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LeonaBio Reports Second Quarter 2026 Financial Results and Provides Business Update

On August 14, 2026 LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, reported financial results for the quarter ended June 30, 2026, and provided recent pipeline and business updates.

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"We enter the second half of 2026 with a clear focus on executing our Phase 3 ELAINE-3 trial and advancing lasofoxifene toward what we believe could be a transformative treatment option for patients with ESR1-mutated metastatic breast cancer," said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. "We have enrolled 495 patients and remain on track to complete enrollment of ELAINE-3 in the fourth quarter of 2026 with topline data expected in the second half of 2027. As the treatment landscape for metastatic breast cancer continues to evolve, we believe the differentiated profile of lasofoxifene positions it to address a significant unmet need as a potential endocrine therapy partner and create opportunities beyond ELAINE-3, including additional combination strategies and future label expansions. The body of clinical and scientific evidence behind lasofoxifene supports our confidence in its potential to greatly benefit patients battling this difficult-to-treat form of breast cancer."

"As we approach the completion of enrollment in this Phase 3 registrational trial, we are investing today in critical CMC, regulatory, and commercial readiness activities to ensure we are well-positioned to bring this therapy to patients as quickly as possible, if approved. With our talented team and the potential to add up to an additional $146 million upon exercise of cash-exercisable warrants issued in our December 2025 financing, we believe LeonaBio is well-positioned to deliver on multiple value-creating milestones in the years ahead," added Dr. Litton.

Clinical Development & Pipeline Programs

Lasofoxifene – A third generation novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to confer potent activity against both wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer.

In December 2025, LeonaBio acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. for rights to develop and commercialize lasofoxifene.

Lasofoxifene is being advanced in ELAINE-3, a Phase 3 clinical trial (NCT05696626), in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, following progression on aromatase inhibitors and CDK4/6 inhibitors. The primary endpoint of the study is a statistically significant improvement in progression free survival (PFS), as determined by blinded, independent central review (BICR). ELAINE-3 aims to establish a new standard of care for this genetically defined patient group with limited treatment options.
The Company expects to complete enrollment of ~600 participants in the Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027.
Lasofoxifene was previously evaluated in two Phase 2 studies in patients with ER+, HER2-negative locally advanced or metastatic breast cancer expressing an ESR1 mutation, ELAINE-1 and ELAINE-2.
ELAINE-1, an open-label, randomized trial comparing lasofoxifene to fulvestrant, showed improved outcomes for lasofoxifene as a potential monotherapy. Although the trial was not powered, results included longer median progression-free survival (5.6 vs. 3.7 months), higher objective response rates (13.3% vs. 2.9%) and a durable complete response lasting more than 2.5 years. The treatment was well-tolerated with patients reporting quality-of-life benefits.
ELAINE-2, an open-label study evaluating lasofoxifene in combination with abemaciclib, demonstrated clinical benefits in heavily pretreated patients, with a median progression-free survival of approximately 13 months, an objective response rate of 56% and a clinical benefit rate of 65.5%. The combination was generally well-tolerated with most adverse events being low grade.
In April 2026, LeonaBio hosted a virtual Key Opinion Leader event with two leading physicians in the breast cancer field to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to transform the standard of care for patients with treatment-resistant ER+, HER2-negative, ESR1-mutated metastatic breast cancer.
The event titled, "Modulation and Combination: the Potential for Lasofoxifene to Transform the Standard-of-Care in Metastatic Breast Cancer," featured a discussion with David Portman, M.D., Chief Executive Officer of Sermonix Pharmaceuticals and an oncology consultant to LeonaBio, along with two physician experts in the breast cancer field. A replay of the event is available on the LeonaBio website under "Events & Presentations" in the "Investor Relations" section here.

Brelgometon (ATH-1105) – A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. Brelgometon is currently in clinical development for the potential treatment of ALS.

LeonaBio’s first-in-human Phase 1 double-blind, placebo-controlled clinical trial (NCT06432647) enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of brelgometon, demonstrating a favorable safety and tolerability profile as well as dose-proportional pharmacokinetics and CNS penetration and supporting its advancement into a Phase 2 proof-of-concept trial.
The Company expects to provide an update on the timing of a proposed Phase 2 proof-of-concept clinical trial following completion of enrollment of the Phase 3 ELAINE-3 clinical trial as it continues to focus on its lasofoxifene program.

Corporate Updates

LeonaBio announced the appointment of Fred Callori, J.D., Natalie Holles and Peter B. Silverman, J.D. to its Board of Directors, effective as of May 5, 2026. The company also announced that John Fluke, Jr., who served on the Board since 2014, retired effective May 4, 2026.

Fred Callori, J.D., has served as a Partner and Managing Director at Perceptive Advisors LLC, an investment firm that specializes in investing in biotechnology stocks, since January 2018.
Natalie Holles has served as the Chief Executive Officer and member of the Board of Directors of Aura Biosciences, a clinical-stage biotechnology company, since April 2026. Ms. Holles served as the Chief Executive Officer of Third Harmonic Bio, a biopharmaceutical company, from August 2021 to December 2025.
Peter B. Silverman, J.D., served as Chief Operating Officer of Merus N.V. (formerly, Nasdaq: MRUS), a biotechnology company, from January 2023 until its acquisition by Genmab A/S in December 2025, and prior to that, Mr. Silverman held several leadership roles at Merus. Mr. Silverman has served as a member of the board of directors of Kinaset Therapeutics, a biopharmaceutical company, since January 2026.

Financial Results

Cash Position. Cash, cash equivalents and investments were $51.1 million as of June 30, 2026, compared to $88.3 million as of December 31, 2025. Net cash used in operations was $37.9 million for the quarter ended June 30, 2026, compared to $21.7 million for the quarter ended June 30, 2025. In conjunction with the December 2025 Sermonix license agreement, LeonaBio announced a $90 million private placement financing of common stock and warrants, with the Series A warrants providing, if exercised in full, up to an additional $146 million to support development through key clinical and regulatory milestones.
Research and Development (R&D) Expenses. R&D expenses were $12.9 million for the quarter ended June 30, 2026, compared to $3.7 million for the quarter ended June 30, 2025. The increase was driven primarily by clinical trial spend related to the ELAINE-3 trial for lasofoxifene.
General and Administrative (G&A) Expenses. G&A expenses were $6.6 million for the quarter ended June 30, 2026, compared to $3.6 million for the quarter ended June 30, 2025. The increase was driven primarily by personnel-related expenses, including stock-based compensation and professional service fees.
Net Loss. Net loss was $19.0 million, or $0.80 per share, for the quarter ended June 30, 2026, compared to a net loss of $7.0 million, or $1.78 per share, for the quarter ended June 30, 2025.

(Press release, LeonaBio, AUG 14, 2026, View Source [SID1234670145])

TuHURA Biosciences Reports Second Quarter 2026 Financial Results and Provides a Corporate Update

On August 14, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported financial results for the Company’s second quarter ended June 30, 2026, and provided a corporate update.

"We have made significant progress in advancing all our programs forward and are positioned to continue driving towards several anticipated milestones targeted for the second half of the year," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "In the second half, we anticipate receiving safe-to-proceed feedback from FDA and to initiating our Phase 1b/2 trial of VISTA in mutNPM1 r/r AML, initiating our in vivo POC studies for MDSC Inhibitors (Bi-specific antibody drug conjugates (ADCs)), potentially receiving orphan drug designation in Merkel cell carcinoma (MCC) for IFx-2.0, and potentially receiving orphan drug designation in AML for TBS-2025. The recent $50 million term credit facility made available to us by our largest shareholder provides us a non-convertible source of operating capital with adequate runway for us to achieve our strategic objectives and execute on our goals."

Second Quarter and Recent Corporate Highlights:

Filed Investigational New Drug (IND) Application for Evaluation of the TBS-2025 VISTA Inhibiting Antibody in Molecularly Defined Subsets of AML and other Blood Related Cancers. The IND is aligned with guidance previously provided by the U.S. Food and Drug Administration (FDA) on the development pathway for both monotherapy and combination with menin inhibitors for Acute Myeloid Leukemia (AML). The FDA noted that the previously planned IND meeting would not be necessary and instead the FDA provided written responses to questions and information related to the Company’s proposed Phase 1b/2 development plan for TBS-2025 in AML.
In April 2026, the Company announced a $50 million credit facility and royalty transaction extending its anticipated cash runway into 2028. Under the terms of the loan agreement for the credit facility, TuHURA will have the ability to draw down on the facility on an as-needed basis to fund monthly expenses for ongoing clinical development and operations. The facility bears a 12% annual interest rate on outstanding funds drawn, with interest paid monthly and principal repayment due at a 5-year maturity date for April 21, 2031. The facility was provided by TuHURA’s largest shareholder.
Currently Anticipated Milestones by Program
IFx-2.0 (Innate Immune Agonist)

2H 2026: Expect to receive orphan drug designation in MCC
1H2027: Expect preliminary results from IR study IFX-2.0 with Keytruda for deep seated MCC
2H 2027: Expect to complete enrollment in the Phase 3 study of IFx-2.0
TBS-2025 (VISTA inhibiting mAb)

2H 2026: Expect to initiate Phase 1b/2 trial of VISTA in mutNPM1 r/r AML
2H 2026: Expect to receive orphan drug designation in AML
1H 2027: Expect preliminary safety and response data for VISTA in mutated NMP1 r/r AML
MDSC Inhibitors (Bi-specific ADCs)

2H 2026: Presentations at key scientific meetings
2H 2026: Initiation of ADC in vivo POC studies
Summary of Financial Results for the Second Quarter 2026
Cash and cash equivalents of $1.0 million at June 30, 2026. In April 2026 and July 2026, the Company received $0.3 million and $0.1 million, respectively, in gross proceeds under the ATM Program. Additionally, the Company has received $5.7 million in gross proceeds to date on the Parkview credit facility, which includes $2.15 million subsequent to June 30, 2026. TuHURA’s total common shares outstanding were approximately 63.7 million at June 30, 2026.

Research and development expenses were $6.6 million and $4.9 million for the 3 months ended June 30, 2026, and 2025, respectively. The increase of $1.7 million was related to an increase in clinical development activity the Company’s ongoing and planned clinical trials.

General and administrative (G&A) expenses were $2.1 million and $1.9 million for the 3 months ended June 30, 2026, and 2025, respectively. The increase of $0.3 million was primarily due to increases in non-cash stock compensation expense and costs associated with being a public company.

Net cash outflows from operating activities were ($13.0) million and ($10.9) million for the 6 months ended June 30, 2026, and 2025, respectively.

Net cash flows from financing activities were $10.6 million and $8.1 million for the 6 months ended June 30, 2026, and 2025, respectively.

(Press release, TuHURA Biosciences, AUG 14, 2026, View Source [SID1234670144])

Phanes Therapeutics Receives FDA Fast Track Designation for Spevatamig in Advanced and Metastatic Biliary Tract Carcinoma

On August 14, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology, reported that the U.S. Federal and Drug Administration (FDA) has granted Fast Track designation for spevatamig in advanced and metastatic biliary tract carcinoma. Spevatamig was also granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024, and orphan drug designation for metastatic pancreatic cancer in 2022. Recently, Phanes has expanded its clinical trial collaboration with Merck to study spevatamig in combination with pembrolizumab for the frontline (1L) treatment of BTC.

"Spevatamig has the potential to be a transformational treatment option for patients with BTC," said Ming Wang, PhD, MBA, CEO of Phanes. "Following the successful completion of enrollment in our Phase 2 clinical trial of spevatamig in combination with chemotherapy for the frontline treatment of metastatic pancreatic ductal adenocarcinoma, we are making significant progress in the Phase 2 study of the molecule in BTC."

Spevatamig is an I2E, an emerging class of IO agents. I2Es are expected to activate macrophages and dendritic cells to recognize and destroy cancer cells, providing a mechanism complementary to immune checkpoint inhibitors (ICIs) to leverage the immune system to attack tumors, especially "cold tumors" that are less likely to respond to ICIs.

ABOUT SPEVATAMIG

Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab.

Phanes is conducting clinical trials with spevatamig in multiple cancer indications, including a Phase 2 study evaluating the safety, tolerability and efficacy of spevatamig in combination with chemotherapy in patients with PDAC in the first-line setting. Spevatamig is an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. It has the potential to become the first I2E for a solid tumor indication and is combinable with various anti-cancer therapies.

(Press release, Phanes Therapeutics, AUG 14, 2026, View Source [SID1234670143])

Citius Oncology, Inc. Reports Fiscal Third Quarter 2026 Financial Results and Provides Business Update

On August 14, 2026 Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported financial results for the fiscal third quarter ended June 30, 2026, and provided a business update.

"Institutional demand (LYMPHIR vials ordered by prescribing centers from wholesalers) is accelerating. Institutional vial orders grew 31% sequentially, from 708 in the quarter ended March 31, 2026 to 926 in the quarter ended June 30, 2026. In July, institutions ordered 383 vials from wholesalers, the largest order month to date, reflecting a 25% increase over the prior quarter’s monthly average order. Currently, 44 institutions have prescribed and ordered LYMPHIR," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology.

"We expect continued institutional demand to drive new wholesaler orders. The Company recognizes revenue when wholesaler orders are fulfilled. Consequently, net revenue for any period reflects actual wholesaler orders fulfilled. In July, we began to see growth in institutional demand translate into increased wholesale orders and associated revenue. The positive trajectory of formulary approvals, institutional adoption, and unit demand gives us confidence in a robust remainder of the fiscal year," added Mazur.

"We generated initial momentum with a lean internal team, maintaining healthy product margins and securing broad market access. In August, our full 29-person-strong commercial and medical affairs organizations expanded to nationwide coverage. The teams are now positioned to accelerate commercial execution and support broader adoption by leveraging the comprehensive, scalable infrastructure already established for LYMPHIR, including patient hub services, marketing and reimbursement support. Citius Oncology is now well positioned to broaden engagement with treatment centers, targeting formulary inclusion at 100 priority institutions by year-end and first-in-class support for health care providers. At the same time, we continue to advance LYMPHIR’s longer-term value proposition through investigator-initiated studies exploring its potential in combination regimens beyond CTCL," added Mazur.

"Overall, the launch is moving in the right direction: more institutions are ordering LYMPHIR, vial demand is increasing, and our commercial footprint is expanding. We believe the underlying increasing demand trends provide a strong basis for the remainder of fiscal 2026," concluded Mazur.

Fiscal Third Quarter 2026 Business Highlights and Subsequent Developments

Secured prescriptions and orders from 44 institutions for LYMPHIR (denileukin diftitox-cxdl), including academic oncology centers, leading National Comprehensive Cancer Network (NCCN) institutions, and community infusion centers;
Increased the number of new ordering institutions by 80% in the quarter ended June 30, 2026, compared to the quarter ended March 31, 2026;
Grew the number of vials ordered by institutions from wholesalers by 31% in the quarter ended June 30, 2026, compared to the quarter ended March 31, 2026, with 383 institutional vials ordered in July 2026, the largest vial order month to date;
Secured near-universal payer coverage, with no reimbursement denials or prior authorization barriers reported to date;
Expanded the commercial organization by 21 additional field-based professionals and added eight medical science liaisons, executed by the Company’s exclusive commercialization partner, EVERSANA;
Engaged U.S. and international CTCL key opinion leaders at the Sixth World Congress of Cutaneous Lymphomas in Montreal through scientific exchange and educational initiatives;
Advanced two investigator-initiated Phase 1 studies of LYMPHIR in combination settings:
Phase 1 data for LYMPHIR with pembrolizumab in recurrent or refractory gynecologic cancers presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating:
20.5 months of median progression-free survival among 48% of efficacy-evaluable patients achieving clinical benefit (10 of 21),
Responses observed in patients previously treated with immune checkpoint inhibitors, including a 24% objective response rate (ORR) overall, and 33% ORR in patients with relapsed or refractory endometrial cancer; and,
Phase 1 data for LYMPHIR administered prior to CAR-T therapy in high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL) presented at 2026 ASTCT & CIBMTR Tandem Meetings, demonstrating:
86% ORR, including 57% complete response (CR) and 29% partial response (PR),
LYMPHIR was well-tolerated with no dose-limiting toxicities observed; and,
Appointed Jonathan Peri, Ph.D., J.D., as an independent director on August 10, 2026, bringing three decades of leadership experience across law, financial services and corporate governance.
Fiscal Third Quarter 2026 Financial Highlights and Subsequent Developments

Cash and cash equivalents of $16.6 million as of June 30, 2026;
Received approximately $9.7 million in net proceeds from the exercise of certain warrants and funded $10.0 million under the first tranche of a senior secured term loan facility of up to $25.0 million;
Revenues of $1.5 million for the three months ended June 30, 2026, compared to no revenue for the three months ended June 30, 2025; and $7.1 million for the nine months ended June 30, 2026, compared to no revenue for the nine months ended June 30, 2025;
Gross profit of $1.0 million for the three months ended June 30, 2026, and $5.5 million for the nine months ended June 30, 2026;
Research and development (R&D) expenses of $0.2 million for the three months ended June 30, 2026, compared to $0.9 million for the prior-year quarter; and $2.3 million for the nine months ended June 30, 2026, compared to $5.3 million for the prior-year period;
General and administrative (G&A) expenses of $4.2 million for the three months ended June 30, 2026, compared to $1.9 million for the prior-year quarter, reflecting the expansion of the commercial organization; nine-month G&A of $30.7 million included a $19.7 million one-time CMO contract cancellation charge recognized in the second fiscal quarter in connection with a notice of termination; and,
Net loss of $8.9 million, or $(0.08) per share, for the three months ended June 30, 2026, compared to $5.4 million, or $(0.08) per share, for the prior-year quarter; and $41.1 million, or $(0.42) per share, for the nine months ended June 30, 2026, compared to $19.8 million, or $(0.28) per share, for the prior-year period.
About LYMPHIR (denileukin diftitox-cxdl)
LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl has demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors. LYMPHIR was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Oncology, AUG 14, 2026, View Source [SID1234670142])

Aptevo Provides 2Q26 Business Update and Reports Second Quarter Financial Results

On August 14, 2026 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported financial results for the quarter ended June 30, 2026 and provided a business update highlighting strong clinical progress for mipletamig, strengthened scientific leadership, non-dilutive funding to advance its solid tumor trispecific pipeline and expansion into radiopharmaceutical therapeutic development through a 50/50 collaboration with Niowave.

"During the second quarter, we made important progress against the programs and initiatives we believe can create near- and long-term value for Aptevo," said Jeff Lamothe, President and Chief Executive Officer of Aptevo. "Mipletamig continues to lead our value creation strategy, with RAINIER generating compelling frontline acute myeloid leukemia data and moving toward completion of dose optimization by year end and Phase 2 regulatory interaction early in 2027. We also strengthened our scientific leadership, secured non-dilutive funding to advance trispecific candidate APVO451, and entered a 50/50 collaboration with Niowave that gives us a cost-effective path into radiopharmaceutical therapeutics and access to isotope supply in a constrained market. Together, these achievements put us in a stronger position to advance our pipeline and pursue multiple opportunities to create shareholder value."

Mipletamig Drives Clinical Momentum with Strong Frontline AML Data and a Path Toward Phase 2

Mipletamig remained Aptevo’s most advanced and central value driver during the quarter, with updated Phase 1b/2 RAINIER trial data continuing to show strong clinical activity in frontline acute myeloid leukemia (AML) when combined with venetoclax and azacitidine. Across 31 evaluable unfit frontline AML patients (through Cohort 5 plus four frontline patients from the completed dose expansion trial), mipletamig demonstrated an 87% clinical benefit rate and an 81% remission rate, supporting its potential to improve standard-of-care outcomes for a patient population with significant unmet need. Safety data observed to date demonstrate mipletamig’s combinability, safety and tolerability in combination with standard-of-care therapy. RAINIER has entered the final stage of dose optimization, positioning Aptevo to complete the Phase 1b RAINIER trial and select the recommended Phase 2 dose this year in anticipation of a Phase 2 regulatory interaction in 1Q27.

Additional Outcomes of Note

55% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level (MRD neg), a result that is typically associated with stronger, more durable responses

36% 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

6 patients treated to date have proceeded to allogeneic stem cell transplant, which represents the best possible outcome in AML treatment and is rarely achieved in the older or unfit frontline patient population

Mipletamig was designed for the way frontline AML is treated: as an added therapeutic component to standard-of-care venetoclax and azacitidine, with the goal of increasing efficacy without materially increasing toxicity burden. Its profile is supported by clinical experience across more than 120 treated patients, no cytokine release syndrome reported in frontline patients through Cohort 5 of the RAINIER trial, activity in a medically unfit frontline population and six patients bridged to transplant, the best possible outcome in the AML treatment landscape. Importantly, mipletamig is not limited to a single genetic alteration or narrow biomarker-defined subgroup, giving it potential applicability across a broader frontline AML population where tolerability, combinability and ease of integration with venetoclax and azacitidine are central to treatment decisions.

Chief Scientific Officer Appointment Strengthens Execution Across an Advancing Oncology Pipeline

Aptevo appointed Mary J. Janatpour, Ph.D., as Senior Vice President and Chief Scientific Officer, adding more than 25 years of oncology research and development leadership to support the Company’s clinical priorities, preclinical strategy and next generation multispecific pipeline. Dr. Janatpour will lead research and preclinical development and play a key role in advancing Aptevo’s expanding portfolio, including its radiopharmaceutical collaboration and trispecific solid tumor programs. Dr. Janatpour has held senior scientific leadership roles across both large biopharmaceutical organizations and emerging biotechnology companies, giving her a rare combination of deep oncology research expertise and hands-on experience building innovative programs in fast-moving development environments.

Non-Dilutive Grant Funding Advances APVO451 and Validates Trispecific Solid Tumor Strategy

Aptevo secured a $1.5 million non-dilutive research grant from the Andy Hill Cancer Research Endowment (CARE) Fund to support investigational new drug (IND)-enabling work for APVO451, a nectin-4-targeted trispecific immunotherapy candidate for solid tumors. The competitive, merit-reviewed award provides meaningful third-party validation for APVO451’s tumor-directed trispecific design and underscores Aptevo’s ability to advance innovative oncology programs through capital-efficient funding strategies. Together, the grant and planned development timeline position APVO451 as an emerging pipeline value driver, with development candidate selection targeted by year-end 2026 and IND-enabling studies planned for the first quarter of 2027.

$1.5 million non-dilutive award to support APVO451 IND-enabling work

Competitive, merit-reviewed grant provides third-party validation for APVO451’s tumor-directed trispecific approach

Development candidate selection targeted by year-end 2026, with IND-enabling studies planned for the first quarter of 2027

Strategic Niowave Collaboration Opens a New Radiopharmaceutical Development Opportunity

Aptevo expanded its development strategy through a 50/50 collaboration with Niowave to develop up to three radiopharmaceutical oncology programs. With radiopharmaceutical therapeutics emerging as one of oncology’s hottest investment areas, the collaboration gives Aptevo a capital-efficient way to enter a field attracting substantial big pharma interest while leveraging its own tumor-targeting expertise. The structure gives Aptevo a cost-efficient path into radiopharmaceutical therapeutics by sharing development costs, while pairing Aptevo’s tumor-targeting expertise with Niowave’s radioisotope production and supply capabilities. Importantly, the collaboration also provides access to isotope supply in a constrained market. Niowave also made an at-the-market equity investment in Aptevo at closing, creating additional alignment between the companies.

50/50 collaboration to develop up to three radiopharmaceutical oncology programs

Strategic equity investment by Niowave at closing, representing an initial 7.9% ownership position, with the potential to build up to 19.99%

Opportunity to extend Aptevo’s tumor-targeting approach into radiopharmaceutical therapeutics for difficult-to-treat cancers

Q2 2026 Financial Position

Aptevo had cash and cash equivalents totaling $9.8 million as of June 30, 2026. During the second quarter of 2026, the company raised $0.6 million under the company’s Standby Equity Purchase Agreements (SEPAs) with Yorkville. For additional APVO financial information and complete access to the company’s filings.

(Press release, Aptevo Therapeutics, AUG 14, 2026, View Source [SID1234670141])