Latest news with #Aptevo
Associated Press
22-05-2025
- Business
- Associated Press
Aptevo Therapeutics Announces 1-for-20 Reverse Stock Split as part of Nasdaq Compliance Plan
SEATTLE, WA / ACCESS Newswire / May 22, 2025 / Aptevo Therapeutics Inc. (NASDAQ:APVO) ('Aptevo' or the 'Company'), today announced that it will conduct a reverse stock split of its outstanding shares of common stock, par value $0.001 per share ('Common Stock'), at a ratio of 1-for-20 (the 'Reverse Stock Split'). The Reverse Stock Split is expected to become effective on May 23, 2025, 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 basis, at market open on May 27, 2025. In connection with the Reverse Stock Split, every 20 shares of Common Stock issued and outstanding as of the Effective Time will be automatically converted into one share of Common Stock. No change will be made to the trading symbol for the Common Stock, 'APVO,' in connection with the Reverse Stock Split. The Reverse Stock Split is part of the Company's plan to maintain compliance with the continued listing standards of 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 May 14, 2025 (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 May 21, 2025. The Reverse Stock Split will reduce the number of shares of outstanding Common Stock from approximately 13.5 million shares (as of the date of this press release) to approximately 0.7 million shares, subject to adjustment for rounding, as discussed below and potential additional issuances through the effective date of the Reverse Stock Split. The Reverse Stock Split will affect all issued and outstanding shares of Common Stock. All outstanding options, restricted stock units, warrants, and other securities entitling their holders to purchase or otherwise receive shares of Common Stock will be adjusted as a result of the reverse split, as required by the terms of each security. The number of shares available to be awarded under the Company's equity incentive plans will also be appropriately adjusted. Following the reverse split, the par value of the Common Stock will remain unchanged at $0.001 par value per share. The Reverse Stock Split will not change the authorized number of shares of Common Stock or preferred stock. No fractional shares will be issued in connection with the Reverse Stock Split, and stockholders who would otherwise be entitled to receive a fractional share of Common Stock will be entitled to receive a cash payment (without interest). Additional information regarding the Reverse Stock Split is available in the Company's definitive proxy statement filed with the U.S. Securities and Exchange Commission ('SEC') on April 25, 2025, and a Current Report on Form 8-K which the Company plans to file following the Effective Time. About Aptevo Therapeutics Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for the treatment of cancer. The company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ('orphan status') for AML according to the Orphan Drug Act. a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR® and ADAPTIR-FLEX® The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit Forward-Looking Statements This press release includes 'forward-looking statements', including information about management's view of the Company's future expectations, plans and prospects, within the safe harbor provisions provided under federal securities laws, including under The Private Securities Litigation Reform Act of 1995. Words such as 'expect,' 'estimate,' 'project,' 'budget,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'may,' 'will,' 'could,' 'should,' 'believes,' 'predicts,' 'potential,' 'continue' and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results and, consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements and factors that may cause such differences include, without limitation, our ability to continue as a going concern; a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems and adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. These risks are not exhaustive, the Company faces known and unknown risks. Additional risks and factors that may affect results of the Company are set forth in the Company's filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from the Company's expectations in any forward-looking statement. Readers are cautioned not to place undue reliance upon any forward-looking statements, including but not limited to statements about the effectuation of the Reverse Stock Split. These reports and filings are available at and are available for download, free of charge, soon after such reports are filed with or furnished to the SEC, on the 'Investors' page of the Company's website at Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, the Company does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. Contact: Miriam Weber Miller Head, Investor Relations & Corporate Communications Aptevo Therapeutics Email: [email protected] or [email protected] Phone: 206-859-6628 SOURCE: Aptevo Therapeutics press release
Yahoo
15-05-2025
- Business
- Yahoo
Aptevo Therapeutics Reports 1Q25 Financial Results And Provides an Update on Mipletamig
9 of 10 frontline AML patients achieve remission with mipletamig + standard of care across two trials Mipletamig triplet combination continues to outperform standard doublet benchmark No cytokine release syndrome observed in the ongoing RAINIER trial: favorable safety profile supports role in frontline AML Cohort 2 enrollment is complete, and Cohort 3 is now enrolling SEATTLE, WA / / May 15, 2025 / 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, 2025, and provided an update on the ongoing mipletamig clinical trial. Business Update"The latest outcomes from the RAINIER trial-remissions that were achieved rapidly and with no reported cytokine release syndrome-underscore the strength of our approach and the potential of mipletamig to redefine frontline AML treatment. With each milestone, we are not only validating the safety and efficacy of our drug, but moving closer to changing the standard of care for patients who have long had limited options. We remain focused on advancing the trial and look forward to sharing further clinical updates in the months ahead. This is more than progress-it's momentum toward a new era in frontline AML care," said Marvin White, President and CEO of Aptevo. Mipletamig Data HighlightsEnrollment continues in the RAINIER dose optimization trial. This is a Phase 1b/2 study evaluating mipletamig in combination with venetoclax and azacitidine, the standard of care for frontline acute myeloid leukemia (AML) patients who are unfit to receive intensive high dose chemotherapy. Cohort 2 enrollment is now complete, and Cohort 3 is now open and enrolling. Mipletamig has been evaluated in almost 100 patients across three clinical studies, thus far, in both combination and monotherapy settings. Outcomes have consistently demonstrated a growing body of evidence that supports its potential role in the treatment of frontline AML. Data Highlights include: Efficacy Results Reported on March 20, 2025 Data from Six frontline AML patients has been reported in the ongoing RAINIER Phase 1b/2 trial evaluating mipletamig in combination with venetoclax and azacitidine. Of these, five of six (5/6) patients have achieved remission within 30 days of being dosed One patient progressed after the first cycle and passed away due to reasons unrelated to the study drug These results build on data from a prior expansion study, in which four additional frontline patients treated with the same triplet combination also achieved remission* In total, 9 of 10 (90%) frontline patients across two trials have achieved remission with mipletamig in combination with standard of care therapy SafetyMipletamig continues to demonstrate a highly favorable safety profile, particularly with respect to cytokine release syndrome (CRS)-a common and often dose-limiting side effect seen in other T-cell engagers and bispecific antibodies. No CRS has been observed in the ongoing RAINIER trial to date This favorable profile is consistent with earlier trials, where CRS was generally minimal and manageable The company attributes this safety profile, a key differentiator, to the engineered CD3 binding domain (CRIS-7) and its ADAPTIR® format, which are designed to reduce cytokine release without compromising T-cell activation or anti-leukemic activity Additional Data RAINIER Cohort 1 data (included in the total patient outcomes above) in which 100% of patients achieved remission within the first 30 days One patient experienced complete remission with minimal residual disease (MRD)-negative status (100% elimination of cancer cells) MRD-negative status is a critical outcome indicating that even the most sensitive diagnostic methods detect no remaining cancer cells. This result is strongly associated with longer-lasting remissions and improved survival rates Phase 1b dose expansion combination therapy (included in the total patient outcomes above) trial in which 100% of frontline patients achieved remission Phase 1a dose escalation monotherapy trial in which 36% of evaluable patients who failed prior regimens experienced substantial leukemic blast reduction to a clinically meaningful degree compared to baseline (range of 17% to 88% reduction), providing evidence of the pharmacodynamic effect of the drug - and efficacy contribution to the triplet combination *Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered CRi. The Company anticipates providing multiple data readouts in 2025 and to present results at the American Society of Hematology meeting in the fourth quarter. About MipletamigMipletamig, a differentiated by design CD123xCD3 bispecific antibody built on Aptevo's ADAPTIR platform and driven by a unique CRIS-7-derived CD3 binding domain, is being investigated as frontline therapy in combination with venetoclax and azacitidine, the current standard of care for AML patients who are unfit for intensive chemotherapy. 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 almost 100 patients. 2025 Summary Financial Results Cash Position: Aptevo had cash and cash equivalents as of March 31, 2025, totaling $2.1 million. This excludes approximately $4.9 million raised by the Company in April and May 2025 through direct offerings and use of the Company's ATM facility. Research and Development Expenses: Research and development expenses decreased by $0.2 million, from $3.8 million for the three months ended March 31, 2024, to $3.6 million for the three months ended March 31, 2025. The decrease was primarily due to lower preclinical and spending due to escalation phase ramping down and was offset by higher mipletamig trial costs from clinical trial patient enrollment. General and Administrative Expenses: General and administrative expenses decreased by $0.6 million, from $3.2 million for the three months ended March 31, 2024, to $2.6 million for the three months ended March 31, 2025. The decrease is primarily due to lower stock-based compensation costs. Other Income, Net: Other income, net consists primarily of interest income from our cash equivalents and short-term rental income. Other income, net was $0.1 million for the three months ended March 31, 2025, and 2024. Net Income (Loss): Aptevo had a net loss of $6.3 million or $4.35 per share for the three months ended March 31, 2025, compared to a net loss of $6.8 million or $368.21 per share for the corresponding period in 2024. Aptevo Therapeutics BALANCE SHEETS(in thousands, except share and per share amounts) March 31, 2025 December 31, 2024 ASSETS Current assets: Cash and cash equivalents $ 2,139 $ 8,714 Prepaid expenses 1,348 1,689 Other current assets 120 256 Total current assets 3,607 10,659 Property and equipment, net 482 543 Operating lease right-of-use asset 4,253 4,389 Total assets $ 8,342 $ 15,591 LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY Current liabilities: Accounts payable and other accrued liabilities $ 3,789 $ 3,053 Accrued compensation 472 1,856 Other current liabilities 1,132 1,298 Total current liabilities 5,393 6,207 Operating lease liability 4,422 4,629 Total liabilities 9,815 10,836 Stockholders' (deficit) equity: Preferred stock: $0.001 par value; 15,000,000 shares authorized, zero sharesissued or outstanding - - Common stock: $0.001 par value; 500,000,000 shares authorized; 1,458,504and 1,458,443 shares issued and outstanding at March 31, 2025, andDecember 31, 2024, respectively 84 84 Additional paid-in capital 252,428 252,248 Accumulated deficit (253,985 ) (247,577 ) Total stockholders' (deficit) equity (1,473 ) 4,755 Total liabilities and stockholders' (deficit) equity $ 8,342 $ 15,591 Aptevo Therapeutics STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) For the Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $ (3,633 ) $ (3,752 ) General and administrative (2,847 ) (3,231 ) Loss from operations (6,480 ) (6,983 ) Other income: Other income from continuing operations, net 72 149 Net loss $ (6,408 ) $ (6,834 ) Basic and diluted net loss per share: $ (4.39 ) $ (368.21 ) Shares used in calculation: 1,458,458 18,560 About Aptevo TherapeuticsAptevo Therapeutics Inc. (Nasdaq:APVO) is a clinical-stage biotechnology Company focused on developing novel bispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIRand ADAPTIR-FLEX. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine and the war between Israel and Hamas, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT:Miriam Weber MillerHead, Investor Relations & Corporate CommunicationsAptevo TherapeuticsEmail: IR@ or Millerm@ 206-859-6628 SOURCE: Aptevo Therapeutics View the original press release on ACCESS Newswire
Associated Press
15-05-2025
- Business
- Associated Press
Aptevo Therapeutics Reports 1Q25 Financial Results And Provides an Update on Mipletamig
9 of 10 frontline AML patients achieve remission with mipletamig + standard of care across two trials Mipletamig triplet combination continues to outperform standard doublet benchmark No cytokine release syndrome observed in the ongoing RAINIER trial: favorable safety profile supports role in frontline AML Cohort 2 enrollment is complete, and Cohort 3 is now enrolling 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, 2025, and provided an update on the ongoing mipletamig clinical trial. Business Update 'The latest outcomes from the RAINIER trial-remissions that were achieved rapidly and with no reported cytokine release syndrome-underscore the strength of our approach and the potential of mipletamig to redefine frontline AML treatment. With each milestone, we are not only validating the safety and efficacy of our drug, but moving closer to changing the standard of care for patients who have long had limited options. We remain focused on advancing the trial and look forward to sharing further clinical updates in the months ahead. This is more than progress-it's momentum toward a new era in frontline AML care,' said Marvin White, President and CEO of Aptevo. Mipletamig Data Highlights Enrollment continues in the RAINIER dose optimization trial. This is a Phase 1b/2 study evaluating mipletamig in combination with venetoclax and azacitidine, the standard of care for frontline acute myeloid leukemia (AML) patients who are unfit to receive intensive high dose chemotherapy. Cohort 2 enrollment is now complete, and Cohort 3 is now open and enrolling. Mipletamig has been evaluated in almost 100 patients across three clinical studies, thus far, in both combination and monotherapy settings. Outcomes have consistently demonstrated a growing body of evidence that supports its potential role in the treatment of frontline AML. Data Highlights include: Efficacy Results Reported on March 20, 2025 Safety Mipletamig continues to demonstrate a highly favorable safety profile, particularly with respect to cytokine release syndrome (CRS)-a common and often dose-limiting side effect seen in other T-cell engagers and bispecific antibodies. Additional Data *Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered CRi. The Company anticipates providing multiple data readouts in 2025 and to present results at the American Society of Hematology meeting in the fourth quarter. About Mipletamig Mipletamig, a differentiated by design CD123xCD3 bispecific antibody built on Aptevo's ADAPTIR platform and driven by a unique CRIS-7-derived CD3 binding domain, is being investigated as frontline therapy in combination with venetoclax and azacitidine, the current standard of care for AML patients who are unfit for intensive chemotherapy. 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 almost 100 patients. 2025 Summary Financial Results Cash Position: Aptevo had cash and cash equivalents as of March 31, 2025, totaling $2.1 million. This excludes approximately $4.9 million raised by the Company in April and May 2025 through direct offerings and use of the Company's ATM facility. Research and Development Expenses: Research and development expenses decreased by $0.2 million, from $3.8 million for the three months ended March 31, 2024, to $3.6 million for the three months ended March 31, 2025. The decrease was primarily due to lower preclinical and spending due to escalation phase ramping down and was offset by higher mipletamig trial costs from clinical trial patient enrollment. General and Administrative Expenses: General and administrative expenses decreased by $0.6 million, from $3.2 million for the three months ended March 31, 2024, to $2.6 million for the three months ended March 31, 2025. The decrease is primarily due to lower stock-based compensation costs. Other Income, Net: Other income, net consists primarily of interest income from our cash equivalents and short-term rental income. Other income, net was $0.1 million for the three months ended March 31, 2025, and 2024. Net Income (Loss): Aptevo had a net loss of $6.3 million or $4.35 per share for the three months ended March 31, 2025, compared to a net loss of $6.8 million or $368.21 per share for the corresponding period in 2024. Aptevo Therapeutics Inc. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts) Aptevo Therapeutics Inc. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) About Aptevo Therapeutics Aptevo Therapeutics Inc. (Nasdaq: APVO) is a clinical-stage biotechnology Company focused on developing novel bispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ('orphan status') for AML according to the Orphan Drug Act. a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIRand ADAPTIR-FLEX. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words 'may,' 'continue to,' 'believes,' 'knows,' 'expects,' 'optimism,' 'potential,' 'designed,' 'promising,' 'plans,' 'will' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine and the war between Israel and Hamas, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT: Miriam Weber Miller Head, Investor Relations & Corporate Communications Aptevo Therapeutics Email: [email protected] or [email protected] Phone: 206-859-6628 SOURCE: Aptevo Therapeutics press release
Associated Press
21-04-2025
- Business
- Associated Press
Aptevo Therapeutics $2.0 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules
SEATTLE, WASHINGTON / ACCESS Newswire / April 21, 2025 / Aptevo Therapeutics Inc. (Nasdaq:APVO) ('Aptevo' or the 'Company'), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, announced today that it has entered into definitive securities purchase agreements for the purchase and sale of 2,324,000 shares of the Company's common stock in a registered direct offering (the 'offering') at a purchase price of $0.862 per share. The offering is expected to close on or about April 22, 2025 subject to the satisfaction of customary closing conditions. Roth Capital Partners is acting as the exclusive placement agent for the offering. Aptevo expects the gross proceeds from the offering to be approximately $2.0 million, before deducting the placement agent's fees and other estimated offering expenses payable by the Company. Aptevo intends to use the net proceeds from the proposed offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes. A shelf registration statement on Form S-3 (File No. 333-284969) relating to the shares of common stock to be issued in the registered direct offering was previously filed with the Securities and Exchange Commission (the 'SEC') and is currently effective. The registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the registered direct offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by email at [email protected]. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the shares of common stock, nor will there be any sale of the shares of common stock in any state or other jurisdiction in which such offer, solicitation or sale is not permitted. About Aptevo Therapeutics Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for the treatment of cancer. The company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ('orphan status') for AML according to the Orphan Drug Act. a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR® and ADAPTIR-FLEX® The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, statements regarding the completion, timing, size and use of proceeds of the offering, the satisfaction of customary closing conditions related to the offering and any other statements containing the words 'may,' 'continue to,' 'believes,' 'expects,' 'optimism,' 'potential,' 'designed,' 'promising,' 'plans,' 'will' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; uncertainties related to market conditions, the satisfaction of customary closing conditions related to the offering, compliance with Nasdaq listing requirements, and changes in regulatory, social, macroeconomic, and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of APVO436, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine, war between Israel and Hamas, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, increased market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT: Miriam Weber Miller Aptevo Therapeutics Email: [email protected] or [email protected] Phone: 206-859-6628 SOURCE: Aptevo Therapeutics press release
Associated Press
20-03-2025
- Business
- Associated Press
RAINIER Trial Data Update: Two Additional AML Patients Achieve Remission Within 30 Days of Treatment
Across two trials, 9 of 10 frontline AML patients achieved remission when treated with mipletamig in combination with the standard of care Triplet Combination with mipletamig continues to outperform doublet combination benchmark No Cytokine Release Syndrome (CRS) has been observed in the RAINIER trial to date Cohort 2 enrollment nears completion SEATTLE, WA / ACCESS Newswire / March 20, 2025 / Aptevo Therapeutics ('Aptevo') (NASDAQ:APVO), a clinical-stage biotechnology company developing novel bispecific immuno-oncology therapeutics based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies, today announced two additional frontline AML patients have achieved remission* within 30 days of treatment in the Company's RAINIER dose optimization trial evaluating mipletamig in combination with standard of care for patients unfit for intensive chemotherapy. In total, 9 of 10 frontline patients across two trials achieved remission* when receiving the triplet combination of mipletamig + venetoclax + azacitidine (ven/aza). Notably, no CRS has been reported in the RAINIER trial to date. The data builds on previously reported favorable outcomes from RAINIER's Cohort 1 and the completed dose expansion trial where 100% of frontline patients achieved remission. Together with the addition of these interim Cohort 2 results, mipletamig has achieved a compelling overall remission rate of 90% among frontline patients. This outperforms the doublet remission* rate from a venetoclax + azacitidine only study, of 66%. Additionally, the frontline patient triplet therapy CR rate of 70% outperforms the CR rate from a venetoclax + azacitidine only study of 36% (Viale-A Pivotal trial).Thus far, all RAINIER patients who achieved remission remain in remission. Cohort 2 will include six patients, dosed at the 18mcg level, the same dose used in combination with ven/aza in the completed expansion trial. Three patients evaluable for efficacy achieved the following outcomes: 'We're now past the halfway mark in Cohort 2 of the RAINIER trial and are thrilled by the continued, highly favorable remission results,' said Dirk Huebner, MD, Chief Medical Officer of Aptevo. " This emerging pattern further supports mipletamig's impact on treatment outcomes in frontline AML patients who are not fit for intensive chemotherapy and who would otherwise receive ven/aza as the standard of care. One of our primary goals with the RAINIER trial is to demonstrate the contribution of mipletamig's unique mechanism of action when used in combination with venetoclax and azacitidine. By targeting AML this way, our approach has the potential to improve outcomes, particularly for elderly patients who have limited treatment options.' Mipletamig, a differentiated by design CD3 x CD123 bispecific antibody built on Aptevo's ADAPTIR platform and driven by a unique CRIS-7 derived binding domain, is being investigated as frontline therapy in combination with venetoclax and azacitidine, the current standard of care for AML patients who are unfit for intensive chemotherapy. 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 almost 100 patients. *Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered (CRi). About RAINIER RAINIER, a frontline AML study, is a Phase 1b/2 dose optimization, multi-center, multi-cohort, open label study of up to 39 patients who are being treated 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 ( a premier contract research organization for the trial. RAINIER will be conducted in two parts. First, a Phase 1b dose optimization study in frontline AML patients followed by a Phase 2 study. Cohort 1 included 3 patients, dosed at the 9mcg level. All patients achieved remission* within 30 days Thus far, all patients who achieved remission remain in remission. One CR patient had no minimal residual disease (MRD-negative status) and was positive for the TP53 genetic mutation, which is generally associated with poor prognosis due to chemotherapy resistance, genetic instability, and overall treatment challenges About Mipletamig Aptevo's wholly owned lead proprietary drug candidate, mipletamig, targeting AML, MDS and other leukemias, 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 a unique CD3 derived from CRIS-7 vs. the CD3 used by other competitors. Mipletamig has received orphan drug designation ('orphan status') for AML according to the Orphan Drug Act. Mipletamig has been evaluated in almost 100 patients over three trials to date. RAINIER, Aptevo's Phase 1b/2 frontline AML program, was initiated in 3Q24. About Aptevo Therapeutics Aptevo Therapeutics Inc. (NASDAQ:APVO) is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for the treatment of cancer. The company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard of care venetoclax + azacitidine. Mipletamig has orphan status for AML according to the Orphan Drug Act. a bispecific conditional 4-1BB agonist that is only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. Aptevo has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR® and ADAPTIR-FLEX®. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final remission data or trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of across multiple tumor types will continue to show clinical benefit, the possibility and timing of future preliminary or interim data readouts for statements related to the progress of and enthusiasm for Aptevo's clinical programs, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words 'may,' 'continue to,' 'believes,' 'knows,' 'expects,' 'optimism,' 'potential,' 'designed,' 'promising,' 'plans,' 'will' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine, war between Israel and Hamas, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. +1 (206) 859 6629
