeutics announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The results, which include clinical activity, safety, tolerability outcomes, pharmacokinetics and pharmacodynamics were presented in a poster session on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress in Barcelona, Spain. ALG.APV-527 is a first-in-class bispecific antibody that targets 4-1BB and the tumor antigen 5T4. The compound is being evaluated in a multi-center, dose escalation trial that has 18 patients included in the safety analysis. These patients received multiple prior rounds of therapy for the treatment of solid tumor types. The trial is approaching full enrollment and interim results include: Nine of 15 efficacy evaluable patients (60%) have a best overall response to date 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. One colon cancer patient with sustained SD remains on study for more than four months. ALG.APV-527 demonstrated positive safety and tolerability across all cohorts. A maximum tolerated dose has not been identified. 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. The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label dose-escalation trial that includes administration of ALG.APV-527 in up to six escalating dose levels in a 3+3 design. The trial is enrolling adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial is assessing the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. The 3+3 design proceeds in cohorts of three patients treated at increasing dose levels. Dose escalation stops when at least two out of three or six patients experience dose limiting toxicities (DLTs) at that dose level. ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. 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. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, has been published in the peer-reviewed publication, Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR). Aankondiging • Sep 14
Alligator Bioscience AB (publ) and Aptevo Therapeutics to Present Positive Interim Phase 1 Data Evaluating ALG.APV- 527 Monotherapy in Multiple Solid Tumor Types At ESMO Congress 2024 Alligator Bioscience AB and Aptevo Therapeutics announced that positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 will be presented in a poster session on September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress 2024, taking place September 13th - 17th, 2024 in Barcelona, Spain. The ALG.APV- 527 Phase 1 trial is a multi-center, multi-cohort, open-label dose-escalation trial that will include administration of ALG.APV-727 up to six escalating dose levels in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. and will enroll adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG. APV-527 will be given intravenously once every two weeks. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, has been published in the peer-reviewed publication, Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR). Aankondiging • Aug 31
Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering. Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 13,513,513
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 13,513,513
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 27,027,026 Aankondiging • Aug 14
Aptevo Therapeutics Inc. Announces That Phase 1B/2 "Rainier" Frontline Acute Myeloid Leukemia (Aml) Trial Initiated Aptevo Therapeutics Inc. announced initiation of the Company's Phase 1b/2 dose optimization trial, "RAINIER," as part of its ongoing program to evaluate APVO436 in combination with venetoclax + azacitidine for frontline patients with acute myeloid leukemia (AML). RAINIER will be conducted in two parts. First, a Phase 1b frontline AML study followed by a Phase 2 study. The Company also announced that APVO436 has received its generic name, mipletamig (mih-ple'-tah-mig) and will refer to its lead candidate by this name moving forward. This frontline AML study is a multi-center, multi-cohort, open label dose finding study of up to 39 patients across five dose levels ranging from 9 mcg - 140 mcg in combination with venetoclax and azacitidine (ven/aza). Subjects will be adults aged 18 or older, newly diagnosed with AML who are not eligible for intensive induction chemotherapy. Phase 1b consists of 28-day cycles of treatment in five sequential cohorts. Aptevo has partnered with Prometrika (https://www.prometrika.com/), a premier contract research organization, for the RAINIER trial. Primary endpoints: Evaluate the safety, tolerability, and maximum tolerated dose (MTD) of increasing doses of APVO436 in combination with venetoclax and azacitidine in patients with newly diagnosed AML. Determine the recommended Phase 2 dose; Assess incidence of cytokine release syndrome (CRS) at each dose level. Secondary Endpoint: Determine the efficacy of increasing doses of APVO436 in combination with venetoclax and azacitidine in patients with newly diagnosed AML. Prior Outcomes: Compelling Results to Date. Dose Escalation (monotherapy); 2 complete remissions (CRs) reported in AML patients who received the drug as a monotherapy. Most CRS cases were low-grade and clinically manageable. Dose Expansion (combination therapy). 91% clinical benefit rate in combination with standard of care venetoclax + azacitidine in venetoclax naïve patients which exceeds benchmark. 75% of frontline patients experienced a CR. Clinically meaningful duration of remission, with no median reached - multiple patients either stayed on treatment or moved to transplant. Only 27% of patients experienced CRS (cytokine release syndrome), which is favorable compared to competitor drugs. Most CRS cases were low-grade and clinically manageable. Aankondiging • Jun 15
Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $5 million. Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 6,024,096
Price\Range: $0.83
Discount Per Security: $0.0581
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 6,024,096
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 12,048,192 Aankondiging • May 09
Aptevo Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $2 million. Aptevo Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $2 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 78,285
Price\Range: $5.109536
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 730,913
Price\Range: $2.189043
Transaction Features: At the Market Offering Aankondiging • Apr 24
Aptevo Therapeutics Inc., Annual General Meeting, Jun 07, 2024 Aptevo Therapeutics Inc., Annual General Meeting, Jun 07, 2024, at 10:00 Pacific Standard Time. Agenda: To elect two nominees to serve on the Company's Board of Directors to hold office until the 2026 Annual Meeting of Stockholders and until their respective successors are duly elected and qualified; to ratify the selection of Moss Adams LLP as the Company's independent registered public accounting firm for the year ending December 31, 2024 ; to approve the Aptevo Therapeutics Inc. Second Amended and Restated 2018 Stock Incentive Plan; to approve, on a non-binding advisory basis, the compensation paid to the Company's named executive officers in 2023, as disclosed in the proxy statement ; to conduct any other business properly brought before the Annual Meeting. Price Target Changed • Apr 23
Price target increased by 49% to US$671 Up from US$451, the current price target is an average from 2 analysts. New target price is 94,407% above last closing price of US$0.71. Stock is down 99% over the past year. The company is forecast to post a net loss per share of US$20.18 next year compared to a net loss per share of US$67.07 last year. Aankondiging • Apr 16
Aptevo Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $4.589753 million. Aptevo Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $4.589753 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 926,666
Price\Range: $1.35
Discount Per Security: $0.09
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 6,800,000
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 2,473,334
Price\Range: $1.3499
Discount Per Security: $0.0945 Aankondiging • Apr 11
Aptevo Therapeutics Inc. Provides Pipeline Update Aptevo Therapeutics Inc. announced advancements in both clinical programs and one preclinical program. 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 and improved from progressive disease to long-lasting stable disease (SD) while on therapy. The patient has remained on study for more than nine months and been successfully transitioned to a higher dose level, which may allow for increased clinical benefit. The trial is more than 50% enrolled and dosing in cohort five (of six) is imminent. The Company is on track to initiate part 1 of its upcoming two-part Phase 1b/2 trial in 1H 2024. The study will further evaluate APVO436 for the treatment of acute myeloid leukemia (AML). Aptevo has partnered with premier CRO, Prometrika, for the upcoming study. The first part 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 a multiple dose levels. The therapeutic combination of venetoclax + azacitidine + APVO436 was selected based on outcomes from the Company's dose expansion trial that showed promising outcomes across all categories of evaluation including safety, efficacy, and duration of remission. APVO711 is currently progressing through preclinical evaluation intended to target a broad range of solid tumors. The Company continues to move this anticancer checkpoint inhibitor with added dual mechanism of action functionality toward the clinic. Key learnings to date include: APVO711 imparts beneficial attributes to both antigen presenting cells and T cells that boost the immune response targeted at controlling tumor cells, Experiments in cultured cells have confirmed that APVO711 enhances tumor cell killing by T cells, In vivo studies have confirmed that APVO711 reduces the size of PD-L1-expressing tumors. 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 50% enrolled. 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 as the Company moves into 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. 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 91% clinical benefit rate in combination with venetoclax + azacitidine in venetoclax nai¨ve 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 commence the first part of the Phase 1b/2 dose optimization program in the first half of 2024. APVO711, a bispecific checkpoint inhibitor with added functionality, targets PD-L1 and CD40, and is designed to function to synergistically induce a biological response. This is achieved by simultaneously engaging in two clinically validated T cell activating mechanisms: 1) blocking of PD-L1/PD-1 inhibitory pathway and 2) CD40 signaling augments APC maturation resulting in enhanced T cell stimulation. APVO711 is designed to activate CD40 only in the presence of PD-L1 binding for an improved safety profile. The Company believes APVO711 has the potential to positively impact the treatment paradigm of multiple solid tumor types for which there is currently significant unmet medical need. New Risk • Apr 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 18% 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 (18% average weekly change). Shareholders have been substantially diluted in the past year (224% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.74m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Aankondiging • Mar 21
Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering. Aptevo Therapeutics Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 922,509
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 1,845,018
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 922,509 Aankondiging • Mar 07
Alligator Bioscience and Aptevo Therapeutics Announce Positive Interim Data of Dose Escalation Phase of ALG.APV-527 Phase 1 Study in Solid Tumor Cancers Expressing Tumor Antigen 5T4 Alligator Bioscience AB and Aptevo Therapeutics announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The multi-center, dose escalation trial is now more than 50% enrolled, and preliminary results include: Treatment was overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing, ALG.APV-527 could be measured 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. Of particular interest, signs of clinical activity were observed for both enrolled patients with heavily pre-treated breast cancer. These patients demonstrated measurable level of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active. One patient remained on study for seven months and a second remains on study beyond nine months. Both patients achieved best overall response of stable disease. The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts (dose levels) in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. 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. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Aankondiging • Mar 05
Aptevo Therapeutics Announces 1-For 44 Reverse Stock Split as Part of Nasdaq Compliance Plan Aptevo Therapeutics Inc. ("Aptevo" or the "Company") announced that it will conduct a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-44 (the "Reverse Stock Split"). The Reverse Stock Split is expected to become effective on March 5, 2024 at 5:01 p.m. Eastern Time (the "Effective Time"), with shares expected to begin trading on the Nasdaq Capital Market, on a split-adjusted, at market open on March 6, 2024. In connection with the Reverse Stock Split, every 44 shares of the Company's common stock issued and outstanding as of the Effective Time will be automatically converted into one share of the Company's common stock. No change will be made to the trading symbol for the Company's shares of common stock or public warrants, "APVO" and "APVTW", respectively, in connection with the reverse split. The Reverse Stock Split is part of the Company's plan to regain compliance with the minimum bid price requirement of $1.00 per share required to maintain continued listing on The Nasdaq Capital Market, among other benefits. New Risk • Nov 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 21% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 21% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (126% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.06m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$38m net loss in 3 years). Aankondiging • Sep 16
Aptevo Therapeutics Receives Non-Compliance Letter from the Staff of the Nasdaq Stock Market On September 13, 2023, Aptevo Therapeutics Inc. (the “Company”) received a letter from the staff of The Nasdaq Stock Market notifying the Company that, for the last 30 consecutive business days, the bid price of the Company’s common stock had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until March 11, 2024 (the “Compliance Date”), to regain compliance with the Bid Price Requirement. To regain compliance with the Bid Price Requirement, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of ten consecutive business days before the Compliance Date. If the Company does not regain compliance with the Bid Price Requirement by the Compliance Date, the Company may be eligible for an additional 180-day period to regain compliance if the Company meets the continued listing requirement for market value of publicly held shares and all other initial listing standards of The Nasdaq Capital Market, with the exception of the bid price requirement, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company does not regain compliance with the Bid Price Requirement by the Compliance Date and is not eligible for an additional compliance period at that time, the Staff will provide written notification to the Company that its common stock will be delisted. At that time, the Company may appeal the Staff’s delisting determination to the Nasdaq Listing Qualifications Panel (the “Panel”). However, there would be no assurance that, if the Company receives a delisting notice and appeals the delisting determination by the Staff to the Panel, such appeal would be successful. The Company intends to actively monitor the closing bid price of its common stock and will evaluate available options to resolve the deficiency and regain compliance with the Bid Price Requirement. New Risk • Aug 11
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$19m Forecast net loss in 3 years: US$14m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. 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 (92% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.56m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Price Target Changed • Aug 10
Price target decreased by 33% to US$12.00 Down from US$18.00, the current price target is provided by 1 analyst. New target price is 2,557% above last closing price of US$0.45. Stock is down 90% over the past year. The company is forecast to post a net loss per share of US$2.24 compared to earnings per share of US$1.38 last year. Aankondiging • Jul 21
Aptevo Therapeutics Inc. Announces Positive Duration of Remission Data from Phase 1B Expansion Trial Evaluating the Bispecific APVO436 for AML Aptevo Therapeutics Inc. announced that its bispecific AML drug candidate APVO436, in combination with emerging standard of care venetoclax and azacitidine, achieved positive duration of remission results in its Phase 1b dose escalation trial. The Company is also providing an update of its APVO436 Phase 2 program design that will include both frontline and relapsed/refractory trials beginning later in the second half of 2023. Duration of Remission (DOR) Positive and clinically meaningful DOR results was observed from the company's bispecific AML drug candidate APVO436 in combination with the emerging standard of care (venetoclax + azacitidine) in venetoclax treatment naïve patients, as follows: High response rate observed - 82% (9/11) of patients had a favorable response and were eligible for inclusion in the DOR analysis; Multiple patients moved to transplant - 3/11 patients responded sufficiently to move to stem cell transplant - receiving stem cell transplant is the treatment option with the best probability for survival and highest benefit to patients; Sustained complete response -Of the patients with responses, one patient remained on study with sustained complete response for 8 cycles (the maximum allowed per protocol) which translated into at least 8 months of response duration; Median DOR not reached - The median DOR was not reached, which is clinically meaningful because a substantial number of patients either stayed on treatment or moved to transplant and did not experience a relapse event. This DOR data adds to a growing body of clinical evidence (safety, tolerability, efficacy and now durability), that provides strong support for the further development of APVO436 in combination therapy for patients with AML. Phase 2 Program Update: The Company's APVO436 Phase 2 program will further evaluate the triplet combination of APVO436 + venetoclax + azacitidine among frontline and relapsed/refractory AML patients who are venetoclax treatment naïve. The Company intends to conduct two trials. The first, among relapsed/refractory patients, will initiate in second half 2023. The second, among frontline patients, will initiate in first half 2024. Aptevo anticipates that approximately 100 patients will participate between the two trials and that interim results will be available in late second half 2024. APVO436 Dose Escalation Trial Results: Safety and Efficacy Data (previously reported): Efficacy: APVO436 demonstrated a 91% clinical benefit* in combination with venetoclax + azacitidine in venetoclax treatment naïve patients, more than doubling the response rate in a composite benchmark across all benefit categories; Safety: APVO436, when given in combination with this regimen, has been shown to be generally safe and well tolerated. Cytokine Release Syndrome(CRS), a common side effect in other trials,was observed in fewer than one quarter of patients within the patient population and in most cases was mild or moderate (grade 1 or 2) and was manageable in the clinic. New Risk • Jul 08
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 51% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (51% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Large one-off items impacting financial results. Market cap is less than US$100m (US$11.5m market cap). New Risk • Jun 25
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.91m 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 Revenue is less than US$1m. Market cap is less than US$10m (US$9.91m market cap). Minor Risks Large one-off items impacting financial results. Shareholders have been diluted in the past year (46% increase in shares outstanding). Reported Earnings • Mar 31
Full year 2022 earnings: EPS exceeds analyst expectations Full year 2022 results: EPS: US$1.38 (up from US$6.27 loss in FY 2021). Net income: US$7.01m (up US$36.4m from FY 2021). Over the last 3 years on average, earnings per share has increased by 70% per year but the company’s share price has fallen by 13% per year, which means it is significantly lagging earnings. Aankondiging • Feb 15
Alligator Bioscience & Aptevo Therapeutics Announce Dosing of First Patient with ALG.APV-527 in Phase 1 Clinical Trial Alligator Bioscience AB and Aptevo Therapeutics announced the dosing of the first patient in the companies’ Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors expressing the tumor-associated antigen 5T4. ALG.APV-527 is a bispecific antibody with a tumor-directed 4-1BB agonistic effect and the ability to specifically stimulate antitumor-specific T cells and NK cells involved in tumor control. The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen, including (but not limited to) non-small cell lung cancer (NSCLC), gastric/gastro-esophageal cancer and head and neck cancer. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetic, pharmacodynamic and preliminary anti-tumor activity of ALG.APV-527. ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB has the ability to 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. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, were recently published in the peer-reviewed publication, Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR). The full article is available via this link: ALG.APV-527 MCT 2022 manuscript. Aankondiging • Jan 10
Aptevo Therapeutics Inc. Files Provisional Patent for Fifth Bispecific Antibody APVO711, Intended for the Treatment of Solid Tumors Aptevo Therapeutics Inc. announced that the Company has filed a provisional patent with the U.S. Patent and Trademark Office pertaining to an anti-PD-L1 x anti-CD40 compound, APVO711, with the potential to fight a range of solid malignancies such as head and neck squamous cell carcinoma, melanoma, and carcinomas of the lung, gastrointestinal tract and colon. The Company plans to initiate pre-clinical studies this year. Valuation Update With 7 Day Price Move • Dec 12
Investor sentiment improved over the past week After last week's 24% share price gain to US$3.91, the stock trades at a trailing P/E ratio of 3.6x. Average forward P/E is 9x in the Biotechs industry in the US. Total loss to shareholders of 50% over the past three years. Major Estimate Revision • Nov 17
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 EPS estimate increased from US$0.66 to US$0.93. Revenue forecast unchanged at US$3.11m. Net income forecast to shrink 570% next year vs 94% decline forecast for Biotechs industry in the US. Consensus price target of US$18.00 unchanged from last update. Share price rose 12% to US$3.11 over the past week. Price Target Changed • Nov 16
Price target decreased to US$18.00 Down from US$28.00, the current price target is an average from 2 analysts. New target price is 437% above last closing price of US$3.35. Stock is down 65% over the past year. The company is forecast to post earnings per share of US$0.93 next year compared to a net loss per share of US$6.27 last year. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. Independent Director Dan Abdun-Nabi was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 11
Third quarter 2022 earnings released: US$1.53 loss per share (vs US$1.45 loss in 3Q 2021) Third quarter 2022 results: US$1.53 loss per share (further deteriorated from US$1.45 loss in 3Q 2021). Net loss: US$7.81m (loss widened 10% from 3Q 2021). Revenue is expected to decline by 131% p.a. on average during the next 2 years, while revenues in the Biotechs industry in the US are expected to grow by 14%. Over the last 3 years on average, earnings per share has increased by 63% per year but the company’s share price has fallen by 31% per year, which means it is significantly lagging earnings. Valuation Update With 7 Day Price Move • Aug 19
Investor sentiment deteriorated over the past week After last week's 22% share price decline to US$3.43, the stock trades at a trailing P/E ratio of 2.8x. Average forward P/E is 9x in the Biotechs industry in the US. Total loss to shareholders of 67% over the past three years. Major Estimate Revision • Aug 18
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$13.9m to US$3.11m. Expected to report profit of -US$5.03, versus loss of US$0.66 per share previously. Biotechs industry in the US expected to see average net income decline 57% next year. Consensus price target down from US$28.00 to US$18.00. Share price fell 11% to US$3.93 over the past week. Reported Earnings • Aug 12
Second quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2022 results: EPS: US$5.55 (up from US$1.78 loss in 2Q 2021). Revenue: US$0 (down 100% from 2Q 2021). Net income: US$27.9m (up US$35.9m from 2Q 2021). Profit margin: (up from net loss in 2Q 2021). Revenue missed analyst estimates by 100%. Earnings per share (EPS) exceeded analyst estimates. Over the next year, revenue is forecast to grow 50%, compared to a 51% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has increased by 57% per year but the company’s share price has fallen by 26% per year, which means it is significantly lagging earnings. Major Estimate Revision • May 19
Consensus revenue estimates fall by 15% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$16.3m to US$13.9m. Forecast losses increased from -US$3.93 to -US$5.03 per share. Biotechs industry in the US expected to see average net income decline 52% next year. Consensus price target of US$28.00 unchanged from last update. Share price rose 14% to US$4.83 over the past week. Price Target Changed • Apr 27
Price target decreased to US$52.50 Down from US$65.67, the current price target is an average from 2 analysts. New target price is 1,203% above last closing price of US$4.03. Stock is down 86% over the past year. The company is forecast to post a net loss per share of US$3.93 next year compared to a net loss per share of US$6.27 last year. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. Independent Director Dan Abdun-Nabi was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 13
Third quarter 2021 earnings released: US$1.45 loss per share (vs US$2.15 loss in 3Q 2020) The company reported a solid third quarter result with improved revenues and control over costs, although losses increased. Third quarter 2021 results: Revenue: US$3.10m (up 112% from 3Q 2020). Net loss: US$7.08m (loss widened 1.9% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 57% per year but the company’s share price has fallen by 34% per year, which means it is significantly lagging earnings. Price Target Changed • Oct 16
Price target decreased to US$59.50 Down from US$65.67, the current price target is an average from 2 analysts. New target price is 297% above last closing price of US$14.99. Board Change • Oct 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. No highly experienced directors. Independent Director Dan Abdun-Nabi was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.